The previous Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations has been integrated in Title VIII of REACH. In accordance with the provisions in this Title, restrictions may be imposed on the manufacturing, placing on the market, and use of dangerous substances and preparations. Restrictions can take many forms, including total bans, concentration limits, and limitation to professional use.
Restrictions shall be decided, by amending Annex XVII, when there is an unacceptable risk to human health or the environment arising from the manufacture, use, or placing on the market of substances, which needs to be addressed on an EUwide basis. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives.
The procedure for restricting a substance may be initiated by a Member State or by the Commission and involves opinions by the Committee for Risk Assessment and the Committee for Socio-economic Analysis. As part of the process ECHA shall invite all interested parties to submit a socio-economic analysis, or information which can contribute to one of the suggested restrictions, examining the advantages and drawbacks of proposed restrictions.
With respect to substances that have been subjected to authorisation, ECHA shall consider whether the use of such a substance in articles poses a risk to human health or the environment that is not adequately controlled. If so, it shall initiate the procedure for making it subject to restrictions.
Final decisions on restrictions are made by the Commission in accordance with the examination procedure. If it does not take the opinions from the ECHA committees into account it must give a detailed explanation. (Arts 68—73.)