Retained EU Law
2012
United Kingdom
Regulation (EU) No 528/2012 on Biocidal Products (retained in UK law as GB BPR via European Union (Withdrawal) Act 2018)
At a glance
Enforced by
What's here
6 compliance obligations, 6 practical guides
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Manufacturer 3
- Any Person 1
- Applicant 1
Plus 1 non-business duty on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Direct — cites this Act
1 guidesSupporting — topic alignment
5 guidesOther Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Manufacturers also bound by 472 other Acts (top 5 shown)
- Pressure Equipment (Safety) Regulations 2016 2016 91 duties
- Lifts Regulations 2016 2016 70 duties
- The Ecodesign for Energy-Related Products and Energy Information Regulations 2021 2021 70 duties
- Non-Automatic Weighing Instruments Regulations 2016 2016 67 duties
- Pyrotechnic Articles (Safety) Regulations 2015 2015 64 duties
Any Person also bound by 2338 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 169 duties
- Merchant Shipping Act 1995 1995 144 duties
- Insolvency (England and Wales) Rules 2016 2016 101 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 95 duties
Applicants also bound by 294 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 46 duties
- Human Medicines Regulations 2012 2012 30 duties
- The Land Registration Rules 2003 2003 25 duties
- Value Added Tax Regulations 1995 1995 18 duties
- Space Industry Regulations 2021 2021 14 duties
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Active substances which are candidates for substitution
Other duties (1) — Crown / regulator
- HSE must assess candidate-for-substitution criteria and consult on potential candidates Statutory regulator
Requirements for applications for authorisation
- Submit required documents with biocidal product authorisation application Applicant
Placing on the market of treated articles
- Ensure treated articles meet GB BPR labelling and substance approval rules Any Person
Compliance with requirements
- Maintain production records and batch samples for biocidal products Manufacturer
Record-keeping and reporting
- Keep records of biocidal products for 10 years and share with HSE on request Manufacturer
Classification, packaging and labelling of biocidal products
- Classify, package and label biocidal products according to approved product characteristics Manufacturer
Browse 113 other sections — procedural / definitional / commencement
This Annex sets out rules to be followed when the...
The reasons for such adaptations to the data requirements must...
Purpose and subject matter
Scope
Definitions
Conditions for approval
Exclusion criteria
Data requirements for an application
Submission and validation of applications
Evaluation of applications
The GB List
Approval of an active substance
Technical guidance notes
Conditions for renewal
Submission and acceptance of applications
Evaluation of applications for renewal
Review of approval of an active substance
Implementing measures
Making available on the market and use of biocidal products
NI Product Market Access
Measures geared to the sustainable use of biocidal products
Conditions for granting an authorisation
Waiving of data requirements
Content of authorisation
Comparative assessment of biocidal products
Technical guidance notes
The Simplified Active Substance List
Eligibility for the simplified authorisation procedure
Applicable procedure
Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
Amendment of the Simplified Active Substance List
Submission and validation of applications
Evaluation of applications
Renewal of a national authorisation
Authorisation through mutual recognition
Mutual recognition in sequence
Mutual recognition in parallel
Referral of objections to the coordination group
Referral of unresolved objections to the Commission
Derogations from mutual recognition
Opinion of the Agency
Application for mutual recognition by official or scientific bodies
Supplementary rules and technical guidance notes
Union authorisation
Biocidal products for which Union authorisation may be granted
Submission and validation of applications
Evaluation of applications
Submission and acceptance of applications
Evaluation of applications for renewal
Obligation for notification of unexpected or adverse effects
Cancellation or amendment of an authorisation
Cancellation of an authorisation at the request of the authorisation holder
Amendment of an authorisation at the request of the authorisation holder
Detailed rules
Period of grace
Parallel trade
Assessment of technical equivalence
Derogation from the requirements
Research and development
Exemption from registration under Regulation (EC) No 1907/2006
Protection of data held by the competent authority
Data protection periods
Letter of access
Data sharing
Compensation for data sharing
Use of data for subsequent applications
Confidentiality
Electronic public access
Safety data sheets
Exchange of information
Advertising
Poison control
Role of the Agency
Biocidal Products Committee
Secretariat of the Agency
Appeals
The budget of the Agency
Formats for submission of information to the competent authority
Fees and charges
The competent authority
Committee procedure
Exercise of the delegation
Regulation procedure
The consent requirement
Urgency procedure
Adaptation to scientific and technical progress
Active substances included in Annex I to Directive 98/8/EC
Penalties
Safeguard clause
Existing transitional measures
Transitional measures concerning active substances evaluated under Directive 98/8/EC
Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
Transitional measures concerning treated articles
Transitional measures concerning access to the active substance dossier
Transitional measures for simplified notification procedure
Transitional measures for mutual recognition applications
Renewal of authorisations subject to mutual recognition under Regulation 492/2014
Transitional measure for national authorisation applications
Transitional measures simplified authorisation applications
Transitional measures for applications for same biocidal product authorisations
Transitional measures for applications for same biocidal product authorisations under the simplified procedure
Transitional measures for Regulation (EU) No 528/2012 authorisations
Transitional measures for ongoing applications for Union authorisations
Transitional measures for Article 95 List
Transitional measure for active substance applications made to the United Kingdom competent authority before 30 March 2019 and subsequently reallocated
Transitional measure for active substance applications made before IP completion day pursuant to Article 93 where the United Kingdom competent authority was not the evaluating competent authority
Transitional measures for renewal of an approval of an active substance
Transitional measures for ongoing applications to change or amend authorisations
Interpretation of Articles 95A to 95M
Repeal
Entry into force
Official guidance
Authoritative sources published by regulators or government explaining this legislation.
- HSE: pesticides and plant protection products (opens in a new tab) from HSE Detailed Guidance
- HSE: biocides (opens in a new tab) from HSE Detailed Guidance
- Report and manage invasive non-native species (GOV.UK) (opens in a new tab) from DEFRA Detailed Guidance
- COSHH and engineering workers - Fumigation - COSHH (opens in a new tab) from HSE Detailed Guidance
- How GB CLP affects other chemical law (opens in a new tab) from HSE Detailed Guidance
- Updating the GB mandatory classification and labelling list (GB MCL List) (opens in a new tab) from HSE Detailed Guidance
- Rodenticides (opens in a new tab) from HSE Detailed Guidance
- Insect monitoring traps (opens in a new tab) from HSE Detailed Guidance
- Unfettered access notification (opens in a new tab) from HSE Detailed Guidance
- Check your product is regulated as a biocidal product (opens in a new tab) from HSE Detailed Guidance
- ... and 38 more
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Health and Safety Executive
Workplace health, safety, and welfare regulation across all industries. Enforces the Health and Safety at Work Act 1974 and related regulations. Investigates …
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Regulators
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