Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 ... (32009R1107)
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
- REGULATION
- (EC) No 1107/2009
- OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- of 21 October 2009
- concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
- CHAPTER I
- GENERAL PROVISIONS
- Article 1
- Subject matter and purpose
- Article 2
- Scope
- Article 3
- Definitions
- CHAPTER II
- ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS
- SECTION 1
- Active substances
- Subsection 1
- Requirements and conditions for approval
- Article 4
- Approval criteria for active substances
- Article 5
- First approval
- Article 6
- Conditions and restrictions
- Subsection 2
- Approval procedure
- Article 7
- Application
- Article 8
- Dossiers
- Article 9
- Admissibility of the application
- Article 10
- Access to the summary dossier
- Article 11
- Draft assessment report
- Article 12
- Conclusion by the Authority
- Article 13
- Approval Regulation
- Subsection 3
- Renewal and review
- Article 14
- Renewal of approval
- Article 15
- Application for renewal
- Article 16
- Access to the information for renewal
- Article 17
- Extension of approval period for the duration of the procedure
- Article 18
- Work programme
- Article 19
- Implementing measures
- Article 20
- Renewal Regulation
- Article 21
- Review of approval
- Subsection 4
- Derogations
- Article 22
- Low-risk active substances
- Article 23
- Approval criteria for basic substances
- Article 24
- Candidates for substitution
- SECTION 2
- Safeners and synergists
- Article 25
- Approval of safeners and synergists
- Article 26
- Safeners and synergists already on the market
- SECTION 3
- Unacceptable co-formulants
- Article 27
- Co-formulants
- CHAPTER III
- PLANT PROTECTION PRODUCTS
- SECTION 1
- Authorisation
- Subsection 1
- Requirements and contents
- Article 28
- Authorisation for placing on the market and use
- Article 29
- Requirements for the authorisation for placing on the market
- Article 30
- Provisional authorisations
- Article 31
- Contents of authorisations
- Article 32
- Duration
- Subsection 2
- Procedure
- Article 33
- Application for authorisation or amendment of an authorisation
- Article 34
- Exemption from the submission of studies
- Article 35
- Member State examining the application
- Article 36
- Examination for authorisation
- Article 37
- Period for examination
- Article 38
- Assessment of equivalence under point (b) of Article 29(1)
- Article 39
- Reporting and exchange of information on applications for authorisation
- Subsection 3
- Mutual recognition of authorisations
- Article 40
- Mutual recognition
- Article 41
- Authorisation
- Article 42
- Procedure
- Subsection 4
- Renewal, withdrawal and amendment
- Article 43
- Renewal of authorisation
- Article 44
- Withdrawal or amendment of an authorisation
- Article 45
- Withdrawal or amendment of an authorisation at the request of the authorisation holder
- Article 46
- Grace period
- Subsection 5
- Special cases
- Article 47
- Placing on the market of low-risk plant protection products
- Article 48
- Placing on the market and use of plant protection products containing a genetically modified organism
- Article 49
- Placing on the market of treated seeds
- Article 50
- Comparative assessment of plant protection products containing candidates for substitution
- Article 51
- Extension of authorisations for minor uses
- Article 52
- Parallel trade
- Subsection 6
- Derogations
- Article 53
- Emergency situations in plant protection
- Article 54
- Research and development
- SECTION 2
- Use and information
- Article 55
- Use of plant protection products
- Article 56
- Information on potentially harmful or unacceptable effects
- Article 57
- Obligation to keep information available
- CHAPTER IV
- ADJUVANTS
- Article 58
- Placing on the market and use of adjuvants
- CHAPTER V
- DATA PROTECTION AND DATA SHARING
- Article 59
- Data protection
- Article 60
- List of test and study reports
- Article 61
- General rules on avoidance of duplicative testing
- Article 62
- Sharing of tests and studies involving vertebrate animals
- CHAPTER VI
- PUBLIC ACCESS TO INFORMATION
- Article 63
- Confidentiality
- CHAPTER VII
- PACKAGING, LABELLING AND ADVERTISING OF PLANT PROTECTION PRODUCTS AND ADJUVANTS
- Article 64
- Packaging and presentation
- Article 65
- Labelling
- Article 66
- Advertising
- CHAPTER VIII
- CONTROLS
- Article 67
- Record-keeping
- Article 68
- Monitoring and controls
- CHAPTER IX
- EMERGENCIES
- Article 69
- Emergency measures
- Article 70
- Emergency measures in cases of extreme urgency
- Article 71
- Other emergency measures
- CHAPTER X
- ADMINISTRATIVE AND FINANCIAL PROVISIONS
- Article 72
- Penalties
- Article 73
- Civil and criminal liability
- Article 74
- Fees and charges
- Article 75
- Competent authority
- Article 76
- Expenditure by the Commission
- Article 77
- Guidance documents
- Article 78
- Amendments and implementing measures
- Article 79
- Committee procedure
- CHAPTER XI
- TRANSITIONAL AND FINAL PROVISIONS
- Article 80
- Transitional measures
- Article 81
- Derogation for safeners and synergists, co-formulants and adjuvants
- Article 82
- Review clause
- Article 83
- Repeal
- Article 84
- Entry into force and application
- ANNEX I
- Definition of zones for the authorisation of plant protection products as referred to in Article 3(17)
- Zone A — North
- Zone B — Centre
- Zone C — South
- ANNEX II
- Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II
- 1. Evaluation
- 2. General decision-making criteria
- 2.2. Submission of further information
- 2.3. Restrictions on approval
- 3. Criteria for the approval of an active substance
- 3.1. Dossier
- 3.2. Efficacy
- 3.3. Relevance of metabolites
- 3.4. Composition of the active substance, safener or synergist
- 3.5. Methods of analysis
- 3.6. Impact on human health
- 3.7. Fate and behaviour in the environment
- 3.7.1.1. Persistence
- 3.7.1.2. Bioaccumulation
- 3.7.1.3. Potential for long-range environmental transport:
- 3.7.2.1. Persistence
- 3.7.2.2. Bioaccumulation
- 3.7.2.3. Toxicity
- 3.7.3.1. Persistence
- 3.7.3.2. Bioaccumulation
- 3.8. Ecotoxicology
- 3.9. Residue definition
- 3.10. Fate and behaviour concerning groundwater
- 4. Candidate for substitution
- 5. Low-risk active substances
- ANNEX III
- List of co-formulants which are not accepted for inclusion in plant protection products as referred to in Article 27
- ANNEX IV
- Comparative assessment pursuant to Article 50
- 1. Conditions for comparative assessment
- 2. Significant difference in risk
- 3. Significant practical or economic disadvantages
- ANNEX V
- Repealed Directives and their successive amendments as referred to in Article 83
- A. Directive 91/414/EEC
- B. Directive 79/117/EEC
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