…ECHA guidance on read-across

Read-across is commonly used to fill data gaps to comply with REACH requirements. ECHA has developed an illustrative example of a read-across approach in order to support companies with their REACH obligations. The example currently comprises:

  • Part 1, providing background information on read-across and describing common shortcomings identified by ECHA when evaluating registration dossiers.
  • Part 2, an illustrative example using a read-across approach to assess a hypothetical substance.

European Chemicals Agency.
Grouping of substances and read-across approach. Part 1: Introductory Note. ECHA-13-R-02-EN. April 2013. http://echa.europa.eu/documents/10162/13628/read_across_introductory_note_en.pdf

Read-across illustrative example. Part 2: Example 1 – Analogue approach: similarity based on breakdown products. ECHA‑13‑R-03-EN. April 2013.



…Harmonised classification and labelling proposals for pesticides and boron compounds

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 Belgian, Dutch, German and Polish authorities to standardise the classification and labelling of the following substances:

  • boric acid
  • disodiumoctaborate anhydrate
  • disodiumoctaborate tetrahydrate
  • fenpyroximate
  • lenacil

European Chemicals Agency. CLH reports.
Proposals for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2.
Boric acid. Version number: 2. 23 April 2013.


Disodiumoctaborate anhydrate. Version number: 3.0. March 2013.


Disodiumoctaborate, tetrahydrate. Version number: 3.0. March 2013.


Fenpyroximate. Version number: 2. March 2013.


Lenacil. Version number: 3. April 2013.



…Call for data on etridiazole’s reproductive toxicity and carcinogenicity

An ECHA news alert (ECHA/NA/13/17) announced the launch of an additional harmonised classification and labelling (CLH) public consultation on the reproductive toxicity and carcinogenicity of etridiazole. Since the last consultation in 2012, concerns have been raised over the relevance of treatment-induced malformations and maternal toxicity, and the interpretation of data concerning its carcinogenic potential is under discussion. New comments are welcomed by 3 June 2013.



…Other items of interest

Clarification on when to submit applications for authorisation.



Draft revised guidance on information requirements and chemical safety assessment (IR&CSA) (PBT assessment) – part C and chapters R.7b, R.7c and R.11 sent to ECHA’s Partner Expert Group (PEG).



Draft revised guidance on IR&CSA – chapter R.7a (mutagenicity-related sections R.7.7.1 to R.7.7.7 only) sent to PEG.



Draft revised guidance on the application of the CLP criteria – part 2: physical hazards, and part 3: health hazards, sent to RAC and Forum.




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

News Home Guest Write For Us? Contact Us