Authors
- CONSOLIDATION
- 2012R0528/20240526_0070010
- Pages
- 178
- Published in
- Belgium
Table of Contents
- Consolidated text: Regulation(EU) No528/2012 of the European Parliament and of the Councilof 22 May 2012 0
- Amended by: 0
- Corrected by: 0
- Regulation(EU) No528/2012 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) 0
- CHAPTER I SCOPE AND DEFINITIONS 0
- Article 1 Purpose and subject matter 0
- Article 2 Scope 0
- Article 3 Definitions 0
- CHAPTER II APPROVAL OF ACTIVE SUBSTANCES 0
- Article 4 Conditions for approval 0
- Article 5 Exclusion criteria 0
- Article 6 Data requirements for an application 0
- Article 7 Submission and validation of applications 0
- Article 8 Evaluation of applications 0
- Article 9 Approval of an active substance 0
- Article 10 Active substances which are candidates for substitution 0
- Article 11 Technical guidance notes 0
- CHAPTER III RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE 0
- Article 12 Conditions for renewal 0
- Article 13 Submission and acceptance of applications 0
- Article 14 Evaluation of applications for renewal 0
- Article 15 Review of approval of an active substance 0
- Article 16 Implementing measures 0
- CHAPTER IV GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS 0
- Article 17 Making available on the market and use of biocidal products 0
- Article 18 Measures geared to the sustainable use of biocidal products 0
- Article 19 Conditions for granting an authorisation 0
- Article 20 Requirements for applications for authorisation 0
- Article 21 Waiving of data requirements 0
- Article 22 Content of authorisation 0
- Article 23 Comparative assessment of biocidal products 0
- Article 24 Technical guidance notes 0
- CHAPTER V SIMPLIFIED AUTHORISATION PROCEDURE 0
- Article 25 Eligibility for the simplified authorisation procedure 0
- Article 26 Applicable procedure 0
- Article 27 Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure 0
- Article 28 Amendment of AnnexI 0
- CHAPTER VI NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS 0
- Article 29 Submission and validation of applications 0
- Article 30 Evaluation of applications 0
- Article 31 Renewal of a national authorisation 0
- CHAPTER VII MUTUAL RECOGNITION PROCEDURES 0
- Article 32 Authorisation through mutual recognition 0
- Article 33 Mutual recognition in sequence 0
- Article 34 Mutual recognition in parallel 0
- Article 35 Referral of objections to the coordination group 0
- Article 36 Referral of unresolved objections to the Commission 0
- Article 37 Derogations from mutual recognition 0
- Article 38 Opinion of the Agency 0
- Article 39 Application for mutual recognition by official or scientific bodies 0
- Article 40 Supplementary rules and technical guidance notes 0
- CHAPTER VIII UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS 0
- SECTION 1 Granting of Union authorisations 0
- Article 41 Union authorisation 0
- Article 42 Biocidal products for which Union authorisation may be granted 0
- Article 43 Submission and validation of applications 0
- Article 44 Evaluation of applications 0
- SECTION 2 Renewal of Union authorisations 0
- Article 45 Submission and acceptance of applications 0
- Article 46 Evaluation of applications for renewal 0
- CHAPTER IX CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS 0
- Article 47 Obligation for notification of unexpected or adverse effects 0
- Article 48 Cancellation or amendment of an authorisation 0
- Article 49 Cancellation of an authorisation at the request of the authorisation holder 0
- Article 50 Amendment of an authorisation at the request of the authorisation holder 0
- Article 51 Detailed rules 0
- Article 52 Period of grace 0
- CHAPTER X PARALLEL TRADE 0
- Article 53 Parallel trade 0
- CHAPTER XI TECHNICAL EQUIVALENCE 0
- Article 54 Assessment of technical equivalence 0
- CHAPTER XII DEROGATIONS 0
- Article 55 Derogation from the requirements 0
- Article 56 Research and development 0
- Article 57 Exemption from registration under Regulation(EC) No1907/2006 0
- CHAPTER XIII TREATED ARTICLES 0
- Article 58 Placing on the market of treated articles 0
- CHAPTER XIV DATA PROTECTION AND DATA-SHARING 0
- Article 59 Protection of data held by competent authorities or the Agency 0
- Article 60 Data protection periods 0
- Article 61 Letter of access 0
- Article 62 Data sharing 0
- Article 63 Compensation for data sharing 0
- Article 64 Use of data for subsequent applications 0
- CHAPTER XV INFORMATION AND COMMUNICATION 0
- SECTION 1 Monitoring and reporting 0
- Article 65 Compliance with requirements 0
- Article 66 Confidentiality 0
- Article 67 Electronic public access 0
- Article 68 Record-keeping and reporting 0
- SECTION 2 Information about biocidal products 0
- Article 69 Classification, packaging and labelling of biocidal products 0
- Article 70 Safety data sheets 0
- Article 71 Register for Biocidal Products 0
- Article 72 Advertising 0
- Article 73 Poison control 0
- CHAPTER XVI THE AGENCY 0
- Article 74 Role of the Agency 0
- Article 75 Biocidal Products Committee 0
- Article 76 Secretariat of the Agency 0
- Article 77 Appeal 0
- Article 78 The budget of the Agency 0
- Article 79 Formats and software for submission of information to the Agency 0
- CHAPTER XVII FINAL PROVISIONS 0
- Article 80 Fees and charges 0
- Article 81 Competent authorities 0
- Article 82 Committee procedure 0
- Article 83 Exercise of the delegation 0
- Article 84 Urgency procedure 0
- Article 85 Adaptation to scientific and technical progress 0
- Article 86 Active substances included in AnnexI to Directive 98/8/EC 0
- Article 87 Penalties 0
- Article 88 Safeguard clause 0
- Article 89 Transitional measures 0
- Article 90 Transitional measures concerning active substances evaluated under Directive 98/8/EC 0
- Article 91 Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC 0
- Article 92 Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC 0
- Article 93 Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC 0
- Article 94 Transitional measures concerning treated articles 0
- Article 95 Transitional measures concerning access to the active substance dossier 0
- Article 96 Repeal 0
- Article 97 Entry into force 0
- ANNEX I 0
- ANNEX II INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES 0
- ANNEX III INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS 0
- ANNEX IV GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS 0
- ANNEX V BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1) 0
- ANNEX VI COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS 0
- ANNEX VII 0