Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May…

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 · European Union · 32012R0528

865 provisions in 5085 nodes · 29 provisions hand work to national law

Defined terms · All instruments · Internet · access to information · accounting · advertising · animal life · approximation of laws · aquatic environment · atmospheric pollutant

CHAPTER I SCOPE AND DEFINITIONS

Article 1 Purpose and subject matter

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

Division

Article 8 Evaluation of applications

Division

Article 9 Approval of an active substance

Article 10 Active substances which are candidates for substitution

Article 11 Technical guidance notes

Division

CHAPTER III RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE

Article 12 Conditions for renewal

Division

Article 13 Submission and acceptance of applications

Article 14 Evaluation of applications for renewal

Article 15 Review of approval of an active substance

Division

Article 16 Implementing measures

Division

CHAPTER IV GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

Article 17 Making available on the market and use of biocidal products

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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

Division

CHAPTER V SIMPLIFIED AUTHORISATION PROCEDURE

Article 25 Eligibility for the simplified authorisation procedure

Article 26 Applicable procedure

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Article 27 Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure

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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

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Article 33 Mutual recognition in sequence

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Article 34 Mutual recognition in parallel

Article 35 Referral of objections to the coordination group

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Article 36 Referral of unresolved objections to the Commission

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Article 37 Derogations from mutual recognition

Article 38 Opinion of the Agency

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Article 39 Application for mutual recognition by official or scientific bodies

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Article 40 Supplementary rules and technical guidance notes

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CHAPTER VIII UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS

SECTION 1 Granting of Union authorisations

Article 41 Union authorisation

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Article 42 Biocidal products for which Union authorisation may be granted

Article 43 Submission and validation of applications

Division

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

Division

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

Division

Article 50 Amendment of an authorisation at the request of the authorisation holder

Article 51 Detailed rules

Article 52 Period of grace

Division

CHAPTER X PARALLEL TRADE

Article 53 Parallel trade

CHAPTER XI TECHNICAL EQUIVALENCE

Article 54 Assessment of technical equivalence

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CHAPTER XII DEROGATIONS

Article 55 Derogation from the requirements

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Article 56 Research and development

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Article 57 Exemption from registration under Regulation (EC) No 1907/2006

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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

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Article 61 Letter of access

Article 62 Data sharing

Article 63 Compensation for data sharing

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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

Division

SECTION 2 Information about biocidal products

Article 69 Classification, packaging and labelling of biocidal products

Article 70 Safety data sheets

Division

Article 71 Register for Biocidal Products

Article 72 Advertising

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Article 73 Poison control

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CHAPTER XVI THE AGENCY

Article 74 Role of the Agency

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Article 75 Biocidal Products Committee

Article 76 Secretariat of the Agency

Article 78 The budget of the Agency

Article 79 Formats and software for submission of information to the Agency

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CHAPTER XVII FINAL PROVISIONS

Article 80 Fees and charges

Article 81 Competent authorities

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Article 82 Committee procedure

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Article 83 Exercise of the delegation

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Article 84 Urgency procedure

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Article 85 Adaptation to scientific and technical progress

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Article 86 Active substances included in Annex I to Directive 98/8/EC

Division

Article 87 Penalties

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Article 88 Safeguard clause

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Article 89 Transitional measures

Article 90 Transitional measures concerning active substances evaluated under Directive 98/8/EC

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Article 91 Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC

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Article 92 Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC

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Article 93 Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC

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Article 94 Transitional measures concerning treated articles

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Article 95 Transitional measures concerning access to the active substance dossier

Article 97 Entry into force

INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES

Division

TITLE 1 CHEMICAL SUBSTANCES

Core data set and additional data set for active substances

Division

Table

Division

TITLE 2 MICRO-ORGANISMS

Core data set and additional data set for active substances

INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS

Division

TITLE 1 CHEMICAL PRODUCTS

Core data set and additional data set for chemical products

Division

Table

Division

TITLE 2 MICRO-ORGANISMS

Core data set and additional data set

GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS

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1. TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY

1.1. Use of existing data

1.1.3. Historical human data

1.2. Weight of evidence

Division

1.3. Qualitative or Quantitative structure-activity relationship ((Q)SAR)

Division

1.4. In vitro methods

1.5. Grouping of substances and read-across approach

2. TESTING IS TECHNICALLY NOT POSSIBLE

Division

3. PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING

BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)

MAIN GROUP 1: Disinfectants

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Product-type 1: Human hygiene

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Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals

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Product-type 3: Veterinary hygiene

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Product-type 4: Food and feed area

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Product-type 5: Drinking water

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MAIN GROUP 2: Preservatives

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Product-type 6: Preservatives for products during storage

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Product-type 7: Film preservatives

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Product-type 8: Wood preservatives

Division

Product-type 9: Fibre, leather, rubber and polymerised materials preservatives

Division

Product-type 10: Construction material preservatives

Division

Product-type 11: Preservatives for liquid-cooling and processing systems

Division

Product-type 12: Slimicides

Division

Product-type 13: Working or cutting fluid preservatives

Division

MAIN GROUP 3: Pest control

Product-type 14: Rodenticides

Division

Product-type 15: Avicides

Division

Product-type 16: Molluscicides, vermicides and products to control other invertebrates

Division

Product-type 17: Piscicides

Division

Product-type 18: Insecticides, acaricides and products to control other arthropods

Division

Product-type 19: Repellents and attractants

Division

Product-type 20: Control of other vertebrates

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MAIN GROUP 4: Other biocidal products

Product-type 21: Antifouling products

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Product-type 22: Embalming and taxidermist fluids

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ANNEX VI

COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS

Division

TERMS AND DEFINITIONS

Division

Technical definitions

(a) Hazard identification

Division

(b) Dose (concentration) — response (effect) assessment

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(d) Risk characterisation

Effects on human and animal health

Effects on human health

Effects on animal health

36.

Division

Effects on the environment

Effects on target organisms

Effects on human and animal health

Effects on human health

Effects on animal health

64.

Division

Effects on the environment

Effects on target organisms

OVERALL INTEGRATION OF CONCLUSIONS