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REACH Registration of Intermediates

Intermediate registration is much cheaper than full registration. It is strongly recommended that companies check with their downstream users whether a substance is used as an intermediate or not before beginning registration.

Definitions of Intermediates under REACH Regulation

  • 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.
  • On-site isolated intermediate and transported isolated intermediate can be registered with reduced requirement.

REACH Registration of Intermediate: Data Requirement

Registration of intermediates(transported or isolated) requires "all available data". The Art 17 (d) and 18(d) of the REACH regulation specify that “if the manufacturer or importer confirms that he is manufacturing and/or using the substance under strictly controlled conditions and he confirms himself or states that he has received confirmation from the users that the substance is used under strictly controlled conditions (section 2.1) and the annual quantity of substance is less than 1000 tonnes, the information requirements on the substance's intrinsic properties (physicochemical, human health and environment properties) are reduced to available data (e.g. information he holds himself or that he can obtain from other sources) and only study summaries have to be submitted if a full study report is available”.

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;

REACH Registration of Intermediate: Cost Estimation

Administrative fees charged by ECHA will be 1600 euros for separate submission and 1200 euros for joint submission. Data fees and consultancy fees vary from substance to substance. Based on our experience, the total cost of registering an intermediate used under SCCs with tonnage band below 1000t/y is around 4,000-6,000 EUR. The total cost of registering an intermediate above 1000t/y is around 10,000 - 30,000 EUR.

Do You Qualify for Intermediate Registration under REACH?

On 11 May 2011 ECHA announced that most (86%) of the more than 400 dossiers on intermediates it screened do not seem to meet the conditions imposed by REACH for them to benefit from the reduced information requirements. ECHA encourages registrants of intermediates to proactively reassess and, where necessary, update their registration dossiers.
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:

  1. the use of the substance must meet the definition of intermediates as described in article 3 (15) of REACH; and
  2. 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, and a description of all the measures taken to ensure strictly controlled conditions at all steps, as well as copy of letters sent to, or received from all downstream users confirming that they use the substance as an intermediate under SCCs.

CIRS has prepared a document to help importers and downstream users to show compliance based on ECHA's latest guidance document. Please complete this form and send it to us so that we can help you evaluate whether your substance meets the conditions of intermediates under SCCs.

This document is available here.

Contact

  • Europe Office
    Unit 1 Ardee Business Park, Hale Street, Ardee, Co. Louth, Ireland
    Tel : +353 41 9806 916 | Fax : +353 41 9806 999
    Email: service@cirs-reach.com