Decision making for AIR active substances

Crop Protection

European Regulatory Conference11-12 March 2015, Brussels

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…

● 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).

Current situation: AIR-3

Expiry date No AS

< 14 June 201440

July 2014 – November 2015

27 (23)

February 2016 –

November 2017

55

> 31 July 2018 28

AIR-3 substances

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

-

Extension

until 1/2017

until 7/2017

until 7/2018

no extension

-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• 0• 1 month• 11 months• 1.5 months• 2 months• 5 months• 3 months• 6 months

-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???

● 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?

What about AIR-4?

Number of Active Substances: AIR-4

2019 2020 20210

20

40

60

80

100

120

140

160

63 AS14 AS146 AS

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…..

-17-

This has to be stopped!

Article 82 review…

…3 months after renewal of approval of active substance!

Art. 43: Renewal of Authorisation

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?