ECHA
Limited services at year-end
We will be closed from 23 December to 2 January. This affects the availability of REACH-IT and support through our contact forms.
News item
REACH
Member State Committee issues four SVHC agreements and two opinions
The Member State Committee (MSC) unanimously agreed on the identification of four substances as substances of very high concern (SVHCs): bisphenol A, PFDA, PTAP and 4-HPbl. Consequently, ECHA will include these substances in the Candidate List in January 2017.
The majority of the MSC’s members also supported the identification of an environmental endocrine disruptor PTBP and a respiratory sensitiser TMA as SVHCs. As no unanimous agreement was reached by the MSC on the SVHC identification of PTBP and TMA, ECHA will submit the MSC opinions and the minority positions on these two substances to the European Commission for further decision making.
News alert
New guide on how to apply for authorisation
The step-by-step guide gives potential applicants practical advice on how to prepare a ‘fit-for-purpose’ application for authorisation. It outlines key issues that companies need to consider, describes the essential information that should be included in an application and presents examples from previous applications. As the guide will be updated from time-to-time, we invite you to provide feedback and suggestions for improvements.
How to apply for authorisation | Feedback survey
New example for assessing acute toxicity with the OECD QSAR Toolbox
The case study (part 2c) illustrates the elements companies should take into account when predicting acute toxicity by the oral route with the QSAR Toolbox. It complements the other QSAR Toolbox case studies published since February 2014.
Case studies | OECD QSAR Toolbox
Restriction dossier for lead and lead compounds submitted
ECHA has submitted a proposal to restrict the placing on the market and use of lead compounds (EC 231-100-4) in PVC and of the placing on the market of PVC articles stabilised with lead compounds. Depending on the outcome, the scope of the restriction might be broad or targeted specifically to articles or article groups that are the main contributors to the risks targeted by this proposal. The Agency's committees are currently performing a conformity check on the dossier. The dossier is available on our website to increase transparency and to help stakeholders prepare for the six month public consultation on the dossier. If the dossier passes conformity, the public consultation is expected in February 2017.
Submitted restriction proposals | ECHA's activities on restrictions
Commission's regulation on bisphenol A in thermal paper published
The European Commission has published a regulation amending Annex XVII to REACH (Restriction List) adding a new entry for bisphenol A (BPA) contained in thermal paper.
Official Journal | Hot topics
New proposals to harmonise classification and labelling
Five new proposals have been received to harmonise the classification and labelling of the following substances:
- 2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol (EC -; CAS 1417782-03-6)
- 5-fluoro-1,3-dimethyl-N-[2-(4-methylpentan-2-yl)phenyl]-1H-pyrazole-4-carboxamide; penflufen (EC -; CAS 494793-67-8)
- Trimethoxyvinylsilane (EC 220-449-8; CAS 2768-02-7)
- Thiophanate-methyl (ISO); dimethyl (1,2-phenylenedicarbamothioyl)biscarbamate (EC 245-740-7; CAS 23564-05-8)
- Formic acid (EC 200-579-1; CAS 64-18-6)
The intention to harmonise the classification and labelling for 3-decen-2-one (EC 235-059-0; CAS 10519-33-2) has been withdrawn.
Submitted CLH proposals | Withdrawn CLH intentions
Substances of Very High Concern (SVHC)
Sweden plans to submit a dossier for identifying perfluorohexane-1-sulphonic acid and its salts as a substance of very high concern. The expected submission date is 7 February 2017.
Current SVHC intentions
Further substances assessed by authorities
The public activities coordination tool (PACT) has been updated with information on eight substances that are undergoing hazard assessment or risk management option analysis by authorities.
Public activities coordination tool
Biocides
Biocidal Products Committee adopts 17 opinions
The Biocidal Products Committee (BPC) has adopted opinions supporting the approval of six active substances for use in biocidal products used as disinfectants and preservatives.
News alert
Board of Appeal
Board of Appeal rules on a contested substance evaluation decision for triclosan
In Case A-018-2014, the appellant contested a substance evaluation decision requiring further information on the substance triclosan. The Board of Appeal rejected most of the pleas and arguments made by the appellant in the appeal.
News item | Board of Appeal decisions
Downstream users
Use map for construction chemicals
The use map for the construction chemicals sector is now available in the use map library on our website. Registrants supplying to this sector should use the information to prepare their 2018 registrations or improve their existing registration dossiers and the exposure scenarios they send down the supply chain. We encourage downstream user sectors that have not started to prepare their use maps to do so now.
Use maps library
Guidance
REACH Guidance document updated
ECHA has published an update of three sections in Chapter R.7a of the Guidance on Information Requirements and Chemical Safety Assessment:
- Section R.7.2 on skin corrosion/irritation, serious eye damage/eye irritation and respiratory tract corrosion/irritation;
- Section R.7.3 on skin and respiratory sensitisation; and
- Section R.7.4 on acute toxicity.
The update addresses the recently revised REACH Annexes VII and/or VIII for these endpoints, making non-animal testing the default requirement for skin corrosion/irritation, serious eye damage/eye irritation and skin sensitisation.
Additionally, the Section R.7.4 update introduces a new possibility to adapt the requirement for an acute toxicity study in some cases based on weight of evidence. This update expands on the information on alternative (i.e. in vitro and non-testing) methods for each endpoint and clarifies when and how to use them for REACH purposes. The recommended testing and assessment strategies for these endpoints have been refined accordingly.
Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.7a
Guidance for identification and naming of substances under REACH and CLP updated
This update (version 2.0) of the Guidance for identification and naming of substances under REACH and CLP adds a new appendix addressing the substance identity profile (SIP) concept and the definition of the compositional profile for the substance the co-registrants agree to register jointly.
Guidance on REACH
New draft for REACH guidance update available
A new draft for updated ECHA guidance on REACH has been sent for the next consultation step:
- Guidance on recommendations for nanomaterials applicable to QSARs and grouping of chemicals sent for MSC consultation
The new draft has been uploaded to the ongoing guidance consultations page on ECHA's website.
Potential registrants for the 2018 deadline may be interested in already viewing the new draft documents.
Ongoing guidance consultations
Translations of the Guidance on labelling and packaging now available
The updated Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 (version 2.0) published in September 2016 is now available in 23 EU languages.
Guidance on labelling and packaging
Calls for information
Public consultation on harmonised classification and labelling
ECHA is looking for comments on the harmonised classification and labelling proposals for:
- 2,2'-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) (EC 403-800-1; CAS 103597-45-1) is used i the production of resins, rubbers and polymers intended for consumer products. It has an existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on the environmental hazard classes.
- dibutylbis(pentane-2,4-dionato-O,O')tin (EC 245-152-0; CAS 22673-19-4) is used in the production of e.g. paints and dyes, and as a catalyst. It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on the reproductive toxicity and specific target organ toxicity - repeated exposure hazard classes.
The deadline for comments is 9 February 2017, 23:59 EET (Helsinki time).
- metaflumizone (ISO); (EZ)-2'-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide E and Z isomers (EC -; CAS [1] 139968-49-3; [2] 852403-68-0) is an active substance (insecticide) used in plant protection products. It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on all hazard classes apart from aspiration hazard and hazardous to the ozone layer.
- carboxin (ISO); 2-methyl-N-phenyl-5,6-dihydro-1,4-oxathiine-3-carboxamide; 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide (EC 226-031-1; CAS 5234-68-4) is an active substance (fungicide) used in plant protection products. It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on all hazard classes except the aspiration hazard and hazardous to the ozone layer.
The deadline for comments is 13 February 2017, 23:59 EET (Helsinki time).
Public consultations
Testing proposals
ECHA has launched 12 new public consultations on testing proposals. The deadline to comment these is 30 January 2016. In total, there are currently 19 public consultations open on testing proposals.
Give comments
Have a look at the 61 currently open consultations on our home page.
All open consultations
