An application is made by a producer (e.g. pesticide manufacturer) for the approval of an active substance. Producers may apply to a Member State of their choice (called a Rapporteur Member State, or RMS).
Evaluation by the Rapporteur Member State
The first step of the assessment by the RMS is to ensure that the dossier (complete data package) is compliant with the requirements of the Regulation (this is the admissibility check). The admissibility check should be carried out within 45 day after receipt of dossier and application fee. The RMS reports their findings to the applicant, other Member States, the European Food Safety Authority (EFSA) and the European Commission.
If the RMS concludes that the dossier is not complete, the applicant is allowed 3 months to provide the missing elements. If the applicant cannot do this within 3 months, the application is declared inadmissible and rejected.
If the dossier is complete, the applicant’s summary dossier (set of ‘tiered’ summaries detailing the applicant’s evaluation and risk assessment for the active substance and product), excluding confidential information as defined in the Regulation, is made publicly available by EFSA.
The evaluation process and production of the draft assessment report (DAR)
Within 12 months after the RMS has notified the applicant, Member States, EFSA and the Commission of the admissibility of the application and after receipt of the evaluation fee, the RMS shall prepare the DAR.
The dossier is evaluated by scientific experts in the areas of physical chemical properties; analytical methods; mammalian toxicology; consumer safety; environmental fate, ecotoxicology and efficacy.
A series of guidance documents have been established to support the harmonisation of the evaluation and risk assessment process. These are publicly available on the Commission’s website. The date of dossier submission determines the guidance documents to be used for the evaluation of the dossier .
Following detailed evaluation of the dossier, the RMS produces a report of their evaluation termed the Draft Assessment Report (DAR). The DAR comprises the following documents:
This presents the overall conclusion on the active substance and comprises three levels:
- Level 1 Statement of the subject matter and purpose of the DAR
- Level 2 Summary of the conclusions reached in each area of the evaluation and risk assessment
- Level 3 Proposed decision with respect to the application
Annex A (volume 2)
A full listing of all tests and studies submitted by the applicant as part of the dossier.
Annex B (volume 3)
A detailed scientific evaluation of the tests, studies and other information. This provides a comprehensive risk assessment considering the risks posed to human health and the environment from the active substance and its supported use(s) in the formulated product(s). This will include a list of tests and studies considered to have been relied on for the conclusions reached.
Annex C (volume 4)
Confidential information, for example method of manufacture and technical specification for the active substance and formulated product(s). If the RMS needs additional studies or information to complete the evaluation, the applicant is allowed maximum 6 months to provide the studies and/or information . In that case , the 12-month period is extended by the additional period granted by the RMS. During the evaluation of the dossier there is a possibility for the applicant to discuss the draft DAR with the scientific experts. The finalised DAR is submitted to the European Commission with copy to EFSA and the applicant.
EFSA peer review process
The Ctgb will only participate (as RMS) in the peer review process if the peer review fee is settled.
Role of European Food Safety Authority (EFSA)
The European Food Safety Authority (EFSA) was established as an independent European Agency operating separately from the European Commission, Parliament and Member States. One of EFSA’s roles is to provide independent scientific advice and risk assessments to underpin European food safety. EFSA’s remit includes plant protection and, in close collaboration with Member States, EFSA is responsible for the peer review of active substances used in plant protection products. EFSA is required to provide an authoritative conclusion on whether the active substance can be expected to meet the approval criteria of Regulation (EC) No 1107/2009. Risk management decisions are taken by the European Commission and Member States following consideration of the conclusions of the EFSA risk assessment process.
Commenting on the Draft Assessment Report
Once the rapporteur’s Draft Assessment Report (DAR) has been received by EFSA, arrangements are made for its distribution to all Member States and the applicant as part of a commenting process. This should be done within 30 days after receipt of the DAR.
Comments are invited on all aspects of the DAR in a standardised format. EFSA experts also consider the DAR at this stage and provide their own comments. EFSA also makes the DAR available for public consultation (specified confidential information is removed) at this stage. EFSA rugulary publishes calls for public consultation on scientific subjects. Comments on the risk assessment can be submitted by any member of the public or interested party. A period of 60 days is allowed for the submission of written comments.
Conclusion by EFSA
EFSA must adopt their conclusion within 150 days of the end of the commenting period (120 day if no expert consultation is foreseen). EFSA can request additional information (‘stop the clock’) allowing 90 days for its submission and 60 days for the rapporteur to evaluate it.
EFSA provides all the comments received to the rapporteur Member State which compiles a Reporting Table. In the Reporting Table the rapporteur provides responses to all comments received. The completed table is returned to EFSA whose experts assess the responses and indicate their proposals for further action. The table therefore identifies whether a comment is addressed, or whether it remains as a concern to be considered further (an open point), or would need to be addressed by further data or information (a ‘data requirement’). It also identifies if discussion of any open point identified should take place at an expert meeting. The Reporting Table is discussed in a bilateral meeting between rapporteur and EFSA after which the Reporting Table is considered final.
All open points, data requirements and points for an expert meeting are transferred from the Reporting Table to the Evaluation Table. This Evaluation Table is the starting point for the further peer review of the DAR. If EFSA needs additional information this can be requested from the applicant and evaluated by the rapporteur Member State. Deadlines are set for the submission and evaluation of additional information.
Additional information as requested by EFSA is evaluated by the RMS and provided in an updated DAR.
Expert meeting and expert meeting report
In an expert meeting, experts are invited from Member States and EFSA. The meeting conclusions are recorded in an expert meeting report (discussion table) and the Evaluation Table is updated. In some circumstances, depending on the extent of the areas of uncertainty in the risk assessment, a substance will only be considered at specific meetings, alternatively, the meetings may be replaced with ‘teleconferences’ targeted at specific areas of concern. The rapporteur is consulted on the outcome of the expert discussions and may be required to revise the risk assessment documentation, taking into account the outcome of expert discussions.
EFSA has an established policy to ensure the independence of its risk assessment work which includes measures to ensure experts are selected on the basis of their scientific expertise and experience in risk assessment and to address any potential conflicts of interest.
The draft EFSA conclusion is circulated to all Member States. The views of Member States are considered by EFSA when finalising their conclusion document; however, the final document presents the independent conclusion reached by the Authority. The EFSA conclusion is a key document as it presents a comprehensive independent summary of the risk assessment. It lists the specific conclusions, reference values and endpoints; identifies particular conditions that may need to be considered in relation to the risk; and the critical areas of concern. The finalised conclusion is sent to the European Commission. On completion of the risk assessment, the conclusion and all of the supporting documentation (with the exception of some specified limited confidential information) are publicly available. Ctgb regards the application process to be ended after the publication of the EFSA conclusion. The application will be financially completed (a final invoice will be send to the applicant).
Commission risk management and decision making process
The final conclusion from EFSA is made available to all Member States and the European Commission.
Within six months of receiving the conclusion from EFSA, the European Commission is required to present a report (termed the Review Report) and a draft Regulation to the Standing Committee on Pesticides, Animals, Food and Feed (SCoPAFF). The SCoPAFF committee, attended by all Member States, considers wider regulatory and legislative aspects to assist the European Commission in formulating regulatory proposals. Consideration will, for example, be given to the need to impose specific provisions to ensure effective risk management such as limitations on the rates and range of uses that may be authorised; the need for no-spray zones; requirements for protective equipment etc. In addition, confirmatory information, to be generated in a specified period (usually within two years of inclusion), may be identified as being necessary to address new requirements established during the evaluation process or that result from new scientific and technical knowledge.
The Standing Committee on Pesticides, Animals, Food and Feed formally gives an opinion (by qualified majority vote) on the proposals made by the European Commission. Agendas and summaries of meetings are available on the European Commission’s website – look for ‘phytopharmaceuticals’ meetings. The Implementing Regulation will then be finalised (adopted) by the European Commission, taking account of the opinion of the SCoPAFF, and published in the Official Journal. The review report is also made available to the public. The European Commission maintains a database on the current status of active substances in the EU.