ECHA Weekly - 15 November 2023

REACH

Call for evidence: restriction of octocrilene

France has launched a call for evidence to support the preparation of a REACH restriction proposal concerning octocrilene.

They are looking for information on this substance and its potential alternatives in plastisol and cosmetic products, including sunscreens.

Information on life cycle, emissions and risks to the environment as well as socio-economic impacts of a potential restriction for the above-mentioned uses is also of interest.

For questions, contact the French Competent Authority ANSES.

Have your say until 10 January 2024.

Consultations on applications for authorisation

We have launched consultations on three applications for authorisation and three review reports covering ten uses of:

• 4-Nonylphenol, branched and linear, ethoxylated (EC -, CAS -)
  • Used for the formulation of a hardener component and its mixing within the aerospace sector.
• 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -)  
  • Used for the extraction of biological material used in articles intended for clinical and industrial in-vitro testing applications.
  • Used in the aerospace sector as a hardener in-two parts polysulfide sealant solutions.
• Potassium dichromate (EC 231-906-6, CAS 7778-50-9) 
  • Used in the manufacture of single-use chemical breathalysers.
• Bis(2-ethylhexyl) phthalate (EC 204-211-0, CAS 117-81-7)
  • Used for the formulation of plastics containing DEHP and their use for the packaging of medical products.
  • Used as a lubricant/sealing agent used in the immediate packaging of medicines.
• Tetraethyllead (EC 201-075-4, CAS 78-00-2)
  • Used for the formulation of aviation fuel.

More information about the uses applied for is available online.

Have your say by using the webform until 10 January 2024.

Authorisation: latest application and sunset dates extended for DEHP uses in medical devices

The European Commission has extended the deadline for applications to use bis(2-ethylhexyl) phthalate (DEHP) in medical devices from 27 November 2023 to 1 January 2029.

The sunset date, after which companies cannot market or use a substance without an authorisation, has been extended from 27 May 2025 to 1 July 2030.

This gives companies possibility to use their resources for assessing DEHP-free alternatives under the Medical Devices Regulation (MDR). Consequently, an application for authorisation under REACH will only be necessary for uses where alternatives are not available or not yet certified under the MDR.

Assessment of regulatory needs reports published

Reports for the following substance groups are now available on our website:

• Oxabicyclo esters
• Tin and simple inorganic tin compounds
• Simple chromium compounds (other than VI)
• Glycosides

If you have questions or feedback related to the assessment work, you can send them to us using this webform.

CLP

New proposals to harmonise classification and labelling

Two intentions have been received for:

• 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran; [galaxolide]; [HHCB] (EC 214-946-9, CAS 1222-05-5)
• tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate (EC 250-418-4, 30989-05-0)

Biocides

Want to keep using DCEMH and DCDMH under product-type 11?

Companies have withdrawn their interest in getting:

• Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH); and
• Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH)

approved in the biocides Review Programme for use in preservatives for liquid-cooling and processing systems (product-type 11).

Notify us by 14 November 2024 to keep these substances in the Review Programme.

Transition of SPC Editor into IUCLID postponed

We have rescheduled the go-live of the SPC Editor into IUCLID project to the first quarter of 2024 due to technical issues. The launch was originally planned for the last quarter of 2023.

We will communicate the new date for the launch at least one month before the go-live to make sure you have sufficient time to prepare for the transition.

Enforcement

Enforcement Forum: November highlights

In its November meeting our Enforcement Forum adopted a new work programme that sets out the EU level enforcement priorities for 2024-2025. These include actions on areas with a high risk of non-compliance such as online sales, imported articles, classification and labelling or complying with restriction requirements.

Occupational exposure limits

Deadline approaching: consultation on 1,3-Butadiene

We are looking for comments on the scientific report for occupational exposure limits on 1,3-Butadiene. 
 
Have your say until 20 November 2023.

Court judgments

GenX identification as substance of very high concern confirmed

In case C-293/22 P, the European Court of Justice has dismissed the appeal brought by Chemours Netherlands against the judgment of the General Court which confirmed ECHA’s decision to identify GenX substances as substances of very high concern (persistence, mobility, potential for long-range transport and observed adverse effects). This judgment is final and no further appeal is available.

D4, D5 and D6 identification as substance of very high concern confirmed

In case C-559/21 P, the European Court of Justice has dismissed the appeal brought by Global Silicones and others against the judgment of the General Court which confirmed ECHA’s decision to identify the substances D4, D5 and D6 as substances of very high concern (persistent, bioaccumulative, toxic or very persistent, very bioaccumulative). This judgment is final and no further appeal is available.

Webinars

Recording available: poison centre webinar

You can now find online the presentations and recording of our webinar for poison centre notifiers of industrial use only mixtures.

The recording contains the live questions and answers part. The written Q&As will be published later on our webinar page.

Others

European Commission workshop on phasing out animal testing

The European Commission organises this workshop as part of their response to the European Citizen's Initiative ‘Save Cruelty-free Cosmetics - Commit to a Europe without Animal Testing'.

Our experts will be joining the event presenting the main outcomes from our New approach methodologies workshop that was organised in May this year and introducing our new report about the key areas of regulatory challenge.

Check the draft agenda and join the workshop on 11-12 December 2023 in Brussels or online.

EU Observatory for Nanomaterials (EUON)

Nanopinion: Ten years of safety assessment of graphene - some lessons learned

Read the latest Nanopinion guest column by Professor Bengt Fadeel, Doctor Alberto Bianco and Professor Maurizio Prato where they discuss the three most important lessons learned during the largest-ever research programme on graphene in the EU.