The European Commission (EC) has published the Regulation (EU) 2015/628 of the Commission concerning the change to Annex XVII, No 63 of the Regulation (EC) No. 1907/2006 of the European Parliament and the European Council concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) regarding lead and its compounds. The changed requirements apply to articles introduced to the market starting from the 1st of June 2016.

The restriction applies to consumer products, if the lead content in articles or accessible parts thereof is equal to or greater than 0.05 % by weight, and those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children. For the purposes of this paragraph, it is considered that an article or accessible part of an article may be placed in the mouth by children if it is smaller than 5 cm or has a detachable or protruding part of that size.

That limit shall not apply where it can be demonstrated that the rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0.05 μg/cm2 per hour (equivalent to 0.05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article.

There are various exemptions to this Regulation, such as crystal glass, enamels and precious and semi-precious stones, keys and locks, music instruments, articles and parts of articles, which contain brass alloys, when the lead content of the brass alloys do not exceed the 0.5 percent by weight, the tips of writing instruments, devotional objects, zinc-carbon batteries and button-cell batteries.

Articles already covered by specific European Union legislation regulating lead content or migration should also, for reasons of consistency, be exempted and comprise:

  • Toys covered by 2009/48/EC
  • Electrical and electronic devices, that are covered by 2011/65/EU
  • Packaging that is covered by Regulation 94/62/EC
  • Objects, that are intended to come into contact with food and which are covered by the Regulation (EC) 1934/2004
  • Jewellery, covered by Annex XVII of the REACH Regulation, No. 63.1

Why is this important

Young children under 36 months often place objects in their mouths. As a consequence of this they can repeatedly be exposed to lead or lead compounds contained in consumer articles. The exposure to lead is especially dangerous for young children because their brains and central nervous systems are still developing.

The repeated exposure to lead, when lead objects or objects which contain lead compounds are placed in the mouth can result in a reduction in IQ, cognitive difficulties and behavioural problems, impairments in school performance and learning difficulties, as well as ADHD and severe and irreversible neurological behavioural and development disorders, seizures and possibly death.

How UL can support you

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