What changes on 23/09/2013

The text in force from 17/07/2012 compared with the text from 23/09/2013.

Read the act as of 23/09/2013 · other versions: 20/11/2019 · 29/03/2021 · 10/06/2021 · 15/04/2022 · 26/05/2024 · 11/06/2024 · 15/06/2026 · 19/08/2026

Chapter I

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

Chapter II

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

Chapter III

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

Chapter IV

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

Chapter V

• amended Article 25 - Eligibility for the simplified authorisation procedure
• amended Article 26 - Applicable procedure
• amended Article 27 - Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
• amended Article 28 - Amendment of Annex I

Chapter VI

• amended Article 29 - Submission and validation of applications
• amended Article 30 - Evaluation of applications
• amended Article 31 - Renewal of a national authorisation

Chapter VII

• amended Article 32 - Authorisation through mutual recognition
• amended Article 33 - Mutual recognition in sequence
• amended Article 34 - Mutual recognition in parallel
• amended Article 35 - Referral of objections to the coordination group
• amended Article 36 - Referral of unresolved objections to the Commission
• amended Article 37 - Derogations from mutual recognition
• amended Article 38 - Opinion of the Agency
• amended Article 39 - Application for mutual recognition by official or scientific bodies

Chapter VIII › Section 1

• amended Article 42 - Biocidal products for which Union authorisation may be granted
• amended Article 43 - Submission and validation of applications
• amended Article 44 - Evaluation of applications

Chapter VIII › Section 2

• amended Article 45 - Submission and acceptance of applications
• amended Article 46 - Evaluation of applications for renewal

Chapter IX

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

Chapter X

• amended Article 53 - Parallel trade

Chapter XI

• amended Article 54 - Assessment of technical equivalence

Chapter XII

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

Chapter XIII

• amended Article 58 - Placing on the market of treated articles

Chapter XIV

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

Chapter XV › Section 1

• amended Article 65 - Compliance with requirements
• amended Article 66 - Confidentiality
• amended Article 67 - Electronic public access
• amended Article 68 - Record-keeping and reporting

Chapter XV › Section 2

• amended Article 69 - Classification, packaging and labelling of biocidal products
• amended Article 71 - Register for Biocidal Products
• amended Article 72 - Advertising

Chapter XVI

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

Chapter XVII

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

Outside any heading

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