by Dr. Martina Schneider
What does “Restriction” mean?
The term “Restriction,” under REACH, refers to compliance to specified restrictions delineated in Annex XVII to the Regulation. Restrictions may limit or ban the manufacture, placing on the market or use of a substance. The REACH Restrictions came into force and repealed the Market and Use Directive (76/769/EEC) on June 1, 2009.
Where are restrictions listed?
Restrictions are listed in Annex XVII of the REACH regulation. Currently, there are 64 entries; however, some of them apply for several substances, e.g. – entry number 28, 29 and 30 apply for substances that have a harmonized CLP classification as carcinogenic 1A, 1B, mutagenic 1A, 1B and toxic to reproduction 1A, 1B and that are listed in the Appendix 1 – 6 of Annex XVII. These substances (on their own or in mixtures with concentrations above the limits defined in the CLP regulation) shall not be supplied to the general public.
What is the process a substance needs to undergo to be restricted?
A Member State, or ECHA on request of the European Commission, can propose restrictions. The intention to prepare a proposal is published on the registry of intentions on the ECHA webpage. Later on, the actual proposal is made public on the ECHA webpage and is open, to everyone, for comments. The final restriction, as proposed by the EU commission and confirmed by the Member states and the European parliament, is published as an amendment to the REACH regulation. Annex XVII was last amended in February 2016.
How should restrictions be communicated on the SDS?
Annex II of the REACH regulations sets out the requirement for the Safety Data Sheets (SDS). The regulation states that if a substance or mixture covered by the SDS is subject to a restriction(s) under REACH, the restriction(s) should be mentioned in section 15.1, “Safety, health and environmental regulations/legislation specific for the substance or mixture,” of the SDS. In case a restriction has been imposed, companies need to update their SDS without delay (REACH, Article 31).
Regulation (EC) No 1907/2006: http://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32006R1907
Restriction procedure: http://echa.europa.eu/regulations/reach/restrictions/restriction-procedure
ECHA Guidance on the compilation of Safety Data sheets: http://echa.europa.eu/documents/10162/13643/sds_en.pdf