Action Plan for reducing and phasing
out phthalates in soft plastics
Ministry of Environment and Energy
June 1999
1
2
Contents
1
Summary
5
2
Background
3
Objectives and Strategy
4
Phthalates in soft plastic: Use and Contamination
9
11
13
5 Seven interdepartmental measures and initiatives
15
5.1 The need for knowledge 15
5.1.1 New knowledge 16
5.2 Danish and international regulation of the use of phthalates 17
5.3 Phthalates and requirements in connection with standardisation 19
5.4 Taxation model for phthalates in selected product groups
20
5.5 Subsidies for the development of substitution opportunities 22
5.6 Environmental awareness in public green procurement policies 22
5.7 Eco-labelling 23
6
Overview of product groups in this action plan
25
7 Proposals for initiatives for individual product groups
7.1 Cars 27
7.2 Floor and wall coverings 28
7.3 Toys
28
7.4 Furniture/Vinyl 30
7.5 Tarpaulins 30
7.6. Medical devices 31
7.7. Rain and workwear 32
7.8 Inlays in lids and caps 33
7.9 Special profiles 33
7.10 Roofing film and membrane film 34
7.11 Gloves for industrial use 34
7.12 Garden and water hoses 35
7.13 Boots and waders 35
7.14 Textiles and PVC prints 36
7.15 Foodstuff hoses 37
7.16 Electrical cables 37
7.17 Fenders and other maritime equipment 38
7.18 Other medical devices 39
7.19 Office supplies 39
7.20 Bags, luggage, etc. 40
7.21 Industrial hoses 40
7.22 Self-adhesive film and tape 40
7.23 Shoes and soles 41
7.24 Soft PVC undersides for carpet tiles and mats 41
7.25 Other products containing soft plastics
XX
8
9
Relationship to PVC initiatives
27
43
Economic consequences for business
45
3
10 International status
47
11 Evaluation / follow-up 49
Appendix 1. Phthalate consumption and emissions
51
Appendix 2. The impact of phthalates on health and the environment
1 The impact of DEHP on health 53
1.1 Summary of draft of EU risk assessment of DEHP
54
2 Health effects of other phthalates 54
2.1 Assessment of the Scientific Committee for Toxicology, Ecotoxicology, and the Environment
55
3 Limit values stipulated for DEHP and other phthalates 56
4 Environmental impact of DEHP 56
5 Environmental impacts of other phthalates
56
Appendix 3. Overview of measures
References
4
61
59
53
1 Summary
Problem
Phthalates are a group of chemical substances which are suspected of
causing long-term damage to the aquatic environment. Animal testing has
proven that some phthalates can cause reductions in fertility and have toxic
effects on testicles. Moreover, some phthalates can be carcinogenic. A
possible link between phthalates and asthma has not yet been determined.
Phthalates are used in very large quantities in e.g. soft plastics. In 1995,
annual phthalate use amounted to approximately 11,000 tonnes and the trend
was rising. The vast majority of phthalate use occurs in connection with
plasticising of PVC by means of diethylhexylphthalate (DEHP).
Phthalates are spread diffusely in connection with use of products which
contain these substances. These products include undersealing of new cars,
floor and wall coverings, electrical cables, toys, furniture, tarpaulins,
medical devices, workwear, rainwear, garden hoses, water hoses, food
hoses, and inlays in lids and caps.
Objective
The long-term objective with respect to phthalates is to phase out all
problematic uses of phthalates in soft plastics. The use of phthalates in soft
plastics constitutes 90 per cent of total phthalate use.
The objective of the initiatives in this Action Plan is to reduce the use of
phthalates by 50 per cent within the next 10 years.
Moreover, the objective is to achieve the greatest reductions within the areas
with the greatest emissions of phthalates. Particularly problematic uses
include floor and wall coverings, tarpaulins, car-undersealing, and textile
printing. If the objectives of this action plan are fulfilled, this will result in
phthalate-emission reductions greater than 50 per cent.
 National bans on
phthalates in toys and
childcare products
 Proposal for taxes on new
products
 Increased initiatives for
public-sector green
procurement
 Common EU regulations
on new cars and textile
printing
 Substitution guidelines
 Information activities
 Developing alternatives
Measures
The Action Plan includes all uses of phthalates in soft plastics. This
plan expresses one aspect of prioritised initiatives, where the choice of
methods must be considered in view of the phthalate amounts used
and the most problematic uses. This Plan addresses individual product
groups, and how a variety of measures can contribute to the reduction
and phasing-out of phthalate use. Such measures include bans, taxes,
subsidies, public-sector green procurement policies, and eco-labelling.
Appendix 3 of this Action Plan features an overview of initiatives with
respect to individual product groups.
Denmark has already introduced a ban on phthalates in toys and
certain childcare articles.
5
This plan proposes a taxation model which covers approximately 65 per
cent of all phthalate use in soft plastics. The product groups covered by this
model include floor and wall coverings, tarpaulins, rainwear, workwear,
roofing film, membrane film, gloves, garden hoses, water hoses, food hoses,
electrical cables, certain office supplies, industrial hoses, and self-adhesive
film.
Other measures are suggested for the remaining 35 per cent of phthalate use:
Cars
 Work is being done to have the EU develop common rules on bans on the
use of phthalates in undersealing of new cars.
 Work is being done to develop environmentally suitable alternatives.
Denmark is a small market, and international initiatives are absolutely
necessary – especially with respect to new cars. Only few alternatives exist,
and independent Danish initiatives will not change the market. Studies have
been made of the feasibility of imposing PVC and phthalate taxes on cars.
Several circumstances imply that such a course of action would not answer
the purpose. For example, high vehicle registration fees are already imposed
on new cars. Consequently, any additional tax on individual cars would need
to be very high in order to affect consumer choice. If on the other hand
taxation were to vary in accordance with the actual PVC and phthalate
content of individual car makes, this would entail that a large number of cars
would need to be dismantled every year in order to check such contents.
Moreover, taxes which would be sufficiently high to affect consumer
behaviour are unlikely to comply with EU legislation.
Consequently, increased international initiatives are required in order to
phase out the use of phthalates in cars. Working for an EU ban is an
important part of these initiatives.
Medical Devices
 For medical devices, the Action Plan recommends that all public-sector
buyers substitute alternatives for phthalates wherever such a course of
action is justifiable in terms of health and the environment.
This group includes many different types of products. Some fall under the
medical legislation, others under the EU directive on medical devices. The
majority of these products are used in direct treatment of patients. An active
green public-sector procurement policy has already succeeded in almost
completely phasing out PVC containing phthalates at certain hospitals. The
experience gained at these institutions must be disseminated, along with
information on alternatives. Initiatives within this area take into account
issues of patient safety, etc. Naturally, such issues must be taken into
account when considering substitution of new products. After a period of
three years, an evaluation will determine whether increased initiatives are
needed on the basis of new developments (new knowledge and alternatives).
Such evaluation will include deliberations on whether there are grounds for
introducing a complete or partial ban.
6
Textile prints
 Work is being done to have the EU introduce common rules on bans on
the use of phthalates in textile prints.
 The objective with regard to PVC textile prints containing phthalates is
to see a voluntary national phasing-out process as soon as possible,
within a three-year period at the latest. The instruments used are
information to importers, retailers, and advertisers on alternatives and
opportunities for labelling.
Moreover, consumer information will be carried out.
To a large extent, fashion determines the use of textile prints. The products
are imported and produced by a number of parties. The structure of the
market will imply disproportionately high administrative costs and great
need for supervision in connection with a national ban, as well as with
taxation. Consequently, the most suitable course of action is to phase out
phthalate use by means of international initiatives. After a period of three
years, evaluation will determine whether the initiatives so far have been
adequate. The need for Danish bans will also be considered at this time.
Other general initiatives in the Action Plan:
 An EU policy paper on Denmark’s position on PVC and phthalates.
 Increased initiatives with respect to public-sector buyers by means of
environmental guidelines and substitution guidelines. Moreover,
discussions with counties and local authorities must be entered into with
a view to agreements within selected areas where satisfactory alternatives
exist.
 Information to consumers and other parties.
 Eco-labelling – the Nordic Svanemærke (‘Swan Label’), as well as the
EU Flower. A precondition for being awarded these labels is that no
phthalates are used in the products.
 Standardisation work promoting opportunities of substituting
alternatives for phthalates.
 The new subsidy scheme on cleaner products etc. gives priority to
subsidies for developing opportunities for substituting PVC and
phthalates.
The initiative directed against phthalates forms part of the overall PVC
strategy. This Action Plan sees Denmark taking the lead internationally
within this field, as no other countries have phthalate policies which are
equally clear and ambitious, with defined objectives and means.
Evaluation
The EU is currently assessing the risks involved with a variety of phthalates.
The Danish Environmental Protection Agency expects the findings of this
risk assessment to improve the basis for the decision-making process with
respect to EU initiatives within the field, including restrictions on phthalate
use.
For this reason, the Action Plan will be revised when the EU risk
assessments are available; however, revision will be carried out after a
maximum period of three years. Continuous assessment will be carried out
in order to determine whether new information dictates a need for further
initiatives.
7
The Danish Environmental Protection Agency will calculate the use of
phthalates in three years. These figures, along with continuous monitoring
activities in the environment, will be used to evaluate and adjust initiatives.
8
2 Background
Phthalates are a group of chemical substances which are used as plasticisers
in PVC, paint, printing ink, glue, and fillers, just as phthalates are used in
other products such as cosmetics.
Concern about phthalate
quantities
Phthalates are on the Danish Environmental Agency list of undesirable
substances. This is partly due to the fact that a series of surveys have proven
that phthalates now exist in worrying quantities in waste-water sludge,
landfill percolates, residues from biogas plants, and compost. This is a cause
for concern as phthalates are suspected of having undesirable long-term
effect on the aquatic environment. Some phthalates reduce fertility and have
toxic effects on testicles. Moreover, animal testing has proven that certain
phthalates can be carcinogenic. Test-tube testing have produced evidence of
oestrogen-like effects for dibutylphthalate and butylbenzylphthalate. A
summary of phthalate impacts on health and the environment can be found
in Appendix 2.
International concern
The USA, Canada, Norway, Sweden, and other European countries also
view the risk to health and the environment with concern. As part of the
programme on existing chemicals, the EU is currently undertaking risk
assessment of the phthalates which are most frequently used.
The Precautionary Principle
Even though exhaustive knowledge of the impact of phthalates on health and
the environment is not currently available, and a wide variety of tests are
still required as a result hereof, application of the Precautionary Principle is
well-founded. Many circumstances speak in favour of this.
A risk to health and the environment has already been proven for a number
of phthalates; for other phthalates, the effects have not yet been determined.
Phthalates are used in large quantities and are spread diffusely when the
finished product is used. If the Precautionary Principle is not applied,
waiting for further evidence may in the long term entail serious
consequences for human health and the environment – especially in light of
the fact that a period of several years will elapse from the time of
implementation of concrete measures to such a time when visible results can
be determined in the environment.
Substituting other phthalates
is problematic
Nine different phthalates are currently being used. Their technical properties
are so similar that in principle, it would be possible to substitute particularly
problematic phthalates with other phthalates. However, most of the
phthalates have only been cursorily tested, and consequently there is little
evidence that the use of other phthalates will result in lesser impacts on
health and the environment.
Danish phthalate
consumption
In 1992, calculations set the annual consumption of phthalates in Denmark
at approximately 10,000 tonnes, of which approximately 90 per cent was
used in soft PVC. No phthalates are produced in Denmark, but the 10,000
tonnes calculated include raw materials to be used in production, as well as
estimated quantities of phthalates in imported products. Phthalate
consumption appears to have risen during the last few years. In 1995,
phthalate consumption for soft PVC constituted approximately 11,000
tonnes.
Diffuse contamination
9
Since phthalates are part of and are released from actual products, it is not
possible to avoid the spreading of substances in the environment solely by
cleaning up the substances at point sources such as wastewater or air
emission. When phthalates are released in connection with product use, they
spread to air, soil, and water. Consequently, such contamination is diffuse
and ubiquitous. If humans and the environment are not to be subjected to
this hazard, it will be necessary to take measures directly against specific
products which contain phthalates.
Initiatives within seven areas
The application of the Precautionary Principle is carried out on the basis of
the extensive use of phthalates and the knowledge that phthalates are widely
spread in the environment. For these reasons, this Action Plan recommends
that measures be taken within a series of specific areas:
1. The need for more knowledge
2. Danish and international regulations on the use of phthalates
3. Requirements with respect to phthalates in connection with
standardisation
4. Taxation model for phthalates
5. Subsidies for the development of substitution options
6. Active public-sector procurement of products without phthalates
7. Eco-labelling
This Action Plan solely addresses the use of phthalates in soft PVC, which
accounts for 90 per cent of all phthalate consumption in Denmark.
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3 Objectives and strategy
The long-term objective is to phase out all problematic phthalate
consumption. Until sufficient evidence supports this, the objective is to
reduce the use and spreading of phthalates. In other words, this is a process
which is to commence now; a process where continuous evaluation and
adjustments are required in order to fulfil the long-term objectives.
The objective of this Action Plan is to reduce phthalate consumption by 50
per cent within the next ten years.
This objective is to be reached by means of concrete measures within the
seven areas outline above. Overall, the Action Plan is based on the
following strategies:
Evidence before substitution
Within a number of areas, additional knowledge and evidence must be
collected about the impact on health and the environment of phthalates and
the alternatives. This knowledge will, along with an assessment of
technological and financial aspects, form the basis of an assessment of the
expediency of substitution.
Greatest risks first
The first areas to be addressed will be those areas with the greatest risk of
releasing phthalates in connection with product use, where phthalates are
used in great quantities, and where initiatives are likely to produce results
Co-operation and time for
developments
Co-operation with Danish importers and manufacturers of products
containing phthalates must be established, and work must be done to ensure
that sufficient time is allowed for developing and changing to alternative
products.
Supervision will be adapted
to product groups
The choice of supervision must be adapted to possibilities and conditions
within individual product groups.
Co-ordination with PVC
initiatives
Initiatives against phthalates in soft plastics must be co-ordinated with the
initiatives against PVC.
International initiatives and
commercial implications
Initiatives must be considered in view of international initiatives and the
implications for enterprises.
Information initiatives
Information initiatives must be carried out with respect to relevant parties on
specific problems and substitution options.
As close to the source as
possible
The best way of containing the spreading of phthalates is to take action as
close to the source as possible. When spreading is caused by the use of
products which contain phthalates, substitution is preferable. Subsequently,
initiatives can be made by cleaning up contamination at point sources by
means of existing options for limiting releases to air and waste water.
Voluntary agreements
11
At present, no areas where voluntary agreements can be made have been
identified.
Opportunities for substitution
The use of phthalates can be changed, either by substituting other substances
for phthalates, e.g. polymers, plasticisers, or adipats, or by substituting other
materials for soft PVC, such as polyethylene (PE), polypropylene (PP),
rubber, textiles, leather, etc., which do not contain plasticisers.
Initiatives to find alternatives
Not all phthalate consumption presents opportunities for substitution which
meet the current requirements for products and materials. As a consequence
hereof it is important that the Danish Environmental Protection Agency
continues co-operation with enterprises to find and describe alternatives
with a view to avoiding phthalate consumption. Some of these alternatives
have already been assessed in terms of health and the environment.
Substitution utilising other plasticisers which have not been sufficiently
tested in terms of their properties with regard to health or the environment is
not deemed to be appropriate.
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4 Phthalates in Soft Plastics: Use and
Contamination
11,000 tonnes of phthalates
The Danish Plastics Federation prepared an account of the consumption of
phthalates in soft PVC in 1995, where calculations show that the total
annual consumption of phthalates constituted approximately 11,000 tonnes,
whereas the corresponding figure for 1992 was approximately 10,000
tonnes. This increase may be caused by an actual increase in phthalate
consumption in the period 1992 to 1995, or it may be caused by the
inclusion of more imported products in the 1995 account.
The review of the individual product groups indicates the consumption of
phthalates, and a total overview of phthalate consumption and emissions can
be found in Appendix 1.
Environmental properties of
phthalates
The phthalates which are mainly used as plasticisers in PVC today are di(2ethylhexyl)phthalate (DEHP) followed by lesser quantities of
diisononylphthalate (DINP), diisodecylphthalate (DIDP), and
butylbenzylphthalate (BBP). As a rule, plasticisers are not reactive
substances with low vapour pressures; the phthalates are not chemically
attached to PVC. Phthalates can be released in small quantities by
evaporation, migration of phthalates to adjacent materials can occur, and
phthalates may be washed out from PVC products by contact with water.
In the production of soft PVC products, phthalates may be released into the
air; such emissions are estimated to constitute 1 -12 tonnes/year /2/, whereas
waste-water emissions from production is estimated at less than one tonne.
The B values of the Danish Environmental Protection Agency Guidelines
No. 6, 1990, Begrænsning af luftforurening fra virksomheder (‘Limiting Air
Contamination from Enterprises’) have been reduced in the 1996
Orientering fra Miljøstyrelsen nr. 15 (‘Information from the Danish
Environmental Protection Agency No. 15’). Production-related contributions
to the air are expected to drop over the next few years.
Total environmental impact
The vast majority of phthalate emissions from soft plastics occur during use
of finished products. This amounts to 5 - 29 tonnes/year to waste water and
0.4 – 5.5 tonnes/year to air. Disposal of products which contain phthalates at
waste incineration plants is estimated to entail total phthalate contributions
of approximately 1.8 tonnes/year, out of which 0.19 tonnes/year to air.
Consequently, the total environmental strain is estimated to constitute 5 - 34
tonnes/year. Moreover, emissions from car undersealing using soft PVC is
estimated at 2 - 10 tonnes/year in Denmark /3,4/.
DEHP in waste-water sludge
The tests so far carried out on DEHP in waste-water sludge have revealed
concentrations ranging from 1 to 190 mg/kg dry matter. In Environmental
Project No. 320/96 the total amount of DEHP which is conducted into
Danish sewage treatment plants is estimated at 32 ± 4 tonnes/year. This
means that emission reductions of 75 per cent must be made with respect to
the highest observations if all sludge is to be usable for agricultural purposes
in the year 2000.
Phthalates at waste deposits
13
1,600 – 4,400 tonnes of phthalates are disposed of at waste deposits/landfills
every year in connection with disposal of products containing PVC. The
quantity of phthalates in deposit/landfill percolate is estimated at
approximately 3.5 kg/year /2/. No measurements have been carried out on
phthalate emission from shredder waste.
Other types of plastic
Besides the use of phthalates in soft PVC, lesser quantities of phthalates can
be found in other types of plastic such as polyvinylflouride (PVF) and
polyurethane (PUR).
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5 Seven interdepartmental measures
and initiatives
This chapter reviews seven interdisciplinary opportunities for initiatives and
measures which are to be used in order to achieved the desired reductions in
the consumption and spreading of phthalates. The following chapter
addresses the proposals for specific measures for each product group.
5.1
Knowledge is required on the
spreading of various sources
Xenobiotic substances and
their fate in the environment
Sludge
The need for knowledge
There is a need to further determine the extent to which significant sources
contribute to the spreading of phthalates. Moreover, it is important to follow
the latest international research on phthalate effects on health and the
environment, and to supplement such research with Danish research within
certain areas. Further investigation should be carried out for areas where
suitable substitution options are not yet available, including work to the
determine the effect on health and the environment of the alternatives.
On the basis of the Commission Regulation No. 793/93, the EU has initiated
risk assessments for DEHP, DOP, DBP, DINP, DIDP, and BBP. Completion
of these risk assessments is expected in 1999/2000. The assessments are
carried out by Sweden, Holland, France, and Norway. Denmark contributes
all relevant information and will supply comments on drafts during the risk
assessment process. The first drafts have been debated in the EU Technical
Working Group. Provisional conclusions on DEHP can be found in
Appendix 2.
The Danish Environmental Protection Agency has instigated a major
project on xenobiotic substances at the National Environmental Research
Institute. Here the occurrence and fates of xenobiotic substances in all
media are determined. Part of this project involves tracing sources at a
number of service enterprises, for example car washes, childcare
institutions, and a hospital. Results from this part of the project are
described in Section 5.1.1 on new knowledge.
In recent years, a series of projects have been instigated with a view to
contributing knowledge on the long-term effects of environmentally harmful
substances in sludge. Focus is placed on the degradation of substances and
their toxic properties in relation to the soil environment. At the same time,
contamination of flora by xenobiotic substances from sludge is being
examined.
Work is being carried out in Denmark and internationally with a view to
obtaining greater clarity on any oestrogen-like effects of phthalates. A report
from the Nordic Council of Ministers, ‘Chemicals with Oestrogen-like
Effects’, contains proposals for criteria which render it possible to
categorise dibutylphthalate (DBP) and butylbenzylphthalate (BBP) as
having oestrogen-like effects /5/. Apart from small amounts of BBP in vinyl
floors, these substances are not used in soft PVC.
15
Oestrogen-like effects
Work is being carried out in Denmark and internationally with a view to
obtaining greater clarity on any oestrogen-like effects of phthalates. A report
from the Nordic Council of Ministers, ‘Chemicals with Oestrogen-like
Effects’, contains proposals for criteria which render it possible to
categorise dibutylphthalate (DBP) and butylbenzylphthalate (BBP) as
having oestrogen-like effects /5/. Apart from small amounts of BBP in vinyl
floors, these substances are not used in soft PVC.
Working groups under the Oslo-Paris Commission are continuing their work
to identify and assign priorities to substances with oestrogen-like effects in
relation to the marine environment.
This area sees substantial Danish research activity, including activity under
Det strategiske Miljøforskningsprogram (‘the Strategic Environmental
Research Programme’) and activity through research programmes under the
Danish Medical Research Council.
Respiratory allergies
In 1998, a project was initiated under Det strategiske
Miljøforskningsprogram (‘the Strategic Environmental Research
Programme’) on the ability of phthalates to aggravate the effects of other
known allergenic substances (house dust, cat hair, and pollen).
Denmark participates in the international development of test methods –
primarily by establishing OECD guidelines for test methods for examining
health and environmental effects which include toxicological and ecotoxicological effects.
Alternative plastics
Surface water run-off
Domestic waste water
16
A number of projects have already been carried out in order to elucidate the
effects on health and the environment of alternative plastics. The knowledge
acquired from these projects on alternatives to soft PVC products is
described in more detail under the relevant product-group headings.
Further projects will be initiated on the assessment, development, and
communication of alternatives to products which contain phthalates.
5.1.1 New knowledge
The Environmental Project No. 355, 1997, Miljøfremmede stoffer i
overfladeafstrømning fra befæstede arealer (‘Xenobiotic Substances in
Surface Water Run-off from Paved/Surfaced Areas’) /3/ includes
measurements of phthalate contributions to waste water from wet and dry
deposition from air as well as contamination from traffic and roads
themselves. Rain-water run-off has been examined at two different sites.
The values measured provide figures for the contribution from traffic and
dry and wet deposition. The average DEHP contents in water were 17 (SD =
23) and 44 (SD = 57) g/litre. Based on one measurement, DEHP
concentrations in sediments from the rainwater system were 28 mg/kg dry
matter and 13 mg/kg dry matter, respectively. In addition to this, smaller
concentrations of DBP, BBP, and DIOP were found. Total DEHP emissions
from these sources are estimated at approximately 8 tonnes/year, out of
which approximately 5 tonnes/year are discharged directly into the aquatic
environment and the remaining portion is processed in waste water
treatment plants.
Among other things, the Environmental Project No. 357, 1997
“Miljøfremmede stoffer i husholdningsspildevand” (‘Xenobiotic Substances
in Domestic Waste Water’) /6/ features measurements of DEHP
contributions from households. The concentrations measured were between
24 - 39 g/litre, which corresponds to between 20 and 70 per cent of the
total DEHP waste-water impact.
Source investigation
A 1998 investigation carried out by the National Environmental Research
Institute features measurement of phthalate emissions from car washes,
hospital waste water, waste water from a glue plant, a laundry, and a
childcare institution. Moreover, contributions from air deposition of
phthalates were measured /4/. Total phthalate emissions from the sources
investigated were estimated at approximately 70 kg/year in the Roskilde
area. In addition to this, phthalate measurements in two watercourses
revealed total phthalate concentrations of 0.249 g/l and 0.714 g/l,
respectively.
Foodstuffs
In 1998, the Danish Veterinary and Food Administration investigated
DEHP, DBP, and BBP contents in samples of a complete day’s diet,
collected by adults. The EU Scientific Committee for Food proposes
migration limits of 3 mg/kg food for DEHP and BBP, and 6 mg/kg for DBP.
One or more of the substances were present in almost all samples; they
were, however, present in maximum average concentrations of no more than
10 per cent of the limits recommended by the EU Scientific Committee.
Processed baby food in jars and breast-milk substitutes were also
investigated. Here, the highest calculated average daily consumption was 7
and 14 per cent of the tolerable daily intake. With some samples, DEHP
consumption was as high as approximately one third of what is acceptable
/7/.
5.2
Danish and international regulation of the use of phthalates
Regulation is already in force
for a number of areas
The use of phthalates is already regulated within a number of areas. With
respect to the production phase, regulation is carried out by means of the
Danish Environmental Protection Agency Guidelines on Air and Waste
Water. Requirements have also been stipulated for the use of waste products
for agricultural purposes. Products which are used for foodstuffs fall within
the scope of the rules stipulated by the Danish Veterinary and Food
Administration on substance emissions and migration from plastics. Medical
devices is regulated by the Danish Medicine Agency. These regulations are
briefly described in the following. Moreover, future opportunities for
regulation are described.
Air
With a view to reducing phthalate emissions into air from production
enterprises, the Danish Environmental Protection Agency stipulated a
recommended limit value (B value) in Orientering (‘Information’) No. 15,
1996 /8/. In these recommendations, the B value for DEHP has been
lowered from 0.02 mg/m3 to 0.005 mg/m3. B values for other phthalates are
set at 0.01 mg/m3.
These values are to be seen as guidelines in relation to the approving
authorities and will be significant in future approvals and in amendments to
existing approvals for listed enterprises. The best technique available must
always be employed to reduce emission of these substances into the air.
The aquatic environment
For the protection of the aquatic environment, requirements are made for the
composition of industrial waste water, both for licenses to discharge waste
water directly into the aquatic environment and for connection to wastewater plants run by the local authorities. The general requirements for
17
connecting industrial waste water are described in the Danish Environmental
Protection Agency Guidelines No. 6, 1994: Tilslutning af industrispildevand
til kommunale spildevandsanlæg (‘Connection of Industrial Waste Water to
Local Authority Sewage Treatment Plants’) /9/. These requirements are to
protect both the waste-water system, recipients, and sludge, and should also
reflect the opportunities of enterprises or trades to limit phthalate discharges
and emissions by means of the best technology available; including cleaner
technology and clean-up, with priority on cleaner technology, and clean-up
as the next best alternative.
The current revision of the guidelines will include expansion and revision of
the list of organic substances and their environmental impact in waste water.
This will include a reassessment of DEHP, which is currently classified as a
C-class substance. In this connection, classifying DEHP as a B-class
substance is under consideration.. The guidelines do not stipulate specific
limit values for C-class substances in waste water which is connected to the
sewage treatment plant, but C-class substances should always be limited by
means of the best technology available. Recommended values are provided
for discharge of B-class substances.
Waste products
An assessment of the impact on health and the environment has led to the
stipulation of limits on DEHP contents in waste products which are intended
for agricultural purposes /10/. As of 1 July 1997, the cut-off value for the
use of sludge, compost, and residues from biogas plants for agricultural
purposes are set at 100 mg/kg dry matter. As of 1 July 2000, the cut-off
value is set at 50 mg/kg dry matter.
Medical devices
Products which are used as medical devices are regulated in the Ministry of
Health Statutory Order No. 734, 10 August 1994 on medical devices. This
legislation is administered by the Danish Medicine Agency.
Foodstuffs
Requirements with respect to phthalate release from plastics are stipulated
in the Ministry of Health Statutory Order No. 1064, 4 December 1996 on
materials and objects intended for contact with foodstuffs. This legislation is
administered by the Danish Veterinary and Food Administration.
Building materials
Previously, subsidies for private urban renewal have entailed environmental
requirements on building materials. The new Act on urban renewal no
longer provides opportunities for making orders stipulating such
requirements. Stipulating environmental requirements in connection with
EU
None of the phthalates are currently classified as hazardous by the EU.
Previous debates have involved classifying DEHP as carcinogenic, but at the
time the feeling was that there were no sufficient grounds for doing so.
The EU has initiated risk assessments of DEHP, DOP, DINP, DIDP, DBP,
and BBP. Completion of these risk assessments is expected in 1999/2000.
Problems in connection with
limits on phthalate use
confined to Denmark
18
If limitations are to apply only to phthalates which are used for production
purposes in Denmark, this can be done under the authority of the Act on
Chemical Substances and Products, but such a course of action may have a
detrimental impact on the competitiveness of Danish enterprises. Also,
this will only affect a limited number of phthalates, as two thirds of the
total phthalate consumption in soft plastics stems from imported
products. Notification must be given to the EU if bans are to include
imports. This must be done in deference to Articles 30-36 of the EU
Treaty , which prohibit import restrictions unless such restrictions can be
justified in terms of national interests in safeguarding personal safety and
health.
With respect to DEHP, DINP, and DIDP, the current view is that there is not
sufficient evidence within all areas to support such a claim.
Toys and certain childcare
articles
In a Recommendation of 1 July 1998, the European Commission has
recommended that Member States should, to the extent that such action is
deemed necessary, ‘adopt the measures required to ensure comprehensive
protection of children under the age of three against toys and childcare
articles which are intended to be put in the mouth and which are made of
soft PVC with phthalate contents, especially the substances DINP, DEHP,
DBP, DIDP, DNOP, and BBP, with particular focus on the substances DINP
and DEHP”. Proposals for common regulation have been debated in the EU.
Danish ban
The Danish Statutory Order No. 151, 15 March 1999 on prohibition of
phthalates in toys and certain childcare articles and other products for
children aged 0-3 entered into force on 1 April 1999.
A number of other European countries have already introduced or are
planning to introduce similar bans.
5.3
Phthalates and requirements in connection with
standardisation
Work should be carried out in Denmark, as well as internationally, to ensure
that considerations with respect to phthalate contents are included in
standardisation work.
Fire and safety requirements
A number of requirements for existing products made of soft PVC with
respect to fire and safety have been stipulated by authorities and product
standards. The medical field in particular has many product requirements,
just as changes to raw-material and ancillary material usage requires
approval from the health authorities. The product requirements are phrased
in terms of performance/properties, such as ductility/flexibility, robustness
against chemical substances, fire retardation, etc.
It will be a prerequisite for substitution of phthalates that alternative
plasticisers or alternative materials can meet these requirements for
performance.
Framework directives
The EU has adopted a series of framework directives which stipulate
requirements with respect to the performance, safety, and health aspects of
specific product groups. In this connection, authority is given to the
European standardisation organisation CEN. The framework directive is
then to be supplemented by standards featuring more specific
recommendations for requirements within these areas. If manufacturers do
not comply with the stipulated standards, they must be able to produce
evidence that their products are equally safe and harmless as they would
have been, had the standards been complied with.
Byggevaredirektivet (the ‘Building Materials Directive’) is a framework
directive (Council Directive of 21 December 1988, 89/106/EEC) which was
implemented by the National Housing and Building Agency Statutory Order
19
No. 559 of 27 June 1994. One of the important requirements in the
Directive in relation to hygiene, health, and the environment is that
buildings must be constructed and erected in a manner which entails no risk
in terms of hygiene or health to residents or neighbours. For example, this
applies in connection with contamination or poisoning of water or soil. This
Directive is to be supplemented by CEN standards, and a list of national
regulation on dangerous substances is included in the authority which has
already been given.
Moreover, standardisation work is being carried out with respect to product
groups such as toys, medical devices, personal protective equipment, and
packaging for foodstuff. Such standardisation is described in more detail
under the headings for each product group.
The Danish Environmental Protection Agency plans to take part in Danish
and European standardisation work to ensure that technical requirements do
not render substitution of phthalates impossible. In the long term, the Danish
Environmental Protection Agency will work to ensure that standards within
selected areas include requirements stipulating that phthalates shall not be
used at all, or to ensure that requirements are made with respect to phthalate
release.
5.4
Possible to find model
Taxation model for phthalates
The Ministry of Taxation, in co-operation with the Danish Environmental
Protection Agency, has investigated the feasibility of a phthalate tax on a
number of selected product groups. Preliminary investigation shows that it is
possible to find a model which satisfies the requirement that any tax should
apply to both phthalates used in Danish production and phthalates which are
imported in finished products.
The Ministry of Taxation has prepared a memorandum on a taxation model;
this memorandum will be submitted for a public hearing at the same time as
this Action Plan is published. The public hearing on the taxation model will
be included in subsequent considerations pending the final decision.
This Action Plan provides a short description of the background and the
model. For further information, see the memorandum from the Ministry of
Taxation.
A tax on phthalates can, in conjunction with other instruments, provide an
incentive to use other products and thereby reduce phthalate emissions. Such
a tax will assist the reduction of soft PVC content in products and provide
an incentive to use other plasticisers than phthalates.
Ideally, taxes should be imposed on all consumption of phthalates in soft
PVC. This is not possible for administrative reasons, as several products
contain soft PVC in unknown quantities, and an account of such contents
would entail great administrative costs. Moreover, the tax has been
restricted to include only those product groups where the desired effect is
likely. No taxes are imposed on products which contain only modest
quantities of soft PVC because such a tax is not expected to have the desired
effect.
20
This means that the basis for taxes is restricted to include only products
where assessment indicates that PVC and phthalate contents can be
calculated by means of a standard rate in accordance with the average PVC
and phthalate contents for products; where such taxes will have the desired
effect, i.e. the use of other materials than PVC and phthalates; and where
recycling is to be stimulated. The product groups selected cover
approximately 65 per cent of all Danish phthalate consumption.
The tax does not vary in relation to the exact phthalate content. This renders
calculation and administration of the tax more simple. At the same time, it is
judged that the tax will continue to have the desired environmental effect, as
manufacturers are rarely able to reduce phthalate contents; rather, they will
choose alternative materials or plasticisers so that substitution ensures that
PVC and/or phthalates are completely eliminated from the product.
For these reasons, a calculated standard rate is proposed for products in the
selected product groups. A proposal will be put forward, suggesting that
these rates are indicated in an appendix to any act that may be adopted.
These rates are calculated on the basis of the expected average PVC and
phthalate contents of products. The basis for the standard rates is DKK 2.00
per kg PVC and DKK 7.00 per kg phthalates.
Selected product gro
ups
The selected product groups in relation to this Action Plan are:
1. Flexible pipes, tubes and hoses (garden hoses, water hoses, foodstuff
hoses, and industrial hoses)
2. Electrical wires with plastic coating
3. Floor, wall, and ceiling coverings
4. Certain office supplies (ring binders, magazine holders, and folders)
5. Clothing (gloves, aprons, rainwear, and protective suits)
6. Tarpaulins, roofing film, and membrane film
7. Tape and self-adhesive film
Estimates which are subject to uncertainty suggest that a tax on phthalate
contents in the selected product groups could in the long term reduce
phthalate consumption by approximately 30 per cent within the selected
groups. It is possible to use alternative plasticisers with respect to the vast
majority of the product groups with phthalate contents.
For administrative reasons the proposed tax has been restricted to apply only
to certain plastic goods where it is deemed possible that the tax will work,
and where the products are homogenous so that a standard-rate tax based on
weight can be calculated on the basis of expected PVC and phthalate
contents. The product groups have been indicated by means of position
numbers from the EU combined nomenclature, a fact which ensures a high
degree of certainty as to which type of products the tax applies to. Using the
EU combined nomenclature eliminates matters of dispute and facilitates
precise delimitation.
21
5.5
Opportunities for subsidies
are to be developed and
supported
Subsidies for the development of substitution opportunities
The opportunities for subsidies for the development of alternatives to
phthalate plasticisers are to be developed and supported.
A series of development products have been initiated with subsidies from
the Renere Teknologi (‘Cleaner Technology’) subsidy scheme. This subsidy
scheme no longer exists, but has been replaced by a new subsidy scheme:
Program for Renere Produkter m.v. (‘Programme for Cleaner Products
etc.’).
Cleaner products
The new subsidy scheme is based among other things on the previous
‘Cleaner Technology’ scheme and is intended to promote the development
and sale of cleaner products. This scheme is administered by a new
Environmental Council for Cleaner Products.
The Council has adopted its annual prioritisation plan for granting subsidies,
which states that in 1999, subsidies can be granted for development and
dissemination of products which substitute phthalates. In addition to this, an
elucidation project on environmental and health assessment of alternatives
will be offered.
5.6
Environmental awareness in public green procurement
policies
The reduction of phthalate consumption must form part of green
procurement policies.
The objective of a green public procurement policy is to use
environmentally conscious green procurement to:
 Reduce impacts on the environment, including environmental impacts
from energy consumption, as a result of public-sector production and
consumption;
 Encourage the rest of society to also use environmentally sound and
energy-efficient, products and production methods.
Requirements for
procurement
The main instrument for carrying out green public procurement is that, in
addition to requirements with respect to quality, function, price, delivery
guarantees, working environment, etc. in procurement and production, the
public sector should also require that products and production methods are
environmentally sound; this includes requirements for energy efficiency.
The work which is carried out by the Ministry for Environment and Energy
on promoting green procurement policies is done within the framework of
the Action Plan on green public procurement, August 1994. Moreover, a coordination group for the promotion of green public procurement has been
appointed to facilitate implementation of the Agreement on Green
Procurement in counties and local authorities from November 1998.
Environmental Guidelines
22
An important part of the Action Plan has been the preparation, since 1997,
of 25 Environmental Guidelines with recommendations for public-sector
buyers on how to include environmental awareness in procurement. Further
Environmental Guidelines are to be prepared in 1999. These Environmental
Guidelines are published by the Danish Environmental Protection Agency
on an ongoing basis and are distributed among public-sector buyers in cooperation with National Procurement Ltd. Denmark and IKA (Indkøbere i
Kommuner og Amter (‘Buyers in Counties and Local Authorities’).
Ten product groups
Eight Environmental Guidelines touch on ten of the product groups which
have been selected in this Action Plan. These Environmental Guidelines
include, or will include, recommendations which can promote substitution
of phthalates and/or soft PVC.
In addition to this, discussions must be entered into with counties and local
authorities with a view to reaching agreement in selected areas where
satisfactory alternatives exist.
5.7
Eco-labelling
Phthalates are to preclude
eco-labelling
The Danish Environmental Protection Agency will work to ensure that the
use of phthalates precludes eco-labelling in the EU, as well as in the Nordic
countries.
The EU Flower
Two sets of criteria for the EU eco-label feature criteria which stipulate that
use of plastisole printing (PVC printing) precludes any awarding of the ecolabel. This applies to T-shirts, bed linen, and textiles generally. Other areas
feature similar requirements, for example, no phthalate content is accepted
in paint and varnish for indoor use.
’Svanen’ – The Nordic Swan
label
In 1997, Denmark joined the Nordic eco-label Svanen (‘the Swan’). The
existing criteria stipulate that adding phthalates precludes any awarding of
the eco-label for product groups which include flooring, textiles, and
furniture - mainly wooden furniture. At present, there are plans to prepare
new criteria for office supplies which may contain PVC. As electrical cables
and wires are found in all machine types, it will be possible to have
requirements for phthalate-free cables in criteria for several product groups.
At present, such requirements exist in one set of criteria. Denmark will work
to ensure that phthalate use precludes any eco-labelling in connection with
criteria development and amendments.
Forward-looking initiatives will focus on the inclusion of requirements for
the exclusion of phthalates in eco-labelling criteria within the EU and the
Nordic Swan Label.
23
24
6 Overview of product groups in this
Action Plan
The most problematic groups
As soft plastics form part of many different product groups, priority has
been given to those groups which are of the greatest concern in terms of
health and/or the environment. This has been done by starting from the
Danish Plastics Federation report /1/ on phthalate use. This report has been
combined with existing knowledge on phthalate spreading, the risk of
phthalate leeching into the aquatic environment, and/or human exposure to
phthalates. This has been used for assigning priorities to product groups, so
that the majority of resources is being directed at the most significant
problem areas.
The first column indicates the product group, the second column indicates
phthalate consumption within each product group, and the ‘comments’
describe the risk of phthalate release or exposure.
Table 6.1
Overview of product groups.
Product groups
Consum
ption
tonnes
Cars
1,000
Floor and wall
coverings
Toys
Medical devices
Inlays in lids
Furniture/vinyl
Tarpaulins
2,000
380
120
120
340
240
Rain and workwear
Profiles
Boots/waders
110
700
140
Roofing film and
membrane film
Gloves
Garden and water hoses
Textiles and PVC
prints
Foodstuff hoses
Electrical cables
Fenders
Other medical devices
300
Office supplies
Bags
Industrial hoses
Self-adhesive film
125
140
15
40
3,500
23
175
800
320
150
50
Comments
PVC from undersealing a major source; from washing and contact
with water
Regular washing (with soap) of floors; frequent exposure to water in
wet rooms.
Children sucking on toys
Bags for bodily fluids, many product restrictions
Migration to foodstuffs
Frequent washing
Outdoor use, phthalate release in connection with rainwater and by
washing
Direct exposure to water, frequent washing for workwear
Some exposure to water outdoors, some washing indoors
Contact with water – directly in the aquatic environment and from
washing
Large surfaces, but, generally, only migration to air. Some water
contact for membrane film in garden pools etc.
Used in connection with cleaning/washing
Exposure to cold water, emitted directly into soil
Frequent washing, soap, and high temperatures
Migration to foodstuffs through imported milk hoses
Very slow emission, increased emission at high temperatures
Direct emission into the sea, no washing
Other product requirements, many different products, some phthalate
release in connection with washing
Many small products, emission to air
Emission to air and in connection with cleaning
25
Shoes/soles
Undersides of carpets
and mats
Other products
80
75
125
26
Phthalate release through rainwater
7 Proposals for initiatives for
individual product groups
This chapter describes phthalate use, environmental impact, possible
alternatives, and relevant measures and instruments for each product group.
Some of these measures are already in force, whereas further investigation is
needed prior to implementation of other measures.
7.1
1,000 tonnes of phthalates
per year
Cars
This product group is given high priority because of the phthalate quantities
used, and because undersealing is an important source of phthalates in waste
water. Approximately 1,000 tonnes of phthalates in soft PVC in cars are
imported each year, out of which approximately 200 tonnes are found in
undersealing, which is intended to prevent rust. Phthalates from
undersealing are released in connection with car washing, wear and tear, and
rain. Phthalate releases from cars are estimated at approximately 2 - 10
tonnes per year /3,4/.
Only very few car makes do not use soft PVC for undersealing. Through car
importers, the Danish Environmental Protection Agency has determined
which car makes do not use phthalates. The alternatives used are
polyurethane and tar compounds. In addition to this, a few new cars have
undersides which are completely galvanised. Some car manufacturers have
stated that they are currently investigating alternative products. Polyurethane
varnish can contain small quantities of phthalates.
Rådet vedrørende genanvendelse og mindre forurenende teknologi (‘the
Council for Recovery and Cleaner Technology’) has granted support for a
project on waste-water discharges from car washes to facilitate
determination and possible limitation of such discharges.
One of the Environmental Guidelines for public-sector buyers addressed the
issue of phthalate leeching from cars. It is recommended that public-sector
buyers demand cars without phthalates in their undersides in an attempt to
contribute to the development of more environmentally sound cars.
However, the alternatives also present problems and the supply of cars with
alternative undersealing is not yet sufficient.
The Danish Environmental Protection Agency will work to ensure
availability of environmentally suitable alternatives and fast substitution, so
that new cars do not use PVC with phthalates for undersealing. The Danish
Environmental Protection Agency will approach the EU to submit proposals
on common rules on bans within this area.
The principal parties concerned are the Danish Car Importers, the Danish
Automotive Trade and Industry Federation, FDM, the Danish Automobile
Dealers Association, the Working Environment Authority, consumer
organisations, and Sammenslutningen af danske benzinforhandlere (‘the
Association of Danish Petrol Dealers’).
27
7.2
Floor and wall coverings
This product group is given high priority due to the quantities used and the
release of phthalates to waste water.
2000 tonnes phthalates
annually
Vinyl wallpaper and vinyl floors are made of soft PVC, and other materials
such as cork tiles may have a PVC coating. Approximately 2,000 tonnes of
phthalates are imported in floor and wall coverings per year. There is no
Danish production. Vinyl floors release DEHP and BBP when washed. Such
release depends among other things on the frequency of washing and is
estimated at 1 – 5 tonnes per year. Smaller quantities may be emitted into air
and consequently cause obnoxious smells.
Technically satisfactory alternatives exist for all uses except for floor
coverings for damp and light-construction wet rooms. Vinyl floors with
other plasticisers than phthalates exist. A suitable plastic alternative has
been found for wall coverings, which also entails a better working
environment at the production stage. /11/.
The National Consumer Agency of Denmark has already prepared the leaflet
Gulve i lange baner (‘Floors Galore’), which contains good information for
consumers. The Nordic Swan-label criteria for floor and wall coverings
preclude the use of phthalates. The Danish Environmental Protection
Agency will investigate the need for further information for other relevant
parties and support eco-labelling of alternative products.
As the existing alternatives are more expensive than products which contain
phthalates, a tax is proposed with a view to reducing phthalate consumption.
Building materials are covered by standardisation work under
Byggevaredirektivet (‘The Building Materials Directive’). The Danish
Environmental Protection Agency will work to include environmental
concerns in such work.
Increased use of Miljørigtig Projektering (‘Environmental Planning’) will
contribute to a reduction in the number of vinyl floors. Moreover, a project
on the preparation of environmental declarations of building materials will
be initiated under the ‘Action Plan to Promote Ecological Building and
Urban Renewal’.
The principal parties concerned are the Danish Flooring Trade Association;
the Ministry of Housing and Building; the Working Environment Authority;
private, co-operative, and public builders; the Danish Building Research
Institute; and the National Consumer Agency of Denmark.
7.3
Toys
This product group is given high priority because of the risk of direct
impacts on health from toys used by young children.
380 tonnes of phthalates per
year
28
This product group comprises various types of toys with various uses. Total
Danish consumption of phthalates in toys is at least 380 tonnes per year.
Denmark has a small production of approximately 80 tonnes of toys which
can be assumed to contain phthalates; most of these toys are exported.
Investigations have shown that several different phthalates are used in toys.
These phthalates can constitute a health hazard, especially with regard to
teething rings and baby toys for children under the age of three due to the
direct release of phthalates to the children during use. The EU Scientific
Committee for Toxicology, Eco-toxicology, and the Environment has issued
several statements on the impact on children’s health caused by the use of
certain types of toys and childcare articles made of soft PVC which contains
phthalates. In these statements, the Committee voices its concern about the
fact that children are exposed to some of these phthalates. Appendix 2
features zero-effect levels and values for the maximum tolerable daily intake
from the Committee statement.
In a Recommendation of 1 July 1998, the European Commission has
recommended that Member States should, to the extent that such action is
deemed necessary, ‘adopt the measures required to ensure comprehensive
protection of children under the age of three against toys and childcare
articles which are intended to be put in the mouth and which are made of
soft PVC with phthalate contents, especially the substances DINP, DEHP,
DBP, DIDP, DNOP, and BBP, with particular focus on the substances DINP
and DEHP”. Proposals for common regulation have been debated in the EU.
The Danish Statutory Order No. 151, 15 March 1999 banning phthalates in
toys for children aged 0-3 and in certain childcare articles etc. entered into
force on 1 April 1999. However, goods which were bought prior to this date
can be sold until 1 April 2000. Inflatable swimming equipment for outdoor
use or use in swimming baths, etc., are permitted until 1 January 2003.
A number of other European countries already have, or are planning, similar
bans.
Toys are encompassed by an EU framework directive (Commission
Directive of 3 May 1988 88/378/EØF) which was implemented by the
National Consumer Agency of Denmark Statutory Order No. 329 of 23 May
1995 on safety requirements for toys and products which due to their
appearance may be mistaken for foods. This framework directive is to be
supplemented by CEN standards. The Danish Environmental Protection
Agency is taking an active part in this task.
Work is also being carried out on CEN standards within the field of
childcare articles; the Danish Environmental Protection Agency is
contributing to this initiative by supplying relevant information on chemical
substances and requirements for investigations on phthalate release.
In many cases, alternative plasticisers or other materials can be used in the
production of toys. Such alternatives must be carefully investigated before
using them for substitution. With support from Rådet vedrørende
genanvendelse og mindre forurenende teknologi (‘the Council on Recycling
and Cleaner Technology’), the Danish Toy Trade Association has initiated a
project to uncover problems with i.a. plastic toys and to investigate the
opportunities for using alternative substances and materials in the
production of toys. On the basis of this project and other sources of
information, procurement guidelines will be prepared for toy importers in
order to enable importers to select those products with the least impact on
health and the environment.
29
There is also a need for information aimed at the principal parties, including
parent and consumer organisations, the toy sector, TME, retailers, trade
unions, local authorities, counties, and the National Consumer Agency of
Denmark.
7.4
Furniture/vinyl
Priority has been given to this field due to the phthalate quantities used and
the possibility of phthalate release caused by washing.
340 tonnes of phthalates per
year
This product group comprises imitation leather made from vinyl (skai) and
furniture film made of soft PVC. The annual phthalate import is
approximately 340 tonnes. Denmark does not produce yard goods, but such
yard goods form part of Danish furniture and imported finished goods.
Phthalate releases can occur in connection with washing and direct
exposure, and to a lesser extent to air.
Alternative materials - textiles and genuine leather – can replace imitation
leather. Moreover, imitation leather can be made from polyurethane. No
knowledge is available on the opportunities for using other plasticisers as
imitation leather is produced in other countries.
Environmental Guidelines on upholstered furniture have been prepared for
public-sector buyers. These Guidelines recommend that plastic parts made
from PVC should not be used. Environmental Guidelines on office chairs
will also be prepared. The Nordic Swan Label has criteria for wooden
furniture and accessories. This includes chairs and benches which contain at
least 60 per cent wood. Such furniture cannot be awarded an eco-label if
phthalates were used as plasticisers in any component parts such as plastics
or glue.
A tax is proposed on import of yard goods with phthalate contents for
Danish production.
The principal parties concerned are Møbelfabrikantforeningen (‘the
Association of Furniture Manufacturers’), the Danish Furniture Retailing
Organisation, consumer organisations, the catering trade, the National
Working Environment Authority, public-sector buyers of office supplies,
and large furniture chain stores such as Ikea.
7.5
Tarpaulins
Priority has been given to this field due to outdoor use and exposure to the
elements.
240 tonnes of phthalates
per year
30
This product group comprises tarpaulins for covering purposes, for example
within the building sector, for lorries, and storage tents. Tarpaulins are made
from yard goods; either nylon or polyester with a PVC coating.
Approximately 200 tonnes of phthalates are used in tarpaulin film produced
in Denmark; an additional 40 tonnes come from imported film. Phthalates
may be released from tarpaulins in production, by washing, to rainwater, and
to the air. The extent of such releases is not accurately determined, but is
estimated at 1 – 3 tonnes per year.
At present, DINP is used almost exclusively in tarpaulins. For special oilproof tarpaulins a polymer plasticiser is used in conjunction with phthalates.
No investigations have been carried out with respect to using other
plasticiser; such changes should be carried out in collaboration with
manufacturers. Other materials can be used with respect to certain uses,
depending on technical requirements for the product. Alternative materials
include flax canvas and polyethylene – possibly reinforced by polyamide
threads. Other alternative materials could be polyester gauze or polyamide
gauze with a coating of thermoplastic elastomer (TPE). These alternatives
will be more expensive as the production machinery is based primarily on
the production of PVC tarpaulins /12/.
With respect to production, phthalate emissions are to be limited by means
of existing regulation in the Danish Environmental Protection Agency
guidelines on air and waste water.
Since changes in plasticiser types will require an increase in production
costs and alternative materials cost more, a tax is proposed on the import of
yard goods for tarpaulin production and finished tarpaulins. Moreover, the
Danish Environmental Protection Agency will ensure that information on
and development of alternatives is initiated. The principal parties concerned
are The Danish Plastics Federation, the building sector, the Federation of
Danish Textile & Clothing, the Working Environment Authority,
contractors, and lorry importers.
7.6
Medical devices
Priority has been given to this product group due to the ability of phthalates
to migrate from plastics to adjacent materials. It is estimated that only in
exceptional cases does a risk of direct impact on health exist.
120 tonnes of phthalates per
year
This product group comprises products which are used directly in the
treatment of patients. Such products include colostomy bags, catheters, urine
bags, infusion sets, and blood bags. In Denmark, approximately 120 tonnes
of phthalates are used annually in these products. This product group
features substantial Danish production, of which a lesser quantity of the
plastics used contain plasticisers other than phthalates. Phthalates can be
released in production and through migration to, for example, fluids/blood.
Alternatives have been found for a number of these products. These
alternatives are partly the use of other plasticisers, partly changing to other
materials. For example, colostomy bags with other plasticisers are
available. In addition to this, hospital supplies which do not contain PVC
have been developed and tested. Blood bags with other plasticisers are also
available. Information on alternatives without PVC can be found in the
handbook PVC-fri indkøb – hvordan? (‘PVC-free Purchase – How?’) /13/.
When substituting, buyers must take into account the existing requirements
for patient safety.
With respect to production, phthalate emissions are to be limited by means
of existing regulation in the Danish Environmental Protection Agency
guidelines on air and waste water.
This area is regulated by an EU Directive 93/42/EØF on medical devices.
This legislation is administered by the Danish Medicine Agency. This
31
Directive is to be supplemented by CEN standards. These standards will be
recommendations only, and will not be binding on manufacturers. Any
products monographs in the European Pharmacopoeia Commission will
remain in force and will similarly serve as recommendations for
manufacturers. At present, limits on phthalate contents in blood bags have
been stipulated by the European Pharmacopoeia Commission. These limits
stipulate the permitted amounts of DEHP which can be extracted in alcohol
and water. In future, work should be carried out in connection with
international standardisation initiatives to ensure the stipulation of limit
values for phthalate releases from other product types.
Recommendations on substitution must be prepared for all public-sector
buyers wherever this is justifiable in terms of health and the environment.
These initiatives will be reviewed after a period of three years. Based on
new knowledge and alternatives, this review will include considerations of
whether further initiatives are required, including considerations on whether
a basis exists for introducing a complete or partial ban.
The principal parties concerned are the Danish Plastics Federation, the
Danish Medicine Agency, the Working Environment Authority, publicsector buyers at hospitals, the Association of County Councils in Denmark,
and patient organisations.
7.7
Rainwear and workwear
Priority has been given to this field due to outdoor use and phthalate release
in connection with washing.
110 tonnes of phthalates per
year
This product group comprises rainwear, protective suits, and other
workwear such as aprons. Textiles with PVC coatings are imported to
Denmark for production purposes and through finished goods. Total
phthalate consumption per year is approximately 110 tonnes. Phthalates are
released when the clothing is washed, in rain, and to the air. The exact
quantities have not been determined, but are estimated to constitute 1 –1.3
tonnes per year.
Alternatives exist within most of the relevant areas, but these alternatives do
not meet all the safety requirements for protective suits against chemicals.
The Danish Environmental Protection Agency will prepare Environmental
Guidelines on workwear aimed at public-sector buyers. The Danish
Environmental Protection Agency will assess the need for information to the
other relevant parties.
Since the cost of the existing alternatives is higher, a tax on yard goods and
finished products is proposed. The principal parties concerned are consumer
organisations, trade unions, the Working Environment Authority, The
Danish Plastics Federation, the Federation of Danish Textile & Clothing,
and retailers.
32
7.8
Inlays in lids and caps
Priority has been given to this field due to direct contact to foodstuffs.
120 tonnes of phthalates per
year
This product group comprises soft inlays in screw caps, screw tops, etc.,
made from soft PVC and used in glass packaging for foodstuffs. The annual
phthalate consumption is approximately 70 tonnes in Danish production and
approximately 50 tonnes from imports. Investigations conducted by the
Danish Veterinary and Food Administration of Danish food packaging
indicates that phthalate consumption is falling. Phthalates can migrate to the
packaged foodstuffs.
It is possible to use other materials if production methods are changed. The
plastic material is to be moulded directly into the cap. This would also entail
benefits to the working environment. Such production has not been initiated
due to the cost of production changes /14/.
The Danish Veterinary and Food Administration regulations on migration
from food packaging apply to this product group. The Packaging Directive
stipulates standards for material properties in relation to recovery and
incineration. The Danish Environmental Protection Agency will ensure that
information is prepared for the relevant parties. The principal parties
concerned are the food industry, the packaging industry, retailers, consumer
organisations, and the Danish Veterinary and Food Administration.
7.9
700 tonnes of phthalates per
year
Special profiles
Priority has been given to this area because of the phthalate quantities used,
and because some products may release phthalates during use.
Special profiles made from PVC are used in e.g. furniture, machines,
building materials, and electric appliances. Annual phthalate consumption in
Denmark comprises approximately 560 tonnes from imported goods and
approximately 140 tonnes from Danish production. The most frequently
used phthalates are DEHP and DINP. Phthalate release can occur in
production and use of products. The extent of such release depends on
specific usage.
Since this product area is a very complex one, it is not immediately possible
to indicate alternatives for all uses. The Danish Environmental Protection
Agency will work to ensure that substitution projects are initiated within
selected area in order to determine the opportunities of using alternative
plasticisers.
With respect to production, phthalate emissions are to be limited by means
of existing regulation in the Danish Environmental Protection Agency
Guidelines on air and waste water. Standards might apply to products with
respect to some uses.
Certain products, such as products for furniture and flooring, can fall within
the scope of eco-labelling criteria which preclude phthalate use. Besides the
Working Environment Authority, the principal parties concerned are found
within the Danish Plastics Federation, the building sector, furniture
manufacturers, and electronics.
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7.10 Roofing film and membrane film
Priority has been given to this area due to the phthalate quantities involved
and because some of the products are used outdoors and in contact with
water.
300 tonnes of phthalates per
year
Roofing film is used on the insides of roofs as shielding and flashing against
water. Membrane film is used for foundations, reservoirs, pools, etc. The
greater part of the annual phthalate consumption of approximately 300
tonnes is from imports; a lesser part is from Danish production. Phthalates
can be emitted to air, and further releases will occur for products used in
contact with water. Total phthalate release is estimated at 0.2 – 4.6 tonnes.
For roofing membranes, several alternatives exist within the plastomer and
elastomer groups. Roofing film must comply with the requirements
stipulated in fire regulations. Investigations are to be conducted to determine
whether these requirements are substance specific or material specific.
A tax on such film with phthalate contents is proposed.
Building materials fall within the scope of standardisation work under the
Byggevaredirektivet (‘Building Material Directive’). With respect to other
uses, the Danish Environmental Protection Agency will examine the need
for further information to the relevant parties. The principal parties
concerned are the Ministry of Housing and Building; the Working
Environment Authority; private, co-operative, and public contractors; the
Danish Building Research Institute; and consumer organisations.
7.11 Gloves for industrial purposes
125 tonnes of phthalates per
year
Priority has been given to these products due to phthalate release from
washing.
This product group comprises gloves used in industry, but not gloves used at
hospitals. The annual phthalate import is approximately 125 tonnes.
Phthalate release occurs when the gloves are washed and by skin contact.
Certain types of gloves may feature special requirements with respect to e.g.
resistance to chemicals, and gloves with alternative plasticisers should be
developed for these areas. According to information from C. Nørgaards´s
Eftf. A/S, a company selling personal protective equipment, PVC has
largely disappeared from the production of industrial gloves. The materials
used today are primarily latex and nitrile. This is to say that in most cases, it
is possible to use other materials.
Work is being carried out in Europe on the preparation of harmonised
standards for personal protective equipment by the working group CEN TC
122 JWG 9. These standards should not obstruct substitution with
alternative materials.
A tax on this product group is proposed.
The Danish Environmental Protection Agency will prepare Environmental
Guidelines on workwear for public-sector buyers. The parties concerned are
34
public-sector buyers, consumer organisations, trade unions, the Working
Environment Authority, chemical industries, and food industries.
7.12 Garden hoses and water hoses
Priority has been given to this product group due to outdoor use and direct
contact with water.
140 tonnes of phthalates per
year
The hoses feature product requirements on pressure conditions and stability
with respect to temperature and exposure to the elements. Approximately
140 tonnes of phthalates (mainly DEHP) are used in Denmark each year, of
which approximately 20 per cent are imported in finished goods. Phthalates
are released to water, but the extent of such releases is not known. It is,
however, estimated at 0.03-0.3 tonnes.
It is possible to use an alternative plasticiser, but this would increase product
costs. Since some hoses are made from recycled materials, such hoses will
still contain lesser phthalate quantities.
Garden hoses with no PVC or phthalates are available to the general
consumer.
With respect to production, phthalate emissions are to be limited by means
of existing regulation in the Danish Environmental Protection Agency
guidelines on air and waste water. The Danish Environmental Protection
Agency will provide for information for the relevant parties.
The cost for alternatives is greater than that of products with phthalates, so a
tax on this product group is proposed. The principal parties concerned are
the Danish Plastics Federation, retailers, the Working Environment
Authority, consumer organisations, nurseries, horticultural societies, and
trade unions.
7.13 Boots and waders
Priority has been given to this product group due to outdoor use and direct
contact with water.
140 tonnes of phthalates per
year
This product group comprises boots and waders containing soft PVC. No
boots made from PVC are produced in Denmark. However, boots and
textiles with PVC coatings are imported for the production of waders. Total
annual phthalate consumption for the entire product group is approximately
140 tonnes. The phthalates are released to water during use and when the
products are washed.
Boots made from other materials are available, and the use of other
materials or plasticisers is possible with respect to yard goods for waders.
This will be investigated in more detail.
The Danish Environmental Protection Agency will prepare Environmental
Guidelines on workwear aimed at public-sector buyers.
The Danish Environmental Protection Agency will ensure that targetoriented information reaches the relevant parties, which include
35
manufacturers, the Federation of Danish Textile & Clothing, retailers,
consumer organisations, trade unions, and the Working Environment
Authority.
7.14 Textiles and PVC prints
Priority has been given to this product group due to the fact that almost the
entire phthalate contents are washed out during the service life of the
products.
5-15 tonnes of phthalates
per year
This product group comprises partly textiles made form soft PVC, partly
textiles with plastisole prints. An annual total of 5 – 15 tonnes of phthalates
are imported and produced in textiles with e.g. PVC prints. Phthalates are
washed out in normal washing, and the total phthalate contribution is judged
to be 2 – 12 tonnes to waste water each year.
Alternatives are available for some textile prints without PVC. Danish
suppliers of printing inks are planning to work on finding suitable
alternatives.
The Danish Environmental Protection Agency has held a series of meetings
with retailers and the large importers; both parties display positive attitudes
with respect to phasing out phthalates in textile prints. However, during the
debate the consensus was that a voluntary agreement should apply to most
phthalate consumption. In view of the market composition, see below, a
voluntary agreement would not cover the market at present, and on this
basis, some importers/retailers have expressed a desire for a ban on
phthalates in textile prints.
The use of textile prints varies as fashion changes. Textile prints are also
used for special promotion or ‘event’ products, e.g. T-shirts with a particular
printed text for a particular event. These products are imported and
manufactured by a number of parties within various sectors, and sales often
take place at flea markets or from shops outside organised retailing.
Promotion products are sold outside the regular retailers.
Due to the composition and non-transparency of the market, the planning of
effective Danish regulation by means of bans would entail
disproportionately high costs. Instead, the Danish Environmental Protection
Agency will work to have phthalates in textile prints banned by means of
EU regulations.
The Danish Environmental Protection Agency will inform importers,
retailers, and the advertising sector of the alternatives and the opportunities
for labelling with a view to phasing out phthalate consumption over the next
three years. In addition to this, information work aimed at consumers will be
carried out.
At the same time, the Danish Environmental Protection Agency will initiate
investigations in order to obtain a better overview of the market and the
developments within the consumption of textile prints with phthalates with a
view to assessing the necessity of and opportunities for further initiatives.
Eco-labelling criteria for T-shirts and bed linen in the EU and the Nordic
Svanemærke (‘Swan Label’) criteria for textiles preclude the use of PVC
36
prints. This also applies to the recently adopted general textile eco-labelling
criteria for the EU. The Danish Environmental Protection Agency will
prepare Environmental Guidelines on workwear aimed at public-sector
buyers.
Moreover, the Danish Environmental Protection Agency will work to ensure
that target-oriented information reaches selected parties, with the principal
parties being consumers, the textile industry, designers, and retailers.
Finally, after a period of three years the initiatives so far will be assessed.
The need for a Danish ban will be considered during this assessment.
7.15 Foodstuff hoses
Priority has been given to this field due to the risk of health impacts, even
though only small amounts of phthalates are used.
40 tonnes of phthalates per
year
This area also comprises hoses used to transport foodstuffs – including milk
and milking hoses. Approximately 30 tonnes of phthalates are imported in
finished goods and approximately 10 tonnes for Danish production. The
phthalates can migrate to foodstuffs.
Milk hoses from soft PVC with alternative polymer plasticisers are
produced in Denmark. Whether all uses can be covered by this type of hose
has not been determined and will be investigated in more detail by the
Danish Environmental Protection Agency.
Foodstuff hoses fall within the scope of rules stipulated by the Danish
Veterinary and Food Administrations on migrations from food packaging.
With respect to milk hoses, the Danish Veterinary and Food Administration
recommends that DEHP releases to milk should not exceed 0.1 mg/kg as
children’s consumption of milk is taken into account. The use of polymer
plasticisers entails greater product costs, which may prove decisive when
selecting a product.
The Danish Environmental Protection Agency is investigating the need for
further information aimed at the relevant parties. A tax on the products is
proposed.
The principal parties concerned are the food industry, the Danish Veterinary
and Food Administration, the Working Environment Authority, consumer
organisations, and the Danish Plastics Federation.
7.16 Electrical cables
This area has been given priority because of the quantities of phthalates
used, even though phthalate releases within this field are of lesser
significance.
3,500 tonnes of phthalates
per year
By far the greatest quantities of phthalates – approximately 3,500 tonnes –
are used for electrical cables. In addition to this, unknown phthalate
quantities are imported in wires and cables in finished products such as
lamps, machines, etc. Denmark has a large production of cables, and
approximately 50 per cent of this production is exported. The requirements
37
stipulated in Stærkstrømsbekendtgørelsen (‘the Statutory Order on Electrical
Power’) and in international standards apply to cables and cabling. Some
phthalate emissions to air may occur during production and use; such
emissions are estimated at 0.8 – 4 tonnes. Phthalate release to water and soil
is deemed to be insignificant.
Alternative plasticisers can be used for certain uses, and other materials can
be used in connection with certain cables. It is possible to use ethylvinylacetate copolymer (EVA) in stead of PVC. Working-environment
problems arise in the production of EVA, as production takes place in high
temperatures and high pressures, and using substances which are flammable
and present an explosion hazard. Energy consumption is approximately 20
per cent greater than that of PVC production. EVA is judged to have lesser
environmental impacts than PVC /14/. As some cables are made from
recycled materials, they will contain lesser quantities of phthalates.
In production, phthalate emissions must be limited through existing
regulation by means of the Danish Environmental Protection Agency
Guidelines on air and waste water.
As the cost of alternatives is significantly greater, a tax is proposed. The
Danish Environmental Protection Agency will investigate whether standards
exist which preclude substitution of phthalates.
A circular on state procurement stipulates that all state institutions and all
state-owned or state-controlled enterprises must take the environment into
account when procurement cables. After more detailed investigation of this
product group, the Danish Environmental Protection Agency will prepare
Environmental Guidelines for public-sector buyers. Electrical cables and
wiring used in finished goods such as washing machines fall/may fall within
the scope of eco-labelling criteria for such product groups.
The parties concerned are the Danish Plastics Federation, consumer
organisations, the Ministry of Housing and Building, fire-fighting
authorities, the Electricity Council, power companies, the building sector,
the Danish Building Research Institute, and retailers.
7.17 Fenders and other maritime equipment
23 tonnes of phthalates per
year
No priority has been given to this area due to the small phthalate quantities
involved. This product group comprises fenders and other maritime
equipment, including marker buoys. Seven tonnes of phthalates are used
annually in Danish production. In addition to this, approximately 16 tonnes
are imported in finished goods. Equipment requirements stipulate that it
must be possible to make completely tight welding seams and that the
materials used must be very elastic and very resistant to wear and exposure
to the elements. Phthalates can be released directly to the ocean, but such
releases are judged to be insignificant.
It may be possible to use alternative plasticisers, but this has not been
verified. Other materials can be used in some cases. Since changes in
production methods would require very substantial investments and
phthalate consumption within this area only constitutes a very small part of
total phthalate consumption, no further action will be initiated for this
product group at present.
38
7.18 Other medical devices
175 tonnes of phthalates per
year
For the purposes of this Action Plan, ‘other medical devices’ means
products which are only indirectly related to patient treatment. Some of
these products may fall within the scope of the Directive on Medical
Devices, while some fall outside this regulation. Among other things, this
product group comprises certain gloves, drawsheets, and shoe covers made
from soft PVC. Product requirements depend on product use, but will
usually involve flexibility, durability, barrier properties, and resistance to
fluids and chemicals. Total annual phthalate consumption is approximately
125 tonnes. A small fraction of this is used in Danish glove production.
Alternative materials exist for several of the known uses. Alternative
materials should be used in cases where the service life of the product is
short and no special requirements are made which can only be met by PVC.
A tax on gloves and textiles with PVC coatings is suggested.. Possible
alternatives are described in the procurement catalogue on PVC-free
products /13/.
The principal parties concerned are the Danish Plastics Federation, the
Danish Medicine Agency, the Working Environment Authority, buyers at
hospitals, the Association of County Councils in Denmark, and patient
organisations.
7.19 Office supplies
800 tonnes of phthalates
per year
This product group comprises ring binders, letter organisers, index binders,
writing pads, folders, clipboards, calendars, etc., which contain soft PVC.
Total annual phthalate consumption is approximately 800 tonnes. The vast
majority is used in Danish production from PVC film.
Alternative materials exist with respect to the vast majority of this product
group. It is possible to produce ring binders, etc., using cardboard and other
plastics instead of PVC.
Possible alternatives are described in the procurement catalogue on PVCfree products /13/. The Danish Environmental Protection Agency will
prepare Environmental Guidelines on office supplies aimed at public-sector
buyers. The Nordic Swan Label is working on criteria on office supplies,
and the Danish Environmental Protection Agency will work to ensure that
these criteria preclude phthalate use. A tax is proposed on magazine
cassettes, ring binders, and folders.
The parties concerned are ‘Dansk Papirforhandlerforening’ (‘the Danish
Paper Distributor Association’), ‘Foreningen af Leverandører til Bog-,
Papir- og Kontorartikelbranchen’ (‘the Association of Suppliers to the
Book, Paper Product, and Office Supplies Sector’), retailers, public-sector
buyers, and consumer organisations.
39
320 tonnes of phthalates
per year
7.20 Bags, luggage, etc.
This product group comprises bags, suitcases and other luggage, cases,
wallets, shoppers, etc., where soft PVC is used as surface coating, inner
coating, or for parts of the products. Annual phthalate consumption is
approximately 320 tonnes, which are mainly imported in finished goods.
Alternative materials for bags, purses, etc., are cotton canvas, textiles with
polyurethane coatings, nylon, polyester, etc. These products will usually be
more expensive than PVC products. Sports bags, school bags, shoppers, etc.,
are often made from nylon with a PVC coating in order to render them
waterproof. Bags can be made temporarily impervious to water by using
silicone; however, the effect will not equal that of PVC /12/.
The Danish Environmental Protection Agency will arrange for the
preparation of information for the relevant parties, i.e. retailers and
consumers. No further initiatives have been given priority for this product
group.
7.21 Industrial hoses
150 tonnes of phthalates per
year
Industrial hoses must be able to withstand pressures, for example up to 25
bar. In addition to this, a series of other requirements exist, depending on
hose usage. Annual phthalate consumption is approximately 150 tonnes, of
which approximately 40 per cent is used in Danish production. It is
technically possible to use an alternative plasticiser, but this would entail
significant rises in sales prices.
With respect to production, phthalate emissions are to be limited by means
of existing regulation in the Danish Environmental Protection Agency
guidelines on air and waste water.
A tax on hoses which contain phthalates is proposed.
The parties concerned are the Working Environment Authority and
industries, including the Danish Plastics Federation.
7.22 Self-adhesive film or tape
50 tonnes of phthalates per
year
This product group comprises self-adhesive film and tape for demarcation
purposes, signs, and decoration. Phthalate imports constitute between 50 –
100 tonnes of phthalates are imported; the margin is caused by the fact that
it has not been absolutely determined whether 50 of those tonnes are other
plasticisers than phthalates. It is technically possible to use other
plasticisers.
A tax on products which contain phthalates is proposed.
The parties concerned are the Danish Plastics Federation, the advertising
sector, and retailers.
40
7.23 Shoes and soles
80 tonnes of phthalates per
year
This product group comprises shoes and parts of shoes, such as soles, labels
for logo imprints, upper parts made from vinyl imitation leather, or PVC
coatings. Annual phthalate consumption is approximately 80 tonnes. The
Danish shoe industry almost exclusively uses polyurethane (PUR) for soles.
In addition to this, various types of rubber may be used.
The parties concerned are the shoe industry, retailers, and consumer
organisations.
7.24 Soft PVC undersides for carpet tiles and mats
75 tonnes of phthalates per
year
This product group comprises carpet tiles and mats with undersides made
from soft PVC. Annual phthalate consumption is approximately 75 tonnes.
Investigations have shown that suitable alternatives exist.
The principal parties concerned are the Danish Flooring Trade Organisation,
carpet manufacturers, and the National Consumer Agency of Denmark.
7.25 Other product groups containing soft plastics
125 tonnes of phthalates
per year
This includes product groups consisting of soft PVC or where soft PVC
forms part of the product, such as tablecloths, curtains, shower curtains,
water beds, protective membranes, and pet and animal articles. The total
phthalate consumption for these products is approximately 125 tonnes.
A tax on products made from textiles with PVC coatings is proposed.
Alternative materials exist from the vast majority of these products.
Alternative materials should be used in cases where products’ useful lives
are short and no special properties are required from the product.
41
42
8 Relationship to PVC initiatives
Difficult to separate
activities
Parallel activities for PVC are being carried out with respect to many of the
product groups which have been given priority in this Action Plan. This
renders it difficult to separate activities aimed at substituting PVC within
specific areas from activities aimed exclusively at phthalates in soft plastics.
The two initiatives intersect when soft PVC which contains phthalates is
replaced by another material.
However, replacing soft PVC with other materials is most suitable for
products with short service lives and products which are difficult to separate
from other waste and which consequently end up in waste-incineration
plants. Such products include packaging, disposable materials, and office
supplies.
Status Report on PVC
Concurrently with this Action Plan, a Status Report on PVC has been
issued. This status report outlines future initiatives for the entire PVC area,
from use of additives to waste disposal.
Co-ordinating initiatives
The Danish Environmental Protection Agency will co-ordinate the
initiatives within the two areas so that experience gained from information
activities and the development of alternatives within the PVC area can be
used in the efforts to substitute alternative plasticisers or other materials for
soft PVC.
The Danish Environmental Protection Agency will gather the experience
gained from those initiatives which have already commenced with a view to
assessment of the need for further initiatives.
43
44
9 Economic consequences for
business
By way of introduction it should be pointed out that it is not possible to
carry out a proper quantitative analysis of the economic consequences for
business on the present basis; all that is possible is to outline some trends or
possible developments for the elements in the overall Action Plan with a
basis in the possible introduction of taxes:
Taxes
Taxes on phthalates in selected product groups which are being sold in the
Danish market entail lower total sales due to price rises (taxes). The scope
of this downturn in sales for each of the relevant product categories depends
on the price rise and its impact on demand (price elasticity).
If domestic and imported goods are affected equally by taxes, the
competitive environment in the Danish market for soft PVC and products
made from soft PVC will not change. However, the increased cost of such
products could cause other products/materials to become more competitive
and take over part of the market, so that the downturn in sales of products
containing phthalates is increased.
Danish enterprises will experience no change in their competitiveness on the
export markets if taxes are reimbursed in connection with exports.
Subsidies
With taxes of 150 per cent it may be profitable for some manufacturers to
produce soft PVC products by means of alternative plasticisers for the
Danish market. Subsidies from Programmet for renere produkter m.v.(‘the
Programme for Cleaner Products, etc.’) for the development of substitution
can help shift the break-even point in the right direction environmentally.
Green procurement policies
and eco-labelling
Certain types of goods may be able to support an additional charge or gain
market shares in relation to traditionally manufactured PVC products (which
may have taxes imposed on them) as a result of their advantages in terms of
health and the environment. This is particularly true for areas with little
competition from imports. Green procurement policies in public enterprises
and eco-labelling will support development of the demand for products
without phthalates – also within areas where no taxes have been imposed.
In view of the size of the total Danish market for the relevant product groups
it seems unlikely that manufacturers outside Denmark will respond
immediately, and any response is only likely to occur within areas where
Danish competitors are successfully using the transition to products without
phthalates to create profiles for themselves.
When changing to production of products without phthalates, Danish export
manufacturers will lose competitive power on the international market due
to increased costs; however, in the long term they will be able to gain a
competitive advantage by being at the forefront due to their environmental
profiles.
45
Conclusions
Carrying out the entire Action Plan is unlikely to have significant long-term
economic consequences for the Danish plastic industry. In addition to a
slight downturn in sales and a similar increase in costs, especially for those
areas where taxes are imposed, cf. the above, changing to alternative
plasticisers could involve costs in connection with new investments in
production equipment – or, rather, investments which are not so much ‘new’
as made slightly sooner than would otherwise be the case. However, the
increases in production costs for phthalate-free products are expected to be
counterbalanced by taxes and subsidies.
If Danish phthalate-free goods gain success at the expense of traditional
PVC this could alter the distribution of market shares between Danish
enterprises, and might also affect imports.
On a long-term basis – and especially if agreement is reached internationally
on phasing out phthalates – Danish enterprises who develop alternatives
early on (for the domestic market) might gain an advantage on the
international market. This was demonstrated in connection with the
development of CFC-free products.
46
10 International status
It is internationally acknowledged that phthalate consumption can entail
risks to health and the environment. The status of initiatives varies from one
country to the next.
Sweden
In 1996, the Swedish Kemikalieinspektion (Chemicals Inspection’)
presented the Swedish government with a report on additives in PVC. This
report in conjunction with other reports will form the basis for government
initiatives. The Chemicals Inspection recommends that the spreading of
phthalates to the environment should be limited; this should be done within
an international framework, and proposals will be prepared in extension of
the EU risk assessments of DEHP, DIDP, and DINP. In the 1997/98
Proposition on Swedish environmental objectives, the government objective
is that all use of phthalates and other plasticisers with harmful or suspected
harmful effects on health and the environment are to be phased out on a
voluntary basis. Sweden has notified a ban on phthalate use in toys and
certain childcare articles for children under the age of three.
Norway
Norway has also notified a ban on phthalate use in toys and certain childcare
articles for children under the age of three.
Austria
A Statutory Order banning the sale of certain types of toys which contain
phthalates and which are intended for children under the age of three has
entered into force.
Germany
The debate in Germany has mainly addressed waste problems. For example,
there is great focus on phthalate leaching from controlled waste
deposits/landfills.
Further to Danish and Dutch investigations on phthalates from teething
rings, the health authorities have enjoined the responsibilities of industries
and retailers in relation to toys. Moreover, they have warned parents against
buying toys made from soft PVC for children under the age of three, as it
cannot be stated with absolute certainty that these products do not involve a
health hazard.
The Netherlands
In the Netherlands, assessments are currently being carried out of lead,
organic tin compounds, and phthalates as additives in PVC. The industry
and importers have been ordered to prepare a plan on recycling of PVC
products. With respect to phthalates, the authorities await the results from
the EU risk assessments, but they have encouraged industries to carry out
investigations on effects and alternatives.
Other EU countries
Greece, Italy, and Finland have notified regulations on bans on phthalate use
in toys and childcare articles.
Canada
Discussions in Canada have addressed problems with respect to chlorine
production, and PVC is now being included in this debate. A Canadian list
of priorities for substances has been prepared. In this list, substances such as
lead and DEHP are declared as toxic.
47
Health hazards with respect to toys are currently under investigation. Toy
distributors have been called on to withdraw toys for young children from
the market on a voluntary basis.
USA
In the USA, the issue of whether phthalates have an oestrogen-like effect
dominates current debate. In the USA, DEHP is classified as a possible
carcinogenic substance with respect to humans.
Phthalate migrations from toys are currently being investigated with a view
to a risk assessment. Toy distributors have been encouraged to withdraw
toys for young children from the market on a voluntary basis.
48
11 Evaluation/follow-up
For many of the areas, a long period of time will elapse before the effects of
a reduction in phthalate consumption can be measured.
If taxes are introduced for the areas proposed, such a course of action in
conjunction with the other measures is estimated to entail a 50 per cent
reduction in phthalate consumption within the next 10 years.
Moreover, the EU is currently undertaking a risk assessment of a number of
phthalates. The Danish Environmental Protection Agency expects the results
from these risk assessments to improve the basis for making decisions on
EU initiatives within the area.
For this reason, this Action Plan will be revised when these risk assessments
are available. However, revision will be carried out after a three-year period
at the latest. Continuous assessment will be carried out in order to determine
whether new information dictates a need for further initiatives.
The Danish Environmental Protection Agency will calculate the
consumption of phthalates in three years. These figures, along with
continuous monitoring activities in the environment, will be used for
evaluation and possible adjustments of initiatives.
49
50
Appendix 1. Phthalate consumption
and emissions
Product
Tonnes of
phthalates
per year
Emission to air
Production Consumption
Cables
3,500
0.5
0.3 - 3.5
Cars
1,000
-
0.1 - 1
2-10
2-11
Floor and wall
coverings
Tarpaulins
2,000
-
0.2
1-5
1.2 - 5
240
0.2-2.4
0.02 - 0.2
0.02 - 0.2 ?
0.2 - 2.8
Garden hoses
140
and water hoses
Other hoses
190
0.01
0.01 - 0.14
0.01 - 0.14
0.03 - 0.3
0.02
0.02 - 0.19
0.02 - 0.19
0.06 - 0.4
Film
300
0.2 - 4
0.03 - 0.3
0.03 - 0.3
0.2 - 4.6
Profiles
700
0.07
0.07 - 0.7
0.07 - 0.7
0.2 - 1.5
Rainwear and
workwear
Boots/waders
110
0.1-1.1
0.01 - 0.1
0.01 - 0.1
1.1 -1.3
140
0.1-1.4
0.01 - 0.14
0.01 - 0.14
1.4 - 1.7
Textiles with
PVC prints
Other groups
5-15
-
2 - 12
2-12
?
?
?
?
?
Release to
water during
use
Total
phthalate
release to the
environment
0.8 - 4
The most widely used phthalate is DEHP. DINP, DIDP, and BBP are used to
lesser extents.
Phthalate emissions for the various product groups are calculated on the basis
of information from the phthalate mass-flow analysis /2/ and the National
Environmental Research Institute source investigations /4/.
Where phthalate emissions are not known, this has been indicated by a
question mark.
51
52
Appendix 2. The impact of phthalates
on health and the environment
Environmental Review, no. 6 1996 “Toxicological Evaluation and Limit
Values for DEHP and Phthalates, other than DEHP” for the Danish
Environmental Protection Agency features an assessment of the impact of
phthalates on health on the basis of available literature.
1.
Health effects of DEHP
Only little information is available on the effects of human exposure to
phthalates. This information is not sufficient to assess the long-term effects
on humans.
Carcinogenic ??
DEHP induces liver changes (peroxisome proliferation, enlarged liver) in
rats, the species with the greatest sensitivity to these effects.
DEHP has displayed carcinogenic effects upon intake by mice and rats
(increased liver-tumour frequency). DEHP is not considered to be
mutagenic. Its carcinogenic effect is thought to be directly related to the
toxic impact on liver cells (including peroxisome proliferation).
It has still not been conclusively determined whether the types of liver
damage described in the above can be induced in humans, but on the basis
of existing data, primates, including humans, are thought to be less sensitive
than rats and mice. However, the aim of using the critical effect for the most
sensitive species was to take into account the possible toxic effects on
humans.
The International Agency for Research on Cancer (IARC) and the American
Environmental Protection Agency (US-EPA) has classified DEHP as a
potential carcinogenic for humans (Group 2B).
In November 1994, The European Scientific Committee for Foodstuffs
(SCF) stipulated a tolerable daily intake (TDI) of 0.05 mg/kg body weight.
This value has been set on the basis of a zero-effect level of 5 mg/kg body
weight per day for peroxisome proliferation in rats and a safety factor of
100.
With a basis in the same studies; a TDI of 5 g/kg per day has been
calculated in relation to the stipulation of limit values in the outdoor
environment. Three safety factors have been used for this: One due to the
fact that humans are assumed to be more sensitive than animals, one to
protect the most sensitive individuals (including children and pregnant
women), and one due to the quality of the research (too few test animals and
short exposure times) and because the mechanisms behind the carcinogenic
effect, including its relevance to humans, has not been fully determined.
Fertility and teratogenecity
(injury to foetuses
Recent research on young rats showed liver impact at the highest
concentration (5,000 ppm) for both males and females. Damaged testicle
53
cells were found in seven
out of ten male rats at
concentrations of 500 PPM.
On the basis of this
research, the zero-effect
level has been set at 50 PPM
(3.7 mg/kg body weight) /16
/. This means that testicle
damage has now been
detected at low
concentrations. Other
research has shown
reductions in fertility after
exposure to DEHP.
The zero-effect level for
impact on fertility by
exposure for both male and
female mice is
approximately 15-20 mg/kg
body weight per day. DEHP
can be teratogenetic for
mice at concentrations
which are not toxic to the
mother animals.
DEHP has had a very weak
effect on oestrogen
receptors in some cell tests,
but no oestrogen activity has
been detected in other cell
tests on yeast cells and
mammal cells. It would
appear that no conclusive
evidence supports theories
of oestrogen-like effects at
present.
1.1 Summary of draft
of EU risk assessment of
DEHP (preliminary
conclusions)
DEHP has a low acute
toxicity by oral intake. The
acute toxicity by skin
contact is assumed to be low
due to the poor skin
absorption.
Sufficient evidence exists
that DEHP reduces fertility
in mice and rats. Moreover,
testicle-cell damage have
been detected after intake of
54
low concentration of DEHP. Research on mice has shown teratogenecity at
concentrations which have no effect on the mother animal. DEHP can be
excreted through breast milk.
On this background it has been proposed that DEHP should in all likelihood
be classified as toxic (T) and harmful to reproduction in Group 2
(substances which are thought to reduce human fertility – where sufficient
evidence is available to strongly suspect that human exposure to the
substance can reduce reproductive abilities).
It is not possible to exclude the possibility of DEHP having an antiandrogenic (hormone-like) effect, however, research has been limited and
the relevance to humans is, as yet, unclear.
On the basis of the uncertainty of the importance of the carcinogenic effect
the following classification is proposed: ‘Harmful’ (Xn) with R40 (risk
indicator phrase no. 40) – ‘potential permanent health damage’, and
Carcinogenic in Group 3 (substances which cause concern as they may
cause cancer in humans – insufficient information is available to carry out
satisfactory assessment).
2.
Health effects of other phthalates
Only little research has been carried out on carcinogenic effects of other
phthalates. DINP and BBP can have some carcinogenic effects on rats,
whereas the data on DAP and DEP are uncertain. No investigation suggests
that phthalates are mutagenic.
For DINP, the European
Scientific Committee for
Foodstuffs has stipulated a
temporary tolerable daily
intake of 0.03 mg/kg body
weight.
Theme Report from the Nordic Council of Ministers: Chemicals with
Oestrogen-like Effects /5/.
For other phthalates with
carbon chains of C4-C6,
impacts on sperm-producing
tissue in the testicles of rats
have been detected. The
lowest effective dosage was
250 mg/kg body weight for
DBP.
The scientific committee (CSTEE) have presented their assessment of the
risk involved with the various phthalates. This table is an overview of the
critical effects, zero-effect levels (NOAEL), and tolerable daily intakes for
the most frequently used substances /17/.
Some phthalates display
teratogenetic effects, but
exposure to very high
concentrations is generally
required. The zero-effect
level for rats is 500 mg/kg
body weight per day. A
relative order for
teratogenetic effects in mice
is probable DPP < DBP <
DHP < DEHP, while no
effects were detected for
DEP and DOP.
Doses with acute toxicity
for short-chained phthalates
range from 7-10 g/kg body
weight and for long-chained
phthalates from 20-35 g/kg
body weight.
2.1
Assessment from the Scientific Committee for Toxicology,
Eco-toxicology, and the Environment
Phthalate
Critical effect
DINP
Increased liver and
kidney weight
DOP
DEHP
Microscopic cell
changes to liver
and pancreas
Damage to
testicles
Zero-effect level
NOAEL
Mg/kg/day
Tolerable daily intake
g/kg body weight/day
15
150
37
370
3.7
37
DIDP
Increased liver
weight
25
250
BBP
Reduced sperm
count
20
200
DBP
Reduced offspring
weight
52a
100b
On the basis of the few
epidemiological
investigations which have
been carried out of human
exposure to phthalates it
appears that the critical
effect of phthalate
inhalation is the
development of
polyneuropathy (nerve
damage). The zero-effect
level for inhalation is
estimated at 0.7 mg/m3 .
Test-tube testing has proven
oestrogen-like effects for
BBP and DBP. A total
assessment of these
substances is provided in the
55
a) Lowest effective
concentration
b) As no zero-effect level
has been determined, an
additional safety factor
of 5 has been stipulated.
3.
Limit values
stipulated for DEHP and
other phthalates
The limit values for soil
have been based on
children’s consumption of
soil. The proposed
toxicological soil-quality
criteria are 25 mg/kg soil for
DEHP and 250 mg/kg for
other phthalates.
The proposed quality
criteria for tap water are 2 
g/l for DEHP and 20 g/l
for other phthalates.
The B value for DEHP for
air has been lowered to
0.005mg/m3 in Main Group
1. For other phthalates in air
the B value is 0.01 mg/m3 in
Main Group 2.
A limit value of 3 mg/m3
has been stipulated for
DEHP in the working
environment.
Notice has been given of a
limit value of 3 mg/m3 for
other phthalates.
4.
Environmental
impact of DEHP
The conclusion of Work
Report No. 54, 1996,
Review of environmental
fate and effects of di(2ethylhexyl)phthalate
features a summary of the
environmental impacts of
DEHP /18/.
56
DEHP can be degraded in laboratory testing when oxygen is present, but not
under oxygen-free conditions. This means that in practise only a smaller
portion of the substance can be expected to be degraded in treatment plants.
It must also be assumed that the substance biodegradability is lower in the
environment than in laboratory testing and at treatment plants.
DEHP has a high potential for bio-accumulation in aquatic organisms. The
substance is not acutely toxic in the aquatic environment, but may have
long-term effects on aquatic organisms.
5.
Environmental impacts of other phthalates
The Environmental Project No. 412, 1998, Review of Environmental fate
and effects of some Phthalate Esters features a summary of the available
knowledge of the environmental impacts of the phthalates DMP, DEP, DBP,
BBP, DINP, and DIDP /19/.
DBP, BBP, DINP, and DIDP can be bio-accumulated in aquatic organisms.
DBP and BBP are very acutely toxic to aquatic organisms. DEP is acutely
toxic to aquatic organisms, DMP is harmful to aquatic organisms, whereas
DINP and DIDP are not acutely toxic.
DBP, BBP, DINP, and DIDP can have long-term effects on aquatic
organisms.
The phthalates can be
degraded in laboratory
testing when oxygen is
present, but degradation
under oxygen-free
conditions is poor for
phthalate esters with long
alkyl chains. In this way,
high DEHP concentrations
have been detected in wastewater sludge (and
sediments). There is less
degradation at lower
temperatures than under
normal laboratory
conditions.
DBP and BBP have been
detected at entry points to
treatment plants; these
quantities are reduced in
treatment by 67-98 per cent
for DBP and 98-100 per
cent for BBP. However,
small concentrations can be
detected in sludge. The
greater the concentration at
the entry point, the greater
the reduction.
57
58
Appendix 3. Overview of measures
Product group
Emissions to
be limited
Cars
X from car
washes
Floor and wall
coverings
Standardisation
Opportunities
for substitution
should be
investigated
X
X (Building
Materials
Directive)
X (Toys Directive)
Toys
X in
production
Medical devices X in
production
Rainwear and
workwear
Inlays in lids
Profiles
Roofing film
and membrane
film
Gloves
taxes
X (for
importers)
X
X
X (Medical
Devices Directive)
ban
taxes
taxes
X
X
X
taxes
X
X (Building
Materials
Directive)
X (Building
Materials
Directive)
(X) with respect to
profiles used in
furniture
taxes
X
X in
production
taxes
taxes
X
Textiles and
PVC printing
X
X (the EU Flower
and Svanemærket
(‘the Swan Label’))
X
Foodstuff hoses
taxes
Electrical cables X in
production
X (Building
Materials
Directive)
(X) with respect to
wires used in
finished machines
X
Other medical
devices
Office supplies
Industrial hoses
Regulatio
n
X
X (Svanemærke
(‘Swan Label’))
Tarpaulins
Purchase
guidelines
X (Svanemærke
(‘Swan Label’))
Furniture/vinyl
Garden hoses
and water hoses
Boots/waders
Eco-labelling
X (under
preparation in the
Nordic Svanemærke
(‘Swan Label’)
X in
production
X
taxes
taxes on
certain
products
taxes on
certain
products
taxes
Self-adhesive
film
taxes
Other products
taxes on
certain
products
59
References
60
/1/
The Danish Plastics Federation, April 1996: Redegørelse om
phthalater i blød PVC (’Report on Phthalates in Soft PVC’).
/2/
The Danish Protection Agency, 1996: Massestrømsanalyse for
phthalater (Mass-flow analysis for phthalates’). Environmental
Project No. 320.
/3/
The Danish Environmental Protection Agency, 1997: Miljøfremmede
stoffer i overfladeafstrømning fra befæstede arealer (‘Xenobiotic
Substances in Surface Water Run-off from Paved/Surfaced Areas’).
Environmental Project No. 355.
/4/
The National Environmental Research Institute, 1998: Sources of
phthalates and nonylphenols in municipal waste water, NERI
technical report no. 225.
/5/
Nordic Council of Ministers, 1996: Chemicals with Oestrogen-like
Effects. TemaNord 580.
/6/
The Danish Environmental Protection Agency, 1997: Miljøfremmede
stoffer i husholdningsspildevand (‘Xenobiotic Substances in
Domestic Waste Water’). Environmental Project No. 357.
/7/
The Danish Veterinary and Food Administration, 1998: Analyse af
plastblødgørere i modermælkserstatninger, børnemad og dagskost
(Analysis of plasticisers in breast-milk substitutes, baby food, and
daily diets’). Report IFT 1998.4.
/8/
The Danish Environmental Protection Agency, 1996: B-værdier (‘B
values’). Orientering No. 15.
/9/
The Danish Environmental Protection Agency, 1994: Tilslutning af
industrispildevand til kommunale spildevandsanlæg (‘Connection of
Industrial Waste Water to Local Authority Sewage Treatment
Plants’). Guidelines No. 6.
/10
The Danish Environmental Protection Agency, 1996: Anvendelse af
affaldsprodukter til jordbrugsformål (Use of Waste Products for
Agricultural Purposes’). Environmental Project No. 328.
/11/
The Danish Environmental Protection Agency, 1991: Substitution af
PVC til gulv- og vægbeklædning (‘Substitution of PVC for Floor and
Wall Coverings’). Work Report No. 9.
/12/
The Danish Environmental Protection Agency, 1990: PVC i
kontorartikler, sundhedssektor, m.v. (PVC in Office Supplies, the
Health Sector, etc.’). Environmental Project No. 132.
/13/
The County of Aarhus and the Danish Environmental Protection
Agency, 1997: PVC fri indkøb - hvordan ? (‘PVC-free Purchase –
How?’).
/14/
The Danish Environmental Protection Agency, 1995: Erfaringer med
substitution af PVC ved renere teknologi og brancheaftale
(‘Experiences gained on the substitution of PVC by means of cleaner
technology and sector agreements’) . Work Report No. 82.
/15/
The Danish Environmental Protection Agency, 1996: Toxicological
Evaluation and Limit Values for DEHP and Phthalates, other than
DEHP, Environmental Review, No. 6.
/16/
Poon et al. 1997: Subchronic oral toxicity of di-n-octyl phthalate and
di(2-ethylhexyl)phthalate in the rat. Food Chem. Toxicol. 35, 225239.
/17/
CSTEE 1998: Opinion on Phthalate migration from soft PVC toys
and child-care articles. Opinion expressed at the 6th CSTEE plenary
meeting. Brussels, 27 November 1998.
/18/
The Danish Environmental Protection Agency, 1996: Review of
environmental fate and effects of di(2-ethylhexyl)phthalate. Work
Report No. 54.
/19/
The Danish Environmental Protection Agency, 1998: Review of
environmental fate and effects of selected phthalate esters.
Environmental Project No. 412.
61