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Directorate-General for Health and Food Safety
Opinion on Phthalate migration from soft PVC toys and child-care articles (to answer four new questions put to the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on the subject), opinion expressed at the 4th CSTEE plenary meeting, Brussels, 16 June 1998.
This opinion must be read in the context of the detailed opinion expressed by the CSTEE in its plenary meeting of 24th April 1998.
At its 4th plenary meeting the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) considered the new set of questions put to them and arrived at the following conclusions:
1. On the basis of the Scientific Opinion of 24 April on phthalates in toys is it possible to say that there is serious and immediate risk?
The Committee considers that an answer to question 1 is dependent upon the definitions of 'immediate' and 'serious' as used by the Commission. The CSTEE considers that the risk it identified in the opinion it adopted at its 3rd plenary meeting is not sufficient to fall within the 'life-threatening' category. The present concerns are related to general long-term toxicity including liver and kidney damage. The induction of liver cancer in rodents by some phthalates is judged to be of little relevance for humans. The opinion adopted at the 3rd plenary meeting emphasised that an important area of uncertainty in assessing the risk was the quantification of exposure. The opinion noted that the Dutch study with adult human volunteers and its comparison with in vitro extraction methods should provide the basis for a standardised and validated in vitro test method on phthalate release. This should give more relevant data on human exposure. Should the Dutch study confirm the CSTEE's assessment, the CSTEE concludes that there is a health concern related to children's articles which can be put in the mouth, if the phthalate extractability is likely to exceed the proposed guideline values.
2. Does it exist at present a standardised, validated method to measure the maximum extracted amounts of phthalates in toys?
The answer to this question is No.
3. If such method does not exist how is it possible to implement the CSTEE recommendations on the guideline values for extractable amounts of phthalates in toys?
Any decision now, will have to be based on scientific judgement and assessments. The CSTEE followed a worst case approach founded on the available data recognising that, following clarification provided by the Dutch study the CSTEE approach might have to be revised.
4. How many methods to measure the maximum extracted amounts of phthalates in toys exist at present and how reliable are they? Which of the existing methods does give the greatest guaranties of reliability?
Currently there are a number of non-standardised and non-validated test methods whose quantification and relative quality is variable. The Committee expects to have the findings of the Dutch study available to it at its Plenary meeting in September. It will then be in a position to offer the Commission more conclusive advice.
Last revision (16/6/1998 - 11.50 a.m.)
This opinion must be read in the context of the detailed opinion expressed by the CSTEE in its plenary meeting of 24th April 1998.
At its 4th plenary meeting the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) considered the new set of questions put to them and arrived at the following conclusions:
1. On the basis of the Scientific Opinion of 24 April on phthalates in toys is it possible to say that there is serious and immediate risk?
The Committee considers that an answer to question 1 is dependent upon the definitions of 'immediate' and 'serious' as used by the Commission. The CSTEE considers that the risk it identified in the opinion it adopted at its 3rd plenary meeting is not sufficient to fall within the 'life-threatening' category. The present concerns are related to general long-term toxicity including liver and kidney damage. The induction of liver cancer in rodents by some phthalates is judged to be of little relevance for humans. The opinion adopted at the 3rd plenary meeting emphasised that an important area of uncertainty in assessing the risk was the quantification of exposure. The opinion noted that the Dutch study with adult human volunteers and its comparison with in vitro extraction methods should provide the basis for a standardised and validated in vitro test method on phthalate release. This should give more relevant data on human exposure. Should the Dutch study confirm the CSTEE's assessment, the CSTEE concludes that there is a health concern related to children's articles which can be put in the mouth, if the phthalate extractability is likely to exceed the proposed guideline values.
2. Does it exist at present a standardised, validated method to measure the maximum extracted amounts of phthalates in toys?
The answer to this question is No.
3. If such method does not exist how is it possible to implement the CSTEE recommendations on the guideline values for extractable amounts of phthalates in toys?
Any decision now, will have to be based on scientific judgement and assessments. The CSTEE followed a worst case approach founded on the available data recognising that, following clarification provided by the Dutch study the CSTEE approach might have to be revised.
4. How many methods to measure the maximum extracted amounts of phthalates in toys exist at present and how reliable are they? Which of the existing methods does give the greatest guaranties of reliability?
Currently there are a number of non-standardised and non-validated test methods whose quantification and relative quality is variable. The Committee expects to have the findings of the Dutch study available to it at its Plenary meeting in September. It will then be in a position to offer the Commission more conclusive advice.
Last revision (16/6/1998 - 11.50 a.m.)
