The EU decision making process for active
substances
Contents
1.
Introduction .................................................................................................................................... 3
2.
The process for new active substance approval ............................................................................. 3
Application by a producer ................................................................................................................... 3
Data requirements and dossier structure ....................................................................................... 3
Electronic Submission of Dossiers................................................................................................... 4
Fees ................................................................................................................................................. 5
Evaluation by a Member State............................................................................................................ 5
The evaluation process and production of the draft assessment report (DAR) ............................. 6
Volume 1 ......................................................................................................................................... 6
Annex A (volume 2) ......................................................................................................................... 6
Annex B (volume 3) ......................................................................................................................... 6
Annex C (volume 4) ......................................................................................................................... 7
EFSA risk assessment process ............................................................................................................. 7
Role of European Food Safety Authority (EFSA) ............................................................................. 7
Commenting on the Draft Assessment Report – production of the Reporting Table and
Evaluation Table .............................................................................................................................. 7
Expert meetings and expert meeting reports ................................................................................. 8
Evaluation meeting and the draft EFSA conclusion ........................................................................ 8
Finalisation of the EFSA conclusion ................................................................................................ 8
HSE Peer-review of other Member States active substance assessments ..................................... 8
Further Information ........................................................................................................................ 9
Commission risk management and decision making process. ........................................................... 9
What happens after an active substance is approved? .................................................................. 9
What happens after a decision not to approve an active substance?.......................................... 10
3. Renewal of Approval for active substances already approved for use in plant protection
products in the EU ................................................................................................................................ 11
First stage of renewal (7 active substances) ................................................................................. 11
Second stage of renewal (31 active substances) .......................................................................... 11
Procedure for the second stage renewal process......................................................................... 12
Procedure for the third stage renewal process. ........................................................................... 13
Role of CRD as co-rapporteur Member State for renewal of active substances .......................... 13
Further Information ...................................................................................................................... 13
1. Introduction
The process for deciding whether a new active substance can be approved for use in plant
protection products, in the European Union (EU), involves all Member States, the European
Food Safety Authority (EFSA) and the European Commission. Members of the public and
other interested parties can also provide comments for consideration in the process,
specifically through the public consultation process of EFSA. Only approved active
substances can be authorised in plant protection products in the EU. An active substance can
only be approved if it meets the requirements and conditions specified in Regulation (EC) No
1107/2009.
Link to flow chart giving simple overview of the process for approval of a new substance.
It should be noted that these requirements and processes also apply to applications for
approval of new safeners and synergists for use in plant protection products.
A similar process also operates for the renewal of active substances already approved for use
in plant protection products. A flow chart giving a simple overview of the process for renewal
of an active substance is available here.
2. The process for new active substance approval
Application by a producer
An application is made by a producer (e.g. pesticide manufacturer) for the approval of an
active substance. The application must comprise a complete ‘dossier’ addressing fully the
data requirements contained in Regulations (EU) No 283/2013 and 284/2013 that implement
Regulation (EC) No 1107/2009.
It should be noted that these requirements and processes also apply to applications for
approval of new safeners and synergists for use in plant protection products.
Data requirements and dossier structure
To support an application for an active substance a complete 'dossier' must be submitted
which must fully address the data requirements given in Commission Regulation (EU) No
283/2013 (for the active substance) and Commission Regulation (EU) No 284/2013 (for the
plant protection product) [see link to EC Pesticides Legislation page below]. The complete
dossier is a very extensive set of documentation comprising not only the required tests and
studies, but also a series of supporting documents providing background information on the
active substance and its uses. A set of 'tiered' summaries detailing the applicant's evaluation
and risk assessment for the active substance and product (the summary dossier) is required in
addition to full copies of all the individual study reports.
Link to EC Pesticides Legislation website page
To enable a risk assessment to be conducted, at least one plant protection product must be
supported by the dossier with comprehensive data to support the risk assessment required for
approval of the active substance.
The dossier should be presented in the format agreed by the Organisation for Economic Cooperation and Development (OECD). This is an internationally agreed format for regulatory
dossier structure.
For chemical substances, the ‘OECD guidelines and criteria for industry for the preparation
and presentation of complete dossiers and of summary dossiers for plant protection products
and their active substances in support of regulatory Decisions in OECD countries (Revision
2, May 2005)’ should be used.
For microbial pesticides, the ‘OECD Guidance for Industry Data Submissions for Microbial
Pest Control Products and their Microbial Pest Control Agents (Dossier Guidance for
Microbials), February 2004, Series on Pesticides No. 23’ should be used.
The OECD guidance documents are based on and are consistent with the previous European
Commission Guidance Document 1663/VI/94 Rev 8 (2 April 1998) and have been approved
by the OECD Working Group on pesticides.
Electronic Submission of Dossiers
Dossiers can be submitted in paper and electronic formats. Electronic submission of complete
dossiers is strongly recommended by CRD provided that they are submitted in the CADDY
format (Computer Aided Dossier Design and supply). Details of our requirements in terms of
numbers of dossier copies are given below:
CRD's requirements for EU regulatory submissions
New active substances if dossier is available on CADDY
No. of complete paper sets of the No. of CADDY CD-ROM sets for
full dossier.
the dossier.
Acting as
rapporteur
0
2
Not rapporteur 0
2
New active substances if dossier is not available on CADDY
No. of complete paper sets of the
full dossier.
Acting as
rapporteur
2
Not acting as
rapporteur
1
No. of CADDY CD-ROM sets
for the dossier.
Renewal of Approved active substances if Dossier is available on CADDY
No. of complete paper sets of the
full dossier.
No. of CADDY CD-ROM sets
for the dossier.
Acting as
rapporteur
0
2
Not acting as
rapporteur
0
2
Revewal of Approved active substances if dossier is not available on CADDY
No. of complete paper sets of the
full dossier.
Acting as
rapporteur
2
Not acting as
rapporteur
1
No. of CADDY CD-ROM sets
for the dossier.
Further information is available on the CADDY website.
Fees
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:
Volume 1
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.
Expert meetings and expert meeting reports
Several active substances are considered in a ‘round’ of expert meetings which usually
comprises 5 meetings: physical chemistry and methods; mammalian toxicology; residues;
environmental fate; and ecotoxicology. Experts are drawn 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. 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.
Evaluation meeting and the draft EFSA conclusion
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 then draft their conclusion document which 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.
Finalisation of the EFSA conclusion
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, 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).
Further Information
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.
What happens after an active substance is approved?
Once an active substance is approved, it can be considered for authorisation and use in plant
protection products in the EU. Member States take decisions at a national level, within a
zonal authorisation process, on whether individual products with specific use
recommendations can be authorised. Member States must ensure authorised plant protection
products comply with harmonised European standards and reflect any conditions or
restrictions that have been agreed for the active substance where appropriate to the plant
protection product. In particular, dossiers supporting products must be evaluated in
accordance with the Uniform Principles which are set out in Commission Regulation (EU)
No 546/2011.
What happens after a decision not to approve an active substance?
The active substance cannot be used in plant protection products in the EU. However, where
an active substance had previously been approved, but failed renewal of approval, products
may be given a period of grace to be withdrawn from the market.
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.
3. Renewal of Approval for active substances already
approved for use in plant protection products in the EU
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 :
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Rapporteur Member States (RMSs) are set out in the Regulation and co-rapporteurs
are identified to support the RMS in the assessment process.
Producers must make an application by the deadline set in the Regulation to indicate
their support for an active substance. For existing active substances more than one
producer may make an application but they are expected to take all reasonable steps to
make a joint submission and failure to do so must be justified.
Applications should include an 'updating statement’ which lays out the new
information that the applicant intends to submit, and should demonstrate that the new
information is necessary to reflect changes:
o - in data requirements;
o - in scientific and technical knowledge since the first inclusion (approval) of
the substance;
o - to representative uses being supported for renewal.
Where an application is considered complete, the applicant must then submit their
‘supplementary dossier’ by a separate deadline set in the Regulation. The
supplementary dossier provides the data and summaries for evaluation by the RMS.
Third parties may also submit information at the deadline.
The supplementary dossier is checked for completeness in 1 month, and 14 days are
allowed to address any deficiencies.
The evaluation of the dossier must be completed by the RMS in 11 months, and a
renewal assessment report (RAR) submitted to the European Commission and copied
to the European Food Safety Authority (EFSA). Although additional information can
be requested by the RMS during this period there is no ‘stop the clock’ provision to
extend the 11 months allowed to produce the RAR.
The RAR is circulated for comment by EFSA and a copy is also made available for
public comment. The supplementary summary dossier is also made publicly available.
The European Commission considers the comments and decides whether to ask EFSA
to produce a conclusion on the risk assessment. The Commission also decides the
form of that consultation i.e. whether specific points should be considered and
whether to request expert consultation.
If EFSA are consulted (and it is anticipated that this will be the case for the majority
of substances) they have 6 months from the request to produce their conclusion.
EFSA may request additional information from the applicant. The applicant has a
maximum of 1 month to submit the information in response to a request and the RMS
then has a maximum of 2 months to evaluate it on behalf of EFSA.
The European Commission must draft a review report for the Standing Committee on
the Food Chain and Animal Health within 6 months of receiving the EFSA conclusion
(or within 6 months of receiving the comments, if no EFSA consultation is requested).
The European Commission then propose approval or non-approval for consideration
by the Standing Committee.
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.
Further Information
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European Commission’s database (for status of active substances in the EU
Voting decisions on active substances and legislation in the EU
Annex A
Annex B
Annex B