Restrictions under REACH (Title VIII, Art. 67-73) limit or ban the manufacture, a use or the placing on the market of substances, if they pose an unacceptable risk to human health or the environment which needs to be addressed on a Community-wide basis.
A substance on its own, in a mixture or in an article can be subject to a restriction. In contrast to the registration requirement, a restriction applies also to substances that are manufactured or imported in quantities of less than 1 tonne/year.
Apart from the general REACH exemptions according to Art. 2 REACH, the use of substances in cosmetic products is exempt, if the restriction addresses a risk to human health and if the use is in the scope of the Cosmetics Regulation.
Restrictions do not apply to the manufacture, placing on the market or use of a substance in scientific research and development. In addition, a specific restriction can define if it also exludes product and process orientated research and development from the scope of that specific restriction. Further, the introduction of new restrictions or amendments of existing restrictions does not apply to the use of substances as on-site isolated intermediate.
List of restrictions
All current restrictions are listed in Annex XVII REACH that is regularly updated. It contains the restrictions already in place before the entry into force of REACH (adopted under Directive 76/769/EC) and the restrictions that have been added since then. The up-to-date list of restrictions can also be found on the ECHA website. Restrictions can address industrial uses, uses by professional users and consumers. An entry of Annex XVII can restrict a single substance or a group of substances defined by their chemical composition (e.g. entry 19: Arsenic compounds) or their hazard classification (e.g. Entry 28: substances classified as carcinogen, 1A/B which are listed in a specific appendix of Annex XVII).
Annex XVII REACH defines precise conditions for each restriction. The substance may not be manufactured, placed on the market or used unless its application complies with these conditions. Further information, e.g. on the conditions of specific restrictions, can be found in ECHA’s Q&As section on restrictions and the ECHA web section on restrictions.
Introducing new restrictons
Member States and ECHA (on request from the European Commission) can submit proposals for new restrictions. These proposals will be published by ECHA on its website which are open to be commented on by concerned parties. ECHA’s Committees for Socio-economic Analysis (SEAC) and for Risk Assessment (RAC) prepare an Opinion on the proposal.
In a first step, interested parties can comment within six months on the restriction proposal itself. In a second round, comments can be submitted within 60 days on SEAC’s draft opinion. The comments will be taken into account when preparing the final RAC and SEAC opinions. The restriction proposal and the two opinions are forwarded to the European Commission for final decision making and the possible amendment of Annex XVII REACH.
For substances that meet the criteria to be classified as a carcinogen, germ cell mutagen or as a reprotoxic, category 1A or 1B, and that could be used by consumers, the Commission can propose restrictions through the use of an accelerated procedure without public consultation and opinions from the RAC and the SEAC (Art. 68(2)).
Further information on the restriction process is made available on the ECHA website.
Besides the formal process to adopt new restrictions, there are two additional procedures where the public is consulted:
- Consultations on new scientific evidence: ECHA, on request of the EU Commission, prepares review reports to evaluate new scientific evidence in relation to certain risks of substances listed in Annex XVII. The draft of such a review report is published and interested parties are invited to provide comments and, in particular, relevant new scientific information that was not included in the draft review report.
- Call for evidence: In the preparatory phase of a new restriction proposal, ECHA may invite interested parties to signal their interest and express their views and concerns in respect to the substance concerned.
For further information on REACH restriction, see the dedicated ECHA website section on restriction.