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Evaluation of new active substances used for plant protection in the European Community

The information provided here is intended as a guide only and does not necessarily represent the views of the Commission Services

  1. What is a new active substance?
  2. What is the procedure?
  3. What is a rapporteur Member State?
  4. Can I choose a rapporteur Member State?
  5. Do I have to pay a fee to the rapporteur Member State?
  6. In what format should the dossier be submitted to the rapporteur Member State?
  7. Do all Member States and the Commission need a dossier?
  8. Where are the data requirements laid down?
  9. Are there any guidelines relating to the data requirements?
  10. What is a completeness check?
  11. Who should prepare the completeness check?
  12. Who else is involved in the completeness check?
  13. What happens after a positive decision on completeness?
  14. How long does a completeness check take?
  15. What is the draft assessment report (monograph)?
  16. How long will it take for the rapporteur Member State to finalise its evaluation and prepare the assessment report?
  17. What is the peer review?
  18. How long does it take to reach an Annex I decision?
  19. What is the co-rapporteur system?
  20. Where are the contact points for the evaluation of new active substances in the Member States?
  21. What is CADDY?



1. What is a new active substance?

A new active substance is defined as a substance which was not authorised in any Member State of the European Community for plant protection before 25 July 1993. An indicative list of active substances on the market at that date has been prepared.

N.B. If you are not sure whether the substance is new or existing. Seek advice from one of the Member States.

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2. What is the procedure?

Application to a member state (rapporteur)
Completeness check
Standing Committee for Food Chain and Animal Health (SCoFCAH) - vote on completeness
Adoption by the Commission of Decision
Publication of Decision in the Official Journal
Provisional authorisations
Preparation of draft assessment report by rapporteur (monograph)
EFSA Peer review
EFSA Conclusions
Standing Committee for Food Chain and Animal Health SCoFCAH (vote on possible Annex I inclusion)
Adoption by the Commission
Publication of Directive in the Official Journal

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3. What is a rapporteur Member State?

The initial scientific and technical evaluation for the European Community is conducted by one of the Member States of the Community: the rapporteur.

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4. Can I choose a rapporteur Member State?

Yes, the applicant is free to choose its own rapporteur for a new active substance.

NB: The applicant is advised to contact the prospective rapporteur Member State well before a dossier is submitted, to discuss key issues for the active substance concerned.

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5. Do I have to pay a fee to the rapporteur Member State?

There is currently no harmonised Community regime for the charging of fees relating to the evaluation of new active substances -most Member States do charge a fee for the work.

NB: Contact the prospective rapporteur Member State to discuss fees.

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6. In what format should the dossier be submitted to the rapporteur Member State?

There is a harmonised dossier structure, which is agreed at European and OECD level.

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7. Do all Member States and the Commission need a dossier?

Yes, but you should wait for instructions from the rapporteur Member State, who will advise you when to send (paper and CADDY) dossiers to the other Member States.

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8. Where are the data requirements laid down?

The data requirements are defined in the Annexes II and III to Council Directive 91/414/EEC.

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9. Are there any guidelines relating to the data requirements?

GGuideline documents are provided for to assist the applicant.

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10. What is a completeness check?

All dossiers have to be checked by the rapporteur Member State in order to establish that they contain all the data and information necessary for a detailed examination.

NB: Explaining the check for completeness with the rapporteur Member State can avoid confusion and delays.

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11. Who should prepare the completeness check?

The applicant should prepare the completeness check for the rapporteur Member State according to a harmonised structure.

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12. Who else is involved in the completeness check?

If the dossier is considered complete by the rapporteur Member State, all other Member States and the Commission become involved. If the Member States and the Commission agree with the rapporteur Member State, there is a vote in the Standing Committee on the Food Chain and Animal Health, the Commission then adopts a decision and publishes it in the Official Journal.

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13. What happens after a positive decision on completeness?

Once a positive decision on completeness is published in the Official Journal of the EC, the rapporteur Member State will begin the detailed evaluation. The applicant may also apply to the Member States for provisionally authorising the active substance as a plant protection product.

NB: the Member States are not obliged to grant provisional authorisations.

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14. How long does a completeness check take?

The decision on completeness from the submission of dossier and completeness check to the publication will take approximately 4-6 months. Delays can occur if the applicant cannot ensure timely dossier distribution.

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15. What is the draft assessment report (monograph)?

On a draft basis of the dossier submitted by the applicant, the rapporteur member state prepares an assessment report (widely know by the term monograph)- which it must submit to the Commission 1 year after the publication of the decision on completeness. The structure of the monograph is harmonised at European and OECD level.

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16. How long will it take for the rapporteur Member State to finalise its evaluation and prepare the assessment report?

The rapporteur Member State has up to 1 year to complete the scientific and technical evaluation and submit its draft assessment report to the Commission Services.

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17. What is the peer review?

The first examination of the rapporteur Member States' assessment report takes place at the peer review meetings organised and coordinated by the European Food Safety Authority. These are specialised meetings (physical chemical properties, fate and behaviour, ecotoxicology, mammalian toxicology residues) attended by experts from a representative cross section of Member States. The purpose of the peer review is to discuss and make recommendations concerning the critical questions relating to a particular dossier and to finalise the conclusions of the risk assessment.

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18. How long does it take to reach an Annex I decision?

On average it takes around 4 years from the date of application to a Member State to the publication of a decision on inclusion. This time can vary greatly depending of the complexity of the dossier, the proposed uses, etc.

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19. What is the co-rapporteur system?

The Commission Services and the Member States are looking at alternative systems for the Community examination of new active substances. One such system is the co-rapporteur system where 2 Member States collaborate. This system is currently entirely voluntary and relies on the co-operation on the applicant and the participating Member States. There are currently at least 6 new active substances being examined by the co-rapporteur system.

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20. Where are the contact points for the evaluation of new active substances in the Member States?

Contact points in the Member States for the evaluation of new active substances.

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21. What is CADDY?

Caddy (Computer Aided Document and Dossier Supply) is a format for presenting dossiers on CD-ROMs, which has been agreed between the Member States and industry.

 
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