Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21…

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 · European Union · 32009R1107

620 provisions in 1779 nodes · 49 provisions hand work to national law

Defined terms · All instruments · EU law · access to information · administrative cooperation · admissibility · advertising · animal life · approximation of laws · biodiversity

CHAPTER I GENERAL PROVISIONS

Article 1 Subject matter and purpose

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

Division

Article 6 Conditions and restrictions

Subsection 2 Approval procedure

Article 7 Application

Article 9 Admissibility of the application

Division

Article 10 Access to the summary dossier

Division

Article 11 Draft assessment report

Division

Article 12 Conclusion by the Authority

Division

Article 13 Approval Regulation

Subsection 3 Renewal and review

Article 14 Renewal of approval

Division

Article 15 Application for renewal

Division

Article 16 Access to the information for renewal

Division

Article 17 Extension of approval period for the duration of the procedure

Article 18 Work programme

Article 19 Implementing measures

Division

Article 20 Renewal Regulation

Article 21 Review of approval

Division

Subsection 4 Derogations

Article 22 Low-risk active substances

Division

Article 23 Approval criteria for basic substances

Article 24 Candidates for substitution

Division

SECTION 2 Safeners and synergists

Article 25 Approval of safeners and synergists

Division

Article 26 Safeners and synergists already on the market

Division

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

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

Division

Article 36 Examination for authorisation

Division

Article 37 Period for examination

Division

Article 38 Assessment of equivalence under point (b) of Article 29(1)

Division

Article 39 Reporting and exchange of information on applications for authorisation

Subsection 3 Mutual recognition of authorisations

Article 40 Mutual recognition

Article 41 Authorisation

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

Division

Article 46 Grace period

Division

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

Division

Article 49 Placing on the market of treated seeds

Division

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

Division

SECTION 2 Use and information

Article 55 Use of plant protection products

Division

Article 56 Information on potentially harmful or unacceptable effects

Division

Article 57 Obligation to keep information available

Article 58 Placing on the market and use of adjuvants

Division

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

Division

Article 62 Sharing of tests and studies involving vertebrate animals

Division

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

Division

Article 65 Labelling

Division

Article 66 Advertising

Division

CHAPTER VIII CONTROLS

Article 67 Record-keeping

Division

Article 68 Monitoring and controls

Division

CHAPTER IX EMERGENCIES

Article 69 Emergency measures

Division

Article 70 Emergency measures in cases of extreme urgency

Division

Article 71 Other emergency measures

Division

CHAPTER X ADMINISTRATIVE AND FINANCIAL PROVISIONS

Article 72 Penalties

Division

Article 73 Civil and criminal liability

Division

Article 74 Fees and charges

Article 75 Competent authority

Division

Article 76 Expenditure by the Commission

Article 77 Guidance documents

Division

Article 78 Amendments and implementing measures

Article 79 Committee procedure

Division

CHAPTER XI TRANSITIONAL AND FINAL PROVISIONS

Article 80 Transitional measures

Article 81 Derogation for safeners and synergists, co-formulants and adjuvants

Division

Article 82 Review clause

Division

Article 83 Repeal

Division

Article 84 Entry into force and application

Definition of zones for the authorisation of plant protection products as referred to in Article 3(17)

Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II

2. General decision-making criteria

Passage

Division

2.2. Submission of further information

2.3. Restrictions on approval

Division

3. Criteria for the approval of an active substance

3.3. Relevance of metabolites

Division

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

3.7.1.2. Bioaccumulation

Division

3.7.1.3. Potential for long-range environmental transport:

3.7.2.2. Bioaccumulation

3.7.3.2. Bioaccumulation

3.9. Residue definition

Division

3.10. Fate and behaviour concerning groundwater

Division

4. Candidate for substitution

Division

5. Low-risk active substances

Division

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

Division

3. Significant practical or economic disadvantages

Division

ANNEX V

Repealed Directives and their successive amendments as referred to in Article 83