The EU Committee on Toxicology, Ecotoxicology and the Environment reported that it had found a potential for phthalate plasticisers - which are suspected to have hormone disrupting properties - to migrate to children's saliva at above safe levels (ENDS Daily 13 February).
In response, the European Council for Plasticisers and Intermediates (ECPI) has expressed grave doubts over the scientific validity of the committee's phthalate migration figures, which a spokesperson described as "half-baked".
"As [the committee] say[s], testing must be done properly, scientifically and realistically," ECPI said. "Therefore it is not surprising that the data so far produced is meaningless in that it is based on studies that are non-standardised, non-validated and non-reproducible."
In the case of one type of phthalate, DINP, the committee estimated a margin of safety of only 2.7 below the no-observed-adverse-effect-level derived from published scientific studies, compared with a benchmark of 100, which it defined as a "level of little concern". Responding for ECPI, David Cadogan told ENDS Daily that "the 2.7 for DINP could just as easily have been 10,000 if they had used different migration tests".
Test methods for measuring the phthalate migration from PVC articles that are chewed or sucked is acknowledged by all sides in the debate as a crucial issue. ECPI and other industry bodies have attacked Danish tests which sparked a wave of official concern in Europe last year as greatly over-estimating real likely migration levels. On the other hand, Greenpeace has repeatedly charged that test methods have underestimated the amount of migration.
In the opinion published on Friday, the EU toxicology committee acknowledged continuing uncertainties over migration calculations, but concluded nevertheless that its best estimate of migration of three phthalates gave "reasons for concern".
The committee said it would look again at the migration estimates when a collaborative study being conducted in the Netherlands is reported later this year. However, as ENDS Daily reported on Friday, the European Commission may take immediate action based on the precautionary principle.
This, according to ECPI, would be unacceptable. "We need to know the exposure before getting into risk assessment and consumer information," Dr Cadogan told ENDS Daily. "It is disappointing to make things public when there are so many question marks....I don't see how anyone could make legislation based on [the committee's findings]."
ECPI, tel: +32 2 676 7260; EU Scientific Committee on Toxicology, Ecotoxicology and the Environment.
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