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New version applies from 20/11/2019. 2 provisions change. Later versions: 29/03/2021, 10/06/2021, 15/04/2022, 26/05/2024, 11/06/2024, 15/06/2026, 19/08/2026.

View as of 20/11/2019 What changes

Regulation (EU) No 528/2012

23/09/2013 → 25/04/2014: 0 inserted · 0 removed · 113 amended · 0 moved · 0 renamed · 68 unchanged

Position-only shifts inside the same heading are not changes. Amended = the printed text changed.

Preamble

amended Preamble

Recitals

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Chapter I - SCOPE AND DEFINITIONS

amended Article 2 - Scope Chapter I
amended Article 3 - Definitions Chapter I

Chapter I · 1 unchanged

Article 1

Chapter II - APPROVAL OF ACTIVE SUBSTANCES

Chapter II · 8 unchanged

Article 4 · Article 5 · Article 6 · Article 7 · Article 8 · Article 9 · Article 10 · Article 11

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

Chapter III · 5 unchanged

Article 12 · Article 13 · Article 14 · Article 15 · Article 16

Chapter IV - GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

amended Article 19 - Conditions for granting an authorisation Chapter IV
amended Article 20 - Requirements for applications for authorisation Chapter IV
amended Article 23 - Comparative assessment of biocidal products Chapter IV

Chapter IV · 5 unchanged

Article 17 · Article 18 · Article 21 · Article 22 · Article 24

Chapter V - SIMPLIFIED AUTHORISATION PROCEDURE

amended Article 28 - Amendment of Annex I Chapter V

Chapter V · 3 unchanged

Article 25 · Article 26 · Article 27

Chapter VI - NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS

Chapter VI · 3 unchanged

Article 29 · Article 30 · Article 31

Chapter VII - MUTUAL RECOGNITION PROCEDURES

amended Article 34 - Mutual recognition in parallel Chapter VII
amended Article 35 - Referral of objections to the coordination group Chapter VII
amended Article 37 - Derogations from mutual recognition Chapter VII

Chapter VII · 6 unchanged

Article 32 · Article 33 · Article 36 · Article 38 · Article 39 · Article 40

Chapter VIII - UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS

amended Article 45 - Submission and acceptance of applications Chapter VIII › Section 2

Chapter VIII · 5 unchanged

Article 41 · Article 42 · Article 43 · Article 44 · Article 46

Chapter IX - CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS

amended Article 52 - Period of grace Chapter IX

Chapter IX · 5 unchanged

Article 47 · Article 48 · Article 49 · Article 50 · Article 51

Chapter XII · 2 unchanged

Article 55 · 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 63 - Compensation for data sharing Chapter XIV

Chapter XIV · 3 unchanged

Article 61 · Article 62 · Article 64

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

Chapter XV · 6 unchanged

Article 68 · Article 69 · Article 70 · Article 71 · Article 72 · Article 73

Chapter XVI - THE AGENCY

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 · 3 unchanged

Article 74 · Article 75 · Article 79

Chapter XVII - FINAL PROVISIONS

amended Article 86 - Active substances included in Annex I to Directive 98/8/EC Chapter XVII
amended Article 89 - Transitional measures 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 96 - Repeal Chapter XVII

Chapter XVII · 11 unchanged

Article 80 · Article 81 · Article 82 · Article 83 · Article 84 · Article 85 · Article 87 · Article 88 · Article 90 · Article 91 · Article 97

Annexes

Annexes · 2 unchanged

Annex IV · Annex VII