News items on REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

Please note: Developments relating to the REACH legislation are unfolding so rapidly that web addresses assigned to documents often get subsequently changed (which occasionally means that the hyperlinks we provide unfortunately do not always work long-term). 

Keep your eye on the REACH ball

…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 http://echa.europa.eu/consultations/restrictions/ongoing_consultations_en.asp 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 http://echa.europa.eu/consultations/harmonised_cl_en.asp). {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.

Added as News items to our website 13 July 2010.

More REACH goals in sight

…Updated guidance released…

Having completed the process through the various committee and consultation stages, updated documents have now been issued for “Guidance on the preparation of dossiers for harmonised classification and labelling”, “Guidance on waste and recovered substances”, and “Guidance on information requirements and chemical safety assessment” Chapter R.14 (occupational exposure estimation), Chapter R.16 (environmental exposure estimation), and Exposure scenario format in Part D (exposure scenario building) and Part F (chemical safety report). The documents, which are dated May 2010, can be obtained via http://guidance.echa.europa.eu/guidance_en.htm from the ECHA website. {181234; 181236; 181250; 181252; 183519; 184130}

…and a freeze on the publication of further revised guidance documents

In a news alert (ECHA/NA/10/31) which is dated 2 June 2010, ECHA has announced that it has placed a six-month moratorium on the publication of ten updated guidance documents until 30 November 2010 (the first REACH registration deadline). This is apparently because industry associations need to devote more time to their members in preparing for the registration deadline (and therefore have less time for involvement in the guidance consultation process). However, ECHA stresses that companies may need to update their registrations following the publication of the revised documents. It also reminds companies of the clarifications that are already in place in the legal text and existing guidance on containment of isolated and transported intermediates, the scope of the exposure assessment, and exposure assessment for the waste life stage.

…Practical guides available

The latest publications in the Practical guide series are on “How to do a registration as a member of a joint submission”, “How to notify substances in the classification and labelling inventory” and “How to avoid unnecessary animal testing”. All the documents are dated May/June 2010 and are accessible (via http://echa.europa.eu/publications_en.asp) on the ECHA website. {185282-3; 185305}

…Notification to the classification and labelling inventory

ECHA is reminding companies that intend to place substances on the market that, from 1 December 2010, they must provide notification within one month and suggests, as a first step, that Practical guide 7 should be read (“How to notify substances in the classification and labelling inventory” – see above). Access http://echa.europa.eu/clp/inventory_notification_en.asp for further information.

…When is an intermediate not an intermediate under REACH?

Industry’s definition of an intermediate apparently differs from that of ECHA and the European Commission. To clarify the meaning of an intermediate under REACH, and to explain when a chemical substance can be registered solely as an intermediate and when a standard registration is required, ECHA has published a 12-page booklet (dated May 2010). This is available at http://guidance.echa.europa.eu/docs/guidance_document/clarificationintermediates_201005_en.pdf on the internet. {169340}

…Updated version of REACH-IT now released

The new version now includes features such as the ‘parallel joint submission’ that allows members of a joint submission to submit their dossiers as soon as the lead dossier has been accepted for processing (i.e. when it has passed the business rules). Also, a new online functionality allows companies to prepare their Classification and Labelling notifications directly in REACH-IT. More information is given in news alert ECHA/NA/10/29, which is dated 31 May 2010.

…Webinars for SIEF members

As a part of its SIEF (Substance Information Exchange Forum) awareness campaign, ECHA has prepared four webinar presentations for member registrants. The four presentations explain in detail how a member registrant who is part of a joint submission can prepare a registration dossier in IUCLID 5.2 and submit it via REACH-IT. The presentations are accessible via http://echa.europa.eu/news/webinars_en.asp on the ECHA website.

…Share and share alike

Data sharing is one of the core principles of REACH, helping to increase the efficiency of the registration system, reduce costs and avoid unnecessary animal testing. However, for companies failing to reach agreement on sharing data, ECHA has now issued dedicated webpages to provide assistance in the event of a dispute. Further information is provided in a news alert (ECHA/NA/10/24) which is dated 18 May 2010, or in the disputes section on the ECHA website (at http://echa.europa.eu/datasharing_en.asp).

…Calls for information to avoid unnecessary animal testing

ECHA publishes all proposals involving tests in vertebrate animals for the end-points specified in Annexes IX and X under REACH, and invites submissions of relevant data to ensure that additional animal testing is only conducted as a last resort. Currently, information is required on 2,3-epoxypropyl neodecanoate (studies on 90-day sub-chronic toxicity, developmental toxicity and two-generation reproductive toxicity). For more information or to submit data (by 12 July 2010) visit http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp on the ECHA website.

…Forum publishes the results of its first industry inspections

The Forum for Exchange of Information on Enforcement has published the results of its first REACH-EN-FORCE project, which involved nearly 1600 inspections (878 manufacturers, 666 importers, 83 only representatives and 858 downstream users) in 23 Member States in addition to Norway and Iceland. Non-compliance with their obligations under REACH was found in 24% of the inspected companies. Forum members agreed to extend the inspection activities until Spring 2011 to assess compliance with the first registration deadline of 30 November 2010. Further information and a link to the project report are given in a press release (ECHA/PR/010/10) which is dated 1 June 2010.

…ECHA's fourth stakeholders' day

Over 350 people from around the world participated in this event, which was held on 19 May 2010. The programme was divided into three sessions: tips and tools for registration and classification and labelling notification, feedback from registration and evaluation, and dissemination. The presentations given at the event can be downloaded from the ECHA website (by accessing http://echa.europa.eu/news/events/4th_stakeholders_day_en.asp).

…RAC opinions on harmonised classification for four chemicals

As announced in a news alert (ECHA/NA/10/28) of 28 January 2010, ECHA’s Risk Assessment Committee (RAC) has agreed the proposals from two Member States (France and Germany) for the harmonised classification and labelling of four chemicals. The substances under scrutiny were tetrahydrofuran, for classification as a carcinogen; gallium arsenide for classification for reproductive toxicity and carcinogenicity (RAC recommended a more severe classification for carcinogenicity than that initially proposed, based on data available for other arsenic compounds); and synthetic and natural cryolites for de-classification for acute oral toxicity (RAC, however, considered the data insufficient to support the additional classification of cryolites for eye irritation and reproductive toxicity). RAC’s deliberations on these substances are available (via http://echa.europa.eu/about/organisation/committees/rac/committee_opinions_en.asp) on the ECHA website. {185365-7}

… Amendment to the REACH Regulation

Annexes II and VI of the REACH Regulation, (EC) No. 1907/2006, have been amended as regards the requirements for the compilation of safety data sheets to bring them in line with the criteria given in Regulation (EC) No. 1272/2008 on the classification and labelling of chemical substances.

[Commission Regulation (EU) No. 453/2010 of 20 May 2010 amending Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union 2010, L133, 1 (visit http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2010:133:SOM:EN:HTML).] {185333}

Added as News items to our website 15 June 2010.

REACH campaign continues

…RAC assesses the use of boric acid and borates by amateur photographers

Under the REACH Regulation (entries 28-30 of Annex XVII) there is a general ban on supplying the general public with substances that are classified as carcinogenic, mutagenic or toxic to reproduction. Asked to consider a derogation for the supply of boric acid and borates for photographic applications, ECHA’s Committee for Risk Assessment has assessed the available toxicity and exposure data, and published its evaluation. The final decision rests with the European Commission.

[Committee for Risk Assessment. Opinion on new scientific evidence on the use of boric acid and borates in photographic applications by consumers. ECHA/RAC/A77-O-0000001273-82-05/F. The opinion (adopted on 29 April 2010) and background documents are available from ECHA (via http://echa.europa.eu/about/organisation/committees/rac/opinions_echa_ed_rac_en.asp).] {185051}

…Chemical safety assessment and reporting tool (Chesar) now available

Chesar (apparently pronounced “Kayzar”) is an IT tool developed by ECHA to help companies prepare their Chemical Safety Assessments (CSA) and Chemical Safety Reports (CSR) and works as a plug-in of the stand-alone version of IUCLID 5.2. Chesar 1.0 will produce the full CSA more efficiently and help to structure the information for the exposure scenarios, although it will not generate a full CSR or the exposure scenarios for the extended safety data sheets. The first upgrade enabling full CSR generation is planned for July 2010. For further information see news alert ECHA/NA/10/21 of 12 May 2010, or visit http://chesar.echa.europa.eu/ (the Chesar section of the ECHA website).

…Dissemination of information on registered substances and mixtures

In view of Article 119 of the REACH Regulation that requires ECHA to allow free online access to certain information it holds on chemicals, the Agency has released a manual that provides details of the intended process for data dissemination. The manual is aimed at industry, and in particular at managers and technical experts within companies who are responsible for ensuring that comprehensive information is entered in registration dossiers. A series of technical annexes is provided to accompany the main manual. In addition, a specific IUCLID 5 plug-in is being developed (expected to be released in June 2010) to enable registrants to verify, when preparing the registration dossier in IUCLID 5, which information would be disseminated on the ECHA website. The manual is expected to be frequently updated, due to technical progress with IUCLID and the Dissemination portal, so it would be wise to check the website regularly for the most recent version of the document.

[REACH-IT Data Submission Manual Part 15 – Dissemination: How to determine what will be published on the ECHA website from the registration dossier. Dated April 2010. The manual and accompanying Annexes can be obtained from ECHA’s dissemination portal to information on registered substances via http://echa.europa.eu/help/help_docs_en.asp?view=dissemination while a search facility can be accessed at http://apps.echa.europa.eu/registered/registered-sub.aspx to find information on registered substances.] {185162}

…Preparing a IUCLID 5 Classification and Labelling (C&L) notification dossier

To help companies identify which of the numerous IUCLID 5 fields are of major importance for ensuring successful submission of a C&L notification, ECHA has recently published a new user manual (which assumes IUCLID is already installed and a user account is available).

[Data Submission Manual Part 12 – How to prepare and submit a classification and labelling notification using IUCLID. Dated March 2010, the document is available from the ECHA website (at http://echa.europa.eu/doc/reachit/data_submission_manual_12_c&l.pdf).] {185163}

…Submitting a dossier through REACH-IT – updated manual

REACH-IT Data Submission Manual Part 4 has been revised to incorporate essential elements of Part 8 of the manual. It explains the initial checks that are made by REACH-IT to determine whether the dossier can be accepted and outlines how and why these checks are carried out. It is also intended to give guidance on how to prepare the substance dataset and the dossier header in order to pass the business rule verification.

[REACH-IT Data Submission Manual Part 4 - How to pass business rule verification (“Enforce rules”). Please note the title has changed (somewhat confusingly) from “How to complete the IUCLID dossier header”. The document, which is dated 15 April 2010, can be accessed on the ECHA website (at http://echa.europa.eu/doc/reachit/how_pass_business_verification.pdf).] {177495}

…Draft guidance documents published

As part of the consultation process when ECHA updates or develops new guidance documentation, discussions take place with a PEG (Partner Expert Group) composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities, followed by discussions involving ECHA Committees and/or the Forum, and a concluding consultation with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure are placed on the ECHA website (for full details, visit http://guidance.echa.europa.eu/guidance4_en.htm). The latest documents to enter this formal consultation process (in April 2010) are a draft Guidance for intermediates and a Guidance on information requirements and chemical safety assessment (Chapter R.5: Adaptation of information requirements). {169340; 181241}

…New guidance released

Having completed the consultation process through the various committee and consultation stages, an updated document has now been issued for the Guidance on information requirements and chemical safety assessment (Chapter R.15: Consumer exposure estimation). The document, which is dated 29 April 2010, is obtainable via http://guidance.echa.europa.eu/guidance_en.htm on the ECHA website. {181251}

…Calls for information to avoid unnecessary animal testing

ECHA publishes all proposals involving tests in vertebrate animals for the end-points specified in Annexes IX and X under REACH, and invites submissions of relevant data to ensure that additional animal testing is only conducted as a last resort. Currently, information is required on 2‑hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl ethanaminium chlorides, esters with C16-18 and C18 unsaturated fatty acids (two-generation reproductive toxicity) and 12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine (repeated-dose inhalation study). For more information or to submit data (by 10 or 18 June 2010) visit the ECHA website (at http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp).

…Changing legal entity made easier

As announced in a recent news alert (ECHA/NA/10/17), dated 16 April 2010, changes in legal personality and ‘Only Representatives’ can now be reported to ECHA in the new version of REACH-IT. ECHA has also reversed its policy on asset sales, allowing registrations to be transferred provided the company supplies evidence of transfer. Further details can be found in a new publication, “Practical Guide 8, how to report changes in legal entities”, which is available at http://echa.europa.eu/doc/publications/practical_guides/pg_legal_entity_change_no8.pdf on the ECHA website.

…Time for a tough talk with SIEF members

To ensure that Lead Dossiers are submitted in time, the Directors’ Contact Group has recommended that Lead Registrants tell all their SIEF (Substance Information Exchange Forum) members the date of intended submission of the Lead Dossier, and to announce a cut-off-date (suggested at two months before the submission date) after which a dormant member’s dossier will be frozen. Further details are given in a news alert ECHA/NA/10/19 of 16 April 2010 (additional background information on SIEFs can be found at http://echa.europa.eu/sief_en.asp).

…Webinar presentations available online for registrants

The eighth to tenth in a series of interactive webinars for Lead Registrants can be accessed (via http://www.echa.europa.eu/news/webinars_en.asp) on the ECHA website. These latest presentations are on classification and labelling, business rules, and data sharing and dissemination.

…Proposal for harmonised Classification, Labelling and Packaging (CLP) of chloroform

Under CLP Regulation (EC) No. 1272/2008, 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 French authorities to standardise the classification of chloroform.

For further information, or to comment on this proposal (by 14 June 2010), visit the ECHA website (at http://echa.europa.eu/consultations/harmonised_cl_en.asp). {185080}

Added as News items to our website 18 May 2010. 

Don’t be grounded – fly high with REACH

…Revised manuals to ensure compliance with the new version of REACH-IT

Since the new version of REACH-IT finally made it online (see news alert ECHA/10/12 dated 25 March 2010), ECHA has updated some of its manuals to accommodate the changes required to ensure “business rule failures” will not apply to dossiers submitted under the new version (2.0). The updated manuals can be accessed via http://echa.europa.eu/help/help_docs_en.asp on ECHA’s website.

…Read all about it – ECHA’s practical guides to preparing registration dossiers

With only seven months to go before the first registration deadline is with us, ECHA has produced a series of six publications to explain the level of detail needed to complete its registration dossiers and to help companies make the best use of integrated testing strategies. The six practical guides cover reporting of the following: in vitro data; robust study summaries; weight of evidence; data waiving; (Q)SARs; read-across and categories. The publications can be accessed via http://www.echa.europa.eu/publications_en.asp (then click on “Practical Guides”). Further information is given in news alert ECHA/NA/10/16 of 9 April 2010. {184827-32}

…Commission determined to speed up registration and authorisation

Following their undertaking given during Hearings in the European Parliament and a visit to ECHA, Vice President Tajani and Commissioner Potočnik have announced the actions they are taking to ensure the successful registration of high-volume chemicals by the 30 November 2010 deadline. Agreement was also reached on setting the criteria for the identification of substances that are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative; these criteria will be set out in the revised Annex XIII of REACH. The Commission has asked ECHA to identify additional priority substances of very high concern (SVHC) for inclusion in the “candidate list” (which currently contains 29 substances), bringing the total to 106 by 2012. More details are given in EU press release IP/10/360 of 25 March 2010.

…Acrylamide branded as SVHC

ECHA has announced in a press release (ECHA/PR/10/05) dated 30 March 2010 that acrylamide has been added to the “Candidate List” of substances of very high concern. A decision will be made later on whether this chemical will be subject to authorisation. The Member State Committee documents in support of inclusion of substances in the list are obtainable from ECHA (via http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp). {182932}

…Draft guidance document published

As part of the consultation process when ECHA updates or develops new guidance documentation, discussions take place with a PEG (Partner Expert Group) composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities, followed by discussions involving ECHA Committees and/or the Forum, and a concluding consultation with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure are placed on the ECHA website (for full details, visit http://guidance.echa.europa.eu/guidance4_en.htm). The latest document to enter this formal consultation process (in March 2010) is a draft Guidance on the compilation of safety data sheets. {184730}

…New guidances released

Having completed the consultation process through the various committee and consultation stages, an updated document has now been issued for the Guidance on information requirements and chemical safety assessment (Chapter R.12: Use descriptor system), as well as a new Guidance for Annex V exemptions from the obligation to register. Both documents are dated March 2010 and are available via http://guidance.echa.europa.eu/guidance_en.htm on the ECHA website. {179540; 181248}

…REACH-IT industry user manual

New titles added to the manual in March 2010 are Part 15 – Manage your Group of Manufacturers or Importers and Part 17 – Legal Entity Change, together with updated versions of Part 6 – Dossier submission and Part 8 – Invoicing. All the documents can be obtained by visiting http://echa.europa.eu/reachit/supp_docs_en.asp on the internet. {179752}

…Calls for information to avoid unnecessary animal testing

ECHA publishes all proposals involving tests in vertebrate animals for the end-points specified in Annexes IX and X under REACH, and invites submissions of relevant data to ensure that additional animal testing is only conducted as a last resort. Currently, information is required on sodium tripolyphosphate (90-day inhalation study in the rat) and 11-aminoundecanoic acid (developmental toxicity). For more information or to submit data (by 24 May 2010) visit the ECHA website (at http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp).

…Webinar presentations available online for registrants

The fourth to seventh in a series of interactive webinars for Lead Registrants can be accessed (via http://www.echa.europa.eu/news/webinars_en.asp) on the ECHA website. These latest presentations are on substance identity (mono-constituent substances, multi-constituent substances and UVCB substances i.e. those of unknown or variable composition, complex reaction products or substances of biological origin), the Technical Completeness Check (including how to use the TCC tool to check the completeness of a dossier before submitting it to ECHA) and Chemical Safety Assessment and Chemical Safety Report, parts 1 and 2.

Added as News items to our website 20 April 2010. 

More time within REACH?

…Imminent launch for updated REACH-IT

Although the planned launch of the new version of REACH-IT was slightly postponed to enable further testing of the system (ECHA News Alert ECHA/NA/10/09 of 19 March 2010), everything is now evidently looking rosy. There will be a temporary REACH-IT shut-down between 22 March, 17:00 EET (Eastern European Time) until 25 March, 9:00 EET (ECHA/NA/10/11, dated 22 March), to enable data to be backed up and migrated to the new system, after which the revised version of REACH-IT will be open for business. Industry may continue to submit and update dossiers prepared with IUCLID versions 5.0 and 5.1 while the current version of REACH-IT is still available, but as soon as REACH-IT re-opens, companies should use the new IUCLID 5.2 format.

…New group formed to tackle industry concerns over REACH deadline

A high level contact group has been set up to address concerns expressed by industry about meeting the 30 November 2010 deadline under REACH for the registration of chemicals that are in the higher tonnage bands and/or are deemed the most hazardous. The Directors’ Contact Group consists of Director-level representatives from the EC, ECHA and various industry associations (CEFIC, Eurométaux, REACH Alliance, Concawe, FECC and UEAPME) and aims to identify the priority issues of concern related to the deadline and, hopefully, to develop practical solutions that can be implemented before June. It is intended that the group will also address concerns over the potential disruption of supplies of high-volume substances to downstream users if the deadline cannot be met. Visit http://ec.europa.eu/environment/chemicals/reach/news_en.htm on the Environment Directorate-General website for further information.

…Progress in evaluating REACH registration dossiers

ECHA has issued a report describing its progress in evaluating REACH registration dossiers in 2009. Only a small proportion of registration dossiers have been evaluated – during 2009 ECHA received 406 complete registration dossiers, and initiated an evaluation on 35 of these. Compliance checks were concluded on 14 of the 27 undertaken and, of eight examinations of testing proposals, one decision has been taken. The report also identifies the most commonly occurring problems, and provides recommendations to help registrants improve the quality of their dossiers. The report, which is entitled “Evaluation under REACH, Progress Report 2009”, is obtainable at http://echa.europa.eu/doc/progress_report_2009.pdf on the ECHA website. {184445}

…Draft guidance documents published

As part of the consultation process when ECHA updates or develops important new guidance documentation, discussions take place with a PEG (Partner Expert Group) composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities, followed by discussions by ECHA Committees and/or the Forum, and a concluding consultation with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure are made available on the ECHA website (via http://guidance.echa.europa.eu/guidance4_en.htm). The latest documents to enter this process (in February or March 2010) are draft guidances on information requirements and chemical safety assessment: a draft of a new Chapter B.8 (Scope of exposure assessment), for inclusion in Part B – Hazard assessment, and a revision of Chapter R.18 – Estimation of exposure from waste life stage. {181232; 181254}

…Appealing against ECHA decisions

A new publication, “Practice Directions to parties to appeal proceedings before the Board of Appeal of the European Chemicals Agency”, is intended to help companies and their representatives prepare appeals against certain ECHA decisions in the most effective way. It includes specific rules, as well as templates and a check list, to enable appellants to ensure that they submit the information necessary for their appeal in due time. The document (dated 8 March 2010) is located at http://echa.europa.eu/doc/appeals/appeals_practice_directions_20100308.pdf on the internet.

…ECHA’s proposed 2-year work plan

An overview of ECHA’s planned activities for 2011-2013 is published in a draft document (open to public comment until 9 May 2010). Further details are given in a press release (ECHA/PR/10/04) dated 12 March 2010.

…ECHA consults on substances of very high concern

Member State competent authorities and ECHA may prepare Annex XV dossiers for substances of very high concern as defined in Article 57 of the REACH regulation. These include substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB). The latest batch of dossiers, all dated February 2010, cover the following compounds: boric acid, disodium tetraborate, tetraboron disodium heptaoxide, sodium and potassium chromate, ammonium and potassium dichromate and trichloroethylene, all of which are proposed as CMR chemicals. These reports (plus ‘commenting forms’ for submission by 22 April 2010) can be obtained from the ECHA website (by visiting http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp). {184510-16}

Added as News items to our website 23 March 2010.

More news on REACH

…ECHA proudly announces the arrival of IUCLID 5.2

In a News Alert (ECHA/NA/10/03) dated 4 February 2010, the European Chemicals Agency announced the launch on 15 February of IUCLID 5.2, which enables registrants to record classification and labelling details and facilitates the automation of dossier processing by REACH-IT. In addition, sections 3.5 and 3.6 on use description have been adapted, as explained in the updated guidance on information requirements and chemical safety assessment. Registrants have until March 2010 to submit their dossiers using previous versions of IUCLID, although data stored in the IUCLID 5.0 or 5.1 formats can be automatically transferred into the new format during installation of IUCLID 5.2. A refinement of REACH-IT (to include a number of new features) is expected to be available in March 2010, and an update to the technical Completeness Check Tool (to reflect the changes within IUCLID) is also in progress.

…Draft guidance documents published

As part of the consultation process when ECHA updates or develops new guidance documentation, discussions take place with a PEG (Partner Expert Group) composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities, followed by discussions by ECHA Committees and/or the Forum, and a concluding consultation with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure are made available on the ECHA website (via http://guidance.echa.europa.eu/guidance4_en.htm).

The latest documents lodged with the PEG (December 2009-February 2010) are new draft guidances on risk communication and on waste and recovered substances, and draft updates on information requirements and chemical safety assessment (Chapters R.8 – Characterisation of dose (concentration)-response for human health characterisation (DNEL/DMEL derivations), R.14 – Occupational exposure estimation, and R.15 – Consumer exposure estimation). Now at the ECHA Committee/Forum stage of the review process (in January/February 2010) are draft updates on (other aspects of) information requirements and chemical safety assessment (Chapter R.16 – Environmental exposure estimation) and on requirements for substances in articles, plus draft guidance on the preparation of dossiers for harmonised classification and labelling (CLH) under Regulation (EC) No. 1272/2008. Nearing conclusion are the consultations on a further draft update covering information requirements and chemical safety assessment (Chapter R.12 – Use descriptor system) and on the draft guidance relating to Annex V exemptions (where REACH registration is deemed inappropriate or unnecessary); these documents were received (on 21 December 2009 and 3 February 2010) for final scrutiny by the EC/Member State competent authorities. {177086; 179540; 181244 ; 181248; 181250-2; 183519; 184130-1}

…Annex IV review

Chemicals included in Annex IV of the REACH regulation are exempted from registration requirements because there is sufficient information for them to be “considered to cause minimum risk because of their intrinsic properties”. A recently published paper summarises the toxicological criteria for demonstrating minimum risk, and also describes the findings of the review that resulted in the Commission’s 2008 amendment to Annex IV. The investigators conclude that “although developed in the frame of REACH registration”, the risk criteria “could be more widely used in the sound management of chemicals” (Blainey M. et al., Regulatory Toxicology and Pharmacology 2010, 56, 111; http://dx.doi.org/10.1016/j.yrtph.2009.09.016). {184196}

Added as News items to our website 18 February 2010.

No freeze on REACH activities

...More substances branded as SVHC

ECHA has added 14 more substances (13 January 2010) to the “Candidate List” of substances of very high concern (ECHA/PR/10/01). Decisions on whether these substances will be subject to authorisation will be taken at a later date.

...Updated manual for REACH registrations and PPORD notifications

A revised version (Release 2.2, dated 15 December 2009) has been recently issued of Data Submission Manual 5: “How to complete a technical dossier for registrations and PPORD [Product and Process Orientated Research and Development] notifications”. The manual is available from ECHA (visit http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual.pdf). {177496}

...First agreement on the need for further animal tests under REACH

The first decision by the Member State Committee on a chemical based on read-across data has not been favourable, suggesting that it may be difficult in some instances to reduce animal testing requirements for registration. After scrutiny of a registrant’s proposal to use read-across from another substance, the Committee deemed that there was not enough justification for this, and that studies for repeated dose toxicity and reproductive toxicity were required. Details concerning the substance (and registrant) have not been made public. More information is given in a news alert (ECHA/NA/09/33) dated 7 December 2009, which reports that a final decision on testing requirements will be reached by ECHA.

...REACH Technical Completeness Check (TCC) plug-in

To enable companies to check whether their registration dossiers are complete before submission, ECHA released (in December 2009) an IUCLID plug-in that can be accessed on the IUCLID website (via http://iuclid.echa.europa.eu/). Since the plug-in can also be used to check the technical completeness of Product and Process Orientated Research and Development (PPORD) dossiers, companies are advised to use it for this purpose, rather than the previous software made available, as the TCC rules have been updated.

...Database on registered substances

On 18 December 2009, ECHA made available (under the REACH Regulation) information submitted by companies on the hazards and safe use of chemical substances that have already been registered, although the Agency pointed out that this data has not been verified. Some information is not disseminated because companies have claimed confidentiality. The database can be accessed via http://apps.echa.europa.eu/registered/registered-sub.aspx on the ECHA website.

...Compliance checks on unfinished NONS dossiers

Under previous legislation there was a requirement for the Notification Of New Substances (NONS), which were assessed by Member State competent authorities. Some of these assessments were not finalised before REACH came into force (revoking the preceding NONS Directive), and toxicity data may be missing from certain dossiers. As a consequence, ECHA is now undertaking a compliance check on unfinished NONS submissions. Further information is given in a news alert (ECHA/NA/09/37) dated 18 December 2009.

...Webinar presentations available online for registrants

The second and third in a series of interactive webinars for Lead Registrants can be accessed (via http://www.echa.europa.eu/news/webinars_en.asp) on the ECHA website. These latest presentations on information requirements cover robust study summaries, weight of evidence approach, use of in vitro data, QSARs, waiving information requirements, read-across and categories.

...Forum check on how formulators comply with REACH

The Forum for Exchange of Information on Enforcement has announced that its next joint REACH enforcement project will focus on formulators of mixtures who are the first level of downstream users in the supply chain. More details can be obtained in a news alert (ECHA/NA/09/34) issued on 14 December 2009.

Added as News items to our website 19 January 2010.

Seasonal delights within REACH

…ECHA guidance documents in the making

As part of the consultation process when ECHA updates or develops new guidance documents, discussions take place with a PEG (a Partner Expert Group composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities), with ECHA Committees and/or the Forum, and finally with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure can be obtained from ECHA (via http://guidance.echa.europa.eu/guidance4_en.htm). The latest document to be lodged (as announced on 11 November 2009) with a PEG under this consultation process is a draft guidance on information requirements and chemical safety assessment (chapter R.16 – Environmental Exposure Estimation). Meanwhile, two documents (as announced on 12 November 2009) have reached the giddy heights of the ECHA Committee/Forum stage of the review process: a draft guidance on Annex V (exemptions from the need to register) of REACH and a revised draft update of the guidance on information requirements and chemical safety assessment (chapter R.12 – Use Descriptor System). {179540; 181248; 181252}

…Calls for information to avoid unnecessary animal testing

ECHA publishes all proposals involving tests in vertebrate animals for the end-points specified in Annexes IX and X under REACH, and invites the submission of relevant data to ensure that animal testing is only conducted as a last resort. Currently, information is required (appropriately enough by 24 December 2009) on “polysulfo (5-hydroxy-1-naphthalen-2-yl-[4-[4-(2-sulfatoethyl-sulfonyl)-phenyl]diazenyl]-1H-pyrazole-3-carboxylic acid), alkali metal salt” for which the applicant is proposing an in vivo study on its genotoxicity. Also requested (by 11 January 2010) is information on 4-((triethoxysilyl)methyl) morpholine, for which studies on developmental and reproductive toxicity and subchronic toxicity are proposed. More information can be found at http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp on the ECHA website.

…REACH-IT takes a Christmas break

From 14 December 2009 until the New Year (3 January), REACH-IT will not be available for dossier submissions. This will allow ECHA to install a new version of the software in order to cope with the large number of registrations expected in 2010. Further information is given in an ECHA news alert dated 20 November 2009 (ECHA/NA/09/30).

…ECHA provides more answers to questions on CLP and REACH

“Frequently asked questions about CLP” is a new publication (dated 4 November 2009) that gives answers to potential queries about the classification, labelling and packaging of substances. It can be downloaded from http://echa.europa.eu/doc/CLP/clp_faq_1_0_20091104.pdf courtesy of ECHA. {183704}

Also available from ECHA (by visiting http://echa.europa.eu/doc/reach/reach_faq.pdf) is Version 3.0 (dated 19 November 2009) of “Frequently asked questions about REACH”. {177761}

…Webinar on preparing and submitting a registration dossier

The first in a series of interactive webinars for Lead Registrants can be accessed (via http://www.echa.europa.eu/news/webinars_en.asp) from ECHA. Presentations given at this virtual REACH-fest cover exporting information as a IUCLID 5 registration dossier and submission via REACH-IT, dossier processing at ECHA and receiving a registration number.

Added as News items to our website 15 December 2009.

New sights within REACH

…Updated ECHA guidance on registration

This document (dated 9 November 2009) has been revised to clarify the information that needs to be submitted for updating dossiers of previously notified substances (NONS). It is available (at http://guidance.echa.europa.eu/docs/guidance_document/registration_en.pdf) from the ECHA (European Chemicals Agency) website. {169341}

…Draft guidance documents for consultation

As part of the consultation procedure when ECHA updates or develops new guidance documentation, discussions take place with a PEG (Partner Expert Group) composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities. The latest consultation documents to reach the PEG stage (as announced on 29 October and 4 November 2009) are the second draft of an updated guidance on requirements for substances in articles (along with comments made on the first draft), and a new guidance document on the preparation of dossiers for harmonised classification and labelling under Regulation (EC) No. 1272/2008. Visit http://guidance.echa.europa.eu/guidance4_en.htm to obtain copies. {178068; 183519}

…Chemical safety assessments made simple

A further publication (announced on 3 November 2009) in ECHA’s “Guidance in a nutshell” series is intended to assist industry in understanding the general provisions for conducting a chemical safety assessment under REACH. Standing at just over 20 pages, it is available from ECHA (via http://guidance.echa.europa.eu/docs/guidance_document/nutshell_guidance_csa_en.pdf). {177085}

…ECETOC advice on using human data for setting DNELs and DMELs

A key conclusion of an ECETOC/TNO workshop held in December 2007 was that, although the REACH guidance on information requirements and chemical safety assessments (Chapter R.8) recognised the value of human data, it included no specific advice on how these data should be used for setting DNELs and DMELs. As a consequence, a document was developed under the auspices of ECETOC and TNO that outlines how human data can be incorporated into DNEL/DMEL derivations. Although the report does not represent approved ECHA advice, the Agency has announced its intention of using the document to assist in the revision of official REACH guidance (probably in 2010).

[Working document for the Expert Review Panel on using human data in DNEL/DMEL (Derived No-Effect Level/ Derived Minimal-Effect Level) derivations. May 2008 – version 2. Available from the website of the European Centre for Ecotoxicology and Toxicology of Chemicals (via http://www.ecetoc.org/index.php?mact=Newsroom,cntnt01,details,0&cntnt01documentid=87&cntnt01dateformat=%25d-%25m-%25Y&cntnt01returnid=76).] {183486}

…Amended format for an Annex XV restriction report

A new combined format for an Annex XV restriction report replaces the existing formats provided in the “Guidance on Annex XV for restrictions” and the “Guidance on socio-economic analysis (SEA) – restrictions”. The amended format (dated 1 October 2009) can be downloaded by visiting http://guidance.echa.europa.eu/docs/authorities/AXV_restriction_format_01102009.doc on the ECHA website.

…ECHA introduces web zone on restrictions

On 5 November 2009 (presumably without any fireworks), ECHA launched a new section of its website (http://echa.europa.eu/restrictions) devoted to existing restrictions and the procedure for new restrictions.

…First appeal against a dismissed registration

A summary of the first appeal against a rejected registration and its outcome was made available (on 4 November 2009) on the Appeals section of the ECHA website. Details can be found at http://echa.europa.eu/appeals_en.asp (click on “Appeal announcements” in the menu).

Added as News items to our website 17 November 2009. 

Autumn – time to gather in more juicy REACH offerings

…Information requirements for repeated dose toxicity and reproductive toxicity

To prevent unnecessary animal tests, ECHA published a fact sheet (ECHA-09-FS-05-EN, dated 15 September 2009) that explains the possible options if short-term repeated dose toxicity and/or reproductive and developmental toxicity tests are not available at the time of registration. This is intended to help companies decide on the data that needs to be included in their dossiers (for substances manufactured or imported at quantities greater than, or equal to, 100 tonnes/year) in order to pass ECHA’s technical completeness check.

…Registration of notified substances

A revised version (dated 1 October 2009) of Data Submission Manual 5: how to complete a technical dossier for registrations and PPORD notifications (Release 2.1) has been published on the ECHA website (at http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual.pdf). New sections are provided to include additional information on when to update a registration that is based on a previous notification, how to claim a registration number for a substance previously notified under the dangerous substances Directive 67/548/EEC, and how to update confidentiality claims. Guidance is also provided on the minimum data requirements for IUCLID 5. {177496}

Aimed at resolving any queries resulting from the revised manual, an update of “Questions and answers for the registrants of previously notified substances” has been made available at http://echa.europa.eu/doc/reachit/prev_not_sub_registrants_qa.pdf on ECHA’s website. {179289}

…Guiding the way for lead registrants

A press release (ECHA/PR/09/14, dated 15 September 2009) provides links to the presentations and ‘webstreaming’ of the workshop for lead registrants held in Brussels on 11 September 2009. Companies can also find information on a series of interactive ‘webinars’ (about one per month between now and early summer 2010). Run by ECHA experts, these will cover: general principles of dossier preparation and submission; information requirements – part I (e.g. robust study summaries, waiving information requirements and justification); information requirements – part II (e.g. QSARs, read-across, categories and in vitro data); substance identity; technical completeness check (TCC tool); chemical safety report (CSR) and chemical safety assessment (CSA) – part I (e.g. CSA tool and human health end-points); CSR and CSA – part II (e.g. CSA tool and environmental end-points); business rules and classification and labelling notifications.

…Time is ticking for downstream users to contact their suppliers about chemical uses

A further press release (ECHA/NA/09/19, dated 12 October 2009) reminds downstream users to inform their suppliers about substance uses if they want these to be included in the chemical safety assessment of the registrant. Less than two months remain before the 30 November 2009 deadline, which applies to substances required to be registered before 1 December 2010. The press release also provides links to background documents and further information.

…List of registered substances published

A list of 156 substances, based on the complete registration dossiers submitted by companies to ECHA before 24 September 2009, is now available to view on the ECHA website (via http://echa.europa.eu/chem_data/registered_substances_en.asp). ECHA notes that not all substances for which a registration had been submitted at this stage could be included.

Added as News items to our website 19 October 2009.

REACH back to work after the summer break

Regulation (EC) No. 440/2008, which describes the test methods pursuant to REACH, has been amended to include, among other changes, a new in vitro test method for skin irritation using reconstructed human epidermis models.
[Commission Regulation (EC) No. 761/2009 of 23 July 2009 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union 2009, L220, 1. The document is available from the EUR-Lex website (at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:220:0001:0094:EN:PDF).] {177087}

…ECHA consults on substances of very high concern

Member State competent authorities and the European Chemicals Agency may prepare Annex XV dossiers for substances of very high concern as defined in Article 57 of the REACH regulation. These include substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB). The latest batch of dossiers, all dated July or August 2009, cover the following compounds: acrylamide; high temperature coal tar pitch; 2,4-dinitrotoluene; diisobutyl phthalate; refractory ceramic fibres of zirconia aluminosilicate or of aluminosilicate; tris(2-chloroethyl) phosphate; lead chromate and the related pigments C.I. Pigments Red 104 and Yellow 34; and various anthracene oils. These reports (plus ‘commenting forms’ for submission by 15 October 2009) are available via http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp from the ECHA website. {182931-9}

…Don’t be backward at coming forward; ECHA’s plea to Lead Registrants

A News Alert from ECHA (ECHA/NA/09/14) dated 31 August 2009, reminds Lead Registrants that they cannot benefit from the dedicated special service being offered to help with their SIEF (Substance Information Exchange Forum) activities if they do not identify themselves and register with ECHA. The Agency is aware that some nominated individuals have concerns about the legal implications of such action and would like to assure them that, from ECHA’s point of view, such a notification does not have legal implications beyond those already stemming from the REACH Regulation.

Added as News items to our website 18 September 2009.

Lazing on a sunny afternoon? Catch up with your REACH reading!

...Annex XV transitional reports

Under article 136 (3) of the REACH Regulation, EU Member States were required to submit transitional reports on the risk assessments and possible risk reduction options for certain existing substances, where the work was not finalised before 1 June 2008. These substances were prioritised under previous legislation (Regulation (EEC) No. 793/93), either due to their large production volumes or because of their potential persistent, bioaccumulative and toxic properties. Annex XV reports on nearly 30 of these substances (which provide information useful to companies planning to register the chemicals) have now been made available on ECHA’s website (via http://echa.europa.eu/chem_data/transit_measures/annex_xv_trans_reports_en.asp). {182768-92}

...Voluntary risk assessment reports on lead and copper compounds

Following an industry initiative, voluntary risk assessment reports on copper compounds (submitted by the European Copper Institute) and lead compounds (submitted by the Lead Development Association International) are available. To access these reports from ECHA visit http://echa.europa.eu/chem_data/transit_measures/vrar_en.asp (site last updated 13 July 2009). {182709-10}

...Hydrogenated oligomerisation products of tetradec-1-ene and alkene 

ECHA has requested information on the reproductive toxicity of the hydrogenated oligomerisation products, including dimers and trimers, of tetradec-1-ene and alkene. This is to ensure that the best use is made of existing information and to avoid unnecessary animal testing. Holders of relevant data were invited in August 2009 to submit information via forms on the ECHA website (at http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp).

...Draft updated guidance document on requirements for substances in articles

When ECHA updates or develops new guidance, a consultation process takes place before the documents are finalised to hopefully ‘iron out’ any shortcomings. The consultation procedure consists of three steps involving discussions with a Partner Expert Group (PEG; composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities), ECHA Committees and/or the Forum, and a concluding consultation with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure are made available on the ECHA website (via http://guidance.echa.europa.eu/guidance4_en.htm). The latest document currently at the PEG stage (as announced on 23 July 2009) is an update of the guidance document on requirements for substances in articles. {178068}

...Number of SIEFs grows – must be the summer sun and showers

...IUCLID 5 upgrade

An upgrade (5.1.1) is available for the standalone and the distributed versions of IUCLID 5. This June 2009 upgrade can be downloaded free of charge from the “Get IUCLID 5” section of the IUCLID 5 website (via http://iuclid.echa.europa.eu/).

No summer holidays yet within REACH?

…Annex XVII of REACH Regulation revised

Amendments have been made to Annex XVII, which imposes restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles that pose an unacceptable risk to human health or the environment.

[Commission Regulation (EC) No. 552/2009 of 22 June 2009 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 Annex XVII. Official Journal of the European Union 2009, L164, 7. Published 26 June 2009. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:164:0007:0031:EN:PDF on the internet.] {182458}

…Draft guidance documents on Annex V exemptions and information requirements

When ECHA (the European Chemicals Agency) updates or develops new guidance, a consultation process takes place to hopefully iron out any shortcomings before the documents are finalised. The consultation procedure consists of three steps involving discussions with a Partner Expert Group (PEG; composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities), dialogue with ECHA Committees and/or the Forum, and a concluding consultation with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure are being made available on the ECHA website (via http://guidance.echa.europa.eu/guidance4_en.htm). Three documents were listed in June 2009 as having reached the PEG stage – a guidance on applying the different exemptions for Annex V of the REACH Regulation, and two updated guidances relating to information requirements and chemical safety assessment (Chapter R. 12: use descriptor system, and Part D: exposure scenario building). {179540; 181234; 181248}

…Guidance in a Nutshell, for those allergic to reading complete works

As reported in ECHA press release ECHA/NA/09/09 of 24 June 2009, simplified versions (both dated 16 June 2009) of the full guidance documents have been published on “requirements for substances in articles” and “registration data and dossier handling”. ECHA warns that these Guidance in a Nutshell documents aim to explain certain aspects of REACH in simple terms and do not contain all the details available in the full guidance publications.

More activity within REACH

…Updated manual for registrations and PPORD notifications

Data Submission Manual 5 has been revised by the European Chemicals Agency and issued as Release 2.0 (dated 12 May 2009). The manual provides guidance relating to the preparation of registration and PPORD (product and process oriented research and development) dossiers, and includes advice on which IUCLID 5 sections/fields need to be filled. It can be downloaded (via http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual.pdf) from the ECHA website. {177496}

…Tighter controls loom a step closer for the first substances of very high concern

Following endorsement by the Member State Committee, ECHA submitted (on 1 June 2009) its recommendation to the European Commission that seven substances of very high concern should be included in the so-called ‘Authorisation List’. The substances named and shamed are: 4,4′‑diaminodiphenylmethane (carcinogenic); bis(2-ethylhexyl) phthalate, benzyl butyl phthalate and dibutyl phthalate (toxic to reproduction); short-chain chlorinated paraffins, musk xylene and hexabromocyclododecane (persistent, bioaccumulative and toxic, and/or very persistent, and very bioaccumulative). A final decision will be taken by the European Commission, after which the listed substances will only be permitted for use within the EU when authorised for specific purposes (under Annex XIV of the REACH Regulation). Further information is obtainable via http://echa.europa.eu/chem_data/authorisation_process/annex_xiv_rec_en.asp on the internet.

REACH for more guidance

…ECHA issues top tips for SIEF members

ECHA has issued a four-page fact sheet to help companies get started in Substance Information Exchange Fora and deal with potential problems in communication between members. REACH fact sheet: “Getting started in SIEFS – top tips” (ECHA-09-FS-01-EN, dated 24 April 2009) is available at http://echa.europa.eu/doc/reach/reach_factsheet_siefs.pdf on ECHA’s website.

...Instructions for name changing

A second fact sheet sets out the duties of companies in cases where they change their name or their legal personality, or sell assets relating to their pre-registration, registration, notification or inquiry. REACH-IT fact sheet: “Duties of companies that change their name or legal personality” (ECHA-09-GF-01-EN, dated 17 April 2009) can be obtained from ECHA (visit http://echa.europa.eu/doc/reachit/fact_sheets/reach_it_factsheet_legal_entity_change_20090417.pdf).

...Further functions added to REACH-IT

REACH-IT has been updated to assist companies with online inquiries and changes in legal entity names. To help with this new functionality, ECHA has published REACH-IT Industry User Manual Part 11: “Online dossier creation and submission for inquiries” (7 April 2009). This is available at http://echa.europa.eu/doc/reachit/industry_user_manual/reachit_online_dossier_creation_inquiry_en.pdf on the internet. {179752}

...Business rules, OK

REACH-IT Data Submission Manual 8: “Business rules validation” (dated 17 April 2009) explains the administrative checks (“business rules”), automated and manual, which are made by ECHA to ensure that a dossier can be accepted for processing. This publication is obtainable at http://echa.europa.eu/doc/reachit/reachit_data_submission_manual_8_business_rules_validation_20090417.pdf from the ECHA website. {181872}

...First co-ordinated REACH enforcement project

REACH-EN-FORCE-1 is a joint project started across Europe in which national inspectors will check pre-registrations, registrations and, where applicable, the provisions for safety data sheets. ECHA states this project will indicate the level of compliance by manufacturers and importers, and hopes to produce a report on this activity in early 2010. See ECHA/PR/09/05, dated 30 April 2009 (at http://echa.europa.eu/doc/press/pr_09_05_enforcement_project_forum%20_20090430.pdf).

Concern mounts over slow start for REACH SIEFs

Chemical Watch reports that there is a growing concern among regulators and industry leaders at the lack of action by members of many REACH substance information exchange group fora (SIEFs). The efficient operation of these mandatory groups is crucial to meeting REACH targets.

Members of the European Chemicals Agency (ECHA) Management Board were given a pessimistic picture of progress at their meeting last week. Although the responsibility for SIEF operation lies in industry’s hands, the Agency is considering what extra advice and support it may be able to give.

In a set of documents issued subsequent to a meeting between the authorities and industry bodies at the end of March, CEFIC warns companies of the need to act now – quote – “The deadlines for the completion of a joint submission dossier are extremely tight so no time must be wasted” – unquote. The organization also urges its members and other major chemical firms to take responsibility now for leading SIEFs or finding someone to do so, if it has not yet begun operating.

This news item was added to website on 14 May 2009. 

More chemicals within REACH

…Updated list of pre-registered substances

As announced in its press release ECHA/PR/09/03 of 27 March 2009, the European Chemicals Agency (ECHA) has issued an updated version of the list of pre-registered substances containing about 143,000 chemicals that were pre-registered between 1 June and 1 December 2008. This new list includes CAS numbers for some substances previously identified only by chemical name and provides identification numbers for chemicals without a current EC number (to make registration easier). The search functions have also been upgraded. ECHA hopes that this latest version will help companies find the correct SIEF (Substance Information Exchange Forum). Since the list contains many preparations and substances that ECHA considers do not require registration, the Agency advises companies to check before proceeding. The list is available at http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx on ECHA’s website. {179288}

…New webpage on socio-economic analysis

Press release ECHA/NI/09/05 of 26 March 2009 publicizes a new webpage on socio-economic analyses in the restriction and authorisation processes of chemical substances under REACH. ECHA's Socio-Economic Analysis and Risk Assessment Committees form opinions about the proposals for restriction or requests for authorisation that are then sent to the European Commission for a decision. Further information on activities in this area is available from ECHA (via http://echa.europa.eu/reach/sea_en.asp).

…IUCLID provides support for Chemical Safety Report preparation

To help companies in the preparation of sections 1-7 of Chemical Safety Reports (CSRs), which are required for substances manufactured or imported above 10 tonnes/year, the IUCLID software team has provided a CSR plug-in for version 5.1 of IUCLID. This allows extraction of data from a IUCLID dataset or dossier and generates a modifiable document in RTF or XML format, based on the ECHA CSR template. The CSR plug-in and user manuals can be downloaded (via http://iuclid.echa.europa.eu/index.php?fuseaction=home.news&type=public&id=19).

…Workshop report on authorisation

Summary proceedings, and workshop presentations, are now available of a meeting (held 21‑22 January 2009) at which representatives of ECHA, EU Member States and the European Commission discussed the implementation of the authorisation process under REACH (visit http://echa.europa.eu/doc/consultations/authorisation/authorisation_workshop_proceedings_20090121.pdf).

Spring activity within REACH

…REACH Regulation is amended (in Annex XI) and corrected

In order to clarify the criteria providing justification for the omission of substance testing, an amendment has been published to Annex XI of Regulation (EC) No. 1907/2006 on REACH. Article 3(20)(c) of the Regulation (on phase-in substances) has also been the subject of a corrigendum.

[Commission Regulation (EC) No. 134/2009 of 16 February 2009 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 Annex XI. Official Journal of the European Union 2009, L46, 3 (available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:046:0003:0005:EN:PDF). Corrigendum to Regulation (EC) No. 1907/2006. Official Journal of the European Union 2009, L36, 84 (available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:036:0084:0084:EN:PDF).]

…Harmonised classification and labelling – epoxiconazole and diantimony trioxide

Under Regulation (EC) No. 1272/2008, suppliers of chemicals (substances and mixtures) are legally obliged to evaluate the hazards of chemicals and to classify and label them appropriately before placing them on the market. In addition, Member State competent authorities or industry may ask for the classification and labelling of a substance to be harmonised across Europe. When proposals for these harmonisations are submitted, the European Chemicals Agency (ECHA) is responsible for organising a public consultation period of 45 days. The first such proposals have now been submitted by Sweden on epoxiconazole (a fungicide) and diantimony trioxide (used as a flame retardant and glass additive, and in the manufacture of pigments and paints). Comments are invited by 9 April 2009; visit http://echa.europa.eu/consultations/harmonised_cl_en.asp for further details. {181038‑9}

…First evaluation progress report published by ECHA

As required by Article 54 of the REACH Regulation, ECHA has issued a report covering the progress made in its evaluation tasks during 2008. Since only 94 registration dossiers were submitted, of which only ten passed the completeness check, the report is brief (four pages) but ECHA anticipates a larger number of dossiers will be evaluated during 2009, allowing it to provide recommendations to potential registrants in the next report.

[European Chemicals Agency. Evaluation Progress Report 2008. ECHA-09-R-01-EN, dated 27 February 2009 (available at http://echa.europa.eu/doc/progress_report_2008.pdf).]

REACHing for chemical accolades

…Application of REACH to nanomaterials

Following ongoing discussions within the REACH Competent Authorities and its subgroup on nanomaterials, a document has been published describing how REACH is seen currently to apply to nano-sized materials, and the challenges that are envisaged in its implementation.

[European Commission. Follow-up to the 6th Meeting of the REACH Competent Authorities for the implementation of Regulation (EC) 1907/2006. Nanomaterials in REACH. 16 December 2008 (available at http://ec.europa.eu/environment/chemicals/reach/pdf/nanomaterials.pdf).] {180904}

…ECHA upgrades for REACH-IT and IUCLID 5

The European Chemicals Agency has updated REACH-IT (released 16 January 2009) by improving searches and messaging modules in order to facilitate the formation of SIEFs (Substance Information Exchange Forums). Further information can be obtained via http://echa.europa.eu/news/press_en.asp#press20090120 on the ECHA website.

A query plug-in is now available which is intended to extend the ways in which data can be searched in a user’s IUCLID 5 database, and to access administrative and scientific data. The query tool plug-in runs only with the latest version of IUCLID (5.1; released 16 January 2009). Visit http://iuclid.echa.europa.eu/ for more information.

…Pre-SIEFS and SIEFs – ECHA explains how to share information

To assist SIEF formation, REACH-IT automatically placed companies that pre-registered chemicals with the same name (or chemical identifiers) in the same pre-SIEF. However, an ECHA document (dated 13 February 2009) reminds companies that they should form SIEFs and make these groups operationally active as soon as possible, particularly in cases where registrations have to be submitted by 1 December 2010. Although the REACH Regulation leaves the management of SIEFs to industry, the ECHA memorandum sets out the key points involved and clarifies the role of the very grandly titled SIEF Formation Facilitator (ECHA document available at http://echa.europa.eu/doc/reachit/sief_key_principles.pdf). {180934}

REACH off to a flying New Year start

…Pre-registered substances

The European Chemicals Agency published (on 19 December 2008) an updated list of about 150,000 substances that had been pre-registered, by 65,000 companies, between 1 June and 1 December 2008. This list is available (via http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx) on the ECHA website. ECHA now has the task of checking the information submitted on substances not listed in the EINECS (existing substances) or ELINCS (new substances) inventories, and will publish the fully screened list at a later date. {179288}

To accompany the end of the pre-registration period for “phase-in” substances, an updated version of “REACH pre-registration questions and answers” has been issued. Release 5 of this document, dated 18 December 2008, is available to download at http://echa.europa.eu/doc/pre-registration/pre_reg_qa_en.pdf on the ECHA website. {177083}

…Industry User Manual

Further parts of this manual (first reported in Toxicology and Regulatory News 2008, 47(12), 206) are now available on: pre-SIEF (Part 5), dossier submission (Part 6), joint submission (Part 7), invoices (Part 8) and advanced search (Part 9), together with an updated version of Part 1 (“getting started with REACH-IT”; Version 1.1). These are all dated 1 December 2008, and can be accessed on the ECHA website (via http://echa.europa.eu/reachit/supp_docs_en.asp). {179752}

…More answers on REACH-IT

Version 1.9 (dated 6 January 2009) of “REACH-IT frequently asked questions” can now be viewed (at http://echa.europa.eu/doc/reachit/reachit_faq.pdf). {178167}

…Updated publications on data submissions

Revised versions of the following Data Submission Manuals have been published: Manual 1 – “How to prepare and submit a PPORD notification” (Release 1.1); Manual 2 – “How to prepare and submit an inquiry dossier” (Release 1.2); Manual 4 – “How to complete the IUCLID 5 dossier header” (Release 1.1); Manual 5 – “How to complete a technical dossier for registrations and PPORD notifications” (Release 1.3). The updated documents, all dated 15 December 2008, are available via http://echa.europa.eu/reachit/supp_docs_en.asp on the ECHA website. {177081; 177495-6; 178836}

…Public consultation on inclusion of substances in Authorisation List

Comments are invited by 14 April 2009 on the proposed prioritisation of seven of the 15 substances on the Candidate List to be subject to authorisation (see Toxicology and Regulatory News 2008, 47(11), 185). The ECHA website provides further background information, and also links to the “commenting form” to be used for each of the chemicals (visit http://echa.europa.eu/consultations/authorisation/draft_recommendations/prioritisations_en.asp).

Added as News items to our website 20 January 2009. 

REACH into the New Year with good cheer

...Bumper pre-registration offerings

Staggeringly, REACH pre-registration, which closed on 1 December 2008, resulted in over 2.2 million submissions (about fifteen times the number expected), covering more than 100,000 substances. Presumably slightly overwhelmed, ECHA (the European Chemicals Agency) is nevertheless still intending to publish the complete list of pre-registered substances on its website by 1 January 2009. The next REACH obligation for pre-registrants is to participate in Substance Information Exchange Fora (SIEFs) where data on animal studies will be shared in order to avoid duplication. For more information, see the Press Release ECHA/PR/08/54 dated 2 December 2008 (available at http://echa.europa.eu/doc/press/pr_08_54_end_of_%20preregistration_20081202.pdf).

...Seasonal closures at ECHA

REACH-IT will be shut down from 17 December 2008 until 5 January 2009, to allow database transfer to an updated version. Dossier submissions via REACH-IT will re-commence from 5 January 2009 (although it will not be available going forwards during weekends or public holidays). The ECHA helpdesk will be closed from 19 December 2008 until 5 January 2009. More information is given in the News Alert ECHA/PR/08/55 (dated 3 December 2008), available at http://echa.europa.eu/doc/press/pr_08_55_xmas_timetable_20081203.pdf from the ECHA website.

...Updated registration guidance

Yet again, ECHA has revised its “guidance on registration” to further clarify the responsibilities of the “only representative” (see Section 1.5.3.4; page 21 of the document). This is apparently to explain more explicitly the position regarding the appointment of a third party representative, the volume of the import to be covered by the only representative, and when the only representative can benefit from Article 28(6) of the REACH Regulation. Version 1.4 (dated 26 November 2008) is available at http://reach.jrc.it/docs/guidance_document/registration_en.pdf?vers=26_11_08 on the internet. {169341}

...ECHA ready for Yuletide quiz

Version 1.5 (dated 26 November 2008) of “REACH-IT frequently asked questions” can now be viewed (at http://echa.europa.eu/doc/reachit/reachit_faq.pdf). {178167}

Also available (at http://echa.europa.eu/doc/reach/reach_faq.pdf) is Version 2.3 (dated 6 November 2008) of “Frequently asked questions on REACH by industry”. {177761}

Added as News items to our website 10 December 2008. 

Deadlines coming within REACH

...Rapid response service for pre-registrations

As the deadline for the pre-registration of “phase-in” substances approaches, the European Chemicals Agency (ECHA) has announced that from now until 1 December 2008 it will be offering enhanced assistance to companies that still intend to pre-register, but who may need help in doing so in time. This service is available to companies located in the EU and EEA (European Economic Area) who can submit queries on pre-registration related issues using a dedicated form on the ECHA website (via http://echa.europa.eu/about/contact-form_en.asp). ECHA says it will answer these questions by e-mail or by phone with highest priority.

...New version of REACH-IT to help meet 1 December pre-registration deadline

On 11 November 2008, ECHA released yet another version of REACH-IT that it hopes will improve the accessibility and performance of the system (it has been operating at its full capacity in recent weeks). Companies will also be able to claim registration numbers online for new substances they notified under previous legislation. In addition, an Industry User Manual on REACH-IT is currently being developed; various parts have already been published and are available to download (via http://echa.europa.eu/reachit/registration-it_en.asp). {179752}

...Updated list of pre-registered substances

The second release of the intermediate list of pre-registered substances has been published by ECHA. As of 1 November 2008 it contains over 50,000 substances and enables downstream users to see whether substances of interest are already pre-registered. The list can be accessed, and searched, online (via http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx). {179288}

...More duties for companies arise from publication of Candidate List

Last updated on 29 October 2008, the first Candidate List of substances of very high concern (SVHC, see Toxicology and Regulatory News 2008, 47(11), 185) can now be obtained from the ECHA website (via http://echa.europa.eu/chem_data/candidate_list_en.asp) together with supporting documents for each of the chemicals. EU and EEA producers or importers of articles containing a listed substance must notify ECHA if it is present above 0.1% (w/w), and its quantities in the articles amount to more than 1 tonne per year per company. A deadline for notification of 1 June 2011 applies to substances included on the Candidate List before 1 December 2010; for those substances added to the list on, or after, 1 December 2010 the notification must be submitted no later than six months after the inclusion. Suppliers also have an immediate legal obligation to provide information on safe use to their customers and, upon request, to consumers. {179287}

...Draft guidance on Annex V of REACH Regulation

The European Commission (EC) services have prepared a draft guidance document on how to interpret Annex V (exempting certain substances from registration). This will now be further developed by ECHA, Member States and relevant stakeholders for subsequent insertion into the Guidance on Registration. Since it was felt that this document might be helpful to companies in relation to registration and pre-registration, it has been made available at http://ec.europa.eu/environment/chemicals/reach/pdf/com_rev_anx_V_guidance_en.pdf, as announced in ECHA News Alert ECHA/PR/08/41 of 7 November 2008. {179540}

...Draft guidance on waste and recovered substances

The EC services have also issued a draft document on “waste and recovered substances”, together with an explanation of concerns expressed by Member States and stakeholders at the REACH Competent Authority meeting on 25-26 September 2008. These documents (dated 29 October 2008) are available via http://ec.europa.eu/enterprise/reach/reach_more_info_en.htm on the web. {179716}

...Updated questions and answers for registrants

Release 3 (dated 30 October 2008) of an ECHA publication providing questions and answers for registrants of previously notified substances (such as when to request a registration number) is now available (via http://echa.europa.eu/doc/reachit/prev_not_sub_registrants_qa.pdf). {179289}

Added as News items to our website 19 November 2008.  

More activity within REACH

…Exemptions under Annexes IV and V of REACH Regulation

Annexes IV and V of the REACH Regulation 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}

…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 http://ecbwbiu5.jrc.it/index.php?fuseaction=home.inquiry&type=public), 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 http://reach.jrc.it/docs/guidance_document/registration_en.pdf?vers=24_09_08).] {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}

Added as News items to our website 21 October 2008.  

REACH for more help

…on temporary procedures for inquiries…

Every potential registrant of a non phase-in substance (or a phase-in substance that has not been pre-registered) must inquire of the European Chemicals Agency (ECHA) whether a registration has already been submitted for the same substance. However, as the inquiry functionality is not yet available on the REACH-IT portal, ECHA has issued instructions (via its website at http://echa.europa.eu/reachit/inquiry_en.asp) on the temporary procedure to be used.

Potential registrants are required to submit certain information that must be created in IUCLID 5, but since it is not possible using this software to identify some new studies that need to be carried out, an “information requirements form” (http://echa.europa.eu/reachit/list_prod_en.asp) should also be attached to section 13 of the IUCLID 5 substance datasheet. Procedures for doing this and for submitting the dossier are described in a new ECHA publication. [European Chemicals Agency. Data Submission Manual 2. How to prepare and submit an inquiry dossier (Release 1.2). Dated 10 July 2008 (http://echa.europa.eu/doc/reachit/how_to_prep_sub_inquiry_doss_en_20080529.pdf).] {178836}

For further help on inquiry dossiers, potential registrants may find it useful to consult a list of questions/answers prepared by ECHA. [European Chemicals Agency. Questions and answers on inquiry (Release 1). Dated 21 August 2008 (http://echa.europa.eu/doc/reachit/echa-08-qa-03-en_inquiry_qa_20080821.pdf).] {178835}

Those requiring only a broad overview of these submission procedures may find a recently issued two-page leaflet instructive. [European Chemicals Agency. How to submit data to ECHA (Release 2.2) (http://echa.europa.eu/doc/reachit/data_submission_leaflet_20080724.pdf).] {178834}

…and guidance documents

A new document with the self-explanatory title “Guidance on information requirements and chemical safety assessment Appendix R.7.13-2: Environmental risk assessment for metals and metal compounds” (dated July 2008) is now accessible from the internet (by visiting http://reach.jrc.it/docs/guidance_document/information_requirements_r7_13_2_en.pdf?vers=30_07_08). {177085}

Other parts of the document on “Guidance on information requirements and chemical safety assessment” (reported in Toxicology and Regulatory News 2008, 47(7), 110) that appear to have been updated (without any such indication on the ECHA website) are chapters R2, R13 and R18 (July 2008) and parts D and G and chapters R7b, R12, R13 and R15 (versions 1.1; May 2008). The latest versions of these documents can be downloaded by appropriate finger clicks (via http://reach.jrc.it/docs/guidance_document/information_requirements_en.htm?time=1221130614#r2). {177085}

Added as News items to our website 17 September 2008.  

Summer REACH events

…Exemptions under Annexes IV and V of the REACH Regulation

The European Commission has prepared a draft proposal for amending Annexes IV and V, and its adoption by the European Parliament is expected in September or October 2008. The European Chemicals Agency (ECHA) is advising companies who are in doubt as to whether they may be affected by these changes to pre-register their chemicals (which entails no obligation to consequently register), rather than miss the 1 December 2008 deadline. The draft regulation (D000689/02) is available from ECHA (via http://echa.europa.eu/reach/legislation_en.asp). {177999}

…Bulk pre-registration substances

Companies may now pre-register up to 500 substances listed in EINECS (European INventory of Existing Commercial chemical Substances) in a single file using a pre-prepared XML format and selecting the bulk upload page in REACH-IT for submission. For substances not listed in EINECS, the REACH-IT online system must be used. Further information is available on the ECHA website (via http://echa.europa.eu/reachit/pre-registration-it_en.asp). ECHA has also published a manual to aid in the preparation and submission of multiple pre-registrations. [European Chemicals Agency. Data Submission Manual 6. Submission of bulk pre-registrations (Release 1). 22 July 2008. Available at http://echa.europa.eu/doc/reachit/bulk_submission_manual_20080722.pdf on the internet.] {177998}

…Data submission form

Apparently as the result of feedback from industry, ECHA has revised the submission form for registration, PPORD (product and process orientated research and development) and inquiry dossiers, allowing companies to nominate alternative contact addresses. The new submission form is available at http://echa.europa.eu/doc/reachit/submission_form.doc (Release 3; 29 July 2008). Ongoing dossier submissions using the previous form are not affected by this change. An amended manual has been issued to help with completion of the new submission form. [European Chemicals Agency. Data Submission Manual 3. How to complete the submission form (Release 3; 28 July 2008). Available at http://echa.europa.eu/doc/reachit/data_submission_manual.pdf on the internet.] {177082}

…Chemical safety report

The template for the chemical safety report (CSR) is now available on the ECHA website (via http://reach.jrc.it/docs/formats/Chemical_Safety_Report_Format.dot). To accompany the CSR, the relevant guidance document has been updated, together with the publication of an Appendix explaining the template. [European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Part F: Chemical Safety Report (Version 2; July 2008). Guidance on information requirements and chemical safety assessment. Appendix to Part F: CSR template with explanation. Both documents are available to download (via http://reach.jrc.it/docs/guidance_document/information_requirements_en.htm?time=1217403231).] {177085}

…Guidance documents on Annex XIV substances and priority setting for evaluation

ECHA’s “Guidance on inclusion of substances in Annex XIV” (August 2008) has been prepared primarily to help the Agency and Member States Competent Authorities with the identification of substances having properties of very high concern and the inclusion of such substances in Annex XIV. It has been suggested that this document will also help companies understand the process involved in the identification of such substances (Guidance available via http://reach.jrc.it/docs/guidance_document/annex_xiv_en.pdf?vers=11_08_08). {178247}

A second document “Guidance on priority setting for evaluation” (August 2008) is intended principally for use within ECHA, but may be of interest to others in gaining an understanding of the approaches used (accessible via http://reach.jrc.it/docs/guidance_document/prioritisation_evaluation_en.pdf?vers=11_08_08). {178248}

…Guidance fact sheets

The following fact sheets are available giving brief (four-page) overviews of the guidance documents covering requirements for substances in articles; registration; data sharing; information requirements and chemical safety assessment (part A), and exposure scenario building (Part D). All are available on the ECHA website (via http://echa.europa.eu/reach/fact_sheet_en.asp). {178068-72}

…Reporting identified uses in IUCLID 5

A temporary user guide has been published on reporting identified uses for REACH in IUCLID that explains in detail how sections 3.5 and 3.6 of the existing IUCLID version 5.0 should be completed. The recommendations are in accordance with the “Guidance on information requirements and chemical safety assessment” (see Toxicology and Regulatory News 2008, 47(7), 110), and according to ECHA should facilitate a smooth transition of the data from the current IUCLID 5.0 to the next IUCLID release 5.1 that is expected to be issued early in 2009. [How to report identified uses for REACH in IUCLID 5.0. July 2008. Available at http://ecbwbiu5.jrc.it/download/How_to_report_identified_uses_for_REACH_in_IUCLID_5.0_2008-07-04.pdf on the internet.] {178158}

…Software tool for checking PPORD completeness

To enable companies to check the completeness of their PPORD notifications before submission, ECHA has launched a software tool that is available to download (via http://ecbwbiu5.jrc.it/index.php?fuseaction=home.completenesscheck&type=public). {178329}

…Payment of fees and charges

Frequently asked questions on payments and charges and technical issues (for example, forgotten passwords) in REACH-IT are available in new publications (updated August 2008) on the ECHA website (via http://echa.europa.eu/reachit/reachit_faq_en.asp) and on the EC Enterprise and Industry website (via http://ec.europa.eu/enterprise/reach/reach_fees_en.htm). {178167; 178225}

Added as News items to our website 20 August 2008.

More REACH news

…ECHA helps with homework…

Under the Temporary Submission Procedures for registrations and PPORD (product and process oriented research and development) notifications, few companies have received top marks for their technical dossiers due to missing or incomplete information. To avoid this in any future submissions, ECHA has issued a manual to help identify “which of the numerous IUCLID 5 fields are of uppermost importance in relation to technical completeness check”.

[European Chemicals Agency. Data Submission Manual 5. How to complete a technical dossier for registrations and PPORD notifications (Release 1, 27 June 2008). Available at http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual_20080701.pdf on the internet.] {177496}

A further manual explains how to submit a valid dossier to ECHA and how to complete the dossier header so that the submission will be accepted for processing. This is a temporary measure as, once REACH-IT is up and running, it will not be possible to submit a dossier without fulfilling these various requirements.

[European Chemicals Agency. Data Submission Manual 4. How to submit a valid dossier to ECHA and complete the dossier header (Release 1, 25 June 2008). Available at http://echa.europa.eu/doc/reachit/how_submit_valid_dossier_20080626.pdf on the internet.] {177495}

…answers questions on REACH-IT…

A new page on the ECHA website (added on 4 July 2008) gives responses to 13 technical questions and 14 administrative questions that are frequently asked in relation to REACH-IT (see http://echa.europa.eu/reachit/reachit_faq_en.asp). {177519}

…and consults on substances of very high concern

Competent Authorities of the Member States and ECHA may prepare Annex XV dossiers for substances of very high concern as defined in Article 57 of the REACH regulation (Regulation (EC) No. 1907/2006). These include substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or substances for which there is scientific evidence of probable cause of serious effects in humans or on the environment (e.g. endocrine disruptors). In a website entry dated 4 July 2008, comments are invited (by 14 August 2008) on the first of these dossiers, which cover the following compounds: benzyl butyl, dibutyl and di(2-ethylhexyl) phthalates; diarsenic trioxide and pentaoxide, lead hydrogen arsenate and triethyl arsenate; anthracene; bis(tributyltin) oxide; cobalt chloride; cyclododecane and hexabromocyclododecane; musk xylene; 4,4′‑diaminodiphenylmethane; short chain chlorinated paraffins (alkanes, C10-13, chloro); and sodium dichromate dihydrate. The documents and “commenting forms” are available (via http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp). {177497}

Added as News items to our website 16 July 2008.

REACH for your holiday reading

...Deluge as ECHA goes operational

Staff at the European Chemicals Agency can expect to be a bit busy – ECHA received almost 5000 pre-registration files in the first week that it was fully operational. The European Commission has informed ECHA that there may be some chemicals that were lawfully on the market before 1 June 2008 but that do not qualify for phase-in status (and therefore do not benefit from the extended registration deadlines). ECHA has been approached, in particular, by importers of certain cosmetic products containing such substances, and has now made it clear in a recent press release that companies manufacturing or importing these substances should “contact ECHA by making a company sign-up, followed by an inquiry” (see http://echa.europa.eu/reachit_en.asp for instructions).

[European Chemicals Agency. Press release: ECHA/PR/08/12. 9 June 2008. Data submission to ECHA active – almost 5000 files received. Available at http://echa.europa.eu/doc/press/PR_08_12_Received_Submissions_Inquiry20080609.pdf on the internet.] {177088}

...Keeping up-to-date on data submission

At present REACH-IT only supports the creation of company accounts, on-line entry and pre-registration of single substances. There are temporary submission procedures for PPORD notifications (product and process oriented research and development), enquiries and registration, details of which are given on the ECHA website (via http://echa.europa.eu/reachit_en.asp – updated 6 June 2008).

More detailed information on data submission is provided in the documents “Data submission manual 1: How to prepare and submit a PPORD Notification”, dated 28 May 2008 (available at http://echa.europa.eu/doc/reachit/how_to_prep_sub_ppord_en_20080529.pdf) and “Data submission manual 3: How to complete the submission form”, dated 31 May 2008 (available at http://echa.europa.eu/doc/reachit/data_submission_manual_20080531.pdf). {177081-2}

Four presentations prepared for training purposes on the different functionalities of REACH-IT are available (via http://echa.europa.eu/reachit/portal_en.asp – updated 16 June 2008). {177089}

...Your questions answered on pre-registration

A document (dated 30 May 2008) providing answers to commonly asked questions covering general (and IT-related) issues when considering pre-registration of substances is available from the European Chemicals Agency (at http://echa.europa.eu/doc/pre-registration/pre-reg-QA_en.pdf). {177083}

...Guidance documents

Sit back and enjoy a good read with the 28 files that make up the new “Guidance on information requirements and chemical safety assessment”. The package of documents (all dated May 2008) describes what is required with respect to substance properties, exposure, use and chemical safety assessment. Issued by the European Chemicals Agency, the Guidance is available at http://reach.jrc.it/docs/guidance_document/information_requirements_en.htm on the ECHA website. {177085}

Another new document, “Guidance on requirements for substances in articles”, aims to assist companies in deciding whether they are manufacturers or importers of substances (on their own or in preparations) or producers/importers of articles. This document, which is dated May 2008, is available at http://reach.jrc.it/docs/guidance_document/articles_en.pdf from ECHA. {177086}

Updated (May 2008) documents on “Guidance for monomers and polymers” and “Guidance on registration”, which usefully list the changes in the appendices, can be downloaded from the ECHA website (via http://reach.jrc.it/guidance_en.htm). {169341-2}

Finally, the “Navigator” (which helps industry to determine its obligations under REACH and find the appropriate guidance on how to fulfil these obligations) has been updated due to the publication of “Guidance on requirements for substances in articles” and “Guidance for Downstream Users”. Navigator sessions conducted before 26 May 2008 can no longer be retrieved. Information on the Navigator is available at http://reach.jrc.it/navigator_en.htm from ECHA. {177084}

...Regulation on the test methods applicable to REACH

For those looking for suitable reading material during the long summer break(?), over 700 pages are available on the test methods that are required to generate information on the physicochemical properties, toxicity and ecotoxicity of substances and preparations.

[Commission Regulation (EC) No. 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union 2008, L142, 1. (Corrigendum to title issued 3 June 2008, ibid. 2008, L143, 55.) Available via http://eur-lex.europa.eu/JOIndex.do?ihmlang=en on the internet.] {177087}

Added as News items to our website 19 June 2008.

REACH for the latest news

...Initial limited scope for the REACH-IT software tool

The European Chemicals Agency (ECHA) announced on 8 May that, due to the “instability” of the current REACH-IT version, it is limiting the first production release to company sign-up and online pre-registration. It noted that temporary procedures would be put in place by 1 June for notifications, enquiries and registration, details of which would be made available on the ECHA website during the week of 19 May. [European Chemicals Agency. The initial scope of the REACH-IT release prudently defined. Press Release of 8 May 2008, available at http://echa.europa.eu/doc/press/pr_reach_it_defin_20080508.pdf on the internet.] {176544}

...Workshop presentations

Presentations given at the REACH workshop “Final countdown to pre-registration and registration of chemicals” on 14 April 2008 and the REACH-IT Stakeholders Workshop on 7 May 2008 are now available on the ECHA website (via http://echa.europa.eu/news/events_en.asp). {176123; 176579}

...Guidance documents

A review is evidently being undertaken to decide if it is legally possible for an “only representative” (representing several “non-Community manufacturers”) to aggregate chemical tonnages. Information on this can be found on pages 23-24 of the most recent (April 2008) ECHA guidance document on registration (http://reach.jrc.it/docs/guidance_document/registration_en.pdf), but expect another update before 1 June 2008. {169341}

A new ECHA document has been issued to assist Member State Competent Authorities and ECHA in preparing and using a socio-economic analysis as part of a proposal to restrict the manufacturing, placing on the market and/or use of a substance under REACH (i.e. when developing an Annex XV dossier for Restriction). It should also be of use to those who need to prepare (or contribute relevant information towards) such analyses. The (May 2008) guidance document is available at http://reach.jrc.it/docs/guidance_document/sea_restrictions_en.pdf on the internet. {176576}

...Guidance fact sheets

Help is at hand for those who have not yet had a chance to fully assimilate “Guidance for downstream users” and “Guidance for identification and naming of substances under REACH”. ECHA has now issued two guidance fact sheets on these topics (both dated 17 April 2008 and available via http://echa.europa.eu/reach/fact_sheet_en.asp), which summarise the key aspects of the guidance documents. {176194-5}

Added as News items to our website 22 May 2008. 

REACH developments

More pre-registration assistance

Under REACH legislation (on the Registration, Evaluation, Authorisation and Restriction of Chemicals), companies that manufacture or import substances into the EU in annual quantities of 1 tonne or more must register them with the European Chemicals Agency (ECHA) in order to ensure continuation of supply. Pre-registration is the first step in this process, and failure to pre-register a chemical between 1 June and 1 December 2008 means that it can no longer be manufactured or imported after 1 December 2008 until it has been registered with ECHA. Pre-registered chemicals benefit from the extended registration deadlines (30 November 2010, 31 May 2013 or 31 May 2018), which depend on the tonnage and the hazardous properties of the substance. ECHA has issued further information on pre-registration to help with this process (available via http://echa.europa.eu/pre-registration_en.asp when last updated on 14 April 2008), while information is available on other topics, including registration and the formation of SIEFs (Substance Information Exchange Fora) via the same site (using the subheadings under “Pre-registration” in the menu). {175974}

The IUCLID 5 pre-registration plug-in can now be downloaded

The IUCLID 5 plug-in referred to in last month’s Toxicology and Regulatory News (2008, 47, 61), one of the options for those companies wishing to pre-register their chemicals from 1 June 2008, has now been made available for downloading, via http://ecbwbiu5.jrc.it/index.php?fuseaction=home.preregistrationPlugin&type=public on the internet. {174933}

REACH guidance for monomers and polymers updated

A further update of the “Guidance for monomers and polymers” (dated March 2008), with changes helpfully listed in an appendix, can be obtained (via http://reach.jrc.it/guidance_en.htm) from ECHA. {169342}

Added as News items to our website 22 April 2008. 

REACH for…

…updated guidance on registration, intermediates and PPORD

Yet more official guidance has been issued in connection with the REACH legislation (on the Registration, Evaluation, Authorisation and Restriction of Chemicals). The latest documents on offer are first updates (all dated February 2008) of the three guidance documents on “Registration”, “Intermediates” and “Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD)”, which can be obtained from ECHA, the European Chemicals Agency (via http://reach.jrc.it/guidance_en.htm). To save having to play spot the difference, the changes made to these guidelines are helpfully tracked in an appendix at the end of each document. {169340-1; 169343}

…workshop presentations

Presentations given at the REACH-IT workshops on 5 October 2007 and 15 February 2008 are now available on the ECHA website (via http://echa.europa.eu/news/events_en.html). {174931-2}

…and pre-registration format

For those wishing to pre-register their substances, which can be done between 1 June and 1 December 2008, the information can either be submitted on-line or using a computer file format specified by ECHA (a IUCLID 5 plug-in). Further details are available at http://ecbwbiu5.jrc.it/index.php?fuseaction=home.preregistration&type=public on the internet. {174933}

Added as News items to our website 19 March 2008.

Guidance now REACHes downstream 

Official guidance on how to deal with the new REACH legislation (on the Registration, Evaluation, Authorisation and Restriction of Chemicals) continues into 2008 with the finalised document on “Guidance for downstream users”. Two key sections of this document were published last year (as previously reported in Toxicology and Regulatory News 2007, 46, 187). The full document is available from the European Chemicals Agency (via http://reach.jrc.it/guidance_en.htm). {172210}

Added as a News item to our website 18 February 2008.

REACH Exemptions

On 23 October 2007, the European Commission published for the first time details of the criteria and process to be applied in considering applications for exemptions under Annex IV of the REACH Regulations. Criteria are provided for determining whether a substance poses only minimum risk, and details are given of the (hefty) information and documentation requirements, together with a description of the overall process. Companies have only until the end of November 2007 to submit proposals for substances to be exempted.

[European Commission (2007). Criteria for inclusion of substances in Annex IV of Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Available at http://ec.europa.eu/environment/chemicals/reach/pdf/annex4_criteria.pdf.] {172356}

Added as a News item to our website 24 October 2007.

REACH for more guidance to the regulations

Official guidance on how to deal with the new EU REACH legislation continues to appear. Although the final document on “Guidance for downstream users” is not yet complete, two key sections of it have been finalised covering “roles and obligations” and “preparing for REACH”. These, together with the (140-page) final document on “Guidance on data sharing”, are available from the European Chemicals Agency (via http://reach.jrc.it/guidance_en.htm). {172208-10}

Two new 2-page brochures are available, one alerting companies to their responsibilities under REACH, the other providing information for exporters to the EU. Both specify the timelines for pre-registration and registration (according to tonnage). They are available at http://ecb.jrc.it/documents/REACH/REACH_BROCHURES/. {171801; 172211}

Added as a News item to our website 23 October 2007.

Keep new guidance documents in REACH

Official advice on how to deal with the new REACH legislation continues to surface. Several new European Commission guidance documents (dated June 2007) can now be obtained from the website of the European Chemicals Agency (via http://reach.jrc.it/guidance_en.htm): “Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern”, “Guidance for the preparation of an Annex XV dossier for restrictions”, “Guidance for the preparation of an Annex XV dossier on harmonised classification and labelling”, “Guidance on dossier and substance evaluation” and “Guidance for the Navigator” (a tool to help companies assess their obligations under REACH). {170965-9}

In addition, an updated version of “Questions and answers on REACH” has been issued by the European Chemicals Bureau and is available at http://ecb.jrc.it/DOCUMENTS/REACH/REACH_PROPOSAL/Questions_and_Answers_on_REACH.pdf. {170970}

Added as a News item to our website 22 August 2007.

REACH in force

The new European regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) came into force on 1 June 2007. This legislation, first published on 30 December 2006, has now been reissued as a corrigendum in the Official Journal of the European Union (http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2007:136:SOM:EN:HTML) using its normal format, and thus reducing the number of pages from 849 to less than 300. Over the next 11 years (2007-2018) manufacturers and importers must register around 30,000 chemicals currently in use, evaluate their safety for both occupational and consumer exposure, and assess whether the most dangerous chemicals can be replaced by less hazardous ones. EU Member States anticipate that Safety Data Sheets (SDS) for new substances, and revisions to existing SDS made after 1 June 2007, will comply with the new regulation; all SDS must be in compliance by 1 December 2010 – the first registration deadline.

Friday 1 June 2007 also saw the “launch” of the new European Chemicals Agency (ECHA) website (http://ec.europa.eu/echa/home_en.html). ECHA, which is based in Helsinki, will be responsible for managing the REACH legislation, and although not set to become fully operational until 1 June 2008, its website is intended to be the single point of entry for all information on REACH. Several guidance documents are already available from the site (via http://reach.jrc.it/guidance_en.htm): “Guidance for intermediates”, “Guidance on registration”, “Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD)”,  “Guidance for monomers and polymers”, “Guidance for identification and naming of substances under REACH” and “IUCLID 5. Guidance and support” (IUCLID is the International Uniform Chemical Information Database).

The software tool IUCLID 5 can now be downloaded from the ECHA site (via http://ecbwbiu5.jrc.it/index.php?fuseaction=home.news&type=public&id=45) to assist companies in their data submissions under the REACH regulation. Data entry forms for IUCLID 5 were modelled on the OECD Harmonised Templates, which provide a standard format for reporting the results of tests on chemicals to determine their properties or effects on human health and the environment. (These templates can be accessed via http://www.oecd.org/document/13/0,2340,en_2649_34379_36206733_1_1_1_1,00.html.)

Added as a News item to our website 20 June 2007.

HSE REACH out to the COT

Numerous guidance documents are being developed to ensure the smooth running of the REACH Regulation. HSE (the Competent Authority for REACH in the UK) is contributing to the preparation of one such guidance on the determination of DNELs (Derived No Effect Levels) and the risk characterisation of non-threshold effects such as mutagenicity and genotoxic carcinogenicity. In the case of mutagens and genotoxic carcinogens that are generally considered not to have a threshold, the use of a Derived Minimal Effect Level (DMEL) has been suggested. The HSE has asked the Committee on Toxicity (COT) to consider and comment on proposed methods for deriving DMELs.

[UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment. Technical Guidance for derivation of DNELs and risk characterisation of non-threshold effects in the context of REACH. Draft COT discussion paper TOX/2007/02, January 2007. Available at http://www.food.gov.uk/multimedia/pdfs/tox200702.pdf {167059}. The draft technical guidance document (Annex 1 to WATCH/2006/8) is available via the Health and Safety Executive (HSE) website at http://www.hse.gov.uk/aboutus/hsc/iacs/acts/watch/agendas.htm, together with various accompanying annexes, under the agenda for the meeting on 9-10 November 2006.]

Added as a News item to our website 19 February 2007.

Formal adoption of REACH

The REACH Regulation was formally adopted on 18 December 2006 by the Council of Environment Ministers, and will enter into force on 1 June 2007, replacing many regulations governing the use of chemicals in the EU. For those of a strong disposition, the final text of the Regulation (all 849 pages) can now be studied in detail.

[Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union 2006, L396, 1. Available at http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_396/l_39620061230en00010849.pdf.] {166453}

Added as a News item to our website 17 January 2007.

REACH – a vote of approval from the European Parliament

Ever nearer to final adoption, the proposed REACH legislation has received the thumbs up from the European Parliament. The Council is expected to adopt the package of measures on 18 December 2006 so that REACH can enter into force on 1 June 2007.

[REACH: Commission welcomes European Parliament vote on new EU chemicals legislation. European Commission Press Release dated 13 December 2006. IP/O6/1799. Available at http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/1799&format=HTML&aged=0&language=EN&guiLanguage=en.] {165976}

For those needing some additional background information on REACH, the Commission has issued a ‘question and answer’ document, which may prove helpful.

[Q and A on the new Chemicals policy, REACH. European Commission Press Release dated 13 December 2006. MEMO/06/488. Available at http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/06/488&format=HTML&aged=0&language=EN&guiLanguage=en.] {165978}

Added as a News item to our website 13 December 2006.

REACH – HSE helpdesk

HSE is to take on the responsibilities of the UK Competent Authority for REACH. Part of HSE’s remit is to provide advice and support to UK business for dealing with the requirements of REACH, and in this connection, HSE is launching a helpdesk that can be contacted on 0845 408 9575 or via e-mail at ukreachca@hse.gsi.gov.uk (please also remember that we will be pleased to help with any REACH queries, click here for further details). HSE will, in addition, be required to liaise with the European Chemicals Agency in Helsinki, coordinate enforcement of the regulations in the UK and evaluate substances of concern.

HSE launches REACH helpdesk. UK Health and Safety Executive. E101:06. 10 October 2006. Available at http://www.hse.gov.uk/press/2006/e06101.htm.] {165571}

Added as a News item to our website 20 November 2006.