Regulation (EU) No 528/2012

Preamble

amended Preamble

Recitals

amended Recital 1
amended Recital 2
amended Recital 3
amended Recital 4
amended Recital 5
amended Recital 6
amended Recital 7
amended Recital 8
amended Recital 9
amended Recital 10
amended Recital 11
amended Recital 12
amended Recital 13
amended Recital 14
amended Recital 15
amended Recital 16
amended Recital 17
amended Recital 18
amended Recital 19
amended Recital 20
amended Recital 21
amended Recital 22
amended Recital 23
amended Recital 24
amended Recital 25
amended Recital 26
amended Recital 27
amended Recital 28
amended Recital 29
amended Recital 30
amended Recital 31
amended Recital 32
amended Recital 33
amended Recital 34
amended Recital 35
amended Recital 36
amended Recital 37
amended Recital 38
amended Recital 39
amended Recital 40
amended Recital 41
amended Recital 42
amended Recital 43
amended Recital 44
amended Recital 45
amended Recital 46
amended Recital 47
amended Recital 48
amended Recital 49
amended Recital 50
amended Recital 51
amended Recital 52
amended Recital 53
amended Recital 54
amended Recital 55
amended Recital 56
amended Recital 57
amended Recital 58
amended Recital 59
amended Recital 60
amended Recital 61
amended Recital 62
amended Recital 63
amended Recital 64
amended Recital 65
amended Recital 66
amended Recital 67
amended Recital 68
amended Recital 69
amended Recital 70
amended Recital 71
amended Recital 72
amended Recital 73
amended Recital 74
amended Recital 75
amended Recital 76

Chapter I - SCOPE AND DEFINITIONS

amended Article 1 - Purpose and subject matter Chapter I
amended Article 2 - Scope Chapter I
amended Article 3 - Definitions Chapter I

Chapter II - APPROVAL OF ACTIVE SUBSTANCES

amended Article 4 - Conditions for approval Chapter II
amended Article 5 - Exclusion criteria Chapter II
amended Article 6 - Data requirements for an application Chapter II
amended Article 7 - Submission and validation of applications Chapter II
amended Article 8 - Evaluation of applications Chapter II
amended Article 9 - Approval of an active substance Chapter II
amended Article 10 - Active substances which are candidates for substitution Chapter II

Chapter II · 1 unchanged

Article 11

Chapter III - RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE

amended Article 12 - Conditions for renewal Chapter III
amended Article 13 - Submission and acceptance of applications Chapter III
amended Article 14 - Evaluation of applications for renewal Chapter III
amended Article 15 - Review of approval of an active substance Chapter III

Chapter III · 1 unchanged

Article 16

Chapter IV - GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

amended Article 17 - Making available on the market and use of biocidal products Chapter IV
amended Article 18 - Measures geared to the sustainable use of biocidal products Chapter IV
amended Article 19 - Conditions for granting an authorisation Chapter IV
amended Article 20 - Requirements for applications for authorisation Chapter IV
amended Article 21 - Waiving of data requirements Chapter IV
amended Article 22 - Content of authorisation Chapter IV
amended Article 23 - Comparative assessment of biocidal products Chapter IV

Chapter IV · 1 unchanged

Article 24

Chapter VII · 1 unchanged

Article 40

Chapter VIII - UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS

amended Article 42 - Biocidal products for which Union authorisation may be granted Chapter VIII › Section 1
amended Article 43 - Submission and validation of applications Chapter VIII › Section 1
amended Article 44 - Evaluation of applications Chapter VIII › Section 1
amended Article 45 - Submission and acceptance of applications Chapter VIII › Section 2
amended Article 46 - Evaluation of applications for renewal Chapter VIII › Section 2

Chapter VIII · 1 unchanged

Article 41

Chapter IX - CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS

amended Article 47 - Obligation for notification of unexpected or adverse effects Chapter IX
amended Article 48 - Cancellation or amendment of an authorisation Chapter IX
amended Article 50 - Amendment of an authorisation at the request of the authorisation holder Chapter IX
amended Article 51 - Detailed rules Chapter IX

Chapter IX · 2 unchanged

Article 49 · Article 52

Chapter X - PARALLEL TRADE

amended Article 53 - Parallel trade Chapter X

Chapter XI - TECHNICAL EQUIVALENCE

amended Article 54 - Assessment of technical equivalence Chapter XI

Chapter XII - DEROGATIONS

amended Article 55 - Derogation from the requirements Chapter XII
amended Article 56 - Research and development Chapter XII

Chapter XII · 1 unchanged

Article 57

Chapter XIII - TREATED ARTICLES

amended Article 58 - Placing on the market of treated articles Chapter XIII

Chapter XIV - DATA PROTECTION AND DATA-SHARING

amended Article 59 - Protection of data held by competent authorities or the Agency Chapter XIV
amended Article 60 - Data protection periods Chapter XIV
amended Article 61 - Letter of access Chapter XIV
amended Article 62 - Data sharing Chapter XIV
amended Article 63 - Compensation for data sharing Chapter XIV
amended Article 64 - Use of data for subsequent applications Chapter XIV

Chapter XV - INFORMATION AND COMMUNICATION

amended Article 65 - Compliance with requirements Chapter XV › Section 1
amended Article 66 - Confidentiality Chapter XV › Section 1
amended Article 67 - Electronic public access Chapter XV › Section 1
amended Article 68 - Record-keeping and reporting Chapter XV › Section 1
amended Article 69 - Classification, packaging and labelling of biocidal products Chapter XV › Section 2
amended Article 71 - Register for Biocidal Products Chapter XV › Section 2
amended Article 72 - Advertising Chapter XV › Section 2

Chapter XV · 2 unchanged

Article 70 · Article 73

Chapter XVI - THE AGENCY

amended Article 74 - Role of the Agency Chapter XVI
amended Article 75 - Biocidal Products Committee Chapter XVI
amended Article 76 - Secretariat of the Agency Chapter XVI
amended Article 77 - Appeal Chapter XVI
amended Article 78 - The budget of the Agency Chapter XVI

Chapter XVI · 1 unchanged

Article 79

Chapter XVII - FINAL PROVISIONS

amended Article 80 - Fees and charges Chapter XVII
amended Article 81 - Competent authorities Chapter XVII
amended Article 82 - Committee procedure Chapter XVII
amended Article 83 - Exercise of the delegation Chapter XVII
amended Article 84 - Urgency procedure Chapter XVII
amended Article 89 - Transitional measures Chapter XVII
amended Article 90 - Transitional measures concerning active substances evaluated under Directive 98/8/EC Chapter XVII
amended Article 91 - Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC Chapter XVII
amended Article 92 - Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC Chapter XVII
amended Article 93 - Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC Chapter XVII
amended Article 94 - Transitional measures concerning treated articles Chapter XVII
amended Article 95 - Transitional measures concerning access to the active substance dossier Chapter XVII
amended Article 97 - Entry into force Chapter XVII

Chapter XVII · 5 unchanged

Article 85 · Article 86 · Article 87 · Article 88 · Article 96

Annexes

amended Annex I
amendedrenamed Annex II - INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES was “Annex II”
amendedrenamed Annex III - INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS was “Annex III”
amendedrenamed Annex IV - GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS was “Annex IV”
amendedrenamed Annex V - BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1) was “Annex V”
amendedrenamed Annex VI - COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS was “Annex VI”
amended Annex VII