Question: The restriction of DEHP in point 51 of Annex XVII, where a limit of 0.1% w/w is set, refers to a quantitative limit that has to do with a risk assessment threshold or it is a limit that has to do with the laboratory method limit of detection? Since this restriction is rather old, we do not have the opinion document to check that and an issue has arised in court regarding this 0.1% limit.
Entry 51 of Annex XVII on phthalates indeed originates already from the year 2005. This was a restriction agreed under the Limitations Working Group.
In the original Directive (2005/84/EC), a reference is made to the Commission Decision (1999/815/EC) under the Toys Directive. That Decision lists earlier national actions against toys and childcare articles, some of them referring to “more than 0.05% of phthalates”.
The restriction history does not explain the basis for the 0.1% limit. However, I have at hand a Q&A document from the Commission from January 2010. This document, in a Q&A addressing entries 51 and 52, states that the threshold of 0.1% was chosen “because it represents a measurable quantity”. This value allows small impurities, but not the use of the substances in the production of the articles.
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