Nickel
Nickel free means that the product does not contain nickel or the nickel solubility is less than 0,5 µg/cm2/week. Such products are safe to use on the skin and do not cause allergic reactions or rashes.
Reach setting (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a European Union regulation designed to promote the safe use of chemicals and reduce their harmful effects on humans and the environment. Annex XVII of the Regulation lists chemicals that are subject to specific restrictions or bans on use.
Listed under heading 27 are nickel and nickel compounds, which are subject to restrictions on their use in products in contact with skin and hair. Such products include jewellery, watches and hair care products. The restrictions relate to the concentration of nickel in these products and are based on the harmfulness of nickel to humans.
- Jewellery that comes into contact with the skin, such as earrings, bracelets and brooches.
- Bath and sauna products, such as bath stones and sauna mats.
- Other products intended for the skin or hair, such as hairdresser's knives and razors.
The purpose of pre-piercing jewellery is to prevent possible adverse effects of piercing, so the material must not be allergenic. The amount of nickel released in contact with the skin must be less than 0,2 µg/cm2/week for primary lenses.
Nickel (CAS No 7440-02-0, EC No 231-111-4) and its compounds
1. Shall not be used
a) in any primary implantable devices intended for pierced ears and other pierced parts of the human body, unless the amount of nickel released from these primary implantable devices is less than 0,2 μg/cm2/week (migration limit);
b) objects intended to come into direct and prolonged contact with the skin, such as
- earrings
- necklaces, bracelets and chains, ankle bracelets and rings
- watch cases, bracelets and buckles
- studs, buckles, rivets, zippers and metal tags when used on clothing,
if the amount of nickel released from parts of these articles in direct and prolonged contact with the skin exceeds 0,5 μg/cm2/week;
c) for articles of the type listed in point (b), where they have a nickel-free coating, unless this coating is sufficient to ensure that the amount of nickel released from parts of these articles which come into direct and prolonged contact with the skin does not exceed 0,5 μg/cm2/week during the normal period of use of the article, which shall be at least two years.
2. Articles referred to in paragraph 1 shall not be placed on the market unless they comply with the requirements set out in that paragraph.
3. Standards adopted by the European Committee for Standardisation (CEN) shall be used as test procedures to ensure compliance of articles with the requirements of paragraphs 1 and 2.
Source: Reach Regulation: https://eur-lex.europa.eu/legal-content/FI/TXT/?uri=CELEX%3A02006R1907-20220501