Brussels, 10 November 1999
Ban of phthalates in childcare articles and toys
The placing on the European market of childcare articles and toys in soft PVC containing phthalates which are intended to be put in the mouth by babies under 3 years should be banned immediately. The European Commission has approved a package of legislative proposals to ban the use of phthalates in soft toys: firstly, an immediate ban on these products because the phthalates released when babies put them in their mouth pose a serious risk to child health. Secondly, the Commission proposes a permanent measure to confirm the ban for this particular use of phthalates in the longer term on a permanent basis. This will take the form of an amendment to the legislation on the marketing of dangerous substances, which for procedural reasons can only be applied by Member States several years from now. In addition, this second measure will require, as a matter of precaution, that other soft PVC toys for the under three's which could be placed in a child's mouth even when this is not intended by the manufacturer, should carry a warning label if they contain phthalates, in order to ensure their safe use under all circumstances.
Recent scientific evidence has shown that checks of phthalates release from such products in soft PVC are not a reliable way to ensure that babies do not absorb dangerous quantities of phthalates. There is therefore a need for a ban with immediate effect. The ban will be enforced within ten days from its final adoption by the Commission, after consultation of the Emergency Committee, composed of Member State representatives and set up under the General Product Safety Directive (92/59/EEC). This procedure is expected to be completed in two weeks.
Phthalates are chemical substances used to plasticize, or soften, PVC. They have been shown to be liable to cause liver, kidney and testicular damage.(1) The phthalates are released in dangerous quantities when soft PVC teethers or dummies, rattles and other toys for young children are sucked and chewed over extended periods by babies, in particular in their "teething" age.
David Byrne, Commissioner for Consumer Protection and Health and Erkki Liikanen, Commissioner for Enterprise and Information Society, who jointly presented this proposal said: "This measure is to protect the youngest and most vulnerable amongst us. We received scientific advice that phthalates pose a serious risk to human health and decided to react immediately when scientists concluded that the available control tests on these products do not provide a reliable guarantee of protection. We are confident that mothers and fathers in Europe will agree with us that everything possible should be done to protect their children".
Since the Commission issued a Recommendation on 1 July 1998, 8 Member States have decided to restrict the use of phthalates in toys and childcare articles (Austria, Denmark, Finland, France, Germany, Greece, Italy and Sweden). Other Member States have relied on a 'controlled use' approach, by measuring phthalate release from toys. The proposed Commission Decision will ensure rapidly a consistent, high level of protection of child health throughout the EU against the serious and immediate risk posed by products intended to be put in the mouth. The proposed Directive aims to harmonise, in the longer tem, the use of phthalates in toys and childcare articles, as well of those intended for mouthing as of those which can be put into the mouth.
Further opinions of the Scientific Committee of Toxicity, Ecotoxicity and the Environment (SCTEE) from 28 September 1999 (1) have shown that the laboratory test methods used for checking the level of phthalate release from these products are not suitable for control purposes. The tests developed in the Netherlands and the UK are according to the scientists currently not suitable to distinguish safe toys from unsafe toys.
A ban is therefore the only practicable approach to guarantee child health. The ban must be introduced immediately by an emergency decision in order to protect babies who are now in their first years. It will take 2-3 years to adopt and implement a permanent ban as in the proposed Directive. Commission services will be in contact with industry, commerce and national control authorities to ensure that any products still on shop shelves are withdrawn at the shortest possible notice.
Toys which are not intended to, but can be put in the mouth pose less of a risk. The risk assessment which has been made by the SCTEE was based on conservative assumptions concerning duration of mouthing and level of phthalate release. These assumptions apply in the case of products intended to be put in the mouth, which may be systematically sucked and chewed by babies, and must therefore comply with stringent safety requirements. Other toys are normally unlikely to pose the same level of risk, in spite of the fact that children may put them in their mouth as part of their "exploration of the world". However, as a matter of precaution, parents and caretakers should be advised not to allow their babies to mouth such toys for extended periods. To that end, the Directive proposed by the Commission provides for such toys to bear an appropriate warning.
(1)Opinions of the SCTEE on phthalates in toys of 24.4.98, 27.11.98 and 28.9.99 are available on http://europa.eu.int/comm/dg24/health/sc/sct/outcome_en.html