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vrijdag 24 februari 2017

HSE eBulletin service Daily Digest Bulletin

HSE e-Bulletin service
86th edition of the REACH Competent Authority

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


Welcome to the HSE Registration, Evaluation, Authorisation & restriction of Chemicals (REACH) eBulletin

The aim of this e-bulletin is to provide you with a free regular update of news and information from the UK REACH Competent Authority and the European Chemicals Agency (ECHA).

Below you will find brief information on a number of topics and issues, each linking to more detailed articles on the HSE or ECHA REACH websites.

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Registration 2018

ECHA's enhanced completeness check

Registrants preparing their registration dossiers for the 2018 deadline should note that ECHA now perform dossier enhanced completeness checks. This is to ensure the dossiers contain the data required by REACH. Recent ECHA results show that for a proportion of dossiers companies were asked for further information in the following areas: Justifications for waiving data; Substance identification; Testing proposals and Chemical safety reports. We would encourage potential registrants to ensure their dossiers are complete in order to avoid extra work. In addition, those companies who have already registered and suspect that their dossier could be improved may wish to address their dossiers and update them. Further information on ECHA's results is available on their website.

Regulatory activity

ECHA updates the list of substances potentially subject to compliance checks

This list includes 60 new substances and registrants are advised to check this and update their related registration dossiers, as required, by 28 April 2017. Information on compliance checks, including a list of the substances potentially subject for compliance checks is available on ECHA's website.


Candidate List update - addition of four new substances of very high concern (SVHCs)

Four new substances have recently been added to the Candidate List of SVHCs for authorisation; totalling 173 substances to date. The substances are:

  • 4,4'-isopropylidenediphenol (bisphenol A; BPA)
  • Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts
  • p-(1,1-dimethylpropyl)phenol
  • 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]

Companies may have legal obligations resulting from the inclusion of the substances. Further information including relevant links is available on ECHA's website.


ECHA shortlists 162 substances for possible regulatory action

ECHA has recently selected substances from REACH registrations as part of its annual IT screening exercise. Member State competent authorities will carry out manual examinations of the dossiers to decide whether regulatory action is needed. ECHA encourage companies to update their dossiers as this helps with the assessments. ECHA will contact those companies who have registered one of the shortlisted substances informing of the potential examination of the registration. ECHA hosted a recent webinar about the screening process. Further details and links to the webinar information and presentations are available on ECHA's website.


DecaBDE restrictions decision published

New restrictions on the use of the flame retardant decaBDE have been published in the Official Journal and Annex XVII to the REACH Regulation has been amended accordingly. The restrictions will apply from 2 March 2019.



Testing proposals

ECHA has launched a consultation on testing proposals. Further details are available on ECHA's website. Comments can be submitted via ECHA's website until 27 March 2017.


Applications for authorisation

ECHA has launched a consultation on 3 applications for authorisation. This is for two substances and covering a total of 4 uses; Sodium dichromate and Chromium trioxide. Further details on the uses that authorisation is applied for is available on ECHA's website. Comments can be submitted via ECHA's website until 5 April 2017. 


Draft guidelines on nickel and PAHs restrictions

ECHA has launched two calls for comments on proposed guidelines for the following:

  • the placing on the market and the use of nickel and nickel compounds in articles intended to come into direct and prolonged contact with the skin (restriction entry 27 of Annex XVII to REACH) 
  • the placing on the market for supply to the general public of articles containing polycyclic aromatic hydrocarbons (PAHs) (restriction entry 50 of Annex XVII to REACH)

Further details are available on ECHA's website. Comments can be submitted via ECHA's website until 19 April 2017.

Reports, Guidance & Updates

Read-across assessment – update

The Read-Across Assessment Framework (RAAF) has been updated and now contains environmental endpoints. This may help registrants anticipate how ECHA assesses their read-across cases and help registrants to improve their dossiers as they can use it to check the quality of their own read-across cases. Further information is available on ECHA's website.  


New advice on using non-animal test methods

ECHA's updated guidance gives advice on how to use non-animal test methods, which are now the default for many endpoints. Registrants are encouraged to take the changes into account when deciding their testing strategies. Further information is available on ECHA's website.


Downstream users: Use map for imaging and printing products published

The downstream sector use map for imaging and printing products is now available in the use maps library of ECHA's website. Use maps provide information on uses and conditions of use consolidated at the sector level. ECHA encourages registrants supplying substances to the imaging and printing sector to use the information from the use map to prepare their 2018 registrations, when updating their existing registration dossiers and for the generation of the exposure scenarios for communication.


Downstream users: Updated Q&As on SDS

The questions and answers addressing safety data sheet issues have been reviewed and updated. These are available on ECHA's website


New draft for REACH guidance update available

New drafts for updated ECHA guidance on REACH have been sent for the next consultation step; they can be viewed on the ongoing guidance consultations page on ECHA's website.

  • Guidance on recommendations for nanomaterials for environmental endpoints sent for CARACAL consultation
  • Guidance on Information Requirements and Chemical Safety Assessment – Chapters R.11, R.7b, R.7c and Part C, related to PBT/vPvB assessment, sent for MSC and BPC consultation
  • Guidance on requirements for substances in articles sent for Forum consultation

IUCLID 6 update

A recent update of IUCLID 6 has introduced new features including IUCLID hyperlinks; DNEL calculator and Public API. ECHA have hosted a recent webinar about the recent update, which is now available on their website.


Chesar Training (6-7 April)

ECHA are offering a Chesar training session in April in Helsinki. Further details are available on ECHA's website


ECHA Seminar on Applications for Authorisation (18-19 April)

This seminar aims to focus on improving future applicants' knowledge of the authorisation application procedure and highlighting the main elements on how to prepare an application. It also aims to look at how the opinion-making process is performed by RAC and SEAC, how the European Commission addresses decision-making and getting practical advice and feedback from previous applicants. Further information including details on registering are available on ECHA's website.



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