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)Text with EEA relevance

Table of Contents

• Consolidated text: Regulation’(EU) No’528/2012 of the European Parliament and of the Councilof 22 May 2012 0
• Amended by: 0
• Corrected by: 0
• 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) 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 Annex’I 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) No’1907/2006 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 Annex’I 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