How effective is the European legislation regarding cancer-related chemical agents?
Environmental pollution has been underestimated as a cause of cancer for a long time. However,
scientific evidence that pollution contributes to the development of cancer is rising. There is still
quite some scientific uncertainty about the exact impact of the environment on the development of
cancer, but there are more and more scientific insights which urge us to be more cautious about a lot
of chemicals we are using at the moment.[1-3] Therefore, prevention of environmental exposure
that causes or helps to cause cancer should be incorporated in cancer policies and cancer control
programmes.
At the moment, cancer-related chemical agents are present everywhere in our living environment.[4,
5] ‘Cancer-related’ not only refers to the chemicals officially classified as carcinogens[6, 7] but also to
substances for which there are strong indications that they (help to) cause cancer, like endocrine
disrupting chemicals (EDCs). Needless to say humans should be exposed to the minimum of and
preferably not at all to these agents. This can be achieved, in the first place, by means of efficient
legislation and policies.
In recent years quite a lot of new legislation has come into force at the European level. But how
effective is it? In a report published in May 2012 that evaluates the impact of European and
national/regional policies regarding cancer-related chemical agents in Belgium/Flanders[8, 9] we
tried to answer that question for REACH – the EU regulation for so-called industrial chemicals[10] –
and for the legislation and policies concerning pesticides.
REACH is in effect since 1 June 2007. For pesticides two new regulations were adopted: the 2009
(agricultural) Pesticides Regulation[11] and the 2012 Biocides (non agricultural pesticides)
Regulation[12]. Furthermore, the 2009 Directive for the Sustainable use of Pesticides[13] came into
effect. This Directive is meant to reduce the use of pesticides and/or their potential risks. Strongly
associated with REACH is the 2009 CLP Regulation[6], the European regulation for the classification,
labelling and packaging of substances and mixtures. As pesticides and biocides are mixtures, they are
also subjected to the CLP Regulation.
This article is a brief summary of the key findings of our report with focus on the European level. Our
evaluation was based on the principle of physical-chemical hygiene and the precautionary principle.
According to the first, we should as much as possible restrict chemicals that are suspicious due to
their intrinsic properties. The principle can be compared to the microbiological hygiene which was
applied in the early twentieth century to push back infectious diseases before the role of bacteria
and virus in these diseases was clear.[14] The precautionary principle essentially states that scientific
uncertainty may never be an excuse not to take measures. When there are enough reasons to
assume that an activity, a product or substance can cause serious, irreversible damage to one’s
health or the environment, preventive though cost-effective measures must be taken.[15]
STEPS FORWARD
In the past years major steps have been taken towards a better physical-chemical hygiene. REACH
certainly is a first important step. REACH has led to a completely new approach to the control of the
production, the import and the use of industrial chemicals in the European Union. The Pesticides
Regulation and the Biocides Regulation follow the same path.
For instance, the three regulations establish categories of substances based on their intrinsically
harmful properties. The intention is to phase out these categories from the market and to replace
them with safer alternatives. In this way we clearly see a shift from a system purely based on risk
assessment, to a more restrictive system which is partly based on the intrinsic hazardous properties
of a substance. REACH sets up a system for a better control of so-called substances of very high
concern (SVHCs). Some of these substances will go through an explicit decision process that has to
make clear whether we really need that substance for its particular uses given the dangers those
uses pose to public health and the environment. In some cases, this will ultimately lead to
substitution by a safer alternative. Also the Pesticides Regulation and the Biocides Regulation will ban
substances belonging to the established harmful categories, with some exceptions possible.
Next to substances with ‘traditional' hazardous properties, such as carcinogenic, mutagenic and
reprotoxic substances (CMRs), considerable attention is paid to EDCs. Furthermore, REACH and the
CLP Regulation require that the properties of many more substances become known and registered.
REACH, as well as the Pesticides Regulation and the Biocides Regulation, refer explicitly to the
precautionary principle and to vulnerable subpopulations. The 2009 Sustainable Use Directive
focuses on substances or pesticides with a lower risk and on sustainable use.
Recent regulatory initiatives also express an awareness among policy makers of the necessity of an
integrated approach, both across policy domains (economy, health, environment) and across
national borders. Several structures and processes have been set up to promote this integrated
approach. Examples of these on an international level are the Stockholm Convention[16] and the
Strategic Approach to International Chemicals Management[17]. On a European level we have,
amongst others, the WHO European Process on Environment and Health[18], which led to the
Environmental Health Action Plan for Europe[19], to National Environmental Health Action Plans and
to the Children’s Environment and Health Action Plan for Europe[20] and national plans in this field.
SHORTCOMINGS
That was the good news. There are some major shortcomings in the design of the legislation too. For
instance, REACH only covers 30.000 of the perhaps 100.000 chemicals already on the market. Also,
REACH does not require registration of chemicals produced or imported in volumes of less than 1
tonne.[21] Moreover, substitution is not always applied where possible: under REACH, the
substitution of SVHCs for which a safer alternative is available is not always required. As for
pesticides, exceptions to the exclusion criteria are possible. When on the basis of documented
evidence included in the application for a pesticide an active substance is necessary to control a
serious danger to plant health which can not be contained by other available means, it may be
approved for a limited period necessary to control that serious danger even if it does not satisfy
some of the exclusion criteria. The decision to authorise agriculural pesticides containing such active
substances approved in accordance with this, is left to the member states and may lead to various
interpretations of what a ‘serious danger’ is.
Furthermore, it will still take a long time before these regulations will be fully implemented. The
REACH process turns out to be a very sluggish and slowly operating tool. After five years of REACH
there are only 138 substances on the candidate list of SVHCs (last update on 19 December 2012[22]).
The substances on this list are due to be put through a strict permission process and may be banned.
On the authorisation list (the list of substances which can not be marketed for a certain use without
authorisation) there are only 14 substances (last update on 14 February 2012[23]). Considering the
thousands of chemicals on the European market, 138 chemicals is a very small quantity. The so-called
SIN-list (SIN means Substitute It Now), which was set up by the NGO ChemSeC as a reaction to the
slow REACH-process and is based on the same REACH-criteria for SVHCs, contained already 378
chemicals after one year[24]. As to pesticides: because they get a market authorisation for a period
up to ten years it will take years before the bans of the new legislation apply to all pesticides and
biocides.
There is still uncertainty about how EDCs will be handled. EDCs are included in REACH and in the
pesticides and biocides regulations – which is as such a positive evolution – but we are still waiting
for a definition of, and criteria and tests to identify EDCs, particularly for the pesticides and biocides
laws. The definition and criteria are expected at the latest by 14 December 2013. A February 2012
report by Andreas Kortenkamp et al.[25] for the European Commission indicates the direction to
follow. The report emphasises the properties of hormone disruptors, including their potential to
cause irreversible and delayed effects. Therefore, they should be placed in a separate regulatory
category, alongside persistent bioaccumulative and toxic chemicals (PBTs) and CMRs. According to
the authors the currently available internationally agreed and validated test methods are useful but
they only consider a limited number of endocrine effects. Furthermore, the EU regulations require
even less information and testing and thus do not capture all the endocrine effects that can be
measured.
The existing regulations also take little or no account of the combined effects of chemicals regardless
available toxicological evidence in this respect. Current risk assessment is still largely based on an
analysis of separate substances. This approach is too simplistic, especially with regard to EDCs[25]. It
leads to an underestimation of their potential danger for our health and the environment. Yet,
awareness about this issue in European policy circles is rising since the EU Environment Council
adopted conclusions on the combined effects of chemicals on 22 December 2009[26]. It urged the
Commission to assess whether and how existing legislation addresses this problem and to suggest
appropriate modifications and guidelines. On 31 May 2012 the Commission engaged itself in its
report to the Council[27] “to launch a new process to ensure that risks associated with chemical
mixtures are properly understood and assessed”[28]. The Commission intends to identify priority
mixtures to be assessed and to ensure that EU legislations deliver consistent risk assessments for
such priority mixtures. Furthermore, the Commission promises to tackle the data and knowledge
gaps. However, the Commission does not propose any adjustments to the EU legislation.
Another problem is the possible later life onset of low dose effects . There are only a few studies that
are conducted long enough to show these effects.
Moreover, there is evidence that combined exposure to chemicals at low doses can produce additive
effects. The possibility of combination effects from multiple chemicals at or even below their
individual threshold dose can’t be ruled out.[29] This means that for some chemicals there are
probably no safety thresholds at all.
Furthermore, although the new regulations mention the need for special attention to vulnerable
groups, some issues remain unaddressed. The current risk assessment process does not deal
sufficiently with the critical moments of exposure during our life course (development of the foetus,
the early childhood, pubertal development) at which we are more vulnerable to chemicals, to the
combined effects of chemicals and to low doses of chemicals[3, 30]. A recent report[31] by the
Danish Environmental Protection Agency concludes that exposure to endocrine disruptors from food,
indoor environment and consumer products should be reduced for pregnant women, and that it is
important to take the total exposure into account. Furthermore, our vulnerability seems also to be
genetically determined[32]. As the genetically vulnerable groups are still largely unknown, it is
probable that, in addition to those population groups already known to be more vulnerable, other
subsets of the population will require extra precautions. Our knowledge about the critical moments
of exposure and the consequences at a later age is still far from sufficient, which emphasises the
urgent need for further research in this fileld. The above mentioned new approaches to EDCs and to
the combined effects of chemicals are a good start, but more measures and action are needed to
tackle the problem in a more adequate manner.
KEY MESSAGES
With the precautionary principle and that of physical-chemical hygiene in mind, the European
regulations discussed in this article prove to be important steps towards a healthier living
environment. Nevertheless, there are still a lot of uncertainties and some knowledge gaps to be
tackled. On the basis of our evaluation we can deduce four key messages that policy makers and
society in general should take into account for an optimal cancer prevention. First of all, we need to
be more alert to early warning signals that a chemical agent might be harmful and we must act more
quickly. As the precautionary principle states: insufficient knowledge is not an excuse not to
intervene. We have to check which agents and applications we really need and use our modern
technology to develop safer and less harmful alternatives[33]. Secondly, substances of high concern
should be substituted whenever safer and cost-effective alternatives are available. Thirdly, we need
to develop protection standards aimed at our real living conditions (where simultaneous and longterm exposure to different chemicals applies, also in low doses). Finally, we must pay more attention
to minimising exposure of vulnerable groups[30]. For all these reasons we indeed believe that the
prevention of environmental exposure that is or may be related to cancer, should become an integral
part of cancer policies and cancer control programmes. Our key messages and the policy proposals in
our May 2012 report[8, 9] can serve as guidance for this.
Competing interests: none declared
Corresponding author:
Cathy Rigolle
Gordunakaai 16A
9000 Ghent
Belgium
cathy.rigolle@tegenkanker.be
tel. +32-9-267.46.53
fax +32-9-233.72.34
Co-authors:
Ward Rommel
Knowledge and Policy Department
Flemish Cancer League
Ghent
Belgium
Hans Neefs
Knowledge and Policy Department
Flemish Cancer League
Antwerp
Belgium
Hedwig Verhaegen
Knowledge and Policy Department
Flemish Cancer League
Brussels
Belgium
Keywords:
cancer
environmental health
health policy
Word count: 2125
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