EkotoxInfo 2/2023 

EkotoxInfo 2/2023 

We encourage you to read the current issue of EkotoxInfo chemical legislation news. In the summary in Febuary 2023 EkotoxInfo you will find the following topics:

  1. European Commission published in january 2023 „Transition pathway for the chemical industry“
  2. New product categories for notifying poison centres
  3. Monomer and polymer guidance updated

REACH Conference will be held in Bratislava 22-23 of May 2023 – Agenda published

  1. European Commission published in january 2023 „Transition pathway for the chemical industry“

In January 2023, the European Commission published the transition pathway for the chemical industry. The pathway is an actionable plan co-developed by the European Commission with EU countries, chemical industry stakeholders, NGOs and other interested parties. It identifies the actions and conditions needed to achieve the green and digital transition and improve resilience in the chemical industry, in line with the updated EU industrial strategy.

Transition pathway for the chemical industry webpage: DocsRoom – European Commission (europa.eu)

Ekotox chemicals management webpages: https://ekotox.eu/chemicals-management/

  1. New product categories for notifying poison centres

ECHA has updated the European product categorisation system (EuPCS). The changes include new and expanded categories and improved product descriptions to help notifiers accurately describe the intended uses of their hazardous mixtures.

Several new product categories have been added including ‘Adhesive removers’, ‘Tyre care products’, ‘Field marking paint’, ‘Gas products for multiple intended uses’, ‘Glass/window treatment products’, ‘Products for care and maintenance of plants’ and ‘Metal surface treatment products’.

The updated EuPCS will be included in the poison centre notification format and made available in the dossier preparation tools in April with the next release of IUCLID. The EuPCS practical guide, which provides adetailed description of each product category and examples of product types, is available in 23 EU languages.

PCN webpages: https://poisoncentres.echa.europa.eu/sk/-/new-product-categories-for-notifying-poison-centres

Ekotox PCN webpages: Poison Centre Notifications – Ekotox EU

  1. Monomer and polymer guidance updated

ECHA’s Guidance on monomers and polymers has been revised to align with the BoA’s decision and includes changes to the description of registration obligations for those importing and manufacturing polymers and monomers.

The key changes relate to:

– the monomer that needs to be registered by the manufacturer or importer of a polymer;

– the calculation of registration tonnages of monomers ending up in the final polymer as a reacted substance;

– the information that registrants of monomers must include in a registration chemical safety report.

ECHA encourages all importers and manufacturers of polymers and monomers to examine the updated guidance and review their registrations to make sure they are complying with these minimum requirements.

ECHA News webpages: https://echa.europa.eu/sk/-/echa-updates-monomer-and-polymer-guidance-following-board-of-appeal-decision

Ekotox REACH Registration webpages: https://ekotox.eu/reach-registration/

  • REACH Conference will be held in Bratislava 22-23 of May 2023

Ekotox Centers together with partners and representatives of Cefic, Eurometaux, EPMF kindly willing to participate on the REACH Conference Bratislava 2023 are delighted to announce the conference Agenda: please ref REACH Conference 2023 webpages:

https://ekotoxtraining.com/events/reach-conference-2023/

EKOTOX CENTERS – consultancy and advisory group focused primarily on legal requirements on EU market in case of products (articles), mixtures and chemical substances, hazard and risk assessment. We cover wide range of regulatory areas to help our customers to comply with specific requirements for their products on EU market.

EKOTOX CENTERS:

Ekotox Hungary Kft., HUNGARY

Ekotoxikologické centrum CZ s.r.o., CZECHIA

Centrum Ekotoksykologiczne Sp. z o.o., POLAND

Ekotoxikologické centrum Bratislava s.r.o., SLOVAKIA

ЕКОТОКС ЦЕНТР УКРАЇНА, Ekotox Center Ukraine LLC., UKRAINE

EKOTOX CENTERS consultancy support https://ekotox.eu/

Monomer and Polymer guidance

Monomer and Polymer guidance

Helsinki, 21 Febuary 2023 – On 29 June 2021, ECHA’s Board of Appeal (BoA) issued a decision on a compliance check case (A-001-2020) regarding registration obligations for polymer importers.

The Board of Appeal’s decision affects registration requirements for monomer and polymer importers and manufacturers.

ECHA’s Guidance on monomers and polymers has been revised to align with the BoA’s decision and includes changes to the description of registration obligations for those importing and manufacturing polymers and monomers.
The key changes relate to:

  • the monomer that needs to be registered by the manufacturer or importer of a polymer;
  • the calculation of registration tonnages of monomers ending up in the final polymer as a reacted substance;
  • the information that registrants of monomers must include in a registration chemical safety report.

ECHA encourages all importers and manufacturers of polymers and monomers to examine the updated guidance and review their registrations to make sure they are complying with these minimum requirements.

Guidance for monomers and polymers

ECHA: Completeness checks of REACH registrations

ECHA: Completeness checks of REACH registrations

REACH Registrations – ECHA will start checking both new registrations and updates to existing ones against the revised requirements.

ECHA carries out a completeness check on each incoming registration as set out in Article 20(2) of the REACH Regulation.

The new and amended checks will take effect as of 1 May 2023 and will apply to both new registrations and updates of existing ones. Registrants should, therefore, prepare for the changes as registrations submitted before may no longer pass the completeness check.

The new and amended checks concern:

  • Substance identity: ensuring correct and consistent identification of a substance’s boundary composition and its constituents and additives based on clarifications made to Annex VI.
  • Standard information requirements based on Annexes VII-XI: supporting registrants in reporting information for endpoints concerning mutagenicity, degradation and aquatic toxicity based on Annex VII-XI information requirements. Registrants adding a new weight-of-evidence adaptation will be prompted to provide arguments for the approach in a more structured format.

ECHA News webpage: https://echa.europa.eu/-/changes-to-completeness-checks-of-reach-registrations-1

EKOTOX EU REACH webpages: https://ekotox.eu/reach-regulation/

EkotoxInfo 1/2023 

EkotoxInfo 1/2023 

We encourage you to read the current issue of EkotoxInfo chemical legislation news. In the summary in January 2023 EkotoxInfo you will find the following topics:

  1. REACH Candidate List +9 = 233 entries
  2. PFASs restriction proposal
  3. 2,4-dinitrotoluene restriction proposal
  4. International Panel on Chemical Pollution (IPCP)
  5. Metals and Inorganics Sectoral Approach (MISA)
  6. EU RoHS Pack-23 Exemption Recommendations Published
  7. Biocides – SPC editor – IUCLID

REACH Conference will be held in Bratislava 22-23 of May 2023

  1. REACH Candidate List + 9 = 233 entries

ECHA has added nine chemicals to the Candidate List because of their hazardous properties.

Under REACH, companies have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List.

Ekotox REACH webpages: https://ekotox.eu/news/reach-candidate-list-233-entries/

  1. PFASs restriction proposal

ECHA: The national authorities of Denmark, Germany, the Netherlands, Norway and Sweden have submitted a proposal to ECHA to restrict per- and polyfluoroalkyl substances (PFASs) under REACH. ECHA will publish the detailed proposal, one of the broadest in the EU’s history, on 7 February 2023.

ECHA REACH PFAS restrictions webpages: https://echa.europa.eu/sk/registry-of-restriction-intentions/-/dislist/details/0b0236e18663449b

  1. 2,4-dinitrotoluene restriction proposal

ECHA: The compiled opinion of the Committees for Risk Assessment and Socio-Economic Analysis for 2,4-dinitrotoluene (EC 204-450-0, CAS 121-14-2) is available.

ECHA REACH 2,4-dinitrotoluene restrictions webpages: https://echa.europa.eu/sk/registry-of-restriction-intentions/-/dislist/details/0b0236e185d7af0bEkotox

  1. International Panel on Chemical Pollution (IPCP)

In 2022, the United Nations Environment Assembly (UNEA) decided to establish a science-policy panel to contribute further to the sound management of chemicals and waste and to prevent pollution.

A possible wording for the scope could be “to strengthen the science-policy interface on the sound management of chemicals, waste, and pollution and associated impacts at global and regional scales to safeguard human and ecosystem health.”

The first session of the ad hoc Open-Ended Working Group on the Science Policy Panel (OEWG-1.2) will be held in Bangkok, Thailand, from the 30th of January to the 3rd of February 2023.

IPCP White Paper Webpage: https://www.ipcp.ch/activities/ipcp-white-paper-on-the-scope-and-functions-of-the-future-science-policy-panel

  1. Metals and Inorganics Sectoral Approach (MISA)

The four-year Metals and Inorganics Sectoral Approach (MISA) programme concluded at the end of 2022. The final report summarising the results of the cooperation between ECHA, Eurometaux and 29 industry associations to resolve metal-specific technical and scientific issues is now available.

MISA Final Report webpage: https://echa.europa.eu/documents/10162/7000431/misa_final_report_en.pdf/?utm_campaign=5f215996711b560001f4f482&utm_content=63b69f76f5b4f00001ea4f9c&utm_medium=smarpshare&utm_source=linkedinWebinars

  1. EU RoHS Pack-23 Exemption Recommendations Published

New report published with recommendations on commonly used EU RoHS exemptions

On December 19, 2022, a report summarizing the assessment of EU RoHS exemptions and recommending a course of action for the European Commission to take on those exemptions was published.

Twelve exemptions to Annex III of the EU RoHS Directive, known as Pack-23, were studied under a joint effort by the Fraunhofer-Institute for Reliability and Microintegration (IZM), the United Nations Institute for Training and Research (UNITAR), and BIO Innovation Services (Bio IS).

Evaluation of exemptions under Directive 2011/65/EU https://rohs.biois.eu/index.html

  1. Biocides – SPC editor – IUCLID

Application for biocidal product authorisation needs to include a summary of product characteristics (SPC). So far, this file has been prepared using the SPC Editor.

In the future, this will change and you will need to use IUCLID to prepare your SPC. To prepare for the transition, you can already find support materials on ECHA’s website. Have a look!

ECH SPC webpages: https://echa.europa.eu/sk/support/dossier-submission-tools/spc-editor?utm_campaign=5b9f6f42c09d200001046698&utm_content=63bd7832162dac0001f05c57&utm_medium=smarpshare&utm_source=linkedin

  • REACH Conference will be held in Bratislava 22-23 of May 2023

Ekotox Centers together with partners and representatives of Cefic, Eurometaux, EPMF kindly willing to participate on the REACH Conference Bratislava 2023 are delighted to announce the conference topics for discussion: please ref REACH Conference 2023 webpages:

https://ekotoxtraining.com/events/reach-conference-2023/

EKOTOX CENTERS – consultancy and advisory group focused primarily on legal requirements on EU market in case of products (articles), mixtures and chemical substances, hazard and risk assessment. We cover wide range of regulatory areas to help our customers to comply with specific requirements for their products on EU market.

EKOTOX CENTERS:

Ekotox Hungary Kft., HUNGARY

Ekotoxikologické centrum CZ s.r.o., CZECHIA

Centrum Ekotoksykologiczne Sp. z o.o., POLAND

Ekotoxikologické centrum Bratislava s.r.o., SLOVAKIA

ЕКОТОКС ЦЕНТР УКРАЇНА, Ekotox Center Ukraine LLC., UKRAINE

EKOTOX CENTERS consultancy support https://ekotox.eu/

REACH Candidate List = 233 entries

REACH Candidate List = 233 entries

Helsinki, 17 January 2023 – ECHA has added nine chemicals to the Candidate List because of their hazardous properties. They are used for example in flame retardants, paints and coatings, inks and toners, coating products, plasticisers and in the manufacture of pulp and paper.

Entries added to the Candidate List on 17 January 2023:

1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] 253-692-3 37853-59-1
2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol 201-236-9 79-94-7
4,4′-sulphonyldiphenol 201-250-5 80-09-1
Barium diboron tetraoxide 237-222-4 13701-59-2
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof – –
Isobutyl 4-hydroxybenzoate 224-208-8 4247-02-3
Melamine 203-615-4 108-78-1
Perfluoroheptanoic acid and its salts – –
reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine 473-390-7 –

ECHA’s Member State Committee confirmed the addition of these substances to the Candidate List. The Candidate List now has 233 entries – some are groups of chemicals so the overall number of impacted chemicals is higher.

These substances may be placed on the Authorisation List in the future. If a substance is on that list, its use will be prohibited unless companies apply for authorisation and the European Commission authorises them to continue its use.

Consequences of the Candidate List

Under REACH, companies have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List.

Suppliers of articles containing a Candidate List substance above a concentration of 0.1 % (weight by weight) have to give their customers and consumers information to be able to use them safely. Consumers have the right to ask suppliers whether the products they buy contain substances of very high concern.

Importers and producers of articles will have to notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list (17 January 2023). Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet.

Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain substances of very high concern in a concentration above 0.1 % (weight by weight). This notification is published in ECHA’s database of substances of concern in products (SCIP).

ECHA News webpage: https://echa.europa.eu/-/echa-adds-nine-hazardous-chemicals-to-candidate-list

Ekotox REACH regulation webpages: https://ekotox.eu/reach-regulation/

Training, webinars, REACH Conference 2023: https://ekotoxtraining.com/

EkotoxInfo 12/2022

EkotoxInfo 12/2022

EKOTOX CENTERS

EkotoxInfo 12/2022

We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:

  1. A reform of Europe’s chemical regulatory framework (REACH) delayed
  2. CLP Regulation revision proposal COM(2022) 748 final
  3. POPs Annexes IV and V amended
  4. Corap: 24 substances to be evaluated in 2023-2025
  5. SDS – Safety Data Sheets control 2023
  6. Webinars for January and February 2023 published
  7. REACH Conference will be held in Bratislava 22-23 of May 2023

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  1. A reform of Europe’s chemical regulatory framework (REACH) delayed

A reform of Europe’s chemical regulatory framework, known as REACH, has been delayed by a year, causing consternation about the European Union’s progress on controlling and harmful chemicals impacting human and environmental health. This effectively means that the reform will not be completed during the current European Commission’s term.

Ekotox REACH webpages: https://ekotox.eu/reach-regulation/

  1. CLP Regulation revision proposal COM(2022) 748 final

The CLP Regulation revision package aims to:

(i)ensure that all hazardous chemicals, including those with ED, PBT, vPvB, PMT and vPvM properties, are classified adequately and uniformly throughout the EU;

(ii)improve the efficiency of hazard communication by making labels more accessible and understandable for users of chemicals, and provide companies with more flexibility, thereby reducing the administrative burden without lowering safety levels;

(iii)make sure that the rules on chemical hazard classification and communication are applied by all relevant actors in the supply chain.

Ekotox news: https://ekotox.eu/news/clp-regulation-revision-proposal-com2022-748-final/

  1. POPs Annexes IV and V amended

REGULATION (EU) 2022/2400 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 November 2022 amending Annexes IV and V to Regulation (EU) 2019/1021 on persistent organic pollutants

Ekotox news: https://ekotox.eu/news/pops-annexes-iv-and-v-amended/

  1. Corap: 24 substances to be evaluated in 2023-2025

Corap: 24 substances were listed for evaluation by EU Member States under the Community rolling action plan (CoRAP) for 2023-2025. Five are planned to be evaluated in 2023, with 19 listed for evaluation in 2024 and 2025.

Ekotox news: https://ekotox.eu/news/corap-24-substances-in-2023-2025/

  1. SDS – Safety Data Sheets control 2023

EU inspections to control safety data sheets (SDS) in the EU-wide enforcement project in 2023

The EU-wide enforcement project (REF-11) in 2023 will look at the quality of information in safety data sheets.

Ekotox news: https://ekotox.eu/news/sds-safety-data-sheets-control-2023/

  1. Webinars for January and February 2023 published

Wide range of webinars available in area of EU chemicals legislation and more:

Ekotoxtraining portal: https://ekotoxtraining.com/

  1. REACH Conference will be held in Bratislava 22-23 of May 2023

Ekotox Centers together with partners and representatives of Cefic, Eurometaux, EPMF kindly willing to participate on the REACH Conference Bratislava 2023 are delighted to announce the conference topics for discussion: please ref REACH Conference 2023 webpages:

https://ekotoxtraining.com/events/reach-conference-2023/

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EKOTOX CENTERS – consultancy and advisory group focused primarily on legal requirements on EU market in case of products (articles), mixtures and chemical substances, hazard and risk assessment. We cover wide range of regulatory areas to help our customers to comply with specific requirements for their products on EU market.

EKOTOX CENTERS:

Ekotox Hungary Kft., HUNGARY

Centrum Ekotoksykologiczne Sp. z o.o., POLAND

Ekotoxikologické centrum CZ s.r.o., CZECH REPUBLIC

Ekotoxikologické centrum Bratislava s.r.o., SLOVAKIA

ЕКОТОКС ЦЕНТР УКРАЇНА, Ekotox Center Ukraine LLC., UKRAINE

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EKOTOX CENTERS consultancy support https://ekotox.eu/

Online consultations, training and webinars: https://ekotoxtraining.com/

SDS – Safety Data Sheets control 2023

SDS – Safety Data Sheets control 2023

EU inspections to control safety data sheets (SDS) in the EU-wide enforcement project in 2023

The EU-wide enforcement project (REF-11) in 2023 will look at the quality of information in safety data sheets.

SDS – Safety data sheets are the main vehicles for communicating safety information in the supply chain. If they are deficient, workers and professionals may not receive adequate information to use hazardous substances and mixtures safely.

The poor quality of information in safety data sheets is a long-standing issue detected also in many earlier enforcement projects – up to 52 % were found to be deficient in the Forum’s REF-2 project in 2013. Experience from enforcement activities in Member States confirms that the issue persists.

SDSs quality

The project will check compliance with the revised requirements under Annex II to REACH, which sets the content and format required for safety data sheets. With the revised requirements entering into force in 2023, this is a timely opportunity to have a harmonised project to check that companies across the EU are fulfilling this duty.

Any SDSs that were compiled according to the old Annex II requirements will have to be rewritten to comply with the updated requirements by 31 December 2022.

Inspections will run in 2023 and report in 2024.

Enforcement Forum webpages: https://echa.europa.eu/about-us/who-we-are/enforcement-forum/forum-enforcement-projects

Ekotox Centers – your partner for compliance !

Ekotox SDS webpages: https://ekotox.eu/safety-data-sheet-sds/

Ekotox assistance and training: https://ekotoxtraining.com/

CLP Regulation revision proposal COM(2022) 748 final

CLP Regulation revision proposal COM(2022) 748 final

The European Commission published their proposal for CLP Regulation on the 19th December.
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
on classification, labelling and packaging of substances and mixtures.
As part of the CLP Regulation revision package, a delegated act will add definitions and scientific and technical criteria to enable substances and mixtures that have endocrine disrupting (‘ED’), persistent, bioaccumulative and toxic (‘PBT’), very persistent and very bioaccumulative (‘vPvB’), persistent, mobile and toxic (‘PMT’), or very persistent and very mobile (‘vPvM’) properties to be classified into established hazard classes.
The impact of adding these new hazard classes has been assessed as part of the overall impact assessment on the revision of the CLP Regulation.
The CLP Regulation revision package aims to:
(i) ensure that all hazardous chemicals, including those with ED, PBT, vPvB, PMT and vPvM properties, are classified adequately and uniformly throughout the EU;
(ii) improve the efficiency of hazard communication by making labels more accessible and understandable for users of chemicals, and provide companies with more flexibility, thereby reducing the administrative burden without lowering safety levels;
(iii) make sure that the rules on chemical hazard classification and communication are applied by all relevant actors in the supply chain.
Ekotox chemicals management webpages: https://ekotox.eu/chemicals-management/
Corap: 24 substances to be evaluated in 2023-2025

Corap: 24 substances to be evaluated in 2023-2025

Member States plan to evaluate 24 substances in 2023-2025

Corap: 24 substances were listed for evaluation by EU Member States under the Community rolling action plan (CoRAP) for 2023-2025.
Five are planned to be evaluated in 2023, with 19 listed for evaluation in 2024 and 2025.

Corap 2023-2023 substances are:
2-Propenoic acid, methyl ester, reaction products with mixed O,Obis(branched and linear pentyl and iso-Bu) phosphorodithioates
Butanoic acid, 4-amino-4-oxosulfo-, N-coco alkyl derivs., monosodium salts, compds. with triethanolamine
tert-butylphenyldiphenyl phosphate (tBuTPP)
N-methylaniline
Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate
3,3′-[methylenebis(oxymethylene)]bisheptane
1,3-diisopropylbenzene
1,4-diisopropylbenzene
Dioctyltin oxide
Bis(2,6-diisopropylphenyl) carbodiimide
Tris[2-chloro-1-(chloromethyl)ethyl] phosphate
A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives
Reaction mass of 1,3-diisopropylbenzene and 1,4-diisopropylbenzene
Benzaldehyde
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
Acrylic acid, monoester with propane-1,2-diol
Octene, hydroformylation products, low-boiling
Diethyl Ether
Sodium hydroxymethanesulphinate
Carbon black
4,4′-Isopropylidenediphenol, ethoxylated
Betaines, C12-14 (even numbered)-alkyldimethyl
5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1-nonanol
4-(4-isopropoxyphenylsulfonyl)phenol
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
Sodium 3-nitrobenzene sulphonate
4,4′-methylene bis(dibutyldithiocarbamate)
Propyl acetate
Oxirane, mono[(C12-14-alkyloxy)methyl] derivs

Draft CoRAP 2023-2025: https://echa.europa.eu/documents/10162/879660/corap_update_2023-2025_en.pdf/1979dfdc-5412-b7a7-4dc2-2be90623d63e?t=1670912130379&utm_medium=email&utm_campaign=weekly&utm_content=20221214

Ekotox Chemicals Management webpages: https://ekotox.eu/chemicals-management/