ECHA has published their latest weekly update (29 November).
Due to changes in the structure of ECHA’s updates, we can no longer link to updates themselves. To ensure BIVDA members continue to receive this information, we have opted to provide the full ECHA notification.
ECHA identifies risks from PVC additives and microparticle releases
Our investigation found that some substances added to polyvinyl chloride (PVC) plastic, like plasticisers, may pose risks to people and the environment. To limit the use of these additives and to minimise releases of PVC microparticles, regulatory action would be necessary.
REACH
European Commission decisions on applications for authorisation
Commission has granted a total of 26 authorisations for 12 uses of the following substances (review period expiry dates are in brackets):
- 4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO) (EC -, CAS -)
- 1 use applied for by RSI ChemRep Europe ltd (4 January 2033)
- 2 uses applied for by Phadia GmbH, Thermo Fisher Scientific Baltics UAB, Brahms GmbH (4 January 2033
- 1 use applied for by Boehringer Ingelheim RCV GmbH & Co KG (19 November 2033)
- Chromium trioxide (EC 215-607-8; CAS 1333-82-0)
- 1 use applied for by Dornbracht AG & Co. KG (31 December 2028)
- 2 uses applied for by Ideal Standard Vidima AD and Ideal Standard Produktions-GmbH (31 December 2028)
- 1 use applied for by Volta Energy Solutions Hungary Kft (10 January 2032)
- 4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO) (EC -, CAS -)
- 1 use applied for by Thermo Fisher Scientific Baltics UAB (4 January 2033)
- 2,2′-dichloro–4,4’-methylenedianiline (MOCA) (EC 202-918-9, CAS 101-14-4)
- 2 uses applied for by Limburgse Urethane Castings NV (31 December 2030 and 31 December 2032)
- 1 use applied for by 12 applicants led by Courbis Synthèse (31 August 2028)
Biocides
Our Biocidal Products Committee (BPC) adopted three opinions on Union authorisations in its November meeting. To conclude the opinion on an active substance application for bronopol, the Committee will convene to an additional virtual meeting on 12 December 2023.
Listen to our Safer Chemicals Podcast with the committee Chair Joost van Galen for more details.
Support for product authorisation available
We have published the following documents related to setting shelf-life and post-authorisation conditions:
- Post-authorisation conditions for biocidal product authorisation: harmonising practices between national and Union authorisation
- Technical agreements for biocides entry for analytical methods and physico-chemical properties
- Shelf-life setting during the authorisation of biocidal products
- Post-authorisation conditions for national and simplified product authorisation: harmonising practices
All documents apply from 15 August 2023 for all ongoing and new national, simplified and Union product authorisation applications, except for the document for shelf-life setting that only applies for new product authorisations submitted after 15 August 2023.
Previous versions of these documents are considered obsolete.
Revised procedure for managing new information on biocidal active substances
The revised documents below apply from 7 August 2023 for all product authorisation applications, as well as active substance approval and renewal applications. Previous versions of these documents are considered obsolete.
- Management of new information on an active substance submitted for a product authorisation application
- Overview of new active substance data submitted at product authorisation
- Procedure for the submission, evaluation and dissemination of data generated after active substance approval
Consultation on the draft act proposing to extend the Review Programme
The European Commission is asking for comments on its draft act concerning the extension of the review period for existing active substances in biocidal products. Have your say until 21 December 2023.
European Commission decisions on active substances
Commission decisions approving:
- sulfur dioxide generated from sulfur by combustion for product-type 4; and
- formic acid as an existing active substance for product-types 2, 3, 4 and 5.
Commission decision not approving:
- silver zinc zeolite as an existing active substance for product-type 4; and
- silver zeolite as an existing active substance for product-type 4.
Read more about the product-types on our website.
European Commission decisions on Union authorisation
Commission has granted a Union authorisation for:
- the single biocidal product ‘Hokoex‘.
ECHA
Piotr Sosnowski is new Deputy Chair of RAC
Dr Piotr Sosnowski has been appointed Deputy Chair of the Committee for Risk Assessment (RAC) as of 1 November 2023.
He has been working in ECHA since August 2007 and has a master’s degree in environmental protection and PhD in technical science. Piotr is Polish.
Court judgements
Court confirms ECHA’s Board of Appeal decisions on substances used in cosmetic products
In cases T-655/20 and T-656/20, the General Court has dismissed the actions brought by Symrise against decisions of ECHA’s Board of Appeal (cases A-009-2018 and A-010-2018) which upheld two ECHA compliance check decisions requesting further information on the properties of the substances homosalate and 2-ethylhexyl salicylate.
The judgments clarify that chemical substances that are used as ingredients in cosmetic products may be subject to animal testing under REACH to establish that workers are safe.
Others
REACH Committee meets in December
The next meeting of the European Commission’s REACH Committee will take place on 14 December 2023. The agenda is available online.
