EkotoxInfo 06/2022

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.


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


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.


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.


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).


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