EU Restricted Substances (REACH Annex XVII) – Weekly Compliance Digest
Appendices to Annex XVII to Regulation (EC) No 1907/2006
What is Annex XVII?
REACH is a complex EU regulation that applies to companies that manufacture, distribute, store and use chemical substances in the EU, either on their own, or as part of mixtures or articles. Companies located outside the EU that market substances, mixtures or articles into the EU are also potentially affected by the REACH regulation.
There are many provisions of REACH, but the most important ones for industry are:
- Registration of chemicals manufactured or imported into the EU above one ton a year.
- Notification and communication requirements associated with Substances of Very High Concern (SVHCs).
- Submission of applications to use or place on the market SVHCs that are included on the Authorisation List (Annex XIV of REACH).
- Creation of extended Safety Data Sheets that include exposure scenarios.
- Restrictions applied to substances (Annex XVII of REACH).
Regarding the last bullet, the REACH regulation’s restriction provision is used to limit or ban the manufacture, placing on the market (including imports) or use of a substance, either on its own, in a mixture or in an article, in order to protect human health and the environment from unacceptable risks posed by chemicals. Restricted substances also include those that do not require registration (e.g. substances manufactured or imported below one ton per year). The Restriction List includes a total of 65 substances.
What happens on March 1st, 2018?
On August 30, 2017, the European Commission made changes to the Restriction List that affect substances prohibited from being placed on the market or used for supply to the general public because they are known or presumed CMRs (Carcinogenic, Mutagenic or toxic for Reproduction). This also applies to mixtures and articles containing such substances in specified concentrations.
Twenty-five CMR substances were affected as part of the August 30, 2017 update. The restrictions under Annex XVII applied to five of them 20 days later. Restrictions on the remaining 20 substances will apply on March 1st, 2018. Click here for the list of the 20 substances (the webpage includes 25 entries, but remove the first 5 entries in section (4)(a) because restrictions on these 5 substances are already in effect). As of March 1st, 2018, companies will not be able to sell these 20 substances to the general public and these substances will be restricted only to professional users under certain conditions.
Companies should verify whether they place any of these 20 substances on the EU market, especially as part of mixtures or articles. Among the 20 substances, check especially for the presence of Bisphenol A/BPA, and Lead and its compounds in your product portfolio, but be sure you’re aware of all 20 substances, just to be safe.
Visit Enablon Insights again next Friday for a new Weekly Compliance Digest!
Download this White Paper from Verisk 3E and Enablon and learn more about global regulatory changes that may affect your organization and best practices for chemical management: