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European Commission revised ANNEX XVII of REACH regulation

2015-05-29 102

European Commission published Regulation (EU) No 628/2015 to amend the item 63 in Annex XVII of 1907/2006/EC on April 23, 2015, This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. New  restriction  are added to this item, that is to those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children. 

Amendments Conditions

The following paragraphs 7 to 10 are added to item 63: 



63 lead and its compounds





‘7.Shall not be placed on the market or used in articles supplied to the general public, if the concentration of lead (expressed as metal) in those 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.

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.

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 in one dimension or has a detachable or protruding part of that size.

 8.By way of derogation, paragraph 7 shall not apply to: (a) jewellery articles covered by paragraph 1; (b) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Directive 69/493/EEC; (c) non-synthetic or reconstructed precious and semi-precious stones (CN code 7103 as established by Regulation (EEC) No 2658/87) unless they have been treated with lead or its compounds or mixtures containing these substances; (d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineral melted at a temperature of at least 500 °C; (e) keys and locks, including padlocks; (f) musical instruments; (g) articles and parts of articles comprising brass alloys, if the concentration of lead (expressed as metal) in the brass alloy does not exceed 0,5 % by weight; (h) the tips of writing instruments; (i) religious articles; (j) portable zinc-carbon batteries and button cell batteries; (k) articles within the scope of: (i) Directive 94/62/EC; (ii) Regulation (EC) No 1935/2004; (iii) Directive 2009/48/EC of the European Parliament and of the Council(*); (iv) Directive 2011/65/EU of the European Parliament and of the Council(**)

9.By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if appropriate, modify this entry accordingly.

10.By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time before 1 June 2016.

CTI Suggestion

New  restriction  are added to this item 63 about lead and its compoundsmore companies  should pay attention to this item. Relative companies are recommended to conduct supply chain survey in advance and focus on the latest update of REACH,.

CTI Service

As the third party inspection institution, CTI becomes the first publicly traded company on the Chinese Stock Exchange. We can provide testing, inspection, audit and certification services to consumers. Moreover, we can also provide professional and comprehensive quality solutions to improve the competitiveness of your products in the global market.