Transcript Title

Crop Protection
European Regulatory Conference
11-12 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
The AIR programmes
● AIR-1 – 7 substances – 14 MS
● AIR-2 – 31 substances – 21 MS
● AIR-3 – 150 substances – 28 MS
● AIR-4 – 223 substances – 28 MS
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.
Current situation: AIR-2
● Regulation (AIR-2) has been published in
December 2010: (EU) No 1141/2010.
● Guidance Document has been noted
(SANCO/10387/2010 - rev. 8).
● 31 substances: 29 dossiers have been received;
decision making is ongoing.
● Expiry of approval: 31 December 2015.
…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…
Current situation: AIR-3
● Legal framework for AIR-3:
- Regulation with the general procedure (Reg. (EU) No
844/2012);
- List of RMS & Co-RMS (Reg. (EU) No 686/2012);
- Guidance Document (SANCO/2012/11251- rev. 4).
● Extensions only possible if an application has
been submitted.
● Strict timelines (29.5 months from dossier
submission till decision).
AIR-3 substances
Expiry date
No AS
Extension
Regulation
< 14 June 2014
40
until 1/2017
Reg. 823/2012
July 2014 –
November 2015
27 (23)
until 7/2017
Reg. 1197/2012
February 2016 –
November 2017
55
until 7/2018
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
> 31 July 2018
28
no extension
-
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:
-8-
•
•
•
•
•
•
•
•
•
Time
0
1 month
11 months
1.5 months
2 months
5 months
3 months
6 months
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-
What about AIR-4?
● Legal framework same as for AIR-3:
- Regulation with the general procedure (Reg. (EU) No
844/2012);
- List of RMS & Co-RMS: in preparation;
- Guidance Document (in principle SANCO/2012/11251
applies).
● Strict timelines (29.5 months from dossier
submission till decision).
● Extensions necessary?
Number of Active Substances: AIR-4
160
140
120
100
63 AS
80
14 AS
60
146 AS
40
20
0
2019
2020
2021
AIR-4: 2019
Batch
Current expiry date
Number of AS
1
28 February 2019
5
2
30 April 2019
22
3
31 July 2019
4
4
31 August 2019
87 ('list 4')
5
31 October 2019
5
6
30 November 2019
7
7
31 December 2019
16
Total
146
AIR-4: 2020
Batch
Current expiry date
Number of AS
1
31 March 2020
1
2
30 April 2020
1
3
31 May 2020
2
4
30 June 2020
2
5
31 July 2020
3
6
31 August 2020
1
7
31 October 2020
2
8
31 December 2020
3
Total
14
AIR-4: 2021
Batch
Current expiry date
Number of AS
1
31 January 2021
2
2
31 March 2021
1
3
30 April 2021
5
4
31 May 2021
35
5
31 July 2021
2
6
30 September 2021
1
7
31 December 2021
17 (7 AIR-1 AS)
Total
63
The AIR-programmes…..
…..the workload…..
This has to be stopped!
Article 82 review…
-17-
Art. 43: Renewal of Authorisation
…3 months after renewal of approval of active substance!
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.
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.
Increasing Article 43 workload…
• Guidance on renewal of authorisations is in
preparation to assist in managing the workload!
New Data Requirements
● Apply from 1 January 2014.
● Active Substance:
- for all applications submitted under Regulation 844/2012
("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/
2013 rev. 3).
Data Requirements - AIR-2
● Active Substance:
- for all applications submitted under Regulation 1141/2010
old data requirements apply.
● Products:
- current text: old data requirements apply only as long as
applications for re-authorisation are submitted before
31 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/
2013 rev. 4 in prep.)
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.
What about the future?
Any questions?