What You Should Know For June 2011: Notifications for REACH SVHCs.

This REACH Advisory is directed to EU producers and importers of articles that contain Candidate List substances. A notification to ECHA is due June 1, 2011.

Background

Under REACH, substances of very high concern (SVHCs) may be placed on a Candidate List of substances. Inclusion of a substance on the Candidate List triggers several required procedures, and potential limitations, impacting the manufacturers, importers and users of the substance and the producers and importers of articles containing the substance. Specific to the articles producers and importers is an obligation to notify ECHA of the presence of Candidate List substances in their articles.

Candidate List Substance Notifications

Pursuant to Article 7 of REACH, beginning on June 1, 2011, article producers and importers must notify ECHA of the presence in their articles of substances that have been on the Candidate List for at least six (6) months. The current Candidate List can be found by clicking here:

http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

The obligation to notify ECHA is triggered for each article producer or importer if both of the following criteria are met:
* A Candidate List substance is present in their articles in quantities above one (1) tonne (annually per company), and
* A Candidate List substance is present in their articles in concentrations above 0.1% (w/w).

The ECHA plans to develop a template form for article producers and importers to use in making Article 7 notifications. ECHA is also considering whether to make the notifications available to the public.

Action Items

Each article producer and importer must make a timely determination as to whether they are obligated to notify ECHA of the presence in their articles of a substance on the Candidate list. In order to do so, each producer and importer of articles should proceed as follows:

* Check the existing list of Candidate List substances (see link, above)
* Continually monitor future additions of substances to the Candidate List

Under REACH Article 7, the notification obligation arises six (6) months after listing

* Determine whether the quantity criteria (>1 tonne per year per company) and concentration criteria (>0.1% (w/w)) are met

* Determine whether the substance has been registered for their use

* Alternatively, determine whether they can exclude human or environmental exposures under normal or reasonably foreseeable conditions of use, including disposal

* If a determination is made that human or environmental exposures can be excluded and, therefore, a notification is not required, REACH Article 7 requires that the producer or importer provide appropriate instructions to the recipient of the article

* If notification is to be made, compile the information required to be included in the notification (see REACH Article 7(4))

* Monitor related ECHA activities, e.g., preparation of a notification form and a decision on whether to make the notification information public.

Finally, producers and importers of articles containing Candidate List substances should be aware that publication of the first version of Annex XIV (list of substances the use of which is subject to authorization) is imminent.

The substances that will be included in the first Annex include the following:

• musk xylene (used as a fabric softener and in detergents)
• MDA (in panels)
• HBCDD (flame retardant, including for textiles)
• 3 phthalates (DEHP, BBP, and DBP)

The Annex XIV listing of these substances will include a sunset date (expected to be in the range of 36-48 months) after which any use of the substances in articles produced or used withing EU will require authorization.

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