REACH News

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

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Harmonised classification and labelling proposals for fluopyram and glutaraldehyde

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 Finnish and German authorities to standardise the classification and labelling of fluopyram and glutaraldehyde

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

N-{2-[3-chloro-5-(trifluoromethyl)pyridin-2-yl]ethyl}-2-(trifluoromethyl)benzamide (ISO name Fluopyram). Version 2.0. September 2013.

http://echa.europa.eu/documents/10162/d4f94500-ef3c-40aa-8174-1f57fd979943

Glutaraldehyde. Version 2.0. 12 September 2013.

http://echa.europa.eu/documents/10162/83745710-7075-4583-b4f5-a381e160c99b

 

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

As announced in a September 2013 news alert (ECHA/NA/13/31), RAC has considered proposals (from industry and the Austrian, Dutch and German authorities) to harmonise the classification and labelling of six chemicals. The following classifications were recommended (some in addition to existing harmonised classifications):

European Chemicals Agency. ECHA/NA/13/31.

http://echa.europa.eu/view-article/-/journal_content/title/rac-concludes-on-six-scientific-opinions

 

Proposed restriction of N-methylpyrrolidone, nonylphenol and nonylphenol ethoxylates

A report submitted to ECHA by the Dutch authorities reviews the human health effects of
N-methylpyrrolidone (NMP), and proposes that this compound should only be manufactured if occupational exposure does not exceed an 8-hour time-weighted average limit of 5 mg/m3, while peak exposures should not exceed 10 mg/m3. In addition, NMP should only be manufactured and used if occupational dermal exposure is avoided through the use of protective clothing and gloves. The critical toxicological endpoints were repeated dose and developmental toxicity.

Another restriction report, submitted by the Swedish authorities, concerns nonylphenol (NP) and nonylphenol ethoxylates (NPEs). It proposes that textile clothing, fabric accessories, and interior textile articles that can be washed in water should not be placed on the market if they contain NP or NPEs (alone or in combination) at concentrations of at least 100 mg/kg textile. Concern for NP and NPEs in the aquatic compartment is based on their combined toxicity to aquatic organisms and potential endocrine-disrupting effects.

ECHA is accepting comments on both reports until 18 March 2014.

European Chemicals Agency. Annex XV restriction reports.

N-methylpyrrolidone (NMP). Proposal for a restriction. Version number 2. 9 August 2013.

http://echa.europa.eu/documents/10162/ee4c88a9-d26f-4872-98fd-fb41646cc9e1

Nonylphenol and nonylphenolethoxylates in textiles. Proposal for a restriction. Version number 3. 29 July 2013.

http://echa.europa.eu/documents/10162/f28b5c79-11e0-4ce2-91db-e53f7daa4d5a

 

Other items of interest

Updated Navigator tool to help industry identify obligations under REACH.

http://echa.europa.eu/view-article/-/journal_content/title/updated-navigator-tool-to-help-industry-identify-obligations-under-reach-published

 

Draft revised guidance for downstream users sent to Competent Authorities for REACH and CLP (CARACAL).

http://echa.europa.eu/documents/10162/966058/du-guidance_to_caracal_201309_en.pdf

 

Draft revised guidance on the compilation of safety data sheets sent to CARACAL.

http://echa.europa.eu/documents/10162/13643/guidance_on_sds_to_caracal_201309_en.pdf

 

Draft updated guidance for the preparation of Annex XV dossiers sent to ECHA’s Member State Committee (MSC).

http://echa.europa.eu/documents/10162/13643/annex_xv_draft_guidance_for_svhc_identification_en.pdf

 

Testing proposals involving vertebrate animals: request for information from third parties on five compounds (deadlines 4 November 2013, 18 November 2013).

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

 

The above items were taken from the November 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).



Harmonised classification and labelling proposals for five chemicals

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 Czech, Dutch, French and Polish authorities to standardise the classification and labelling of:

European Chemicals Agency. CLH reports.

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

Bisphenol A. Version 2. 17 July 2013.

http://echa.europa.eu/documents/10162/36b05a93-3e3c-44b1-bc8d-bff66b4b37ae

Chlorobenzene. Version 2. 30 July 2013.

http://echa.europa.eu/documents/10162/3b2c4055-928f-4b43-a68c-0937989095f0

Flumioxazin (ISO); N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide. Version 5. 2 August 2013.

http://echa.europa.eu/documents/10162/bd557890-c056-41ce-bdeb-11411897fd91

Methyloxirane (propylene oxide). Version 2. August 2013.

http://echa.europa.eu/documents/10162/fc741f39-3771-4fb4-837a-a0a9140bb299

1-Methyl-2-pyrrolidone. Version 2. August 2013.

http://echa.europa.eu/documents/10162/9a6bb3e4-6265-41d2-b963-00e37f95a20e

  

Consultations on seven potential Substances of Very High Concern (SVHCs)

Member State competent authorities and the European Chemicals Agency may prepare Annex XV dossiers for SVHCs, as defined in Article 57 of the REACH regulation. SVHCs include substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or of an equivalent level of concern. The latest Annex XV dossiers have been released by the Austrian, Dutch, German and Swedish authorities, and cover the following potential SVHCs:

European Chemicals Agency. Annex XV dossiers. Proposals for the identification of a substance as a Category 1A or 1B CMR, PBT, vPvB or a substance of an equivalent level on concern. Proposals available for comment until 17 October 2013.

http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-identification

 

RAC opinion on the reproductive toxicity of gallium arsenide

RAC has revised and adopted its draft opinion on the reproductive toxicity of gallium arsenide, which considers new data made available since its previously adopted (2010) opinion. Based on “clear evidence of testicular toxicity in two species”, the new draft assessment supports the originally proposed classification of gallium arsenide as a presumed human reproductive toxicant (category 1B).

 

European Chemicals Agency. Committee for Risk Assessment (RAC). Opinion on gallium arsenide in relation to toxicity to reproduction. ECHA/RAC/A77-O-0000001412-86-11/F. Adopted 23 July 2013.

http://echa.europa.eu/documents/10162/13641/rac_opinion_adopted_a77_gaas_en.pdf

 

ECHA finalises its report on di-isodecyl phthalate (DIDP) and di-isononyl phthalate (DINP)

In ECHA’s final review report, the current legislation preventing the use of these phthalates in toys and childcare articles which can be placed in the mouth was considered to be sufficiently protective of childhood exposure. For adults, it was “not likely” that exposure to DIDP or DINP from the use of sex toys would result in a liver toxicity risk, but it was noted that there were substantial uncertainties regarding exposure levels duration and migration rates. No further risk management measures were considered necessary to be needed to reduce exposure levels for adults or children.

European Chemicals Agency. Evaluation of new scientific evidence concerning DINP and DIDP in relation to entry 52 of Annex XVII to REACH Regulation (EC) No 1907/2006. Final review report. ECHA-13-R-07-EN. August 2013.

http://echa.europa.eu/documents/10162/31b4067e-de40-4044-93e8-9c9ff1960715

 

Other items of interest

IUCLID version 5.5.1 now available.

http://echa.europa.eu/view-article/-/journal_content/title/iuclid-5_5_1-now-available

 

Registration numbers granted to 9030 dossiers submitted to ECHA by 31 May 2013, corresponding to 2998 more substances registered under REACH.

http://echa.europa.eu/view-article/-/journal_content/title/registration-numbers-granted-to-9-030-reach-2013-registrations

 

Draft revised guidance on the application of the CLP Criteria (Part 3: health hazards) sent to CARACAL.

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

 

Testing proposals involving vertebrate animals: request for information from third parties on three compounds (deadlines 18 October 2013 and; 24 October 2013).

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

 

The above items were taken from the October 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

 



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