…Draft amendments to Annexes XIV and XVII

September saw the release of a draft Commission Regulation amending Annex XIV (the list of substances subject to authorisation) of the REACH Regulation. The draft proposes the inclusion in this Annex of the following eight substances of very high concern (SVHCs): diisobutyl phthalate, diarsenic trioxide, diarsenic pentaoxide, lead chromate, lead sulphochromate yellow (C.I. Pigment Yellow 34), lead chromate molybdate sulphate red (C.I. Pigment Red 104), tris(2-chloroethyl) phosphate and 2,4-dinitrotolune. Also released was a draft Commission Regulation amending Annex XVII (restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles).

European Commission (2011). Draft Commission Regulations amending Annex XIV and Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’). D015867/01; D007340/03. For information on how to obtain these draft amendments, visit http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/review-annexes/index_en.htm#h2-8 online. {166453}

…Proposals for harmonised classification and labelling

Under EC Regulation No. 1272/2008 on Classification, Labelling and Packaging, there is a legal obligation for suppliers to evaluate the hazards of chemicals (substances and mixtures) to be placed on the market, and to classify and label them appropriately. An option also exists for Member State Competent Authorities or industry to ask for the classification and labelling of a substance to be harmonised across Europe, whereupon the European Chemicals Agency organises a public consultation period of 45 days. Under this scheme, proposals have been submitted recently by the German and Danish authorities to standardise the classifications of 1,1’,1’’-nitrilotripropan-2-ol and of styrene.

Visit the ECHA website (at to view the background scientific reports, obtain further information, or to comment on these proposals (by 17 or 24 November 2011). {188623; 188647}

…REACH restriction proposal for four phthalates

An Annex XV restriction report produced by the Danish Competent Authority reviews the health and environmental effects of four phthalates (bis(2-ethylhexyl)phthalate, benzyl butyl phthalate, dibutyl phthalate and diisobutyl phthalate). A ban (following a transition period) is proposed “for the placing on the market of articles intended for indoor use and articles that may come into direct contact with the skin or mucous membranes, containing one or more of these four phthalates in a concentration greater than 0.1 % by weight of any plasticised material”. The health and environmental effects of a number of alternative plasticisers, as potential replacements for these phthalates, are also reviewed. This proposal will be open for comment until 16 March 2012, but ECHA encourages interested parties to submit their opinions by 16 December 2011.

For more information, visit http://echa.europa.eu/reach/restriction/restrictions_under_consideration_en.asp online. {188639}

…Seven opinions adopted by ECHA’s Committee for Risk Assessment (RAC)

As announced in a September 2011 news alert (ECHA/NA/11/40), RAC has considered seven proposals from different Member States (France, Germany, the Netherlands and the UK) to harmonise classification and labelling. RAC agreed with proposals on the following chemicals: polyhexamethylene biguanide hydrochloride, for classification as being acutely toxic (orally and by inhalation), damaging to the eye, a skin sensitiser, toxic to the respiratory tract following repeated exposure, a suspected carcinogen, and hazardous to the aquatic environment; di-n-hexyl phthalate as toxic to reproduction; fenamiphos as acutely toxic (orally and by inhalation) and an eye irritant; trichloromethylstannane as toxic to reproduction; MMT(EHMA) (2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate) as toxic to reproduction; aclonifen (2-chloro-6-nitro-3-phenoxy-benzenamine) as a suspected carcinogen, a skin sensitizer and as hazardous to the aquatic environment; perestane as acutely toxic (orally, dermally and by inhalation), corrosive to the skin, and toxic to the eye after a single exposure. RAC also agreed to remove the classification of mutagenicity from perestane. Proposals for the classification of trichloromethylstannane and MMT(EHMA) as mutagenic were not approved. The decisions of RAC on these substances are available on ECHA’s website (via http://echa.europa.eu/about/organisation/committees/rac/committee_opinions_en.asp). {188640-6}

…Other items of interest

Final reports have been published from two REACH Implementation Projects on Nanomaterials. The RIP-oN 2 project addresses the REACH information requirements on intrinsic properties of nanomaterials, and the information needed for safety evaluation of nanomaterials. The RIP-oN 3 project addresses exposure assessments and hazard and risk characterisation for nanomaterials within the REACH context ). {188702}

The Committee for Socio-economic Analysis (SEAC) has adopted three scientific opinions on lead, mercury and phenylmercuries (http://echa.europa.eu/news/na/201109/na_11_39_seac_three_opinions_20110920_en.asp).

The names of SVHCs on the Candidate List are now available in 22 languages in the ECHA-term database (http://fceg.espsrv.com/f/tr.aspx/?&x=pv&6Uh&h=puwux/.9aa=txu/lh&x=pv&=:kjc1sr77&x=pv&6270j29lhbe757jNCLM).

The Registry of Intentions for Annex XV dossiers has been updated for Harmonised Classification and Labelling (one new intention), Substances of Very High Concern (three new intentions) and Restrictions (chromium VI compounds in leather articles) ).

Draft revision of the Guidance on Registration sent to ECHA’s Partners Expert Group (PEG) (http://guidance.echa.europa.eu/docs/draft_documents/registration_version2_draft%20_PEG_20110930.pdf ). {169341}

ECHA launches a new procedure for submitting alternative chemical name requests (http://echa.europa.eu/news/na/201109/na_11_46_alternative_chemical_name_in_mixtures_en.asp).

ECHA urges companies to start preparing for the 2013 REACH registration deadline (http://echa.europa.eu/news/pr/201109/pr_11_21_2013_reach_deadline_campaign_20110922_en.asp).

ECHA Management Board adopts Work Programme for 2012 and policy on avoiding potential conflicts of interest (http://echa.europa.eu/news/pr/201110/pr_11_22_mb_malta_20111004_en.asp).

A report of the Directors’ Contact Group (DCG) is available, presenting achievements, lessons learnt and recommendations on meeting the first REACH registration deadline (http://echa.europa.eu/news/na/201109/na_11_43_DCG_en.asp).

ECHA publishes the analysis of substances that were not registered by the first deadline despite the reported intentions (http://fceg.espsrv.com/f/tr.aspx/?&x=pv&6Uh&h=puwux/.9aa=txq/lh&x=pv&=:kjc1sr77&x=pv&629lhbe757jsd7ljra5styrt/xqe6nrtqsrrih6jj3c90fpeegpi09-jj7g&9ns1sp_/tpp&d25jfNCLM).

ECHA’s Board of Appeal publishes two final decisions (http://echa.europa.eu/news/pr/201110/pr_11_24_echa_boa_publish_two_decisions_en.asp).

In the light of the Board of Appeal’s decisions, ECHA is modifying its standard letters to registrants and reminds potential registrants on the importance of paying their REACH fees on time (http://echa.europa.eu/news/na/201110/na_11_49_boa_20111013_en.asp).

Highlights of the tenth plenary meeting of the Forum (http://echa.europa.eu/news/pr/201110/pr_11_23_forum_plenary_meeting_20111010_en.asp).

ECHA supports the data sharing process between registrants by removing invalid pre-registrations from its REACH-IT database (http://echa.europa.eu/news/na/201109/na_11_42_removal_of_pre-registrations_en.asp).

ENES – an Exchange Network on Exposure Scenarios – set up by ECHA (http://echa.europa.eu/news/na/201109/na_11_44_ENES_en.asp).

IUCLID 5 stand-alone installation video tutorials are now available (http://echa.europa.eu/news/na/201110/na_11_47_iuclid5_videos_en.asp).

ECHA invites Industry Users of the QSAR Toolbox for a workshop in November (http://echa.europa.eu/news/na/201110/na_11_48_qsar_toolbox_workshop_en.asp).

A draft decision for one testing proposal referred to the Commission for the first time by ECHA (http://echa.europa.eu/news/na/201109/na_11_45_MSC_en.asp).

Testing proposals involving vertebrate animals: request for information from third parties on over 40 substances (14 October 2011; 15 September 2011) (http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp?consultations_status=current).

The above items were taken from the November 2011 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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