WRITTEN QUESTION E-2055/98

by Felipe Camisón Asensio (PPE) to the Commission

(7 July 1998)

Subject: Possible dangers of phthalates contained in toys

1. Has the Commission any scientific evidence concerning the dangers of phthalates add to PVC in order to increase the flexibility of teething rings mounted on toys?

2. How does it consider that safety requirements can be reconciled with the social and economic interests of the industrial sector concerned?

Joint answer

to Written Questions E-0755/98, E-0830/98, E-0996/98, E-1536/98, E-1806/98 and E-2055/98 given by Mrs Bonino on behalf of the Commission

(20 July 1998)

The Commission has been informed by some Member States, through notification of measures taken or planned, of risks for child health posed by certain child-care articles and toys in soft PVC containing phthalates. Following this information, the Commission has held consultations with the Member States on the nature of the risks in question and the measures to be taken.

Due to the complexity of the scientific issues involved, the Commission has also consulted on the subject the scientific committee on toxicity, eco-toxicity and the environment (SCTEE) which has delivered an opinion on phthalates in PVC toys on 24 April 1998, completed by further clarifications on 16 June 1998. The SCTEE has noted that the use of toys and child-care articles in soft PVC containing phthalates involves an exposure of babies to such substances, which, based on the data available at present, may exceed, in the case of two of them (DINP and DEHP) the levels considered to be safe.

The SCTEE has concluded that the low margin of safety for DINP gives reason for concern. Although the margin of safety for DEHP is below 100 (the level considered to be safe) the SCTEE is less concerned with the estimated level of DEHP exposure, since humans appear to be less sensitive towards the critical effect of DEHP. The SCTEE has also recommended guideline values for maximum tolerable extractable amounts for six phthalates, which are found in the products in question. However, the SCTEE has underlined that no standard method is available at present for measuring phthalate migration. Finally, the SCTEE has noted that more relevant data on human exposure caused by such toys and child-care articles might be available in September 1998 as a result of an ongoing study performed in the Netherlands.

In the light of the information available, it appears that babies are liable to be exposed to certain phthalates released by toys and child-care articles in soft PVC, in excess of the tolerable levels. Phthalates are substances which are considered to be liable to provoke adverse health effects.

Existing Community legislation, in particular Directive 88/378/EEC(1) on toys and 76/769/EEC(2) on restrictions of marketing and use of certain dangerous substances and preparations do not, as they stand at present, cover the products and risks in question.

Therefore the Commission has invited the Member States to take measures in order to ensure a high level of child health protection with regard to child care articles and toys intended to be put into the mouth in soft PVC containing phtalates. Restrictive measures must be notified to the Commission. Particular attention should be drawn to the two phthalates DINP and DEHP because they are the most commonly used. Member States should inform the Commission about testing methods used, the levels of migration found and the conclusions drawn from the findings. Member States are invited to cooperate in the development of a common Community testing method to measure the release of phtalates from the products in question. The recommendation will be reconsidered when new developments in testing methods are available.

The Commission will put forward a proposal for permanent legislation ensuring a high level of safety and health under harmonised conditions.

(1) OJ L 187, 16.7.1988.

(2) OJ L 262, 27.9.1976.