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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.

Updates had already been published in January 2021. In the new versions of February 2021, the deadlines for the submission of the renewal application of some active substances of the AIR4 and AIR5 programmes have been extended according to the Regulation (EU) 2020/1740. For memory, this regulation applies from 27 March 2021 for all active substances whose approval period expires on or after 27 March 2024. Applications according to the new rules must be submitted no later than 3 years before the expiry of the active substance.

 

To download: 

SANTE-2016-11734–rev 24 (February 2021): AIR IV renewal programme applications for renewal of approval

SANTE-2019-13022–rev 6 (February 2021): The 5th renewal programme applications for renewal of approval

 

See also our previous articles: 

EUROPE – COM: Updated overview of AIR4 and AIR5 applications

EUROPE – COM: Updated overview of AIR5 applications

 

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 programmes

The AIR4 and AIR5 work programmes for active substances renewal have just been updated by DG SANTE following the recent publication of Regulation (EU) No 2020/1740 repealing Regulation (EU) No 844/2012 as regards the provisions necessary for the implementation of the renewal procedure for active substances under Regulation (EC) No 1107/2009.

Application dates for substances for which the new renewal rules apply according to Reg. (EU) No 2020/1740 have been indicated. The application consists of providing the complete renewal dossier.

The “old renewal rules” of Regulation (EU) No 844/2012 still apply to most of the active substances of the AIR4 programme. Only some active substances from group 4(2) are covered by the “new renewal rules”.

In addition, the “new renewal rules” apply to the majority of the active substances of the AIR5 programme.

 

To download: 

SANTE-2016-10616-rev 13 (December 2020): Draft working document AIR IV renewal programme

SANTE-2018-10048-rev 4 (December 2020): Draft working document establishing the fifth renewal programme

 

See also our previous articles: 

EUROPE – COM: updated AIR4 and AIR5 work programme

EUROPE – COM: New renewal procedure for active substances

 

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 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 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: Updates of AIR 3 and AIR 4 working documents

AIR 3 programme

SANCO/2012-11284 – Rev. 22 – December 2018 – Draft working document – AIR III Renewal programme

This 22nd revision contains new expiry dates set by Regulation (EU) No. 2018/1262 of 20 September 2018 (for: 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide,  deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron) and by Regulation (EU) No. 2018/1796 of 20 November 2018 (for amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron).

 

AIR 4 programme

SANTE-2016-10616Rev. 10 – December 2018 – Draft working document – AIR IV Renewal programme

SANTE-2016-11734 – Rev. 11 – December 2018 – Draft working document – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

These new versions update revision 9 and 10 of June 2018 of guidance documents SANTE-2016-10616 (AIR IV Renewal programme) and SANTE-2016-11734 (application overview for AIR IV substances).

 

See also our previous articles:

EUROPE: Updates of AIR 3 and AIR 4 working documents (23 July 2018)

 

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

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

 

EUROPE: Updates of AIR 3 and AIR 4 working documents

AIR 3 programme

SANCO/2012/11284 – Rev. 21  – June 2018 – Draft working document – AIR III Renewal programme

This 21th revision contains new expiry dates set by Regulation (EU) 2018/524 of 28 March 2018 (Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram) and Regulation (EU) 2018/917 of 27 June 2018 (alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor). It also contains the renewal of active substances (Ampelomyces quisqualis strain AQ10, carfentrazone-ethyl and trifloxystrobin).

 

AIR 4 programme

SANTE-2016-10616-rev 9 – June 2018 – AIR IV Renewal programme

SANTE-2016-11734-rev.10 –  June 2018 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

These new versions update revision 8 of October 2017 and 9 of February 2018 of guidance documents SANTE-2016-10616 (AIR IV Renewal programme) and SANTE-2016-11734 (application overview for AIR IV substances).

 

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

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

EUROPE: Updates of AIR 3 and AIR 4 working documents

AIR 3 programme

SANCO/2012/11284 – Rev. 20 – February 2018 – Draft working document – AIR III Renewal programme

This new revision contains new expiry dates for substances in batch 3 and batch 7 as set by Regulation (EU) 2018/84 (chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide).

AIR 4 programme

SANTE-2016-11734–rev.9 – February 2018 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

This new version updates revision 7 of October 2017.

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

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

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/

 

EUROPE: Updates of AIR 3 and AIR 4 Guidance documents

A number of SANCO and SANTE guidance documents have been updated:

 

AIR 3 programme

SANCO/2012/11284 – Rev. 19 – November 2017 – Draft working document – AIR III Renewal programme

The new revision contains new expiry dates for substances in batch 1, batch 2, batch 3, batch 5, 6, and 7.

Note that revision 19 replaces revision 18 that was uploaded prematurely by mistake. The extensions for batches 3 and 7 (all from 31.01.2018 to 31.01.2019) were deleted.

 

AIR 4 programme

SANTE-2016-10616–rev 8 – October 2017 – Draft working document – AIR IV Renewal Programme

The new revision shows the non-approval of tall oil pitch and tall oil crude, and the phase out of triflumizole and spirodiclofen (no applications received). A new page is added to the Working Document, with implementing Regulations (extensions).

SANTE-2016-11734–rev.7 October 2017 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

This revision presents an overview of received applications, namely carbon dioxide (name change of the Carbon Dioxide Renewal Taskforce), cyflufenamid (applicant is Envigo, on behalf of Nisso Chemical Europe) and flonicamid (an application was received on 29.08.2017, name of the applicant not provided).

 

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

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