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ECHA to Revise Definition of Intermediates under REACH

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The European Commission has discussed about the revised draft guidance documents for intermediates submitted by ECHA. The revised draft give a more specific definition on intermediates and the identification of intermediates also become stricter.

The revised draft makes it clear that substances can be registered as intermediates under REACH when the following three cumulative conditions to be fulfilled:

1) “the first of those conditions concerns the intended purpose at the time of the manufacture and use of a substance as an intermediate, which consists of transforming the intermediate substance into another”;

2) “the second condition concerns the technical means by which that processing takes place, namely a chemical process known as ‘synthesis’”;

3) “the third condition restricts the scope of the definition of ‘intermediate’ to uses of a substance which remains confined to a controlled environment, which may be either the equipment within which synthesis takes place, or the site in which the manufacturing and synthesis takes place or to which that substance is transported, ‘site’ being defined in Article 3(16) of the REACH Regulation as a ‘single location’ in which infrastructure and facilities are installed”.

For a long period of time, the industry shares a different opinion on the definition of intermediates with the REACH Regulation and the Guidance Documents for Intermediates. Based on the draft guidance, the use of a substance as a catalyst and chemical reactant in the manufacturing of articles is not an intermediate use, such as surface modification materials that can be bonded to surfaces and some new materials on lithium electrodes.

Up to 28 February, about 2583 enterprises have submitted a total of 19434 registration dossiers for intermediate registration, covering 9662 substances. The number of registration dossiers for intermediates accounts for 20% of all the registration dossiers. Intermediates registration is favored by enterprises as related enterprises can enjoy data reduction/exemption and a preferential administrative fee once their substances meet the following two conditions:

  1. meets the definition of intermediates;
  2. satisfy the strictly controlled conditions;

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