Chemicals in politics and
everyday life
EU’s chemicals regulation REACH, endocrine disrupting
chemicals, nanomaterials and cocktail effects
Chemicals in politics and everyday life
EU's chemicals regulation REACH, endocrine disrupting chemicals,
nanomaterials and cocktail effects
The Danish Ecological Council
May 2014
Contents
Preface
Introduction to chemicals in society
1 EU and REACH
How is the EU structured?
4
5
47
Brominated flame retardants
54
3 Chemicals in everyday life
Chemicals in food 58
50
7
8
How can the EU be influenced?
10
Chemicals legislation in the EU
12
Risk assessment
57
60
15
Chemicals in clothing and textiles
The horror show – are we hormonal ticking
Limit values
16
time bombs? 64
How large concentrations can humans tolerate?
17
REACH –Step-by-step
19
Registration
19
4 Cocktail effects and Nanomaterials
Cocktail effects
68
Evaluation
19
Nanomaterials
72
Autorisation
20
"Right to know”
22
5 Hazardous chemicals can be replaced 77
Classification and labelling
25
Legislation deficiencies
27
Substitution of hazardous chemicals
What is a substitution and why do it?
78
78
2 Endocrine disrupting substances
29
Warning lists and substitution
Substitution portals and networks
Intro. to endocrine disrupting substances
30
Consumer role
79
Parabenes
34
Phthalates 39
Glossary
81
Phthalates in hospitals 44
Chemicals in politics and everyday life –
EU’s chemicals regulation REACH, endocrine disrupting
chemicals, nanomaterials and cocktail effects
1. edition, May 2014
ISBN: 978-87-92044-43-3
Text by: Lone Mikkelsen – The Danish Ecological Council
(unless otherwise stated)
Translation by: Karen Bahn Kristensen, Maria Lund Jensen
Design and layout: Birgitte Fjord | Grafisk design
Front page photo: wragg
Ph o to R T i ma g es
Bisphenol A
Fluorinated substances – PFOA/PFOS
This publication can be downloaded free of charge from the
Danish Ecological Council’s website: www.ecocouncil.dk
Quoting, copying and other use of the content of this
publication is permitted and encouraged as long as credit is
given to its source.
Published by: The Danish Ecological Council – with funding
from the Villum Foundation
The Danish Ecological Council
Blegdamsvej 4B
DK-2200 Copenhagen N
Tel. +45 3315 0977
email: info@ecocouncil.dk
web: www.ecocouncil.dk
67
78
79
PREFACE
4
Preface
In this teaching material, we discuss the problems
relating to the so-called endocrine disrupting substances, cumulative effects of chemicals – often referred to
as cocktail effects – as well as nanomaterials. These
different types of chemicals are present in a large
number of products that surround us in our everyday
lives and are an important part of our modern lifestyle.
Many of the products containing these chemicals have
made our lives easier or smarter, but far too many of
these substances have not yet been sufficiently studied
for potential harmful effects on human health, animals,
and the environment. Experts suspect endocrine
disrupting substances of affecting a large number of
processes in our body, for instance, the age where
children/young people reach puberty and, later, their
ability to have children. In addition, the substances are
under suspicion of causing cancer and genital abnormalities. Recently, these substances have also come
under suspicion of having an impact on obesity and
development of diabetes, the latter gradually becoming
one of the major lifestyle diseases. Nanomaterials have
also been in focus for a long time. Not only due to their
extremely modest size, but also in particular due to the
fact that, in line with endocrine disrupting substances,
they are under suspicion of harming human health and
the environment.
Many substances are already regulated by the common European chemicals legislation, REACH. However,
many of the permitted chemicals on the market are still
suspected of having endocrine disrupting effects and of
contributing to cocktail effects. It is the producer’s and/
or industry’s responsibility to prove that the substance
produced or used in their products is not hazardous for
consumers. However, since there are still no criteria for
how to establish whether a chemical is an endocrine
disruptor these substances will slip through the safety
net of legislation. To secure consumers against any
health hazard it is important that these substances are
better regulated. Therefore, it is necessary to increase
focus on chemicals altogether.
In this electronic publication, we explain the structure of the European Union (EU) and how legislation
adopted at EU level is implemented and enforced at
national level. In addition, we discuss the contents of
the common European chemicals legislation in general.
Subsequently, the most important groups of endocrine
disrupting substances are described with a review of
how we are exposed to these substances every day
and what impact this might have for our health and the
environment. Furthermore, cocktail effects and nanomaterials are described. Each of these sections include
examples of what each of us can do in our everyday
lives to reduce the risk of being exposed to hazardous
chemicals.
The contents of this electronic publication may be
rather complicated and contain difficult terms, so at the
end of the text you can find a glossary with explanations. When terms included in the glossary appear in
the text, they are marked in italics. However, they are
not marked in those sections dealing with the specific
term and in places where we find that detailed explanations are superfluous. In addition, some terms appear so
often that any marking would disturb the reading (e.g.
terms like “chemical” and “the EU”).
This electronic publication is produced with the aim of
being used within several different subjects and teaching courses, as well as in interdisciplinary projects. You
may use it from beginning to end or select sections
applicable to specific teaching subjects. Each section is
written so it can stand alone, but refers to supporting
sections if specific passages need further explanation.
We wish you a pleasant reading!
INTRODUCTION
5
Introduction to chemicals in society
Chemicals are present everywhere in our society
and they come as both natural and industrial substances. At all times, humans and the environment have
been exposed to chemicals. Whether they are natural
or man-made has nothing to do with their potential
harmful effects on human health and the environment.
Incorrectly, many believe that if a substance is natural,
it has no harmful effect. Regrettably, this is not the case!
There are many examples of naturally occurring chemicals being harmful. To give just one example, think
about natural aromatics (fragrances). There are no less
than 2,500 fragrances, which are combined endlessly in
the manufacture of perfumes, personal care products,
cleaning agents, etc. A perfume may easily consist of up
to 300 different fragrances. Of these 2,500 fragrances
at least 100 are suspected of being allergenic, while 26
have been proven to be so. When a substance has been
proven to be allergenic it must be mentioned by name
in the informative label of the product. This means that
if it says ‘perfume’ followed by a name, you know that
the product contains a fragrance known to be allergenic.
Furthermore, cosmetics often contain preservatives to
ensure longevity of the products. There is an ongoing
discussion whether the use of preservatives for, in particular, skin care products such as body lotion is really
necessary. Lotions in pots, for instance, are problematic.
When our fingers – more or less contaminated with bacteria – daily are in direct contact with the entire content
there is a major need for preservation with antibacterial
agents to prevent the lotion from developing mildew.
However, using closed packages such as tubes can
largely solve this problem.
It is a fact that we cannot avoid chemicals in our
everyday lives, since many of them occur naturally;
however, we can control to what extent we are exposed
to them, by avoiding those that are really not necessary.
Still today, the harmful consequences these chemicals
have for humans and the environment are not fully
known. This fact alone should be sufficient for acting
according to the precautionary principle. Using the
precautionary principle means that chemicals may only
be used when it is necessary for social and/or economic
reasons 1. An example of a social argument for using a
certain chemical substance that is harmful to our health
is a vaccine, which due to heat, only can be preserved in
tropical climates if mercury is used as a preservative. In
this case, it is more important for an infant to have the
vaccine – which may mean survival – than to protect it
against a minor quantity of mercury. For such considerations, however, specific analyses must be made before
making a final decision. In our part of the world we can
most often do without hazardous substances (or at least
use less hazardous alternatives).
Every day we are in contact with a range of products
without knowing whether they are full of hazardous chemicals such as endocrine disrupting substances and/or allergenic and carcinogenic compounds.
Moreover, our knowledge about most of the chemicals
that we use today is extremely limited. As consumers,
we should feel sure that there are no substances of high
concern in the products we use every day, whether
they are manufactured in the European Union (EU) or
imported from other countries. Quite simply, it is not
acceptable that hazardous substances are allowed in
products when alternatives that are less harmful to
human health and the environment are available.
Chemicals are a natural part of the material wealth
and comfort we live with today and many of us would
rather not be without them; but they have also created
enormous health and environmental problems. Today,
a number of manufactured chemicals have been spread
all over the world and are found in water, air, and soil.
It has been proven that these chemicals – even in very
small quantities – can affect eco-systems and animals,
leading to problems such as accumulation of pollutants
in polar bears and whales with ensuing health impacts.
Furthermore, hermaphroditic fish and snails have been
found, among other places, in Denmark and herma-
phroditic alligators have been found in the US, suspected to be caused by an increasing exposure to man made
(hormone disrupting) chemicals.
1 A socio-economic analysis is a well established method for balancing pros and cons of an action for society as a whole.
INTRODUCTION
Many scientific surveys have shown that girls today
reach puberty earlier 2 and in Denmark an increasing
number of boys are born without descended testicles
(cryptorchidism) or with a penis malformation with an
abnormal ventral opening of the urethra (hypospadias)3.
In addition, Denmark shares the world record with
Norway when it comes to the number of people with
testicular cancer (see Figure 1). An increasing number
of researchers confirm that these health impacts are
caused, entirely or partly, by exposure to endocrine
disrupting substances.
In 2004, the WWF (World Wildlife Fund) conducted a
well-known survey in which blood samples from the
ministers of the environment and health from 13 EU
countries were tested. The blood samples were screened
for a range of industrial (manufactured) chemicals
that may have a negative impact on health and the
environment and are present, among others, in ordinary
consumer goods such as electronics, carpets, furniture,
pizza boxes, and packages for microwave popcorn. On
Figure 1 Denmark and testicular cancer
The graph shows that Denmark is the EU country with the
largest rate of testicular cancer incidences. The columns
show how many have been diagnosed with testicular
cancer. The lowest axis shows the number of persons per
6
average, 37 chemicals per person were found among the
103 persons tested. In the blood of the former Danish
Minister for the Environment (Hans Christian Schmidt)
36 chemicals were found. Of the substances found,
some were banned several decades ago, but many
of them are still in use or present as pollutants in the
surrounding environment presenting a threat against
our health and nature. Many of the chemicals found
in the ministers’ blood are persistent, bio accumulative and toxic (poisonous) – called PBT substances.
In addition, many of them can disturb the endocrine
system of animals and humans. The problem relating to
PBT substances is their persistency in our environment,
even after production and consumption has stopped.
PBTs cannot degrade or only do so very slowly; in
addition, large quantities accumulate in the fatty tissue
of animals and humans, as they are liposoluble. An
example is polychlorinated biphenyls (PCBs), which are
a group of industrial chemicals developed in the 1920s.
They were in particular used in the electronics industry
due to their insulating properties and low flammability.
Later it was discovered that these
substances might lead to, among other
things, brain damage and today they
are banned almost all over the world.
Sweden was one of the countries that
adopted a ban already back in 1972.
It is assessed that some 2 million
tonnes of PCB has been produced.
Some of this PCB has been incinerated
or landfilled. However, a large part is
still present in our surroundings, for
instance, in buildings and electronics.
The rest has been discharged into the
oceans and has entered nature’s cycle.
The result is that animals and humans
will be exposed to these substances in
generations to come. PBTs are found
in seals and polar bears in the Arctic,
an area where the substances never
were used but have been transported
by water and air. To avoid similar problems in the future
it is crucial that the chemicals legislation becomes
stricter! We have to regulate the chemicals before they
enter the market.
100,000. Source: http://info.cancerresearchuk.org/cancerstats/types/testis/incidence/uk-testicular-cancer-incidencestatistics. (2008).
2 Danish Environmental Protection Agency. ”Langtidseffekter af prænatal pesticideksponering” (Long-term effects of prenatal exposure to pesticides):
http://www2.mst.dk/Udgiv/publikationer/2012/06/978-87-92779-71-7.pdf
3 Gabel, P. et al. 2011. The risk of cryptorchidism among sons of women working in horticulture in Denmark: a cohort study. Environmental Health: A Global Access Science
Source, 10: 100
P ho t o P i et ro N aj - Ol ea ri
1
EU and REACH
EU AND REACH > HOW IS THE EU STRUCTURED?
8
How is the EU structured?
Since 1973, Denmark has been a member of the
European Union (EU). Consequently, many aspects of
our everyday life are subject to a number of common
laws and regulations that are enacted and managed
at EU level. It affects such different aspects as what
you eat, what you wear, how large CO2 emissions our
countries may have, and in which parts of the oceans
fishermen may catch fish.
The EU primarily legislates in fields where problems are
best solved in union. When it comes to chemicals, for
instance, it is evident that all countries wish to protect
their citizens against harmful chemicals. However, it
would be much more expensive if each country has its
own set of rules for which substances may be present
in different consumer goods such as toys, electrical
appliances, and cosmetics. In addition, each country
alone would not have the capacity to regulate the many
thousands of substances and products that are produced
and imported from all over the world. Common rules
mean that companies may benefit from producing their
goods in much larger quantities and that more companies compete. At the same time, countries together are
in a better position to adopt common rules, request risk
assessments of the multitude of substances, and assess
all the data to be submitted by the producers. In order
to regulate all these different fields the EU institutions
adopt rules that must be followed in the member states
according to a set of guidelines depending on the type
of ‘act’ to be introduced. These new acts or rules come
in the form of regulations, directives, decisions, recommendations, and opinions. The difference among them
is primarily the way in which they are handled in the
member states.
• A regulation applies directly all over the EU. This
means that it is binding in all details and applies to all
member states as soon as it has been adopted.
• A directive is binding for each member state
regarding the objective – such as a ban on a chemical
substance – but the national authorities can implement it in their national legislation as they see fit.
• A decision is binding in all details. When it is stated
to whom it is directed it is only binding to those
mentioned.
• Recommendations and opinions are not binding.
The EU has 28 member states. The newest member is Croatia, which joined in
the summer of 2013. EU institutions are
primarily located in Brussels in Belgium, but
Luxembourg City and Strasbourg also have
important EU institutions.
EU AND REACH > HOW IS THE EU STRUCTURED?
9
Figure 2 The European Union
European Commission
Has the right of legislative initiative
European Parliament
Council of the European
Organized in 8 political groups.
Union
Adopts or rejects legislative pro-
Shares legislative and
posals together with the Council
budgetary powers equally
through the co-decision procedure
with the Parliament
European Court of Justice
Interprets EU law to make sure it is applied in
the same way in all EU countries
Structure of the European Union with its four key institutions; the European Commission, the European Parliament, the
Council of the European Union, and the European Court of Justice.
The most important institutions in the EU are the
European Commission, the European Parliament, the
Council of the European Union, and the Court of Justice
of the European Union, normally referred to as the
European Court of Justice (see Figure 2).
The European Commission consists of a political management with one commissioner from each member state
as well as officials. Each commissioner runs a department. The departments are known as DirectoratesGeneral (DGs). The Commission proposes acts and rules
for the entire EU so any country is treated fairly. In
addition, it is the responsibility of the Commission that
all member states comply with the common legislation.
If it finds that violations take place, it may bring a case
against a specific member state before the European
Court of Justice.
When the Commission has submitted a legislative proposal, it must be adopted in the European Parliament
and the Council of the European Union. Together, these
two institutions have the legislative power in the EU.
They cannot submit legislative proposal themselves,
but they adopt, amend, or reject the proposals of the
Commission.
You may say that the Parliament is the spokesperson
of the Europeans since it consists of directly elected
politicians. Denmark has 13 members of the European
Parliament, representing different political parties. By
contrast, the Council of the European Union consists of
a number of ministers with responsibility for a given
area, for instance the Council of Environment and the
European Council that consists of the Heads of State or
Government of the 28 member states.
To distribute influence and power as equally as possible
between the European institutions it is the role of the
Parliament to control the Commission. For instance,
the members of Parliament must approve a new
Commission when the member states have designated
new commissioners 4.
In view of creating dynamics in the EU, the Council is
presided over for a period of six months by each member state in turn. This is called the EU presidency. The
country holding the EU presidency has two main tasks:
1. To organise and chair the meetings in the different
configurations of the Council. For instance, the
Danish Minister for the Environment chairs meetings
in the Council of Environment when Denmark holds
the presidency. The presidency must always act in
a neutral and impartial manner.
2. To represent the Council towards other EU institutions, not least the European Parliament and the
European Commission. Here, the presidency is the
other member states’ spokesperson in negotiations
with the Parliament and the Commission.
4 The EU and the Danish Folketing (Parliament): http://www.eu-oplysningen.dk/upload/application/pdf/4fb582d3/EU%20og%20Folketinget_2010%20pdf.pdf
EU AND REACH > HOW CAN THE EU BE INFLUENCED?
10
How can the EU be influenced?
Many players seek to influence decisions in the EU.
These players may be a large private corporation, a company, a trade union, an environmental organisation,
or a local player such as a Danish regional council. The
environmental organisations, for instance, normally
seek to promote their own case, while large companies
and trade organisations often hire lobbyists. A lobbyist
is a person representing a specific interest towards
politicians and officials, seeking to influence legislative
work in the EU in the desired direction. Lobbyism takes
place in all stages of the EU decision-making process
and towards all parties. Many interest organisations,
companies, and regions and municipalities in Denmark
have staff members located in Brussels. They seek to
influence decision-makers in the EU institutions by
presenting their interests; and they gather knowledge
early in the decision-making process. This knowledge
is communicated back home to be used by the ‘mother
organisation/company’ in the Danish decision-making
process. Actually, lobbyists are an indispensable part
of the democratic law-making process in both Denmark
and the EU. Lobbyists inform politicians about possible
consequences of specific decisions and legislative proposals. This gives politicians a better decision-making
basis.
An estimated 15,000 lobbyists work in Brussels.
Around 60 % of the lobbyists represent private
industry and 21 % represent the public sector. The
remaining 19 % represent other organisations such
as trade unions, consumer and environmental groups
(including several NGOs 5), churches, and think tanks 6.
There is clearly an unequal distribution of interest
organisations. This is primarily due to the fact that
companies and industrial organisations have by far the
largest financial resources. Another reason is historical
facts. The EU is the continuation of what started as the
European Coal and Steel Community (ECSC) and it was
thus primarily an economic cooperation. This meant
that major specific interests were at stake for private
industry in particular when legislation was designed.
In the different member states, there is more or less
democratic influence on how votes are cast in the
EU. When Denmark votes for or against a proposal in
the Council it is done on the background of a thorough
decision-making process – the EU coordination process.
First, Government reaches an agreement and then
it makes sure not to have a majority in the Danish
Parliament against their view on the specific case. The
European Affairs Committee does this giving its mandate to Government on how to vote. In other countries,
the national parliament has far less influence on their
government’s policy in the EU. When a law has been
finally adopted at EU level, it must be implemented in
the different member states.
Lobbyism may influence votes in the
European Commission, the Parliament,
and the Council of the European Union.
5 Non-governmental Organisation (NGO); an organisation that is neither supported nor controlled by government
6 Source: EUropa på vej (EUrope on the road) by Mads Dagnis Jensen and Julie Hassing Nielsen
EU AND REACH > HOW CAN THE EU BE INFLUENCED?
11
The European Parliament has gained increasing
influence on the EU environmental policy up through
the years. The Parliament is the European institution
working with the largest degree of openness and
thus, the easiest institution to influence. In the Danish
debate, it has often appeared as if it is impossible to get
any influence on the EU decision-making processes.
However, the experience of, for instance, environmental organisations, is that it is equally difficult to influence EU decisions and the Danish Parliament. However,
it is a prerequisite that groups cooperate across borders.
There are some general trends in relation to the votes
in environmental issues among the different groups
of parties in the European Parliament; thereby it is
important how to plan lobbying. The green group in
the Parliament naturally gives high priority to environmental issues. In addition, the Social Democrat group
– the progressive alliance of socialists and democrats
– and other left-wing groups have some emphasis on
In the US, there are laws to control lobby activities,
while in the EU there is basically free scope for how
the different organisations choose to influence politics.
However, to secure a meaningful discussion about
how to set up the framework for lobbying at EU level
it is necessary to define a basic framework for the
interplay between EU institutions and lobbyists. In
this regard, the European Commission has drawn up a
basic guideline presented in the Green Paper 'European
Transparency Initiative’ 8, which was launched in 2006
and followed up in 2007:
environmental problems. The large conservative and
Christian democrats groups are normally more reluctant
and much more willing to focus on short-term financial
interests of industry. The liberal group is often positioned in-between while the right-wing groups have
the least environmental focus.
tention of the European institutions. In some cases,
the Community offers financial support in order
to ensure that views of certain interest groups are
effectively voiced at European level (e.g. consumer
interests, disabled citizens, environmental interests etc.).
3. At the same time, undue influence should not be
exerted on the European institutions through
improper lobbying.
4. When lobby groups seek to contribute to EU policy
development, it must be clear to the general public,
which input they provide to the European institutions. It must also be clear who they represent,
what their mission is and how they are funded.
5. Measures in the field of transparency must be
effective and proportionate.
Nature, environment, and consumer organisations in
the EU member states cooperate closely. Greenpeace
and the World Wildlife Fund (WWF) are genuine
international organisations and in addition, there are
umbrella organisations in which the different national
organisations cooperate. The largest umbrella organisation is European Environment Bureau (EEB) that operates broadly with working groups within, for instance,
chemicals policy, nanotechnology, and air pollution.
There are also more specialised umbrella organisations
such as Pesticide Action Network (PAN-Europe) focusing on the reduction of pesticides. These organisations
have their offices in Brussels where they follow EU’s
work closely, and there is lively e-mail communication
between these offices and the associated organisations in all EU member states. The same is true for the
consumer organisations that have joined forces in the
umbrella organisation BEUC (The European Consumer
Organisation) in Brussels. Many parliamentarians 7 –
including many of the Danish ones – are very aware
that they are overwhelmed with arguments from
industry organisations (industry, agriculture, hauliers,
airlines, etc.) and are therefore open for arguments
from the green organisations to create a balanced basis
for decision-making.
1. Lobbying is a legitimate part of the democratic
system, regardless of whether it is carried out
by individual citizens or companies, civil society
organisations and other interest groups or firms
working on behalf of third parties (public affairs
professionals, think tanks and lawyers).
2. Lobbyists can help bring important issues to the at-
In an attempt to create more openness around decisionmaking processes and the role of lobbyists in the EU,
the European Commission introduced a voluntary
transparency register in June 2008. This is a first step,
but it is still not transparent who is walking around the
corridors. The problem of a voluntary scheme may be
that only ‘the good guys’ sign up. To be able to control
lobbyism to the benefit of all EU citizens it would be
extremely advantageous to know who the lobbyists are
and how many of them are around. A mandatory transparency register may be the solution to this problem. At
the same time, it would give decision-makers a chance
to know who they are dealing with and which interests
have been heard in a case.
7 Members of the European Parliament, who are democratically elected, are called parliamentarians.
8 http://ec.europa.eu/transparency/eti/index_en.htm#one; Green Paper 'European Transparency Initiative’, European Commission, May 2006
EU AND REACH > CHEMICALS LEGISLATION IN THE EU
12
Chemicals legislation in the EU
In December 2006, the EU adopted a new common
chemicals regulation: REACH. REACH came into effect
on 1 June 2007, replacing some 40 previous directives.
Since the adoption of REACH, chemical producers and
importers are responsible for acquiring information
about the properties of substances, including any
risk in their use, before they can be approved. Before
REACH took effect it was up to the authorities to
prove that a chemical was hazardous if they wanted it
removed from the market. The purpose of the regulation is to secure that the around 100,000 different
chemicals used in the EU are tested regarding safety for
humans and the environment and that they are used
safely. With REACH, it was established that the chemicals legislation in Europe is based on the precautionary
principle. Before that, all existing chemicals could
be used freely unless an authority had proven a risk
posed by a specific chemical product and subsequently
banned its use. Only for substances placed on the market after 1981 tests were automatically required. With
REACH, it is the industry that must prove that they
produce and use chemicals in a safe manner. REACH
covers individual substances (the chemical substance),
substances in chemical preparations, and substances
in articles (see definitions below). The regulation also
means that the use of particularly problematic substances (often called SVHC-substances; Substances of
Very High Concern) will in due time require a permit.
The most hazardous of these substances must be substituted (replaced) if suitable alternative substances or
technologies are available.
In connection with the implementation of REACH, the
European Chemicals Agency (ECHA) was established.
ECHA plays a key role in the general process relating
to guidelines for the use of chemicals. ECHA is located
in Helsinki, Finland and is the institution that receives
registration of existing chemicals. All registrations are
scrutinised and selected substances are then assessed
by the authorities of the EU member states who can
either approve or set limits for chemicals that they
find will pose a health risk to consumers. This is done
to secure coherent legislation all over the EU. Each
member state may in periods draw up special national
rules. For instance, Denmark has done this with the
ban on Bisphenol A in baby’s bottles, using the precautionary principle (see section ’BISPHENOL A’). When
REACH – a brief introduction
• REACH is the extensive EU chemicals regulation and is short for: Registration, Evaluation,
Authorisation of CHemicals.
• The aim of REACH is to secure a high level of
protection of human health and the environment
and to increase competitiveness and innovation in
companies.
• After the introduction of REACH the responsibility for acquiring information about the substances’ properties and the risks associated with
their use in connection with permitting is vested
with the chemicals producers and importers.
Definitions – chemical substances,
products, mixtures and articles
Chemicals is a general term for chemical substances and mixtures of these .
A chemical substance is a chemical element and
its compounds in the natural state or obtained by
any manufacturing process, including any additive
necessary to preserve its stability and any impurity
deriving from the process used, but excluding any
solvent, which may be separated without affecting
the stability of the substance or changing its
composition.
A chemical product/mixture is a mixture or
solution composed of two or more substances. A
chemical product can be solid, liquid or gaseous.
An article is an object which during production is
given a special shape, surface or design which determines its function to a greater degree than does its
chemical composition.
EU AND REACH > CHEMICALS LEGISLATION IN THE EU
13
Figure 3 REACH timeline
Deadline of registration :
Substances > 1 ton/year
Deadline of registration:
Deadline of registration:
Substances > 100 tonnes/year
Substances > 1000 tonnes/year
R50/R53 substances > 100 tonnes/year
CMR substances category 1 and 2 > 1 ton/year
Public announcement of
pre-registered substances by
ECHA. Start of registration
Pre-registration
REACH enters
into force
1/6 2007
1/6-30/11 2008
1/1 2009
1/12 2010
1 /6 2013
1/6 2018
Time line of full implementation of REACH. Even though
find suitable alternatives to those chemicals that will be
this chemicals regulation came into effect already back in
banned with REACH, and that retailers must have time to
2007 it is seen here that it will not be fully implemented
replace parts of their assortment. R50/R53 substances:
until 2018. This is due, among other causes, to the fact
classified as harmful to the environment.
that producers and companies must have a chance to
an EU member state uses this rule the specific case is
discussed at EU level and subsequently the rule will
apply all over the EU or the country in question will
be told to withdraw the ban in order to have identical
rules for all EU member states. If not complied with,
the country in question may be brought before the
European Court of Justice for breach of the Treaty. If a
country has been found guilty of infringement of the
Treaty, it may be sentenced with a fine if it continues to
disobey the same rules.
Before REACH came into force a time line was made for
its full implementation (see Figure 3), as many years
will be needed to register, evaluate, and authorise
the around 100,000 chemical substances that are
believed to be on the market in the EU 9. The time line
has been designed in a way that registration prioritises
the most health-hazardous substances, the so-called
CMR substances 10 together with environmentally
hazardous substances, and substances produced in the
largest quantities (> 1,000 tonnes/year). Then there
is a registration deadline for substances produced in
quantities over 100 tonnes/year and finally registration must be made of substances with a production
of more than 1 tonne/year. All quantity limits apply
to a single company’s production or import of a given
substance into the EU.
It is a key objective of REACH to promote substitution
(replacement) of particularly hazardous chemicals with
safer alternatives – so far, however, this has only been
the case for very few substances. However, just the
mere existence of the REACH authorisation process
sends a clear message to companies to the effect that
they should go through all the chemicals they are using
and start replacing hazardous substances with safer
alternatives. The intention is that this legislation will
promote innovation and lead to safer processes and the
use of alternative techniques. Whether this intention
9 The European INventory of Existing Commercial chemical Substances (EINECS): http://esis.jrc.ec.europa.eu/index.php?PGM=ein
10 CMR means Carcinogenic (causes cancer), Mutagenic (changes genes) and Reprotoxic (harms reproduction), applies to production > 1 tonne/year/producer..
EU AND REACH > CHEMICALS LEGISLATION IN THE EU
comes true will be seen in the coming years’ administration of the regulation. If substitution of the mentioned substances is not possible for technical reasons
(e.g. there is no suitable substance on the market that
can replace the hazardous one) or if it is estimated that
the alternative substance is too expensive, substances
will only be permitted when the socio-economic benefits exceed the risks. This means that the social and
economic benefits compared with human health should
be larger than the risk associated with the use of the
chemical. To give an example, it could be chemicals
used for treatment of water in developing countries here it is more important that people get clean water
than to protect them against a small amount of chemicals, even if the substances used may be suspected of
being endocrine disrupting or carcinogenic.
Some substances are exempt from registration under
REACH. For instance, pesticides and biocides (regulated under Statutory Order on plant protection products),
substances used in medicinal products for human and
veterinary use and substances used in food or feeding
stuffs. In addition, cosmetics are not covered by the
REACH scope. Earlier cosmetics were regulated under
the special cosmetics directive, which was implemented in Danish law in the form of the Statutory Order on
cosmetics. In June 2013, this changed to a regulation on
cosmetic products. However, all cosmetic products must
be registered under REACH, but the chemical safety
report is not required to cover evaluations of risks for
human health.
The above clearly shows how many exemptions are contained in REACH – and these are just a few examples.
Before describing the regulation in detail below
(”REACH – Step by step”) we should be familiar with
a few terms. For instance, that a distinction is made
between an article and a product – and that different
rules apply to them 11.
•
•
A chemical substance is a chemical element
and its compounds in the natural state or obtained
by any manufacturing process. In technical and
legal terms a chemical substance is defined as ‘the
substance as it occurs or as it is manufactured’.
A chemical product/mixture is a uniform
mixture or solution composed of two or more
substances. A chemical product may be solid, liquid,
or gaseous. Paints and detergents are examples of
chemical products.
11 Website of the Danish Environmental Protection Agency: www.mst.dk
14
•
An article is an object, which during production is
given a special shape, surface or design, which determines its function to a greater degree than does
its chemical composition. Examples of articles are
cars, textiles, batteries, wallpaper, and electronic
equipment.
When we use the word ‘chemicals’ in this text it covers
both chemicals and mixtures of chemicals. It is often
seen that only the terms ‘chemicals’ and ‘articles’ are
used, but you should be aware of the statutory differences, where a distinction is made between the four
terms described above.
EU AND REACH > RISK ASSESSMENT
15
Risk assessment
When you wish to examine whether chemicals
have hazardous effects on human health and the
environment, you make a so-called risk assessment.
However, making risk assessments is not a walk in the
park. You must be familiar with many factors in order
for it to become a satisfactory analysis and in addition,
you often make separate assessments for humans (human risk assessment) and the environment (ecotoxicological risk assessment). The human risk assessment
is generally the least complicated and in many cases
the most precise, since only one species – man – is
being studied. In the ecotoxicological risk assessment
it is the impact on the environment in general that is
assessed and this includes obviously thousands of
species. The purpose of a risk assessment is to gather
all existing knowledge into a uniform presentation in
order for decisions on regulation, if any, to be made in a
consequent and clear manner where all scientific data
is taken into consideration.
seek to describe all possible ways in which people and
the environment may be exposed to a substance. The
process is extremely time consuming and this is one of
the reasons why regulating chemicals is a very slow
process. Therefore, environmental groups and trade
unions often request that substances must be regulated based on the hazardous properties and not wait
for a risk assessment.
The risk assessment is an important requirement in EU
legislation in connection with control of production,
use, and discharge of chemicals. The statutory risk
assessment is very comprehensive. It is described in
”The Technical Guidance Document” (TGD) 12, where
the primary objective is to look at possible effects
from individual chemicals on human health and the
environment. The risk assessment is a prerequisite for
environmental and health effects of a given substance
to be implemented and regulated in specific legislation.
Normally, extensive scientific work and documentation will be available to be used by an authority - such
as the Danish Working Environment Authority - for
making a risk assessment. An example of such may be
researchers having studied how lead affects human
health. They may for instance have made tests, for
carcinogenic effects, effects on the cardiovascular
system, teratogenic effects, behavioural effects, and
allergenic effects. The results from all these tests are
then studied in order to end up with a risk assessment
with the broadest possible coverage.
The disadvantage of a risk assessment is that the
procedure becomes very comprehensive – because you
12 http://ihcp.jrc.ec.europa.eu/our_activities/public-health/risk_assessment_of_Biocides/doc/tgd
EU AND REACH > LIMIT VALUES
16
Limit values
A limit value of a substance determines how large a
quantity of the substance may be present, for instance,
in food or in soil. Limit values reflect how much experts
believe we can ingest every day thoughout life without
having an increased risk of diseases etc. Therefore,
minor exceedances of the limit value for short periods
of time have no health effects.
When setting a limit value for chemicals contents
in food, experts must first find out how much of the
substance a person can tolerate. Then they must know
how much we typically eat of different foodstuffs.
Against this background, a limit value is set of how
large a quantity of the substance may be found in each
foodstuff.
have been exposed to endocrine disrupting substances
for a long period or in particularly sensitive periods of
our life, for instance at the embryonic stage.
There is no guarantee that the assessment of the
health effects of a substance will not change. Limit
values may change if new knowledge shows that this is
called for. For instance, new research results may show
novel properties of the substance.
Despite much research in endocrine disrupting
substances, we know very little about these substances’ impact on human health in the quantities we
are exposed to in everyday life. The endocrine system
generally restores itself after short external impacts,
but we do not know whether this is also true when we
We know several examples where the development of
animals has been affected after prolonged contact with
endocrine disrupting substances. Fish and snails with
gender disorder have been found, and in several cases,
it has been substantiated that the disorders were due
to contamination with endocrine disrupting substances. In other cases, the cause has not been found. In
addition, it has been established through animal tests
that certain chemicals affect the hormonal balance of
animals and thus their normal gender development.
This indicates that it might be beneficial for human
health and the environment if we could work in the
direction of having limit values for different endocrine
disrupting substances. Alternatively, the substances
should be phased out completely if it turns out that
it is impossible to set a lower limit value under which
the substance has no effects on human health and the
environment.
Acute effects of a chemical are normally tested by
making so-called LD50 tests. In such tests, test animals
(e.g. mice) are exposed to such high doses of a given
substance that many of them die. The purpose is to find
Response
Response
Figure 4 Dose-response curves
Dose
Dose
Dose-response curves as they are generally presented. To
the right is a linear curve. This describes, for instance, a
the left is a sigmoid curve, which is the most common one.
carcinogenic substance where no threshold value can be
Here, there will be a lower threshold value where expo-
set, under which exposure to the substance does not lead
sure to a given substance does not lead to harmful effects;
to higher risk of developing cancer. No matter how small a
after this, higher doses will lead to higher response. To
dose you are exposed to it increases the risk of disease.
EU AND REACH > LIMIT VALUES
17
the dose, by which 50 % of the exposed animals die,
also called the LD50 value.
For carcinogenic substances, there is no lower limit
value. This means that you cannot be exposed to even
the slightest concentration of the substance without
having a somewhat higher risk of developing cancer.
When this is the case, the term ‘lifetime risk’ is often
used. In Denmark, we generally tolerate a lifetime risk
of 10 -6. This means that we tolerate one additional case
Phot o C at heri ne Lane
In the establishment of limit values researchers uses
a number of scientific tests to assess whether or not
a limit value of the chemical substance can be found.
Finding a limit value means that if you are exposed to
concentrations of the substance that is below this limit
it will not have harmful effects; by contrast, exposure
to higher concentrations may lead to damage to human
health and/or the environment.
Experts decide, based on scientific data, the quantities of
various substances allowed in our food. This is to ensure,
that the population is not exposed to health risks from
normal intake of food and drinks.
of cancer based on exposure to the given substance for
each one million people during a normal lifetime, which
has been set at 70 years.
How large concentrations can
humans tolerate?
The health risk of chemical substances in foodstuffs is
assessed based on scientific studies that cover, among
other things, feeding tests on animals such as mice
and rats. In most cases, these assessments of additives,
contaminants, and natural toxins in food are made
by international scientific committees such as the EU
Scientific Committee for Food or in the UN by the FAO/
WHO Joint Expert Committee on Food Additives (JECFA).
The Danish Veterinary and Food Administration also
has the expertise to make these assessments and has
participated actively in international work for many
years.
In the assessment of substances, an Acceptable Daily
Intake (ADI) or a Tolerable Daily Intake (TDI) value is
often established. These values are very similar, as
both are expressions of the highest amount of a given
substance that we can be exposed to without any
health effects (see below). According to the FAO/WHO
JECFA expert committee this quantity is normally one
hundredth of the highest dose that a test animal can
ingest daily throughout life without observed damage (in animal tests this factor is called NOAEL – ”No
Observed Adverse Effects Level”). The safety factor of
100 varies according to the substance in question. This
factor takes into consideration the variation between
different species, for instance between mice and
humans and the variations from one person to another,
for instance the physical variation between children
and adults. This means that if an animal test has shown
that a given substance does not have harmful effects to
health in a concentration of 4.5 mg/kg body weight/day
you find the corresponding ADI/TDI with the calculation:
So on the basis of this animal test it will be assessed
that a person can tolerate an intake of 45 μg/kg body
weight/day of the given substance.
ADI is short for “Acceptable Daily Intake" and is normally used for substances that may be used in the
production of foodstuffs, but will need an evaluation
before they are permitted. This means that a chemical substance is deliberately added to attain a desired
effect despite the negative side effects that may occur.
ADI is a measurement for how large a quantity of the
substance a person can ingest throughout life without
any health risk. Examples of substances with an ADI
value are additives, including colorants, preservatives,
and sweeteners.
All approved additives are included in the so-called ‘ positive list’. From this list, it appears which additives may be
added to which foodstuffs and in which quantities.
EU AND REACH > LIMIT VALUES
TDI is short for “Tolerable Daily Intake" and is used for
substances whose presence in foodstuffs cannot be
completely controlled and as a consequence have to be
tolerated to some extent. This is the case, for instance,
for heavy metals and dioxins that are found as pollution
in the environment. The tolerable daily intake is the
quantity of the substance that a person is assessed to
be able to ingest every day throughout life without any
health risk. Examples of substances with a TDI value are
lead and cadmium. Often a safety factor is used significantly below 100 as mentioned above – mostly due to
the diffuse pollution that cannot be removed.
ADI and TDI are established based on our knowledge
about the toxicity of the specific substance. This
knowledge comes, among other sources, from animal
tests. Any impacts in the long-term perspective are
also considered; for instance, whether a substance can
cause cancer. Experts furthermore request results from
so-called reproduction tests clarifying the effect from
the substance on test animals’ fertility and health over
several generations. If knowledge is available about
a substance’s effect on humans, for instance from
the use in medicine or from chemical contamination
incidents this is also considered in the evaluation.
It is important to note that ADI and TDI are not a hazard
limit, nor an absolute limit value, but an expression of
an expert evaluation based on scientific data about
what you may ingest all your life without any risks.
Even if it is not desirable, minor exceedances of the
established values for short periods will have no health
effect due to the safety factor. If this is significantly below 100, however, it may still be problematic. Not least
because the cocktail effects, where several substances
are present in the same product, have not been taken
into consideration. Therefore, it is possible that the
safety factors used in the establishment of ADI and TDI
do not always give the intended level of protection.
18
EU AND REACH > REACH – STEP-BY-STEP
19
REACH –Step-by-step
Figure 5 How to understand REACH
R (egistration)
E (valuation)
A (uthorisation of)
CH (emicals)
REACH is the European regulation on chemicals and their safe use. As explained in the figure the name is
an abbreviation.
Registration
Registration is the first phase of the REACH regulation.
Producers are requested to submit specified health
and safety information about all substances produced
or imported and thereby present on the European
market. Health information must be based on research
for which specific tests and analyses, agreed upon
in the EU, must be applied. The obligation of registration applies to all chemicals produced or imported
as substances or as part of a mixture in quantities
above one tonne per year per producer/importer (see,
however, the time line for implementation, Figure 3).
Furthermore, producers and importers must register if
there is an intended release of one or more chemicals
from the article. An example of an article with an
intended release is an eraser or a tissue with a scent.
In the latter case, there will be an intended release of
fragrance.
The report on health and safety data must be submitted to ECHA in Helsinki. A pre-registration of
substances, which were already on the market when
REACH entered into effect, took place during 2008 and
resulted in a list of more than 140,000 substances. The
pre-registration was necessary in relation to companies
continued use of the substances they had used hitherto
and it applied to all companies producing or importing a
chemical substance in quantities above 1 tonne/year.
If a company had not pre-registered a substance by 1
December 2008, it would not later on be able to register
its substances within the deadlines established in
REACH. Thereby the so-called “no data – no market”
rule applies with the consequence that the company
will have to interrupt its production, import, and/or
marketing of the substance or the chemical product in
which the substance is an ingredient. The reasoning
behind this pre-registration was among other things
a desire to reduce companies’ costs in connection with
subsequent registrations. In the pre-registration companies only had to state the identity of the substance,
the name of the company, and similar data. By the
end of the pre-registration period all companies were
divi-ded into groups with other companies using the
same substances. In this way they were invited to join
forces in the actual registration so that, for instance,
animal tests were not repeated unnecessarily, thereby
redu-cing the use of laboratory animals. In the end the
costs were, as mentioned, reduced for everybody.
Evaluation
In view of standardising the evaluation of the registered substances, the European Chemicals Agency
EU AND REACH > REACH – STEP-BY-STEP
ECHA reviews the submitted data and estimates the
hazardousness of substances in cooperation with the
authorities of the member states. ECHA is in charge of
the practical management of the registrations, evaluation of proposed tests, and of monitoring that the
registrations comply with requirements. ECHA also
handles the practical administration of the authorisation scheme, as well as preparation of guidelines to
industry and authorities about how best to comply
with the requirements associated with REACH.
A registration application as a minimum goes through
two consecutive evaluations with each their purpose.
First, the Agency carries out a completeness check.
Here it is assessed whether all necessary items in the
application are correctly filled in, but the correctness
and quality of data are not assessed. Then, at random
sampling level, a control of correctness of submitted
data is made – a so-called compliance check. This
control may lead to a request to the company having
submitted the registration that it submits further
information if the original data are insufficient for
ascertaining that the substance does not pose a risk to
human health and the environment.
20
Authorisation
The authorisation process is the last phase of REACH.
You can say that the ECHA “Candidate List” is the key
of the entire authorisation process. The substances on
this list comply with the criteria for “substances of very
high concern”. Both member states and EU authorities
may designate hazardous chemicals for entry on the
Candidate List. A substance belonging to the group of
substances of very high concern complies with one or
more of the following criteria:
•
•
•
is classified as a CMR substance in category 1 or 2
(An EU categorization system)
is a PBT substance or a vPvB substance
there is scientific documentation of other probable
serious impacts on human health or the environment. This applies, for instance, to endocrine
disrupting substances.
CMR substances:
Carcinogenic, mutagenic and/or reprotoxic
PBT substances:
Persistent, bioaccumulative and toxic
vPvB substances:
Very persistent, very bioaccumulative
The EU chemicals regulation REACH was
adopted in 2006 and entered into force
in 2007.
CMR is short for carcinogenic, mutagenic and reprotoxic.
This abbreviation is used for substances that are
carcinogenic, may cause mutations in our genes, and/
or are harmful to our reproductive system (harms the
ability to reproduce).
PBT is short for persistent, bioaccumulative, and toxic.
Persistent means that the substance decomposes
very slowly in nature. Bioaccumulative means that it
accumulates in living organisms, as certain pollutants,
such as PCB and mercury are known to do. In addition,
it is toxic (poisonous) and thus has several harmful
properties effecting human health and the environment. In contrast to the CMR substances, for which just
one of the properties must be present, all three properties must be met for a substance to be called PBT. When
we talk about vPvB substances things get a lot worse.
It means very Persistent and very Bioaccumulative
– and it may even not decompose at all. In return, these
substances do not need to be toxic, but may be poisonous to a minor degree – the high persistence makes
them very problematic anyhow.
EU AND REACH > REACH – STEP-BY-STEP
An entry on the Candidate List is the first step towards
a substance being included in the so-called authorisation list. Once a substance appears on this list it means
that companies still wishing to produce, import, or use
the substance must apply for an authorisation/permit
within a specific deadline 13. The application for authorisation must normally be submitted no later than 18
months before this date. An authorisation to continued
production, import, or use of the substance is only
given if the benefits of continued use of the substance
outweigh the risks or if the potential risks are considered limited or under ”adequate control”. This means
that the substances in the future can only be used for
purposes approved by the authorities. However, the notion of ”adequate control” is controversial. For instance,
it may mean that a substance is used in so-called closed
systems – it may be substances chemically bound in
plastics – and then requirements are not nearly as
strict. However, history has shown that systems originally considered as closed are often not so in practice
– for instance, when the products in question are to be
disposed after the end of their useful life. In addition,
it is not certain when a substance is so hazardous that
it must be subject to the full authorisation scheme. For
example, REACH stipulates that this is only the case
for endocrine disrupting substances, if no threshold
value under which they can be considered safe exists.
According to the plan, this should have been decided
in the EU before June 2013, but the decision has been
postponed. Still there is much uncertainty and discussion whether such threshold values can be established.
An extensive report has been published describing all
the research implying that it is not possible to establish
a threshold value for endocrine disrupting substances,
since they may be harmful to health even at very low
concentrations, even though we do not see the same
effects at high concentrations of the same substance 14.
The responsibility for applying for authorisation is
solely with the producer or the importer of a substance
and in this way, the consumer should (in theory) be protected against hazardous chemicals. An authorisation
is not given to a substance as a whole, but to a specific
application of the substance for a specific applicant. To
protect the European consumers further authorisations
are re-evaluated within a given deadline. Furthermore,
an authorisation can be revoked at any time if the
conditions for the original authorisation have changed
in a way that influences the risk, the socio-economic
21
consequences, or the possibilities of substituting the
substance with a less hazardous alternative.
At least twice a year the Candidate List is updated with
new substances. Proposals for new substances come
from ECHA or individual member states, but substances
are not included in the list until ECHA has submitted it
for a public consultation and found a majority among
the member states. Once a substance has entered the
Candidate List, it will not be removed, even if it becomes
subject to authorisation.
Despite the fact that REACH took effect in June 2007,
the first substances did not appear in the authorisation
scheme until early 2011. Today (early 2014) there are
151 substances on the Candidate List and 22 substances
on the Authorisation List. One of the most important
objectives of REACH is that all substances of very high
concern (SVHC) must be on the list by 2020 in order to
decide whether to substitute them with less hazardous
substances. It is estimated that around 1,500 SVHCs
are on the market. If the EU does not speed up their
work this group of hazardous substances will not be on
the list until at least 2060.
Figure 6 The stepwise structure of REACH
REACH works step by step, as indicated in the figure.
Once a chemical product has been registered with ECHA
it must be evaluated to decide on its further fate on the
European market. If the substance is dangerous to human
health and the environment its production and use will be
regulated or banned.
13 This deadline is called the “sunset date” and refers to the date after which the use of the substance must cease.
14 Hormones and Endocrine-Disrupting Chemicals: Low-Dose Effects and Nonmonotonic Dose Responses, Vandenberg L et al., Endocrine Reviews, June 2012.
EU AND REACH > REACH – STEP-BY-STEP
The authorisation process is very expensive and time
consuming. First, an extensive survey of the chemical
must be made and subsequently a detailed documentation of the chemical risks and hazards for human health
and the environment must be drawn up. In addition,
there is no guarantee that an authorisation will be
given, so a company may have spent many resources
in the form of time and money to defend a chemical
that may not be authorised in the end. This motivates
competitors and other third parties to present a solution with less hazardous substances, which is a benefit
for consumer safety. Furthermore, under REACH, ECHA
must consider other available information about alternative chemicals when they decide on authorisations.
The purpose is to reduce the risk associated with
substances of very high concern and preferably
substitute these chemicals whenever it is economically
and technically feasible.
The authorisation scheme rests on the principle of
substitution stating: “hazardous substances should
be substituted where a safer alternative is available”. The alternatives may be less harmful chemicals,
technical changes of processes, or implementation of
alternative technologies in the production.
When a company applies for authorisation to use a
substance of very high concern it must provide an
analysis of possible suitable alternatives. Industry
must substitute the most hazardous substances if
suitable alternative substances are available. For other
substances of high concern that are assessed to be
used “sufficiently safely”, industry must prepare a plan
for substitution with suitable alternatives, but they are
not obliged to follow it.
In Denmark, the Danish Environmental Protection
Agency is the supervisory authority in relation to compliance with the rules of the EU chemicals legislation,
which includes around 50 different Statutory Orders,
Regulations, and Circulars; among them REACH. In
practice, a special unit in the Danish Environmental
Protection Agency – the Chemical Inspection Service
– carries out practical monitoring and supervision to
ensure that importers, producers, and distributors
of chemical substances comply with the regulations.
Whether you are a consumer or an importer/producer/
retailer, the Chemical Inspection Service is the unit to
contact if you wish to report a product you suspect of
not complying with the chemicals legislation.
22
"Right to Know”
When a substance is on the Candidate List the consumers have the right to know whether the substance
in question is found in a given product. The duty of
information to customers applies to chemical mixtures
as well as to products in solid form, including ordinary
consumer products such as clothing, shoes, electronics,
kitchenware, toys, and furniture. These products are
defined as articles under REACH, and all purchasers of
these goods must according to REACH be in a position
to acquire information about the contents of Candidate
List substances. This is the case for articles produced in
the EU or imported from non-EU countries. Therefore,
as a consumer you can enter a clothes shop and ask
whether there are hazardous chemicals in the pants
you consider buying. The retailer (or the producer/importer) must be able to provide this information within
45 working days after the request.
REACH is undoubtedly a large step towards higher
safety for European citizens. In addition, the regulation
ensures that Europe cooperates to reduce the risks
from hazardous chemicals for human health and the
environment by harmonising legislation and thereby
avoiding unfair competition between member states.
At the same time, the REACH process is very tedious
and changes often take a long time. It may take years
from a chemical product comes under suspicion of
being hazardous until it is subjected to legislation and
maybe banned. In an attempt to influence the process
of having hazardous chemicals added on the Candidate
List several European organisations have drawn up
their own suggestions for a list of chemicals that they
believe have a proven harmful effect on human health
and/or the environment. Examples of such lists are
given below.
SIN list:
The purpose of the SIN list (Substitute It Now), which is
drawn up by the Swedish environmental organisation
ChemSec, is to speed up the transition to a world free of
hazardous chemicals. The third version of the list (SIN
List 2.1) consists of 626 chemicals that ChemSec has
identified as Substances of Very High Concern based
on the criteria established by REACH. The SIN list is
based on the very simple concept: replacing hazardous
chemicals with safer alternatives. ChemSec finds that
there is an urgent need to reduce exposure of people
and animals to endocrine disrupting substances.
When they launched SIN List 2.1 intensive media work
was used to invite the European Commission and
EU AND REACH > REACH – STEP-BY-STEP
23
at ministerial conferences in international organisations such as the UNEP (United Nations Environment
Programme) under the UN, or they may be made at a
world summit. When a global environmental agreement
has been finally adopted, the Danish Environmental
Protection Agency is responsible for its implementation and compliance in Denmark.
There are specific agreements that deal with welldefined groups of chemicals. Below we briefly describe
the two most important global agreements:
Phot o t oos
•
Several global agreements have been made to attain
the convention covered twelve substances or
substance groups, but it has subsequently been
extended with another ten POPs.
increased protection of human health and the environment in relation to chemicals.
The convention has been signed by 150 governments, including the EU member states and the EU
Council of Ministers on behalf of the entire union.
This was done at a conference in Stockholm in
2001. However, the convention did not come into
effect until 17 May 2004. It bans the production
and use of particularly hazardous substances.
Today (ultimo 2013) the list covers 22 substances
such as PCB and a number of pesticides such as
DDT 16. For some of the substances, however, there
are a number of exemptions.
New substances may be included in the list if there
is scientific data for persistence, bioaccumulation
and potential for spreading (whether they are
spread, for instance, through air and water pollution) as well as adverse effects on human health
and the environment. Relevant data are acquired
through a scientific committee. If the criteria for
inclusion are met, the committee studies further
information and prepare an evaluation of risk
management if needed. Then the committee
presents a recommendation about how to include
the new substances in the convention. The final
decision is made by what is called the conference
the EU member states to prioritise regulation of these
substances through REACH and companies were urged
to start phasing out the substances.
ETUC list (The Trade Union Priority List):
In addition, the European Trade Union Confederation
(ETUC) has drawn up a list of substances of very high
concern (SVHC) that should be prioritised for inclusion
in the Candidate List from a trade union’s point of
view. The list contains 334 chemicals (early 2014). The
purpose is to enhance REACH and urge industry to
develop safer substances so that REACH can combine
higher competitiveness for European industry with
a higher protection of workers, consumers, and the
environment.
Global agreements:
In addition to the European environmental legislation,
which all EU member states must comply with, there
are a number of global agreements setting up rules
for all countries in the world in relation to various
chemicals and other environmental issues. Decisions
on starting negotiations about an international agreement in the environmental field are normally made
The Stockholm Convention – is a global convention regulating the POP substances 15. POP is short
for persistent organic pollutants, which means that
they do not decompose in the environment, but
accumulate in the food chain. The purpose of the
convention is to protect human health and the environment against the POP substances. Originally,
15 http://chm.pops.int/Home/tabid/2121/mctl/ViewDetails/EventModID/871/EventID/230/xmid/6921/Default.aspx POP is short for Persistent Organic Pollutants, which
means that they decompose extremely slowly. There is therefore a great risk that these substances remain in our environment and in the worst case scenario accumulate in the food web.
16 PCB is short for Polychlorinated biphenyl. The substance used to be present in construction materials, but was banned in 1977 when harmful effects were seen on human health and the environment. DDT is short for dichlorodiphenyltrichloroethane. This chemical was also banned due to its severe side effects.
EU AND REACH > REACH – STEP-BY-STEP
of the parties – composed of the Parties to the
Convention (the signatory countries) and their
potential observers. The conference of the parties
sets up procedural rules and makes all the important decisions.
Every five years all signatory countries must
prepare an updated national implementation plan
describing the POP situation in the country and
plans for implementation of the country’s duties
under the convention.
•
The Rotterdam convention (also called the PIC
convention: Prior Informed Consent) 17 – is a global
environmental agreement with the purpose of
protecting human health and the environment by
sharing information about hazardous chemicals,
including how safely to store, transport, use, and
dispose these chemicals. Member states must be
able to decide which harmful substances they wish
to import, and in particular, developing countries
must be able to protect themselves against the
import of particularly hazardous chemicals.
Negotiations on the PIC convention were concluded
at a conference of diplomats in Rotterdam in 1998.
The convention covers export of chemicals that
are banned or severely regulated in the country of
export. Before export, the country of export must
ensure that the authorities of the country of import
are informed about the restrictions placed on the
substance in question in the country of export.
In addition, the convention sets requirements for
labelling and classification of the PIC chemicals.
Today (early 2014), the list covers 47 chemicals
whereas 33 are pesticides.
In addition, an increasing number of countries copy the
REACH Regulation into their own legislation. This is
mainly due to the fact that countries having significant
exports to Europe – not least China and India - must
comply with many of the REACH rules in order to
continue exportation. Thus, Chinese companies must
submit detailed information about classification and
labelling, hazardous properties of chemicals, including
possible effects on human health and the environment,
as well as area of use and safety procedures, almost as
if China was also subjected to REACH.
Finally, there is a global chemicals strategy: Strategic
Approach to International Chemicals Management
17 http://www.pic.int/
24
(SAICM). This strategy is meant to play the role as the
key global instrument in the efforts to attain the objective of the UN Summit in Johannesburg in 2002: by
2020, chemicals must be used and produced in a way
that minimises significant adverse impacts on human
health and the environment. It is positive that we now
have a global agreement, but unfortunately, compliance with it is voluntary for the countries. There are
no statutory obligations and this obviously means that
some countries will do nothing. The US, among other
countries, was a strong opponent to the strategy and
managed to weaken the agreement in several important fields. As an example the precautionary principle
and the principle of substitution, both of which are key
issues in REACH, were not included.
EU AND REACH > CLASSIFICATION AND LABELLING
25
Classification and labelling
Hazardous chemicals and products must be
classified. The purpose of classification and labelling
is to inform and warn the user about the hazardous
properties of chemical products. In 2009, new rules on
classification and labelling came into effect. The new
Regulation on classification, labelling and packaging is
known as the CLP Regulation. The purpose is to create a
global harmonised classification of chemicals ensuring
that the same hazards will be described and labelled in
the same way all around the world. Meaning, when a
chemical is classified as a carcinogenic in Europe it will
have the same classification in, for instance, Japan.
effect in 2010, which is based on a globally harmonised
system (GHS). This system will over time be extended
to cover the entire world, and the harmonisation of the
global hazard labelling will help users of chemicals understand their hazardous properties no matter where
in the world you find the chemical. The hazard labelling
will appear on the label of the package. In addition to
the new symbols, the label will also state information
about the nature of the hazard and precautions during
use. Furthermore, the label will state a signal word,
which may be “warning” or “danger”, the latter being
placed on the most hazardous products.
Most people are familiar with the orange hazard symbols. However, a new classification system came into
Figure 7 Global hazard labellings for chemical products
Health hazard: Chemicals that may cause skin or eye irritation, skin sensitization, respiratory tract irritation, or narcotic effects. Examples of products carrying this label are
toilet cleanser, antifreeze, and decalcifier.
Corrosive: Chemicals that have a skin corrosive effect, may cause serious eye damage,
or have corrosive effect on metals. Examples of products are hydrochloric acid and drain
cleaner.
Flammable: Flammable substances and their vapours, gases, aerosols, and solid matter.
Examples of products are spirits, nail polish remover, and motor fuel.
Environment hazards: Chemicals that are hazardous for the environment. Examples of
products are paints, petrol, and turpentine.
Chronic health hazard: Chemicals that cause chronic damage such as cancer, are
harmful to the genetic material and to reproduction. It also covers chemicals that are allergenic by aspiration, or cause organ damage or lung damage by aspiration. Examples
of products are petrol, turpentine, and lamp oil.
Oxidising: Chemicals that may cause or contribute to the burning of another material.
Examples of products are bleaching agents and oxygen used for patients with breathing
problems.
Box continues on the following page
EU AND REACH > CLASSIFICATION AND LABELLING
26
Acute toxic: Chemicals that are acute toxic by ingestion, skin contact, and/or aspiration.
Chemicals carrying this pictogram may be potentially lethal. Examples of products are
certain pesticides and methanol (wood alcohol).
Gases under pressure: Gases that are stored in containers under pressure (2 bar or
higher). Examples of products: oxygen bottles and welding gas.
Explosive: Explosive chemicals and articles. Examples of products are nitroglycerine,
ammunition, and fireworks.
Packages containing a chemical substance or product/mixture classified as hazardous must carry a hazard labelling 18.
The purpose is to secure users of the products against damage. Here the nine hazard symbols are explained with examples of products carrying the label.
18 Danish Environmental Protection Agency. Leaflet on new hazard pictograms (in Danish).
EU AND REACH > LEGISLATION DEFICIENCIES
27
Legislation deficiencies
When REACH came into effect in 2007, it was in
many ways a giant step on the way to a more toxic-free
Europe, but we must also admit that the regulation in
many ways is insufficient. Industry has exemptions and
loopholes, and several important decisions, for instance
regarding endocrine disrupting substances and nanomaterials, have been postponed for future revisions of
the regulation (a revision opens up for amendments in
the legislative text).
There are a number of critical fields in the regulation 19.
Some of them are discussed below:
Endocrine disrupting substances were just about
to be included in the regulation in line with for example
carcinogenic substances. There was a majority for
the proposal in the Council of the European Union
and it was backed vividly be several political groups
in the European Parliament. Still, vehement discussions between the Council of the European Union, the
EU Commission, and the Parliament meant that the
decision whether or not to include these chemicals was
postponed until 2013. The Commission has still not
presented a proposal for a solution.
If endocrine disrupting substances from the outset had
been put on the same footing as carcinogenic substances in REACH they should have been substituted with
less hazardous chemicals by now, unless producers/importers could prove, that they were used in a quantity
that is not harmful or that they were used in a closed
system and thereby were under “adequate control”.
Denmark is a frontrunner in the fight against endocrine disrupting substances, and in 2011, the Danish
Environmental Protection Agency submitted a proposal
to the EU Commission concerning criteria for identification of endocrine disrupting substances and possible
options for regulation. In the proposal, the Danish
Environmental Protection Agency has focus on the following criteria for identification of endocrine disrupting
substances:
19 Navigating REACH; Published August 2007
1) they must be scientifically based.
2) they must rest on recent knowledge, but also
consider new knowledge when available.
3) they must cover health and the environment alike.
4) they must cover all applications across the legislation.
In both the US, Japan, and the EU we have major
research programmes on endocrine disrupting substances. The more knowledge we have – the more we
find evidence that endocrine disrupting substances also
affect human health. However, so far we have limited
knowledge about the effects of the substances and the
concentrations causing an effect.
Internationally accepted test methods specifically for
endocrine disrupting substances are yet to be developed. Therefore, only very few existing chemicals are
accepted as being endocrine disrupting – despite the
fact that animal tests indicate that a far larger number
has this adverse property.
Chemicals considered as being of very high concern
and therefore in principle should be phased out are
subject to a specific authorisation scheme (see section
”REACH – Step-by-step”). For hazardous substances for
which it has been assessed that they are used in a sufficiently safe manner, industry must prepare a plan for
substitution, but is not under any obligation to follow
it. This means that “safe use” – which is not specified in
further detail in REACH – can replace “the principle of
substitution”. In worst-case this may lead to that even
when safer alternatives are available, companies can
continue to import, produce, and use many hazardous
substances that may cause cancer, congenital malformation, reproductive diseases, and hormonal imbalances.
Cocktail effects of chemicals are also a problem that
has only been briefly considered in the legislation.
Today, risk assessments are based on the effects of the
individual chemicals despite the fact that it is generally
accepted that we are exposed to a “chemical cocktail” of
many different substances on a daily basis. To secure a
high level of protection against hazardous chemicals it
EU AND REACH > LEGISLATION DEFICIENCIES
28
thus, they will not be examined for harmful effects on
human health and the environment. Due to the lack
of registration and control there is a general lack of
knowledge about who produces what, why, and in how
large quantities.
The problem can be solved either by changing the
REACH text or by developing a so-called “stand-alone”
legislation establishing how REACH tools and provisions must apply to nanomaterials. The first option does
not seem possible at present since the EU Commission
does not wish to open for changes in the REACH text
for quite some time ahead.
When regulating harmful chemicals the pros and cons
concerning business, human health and the environment
are weighted.
is therefore important to consider how cocktail effects
can be covered by the European chemicals legislation.
Since there are thousands of chemicals on the market,
we must acknowledge that it is not possible to study
all combinations. However, recognized calculation
models exist to estimate effects from mixtures based
on knowledge about the different chemicals. Therefore,
political initiatives are now called for to ensure that
legislation (e.g. REACH, CLP, and the regulation on
cosmetic products) will cover cocktail effects in order to
protect human health and the environment against the
harmful effects of mixtures.
Nanomaterials are regulated under a number of
existing statutory instruments of which REACH is the
most important one. All of these instruments, however,
have their limitations when it comes to efficient treatment of this substance group. First of all, we need a
clear definition of nanomaterials. Today, the wording is
so broad that it is unclear whether a nanomaterial with
other physical and chemical properties than the same
chemical material in a larger form (normally above
100 nm) must be assessed separately. In practice, this
means that it is up to producers whether they choose to
follow the rules, including the registration procedure in
connection with nanomaterials. This is a barrier to any
effort of applying REACH as a regulation instrument
for monitoring the use of these substances. In addition,
REACH has the so-called tonnage limits entailing that
substances produced or imported in smaller quantities
than 1 tonne per year per producer/importer are not
covered by the duty to register. This is a problem since
many nanomaterials, due to their limited size, are not
produced in quantities exceeding this tonnage limit and
REACH registration only applies to some 30,000 of
the more than 100,000 chemicals believed to be on the
European market today. This is due to the fact, that registration only covers substances that are produced or
imported in quantities above 1 tonne/year/producer or
importer – and not until 2018 this many chemicals will
be included (see the time line in Figure 3). In addition,
for 60 % of the 30,000 chemicals we expect a lack of
information due to the loopholes in the system, even if
the authorities have the right to request more complete
information. The result will probably be an insufficient
amount of data to decide whether a substance is
hazardous or not. Hence, far too many substances will
remain on the market despite risks for human health
and the environment.
2
P ho t o h id e sy
Endocrine disrupting
substances
ENDOCRINE DISRUPTING SUBSTANCES > INTRODUCTION
30
Introduction to endocrine disrupting
substances
The EU legislation defines an endocrine disrupting
substance as an exogenous substance that alters
function(s) of the endocrine system and consequently
causes adverse health effects in an intact organism, or
its progeny, or (sub) populations.
What is an endocrine disrupter?
An exogenous substance that alters
function(s) of the endocrine system and
consequently causes adverse health effects
in an intact organism, or its progeny, or (sub)
populations.
In other words, an endocrine disrupting substance is a
chemical that affects our natural hormonal balance in
various ways. Hormones control a large number of processes in our organism and are decisive to metabolism,
the nervous system – including the development of the
brain, growth, and reproduction. Therefore, it is evident
that changes in the hormonal balance can have very
serious consequences. In addition, we are particularly
sensitive to endocrine disrupting substance in certain
life stages. This applies to the embryonic stage where
the embryo is affected through the mother, the period
just after birth, and the infant stage. In these periods,
we only produce very little sex hormones ourselves
and are therefore particularly vulnerable to impacts
on the endocrine system. During the embryonic stage,
our body’s detoxification system is underdeveloped and
therefore the embryo can only to some extent, secrete
the chemicals. Moreover, the blood–brain barrier does
not exist and thus the chemicals have easy “access”
to the brain and the rest of the body when they are
carried around with the blood.
Endocrine disrupting substances are among others
linked to low fertility, genital malformation, and breast
and testicular cancer. The substances can also cause
obesity and several studies indicate that some can
harm several generations after the first exposure. This
means that also children and grandchildren are affected
by an exposure that took place many years before their
birth. Despite much research in well-known endocrine
disrupting substances, very little about these substances’ impact on human health in the quantities we
are exposed to in everyday life is known. So the final
proof that the chemicals cause these effects in people
is still lacking. However, there is general agreement
among researchers, authorities, and politicians that we
have sufficient indications to act based on the so-called
precautionary principle, i.e. legislation and regulation
based on reasonable suspicion.
According to the Danish Environmental Protection
Agency, exposing test animals to endocrine disrupting substances may lead to an increased occurrence
of genital deformation, undescended testicles, lower
sperm quality among adult males, and precocious
puberty among the females 20. And it does not look
much better for humans.
The Department of Growth and Reproduction of Rigshospitalet (the largest hospital in Denmark) suspects,
among others, endocrine disrupting substances of
contributing to the following 21:
•
•
one of five Danish males between 18 and 20 have
a sperm quality below the normal value set by the
WHO.
in Denmark we have seen a large increase in
testicular cancer in the last 60 years, and Denmark
is with Norway the countries in Europe with the
highest incidence of this type of cancer (see Figure
8). Almost one percent of Danish men risk getting
testicular cancer during their lifetime.
20 Identification of chemicals in consumer products. Number 103 2009 “Combined effects on two year old children – The Toddler’s chemical cocktail” http://www.mst.dk/
NR/rdonlyres/FE3B1D94-B3F2-4CBD-ABC4-D1B24158C26F/0/65000_english.pdf
21 Sources: Niels Erik Skakkebæk, Professor, Rigshospitalet and Ph.d. and doctor at Rigshospitalet Lise Aksglæde: see among others (Danish only)
http://www.tidsskriftet.no/?seks_id=1659942 and http://videnskab.dk/content/dk/krop_sundhed/forskere_slas_om_unge_pigers_bryster
ENDOCRINE DISRUPTING SUBSTANCES > INTRODUCTION
31
Figure 8 Testicular cancer in the Nordic countries
Testis
Incidence: ASR (World) Age 0-85+
A statistical view of the development of testicular cancer
with a standard age structure. Age-standardisation is
in Denmark, Finland, Norway, and Sweden. The x-axis
necessary in order to compare figures for incidences/
shows time and the y-axis shows the rate of incidences
mortality between population groups with different age
per 100,000 persons. The rate expresses the number of
composition since age is a very important factor in terms
new incidences per 100,000 persons per year. An age-
of getting cancer. Source: NORDCAN © Association of the
standardised rate is the rate as it would be in a population
Nordic Cancer Registries (7.1. 2014).
•
In March 2013, WHO and the UN Environment
Programme (UNEP) published an updated version,
where endocrine disrupters were described as a 'global
threat'. The final conclusion of the report was that
exposure to endocrine disruptors give reason for global
concern for people and the environment.
•
•
Nine percent of Danish boys are born with
cryptorchidism (undescended testicles). This is
a significantly higher number than in the 1960s.
Cryptorchidism is correlated with higher risk of low
sperm quality and testicular cancer.
The testosterone level in Danish men’s blood is
decreasing. Men born after the 1930s-40s have
a lower testosterone level than their fathers and
grandfathers had at comparable ages.
Danish girls reach puberty earlier by as much as
one year compared to 15 years ago.
The World Health Organization WHO has previously
studied all the knowledge available on endocrine
disrupting substances. At that time, no definitive proof
was found that it is detrimental for humans to be in
contact with the substances despite the fact that it
affects development, for instance, in mice and rats.
However, if the suspicion that the substances disturb
the endocrine system and thereby human development and reproduction is true, it may have serious
consequences for humanity in the long-term perspective. Therefore, it may be necessary to act under the
precautionary principle to protect consumers, also
when the proof is not definitive.
Most often, we are exposed to hormone disrupting
chemicals through our food, such as residues of plant
protection products (pesticides), other substances from
ENDOCRINE DISRUPTING SUBSTANCES > INTRODUCTION
pollution, natural phyto-oestrogens (“phyto” comes
from Greek and means plant) and animal oestrogens,
but we also absorb small amounts through our skin
(e.g. through cuts and rashes). We find the endocrine
disrupting substances in multiple places. For example
in the external environment, where the burning of
organic materials, among others, releases dioxin,
which is a very harmful substance for humans and
animals. During long-time exposure, this toxin leads
to increased risk of cancer, reproductive disturbances,
reduced immunity, neurotoxic effects, and endocrine
disorders. In addition, we are exposed to endocrine
disrupting substances in consumer products such as
plastics, toys, cosmetics, electronics, clothing, and
many others.
32
are very different, but common to them all is that they
can be bound to the body’s hormone receptors just
like the body’s own hormones. They can also affect
formation, transport, and excretion of the body’s own
hormones. The hormonal effects are caused by many
different mechanisms, such as:
•
•
•
•
•
Innumerable substances are found to either have
endocrine disrupting effects or are being suspected of
having it. Chemically, endocrine disrupting substances
imitating the effects of natural hormones
blocking the effects of natural hormones
affecting the body’s metabolism of natural hormones. Can result in hormones remaining in the
body for longer or shorter periods than intended.
affecting the synthesis (formation) of natural
hormones in a way that the body is exposed to a
too high or too low concentration of hormones
affecting the transport of natural hormones. Can
result in specific hormones not being transported
to their target organs.
Hormones and receptors
In order to work, a hormone needs to bind to a receptor,
whereby a signal is released. A hormone can have one specific or several different receptors that is suited for binding.
When the hormone binds to a receptor on a cell membrane,
a reaction is initiated in the cell via the receptor. This may
include an activation of specific enzymes, which in turn
controls other reactions in the cell, for example phosphorylation of proteins for the formation of cyclic nucleotides,
e.g. cyclic adenosine monophosphate (cAMP; part of cell
energy metabolism). The cyclic nucleotides serve as intracellular signaling molecules (second messengers), which
for instance activate enzyme systems. In this way, the
body gets different signals via hormones.
The problem with endocrine disrupting substances
is that they can affect the body in the same way as our
natural hormones. This can be critical, as the body's own
Agonist
hormones are very carefully expressed, i.e. in very precise
doses and at very specific times in our lives. Therefore,
even very small changes can have a significant impact on
our health.
An agonist is a substance that has the same effect as
the natural ligand. This means that the agonist will bind to
the same receptors and exert the same effects as the natural ligand. Put in a very simplified way, it can be compared
to the way a key (the agonist) fits in a lock (the receptor).
In contrast, an antagonist favors and binds (not necessarily to the same site) to the receptor, thereby inhibiting
the receptor from binding the natural ligand. In this manner,
the activity is turned off so to speak, and the body cannot
receive the signals that its natural hormones should start.
Antagonist
Cell membrane
Response
- Response
ENDOCRINE DISRUPTING SUBSTANCES > INTRODUCTION
These mechanisms are divided into three main groups:
1) They can imitate the effect of a naturally produced
hormone such as oestrogen or testosterone
and thereby cause similar reactions in the body
(Agonism).
2) They can block the receptors in the cells receiving
the hormones and thereby prevent the normal
hormones from working (Antagonism).
3) They can affect synthesis, transport, metabolism,
and/or excretion of hormones and thereby change
the concentration of natural hormones. The endocrine disrupting chemicals can mimic the body's
natural hormones in different ways:
33
heating, and waste incineration. Dioxin is a generic
description of a group of chlorine-containing toxins
that are formed in the burning of organic materials
in the presence of chlorine.
Endocrine disrupting substances have very different
decomposition rates in living organisms. Phthalates,
for instance, decompose very quickly and are then
excreted in the urine, while other substances such
as PCB compounds are heavily decomposable and
accumulate in the fatty tissue. For the same reason
heavily decomposable substances can still be measured
in humans, for instance in mothers milk and fat, many
years after the industry has phased them out.
oestrogen-like effect: The naturally occurring female sex hormones are oestradiol, oestril,
and oestrone, overall referred to as oestrogens.
Hormones work by binding to their specific recep-
Some of the most discussed endocrine disrupting
substances are parabens, phthalates, bisphenol A,
fluorinated substances (in particular PFOA and PFOS),
and brominated flame retardants. These substances
tors. When this binding occurs in the right way, a
response is triggered. Chemicals with oestrogenlike effects may especially be harmful to male
embryos, as they only tolerate a very low concentration of oestrogen.
Examples of substances with oestrogen-like effects
are bisphenol A, certain phthalates, methoxychlor
(a chlorine-containing pesticide), DDT and its
decomposition products, and certain conversion
products of the industrial chemical PCB.
antiandrogen effect: Chemicals with this effect
mechanism prevent testosterone and other male
sex hormones from working in the way they
should. This effect is especially critical for male
embryos as it may cause incomplete development
of, particularly, reproductive organs.
Substances that may have an antiandrogen effect
are, for instance, the phthalates BBP, DBP, DEHP,
and DINP.
thyroid gland effects: Chemicals that may have
a disturbing effect on the transport and decomposition of the hormones of the thyroid gland (thyroxine and triiodothyronine). For example, this may
affect the development of the brain of embryos
whose mothers are exposed to these substances
and predispose the embryo to obesity. The latter
is due to hormones with a negative effect on the
production of thyroxine, which causes a reduction
of the resting metabolic rate, which in turn may
affect the energy expenditure.
Examples of substances with an effect on the
thyroid gland are PAHs and dioxins. PAH is formed
in the incomplete burning of organic materials.
The most significant sources are traffic pollution,
are discussed below.
ENDOCRINE DISRUPTING SUBSTANCES > PARABENS 34
Parabens
By Claus Jørgensen, The Danish Consumer Council
Most consumers today have heard about parabens
and have probably also heard that they are suspected
of having endocrine disrupting effects. This is largely
due to the fact that parabens and their hormone-like
effects have been discussed for almost 20 years in the
media and because there is still no consensus about the
potential harmful effects.
What are parabens?
The term ‘parabens’ covers a number of chemicals that
all consist of a benzene ring with a hydroxy group and
an alkyl group. What distinguishes one paraben from another is the number of carbon atoms on the alkyl chain.
In Figure 9, the most common parabens are shown
with their respective structural formulas: butyl, ethyl,
isobutyl, isopropyl, methyl and propyl parabens.
Figure 9 Chemical structures of the six most common
parabens
Butylparaben
Ethylparaben
Isobutylparaben
Isopropylparaben
Methylparaben
Propylparaben
Source: forbrugerkemi.dk
Info on parabens
Parabens are commonly used preservatives, e.g.
used in cosmetics and lotions as well as certain types
of food and medical products to prevent bacterial and
fungal growth, thus improving the durability. There
are several types of parabens, which are often used in
the same product in order to preserve as efficiently as
possible.
Parabens have been shown to have the ability to
slightly mimic estrogen in most types of cell-based
experiments and in animal studies. It has previously
been shown in animal experiments that exposure to
potent estrogenic compounds can be toxic to reproduction in both female and male rats. In adult women the
estrogen levels, by nature, is so high that you can think
that the doses you are exposed to from outside sources,
will only be a drop in the ocean. In contrast, normal
estrogen levels are very low in fetuses and children, so
here the exposure can have a very big impact.
The substances are used as preservatives in cosmetics
and drugs; they preserve the products and inhibit
bacterial growth in lotions, shampoos, sunscreens,
headache tablets, and anti-smoking preparations.
Two of the parabens; ethyl and methyl paraben and
their salts are also permitted in foodstuffs 22 with the E
numbers: E214, E215, E218 and E219.
Parabens are artificial compounds manufactured in
laboratories and are primarily used in cosmetics. The
substances are also used in cosmetics manufactured
for children, which was documented in a survey from
the Danish Environmental Protection Agency in 2007 23.
It showed that all the mentioned parabens were used
in products for children – propyl paraben was found
in 70 products and butyl paraben in 48 products. In
2009, the Danish Consumer Council asked consumers
to report products containing one or more substances
on the EU list of substances having shown endocrine
disrupting effects in animal tests, including several
parabens. Of the more than 1,200 products reported up
to March 2012, 92 % contain one or more parabens.
22 Danish Veterinary and Food Administration: http://www.foedevarestyrelsen.dk/SiteCollectionDocuments/25_PDF_word_filer%20til%20download/06kontor/Positivlisten%202011%20-%20netudgave%20_01.08.pdf
23 Danish Environmental Protection Agency:
www2.mst.dk/common/Udgivramme/Frame.asp?http://www2.mst.dk/Udgiv/publikationer/2007/978-87-7052-634-4/html/helepubl.htm
ENDOCRINE DISRUPTING SUBSTANCES > PARABENS
According to the National Allergy Research Centre 24,
parabens are also used in other types of products such
as glue, shoe polish, and industrial products. Here, they
are referred to with synonyms (see box) and it may be
hard for consumers to navigate through the jungle of
chemicals when the substances occur with different
names depending on the product in which they are used.
Even though two parabens (ethyl- and methylparaben)
are permitted in foodstuffs, Danish consumers rarely
find them on the shelves, primarily because of a Danish
tradition for not using them in food production. In the
past, propylparaben (E216) was permitted, but the
EU banned the substance in 2006 due to its endocrine
disrupting properties 25. According to the Danish
Veterinary and Food Administration the two permitted parabens may be used in confectionery products
(candy), snacks, surface treatment of dried meat
products, and jelly layer on meat products and patés
35
Synonyms for parabens when used in
products other than cosmetics and food
Methyl 4-hydroxybenzoate
Methyl paraoxybenzoate
Ethyl 4-hydroxybenzoate
Ethyl paraoxybenzoate
Propyl 4-hydroxybenzoate
Propyl paraoxybenzoate
Butyl 4-hydroxybenzoate
Butyl paraoxybenzoate
Isopropyl 4-hydroxybenzoate
Isopropyl paraoxybenzoate
Isobutyl 4-hydroxybenzoate
Isobutyl paraoxybenzoate
with the exception of liver paté.
Good preservatives
According to the Danish Asthma and Allergy
Association26 the cosmetics sector only started using
parabens in the 1920s and the food sector started
some 20 years later. Parabens are the best-studied
preservatives on the market. They are good at preserving, i.e. preventing bacteria growth and putrefaction,
and allergic incidences are rarely seen with this group
of substances. They are active towards many different
types of bacteria and are gentle to the skin, which
makes them suitable, for instance, in lotions, deodorants, and other cosmetics used on the skin.
On the other hand, the National Allergy Research
Centre describes preservatives as slightly allergenic,
which is confirmed by the Danish Environmental
Protection Agency 27. However, the latter states that
parabens, in contrast to other preservatives, rarely
cause allergic reactions when used in cosmetics.
Parabens must be declared in cosmetics and foodstuffs
allowing consumers to see which substances they are
exposed to. The permitted paraben content in cosmetics is regulated at EU level; a product cannot contain
more than 0.4 % methylparaben, 0.4 % ethylparaben,
0.19 % propylparaben, and 0.19 % butylparaben.
Oestrogen-like effects
Parabens are extensively used in cosmetics and are
believed to be among the least allergenic preservatives.
Despite this fact, the debate about parabens is very
intense and visible, since both in vitro and in vivo studies have shown that parabens may have oestrogen-like
effects and thus affect the hormonal balance. In 2007,
the EU published a list of substances having documented effects in in vitro and/or in vivo tests 28. On this list,
most of the parabens are present.
However, already back in the 1990s the endocrine
disrupting effects of butylparaben came into focus. In
their tests of cosmetics and care products, the Centre
of Green Information dismissed products containing
butylparaben. The Centre referred to some of the first
scientific articles describing environmentally harmful and endocrine disrupting effects from the use of
butylparaben. Later, scientific tests have documented
that the other parabens have similar, although weaker,
endocrine disrupting effects.
In the report 29 behind the EU list of substances having
shown endocrine disrupting effects the authors have
gathered examples of the effects found in tests using
animals or cells. A selection of parabens with shown
oestrogen-like effects is listed in Table 1.
24 National Allergy Research Centre: www.videncenterforallergi.dk
25 Danish Veterinary and Food Administration: http://www.foedevarestyrelsen.dk/Foedevarer/Tilsaetningsstoffer_og_teknologi/Tilsaetningsstoffer/Sider/parabener.aspx
26 Danish Asthma and Allergy Association: www.astma-allergi.dk
27 Danish Environmental Protection Agency: http://www.mst.dk/Borger/Kemikalier/Kosmetikguiden/Hvordan+er+det+lige+med/parabener.htm
28 EU Commission: http://ec.europa.eu/environment/endocrine/documents/final_report_2007.pdf
29 EU Scientific Committee: http://ec.europa.eu/environment/endocrine/documents/final_report_2007.pdf
ENDOCRINE DISRUPTING SUBSTANCES > PARABENS
36
Table 1 Selection of parabens with proven oestrogen-like effects in animal tests
Substance
Oestrogen-like effects found in
Ethylparaben
Rats, mice, and fish
Propylparaben
Rats and fish
Butylparaben
Mice and fish
Methylparaben
Mice
Source: DHI, 2007 – Study on enhancing the Endocrine Disruptor priority list with a
focus on low production volume chemicals – ENV.D.4/ETU/2005/0028r
Parabens are regulated continuously and the permitted
concentration in cosmetics has been reduced. Back in
2005, the first of a number of scientific evaluations
In Denmark it is not permitted to use butyl, propyl-,
isobutyl-, and isopropylparabens or their respective
salts in cosmetics and care products for children below
from the EU Scientific Committee on Consumer safety
(SCCS) was published. It concluded that parabens could
not be linked to breast cancer 30. It was followed by
evaluations concluding that the use of methyl- and
ethylparaben was safe in the permitted concentrations,
and the committee requested more information about
the other parabens 31. In 2006 and 2008 further evaluations from SCCS were published in which the scientific
committee rejected the materials submitted by the
cosmetics sector 32,33. The committee insisted that it
could not say anything about the safety of several of
the parabens. However, methyl- and ethylparaben
were still claimed to be safe.
the age of three 35. A majority in the Danish Parliament
decided this in spring 2011. Denmark is the only EU
member state having a ban on these parabens. It is now
up to the EU to assess whether the ban, which is based
on the precautionary principle, should be extended to
cover all EU member states, or whether Denmark must
withdraw this special ban.
The cosmetics sector was then asked to submit data
showing that the parabens were safe; so far, this has
not been done. When the most recent evaluation from
the committee was published in 2011, it was assessed
that the permitted concentrations of butyl- and propylparaben were to be lowered and that several other, not
very common, parabens were to be banned. Again, the
committee concluded that the use of ethyl- and methylparaben was safe 34.
Today, parabens are still permitted in limited quantities
in the official EU regulation, but their use is still questioned, among others by Denmark that has introduced
a special ban beyond EU legislation.
The background for the Danish ban is a report published by the Danish Environmental Protection Agency
in autumn 2009 in which it was studied how many
endocrine disrupting substances a two-year old child
gets into contact with during one day. In the study, the
risk of a two-year old child’s daily exposure to endocrine disrupting substances, exceeding the maximum
acceptable level, (defined bythe Danish Environmental
Protection Agency), was calculated. Based on the
report, the former Minister for the Environment
Troels Lund Poulsen (Liberal) recommended that
parents avoid care products containing propyl- and
butylparaben.
In the report, the authors used a measuring method
attempting to evaluate the cocktail effects of the many
endocrine disrupting substances the two-year old child
is exposed to on a daily basis. It was the result of this
work, which led the Minister to state, that precaution is
needed in the use of the two mentioned parabens.
30 EU Scientific Commitee: http://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_00d.pdf
31 EU Scientific Commitee: http://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_019.pdf
32 EU Scientific Commitee: http://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_074.pdf
33 EU Scientific Commitee: http://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_138.pdf
34 EU Scientific Commitee: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf
35 Danish Environmental Protection Agency: www.mim.dk/Nyheder/2010/20101220_forbudparabener.htm
ENDOCRINE DISRUPTING SUBSTANCES > PARABENS
37
REMEMBER
NGO opinion
In Denmark and the rest of the world, consumer and
environmental groups have pointed out for years
that regulation of endocrine disrupting substances
is deficient 36. New research on cocktail effects of
chemicals has further increased concern among NGOs
about the substances. Therefore, they continue to put
pressure on the authorities and producers in order to
have substances regulated in a way that considers all
known factors.
that NGO is short for ”non governmental organisation”, meaning that it is not subsidised by government.
This means that such groups only work for funds raised
among different donors or from member contributions;
thereby they are not dependent on state opinions.
by consumers, if they cannot use parabens. If the demand for products without hazardous chemistry were
to increase, producers would see a competitive benefit
in substituting preservatives harmful to health with
substances without any adverse health effects. In addition, more generally it would be possible to pack care
products in tubes instead of, for instance, in pots with
a lid. When a product is sold in a tube, the direct contact
Parabens are not seen as being worse than other
substances suspected of being endocrine disrupting
for humans and animals. But since ’paraben’ is easy to
remember for consumers and journalists - by contrast
to, for instance, ethylhexyl methoxycinnamate or
4-Methylbenzylidene Camphor, and since they are
extremely common in cosmetics, the media often have
this substance group in focus.
between the product and bacteria from, for instance,
our hands (a very large source of contamination) will
Some organisations, such as the Danish Asthma and
Allergy Association, are not very concerned about
parabens; they believe that the health effects are so
weak that they are actually not harmful to humans 37.
Industry associations for producers and retailers also do
not share the concern of the NGOs 38.
It is a fact, however, that there are a number of permitted preservatives 39 (56 are approved for cosmetics)
that could be used instead. Many of them have adverse
allergenic effects and would not be suitable as substitutes, while others seem to have no health effects.
So why are parabens not replaced by other less harmful
substances? According to SPT (Soap and Perfumery
Manufacturer Association), you cannot just replace
a preservative with an alternative, since substances
have different properties and therefore are suitable for
different products. Therefore, producers face the challenge of making a similar product as the one preferred
Ph o to i cy i ma g e
Alternatives to parabens
The advantage of parabens is that they are thoroughly
tested and benign for allergy. Other more recently
developed preservatives cause larger allergy problems
and are at worst not tested as thoroughly as parabens.
It is more important to add preservatives such as
parabens when care products are sold in open containers as the product will be contaminated with
bacteria more easily, for instance from our hands.
36 In Denmark: The Danish Consumer Council, the Ecological Council, and Greenpeace; Internationally: European consumer groups ANEC and BEUC, the European organisation of green NGOs EEB, Greenpeace and ChemSec, among others.
37 Danish Asthma and Allergy Association: http://dinhverdag.astma-allergi.dk/deklarationer/forbruger/parabener
38 http://politiken.dk/tjek/sundhedogmotion/forbrugerkemi/ECE846125/kosmetikindustrien-forbrugerraadet-lyver/ and http://spt.dk/frame.cfm/cms/id=1013/sprog=1/
grp=9/menu=4/
39 https://www.retsinformation.dk/Forms/R0710.aspx?id=12915#B5
ENDOCRINE DISRUPTING SUBSTANCES > PARABENS
38
Figure 10 The Nordic Ecolabel
New research shows that exposure to a “cocktail” of
several endocrine disrupting substances, even in very
low concentrations, can have effects that are harmful
to health – even when no effects are seen of the individual substances in higher concentrations. However,
with today’s legislation we only consider whether each
substance is harmless at its specific limit value – so possible cocktail effects are not considered. You can read
more about this type of effect in the section ”COCKTAIL
EFFECTS”.
The Nordic Ecolabel (also known as the Nordic Swan) is
one of many ecolabelling schemes. You can read more in
the section “Chemicals in clothing and textiles”.
be reduced, thereby reducing the risk of developing
mold. This would reduce or even eliminate the need for
adding preservatives to various care products.
For many years, it has been possible to produce care
products and cosmetics in such a careful way that
producers can obtain an ecolabelling. The Nordic Swan
has set up criteria for labelling of cosmetics. One of the
criteria is that the product must be produced without
the use of parabens. Just like all other substances
on the EU list of endocrine disrupting substances
parabens are banned from Swan labelled products. It
is thus possible to have a production without using
substances suspected of being endocrine disruptors,
which is clearly seen from the number of Swan labelled
products on the Danish market. So far, 27 deodorants,
69 facial care and cleansing products, 82 baby care
products, and 54 hair styling products are approved
under the Nordic Swan label.
Parabens – also in the future?
Today, it is generally agreed that we have scientific
proof of the correlation between parabens and endocrine disrupting effects. However, when we wish to
determine the importance of these effects on humans
there are many different opinions.
Denmark is a pioneer in the fight against cocktail effects.
Only time will show whether the EU will follow suit
and ban butyl- and propylparaben. In Denmark the
Danish Environmental Protection Agency has focus on
the problem, for instance by informing consumers in
campaigns. The latest campaign was based on a major
survey focusing on products for pregnant women and
giving tips and guidance for women trying to get pregnant. In addition, the Danish government put hormone
chemistry and cocktail effects on the agenda under the
Danish EU Presidency in the first semester of 2012.
Much work is being done to develop methods to tackle
cocktail effects, for instance at the Technical University
of Denmark (DTU). Undoubtedly, we will see new
methods for calculating risks from chemicals and this
may mean that parabens will disappear completely
from consumer products: maybe even before we see
a direct ban. Already today, we see more and more
cosmetics and care products on the Danish market
without parabens – and often carrying the Nordic Swan
label 40. On top of the consideration for human health
and the environment this may be due to the fact that
producers see a competitive benefit from being in front
and that consumers increasingly demand products free
from chemicals suspected of harming humans and the
environment.
Authorities and producers are still very much of the
opinion that there are no problems related to the substances as long as the limit values are respected. Today
parabens are therefore permitted in limited amounts apart from the number of parabens banned in Denmark
in products for children below the age of three.
40 The Danish Consumer Council published in March 2012 a list of 52 brands/companies no longer using substances on the EU list of endocrine disrupting substances,
including Matas and COOP that have phased out substances from their own brands. http://taenk.dk/nyheder/kosmetikproducenter-dropper-hormonkemi
ENDOCRINE DISRUPTING SUBSTANCES > PHTHALATES
39
Phthalates
By Eline Aggerholm Kristensen, The Danish Ecological Council
Polyvinyl chloride (PVC) is a plastic consisting
of many vinyl chloride molecules on a long chain (see
Figure 11). PVC is a very hard material and therefore
needs to get more flexible and soft. For this purpose,
the so-called phthalates are often used. Phthalates
is a common term for different esters of phthalic acid;
they are formed from a simple condensation reaction41
between alcohol and carboxylic acid splitting off water.
What are phthalates?
Phthalates are manufactured from mineral oil. They
have no or only a weak odour and are increasingly
lipophilic (dissolves in fats) depending on the length
of their chain. Phthalates have many different chain
lengths but generally, the long-chained phthalates
are used as plasticisers while the short-chained are
used in cosmetics. Generally, they are used to improve
flexibility, adhesion, or bendable properties of many
consumer products. The plasticising effect means that
they permit movement in and between the polyvinyl
chloride chains of PVC (see Figure 11). Primarily,
phthalates are used to soften PVC plastics used in,
among other things, rainwear, rubber boots, electronics, floor coverings, toys, binders, shower curtains,
oilcloth, and T-shirt prints. Phthalates are also added
to other products such as cosmetics, pharmaceuticals,
Figure 11 PVC consists of many vinyl chloride molecules (CH2=CHCl) on a long chain. At the right-hand side of the figure
the structure of a phthalate is shown
Standard formulas for PVC and phthalate
Vinyl chloride:
CH2 = CHCl
Polyvinyl chloride:
-CH2-CHCl-CH2-CHCl-CH2-CHCl
PVC
Phthalate
The binding of phthalates to PVC
The phthalates are bound to the PVC through weak
electrical forces. These forces occur because both the PVC
and the phthalates have some imbalances in the distribution of electrons. The atomic oxygen in the phthalates
and the atomic chlorine in the PVC pull in those electrons
that are shared with their neighboring atoms, whereby
Example of a partial electrical bond between
two molecules wherein atomic oxygen pulls the
electrons from a neighboring atom leading to
partial charges.
partial negative and partial positive charges occur. The
partial negative charges in the phthalates are attracted to
the partial positive in the PVC and vice versa. Such weak
electrical bonds between neutral molecules are called Van
der Waals forces. Flexible PVC products contain up to 40%
of phthalate.
Phthalate
Polyvinyl chloride
41 A condensation reaction is a chemical reaction in which two molecules or functional groups combine into one molecule splitting off a smaller molecule (very often water).
ENDOCRINE DISRUPTING SUBSTANCES > PHTHALATES
and paints; here they are primarily used due to their
adhesive properties. Humans are generally exposed
to many phthalates as they are released from the
products we use. Phthalates readily release since they
are only attached to the PVC through weak electrical
forces that decrease gradually throughout the lifetime
of the products (see box). The softer the PVC product
the more phthalates it contains (up to 40 %) and the
more it can release.
40
is how to use them, because results from animal tests
cannot be transferred directly to humans (see section
about “LIMIT VALUES“).
Harmful effects of phthalates
There are many differences between laboratory
tests and the real world. Humans are exposed to a
mixture of substances, whereas test animals are often
exposed only to the specific chemical under scrutiny.
Furthermore, we decompose phthalates in a different
way than other animals, and the disease mechanisms
among different species are not always the same.
However, animal tests may indicate which effects the
phthalates may have on humans.
Another way to determine whether phthalates have
harmful effects on human health is biomonitoring
studies. In these studies certain biomarkers, such as
the level of specific enzymes in our blood, and the
decrease/increase of body weight of humans known
to have a high concentration of phthalates in their
Extensive research on the harmful effects of phthalates has been carried out. Thousands of animal tests
(in vivo) have been made to elucidate different aspects
of exposure, such as type of phthalate, exposure
method (through skin, food, mother's milk, inhalation
etc.), determination of harmful concentrations, duration of exposure (acute or long-lasting for months/
years/generations), type of test animal, life stage etc.
However, even when results are available the question
blood, are monitored. Epidemiological studies on an
entire population are also popular due to the very high
number of “test persons”, which makes the results
very robust. Such a population of humans may be an
entire community known to have been exposed to a
specific chemical pollution – for example a chemical
release from a nearby factory. Several epidemiological studies have revealed possible relations between
exposure to phthalates and male reproductive
The phthalate molecules are released gradually to the
surrounding environment such as air, water, skin, or
foodstuffs. With time, this results in the PVC products
becoming less flexible, harder and finally brittle. And
as studies show, large quantities of phthalates released
from PVC products such as vinyl flooring end up in
ordinary house dust.42
Table 2 Examples of phthalates with their short names and structural formulas
Name
Acronym
Structural formula
Dimethyl phthalate
DMP
C6H4(COOCH3)2
Diethyl phthalate
DEP
C6H4(COOC2H5)2
Di-n-propyl phthalate
DPP
C6H4[COO(CH2]2CH3)
Di-n-butyl phthalate
DBP
C6H4[COO(CH2]3CH3)
Diisobutyl phthalate
DIBP
C6H4[COOCH2CH(CH3)2]2
Benzyl butyl phthalate
BBP
CH3(CH2)3OOCC6H4COOCH2C6H5
Butyl decyl phthalate
BDP
CH3(CH2)3OOCC6H4COO(CH2)9CH
Di(2-ethylhexyl) phthalate
DEHP
C6H4[COOCH2CH(C2H5)(CH2)3CH3]2
Diisononyl phthalate
DINP
C6H4[COO(CH2)6CH(CH3)2]2
Diisodecyl phthalate
DIDP
C6H4[COO(CH2)7CH(CH3)2]2
42 Report from ChemSec and Swedish Society for Nature Conservation (2011): http://www.chemsec.org/images/stories/2011/chemsec/home_sweet_home_lowres.pdf
ENDOCRINE DISRUPTING SUBSTANCES > PHTHALATES
41
Table 3 Examples of suspected harmful effects by ptalates
Hypospadias
incomplete development of the urethra so that the opening of the urethra is at varying distance
from the top of the penis head. Malformation is accompanied by split foreskin and in some cases of
curvature of the penis
Cryptorchidism
a condition in which the testes are not yet in the scrotum at birth
Reduced sperm quality
40 % of young otherwise healthy Danish men have decreased sperm quality, which can lead to
fertility problems. 6 % have such poor sperm quality that they cannot have children without being
helped
Testicular and breast cancer
hormone-related diseases
Obesity and insulin
resistance
there has been shown a connection between these conditions and the level of metabolites (products from metabolism) from phthalates in men. It is suggested that especially exposure to phthalates – and other endocrine disruptors – in the fetal stage, increases the risk of obesity later in life
Feminisation
effects of endocrine disrupting chemicals seen in rodents, fish and amphibians - e.g. reduced distance between the anus and the root of the penis
Some health effects have been demonstrated in animal tests (e.g. cryptorchidism and various kinds of cancer) while others
are suspected of being caused by phthalates and other endocrine disrupting substances (e.g. reduced sperm quality).
disorders 43, low sperm quality44 and fertility45, precocious puberty among girls46, asthma47, obesity48, and
effects on the thyroid gland49.
In vitro testing is another option to test harmful
effects of different chemicals. For example by screening, where a general impression of many chemicals is
obtained by testing them on a (human) cell line – e.g.
cells from the lungs if you wish to examine what happens when the substances are inhaled. Such tests are
advantageous since they are fast and cheap and use no
or only few test animals. They give an idea of how the
substance affects certain specific biological endpoints
(such as lung cells in this case) and may further give
an indication of whether the chemical substance is
harmful to health. What should have particular focus
in in vitro screenings is that this kind of test only looks
at the specific cell type and thus can’t exclude other effects (such as the blood vessels being damaged when
inhaling a specific substance, even when the lung cells
are not). In vitro tests can thereby not acquit a chemical substance of being harmful to health just because
we do not see any effects on the specific endpoint
measured.
The extensive research on phthalates have revealed
several effect mechanisms – they may behave like
oestrogens in the body and bind to the oestrogen
receptors or act as antiandrogens by blocking the male
sex hormone effects or its production.
Table 3 gives some examples of possible carcinogenic,
mutagenic, reprotoxic, and endocrine disrupting effects
of phthalates.
It is generally agreed, that exposure during the
embryonic stage increases the risk of serious and
permanent changes in humans and animals more than
exposure of adults. The endocrine system plays a key
role throughout our life, but a well-working endocrine
system is of utmost importance for the normal development of an embryo and a child.
Another problem that gets increasing attention is the
risk of so-called cocktail effects of different chemicals.
In brief, cocktail effects arise when we are exposed
43 Swan et al. 2005. Decrease in Anogenital Distance among Male Infants with Prenatal Phthalate Exposure. Environ Health Perspect, 113(8): 1056–1061
44 Duty et al. 2003. Phthalate Exposure and Human Semen Parameters. Epidemiology 14:269 –277
45 Tranfo et al. 2012. Urinary phthalate monoesters concentration in couples with infertility problems. Toxicol Lett. 213(1):15-20
46 Wolff et al. 2010. Investigation of Relationships between Urinary Biomarkers of Phytoestrogens, Phthalates, and Phenols and Pubertal Stages in Girls. Environ Health
Perspect 118(7): 1039–1046
47 Just et al. 2012. Children's Urinary Phthalate Metabolites and Fractional Exhaled Nitric Oxide in an Urban Cohort. American Journal of Respiratory and Critical Care Medicine, 186:9 830
48 Teitelbaum et al. 2012. Associations between phthalate metabolite urinary concentrations and body size measures in New York City children. Environmental Research,
112:186-93
49 Whyatt et al. 2012. Maternal Prenatal Urinary Phthalate Metabolite Concentrations and Child Mental, Psychomotor, and Behavioral Development at 3 Years of Age. Environmental Health Perspectives, 120:2 290-295
ENDOCRINE DISRUPTING SUBSTANCES > PHTHALATES
simultaneously to several different chemicals, such as
when children are playing on the floor and inhale house
dust, which generally contains a mix of chemicals from
the household electronics, furniture etc. The effect
of this exposure may be different (worse) than the
effect of each chemical alone (read more in the section
“Cocktail effects“).
Phthalates are everywhere in our surroundings. The
Danish Veterinary and Food Administration made a
study in 2003 estimating the total daily exposure of
DEHP, DBP, BBP, DINP and DIDP to be 96.8 µg/kg body
weight/day for adults and 927 µg/kg body weight/day
for infants between 6 and 12 months. The much higher
exposure of infants compared with adults is primarily
due to the fact that they often move about on the floor
where dust is accumulated and have much “hand-tomouth” contact.
In 2006, Greenpeace studied the blood of a number of
famous Danes for selected chemicals. On average, they
found three types of phthalates in each blood sample.
Other studies have shown the presence of phthalates
and their metabolites in urine, blood from the umbilical
cord, amniotic fluid, saliva, mother's milk, and placental
tissue.
Phthalates decompose relatively easily into their
metabolites, so-called phthalate monoesters, and are
readily secreted from the organism. Therefore, it takes
a daily exposure to maintain a measurable content in,
for example, blood and urine.
Phthalates in the environment
Phthalates and their metabolites ultimately end up in
the environment and thereby also in the food chain.
Discharges take place through rain or wastewater
where the substances are led to the aquatic environment or found in sludge from wastewater treatment
plants. On the sea floor, the lipophilic phthalates
will bind to organic particles and settle, while in the
wastewater treatment plant they will bind to sewage
sludge that is later used as a fertiliser on agricultural
land. Therefore, soil and sediment will often contain
relatively large quantities of phthalates. Some phthalates are bioaccumulative and are found in aquatic
organisms. In this context, we have examples of feminisation in the form of development of ovaries instead of
testicles in male fish, frogs, and other amphibians living
in phthalate contaminated aquatic environments. All
these damages are suspected of being caused by the
endocrine disrupting effects of phthalates.
42
Reduction of phthalate exposure – phasing out,
taxation, legislation
There is a solution to the phthalate problem, since quite
many alternatives are on the market that may replace
the traditional PVC and phthalate products. It is beneficial for the environment if not just phthalates, but also
the PVC plastics, are replaced. PVC is neither suitable
for recycling due to the content of heavy metals; nor for
landfilling due to the long-term leaching of phthalates;
nor for incineration due to formation of, among other
things, hydrochloric acid and dioxin. The hydrochloric
acid is neutralised in Danish incineration plants, but it
generates a residue that must be landfilled in special
deposits to prevent pollution of the groundwater. By
far, most dioxin is decomposed or captured in filters.
However, even small amounts of dioxin are extremely
toxic for humans and thus constitute an undesired and
unacceptable pollution. The alternative plasticisers
may also be released from PVC. Substitution therefore
requires extensive research to secure that we do not
just replace one endocrine disrupting substance with
another harmful substance.
The largest problem regarding alternatives to phthalates is that there are relatively few on the market and
they are in general more expensive than phthalates.
For producers to see the advantage of developing alternatives they must have some certainty that they can
sell their products. Right now, the market for alternative products is limited by their higher price compared
with traditional phthalate-containing products. This
is a barrier to further development and competition in
this field. For instance, it is important for hospitals that
the medical equipment complies with the highest technical standards and that the economy is healthy. If the
phthalate-free products are inferior to the traditional
products, such as being less flexible, and also more
expensive, these products are not selected. There are,
however, many good alternatives to PVC products, for
instance polyethylene, polyester, and silicone. These
are already used in products with a ban on certain
phthalates – such as toys.
Increased competition on the market will promote
product development and ensure products of a high
standard at competitive prices. One of the ways of
accelerating this process is by levying green taxes.
In 2000, Denmark introduced a PVC and phthalate
tax. The tax amounts to DKK 2/kg PVC and DKK 7/kg
phthalates. The purpose of the tax was to reduce the
consumption of phthalates and it has been successful
within several fields, such as in cable production. The
Danish company “nkt cables” has developed cables
ENDOCRINE DISRUPTING SUBSTANCES > PHTHALATES
Figure 12 Symbol on plastic products, which indicates
the type of plastic – this indicates PVC
Soft plastics of the type PVC are normally softened
with phthalates. Some of the phthalates are endocrine disrupting or suspected of being so. Much
plastic, particularly packaging, is labelled with three
arrows forming a triangle with a number in the
centre. This labelling is not mandatory in Denmark.
substituting polyvinylchloride (PVC) that was stabilised with lead and softened with phthalates. Their
NOPOVIC® cable type is based on a mixture of halogenfree polymers containing non-flammable minerals
such as magnesium and aluminium hydrates. They
are competitive since they are exempt from the taxes
levied on PVC and phthalates, and furthermore the
company can promote themselves as eco-friendly.
In a report from 2006, the Danish Environmental
Protection Agency showed a decreasing trend concerning the use of phthalates 50. However, the tax has not
had the intended effect regarding hospitals. If the
phthalate tax was increased, the alternatives would
have an additional cost reduction and there would thus
be no savings from using the phthalate-containing
products. On the other hand, there are examples that
a phthalate-free purchasing policy does not necessarily constitute an additional cost. In the Dutch
’Westfriesgasthuis’ Hospital, all phthalate-containing
products have been replaced in the children’s care
unit, apart from blood bags, without having entailed
additional costs.
Since phthalates are found in many product types, they
are regulated under several different pieces of legislation. These include the EU chemicals legislation REACH,
the directives on toys and medicinal products, the
directive on medical devices, the Cosmetics Regulation
and legislation regarding food contact materials.
Di 2-ethylhexyl phthalate (DEHP) is one of the most
common and discussed phthalates. The substance
50 http://www.ft.dk/samling/20051/almdel/mpu/bilag/343/267804/index.htm
43
appears on many warning lists, including the European
Candidate List under the REACH regulation, the Danish
Environmental Protection Agency’s list of undesirable
substances, and the EU priority list of possible endocrine disrupting substances. Common to all products
containing DEHP is, however, that they must be marked.
In 2011, the Danish government prepared a scientifically based proposal for a Danish ban on the use of four
phthalates – DEHP, DBP, BBP and DIBP – and a proposal
to have them banned in the longer-term perspective
all over the EU. This was done based on the health
effects from the substances when they appear in
mixtures (so-called cocktail effects). However, medical
devices, among others, are exempt from the proposal.
The first assessment of the proposal (June 2012) was
made by two of the European Chemicals Agency’s
(ECHAs) scientific committees – the Committee for
Risk Assessment (RAC) and the Committee for SocioEconomic Analysis (SEAC). Their recommendation
to ECHA was that there was not sufficient data to
substantiate the proposal. Therefore, it is expected
that the Commission will reject the proposal. However,
the Danish government chose initially to take the case
further and introduce a national ban on the four phthalates in a variety of product lines. The national prohibition was scheduled to enter into force in December
2013, but the government decided to postpone the
proposal for two years after pressure from the industry.
In the EU, special rules for phthalates in toys for children aged 3-14 have applied since 2007. The phthalates
DEHP, DBP, and BBP are banned in toys and articles for
infants in concentrations above 0.1 % (weight); in addition, the phthalates DINP, DIDP, and DNOP are forbidden
in toys (same limit value as above), if they can be put
in the mouth. In addition, Denmark has had special
rules since 1999 for phthalates in toys and articles for
infants. There is a ban on the import, sale, and use of
phthalates in toys and articles for infants aged 0-3 if
the articles contain phthalates in concentrations above
0.05 % (weight). In addition to ordinary toys, it also
applies to other products for infants, such as nursing
pillows, baby slings, soothers, and bathing gear. Any
person producing, importing, or selling toys and articles
for infants is responsible for compliance with the above
rules. In other words, the companies must make sure
that the articles do not contain banned phthalates. Due
to the stringent Danish special rules, Danish importers
must be particularly aware when they import from
other EU member states.
ENDOCRINE DISRUPTING SUBSTANCES > PHTHALATES
Phthalates in hospitals
Endocrine disrupting substances are present in many
places in hospitals despite 30 years old knowledge that
phthalates are released from medical devices 51.
Most medical devices made of PVC have a phthalate
content of 20-40 % (weight), while PVC tubes may
contain as much as 80 %. Primarily bis(2-ethylhexyl)
phthalate (DEHP) is used for this purpose. Devices include bags for blood, infusions, and nutrition mixtures,
tubes, catheters, single-use gloves, and much more. In
addition to medical devices phthalates are also found
in more ordinary products at hospitals, such as vinyl
floors, shower curtains, carpets, curtains, windows,
and construction materials.
In which ways are patients exposed?
Normally, when we speak about exposure to phthalates and other substances we mean impacts through
scratches or through the respiratory system. Various
barriers in the body (such as skin, pleura, and cellular
membranes) affect and partly reduce the assimilation of phthalates. Some of the substances pass the
barriers and reach the blood; subsequently they are
transported around the body and cause various harmful effects. Some phthalates even accumulate in the
uterus and are transferred to the foetus during pregnancy. However, at hospitals there are more channels
of exposure. The most significant one adding to the
normal channels of exposure is intravenous exposure,
for instance through nutrition mixtures.
The reason humans and animals can assimilate
phthalates is as earlier mentioned that phthalates are
not chemically bound to PVC and thus are released
44
from the plastic when the equipment gets in contact
with liquids, fats, and/or heat. The phthalate DEHP is
lipophilic, and is therefore primarily released to fatty
dissolutions such as blood and nutrition mixtures.
Situations at the hospital where patients are particularly exposed to phthalates are in connection with
long-term and repeated hospitalization. In addition
there are areas where much equipment is naturally
required, such as blood transfusions, haemodialysis
(see below), and infusion of nutrition. Patients receiving dialysis are among the most exposed persons.
The function of the kidney is to clean the blood, and
when the kidneys can no longer assume this function, patients receive dialysis. This may be in the form
of haemodialysis where the blood is led through a
pipe out of the body into an artificial kidney where
it is cleaned before being led back into the body. This
entails long-lasting contact between blood and tubes
and thereby the possibility of an increased content of
phthalates in the treated blood. Another example of a
patient group that is particularly exposed are premature babies. This scenario will be discussed in the
below “case study” on neonatal care units.
Legislation
Medical devices are covered by three EU directives
that have been up for revision in 2012 and 2013, and
will be made into regulations in 2014. At present, the
directives do not contain any restrictions on the use of
phthalates and other endocrine disrupting substances.
In addition, chemical substances found in medical
devices are regulated by REACH, but as mentioned,
there is only labelling obligations for the use of DEHP.
In the above-mentioned Danish ban, medical devices
Exposure to phthalates has many sources.
Due to phthalates in medical devices
patients receiving dialysis, among others,
risk getting large quantities of phthalates
F o to Pi cs f i v e
directly into their blood through tubes.
51 Kevy et al. 1981. The need for a new plasticizer for polyvinyl chloride medical devices. Trans Am Soc Artif intern Organs, 27:386-390
ENDOCRINE DISRUPTING SUBSTANCES > PHTHALATES
are exempted. Amendments to the current proposal
for the new regulations have been adopted by the EU
Plenary in October 2013. The amendments include a
ban on hazardous chemicals in medical devices, and
applies to chemicals that are carcinogenic, mutagenic
and reprotoxic (CMR substances) and chemicals which
have endocrine disrupting properties – and which
are contained in invasive medical devices, or devices
that come into contact with the patient or are used to
administer, transport or store medicines, body fluids
or other substances. The amendment allows the
hazardous chemicals to remain in medical devices for a
maximum of four years during an exemption process.
Why are phthalates and PVC used so extensively
in medical devices?
PVC and phthalates have many useful properties. This
is why they are used extensively all over the world.
In some fields, it is difficult to find good alternatives
complying with the standards set by the traditional
products. Blood bags are a good example. Here, PVC
meets many functional requirements, for instance in
terms of flexibility, transparency, centrifuging, handling,
and weldability.
Other aspects also contribute to maintaining
phthalate-containing PVC equipment for medical use.
An extensive infrastructure has been developed for
manufacture of the material. It is a relatively cheap
product; it is well tested and complies with current
legislation.
Many companies today offer phthalate-free alternatives to medical devices or alternative plasticisers.
One example is a non-toxic plasticiser developed by
Danisco on the basis of castor oil. Another example is
a phthalate-free plastic granulate for use in medical
devices from Danish Melitek. Many hospitals already
use phthalate-free products. At the Southern Jutland
Hospital in Denmark, there is a general focus on procurement of products without DEHP. At the neonatal
care unit, they use DEHP-free catheters, intravenous
tubes, tongue depressors, nutrition tubes, soothers, and bandages. At the Dutch Westfriesgasthuis
Hospital, the entire child-care unit is PVC and phthalate-free, apart from blood bags. More examples can be
found in publications from Health Care Without Harm
and on the Danish website http://www.eco-forum.
dk/medicoartikler/ from the Danish Environmental
Protection Agency.
45
In a present EU project named PVCFreeBloodBag,
running up to 2015, a PVC and phthalate-free blood
bag is being developed. Blood bags are one of the only
products to which no good alternatives to the phthalates presently used have been found. The project
covers many producers, among others Danish Totax
Plastics A/S and Melitek A/S, Italian Haemotronic
S.p.A., and Finnish Wipak Medical. Blood transfusions
are one of the medical treatments that save most lives,
and requirements to blood bags are high. The plastic
material must not affect the quality of the blood, it
must withstand temperatures up to 70 °C and sterilisation. In addition, it must withstand centrifuging in ultracentrifuges working at speeds of up to 5,000 times
the relative centrifugal force (5,000*g). An additional
advantage of the traditional blood bags is that DEHP
has a stabilising effect on the membrane of the red
blood cells, thereby reducing haemolysis52 and osmotic
structural weakness53. Unfortunately, the blood lipids
cause the lipophilic DEHP to be released from the PVC
plastic and the harmful substances can thereby be
transferred to the person receiving blood.
Case study – Neonatal care units
Premature babies in intensive care often need extensive help to survive, as they are not fully developed
at birth. Some babies may need help to breathe and
are placed in a respirator with a tube through the
mouth down the trachea. In many premature babies, a
As yet, there are no alternatives to the phthalates used
in blood bags, but the EU supports a project with the
purpose of developing a product by 2015.
52 Hemolysis refers to the situation in which red blood cells release hemoglobin (and other contents) to the surrounding fluid because the cell membrane is damaged.
53 To equalize the concentration difference between the red blood cell's internal environment and the external environment (osmosis), fluids will penetrate into the cells
and the membrane will weaken. In worst case, the membrane may rupture when the cell is unable to expand further.
ENDOCRINE DISRUPTING SUBSTANCES > PHTHALATES
venflon is inserted 54. This intravenous access is used
to administer liquids (such as electrolyte liquids) and
medicine directly into the bloodstream. Other procedures include blood transfusion, oxygenation of the
blood in a machine – a technique called Extra Corporal
Membrane Oxygenation (ECMO) – and feeding of nutrition mixtures through probes. Premature babies are
thereby exposed to phthalates in many different ways
and in many cases, they get the substances directly
into the blood, which poses a larger risk than dermal
exposure (assimilation through the skin). In hospital
equipment – also for premature babies - DEHP is the
preferred type of phthalate. Unfortunately, also an
endocrine disrupting chemical affecting, among other
things, reproduction and development.
46
of this enzyme. The concentration of phthalates in
babies’ bodies ends up higher – particularly among the
premature babies – than in adults, since the quantity
of children’s body fat is much lower.
The endocrine system plays a decisive role in the
early developmental stages, and premature babies
are thereby particularly vulnerable, as they are still
Through the medical equipment used in the treatment
of premature babies they may be exposed to concentrations of DEHP far exceeding the concentration for
”no observed adverse effect level” (NOAEL), i.e. the
level below which no harmful effects to health have
been seen in animal tests (read more in the section
“Cocktail effects“). Tests have shown that tubes for
lung ventilation (endotracheal tubes) release 6-12 %
DEHP during use 55. This release presumably accumulates in the lungs; an argument that is substantiated
by the discovery of DEHP in the lungs of babies after
mechanical ventilation. In addition, studies have
shown that while a normal exposure to DEHP is 3-30
µg/kg body weight/day, premature babies that are fed
developing. They have less efficient blood-brain and
blood-testicle barriers and substances thereby move
easier from the bloodstream to the brain and testicles,
respectively. Premature babies also have more difficulty secreting phthalates and their decomposition
products, as their metabolic detoxification routes are
still not sufficiently developed. Lipase (an enzyme
decomposing lipids) from the pancreas is the primary
detoxifier, and premature babies have very low levels
by one of the two methods mentioned in Figure 13, are
exposed to 40-140 µg/kg body weight/day (enteral
nutrition) and 2500 µg/kg body weight/day (total parental nutrition), respectively. Such exposures may be
up to several hundred times higher than recommended
by the authorities. In the light of the fact that gavage
feeding often takes place over a long period of time,
this single exposure route can cause a very high DEHP
load, which is a health hazard for the newborn babies.
Figure 13 Phthalates are transferred to the blood
Different types of treatment involving
PVC products and thereby a risk of
having phthalates transferred into the
blood.
ECMO: ExtraCorporeal Membrane
Oxygenation – a heart-lung machine
that takes over the heart-lung functions while the organs fully develop.
Electrolyte infusion: is done to
stabilise liquid and ion balance.
Enteral nutrition: nutrition by tube
directly into the gastrointestinal tract.
Total parenteral nutrition: nutrition
given through the blood – is only used
when nutrients cannot be ingested,
digested, or absorbed.
54 A venflon is a thin plastic catheter that is introduced in a vein of a patient.
55 Latini et al. 1999. Materials degradation in endotracheal tubes: a potential contributor to bronchopulmonary disease (letter). Acta Paeditr, 88: 1174-1175
ENDOCRINE DISRUPTING SUBSTANCES > BISPHENOL A
47
Bisphenol A
Bisphenol A (BPA) is an industrial chemical.
It is an organic substance consisting of two phenol
molecules (See Figure 14). Every year around 700,000
tonnes of BPA is manufactured in the EU, of which
the major part is used in the manufacture of polycarbonate – hard impact-resistant plastic. Polycarbonate
has several applications, for instance plastic containers
for food and drinks such as baby bottles, cans, water
coolers, etc. as well as electronic equipment and in cars.
In addition, BPA is used in paints, varnish, glues, and
flooring. Several different organisations have studied a
selection of food and drinks in cans and have found BPA
in all samples; this indicates that the substance leaks
from the package into the contents. The concentrations
found in the different foodstuffs are very low and
thereby hardly harmful to health, if the consumer only
eats the foodstuff in question. If, however, the total
intake over an entire day, consisting of many different
food and drinks together, is considered together with
other exposures, e.g. from receipts on thermal paper,
the total load may give reason to concern.
In 2006, EFSA (European Food Safety Authority)
decided upon a limit value for tolerable daily intake (TDI
value) of BPA of 50 μg/kg body weight/day. There has
been much discussion whether, and to which extent,
BPA has a harmful effect on health when ingested
in quantities below this limit. Conclusions seem to
depend on the design of the different tests. Certain
research results indicate that the substance may have
an endocrine disrupting effect on fish and snails, even
in concentrations lower than TDI. Tests with mammals have shown that the substance has an endocrine
disrupting oestrogen-like effect and reduces fertility. So
even if the substance does not accumulate much in the
organism (animal and human data suggest that it tends
to be rapidly metabolized, with elimination thought
to be virtually complete within 24 hours of acute
exposure), the endocrine disrupting effects still give
reason to concern. In 2007, a scientific article described
how concentrations had been found in human blood,
urine, placenta, umbilical cord, amniotic fluid, and
breast milk 56. This shows that the substance may be
Figure 14 Structural formula for 2,2-bis(4-hydroxyphenyl)propane (Bisphenol A).
transferred from mother to foetus during pregnancy
and through breastfeeding.
In addition to the oestrogen-like effect, cellular tests
also have shown anti-androgen effects (hampering the
biological effects of male sex hormones such as testosterone) of BPA.
BPA is suspected, among others, of having health
effects contributing to obesity, diabetes, cardiovascular
diseases, behavioural changes in children, etc. In addition, the substance is suspected of being a contributory
cause of the increasing instances of infertility, malformation of the reproductive organs, as well as breast and
prostate cancer that have occurred for the last 50 years
in Europe and the US. A scientific article from 2010
states that more than 150 studies describing a negative
effect on animals exposed to a BPA dose lower than the
established TDI of 50 μg/kg body weight/day exist 57.
This is especially a reason for concern in relation to foetuses, newborn babies, and infants, since the brain and
other organs are particularly vulnerable to exogenous
hormones in the development stage.
One may wonder why BPA is approved as a food contact
material in the EU when so many studies indicate
that the substance may have major consequences for
human health and the environment. In recent years,
however, limited bans on BPA have been introduced
after pressure from NGOs and researchers around
the world, particularly in products for infants. BPA
is subjected to category 1 on the EU priority list of
56 Vandenberg LN, Hauser R, Marcus M, Olea N, Welshons WV. Human exposure to bisphenol A (BPA). Reprod Toxicol 2007;24:139-77
57 Vandenberg LN, Chahoud I, Heindel JJ, Padmanabhan V, Paumgartten FJR, Schoenfelder G. Urinary, circulating and tissue biomonitoring studies indicate widespread
exposure to bisphenol A. Environ Health Perspect, online 23 March 2010.
ENDOCRINE DISRUPTING SUBSTANCES > BISPHENOL A
48
suspected endocrine disrupting substances. Category
1 contains 194 substances and for this group of
substances the endocrine disrupting effects have been
documented in at least one survey of living animals.
In addition, BPA appears on the Danish Environmental
Protection Agency’s list of undesirable substances.
This list contains chemicals and substance groups that
the Agency regards as having undesired health and/
or environmental effects, or that deserve special focus
based on suspicion of problematic properties. The list is
a guideline for producers, product developers, purchasers, and other players and is intended to be a signal
about which chemicals will be restricted or completely
phased out in the future.
Despite the fact that BPA appears in many consumer
products, Denmark has actually been a frontrunner in terms of limitations for many years. Former
Minister for Food, Agriculture and Fisheries, Eva Kjer
Hansen, invited the EU Commission to initiate further
surveys of BPA's potential harmful effects to health
in September 2008. On 30 March 2010, Denmark as
the first EU country (Canada was already ahead, see
below) adopted legislation banning BPA in food contact
materials for infants 0-3 years of age based on the
precautionary principle. The ban covers baby bottles
and feeding cups as well as packaging (e.g. cans and
lids for jars) destined for contact with food for infants
aged 0-3 years. Special rules at the National level can
only be temporary, since all EU member states must
follow the common European legislation, in this case
primarily REACH and the Safety of Toys Directive.
When a country makes a national special rule the case
is discussed at EU level and subsequently the rule will
apply all over the EU or the country in question will
be told to withdraw the ban in order to have identical
European legislation. If not, the country in question
may be brought before the European Court of Justice
for breach of the Treaty. If a country has been found
guilty of breach of the Treaty, it may be sentenced with
a fine if it continues to disobey the same rules.
In this case, Denmark won the case, and since 1st
July 2010 it has not been allowed to sell baby bottles
containing BPA all over the EU.
France will be the first country worldwide to introduce
a much more extensive ban on BPA. The ban, which
will be fully enforced on 1st January 2014, covers all
materials that get into contact with food. This ban will
be a major challenge for producers of preserves and
soft drinks since BPA as mentioned is a constituent of
the epoxy that makes the inner lining in close to all
cans containing food and drinks as well as many lids for
Cans contain the endocrine disrupting substance bisphenol A that is readily transferred to foodstuffs and thereby
through the diet to humans.
glass containers. Until the ban enters into effect cans
and other products for pregnant women and infants
must be marked that they contain BPA. The French ban
protects all population groups, young and old, and it is
important that Denmark and, preferably, the entire EU
follow suit to secure the entire population. EU now has
to decide if they support the ban and thereby introduce
a general EU regulation on the substance or if France
must redraw it.
At the global level, particularly Canada is advanced in its
protection of the population against exposure to BPA.
Canada was the first country in the world to ban the
substance in baby bottles and a number of measures
have been launched to control the BPA contents in
foodstuffs, especially for children, as well as releases to
the environment.
In addition, more and more producers worldwide phase
out BPA on a voluntary basis. This may partly be due
to the fact that they see a competitive benefit as still
more consumers demand BPA-free products due to the
uncertainties related to the health effects; it may also
be a benefit to be abreast of legislation. As an example,
Campbell's, the world 's largest soup manufacturer in
2012 announced that the company would start phasing
out BPA from their packaging material. The decision
ENDOCRINE DISRUPTING SUBSTANCES > BISPHENOL A
49
was made after Campbell's had received more than
70,000 letters from consumers as a reaction to a survey
in which 12 preserved products from different companies were tested for their release of BPA. Campbell’s
produced the four products with the highest BPA levels.
In addition, Tupperware, which primarily produces
plastic containers for the storage of food, has chosen
completely to phase out BPA – this, however, only
applies to production in the US and Canada. Many of
the Tupperware products are already BPA-free and for
certain other products the substitution is progressive.
Alternatives to bisphenol A
As a direct consequence of the BPA ban in baby bottles
in many countries, several alternatives to polycarbonate have appeared on the market. However, many
of the alternatives found on the European market
are just other forms of bisphenols (S, F, B, and E), of
which some also seem to have endocrine disrupting
effects. In addition, BPA has been found in plastic
types that are not made of polycarbonate, where it
may have been used as a subsidiary material. This fact
reflects deficient legislation. Producers should not be
allowed to replace one harmful chemical substance
with another harmful one, and according to legislation,
they must document that there are no dangers from
using a given material. The problem is that endocrine
disrupting substances are not sufficiently covered by
the chemicals legislation. Therefore, producers may
find loopholes in the law so they do not need to test the
substances further.
Today, the best way for consumers to avoid BPA is to
use glass bottles and containers wherever possible.
For cans, it is almost impossible to be sure, unless they
contain foodstuffs for infants aged 0-3 where the use
is banned.
Denmark was the first EU country to ban bisphenol A in
baby bottles. Since then, the ban has been extended to
cover all EU member states.
ENDOCRINE DISRUPTING SUBSTANCES > FLUORINATED SUBSTANCES – PFOA/PFOS 50
Fluorinated substances –
PFOA/PFOS
Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) are synthetic fluorine-containing substances that have a very long decomposition
time in nature. PFOS contains a linear perfluoroalkyl
chain58 on eight carbon atoms and a sulphonic acid or
its salt as a functional group (see Figure 15).
The fluorinated substances can be divided into two
main groups: perfluorinated and polyfluorinated.
However, as a whole these two substance groups are
called PFC substances (perfluorinated substances).
They all consist of a chain of carbon atoms (C) – a
tail – where all (or almost all) hydrogen atoms (H) are
replaced by fluorine (F) or with at least three fluorine
atoms. The tail can be of varying length (typically
between 4 and 12 carbon atoms) and the strong C-F
bond makes it nearly non-decomposable. The strong
C-F bond also obstructs PFCs from making strong as
well as weak bonds to other substances and therefore
does not dissolve in oil or water. Instead, they float on
the surface like sulphone in water and are thus called a
surfactant.
Figure 15 Chemical structure of A) PFOA and B) PFOS.
A.
B.
Per- and polyfluorinated substances
In the perfluorinated substances all the atomic
hydrogen (H) on the carbon molecule (C) are replaced with
fluorine (F).
In the polyfluorinated substances, there are at least
three atomic fluorine, but there is still atomic hydrogen at
some of the carbon atoms, which make substances able to
further decompose - often to perfluorinated substances.
Examples of polyfluorinated substances are fluorotelomer
alcohols (precursors for the design of other substances)
and di-PAPs (impregnating substances). In contrast to
PFOA and PFOS, the fluorinated tail and head of the
acid-containing di-PAPs are linked to a phosphate ester
bond, which makes the bond susceptible to degradation by
enzymes that are common in nature. Di-PAPs can among
others be degraded to PFOA.
Di-PAPs
Fluorotelomer alcohol
58 An alkyl consists of carbon and hydrogen atoms. An example of a simple alkyl is methyl (-CH3).
ENDOCRINE DISRUPTING SUBSTANCES > FLUORINATED SUBSTANCES – PFOA/PFOS
The fluorinated substances are found in innumerable
products and function both as a water and fat repellent.
They appear in almost all impregnations causing stains
to be wiped off easily from, for instance, flagstones,
tablecloths, sofas, and nursing pillows. The substances
also secure that water does not penetrate your shoes
and coats when you have treated them with a Gore-Tex
spray. PFCs are also present as coatings (Teflon) on
non-stick cookware where water and fat are seen as
small pearls, and on the paper and cardboard packages
that contain hot food without absorbing fat as would
happen with normal paper. The PFCs are so useful
and fancy that we actually do not wish to know other
than that it works. For what if it means that we cannot
use these substances due to the unexpected harmful
effects to health?
Not surprisingly, there is a correlation between the
fact that when a substance has remarkable effects in
products, it also has it in our bodies or the surrounding environment. In addition, when the substances
appear in numerous products and do not decompose
in nature we now find high concentrations of them all
over the environment and in animals and humans. For
instance, PFOA has been found in all pregnant Danish
women who were tested. When fluorinated substances
are tested on rats, the animals develop cancer, grow
fat, and die prematurely. Spray products with these
substances destroy the rats’ lung function and they
die shortly after. Luckily, humans are not rats, but the
many harmful effects should lead us to think again
before uncritically permitting and using the substances. In humans, PFOA has been found accumulated in
blood cells, liver, kidneys, and other organs where the
substance is suspected of harmful effects 59. In addition
to concerns about the substances’ potential harmful
effects on our organs, several fluorinated compounds
have also been shown to be endocrine disrupting and
others are suspected of being so. For instance, PFOA exposure can lead to early puberty in girls 60. Other PFOA
studies indicate that women have difficulties getting
pregnant and that men have lower sperm quality61. A
study of 1,240 Danish women showed a connection
between a high content of PFOA and PFOS in the blood
51
and difficulties getting pregnant - it took them between
6 and 12 months longer. The same high chemical concentrations in the mother also affected the birth weight
of babies and increased the risk of premature birth62.
Furthermore, other recent studies indicate a correlation
between a high content of PFC substances in human
blood and increased cholesterol levels and obesity, as
well as higher risk among women for diseases in the
thyroid gland, i.e. diseases that impairs the energy
metabolism in the body and thus may lead to obesity63.
Finally, a study has shown that prenatal exposure (i.e.
the baby is exposed to the chemical at the embryonic
stage) to PFOA increases the risk of obesity at the age
of 20 64.
The fluorinated substances have been used for more
than 50 years, but in recent years, they have become
more widespread. It is only within the last eight to ten
years they have come in focus due to harmful effects to
health. How the substances actually disturb the body
is still not known, but a number of studies have been
made – mostly on rats – seeking to clarify the mechanisms. There are indications that proteins binding to
fluorinated substances are prevented from functioning
as intended.
The perfluorinated substances are the most well-studied.
However, a general property of PFC substances is that
they are both fat and water repellent and therefore do
not accumulate in fatty tissue nor are excreted with
urine. In fact, the perfluorinated substances are so
stable that the body's normal excretion mechanisms
– which otherwise makes substances to be excreted,
water soluble - does not work. Instead, PFC substances
accumulate and bind almost exclusively to proteins in
the blood, liver, kidneys, lungs and other organs.
PFC substances are extremely bioaccumulative and have
the longest half-lives (half of the substance has been degraded) of all known chemicals in humans – as much as
four to eight years. This means that if you are exposed
to these substances on a regular basis the concentration
in the blood and the body’s organs steadily increases.
Moreover, we are exposed constantly, because PFCs
59 Lau C et al., 2007. Perfluoroalkyl acids: a review of monitoring and toxicological findings. Toxicol. Sci. 99 (2): 366–94
60 Fletcher, T. et al., 2010. Status report Patterns of age of puberty among children in the Mid-Ohio Valley in relation to Perfluorooctanoic Acid (PFOA) and Perfluorooctane
Sulfonate (PFOS).
61 Fei, C. et al., 2009. Maternal levels of perfluorinated chemicals and subfecundity. Human Reproduction, Vol.1, No.1 pp. 1–6.
62 Fei C. et al., 2010. Perfluorinated Chemicals and Reproductive and Child Health Outcomes in Humans: A Study within the Danish National Birth Cohort. Afhandling, 128
pages
63 Melzer D. et al., 2010. Association between Serum Perfluorooctanoic Acid (PFOA) and Thyroid Disease in the U.S. National Health and Nutrition Examination Survey.
Environ Health Perspect, 118:686-92
64 Halldorsson T.I. et al., 2012. Prenatal Exposure to Perfluorooctanoate and Risk of Overweight at 20 Years of Age: A Prospective Cohort Study. Environ Health Perspect,
120:668-73
ENDOCRINE DISRUPTING SUBSTANCES > FLUORINATED SUBSTANCES – PFOA/PFOS
occur in all possible places: indoor, outdoor, in soil,
groundwater and surface water. Even in the Pacific at 1
km. depth traces of the substances have been found. In
addition, polar bears, minks, birds, humans, and aquatic
animals such as fish, seal, otter, sea lion, and dolphin
have been tested positive for PFCs.
Humans are presumably primarily exposed to PFC
substances through food, but the concentrations in
question are not yet fully known. For instance, measurable, but relatively low concentrations of the simple
PFC substances with one alkyl chain are found in fish
from the Baltic Sea, but this is not the major source to
human exposure. Many other and larger fluorinated
substances are found in the impregnation agents used
in paper and cardboard packaging for foodstuffs, but
their possible harmful effects on health are hardly
investigated. However, studies have shown that
packaging, such as bags for microwave popcorn, release
many chemicals (including PFCs) to the packed food - in
this case the popcorn. It is believed today that food
contact materials are the most significant source of PFC
exposure. The box below illustrates the problem.
The University of Copenhagen-LIFE, the Technical
University of Denmark-FOOD, and the University of
Toronto have studied the PFC level in 74 samples of
paper and cardboard intended for packaging of food
or containing food products. The samples were taken
in Danish, Swedish, and Canadian stores, and 42 of
the 74 samples tested positive for PFC impregnating
agents (di-PAPs). Particularly high concentrations of
these substances were found in packaging intended for
fat foodstuffs, high temperatures, or long shelf lives.
Di-PAPs are polyfluorinated substances decomposing
in the body into perfluorinated acids such as PFOA (see
box on per- and polyfluorinated substances). It is very
unfortunate that we are exposed to such high doses
of PFC substances every time we eat, for instance,
microwave popcorn.
However, the problems are not over yet; when PFCs
are used in paper and cardboard production they will
continue to pollute when the paper ware is recycled or
incinerated, because of their persistence.
We can also be exposed to fluorinated substances if
we work in an environment where they are used. For
example, when we spray a coat, shoes, or a sofa with
impregnation agents, or treat flagstones or our cars
with fluorine wax.
It is not completely clear whether PFCs can penetrate the
skin. Nevertheless having it on the skin possesses a risk
of getting it into our mouth when we eat, drink or smoke.
52
The packaging contains fluorinated
substances!
Paper and cardboard packaging for food products
increasingly contains fluorinated substances.
A Danish study found PFC substances in 42 out of 71
samples of paper and board for food packaging! One
example of these high levels was seen in the packaging
for microwave popcorn.
American studies have shown that a person who eats
a bag of microwave popcorn ingest 0.11 mg of fluoride
compounds. This dose is twice as high as what the limit
value (TDI = 0.0015 mg fluoride compounds/kg body
weight/day) allows a child of 35 kg (approximately a
10-year-old child) to ingest per day.
TIPS!
• Be aware of the type of packaging your food is
wrapped in, and the one you use yourself
• Use the packaging for what it is intended for - paper
towel for example, is not approved as a food contact
material
• Use glass and ceramics instead of plastic and paper –
especially in the oven.
In addition, especially infants, but also others, may be
exposed through house dust when the substances are
worn off furniture and accumulate in the dust.
Legislation
PFOS were banned in May 2009 with Annex B of the
Stockholm Convention (read more about this convention in the section ”REACH -Step-by-Step”) on persistent organic pollutants (POP-substances). Therefore,
PFOS is now completely phased out globally except in
situations where it has been found that a substitution
is not possible for social or economic reasons. PFOA on
the other hand is still not banned, neither in the EU
ENDOCRINE DISRUPTING SUBSTANCES > FLUORINATED SUBSTANCES – PFOA/PFOS
nor in other parts of the world, and there are hardly
any restrictions on its use. However, this chemical is
barely used in Danish industry. In addition, it appears
on the list of undesirable substances of the Danish
Environmental Protection Agency and the SIN list due
to the fact that the substance is carcinogenic, reprotoxic, persistent, and is found all over our environment
and in humans. However, compounds such as di-PAPs,
which are decomposed into PFOA in the body, are
completely unregulated today.
53
for instance silicone for impregnation of textiles. In
addition, Teflon, used as kitchenware coating, can be
replaced with titanium and good alternatives are also
available within other product groups, such as paints
and varnish.
Hardcore and ambitious legislation is needed for entire
groups of substances if the fluorinated compounds are
to be phased out. The fluorinated substances have so
many chemical formulas working together that it is
totally insufficient to legislate on one substance at the
time. Unfortunately, even despite harsher legislation
the fluorinated substances are here to stay. Even if we
stop their manufacture completely tomorrow, they will
never disappear. The only way to remove them is by
incineration, but this process entails a risk of CFC gas
(short for Chloro-Fluoro-Carbon) formation that depletes the ozone layer and is strong greenhouse gases,
so there is really no good solution. In the best case, we
can hope the substances bind to sediment encapsulated
in the sea floor and/or in soil over time. Meanwhile,
chemical industries keep on working to develop socalled ”biodegradable fluorinated substances” (shorter
fluorine chains), which may be less harmful to health.
There are no specific limit values to PFC substance
exposure and toxicological tests are sparse and do not
necessarily survey endocrine disrupting effects. For
impregnation agents containing the more complex PFC
substances, hardly any analysis methods can be used
to determine the total exposure and possible effects
on human health and the environment. The reason is
partly that clean substances cannot be acquired and
partly that chemical manufacturers for confidentiality reasons will not inform about their fluorinated
industrial mixtures for research analysis. The EU may
force producers to hand over their PFC mixtures, but
this process is laborious especially when there are no
specific limit values for the substances. In practice,
companies are free to use risky chemicals, thereby
literally turning humans into test animals.
At the global level, the manufacture of polyfluorinated
substances is estimated to 10,000 tonnes a year 65.
However, there are many possible substitutions,
65 Source: Ministry of the Environment: http://www2.mst.dk/common/Udgivramme/Frame.asp?http://www2.mst.dk/udgiv/publikationer/2008/978-87-7052-843-6/
html/kap01.htm
ENDOCRINE DISRUPTING SUBSTANCES > BROMINATED FLAME RETARDANTS
54
Brominated flame retardants
As the name implies, “Brominated flame retardants”
are chemicals often added to different products, especially electronics, because they reduce the risk of fire
during use. The content of bromine increases the ignition temperature so the product does not catch fire so
easily. If the material catches fire anyway, bromine
acid will form (HBr) and hinder free radicals (e.g. H+)
from reacting with oxygen resulting in a mitigating
effect on continued burning (See Figure 16).
year. The substance tetrabromobisphenol A, TBBPA,
(see Figure 17) and its derivatives account for almost
half the consumption – a total of 47 %.
Around 70 different chemicals are used as brominated
flame retardants. Around 40 of these are used extensively mostly in electronic equipment. None of these
Brominated flame retardants may constitute as
much as 22 % of the material in which they are used.
TBBPA has been found in the blood of eight out of ten
computer technicians66, 67. A Swedish survey has also
shown that employees in the WEEE (waste electrical
and electronic equipment) sector have up to 70 times
higher contents of brominated flame retardants in
their blood than other citizens. As mentioned, the substances are found in the blood and they are persistent,
substances are produced in Denmark, but at least 13 of
the brominated flame retardants are used in manufacturing processes in Danish companies. It is estimated
that between 300 and 600 tonnes are imported each
which means that they do not – or only very slowly
– decompose in nature or in organisms. Due to this,
the concentration will increase constantly up through
the food chain and be highest in predators, including
Figure 16 How does brominated flame retardants work?
When a fire is about to break out, for instance in a TV,
process (hydrogen ion, H+ and hydroxide ion, OH-), and
the high temperatures causes the plastic material – here
bromine acid is formed (HBr). The ensuing chain reaction
with polyethene as an example – to decompose into
shorter chains. At the same time bromine (Br-) will be
will prevent the free radicals from reacting with oxygen,
released from the brominated flame retardants causing
could otherwise catch fire.
the product not to burn easily. Bromium will combine with
Source: Jensen C.B., Økotoksikologi (Ecotoxicology), 2008.
thereby keeping the temperature low in the TV, which
the free radicals that have formed during the ignition
66 Dansk Kemi (Danish Chemistry), 86, No. 8, 2005. TBBPA, valg mellem pest eller kolera (TBBPA, a choice between pest and cholera).
67 Jakobsson K.; Exposure to polybrominated diphenyl ethers and tetrabromobisphenol A among computer technicians; 2002; Chemosphere 46:709–716
ENDOCRINE DISRUPTING SUBSTANCES > BROMINATED FLAME RETARDANTS
Figure 17 Structural formula of TBBPA
55
exposed to the substances for a long period, than
what we have seen so far in animal tests. There is thus
reason to suspect that brominated flame retardants
are hazardous, both to human health and the environment. The health hazard is best documented for two
types of brominated flame retardants, PBB (polybrominated biphenyls) and PBDE (polybrominated diphenyl ethers). In addition, the Danish Environmental
Protection Agency has assessed TBBPA to be toxic for
aquatic organisms and to cause harmful long-term
effects in the aquatic environment.
Structural formula of the flame retardant tetrabromobisphenol A (TBBPA). The substance consists of bisphenol
with four bromium atoms attached; it is derived from
bisphenol A.
humans. With a fancy word, this is called biomagnification. Biomagnification was observed already in the
1950s and 60s with mercury and DDT, among others.
Regrettably, we repeat the same mistakes today, just
with other substances with a similar effect.
When we use and dispose products containing
brominated flame retardants the substances may
be released into the surroundings. In our homes, the
substances bind to for example dust and when the
products are thrown away the flame retardants may
end up in the environment.
Adverse health effects of brominated flame
retardants
Brominated flame retardants have a number of
negative effects on human health and the environment. Studies on mice and rats have shown that these
substances may affect the development of the foetus,
reduce reproductive capacity and cause neurological
changes. They also affect the function of the thyroid
gland and are suspected of being carcinogenic. The
concentrations needed to cause the above effects are
higher than what we see in humans. However, there
is much reason for concern, not least as brominated
flame retardants accumulate in the fatty tissue (they
are lipophilic). They will therefore be present in the
organism for a very long time (they are bioaccumulative). This also means that in real life the substances
will remain in the body for much longer than in the
animal tests that have shown effects. Therefore,
there may be more and/or other health effects when
Therefore, it is important to be aware of how to treat
waste electronics. You should not just throw your
used electronics in the waste bin. It is a statutory
requirement that waste electronics (WEEE) must be
disposed of in an environmentally safe manner. In
practice, this means at the nearest recycling centre.
From here, WEEE is transported to a factory dismantling it into components that are sent for reprocessing
so that raw materials can be recycled. Some years back
a survey among 2,000 homes in the municipalities of
Copenhagen and Frederiksberg (Denmark) showed
that much WEEE ends up in the waste bin68. Every
week households in these two municipalities discarded an average of 83 kilograms of small electronic
items in their waste bin. If these figures are converted
to the national level it corresponds to thousands of
tonnes of WEEE that are sent for incineration every
year, without any kind of recycling of raw materials.
Subsequently, experiments have been introduced in
different city districts where every home gets a little
box for collection of small WEEE. The box is picked
up similar to other schemes for paper, glass, and
cardboard.
In 2012, the Danish Environmental Protection Agency
made a survey of domestic waste showing that annually in Denmark 19.4 tonnes of mobile phones and
25.4 tonnes of energy-saving bulbs are discarded with
the domestic waste 69. Nine of ten used mobile phones
end up in the bin instead of the recycling centre where
the hazardous waste can be treated correctly, so that
it harms human health and the environment as little
as possible. This is most likely less of a problem today
because of the increase in the resale of used mobile
phones.
68 Petersen, Claus (2006): Sammensætning af dagrenovation i København og Frederiksberg. (Composition of domestic waste in Copenhagen and Frederiksberg) Report
prepared by Econet AS for: City of Frederiksberg, City of Copenhagen and R98
69 Danish Environmental Protection Agency (2012): Kortlægning af dagrenovation i enfamilieboliger. (Survey of domestic waste in single-family dwellings) http://www2.
mst.dk/Udgiv/publikationer/2012/05/978-87-92779-94-6.pdf
ENDOCRINE DISRUPTING SUBSTANCES > BROMINATED FLAME RETARDANTS
56
and phased out the use of PVC and brominated flame
retardants. This has been possible, among other
reasons, due to reduced energy consumption in their
products – thereby less heat is developed and the risk
of fire is reduced. Apple has also replaced the typical
plastic surface with aluminium.
Most electronics on the market still contain brominated
flame retardants, which are increasingly suspected of
Electronics without brominated flame retardants are
available today. The selection is still not very large,
but if a consumer demands goods – such as PCs, printers, and copiers – with either the Nordic Swan label,
the EU-Flower or the German Blue Angel he can avoid
many hazardous substances. As requirements become
stricter, the problematic brominated flame retardants
will disappear completely from ecolabelled products.
being endocrine disrupting.
As a consumer, you also have the right to know the
content of “substances of very high concern” in the
goods you acquire. You must ask for this information
Legislation
Different pieces of legislation exist that are meant
to reduce the problem of hazardous chemicals in
electronics and electronic waste. However, there have
been a variety of difficulties in the implementation of
effective rules and conventions in the waste sector.
Furthermore, there are problems with the collection
of the waste. Still, there are special rules for hazardous substances in this group of products, namely the
RoHS directive (Restriction of the Use of Certain
Hazardous Substances in Electrical and Electronic
Equipment) and the WEEE directive (Waste Electrical
and Electronic Equipment). In pursuance of the RoHS
directive, PBB and PBDE have been banned from
electrical and electronic equipment from 1st July 2006.
In the EU, there is also a general ban on two of the most
problematic brominated flame retardants: penta-BDE
and octa-BDE. The ban entered into force mid-2004.
Unfortunately, studies indicate that consumers are
more concerned about design and price, than about
health and the environment, when buying electronics. However, it seems that the RoHS directive has
changed the trend among producers on the market.
Several large producers have increased their focus
on hazardous chemistry. This is to the benefit of
consumers, the environment, and the companies as
well, which can market less hazardous and environmentally harmful products and also be at the cutting
edge of any subsequent more severe legislation
where the hazardous chemicals may be banned. Apple
is one of the producers that have taken the first step
yourself, where after the retailer is obliged to reply
within 45 days whether the product contains one
of, so far, 151 substances (January 2014) that the EU
assesses to be of very high concern (appearing on the
so-called Candidate List). However, TBBPA is not on
this list and it will not be included as it stands today.
Therefore, regarding brominated flame retardants,
consumers are not sufficiently protected by this ”right
to know” rule.
3
Fo t o V nl it
Chemicals in everyday life
CHEMICALS IN EVERYDAY LIFE > CHEMICALS IN FOOD
58
Chemicals in food
We are extensively exposed to chemicals through
our food in the form of pesticides, parabens, bisphenol
A, and dyes and fragrances, but there is much we
can do ourselves to reduce this exposure. Especially
candy, snacks, and soft drinks are filled with additives.
Additives are used in food due to their special properties. Some properties prolong the shelf life, others give
a certain consistency or colour. Many foodstuffs would
not last in a sales process, all the way from production,
through transport to supermarket, if no preservatives
were added. Therefore, these substances may in some
cases be necessary, but it is important that they are
used moderately. Generally, there is no difference
is whether consumers should be exposed to a possible
risk just to give the sausage the “right” red colour.
in terms of health effects of additives whether they
are synthetic or natural. Many people consider plant
products – “natural additives” – as harmless and
healthy, but this is far from the entire truth, since
these products also can pose a health risk. Essential
oils (e.g. lavender or lemon oil) are a frequent cause of
allergies. Before additives can be used in foodstuffs,
they must be permitted in the EU and appear on the
so-called positive list. However, for many substances
professionals constantly disagree whether specific
additives have been investigated sufficiently for possible toxicological effects, even when they have been
successfully through a permit procedure.
their sodium salts. These parabens are on the EU list
of substances suspected of being endocrine disruptors
and are classified as Category 170.
Azo dyes are mostly known from textiles but these
dyes are also used extensively in foodstuffs. Azo dyes
are a group of synthetic dyes that all contain the socalled “azo group” (See Figure 18).
Figure 18 Structural formula of an azo group
Fo t o Pg i a m
Many additives are suspected of being carcinogenic.
Nitrite is used as a preservative, for instance, in wine
and sausages and also enhances the colour and taste
of the product. Unfortunately, nitrite is very poisonous, if it is ingested in too large quantities (much
larger quantities than what is found in foodstuffs),
and can be transformed into substances called nitrosamines known to be highly carcinogenic. We still do
not know all the consequences of this. In the organic
food production, this uncertainty has been taken into
consideration to the benefit of consumers. It is not
permitted to add nitrite at all to organic products. The
continued use of nitrite illustrates a problem – we
still use specific substances that are suspected of
being harmful to health, despite the fact that we can
do without them in food production. Nitrite is not
indispensable in food preservation and the question
Parabens, which most people normally only associate
with care products such as shampoos, body lotion,
and similar, are also widely used in foodstuffs, where
they have a preserving effect. It is even more difficult to establish whether parabens are present in
foodstuffs or not, than in care products, since food
is only labelled with E numbers. Four parabens are
permitted in foodstuffs: E214, E215, E218, and E219.
Occasionally, the names are stated instead as ethylp-hydroxybenzoate, methyl-p-hydroxybenzoate and
Azo dyes are found in many different foodstuffs but
mainly in candy, soft drinks, and juices. Foodstuffs
containing the five mostly used azo dyes must in the
future be marked with this ominous phrase; “May have
an adverse effect on activity and attention in children”.
70 Category 1: Substances with documented endocrine disrupting activity in at least one study of a living organism. These substances have top priority for further studies.
CHEMICALS IN EVERYDAY LIFE > CHEMICALS IN FOOD
Ten different azo dyes are permitted in limited
quantities in a large number of foodstuffs in the
EU. Again, a way to avoid these chemicals is to buy
organic food. All azo dyes have been shown to cause
allergenic symptoms, such as asthma and hay fever.
In addition, aggravation of hyperactivity in children
has been observed repeatedly71. Before the introduction of a common European chemicals legislation, we
did not add colorants to basic food such as yoghurt
or food specifically intended for children in Denmark.
There has long been demands that azo dyes should
be banned completely in the EU, and thereby also be
phased out from the Danish market, but so far unsuccessfully. However, in 2008 it was decided that azo
dyes in foodstuffs, including candy, soft drinks, and
cakes - had to be labelled. The EU decision came into
effect in 2010 and in practice it means that foodstuffs
containing the six most used azo dyes must be marked
with the ominous phrase; “May have an adverse effect
on activity and attention in children”. The argument
for not banning the substances completely is that
we need more scientific proof despite the abovementioned research results. On the other hand, the
existing results should be sufficient for EU decisionmakers to make use of the precautionary principle
of the Treaty and to give the consumers the benefit
of doubt regarding the harmful effects. Especially
because there are suitable and unproblematic alternatives to the azo dyes.
When it comes to risk assessment of food and feed
safety in the EU, the responsibility lies with the
European Food Safety Authority – EFSA. In 2002, EFSA
was established as part of an extensive programme
to improve food safety in the EU, to guarantee a high
degree of consumer protection and to re-establish
and maintain confidence in food supply in the EU. The
entire food production “from soil to table”, i.e. from the
primary production (including feed safety) to delivery
of food to consumers, is the responsibility of EFSA.
If there is a risk that humans get too much contamination through food, it is first and foremost important
to reduce the source of the pollution, as this is the
most efficient measure. For example, the use of
unleaded petrol is one of the main reasons that in
particular vegetables and fruit, but also meat, contain
significantly less lead today than some years back.
For pesticides and other processing aids, only the
most hazardous substances have been banned in
59
conventional production, but the authorities have
made rules for how to use the unbanned materials in
order to reduce residues in foodstuffs. Organic producers avoid pesticides completely.
Concerning natural toxins and environmental pollution, limit values are calculated and established
against the background of total dietary composition.
Thereby the contribution from different foodstuffs to
total intake of the substance in question is accounted
for. Tolerable daily intake (TDI) is generally measured
in micrograms (µg). TDI indicates the quantity of a
chemical a person can ingest through the diet every
day, throughout life, without any negative health
effects (see the section ”Limit values”). The TDI value
is, so to speak, distributed throughout all food. The
intake of a certain pollutant in an average diet can
therefore in principle not exceed TDI, when the limit
values are complied. Unfortunately, we do not have
official TDI values for a large number of important
chemicals. This applies, among others, to brominated
flame retardants; an expert committee of the World
Health Organization (WHO) concluded in 2005 that the
available information and data were too sparse to set
up TDI values.
The largest problem associated with a TDI value is
that it does not consider cocktail effects. Today it
is generally known and accepted that it may have
health impacts that we are exposed to many different
chemicals on a daily basis. However, there are still no
guidelines for how to tackle this problem. This means
that the traditional way of calculating TDI values may
lead to a significant underestimate of the risk.
For natural ingredients or pollutions that, among
other sources, origin in the manufacturing processes,
it is not always possible to set up a limit value. Instead,
information and guidance is provided to the consumers to secure them against health risks. For example,
we have dietary guidelines for pregnant women,
including that they should not eat more than 100
grams of predatory fish a week, since predatory fish
may contain mercury.
As a general rule, a varied diet is important to avoid a
high intake of a single pollutant.
71 Assessment of the results of the study by McCann et al. (2007) on the effect of some colours and sodium benzoate on children’s behaviour - Scientific Opinion of the
Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) - http://www.efsa.europa.eu/en/efsajournal/doc/660.pdf
CHEMICALS IN EVERYDAY LIFE > CHEMICALS IN CLOTHING AND TEXTILES
60
Chemicals in clothing and textiles
Textiles are also covered by REACH and therefore
consumers have the right to get information about any
contents of substances on the Candidate List, if they ask
for it. Unfortunately, legislation is not very extensive
in this field and children and adults may be exposed to
dyes, preservatives, and other chemicals through their
clothes. The extent of chemicals in clothes production
can be illustrated by the fact that 0.5-1 kilogram of
chemicals is used for the manufacture of one T-shirt72.
For this reason, you should always wash new clothes
before use, to reduce the release of these substances
on the skin73. However, this does not solve the problem
relating to the use of hazardous chemicals. Chemicals
washed out of the clothes end up in the aquatic environment where they obviously also do much harm, while
other chemicals will remain in the clothes, even after
wash. Particularly phthalates, some heavy metals, and
antibacterial agents are not washed from the textiles in
household washing. However, phthalates, and to some
extent heavy metals, can to a certain degree be avoided
by buying textiles marked with ecolabels or health
labels such as the Nordic Swan or the EU-flower.
Consumers have problems relating to chemicals in
textiles, but another group of people are affected much
Part of the Danish Environmental Protection Agency’s
campaign use a well-known Danish children’s song
(slightly modified) to convey their message.
more severely. In the working environment, there is
extremely high exposures to chemicals, where many
workers are at great risk of getting sick of fumes from
and through direct contact with harmful chemicals.
Report from Greenpeace led to major mindset changes in the textile industry
P ho t o R o b e rt o Gen naro
brands, such as Nike, Adidas, Puma, Calvin Klein and H&M.
One month later a follow-up report 'Dirty Laundry 2: Hung
Out to Dry' was launched. Here they had tested 78 newly
purchased items of clothing from 15 international brands. In
two thirds of the clothes were found nonylphenol, which is
a toxic, non-degradable and endocrine disrupting chemical
particularly used in the dyeing of textiles.
In July 2011, Greenpeace released the report 'Dirty
A few weeks after the publication of the report, PUMA
announced that the company will eliminate all hazardous
chemicals from their production by 2020. Shortly thereafter
Nike and Adidas followed that statement. Also the Swedish
fashion giant H&M has promised to phase out the use of
Laundry', where they revealed textile factories release
of toxic chemicals into rivers in China. These factories
are suppliers to some of the major multinational clothing
hazardous chemicals and furthermore to publish data of
pollution from the factories where their clothing are produced. Source: Greenpeace www.greenpeace.org/denmark
72 Danish Environmental Protection Agency: http://www.mst.dk/Borger/Kampagner/toejkemi/
73 Danish Environmental Protection Agency campaign ”Kemikalier i tøjet er hverken for børn eller voksne”: http://www.mst.dk/Borger/Kampagner/toejkemi/toejkemi.htm
(Chemicals in clothes are no good for children and adults”)
CHEMICALS IN EVERYDAY LIFE > CHEMICALS IN CLOTHING AND TEXTILES
61
Carcinogen found in bags sold in Denmark
Phot o Pas t i cci o
lining of the bag and the amount exceeded the threshold
limit more than 33 times. Such large quantities of the
dangerous substance led to the withdrawal of the bags
from the market and were subsequently handled and
disposed as 'hazardous waste' – bags, that many consumers
had already bought. The Danish Environmental Agency
wrote to the clothing group: "This azo dye is a highly potent
(strong) carcinogen and both direct skin contact with the
colored lining as well as indirect skin contact through
spillovers from the lining to food, hands, lipstick, creams,
etc. should be avoided."
In the summer of 2011, the azo dye Azobenzene,
which by the Environmental Protection Agency is described
as "a very potent carcinogen", was found in a fashion bag
sold from Danish stores. The substance was found in the
This is not least the case in developing countries where
working conditions might be extremely poor. Today,
almost all production takes place in low-pay areas
that have low or no requirements for discharges of
wastewater and use of chemicals, including China,
Bangladesh, and India. H&M is a frontrunner in terms of
phasing out hazardous chemicals in textiles. In autumn
2011 the same clothing company made an ambitious
commitment to all the citizens of the world and their
descendants: “H&M is committed to continuously
eliminate the use of all hazardous chemicals and hence
achieve zero discharge in all production procedures
associated with the making and using of H&M products,
at the latest by 2020”. For example, the fashion chain
has already introduced a ban on the use of PFOA and
PFOS and PFOS-related substances.
In addition to chemical residues in conventional clothing, some clothes items also have plastic prints (so
called plastisol print). The prints are often made from
polyvinyl chloride (PVC) softened with phthalates
that are suspected of having endocrine disrupting
effects. Particularly in children’s clothes, this may be a
problem, since young children tend to suck and chew
on their clothes, which puts them in direct contact
with the chemicals. Many of the substances used for
the manufacture of clothing are furthermore allergenic. Particularly the black colorant p-Phenylenediamine
(PPD), which is found in black and very dark clothes, is
strongly allergenic. Another very problematic chemical product is formaldehyde, which is used to make
the product “wrinkle-free”. In the US formaldehyde is
now included on the list of substances causing cancer
It is worthwhile to be a critical consumer, and for instance
ask the supplier if a product or its packaging contains any of
the so-called Substances of Very High Concern (substances
on the EU Candidate List).
in the human organism, but its use is still permitted
in small concentrations. In the EU, the maximum
permitted concentration of formaldehyde in finished
products is 0.2 % and any product containing more
than 0.05 % must carry a mention that the product
contains formaldehyde. Only specific ecolabelling
schemes have completely banned the use of formaldehyde in textiles. In general, the probability of
chemical residues in textiles is increased in those with
special properties. This group includes water repellent and windbreak textiles (typically impregnated),
anti-bacterial textiles, which may contain silver in
nanometre size, and flame retardant textiles containing brominated flame retardants. Table 4 shows an
outline of chemicals in new clothes. In addition, the
general purpose of the chemical is described along with
the harmful effects to health.
In 2010, a large consumer survey showed that price
is the key factor when Danes buy textiles or clothing
for their children and themselves. If you, on the other
hand, want to consider health and the environment
when buying clothing and other textiles, you may use
the following tips:
• buy organic textiles
• look for one of the official ecolabels: GOTS, the Nordic
Swan, or the EU-Flower
• avoid plastic prints made from PVC
• avoid rainwear and wellies made from PVC
• avoid using impregnation agents with fluorated
compounds (PFCs)
• avoid clothing with a smell of chemicals or perfume
The fragrance may be added to hide the chemical smell
CHEMICALS IN EVERYDAY LIFE > CHEMICALS IN CLOTHING AND TEXTILES
62
Table 4 Tips from the Danish Environmental Protection Agency on how to avoid undesired chemicals in your clothes
Type of chemical
What are the chemicals used for? What is the problem?
What can you do?
Antibacterial
agents
Antibacterial agents such as
triclosan and nanosilver are
added to clothing to kill bacteria and thus prevent odours.
The agents are used in e.g
sportswear, outdoor clothing,
and stockings.
Triclosan may be skin irritant. In
addition, there is a risk that the
antibacterial agents may promote resistant bacteria. Antibacterial agents may be very toxic
to the aquatic environment.
Do not buy clothing treated with
antibacterial agents. Therefore
avoid words like “antibacterial”
and “odourless”.
Colorants
In the colouring of textiles, a
large number of different colorants are used. Some colours
contain heavy metals such as
chromium, copper, nickel, zinc,
cadmium, and lead.
A number of colorants are considered to be allergenic. Some
also of being carcinogenic and
many are toxic to the aquatic
environment. Especially heavy
metals are problematic for both
health and environment.
Wash your clothes before use.
Optical brighteners
Optical brighteners are used to
make textiles appear whiter.
Optical brighteners are heavily
decomposable and very toxic to
the aquatic environment. They
may also be skin irritant.
Wash your clothes before use.
Avoid detergents containing
optical brighteners.
Flame retardants
Some textiles are treated with
flame retardants to prevent
them from catching fire. Textiles in question are typically
furnishing fabrics, textiles in
cars and clothes used for special
purposes, such as clothes worn
by professionals.
Flame retardants may be problematic since they accumulate
in the environment and they are
suspected of reducing reproduction and causing congenital
malformation and cancer. Some
of the brominated flame retardants have been banned from
textiles since 2004.
Do not buy clothing treated with
flame retardants.
Phthalates
Prints on clothing and textiles may be of PVC softened
with phthalates. In Denmark,
phthalates are banned in toys
and articles for infants below
the age of 3, but are permitted
in ordinary clothes – also for
children.”
Some of the phthalates are endocrine disrupting or suspected
of being so – and they are
suspected of reducing reproduction.
Do not buy clothing with PVC
prints (also called plastisol
prints or rubber prints) containing phthalates. Ask in the shop.
Impregnation
agents
Impregnation agents are used to
give a water and dirt repellent
effect.
The agents may contain fluorinated substances suspected
of being both carcinogenic and
endocrine disrupting. Several,
however, are banned in the EU
while others are still permitted. Fluorinated substances are
heavily decomposable and accumulate in the environment.
Avoid impregnation with fluorinated compounds.
Formaldehyde
Formaldehyde is added to
textiles to prevent them from
shrinking and wrinkling, to fix
colour and repel dirt. In addition, formaldehyde is used as a
preservative to prevent clothes
from rotting during transport
over long distances.
Formaldehyde may cause skin
irritation and allergenic reactions. In addition, formaldehyde
is carcinogenic by inhalation - in
particularly high doses that will
typically only occur in the working environment during production and use of formaldehyde.
Wash your clothes before use.
Source: Danish Environmental Protection Agency 2011
CHEMICALS IN EVERYDAY LIFE > CHEMICALS IN CLOTHING AND TEXTILES
63
Figure 19 A selection of labelling schemes
The Nordic Swan
The EU-Flower
Fairtrade
Oeko-Tex®
A selection of labelling schemes that can help consumers
types of labels: Organic labels, ecolabels, fair trade labels,
avoid many chemicals. Generally, there are four different
and health labels. They are described below.
• avoid buying antiwrinkle clothing (often contains
formaldehyde)
• avoid clothing described as antibacterial, mildew resistant, or similar (most probably contains nano-silver).
Clothes with the Nordic Swan label don't contain
substances that are suspected of being endocrine
disrupting.
The EU-Flower has requirements for the manufacturing
process from the cotton arrives at the factory until it
There are many labelling schemes for clothing that
help consumers buy goods that are either less harmful
to health, the environment and/or to those producing
it (See Figure 19).
ends up in Danish shops, including requirements for use
of chemicals. However, the EU-Flower does not have
requirements for organic raw materials, but does have
rules for the kinds of pesticides used in the fields.
Both the Nordic Swan and the EU-Flower ban the use of
PVC prints on the clothes, and colorants causing allergy
or that are suspected of causing cancer may not be used.
Organic labels:
If you wish to buy organic clothing there are several
labels you can look for. Some organic labels only have
requirements that the material, e.g. the cotton, is
organic while others also have environmental and
health requirements for the production stage. Some of
these labels comply with the criteria for Global Organic
Textile Standard (GOTS), which is the closest we get to
a global standard for organic clothing. GOTS requires
that the clothes are manufactured from organic raw
materials and that it is processed in an environmentally correct manner at the factory. In addition, it
must not contain phthalates. There are a number of
other organic labels for clothing in Denmark, including
Demeter and Soil Association.
Environmental labels:
When you buy ecolabelled clothing or furnishing
fabrics, particularly such labelled with either the
Nordic Swan or the EU-Flower you choose one of the
least environmentally harmful products on the market.
The criteria for these labelling schemes are normally
strengthened every three years to secure that the
labelled products are always in the best category when
it comes to environmental and health considerations.
At the same time, the labels guarantee that the quality
and function of the product are at least as good as for
comparable, non-labelled products.
Fairtrade label:
The Fairtrade label, which used to be known as Max
Havelaar, is also used on clothing and is an international labelling scheme. The label guarantees that
farmers and workers in developing countries have
decent working conditions and get a minimum price
for their products. The farmers are paid a special supplement for organic farming if they have converted
their production, but there is no requirements for organic farming in the Fairtrade labelling since it would
exclude some of the weakest farmers. Around 75 % of
Fairtrade labelled products on the Danish market are
also organic, and if so this will appear from an organic
label next to the Fairtrade label.
Health labels:
“Confidence in Textiles” – Oeko-tex® is the world’s
leading health label for textiles, but it entails no
environmental requirements. It guarantees that
the clothes contain a minimum of a large number of
substances of high concern. For instance, there are
rules for how many chemical residues, pesticides, and
formaldehyde the textiles contain. By contrast, it says
nothing about how and with which substances the
textile has been manufactured. For example, there is
no general ban on the use of phthalates in the clothes.
CHEMICALS IN EVERYDAY LIFE > THE HORROR SHOW
64
The horror show – are we hormonal
ticking time bombs?
A case story
On a daily basis, more than 100 substances that
affect our endocrine system one way or the other
surround us. If on top of that we are exposed to several
different harmful chemicals simultaneously, the result
may be the so-called cocktail effects. We are exposed
to the substances around the clock, but we can make
many choices that reduce exposure.
Already when we go through our regular morning routines, we are exposed to large quantities of endocrine
disrupting substances. In the shower, they are found in
the care products we use such as shampoo, conditioner,
and shower gel. Later, when we use body lotion and – as
many girls and women do – put on make-up, we can
again be exposed to harmful substances. As explained
in the above section (See ”Chemicals in clothing and
textiles”) exposure increases when we start dressing.
Breakfast and other meals during the day can also
contain endocrine disrupting substances and other undesired chemicals as can food packagings. Actually, it is
presumably through our diet that exposure is highest.
When we read our newspaper, we are potentially
exposed to harmful chemicals from the printing ink
and when we check our e-mail before leaving home,
we are exposed to brominated flame retardants from
the computer and some of our furniture. In addition to
all these exposures, a person inhales large quantities
of air during a day. In kilograms this is much more than
what we eat and drink in one day, and the air is most
probably also polluted with hazardous chemicals.
This scenario clearly illustrates that there is a large risk
of exposure to numerous chemicals during a day – often
in concentrations that by far exceeds the limit values
set up to protect human health and the environment.
Also, cocktail effects of all these chemicals may arise
when we are exposed to many different chemicals at
the same time (read more about this issue in the section
”Cocktail effects”).
Naturally, we cannot do without chemicals in our daily
lives, but we can phase out the most harmful ones.
Many consumer products contain unnecessary endocrine disrupting chemicals that can easily be replaced
or left out completely, such as some preservatives in
care products. For example, if we keep lotions and hair
wax in tubes instead of open cans they preserve fine
without harmful chemicals. In many other products,
the most hazardous chemicals can be substituted with
other substances that are thoroughlytested and scientifically proven harmless. This is the case, for instance
with the plasticisers phthalates, which can be replaced
by polyester and silicone.
The Swedish Society for Nature Conservation together
with other NGOs have tested dust from bedrooms
in a large number of European, African, and Asian
countries 74. In September 2011, the Society published a
report showing that a hazardous mixture of endocrine
disrupting substances is hidden under our beds regardless of the country of origin of the house dust. The
chemicals are present in levels that are much higher
than previous findings. These results cause concern,
since endocrine disrupting substances are increasingly
suspected of being the cause of a number of health
problems. For instance, a rising number of boys are
born with genital deformation and still more women
get breast cancer. In addition, it has been seen that
the male part of the population in many countries has
reduced fertility. Women therefore take longer to get
pregnant, must receive treatment to get pregnant, or
cannot have babies at all.
Europeans spend up to 90 % of their time indoors 75
where exposure to chemicals may be up to 1,000
times higher than outdoors (see Figure 20 with possible sources of chemicals released in our homes). This
much higher rate of exposure is due to the fact that
decomposition of organic chemicals is very limited
indoors due to the often very dry air and the absence
of microorganisms and sunlight (UV radiation accelerates decomposition). The circulation of air in modern
insulated buildings, as they are in our cool climate, is
also limited, contributing to a very long decomposition
74 ”Home sweet home - dusty surprises under the bed”; 2011; http://www.chemsec.org/images/stories/2011/chemsec/home_sweet_home_lowres.pdf
75 www.bolius.dk
CHEMICALS IN EVERYDAY LIFE > THE HORROR SHOW
65
Figure 20 We are surrounded by chemicals
COUCH
ELECTRONICS
WOODEN
FURNITURE
CABLES
FLOOR
A small selection of chemicals that may be released from the items we have in our homes. BF: brominated flame
retardants; DS: disinfecting substances; FA: formaldehyde; PS: polyfluorinated substances.
time for chemicals in the indoor environment.
Generally, young children spend even more time in their
homes than adults. Other factors affecting exposure
are associated with physiology and behaviour. Children
spend much time on the floor and young children
often have “hand-to-mouth contact”, which means
that they generally ingest more dust than adults do. A
poor indoor environment may cause symptoms such
as irritated eyes, headaches, tiredness, and allergy –
and in the worst case more serious diseases such as
cancer and cardiovascular diseases. Therefore, it is not
hard to imagine that relatively high concentrations of
chemicals suspected of being endocrine disrupting may
threaten our health conditions.
According to the Swedish report, the endocrine disrupting substances found in the dust included brominated
flame retardants, phthalates, bisphenol A, parabens,
polychlorinated biphenyls (PCB), alkylphenols, perfluorinated substances (PFCs), and pesticides. Most of
these substances and their names are not familiar to
many people, but most of us have them in our homes in
various concentrations - first in consumer products and
later on in dust. This is due to the fact, that endocrine
disrupting substances are released from many of the
products in which they occur, due to either heating or
wear. In addition, they are found in products that are
normal in our homes, including furniture, electronics, cosmetics, and toys (see Figure 20). As described
above, it is possible to replace the most hazardous
chemicals with less hazardous or harmless substances
in many of these products. However, since there is no
ban on their use it is difficult to make producers replace
a substance that is already part of their production.
This is often due to economics – it may be expensive to
change production or the new substance may be more
expensive – but ignorance about suitable alternatives
may also be a reason. Therefore, it is necessary to have
these substances included in the European chemicals
regulation in order to have a level playing field. This will
entail larger demand for the alternative less harmful
substances and thereby decreasing prices. In addition,
it will balance the distortion of competition that arises
if one producer chooses to take the lead to ensure that
his products are harmless to human health and the
environment. The way it is today a company that takes
the lead regarding substitution of hazardous chemicals
risks to be priced out of the market.
Multitudes of guides are available on the Internet helping us to become greener consumers. In addition, various campaigns are made to help ordinary consumers
CHEMICALS IN EVERYDAY LIFE > THE HORROR SHOW
act reasonably in relation to their health. For instance,
the Danish Ministry of the Environment makes many
campaigns that are often directed at specific target
groups, such as teenagers, parents of young children,
pregnant women, etc. In many cases, a scientific survey
is behind the campaigns that thus also can be used
in European/international contexts. For instance,
Denmark has used such scientific data in a legislative
proposal aiming to ban bisphenol A in baby bottles
(read more in the section ”Bisphenol A”). As from July
2010, this ban took effect all over the EU.
66
4
Pho t o Lao s hi
Cocktail effects and
Nanomaterials
COCKTAIL EFFECTS AND NANOMATERIALS > COCKTAIL EFFECTS 68
Cocktail effects
Every day humans and the environment are exposed to
Foto D an Brandenburg
a cocktail of all the chemicals that surrounds us in our
everyday lives. The chemicals are released from e.g.
electronics, furniture, clothing and food packaging.
Just as people are exposed to chemicals from
many different sources (discussed in the section ”The
Horror Show – are we hormonal ticking time bombs?”)
exposure also affects the environment. This may be in
the form of pesticides from agriculture, discharges and
sludge from wastewater treatment plants and overflow
from sewers, as well as atmospheric accumulation of
heavy metals and various chemicals transported by the
wind. Both people and the environment are therefore
exposed to many different chemicals on a daily basis
and no existing legislation protects us from adverse
effects from this chemical cocktail.
A cocktail effect is also referred to as a combined effect
or a synergetic effect. It means that all chemicals found
in a mixture contribute to the total effect of that mixture. A cocktail effect may arise from many scenarios,
but people are primarily exposed through their diet or
the air we breathe. Such scenarios may be:
• exposure to several different pesticides occurring in
the same food product which are thereby ingested
with the diet.
• exposure to many different kinds of chemicals occurring in consumer products such as parabens from
cosmetics and care products and phthalates and
fluorinated substances from clothes.
• exposure to house dust, where chemicals released
from ordinary consumer products in the home accumulate. These are, for instance, brominated flame
retardants from electronics, PVC and phthalates
from vinyl floors, and disinfectants from furniture.
Particularly young children are exposed in this way
as they crawl on the floor.
Today we know that chemicals that individually and at
low concentrations are harmless to human health and
the environment may have harmful effects if they occur
in mixtures. Thus, it may seem evident that assessments should consider the toxicity of chemical mixtures
as a whole. However, with today’s procedure, we study
the toxicity of each single chemical substance in a
given mixture separately, and the responsibility lies
with the producer. One of the problems with chemical
mixtures is that they come in overwhelming numbers.
With around 80,000-100,000 chemicals76, 77 in mass
76 EU definition: Chemicals are the common term for chemical substances and mixtures whereas a chemical substance is defined as ‘the substance as it occurs or as it is
manufactured’.
77 http://ec.europa.eu/environment/chemicals/exist_subst/einecs.htm
COCKTAIL EFFECTS AND NANOMATERIALS > COCKTAIL EFFECTS 69
The problem of chemical mixtures concerns all groups
of chemicals such as carcinogenic substances, allergenic substances and endocrine disrupting substances.
But only for the latter – the endocrine disrupting
substances – has research on cocktail effects been
made. Danish research has shown that when test
animals are exposed to mixtures of endocrine disrupting substances it may cause serious reproductive
disturbances 78. This has been seen in concentrations
so low that each chemical separately would not cause
measurable health effects.
Many pesticides are used in agriculture. Therefore, foodstuffs can contain a large number of different chemicals
that humans are exposed to through their diet. The
chemical cocktail we are exposed to may have adverse
health effects.
production, there are more potential combinations
than could ever be tested for toxicity. In addition to
the number of potential mixtures, also the number and
concentrations of chemicals in a chemical mixture have
an impact on the toxicity of the mixture. Furthermore,
which organism is exposed to the chemical mixture
also matters. A mixture may have one effect on plants,
another one on humans, and a third effect on fish.
Therefore, it is not sufficient to assess chemicals one
by one. However, there are still discussions about how
best to calculate the risks associated with mixtures
of chemicals and who should prepare the risk assessments. With the risk assessment methods available
today it is almost impossible to assess the risks associated with all possible chemical mixtures. Furthermore,
it is difficult to set up realistic scenarios in scientific
tests, since it is not possible to use humans as test
organisms when serious effects are tested. Limit values
for chemicals found as additives in foodstuffs, softening phthalates in toys, or in the working environment,
are often established based on a concentration found
harmless, for instance, in animal tests. This “safe”
concentration is further divided by a safety factor (in
many cases 100), which is assumed to be sufficient in
order to protect human health and the environment.
Subsequently, when doing risk assessments, it is
tested, on the basis of this limit value, how much the
overall exposure is for each substance. This is done
without considering that humans and the environment
are actually exposed to many different chemicals from
many different sources at the same time, not considering the cocktail effects.
To minimise the risk of these cocktail effects as much
as possible there has in recent years been an increasing
focus on research where effects of mixed contaminations (where many different chemicals were at play)
have been studied. Increasingly, these test results
indicate that in most cases it is possible to calculate the
cocktail effects of mixtures by two relatively simple
concepts: Concentration Addition (CA) and Independent
Action (IA). CA presupposes that the different chemicals in a mixture have the same effect mode, while IA
presupposes that the different chemicals in a mixture
have different effect modes, for instance one chemical affects the liver while another affects the blood
vessels. Both methods are based on precise knowledge
about the quantitative and qualitative composition of
the mixture, so it is decisive to have single substance
assessments of high quality.
Concentration Addition
The method is based on the assumption that all chemicals in a given mixture have the same effect mechanism, but the strength of the effect may be different
for the different chemicals. The concentrations causing
exposure are simply added and thereby the total effect
is found.
It can be explained by comparing with the intake of
alcohol. Everybody knows that you do not get drunk
from half a beer. Nor from a small glass of wine. One Gin
& Tonic does not make you stumble. And one whiskey
will not knock you out. However, if we drink all of these
one after the other, most of us would feel a certain
effect of the total amount of alcohol. Very simply, in
this case, the concentrations of each drink are added
and the total effect of the “cocktail” is inebriation. Here
different substances with the same effect mechanism
individually have no or only very little effect, but the
sum of them has a harmful effect to health.
78 Hass U et al., 2012. Adverse effects on sexual development in rat offspring after low dose exposure to a mixture of endocrine disrupting pesticides. Reprod Toxicol.
34(2):261-74.
COCKTAIL EFFECTS AND NANOMATERIALS > COCKTAIL EFFECTS Independent Action
This method is based on the fact that chemicals in a
given mixture have different effect mechanisms, i.e.
they work on different targets in the organism; but all
chemicals in general contribute to the same type of
effect – e.g. it is fatal or affects reproduction or growth.
In this method, the effects of the different substances
are added to find the total effect of a mixture. This
method has the fundamental problem that the total
effect is calculated from observed effects of individual
substances. Therefore, a given mixture effect will be
missed if a chemical occurs in a concentration that is
lower than the “zero effect concentration” (a defined
limit under which the given substance has no harmful
effect).
It is a key assumption of both methods that the individual substances in a mixture do not affect each other
mutually with regard, for instance, to assimilation,
transport, metabolism, or excretion. In addition, the
substances are not supposed to affect each other’s
effect mode in the exposed organisms.
Both models have their uncertainties, since they rest on
assumptions that would rarely be seen 100 % satisfied
in reality. Generally, the Concentration Addition method
tends to slightly overestimate the effect of mixtures
with different effect mechanisms, while it seems that
Independent Action often underestimates the effects
of chemicals with the same effect mechanisms. In other
words, if the choice is between the two models for risk
assessment, Concentration Addition will give a higher
degree of protection than Independent Action.
Three types of cocktail effects
Cocktail effects come in different ways:
1. Additive effect
2. Antagonistic effect
3. Synergistic effect
Additive effect. The total effect of several different
substances corresponds to the sum of the different substance effects. This type of effect thereby corresponds
to what you can calculate with the above-mentioned
Independent Action model.
However, it is not as transparent as it may sound; for
instance, you add the four effects seen/measured in
the four different chemicals. In that case, the effect
could be stated as 0+2+0+1 = 3. Here it seems that two
of the chemicals have no effect. However, all chemicals
have an effect - some of them are just not measurable.
70
Therefore, the two effects that seem to have zero effect
may have one when they are added, and the additive
effect of the four chemicals might thus be four or five
instead of three. In other words, for some substances
the concentration we are exposed to from the single
substance may be so low that it would not cause any
harmful effects to health. However, if you are exposed
to the same concentration of the substance in combination with other substances, then it may have an effect.
It is believed, that additive effects are the most common form of cocktail effect.
Antagonistic effect. Chemicals occurring together
sometimes neutralise or reduce the effects of each
other. In this type of interaction, it is less hazardous to
be exposed to several substances at the same time than
what should be expected based on knowledge about
the effects of each individual chemical substance. In
other words, 2+2 = 3. The antagonistic effect is only
seen when the chemicals react with each other (affect
each other). They can do this by either precipitation or
by increasing each other’s turnovers (metabolism). In
such a case, neither the Concentration Addition nor the
Independent Action model can be used as the model for
calculation of cocktail effects.
Synergistic effect. In this type of effect chemicals in
a mixture enhance each other’s effect. The effect of the
substances in combination is thus larger than expected
based on the effects of the individual substances. In
this case, the risk of health effects from the chemicals
is higher when you are exposed to a mixture of the substances than when you are exposed to the individual
substances.
An example of substances that may have synergistic
effects are certain fungicides that are known to reduce
the activity of the enzymes that decompose xenobiotics, in humans among others. If a person is exposed
to these fungicides, other xenobiotics getting into the
body cannot decompose and will thus remain in the
body for a longer time. This will presumably increase
the toxicity. A mixture of a fungicide and a toxin where
the fungicide impedes the decomposition of the toxin
will therefore release a synergistic effect.
So far, synergistic effects have had most focus, as it is
evidently the most alarming. In addition, the synergistic effects are different from one chemical mixture to
another and from one organism to another; thereby it
is very difficult to determine their effect. However, it is
also very important to have focus on additive effects
as the individual chemicals in a chemical mixture often
COCKTAIL EFFECTS AND NANOMATERIALS > COCKTAIL EFFECTS 71
Phot o Lev ent Konuk
will be present in so small concentrations or have so low
an effect that they are considered harmless. However,
in mixtures even apparently harmless concentrations
and/or effects may turn out to be harmful after all.
From the sparse knowledge available on synergistic
effects, they seem to occur very rarely. Generally,
synergism would not be a problem if only this effect
was exploited by using smaller quantities of these substances to attain the same effect. However, the problem
arises because legislation is based on the potential for
harm of individual substances. Thereby, substances
causing synergistic effects are often not identified.
Even small concentrations of pesticides in our food has
The Technical University of Denmark, DTU-FOOD
published in 2009 a study79 showing that the impact
from a simultaneously exposure to several different
endocrine disrupting substances multiplies greatly
the hormonal damage in male rats. By contrast, only
few effects were seen in rats exposed to the individual
been shown in some cases to have adverse health effects
substances one by one. Some test groups of pregnant
rats were exposed to one endocrine disrupting chemical while other groups of pregnant rats were given very
low doses of several endocrine disrupting chemicals
that individually have no harmful effect in small doses.
The effects on the offspring of the latter groups of
animals were alarming. The male offspring had, inter
alia, severe malformation of the reproductive organs,
caused by sex hormone (testosterone) disturbances.
The article concludes that the principles can most probably be transferred to humans, as testosterone also is
crucial for development in the embryonic stage of male
babies.
legislation REACH, which entails a major risk for
European citizens. So far, authorities set up limit values
for individual substances only. However, legislation
should take into account that we are exposed to many
different chemicals at the same time on a daily basis.
This has become a priority area for the Danish government, and during the Danish EU presidency in spring
2012, it was decided to prioritise this area in the next
ten years; this has subsequently been included in the
so-called 7th EU Environment Action Programme. In the
Environment Action Programme the EU environmental
policy is adopted for a ten-year period. It contains fields
of special attention in the EU, where improvements are
called for.
when they occur in combination.
effects are not included in the European chemicals
In an expert report 80 from 2009 it was concluded that
”with the knowledge attained in recent years it is both
possible and necessary to include the risk of cocktail
effects in the risk assessment of endocrine disrupting
substances”.
Legislation
Fortunately, there is an increasing focus on the problems relating to chemical mixtures, but it is important
that the research community, authorities, and ultimately politicians work with determination. We need
to develop new and better tools, including new and
better laboratory methods and mathematical models
for prediction of cocktail effects. In addition, legislation should be more stringent. As it is today, cocktail
79 Christiansen S. et al., 2009. Synergistic Disruption of External Male Sex Organ Development by a Mixture of Four Antiandrogens. Environmental Health Perspectives.
Volume 117 number 12:1839-1846
80 Ministry of the Environment. “Expert workshop on combination effects of chemicals”. http://www.mst.dk/NR/rdonlyres/C59693B7-2421-4748-89F05937496E0A28/0/BILAG_2_Expertworkshop.pdf
COCKTAIL EFFECTS AND NANOMATERIALS > NANOMATERIALS
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Nanomaterials
Figure 21 How small is a nanoparticle?
The size of a nanoparticle compared with a football and the globe. The difference in size between a nanoparticle and a
football corresponds to the difference in size between a football and the globe.
Nano refers to the size of the particles or the
material in question. The word nano comes from Greek
and means ‘dwarf’. A nanomaterial is defined as having
one or more external dimensions in the size range
1 - 100 nm. Mathematically, nano means one-billionth
and since a nanometre thus is one-billionth of a metre,
these materials are far smaller than what can be seen
with the naked eye. For instance, we can compare
with a human hair, which is 80,000 times thicker
than a nanometre, or we can compare a nanometre, a
football, and the globe. Here the difference between a
nanometre and a football corresponds to the difference
between a football and the globe (see Figure 21).
Nanomaterials can be used in a wide range of different
products, including:
• nanostructures that improve the performance of
computers and other electronics
• active nanoparticles in catalytic converters in
vehicles contributing to removal of harmful gases
from the exhaust
• nanomedicine that can be targeted at specific organs
• antibacterial treatment of sportswear
• sun tanning filters of titanium dioxide(TiO2) in sun
tanning products
• water repellent surface treatment products for stain
resistant sofas and similar textiles
• carbon nanotubes that improve the strength of
light-weight materials such as rackets, bicycle
frames, and windmills
• pigment in paints
• and several other products....
Clearly, nanomaterials are used in very different types
of products many of which are covered by different
pieces of legislation and hence make it difficult to
protect both human health and the environment in
general. The issue is further complicated by the fact
that so far nanomaterials are not covered by any legislation. Instead, they are treated as the same substance
at a larger scale. This means that nanosized silver,
which is used among others in sportswear to prevent
odour, is regulated in the same way as silver in larger
forms, as we know it from jewellery.
A nanomaterial can be manufactured from a known
chemical substance or from a completely new chemical
compound and it may consist of one or more substances. Nanosized chemicals can be exploited technologically in new contexts, since the size alone can
give the material special properties. One reason being
that nanomaterials with the same mass as the original
substance have a surface that is much larger than the
same particles of ‘normal’ size. Nanosized materials can
in this way have inexpedient physical, chemical, and
COCKTAIL EFFECTS AND NANOMATERIALS > NANOMATERIALS
73
TiO2 as photocatalyst
In the presence of UV light, titanium dioxide (TiO2) is a very
efficient photocatalyst. In atmospheric air, there is always
a naturally occurring water film on almost any surface.
The water molecules are split by catalytic TiO2 to the very
reactive hydroxyl radicals (.OH), which can break down
organic molecules. Oxygen O2 from the air can also be split
by TiO2. Under the influence of UV light, the CO2 is split to
superoxide molecules (O2·-), which also participate in the
decomposition of organic molecules.
and organic dirt, which in then rinsed off the hydrophilic
("water-loving") surface.
Both molecules are potent antioxidants, and the primary
degradation products after complete oxidation of an organic
molecule are CO2, water and NO2 (see figure). Despite the
fact that the reaction products are comparable to a complete combustion, the reaction mechanism is very different.
The figure is a schematic illustration of the photocatalytic
effect of TiO2. In the presence of sunlight (or other UV radiation) TiO2 splits H2O and O2 to the very reactive hydroxyl
radicals (.OH) and superoxide molecules (O2·-). The radicals
degrades both nitrogen oxides (NOx) from air pollution
biological properties, since the surface of the particles
often trigger an effect, such as a photocatalytic effect
(see box), which in some cases can cause damage to the
environment.
Even if a material is harmless in a larger form, it may
be hazardous when it occurs in nanosize. For instance,
gold and silver jewellery is harmless, while nanoparticles of the same materials both are more reactive and
so small that they may penetrate the cells of humans,
animals, and plants (see Figure 22). One of the special
features of nanoparticles is that they can penetrate
into the deepest regions of the lungs – the alveoli –
where they cannot be removed easily (see Figure 24).
Larger particles cannot penetrate further down than to
an area of ciliated epithilium. Cilia move together and
carry out mucus of the respiratory tract. Particles of
larger size will stick to the mucus. When nanoparticles
end up in the alveoli they will remain there for such
a long time that inflammation might develop. This
phenomenon is a contributory factor to the development of cancer and cardiovascular disease. Research
from The Danish NanoSafety Centre, at the University
of Copenhagen, and the National Research Centre for
the Working Environment, among other institutions,
have shown that these damages can occur at concentrations that humans are exposed to in the working
environment.
Therefore, due only to their size, nanomaterials have
some new features, which means that we cannot
automatically assume that they are harmless, merely
based on the fact that their larger 'siblings' are. This
illustrates the necessity for nanomaterials to be seen
as an individual substance group, for which specific
Figure 22 Routes of exposure
Nanoparticles are absorbed through the mouth, the skin
(especially in wounds and cuts), and by inhalation through
the respiratory tract.
COCKTAIL EFFECTS AND NANOMATERIALS > NANOMATERIALS
legislation should be subjected ensuring that human
health and the environment are not harmed.
The health uncertainties relating to the use of nanoparticles are primarily found in the production stage
where the staff may be under constant exposure to
free nanoparticles, i.e. particles that are not bound to
other materials and thereby occur free in the air. When
the product is finished, the nanoparticles will normally
be bound or encapsulated in the product. However, also
here a risk of exposure exists, since the nanoparticles
may be released, for instance, by wear of the product or
in the waste management stage.
It is important that we become capable of including
considerations about risks and environmental impacts
when we use and develop nanoproducts. Hence, more
research is needed in so-called nanotoxicology, where
scientists study the toxicity of nanosized materials.
When we wish to know whether there is a risk associated with the use of a substance there are two main
questions to be answered:
1. To which degree are we exposed to the substance?
2. How hazardous is the substance?
To begin with, if we are not exposed to a substance it is
not dangerous. However, it is rather hard to find a product that contains nanomaterials where there at no time
of its lifecycle (production, consumption, waste disposal)
exists a risk of exposure for humans or the environment.
It is said, that the sum of the exposure and the hazard
related to the substance determines the total risk of
using the substance. This is illustrated in Figure 23.
Figure 23 The risk of chemicals
EXPOSURE
R
I
S
K
HAZARD
How exposure and hazard can entail a risk of use of a
given substance.
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Undoubtedly, nanoparticles have many fine properties, when they are added to consumer products and
products for industry, but their potential health impacts
are not yet fully understood and therefore caution is
needed.
We have several examples from the past where it was
realised too late that the use of a given substance had
severe consequences. An example known to most is
the use of asbestos. Asbestos was used in the 19th
and 20th centuries as a construction material due to
its fireproofing and insulating properties. Not until the
1980s was asbestos banned completely in Denmark
and today it is not permitted to manufacture, import,
or use asbestos or asbestos containing materials of any
kind. More than 40 countries have a similar ban, including most countries in the European Union. However,
it is permitted to remove asbestos from buildings,
for instance, but this work is subject to major safety
precautions.
Asbestos is a health hazard especially because of its
small size. When we inhale asbestos fibres, they can
penetrate into the remotest parts of the lungs, as they
are much smaller than 3 μm, which is the diameter
of the thinnest branches of the lungs. Therefore,
asbestos dust will accumulate in the lungs and cannot
be removed. Inhalation of asbestos dust increases the
risk of cancer in the lungs, the pleura, the ovaries, the
peritoneum, and the throat. Moreover, some studies
indicate that asbestos increases the risk of cancer in the
intestines and the gullet.
It is estimated that around 400 incidents of asbestos
related cancer occur in Denmark every year, and this
figure is not on the decrease despite the fact that
asbestos has been banned for many years. This is,
among other reasons, caused by the fact that cancer in
the pleura takes about 25-30 years to develop.
Today, many opponents of the unregulated use of nanomaterials fear that the future will reveal similar adverse
health impacts in humans exposed to nanoparticles.
Example of how animal tests can simulate the
working environment
In their working environment, painters are exposed to
paints with nanoparticles added, for instance, as a pigment. These types of products are often not sufficiently
studied in relation to potential harmful effects to human health and the environment. There are therefore
concerns that paints containing nanomaterials may be
a contributory cause of unforeseen industrial injuries
for this profession. So far, a correlation between the
COCKTAIL EFFECTS AND NANOMATERIALS > NANOMATERIALS
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Figure 24 Lung anatomy
Difference between mass and surface
A calculated example of the difference between
exposure to a specific mass (weight) of nanoparticles
and a specific surface area of the same nanoparticles.
Many believe that it is the surface (or more precisely,
what is attached to the surface) of the particles that
might have adverse health effects.
Titanium dioxide large : the size is 288 nm and the
surface area is 21 m2/g
Titanium dioxide small: the size is 21 nm and the surface
area is 107.7 m2/g
Lungs with bronchial tubes and alveoli.
Source: National Institute on Alcohol Abuse and Alcoholism.
For titanium dioxide large:
Focus on the Lung.
frequency of nanoparticles in the working environment
and hospitalisation has been found.
In Denmark, the limit value for airborne TiO2 (used as a
white pigment in paints) in the working environment
is 6 mg/m3 and ranges from 3 to 10 mg/m3 in the other
European countries. In 2006, the International Agency
for Research on Cancer (IARC) concluded that TiO2
might be carcinogenic for humans (Group 2B).
In an animal study, the aim was to simulate human inhalation of nanoparticles. Mice had TiO2 particles blown
into their lungs (corresponding to humans inhaling particles) at a dose of 0.5 mg/kg body weight, which corresponds to a slightly higher dose than what we may
be exposed to as a maximum at our workplace. This can
be calculated in the following way: It is assumed that
every day a person inhales 8 m3 air during his working
hours and 100 % of the inhaled substance is deposited
in the lungs – thereby the limit value corresponds to
0.64 mg/kg body weight for a person weighing 75 kg.
Mathematical models, however, have shown that only
10-20 % of the inhaled particles between 0.1 and 1 µm
diameter (corresponds to 100 and 1000 nm, respectively) will reach the alveolar regions of the lungs (see
Figure 24) from where they may be transferred to the
bloodstream if they are sufficiently small.
In this study it was found that all the particles were 1
µm in diameter or smaller. Converted, this means that
0.064-0.128 mg/kg body weight of the TiO2 particles
end up in the alveolar regions. This is described in
detail in the box.
8 m3 * 6 mg/m3
75 kg
= 0.64 mg/kg body weight
(10 % of the inhaled particles will reach the lungs)
0.10 * 0.64 mg/kg body weight = 0.064 mg/kg body
weight
(20 % of the inhaled particles will reach the lungs)
0.20 * 0.64 mg/kg body weight = 0.128 mg/kg body
weight
This means that between 0.064 and 0.128 mg TiO2/kg
body weight will reach the alveolar part of the lungs
when exposed to 6 mg TiO2/m3, over an entire working day.
A mouse weighs on average 0.02 kg, which means
that each mouse was exposed to: 0.5 mg TiO2/kg body
weight * 0.02 kg body weight = 0.01 mg TiO2/mouse =
0.00001 g TiO2/mouse
Converted to surface area, each mouse was exposed to:
21 m2/g * 0.00001 g = 0.00021 m2 = 2.1 cm2 titanium
dioxide large
The same can be calculated for titanium dioxide small ,
which gives a result of 10.8 cm2 titanium dioxide small
This example clearly shows what the difference in size
of nanoparticles can lead to regarding health effects. It
can for example have a large impact if the surface area
of the nanoparticle is highly reactive. And the smaller
the nanoparticle, the greater an amount will reach
deeply into the lungs, and thus result in a much larger
surface area.
COCKTAIL EFFECTS AND NANOMATERIALS > NANOMATERIALS
The box illustrates that a given limit value for the
exposure of nanoparticles cannot follow the traditional
way of determining the value with mass (weight) as
offset. As mentioned, the limit value for TiO2 at the
workplace (occupational health limit value) is 6 mg/m3
in Denmark. However, the number of reactive nanoparticles that enter your lungs depends largely on the size
of the particles and less on the quantity (by weight).
Therefore, the general limit value may not be expedient
for nanoparticles. It is discussed whether it would be
more accurate to calculate limit values for nanoparticles
based on surface area.
If we instead had limit values based on the surface
of particles in the working environment, the two
particle types used in this study would give completely
different results. The smallest particle was 21 nm and
the largest 288 nm. This means, that even if the mice
received the same mass (weight) concentration (0.5
mg/kg body weight), the mice exposed to the smallest
particle type were exposed to particles with a much
larger surface area compared to the mice exposed to
the largest particles. It is assumed that the surface of
nanoparticles is the most reactive and thereby the
one that can cause most damage to human health and
the environment. This example clearly indicates that
nanoparticles should not be regulated in the same way
as their larger “siblings”.
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5
env i ro m ant i c
Hazardous chemicals can
be replaced
HAZARDOUS CHEMICALS CAN BE REPLACED > SUBSTITUTION 78
Substitution of hazardous
chemicals
Much research is done to find harmless substances
P hoto A netta_R
that may replace hazardous chemicals.
What is a substitution and why do it?
Substitution means replacement of hazardous chemicals used in products or processes with less hazardous
alternatives. These alternatives may be less harmful
chemicals, technical changes of processes, or implementation of alternative technologies in the production. By phasing out the use of a hazardous chemical
substance, a further exposure of both humans and the
environment stops completely. The principle of substitution is incorporated in the EU chemicals legislation,
REACH, which applies for substances of very high
concern (SVHC). However, it has its limitations as
situations are excluded where hazardous substances
are used in industrial production or processes in a way
that is considered “adequately controlled”. This applies
to so-called closed systems (e.g. at production level)
where humans and the environment are not exposed
to the substances. Still, experience shows that such
systems are often not as closed as they seem. One explanation is, that not the entire life cycle is considered
when deciding if a chemical is “adequately controlled“
(e.g. the consumption and waste stages might be
excluded) and thus, humans and the environment may
be exposed to the hazardous chemicals.
There may be many reasons for a company to opt
for substitution. One reason may be requirements
or demands from customers. Another may be new
knowledge about production methods and alternative
ingredients, or there may be new legislation coming up. Companies may also seek to be ahead of the
chemicals legislation. They may obtain a competitive
advantage by creating a green image, thereby getting
publicity and attracting more consumer groups. It may
also improve the working environment of the company
and reduce costs due to the fact that there will be less
hazardous waste to handle.
Warning lists and substitution
Many of the companies substituting chemicals are
using the REACH Candidate List as a guideline for
which substances to avoid. Thereby, they can get a
jump-start that may pay off when a potential hazardous substance that is already substituted with time is
subjected to authorisation and they often would have
to substitute anyway. REACH in itself is thereby a good
guidance for companies, since it provides an insight
into which substances are problematic and worthwhile
HAZARDOUS CHEMICALS CAN BE REPLACED > SUBSTITUTION
to substitute and further which substances are poorly
suitable substitutions. The disadvantage is that the
Candidate List so far covers only 151 substances
(January 2014) while it is estimated that at least 1,500
hazardous chemicals that should be characterized as
SVHC are on the market. Therefore, it may pay off for
companies also to include more extensive lists when
considering substitution (see more about these lists in
the section ”REACH – Step-by-step”).
In Denmark, the Danish Environmental Protection
Agency has drawn up List Of Undesirable Substances
(LOUS), which is a signal list and a guidance for producers, product developers, purchasers, and other stake
holders, about which substances they can focus on
in their work with substitution or stop the usage of.
It consists of 40 substances/groups of substances
selected for their problematic effects according to criteria defined by the Danish Environmental Protection
Agency. Only substances used in Denmark in quantities
exceeding 100 tonnes/year are included in the list. A
more extensive list is the List of Effect. This list contains substances, which are considered as problematic
according to their effect on human health and the
environment and should be avoided when substituting to other substances. The List of Effect consists of
around 19,500 substances selected according to the
following criteria:
• having problematic characteristics according to the
”EU list of hazardous substances”
• having problematic characteristics according to
computer-based model calculations on the ”Danish
Environmental Protection Agency’s Advisory list for
self-classification of hazardous substances” (QSAR-list)
• identified PBT/vPvB substances in the EU
• substances on the “EU priority list of substances
that must be further examined for endocrine
disrupting properties”.
The List of Effect is a very good tool for companies
aiming to avoid substances with harmful effects, when
they are looking for better alternatives in a substitution case.
The Swedish NGO ChemSec
has published the ”SIN list”,
covering the most hazardous chemicals under EU
law. The SIN list contains
substances identified
by ChemSec and comply
with the criteria for the
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Candidate List under REACH. The SIN list, however,
contains far more substances than the Candidate List
(at the moment 626 vs. 151) and is thereby a far more
useful tool for companies. The list contains substances
that may be carcinogenic, change DNA, have endocrine
disrupting properties, and/or harm the reproductive system. It also covers toxic substances that are
persistent and accumulate in nature with the ensuing
potential of causing severe and long-term irreversible
effects.
Substitution portals and networks
There are networks in
which companies involved
in substitution processes
meet and share experiences
with other companies
wishing to reduce their
use of hazardous chemicals. Sweden is home to
a ’ChemSec Business group’ covering, among others,
Boots, Dell, IKEA, and Sony Ericsson. In the US there is a
group ’BizNGO’ with Construction Specialities, Staples,
Hewlett-Packard, and Method among their members.
Another tool for companies wishing to substitute is the
substitution portal “SUBSPORT”, which is an EU LIFE+
supported project. SUBSPORT is an internet portal disseminating knowledge about substances and technologies that may be alternatives to hazardous chemicals. It
also provides tools and advice in the evaluation of substances, as well as information about how to manage
a substitution process. Starting a substitution process
may be quite a challenge for a company – both in terms
of finances and resources, so it is important that good
tools are available. Warning lists, networks, and portals
may help companies getting started, thereby promoting
the entire field of substitution.
Consumer's role
Consumers can do a great deal to reduce the contact
with hazardous chemicals. You can look for ecolabelled
goods – they are found within almost all product
groups such as car care products, nappies, glues, paints,
personal care products, furniture, candles, televisions,
etc. There are many labelling schemes in Denmark and
the rest of Europe – figure 25 shows a small selection.
The Nordic Swan is, as the name indicates, a Nordic
label, while the comparable European label is named
the EU-Flower. These labels set up a number of
requirements for the producers as to the content of
HAZARDOUS CHEMICALS CAN BE REPLACED > SUBSTITUTION
Figure 25 Common ecolabels
80
environmentally harmful products in consumption or
production, taxes on the discharge of pollutants, and
taxes on scarce natural resources.
Thanks to green taxes of the right magnitude the price
of a product better reflects the entire resource usage
associated with production, use, and final disposal of
the product – and not only the resource consumption
that should be paid by the producing company on
the ordinary market. As a consumer, you are thereby
financially encouraged to affect the production of
consumer goods, since environmentally harmful
products become more expensive. In general, this will
increase motivation for choosing the environmentally
less harmful goods.
Four of the most common and well-known ecolabels on
the European market. The Nordic Swan label is only on the
Nordic market, as the name indicates.
chemicals in their products. These requirements often
go beyond REACH and Danish legislation.
The Danish Ø-label is for foodstuffs from organic
farming without the use of pesticides. There is also a
European organic label, the Euro-leaf, which is used
increasingly on products on the Danish market.
In Denmark, “green taxes” have been levied since
1970 and made up 4.1 % of the gross national product
(GNP) – or around 9 % of total tax revenues in 2012.
Green taxes are incentives for the market and consumers toward more eco-friendly behaviour and the
development of green technologies. Ideally, the green
tax corresponds to the environmental costs associated
with producing, consuming, and disposing of goods.
However, often it is not possible to calculate these
costs, so the tax is established in relation to what it
takes to shift the consumption to more eco-friendly
products. Examples of areas with green taxes are
petrol, registration of vehicles, packaging, pesticides,
wastewater, and PVC and phthalates. For every shower
you take, you pay a tax. When you drive your car
(instead of taking the bike) – and when you use disposable tableware (instead of an ordinary plate) you pay
green taxes or environmental taxes. All these green
taxes are meant to make you consume less.
Green taxes are divided into three categories: energy
taxes, transport taxes, and environmental taxes.
Environmental taxes are further divided into taxes on
CHEMICALS IN POLITICS AND EVERYDAY LIFE > GLOSSARY 81
GLOSSARY
Accumulate Pile up or concentrate. When environmental
toxins do not decompose, or only do so to a slight degree, there
will be an accumulation in the upper parts of the food chain.
Agonism When a chemical substance imitates the effect of
a naturally produced hormone and thereby causes similar
reactions in the body. The substance is called an agonist. It
may for instance, cause a too large oestrogen response, which
may be critical to male foetuses.
Allergen A substance that may cause allergy. Commonly known
allergens are nickel, for instance in jewellery, pet fur, and pollen.
Antagonism When a chemical substance is similar to a certain hormone, but does not have the same effect mechanism.
The substance is called an antagonist. The substance may, for
instance, bind to receptors “belonging” to specific hormones
and thereby block an important hormonal response from the
real hormone.
Article (EU definition) An article is an object, which during
production is given a special shape, surface, or design which
determines its function to a greater degree than does its
chemical composition. This may be clothing or a bicycle.
Authorisation Authorisation is an important term in the EU
chemicals regulation REACH. For especially hazardous chemicals, companies must apply for authorisation to continue
producing/dealing with these substances. The Candidate List
plays a key role in the authorisation process.
Authorisation list EU list of chemicals for which companies
must apply for authorisation if they wish to continue producing
one or more of the substances on the list, or articles in which
they are a constituent.
Bioaccumulation Continuous increase in the amounts of a
substance in an organism. A term used when a chemical substance, such as a brominated flame retardant, accumulates
in a living organism throughout a lifetime. If the organism
assimilates more than it secretes, it is called bioaccumulation.
Bioaccumulation is both bioconcentration, i.e. the concentration of an environmental toxin grows more in a living
organism than in its surroundings, and biomagnification, i.e.
the accumulation of the environmental toxin may increase up
through the food chain.
Biocide A chemical substance destined for the control of vermin, bacteria, fungi, etc. Biocide products must be approved
by the Danish Environmental Protection Agency before being
placed on the market.
Biomagnification When a substance accumulates in an
organism through the food chain.
Bisphenol A Chemical substance used in the manufacture
of certain types of plastics, such as single-use water bottles.
Suspected of endocrine disrupting effects. Is to some extent
regulated in the EU.
Brominated flame retardants Brominated flame retardants are bromine-containing, organic substances added to
electronic equipment, furniture, construction materials,
textiles, duvets, toys, and much more to prevent or limit fire
hazards. Some of the substances accumulate in the environment and are suspected of causing congenital malformation
and cancer, among other diseases. In addition, suspected of
being an endocrine disruptor.
Candidate List EU list of chemicals that are considered to be
of very high concern. The problematic chemicals have harmful
long-term effects on human health or they are harmful to
the environment. Substances on this list are candidates
for the authorisation list. You can always find the latest
version of the list here: http://echa.europa.eu/chem_data/
authorisation_process/candidate_list_table_en.asp
Carcinogen A substance that is carcinogenic i.e. increases
the risk of developing cancer.
Chemical (EU definition) A common term for chemicals and
chemical mixtures.
Chemical mixture (EU definition) A uniform mixture or
solution composed of two or more substances. A chemical
product may be solid, liquid, or gaseous.
Chemical substance (EU definition) A chemical element
and its compounds in the natural state or obtained by any
manufacturing process.
Circular An administrative communication that may assist in
the interpretation of a statutory act. A circular is emitted, for
instance by a ministry and is in itself not binding to citizens.
CLP regulation Classification, Labelling and Packaging. The
purpose of the regulation is to create a global harmonised
classification of chemicals in order for them to have the same
labelling all over the world.
CMR substances: Substances that are Carcinogenic (causes
cancer), Mutagenic (changes genes) and/or Reprotoxic (harms
reproduction).
Cocktail effects All chemicals found in a mixture contribute
to the total effect of that mixture on human health and the
environment, such as toxicity. This means that chemicals that
are harmless to human health and the environment individually and in low concentrations may have harmful effects if
they occur together.
Council of the European Union Together with the
European Parliament, it adopts the legislative proposals put
forward by the Commission.
DDT In the past, it was used as an insecticide (a chemical
used against insects). Unfortunately, it proved to have many
inexpedient side effects and therefore today the use of DDT
is banned or strongly limited in most parts of the world.
However, it is still used in many developing countries, especially in connection with the fight against malaria-carrying
mosquitoes, as it has been estimated that the socio-economic
benefits stand up for its continued use. In this case, the social
benefits (fewer malaria cases) carry most weight.
CHEMICALS IN POLITICS AND EVERYDAY LIFE > GLOSSARY Dioxin Generic description of a group of chlorine-containing
toxins that are formed in the burning of organic materials in
the presence of chlorine. Dioxin is very harmful to human
health and the environment and leads, among others, to
an increased risk of cancer, reproductive disturbances, and
reduced immunity.
Directive A directive is one of the statutory instruments
used in the EU. Directives are binding to all the member
states. It generally addresses and establishes a target to be
reached and then it is up to the member states to decide how
to implement the directive. Directives must be implemented
in national law before they take effect and this must be
done before a certain deadline set up in the directive - often
two years. When the implementation is complete, the EU
Commission must be notified.
82
European Court of Justice Decides in cases the EU
Commission has brought against specific member states in,
for instance, violations of current EU legislation.
European Parliament Together with the Council of the
European Union, it adopts the legislative proposals put forward by the Commission. All EU member states have directly
elected representatives in the Parliament.
Exposure Means “exposed to”. Concentration or amount of
a substance to which a person or certain organisms or cells
are exposed. We may be exposed to a substance by inhalation
or through the skin, for instance, if chemicals occur in sun
tanning products or similar.
ECHA (the European CHemicals Agency) Ensures that the
EU chemicals regulation, REACH and the regulation on classification, labelling, and packaging (CLP) is implemented in a
harmonised way in Europe. This institution receives registration of existing chemicals.
Fluorinated substances There are two groups of
fluorinated substances: polyfluorinated and perfluorinated. The term polyfluorinated refers to the group of
substances where there are several fluorine compounds
on the carbon chain, replacing hydrogen. A fully
fluorinated substance is an organic compound where all
hydrogens on a carbon chain are replaced with fluorine.
These substances are called perfluorinated substances.
Perfluorinated substances are distinguished by containing
as a minimum one other atom than carbon and fluorine.
The substances are suspected of having various endocrine
disrupting effects in humans. They are furthermore suspected
of being carcinogenic.
Endocrine disrupting substances An exogenous substance (e.g. industrially manufactured chemicals) that alters
function(s) of the endocrine (hormonal) system and consequently causes adverse health effects in an intact organism,
or its progeny, or (sub)populations.
Free radicals A radical or a free radical is the term used
for an atom or a compound with an unpaired electron or an
incompletely filled electron shell. Unpaired electrons are
very reactive and radicals therefore easily become parts of
chemical reactions.
Esther Series of chemical compounds formed in the reaction
between a carboxylic acid (COOH) and an alcohol (common
name for chemical compounds with a hydroxy group (i.e. an
OH group) while splitting off water. Polyester is a category
of polymers with the functional group of ester in their main
chain.
Implementation Incorporation of a policy or an act in
practice to have legal effect.
EC50 Effective Concentration 50 %. The concentration of
a given chemical where a harmful effect to health is seen
in 50 % of the test animals exposed to the substance. The
effect may be, for instance, reduced growth, DNA damage, or
damaging effects on embryos.
EU Short for European Union. Consists of 28 member states
all situated in Europe. The citizens of the member states have
the right to live, work, travel, and invest in the other member
states. The EU has a number of common laws, including the
chemicals regulation REACH.
EU Presidency EU member states take turns in assuming
the Council of the European Union for a period of six months.
The changing presidencies mean that each country to a
certain extent has the possibility to influence the agenda of
the EU. It also gives some dynamics to the EU cooperation and
enhances the anchoring in the member states - the member
states feel, so to speak, a stronger attachment.
Denmark has had the presidency seven times since we joined
in 1972, most recently in the first semester of 2012.
European Commission The Commission proposes acts
and rules for the entire EU so as to treat any country fairly.
In addition, it is the responsibility of the Commission that all
member states comply with the common legislation.
In vitro tests Scientific tests made on cells. Tests are made
outside the living organism – typically in a test tube or a petri
dish.
In vivo tests Scientific tests made on a living organism typically on test animals, but they also include clinical tests
on humans.
LD50/LC50 Lethal Dose/Lethal Concentration for 50 % of
the test animals exposed to the substance. The amount
(weight)/concentration of a toxic substance needed for half
of a group of test animals to die while the other half survives.
LD50 is used when the test animals are actively given the
substance (e.g. in their food) and LC50 is when the test organism are for example fish swimming in water with the given
concentration.
Lipophilic Refers to the ability of a chemical compound to dissolve in fats. These substances bind to fat rather than water.
Metabolites Intermediates and products of the metabolism.
They are often referred to as decomposition products.
Mutagen A substance is a mutagen when it causes mutations. A mutation is a change in the hereditary material (DNA)
and leads to changes in the expression of genes. For instance,
some proteins will subsequently not be expressed.
CHEMICALS IN POLITICS AND EVERYDAY LIFE > GLOSSARY
Nano The word comes from Greek and means ‘dwarf’. 1 nanometre (nm) corresponds to 0.000000001 m (10 -9 m).
NGO (Non-Governmental Organisation) An organisation
that is neither supported nor controlled by government.
PAH (Polycyclic Aromatic Hydrocarbons) A group of more
than 100 substances found in different combinations of
aromatic rings, so-called benzene rings. Several members of
the substance group have been proven to be carcinogenic.
Most PAHs enter the environment via the atmosphere from a
variety of combustion processes.
Parabens A group of chemical substances (preservatives)
that make cosmetics and food products last longer. A varying
number of carbon atoms binding to an ester group forms the
different parabens. The substances are suspected of having
various endocrine disrupting effects in humans.
PBT (Persistent, Bioaccumulating, Toxic) PBT substances
are chemical substances with all three properties: Persistent –
decomposes very slowly in nature; bioaccumulative - accumulates in living organisms throughout their lifetime. In
addition it is toxic to human health and/or the environment.
For a substance to be classified as a PBT substance all three
parameters must be met.
PCB (Poly Chlorinated Biphenyls): An industrial chemical
(artificially made) that decomposes very slowly. In addition,
it accumulates in the upper parts of the food chain and
spreads over large distances in nature. Both oestrogenic and
anti-oestrogenic effects have been proven from various PCB
compounds. In Denmark, there has been a ban on the production and sale of PCB since 1986.
Persistent Decomposes very slowly in nature and in living
organisms.
Pesticide A chemical substance used to control weed,
protect crop against vermin attacks and fungi, or for affecting
plant growth. Before a pesticide is permitted the producer
must document that the pesticide residues, for instance in a
food product, are not toxic to humans.
Phthalates A group of chemical substances that
are used to soften and smoothen plastics. Phthalates
are the term used for esters of phthalic acid.
They may be present in different consumer goods such as
oilcloth, shower curtains, clothing (in plastic prints), wellies,
etc. The substances are suspected of having various endocrine disrupting effects in humans.
Polymer A polymer is a natural or synthetic compound with
a high molecular weight formed by linking together up to
several million identical or at least comparable units (monomers). The linking process is called polymerisation. Polymers
are often referred to as plastics, such as polyvinyl chloride
(PVC), polyethylene, and polycarbonate.
POP substances (Persistent Organic Pollutants)
Environmental toxins that decompose extremely slowly.
There is a great risk that these substances remain in our
environment and in worst case accumulate in the food chain.
The substances are hazardous for human health and the
environment.
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Precautionary principle One of the REACH cornerstones.
This principle makes it possible to react fast when there is a
possible danger to the health of humans, animals, and plants,
or to the environment. In cases where the available scientific
data does not allow for a complete risk assessment, the
precautionary principle can prevent the placing on the market
of products that may be hazardous. It also makes it possible to
withdraw such products from the market.
REACH The European chemicals regulation. REACH is short
for Registration, Evaluation and Authorisation of Chemicals.
REACH is a regulation, which means that it applies all over the
EU and that countries must comply with it. It is not allowed to
introduce less stringent legislation in any EU member state.
Reactive When a particle/an atom has a huge impact,
because of very reactive free unpaired electrons or an
incompletely filled electron shell. This may cause an immediate launch of a chemical process under certain conditions.
Regulation A regulation is one of the statutory instruments
used in the EU. A regulation is universal. This means that it
is not directed at a certain group of persons or institutions,
but to the entire population. Regulations apply directly in
the member states, which means that they enter into force
and have legal effect, once they are adopted in the EU. Unlike
directives, they are not first to be implemented in the national
legislation. Regulations are binding, and thus provide rights
and duties just like national legislation.
SIN list (Substitute It Now). A list prepared by the Swedish
environmental organisation ChemSec. The purpose is to
promote the transition to a world free from industrial toxins
by listing those chemicals ChemSec believes should be substituted by less hazardous substances. The substances on the
list are selected in an evaluation against the REACH criteria
for “substances of very high concern”.
Statutory Order A statute that applies further legislation
to an existing act – often more detailed. The Statutory Order
has the same effect as an act in relation to authorities and
citizens.
Synergy Synergism or synergistic effect is the interplay
between two or more chemicals, for instance in a mixture,
that results in a larger effect than merely the sum of the
effects given by each individual chemical.
TDI (Tolerable Daily Intake) A value stating how much of a
chemical substance a person can tolerate every day throughout his life. The value is established based on scientific tests
and generally a safety factor (e.g. 100) has been added. In
addition, it has been taken into account that we are exposed
to the given pollution from several sources, e.g. from both our
diet and the inhalation of air.
Toxic Poisonous.
vPvB (very Persistent, very Bioaccumulating) Used for a
chemical substance that is heavily decomposable (may not
decompose at all) and very bioaccumulating.
With this teaching material, we want to increase the focus on
endocrine disrupting chemicals, the combination effects of chemicals
– the so-called cocktail effects – and nano materials.
The common European chemicals regulation REACH regulates many of the
chemicals produced today and thus increase the safety of people and the
environment. Still, we surround ourselves with a wide range of consumer products that may contain substances suspected of having endocrine disrupting
effects or that contribute to cocktail effects. Thus, there are gaps and shortcomings in the legislation that it is important to rectify.
In this electronic publication the construction of the European Union (EU) is
clarified along with an explanation of how the individual member states suggest and follow legislation adopted at EU level. Furthermore, the common European chemicals legislation is explained in further detail, whereas legislation for
specific product groups e.g. the Toys Safety Directive and the Cosmetic Products
Regulation are briefly described where relevant. The most common groups of
endocrine disrupting chemicals and our daily exposure to them are described
and subsequently what this means for human health and the environment.
Cocktail effects and nanomaterials are examined separately, along with
a description of the possibilities of replacing harmful chemicals with less
hazardous substances. Each chapter provides examples of what you can do
as a consumer to reduce the risk of exposure to hazardous chemicals.
This electronic publication is useful at several different educational levels and in
different courses as well as for interdisciplinary projects – especially at university level and for project assignments in high school. It can be read from start to
finish, or you can pick out sections in order to meet specific educational needs.
Each section is written to stand alone, but refers to a supporting section in case
specific passages needs further explanation for better, or full, understanding.