…Exemptions under Annexes IV and V of REACH Regulation

Annexes IV and V of the REACH Regulation (on the Registration, Evaluation, Authorisation and Restriction of Chemicals) have been amended. Three substances have been removed from the exemptions listed in Annex IV: vitamin A (due to possible reproductive toxicity) and carbon and graphite (since the same EINECS/CAS numbers are applied to the nano-sized substances, which do not meet the exemption criteria). However, fructose, galactose and lactose have been added to Annex IV, since it is felt there is sufficient data to conclude that they are of minimal safety concern due to their intrinsic properties. Other changes include the transfer of substances between the two Annexes.

[Commission Regulation (EC) No. 987/2008 of 8 October 2008 amending Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V. Official Journal of the European Union 2008, L268, 14. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:268:0014:0019:EN:PDF on the internet.] {177999}

…ECHA provides new web section for information on chemicals

As reported in a press release (ECHA/PR/08/29, dated 24 September 2008), the European Chemicals Agency has launched a new section on its website called “ECHA CHEM” (http://echa.europa.eu/chem_data_en.asp). This is intended to be the home for “public information and documents from REACH processes as they become available” (as required under the REACH Regulation). The first information to be published is the Registry of Intentions, which provides a list of substances for which ECHA, and the Member States Competent Authorities, intend to submit an Annex XV dossier (identifying SVHC or Substances of Very High Concern), proposals for harmonised classification and labelling, and proposals for restrictions. Also available is an inventory of Annex XV dossiers already submitted with a link to those proposals that are, or have been, available for public comment (see Toxicology and Regulatory News 2008, 47(8), 129). {177497}

Future additions to this site will include non-confidential information submitted in registration dossiers and a directory of pre-registered substances; an interim list of the nearly 40,000 substances pre-registered before 1 October 2008 is already available (via http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx) and the full list is planned for 1 January 2009. {179288}

[Developments relating to the REACH legislation are unfolding so rapidly that web addresses (urls) assigned to documents often get subsequently changed (which occasionally means that the hyperlinks we provide unfortunately do not always work long-term).]
…First 15 SVHC

The Member State Committee has unanimously agreed (9 October 2008) on the identification of 14 SVHC. These, along with a further substance already identified as a SVHC (as no comments were made during the public consultation) will now go forward to the “Candidate List” of substances for possible authorisation under REACH. These 15 substances are: anthracene, 4,4’‑diaminodiphenylmethane, cobalt dichloride, diarsenic pentaoxide and trioxide, sodium dichromate, musk xylene, benzyl butyl-, dibutyl- and di(2-ethylhexyl) phthalates, hexabromocyclododecane (including the major diastereoisomers identified, α‑, β‑ and γ‑HBCDD), C10-13 chloro alkanes (short chain chlorinated paraffins), bis(tributyltin)oxide, lead hydrogen arsenate and triethyl arsenate. For a 16th substance, cyclododecane, which had also been suggested as a SVHC contender, the Committee considered there to be insufficient data available to justify inclusion. After a formal decision, the Candidate List of SVHC will be published on the “ECHA CHEM” section of the Agency website (http://echa.europa.eu/chem_data_en.asp). {179287}

…ECHA plea for reflection on pre-registrations

By mid-September 2008 over 350,000 pre-registrations had been submitted, a number of which may not be valid according to ECHA. Two (enterprising?) companies have submitted pre-registrations covering the entire European Inventory of Existing Commercial Chemical Substances (EINECS) of over 100,000 chemicals, which has not amused the Agency. In a recent press release it requests that companies pre-register only those substances they intend to register and that in future a restriction of 10,000 files will apply to bulk pre-registration submissions (without prior consultation with ECHA). This Press Release (ECHA/PR/08/27 of 19 September 2008), which also gives more information on the problems encountered with some pre-registrations, can be accessed via http://echa.europa.eu/news/press_en.asp on the Agency website. {179286}

…Recommended ECHA approach for pre-registration of certain substances

Following its discussion with the European Commission on 26 September 2008, ECHA recommends that for certain types of chemicals, such as re-imported substances (Article 2.7c), recovered substances (Article 2.7d), monomers in polymers (Article 6.3) and substances intended to be released from articles (Article 7.6), companies should pre-register by 1 December 2008 – the end of the pre-registration period – if they are not sure that the substance(s) concerned will be registered. The relevant News Alert (ECHA/PR/08/32 of 6 October 2008) is available via http://echa.europa.eu/doc/press/pr_08_32_pre_reg_followup_20081006.pdf from ECHA. {179181}

…ECHA provides help with inquiry dossiers

A new software tool has been developed to help companies with the preparation of inquiry dossiers (to ascertain whether a non phase-in substance, or phase-in substance that has not been pre-registered, is in the registration process). The tool will identify the fields in the IUCLID 5 dossier, which should be completed. The “Inquiry Dossier Preliminary Check Tool” is available to download (via , as reported in a IUCLID 5 news announcement of 30 September 2008. {179291}

…More questions answered by ECHA

A new publication (dated 18 September 2008) which provides answers for registrants of previously notified substances (such as when to request a registration number) is available on the ECHA website (via http://echa.europa.eu/doc/reachit/prev_not_sub_registrants_qa.pdf). {179289}

An updated version (dated 12 September 2008) of frequently asked questions on payments and charges, and technical issues, in REACH-IT, now includes six more answers (for example, on the time taken to receive a bulk pre-registration number). The document is available from ECHA (via http://echa.europa.eu/reachit/reachit_faq_en.asp). {178167}

…Updated ECHA guidance on registration

Yet again the ECHA registration guidance document has been updated, this time to clarify the responsibilities of the “only representative”. [European Chemicals Agency. Guidance on registration. May 2008; Version 1.3. Published 24 September 2008 (available at {169341}

…ECHA provides slide show for autumn evenings

Presentations given at the first Stakeholders’ Day on 10 October 2008 are now available to view on the ECHA website (via http://echa.europa.eu/news/events/1st_stakeholders_day_en.asp). {179290}

The above items were taken from the November 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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