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 (urls) assigned to documents often get subsequently changed (which occasionally means that the hyperlinks we provide unfortunately do not always work long-term). 

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.