A guideline on the scope of the Entry 63 (paragraphs 7 to 10) of Annex XVII to REACH on “Lead and its compounds in articles supplied to the general public that can be mouthed by children” is formulated by the European Chemicals Agency (ECHA). It aims to assist producers, importers, distributors, and users of articles, as well as Member States' competent and enforcement authorities, in understanding and complying with their obligations under the REACH Regulation.

The document is focused on clarification of concepts of “Placed in the mouth by children”, “Accessible part of an article”, “Normal and reasonable foreseeable condition of use”. In addition, indicative lists of examples of articles which fall in or out of the scope of the restriction are given.

This restriction targets articles and accessible parts of articles which meet all the 3 following conditions:
(a) are supplied to the general public and contain lead or lead compounds at concentrations of lead, expressed as metal, equal to or greater than 0.05% by weight;
(b) may be placed in the mouth by small children during normal or reasonably foreseeable conditions of use;
(c) are not covered by a derogation.

Meanwhile, a stepwise approach is developed assessing whether an article (or accessible parts thereof) is within or outside the scope of this restriction on a case-by case basis. The approach undoubtedly provides you with an easier way to check if your articles shall comply with the new lead restriction.


Please refer to the linked document for specifics.

C&K Testing advises that the new lead restriction shall apply on 1 June 2016. Businesses can check whether their products fall under the scope of this restriction before any taking any measures. However, the lead present in such products with the scope shall be properly controlled through redesign of appearance or improvement of technical procedures.

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Further information
Regulation (EU) 2015/628
Guideline