The EU's long-standing quest to see in place a permanent legislative act restricting phthalates in toys and other articles that are handled by children has ended in the adoption and publication of a simple but hard-hitting text. Producers and importers in all 25 Member States have to finally live with the new EU law, Directive 2005/84/EC amending for the 22nd time Directive 76/769/EEC (which is the framework EU law restricting dangerous substances).
The Directive requires transposition by 16 July 2006 into Member States' statute books, and its provisions will have to be respected by manufacturers and importers alike from 16 January 2007.
The new Directive firstly defines "childcare article", which means "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children." Hong Kong's toy industry will already be well-versed with the sort of articles that fall within this definition, such as the ubiquitous baby-soother, which comes in all kinds of shapes and types.
The Annex to Directive 2005/84/EC, which is the most relevant part of the text for traders, lays down the following restrictions:
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The phthalates commonly referred to as DEHP, DBP and BBP shall not be used as substances or as constituents of preparations, at concentrations of greater than 0.1% by mass of the plasticised material, in toys or childcare articles.
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Moreover, such toys and childcare articles containing DEHP, DBP and BBP in a concentration greater than the limit of 0.1% by mass shall not be placed on the EU market.
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As for the phthalates DINP, DIDP and DNOP, these shall not be used as substances or as constituents of preparations, at concentrations of greater than 0.1% by mass of the plasticised material, in toys and childcare articles which can be placed in the mouth of children.
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Such toys and childcare articles containing DINP, DIDP and DNOP in a concentration greater than the limit of 0.1% by mass shall not be placed on the EU market.
Traders will straightaway see that the Directive's coverage of toys and articles is greater where DEHP, DBP and BBP are concerned (all toys and childcare articles rather than only those placed in the mouth of children). The explanation given is that for these three substances, official risk assessments have been able to classify them as "reprotoxic, category 2". On the other hand, scientific evidence regarding DINP, DIDP and DNOP is, in the Directive's words, "either lacking or conflictual". The Community thus resorts to the use of the oft-used and notorious "precautionary principle" (which allows measures to be imposed where there is simply a likelihood of risk rather than real risk). However, the restrictions for these latter three substances are less severe "for reasons of proportionality".
According to the new Directive, the Commission is required, by 16 January 2010, to re-evaluate the above-mentioned measures in the light of new scientific information on the six phthalates and their substitutes. If justified, the measures are to be modified accordingly.
