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HSE Biocides eBulletin

Issued: 14 January 2022

This eBulletin contains information on regulating biocides in Northern Ireland (NI). 

The EU Biocidal Products Regulation (EU BPR) operates independently from the GB Biocidal Products Regulation (GB BPR), which applies in Great Britain.

Separate eBulletins containing information specific to regulating biocides in Great Britain are issued as appropriate.

Reminder – upcoming EU active substance renewal submission deadlines

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

Under the EU 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 EU BPR. This affects NI:

• (±)-5-amino-1-(2,6- dichloro-α,α,α,- trifluoro-p-tolyl)-4- trifluoromethylsulfinylpyrazole-3-carbonitrile (1:1) (Fipronil) (CAS 120068-37-3 EC 424-610-5) in product type 18
  29 March 2022
  
  
• S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2- dimethylcyclopropane carboxylate (Deltamethrin) (CAS 52918-63-5 EC 258-256-6) in product type 18
  29 March 2022
  
  
• Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 (CAS n/a EC n/a) in product type 18
  29 March 2022
  
  
• Reaction mass of (R)-α-cyano- 3-phenoxybenzyl (1S,3S)-3-[(Z)-2- chloro-3,3,3-trifluoropro- penyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3- trifluoropropenyl]-2,2- dimethylcyclopropanecarboxylate (1:1) (lambda-cyhalothrin) (CAS 91465-08-6 EC 415-130-7) in product type 18
  29 March 2022
  
  
• (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol (Cholecalciferol) (CAS 67-97-0 EC 200-673-2) in product type 14
  28 December 2022
  
  
• (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin (Warfarin) (CAS 81-81-2 EC 201-377-6) in product type 14
  28 December 2022
  
  
• 3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin (Difenacoum) (CAS 56073-07-5 EC 259-978-4) in product type 14
  28 December 2022
  
  
• 3-[3-(4’-Bromo[1,1’-biphenyl]-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-1-benzopyran-2-one (Bromadiolone) (CAS 28772-56-7 EC 249-205-9) in product type 14
  28 December 2022
  
  
• 3-[3-(4′-bromo[1,1′biphenyl]-4-yl)-1,2,3,4-tetrahydronaphth-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one (Difethialone) (CAS 104653-34-1 EC n/a) in product type 14
  28 December 2022
  
  
• 3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydro-1-napthyl]-4-hydroxycoumarin (Brodifacoum) (CAS 56073-10-0 EC 259-980-5) in product type 14
  28 December 2022
  
  
• 4-hydroxy-3-[(1RS,3RS;1RS,3RS)-1,2,3,4-tetrahydro-3-[4-(4-trifluoromethylbenzyloxy)phenyl]-1-naphthyl]coumarin (Flocoumafen) (CAS 90035-08-8 EC 421-960-0) in product type 14
  28 December 2022
  
  
• Chlorophacinone (CAS 3691-35-8 EC 223-003-0) in product type 14
  28 December 2022
  
  
• Coumatetralyl (CAS 5836-29-3 EC 227-424-0) in product type 14
  28 December 2022
  
  
• polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8 (PHMB (1600;1.8)) (CAS 27083-27-8/32289-58-0 EC n/a) in product types 2, 3 and 11
  28 December 2022

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 EU 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 EU BPR, the approvals will expire. This means the active substances can no longer be used in biocidal products of the relevant product types in Northern Ireland.

Reminder – upcoming EU active substance expiry date

Biocidal products must be phased off the NI market

The active substance/product type combination listed below is due to expire under the EU BPR on the following date. This affects NI:

• N,N′-methylenebismorpholine (MBM) (CAS 5625-90-1 EC 227-062-3) in product types 6 and 13
  31 March 2022

Once the approval expires, the active substance can no longer be used in biocidal products of the relevant product types in Northern Ireland.

If you hold an affected EU BPR product authorisation or Control of Pesticides Regulations (COPR) product approval, we will contact you about cancelling or revoking your authorisation or approval.

You will have an opportunity to submit comments or additional information and we will take account of these when finalising our decision.

If you are aware of any disproportionate negative effects that are likely to arise from the expiry of any of the active substance/product type combinations listed above, please contact us.