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ECHA Recommends Seven New Substances For REACH Authorisation List

ECHA Proposes Seven New Substances For AuthorisationThe European Chemicals Agency (ECHA) has this month recommended seven Substances of Very High Concern (SVHCs) to be added to the REACH Authorisation List. The seven substances – which have been prioritised from the Candidate List – have been recommended by the agency due to their intrinsic properties in combination with high volume and widespread uses, which may pose a threat to human health or the environment.


Substances of Very High Concern

The first step in the authorisation process is to identify chemical substances that may have serious effects on human health or the environment. Either a Member State or ECHA (at the request of the European Commission) can propose a substance to be identified as an SVHC.

This proposal is prepared in accordance with Annex XV of REACH, and once published, it is open for public comment. The proposal and any comments are then passed on to ECHA’s Member State Committee (MSC) who decide whether the substance should be identified as an SVHC, and if it is, it will be added to the Candidate List.

The Authorisation List

ECHA regularly assesses substances on the Candidate List and will then submit recommendations to the European Commission on which substances should be included in the REACH Authorisation List. Recommendations are primarily based on the information contained in the REACH Dossiers, therefore if you are a manufacturer or importer of chemicals which are subject to REACH registration, it is important that your dossiers are kept up to date.

Currently, it appears that substances with suspected Persistent, Bioaccumulative and Toxic (PBT) properties and/or Very Persistent and Very Bioaccumulative (vPvB) properties are being prioritised by ECHA for inclusion in the Authorisation List.

If a substance is included in the Authorisation List, it cannot be placed on the market or used after a given date unless it has an authorisation for a specific use.

Which Seven Substances Have Been Recommended For Authorisation?

ECHA’s eighth recommendation to the European Commission to prioritise SVHCs for inclusion in the Authorisation List contains the following seven substances:

  • 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3- dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5- methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] (karanal group): Used as a fragrance in soaps and detergents, this substance has been recommended for its vPvB properties.
  • 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328): Used as a UV stabiliser; for example in plastic products, rubber and coatings, this substance has been prioritised for its PBT and vPvB properties.
  • 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327): Although this substance has no registered uses, it has been recommended for authorisation based on its structural similarities with (UV-328).
  • 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350): Although this substance has no registered uses, it has also been prioritised based on its structural similarities with (UV-328).
  • 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320): Although this substance has no registered uses, it too has been recommended for authorisation based on its structural similarities with (UV-328).
  • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; and 1,2- benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC 201-559-5): Used as a plasticiser in PVC compounds and as an adhesive, these substances have been recommended for the Authorisation List as they are considered to be toxic for reproduction. (Whilst these are technically two substances, they have been grouped together as the second substance is not registered, and therefore no information is available).
  • 1-methyl-2-pyrrolidone (NMP): A widely used solvent in products such as coatings, cleaning agents and functional fluids, this substance has also been recommended for authorisation as it is considered to be toxic for reproduction.

As noted above, while some of these substances are not currently used in the EU, they could replace other substances recommended for or already on the Authorisation List, and have been prioritised to ‘avoid regrettable substitution’.

ECHA organised a public consultation on the draft recommendation between March and June of last year, before the MSC considered the comments received and adopted its opinion on 11th December 2017.

The final decision on the inclusion of the seven substances in the Authorisation List and on the dates by which companies will need to apply for authorisation to ECHA will be made in due course by the European Commission, in collaboration with the Member States and the European Parliament.

Next Steps

If a substance is added to the Authorisation List, manufacturers, importers and downstream users must seek approval before using it or placing it on the market.

If you are a manufacturer or importer of any of these SVHCs, you should be aware of the potential legal implications for your business.

At UL Safeware Quasar we have a dedicated team of expert Regulatory Consultants who have a comprehensive understanding of chemical regulations across the globe, and are constantly monitoring the regulations to help hundreds of companies sustain chemical compliance.

For other UL Safeware Quasar and industry relevant information visit our news page. We also send out fortnightly newsletters to keep you informed on all the latest regulatory news and other topical, industry relevant content. You can subscribe to our newsletter here.

Useful Information

ECHA Recommends 7 Substances To Be Added To REACH Authorisation List (March 2017)

ECHA Press Release

Annex To The ECHA Press Release [PDF]

ECHA’s Eight Recommendation To The European Commission [PDF]