25 New CMRs Added to REACH Annex XVII

25 New CMRs Added to REACH Annex XVII

The European Commission (EC) recently announced 25 new carcinogens, mutagens and/or reproductive toxicants (termed ‘CMRs’) have been added to Annex XVII of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. The new REACH CMRs include several substances relevant to food contact materials, among other areas of concern to compliance personnel.

Companies will need to survey their supply chains to determine if these substances are in use, and whether their specific types of use are in compliance with the requirements of Annex XVII.

Keep pace with changes to the REACH Regulation. Download The REACH Handbook: Your Guide to SVHC Compliance to learn how.

New CMRs Added to Annex XVII

Six of the 25 new CMRs added to Annex XVII were restricted on September 19, 2017, while the remaining 19 substances will fall under restriction on March 1, 2018. As of their respective enforcement dates, the manufacture, placing on the market and use of these substances will be limited.

Per Annex XVII, the six substances restricted since September 19 are:

  1. Tetrahydro-2-furyl-methanol; tetrahydrofurfuryl alcohol
  2. Gallium arsenide
  3. Tributyltin compounds, with the exception of those specified elsewhere in Annex XVII
  4. 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear
  5. Imidazole
  6. Flumioxazin (ISO); 2-[7-fluoro-3-oxo-4- (prop-2- yn-1-yl)-3,4-dihydro-2H-1,4-benzoxazin-6-yl]- 4,5,6,7-tetrahydro-1H-isoindole-1,3 (2H)-dione

The remaining 19 substances due for enforcement in March 2018 can be found here.

Requirements for CMRs

As per the terms of REACH Annex XVII, these CMR substances may not be sold to the general public (a) as substances, (b) as constituents of other substances or (c) in mixtures, and must be marked as “restricted to professional users” where appropriate. Users should also note there are specific conditions under which the use of CMR substances is permitted, although correct classification, labelling and packaging (CLP) are still required for these substances.

Implications for Companies

These changes to Annex XVII mean companies in scope of REACH will need to conduct a deep dive analysis into their supply chains to identify and assess CMR substance usage. Assent’s REACH Module helps companies maintain compliance with REACH by notifying them when new CMRs and other substances become restricted under the Regulation.

For more information on compliance with the REACH Regulation and about how Assent can help take the effort out of your REACH compliance program, contact our regulatory compliance experts at info@assentcompliance.com.