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REACH concern amid 350,000 ...

REACH concern amid 350,000 pre-registrations

19 Sep 2008

European Chemicals Agency finds applications in breach of the regulatatory requirements for registration under the new European chemical health & safety rules and could be subject to enforcement actions by the authorities of the relevant Member States.

Helsinki - The European Chemicals Agency (ECHA) had received over 350,000 pre-registrations under REACH as of 15 Sept, including almost 140,000 from the UK (see table below). However, it noted, some of these applications were in breach of the regulatatory requirements for registration under the new European chemical health & safety rules and could be subject to enforcement actions by the authorities of the relevant Member States.

In a statement, the ECHA reminded companies that before they submit a pre-registration REACH-IT requires them to declare that the substances they pre-register are phase-in substances within the meaning of Article 3 (20) of the REACH Regulation (REACH).

Highlighting another pre-registration issue, the agency also stressed that representatives "can only be appointed by a person outside the EU Community who manufactures a substance, formulates a preparation or produces an article that is imported into the EU, and that the documents showing this must be available."

ECHA also found pre-registrations from two companies that covered the entire EC inventory; a practice, it said, is not in accordance with the aim of pre-registration which is designed for data sharing in advance of the registration. "Preregistration of the entire inventory impacts heavily on the usefulness of the list of pre-registered substances. On the one hand, for a company pre-registering the whole inventory participation in the Substance Information Exchange Fora (SIEFs) will become unmanageable. On the other hand, this is in particular disadvantageous for downstream users, who should be able to notify ECHA of their interest in a substance not appearing on the list of pre-registered substances."

Indeed, ECHA is now to restrict the number of substances that can be submitted via bulk pre-registration files at 10,000. Company seeking to pre-register more than 10,000 substances will need to contact the ECHA Helpdesk for prior approval.

REACH-IT Pre-registrations

AUSTRIA 172 1,449

BELGIUM 457 5,577

BULGARIA 91 397

CYPRUS 37 76

CZECH R. 173 1,974

DENMARK 72 759

ESTONIA 28 166

FINLAND 346 1,397

FRANCE 830 9,945

GERMANY 1,886 141,185

GREECE 58 404