HSE Biocides ebulletin: Consultation on changes to GB BPR data requirements | Active substances no longer supported | Upcoming active substance renewal submission deadlines

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Reminder – HSE is consulting on changes to data requirements in GB BPR

Deadline: 14 March 2023

Annexes II and III of GB BPR detail the information that must be submitted by an applicant who wishes to apply for a biocidal active substance or product to be approved.

 

Flexibility within the GB BPR allows the data requirements in Annexes II and III to be updated to take account of current scientific and technical knowledge.

 

HSE proposes that Annexes II and III of GB BPR should be modified to meet the needs of GB. The aims of the changes are to:

  • keep up with technical and scientific progress
  • adopt new testing methods
  • encourage in vitro studies rather than in vivo animal studies

HSE has launched a consultation to gather views on the proposed changes. 

 

View the consultation, where you can submit your comments to HSE.

 

The consultation closes on 14 March 2023.


Active substances no longer supported in GB

Future non-approval decisions to be taken for unsupported active substances in GB

Following an opportunity for any person, company or taskforce/consortium to take up or take over the role of participant in the GB Review Programme for several active substance/product type combinations no compliant notifications and/or dossiers were received.

 

Find out which active substance/product type combinations are no longer supported.

 

IMPORTANT: Product manufacturers are advised to check the non-compliant notifications list to find out if the unsupported active substances listed are used in their products and prepare to remove them from the market.

 

In cases where active substance/product type combinations are not supported, GB biocides regulations require that these active substance/product type combinations are subject to a GB non-approval decision.

 

Once a decision is taken, biocidal products containing these active substances in the relevant product types will have to be removed from the GB market. HSE will provide separate updates on the decision and relevant phase-out periods.

 

If you are aware of any disproportionate negative effects that are likely to arise from the non-approval of any of the active substance/product type combinations listed above, please contact us by 9 April 2023.


Reminder - upcoming GB active substance renewal submission deadlines

Apply for active substance renewal by the deadlines to keep products on the GB market

Under the GB BPR, active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date.

 

The 550-day deadlines are coming up for the following active substance/product type combinations under GB BPR:

  • bis(N-cyclohexyl-diazenium-dioxy)-copper (Cu-HDO) (CAS 312600-89-8 EC n/a) in product type 8
    28 February 2024

  • Iodine (CAS 7553-56-2 EC 231-442-4) in product types 1, 3, 4 and 22
    28 February 2024

  • Isopropyl-(2E,4E,7S)-11-methoxy-3,7,11-trimethyl-2,4-dodeca-dienoate (S-methoprene) (CAS 65733-16-6 EC n/a) in product type 18
    28 February 2024

  • n-Decanoic acid (Decanoic acid) (CAS 334-48-5 EC 206-376-4) in product types 4, 18 and 19
    28 February 2024

  • n-Octanoic acid (Octanoic acid) (CAS 124-07-2 EC 204-677-5) in product types 4 and 18
    28 February 2024

  • Polyvinylpyrrolidone iodine (CAS 25655-41-8 EC n/a) in product types 1, 3 and 22
    28 February 2024

Any person, company or taskforce/consortium can support an active substance/product type combination for renewal – it doesn’t have to be the original supporter.

 

Check the GB Article 95 List to see who the original supporters were.

 

If a renewal application is not submitted for the above active substance/product type combinations under GB BPR, the approvals will expire. This means the active substances can no longer be used in biocidal products of the relevant product types in GB.

 

 

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