L 344/40 Official Journal of the European Union 27.12.2005 DIRECTIVE 2005/84/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 December 2005 amending for the 22nd 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) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO- PEAN UNION, Having regard to the Treaty establishing the European Commu- nity, and in particular Article 95 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1)  Article 14 of the Treaty establishes an area without inter- nal frontiers in which the free movement of goods, per- sons, services and capital is ensured. (2)  Work on the internal market should improve the quality of life, health protection and consumer safety. This Directive complies with the requirements of ensuring a high level of health protection and of consumer protection in the defi- nition and implementation of all Community policies and activities. (3)  The use of certain phthalates in toys and childcare articles made of plasticised material or including parts made of plasticised material should be prohibited as the presence of certain phthalates presents or could potentially present risks related to the health of children. Toys and childcare articles which, although not intended for that purpose, can be put in the mouth, may under certain circumstances present a risk to the health of small children if they are made of plasticised material, or include parts made of plas- ticised material, which contains certain phthalates. (4)  The Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE), after being consulted by the Com- mission, has delivered opinions on the health risks raised by these phthalates. () OJ C 116 E, 26.4.2000, p. 14. (2) OJ C 117, 26.4.2000, p. 59. (®) Opinion of the European Parliament of 6 July 2000 (O] C 121, 24.4.2001, p. 410), Council Common Position of 4 April 2005 (OJ C 144 E, 14.6.2005, p. 24), Position of the European Parliament of 5 July 2005 (not yet published in the Official Journal) and Council Decision of 23 November 2005. (5)  Commission Recommendation 98/485/EC of 1 July 1998 on childcare articles and toys intended to be placed in the mouth by children of less than three years of age, made of soft PVC containing certain phthalates (¥), invited Member States to take measures to ensure a high level of child health protection with regard to these products. (6)  Since 1999, the use of six phthalates in toys and childcare articles intended to be placed in the mouth by children under the age of three is subject to a temporary ban at European Union level following the adoption of Commis- sion Decision 1999/815/EC (°) in the framework of Coun- cil Directive 92/59/EEC of 29 June 1992 on general product safety (¢). This Decision is being renewed regularly. (7)  Limitations already adopted by certain Member States on the placing on the market of toys and childcare articles because of their phthalate content directly affect the completion and functioning of the internal market. It is therefore necessary to approximate the laws of the Mem- ber States in this field and consequently to amend Annex I to Directive 76/769/EEC (7). (8)  The precautionary principle should be applied where sci- entific evaluation does not allow the risk to be determined with sufficient certainty in order to ensure a high level of protection of health, in particular for children. (9)  Children as developing organisms are particularly vulner- able to reprotoxic substances. Therefore, the exposure of children to all practically avoidable sources of emissions of these substances, especially from articles which are put into the mouth by children, should be reduced as far as possible. (4 OJL 217, 5.8.1998, p. 35. (°) OJ L 315, 9.12.1999, p. 46. Decision as last amended by Decision 2004/781/EC (O] L 344, 20.11.2004, p. 35). () O] L 228, 11.8.1992, p. 24. Directive repealed by Directive 2001/95/EC of the European Parliament and of the Council (OJ L 11, 15.1.2002, p. 4). (’) OJ L 262,27.9.1976, p. 201. Directive as last amended by Commis- sion Directive 2004/98/EC (OJ L 305, 1.10.2004, p. 63).