Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Directive of the European Parliament and the Council amending for the twenty-second time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles)
Date: 2005-04-12
Institutions: European Commission
Subjects: approximation of laws, carcinogenic substance, consumer protection, dangerous substance, early childhood, marketing standard, toxic substance, toy industry

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 12.4.2005 
COM(2005) 143 final 

1999/0238 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning the 

common position of the Council on the adoption of a Directive of the European 
Parliament and the Council amending for the twenty-second time Council Directive 
76/769/EEC on the approximation of the laws, regulations and administrative provisions 
of the Member States relating to restrictions on the marketing and use of certain 
dangerous substances and preparations (phthalates in toys and childcare articles) 

EN 

   EN 

 
 
 
  
 
 
1999/0238 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning the 

common position of the Council on the adoption of a Directive of the European 
Parliament and the Council amending for the twenty-second time Council Directive 
76/769/EEC on the approximation of the laws, regulations and administrative provisions 
of the Member States relating to restrictions on the marketing and use of certain 
dangerous substances and preparations (phthalates in toys and childcare articles) 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM(1999) 577 final – 1999/0238 COD): 

10 November 1999. 

Date of the opinion of the European Economic and Social 
Committee: 

1 March 2000. 

Date of the opinion of the European Parliament, first reading: 

6 July 2000. 

Date of adoption of the common position: 

4 April 2005 

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL 

The Commission made a first proposal to amend Directive 76/769/EEC in order to introduce a 
ban on the use of six phthalates in toys and childcare articles intended to be put in the mouth 
by children under the age of three on 10 November 1999 (COM (1999) 577/final). 

In  the  subsequent  discussions,  the  Council  decided  to  wait  for  the  results  of  a  series  of 
comprehensive  risk  assessments  under  Council  Regulation  (EEC)  793/93  on  the  evaluation 
and  control  of  risks  of  existing  substances  which  had  been  initiated  in  the  meantime.  From 
these risk assessments, new scientific data has now become available. 

In  addition  to  the  proposal  for  a  permanent  limitation,  the  Commission  in  1999  adopted 
temporary  measures  under  Commission  Decision  1999/815/EC  on  the  basis  of  article  9  of 
Directive  92/59/EEC  of  the  Council  banning  the  use  of  6  phthalates  in  toys  and  childcare 
articles  intended  to  be  put  in  the  mouth  by  children  under  the  age  of  three  years.  The 
Commission has been renewing these temporary bans by prolonging the duration of Decision 
1999/815/EC on a regular (3 monthly / 6 monthly) basis. Member States have also adopted 
differing limitations on phthalates in toys and childcare articles.  

EN 

2 

   EN 

 
 
 
 
 
For  all  parties  involved,  including  industry,  the  instability  of  the  legal  situation  and  the 
partition  of  the  internal  market  are  creating  difficulties.  A  stable  legal  situation  should 
therefore be created as soon as possible. 

3. 

COMMENTS ON THE COMMON POSITION 

Based on current scientific information and taking into account the opinion of the European 
Parliament at 1st reading, the new proposal contained in the Council's Common Position aims 
to take the necessary measures, in line with the precautionary principle, while differentiating 
between  the  different  phthalates  according  to  their  individual  potential  to  cause  a  risk  to 
children.  

The Common Position of the Council represents a fresh start after several years of stalemate 
and therefore does not address each of the amendments proposed by the European Parliament 
during  the  first  reading.  As  far  as  the  group  of  phthalates  are  concerned  which  have  been 
classified  as  CMR  (carcinogen,  mutagen,  reprotoxic)  substances,  the  proposal  goes  further 
than the amendments of the European Parliament by  banning their use in toys regardless of 
the age-group. For the other group of phthalates, the Common Position follows the proposed 
amendments. A review clause, as suggested by the European Parliament, has been included in 
the proposal. 

The  amendments  relating  to  the  labelling  of  toys  and  childcare  articles  and  the  banning  of 
fragrances  have  not  been  taken  into  account,  because  bearing  in  mind  the  risk  assessment 
results  and  the  wider  scope  of  the  proposed  limitations  as  compared  to  the  ones  initially 
proposed these measures were not considered proportional. 

3.1. 

DEHP, DBP and BBP 

A result of the risk assessments was that DEHP1, DBP2, and BBP3 are toxic for reproduction. 
Accordingly,  they  were  classified  as  CMR  (carcinogen,  mutagen,  reprotoxic)  substances, 
category 2.  

There are a number of considerations that justify, on precautionary grounds, the total ban of 
these substances from products such as toys which, by definition, are intended for children:  

•  Children  are  developing  organisms  and  as  such  are  particularly  vulnerable  to 
chemicals with the particular properties in question (reproductive toxicants and/or 
endocrine  disruption).  For  that  reason,  the  maximum  level  of  protection  for 
children must be given in the case of exposure from avoidable sources. 

•  Exposure to DEHP, DBP and BBP from toys is avoidable and for children there is 

no evident need for or benefit from their use in toys. 

•  Exposure to DEHP, DBP and BBP from toys is possibly the largest fraction of the 
these  chemicals  from  all  known  sources 

total  exposure  of  children 
(environment, indoor air, food etc) that can be controlled by concrete measures.  

to 

1 
2 
3 

bis (2-ethylhexyl) phthalate 
dibutyl phthalate 
benzyl butyl phthalate 

EN 

3 

   EN 

 
                                                 
•  There  are  significant  uncertainties  concerning  the  exposure  of  children  to  these 
phthalates  from  toys  (mouthing  time  and  direct  absorption  from  the  mouth)  and 
from  other  sources  (use  of  surrogate  chemicals  to  calculate  exposure  to  these 
chemicals  from  indoor  air,  outdoor  air,  etc)  that  may  further  intensify  the  total 
exposure and risk. Because of these uncertainties, the quantification of risk by the 
technical experts (whether under Council Regulation 793/93/EEC or the Scientific 
Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) has been only 
approximate and indicative. 

DEHP, DBP and BBP should therefore be banned in all toys and childcare articles. 

3.2. 

DINP, DIDP and DNOP 

On DINP4 there are divergent opinions between the risk assessment under Council Regulation 
(EEC) 793/93 on the evaluation and control of risks of existing substances on the one hand 
and  the  SCTEE  on  the  other.  This  difference  of  opinion  concerns  the  interpretation  of  the 
effects (spongiosis hepatis) observed in liver cells of experimental animals in toxicity studies 
conducted with DINP. The SCTEE concluded that there is a need for limiting the risks and 
shared  the  views  of  the  Chronic  Hazard  Advisory  Panel  on  DINP  of  the  US  Consumer 
Product  Safety  Commission  on  the  interpretation  of  the  data.  The  risk  assessment  resulting 
from the Technical Meeting under Regulation 793/93/EEC concluded that there is at present 
no  need  for  further  information  and/or  testing  or  for  risk  reduction  measures  beyond  those 
which are already being applied. 

These diverging views result in part the unpredictable behaviour of children and thus to the 
problem of correctly determining the daily intake of a given substance. The EU must aim at a 
high  level  of  protection  of  the  health  and  safety  of  its  citizens,  especially  of  children.  It  is 
legitimate  to  take  this  factor  into  account  when  deciding  on  risk  reduction  measures  for 
children.  For  precautionary  reasons  and  also  taking  into  account  the  proportionality 
requirement of the Communication on the Precautionary Principle, it is proposed that DINP 
should be banned in toys and childcare articles that can be mouthed by the most vulnerable 
age group of children, namely those under the age of three, until further scientific information 
becomes available. 

For  DIDP5  the  situation  is  similar  to  that  for  DINP.  The  risk  assessment  under  Regulation 
793/93/EEC concluded that if DIDP would be used in soft PVC toys at the levels DINP and 
DEHP are currently used (35-45%), the situation would give cause for concern. In its review 
of the risk assessment under 793/93/EEC the SCTEE concluded that there are no reasons for 
concern, not because of disagreement with the hypothesis of the risk assessment, but because 
there is at present no market evidence that DIDP is used at such high levels. Besides, in its 
original opinion of 1998 the Scientific Committee had noted that should DIDP (and the other 
phthalates)  be  used  at  levels  comparable  to  DINP  and  DEHP  there  might  be  reasons  for 
concern. The SCTEE and the risk assessment therefore agree that if DIDP were to be used at 
high levels then there would be cause for concern. 

For the above stated reasons, there should be comparable proportionate measures proposed for 
DINP  and  DIDP.  Furthermore,  the  uncertainties  (mouthing  times,  exposure  from  other 

4 
5 

di-isononyl phthalate 
di-isodecyl phthalate 

EN 

4 

   EN 

 
                                                 
sources, etc) and other precautionary considerations set out above for DEHP, DBP and BBP 
are very relevant in deciding the appropriate risk management measures. 

Regarding DNOP6, for which no EU risk assessment has been made because it is not being 
intentionally used in toys and childcare articles, the SCTEE already said in 1998 that if DNOP 
were used in doses similar to those of DEHP and DINP, larger releases from the toys would 
occur and lower margins of safety would be expected. DNOP was shown to cause alterations 
in the liver and thyroid. The SCTEE recognised "that there [were] uncertainties with respect 
to  the  actual  exposures...because  the  measured  amounts  show  [a]  large  variation  throughout 
the various reported studies.” In addition, the SCTEE pointed to the fact "that more than one 
phthalate may occur in children's toys or there may be additional exposures through food, air 
and by dermal contact to these phthalates."  

The Commission therefore takes the view that based on precautionary considerations, linked 
to  the  lack  of  data  and  due  to  existing  uncertainties,  DNOP  should  be  subject  to  the  same 
restrictions as DINP and DIDP. 

3.3. 

Availability  and  safety  profiles  of  alternative  substances  that  could  be  used  as 
plasticizers in soft PVC toys. 

Besides phthalates, a number of substances can be used as plasticisers of soft PVC toys. 

In light of discussions on alternative plasticisers, the Commission requested an evaluation by 
the  SCTEE  of  the  available  information  of  certain  plasticisers,  most  notably  citrates  and 
adipates. In its initial  opinion  of  28  September  1999,  the  SCTEE concluded that  there were 
significant gaps in the amount of information on the potential substitutes which needed to be 
filled before their use in PVC toys and childcare articles could be properly evaluated. 

In response the citrate industry conducted a number of safety and exposure studies (with adult 
volunteers)  with  Acetyl  Tri-Butyl  Citrate  (ATBC)  which  were  eventually  submitted  for 
evaluation to the SCTEE. In a new opinion of 8 January 2004, the SCTEE concluded that the 
data gaps were properly covered by the new data and that there is no safety concern with the 
use of ATBC as a plasticiser for PVC toys and childcare articles that are mouthed by small 
children. 

3.4. 

Other relevant developments: Child mouthing studies 

Since  the  measures  banning  the  use  of  the  six  phthalates  in  soft  PVC  toys  and  childcare 
articles were put in place by the adoption of Commission Decision 1999/815/EC, a number of 
studies have been conducted to assess child mouthing behaviour. 

The results of these studies vary depending on the design and in particular on the total length 
of time that children are observed, the inclusion or exclusion of toys intended to be mouthed, 
the  reporting  of  the  mouthing  times  (averages  versus  95  percentile  versus  maximum  worst 
case),  whether  mouthing  times  are  taken  as  cumulative  or  as  incremental,  and  the 
categorisation of objects mouthed by children. As a result, depending on the protocol of the 
child observation study, children have been shown to mouth objects for times anywhere from 
several  minutes  (US  CPSC)  to  over  6  hours  (UK  DTI,  Japanese  reports),  re-inforcing  the 

6 

dioctyl phthalate 

EN 

5 

   EN 

 
                                                 
uncertainty  over  what  are  the  ‘real’  worst  case  mouthing  times  and  the  need  to  exercise  an 
appropriate degree of caution in the exposure assumptions concerning phthalates from toys. 

3.5. 

Additional guidance 

The  Commission  has  made  a  declaration  at  the  Competitive  Council  Meeting  on  24 
September 2004 announcing its intention to prepare a guidance document in order to facilitate 
the implementation of the Directive (see annex). This document will address in particular the 
provisions  on  restrictions  of  certain  substances  in  toys  and  childcare  articles  intended  for 
children under three years of age insofar as they concern the condition "which can be placed 
in the mouth by them" as specified in the annex to the Directive. 

4. 

CONCLUSION 

The  Commission  supports  the  common  position  because  it  is  founded  on  the  precautionary 
measures needed to protect children having regard also to considerable scientific uncertainty 
as  to  whether  certain  phthalates  can  present  a  risk  to  them.  In  addition  the  Commission 
supports  the  common  position  provisions  for  the  review  of  scientific  developments  on 
phthalates and their potential substitutes after 4 years. 

EN 

6 

   EN 

 
ANNEX 

Declaration by the Commission 

As soon as the Directive relating to restrictions on the marketing and use of phthalates in toys 
and  childcare  articles  (22nd  amendment  of  Council  Directive  76/769/EEC  relating  to 
restrictions  on  the  marketing  and  use  of  certain  dangerous  preparations)  is  adopted,  the 
Commission, in consultation with Member States’ experts responsible for the management of 
Directive  76/769/EEC  and  stakeholders,  will  prepare  a  guidance  document  in  order  to 
facilitate  the  implementation  of  the  Directive.  The  document  will  address  in  particular  the 
provisions  on  restrictions  of  certain  substances  in  toys  and  childcare  articles  intended  for 
children under three years of age insofar as they concern the condition "which can be placed 
in the mouth by them" as specified in the annex to the Directive 

In  the  context  of  this  work,  the  aspects  related  to  “accessible”  plasticised  material  and 
“handheld” toys will be examined. 

EN 

7 

   EN