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EUROPE – COM: Updated overview of AIR4 and AIR5 applications

The overview of the applications for renewal of approval under article 14 of Regulation (EC) No 1107/2009  for the active substances of the AIR4 and AIR5 programmes have just been updated by DG SANTE.

These new versions dated October 2020 replace the previous revisions dated September 2020.

 

To download: 

SANTE-2016-11734–rev 22 (October 2020): AIR IV renewal programme applications for renewal of approval

SANTE-2019-13022–rev 4 (October 2020): The 5th renewal programme applications for renewal of approval

 

See also our previous articles: 

EUROPE – COM: Updated overview of AIR5 applications

EUROPE – COM: Updated overview of AIR4 and AIR5 applications

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE – COM: Updated overview of AIR5 applications

The overview of the applications for renewal of approval under article 14 of Regulation (EC) No 1107/2009  for the active substances of the AIR5 programme has just been updated by DG SANTE.

This new version dated September 2020 replaces the previous revision dated June 2020.

 

To download: 

SANTE-2019-13022–rev 3 (September 2020): The 5th renewal programme applications for renewal of approval

 

See also our previous article: 

EUROPE – COM: Updated overview of AIR4 and AIR5 applications

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

EUROPE – COM: Updated overview of AIR4 and AIR5 applications

The overview of the applications for renewal of approval under article 14 of Regulation (EC) No 1107/2009  for the active substances of the AIR4 and AIR5 programmes have just been updated by DG SANTE.

These new versions dated June 2020 replace the previous revisions dated March 2020 and February 2020 respectively.

 

To download: 

SANTE-2016-11734-rev 20 (June 2020): AIR IV renewal programme applications for renewal of approval

SANTE-2019- 13022–rev 2 (June 2020): The 5th renewal programme applications for renewal of approval

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

EUROPE – COM: updated AIR4 and AIR5 work programme

The AIR4 and AIR5 work programmes for active substances renewal have just been updated by DG SANTE following the recent publication of Regulation (EU) 2020/103 amending Regulation (EU) No 844/2012 as regards the provisions necessary for the implementation of the renewal procedure under Regulation (EC) No 1107/2009.

In these new versions of the work programmes, the submission date of the supplementary dossiers for the substances with an expiry date as from 13 May 2023 is set to 33 months instead of 30 months before the expiry of the approval.

 

To download: 

SANTE-2016-10616-rev 12 (February 2020): Draft working document AIR IV renewal programme

SANTE-2018- 10048–rev 3 (February 2020): Draft working document establishing the fifth renewal programme

 

See also our previous article: 

EUROPE: Synchronisation of the renewal procedure for active substances with the harmonised classification process

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

EUROPE: AIR5 work programme

Further to the publication in January of Regulation (EU) 2018/155 allocating the MS for the renewal of AIR5 active substances, the Commission has released a work programme:

  • the decision of 06 June 2018 gives priority to the evaluation of active substances that may fail the approval criteria (= that meet the “cut-off” criteria) and of candidates for substitution, and groups the evaluation of active substances with similar properties
  • the draft working document SANTE/2018/10048 provides an overview of indicative dates for application and dossier submission of 66 active substances. They are divided into 2 groups: no change in expiry date, a.s. to be potentially extended.

 

To download:

Commission Implementing Decision of 6 June 2018 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council

SANTE-2018-10048–rev 1 (June 2018): Draft working document establishing the fifth renewal programme

 

See also our previous article:

EUROPE: Allocation of MS for AIR4 and AIR5 active substances

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/30

 

EUROPE: Allocation of MS for AIR4 and AIR5 active substances

Regulation (EU) 686/2012 indicates for each active substance a rapporteur member state (RMS) and a co-rapporteur member state (cRMS) that have been allocated for the renewal procedure.

AIR4 active substances are substances whose approval expires after 31 December 2018 and not later than 31 December 2021. In view of the length of the evaluation process and the recent notification by the United Kingdom pursuant to Article 50 of the Treaty on European Union, it was necessary to re-allocate the evaluation of the active substances for which the United Kingdom was the RMS or the cRMS, and for which no supplementary dossier had been submitted yet. The updates set by Regulation (EU) 2018/155 concern the following active substances: Aluminium ammonium sulphate, Azoxystrobin, Bupirimate, Carbetamide, Chlormequat, Ethylene, Fenbuconazole, Fluopicolide, Fluquinconazole, Flutriafol, Garlic extract, Metazachlor, Myclobutanil, Paclobutrazol, Pepper, Plant oils/Citronella oil, Propaquizafop, Quizalofop-P-ethyl, Quizalofop-P-tefuryl, Tri-allate and Urea.

AIR5 active substances are substances whose approval expires after 31 December 2021 and not later than 31 December 2024 and for which the evaluation had not been allocated yet. The allocation of RMS and cRMS is set by Regulation (EU) 2018/155 for each AIR5 active substance.

 

To download:  

COMMISSION IMPLEMENTING REGULATION (EU) 2018/155 of 31 January 2018 amending Implementing Regulation (EU) No 686/2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/