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Health and Consumer Protection

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Commission recommends to watch soft PVC child-care articles and toys intended to be put into the mouth and act if necessary

Brussels, 1 July 1998

The recommendation, adopted today by the European Commission, covers child-care articles and toys made of soft PVC containing phtalates, for children under three years of age, which are intended to be put into the mouth, such as teething rings. Phthalates are used to soften plastic, but they are considered to be liable to provoke negative health effects at high level of exposure: this may happen when they are washed out by saliva while children suck or chew the toys. The Member States are invited to check the level of migration of phthalates. If the migration of phthalates exceed the limits proposed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE), the Commission recommends to the Member States to act in order to ensure the safety and health of children. The Commission will put forward a proposal for permanent legislation ensuring a high level of safety and health under harmonised conditions.

In detail, the recommendation that was submitted by Consumer Commissioner Emma Bonino in agreement with Environmental Commissioner Ritt Bjerregaard, invites the Member States to take measures in order to ensure a high level of children health protection with regard to child care and toys intended to be put into the mouth in soft PVC containing phtalates and to control the release of six phthalates in the products in question, while Community legislation for permanent protection is under way. 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 products in question. The recommendation will be reconsidered when new developments in testing methods are available.

The Commission submits this recommendation taking into account scientific advice, after some Member States had requested action to protect children's health. In March and April 1998 the Danish and Spanish authorities had asked Ms Bonino for a rapid Community solution after they had found high migration rates of phthalates in certain child-care articles and withdrawn certain specific products from their markets. Other Member States had announced that they would act on their own if the Commission does not find a Community solution.

The SCTEE had identified the six phtalates most frequently encountered in analyses of the soft PVC products in question. In its opinion in April 1998, completed in June 1998, the SCTEE concluded that low safety margins gave reason for concern for the phtalate DINP but less concern for the level of exposure of the phthalate DEHP and that the present risks are related to long term toxicity including liver and kidney damage. Currently, there is no standardised method for simulating and measuring the phthalates release from toys, which are intended to be put into the mouths. A study conducted by the Dutch Health Authorities in collaboration with industrial associations and consumer groups aims at developing such a method and should be available by end of August this year.

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