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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.

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EUROPE: Updates of AIR 4 Guidance documents

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

AIR 4 programme

SANTE-2016-10616–rev 7 – May 2017 – Draft working document – AIR IV Renewal Programme

Applications for tall oil crude and tall oil pitch (repellents by smell of animal or plant origin) were withdrawn and Quizalofop-P-tefuryl moved from group 3 (“substances that may fail to satisfy approval criteria”) to group 4.1 (“substances with current expiry dates between 31 July 2019 and 31 December 2021 that will be postponed two years”).

 

SANTE-2016-11734–rev.5 May 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

Some applicant names were updated, a second Task Force for Sulphur was listed, applications for tall oil crude and tall oil pitch were withdrawn. Applications were received for 3 active substances: cyflufenamid, malathion and fluopicolide.

 

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

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EUROPE – AIR 4 work programme : grouping and prioritising substances

In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals for all the active substances of AIR4 work programme, Commission Implementing Decision 2016/C 357/05 was published on 29 September 2016 with the aim of grouping together similar active substances setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.

The Decision states that the assessment of applications for the renewal of approvals of presumed low-risk active substances and active substances expected to fall under the “cut-off” criteria of Regulation (EC) No 1107/2009 shall be prioritised without delay or with as little delay as possible.

The approval of other substances can be extended in due time if necessary in accordance with Article 17 of Regulation (EC) No 1107/2009. These prioritising rules covers groups 2, 3 and 4 as defined in the AIR 4 working document SANTE-2016-10616–rev 3 (July 2016).

 

To download:

Decision 2016/C 357/05

AIR 4 working document SANTE-2016-10616–rev 3 (July 2016)

 

Our previous article:

EUROPE : Publication of AIR 4 working document

 

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

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EUROPE : Publication of AIR 4 working document

The AIR 4 working document has just been published by DG SANTE. This document provides an overview of indicative submission dates for supplementary dossiers for the renewal of substances expiring between 1 January 2019 and 31 December 2021. It is foreseen that the document will be updated regularly.

For group 1 (51 substances with expiry date before 30/04/2019), the expiry dates will not be postponed since they have the earliest expiration dates.

Substances from group 2 (38 presumed low-risk substances)  have priority. However, because the majority of substances in both Group 1 and Group 2 have expiry dates in 2019, all substances in Group 2 will be postponed by one year. Further extensions are still possible.

For group 3 (15 substances that may be expected to fall under the “cut-off” criteria of Regulation 1107/2009) the expiry dates will not be postponed.

The group 4 (110 substances with current expiry dates between 31/07/2019 and 31/12/2021) is divided to even out the workload. Indeed, 43 substances are postponed by 2 years and 67 substances are postponed by 3 years. A Regulation will be prepared to set new expiry dates.

To be noted:

The applicant must submit an application for renewal 3 years before the current deadline if they wish to renew the approval of the substance. Only when an application is received will the Commission take action and extend the current approval period. If an application is not received, the current expiry date will remain.  

 

To download:

Draft working document AIR IV renewal programme – SANTE-2016-10616–rev 3 (July 2016)

 

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

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EUROPE: Allocation of MS for AIR4 active substances

AIR4 active substances are substances whose approval expires after 31 December 2018 and not later than 31 December 2021.

Regulation (EU) 2016/183 indicates for each of the 223 active substances a rapporteur member state (RMS) and a co-rapporteur member state (cRMS) that have been allocated for the renewal procedure.

 

COMMISSION IMPLEMENTING REGULATION (EU) 2016/183 of 11 February 2016 amending Implementing Regulation (EU) No 686/2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances whose approval expires by 31 December 2018 at the latest

 

Lynxee consulting’s team is at your disposal to prepare your AIR4 renewal dossiers.

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