The eu decision making process for active substances
Further information is available on the CADDY website.
We charge fees to ensure that the full economic costs of evaluating and processing applications are recovered. Each year we review the costs of the work (using detailed work recording data), and following consultation with applicants and approval holders, we set the fees for the next year.
More on Application Fees...
Evaluation by a Member State
Producers apply to a Member State of their choice (called a ‘rapporteur’ member state, or RMS) to initially assess and evaluate their dossier.
The first step of the assessment by the RMS is to ensure that the application dossier (complete data package) is compliant with the requirements of the Regulation (this is the admissibility check). The RMS then reports their findings to the applicant, other Member States, the European Food Safety Authority (EFSA) and the European Commission.
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 defined in the Regulation, is made publicly available at this stage by EFSA.
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.
The evaluation process and production of the draft assessment report (DAR)
The dossier is evaluated by specialist scientists in the areas of physical chemical properties; analytical methods; mammalian toxicology; operator exposure; environmental fate and ecotoxicology.
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.
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 four 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 on whether the substance should be approved together with any proposed conditions or restrictions that should be associated with an approval, if appropriate;
Level 4 Where necessary, a list of further studies or information necessary to allow a decision to be made and information or studies necessary to remove any conditions or restrictions associated with the inclusion.
Annex A (volume 2)
A full listing of all tests and studies submitted as part of the dossier.
Annex B (volume 3)
A detailed scientific evaluation of the tests, studies and other information considered in preparing the DAR. 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).
The finalised DAR is submitted to the Pesticides Unit of EFSA by the RMS.
EFSA risk assessment process
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 – production of the Reporting Table and Evaluation Table
Once the rapporteur's Draft Assessment Report (DAR) has been received by EFSA's Pesticides Unit, arrangements are made for its distribution to all Member States and the applicant as part of a commenting process. 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's Pesticides Unit also makes the DAR available for public consultation (specified confidential information is removed) at this stage. Open public consultations are listed on the EFSA website. Comments on the risk assessment can be submitted by any member of the public or interested party.
EFSA provides all the comments received to the rapporteur Member State which compiles a Reporting Table with comments grouped in a column in relation to the relevant section of the DAR. The rapporteur then provides their response in a column alongside each comment received. The completed table is returned to EFSA whose experts assess the responses and indicate in a final column their proposals for further action. The table therefore identifies whether the 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 gap’). It also identifies if discussion of any open points identified should take place at an expert meeting. Depending on the risks identified, and the process being followed, there may be further consultation at this stage to decide if further EFSA consideration is merited, and if expert consultation is necessary.
If expert consideration is required, an ‘Evaluation Table’ may be produced which lists all the open points and data gaps identified in the commenting period. This Evaluation Table is considered together with the DAR and, in some circumstances, any Addenda (evaluating further studies or information) to the DAR at expert meetings organised by the Pesticides Unit of EFSA. If EFSA needs additional information this can be requested from the applicant and evaluated by the rapporteur Member State. There are set deadlines for the submission and evaluation of additional information.
The finalised conclusion is sent to the European Commission. On completion of the risk assessment, EFSA makes the conclusion and all of the supporting documentation (with the exception of some specified limited confidential information) publicly available on their website.
HSE Peer-review of other Member States active substance assessments
Certain active substance evaluations for plant protection products under EU Regulation 1107/2009 prepared by other Member States are peer-reviewed by HSE and comments submitted to the relevant parties. These evaluations may include draft assessment reports for new active substances, draft renewal assessment reports and confirmatory information assessments. The commenting is limited to active substances of concern or importance to the UK. This work involves the peer-review of the assessment received, preparation of comments, subsequent follow-up processes, attendance at expert meetings at EFSA (European Food Standard Authority) and review of the final output (EFSA Conclusion).
Rapporteur Member State assessment reports submitted for the EU peer review of active substances used in plant protection products
Public consultation on rapporteur Member State assessment reports submitted for the EU peer review of active substances used in plant protection products
Commission risk management and decision making process.
The final conclusion from the European Food Safety Authority (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.
It should be noted that the above processes also apply to applications for approval of new safeners and synergists for use in plant protection products.
Under previous legislation, Directive 91/414/EEC, which introduced uniform regulatory standards in the EU, all previously existing active substances were reviewed against the harmonised EU principles established by that legislation. Active substances that were not supported by producers or found, on the basis of a comprehensive scientific risk assessment, not to meet the necessary standards required by that legislation, were not approved for use in plant protection products. Existing products containing these active substances were withdrawn from the EU market.
There is currently an ongoing programme to renew the Approval of all active substances, approved under Directive 91/414/EEC, to ensure that they are considered against the latest standards and that they meet the criteria set out in the current legislation, Regulation (EC) No 1107/2009.
Similarly to the first review programme for existing active substances under 91/414/EEC, the renewal programme for approved active substances under Regulation (EC) No 1107/2009 is issued via specific Regulations.
Regulation (EC) No 1107/2009 also contains a provision for a Regulation to be adopted by 14 December 2014 establishing a programme for the gradual review of safeners and synergists already on the market.
First stage of renewal (7 active substances)
The current renewal (review) process started with the first seven active substances listed on Annex I, of Council Directive 91/414/EEC, going through a renewal programme laid down in Commission Regulation (EC) No 737/2007 (also known as the 'AIR' project). This was seen as a pilot project for future stages of the renewal programme where decisions would be made under Regulation (EC) No 1107/2009. These substances have now been successfully renewed and added to the List of Approved active substances.
Second stage of renewal (31 active substances)
A second list of substances scheduled for review and renewal (also known as the 'AIR 2' list) was published in Commission Regulation (EU) No 1141/2010 (also known as the second Renewal Regulation). This Regulation laid down the procedure for the submission and appraisal of applications for renewal. Although this part of the renewal procedure started while Directive 91/414/EEC still applied, the decisions on renewals will be taken under Regulation (EC) No 1107/2009 and active substances will have to meet the approval criteria laid out in that Regulation. A guidance document is available to support the second stage renewal process.
This second Renewal Regulation lists 31 active substances which originally had approval ('Annex I inclusion') expiry dates for 2011 and 2012. However, in order to allow time for the renewal procedure to be completed, these expiry dates have been extended to 31 December 2015 by Commission Directive 2010/77/EU of 10 November 2010.
Procedure for the second stage renewal process.
A summary flow diagram is provided to illustrate the key steps in the renewal process.
The main elements are similar to those followed for approval of new active substances but there are some differences in the detailed procedures and timelines.
The key differences are :
Once an active substance is approved under the renewal programme, all existing products containing that substance are considered in a renewal process for authorised products. Further information on this process is available in a guidance document.
Procedure for the third stage renewal process.
The development of the third stage of the renewal programme is being finalised and information will be provided once final details are available.
It is anticipated that the procedural steps will be broadly similar to those of the second stage. It should be noted that applicants are required to submit an application no later than 3 years before the end of the approval period for the active substance (this is set out in Article 15 of Regulation (EC) No 1107/2009).
Role of CRD as co-rapporteur Member State for renewal of active substances
Regulation 686/2012 sets out for each substance in the third stage of the renewal programme (those with expiry dates on or before 31 December 2018) the Rapporteur Member State (RMS) and co-RMS.
Regulations 1141/2010 and 844/2012 set out the provisions necessary for the renewal procedure for active substances for the second and third stages of the renewal programme. The Regulations make reference to the parts of the process where the co-RMS is involved. Where the UK is designated as co-RMS, a charge will be applied to each dossier submitter (£35,000 or £7,500 for biopesticides and pheromones) before the EFSA peer review process begins; in these cases CRD will review the Renewal Assessment Report as prepared by the RMS prior to submission to EFSA, and will ensure appropriate input is made during the peer review process.
The RMS shall take the lead during the evaluation and peer-review process, however, the RMS and co-RMS will work together to ensure full consideration is given to the substance being renewed, as appropriate.
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