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Update: Conclusion on six active substance for Approval by The Biocidal Products Committee

Active substances

The Biocidal Products Committee (BPC) adopted opinions supporting the approval of six active substances for several product-types (PT).

The active substance-product type combinations which the BPC concluded on include:

  • Icaridin- for PT 19 (repellents and attractants);
  • Cyanamide- for PT 3 (veterinary hygiene) and 18 (insecticides, acaricides and products to control other arthropods);
  • Formaldehyde- for PT 2 (disinfectants and algaecides not intended for direct application to humans or animals) and 3 (veterinary hygiene);
  • Carbendazim- for PT 7 (film preservatives) and 10 (construction material preservatives).
  • Glyoxal for PT 2, 3 and 4 (food and feed area);
  • Reaction mass of peracetic acid and peroxyoctanoic acid for product-types 2, 3 and 4.

The BPC also released an opinion on Chlorophene for PT 2 not supporting the approval of this active substance / product-type combination due to unacceptable risks. Consequently, companies currently benefiting from transitional measures for this combination will have 180 days to cease production of biocidal products containing this active substance, and another 180 days for the use of existing stocks of these products.

The approval and non-approval decisions are expected to be released soon. The European Commission met from 4 to 5 March, to discuss these opinions.

Upcoming Deadlines

Companies have until September 5th, 2020 to declare their interest in notifying Brandy and Peanut Butter for inclusion in the Review Programme for use in PT 19 (repellents and attractants).

These two substances benefit from the derogation from food and feed.

Based on these notifications and recommendations from ECHA, the European Commission will decide on the inclusion of these two substances in the Review Programme for PT 19.

Product authorisation

Different routes for product authorisation are available to companies seeking authorisation of their biocidal products and are contingent on the cost, geographical market coverage, active substance hazard profile, data requirements and submission requirements. The Approval Decision of each active substance will set a specified amount of time by which the active substances will be included on the Union List (Inclusion Date) which is around 2 years; this is also the time biocidal product suppliers will have to submit their product authorisation application to Member States and/or ECHA. Therefore, companies are advised to commence preparing their product authorisation applications from the release date of the approval decision, or if possible, from the date of the BPC’s opinion on approval.


How we can help:

Beyond the initial obligations, Yordas has over a decade of experience in supporting clients with Biocidal product authorisations including (but not limited to) Article 95 provisions, Compliance management, risk assessment, advice on authorisation routes, data sharing and technical data requirements.

Our chemistry department can support with assessing substitution of active substances in biocidal products in case of non-approval decisions as well as evaluating unacceptable risks to the population or the environment.

For further information see:


Authors:

Anas Hussain, Associate Regulatory Consultant, Yordas Group

Rémi Vacherot, Senior Toxicologist, Yordas Group