Opinion of the Commission pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Directive of the European Parliament and of the Council amending for the twenty-second time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles) amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2005-09-16
Institutions: European Commission
Subjects: amendment, consumer protection, dangerous substance, early childhood, interinstitutional relations (EU), product safety, public health, toy industry

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 16.9.2005 
COM(2005) 434 final 

1999/0238 COD 

OPINION OF THE COMMISSION 

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the 
European Parliament's amendments to the Council's common position regarding the 
proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending for the twenty-second time Council Directive 76/769/EEC relating to 
restrictions on the marketing and use of certain dangerous substances and preparations 
(phthalates in toys and childcare articles) 

AMENDING THE PROPOSAL OF THE COMMISSION  
pursuant to Article 250 (2) of the EC Treaty

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1. 

INTRODUCTION 

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is 
to  deliver  an  opinion  on  the  amendments  proposed  by  the  European  Parliament  at  second 
reading.  The  Commission  sets  out  its  opinion  below  on  the  amendments  proposed  by 
Parliament. 

2. 

BACKGROUND 

(a) 

Date of the Commission decision: 10 November 1999 

(b) 

Date of transmission to Parliament and Council: 10 November 1999 

(c) 

Opinion of the Economic and Social Committee: 1 March 2000 

(d) 

Date of the opinion of the first reading in Parliament: 6 July 2000 

(e) 

(f) 

Date of adoption of the common position: 4 April 2005 (unanimity) 

Date of the opinion of the second reading: 5 July 2005  

3. 

PURPOSE OF THE PROPOSAL 

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

first  proposal 

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  mouths  of  children  under  the  age  of  three  years.  The 
Commission has been renewing these temporary bans by extending 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.  

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

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4. 

OPINION  OF  THE  COMMISSION  ON  THE  AMENDMENTS  BY  THE 
EUROPEAN PARLIAMENT 

Amendments accepted by the Commission 

The  Commission  can  accept  in  full  all  4  amendments  adopted  by  the  European  Parliament. 
They are the result of a compromise package agreed between the European Parliament and the 
Council with a view to the adoption of the Directive in second reading. The amendments are 
in line with the objectives of the Commission’s proposal and maintain the balance of interests 
achieved in the common position.  

The amendments to the Common Position mainly refer to the extension of the restriction of 
the  three  phthalates  DINP,  DIDP  and  DNOP  to  all  toys  that  can  be  placed  in  the  mouth  by 
children.  In  addition,  the  definition  of  childcare  articles  was  extended  to  include  the  word 
"hygiene", and the Commission was asked to also review other applications, notably medical 
devices. 

The conclusion of the compromise package has been facilitated by two declarations which the 
Commission made during the July 2005 Plenary session (see annex). 

5. 

CONCLUSION 

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out 
above. 

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Declarations by the Commission: 

ANNEX 

Guidance document (already made at Competitiveness Council on 24 September 2004): 

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 insofar as they concern the condition "which can be placed in the mouth" 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. 

Fragrances 

The  Commission  confirms  its  intention  to  address  the  issue  of  fragrances  in  toys  in  the 
framework of the revision of the Directive on the Safety of Toys. This will have the advantage 
of identifying what falls within the scope of “fragrances”, consider the appropriate measures 
to deal with the risks identified and ensure consistency with the other legislative provisions of 
the said Directive.  

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