Retained EU Law SI 2012 United Kingdom

Regulation (EU) No 528/2012 on Biocidal Products (retained in UK law as GB BPR via European Union (Withdrawal) Act 2018)

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
HSE
Status
Amended (in force with amendments)
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer3 Any Person1 Applicant1

Plus 1 duty on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Manufacturer — also bound by 502 other Acts
Any Person — also bound by 2340 other Acts
Applicant — also bound by 307 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

s.art010 Active substances which are candidates for substitution Regulated
Other duties (1) — Crown / regulator
  • HSE must assess candidate-for-substitution criteria and consult on potential candidatesStatutory regulator
s.art020 Requirements for applications for authorisation Regulated
  • Submit required documents with biocidal product authorisation applicationApplicant
s.art058 Placing on the market of treated articles Regulated
  • Ensure treated articles meet GB BPR labelling and substance approval rulesAny Person
s.art065 Compliance with requirements Regulated
  • Maintain production records and batch samples for biocidal productsManufacturer
s.art068 Record-keeping and reporting Regulated
  • Keep records of biocidal products for 10 years and share with HSE on requestManufacturer
s.art069 Classification, packaging and labelling of biocidal products Regulated
  • Classify, package and label biocidal products according to approved product characteristicsManufacturer
113 other provisions — procedural and definitional
s.annex iv para.1 This Annex sets out rules to be followed when the...
s.annex iv para.2 The reasons for such adaptations to the data requirements must...
s.art001 Purpose and subject matter
s.art002 Scope
s.art003 Definitions
s.art004 Conditions for approval
s.art005 Exclusion criteria
s.art006 Data requirements for an application
s.art007 Submission and validation of applications
s.art008 Evaluation of applications
s.art008 The GB List
s.art009 Approval of an active substance
s.art011 Technical guidance notes
s.art012 Conditions for renewal
s.art013 Submission and acceptance of applications
s.art014 Evaluation of applications for renewal
s.art015 Review of approval of an active substance
s.art016 Implementing measures
s.art017 Making available on the market and use of biocidal products
s.art017 NI Product Market Access
s.art018 Measures geared to the sustainable use of biocidal products
s.art019 Conditions for granting an authorisation
s.art021 Waiving of data requirements
s.art022 Content of authorisation
s.art023 Comparative assessment of biocidal products
s.art024 Technical guidance notes
s.art024 The Simplified Active Substance List
s.art025 Eligibility for the simplified authorisation procedure
s.art026 Applicable procedure
s.art027 Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
s.art028 Amendment of the Simplified Active Substance List
s.art029 Submission and validation of applications
s.art030 Evaluation of applications
s.art031 Renewal of a national authorisation
s.art032 Authorisation through mutual recognition
s.art033 Mutual recognition in sequence
s.art034 Mutual recognition in parallel
s.art035 Referral of objections to the coordination group
s.art036 Referral of unresolved objections to the Commission
s.art037 Derogations from mutual recognition
s.art038 Opinion of the Agency
s.art039 Application for mutual recognition by official or scientific bodies
s.art040 Supplementary rules and technical guidance notes
s.art041 Union authorisation
s.art042 Biocidal products for which Union authorisation may be granted
s.art043 Submission and validation of applications
s.art044 Evaluation of applications
s.art045 Submission and acceptance of applications
s.art046 Evaluation of applications for renewal
s.art047 Obligation for notification of unexpected or adverse effects
s.art048 Cancellation or amendment of an authorisation
s.art049 Cancellation of an authorisation at the request of the authorisation holder
s.art050 Amendment of an authorisation at the request of the authorisation holder
s.art051 Detailed rules
s.art052 Period of grace
s.art053 Parallel trade
s.art054 Assessment of technical equivalence
s.art055 Derogation from the requirements
s.art056 Research and development
s.art057 Exemption from registration under Regulation (EC) No 1907/2006
s.art059 Protection of data held by the competent authority
s.art060 Data protection periods
s.art061 Letter of access
s.art062 Data sharing
s.art063 Compensation for data sharing
s.art064 Use of data for subsequent applications
s.art066 Confidentiality
s.art067 Electronic public access
s.art070 Safety data sheets
s.art071 Exchange of information
s.art072 Advertising
s.art073 Poison control
s.art074 Role of the Agency
s.art075 Biocidal Products Committee
s.art076 Secretariat of the Agency
s.art077 Appeals
s.art078 The budget of the Agency
s.art079 Formats for submission of information to the competent authority
s.art080 Fees and charges
s.art081 The competent authority
s.art082 Committee procedure
s.art083 Exercise of the delegation
s.art083 Regulation procedure
s.art083 The consent requirement
s.art084 Urgency procedure
s.art085 Adaptation to scientific and technical progress
s.art086 Active substances included in Annex I to Directive 98/8/EC
s.art087 Penalties
s.art088 Safeguard clause
s.art089 Existing transitional measures
s.art090 Transitional measures concerning active substances evaluated under Directive 98/8/EC
s.art091 Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
s.art092 Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
s.art093 Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
s.art094 Transitional measures concerning treated articles
s.art095 Transitional measures concerning access to the active substance dossier
s.art095 Transitional measures for simplified notification procedure
s.art095 Transitional measures for mutual recognition applications
s.art095 Renewal of authorisations subject to mutual recognition under Regulation 492/2014
s.art095 Transitional measure for national authorisation applications
s.art095 Transitional measures simplified authorisation applications
s.art095 Transitional measures for applications for same biocidal product authorisations
s.art095 Transitional measures for applications for same biocidal product authorisations under the simplified procedure
s.art095 Transitional measures for Regulation (EU) No 528/2012 authorisations
s.art095 Transitional measures for ongoing applications for Union authorisations
s.art095 Transitional measures for Article 95 List
s.art095 Transitional measure for active substance applications made to the United Kingdom competent authority before 30 March 2019 and subsequently reallocated
s.art095 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
s.art095 Transitional measures for renewal of an approval of an active substance
s.art095 Transitional measures for ongoing applications to change or amend authorisations
s.art095 Interpretation of Articles 95A to 95M
s.art096 Repeal
s.art097 Entry into force

Help complying

Guvnor’s practical routes through this instrument.

Biocides and Pesticides Authorisation

Get HSE CRD authorisation for biocidal and pesticidal products.
5 more guides that reference this instrument
Building and landscape services: compliance checklist Chemical manufacturer: compliance checklist Meet your pest control, landscaping and waste duties Place chemical substances and products on the GB market Which chemical regulations apply to your products and site

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.