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
EC number |
Name/group |
Restriction |
Comment |
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Category 1 — Substances authorised as food additives according to Regulation (EC) No 1333/2008 |
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200-018-0 |
Lactic acid |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 270 |
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204-823-8 |
Sodium acetate |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 262 |
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208-534-8 |
Sodium benzoate |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 211 |
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201-766-0 |
(+)-Tartaric acid |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 334 |
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200-580-7 |
Acetic acid |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 260 |
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201-176-3 |
Propionic acid |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 280 |
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Category 2 — Substances included in Annex IV to Regulation (EC) No 1907/2006 |
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200-066-2 |
Ascorbic acid |
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232-278-6 |
Linseed oil |
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Category 4 — Traditionally used substances of natural origin |
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Natural oil |
Lavender oil |
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CAS 8000-28-0 |
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Natural oil |
Peppermint oil |
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CAS 8006-90-4 |
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Category 5 — Pheromones |
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222-226-0 |
Oct-1-en-3-ol |
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Mixture |
Webbing clothes moths pheromone |
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Category 6 — Substances included in Annex I or IA to Directive 98/8/EC |
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204-696-9 |
Carbon dioxide |
Only for use in ready-for-use gas canisters functioning together with a trapping device |
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231-783-9 |
Nitrogen |
Only for use in limited quantities in ready-for-use canisters |
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250-753-6 |
(Z,E)-Tetradec-9,12-dienyl acetate |
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Category 7 — Other |
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Baculovirus |
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215-108-5 |
Bentonite |
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203-376-6 |
Citronellal |
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231-753-5 |
Iron sulphate |
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ANNEX II
INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
TITLE 1
CHEMICAL SUBSTANCES
Core data set and additional data set for active substances
Column 1 Information required |
Column 2 All data is CDS unless indicated as ADS |
Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
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1. APPLICANT |
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2. IDENTITY OF THE ACTIVE SUBSTANCE |
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For the active substance, the information given in this Section shall be sufficient to enable the active substance to be identified. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated |
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3. PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE |
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3.1. Appearance(4) |
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3.7. Vapour pressure(5) |
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4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS |
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4.17. Additional physical indicators for hazards |
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5. METHODS OF DETECTION AND IDENTIFICATION |
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5.2. Analytical methods for monitoring purposes including recovery rates and the limits of quantification and detection for the active substance, and for residues thereof in/on the following where relevant |
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6. EFFECTIVENESS AGAINST TARGET ORGANISMS |
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6.7. Any known limitations on efficacy |
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7. INTENDED USES AND EXPOSURE |
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7.6. Exposure data in conformity with Annex VI to this Regulation |
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8. TOXICOLOGICAL PROFILE FOR HUMAN AND ANIMAL INCLUDING METABOLISM |
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Step 2 does not need to be conducted if:
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8.5. Mutagenicity |
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The assessment of this endpoint shall comprise the following consecutive steps:
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The study/ies do(es) not generally need to be conducted if:
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The study/ies do(es) not generally need to be conducted if:
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The study need not be conducted if:
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8.8. Toxicokinetics and metabolism studies in mammals |
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The toxicokinetics and metabolism studies should provide basic data about the rate and extent of absorption, the tissue distribution and the relevant metabolic pathway including the degree of metabolism, the routes and rate of excretion and the relevant metabolites |
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The repeated dose toxicity study (28 or 90 days) does not need to be conducted if:
In order to reduce testing carried out on vertebrates and in particular the need for free-standing single-endpoint studies, the design of the repeated dose toxicity studies shall take account of the possibility to explore several endpoints within the framework of one study |
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The short-term toxicity study (28 days) does not need to be conducted if:
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The sub-chronic toxicity study (90 days) does not need to be conducted if:
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The long-term toxicity study (≥ 12 months) does not need to be conducted if:
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The studies need not be conducted if:
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A carcinogenicity study does not need to be conducted if:
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8.12. Relevant health data, observations and treatments |
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Justification should be provided if data is not available |
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9. ECOTOXICOLOGICAL STUDIES |
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9.1. Toxicity to Aquatic Organisms |
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The study does not need to be conducted if:
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9.1.2. Short-term toxicity testing on aquatic invertebrates |
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9.1.3. Growth inhibition study on algae |
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The experimental determination may not need to be carried out if:
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For endpoint 9.4.3 the study does not need to be conducted if:
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Data are derived from the mammalian toxicological assessment. The most sensitive relevant mammalian long-term toxicological endpoint (NOAEL) expressed as mg test compound/kg bw/day shall be reported |
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10. ENVIRONMENTAL FATE AND BEHAVIOUR |
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10.1. Fate and behaviour in water and sediment |
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10.1.1. Degradation, initial studies |
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If the assessment performed indicates the need to investigate further the degradation of the substance and its degradation products or the active substance has an overall low or absent abiotic degradation, then the tests described in 10.1.3 and 10.3.2 and where appropriate — in 10.4 shall be required. The choice of the appropriate test(s) depends on the results of the initial assessment performed |
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10.1.3. Rate and route of degradation including identification of metabolites and degradation products |
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ADS |
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ADS |
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10.3. Fate and behaviour in air |
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ADS |
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ADS |
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ADS |
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ADS |
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||||||||||||||||||||||
11. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT |
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12. CLASSIFICATION, LABELLING AND PACKAGING |
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||||||||||||||||||||||
12.2. The hazard classification of the substance resulting from the application of Regulation (EC) No 1272/2008 |
||||||||||||||||||||||||
In addition, for each entry, the reasons why no classification is given for an endpoint should be provided |
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TITLE 2
MICRO-ORGANISMS
Core data set and additional data set for active substances
Column 1 Information required |
Column 2 All data is CDS unless indicated as ADS |
Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
||
1. APPLICANT |
||||
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2. IDENTITY OF THE MICRO-ORGANISM |
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||
3. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM |
||||
3.1. General information on the micro-organism |
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4. METHODS OF DETECTION AND IDENTIFICATION |
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5. EFFECTIVENESS AGAINST TARGET ORGANISM |
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5.8. Any known limitations on efficacy |
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6. INTENDED USES AND EXPOSURE |
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||
6.5. Exposure data applying, as appropriate, the methodologies described in Section 5 of Annex I to Regulation (EC) No 1907/2006 |
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|
Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. |
||
7.1. Basic information |
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7.2. Basic studies |
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7.2.2. Acute toxicity, pathogenicity, and infectiveness |
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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|
ADS |
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|
Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. |
||
8.1. Effects on aquatic organisms |
||||
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ADS |
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ADS |
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ADS |
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ADS |
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ADS |
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||
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||
9. ENVIRONMENTAL FATE AND BEHAVIOUR |
||||
9.1. Persistence and multiplication |
||||
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||
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||
10. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT |
||||
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||
11. CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM |
||||
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||
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|
|
ANNEX III
INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
TITLE 1
CHEMICAL PRODUCTS
Core data set and additional data set for chemical products
Column 1 Information required: |
Column 2 All data is CDS unless indicated as ADS |
Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
||||||||||||
1. APPLICANT |
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||||||||||||
2. IDENTITY OF THE BIOCIDAL PRODUCT |
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||||||||||||
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||||||||||||
3. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES |
||||||||||||||
3.1. Appearance (at 20 °C and 101,3 kPa) |
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||||||||||||
3.4. Storage stability, stability and shelf-life |
||||||||||||||
3.4.1. Storage stability tests |
||||||||||||||
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||||||||||||
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|
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||||||||||||
3.4.2. Effects on content of the active substance and technical characteristics of the biocidal product |
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||||||||||||
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||||||||||||
3.5. Technical characteristics of the biocidal product |
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||||||||||||
3.6. Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised |
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||||||||||||
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS |
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||||||||||||
4.17. Additional physical indications of hazard |
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||||||||||||
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|
|
||||||||||||
5. METHODS OF DETECTION AND IDENTIFICATION |
||||||||||||||
|
|
|
||||||||||||
|
ADS |
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||||||||||||
|
ADS |
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||||||||||||
|
ADS |
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||||||||||||
|
ADS |
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||||||||||||
|
ADS |
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||||||||||||
|
ADS |
|
||||||||||||
6. EFFECTIVENESS AGAINST TARGET ORGANISMS |
||||||||||||||
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||||||||||||
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||||||||||||
6.8. Any known limitations on efficacy |
||||||||||||||
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|
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||||||||||||
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|
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||||||||||||
|
|
|
||||||||||||
7. INTENDED USES AND EXPOSURE |
||||||||||||||
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||||||||||||
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||||||||||||
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||||||||||||
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||||||||||||
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||||||||||||
|
|
|
||||||||||||
7.10. Exposure data in conformity with Annex VI to this Regulation |
||||||||||||||
|
|
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||||||||||||
|
|
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||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
8. TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS |
||||||||||||||
|
|
Testing on the product/mixture does not need to be conducted if:
|
||||||||||||
|
|
Testing on the product/mixture does not need to be conducted if:
|
||||||||||||
|
|
Testing on the product/mixture does not need to be conducted if:
|
||||||||||||
|
ADS |
Testing on the product/mixture does not need to be conducted if:
|
||||||||||||
|
|
Testing on the product/mixture does not need to be conducted if:
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
Testing on the mixture of products does not need to be conducted if:
|
||||||||||||
|
|
|
||||||||||||
|
|
Testing on the product/mixture does not need to be conducted if:
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
9. ECOTOXICOLOGICAL STUDIES |
||||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
ADS |
Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment |
||||||||||||
9.4. If the biocidal product is in the form of bait or granules the following studies may be required: |
||||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
ADS |
|
||||||||||||
10. ENVIRONMENTAL FATE AND BEHAVIOUR |
||||||||||||||
The test requirements below are applicable only to the relevant components of the biocidal product |
|
|
||||||||||||
|
|
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
|
ADS |
|
||||||||||||
11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT |
||||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
11.4. Possibility of destruction or decontamination following release in or on the following: |
||||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
12. CLASSIFICATION, LABELLING, AND PACKAGING |
||||||||||||||
As established in point (b) of Article 20(1), proposals including justification for the hazard and precautionary statements in accordance with the provisions set in Directive 1999/45/EC and Regulation (EC) No 1272/2008 must be submitted. Example labels, instructions for use and safety data sheets shall be provided |
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
||||||||||||
|
|
|
TITLE 2
MICRO-ORGANISMS
Core data set and additional data set
Column 1 Information required: |
Column 2 All data is CDS unless indicated as ADS |
Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
||||||||
1. APPLICANT |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
2. IDENTITY OF THE BIOCIDAL PRODUCTS |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
3. BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT |
||||||||||
|
|
|
||||||||
3.2. Appearance (at 20 °C and 101,3 kPa) |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
3.5. Storage stability, stability and shelf-life |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
3.6. Technical characteristics of the biocidal product |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
3.7. Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
4.12. Other physical indications of hazard |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
5. METHODS OF DETECTION AND IDENTIFICATION |
||||||||||
|
|
|
||||||||
|
ADS |
|
||||||||
6. EFFECTIVENESS AGAINST TARGET ORGANISM |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
6.8. Any other known limitations on efficacy including resistance |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
7. INTENDED USES AND EXPOSURE |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
7.9. Exposure data |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
Testing on the product/mixture does not need to be conducted if:
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
ADS |
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
Testing on the product/mixture does not need to be conducted if:
|
||||||||
|
|
Testing on the mixture of products does not need to be conducted if:
|
||||||||
|
ADS |
|
||||||||
9. ECOTOXICOLOGICAL STUDIES |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
ADS |
Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment |
||||||||
|
ADS |
|
||||||||
|
||||||||||
|
||||||||||
|
ADS |
|
||||||||
10. ENVIRONMENTAL FATE AND BEHAVIOUR |
||||||||||
|
|
|
||||||||
|
ADS |
|
||||||||
|
ADS |
|
||||||||
|
ADS |
|
||||||||
11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
11.3. Procedures for destruction or decontamination of the biocidal product and its packaging |
||||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
12. CLASSIFICATION, LABELLING AND PACKAGING |
||||||||||
Example labels, instructions for use and safety data sheets shall be provided |
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
||||||||
|
|
|
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
Directive 98/8/EC |
This Regulation |
— |
Article 1 |
Article 1 |
Article 2 |
Article 2 |
Article 3 |
Article 10 |
Article 4 |
Article 10 |
Article 5 |
— |
Article 6 |
Article 11(1)(a) |
6(1) |
Article 11(1)(a)(i) and (ii) |
6(2) |
— |
6(3) |
— |
6(4) |
— |
Article 7 |
Article 11(1)(a) |
7(1) |
— |
7(2) |
— |
7(3) |
— |
7(4) |
— |
7(5) |
— |
7(6) |
— |
Article 8 |
Article 11(2), first subparagraph |
8(1) |
Article 11(2), second subparagraph |
8(2) |
Article 10(1), first subparagraph |
8(3) |
— |
8(4) |
— |
Article 9 |
11(4) |
9(1) |
— |
9(2) |
— |
Article 10 |
Article 33 |
Article 11 |
Article 10(4) |
Article 12 |
— |
12(1) |
— |
12(2) |
— |
12(3) |
— |
Article 13 |
— |
Article 14 |
— |
Article 15 |
— |
Article 16 |
— |
Article 17 |
Article 3(1) |
17(1) |
Article 8(1) |
17(2) |
— |
17(3) |
Article 3(6) |
17(4) |
Article 3(7) |
17(5) |
— |
17(6) |
— |
Article 18 |
— |
Article 19 |
Article 5(1) |
19(1) |
Article 5(1)(b) |
19(2) |
— |
19(3) |
Article 5(2) |
19(4) |
— |
19(5) |
Article 2(1)(j) |
19(6) |
— |
19(7) |
— |
19(8) |
— |
19(9) |
— |
Article 20 |
Article 8(2) |
20(1) |
Article 8(12) |
20(2) |
— |
20(3) |
— |
Article 21 |
— |
Article 22 |
Article 5(3) |
22(1) |
— |
22(2) |
— |
Article 23 |
— |
23(1) |
Article 10(5)(i) |
23(2) |
— |
23(3) |
— |
23(4) |
— |
23(5) |
— |
23(6) |
Article 33 |
Article 24 |
— |
Article 25 |
— |
Article 26 |
— |
Article 27 |
— |
Article 28 |
— |
Article 29 |
— |
Article 30 |
— |
Article 31 |
Article 4 |
Article 32 |
— |
Article 33 |
— |
Article 34 |
— |
Article 35 |
Article 4(4) |
Article 36 |
— |
Article 37 |
— |
Article 38 |
— |
Article 39 |
— |
Article 40 |
— |
Article 41 |
— |
Article 42 |
— |
Article 43 |
— |
Article 44 |
— |
Article 45 |
— |
Article 46 |
— |
Article 47 |
Article 7 |
Article 48 |
Article 7 |
Article 49 |
Article 7 |
Article 50 |
— |
Article 51 |
— |
Article 52 |
— |
Article 53 |
— |
Article 54 |
Article 15 |
Article 55 |
Article 17 |
Article 56 |
— |
Article 57 |
— |
Article 58 |
Article 12 |
Article 59 |
— |
Article 60 |
— |
60(1) |
Article 12(1)(c)(ii) and (1)(b) and (1)(d)(ii) |
60(2) |
Article 12(2)(c)(i) and (ii) |
60(3) |
— |
Article 61 |
— |
Article 62 |
— |
Article 63 |
Article 13(2) |
63(1) |
— |
63(2) |
— |
63(3) |
Article 13(1) |
Article 64 |
— |
Article 65 |
Article 24 |
65(1) |
— |
65(2) |
Article 24 |
65(3) |
— |
65(4) |
— |
Article 66 |
— |
66(1) |
— |
66(2) |
— |
66(3) |
Article 19(1) |
66(4) |
— |
Article 67 |
— |
Article 68 |
— |
Article 69 |
Article 20(1) and 20(2) |
Article 69(1) |
Article 20(3) |
Article 69(2) |
Article 20(6) |
Article 69(2) |
Article 21, second subparagraph |
Article 70 |
— |
Article 71 |
— |
Article 72 |
Article 22(1), first and second subparagraphs |
72(1) |
Article 22(1), third subparagraph |
72(2) |
Article 22(2) |
72(3) |
— |
Article 73 |
— |
Article 74 |
— |
Article 75 |
— |
Article 76 |
— |
Article 77 |
— |
Article 78 |
— |
Article 79 |
— |
Article 80 |
— |
80(1) |
Article 25 |
80(2) |
— |
80(3) |
Article 26 |
Article 81 |
Article 28 |
Article 82 |
— |
Article 83 |
— |
Article 84 |
Article 29 |
Article 85 |
— |
Article 86 |
— |
Article 87 |
Article 32 |
Article 88 |
— |
Article 89 |
— |
Article 90 |
— |
Article 91 |
— |
Article 92 |
— |
Article 93 |
— |
Article 94 |
— |
Article 95 |
— |
Article 96 |
— |
Article 97 |
Annex IA |
Annex I |
Annex II A, III A and IV A |
Annex II |
Annex II B, III B and IV B |
Annex III |
— |
Annex IV |
Annex V |
Annex V |
Annex VI |
Annex VI |