…Review of criteria for non-aquatic organisms within PBT/vPvB frameworks
The current European and international criteria for assessing the persistent, bioaccumulative and toxic (PBT) or very persistent/very bioaccumulative (vPvB) nature of chemicals largely focus on the effects of these substances in aquatic species. There are, however, indications that some organic chemicals not classified as PBT/vPvB (from aquatic data) can bioaccumulate in non-aquatic food chains. A report by JRC reviews the relevant literature and regulatory information on chemical bioaccumulation in non-aquatic species, aiming to support an eventual revision of relevant guidance documents e.g. for REACH.
Gottardo S et al. (2014). Review of available criteria for non-aquatic organisms within PBT/vPvB frameworks. Part I: Bioaccumulation assessment. Joint Research Centre of the European Commission, Institute for Health and Consumer Protection. JRC Science and Policy Reports. EUR 26802 EN. https://ec.europa.eu/jrc/sites/default/files/i4.nbs_pbt_bioaccumulation_non-aquatic_part_i_online.pdf


…Proposals for harmonised classification and labelling
Under Regulation (EC) 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, proposals have been submitted by the German and Norwegian authorities to standardise the classification and labelling of chlorophene and 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one.
European Chemicals Agency. CLH reports. Proposals for harmonised classification and labelling based on Regulation (EC) No. 1272/2008 (CLP Regulation), Annex VI, Part 2.
Chlorophene. Version 4. 26 August 2014. http://echa.europa.eu/documents/10162/ac6a6afc-aff1-4e06-bd8e-5fab3b88543a
2-Methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one. Version 1. 30 July 2014. http://echa.europa.eu/documents/10162/75556bf1-9729-4d7d-9bd4-b6de6f4da035


…Additional consultation launched on the classification and labelling of acetochlor
The September 2013 harmonised classification and labelling (CLH) report on acetochlor has already been subject to public consultation, but an additional consultation has been launched on the reproductive toxicity of this herbicide. Although the dossier submitter did not originally propose classification for reproductive toxicity, data from repeated dose and reproductive toxicity studies “could indicate that classification … may be warranted”.
European Chemicals Agency (2014). ECHA calls for a new round of comments on the reproductive toxicity of acetochlor. ECHA/NA/14/42. http://echa.europa.eu/view-article/-/journal_content/title/echa-calls-for-a-new-round-of-comments-on-the-reproductive-toxicity-of-acetochlor
For the September 2013 CLH report, see http://echa.europa.eu/documents/10162/f097b7bf-0c47-4414-b942-fae16b9e6bc4


…ECHA’s Committee for Risk Assessment (RAC) adopts five opinions on harmonised classification and labelling
As announced in a September 2014 news alert, RAC has considered proposals (from the Dutch, Italian, Portuguese and UK authorities) to harmonise the classification and labelling of:
• chloralose
• N,N-dimethylacetamide
• heptadecafluorononanoic acid (PFNA) and its sodium and ammonium salts
• iodomethane
• methanol
European Chemicals Agency (2014). RAC concludes on scientific opinions for CLH. ECHA/NA/14/40. http://echa.europa.eu/view-article/-/journal_content/title/rac-concludes-on-scientific-opinions-for-c-1


…Proposed restriction of decabromodiphenyl ether (decaBDE)
A recent Annex XV report submitted by the Finnish and Norwegian authorities proposes a restriction on the manufacture, use and placing on the market of decaBDE, either as a substance by itself or when present in other substances at concentrations of 0.1% by weight or more. Articles (or parts thereof) containing decaBDE at 0.1% or more shall also not be placed on the market. The proposal is based on concerns over the environmental effects and persistence of decaBDE, but data relevant to human health are also considered.
European Chemicals Agency. Annex XV restriction report. Proposal for a restriction. Bis(pentabromophenyl) ether. Version number 1. 1 August 2014. http://echa.europa.eu/documents/10162/a3f810b8-511d-4fd0-8d78-8a8a7ea363bc


…Consultations on ten 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, Danish, German and Swedish authorities, and cover the following chemicals (some of which are already classified as SVHCs):
• 2-benzotriazol-2-yl-4,6-ditertbutylphenol (UV-320)
• 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)
• benzyl butyl phthalate (BBP)
• bis(2-ethylhexyl) phthalate (DEHP)
• cadmium fluoride
• cadmium sulphate
• dibutyl phthalate (DBP)
• diisobutyl phthalate (DIBP)
• 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)
• reaction mass of DOTE and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MOTE)
European Chemicals Agency. Annex XV dossiers. Proposals for identification of substances of very high concern on the basis of the criteria set out in REACH Article 57. Proposals, dated August 2014, available for comment until 16 October 2014. http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-identification


…Public consultation on substances to be added to ECHA’s Authorisation List
A public consultation has been launched on a draft recommendation that the following priority substances from ECHA’s Candidate List should be subject to authorisation:
• four boron substances: boric acid; anhydrous disodium tetraborate; diboron trioxide; and tetraboron disodium heptaoxide hydrate
• 1-bromopropane
• two coal tar substances: anthracene oil and coal tar pitch, high temperature
• seven lead substances: lead tetraoxide; lead monoxide; tetralead trioxide sulphate; pentalead tetraoxide sulphate; silicic acid, lead salt; pyrochlore, antimony lead yellow; and acetic acid, lead salt, basic
• 4-nonylphenol, branched and linear, ethoxylated
• seven phthalates: diisopentylphthalate; 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich; 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters; 1,2-benzenedicarboxylic acid, dipentylester, branched and linear; bis(2-methoxyethyl) phthalate; n-pentyl-isopentylphthalate; and dipentyl phthalate
Comments on these recommendations should be submitted to ECHA by 30 November.
European Chemicals Agency (2014). ECHA’s proposal to add new substances to the Authorisation List is now in public consultation. ECHA/PR/14/12. http://echa.europa.eu/view-article/-/journal_content/title/echas-proposal-to-add-new-substances-to-the-authorisation-list-is-now-in-public-consultation


…Applications for authorisation supported by RAC and SEAC
ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) have issued opinions in support of authorising the use of three substances of very high concern (SVHCs): bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and diarsenic trioxide.
RAC also adopted its opinion clarifying an existing restriction on the use of cadmium and its compounds in paints. SEAC reached agreement on the same proposal, and also on a draft opinion on restricting the manufacturing and use of 1 methyl-2-pyrrolidone (NMP). SEAC also adopted its final opinion on a Swedish proposal to restrict nonylphenols and nonylphenol ethoxylates in textiles.
European Chemicals Agency (2014). ECHA Committees support 16 uses of substances of very high concern. ECHA/NA/14/41. http://echa.europa.eu/view-article/-/journal_content/title/echa-committees-support-16-uses-of-substances-of-very-high-concern


…Other items of interest
Draft update of ECHA’s guidance on information requirements and chemical safety assessment (IR&CSA) – Part C and Chapters R.7b, R.7c and R.11, related to the PBT/vPvB assessment.

Revised draft update of ECHA’s guidance on scientific research and development (SR&D) and product and process orientated research and development (PPORD) sent to Competent Authorities for REACH and CLP (CARACAL).

Testing proposals involving vertebrate animals: request for information from third parties on 29 substances (deadline 3 November).


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

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