UK: REACH – Issues Emerging In The First Month Of Pre-Registration

Last Updated: 11 July 2008
Article by Paul Sheridan, Valentina Keys and Kate Warnock-Smith

The pre-registration of chemicals under Regulation (EC) No 1907/2006 ("REACH") started on 1 June 2008. By 13 June 2008, the European Chemicals Agency (ECHA) had received pre-registrations from 1,427 companies and had created 7,360 pre-registrations. So far, the pre-registration process has highlighted two issues which are being addressed by ECHA: (1) errors in the submission of data in pre-registration dossiers by companies, and (2) identification of substances which may be classified as substances of very high concern (SVHC).

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The pre-registration of chemicals under Regulation (EC) No 1907/2006 ("REACH") started on 1 June 2008.  By 13 June 2008, the European Chemicals Agency (ECHA) had received pre-registrations from 1,427 companies and had created 7,360 pre-registrations.  So far, the pre-registration process has highlighted two issues which are being addressed by ECHA: (1) errors in the submission of data in pre-registration dossiers by companies, and (2) identification of substances which may be classified as substances of very high concern (SVHC).

New Guidelines For Submission Of Pre-Registration Dossiers

Pre-registration for single chemicals is available on-line via the REACH-IT portal.  According to ECHA, for 2% of these REACH-IT pre-registrations, chemical identity information was not provided in line with ECHA guidelines. 

The option to bulk pre-register more than one chemical at a time is not yet available on the REACH-IT portal and companies must therefore use a temporary manual registration procedure.  Apparently, many of the dossiers submitted via the temporary submission procedure could not be processed due to inadequate or incomplete information.  In response to this, ECHA has published two new guidance documents to assist companies in preparing and submitting dossiers for pre-registering their chemicals: Data Submission Manual 4: How to submit a valid dossier to ECHA and complete the dossier and Data Submission Manual 5: How to complete a Technical Dossier for Registration and PPORD Notifications.  ECHA hopes that by using these manuals, companies will have more certainty that their dossiers pass the completeness check at the first submission. 

Pre-registration (which has the advantage of giving companies extended registration deadlines) ends on 30 November 2008. Companies should therefore take full advantage of the time available to them to ensure registration dossiers are complete and contain all the correct information, as incomplete pre-registration dossiers will not be accepted by ECHA. 

Substances With Properties Of Very High Concern (SVHCs)

On 30 June 2008, ECHA began a public consultation on the first draft list of substances that could become subject to stringent authorisation requirements prohibiting marketing and use unless manufacturers and importers can show there is a compelling reason to allow their manufacture. Each entry on the "candidate list" of SVHCs has been suggested by the Government of an EU Member State.

SVHCs are defined in Article 57 of REACH and include substances which are:

  • Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC,

  • Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or

  • Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters)

The 16 substances on the candidate list are anthracene, 4,4'-diaminodiphenylmethane, dibutyl phthalate (DBP), cyclododecane, cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide sodium dichromate, musk xylene, DEHP, Hexabromocyclododecane (HBCDD), short chain chlorinated paraffins (SCCPs), bis(tributyltin)oxide, lead hydrogen arsenate, triethyl arsenate and benzyl butyl phthalate (BBP).

The strict authorisation requirements oblige those manufacturers, importers or suppliers using or making available a substance in the SVHC candidate list to apply for an authorisation for each use of the substance within the deadlines set and to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants would also need to analyse whether there are safer suitable alternative substances or technologies. If there are, they must prepare substitution plans, if not they should provide information on research and development activities. The European Commission may amend or withdraw any authorisation on review if suitable substitutes become available.

In respect of the 16 substances, stakeholders are invited to submit scientific commentary on the identification of the substances as SVHCs as well as further information relating to the use and exposure of the substances and safer alternative substances and techniques. The commentary and information should be submitted by 14 August 2008. Following stakeholder input, a committee of EU Member State experts convened by ECHA will vote on the list. ECHA hopes to publish a final list in October 2008. This list will be created as an annex to REACH (Annex XIV) which covers substances that are subject to authorisation requirements. It is anticipated that the list will gradually increase as more information becomes available on other substances under the REACH registration process.

To access the consultation and instructions on how to make submissions to the consultation, click here.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 10/07/2008.

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