Plant protection products (pesticides to protect plant/crops) are regulated in the EU by Regulation (EC) No 1107/2009, which repealed and replaced Council Directive 91/414/EEC on 14 June 2011.
The Regulation aims to harmonise, as far as possible, the overall arrangements for authorisation of plant protection products within the EU. Its main elements are as follows:
- Active substances, safeners and synergists are approved at EU level , following assessment against a set of agreed criteria.
- Those criteria cover both the intrinsic properties of active substances, safeners and synergists (i.e. an assessment of their hazard), and the risks arising from the use of plant protection products which contain them.
- Active substances that have been shown to be without unacceptable risk to people or the environment and added to the list of approved active substances are contained in Commission Implementing Regulation (EU) No 540/2011. Inclusion is for a maximum period of 15 years but is renewable, and can be subject to conditions and reviewed at any time.
- Substances which demonstrate a less favourable toxicological profile but which still satisfy the criteria for approval may be approved as candidates for substitution.
- Existing active substances which have already undergone a review under Council Directive 91/414/EEC are deemed to be approved under Regulation (EC) No 1107/2009.
- Products containing approved active substances are authorised by Member States working within three zones to share assessments and recognise each other’s authorisations.
- Member States can only authorise the marketing and use of plant protection products after an active substance has been added to the list of approved active substances. Transitional arrangements apply for new active substances for which an application for approval has been submitted and declared complete before 14 June 2011 under Council Directive 91/414/EEC. These may also be authorised whilst the substance is considered for approval.
- Products containing active substances approved as candidates for substitution are subject to comparative assessment. Such products are withdrawn if that assessment identifies alternative products or methods of control which are significantly safer and can be used without significant drawbacks.
- The Regulation also applies to safeners and synergists in plant protection products. New safeners and synergists will need to undergo the same procedures and satisfy the same requirements as for active substances. Existing safeners and synergists will undergo a review programme to be established by the adoption of a Regulation by 14 December 2014 (Article 26).
The Regulation and its Implementing Regulations also set out common rules and guidance on data requirements; data evaluation; risk assessment; the protection of commercial information (data protection); and public access to information on pesticides.
The List of approved active substances (Commission Implementing Regulation (EU) No 540/2011)
This is the ‘positive’ list of active substances that are approved for use in plant protection products within the EU. Before an active substance can be considered for inclusion in the List of Approved active substances, companies must submit a complete data package (dossier) on both the active substance and at least one formulated plant protection product containing that active substance. The data required cover a wide range of matters including:
- the identity of an active substance and plant protection product;
- the physical and chemical properties;
- the effects on target pests; and
- the risks to operators, workers, consumers, the environment and non-target plants and animals.
The submitted dossier is assessed by a rapporteur member State on behalf of the EU to determine the intrinsic hazard of the active substance, safeners and synergists, and the risks of their use in the plant protection product. The rapporteur’s draft assessment report is peer reviewed by the European Food Safety Authority, which provides its conclusion to the Commission and may also suggest options for risk management. In light of this conclusion, a proposal for approval or non-approval is made by the European Commission which is subject to a vote by all Member States in the Standing Committee on the Food Chain and Animal Health before adoption. Existing active substances subject to a non-approval decision must be withdrawn from the EU market.
Active substance data requirements (Commission Regulation (EU) No 544/2011)
Commission Regulation (EU) No 544/2011 provides a comprehensive list of the tests and studies required to support an active substance for Approval. Part A deals with requirements for chemical substances and Part B for micro-organisms including viruses.
Plant protection products data requirements (Commission Regulation (EU) No 545/2011)
Commission Regulation (EU) No 545/2011 provides a comprehensive list of the tests and studies required for the formulated plant protection product, either to support an application for product authorisation at Member State level following Approval of the active substance and listing in the Approved List of active substances, or required for at least one representative product to support an application for the Approval of an active substance. As before, Part A of the Annex deals with requirements for chemical preparations and Part B for preparations of micro-organisms including viruses.
Uniform Principles for evaluation and authorisation of plant protection products (Commission Regulation(EU) No 546/2011)
This lays out the "Uniform Principles" which are the harmonised criteria for evaluating plant protection products at a national level. Application of the Uniform Principles ensures that authorisations issued in all Member States are assessed to the same standards. Part I deals with the evaluation and authorisation of chemical plant protection products, and Part II deals with the evaluation of plant protection products containing micro-organisms.
Labelling requirements for plant protection products (Commission Regulation (EU) No 547/2011)
Classification and labelling of plant protection products is covered by the ‘Dangerous Substances Directive’ and the ‘Dangerous Preparations Directive’, which are gradually being replaced by the EU Regulation on Classification, Labelling and Packaging of Substances and Mixtures (known as the CLP Regulation). However, Commission Regulation (EU) No 547/2011 provides additional specific phrases for special risks and safety precautions for plant protection products.
For further information about classification and labelling
Authorisation of Plant Protection Products
Regulation (EC) No 1107/2009 provides two basic approaches to product authorisation – zonal authorisation (Articles 33 – 39) and mutual recognition (Articles 40 – 42). These have specific and directly binding timelines and procedures which are elaborated in further EU Guidance.
Zonal authorisation in Regulation (EC) No 1107/2009 is the standard procedure to be followed for product authorisation or amendment to an authorisation, and applies to all applications made from 14 June 2011 not covered by the transitional arrangements.
The zonal authorisation procedure is similar to the voluntary re-registration work-sharing procedure developed under Directive 91/414/EEC to facilitate product re-registration. Wherever possible the voluntary procedures have been aligned with the zonal authorisation procedure in Regulation (EC) No 1107/2009 to allow a smooth transition between the two processes.
Mutual recognition applies to all authorisations in MS, which were either granted under Directive 91/414/EEC in compliance with Annexes II, III and VI of that Directive or under Regulation (EC) No 1107/2009.
For further information on zonal and mutual recognition authorisations
Under transitional arrangements, Member States may provisionally authorise products containing new active substances where the submitted dossier was considered to be complete before the introduction of Regulation (EC) No 1107/2009. Provisional authorisation is allowed for a period of up to three years. Such authorisations may be mutually recognised by other member States if they wish to do so.