• REACH Authorisation List

12 New Substances on REACH Authorisation List – Weekly Compliance Digest

July 7, 2017 By
In this edition of the Weekly Compliance Digest, we cover the addition of 12 new substances to the REACH Authorisation List in the EU.

Annex XIV to Regulation (EC) No 1907/2006

What is it?

On June 19, 2017, the European Chemicals Agency (ECHA) announced the addition of 12 new substances to the Authorisation List (Annex XIV). As a result, the Authorisation List now contains 43 substances.

Substances included in the Authorisation List can only be placed on the EU market or used after a given date if an authorisation is granted for a specific use, or the use is exempted from authorisation. The EU’s REACH regulation allows manufacturers, importers or downstream users to apply for an authorisation for the placing on the market or the use of a substance on the Authorisation List. Authorisations are granted if applicants can demonstrate that risks from the uses of the substances are adequately controlled.

Even though there are currently 43 substances on the REACH Authorisation List, there are 174 substances on the Candidate List of SVHCs from which substances are considered for inclusion in the Authorisation List, therefore the Authorisation List is expected to grow.

What are the substances?

Here are the 12 substances, along with examples of uses if provided by ECHA, and CAS numbers (if available). Links to substance infocards are also included.

1-bromopropane
CAS: 106-94-5
This substance is used in washing & cleaning products, extraction agents and metal surface treatment products.

Diisopentyl phthalate
CAS: 605-50-5

1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich
CAS: 71888-89-6

1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters
CAS: 68515-42-4

1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear
CAS: 84777-06-0

Bis(2-methoxyethyl) phthalate
CAS: 117-82-8

Dipentyl phthalate
CAS: 131-18-0

N-pentyl-isopentylphthalate
CAS: 776297-69-9

Anthracene oil
CAS: 90640-80-5
This substance is used for the manufacture of chemicals, mineral products (e.g. plasters, cement) and metals.

Pitch, coal tar, high-temp.
CAS: 65996-93-2
This substance can be found in products with material based on plastic (e.g. food packaging and storage, toys, mobile phones). In addition, it is used for the manufacture of chemicals, metals and mineral products (e.g. plasters, cement).

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
CAS: –

4-Nonylphenol, branched and linear, ethoxylated
CAS: –

On the webpage of the Authorisation List and in the text of the regulation, a “latest application date” is provided for each substance. This is the date by which an application to continue or start using or placing the substance on the market must be received. The “sunset date” refers to the date from which the placing on the market and the use of that substance will be prohibited unless an exemption applies or an authorisation is granted, or an authorisation application has been submitted before the application date but a decision on the application has not yet been made.

What is next?

Companies located in the EU or EEA should analyze their product portfolio and determine whether any of the following conditions applies regarding any of the 12 new substances placed on the authorisation list:

  • Is the substance used in the manufacturing process, or any other process?
  • Is the substance placed on the EU/EEA market on its own?
  • Is the substance placed on the EU/EEA market as part of a mixture or article?

Companies located in non-EU countries that export into the EU/EEA should analyze their product portfolio and determine whether any of the following conditions applies regarding any of the 12 new substances placed on the authorisation list:

  • Is the substance placed on the EU/EEA market on its own?
  • Is the substance placed on the EU/EEA market as part of a mixture or article?

If any condition applies, companies should check if their particular use of the substance is subject to authorisation. If yes, companies should either apply for authorisation or consider substituting the substance for an alternative.

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