The ECHA has published a guide to help economic operators and regulatory bodies better interpret the scope of entry 63 of REACH Annex XVII.
Online PR News – 26-June-2016 – Geneva, Switzerland – On May 25, 2016, the European Chemicals Agency (ECHA) published a guidance document to help economic operators and regulatory bodies better interpret the scope of entry 63 of REACH Annex XVII. This regulation seeks to restrict lead in articles for the general public that can be mouthed by children.
Produced in response to a request from by the European Commission, the ECHA document seeks to create a common understanding of the scope of the restriction and assist with effective implementation of the obligations issued under REACH.
The guidance document provides a ‘stepwise approach/decision tree’ to assist economic operators and law enforcement authorities determine whether an article falls under the scope of REACH Annex XVII. Since the restriction applies only to articles that reasonably present a risk to children, articles intended exclusively for professional or industrial use are excluded from the scope of the restriction.
The ECHA, in its guidance document, concludes that the restriction applies to products which meet all of the following criteria:
- Products supplied to the general public that contain 0.05% or more lead, or its compounds
- Products which may be placed in the mouth by small children in normal usage. The ECHA has deemed children of 6 to 36 months to be at the greatest risk
- Products that are not covered by an exemption
The ECHA has established that a major determining factor, when considering the scope of the restriction, is whether the article or accessible part of an article can be placed in the mouth by a child. To fall under the scope of the restriction the article must be less than 5cm in one dimension or have a detachable or protruding part of less than 5cm. To come under the scope of the restriction regarding placement into the mouth, it must be possible for the child to suck or chew the article – licking is not regarded as placement into the mouth.
The guidance document also concludes that accessibility, determined by accordance with EN 71-1, the normal function of the article, and whether ‘reasonably foreseeable’ conditions of use, for example, appearance, function, or height, may incline children to place the article into their mouth.
The guidance document also includes a list of examples of items that fall within the scope of Annex XVII. This list is not an exhaustive list of products, but does show the breadth of items that do fall under the scope of the restriction. They include: accessories, childcare products, clothing, haberdashery, footwear, interior decorations, outdoor articles, sport and leisure items and stationery.
Due to the wide scope of Annex XVII, companies operating in the European Union are now advised to check their compliance with the guidance issued by the ECHA. SGS has the expertise, combined with consultancy services and experience in consumer product supply chains, to assist manufacturers with REACH compliance.
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SGS offers the full-range of inspection, testing, certification, verification and training services. SGS, through its global network of over 40 laboratories, can help companies throughout the world achieve REACH compliance. Learn more about SGS’s REACH Services (www.sgs.com/reach).
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