Access to documents: Biocidal active substances and products
Under Article 67 of the GB Biocidal Products Regulation (GB BPR), HSE must make publicly available certain information on active substances and products, where held by HSE, from the date on which an approval or authorisation decision is made in Great Britain (England, Scotland and Wales).
This means that from the date that an active substance is approved, or a product is authorised, in Great Britain a non-confidential version of the Competent Authority Report (CAR) or Product Assessment Report (PAR) will be made available to the public.
Action for active substance supporters and product authorisation holders
At the end of the approval / authorisation process, HSE will ask active substance supporters and product authorisation holders to consider, against the guidelines in Articles 66 (2) and (3) of GB BPR, which elements or sections of the CAR / PAR you would wish to be kept confidential (redacted).
To prevent the process from becoming too time consuming, it is important that active substance supporters and product authorisation holders follow the instructions provided by HSE. HSE has software to securely redact the documents and will complete this on your behalf.
You will need to consider that:
- only the information listed in Article 66 (2) may be redacted without the need to provide a justification
- information listed in Article 66 (3), Article 67 (1) and Article 67 (2) cannot be redacted
- information which is already publicly available (for example information already published in the active substance assessment report) cannot be redacted
- be based on the protection of commercial interests or the privacy or safety of the persons concerned
- provide substantial reasoning
- present reasonably foreseeable risk
- not be purely hypothetical
- not simply state that disclosing a piece of information would be commercially harmful
- not rely on claims of preventing illegal use of data or protecting intellectual property - publication of such information does not waive GB BPR or other data protection rights
Redaction is only possible where HSE accepts that the provided justifications are valid. CAR and PAR documents are owned by HSE and active substance supporters and product authorisation holders do not have the right to prevent their publication.
Examples of what might be kept confidential
Things that may be kept confidential could include:
- full composition details
- confidential annexes
- vertebrate studies - study author names and laboratory locations
- details of agreement with active substance suppliers - for example, sources of letters of access and details of active substance technical equivalence
- specifically named contacts and their contact details
- the precise tonnage of the active substance or biocidal product manufactured or made available on the market
- application reference numbers
Things that may not be kept confidential could include:
- names and addresses of:
- authorisation holder
- biocidal product manufacturer / manufacturing site
- active substance manufacturer / manufacturing site
- active substance(s) content
- name of the biocidal product
- active substance classification and labelling, including whether it meets any of the substitution criteria set out in Article 5(1)
- active substance physiochemical endpoints
- active substance toxicological and ecotoxicological endpoints
- physical and chemical data on the biocidal product
- substances of concern
- any methods for rendering the active substance or biocidal product harmless
- results of the tests required to determine the product's:
- effects on humans
- effects on animals
- effects on the environment
- ability to promote resistance
- safety data sheets
- methods of analysis
- information that is available in the product SPC - for example, methods of disposal, risk mitigation measures, first aid and medical procedures
- information that is already publicly available
The GB List of Active Substances and list of UK authorised biocidal products indicate where documents are held by HSE and how you can access them.