NEWS

EU Amending AnnexXVII to REACH as regards lead and its compounds

On 23 April 2015, European Commission published Commission Regulation(EU) No 2015/628 amending Annex XVII to Regulation(EC) No 1907/2006, column 2 of entry 63 as regards lead and its compounds. With paragraph 6 being replaced and paragraphs 7 to 10 added. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall be implemented from 1 June 2016.

According to the regulation, if articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children, the concentration of lead (expressed as metal) in those articles or accessible parts thereof should be less than 0.05 % by weight. This regulation covers various products, such as household goods, children product, textile, footwear, bags and suitcases, stationery, sports and leisure goods. However, 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 /cm 2 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.

In AnnexXVII to Regulation(EC) No 1907/2006, column 2 of entry 63 is amended as follows:

(1) Paragraph 6 is replaced by the following:
6. By 9 October 2017, the Commission shall re-evaluate paragraphs 1 to 5 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 1 and, if appropriate, modify this entry accordingly.’

(2) The following paragraphs 7 to 10 are added:
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.

See below attachment for detail information:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2015_104_R_0003&from=EN