Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 M... (32012R0528)
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
- 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)
- CHAPTER I
- SCOPE AND DEFINITIONS
- Article 1
- Purpose and subject matter
- Article 2
- Scope
- Article 3
- Definitions
- CHAPTER II
- APPROVAL OF ACTIVE SUBSTANCES
- Article 4
- Conditions for approval
- Article 5
- Exclusion criteria
- Article 6
- Data requirements for an application
- Article 7
- Submission and validation of applications
- Article 8
- Evaluation of applications
- Article 9
- Approval of an active substance
- Article 10
- Active substances which are candidates for substitution
- Article 11
- Technical guidance notes
- CHAPTER III
- RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE
- Article 12
- Conditions for renewal
- Article 13
- Submission and acceptance of applications
- Article 14
- Evaluation of applications for renewal
- Article 15
- Review of approval of an active substance
- Article 16
- Implementing measures
- CHAPTER IV
- GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS
- Article 17
- Making available on the market and use of biocidal products
- Article 18
- Measures geared to the sustainable use of biocidal products
- Article 19
- Conditions for granting an authorisation
- Article 20
- Requirements for applications for authorisation
- Article 21
- Waiving of data requirements
- Article 22
- Content of authorisation
- Article 23
- Comparative assessment of biocidal products
- Article 24
- Technical guidance notes
- CHAPTER V
- SIMPLIFIED AUTHORISATION PROCEDURE
- Article 25
- Eligibility for the simplified authorisation procedure
- Article 26
- Applicable procedure
- Article 27
- Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
- Article 28
- Amendment of Annex I
- CHAPTER VI
- NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS
- Article 29
- Submission and validation of applications
- Article 30
- Evaluation of applications
- Article 31
- Renewal of a national authorisation
- CHAPTER VII
- MUTUAL RECOGNITION PROCEDURES
- Article 32
- Authorisation through mutual recognition
- Article 33
- Mutual recognition in sequence
- Article 34
- Mutual recognition in parallel
- Article 35
- Referral of objections to the coordination group
- Article 36
- Referral of unresolved objections to the Commission
- Article 37
- Derogations from mutual recognition
- Article 38
- Opinion of the Agency
- Article 39
- Application for mutual recognition by official or scientific bodies
- Article 40
- Supplementary rules and technical guidance notes
- CHAPTER VIII
- UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS
- SECTION 1
- Granting of Union authorisations
- Article 41
- Union authorisation
- Article 42
- Biocidal products for which Union authorisation may be granted
- Article 43
- Submission and validation of applications
- Article 44
- Evaluation of applications
- SECTION 2
- Renewal of Union authorisations
- Article 45
- Submission and acceptance of applications
- Article 46
- Evaluation of applications for renewal
- CHAPTER IX
- CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS
- Article 47
- Obligation for notification of unexpected or adverse effects
- Article 48
- Cancellation or amendment of an authorisation
- Article 49
- Cancellation of an authorisation at the request of the authorisation holder
- Article 50
- Amendment of an authorisation at the request of the authorisation holder
- Article 51
- Detailed rules
- Article 52
- Period of grace
- CHAPTER X
- PARALLEL TRADE
- Article 53
- Parallel trade
- CHAPTER XI
- TECHNICAL EQUIVALENCE
- Article 54
- Assessment of technical equivalence
- CHAPTER XII
- DEROGATIONS
- Article 55
- Derogation from the requirements
- Article 56
- Research and development
- Article 57
- Exemption from registration under Regulation (EC) No 1907/2006
- CHAPTER XIII
- TREATED ARTICLES
- Article 58
- Placing on the market of treated articles
- CHAPTER XIV
- DATA PROTECTION AND DATA-SHARING
- Article 59
- Protection of data held by competent authorities or the Agency
- Article 60
- Data protection periods
- Article 61
- Letter of access
- Article 62
- Data sharing
- Article 63
- Compensation for data sharing
- Article 64
- Use of data for subsequent applications
- CHAPTER XV
- INFORMATION AND COMMUNICATION
- SECTION 1
- Monitoring and reporting
- Article 65
- Compliance with requirements
- Article 66
- Confidentiality
- Article 67
- Electronic public access
- Article 68
- Record-keeping and reporting
- SECTION 2
- Information about biocidal products
- Article 69
- Classification, packaging and labelling of biocidal products
- Article 70
- Safety data sheets
- Article 71
- Register for Biocidal Products
- Article 72
- Advertising
- Article 73
- Poison control
- CHAPTER XVI
- THE AGENCY
- Article 74
- Role of the Agency
- Article 75
- Biocidal Products Committee
- Article 76
- Secretariat of the Agency
- Article 77
- Appeal
- Article 78
- The budget of the Agency
- Article 79
- Formats and software for submission of information to the Agency
- CHAPTER XVII
- FINAL PROVISIONS
- Article 80
- Fees and charges
- Article 81
- Competent authorities
- Article 82
- Committee procedure
- Article 83
- Exercise of the delegation
- Article 84
- Urgency procedure
- Article 85
- Adaptation to scientific and technical progress
- Article 86
- Active substances included in Annex I to Directive 98/8/EC
- Article 87
- Penalties
- Article 88
- Safeguard clause
- Article 89
- Transitional measures
- Article 90
- Transitional measures concerning active substances evaluated under Directive 98/8/EC
- Article 91
- Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
- Article 92
- Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
- Article 93
- Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
- Article 94
- Transitional measures concerning treated articles
- Article 95
- Transitional measures concerning access to the active substance dossier
- Article 96
- Repeal
- Article 97
- Entry into force
- ANNEX I
- ANNEX II
- INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
- TITLE 1
- CHEMICAL SUBSTANCES
- Core data set and additional data set for active substances
- TITLE 2
- MICRO-ORGANISMS
- Core data set and additional data set for active substances
- ANNEX III
- INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
- TITLE 1
- CHEMICAL PRODUCTS
- Core data set and additional data set for chemical products
- TITLE 2
- MICRO-ORGANISMS
- Core data set and additional data set
- ANNEX IV
- GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS
- 1. TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY
- 1.1. Use of existing data
- 1.1.3. Historical human data
- 1.2. Weight of evidence
- 1.3. Qualitative or Quantitative structure-activity relationship ((Q)SAR)
- 1.4. In vitro methods
- 1.5. Grouping of substances and read-across approach
- 2. TESTING IS TECHNICALLY NOT POSSIBLE
- 3. PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING
- ANNEX V
- BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)
- MAIN GROUP 1:
- Disinfectants
- Product-type 1: Human hygiene
- Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals
- Product-type 3: Veterinary hygiene
- Product-type 4: Food and feed area
- Product-type 5: Drinking water
- MAIN GROUP 2:
- Preservatives
- Product-type 6: Preservatives for products during storage
- Product-type 7: Film preservatives
- Product-type 8: Wood preservatives
- Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
- Product-type 10: Construction material preservatives
- Product-type 11: Preservatives for liquid-cooling and processing systems
- Product-type 12: Slimicides
- Product-type 13: Working or cutting fluid preservatives
- MAIN GROUP 3:
- Pest control
- Product-type 14: Rodenticides
- Product-type 15: Avicides
- Product-type 16: Molluscicides, vermicides and products to control other invertebrates
- Product-type 17: Piscicides
- Product-type 18: Insecticides, acaricides and products to control other arthropods
- Product-type 19: Repellents and attractants
- Product-type 20: Control of other vertebrates
- MAIN GROUP 4:
- Other biocidal products
- Product-type 21: Antifouling products
- Product-type 22: Embalming and taxidermist fluids
- ANNEX VI
- COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
- TERMS AND DEFINITIONS
- Technical definitions
- (a) Hazard identification
- (b) Dose (concentration) — response (effect) assessment
- (c) Exposure assessment
- (d) Risk characterisation
- (e) Environment
- INTRODUCTION
- ASSESSMENT
- General principles
- Effects on human and animal health
- Effects on human health
- Effects on animal health
- Effects on the environment
- Effects on target organisms
- Efficacy
- Summary
- CONCLUSIONS
- General principles
- Effects on human and animal health
- Effects on human health
- Effects on animal health
- Effects on the environment
- Water
- Soil
- Air
- Non-target organisms
- Effects on target organisms
- Efficacy
- Summary
- OVERALL INTEGRATION OF CONCLUSIONS
- ANNEX VII
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