Consultations: Submitting information on potential candidates for substitution under GB Biocidal Products Regulations (GB BPR)

This guidance provides interested third parties with guidelines to submit information for the consultation on active substances considered potential candidates for substitution.

This guidance provides guidance on confidentiality issues and on the submission and organisation of relevant information for the consultation.

Purpose of the consultation

GB BPR Article 10 (1) specifies that an active substance shall be considered a candidate for substitution when it meets any of the following criteria:

it meets at least one of the exclusion criteria listed in Article 5 (1) but may be approved in accordance with Article 5 (2)
it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser
its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario
it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006
there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use t hat could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures

When HSE’s evaluation indicates that an active substance meets any of the substitution criteria above, GB BPR Article 10 (3) requires us to make information on the potential candidate for substitution publicly available, for a period of no more than 60 days (the consultation period). During this time interested third parties may submit relevant information, including information on available substitutions.

The purpose of the consultation is to gather relevant information, especially on the availability, or lack, of suitable alternatives, including non-chemical measures. Information on the availability of suitable alternatives is particularly important when a comparative assessment needs to be performed at the product authorisation stage.

A public consultation is also needed when evaluation indicates that an active substance meets one of the exclusion criteria of Article 5 (1) of the GB BPR . In such cases the information gathered on the availability, or lack, of possible alternatives will help decide whether the conditions of Article 5 (2) of GB BPR are met, and therefore whether the active substance can be approved (or renewed).

Consultation submissions from interested third parties will, where relevant, be a key consideration before HSE finalises its decision. HSE will not take into account any information submitted after the 60-day deadline in the decision making process.

Information submission

Interested third parties can submit information for the particular consultation via HSE’s consultations hub.

Consultations will first ask for information on who you are and contact details. We may use these to contact you if there are questions about your submissions.

The consultation will then ask if you believe there are available suitable alternatives for the active substance that is considered as a potential candidate for substitution. The answer given will determine the routing for the remaining sections of the survey.

Suitable alternatives: Further information

If you are aware of any suitable alternatives you should complete the commenting template for information on alternatives.

Most consultations will include two commenting templates to provide details on the availability of suitable alternatives:

non-confidential (public version) commenting template
confidential commenting template

No suitable alternatives: Further information

If you are not aware of any suitable alternatives you should complete the commenting template for supporting the approval or renewal.

Most consultations will include two commenting templates to provide details on the lack of suitable alternatives:

non-confidential (public version) commenting template
confidential commenting template

Use of commenting templates

A non-confidential (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 also complete a confidential commenting template and submit both versions through the consultation hub.

If claiming confidentiality for information submitted, you must provide justification to explain why it should be kept confidential. Provided that the justification is accepted, information claimed to be confidential will be available only to HSE except under certain circumstances. In all other cases the information collected through a consultation will be made public.

You may answer any or all of the questions contained within the consultation. Please ensure you provide clear and specific information, as this will help facilitate the decision-making process.

Please note, you will be given the opportunity to attach any documents to substantiate your submission at the end of the survey. Please ensure the information you provide in your submission is well-referenced and clearly explains the significance of any attached documents.

Specific details of what to include in these commenting templates is given in the section Providing relevant information for consideration.

Confidentiality

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.

The confidentiality justifications provided should explicitly cover the following:

Demonstration of Commercial Interest

Description of the nature of the third-party commercial interest and demonstration that this commercial interest is worthy of protection by the non-disclosure of information. Demonstration of any specific measures the submitter has taken to keep the information claimed confidential secret to date.

Demonstration of Potential Harm

Explanation of why release of the information claimed confidential would be likely to cause potential harm to the commercial interest and the specific nature of those harmful effects. A causal link between disclosure and such harmful effects should be clearly explained.

Limitation to Validity of Claim

The period of time for which the claim will be valid: until a certain date, until the occurrence of a particular event (which should be clearly specified), or indefinitely.

Providing relevant information for consideration: Suitable alternatives

Interested third parties can provide relevant information to aid the consultation on potential candidates for substitution. The commenting templates that you are asked to complete on availability of suitable alternatives encompass 7 topics, which are key considerations. The information provided must contain at least the topics 1 to 5 described below.

Any contribution must provide sufficient information, explanation and any necessary justification. Contributions should not consist of simple, basic statements that a substance is needed or not needed.

Regarding the existence of suitable alternatives, it is important that the information provided outlines the specific uses (for example, target pest, product user group, use area) for which alternatives exist.

Please note that clear and specific information facilitates the decision-making process related to either the approval or renewal of the active substances (for those meeting one of the exclusion criteria) or the authorisation of biocidal products.

1. Alternative identity and properties

You may find the following ECHA guidance useful for this section. Guidance for identification and naming of substances under REACH and CLP.

Chemical substance

If the alternative is a chemical substance, please describe the points listed below. They are numbered in accordance with the data requirements.

The specific requirements of each point are detailed in the legislation, which can be found by following this link to GB BPR Annex II, Title 1, Chemical Substances.

2. Identity of the active substance
3. Physical and chemical properties of the active substance
4. Physical hazards and respective characteristics
5. Methods of detection and identification
6. Effectiveness against target organisms
7. Intended uses and exposure
11. Measures necessary to protect humans, animals and the environment
12. Classification, labelling and packaging

Micro organism

If the alternative is a micro-organism, please describe the points listed below.

They are numbered in accordance with the data requirements.

The specific requirements of each point are detailed in the legislation, which can be found by following this link to GB BPR Annex II, Title 2, Micro-organisms

2. Identity of the micro-organism
3. Biological properties of the micro-organism
4. Methods of detection and identification
5. Effectiveness against target organisms
6. Intended uses and exposure
10. Measures necessary to protect humans, animals and the environment
11. Classification, labelling and packaging of the micro-organism

Other

If the alternative is neither a chemical substance nor a micro-organism, please provide a description of it.

If the alternative is any combination thereof, please provide all of the above.

2. Technical feasibility

Show that the alternative you propose can fulfil the function of the potential candidate for substitution.

Describe the precise functions or tasks performed by the alternative for the uses in question. Include a description and outcome of the process and, where relevant, under what process conditions the function must be performed.

If possible, discuss any adaptations or changes in the technology, process, procedure, device, modification of end product or other solutions necessary to replace the potential candidate for substitution for the specified uses (for example, the requirements for equipment, risk management measures, energy, personnel changes and training needs, raw materials, waste) and how these affect the technical feasibility of the alternative.

If possible, include any other benefits (corporate image, compliance legislation, worker safety, relation with community) and obstacles or difficulties identified or expected in relation to replacing the potential candidate for substitution for the specified uses.

If possible, support your analysis with information on research and development activities. Document the methodology, data sources and their reliability, assumptions made, uncertainties and their effects on the conclusions on the technical feasibility of the alternative.

3. Economic feasibility

If possible, estimate the direct and indirect costs and revenues associated with the transitioning to the alternative. Detail the methodology, the sources of data and its quality and reliability, the assumptions and uncertainties in the analysis and their impact on the conclusions of the assessment. Clearly set out the boundaries of the assessment and show the reasoning for the setting of these boundaries.

4. Hazard and risks of the alternative

Describe the risks to human health and the environment associated with the use of the alternative for which you are providing comments.

Discuss whether the transfer to the alternative would result in reduced overall risks to human health and the environment. In the risk assessment of the alternative, consider any relevant risks and effects associated with the alternative. These may also be related to other aspects affecting the overall hazard, risk reduction capacity of the transfer to the alternative, such as changes in energy or raw material consumption.

Support your analysis with information on research and development activities, if appropriate. Describe the methodology of comparing the risks of the potential candidate for substitution and the alternative. Document the data sources used, their quality and reliability, the assumptions made, the uncertainties in the analysis and their impact on the conclusions of the assessment.

5. Availability

For suitable alternatives, discuss whether they are available (in the required quantity) without undue delay. Include information on the data sources and their reliability.

6. Conclusion on suitability and availability of the alternative

Conclude on the overall suitability and availability of the alternative for the potential candidate for substitution for which you are submitting this information.

7. Other comments

Include other information you may have on the alternative.

References

Ensure that the information you provide is well-referenced throughout the document. Include a list of references here.

Providing relevant information for consideration: No suitable alternatives

If you wish to respond as an interested third party, by providing information on why there are no suitable alternatives, please give an economic and technical justification. You may wish to include details based on topics 1 to 7 above where appropriate.

Regarding the absence of suitable alternatives, it is important that the information provided outlines the specific uses for which alternatives do not exist.