…Great summer offers to lead registrants

Hoping to promote early registrations, ECHA will address requests from Lead Registrants on a priority basis, giving assistance over the telephone when appropriate. Lead Registrants who have not yet given notification of their appointment must do so via the web form on ECHA’s website and create the Joint Submission Object in REACH-IT. As members can only submit their dossiers once the lead dossier has passed the “business rules”, early submission of the lead dossier is pivotal for all member registrants. Further information can be found in a press release (ECHA/PR/10/14) that is dated 24 June 2010.

…Three for the price of two deal for early registration

According to the ECHA e-News of 30 June 2010, companies that submit their dossiers by 1 October 2010 are promised that they will receive the outcome of the completeness check within three weeks, allowing them time to resubmit up to twice if necessary before the 30 November 2010 deadline. However, for those submitting after 30 September 2010, the registrant will be informed if the dossier is incomplete by 1 March 2011 and given a further four months to provide the requested information. If the information is still not satisfactory, then the registration has failed and the substance cannot legally be manufactured or imported in the European Union. In fact, “the manufacturing or import since the registration deadline will have been illegal”.

…Make sure the substances you use will be legal after November

The ECHA e-News of 23 June 2010 urges downstream users, manufacturers and importers to check whether there are plans to register their substances in 2010. Substances that are subject to, but miss, the 30 November 2010 registration deadline, cannot legally be manufactured, imported or used within the EU after 1 December 2010. The Agency suggests checking the list of substances that companies are preparing to register under REACH, and if any are missing to take urgent action, including informing ECHA. Further information is given on the ECHA website (visit http://echa.europa.eu/chem_data/list_registration_2010_en.asp).

…Guidance and support on nanomaterials in IUCLID 5.2

This latest manual is aimed at helping companies in the preparation of dossiers for nanomaterials. It is noted that, in principle, there is no difference between these dossiers and those prepared for other types of substances, except that no internationally agreed naming and identification conventions are as yet available for nano-sized chemicals. This could lead to inconsistencies in the information on identification given in the dossier. It is suggested that “registrants may wish to take advantage of (preliminary) guidance of the OECD Working Party on Manufactured Nanomaterials…on testing, exposure measurements and mitigation of nanomaterials”.

[Nanomaterials in IUCLID 5.2. Published June 2010. The document is available (via http://iuclid.eu/index.php?fuseaction=home.documentation&type=public#reachmanual) on the ECHA website.] {185467}

…Eight more substances identified as SVHC…

ECHA has announced in a press release (ECHA/PR/10/12) dated 18 June 2010, that eight more substances, all of which are carcinogenic, mutagenic or reprotoxic (CMR), have been added to the ‘Candidate List’ of substances of very high concern for authorisation. The substances are trichloroethylene, boric acid, disodium tetraborate anhydrous, tetraboron disodium heptaoxide hydrate, sodium chromate, potassium chromate, ammonium dichromate and potassium dichromate. A decision will be made later on whether these chemicals will be subject to authorisation. ECHA reminds companies that they may have legal obligations resulting from the addition of these chemicals to the Candidate List. Member State Committee documents in support of the inclusion of these substances in the list can be obtained from the ECHA website (via http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp). {185485‑92}

…and another eight proposed for inclusion in Annex XIV of the REACH Regulation

In a press release (ECHA/PR/10/15) dated 1 July 2010, ECHA has announced its draft recommendation that eight of the fifteen substances that were added to the Candidate List in the first quarter of 2010 should be included in the Authorisation List (i.e. Annex XIV of the REACH Regulation, EC 1907/2006). The selected substances are diisobutyl phthalate, diarsenic trioxide, diarsenic pentaoxide, lead chromate, lead sulfochromate yellow, lead chromate molybdate sulfate red, tris (2‑chloroethyl) phosphate and 2,4-dinitrotoluene. To obtain further information on this process or to submit data (by 30 September 2010) visit the ECHA website (at http://echa.europa.eu/consultations/authorisation/draft_recommendations/recommendations_en.asp).

…Agreement on the need for further animal tests under REACH

The Member State Committee has agreed with the proposal submitted by the registrant that developmental and reproductive toxicity studies are required for “hydrogenated oligomerisation products, including dimers and trimers, of tetradec-1-ene and alkene”. A final decision on these testing requirements will be made by ECHA. For more information see the ECHA news alert dated 11 June 2010 (ECHA/NA/10/32).

…Reporting substance identity in IUCLID 5.2

In a news alert (ECHA/NA/10/34) dated 21 June 2010, ECHA has announced the publication of a new manual to provide comprehensive and illustrative technical assistance in how to report and structure the identification of a substance in sections 1.1 and 1.2 of an IUCLID 5 dossier. It also explains which verifications REACH-IT applies to registration dossiers to ensure that the substance identification is consistent with other related information held in the database (pre-registration, inquiry, joint submission). In addition, specific considerations are made in the case of a pre-SIEF (Substance Information Exchange Forum) that has merged or split. It should be noted that the manual does not provide guidance on how to correctly identify a substance in accordance with the REACH regulation; links to the appropriate information on this are given in the introduction to the manual.

[Data Submission Manual. Part 18 – How to report the substance identity in IUCLID 5 for registration under REACH. Published in June 2010, the document is available at http://echa.europa.eu/doc/reachit/dsm18/substance_id_report_iuclid_en.pdf on the internet.] {185484}

…Evaluation of different crystalline forms – ECHA guide on identification issues

A new publication (dated 24 June 2010) in the Practical Guide series explains that although inorganic substances may have the same chemical composition, if they have different crystalline forms, they are regarded as different substances under REACH. The brief advice presented in the Practical Guide explains the approach ECHA will adopt in evaluating the identity of inorganic substances, and is intended to help potential registrants prepare their registration dossiers. ECHA will apparently update this guide whenever it becomes aware of issues that should be covered.

[Practical guide 11: How to address specific substance identification issues. The document is available at http://echa.europa.eu/doc/publications/practical_guides/pg_substance_id.pdf from ECHA.] {185517}

…REACH-IT industry user manual update

A revision of Part 7 – “Joint submission” has been published to reflect the enhanced joint submission functionality in REACH-IT 2.0.5. The document, dated May 2010, can be obtained at http://echa.europa.eu/doc/reachit/industry_user_manual/reachit_joint_submission_en.pdf on the ECHA website. {179752}

…More updated manuals for data submission

Yet another revision has been made to REACH-IT Data Submission Manual Part 4 to provide a more comprehensive explanation of the three instances where the legal entity needs to be indicated during the process of creating a dataset, creating a dossier and submitting it.

[REACH-IT Data Submission Manual Part 4 – How to pass business rule verification (“Enforce rules”). Version 2.4. The document, which is dated June 2010, can be accessed on the ECHA website (at http://echa.europa.eu/doc/reachit/how_pass_business_verification.pdf).] {177495}

The latest update of Data Submission Manual 2 explains the inquiry dossier submission process using REACH-IT 2.0 and IUCLID 5.2.

[Data Submission Manual 2 – How to prepare and submit an inquiry dossier. Version 1.4. The revised document, which is dated March 2010, is available from the ECHA website (at http://echa.europa.eu/doc/reachit/how_to_prep_sub_inquiry_doss_en.pdf).] {178836}

Amendments have been made to Data Submission Manual 5 to reflect the changes brought about by IUCLID 5.2 and the joint information requirements.

[Data Submission Manual 5 – How to complete a technical dossier for registrations and PPORD notifications. Version 2.5. The document, which is dated May 2010, can be obtained from ECHA (visit http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual.pdf).] {177496}

…Check what is published from your dossier – a new IT tool from ECHA

As announced in a news alert (ECHA/NA/10/36) dated 30 June 2010, a new IT tool enables companies to see what information ECHA will make public on the internet from their registration dossiers. The tool, which is an IUCLID 5.2 dissemination plug-in, is available via http://iuclid.echa.europa.eu/index.php?fuseaction=home.news&type=public&id=37 on the ECHA website. The accompanying manual (reported in Toxicology and Regulatory News 2010, 49(6), 55) explains the obligations under Article 119 of the REACH Regulation (EC 1907/2006) for ECHA to allow free online access to certain information it holds on chemicals, and is available via http://echa.europa.eu/help/help_docs_en.asp?view=dissemination on the internet.

…First proposals for restriction under REACH

As announced in a press release (ECHA/PR/10/13) dated 21 June 2010, the French Competent Authority has proposed that the use of lead and its compounds in jewellery and the use of dimethyl fumarate in consumer articles should be restricted. Three months after the Annex XV restriction reports are published, the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) will meet with the French Competent Authority before forming their opinions on the proposals. Although comments can be submitted until 21 December 2010, interested parties are encouraged to submit by 21 September 2010, so that the comments can be taken into account at this meeting. To view the supporting documentation, or to comment on the proposals, visit on the ECHA website {185494-5}

…Member registrant webinars

As part of its SIEF (Substance Information Exchange Forum) awareness campaign, ECHA has published the presentations given at four webinar sessions on “joint submission – member registrants”, which took place on 28-29 April 2010. The issues focused on were: dossier preparation by a member registrant, dossier creation in IUCLID 5.2 by a member, overview of requirements and tools for the chemical safety report, and submission of a registration dossier via REACH-IT. The presentations and videos of these webinars can be accessed via http://echa.europa.eu/news/webinars_en.asp on the ECHA website.

…Updated REACH-IT frequently asked questions (technical aspects)

Version 3.3 of this document, which is dated 7 June 2010, is now available on the ECHA website (at http://echa.europa.eu/doc/reachit/r-it_faq_tech_asp_v3_3_20100607.pdf). In addition to various amendments, it now includes some answers on working with classification and labelling notifications. ECHA points out that the tonnage bands for which an intermediate has been registered, using the corresponding IUCLID intermediate template, are displayed incorrectly in the Reference Number History section of REACH-IT. See page 19 of the document for further information.

…Proposal for harmonised classification and labelling of leucomalachite green

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 ECHA organises a public consultation period of 45 days. Under this scheme, a proposal has been recently submitted by the UK authorities to standardise the classification of leucomalachite green. To view the background scientific report, obtain further information, or comment on this proposal (by 5 August 2010), visit the ECHA website (at . {185493}

…Report format for harmonised classification and labelling proposals

Just arrived on the ECHA website (access http://guidance.echa.europa.eu/formats_en.htm) is a new report format for Member States Competent Authorities and industry to propose the harmonised classification and labelling of a substance.

The above items were taken from the August 2010 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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