… ECHA updates guidance on the application of the CLP Criteria

Updates to Part 2: Physical hazards and Part 3: Health hazards take account of recent adaptations to the CLP Regulation. A corrigendum relates to Part 1: General principles for classification and labelling, and Part 4: Environmental hazards.

European Chemicals Agency. Guidance on the application of the CLP criteria. Guidance to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. ECHA-13-G-10-EN. Version 4.0. November 2013.


… Updated guidance for downstream users and on the compilation of safety data sheetsAs announced in a December 2013 news alert (ECHA/NA/13/43), RAC has considered proposals (from industry and the Belgian, Dutch, French, German, Irish and Swedish authorities) to harmonise the classification and labelling of the following eight chemicals (or groups of chemicals):

  • bifenazate
  • branched dodecylphenol (‘TPP’)
  • fenpyroximate
  • lead
  • lenacil
  • sulfoxaflor
  • tributyltin compounds
  • trisulfuron methyl

European Chemicals Agency. ECHA/NA/13/43.


… Harmonised classification and labelling proposalsUnder 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, French, German, Spanish, Swedish and UK authorities to standardise the classification and labelling of:

  • acetochlor
  • Bordeaux mixture (reaction products of copper sulphate with calcium dihydroxide)
  • copper
  • copper carbonate
  • copper hydroxide
  • copper (I) oxide
  • copper (II) oxide
  • copper oxychloride
  • copper sulphate (tribasic)
  • copper sulphate pentahydrate
  • copper thiocyanate
  • N,N-dimethylacetamide
  • 3,7-dimethylocta-2,6-dienenitrile
  • iodomethane
  • PFNA (2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluorononanoic acid) and its sodium and ammonium salts
  • reaction mass of bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate and 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane

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

http://www.echa.europa.eu/harmonised-classification-and-labelling-consultation (also see “Previous consultations”).

… Danish EPA utilises quantitative structure-activity relationships on REACH substancesSubstances classified as carcinogenic, mutagenic or toxic to reproduction (CMR), and manufactured or imported into the EU in quantities of at least 1 tonne per year, were required under REACH to be registered by December 2010. For many substances, few or no experimental data exist, which may result in CMR properties going unrecognised. A recent project by the Danish EPA used QSAR models to screen about 70,000 REACH substances (either not registered, or registered and not classified with respect to CMR) to produce working lists of substances with potential CMR properties. It is hoped that these lists may be used by authorities or industry to prioritise substances for further work.

Wedebye EB et al. (2014). Use of QSAR to identify potential CMR substances of relevance under the REACH regulation. Danish Ministry of the Environment. Environmental Protection Agency. Environmental Project No.1503.


… Other items of interestOECD QSAR Toolbox Version 3.2 now available (please see the International section of this issue of Toxicology and Regulatory News for more information).


Is your substance identity information up-to-date?


ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) agree on restrictions and authorisations.


RAC and SEAC adopt opinions on first application for authorisation to use bis(2-ethylhexyl)phthalate (DEHP).


ECHA’s Member State Committee (MSC) deals with testing proposals of alkenes and petroleum substances.


Draft update of the guidance for the preparation of Annex XV dossiers on the identification of substances of very high concern (SVHC) sent to Competent Authorities for REACH and CLP (CARACAL).


ECHA publishes corrigendum to the information requirements and chemical safety assessment (IR&CSA) guidance: Chapter R.7a – Endpoint specific guidance.


Revised draft guidance on the preparation of dossiers for harmonised classification and labelling sent for Partner Expert Group (PEG) consultation.


Two new ‘guidance in a nutshell’ documents available for downstream users and on the compilation of safety data sheets.


Fact sheet explains toll manufacturer responsibilities under REACH.


Testing proposals involving vertebrate animals: request for information from third parties on one compound (deadline 3 February 2014).


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

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