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April 21, 2010

ECHA Publishes List of Substances Identified for Registration in 2010

Bergeson & Campbell, P.C.

On April 16, 2010, the European Chemicals Agency (ECHA) published a list of substances that companies intend to register under the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation by the November 30, 2010, deadline. The list is based on feedback received from companies and registrations already submitted via the authorized channels. One reason that this exercise is likely being undertaken now by ECHA is to enable ECHA to identify which entities are undertaking registrations for which substances and likewise to identify any substances for which a registration in 2010 should be performed but is not yet documented as such in REACH-IT. ECHA may also be attempting to understand better which substances are likely to be submitted for registration in 2010 and thus to be prepared administratively to shoulder the workload. Finally, although not mentioned by ECHA, this information will be important for another reason. As you know, in association with the Classification, Labeling and Packaging (CLP) Regulation 1272/2008, proposed classification and labeling must be notified for hazardous substances and mixtures within one month from December 1, 2010. For substances for which there is no Lead Registrant and REACH registration is not required by 2010, ECHA may be able to get a better sense of the consequences of non-alignment on classification and labeling resulting from the absence of Lead Registrants and take steps to address the lack of harmonized classification and labeling.

Who Needs to Consult the List?

The list is published to give downstream users, manufacturers, and importers the opportunity to check registrations that are being prepared for substances that need to be registered by November 30, 2010. The presence of a substance on the list means that at least one company has indicated its intention to register the substance in 2010 (as identified by the European Commission (EC) number and substance name). The list focuses on substances identified by their EC number or pre-registration list number and not via Substance Information Exchange Fora (SIEF). The list is solely based on the information provided by potential registrants and is not intended to be an exhaustive list of substances that must be or will be registered in 2010. ECHA neither guarantees the accuracy nor the validity of the information contained in the list. This list is important because substances that should be registered by this date but are not, cannot legally be manufactured, imported, supplied, or used within the EU after December 1, 2010.

It is important to consult the list if you are:

  • A downstream user who uses a substance:
    • at more than 1,000 tons per annum (tpa), or
    • that is labeled as carcinogenic, mutagenic, or toxic to reproduction (CMR Cat. 1&2/1A&1B) at more than 1 tpa, or
    • that is labeled as R50/53 (very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment) at more than 100 tpa, and
    • that is not exempted according to Annexes IV or V of REACH, and
    • that does not meet the criteria of Article 2 of the REACH regulation.
  • A manufacturer/importer that makes/imports a substance, which complies with the same criteria as noted above.

What If a Substance in Use Is Not on the List?

Downstream users are urged to contact their supplier and enquire about its intention to register and inform ECHA about its substance (EC number and name) by filling the web form. The web form for downstream users is available online.

Manufacturers/importers/Only Representatives (OR) are urged to inform ECHA of their intention to register by November 30, 2010, by filling the web form. Each web form is slightly modified to distinguish and extract pertinent information about pre-registered substances by role (downstream user, manufacturer, importer, and OR). The web form for manufacturers, importers, and ORs is available online.

ECHA notes that it will periodically publish updates of the list.