EU nickel restriction: background and ECHA s activities - guideline Workshop on EU nickel restriction Nickel Institute 27 June 2017 Kirsi Sihvonen Risk Management Implementation Unit European Chemicals Agency
Nickel restriction entry 27 of Annex XVII to REACH Concerns nickel and nickel compounds in Post assemblies inserted in pierces ears and other pierced parts of the human body Articles intended to come into direct and prolonged contact with the skin such as: Earrings, Necklaces, bracelets and chains, anklets, finger rings, Rivet buttons, tighteners, rivets, zippers and metal marks, when these are used in garments Also in similar articles with a non-nickel coating, unless the coating is sufficient to ensure that the rate of release is not exceeded for a period of at least two years of normal use of the article Migration limit values provided 2
Why restriction was introduced? Original directive 94/27/EC the presence of nickel in certain objects coming into direct and prolonged contact with the skin may cause sensitization of humans to nickel and may lead to allergic reactions; whereas for these reasons the use of nickel in such objects should be limited 3
Background for ECHA s activities Restriction on nickel and nickel compounds entry 27 of Annex XVII to REACH intended to come into direct and prolonged contact with the skin Non-exhaustive list of articles + mobile phones* Commission s request to ECHA to prepare the guideline Call for comments on the draft guideline ended in April 2017 More than 80 comments received Update of the guideline ongoing * Q&A 663: https://echa.europa.eu/support/qas-support/qas 4
Prolonged contact with the skin Science-based definition More than 10 minutes on three or more occasions within two weeks or More than 30 minutes on one or more occasions within two weeks Continuous contact needed Q&A 935: https://echa.europa.eu/support/qas-support/qas 5
Why is the guideline needed? Improve common understanding intended to clarified Normal conditions of use Reasonably foreseeable conditions of use Direct contact with the skin Surfaces of articles (or parts) are touched or are in touch with the skin Further clarification of prolonged contact Carrying an article, sitting on it, leaning on it, holding on to it or wearing it for a prolonged period of time 6
Rationale behind the examples Reasonable assumptions of the likely contact time Articles within the scope Similar types of articles to those listed in entry/in the Q&A Articles for which occurence of allergic contact dermatitis reported and which fall under the definition of prolonged contact with skin Articles designed to be in direct and prolonged contact with skin Articles outside the scope Articles in direct contact with skin for short periods Inaccessible internal articles 7
Articles proposed to be within the scope - Pattern of use Grips umrella, scissors etc. Handles pram, garden equipments etc. Tools and utensils used by hand needles, tweezers etc. Hand-held equipments and devices cameras, calculators etc. Seats, backs and arm-rests Steering wheels etc. 8
Comments in favour and against In favour A wanted step to prevent disease Important clarifications done Inclusion of articles well founded Short term and repetitive contact to be considered later (new restriction?) Against No scientific basis for Prolonged contact definition intended to is not the same as reasonably foreseeable conditions of use Few case reports do not justify inclusion Availability of alternatives and impact assessment are missing Better enforcement of articles listed in entry 9
Suggested to include and exclude Include Grips and handrails in public vehicles Lace suspenders and similar type of articles Tattooing needles etc. Exclude Table 2 and 3 articles: shower head handles keys, keyrings, keyfobs musical instruments hand-tools etc. 10
Next steps Update of the guideline Consultation of the CARACAL members in autumn Discussions and possible endorsement in CARACAL in November 2017 Publication of the guideline as a Q&A on ECHA s website 11
Discussion points Feedback on the proposed guideline Views on the process Something essential missing? 12