75th edition of the REACH Competent Authority e-bulletin

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Registration, Evaluation, Authorisation & restriction of Chemicals (REACH) eBulletin

New guidance from the UK Chemicals Stakeholder Forum (UKCSF)

The UK Chemicals Stakeholder Forum (UKCSF) has recently published new business-friendly guidance on the REACH 2018 registration deadline. This guide draws on the experience of the wide range of CSF members from industry. The CSF has also updated their REACH authorisation guidance, which was first published in April 2014.

The ‘Forum Guidance for SMEs and Downstream Users on the REACH 2018 Registration Deadline’ (along with an explanatory note) aims to raise awareness of the deadline and to help companies consider what they have to do. In particular in preparing and submitting dossiers to ECHA. It is also aimed at downstream users who need to assess the potential for disruption of their supply chains if substances which they depend on are not registered.

The ‘updated Forum Guidance for SMEs and Downstream Users on REACH Authorisation’ provides an introduction to REACH authorisation, what it might mean for  businesses and where they can go to find out further information and get help.  

Both sets of guidance are available as publications on the UKCSF website under the ‘Publications’ section. Further details on the role of the UKCSF can also be found on its website.


New implementing regulation on REACH data sharing

The European Commission has brought in a new regulation which seeks to clarify the requirements for data-sharing under REACH. It aims to define the terms ‘fair, transparent and non-discriminatory' and sets rules to make sure that the data-sharing agreements in substance information exchange forums (SIEFs) are both clear and comprehensive. Potential registrants joining a SIEF are given the right to request a breakdown of the study and administrative costs that make up the price for the joint registration.

The Implementing Regulation on joint submission of data and data-sharing was published in the Official Journal on 6 January and enters into force on 26 January 2016. ECHA will update its IT tools, related guidance documents and other support material to reflect the changes.

Further information including a link to the regulation, is available on ECHA’s website.


New revised dissemination database - launch date 20 January

ECHA’s dissemination database is one of the biggest regulatory databases on chemicals in the world. ECHA plan to launch a revised database on 20 January which will involve a new way of finding out about the chemicals used in Europe. Information on up to 120 000 chemicals will be structured in three layers: the simple info card; the more detailed brief profile and the full source data. Each layer is designed for audiences with different levels of knowledge, with the info card being the simplest level. Further information will be available on ECHA’s website in due course.


ECHA committee activity

Committee for Risk Assessment (RAC)

RAC have recently:

  • Concluded on the restriction proposal on methanol, in support of Poland’s proposal. This is to restrict the concentration limits of methanol in windscreen washing fluids and denatured ethanol. The proposed restriction is intended to prevent poisoning caused by the consumption of windshield washing fluids and denatured alcohol containing methanol.
  • Agreed draft opinions for authorisation applications for uses of: 1,2-dichloroethane (EDC) as a process and extracting solvent in the manufacture of a pharmaceutical active ingredient; sodium chromate as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators (the type used in e.g., hotel rooms, caravans and camper vans); sodium dichromate in copper/lead separation in concentrators handling complex sulphide ores.

Further information is available on ECHA’s website.  

  

Committee for Socio-economic Assessment (SEAC) 

SEAC have recently:

  • Concluded on the restriction proposal for bisphenol A (BPA) in thermal paper (e.g. used for point-of-sale tickets and receipts). They concluded that the socio-economic benefits are unlikely to outweigh the costs of the proposed restriction on BPA. The Commission now decide on whether to add BPA to the REACH restrictions list. Further information is available on ECHA’s website.
  • Concluded on the restriction proposal on PFOA (pentadecafluorooctanoic acid) and PFOA-related substances on their manufacture, marketing and use. They concluded that the proposed restriction is the most appropriate EU-wide measure to address the identified risks. This is in terms of the proportionality of its socio-economic benefits to its socio-economic costs, provided that the conditions are modified to introduce a series of additional derogations
  • Agreed on draft opinions supporting the restriction of methanol in windshield washing fluids, in support of the proposal by Poland. The public consultation on SEAC’s draft opinion is now open until 9 February 2016. SEAC plans to adopt its final opinion in March 2016.
  • Agreed on draft opinions supporting authorisation applications for three substances: sodium chromate, sodium dichromate and 1,2-dichloroethane (EDC) [see above for details of the uses].

Further information is available on ECHA’s website. 


New substances of very high concern (SVHCs) added to the Candidate List

ECHA has added five new SVHCs to the Candidate List, which now contains a total of 168 substances. The Candidate List substances are candidates for possible inclusion in the Authorisation List. The new substances added are as follows:

  • Nitrobenzene
  • 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)
  • 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)
  • 1,3-propanesultone
  • Perfluorononan-1-oic-acid and its sodium and ammonium salts

Further information is available on ECHA's website.


MSC supports inclusion of HDDA to the Candidate List

Sweden has proposed the identification of the skin sensitiser hexamethylene diacrylate (HDDA) as a SVHC for inclusion on the Candidate List. The majority of the Member State Committee's (MSC) members support this proposal and their opinion, plus the minority position of those who did not agree, will now be sent to the European Commission for their final decision. Further information is available on ECHA’s website.


Update to the list of substances potentially subject to compliance checks

ECHA has recently updated the list of substances that might be chosen for compliance checks. Registrants are advised to check this list, which now includes 50 new substances. If required, they can update their related registration dossiers by 29 February 2016, i.e., before the compliance check starts. The list is only indicative and non-exhaustive and so ECHA can open further compliance checks on any dossier at any time and without prior notice to the registrants. Further information is available on ECHA’s website.


Call for evidence - lead stabilisers in PVC

The European Commission has requested ECHA to start the preparation of an Annex XV restriction dossier concerning lead stabilisers in PVC. ECHA will assess the risks to human health and the environment associated to the use of lead compounds as stabilisers in PVC articles. This call for evidence is open until 15 February 2016.


REACH 2018 webinar on 2 March - ‘Get organised with your co-registrants - SIEF management and data sharing’

This webinar gives information of the tasks that a substance information exchange forum (SIEF) needs to undertake to prepare a registration dossier, including information about fair, transparent and non-discriminatory data and cost sharing. You can register for the event now via ECHA’s website.


Published / Guidance

Updated guidance on substances in articles - Following the judgement of the Court of Justice, ECHA has published a quick update to its guidance on requirements for substances in articles. A more comprehensive update will follow this year. Further information including a link to the guidance is available on ECHA’s website.

Downstream users’ web pages - ECHA invites all downstream users to play a role in the REACH 2018 preparations by encouraging their suppliers to engage with these activities. ECHA have provided a specific section on their website to help keep users informed on how REACH 2018 can affect them. In addition they will provide updates on other REACH and CLP aspects important to downstream users.

Readers' guide available for preparing an application for authorisation - ECHA has published a readers' guide providing potential applicants, and their advisors, key information on preparing and submitting an application for authorisation. It covers guidance documents, questions and answers and information on how the applications are evaluated by the Committees for Risk Assessment and Socio-economic Analysis. The readers' guide will be updated, based on readers' feedback and the publication of new documents.

Conclusions and evaluation reports for 16 substance evaluation cases are available - The conclusion documents and evaluation reports for 16 substance evaluation cases which have been concluded are available on ECHA's website. The conclusion document provides the view of the evaluating Member State on the need for regulatory risk management measures. These can be found on the ECHA’s Substance evaluation – CoRAP webpage

NGOs and ECHA discuss future priorities for risk management and alternatives to animal testing - The December NGO-ECHA meeting covered topics such as ECHA's planned activities on substitution, on-going work to improve the public consultation process and an update on animal welfare topics. The NGO-ECHA discussion platform has been established to discuss topical issues of interest to civil society. A note from the December meeting is available on ECHA’s website

New case study for assessing chemical hazards with the QSAR Toolbox - The QSAR Toolbox can help registrants to fill their data gaps without testing on animals. ECHA has published a new illustrative example which demonstrates what elements need to be taken into account when predicting long-term toxicity to fish with the QSAR Toolbox. The new example (part 2b) has been added to the QSAR Toolbox case studies. Further information can be found on ECHA’s website.


Free guidance on the Registration, Evaluation, Authorisation & restriction of CHemicals regulations is available on HSE's website.

 

This bulletin provides a sample of the wide range of information that can be found under ‘What’s New' on HSE’s website.

 

Please feel free to use this information and pass it on, using your own networks.

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