The 13th revision of the REACH Candidate List (CL) has now been published by European Chemical Agency (ECHA) with the addition of two substances on 15, June 2015.
ECHA included these two substances to the CL based on the proposals from Member States, Sweden and Netherlands respectively. ECHA conducted the SVHC identification process with involvement of the Member State Committee (MSC) prior to the decision. REACH CL now contains 163 substances. Of these, 31 have been included in the Authorization List.
The 2 Substances included on CL are:
|Name||EC Number||CAS Number||Reason for proposing||Date of inclusion|
|1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)||271-094-0||68515-51-5||Toxic for Reproduction (Article 57 c)||
|5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane , 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane  [covering any of the individual isomers of  and  or any combination thereof]||–||–||vPvB (Article 57 e)||
ECHA defines the 2 substances:
“The first new entry covers a series of mixed alkyl diesters (EC 271-094-0, CAS 68515-51-5; EC 272-013-1, CAS 68648-93-1) which were added to the list due to their reproductive toxicity properties where they contain ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5). These substances are used as plasticisers and lubricants, including use in adhesives, coatings, building material, cable compounding, polymer foils, PVC compounds and artist supply (e.g. modelling clay and finger paints).
The second SVHC has been added as a group entry with very persistent and very bio accumulative properties. This group of substances covers for example, the product with the trade name “karanal”. Public information sources indicate that the main use of karanal is as a fragrance ingredient.”
The SVHC identification process was undertaken as mentioned below:
- ECHA received two dossiers in accordance with Annex XV to REACH for substances from Member States (Sweden & Netherlands), which in their opinion meet the criteria of substances of very high concern (SVHCs) set out in Article 57 of REACH.
- On 2 March 2015, the Agency invited all interested parties to submit comments on the Annex XV dossiers, as stated in Article59 (4) REACH.
- The public commenting period for all substances ended on 16 April 2015.
- In accordance with Article59 (5) REACH, the deadline for Member States or their agency to comment on the identification of the substances as SVHCs was 4 May 2015.
- Post the deadline ECHA received comments on the identification as SVHCs for the proposed substances. Thus, according to Article59 (7) of REACH the dossiers related to these substances were referred to the MSC.
- The MSC unanimously agreed via written procedure, which closed on 29 May 2015, that the proposed substances met the criteria set out in Article 57 of REACH for identification as SVHCs.
- Therefore, according to Article59 (8) of REACH, ECHA included these substances in the CL on 12 June 2015.
- In accordance with Article 59 (10) REACH, now the revised CL is published on ECHA’s website on 15 June 2015 by the decision ED/39/2015.
Further, with the inclusion of substances in the CL, suppliers are now required to inform their customers about the presence of these substances in their products. Monitoring of CL holds tremendous benefit for the suppliers and product manufacturers. Compliance of their products depends on the presence or absence of SVHCs in their products. Because of the dynamic nature of CL, continuous monitoring of CL is required to maintain the products in compliance status.
REACH CL gets updated twice in a year, which means suppliers and product manufacturers have only six months to finish the analysis of their entire product portfolio against the latest additions to CL and determine their compliance status.
The task is resource intensive and requires periodic reviews to stay updated on REACH CL and choose the required action plan for getting compliant. This allows them to steer ahead of competition in the European market and increase revenues.