The European Commission (EC) has published Commission Regulation (EU) 2015/628, amending Annex XVII entry 63 to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead and its compounds. The amended requirements will apply to articles placed on the market beginning June 1, 2016.
The restriction covers consumer items if the lead concentration 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.” Meaning it is smaller than 5cm in one dimension, 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.
Several exemptions from this Regulation are granted such as crystal glass, enamels and precious and semi-precious stones, keys and locks, musical instruments, articles and parts of articles comprising brass alloys, if the concentration of lead in the brass alloy does not exceed 0,5 % by weight, tips of writing instruments, religious articles, portable zinc-carbon batteries and button cell batteries.
Additionally, articles already covered by specific Union legislation regulating lead content or migration should, for reasons of consistency, be exempted, and include:
- Toys covered by Directive 2009/48/EC
- Electrical and Electronic Equipment covered by Directive 2011/65/EU
- Packaging covered by Directive 94/62/EC
- Articles intended to come in contact with food covered by Regulation (EC) 1934/2004
- Jewelry covered by Annex XVII of REACH, entry 63.
Why It Matters
Due to their mouthing behavior, children, especially those under 36 months, may be repeatedly exposed to lead released from consumer articles containing lead or lead compounds. Lead exposure is especially dangerous in young children as their brain and central nervous system is still developing.
Repeated exposure to lead from mouthing of articles, containing lead or its compounds can cause loss in IQ, cognitive and behavioral problems, academic impairment and learning disabilities, and ADHD, as well as severe and irreversible neurobehavioral and neurodevelopmental effects, seizures and possibly death.
How UL Can Help
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