Chemicals legislation is quite a vivid regulatory arena. As is the case in the
science of Chemistry itself there is also no standstill in chemicals legislation.
Most of the relevant regulations are subject to chronic revisions.
In order to keep up with the actual legislation beyond the efforts of a looseleaf-
collection
the series
CSL: Consolidated Substances Legislation
has been created.
It offers a firm outline regarding the different fields of substances legislation
(besides the general substances legislation like REACH also cosmetics
legislation, etc.) and provides users with the relevant legislative texts in an
actual and consolidated manner. I.e. starting from the original regulation
all modifications can be found at their respective position within the legal
text. Therefore, the need for a detailed compilation of each and any
corrigendum, amendment and adaptation to the technical progress can be
reduced to a minimum.
The area of substances legislation is both a fascinating and demanding legal
field that can hardly be compared to any other, as its regulations create
direct effects on everyone.
The series CSL offers a new access to its origins.
Table of contents of the consolidated version
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
Objectives and Topics of the Regulation
The primary objective of Regulation (EC) No 1107/2009 is to ensure a high level of protection for both human and animal health and the environment while facilitating the free movement of plant protection products within the European Union. By harmonizing the approval processes for active substances and the authorization of products, the regulation seeks to remove trade obstacles and ensure consistent safety standards across all Member States, while promoting the use of sustainable alternatives like integrated pest management.
- Harmonized approval criteria for active substances, safeners, and synergists.
- Establishment of uniform principles for the authorization of plant protection products.
- Implementation of mutual recognition to reduce administrative burdens and increase product availability.
- Promotion of human, animal, and environmental safety through strict data requirements and data sharing obligations.
- Specific rules for the comparative assessment of candidates for substitution and the management of minor uses.
Excerpt from the Regulation
Article 1 Subject matter and purpose
1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community.
2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and co-formulants.
3. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production.
4. The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. In particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory.
Summary of Chapters
CHAPTER I GENERAL PROVISIONS: This chapter defines the scope, purpose, and foundational definitions of the regulation, emphasizing the precautionary principle and the overarching goal of high safety standards.
CHAPTER II ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS: This chapter outlines the rigorous criteria and procedures for approving active substances, safeners, and synergists, including renewal and review mechanisms and specific derogations.
CHAPTER III PLANT PROTECTION PRODUCTS: This chapter establishes the framework for authorizing plant protection products, including mutual recognition, renewal of authorizations, and handling of special cases like minor uses and parallel trade.
CHAPTER IV ADJUVANTS: This chapter focuses on the specific requirements for the placing on the market and use of adjuvants, ensuring they meet safety criteria.
CHAPTER V DATA PROTECTION AND DATA SHARING: This chapter governs the protection of test and study reports to stimulate research while mandating data sharing to avoid unnecessary testing on vertebrate animals.
CHAPTER VI PUBLIC ACCESS TO INFORMATION: This chapter addresses transparency and the conditions under which information can be treated as confidential regarding commercial interests or privacy.
CHAPTER VII PACKAGING, LABELLING AND ADVERTISING OF PLANT PROTECTION PRODUCTS AND ADJUVANTS: This chapter sets standards for clear communication to users and the public to ensure safe handling and minimize misleading claims.
CHAPTER VIII CONTROLS: This chapter mandates record-keeping by producers and users, and establishes monitoring and control mechanisms to verify compliance.
CHAPTER IX EMERGENCIES: This chapter defines emergency procedures for managing situations where a substance or product poses a serious, unforeseen risk to health or the environment.
CHAPTER X ADMINISTRATIVE AND FINANCIAL PROVISIONS: This chapter outlines enforcement via penalties, civil liability, cost recovery through fees, and the organization of competent authorities.
CHAPTER XI TRANSITIONAL AND FINAL PROVISIONS: This chapter details how existing authorizations under previous directives are handled and defines the timeline for the full application of this regulation.
Keywords
Plant protection products, Active substances, Regulation 1107/2009, Authorization, European Union, Food safety, Environmental protection, Integrated pest management, Data protection, Mutual recognition, Safeners, Synergists, Co-formulants, Minor uses, Precautionary principle
Frequently Asked Questions
What is the primary objective of Regulation (EC) No 1107/2009?
The regulation aims to ensure a high level of protection for human and animal health and the environment, while improving the internal market's functionality by harmonizing rules for the authorization of plant protection products.
Which substances fall under the regulatory scope of this text?
The regulation applies to active substances, safeners, synergists, co-formulants, and adjuvants used in plant protection products, including micro-organisms.
What is the role of the Member States in the authorization process?
Member States are responsible for evaluating applications within their designated zones, granting or refusing authorizations, performing official controls, and ensuring compliance within their territory.
How are animal welfare concerns addressed in the regulation?
The regulation requires that tests on vertebrate animals are performed as a last resort, mandating data sharing to prevent the duplication of tests on animals.
What is a "candidate for substitution" in the context of this regulation?
A candidate for substitution is an active substance with specific problematic properties that must undergo a comparative assessment to determine if safer alternatives, either chemical or non-chemical, are available.
How is data protection managed for companies submitting studies?
The regulation provides temporary protection for study reports to incentivize research, allowing the owner to prevent other applicants from using their data for a defined period, subject to specific conditions.
What measures are available in cases of extreme urgency?
In cases of extreme urgency, the European Commission can provisionally adopt emergency measures to restrict or prohibit the use of a substance or product that poses a serious risk, subject to subsequent confirmation or amendment.
How does the regulation handle minor uses of plant protection products?
The regulation includes specific provisions to facilitate the extension of existing authorizations to "minor uses" to ensure that agricultural diversification is not hindered by the lack of available products.
- Arbeit zitieren
- Stefanie Merenyi (Autor:in), 2014, Plant Protection Products: REGULATION (EC) No 1107/2009, München, GRIN Verlag, https://www.grin.com/document/275060
