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

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-2023/

2. 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

3. 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.

4. 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.

5. 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.

6. 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.

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

7. 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/reach-regulation/

8. 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/

9. 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/

10. 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