…Five 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 recently submitted by the Austrian and French authorities to standardise the classification and labelling of

  • muscalure (cis-tricos-9-ene)
  • etofenprox
  • fenpyrazamine
  • EHMA (dimethyltin bis(2-ethylhexylmercaptoacetate))
  • DMTC (dimethyltin dichloride)


…Classification & Labelling (C&L) Inventory Database

ECHA has launched its C&L Inventory Database (press release ECHA/PR/2/2012), containing over three million submission records covering more than 90,000 chemical substances, representing the largest database of self-classified substances available globally.

European Chemicals Agency (2012). C&L Inventory database.


…OECD Test Guideline 443 – a new option for reproductive toxicity under REACH

A recent news alert (ECHA/NA/12/02) states that, under certain conditions, data from extended one-generation reproductive toxicity studies (carried out according to OECD Test Guideline 443) can be used to fulfill the current information requirements for a “two-generation reproductive toxicity study” under REACH. Test Guideline 443 was adopted by the OECD in July 2011 (see Toxicology and Regulatory News 2011, 50(10), 126).


…Eight chemicals added to the list of substances subject to authorisation

The following substances of very high concern have been added to Annex XIV of the REACH regulation, as a result of being carcinogenic and/or toxic for reproduction:

  • diisobutyl phthalate (DIBP)
  • diarsenic trioxide
  • diarsenic pentaoxide
  • lead chromate
  • lead sulfochromate yellow (C.I. Pigment Yellow 34)
  • lead chromate molybdate sulphate red (C.I. Pigment Red 104)
  • tris (2-chloroethyl) phosphate (TCEP)
  • 2,4-dinitrotoluene (2,4-DNT)

This comes following a decision adopted by the European Commission on 14 February 2012.

European Chemicals Agency. Commission Regulation (EU) No 125/2012 of 14 February 2012 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’).


[Please note: link failed to work at time of going to press.]

…New substances added to Annex XVII of the REACH regulation

A number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) have been added to Annex XVII to Regulation (EC) No 1907/2006, which imposes restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles that pose an unacceptable risk to human health or the environment. Also included in this amendment is a time-limited derogation for boron compounds used as household detergents and cleaners.

European Chemicals Agency. Commission Regulation (EU) No 109/2012 of 9 February 2012 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 Annex XVII (CMR substances).


…Other items of interest

Applying for authorisation.


Pre-submission information sessions for authorisation applicants.


2300 substances already identified for registration by 2013.


Ban on dichloromethane in paint strippers from 6 June 2012 (for consumers and professional users outside industrial installations).


Training course on chemical safety assessment for REACH 2013 registration deadline.


The presentations and recording of the Lead Registrant workshop are now available.


Guidance in a nutshell and Guidance Fact Sheet on Substance identification now available in 22 EU languages.


Second draft revised Guidance on Registration sent to Forum and Member State Committees.


Study on communication of information on the safe use of chemicals to the general public submitted by ECHA to the European Commission.


ECHA’s Registry of Intentions of Substances of Very High Concern updated with six new intentions.


ECHA’s Registry of Intentions of Harmonised Classification and Labelling updated with six new intentions.


Testing proposals involving vertebrate animals: request for information from third parties on seven substances (deadline 1 March 2012; 19 March 2012).



The above items were taken from the March 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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