WRITTEN QUESTION E-0951/01

by Christopher Huhne (ELDR) to the Commission

(28 March 2001)

Subject: Restrictions on the use of phthalates

Is the Commission satisfied that the current restrictions on the use of phthalates are adequate to meet the potential dangers? In particular, it is considering restrictions not only on teething toys but on other toys, packaging, PVC flooring and windows, cosmetics and emulsion paint? Will the Commission outline the potential effects suggested by the scientific evidence of certain levels of phthalates for hormone disruptions and reproductive abnormalities? Is the Commission aware of alternative products that could be used to perform the same tasks without the same side-effects?

Answer given by Mr Liikanen on behalf of the Commission

(11 June 2001)

The use of six phthalates in toys and childcare articles intended to be mouthed by children under the age of three is subject to a temporary ban in the framework of Council Directive 92/59/EEC of 29 June 1992, on general product safety(1), pending a permanent ban under Council Directive 76/769/EEC of 27 July 1976 on restrictions on the marketing and use of dangerous substances and preparations(2).

The Commission adopted in November 1999 a proposal to restrict the marketing and use of certain phthalates in toys. The Commission's proposal consists of a ban on the use of six phthalates in toys and childcare articles intended to be put in the mouth of children under the age of three and of a requirement to label other toys for children under three that could be put in the mouth although not intended for that purpose.

The Commission's proposal is currently subject to consideration by the Parliament and the Council according to Article 251 (ex Article 189b) of the EC Treaty.

The possible risks to health and to the environment of the phthalates most commonly used are currently evaluated in the framework of Council Regulation (EEC) No 793/93 of 23 March 1993, on the evaluation and control of the risks of existing substances(3). As these are comprehensive evaluations of all available data on the toxicity and the effects of chemicals, covering all exposure situations from all known uses, the Commission would expect to have an in-depth analysis of the potential endocrine disrupting and reproductive toxicity effects of phthalates. The outcome of the risk assessments will provide the Commission with the appropriate scientific basis to propose further measures, as appropriate. In addition, the particular use of phthalates in PVC has been raised in the Commission's Green Paper on polyvinyl chloride (PVC)(4). The Green Paper has been discussed in the Council and the Parliament has adopted a Resolution on 3 April 2001. Following these discussions and extensive consultations with other stakeholders, the Commission intends to propose a Community strategy on PVC that will aim to address all outstanding issues including those which may concern the use of phthalates in these applications.

The risk assessments will be peer-reviewed by the Scientific Committee on Toxicity Ecotoxicity and the Environment (CSTEE) and will be summarised in Commission Recommendations published in the Official Journal. Where unacceptable risks are identified, the Commission will consider additional risk reduction measures, as appropriate, in those areas where concerns have been indicated.

Concerning the use of alternatives to phthalates, studies conducted at the request of the Commission identified a number of potential substitutes to phthalates and to soft PVC. To obtain a view on their safety profiles as compared with phthalates, the Commission requested the opinion of the CSTEE. In two separate opinions, the CSTEE concluded that there were significant gaps in the amount of scientific information available on the potential substitutes, which need to be filled in order to support their safe use. The Commission remains optimistic that such information will become available in the near future.

(1) OJ L 228, 11.8.1992.

(2) OJ L 262, 27.9.1976.

(3) OJ L 84, 5.4.1993.

(4) COM(2000) 469 final.