WRITTEN QUESTION P-3050/98

by Hiltrud Breyer (V) to the Commission

(2 October 1998)

Subject: Dutch study of phthalates

1. Why did the Scientific Committee for Toxicity, Ecotoxicity and the Environment set a higher TDI level in April 1998 than in 1994?

2. Why was the assumed weight of the baby raised from 5 kg in the committee's report of February to 8 kg in that of April 1998 and the assumed sucking time reduced from 12 to 6 hours, with the result that only 2, instead of the former 3, phthalates were classified as potentially dangerous?

3. The Scientific Committee estimates that phthalate intake from toys only accounts for 10-30 % of total exposure. Why does the Committee nevertheless take the full TDI value (instead of only 10-30 %) as the basis for its recommendation regarding the withdrawal of phthalates, thus ignoring a fact which it had earlier pointed out itself?

4. Is the Commission of the opinion that products that may cause long-term damage to young children should at least be withdrawn from the market until it has been unequivocally demonstrated that they are harmless?

5. The Commission certainly shares the Member's opinion that experiments with children are ethically indefensible. How can the Commission nevertheless allow a situation where millions of children are exposed to phthalates for hours at a time on a daily basis although 15 minutes in the laboratory has already been deemed twice to be ethically indefensible?

6. What measures does the Commission intend to take to ensure that children do not continue to be freely exposed to the danger of phthalates?

Answer given by Mrs Bonino on behalf of the Commission

(23 October 1998)

1. In its initial evaluation the scientific committee on toxicity, ecotoxicity and the environment (SCTEE) took account of past data, in particular the tolerable daily intake (TDIs) identified by the scientific committee for food (SCF). For the most part these had been expressed in opinions of the SCF in 1996. However in its effects assessment (included in the SCTEE opinion on phtalates in toys of 24 April 1998), the CSTEE considered that new data had become available which superseded the older data.

2. In its first report of February 1998, the SCTEE had assumed an exposure period of 12 hours and a body weight of 5 kg, on the basis of a draft report of CEN (European committee of standardisation). Subsequently, the SCTEE, following criticisms of those assumptions, reviewed these criteria and in April 1998 concluded that those values were "overly conservative for infants using polyvinyl chloride (PVC)-based teethers" and decided to use an exposure period of 6 hours and a body weight of 8 kg.

3. The SCTEE has highlighted the need to take into account sources of child exposure to phthalates other than toys and childcare articles. However, it has underlined the uncertainties surrounding the quantification of those sources.

The percentage of 10-30 % for the contribution of the other sources refers to all phthalates and does not provide a sufficient basis for adjustment of the phthalate-specific TDIs mentioned in the SCTEE opinion. Therefore the Commission, in its 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(1), has indicatively included the guidance values for phthalates in toys which are recommended by the SCTEE, without adjustment, while drawing the attention of the Member States to the need to take into account the whole opinion when assessing the safety of the products in question and deciding the measures to be taken.

In fact, the Recommendation states that in vetting these products, Member States shall monitor the levels of migration of these substances in the context of appropriate checks, taking into account the opinion delivered by SCTEE on 24 April 1998 and notably the migration limit values for phthalates released by these products recommended by this committee and reproduced in the Annex.

In this perspective, the guidance values of the Recommendation should be seen as indicative upper limits and the Member States, in assessing the safety of specific products, should apply the precautionary approach.

4. The Commission takes the view that childcare articles and toys intended to be placed in the mouth by babies under 3 years, in soft PVC containing phthalates, should indeed be prohibited from marketing and withdrawn from the market where there are indications that they can harm child health, in particular taking into account the data included in the SCTEE opinion. In the absence of specific Community legislation in this area it is up to the Member States to assess the risks posed by specific products and decide the measures to be taken, in the light of the obligation established by Council Directive 92/59/EEC of 29 June 1992 on general product safety(2) under which only safe products may be placed on the market. The Member States must ensure that any such measures are justified and proportional.

5. The Commission considers that young children in the Community should not be allowed to be dangerously exposed to phthalates, taking into account the available scientific knowledge. The Commission intends to propose Community legislation in this area as soon as possible. Pending the entry into force of such legislation the Commission invites the Member States to check the market for these products and take the appropriate action at national level. The issue of tests on babies is a separate issue and involves considerations going beyond the specific products and risks in question.

6. The measures taken or planned by the Commission have been mentioned above. It should be noted in addition that the Commission is consulting the SCTEE again in order to obtain an updated opinion in the light of new studies on the subject which have been published recently. When it has the updated opinion of the SCTEE, the Commission will consider whether any modifications of its present policy in this area are necessary.

(1) OJ L 217, 5.8.1998.

(2) OJ L 228, 11.8.1992.