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woensdag 31 januari 2018

HSE eBulletin service Daily Digest Bulletin

HSE e-Bulletin service
93rd edition of the REACH Competent Authority e-bulletin

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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

Reminder - Stakeholders' Day on 31 January

ECHA will host this event which is aimed to give last minute tips for the registration deadline and discuss what happens next. The event can be followed live online.

 

The Directors' Contact Group (DCG) recommendations to help SME registrants

The DCG has published its recommendation of four actions to help ease the cost burden on first-time registrants for accessing data and the joint submission for their 2018 registration. They are:

  • Reducing the costs of data for 1-10 tonne registrants by exploring data waiving arguments
  • Addressing situations caused by late data-sharing negotiations or pending dispute decisions
  • Reducing the cost burden on SMEs by allowing payment in instalments
  • Offering a low-cost affordable lump sum payment option for 1-10 tonne registrants

The DCG has also re-activated four solutions designed already for previous registration deadlines for the forthcoming 2018 deadline. These solutions are related to the following issues:

  • Completeness of dossiers
  • Legal Entity change
  • Dependency on the Lead Registrant
  • Substance with no registration intentions

Further information is available on ECHA's website.

 

IUCLID Cloud

An update of the cloud version of IUCLID now gives step-by-step guidance on how to build a complete registration dossier for the 2018 deadline. Further information including relevant links is available on ECHA's website.


An update of the Cloud Services webpage gives more information about the security aspects of the services and the benefits the cloud offers to consultants. It also includes a simple presentation about the tool.

 

Three new video tutorials are available online for the IUCLID Cloud on how to get help; how to use the dissemination preview and how to use guided dossier preparation.


Regulatory activity

Restrictions

The Commission has amended the Restriction List (Annex XVII) to include the substances octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5). The decision is available online.


ECHA are developing a proposal to restrict the use of oxo-plastics and microplastics (in consumer or professional use products) following a request from the Commission. Further information is available on ECHA's website.

Three new restriction intentions have been published for the following substances (all expected to be submitted by 11 January 2019):

  • Formaldehyde and formaldehyde releasers (by ECHA)
  • Calcium cyanamide (by ECHA)
  • Substances meeting the classification criteria as skin sensitisers and skin irritants (by France)

Current Restriction intentions are available on ECHA's website.

ECHA also invites comments on information related to formaldehyde and formaldehyde releasers to help with the preparation of the dossier. The deadline is 11 April 2018. Comments can be given via ECHA's website.

  

Evaluation

ECHA has selected 236 substances for further scrutiny by the Member State competent authorities in its annual screening exercise. The competent authorities will carry out a manual examination of dossiers they prioritise to decide whether or not regulatory action is needed. Further information is available on ECHA's website.

 

ECHA have changed their procedures so that registrants of transported isolated intermediates will also receive substance evaluation draft decisions. This change will give all registrants an equal possibility to comment on substance evaluation decisions. Further information is available on ECHA's website.

 

Substances of very high concern (SVHC)

Seven new SVHCs have been added to the Candidate List:

  • Chrysene
  • Benz[a]anthracene
  • Cadmium nitrate
  • Cadmium hydroxide
  • Cadmium carbonate
  • Dechlorane Plus(TM)
  • Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear]

In addition the entry for bisphenol A (BPA) was updated to reflect an additional reason for inclusion due to its endocrine disrupting properties causing adverse effects to the environment.

Companies may have legal obligations resulting from the inclusion of the substance in the Candidate List. Further information is available on ECHA's website.

 

New intentions for identification as a SVHC have been received for the following substances:

  • Disodium octaborate
  • Octamethylcyclotetrasiloxane (D4)
  • Decamethylcyclopentasiloxane (D5)
  • Dodecamethylcyclohexasiloxane (D6)
  • Benzo[ghi]perylene

The registry of current SVHC intentions is available on ECHA's website.

The proposal for tricobalt tetraoxide containing ≥ 0.1 % w/w nickel oxides has been withdrawn. The list of withdrawn SVHC intentions and submissions is available on ECHA's website.

 

Authorisation

RAC and SEAC Committees' opinions on applications for authorisation are now available on ECHA's website for:

  • one use of 2,2'-dichloro-4,4'-methylenedianiline (MOCA) by REACHLaw Ltd in its legal capacity as OR of Suzhou Xiangyuan Special Fine Chemical Co., Ltd
  • one use of chromium trioxide by Wesco Aircraft EMEA, LTD
  • one use of sodium dichromate by Wesco Aircraft EMEA, LTD
  • one use of potassium dichromate by Wesco Aircraft EMEA, LTD
  • two uses of sodium chromate by Aviall Services Inc and Wesco Aircraft EMEA, LTD

 

The Commission has granted authorisations for the uses of the following substances:

  • one use of sodium dichromate by Gruppo Colle s.r.l.
  • one use of 1,2–dichloroethane (EDC) by GE Healthcare Bio-Sciences AB
  • one use of ammonium dichromate by Veco B.V.
  • two uses of chromium trioxide by Abloy Oy
  • two uses of 1,2–dichloroethane (EDC) by BASF SE
  • one use of acids generated from chromium trioxide and their oligomers by Robert Bosch GmbH

 

The Commission has published a study on the impacts of authorisation showing that the authorisation system is achieving its objectives in terms of both substitution and the reduction of human health and environmental risks when SVHCs are used.

 

RAC and SEAC have recently agreed on advice relating to applications for authorisation for substances on the Authorisation List with endocrine disrupting properties for the environment. This relates to the substances octylphenol ethoxylates (OPnEO) and nonylphenol ethoxylates (NPnEO). RAC's Q&As on risk-related considerations help applicants to understand how RAC will evaluate any predicted no-effect concentration (PNEC) values proposed and how a 'non-threshold' approach to authorisation could be described in their application. SEAC's advice describes one possible approach for socio-economic analysis that an applicant may use to justify the authorisation for a substance. The relevant document is available on the Evaluating applications webpage on ECHA's website.


Consultations

Draft opinions of SEAC concerning two restriction proposals

Comments are welcome on SEACs draft opinions concerning restriction proposals for diisocyanates (by Germany) and lead stabilisers in PVC articles (by ECHA). The deadline for comments is 20 February 2018. Comments can be given via the 'Submitted restrictions under consideration' webpage on ECHA's website.

 

Proposal submitted to restrict certain substances in tattoo inks and permanent make-up

ECHA (supported by Denmark, Italy and Norway) has submitted a proposal to restrict the placing on the market and use of tattoo inks and permanent make-up containing certain chemical substances. The deadline for comments is 20 June but ECHA's scientific committees welcome early comments by 16 February. This is to assist them in the first discussion of the proposal in March. Comments can be given via the 'Submitted restrictions under consideration' webpage on ECHA's website.

 

Proposal submitted to restrict C9-C14 Perfluorocarboxylic Acids (PFCAs)

Germany (in collaboration with Sweden) has submitted a proposal to restrict the manufacturing and the placing on the market of C9-C14 Perfluorocarboxylic Acids (PFCAs) (PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFTeDA), their salts and precursors as constituents of other substances, mixtures and in articles or any parts thereof containing one of the substances. The deadline for comments is 20 June but ECHA's scientific committees welcome early comments by 16 February. This is to assist them in the first discussion of the proposal in March. Comments can be given via the 'Submitted restrictions under consideration' webpage on ECHA's website.


Reports, Guidance & Updates

Use of bisphenol-A and its alternatives in thermal paper in the EU 2014-16

Based on the Commission's request, ECHA have surveyed manufacturers selling thermal paper in the EU on the use of bisphenol-A, bisphenol-S and other developers. The results are presented in the survey summary. The survey will continue and the summary report will regularly be updated.


ENES11 report available

Information from the Exchange Network on Exposure Scenarios (ENES) November 2017 meeting is now available on ECHA's website 

 

Use maps update

ECHA have published in their use maps library:

  • The use map of the association of European plastics converters (EuPC). In addition, EuPC provides a guidance document and a tool to derive conditions of use for the workers assessment. Registrants supplying to this sector are invited to use the information to prepare their 2018 registrations or improve their existing registration dossiers.
  • Concawe's specific consumer exposure determinants for the use of fuels. A handbook containing supporting explanations is also provided. Registrants supplying substances for this use are invited to use the information to prepare their 2018 registrations or improve

 

Communication in the supply chain webpages update

The webpages now provide information on the roles of other actors in the supply chain, as well as on tools that help them to meet their obligations. In addition, the downstream user web pages have been moved under this topic, to reflect the significance of downstream users' roles and responsibilities.


Events

Webinar: How are substances shortlisted and manually screened? (1 February 2018)

This aims to provide information on the manual screening process, identify substances that may have hazardous properties and cover the timelines for screening and the criteria for shortlisting. Registration for the webinar is via ECHA's website.

 

Webinar: Guided dossier preparation in the IUCLID Cloud (7 February 2018)

This aims to covers a feature for SMEs that gives an alternative way of preparing IUCLID dossiers using IUCLID Cloud. This 'Guided dossier preparation for REACH 2018' feature presents an SME with a series of well-defined tasks to complete based on the type of dossier they intend to submit. The guided approach includes task-specific help and links to relevant guidance documents and texts. Registration for the webinar is via ECHA's website.

 

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