EU REACH

Revision of REACH regulation to be postponed

Revision of REACH regulation to be postponed

REACH regulation revision to be postponed till end of 2023

On 18 October 2022, the European Commission adopted its 2023 Commission work programme

REACH revision is postponed to the end of 2023 (legislative, incl. impact assessment, Article 114 TFEU, Q4 2023).

„After consultations with key stakeholders, we will propose a targeted revision of the legislation on the registration, evaluation and authorisation of chemicals (REACH) with the aim of securing European competitive advantages and innovation by promoting sustainable chemicals, simplifying and streamlining the regulatory process, reducing burden and protecting human health and the environment.“

https://ec.europa.eu/info/sites/default/files/cwp_2023.pdf

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

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Nine proposals to identify new substances of very high concern (SVHC)

Nine proposals to identify new substances of very high concern (SVHC)

ECHA is looking for comments on nine proposals to identify new substances of very high concern. Give comments by 17 October 2022.

Helsinki, 7 September 2022 – The substances and examples of their uses are:

The deadline for comments is 17 October 2022.

Further information: https://echa.europa.eu/-/have-your-say-nine-proposals-to-identify-new-substances-of-very-high-concern

Chromium VI authorisation: information sessions for groups of applicants

Chromium VI authorisation: information sessions for groups of applicants

Chromium VI authorisation

ECHA August 24, 2022

As a high number of authorisation applications are expected for hexavalent chromium (Cr(VI)) uses in the coming years, the way of information sessions for these uses will be changed. In the future, will organised for groups of several applicants.

The first group session will take place on 15 February 2023, and more will be organised after that based on need. Future dates will be announced in the bulletin.

Teleconference Based Information Sessions: https://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions

Ekotox Centers can help you!

expert advice

Ekotox REACH Authorisation webpages: https://ekotox.eu/reach-authorisation/

SAFETY DATA SHEETS 2022 – don’t miss the deadline !

SAFETY DATA SHEETS 2022 – don’t miss the deadline !

Safety Data Sheets (SDS) are documents for communicating information on the hazards of chemicals and mixtures and the risks they pose to human health and the environment.

The European Commission amended Annex II of REACH, concerning the compilation of Safety Data Sheets (SDS):

COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

31st December 2022 – after this date, all safety data sheets will need to be updated to the new requirements. 

The new requirements include:

  • Alignment of SDS with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revisions 7 and 8;

  • Inclusion of Unique Formula Identifiers (UFIs) to Section 1 (in line with Regulation (EU) 2017/542);

  • Additional information requirements for substances placed on the market as a nanoform (in line with Regulation (EU) 2018/1881) and for substances and mixtures with endocrine-disrupting properties;

  • Addition of the Specific Concentration Limits (SCLs), multiplying factors and acute toxicity estimates (ATE), if available, set in accordance with CLP 1272/2008.

The main sections of the SDS which have undergone revision are 1, 2, 3, 9, 11 and 12.

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

expert advice

Please contact the Ekotox Regulatory Team if you would like more guidance around the new requirements and the specific impact on your products.

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Chromium trioxide – REACH Authorisation Deadlines

Chromium trioxide – REACH Authorisation Deadlines

Chromium trioxide (EC No. 215-607-8; CAS No. 1333-82-0) is widely used in plating and surface treatment.

Notifications from 1 026 sites across Europe submitted by May 2021 confirm that chromium trioxide is still widely used in functional or hard chrome plating and surface treatment. The annual usage is estimated to be 7 000 tonnes. The substance of very high concern was placed on the Authorisation List in 2013 and its use has needed a specific authorisation in the EU since 2017.

By notifying the uses to ECHA, companies confirm that they follow the conditions for use set in the authorisation decisions granted to their suppliers. As part of the conditions, they must inform ECHA by the end of 2021 how their workers are exposed to chromium trioxide. This information will help companies to protect their workers even better by minimising their exposure to the carcinogen.

In December 2020 European Commission published 2 decisions granting authorisation to use the chemical until September 2024.

Enforcement authorities can now carry out inspections as necessary.

There are 2 principal duties for companies using chromium trioxide:

  1. Apply for REACH authorisation in time;
  2. Comply with the conditions comunicated by suppliers through extended safety data sheets.

The chromium trioxide applications for REACH authorisation by companies is now accelerating.

Actual Applications for authorisation – current consultations: https://echa.europa.eu/applications-for-authorisation-consultation

Joint authorisation originally applied by CETAC consortium (and others) will be ineffective after September 2024.

Ekotox Centers offer complex services to prepare all necessary documents on behalf of the customers. To stay on the market there is need for immediate action!

On the same time there is a duty to comply with the safety measures and operational conditions – requirements defined for downstream users by eSDS. To be sure that all is in compliance Ekotox Centers provide support to manage „Internal Dossiers for REACH Authorisation Compliance“ (IDRAC).

For more information ECHA news: https://echa.europa.eu/-/chromium-trioxide-widely-used-in-plating-and-surface-treatment

Ekotox REACH Authorisation web pages: https://ekotox.eu/reach-authorisation/

Application for REACH Authorisation – chromium trioxide – Ekotox Project: https://ekotox.eu/application-for-reach-authorisation-of-chromium-trioxide/

Skin sensitising substances in consumer mixtures

Skin sensitising substances in consumer mixtures

Skin sensitising substances in consumer mixtures: Current call for comments and evidence

The France, Ireland and Germany request interested parties to submit information on skin sensitising substances in mixtures intended for consumers, including data on types of uses, planned substitutions, epidemiological data on allergic contact dermatitis and information on healthcare costs.

Deadline for providing input: 30/09/2022.

The objective of this Call for Evidence is to gather information on:

  • the sectors, and type of uses/applications concerned,
  • measures currently in place (e.g. changed formulation, reduction of concentration, specific packaging, conditions of use) to minimise consumer exposure,
  • experience regarding substitution efforts, availability and costs of alternatives or reasons for non-substitution,
  • the potency of the skin sensitising substances and their technical functions in the mixtures,
  • on safe use of consumer products,
  • epidemiology of allergic contact dermatitis and other health-related information including health costs,
  • analytical methods to detect the presence of skin sensitising substances in mixtures.

For any clarifications, please contact the German Competent Authority: chemg (at) baua.bund.de

link to ECHA webpages: Current calls for comments and evidence – ECHA (europa.eu)

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

EkotoxInfo 06/2022

EkotoxInfo 06/2022

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 new definition of a nanomaterial
  2. POP’s Persistent Organic Pollutants
  3. Summary of the RAC and SEAC committees
  4. Enforcement Forum Inspection Reports
  5. Further reviews of the active substances in biocidal products
  6. Group assessment of chemicals
  7. Another substance on the candidate list
  8. New developments concerning the authorisation of biocidal products
  9. Confirmed projections of an increase in sales of heated tobacco products in EU countries

A new definition of a nanomaterial

The EC proposed new definition of nanomaterials, which will replace the one from 2011. Nanomaterial is subject to regulatory control, it has the power to regulate chemicals (REACH) as well as regulations regarding their use in certain applications, such as biocides, cosmetics or food.

https://ec.europa.eu/environment/chemicals/nanotech/pdf/C_2022_3689_1_EN_ACT_part1_v6.pdf

POP’s Persistent Organic Pollutants

The Commission adopts an agreement to protect human health and the environment against persistent organic pollutants (POPs). The agreement paves the way for the establishment of strict limits for these chemicals in waste. Existing limits have been tightened for five substances and new limits have been agreed for four new substances

https://environment.ec.europa.eu/news/commission-welcomes-political-agreement-persistent-chemicals-waste-2022-06-21_en

Summary of the RAC and SEAC committees

The Committee adopted opinions on the harmonized classification and labelling of glyphosate and silver and the restriction of lead content in shooting and fishing ammunition. Opinion supporting the restriction of 2,4-dinitrotoluene (2,4-DNT) in articles has been completed. The Committee also adopted an opinion on the reduction of Dechlorane Plus. The consultation on the draft opinions started in June and you can submit your comments on the ECHA website.

https://echa.europa.eu/pl/-/highlights-from-june-2022-rac-and-seac-meetings

Enforcement Forum Inspection Reports

The inspectors carried out checks on the REACH authorization requirements for substances from Annex XIV of REACH. Another project examined whether substances recovered from waste should be registered under REACH or whether they could benefit from an exemption. EU-wide inspections of biocidal products containing approved or not yet approved active substances are also ongoing until the end of the year. Reports on the results of the inspection will be published at the end of 2022.

https://echa.europa.eu/pl/-/highlights-from-june-forum-meeting

Further reviews of the active substances in biocidal products

The ECHA Committee adopted a record number of opinions at its June meeting. They concern nine opinions on EU authorization, five on applications for active substances, including: active chlorine, calcium compounds, peracetic acid, lactic acid and IPBC. The Committee does not support the EU authorization for hydrogen peroxide in group 2. Please note that biocidal products containing approved active substances are subject to product registration under the new European procedures.

Biocides – Registration / Authorisation – Ekotox EU

Group assessment of chemicals

ECHA published the 4th substance evaluation report in 2021. In 2021, evaluations of over 1,900 substances were finalized, most of them grouped on the basis of their structural similarity. About 25% of the substances assessed require further risk management. Companies need to proactively update their REACH registrations with up-to-date information on substances. The ECHA report also highlights the sharp increase in the number of substances requiring harmonized classification and labeling (CLH).

https://echa.europa.eu/documents/10162/5641810/irs_annual_report_2021_en.pdf/b38d8eec-d375-beb2-98b2-1fb0feb3612a?t=1655382672222

Another substance on the candidate list

N- (hydroxymethyl) acrylamide was added to the Candidate List as it may cause cancer or genetic defects. These substances may be included in the authorization list in the future. If a substance is on this list, its use will be prohibited unless companies apply for authorization and the European Commission allows them to continue using it.

REACH Authorisation – Ekotox EU

 

New developments concerning the authorisation of biocidal products

The biocidal product SOPUROXID contains peroxyacetic acid as an active substance which is included in the Union list of approved active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012. Authorised by the European Union with effect from 12 July 2022 to 30 June 2032 for PT2 (Disinfectants and algaecides not intended for direct application to humans or animals), PT3 (Veterinary hygiene) and PT4 (Food and feed area) in the form of a soluble concentrate for indoor industrial and professional use, method of application – hand treatment (mopping).

(Commission Implementing Regulation (EU) 2022/964) link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0964&from=EN

 

Confirmed projections of an increase in sales of heated tobacco products in EU countries

The European Commission has published an analysis of sales and use of heated tobacco products among consumers under 25, confirming an increase in sales at retail level of more than 10% between 2018 and 2020 in more than five Member States from data in the EU-CEG database.

(REPORT FROM THE COMMISSION on the establishment of a substantial change of circumstances for heated tobacco products in line with Directive 2014/40/EU) link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52022DC0279&from=EN

 

 

EkotoxInfo 04/2022

EkotoxInfo 04/2022

We encourage you to read the current news of EkotoxInfo chemical news.

In the summary of last month you will find the following topics:

  1. Update of the safety data sheets by the end of 2022
  2. Mapping of potentially harmful chemicals
  3. Summary of the March meeting of the Biocidal Products Committee
  4. Summary of the RAC and SEAC meeting
  5. New CoRAP substance evaluation list for 2022-2024
  6. Revision of the REACH and CLP regulations
  7. Updating the registration requirements for substances in REACH
  8. Five more substances added to the REACH Authorization List
  9. Updating the list of chemicals subject to export notification
  10. New developments concerning the approval of biocidal products

 

  1. Update of safety data sheets by the end of 2022.

We remind you that in June 2020. Regulation 2020/878 / EU was published, amending Annex II [the content of the safety data sheet] to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The new template for safety data sheets takes into account, inter alia: the need to provide specific concentration limits, as well as multiplication factors and acute toxicity estimates; obligation to provide information on nanoform of particles and the presence of endocrine disruptors.

All existing safety data sheets without changes can be used until December 31, 2022. After this date, only safety data sheets that comply with the latest template as defined in Regulation 2020/878 / EU may be in circulation.

Ekotox SDS webpages: https://ekotox.eu/sds-new-requirements-2022/

  1. Mapping potentially harmful chemicals

In 2021. ECHA assessed a total of 1900 chemicals and categorized them based on the further regulatory needs for each substance. ECHA’s goal is to review by 2027 all registered chemicals above 1 tonne per year, assign them to the appropriate category and evaluate the further regulatory action of each substance (or group of substances).

On the ECHA website you will find the full list of substances with the assigned category, or information on whether the substance is subject to further regulatory needs, whether the evaluation has already been completed or is under development.

The results of the assessment are a key issue for entrepreneurs as they can affect:

  • inclusion of a substance in the authorization list
  • restrictions on the use of certain substances, including ED substances
  • the need to update REACH registration

ECHA link: https://echa.europa.eu/pl/-/mapping-of-potentially-harmful-chemicals-on-target-to-meet-2027-goal

  1. Summary of the March meeting of the Biocidal Products Committee

During the meeting, the committee adopted 3 opinions for active substances:

  • methylene dithiocyanate – no support for use in group 12
  • (13Z) -hexadec-13-en-11-yn-1-yl acetate – approval in group 9 supported
  • propiconazole – identified as meeting the exclusion criteria in Group 8

In addition, the committee adopted the following four positive opinions on EU authorizations:

  • Propan-1-ol – PT1
  • Propan-2-ol – PT2 and PT4
  • L – (+) lactic acid – PT2
  • Active chlorine released from sodium hypochlorite – PT2

Entrepreneurs using the substances listed in the above product groups, after their official approval, will have to apply for registration in European procedures in order to keep the products on the market.

ECHA link: https://echa.europa.eu/pl/-/highlights-from-march-bpc-meeting

  1. Summary of the RAC and SEAC meeting

In March, a meeting of the Risk Assessment Committees (RAC) and the Socio-Economic Analysis Committee (SEAC) was held. Norway’s proposed restrictions on Dechlorate Plus were supported, arguing that each of the proposed options could be proportional to the benefits to society and the costs incurred. At the meeting, both committees adopted an opinion on the review and evaluation of the industrial use of 1,2-dichloroethane and two opinions on the establishment of occupational exposure limit values (OELs) for 1,4-dioxane and isoprene. In addition, 10 opinions on harmonized classification and labeling were adopted, including the classification of sulfur and multi-wall carbon nanotubes.

ECHA link: https://echa.europa.eu/pl/-/highlights-from-march-rac-and-seac-meetings

  1. New CoRAP substance evaluation list for 2022-2024

The Community rolling plan (CoRAP) has been updated for the period 2022-2024 and is published on the website of the European Chemicals Agency. The plan provides for the evaluation of 27 substances suspected of posing a risk to human health and the environment. Of the 27 substances listed, two were reallocated and 25 substances were moved from the previous list (2021-2023) published on March 17, 2021. Registrants should check whether their dossiers for substances need to be updated with relevant new information, for example on hazard, tonnage, use and exposure, and that the registration dossier does not need to be updated.

Ekotox REACH webpages: https://ekotox.eu/news/community-rolling-action-plan-update-covering-the-years-2022-2023-and-2024/

  1. Revision of the REACH and CLP regulations

The public consultation on the amendment to the REACH regulation ended on April 15, and the legislative process has moved to the next stage. The impact assessment should be finalized and presented with the Commission proposal in Q4 2022. The revision of the REACH regulation will have a significant impact on producers, workers and users of chemicals across Europe. Some planned changes to the REACH Regulation are expected to increase costs for industry. The CLP Regulation will also be subject to targeted revision, along with other sector-specific chemicals legislation, and the adaptation of the CLP revision is planned for Q2 2022.

EC link: https://www.europarl.europa.eu/legislative-train/

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

  1. Update of substance registration requirements in REACH

On March 24, 2022, the European Commission published amendments to Annexes VI to X of the REACH Regulation (COMMISSION REGULATION (EU) 2022/477). The update of the annexes includes revised requirements for the registration of chemical substances in the European Union under REACH. In the second half of 2022, ECHA will publish an updated guide to registration requirements. Firms should start preparing to update their substance registration dossiers as the changes will apply in October 2022.

Ekotox REACH webpages: https://ekotox.eu/news/updating-requirements-for-chemical-substances-registration-under-reach/

  1. Five more substances added to the REACH Authorization List

ECHA has identified five substances as substances of very high concern (SVHC) due to their reprotoxic, carcinogenic or endocrine disrupting properties. The amendment of the legal act of the list of substances which cover the granting of authorization for use (Annex XIV to REACH) was published on April 11 in the EU Official Journal. Companies wishing to continue using these substances after the sunset date has been indicated will need to submit an application for authorization.

Ekotox REACH authorisation link: https://ekotox.eu/news/five-substances-added-to-eu-reach-authorisation-list/

  1. Update of the list of chemicals subject to export notification

The European Commission has updated Annexes I and V to the Prior Informed Consent Regulation (PIC Regulation, (EU) No. 649/2012). The PIC Regulation regulates the import and export of certain hazardous chemicals and places obligations on companies that wish to export these chemicals to non-EU countries. The update was released on April 20, 2022, and will take effect on July 1, 2022.

Ekotox PIC webpages: https://ekotox.eu/news/updated-list-of-chemicals-covered-by-pic-export-notification-22/

  1. New developments concerning the approval of biocidal products

Biocide ARIEL chlorine Professional System 5 chlorine bleach for white wash – contains the active substance active chlorine released from sodium hypochlorite, which is included in the list of approved active substances. The authorisation was granted for the period from 24 April 2022 to 31 March 2032.

(COMMISSION IMPLEMENTING DECISION (EU) 2022/527) link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0527

FREE WEBINAR: May 24 2022; 9:00 – 11:00

EU Reform of „the authorisation and restrictions“ system

https://ekotoxtraining.com/events/eu-reform-of-the-authorisation-and-restrictions-system/

 

 

EU Restriction Roadmap by 2030

EU Restriction Roadmap by 2030

On the 25 April 2022, the European Commission published a “Restrictions Roadmap” as part of the EU’s Chemicals Strategy. It is in no way legally binding, but rather provides a view into future EU environmental compliance policy. The roadmap provides a list of groups of widely used chemicals of concern that will be targeted for restrictions at the European level in the coming years. This is important because this gives all stakeholders long-term visibility on planned regulatory action and thereby can facilitate existing and future substitution efforts towards safe alternatives.

The plan focuses on entire classes of chemical substances rather than regulating them individually or in small groups as is currently the case. The Restrictions Roadmap will use a group approach to regulating chemicals, in which the most harmful member of a chemical family defines legal restrictions for the whole family. If implemented as intended, thousands of chemical substances will rapidly be restricted in the EU. In total, the European Environmental Bureau (EEB) has estimated the Restrictions Roadmap will lead to the restriction of roughly 5,000 to 7,000, but industry association CEFIC say that up to 12,000 substances could ultimately fall within the scope of the new proposal, which would constitute the world’s “largest ever ban of toxic chemicals”.

European Environmental Bureau ingles out 6 groups of chemicals to be restricted:

  • Polyvinyl Chloride (PVC) and its additives
  • PFAS (non-essential uses)
  • Bisphenols, including BPA
  • Flame retardants
  • Chemicals in childcare products that cause cancer, genetic mutation or harm the reproductive system (CMRs)
  • Toxic chemicals in single use nappies / diapers

The roadmap sets out priorities for the European Chemicals Agency before the revision of the REACH Regulation (estimated for 2027). According to the roadmap, the restriction process will begin within two years by between 2025 – 2027. All substances will be gone by 2030.

COMMISSION STAFF WORKING DOCUMENT Restrictions Roadmap under the Chemicals Strategy for Sustainability:

https://ec.europa.eu/docsroom/documents/49734?fbclid=IwAR0Ftb0aCg9_umH4lMvPBAuwekVQZiqGrL4jnOD7urUYAwz3nT6o8FHUd8E

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

UPDATING REQUIREMENTS FOR CHEMICAL SUBSTANCES REGISTRATION UNDER REACH

UPDATING REQUIREMENTS FOR CHEMICAL SUBSTANCES REGISTRATION UNDER REACH

ECHA/NR/22/09 April, 12

On March 24 2022, the European Commission published amendments to Annexes VI – X of the REACH Regulation (COMMISSION REGULATION (EU) 2022/477).

The update of the annexes includes revised requirements for the registration of chemical substances in the European Union under REACH. The changes mainly concern:

  • determining when further in vivo and in vitro tests on the mutagenic potential of the substance are needed;
  • identification of the preferred animal species and administration routes in reproductive toxicity studies;
  • clarification of when long-term studies should be performed instead of short-term aquatic toxicity studies and terrestrial organisms studies;
  • identify the need for a degradation and bioaccumulation study.

In addition, the registration dossier for substances should include the description of nanoforms, identify crystal structures and UVCB substances, clarify information on impurities and additives, as well as analytical information.

In the second half of 2022, ECHA will publish an updated guide to registration requirements. Companies should start preparing to update their substance registration dossiers as the changes will apply in October 2022.

ECHA link: https://echa.europa.eu/en/-/upcoming-changes-to-reach-information-requirements-1

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

Ekotox Training: https://ekotoxtraining.com