The EU Commission has placed over 20 carcinogenic, mutagenic, or reprotoxic substances on Annex XVII list of restricted substances under REACH.
On 31 August 2017, the Official Journal of the European Union published Directive (EU) 2017/1510 amending Annex XVII of REACH Regulation (EC) No 1907/2006 to include more than 20 substances recently classified as carcinogenic, mutagenic and reproductive (CMR) category 1A and 1B.
This Regulation will enter into force 20 days after its publication in the EU’s Official Journal.
REACH Restriction
The Annex XVII of REACH regulation contains the list of restrictions of certain hazardous substances, mixtures and articles for their marketing and use on the European market. A restriction can apply to any substance on its own, in a mixture or in an article, including those that do not require registration. The list is often known as the REACH restricted substances list or simply as REACH Annex XVII.
Restriction is one way that REACH reduces the risks posed by hazardous substances and this can take many forms including general bans on all uses, bans on specific uses, bans for products available to the general public and limits on the concentration of the substance.
CMRs Under REACH
Under REACH, CMRs Entries 28, 29 and 30 of Annex XVII prohibit the placing on the market, or use for supply to the general public, substances that are classified as carcinogenic, mutagenic or toxic to reproduction (CMR) category 1A or AB, where that substance also appears with a harmonised classification to the same effect on Annex VI of the CLP Regulation.
This restriction extends to the listed substances when sold as substances, when they are constituents of other substances, or when present in mixtures containing such substances in specified concentrations.
Changes made to REACH Annex XVII
With a number of substances having recently been amended or added as CMRs to Annex VI of CLP, Annex XVII of the REACH Regulation has been updated accordingly, resulting in over 20 new or updated CMRs.
Additions that may be of particular interest include:
- Bisphenol A
- Lead powder and Lead massive
- Phenol, dodecyl-, branched and certain related substances
- Certain tributyltin compounds
- Tetrahydro-2-furyl-methanol
The addition of Bisphenol A, will affect products such as Epoxy Resins. The addition of Phenol and its derivatives could mean the end of phenolic resin products and cause problems for suppliers of products such as etch primers etc.
Deadlines
Restrictions shall apply from 1st March 2018 for most of the newly added CMRs and after this date, these substances, either on their own or in a mixture, cannot be sold to the general public. They must also be marked visibly, legibly and indelibly with ‘Restricted to professional users’.
Restrictions for six of the entries will come into force on September 19th 2017, just 20 days after the amendment was published.
See HERE to find out which substances the earlier effective date applies to.
See HERE for the full list of substances which have been added as CMRs.