PURPOSE: to ban the use of phthalates in toys and childcare articles.

LEGISLATIVE ACT: Directive 2005/84 of the European Parliament and of the Council amending for the 22 nd time Council Directive 76/769 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).

CONTENT: The scope of Directive 76/769 has been extended to include the use of phthalates in toys and “childcare articles” (meaning any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children). In doing so the Community has effectively banned and restricted the use of phthalates in toys and childcare articles. The Commission will re-evaluate the situation by 16 January 2010 at the latest. By 16 July 2006, the Member States must adopt and publish the laws, regulation and administrative provisions necessary to comply with this Directive. The measures must apply from 16 January 2007.

ENTRY INTO FORCE: 16 January 2006.

Directive 2005/84
OJ L 344 27.12.2005, p. 0040-0043

03645/1/2005

The Commission states that it accepts in full all four amendments adopted by the European Parliament.

They are the result of a compromise package agreed between the 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. (Please see the summary of 05/07/2005.)

Accordingly, the Commission amends its proposal as set out above.

COM(2005)0434
EUR-Lex

SP(2005)2923

The European Parliament adopted a resolution drafted by Antonios TRAKATELLIS (EPP-ED, EL) and voted in favour of a permanent ban on six phthalates in toys and childcare articles. The plenary approved the compromise reached by the rapporteur with the Council just after the vote that took place on 14/06/2005 in the Environment Committee.

DINP , DIDP and DNOP shall not be used as substances or as constituents of preparations, at concentrations of greater than 0.1% by mass of the plasticised material, in toys and childcare articles which can be placed in the mouth by children. The ban applies irrespective of the age for which the toys and articles are made.

In addition a new definition of childcare articles includes any product intended to facilitate hygiene.

A new recital states that the Commission will review other applications of articles made from plasticised material or including parts made from plasticised material which may expose people to risks, especially those used in medical devices.

Finally, there are two Statements annexed to the resolution. One concerns the fact that 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. The aspects related to “accessible” plasticised material and “handheld” toys will be examined.

The second statement confirms the Commission’s intention to address the issue of fragrances in toys in the framework of the revision of Council Directive 88/378/EEC on the safety of toys. This will identify exactly what should be understood as fragrances, consider the appropriate measures to deal with the risks identified and ensure consistency with the other legislative provisions of the said Directive.

T6-0266/2005
OJ C 157 06.07.2006, p. 0018-0057 E

Results of vote in Parliament

The European Parliament adopted a resolution drafted by Antonios TRAKATELLIS (EPP-ED, EL) and voted in favour of a permanent ban on six phthalates in toys and childcare articles. The plenary approved the compromise reached by the rapporteur with the Council just after the vote that took place on 14/06/2005 in the Environment Committee.

DINP , DIDP and DNOP shall not be used as substances or as constituents of preparations, at concentrations of greater than 0.1% by mass of the plasticised material, in toys and childcare articles which can be placed in the mouth by children. The ban applies irrespective of the age for which the toys and articles are made.

In addition a new definition of childcare articles includes any product intended to facilitate hygiene.

A new recital states that the Commission will review other applications of articles made from plasticised material or including parts made from plasticised material which may expose people to risks, especially those used in medical devices.

Finally, there are two Statements annexed to the resolution. One concerns the fact that 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. The aspects related to “accessible” plasticised material and “handheld” toys will be examined.

The second statement confirms the Commission’s intention to address the issue of fragrances in toys in the framework of the revision of Council Directive 88/378/EEC on the safety of toys. This will identify exactly what should be understood as fragrances, consider the appropriate measures to deal with the risks identified and ensure consistency with the other legislative provisions of the said Directive.

T6-0266/2005

Debate in Parliament

A6-0196/2005

A6-0196/2005

The committee adopted the report by Antonios TRAKATELLIS (EPP-ED, EL) amending the Council's common position under the 2nd reading of the codecision procedure. It reinstated, sometimes in modified form, a number of amendments adopted by Parliament at 1st reading which were not taken up by the Council:

- although the Council had imposed a ban on the use of DINP , DIDP and DNOP in toys and childcare articles intended for children under three which could come into contact with the mouth, the committee upheld Parliament's position from 1st reading that this ban should not be restricted to toys for the under-threes, given that babies and very small children will often want to play with the toys of their older siblings and may put them into their mouths. It therefore reinstated Parliament's 1st reading amendment banning the use of the three phthalates in question in "parts of toys and childcare articles intended to be placed in the mouth or in toys and childcare articles which can be placed in the mouth by children";

- MEPs also upheld Parliament's previous argument that, for all other toys, provision must be made, on the basis of the precautionary principle, for adequate labelling so that parents are informed of the presence of these three phthalates. They accordingly reinstated the 1st reading amendments requiring toys and childcare articles containing DINP, DIDP and DNOP to be properly labelled, with a pictogram "in an easily legible and indelible form" and the warning " Contains phthalates - Not to be kept in the mouth";

- another amendment reinstated from 1st reading stipulated that fragrances could not be added to toys or childcare products containing the above three phthalates, if children can put them in their mouths. The committee repeated Parliament's argument that such fragrances increased the tendency of small children to put these items in their mouths;

- the Commission should review the use of all these phthalates in articles used in healthcare, food packaging and floor coverings.

The committee also adopted some new amendments:

- the new definition of childcare articles introduced by the Council was slightly extended in order to cover such products as changing tables and mats;

- a new Article 1A was introduced to ensure that the monitoring requirements mentioned in the new recital 14 of the common position would be included in the enacting terms of the directive;

- the directive should be reviewed 3 years after its entry into force, rather than 5 years as proposed by the Council.

PE359.998

PE359.891

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.

Lastly, t he Commission 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. 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.

COM(2005)0143
EUR-Lex

01182/2005

The Council’s common position 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.

The Council wishes to move forward in the same direction as the European Parliament, by significantly broadening the scope of the ban, replacing labelling with an outright ban. The Council believes that this will greatly assist towards adopting a permanent ban, subject to a continuous review, leading to an even broader ban, should new scientific evidence arise after its entry into force.

More specifically, as far as the group of phthalates is 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.

Moreover, the Council has introduced new modifications as follows:

- the introduction of the obligation for the Commission to review these measures within four years from their entry into force;

- compliance with the guidelines on drafting legislative texts, and to add the obligation for Member States to notify the transposition measures to the Commission;

- in the Annex, the scope of the ban has been clarified, by extending it, for DEHP, DBP and BBP to all toys and childcare articles; for DINP, DIDP and DNOP, the ban will cover toys and childcare articles intended for children under three years of age and which can be placed in the mouth by them. In both cases, it has been clarified that the concentration limit of 0,1 % of the mass applies to the plasticised material mass, so that in case of items which include both plasticised material and other components, it

remains applicable in full to the plasticised part only.

05467/1/2005
OJ C 144 14.06.2005, p. 0024-0029 E

The Council’s common position 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.

The Council wishes to move forward in the same direction as the European Parliament, by significantly broadening the scope of the ban, replacing labelling with an outright ban. The Council believes that this will greatly assist towards adopting a permanent ban, subject to a continuous review, leading to an even broader ban, should new scientific evidence arise after its entry into force.

More specifically, as far as the group of phthalates is 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.

Moreover, the Council has introduced new modifications as follows:

- the introduction of the obligation for the Commission to review these measures within four years from their entry into force;

- compliance with the guidelines on drafting legislative texts, and to add the obligation for Member States to notify the transposition measures to the Commission;

- in the Annex, the scope of the ban has been clarified, by extending it, for DEHP, DBP and BBP to all toys and childcare articles; for DINP, DIDP and DNOP, the ban will cover toys and childcare articles intended for children under three years of age and which can be placed in the mouth by them. In both cases, it has been clarified that the concentration limit of 0,1 % of the mass applies to the plasticised material mass, so that in case of items which include both plasticised material and other components, it

remains applicable in full to the plasticised part only.

05467/1/2005

2389

2289

T5-0334/2000
OJ C 121 24.04.2001, p. 0176-0410

T5-0334/2000

Debate in Parliament

2265

A5-0149/2000
OJ C 067 01.03.2001, p. 0010

A5-0149/2000

CES0243/2000
OJ C 117 26.04.2000, p. 0059

PURPOSE: To harmonise provisions relating to phthalates in toys and child care articles in order to ensure a high level of health protection, notably of young children.

PROPOSED ACT: Directive of the European Parliament and of the Council.

CONTENT: The purpose of the proposed Directive is to harmonise provisions on phthalates is toys and child care articles in order to ensure a high level of health protection for young children under the age of three. The proposed Directive is being presented on the back of research conducted in Denmark and Spain, which indicates that unsafe levels of phthalates are migrating from certain soft PVC child care articles. The Commission’s preferred route of action is to initiate an outright ban on the use of certain phthalates in PVC toys and child care articles put in the mouth by small children under the age of three. An additional provision would ensure that soft PVC toys intended for children under the age of three, which could be put in the mouth, should carry a label alerting carers that children should not put those toys in their mouths. To enact the ban the Commission is proposing to amend, for the twenty second time, Directive 76/769/EEC relating to restriction on the marketing and use of certain dangerous substances and preparations (phthalates). At the same time it is proposing an amendment to Council Directive 88/378/EEC concerning the safety of toys. The phthalates concerned are DINP and DEHP. It should be noted that a ban was chosen over an above testing methods given that tests for detecting the migration of phthalates are incomplete and are therefore not sufficiently good enough for regulatory purposes.

As the adoption and implementation of the proposed ban on phthalates will take a certain period of time, the Commission is proposing to simultaneously agree to Council Decision, Article 9 of the Directive on Product Safety, which requires the Member States to take temporary measures to implement the prohibition within less than 10 days.

Given that most of the Member States have already notified their intention to introduce (in the framework of Commission Recommendation 98/485/EC) national bans on the use of phthalates in toys, the costs are considered minimal. In addition, industry has adapted to the situation and in a majority of Member States, most of the products in question no longer contain phthalates.

EUR-Lex
OJ C 116 26.04.2000, p. 0014 E
COM(1999)0577

PURPOSE: To harmonise provisions relating to phthalates in toys and child care articles in order to ensure a high level of health protection, notably of young children.

PROPOSED ACT: Directive of the European Parliament and of the Council.

CONTENT: The purpose of the proposed Directive is to harmonise provisions on phthalates is toys and child care articles in order to ensure a high level of health protection for young children under the age of three. The proposed Directive is being presented on the back of research conducted in Denmark and Spain, which indicates that unsafe levels of phthalates are migrating from certain soft PVC child care articles. The Commission’s preferred route of action is to initiate an outright ban on the use of certain phthalates in PVC toys and child care articles put in the mouth by small children under the age of three. An additional provision would ensure that soft PVC toys intended for children under the age of three, which could be put in the mouth, should carry a label alerting carers that children should not put those toys in their mouths. To enact the ban the Commission is proposing to amend, for the twenty second time, Directive 76/769/EEC relating to restriction on the marketing and use of certain dangerous substances and preparations (phthalates). At the same time it is proposing an amendment to Council Directive 88/378/EEC concerning the safety of toys. The phthalates concerned are DINP and DEHP. It should be noted that a ban was chosen over an above testing methods given that tests for detecting the migration of phthalates are incomplete and are therefore not sufficiently good enough for regulatory purposes.

As the adoption and implementation of the proposed ban on phthalates will take a certain period of time, the Commission is proposing to simultaneously agree to Council Decision, Article 9 of the Directive on Product Safety, which requires the Member States to take temporary measures to implement the prohibition within less than 10 days.

Given that most of the Member States have already notified their intention to introduce (in the framework of Commission Recommendation 98/485/EC) national bans on the use of phthalates in toys, the costs are considered minimal. In addition, industry has adapted to the situation and in a majority of Member States, most of the products in question no longer contain phthalates.

EUR-Lex
COM(1999)0577