What changes on 17/07/2012
The text in force from 09/06/2012 compared with the text from 17/07/2012.
181 inserted
0 amended
0 deleted
0 moved
Read the act as of 17/07/2012 · 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
- inserted Article 1 - Purpose and subject matter
- inserted Article 2 - Scope
- inserted Article 3 - Definitions
Chapter II
- inserted Article 4 - Conditions for approval
- inserted Article 5 - Exclusion criteria
- inserted Article 6 - Data requirements for an application
- inserted Article 7 - Submission and validation of applications
- inserted Article 8 - Evaluation of applications
- inserted Article 9 - Approval of an active substance
- inserted Article 10 - Active substances which are candidates for substitution
- inserted Article 11 - Technical guidance notes
Chapter III
- inserted Article 12 - Conditions for renewal
- inserted Article 13 - Submission and acceptance of applications
- inserted Article 14 - Evaluation of applications for renewal
- inserted Article 15 - Review of approval of an active substance
- inserted Article 16 - Implementing measures
Chapter IV
- inserted Article 17 - Making available on the market and use of biocidal products
- inserted Article 18 - Measures geared to the sustainable use of biocidal products
- inserted Article 19 - Conditions for granting an authorisation
- inserted Article 20 - Requirements for applications for authorisation
- inserted Article 21 - Waiving of data requirements
- inserted Article 22 - Content of authorisation
- inserted Article 23 - Comparative assessment of biocidal products
- inserted Article 24 - Technical guidance notes
Chapter V
- inserted Article 25 - Eligibility for the simplified authorisation procedure
- inserted Article 26 - Applicable procedure
- inserted Article 27 - Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
- inserted Article 28 - Amendment of Annex I
Chapter VI
- inserted Article 29 - Submission and validation of applications
- inserted Article 30 - Evaluation of applications
- inserted Article 31 - Renewal of a national authorisation
Chapter VII
- inserted Article 32 - Authorisation through mutual recognition
- inserted Article 33 - Mutual recognition in sequence
- inserted Article 34 - Mutual recognition in parallel
- inserted Article 35 - Referral of objections to the coordination group
- inserted Article 36 - Referral of unresolved objections to the Commission
- inserted Article 37 - Derogations from mutual recognition
- inserted Article 38 - Opinion of the Agency
- inserted Article 39 - Application for mutual recognition by official or scientific bodies
- inserted Article 40 - Supplementary rules and technical guidance notes
Chapter VIII › Section 1
- inserted Article 41 - Union authorisation
- inserted Article 42 - Biocidal products for which Union authorisation may be granted
- inserted Article 43 - Submission and validation of applications
- inserted Article 44 - Evaluation of applications
Chapter VIII › Section 2
- inserted Article 45 - Submission and acceptance of applications
- inserted Article 46 - Evaluation of applications for renewal
Chapter IX
- inserted Article 47 - Obligation for notification of unexpected or adverse effects
- inserted Article 48 - Cancellation or amendment of an authorisation
- inserted Article 49 - Cancellation of an authorisation at the request of the authorisation holder
- inserted Article 50 - Amendment of an authorisation at the request of the authorisation holder
- inserted Article 51 - Detailed rules
- inserted Article 52 - Period of grace
Chapter X
- inserted Article 53 - Parallel trade
Chapter XI
Chapter XII
- inserted Article 55 - Derogation from the requirements
- inserted Article 56 - Research and development
- inserted Article 57 - Exemption from registration under Regulation (EC) No 1907/2006
Chapter XIII
Chapter XIV
- inserted Article 59 - Protection of data held by competent authorities or the Agency
- inserted Article 60 - Data protection periods
- inserted Article 61 - Letter of access
- inserted Article 62 - Data sharing
- inserted Article 63 - Compensation for data sharing
- inserted Article 64 - Use of data for subsequent applications
Chapter XV › Section 1
- inserted Article 65 - Compliance with requirements
- inserted Article 66 - Confidentiality
- inserted Article 67 - Electronic public access
- inserted Article 68 - Record-keeping and reporting
Chapter XV › Section 2
- inserted Article 69 - Classification, packaging and labelling of biocidal products
- inserted Article 70 - Safety data sheets
- inserted Article 71 - Register for Biocidal Products
- inserted Article 72 - Advertising
- inserted Article 73 - Poison control
Chapter XVI
- inserted Article 74 - Role of the Agency
- inserted Article 75 - Biocidal Products Committee
- inserted Article 76 - Secretariat of the Agency
- inserted Article 77 - Appeal
- inserted Article 78 - The budget of the Agency
- inserted Article 79 - Formats and software for submission of information to the Agency
Chapter XVII
- inserted Article 80 - Fees and charges
- inserted Article 81 - Competent authorities
- inserted Article 82 - Committee procedure
- inserted Article 83 - Exercise of the delegation
- inserted Article 84 - Urgency procedure
- inserted Article 85 - Adaptation to scientific and technical progress
- inserted Article 86 - Active substances included in Annex I to Directive 98/8/EC
- inserted Article 87 - Penalties
- inserted Article 88 - Safeguard clause
- inserted Article 89 - Transitional measures
- inserted Article 90 - Transitional measures concerning active substances evaluated under Directive 98/8/EC
- inserted Article 91 - Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
- inserted Article 92 - Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
- inserted Article 93 - Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
- inserted Article 94 - Transitional measures concerning treated articles
- inserted Article 95 - Transitional measures concerning access to the active substance dossier
- inserted Article 96 - Repeal
- inserted Article 97 - Entry into force
Outside any heading
- inserted Recital 1
- inserted Recital 2
- inserted Recital 3
- inserted Recital 4
- inserted Recital 5
- inserted Recital 6
- inserted Recital 7
- inserted Recital 8
- inserted Recital 9
- inserted Recital 10
- inserted Recital 11
- inserted Recital 12
- inserted Recital 13
- inserted Recital 14
- inserted Recital 15
- inserted Recital 16
- inserted Recital 17
- inserted Recital 18
- inserted Recital 19
- inserted Recital 20
- inserted Recital 21
- inserted Recital 22
- inserted Recital 23
- inserted Recital 24
- inserted Recital 25
- inserted Recital 26
- inserted Recital 27
- inserted Recital 28
- inserted Recital 29
- inserted Recital 30
- inserted Recital 31
- inserted Recital 32
- inserted Recital 33
- inserted Recital 34
- inserted Recital 35
- inserted Recital 36
- inserted Recital 37
- inserted Recital 38
- inserted Recital 39
- inserted Recital 40
- inserted Recital 41
- inserted Recital 42
- inserted Recital 43
- inserted Recital 44
- inserted Recital 45
- inserted Recital 46
- inserted Recital 47
- inserted Recital 48
- inserted Recital 49
- inserted Recital 50
- inserted Recital 51
- inserted Recital 52
- inserted Recital 53
- inserted Recital 54
- inserted Recital 55
- inserted Recital 56
- inserted Recital 57
- inserted Recital 58
- inserted Recital 59
- inserted Recital 60
- inserted Recital 61
- inserted Recital 62
- inserted Recital 63
- inserted Recital 64
- inserted Recital 65
- inserted Recital 66
- inserted Recital 67
- inserted Recital 68
- inserted Recital 69
- inserted Recital 70
- inserted Recital 71
- inserted Recital 72
- inserted Recital 73
- inserted Recital 74
- inserted Recital 75
- inserted Recital 76
- inserted Preamble
- inserted Annex I
- inserted Annex II
- inserted Annex III
- inserted Annex IV
- inserted Annex V
- inserted Annex VI
- inserted Annex VII