The Cardno ChemRisk View
Getting the Lead Out: The European Union’s Recent Restrictions on Lead in Mouthable Consumer Products
Posted on behalf of the author, Whitney Christian
On April 22, 2015, the European Commission published Commission Regulation 2015/628 amending Annex XVII of the REACH law, Regulation No. 1907/2006, regarding restrictions on the use of lead and lead compounds in consumer products. The amendment was sparked by a proposal from Sweden to the European Chemical Agency on December 21, 2012, prohibiting the marketing of consumer products that can be placed in the mouths of children and contain lead and its compounds exceeding a certain threshold. This restriction stemmed from concerns that mouthing the materials that contain lead can result in “severe and irreversible neurobehavioral and neurodevelopmental effects” to which developing children (< 36 months) are particularly sensitive. The proposal was backed by the Committee for Risk Assessment on December 10, 2013 as well as the Committee for Socio-Economic Analysis on March 13, 2014, as the most appropriate Union-wide measure to address the risk posed by lead in consumer products.
The amendment, which goes into effect June 1, 2016, states that consumer products shall not be placed on the market if the concentration of lead (expressed as metal) is ≥ 0.05% by weight of the product or an accessible part of the product, and those products or accessible parts thereof can be placed in the mouth by children during normal or reasonably foreseeable conditions of use. A product that is smaller than 5 cm in one dimension or has a detachable or protruding part of that size is considered mouthable. The restriction does not apply to products or accessible parts of products that can be shown not to release lead at a rate exceeding 0.05 µg/cm2 per hour. If the product or part is coated, the coating must be sufficient to ensure that the lead release rate is not exceeded for at least two years. In addition, certain jewelry articles, crystal glass, non-synthetic or reconstructed precious and semi-precious stones (unless treated with lead), enamels, keys and locks (e.g., padlocks), musical instruments, articles composed of brass alloys containing < 0.05% lead by weight, tips of writing instruments, religious articles, and portable zinc-carbon batteries and button cell batteries are exempt as well as articles containing lead already covered by other EU restrictions (Directive 94/62/EC, Regulation No. 1935/2004, Directive 2009/48/EC, and Directive 2011/65/EU). In particular, the exemption placed on keys, locks, and musical instruments is based on the “lack of suitable alternatives to lead in the manufacture of those articles” and because “the possible adverse socioeconomic impact of applying the restriction to them could be significant.”
Although The Union’s new restrictions on Pb may have an economic impact on certain industries, a substantial reduction in adverse effects from Pb exposure is anticipated to out-weigh these and benefit the health of future generations.