REACH
Update to the list of substances potentially subject for compliance checks
ECHA has updated the list of substances that might be chosen for compliance checks. The list includes 93 new substances. Registrants are advised to check this list and if needed, update their related registration dossiers by 13 January 2017.
Since January 2015, ECHA publishes a list of substances for which a compliance check would in all probability be conducted. This gives the registrants the possibility for early dossier updates before the compliance check starts. However, the list is indicative and non-exhaustive: ECHA reserves the right to open further compliance checks on any dossier at any time and without prior notice to the registrants.
List of substances | Compliance checks
Persistency assessment well in place
For the first time, the Expert Group for persistent, bioaccumulative and toxic properties of chemicals (PBT EG) had an opportunity at their October meeting to discuss degradation simulation test results submitted after a substance evaluation decision. The group confirmed that there was no need for additional degradation tests for the assessment of the persistency of the substance based on the provided results on only one environmental compartment. The requested simulation degradation test had proven to be most efficient choice. If other tests had been chosen for the decision, it would have led to requests for further expensive simulation tests (up to four more in the worst case). For the first time, the expert group acknowledges the efficiency of the persistency testing strategy, which has been further clarified in the PBT guidance update still in progress.
So far, the expert group has discussed in total 158 substance under REACH. Of these 134 substances are now included in the Community rolling action plan indicating a PBT/vPvB (very persistent and very bioaccumulative) concern.
PBT Expert Group web page
Guidance on the environmental assessment of essential oils translated
The English version of the guidelines prepared by the European industry associations for essential oils was published in May 2016. It has now been translated into seven EU languages: Bulgarian, German, Spanish, French, Croatian, Italian and Portuguese. The limited number of language versions is due to the limited number of Member States producing essential oil.
Sector-specific support
CLP
Translations of the manual on "How to prepare a classification and labelling notification" now available
The manual, first published in English in April 2016, is now available on ECHA’s website in 23 EU languages.
Manuals
Biocides
New features in biocides IT tools
The biocides submission tool (R4BP 3) has been updated to support new features for Union authorisation and authorisation of same biocidal products. The tool for creating summaries of product characteristics (SPC Editor) now supports the creation of a biocidal product family with sub-families.
News item
Practical advice on authorisation for same biocidal products
The Practical Guide on the Biocidal Products Regulation has a new section on applying for authorisation for same biocidal products. The guide explains how you can now go from wider to narrower authorisation for identical products (for example, from Union to national authorisation). At the same time, the entire guide has been updated. A new web page also explains the options available. An updated regulation on the authorisation of same biocidal products entered into force on 1 November 2016.
Practical guide | Web page | Webinar | News item
Board of Appeal
Board of Appeal decision on a compliance check for 4-MHHPA published
The appellant in case A-004-2015 challenged a compliance check decision in which ECHA rejected a proposed read-across for data on sub-chronic toxicity and developmental toxicity from various cyclic anhydrides to the registered substance, 4-MHHPA.
The BoA decision addresses, amongst other things, whether the read-across proposed was adequately justified, the requirements placed on ECHA to consult with concerned registrants on various iterations of a draft decision, and whether the fact that 4-MHHPA was considered to be a substance of very high concern and strict risk management measures were already in place meant that certain standard registration information was not required.
The Board of Appeal found that ECHA did not commit an error of assessment in rejecting the proposed read-across. The Board of Appeal also found that the appellant’s right to be heard had been respected, and that the appellant could not waive standard information requirements on the basis that 4-MHHPA is already considered to be a SVHC. The appeal was dismissed.
Board of Appeal decisions
Announcement of a new appeal
The Board of Appeal has published an announcement in case A-007-2016 which concerns a data-sharing decision under the Biocidal Products Regulation.
Appeal announcement
Calls for information
Consultation on harmonised classification and labelling
ECHA has launched a public consultation on the harmonised classification and labelling proposal for dodecyl methacrylate (EC 205-570-6; CAS 142-90-5) mainly used as a monomer for the production of polymers included in various products as a binding agent in paints and coatings or adhesives. It has an existing harmonised classification and labelling in Annex VI to the CLP Regulation as Skin Irrit. 2, Eye Irrit. 2, STOT SE 3 and for its aquatic acute and chronic toxicity. The prososal from the dossier submitter is to remove dodecyl methacrylate from Annex VI to the CLP Regulation. We invite you to provide comments on the deletion of skin and eye irritation, specific target organ toxicity – single exposure and aquatic toxicity. Submit your comments by 19 December 2016 at 23:59 Helsinki time (EET).
Public consultation
Have a look at the 15 currently open consultations on our home page.
All open consultations
