Assessment and approval of active substances

 

Active substances in plant protection products are assessed and approved jointly within the European Union.

 

For the purposes of active substances, existing active substance (EAS) denotes substances placed on the market before 1993, while new active substance (NAS) means those placed on the market thereafter.

 

The competent authorities in Member States carry out risk assessment on active substances on the grounds of the information submitted by the applicants. The approval of active substance is based on the conclusion by the European Food Safety Authority (EFSA), and is voted on in the EU Standing Committee on Plants, Animals, Food and Feed.

 
Decisions regarding active substances can be found in the Commission's active substance database.

 

First review programme for existing active substances

 

The first review programme of active substances in plant protection products on the EU level was accomplished in 1992—2009. For some substances, the assessment was delayed as much as to 2012. This assessment round was effected following the requirements of the then-valid Directive on Plant Protection Products 91/414. The related active substances were approved for 10 years.

 

The assessment for active substances in accordance with the new Regulation on Plant Protection Products (EC) No 1107/2009 is similar to that laid down by the earlier Directive.

 

 

Current programme for renewal (second review) of active substances

 

First stage of renewal assessment (AIR1)

 

The work for the renewal of active substances started in the European Commission while the Directive on Plant Protection Products was still in force. The first renewal phase was AIR1 pilot project (AIR = Annex I Renewal), enacted by the Commission Regulation (EC) No 737/2007

(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:169:0010:0018:EN:PDF).
The first renewal phase comprised seven active substances. Finland did not participate in the evaluation work, which was completed in 2011.

 

Second stage of renewal assessment (AIR2)

 

The renewal of second group of active substances was subject to the Regulation (EC) No 1141/2010
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:322:0010:0019::PDF).

This renewal work was launched while the Directive on Plant Protection Products was still in force. Despite this, the approvals or non-approvals of active substances are made pursuant to the new Regulation (EC) No 1107/2009. The Commission has published a separate Guidance Document on the subject (SANCO/10387/2010 rev. 8, 28.10.2010

(http://ec.europa.eu/food/plant/plant_protection_products/approval_active_substances/docs/renewal_guidance_en.pdf).

The AIR2 programme includes 31 active substances. Finland participates in the programme as the co-rapporteur Member State (co-RMS) for famoxadone, while the rapporteur member state (RMS) is the United Kingdom (UK).

 

Third stage of renewal assessment (AIR3)

 

The AIR3 programme, is run under the Implementing Regulation (EU) No 844/2012 in other words the Renewal Regulation
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:252:0026:0032:EN:PDF),

and the Guidance Document SANCO/2012/11251 rev. 1.2, July 2012

(http://ec.europa.eu/food/plant/pesticides/approval_active_substances/docs/guidance_renewal__1141_2010_en.pdf).

The AIR3 programme includes 150 active substances whose approval expiry dates fall between 1 January 2013 and 31 December 2018, divided between the EU member states, as laid down by the Implementing Regulation (EC) No 686/2012
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:200:0005:0010:EN:PDF).

Finland is the rapporteur Member State for six active substances (amidosulfuron, clopyralid, desmedipham, phenmedipham, foramsulfuron and propiconazole) and the co-rapporteur Member State for five active substances (fenoxaprop-P, imazosulfuron, iodosulfuron, rimsulfuron and thiophanate-methyl). The renewal programme AIR3 was initiated in 2014.

 

 

Documentation (dossier) on active substance to be submitted

 

Assessment of active substance

 

Finland is the rapporteur Member State (RMS):

  • 3 copies on a CD
  • 1 copy on paper

 

Finland is the co-rapporteur Member State (co-RMS):

  • 3 copies on a CD

 

Finland is not the rapporteur nor the co-rapporteur Member State:

  • 1 copy on a CD

 

Please note! Summaries of the copies on a CD shall be in Word format.