In this edition of the Weekly Compliance Digest, we cover the EU REACH regulation and seven substances that are being proposed for authorisation under REACH.
Annex XIV to REACH
What is it?
Last week, the European Chemicals Agency (ECHA) announced the start of a public consultation period on seven substances that are proposed to be subjected to authorization under the REACH regulation. The seven substances are already on the . ECHA is considering recommending the European Commission to include the seven substances to the Authorisation List (Annex XIV to REACH), which would further regulate the use of the seven substances.
ECHA is seeking comments on the priority of the substances, their uses, possible exemptions from the authorisation requirement, the structure and complexity of supply chains, and on the proposed transitional arrangements. At the same time, the European Commission is calling for information on the possible socio-economic consequences of including these seven substances in the Authorisation List.
If a substance is included in the Authorisation List, it can only be placed on the EU market or used after a given date if an authorisation is granted for a specific use. Companies that are using, manufacturing or importing these substances can apply for authorisation.
Who is affected?
Here are the seven substances, along with examples of uses in the scope of the authorisation, and industries potentially affected:
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
Examples of uses: Fragrance in soaps and detergents
Industries potentially affected: Health Care and Personal Products; Cleaning and Hygiene Industry
Examples of uses: Solvent in coatings, cleaning agents, functional fluids
Industries potentially affected: Paints and Coatings; Water Treatment Products (including water treatment in Oil & Gas operations); Laboratory Chemicals
Four phenolic benzotriazoles (UV-328, UV-327, UV-350, UV-320)
Examples of uses: UV filter in plastic products, adhesives, sealings
Industries potentially affected: Paints and Coatings; Printing Inks; Plastic Products (e.g. plastic in food packaging and storage, toys, mobile phones)
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 201-559-5)
Examples of uses: Plasticiser in PVC, adhesive
Industries potentially affected: Paints and Coatings; Plastic Products
Manufacturers and distributors based outside of the EU are also affected by the inclusion of substances on the REACH Authorisation List (Annex XIV) if they export their products into the EU. This applies to Annex XIV substances on their own, and also potentially to mixtures containing them, based on concentration values and mixture classifications, and also potentially to articles containing them. For example, if not specifically exempted otherwise, the incorporation of an Annex XIV substance into an article is a use which is subject to the authorisation requirement.
What is next?
Comments can be submitted until June 2, 2017. Based on the opinion of ECHA’s Member State Committee and the public comments, ECHA will provide its final recommendation to the European Commission. The Commission will then decide on the substances to include in the Authorisation List and on the respective conditions applicable for each substance.
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