Companies should ensure that their registration dossiers for intermediates comply with REACH
Media enquiries: ECHA Press
After screening over 400 dossiers of substances registered as intermediates, ECHA has discovered that the majority of them do not seem to meet the conditions imposed by REACH that would justify benefiting from reduced information requirements. ECHA encourages registrants of intermediates to proactively reassess and, where necessary, update their registration dossiers.
Helsinki, 11 May 2011 - Under REACH, the information that companies need to provide for certain types of isolated intermediates may be reduced compared to requirements for other substances provided that the use of the substance fulfils the following two conditions:
- The use of the substance meets the definition of an intermediate as described in REACH Article 3(15) and further explained in the Guidance on intermediates; and
- The substance is manufactured and/or used under strictly controlled conditions.
ECHA's screening of over 400 registration dossiers for intermediates has indicated that 86% of them seem not to contain sufficient information to demonstrate that these conditions are fulfilled.
To ensure the safe use of chemicals and to demonstrate that they comply with the REACH Regulation, registrants' dossiers should provide sufficient information showing that they satisfy the specific conditions for intermediates (Articles 17 and 18 of REACH). The ECHA Guidance on intermediates which was updated in December 2010 helps registrants to assess the intermediate status of their substance and lists information elements that they shall provide in their registration dossiers.
In order to demonstrate that a substance's use fulfils the criteria of an isolated intermediate, a registrant should provide information on the identity of the transformation products resulting from the use of the substance and/or information on the manufacturing processes related to the registered substances. The registration dossier for an intermediate shall also include sufficiently detailed information on the risk management measures describing how strictly controlled conditions are ensured, including a description of the technical means used to rigorously contain the substance. This will enable ECHA to verify the intermediate status.
ECHA may conclude that a registration dossier claimed to be an intermediate is not fulfilling the conditions for reduced information requirements and therefore conclude that a standard dossier should be prepared instead.
ECHA has already communicated with registrants of a number of intermediate dossiers on missing or doubtful information, by inviting them to update the dossiers. However, registrants should not necessarily await dossier or substance evaluation steps to bring their dossiers in line with the legislation and updated guidance but proactively document that they are taking steps solely or in the SIEF to reassess the dossier against new guidance development and may subsequently update registration dossiers of intermediates. That documentation can then be shown to inspectors on demand.
ECHA will continue to examine registration dossiers of isolated intermediates to ensure that the information gap on these substances is not left unfilled by unduely considering these substances as intermediates.
Appendix 3: Format for documenting information on risk management in a registration dossier for isolated on-site and transported intermediates gives advice on: How to report information on risk management measures for on-site and transported isolated intermediates in registrations?
Appendix 4, Definition of intermediates as agreed by Commission, Member States and ECHA on 4 May 2010 gives advice on:
How to assess the intermediate status of the substance?