Biocides resources

Databases

Control of Pesticides Regulations (COPR)

COPR approved biocidal products - find details of the products that are approved under COPR in Great Britain (GB) and Northern Ireland (NI)

GB Biocidal Products Regulation (GB BPR)

• The GB List of Active Substances - find details of biocidal active substances in Great Britain (GB), including the GB Simplified Active Substance List as a subset
• The GB Article 95 List - find details of the suppliers for active substance / product type combinations that can be used in biocidal products in Great Britain (GB)
• UK authorised biocidal products overview - find details of the products that are authorised under GB BPR

Forms

Control of Pesticides Regulations (COPR)

• COPR approval - Use this form to apply for product approval under COPR
• R&D - Use this form to apply to HSE for an experimental permit under COPR

GB Biocidal Products Regulation (GB BPR)

• Active Substance - Use this application form to apply for active substance approval under GB BPR
• Article 95 - Use this application form to apply to get on the GB Article 95 List
• Declaration of Interest - Use this application form to declare your interest in supporting an active substance in the GB Review Programme
• Essential Use - Use this application form to apply for an essential use authorisation for a biocidal product under GB BPR
• Notification - Use this application form to notify your intention to support an active substance in the GB Review Programme
• Product - Use this application form to apply for product / product family authorisation / amendment under the GB BPR
• R&D - Use this form to notify HSE about experimental testing under GB BPR
• Data Sharing - Use this form to ask HSE if equivalent vertebrate tests or studies have already been conducted
• Data Access - Use this form to request to refer to data if you have not been able to reach an agreement with the data owner
• Last resort justification - Use this form to consult HSE on the appropriateness of a last resort justification before you commence testing on vertebrates
• Critical Situation Permit - Use this form to apply for a critical situation permit for a biocidal product under GB BPR
• Unfettered access notification form - Use this form to notify HSE about putting your NI authorised biocidal product on the GB market

Guidance

GB Biocidal Products Regulation (GB BPR)

• Fact sheets - ‘Working with biocides after Brexit: actions and deadlines’
• Guidance on information requirements - guidance documents to help you fulfil the information requirements for applications for active substance approval and biocidal product / biocidal product family authorisation under GB BPR
• ECHA Biocides Submission Manuals - use the manuals available for EU BPR to help you to build an IUCLID dossier for applications under GB BPR
• Guidance and training on IUCLID - use the guidance available on the IUCLID website to help you to use IUCLID

The law

Control of Pesticides Regulations (COPR)

• Control of Pesticides Regulations 1986 (COPR) - the older law that sets out the detailed rules for the control of certain biocides in Great Britain (GB) and Northern Ireland (NI)
• The Control of Pesticides (Amendment) Regulations 1997 - amends and updates COPR
• Food and Environment Protection Act 1985 (FEPA) - sets the basic principles for regulating certain biocides in GB and NI, including those relating to enforcement of COPR
• Pesticides (Fees and Enforcement) Act 1989 - allows HSE to charge for work on COPR and includes an amendment to the section of FEPA relating to enforcement of COPR

GB Biocidal Products Regulation (GB BPR)

Consolidated versions of the GB biocides laws are not currently available.

To assist our stakeholders in complying with their duties, the pages of the HSE biocides website outline the provisions and duties of GB biocides law.

If you want to read the laws, you will need to consult both the relevant EU law and the UK laws that amend it.

The following list of EU biocides regulations have been copied into GB law:

• Biocidal Products Regulation (BPR) - the EU law on biocides
• Changes Regulation the EU law on making changes to biocidal product authorisations under BPR
• Same Biocidal Products Regulation - the EU law on applying for a same biocidal product authorisation under BPR
• Review Regulation - the EU law on implementing the Review Programme of biocidal active substances
• Amending Annex I - the EU law on amending Annex I (list of simplified active substances)

Please note that any changes made to the above EU laws after 31 December 2020 are not applicable in GB.

The UK laws that amend the retained EU biocides laws listed above and ensure that they can operate effectively in GB are:

• the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (CMGO Regs 2019)
• the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc) (EU Exit) Regulations 2020 (CMGO Regs 2020) – also implements the Northern Ireland protocol and outlines the transitional provisions for applications, approvals and authorisations in GB

The CMGO Regs 2019 and 2020 also amend the following existing UK regulations to enable them to operate effectively alongside the retained EU regulations listed above:

• The Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 - sets out additional rules for the control of biocides in the UK, including those relating to enforcement of BPR
• Health and Safety and Nuclear (Fees) Regulations 2016 - the law on the fees that can be charged for work under BPR

Leaflets

There are a range of leaflets available to download, covering different aspects of biocide safety and use.

Publications

• Control of substances hazardous to health (Fifth edition) - The Control of Substances Hazardous to Health Regulations 2002 (as amended). Approved code of practice and guidance
  L5 ISBN 978 0 7176 2981 7 - provides guidance on the COSHH Regulations 2002.
  Available to download for free or to buy from HSE Books.
• Fumigation: Health and safety guidance for employers and technicians carrying out fumigation operations
  HSG251 ISBN 978 0 7176 2999 2 - provides practical guidance on the COSHH Regulations 2002.
  Available to download for free.

Templates

GB Biocidal Products Regulation (GB BPR)

• Active Substance Draft Risk Assessment Report (RAR) - Use this template to submit your risk assessment for the active substance and representative product as part of your application for active substance approval
• National Authorisation Product Assessment Report (PAR) - >Use this template to submit your risk assessment for the biocidal product / biocidal product family as part of your application for national authorisation
• Simplified Authorisation Product Assessment Report (PAR) - Use this template to submit your risk assessment for the biocidal product / biocidal product family as part of your application for simplified authorisation
• Single Biocidal Product Summary of Product Characteristics (SPC) - Use this template to submit your SPC for a single biocidal product as part of your application for authorisation
• Biocidal Product Family Meta Summary of Product Characteristics (SPC) - >Use this template to submit your meta SPCs for a biocidal product family as part of your application for authorisation
• Reference List of Studies - Use this template to submit your reference list of studies as part of your application for active substance approval or biocidal product / biocidal product family authorisation

Tools

IUCLID (International Uniform Chemical Information Database) - the preferred format for submitting active substance and biocidal product dossiers to HSE under GB BPR

Useful links

Provides links to other government departments, the European Union and trade associations' websites.