GB Biocidal Products Regulation (GB BPR) – Anticoagulant rodenticide product renewals – assessment of alternatives

Overview

Applicant: Various rodenticide product authorisation holders

Substance name: Anticoagulant rodenticides

• Difethialone (CAS 104653-34-1, EC 600-594-7)
• Difenacoum (CAS 56073-07-5, EC 259-978-4)
• Bromadiolone (CAS 28772-56-7, EC 249-205-9)
• Brodifacoum (CAS 56073-10-0, EC 259-980-5)
• Flocoumafen (CAS 90035-08-8, EC 421-960-0)
• Coumatetralyl (CAS 5836-29-3, EC 227-424-0)

Product type (PT): 14

Proposed Uses: Anticoagulant rodenticides are used by the general public and professional users to control rats and mice indoors and outdoors around buildings, as well as rats in sewers. The use of anticoagulant rodenticides in Great Britain (GB) by professionals must follow the requirements of one of the UK rodenticide stewardship regimes.

Background: Rodenticide products containing anticoagulant active substances are currently under assessment for renewal in GB.

Under the GB Biocidal Products Regulation (GB BPR), the anticoagulant rodenticide active substances have been identified as fulfilling Article 5(1)(c) and, in most cases, (e) exclusion criteria: Toxic for reproduction Category 1A or 1B and substances containing PBT constituents. Anticoagulant active substances are currently approved for PT14 as they meet the condition specified in Article 5(2)(b) of the GB BPR:

• The active substance is essential to prevent a serious danger to human health, animal health or the environment.

Article 10(1) states an active substance shall be considered a candidate for substitution if it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2).

Where a biocidal product contains an active substance that is a candidate for substitution, a comparative assessment must be carried out as set out in Article 23 before the product can be authorised or renewed.

HSE’s comparative assessment for the renewal of anticoagulant rodenticide products will consider what other authorised biocidal products or non-chemical control or prevention methods exist for the same uses and whether they:

• have a significantly lower overall risk for human health, animal health and the environment
• are sufficiently effective
• have any other significant economic or practical disadvantages

It will also consider whether the chemical diversity of active substances available for the same uses is adequate to minimise resistance occurring in the target organisms (rats and mice).

To inform this assessment, HSE has launched a public consultation to gather information on the availability of suitable and sufficient alternatives to anticoagulant rodenticides.

Information on the availability of suitable and sufficient alternatives is normally collected through public consultation as part of the active substance approval or renewal process for candidates for substitution under Article 10(3) of GB BPR. However, HSE has prioritised assessing the anticoagulant rodenticide products for renewal ahead of the renewal of the active substances they contain. This public consultation has been brought forward to ensure that the most up to date information can be considered.

Who should contribute

To inform the decision-making process on the availability of suitable and sufficient alternatives, it is important that contributions to the consultation are made by those with roles and responsibilities in:

• rodent control
• the protection of public health
• the protection of animal health and wildlife
• the protection of critical national infrastructures such as energy networks, water supplies and military defence systems
• hygiene in the food supply chain, including agriculture and production, manufacture, distribution and storage

Suitable alternatives are substances, methods or technologies that would result in reduced risks (e.g. classification, properties, exposure, use pattern), are effective under field conditions, and technically and economically feasible. To be considered, contributions must include justifications and / or data, and not simple statements that a substance or product is needed or should be banned.

Further information and guidance is available on the HSE website.

How to submit comments

Provide any available information on possible alternatives using the commenting templates in the related section of the survey. A ‘public version’ should always be completed and will be published after the consultation has closed. If you want to include confidential information in your submission, please additionally complete a ‘confidential version’ and submit both versions as attachments.

You will also have the opportunity to provide any information on why currently available alternatives may not be suitable and sufficient to fully replace anticoagulant rodenticides.

Information collected through the consultation will be made public. If you claim information to be confidential, you will need to provide an appropriate justification for non-publication.

Confidentiality and GDPR

HSE tries to make its public consultations as thorough and open as possible.

Information provided in response to public consultations may be subject to publication or disclosure in accordance with the access to information regimes (these are primarily the Freedom of Information Act 2000 (FOIA), the UK General Data Protection Regulations (UK GDPR) and the Data Protection Act 2018 and the Environmental Information Regulations 2004 (EIR)). Statutory Codes of Practice under the FOIA and EIR also deal with confidentiality obligations, among other things.

If you would like us to treat any of the information you provide as confidential, please make this clear in your response. If we receive a request under FOIA or EIR for the information you have provided, we will take full account of your explanation, but we cannot give an assurance that confidentiality can be maintained in all circumstances.

An automatic confidentiality disclaimer generated by your IT system will be disregarded for these purposes. Requests for confidentiality should be made explicit within the body of the response.

HSE will process all personal data in accordance with the UK GDPR. This means that personal data will not normally be disclosed to third parties and any such disclosures will only be made in accordance with the Regulations.

HSE will take into account the information collected during this consultation process when deciding whether to recommend continued authorisation, restricted authorisation or non-authorisation of anticoagulant rodenticide products under GB BPR. You may answer any or all of the following questions. Please ensure to provide clear and specific information, as this will help facilitate the decision making process.

Please note, at the end of the survey you will be given the opportunity to attach any document(s) you feel may be relevant, so please ensure the information you provide is well-referenced in your answer(s).