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http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm




                                                                                                  Source document:
                                      Phthalates in school                                        SCHER (2008)

                                           supplies                                               Summary & Details:
                                                                                                  GreenFacts (2009)




                                                              1. Introduction: why is there a concern over
Context - Phthalates are additives that                          phthalates in school supplies?.................2
are widely used in plastics to make them                      2. How was the Danish study on phthalates in
soft and flexible.                                               school supplies conducted?.....................2
                                                              3. To what extent can children be exposed to
To protect children from potential health                        phthalates through erasers?....................3
effects, certain phthalates are no longer                     4. To what extent are people exposed to
used in toys and childcare articles.                             phthalates? ..........................................3
However, some school supplies – such                          5. What daily exposure levels to phthalates are
as erasers, bags or pencil cases – were                          considered safe?....................................4
found to contain these phthalates.                            6. Conclusions..........................................4

Can regularly chewing on such articles
cause harmful health effects?

An assessment by the European
Commission Scientific Committee on
Health and Environmental Risks (SCHER)


                 The answers to these questions are a faithful summary of the scientific opinion
           produced in 2008 by the Scientific Committee on Health and Environmental Risks (SCHER):
                                  "Opinion on phthalates in school supplies"

     The full publication is available at: http://copublications.greenfacts.org/en/phthalates-school-supplies/
                    and at: http://ec.europa.eu/health/opinions/en/phthalates-school-supplies/



      This PDF Document is the Level 1 of a GreenFacts Co-Publication. GreenFacts Co-Publications are published
      in several languages as questions and answers, in a copyrighted user-friendly Three-Level Structure of
      increasing detail:

           •   Each question is answered in Level 1 with a short summary.
           •   These answers are developed in more detail in Level 2.
           •   Level 3 consists of the Source document, the internationally recognised scientific opinion which
               is faithfully summarised in Level 2 and further in Level 1.


             All GreenFacts Co-Publications are available at: http://copublications.greenfacts.org/
    and at: http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm
http://www.greenfacts.org/                 Copyright © DG Health and Consumers of the European Commission.                    page 2/7
http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm




1. Introduction: why is there a concern over phthalates in school supplies?

Phthalates are a group of chemical compounds used in the production
of plastics such as PVC to make them softer and more flexible. When
present in consumer products, phthalates can be released because
they are not chemically bound to the plastics. This may lead to
human exposure, which has raised public concern. Many different
phthalates exist with different properties, uses, and health effects.

Because of their potential effects on human health, the European
Union has banned the use of six specific phthalates in products for                                The Danish EPA found a
children. Notably, DEHP, DBP and BBP have been banned in all toys                                  variety of phthalates in
                                                                                                   school supplies.
and childcare articles, and DINP, DIDP and DNOP have been banned                                   Source: scol22, sxc.hu
only in those articles that children could suck and chew on.

In a recent study, the Danish Environmental Protection Agency (EPA) found a variety of
phthalates in school supplies – including in erasers – and concluded that, in general, the
tested supplies do not pose any health risks when used normally.

However, the Danish study warned that some of the tested erasers which contained DEHP
may present health risks, when children regularly suck and chew on them.

Also, some manufacturers might now use other types of phthalates which have not been
banned in consumer products.


2. How was the Danish study on phthalates in school supplies conducted?

2.1 In the framework of the study carried out by the Danish
Environmental Protection Agency (Danish EPA), a number of school
bags, toy bags, pencil cases, and erasers available in shops were
analysed to see the type and the amount of chemical substances
they contained and how much would be released if children bit or
licked them.                                                                                       A number of items,
                                                                                                   including erasers, were
                                                                                                   analysed for chemical
                                                                                                   content.
The school supplies items considered most relevant were erasers                                    Source: Allen Pope
due to their small size that makes them likely candidates for repeated
chewing. Of the 26 erasers analysed in detail, three contained DEHP and six DINP. Some
of the other school supplies also contained some DIBP or DBP. In general, the tested school
supplies were considered not to present a health risk for children, except erasers containing
DEHP.

The European Commission Scientific Committee on Health and Environmental Risks (SCHER)
agreed with the Danish EPA that, among all school supplies tested, the only ones that may
be of concern are erasers as children could repeatedly suck or chew on them.

2.2 However, the SCHER considers that a proper risk assessment of the potential exposure
to phthalates from erasers cannot be made based on the Danish study because of the
various shortcomings in the way it was designed and conclusions were drawn. Indeed,
measurements of how much phthalate passes into artificial saliva were made only on one
eraser and in ways that probably resulted in great overestimates of the true values.
Moreover, the method used had other weaknesses and the results are very uncertain.
http://www.greenfacts.org/                 Copyright © DG Health and Consumers of the European Commission.                        page 3/7
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3. To what extent can children be exposed to phthalates through erasers?

The exposure of children to DEHP and DINP from erasers by licking
and chewing depends on how long they keep the eraser in their
mouths, how many small bits of eraser they swallow, how much of
the phthalates passes into saliva or into gastric juice, and how the
substance is taken up by the body through digestion.

The study from the Danish EPA gives estimates of how much passes
into saliva if a child puts an eraser in its mouth during an hour per
day, a situation that is considered reasonable worst-case scenarios     Exposure of children to
                                                                        phthalates from erasers
by the European Commission Scientific Committee on Health and           is from chewing or licking.
                                                                        Source: GreenFacts
Environmental Risks (SCHER). It is assumed that all the phthalates
in saliva or gastric juice passes into the body through digestion. The hardest factor to
estimate is how much of the eraser is swallowed after chewing bits off it; and this is the
largest source of uncertainty in the assessment.

With these assumptions, the combined worst-case scenarios result in exposures four times
higher than the tolerable daily intake (TDI) for DEHP. However, licking on erasers and
swallowing bits of them is a short-lived habit and children are unlikely to swallow large
amounts of eraser in this way. The exposure time is short and phthalates are rapidly
transformed and eliminated from the body. Therefore, comparing such worst-case short-term
exposures with the TDI, which is meant for regular, lifetime exposures, is not really
appropriate here.


4. To what extent are people exposed to phthalates?

The EU-Risk Assessment Reports (RAR) on various phthalates
estimated the likely exposure from food, materials and the
environment.

Although little is known about how DEHP and other phthalates are
taken in, transformed and eliminated by the body and how exposure
varies for different age groups, the average exposure of children is
known to be approximately twice that of adults. Different lifestyle
factors, eating behaviours, and the ingestion of dust from indoor
surfaces by children may play a role. The diet, particularly fatty food,
is responsible for most of the DEHP exposure in adults while it only                               The diet, particularly fatty
                                                                                                   food, is responsible for
accounts for half of the DEHP that children take in, which suggests                                most of the DEHP
that, for children, other important sources exist.                                                 exposure in adults.
                                                                                                   Source: Steve Woods

While DEHP was the phthalate most commonly used in consumer products in the 1990s,
since then it has been increasingly replaced by DIDP because of health concerns. The change
in use has been reflected in a change in exposure to these two phthalates. The levels of
exposures of the general population to DEHP – estimated based on urine samples – are on
average well below the tolerable daily intake (TDI). However, some groups of the population,
notably people exposed through medical procedures such as kidney dialysis, might be
exposed to considerably higher levels which approach or even exceed the TDI.

In the case of the other phthalates assessed by the EU Risk Assessment reports, calculated
exposures are below the tolerable level except for DBP. A significant portion of the population
may be exposed to doses of DBP above the TDI and efforts to further reduce exposures are
needed.
http://www.greenfacts.org/                 Copyright © DG Health and Consumers of the European Commission.                              page 4/7
http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm




            Overview of the main phthalates and their applications [see Annex 1, p. 6]


5. What daily exposure levels to phthalates are considered safe?

Current understanding about the effects of exposure to a specific
phthalate on human health is mainly based on findings from animal
studies.

Above certain exposure levels the different phthalates can cause                                          See also our publication
harmful effects in animals. For a given phthalate, the harmful effects                                    on Di-butyl phthalate [see
                                                                                                          http://www.greenfacts.org/
that occur at the lowest levels of exposure are referred to as critical                                   en/dbp-dibutyl-phthalate/
toxic effects.                                                                                            index.htm]



These critical toxic effects include effects on reproduction (DEHP,
BBP, DBP, DIBP), on development (BBP, DBP, DIBP), on the liver
(DINP, DIDP, DNOP), and on the thyroid (DNOP).

Based on available experimental findings a tolerable daily intake                                         See also our publication
(TDI) has been established for humans for the different phthalates,                                       on Di-isodecyl &
                                                                                                          Di-isononyl phthalates
except for DNOP and DIBP. The TDI is an estimate of the amount                                            [see
                                                                                                          http://www.greenfacts.org/
that can be taken in by humans on a daily basis over a lifetime                                           en/dinp-didp/index.htm]
without appreciable health risk.


Overview table of critical toxic effects and Tolerable Daily Intakes (TDI)
Phthalate      Critical Toxic Effect on    Tolerable daily intake (in mg per kg body weight                     EU ban
                                                                per day)

DEHP        Reproduction                                         0.05
                                                                                              Banned in all toys and childcare articles, and
BBP                                                              0.5
            Reproduction and development                                                                      in cosmetics
DBP                                                              0.01

DINP
            Liver                                                0.15                         Banned in toys and childcare products that
DIDP
                                                                                                 children could put into their mouths
DNOP        Liver and thyroid
                                                           No TDI available
DIBP        Reproduction and development                                                      -




6. Conclusions

The European Commission Scientific Committee on Health and
Environmental Risks (SCHER) concludes that the phthalates found
in the school supplies tested by the Danish Environment Protection
Agency do not significantly contribute to the total amount of
phthalates taken in by children.
                                                                                                          Phthalates in tested
                                                                                                          school supplies do not
Based on urine samples from people of different ages, it is concluded                                     contribute significantly to
                                                                                                          total exposure of children.
that total exposures to individual phthalates in the general population                                   Source: Ivaylo Georgiev
are below tolerable daily intakes (TDI), except in the case of DBP
for which efforts to further reduce exposures are needed. Exposure to DEHP may exceed
the tolerable intake in some specific population groups, namely people exposed through
medical procedures such as kidney dialysis.

Even in the case when children bite off pieces from erasers and swallow them, the SCHER
considers that it is unlikely that this exposure leads to health consequences.
http://www.greenfacts.org/                 Copyright © DG Health and Consumers of the European Commission.   page 5/7
http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm




In any case, the Scientific Committee stresses the great uncertainty of the evaluation carried
out by the Danish EPA and recommends further research.
http://www.greenfacts.org/                    Copyright © DG Health and Consumers of the                                                 page 6/7
                                                        European Commission.




Annex

Annex 1:

Some phthalates and their applications
Acronym    Full name                  Examples of applications                                                                  EU ban
                                      (past or present)

                                      Perfumes, flexible PVC products (shower curtains, garden hoses, diapers, food containers,
DEHP       Di-Ethyl-Hexyl-Phthalate   plastic film for food packaging, bloodbags, catheters, gloves, and other medical
                                      equipments such as tubes for fluids, etc.)                                                 Banned in all toys
                                                                                                                                 and childcare
BBP        Butyl-Benzyl-Phthalate     Perfumes, hair sprays, adhesives and glues, automotive products, vinyl floor coverings articles, and in
                                                                                                                                 cosmetics
                                      Plastics such as PVC, adhesives, printing inks, sealants, grouting agents used in
DBP        Dibutyl-Phthalate
                                      construction, additive to perfumes, deodorants, hair sprays, nail polish, and insecticides

                                      Mostly in PVC as a plasticizer; Remaining in rubbers, inks, adhesives and sealants, paints
DINP       Di-Isononyl Phthalate
                                      and lacquers.                                                                              Banned in toys and
                                                                                                                                 childcare products
                                      Mostly in PVC as a plasticizer; Remaining in rubbers, anti-corrosion paints, anti-fouling
DIDP       Di-Isodecyl-Phthalate                                                                                                 that children could
                                      paints, sealing compounds, and textile inks.
                                                                                                                                 put into their
                                      Medical tubing and blood storage bags, wire and cables, carpetback coating, floor tile, mouths
DNOP       Di-n-Octyl-Phthalate
                                      and adhesives, cosmetics and pesticides.

                                      Nitro cellulose plastic, nail polish, explosive material, lacquer Similar application and
DIBP       Di-isobutyl phthalate                                                                                                -
                                      properties as DBP: used as a substitute, e.g. in PVC, paints, printing inks and adhesives



                                                           Source: GreenFacts
http://www.greenfacts.org/   Copyright © DG Health and Consumers of the        page 7/7
                                       European Commission.




The Three-Level Structure used to communicate this SCHER Opinion is copyrighted by
Cogeneris sprl [see http://www.greenfacts.org].

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Phthalates in school supplies

  • 1. http://www.greenfacts.org/ Copyright © DG Health and Consumers of the European Commission. page 1/7 http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm Source document: Phthalates in school SCHER (2008) supplies Summary & Details: GreenFacts (2009) 1. Introduction: why is there a concern over Context - Phthalates are additives that phthalates in school supplies?.................2 are widely used in plastics to make them 2. How was the Danish study on phthalates in soft and flexible. school supplies conducted?.....................2 3. To what extent can children be exposed to To protect children from potential health phthalates through erasers?....................3 effects, certain phthalates are no longer 4. To what extent are people exposed to used in toys and childcare articles. phthalates? ..........................................3 However, some school supplies – such 5. What daily exposure levels to phthalates are as erasers, bags or pencil cases – were considered safe?....................................4 found to contain these phthalates. 6. Conclusions..........................................4 Can regularly chewing on such articles cause harmful health effects? An assessment by the European Commission Scientific Committee on Health and Environmental Risks (SCHER) The answers to these questions are a faithful summary of the scientific opinion produced in 2008 by the Scientific Committee on Health and Environmental Risks (SCHER): "Opinion on phthalates in school supplies" The full publication is available at: http://copublications.greenfacts.org/en/phthalates-school-supplies/ and at: http://ec.europa.eu/health/opinions/en/phthalates-school-supplies/ This PDF Document is the Level 1 of a GreenFacts Co-Publication. GreenFacts Co-Publications are published in several languages as questions and answers, in a copyrighted user-friendly Three-Level Structure of increasing detail: • Each question is answered in Level 1 with a short summary. • These answers are developed in more detail in Level 2. • Level 3 consists of the Source document, the internationally recognised scientific opinion which is faithfully summarised in Level 2 and further in Level 1. All GreenFacts Co-Publications are available at: http://copublications.greenfacts.org/ and at: http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm
  • 2. http://www.greenfacts.org/ Copyright © DG Health and Consumers of the European Commission. page 2/7 http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm 1. Introduction: why is there a concern over phthalates in school supplies? Phthalates are a group of chemical compounds used in the production of plastics such as PVC to make them softer and more flexible. When present in consumer products, phthalates can be released because they are not chemically bound to the plastics. This may lead to human exposure, which has raised public concern. Many different phthalates exist with different properties, uses, and health effects. Because of their potential effects on human health, the European Union has banned the use of six specific phthalates in products for The Danish EPA found a children. Notably, DEHP, DBP and BBP have been banned in all toys variety of phthalates in school supplies. and childcare articles, and DINP, DIDP and DNOP have been banned Source: scol22, sxc.hu only in those articles that children could suck and chew on. In a recent study, the Danish Environmental Protection Agency (EPA) found a variety of phthalates in school supplies – including in erasers – and concluded that, in general, the tested supplies do not pose any health risks when used normally. However, the Danish study warned that some of the tested erasers which contained DEHP may present health risks, when children regularly suck and chew on them. Also, some manufacturers might now use other types of phthalates which have not been banned in consumer products. 2. How was the Danish study on phthalates in school supplies conducted? 2.1 In the framework of the study carried out by the Danish Environmental Protection Agency (Danish EPA), a number of school bags, toy bags, pencil cases, and erasers available in shops were analysed to see the type and the amount of chemical substances they contained and how much would be released if children bit or licked them. A number of items, including erasers, were analysed for chemical content. The school supplies items considered most relevant were erasers Source: Allen Pope due to their small size that makes them likely candidates for repeated chewing. Of the 26 erasers analysed in detail, three contained DEHP and six DINP. Some of the other school supplies also contained some DIBP or DBP. In general, the tested school supplies were considered not to present a health risk for children, except erasers containing DEHP. The European Commission Scientific Committee on Health and Environmental Risks (SCHER) agreed with the Danish EPA that, among all school supplies tested, the only ones that may be of concern are erasers as children could repeatedly suck or chew on them. 2.2 However, the SCHER considers that a proper risk assessment of the potential exposure to phthalates from erasers cannot be made based on the Danish study because of the various shortcomings in the way it was designed and conclusions were drawn. Indeed, measurements of how much phthalate passes into artificial saliva were made only on one eraser and in ways that probably resulted in great overestimates of the true values. Moreover, the method used had other weaknesses and the results are very uncertain.
  • 3. http://www.greenfacts.org/ Copyright © DG Health and Consumers of the European Commission. page 3/7 http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm 3. To what extent can children be exposed to phthalates through erasers? The exposure of children to DEHP and DINP from erasers by licking and chewing depends on how long they keep the eraser in their mouths, how many small bits of eraser they swallow, how much of the phthalates passes into saliva or into gastric juice, and how the substance is taken up by the body through digestion. The study from the Danish EPA gives estimates of how much passes into saliva if a child puts an eraser in its mouth during an hour per day, a situation that is considered reasonable worst-case scenarios Exposure of children to phthalates from erasers by the European Commission Scientific Committee on Health and is from chewing or licking. Source: GreenFacts Environmental Risks (SCHER). It is assumed that all the phthalates in saliva or gastric juice passes into the body through digestion. The hardest factor to estimate is how much of the eraser is swallowed after chewing bits off it; and this is the largest source of uncertainty in the assessment. With these assumptions, the combined worst-case scenarios result in exposures four times higher than the tolerable daily intake (TDI) for DEHP. However, licking on erasers and swallowing bits of them is a short-lived habit and children are unlikely to swallow large amounts of eraser in this way. The exposure time is short and phthalates are rapidly transformed and eliminated from the body. Therefore, comparing such worst-case short-term exposures with the TDI, which is meant for regular, lifetime exposures, is not really appropriate here. 4. To what extent are people exposed to phthalates? The EU-Risk Assessment Reports (RAR) on various phthalates estimated the likely exposure from food, materials and the environment. Although little is known about how DEHP and other phthalates are taken in, transformed and eliminated by the body and how exposure varies for different age groups, the average exposure of children is known to be approximately twice that of adults. Different lifestyle factors, eating behaviours, and the ingestion of dust from indoor surfaces by children may play a role. The diet, particularly fatty food, is responsible for most of the DEHP exposure in adults while it only The diet, particularly fatty food, is responsible for accounts for half of the DEHP that children take in, which suggests most of the DEHP that, for children, other important sources exist. exposure in adults. Source: Steve Woods While DEHP was the phthalate most commonly used in consumer products in the 1990s, since then it has been increasingly replaced by DIDP because of health concerns. The change in use has been reflected in a change in exposure to these two phthalates. The levels of exposures of the general population to DEHP – estimated based on urine samples – are on average well below the tolerable daily intake (TDI). However, some groups of the population, notably people exposed through medical procedures such as kidney dialysis, might be exposed to considerably higher levels which approach or even exceed the TDI. In the case of the other phthalates assessed by the EU Risk Assessment reports, calculated exposures are below the tolerable level except for DBP. A significant portion of the population may be exposed to doses of DBP above the TDI and efforts to further reduce exposures are needed.
  • 4. http://www.greenfacts.org/ Copyright © DG Health and Consumers of the European Commission. page 4/7 http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm Overview of the main phthalates and their applications [see Annex 1, p. 6] 5. What daily exposure levels to phthalates are considered safe? Current understanding about the effects of exposure to a specific phthalate on human health is mainly based on findings from animal studies. Above certain exposure levels the different phthalates can cause See also our publication harmful effects in animals. For a given phthalate, the harmful effects on Di-butyl phthalate [see http://www.greenfacts.org/ that occur at the lowest levels of exposure are referred to as critical en/dbp-dibutyl-phthalate/ toxic effects. index.htm] These critical toxic effects include effects on reproduction (DEHP, BBP, DBP, DIBP), on development (BBP, DBP, DIBP), on the liver (DINP, DIDP, DNOP), and on the thyroid (DNOP). Based on available experimental findings a tolerable daily intake See also our publication (TDI) has been established for humans for the different phthalates, on Di-isodecyl & Di-isononyl phthalates except for DNOP and DIBP. The TDI is an estimate of the amount [see http://www.greenfacts.org/ that can be taken in by humans on a daily basis over a lifetime en/dinp-didp/index.htm] without appreciable health risk. Overview table of critical toxic effects and Tolerable Daily Intakes (TDI) Phthalate Critical Toxic Effect on Tolerable daily intake (in mg per kg body weight EU ban per day) DEHP Reproduction 0.05 Banned in all toys and childcare articles, and BBP 0.5 Reproduction and development in cosmetics DBP 0.01 DINP Liver 0.15 Banned in toys and childcare products that DIDP children could put into their mouths DNOP Liver and thyroid No TDI available DIBP Reproduction and development - 6. Conclusions The European Commission Scientific Committee on Health and Environmental Risks (SCHER) concludes that the phthalates found in the school supplies tested by the Danish Environment Protection Agency do not significantly contribute to the total amount of phthalates taken in by children. Phthalates in tested school supplies do not Based on urine samples from people of different ages, it is concluded contribute significantly to total exposure of children. that total exposures to individual phthalates in the general population Source: Ivaylo Georgiev are below tolerable daily intakes (TDI), except in the case of DBP for which efforts to further reduce exposures are needed. Exposure to DEHP may exceed the tolerable intake in some specific population groups, namely people exposed through medical procedures such as kidney dialysis. Even in the case when children bite off pieces from erasers and swallow them, the SCHER considers that it is unlikely that this exposure leads to health consequences.
  • 5. http://www.greenfacts.org/ Copyright © DG Health and Consumers of the European Commission. page 5/7 http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_en.htm In any case, the Scientific Committee stresses the great uncertainty of the evaluation carried out by the Danish EPA and recommends further research.
  • 6. http://www.greenfacts.org/ Copyright © DG Health and Consumers of the page 6/7 European Commission. Annex Annex 1: Some phthalates and their applications Acronym Full name Examples of applications EU ban (past or present) Perfumes, flexible PVC products (shower curtains, garden hoses, diapers, food containers, DEHP Di-Ethyl-Hexyl-Phthalate plastic film for food packaging, bloodbags, catheters, gloves, and other medical equipments such as tubes for fluids, etc.) Banned in all toys and childcare BBP Butyl-Benzyl-Phthalate Perfumes, hair sprays, adhesives and glues, automotive products, vinyl floor coverings articles, and in cosmetics Plastics such as PVC, adhesives, printing inks, sealants, grouting agents used in DBP Dibutyl-Phthalate construction, additive to perfumes, deodorants, hair sprays, nail polish, and insecticides Mostly in PVC as a plasticizer; Remaining in rubbers, inks, adhesives and sealants, paints DINP Di-Isononyl Phthalate and lacquers. Banned in toys and childcare products Mostly in PVC as a plasticizer; Remaining in rubbers, anti-corrosion paints, anti-fouling DIDP Di-Isodecyl-Phthalate that children could paints, sealing compounds, and textile inks. put into their Medical tubing and blood storage bags, wire and cables, carpetback coating, floor tile, mouths DNOP Di-n-Octyl-Phthalate and adhesives, cosmetics and pesticides. Nitro cellulose plastic, nail polish, explosive material, lacquer Similar application and DIBP Di-isobutyl phthalate - properties as DBP: used as a substitute, e.g. in PVC, paints, printing inks and adhesives Source: GreenFacts
  • 7. http://www.greenfacts.org/ Copyright © DG Health and Consumers of the page 7/7 European Commission. The Three-Level Structure used to communicate this SCHER Opinion is copyrighted by Cogeneris sprl [see http://www.greenfacts.org].