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ECHA Drafts Guideline on The Scope of Amendment of Entry 63 of Annex XVII to REACH: Lead in articles supplied to the general public that can be mouthed by children

September 15, 2015

EUROPEAN UNION  ̶  The European Chemicals Agency (ECHA) has provided a guideline concerning the interpretation of certain aspects of the scope of the new upcoming provisions1 (listed in Annex 5) of entry 63 of Annex XVII to REACH Regulation (EU) No 1907/2006 on lead and its compounds in articles supplied to the general public. Note that it does not apply to the restriction of lead in jewelry.

The restriction provisions of entry 63 (new paragraphs) aim to reduce the risks to consumers, particularly to children, caused by chronic exposure to lead via articles, which can result in severe and irreversible neurotoxic effects. The primary group at risk is children between 6 and 36 months of age.

To achieve the maximum risk reduction capacity, this restriction targets articles which meet all the three following conditions:

(a) are supplied to the general public and contain lead or lead compounds in any accessible part of the article at concentrations equal to or greater than 0.05% by weight;

(b) are likely to be placed in the mouth by small children;

(c) are not already covered by any other EU specific legislation where lead is regulated.

The following broad categories of mouthable consumer articles have been identified in the EU market:

  • Accessories – Key rings (lead in both metal and colored parts), bags, purses and cases (lead in both colored polymer materials and metal details such as buckles);
  • Clothes (lead in metal buttons, zippers, rivets etc., plastic buttons, textile and polymer materials);
  • Interior decorations (lead in both metal parts and polymers, including coatings);
  • Stationery (lead in both metal parts and polymers, including coatings);
  • Sports and leisure (lead in both metal parts and polymers, including coatings);
  • Keys (lead in alloy used to make keys).

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