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New decisions on Phthalates in Soft PVC Toys

Present Legal Situation:
The decision of the EU commission to prohibit marketing of such toys for children under 3 years and baby articles which are intended to be taken into the mouth and which consist of phthalate-containing soft PVC, has been extended for the eighth time - now until February 20, 2002.
What articles are concerned by the prohibition? Teetheres, figures for teething, mouth pieces, baby soothers, pacifiers etc..

Parallel to this, an additional German ban on these materials for toys for children under 3 years which are intendedly or foreseeably taken into the mouth is existing (6th regulation for modification of the Consumer Goods Ordinance).

What articles are additionally concerned by this severe German ban? Squeeze animals, bathtub toys, simple figures and dolls etc. which are obviously intended for children under 3 years.

Possible Development:
The possible danger potential refers exclusively to a possible release of the phthalate-containing softeners from the PVC materials as a result of mechanical stress (biting, chewing, sucking etc.).
The a. m. current bans had been enacted above all due to the fact that up to now there was no valid method to ensure the observation of the existing limit values for the migration (solubility) of phthalates.

Recently, there were some important developments with regard to the test methods for the migration of phthalates.

The test method "Head over Heals" (HoH), which had therefore be developped, simulates the practical mechanical stress of the phthalate-containing PVC materials during biting and sucking action by children. By means of this method and under consideration of the limit values, a realistic assessment of the used materials will be possible.

The "Scientific committee on toxicity, ecotoxicity and the environment" (CSTEE) confirms in a first statement that the test method "HoH" has a good comparability and reproducibility.

At the moment, a final judgement is still to be expected.