1. Decision making for AIR active substances
Crop Protection
European Regulatory Conference March 2015, Brussels
Decision making for AIR active substances
Jeroen Meeussen
European Commission
DG SANTE (Health and Food Safety Directorate-General)
Unit Pesticides and Biocides

2. The AIR programmes AIR-1 – 7 substances – 14 MS

3. Current situation: AIR-1
All decisions on Annex I Renewal (AIR-1) substances have been taken - 7 substances.
Regulation is applicable from: 1 January 2012.
Re-authorisation of products: 31 December 2015.
Expiry of approval: 31 December 2021.

4. Current situation: AIR-2
Regulation (AIR-2) has been published in December 2010: (EU) No 1141/2010.
Guidance Document has been noted (SANCO/10387/ rev. 8).
31 substances: 29 dossiers have been received; decision making is ongoing.
Expiry of approval: 31 December 2015.

5. …but
Emerging concerns about delays: …until now only one decision on renewal of approval has been taken…
and
Decisions apply from 1 January 2016: … as a consequence new data requirements would apply to the re-authorisation of PPPs…

6. Current situation: AIR-3
Legal framework for AIR-3: - Regulation with the general procedure (Reg. (EU) No /2012); - List of RMS & Co-RMS (Reg. (EU) No 686/2012); - Guidance Document (SANCO/2012/ rev. 4).
Extensions only possible if an application has been submitted.
Strict timelines (29.5 months from dossier submission till decision).

7. AIR-3 substances Expiry date No AS Extension Regulation
< 14 June 2014 40
July 2014 – November 2015
27 (23)
February 2016 – November 2017 55
> 31 July 2018 28
Extension
until 1/2017
until 7/2017
until 7/2018
no extension
Regulation
Reg. 823/2012
Reg. 1197/2012
Reg. 533/2013; Reg. 762/2013;
Reg. 1136/2013; Reg. 85/2014;
Reg. 487/2014; Reg. 678/2014;
Reg. 878/2014;
2 Reg. to be published -

8. Renewal Timelines (Reg. 844/2012)
Activity
- Dossier submission:
- Admissibility check:
- Renewal Assessment Report (RAR):
- RAR circulated to MS and applicant:
- Public Commenting (incl. MS & applicant):
- EFSA peer-review:
- Stop the clock:
- COM decision:
Time
1 month
11 months
1.5 months
2 months
5 months
3 months
6 months
-8-

9. Renewal Timelines (Reg. 844/2012)
Time needed from dossier submission to COM decision:
29.5 months
Available time according to Reg. 844/2012:
30 months
Did we developed a
workable programme???
-9-

10. What about AIR-4?
Legal framework same as for AIR-3: - Regulation with the general procedure (Reg. (EU) No /2012); - List of RMS & Co-RMS: in preparation; - Guidance Document (in principle SANCO/2012/ applies).
Strict timelines (29.5 months from dossier submission till decision).
Extensions necessary?

11. Number of Active Substances: AIR-4

12. AIR-4: 2019 Batch Current expiry date Number of AS 1 28 February 20195 2
30 April 2019 22 3
31 July 2019 4
31 August 2019
87 ('list 4')
31 October 2019 6
30 November 2019 7
31 December 2019 16
Total
146

13. AIR-4: 2020 Batch Current expiry date Number of AS 1 31 March 2020 2
30 April 2020 3
31 May 2020 4
30 June 2020 5
31 July 2020 6
31 August 2020 7
31 October 2020 8
31 December 2020
Total 14

14. AIR-4: 2021 Batch Current expiry date Number of AS 1 31 January 2021 2
31 March 2021 3
30 April 2021 5 4
31 May 2021 35
31 July 2021 6
30 September 2021 7
31 December 2021
17 (7 AIR-1 AS)
Total 63

15. The AIR-programmes…..

16. …..the workload…..

17. This has to be stopped!
Article 82 review…
-17-

18. Art. 43: Renewal of Authorisation
…3 months after renewal of approval of active substance!
Art. 43: Renewal of Authorisation

19. Renewal of Authorisation
Application (incl. dRR) 3 months after Commission decision to renew the approval of the active substance.
Difficult to prepare a dossier incl. risk assessments for product re-authorisation before the active substance endpoints are finalised.
Choice of zonal rapporteurs.
Capacity issues.
Products containing mixtures of active substances will trigger multiple Article 43 submissions and reviews.

20. Renewal of Authorisation
Article 43(6): ‘reasons beyond the control of the authorisation holder.’
If it is not possible for the applicant to provide studies in time due to a new endpoint.
Applicant has to justify the lack of data.
Member States may find it appropriate to apply Article 43(6) and delay re-authorisation of the product.
Member States have the responsibility to ensure that appropriate protection standards are respected.

21. Increasing Article 43 workload…
Guidance on renewal of authorisations is in preparation to assist in managing the workload!

22. New Data Requirements Apply from 1 January 2014.
Active Substance: - for all applications submitted under Regulation 844/ ("AIR-3" and beyond).
Products: - Not to AIR-1 as long as applications for re-authorisation are submitted before 31 December 2015; - What about AIR-2? - Applicable to all re-authorisations AIR-3.
Guidance Document on transitional measures (SANCO/11509/ rev. 3).

23. Data Requirements - AIR-2
Active Substance: - for all applications submitted under Regulation 1141/ old data requirements apply.
Products: - current text: old data requirements apply only as long as applications for re-authorisation are submitted before December 2015.
Legislation in preparation to ensure that old data requirements continue to apply as regards re-authorisations of PPPs containing an AIR-2 substance.
Guidance Document on transitional measures (SANCO/11509/ rev. 4 in prep.)

24. Conclusions
Legal framework for renewal of approval of active substances is in place.
Challenge to cope with the deadlines.
Reflect on a change of the system of renewal of approval of AS and re-authorisation of PPPs in light of Article 82 review.
A workshop late 2015/early 2016 might be a first step.

25. What about the future?
Any questions?