REACH 2018: Assess your substance to show safe use
Companies registering the same substance must work together to compile and share information on the hazards and risks of their substance to demonstrate safe use. If new data needs to be generated, alternatives to animal testing must always be considered first. All information should be reported in a registration dossier and submitted to ECHA by 31 May 2018.
New practical guide advises SMEs on REACH information requirements
The guide is targeted to managers of small and medium-sized businesses and REACH coordinators who are responsible for gathering the information needed to compile REACH registration dossiers. It clarifies what information on a chemical is needed for registration, how this information can be generated and what kind of help is available. SMEs can benefit from the information when they negotiate with external service providers, such as laboratories or contract research organisations, as they will have a clearer picture of the tests required. Translations of the guide will be available in the autumn.
Practical advice on how to use alternatives to animal testing now combined in one guide
We have combined five practical guides on how to use alternative approaches and report data in the registration dossier into one guide called ‘How to use alternatives to animal testing to fulfil your information requirements for REACH registration'. It will help you to better understand your obligations to avoid unnecessary testing on animals while still making sure that you have sufficient information on your substances for classification and risk assessment. It also highlights the many opportunities to use alternatives to animal testing and how you can report the results of these approaches correctly. Translations of the guide will be available in the autumn.
Restriction dossier for N,N-Dimethylformamide submitted
Italy has submitted a proposal to restrict N,N-Dimethylformamide (DMF) in articles. ECHA has published the dossier on its website and ECHA's committees will perform a conformity check on the dossier to be finalised at the September plenary sessions of RAC and SEAC. The six-month public consultation on the dossier is expected to start in mid-September 2016 if the dossier passes conformity.
The Austrian competent authority plans to submit an dossier to identify 4-heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] as a substance of very high concern (SVHC). The expected submission date is 8 August 2016.
The Austrian competent authority has published a risk management option analysis (RMOA) conclusion document of phenol, heptyl derivatives (EC 276-743-1) in the public activities coordination tool (PACT).
Public consultation launched on eight anticoagulant rodenticide active substances
ECHA is collecting information to help the European Commission and Member States decide whether to renew the approval of eight anticoagulant rodenticide active substances. The substances are: chlorophacinone, coumatetralyl, warfarin, bromadiolone, difenacoum, brodifacoum, difethialone and flocoumafen.
Biocides dissemination manual updated to reflect changes in IUCLID 6
The manual presents what information from companies' applications for active substance approvals and authorisations of biocidal products submitted with IUCLID 6 will be made publicly available. This includes information from the new elements, such as assessment entities, new composition types and nanoforms of substances. In addition, ECHA will start publishing endpoint summary records, other substance identifiers in Section 1.1 of IUCLID and justifications for waiving data (if not claimed confidential). The reliability score of a study will also be available.
The changes in dissemination policy apply to applications submitted as of 6 July 2016. The data will be published with the publication of active substances and biocidal products dossiers.
How to identify which risk management measures to communicate for mixtures
Formulators need to communicate safe use information for mixtures under REACH. One approach is to identify the lead components and derive safe use information for mixtures using the exposure scenarios. A Cefic/VCI task force published a practical guide in March on a lead component identification (LCID) methodology they have developed for this purpose. A spreadsheet tool (version 1.0) has now been published to partially automate the methodology.
Consultation on harmonised classification and labelling
ECHA is seeking comments on the harmonised classification and labelling proposals for:
4,4'-sulfonylbisphenol, polymer with ammonium chloride (NH4Cl), pentachlorophosphorane and phenol (EC 439-270-3, CAS 260408-02-4). The substance is used as a halogen-free flame-retardant and fire preventing agent. It has an existing harmonised classification and labelling entry (CLP Regulation, Annex VI, No. 604-083-00-X). Comments are invited on the removal of the hazardous to the aquatic environment hazard class.
Fludioxonil (ISO); 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile (CAS 131341-86-1). Fludioxonil is formulated as a preservative product in building materials, paints, silicon coatings, sealants and grouts. Comments are invited on the following hazard classes: physical hazards, health hazards, and environmental hazards excluding hazardous to the ozone layer.