ECHA's Biocides Consultation & Its Outcome

ECHA’s Biocides Consultation & Its Outcome

The European Chemicals Agency (ECHA) plays a crucial role in ensuring the safety of chemicals used within the European Union (EU). One of its significant responsibilities involves the regulation of biocidal products, which are substances that destroy, deter, or control harmful organisms. This blog explores the consultation process and its outcomes, highlighting its importance in safeguarding public health and the environment.

Consultation On Biocides:

Biocidal products encompass a wide range of applications, including disinfectants, pest control agents, preservatives, and antifouling products. Hence, ECHA held a consultation with third parties regarding the collection of information for the alternatives of active substances. These identification helps in finding the right substitution for the active substance if they are evaluated by the National Authority. This approach is essential to compare and assess for the authorization of the substitutes for biocidal substances. 

In case, the National Authority finds that active substances are potentially risks for the human and environment, and thereby meeting the conditions of Biocidal Products Regulation (BPR) the substance needs an alternative or substitute. Also, the consultation asks the supply chains and manufactures to provide sufficient data on the derogation of biocidal substances. In case, the active substance has a derogation of five years at its maximum, an essential component for the human health and a substitute cannot be found for it, then the committee needs to rethink about the decision. However, it is essential for a third-party consultation to gather the necessary information on the appropriate substitutes with justifications to make an informed-decision. 

The first third party consultation was held at the start of May, and the consultation will generally happen during the evaluation of active substance. During the consultation, the National Authority has evaluated and the additional information helps in a comprehensive assessment of the biocidal substance. 

Outcome On ECHA Consultation:

ECHA’s Biocidal Products Committee (BPC) authorized four active substances and seven as per Union Authorization. 

  • Dinotefuran – Need Renewal product-type 18 (insecticides, acaricides and products to control other arthropods)
  • Polymeric Betaine – Approved product-type 8 (wood preservatives)
  • Medetomidine – Needs Renewal product-type 21 (antifouling products)
  • 5-Chloro-2-methyl-2H-isothiazol-3-one (CIT) – Approved product-type 6 (preservatives for products during storage)

Seven Substances Based On Union Authorization:

Biocidal product containing 

  • propan-2-ol for product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals)
  • Propan-1-ol and propan-2-ol for product-type 1 (disinfectants for human hygiene)
  • Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with supercritical carbon dioxide for product-type 19 (repellents and attractants for pest control)
  • Glutaral (Glutaraldehyde); Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) for product-type 6, 11 (preservatives for liquid-cooling and processing systems) and 12 (slimicides)
  • Reaction mass of 5-chloro-2-methyl-2h-isothiazol 3-one and 2-methyl-2h-is thiazol-3-one (3:1) for product-type 4 (disinfectants for food and feed area), 11 and 12.
  • Peracetic acid for product-type 2, 3 (disinfectants for veterinary hygiene) and 4.

The BPC did not endorse authorisation for a product family containing hydrogen peroxide for product-type 4. However, the Member States will not approve and authorize the products if the supply chain or company failed to surrender the necessary information within the prescribed timeline. Hence, as a result, the BPC committee’s opinion will become unfavorable for companies that do not provide the appropriate data. 

The EU Member States with the European Commission, will make the final decisions based on the BPC’s opinions. The next meeting is scheduled for 17 and 18 September 2024. 

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