Definitions of Intermediates under REACH Regulation

Intermediate substance: a substance manufactured, consumed or used to be transformed, through a chemical process, into another substance (hereinafter referred to as “synthesis”):

Non-isolated intermediates: are exempt from REACH registration: A substance that is manufactured solely for the purpose of being transformed into another substance (or synthesis) and is used up within this reaction. Non-isolated intermediate is not intentionally removed from the synthesizing equipment. Other intermediate other than non-isolated intermediate are called isolated intermediates, which can be divided into two sub groups: On-site isolated intermediate and transported intermediate.

On-site isolated intermediate: A substance manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which takes places on the same site and which is operated by one or more legal entities.

Transported isolated intermediate: A substance(for example, pharmaceutical intermediate) manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which is transported between or supplied to other sites.

Intermediate REACH Registration:

NON-ISOLATED INTERMEDIATES:

For the use of a substance as a non-isolated intermediate, there are no obligations under REACH Regulation (Article 2, paragraph 1, point C).

ON SITE / TRANSPORTED ISOLATED INTERMEDIATE:

Manufacturers of isolated / transported intermediate products in quantities in excess of 1 tonne/year must submit a registration dossier unless the substance is exempt from the registration provisions.On site/transported isolated intermediate reporting agents may provide reduced registration information pursuant to Art. 17 (2) and art. 18 paragraph 4 if they confirm that the substance is manufactured and used under strictly controlled conditions.

Besides the available data on substance’s intrinsic properties, the registrant still has to provide the following information:

• A brief general description of the use;
• Details of the risk management measures applied and recommended to the use;
• The identity of the manufacturer or importer;
• The identity of the intermediate;
• The classification of the intermediate;

According to REACH, two critical conditions need to be met for an on-site or transported isolated intermediate to benefit from the reduced data set provisions of articles 17 and 18 of REACH:

• the use of the substance must meet the definition of intermediates as described in article 3 (15) of REACH; and
• the substance must be manufactured and/or used under strictly controlled conditions (SCC).

In view of these conditions, ECHA is asking registrants to collect and send:

• an extensive amount of information including a description of the chemical reactions that take place,
• a description of all the measures taken to ensure strictly controlled conditions at all steps,
• a copy of letters sent to, or received from all downstream users confirming that they use the substance as an intermediate under SCCs.

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