REACH News

All these items were written for inclusion in our monthly publication Toxicology and Regulatory News.

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…Proposals for harmonised classification and labelling

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

European Chemicals Agency. CLH reports. Proposals for harmonised classification and labelling based on Regulation (EC) No. 1272/2008 (CLP Regulation), Annex VI, Part 2.

Benzovindiflupyr. Version 2. March 2014. http://echa.europa.eu/documents/10162/948ba9cd-aed3-4d2f-ba25-e506c391007d

Pencycuron. Version 4. April 2014. http://echa.europa.eu/documents/10162/7976a0ab-9d1c-43de-af7f-ce5b787f461f

 

 

…Other items of interest

ECHA opens public consultation on alternatives to hexabromocyclododecane (HBCDD).

http://echa.europa.eu/view-article/-/journal_content/title/echa-opens-public-consultation-on-alternatives-to-hexabromocyclododecane-hbcdd-

 

Testing proposals involving vertebrate animals: request for information from third parties on 40 substances (deadlines 13 or 30 June 2014).

http://echa.europa.eu/information-on-chemicals/testing-proposals/current

 

 

The above items were taken from the June 2014 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).



… IUCLID and REACH-IT updated

IUCLID version 5.6.0 features new content and fixes, updating the classification and labelling section according to the fourth revision of the Globally Harmonised System (GHS) (as incorporated in the fourth update of the CLP Regulation).

Meanwhile, REACH-IT version 2.7 clarifies communication between ECHA and companies. It also allows applications for authorisation to be submitted.

European Chemicals Agency (2014).

International Uniform Chemical Information Database. [16/04/2014] IUCLID 5.6.0 is now available.

http://iuclid.eu/index.php?fuseaction=home.news&type=public&id=70

New version of REACH-IT clarifies communication between ECHA and companies. ECHA/NA/14/19. http://echa.europa.eu/view-article/-/journal_content/title/new-version-of-reach-it-clarifies-communication-between-echa-and-companies

 

 

… Harmonised classification and labelling proposals

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

European Chemicals Agency. CLH reports. Proposals for harmonised classification and labelling based on Regulation (EC) No. 1272/2008 (CLP Regulation), Annex VI, Part 2.

Diisobutylphthalate (DIBP). Version number 2. March 2014. http://echa.europa.eu/documents/10162/59594fc5-519a-4e97-b0f8-7a45b5db04ce

Triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1-(1H-imidazol-1-yl)-2-propoxyethanimine. Version number 3. August 2013. http://echa.europa.eu/documents/10162/5bb18b2d-438d-4148-9a0d-a711633b8b1b

 

 

… ECHA’s Committee for Risk Assessment (RAC) adopts opinions on sixteen chemicals

As announced in a March 2014 news alert, RAC has considered proposals (from the Danish, Dutch, Finnish, French, Irish, Italian, Norwegian, Polish, Spanish and Swedish authorities) to harmonise the classification and labelling of:

European Chemicals Agency (2014). ECHA/NA/14/12. http://echa.europa.eu/view-article/-/journal_content/title/rac-delivers-sixteen-clh-opinions

 

… Proposed restriction of chrysotile and cadmium

Recent Annex XV reports include a document submitted by ECHA, amending its restriction on chrysotile asbestos, and a report submitted by the Swedish authorities, proposing a restriction on the marketing and use of cadmium and cadmium compounds in artists’ paints.

European Chemicals Agency. Annex XV restriction reports.

Cadmium and its compounds in artists’ paints. Proposal for a restriction. Version number 1. 17 December 2013.

http://echa.europa.eu/documents/10162/04846943-29dc-40c0-9bc5-0116d3757e83

Chrysotile. Amendment to a restriction. Version number 1.0. 17 January 2014.

http://echa.europa.eu/documents/10162/2b3127c7-7a10-46b2-8d05-045d78083e04

 

 

… Substance evaluation plan for 2014-2016 adopted by ECHA

ECHA has released the annual update of its Community Rolling Action Plan (CoRAP), listing the chemicals to be evaluated by Member States between 2014 and 2016. A total of 120 substances are involved, including 67 from the update published last year.

European Chemicals Agency (2014). ECHA adopts the substance evaluation plan for 2014-2016. ECHA/PR/14/08.

http://echa.europa.eu/view-article/-/journal_content/title/echa-adopts-substance-evaluation-plan-for-2014-2016

 

 

… First CoRAP evaluation decisions published

ECHA has published its first decisions on substance evaluation, covering the following 14 substances listed in the CoRAP for 2012:

European Chemicals Agency (2014). First substance evaluation decisions published. ECHA/NA/14/14.

http://echa.europa.eu/view-article/-/journal_content/title/first-substance-evaluation-decisions-published

 

 

… Illustrative example on QSAR Toolbox

The OECD QSAR Toolbox can be used to fill toxicity and ecotoxicity data gaps in chemical hazard assessments, using read-across methods such as (quantitative) structure-activity relationships. ECHA has recently published an illustrative example to encourage the use of this software for the 2018 REACH deadline. Case studies on selected substances are provided, together with relevant background information and general considerations.

European Chemicals Agency (2014). Illustrative example with the OECD QSAR Toolbox workflow. Part 1: Introductory note. Part 2: Case studies. http://echa.europa.eu/web/guest/support/oecd-qsar-toolbox

 

 

… REACH best practice on nanomaterials

A report has been released by ECHA, summarising the outcomes of the third meeting of the Group Assessing Already Registered Nanomaterials (GAARN), involving experts from the European Commission, ECHA, Member States and industry. According to ECHA, GAARN’s outcomes “can be viewed as generic recommendations for the exposure assessment and risk characterisation of [nanomaterials] under REACH”.

European Chemicals Agency (2014). Human health and environmental exposure assessment and risk characterisation of nanomaterials. Best practice for REACH registrants.

http://echa.europa.eu/documents/10162/5399565/best_practices_human_health_environment_nano_3rd_en.pdf

 

 

… Call for evidence on perfluorooctanoic acid (PFOA) and related substances

In preparation for a restriction proposal for PFOA and related substances, the German and Norwegian authorities call for data to be submitted on suitable alternatives by 30 April 2014.

European Chemicals Agency (2014). Call for evidence. Perfluorooctanoic acid (PFOA), and any other linear or branched perfluoroheptyl derivative with the formula C7F15-X and any linear or branched perfluorooctyl derivative with the formula C8F17-X (where X=any group, including salts, other than F, Cl, Br), except those derivatives with the formula C8F17-SO2X', C8F17-C(=O)OH or C8F17-CF2-X' (where X'=any group, including salts).

http://echa.europa.eu/addressing-chemicals-of-concern/restriction/call-for-evidence-consultation/-/substance/5601/search/+/term

 

 

… Agreement from RAC and SEAC on restriction and authorisation

ECHA's Committee for Socio-economic Analysis (SEAC) has adopted an opinion on the restriction proposal of lead in consumer articles submitted by Sweden. Several draft opinions on applications for authorisation of dibutyl phthalate (DBP) and di(ethylhexyl)phthalate (DEHP) were also agreed upon by SEAC and ECHA’s Committee for Risk Assessment (RAC). In addition, progress has been made by RAC in developing dose-response relationships for the carcinogenicity of trichloroethylene.

European Chemicals Agency (2014). RAC and SEAC agree on new opinions on restriction and authorisation. ECHA/NA/14/13.

http://echa.europa.eu/view-article/-/journal_content/title/rac-and-seac-agree-on-new-opinions-on-restriction-and-authorisation

 

 

… Other items of interest

New features included in ECHA’s dissemination database.

http://echa.europa.eu/view-article/-/journal_content/title/new-features-included-in-echas-dissemination-database

 

ECHA webpage aims to support registrants by indicating how OECD and EU test guidelines may be used to meet information requirements under REACH. http://echa.europa.eu/support/oecd-eu-test-guidelines

 

European Commission calls for feedback on substance identity and sameness of complex substances.

http://echa.europa.eu/view-article/-/journal_content/title/european-commission-calls-for-feedback-on-substance-identity-and-sameness-of-complex-substances

 

Forum launches authorisation pilot and presents preliminary results of the third enforcement project.

http://echa.europa.eu/view-article/-/journal_content/title/forum-launches-authorisation-pilot-and-presents-preliminary-results-of-the-third-enforcement-project

 

Draft revised guidance on the preparation of dossiers for harmonised classification and labelling sent to ECHA’s Committee for Risk Assessment (RAC) and Biocidal Products Committee (BPC).

http://echa.europa.eu/documents/10162/13562/clh_draft_guidance_to_rac_bpc_201403_en.pdf

 

Board of Appeal decision emphasising the various roles in the registration process. http://echa.europa.eu/view-article/-/journal_content/title/board-of-appeal-s-decision-emphasises-the-various-roles-in-the-registration-process

 

Board of Appeal decision examining the substance identity requirements for a UVCB substance (a substance of unknown or variable composition, complex reaction products or biological materials). http://echa.europa.eu/view-article/-/journal_content/title/board-of-appeal-news-item-board-of-appeals-decision-examines-the-substance-identity-requirements-for-a-uvcb-substance

 

 

New report from ECHA and the European Aviation Safety Agency (EASA) highlights the key aspects of the authorisation process for the aviation industry. http://echa.europa.eu/view-article/-/journal_content/title/a-new-echa-easa-report-highlights-the-key-aspects-of-the-authorisation-process-for-the-aviation-industry

 

Registrants should get ready to comment on substance evaluation draft decisions.

http://echa.europa.eu/view-article/-/journal_content/title/registrants-should-get-ready-to-comment-substance-evaluation-draft-decisions

 

Testing proposals involving vertebrate animals: request for information from third parties on over 50 chemicals (deadline 5, 19 or 30 May 2014). http://echa.europa.eu/information-on-chemicals/testing-proposals/current

 

 

The above items were taken from the May 2014 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).



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