Posts

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: New renewal procedure for active substances

Commission Regulation (EU) 2020/1740 of 20 November 2020 repeals Commission Regulation (EU) 844/2012 and sets out the new provisions necessary for the implementation of the renewal procedure for active substances. This follows the adoption of Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in all areas of the food chain where the European Food Safety Authority (EFSA) conducts a scientific risk assessment. Both regulations will apply from 27 March 2021.

The main changes deal with the schedule of the different steps of the renewal procedure, in particular:

  • the provision of pre-submission advice on intended tests and studies for the purposes of a renewal, preceded by a specific notification by the potential applicant and consultation of third parties;
  • the submission of renewal applications on a central online system via the IUCLID software at least three years before the expiry of the approval period of an active substance.

Regulation (EU) 2020/1740 applies for all active substances whose approval period expires on or after 27 March 2024.

In this context, for several active substances, the approval periods have been extended by Regulation (EU) 2020/2007 of 8 December 2020 to allow applicants to prepare and submit their dossiers in the required format.

 

To download: 

Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020

Commission Implementing Regulation (EU) 2020/2007 of 8 December 2020

 

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

Commission Implementing Regulation (EU) 2020/103 of 17 January 2020 amends 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.

A 3-month additional time is allowed to the rapporteur Member State for preparing the draft renewal assessment report of the active substance (RAR) and the dossier of harmonised classification and labelling submitted to the European Chemicals Agency (ECHA). In consequence, the European Food Safety Authority (EFSA) will also have these 3 additional months for preparing its conclusion. In return, the period allowed to the applicants will be reduced by 3 months between the submission of the application of renewal and the submission of the supplementary dossiers.

Thus, supplementary dossiers should be submitted no later than 33 months, instead of 30 months, before the expiry of the approval. 

The rapporteur Member State will have 13 months, instead of 12 months, to prepare and submit the renewal assessment report (RAR) to the Commission and to EFSA. Additional information requests to the applicants and consultation of EFSA and other member states do not lead to an extension of the period of 13 months.

The rapporteur Member State should submit at the latest at the time of submission a proposal to ECHA to obtain an opinion on harmonised classification of the active substance at least for the following hazard classes: 

  • explosives,
  • acute toxicity, 
  • skin corrosion/irritation, 
  • serious eye damage/eye irritation,
  • respiratory or skin sensitisation,
  • germ cell mutagenicity,
  • carcinogenicity,
  • reproductive toxicity,
  • specific target organ toxicity, single exposure,
  • specific target organ toxicity, repeated exposure,
  • hazardous to the aquatic environment.

The Committee for Risk Assessment from ECHA should adopt the opinion within 13 months from the submission of the dossier.

 

These new implementations apply to renewal procedures of active substances for which the approval period expires on or after 13 May 2023, excepted the substances for which supplementary dossiers have already been submitted before 17 January 2020.

 

To download: 

COMMISSION IMPLEMENTING REGULATION (EU) 2020/103 of 17 January 2020 amending Implementing Regulation (EU) No 844/2012 as regards the harmonised classification of active substances

 

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

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

 

FRANCE – ANSES: Management of PPPs applications following the renewal of active substances approval

ANSES published on 18.10.2018 a memo describing the management of applications for PPPs authorisation following the renewal of active substances approval. This memo recalls the regulatory context of the active substances renewal in the framework of Regulation (EC) No. 1107/2009 and describes the consequences of the active substances renewal for the applications for PPPs authorisation before and after the active substance renewal, in the case of applications for new PPPs authorisation as well as in the case of PPPs already approved (Article 43).

Applications related to PPPs for which the authorisation is being renewed under article 43 are classified into three categories described in the memo: applications essentially administrative that may be processed during the process of authorisation renewal, applications that cannot be processed by ANSES during the period of evaluation of the authorisation renewal (frozen period) and applications that may be processed in parallel with the renewal authorisation, for which the evaluation cannot be finalised before  the renewal evaluation is complete.

Finally, the theoretical timelines for the renewal of PPP authorisations pursuant to Article 43 of Regulation (EC) No.1107/2009 and to the Guidance document on the Renewal of Authorisations is set out in appendix and details on the definition of the frozen period are given.

 

To download:

Gestion des demandes relatives à la mise sur le marché de produits phytopharmaceutiques suite au renouvellement de l’approbation de substances actives (in French)

 

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

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

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.

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