Chemical name: Nickel Final regulatory action has been taken for the category: Industrial Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: 1. Shall not be used: (a) in post assemblies which are inserted into pierced ears and other pierced parts of the human body during epithelization of the wound caused by piercing, whether subsequently removed or not, unless such post assemblies and homogeneous and the concentration of nickel - expressed as mass of nickel to total mass - is less than 0.05% (b) in articles intended to come into direct and prolonged contact with the skin such as: earrings necklaces, bracelets and chains, anklets, finger rings wrist watch cases, watch straps and tighteners rivet buttons, tighteners, rivets, zippers and metal marks, when these are used in garments, if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0.5 ug/cm2/week; (c) in articles such as those listed in paragraph (b) where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such articles coming into direct and prolonged contact with the skin will not exceed 0.5 ug/cm2/week for a period of at least two years of normal use of the article. 2. Articles which are the subject of paragraph 1(a) to (c) shall not be placed on the market unless they conform to the requirements set out in those points. The standards adopted by the European Committee for Standardization (CEN) shall be used as the test methods for demonstrating the conformity of articles to paragraphs 1 and 2. Use or uses that remain allowed: All other uses not listed above. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Shall not be used in post assemblies which are inserted into pierced ears and other pierced parts of the human body during epithelization of the wound caused by piercing, whether subsequently removed or not, unless such post assemblies are homogenous and the concentration of nickel - expressed as mass of nickel to total mass - is less than 0.05%; in articles intended to come into direct and prolonged contact with the skin. Certain exceptions apply. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: Nickel is the most common cause of allergic contact dermatitis. Carcinogenic in animals; insufficient data for man. Date of entry into force of the final regulatory action: 01/01/2001 |