Beyond AIR-4

Date: 8 April 2020

As you can already see from our previous posts, Annex-I-Renewal is a never-ending story. Active substances are (re)approved (“included into Annex I”) only for a limited period of time; where after they have to be reassessed. One interesting difference between (first) approval and re-approval concerns this approval time: while normal a.s. (i.e. those not being Candidates for Substitution or Low Risk Active Substances) are (first) approved for 10 years, their re-approval is normally issued for 15 years.

Although the fact of renewal will remain, we can at least change the expression which is no longer adequate: AIR-5 no longer mentions any “Annex-I”, but is officially called “The 5th renewal programme” – but everyone will understand what you say, if you mention AIR-5. It calls upon 65 a.s. with expiry dates between 1 January 2022 and 31 December 2024 (Commission Implementing Decision C/2018/3434). In this case, a.s. with similar properties are grouped together. As before, those that “may fail to satisfy the approval criteria” and – unlike before - those that are listed as candidates for substitution will be prioritised and these assessments “shall be carried out without delay or with as little delay as possible”, i.e. without extension of the expiry date of the a.s.

And finally, due to the similarities in their respective properties, the following a.s. are grouped and their expiry dates are amended accordingly (SANTE-2018- 10048):

(i)   fluxapyroxad, bixafen, sedaxane, penflufen and penthiopyrad;
(ii)  disodium phosphonates and potassium phosphonates;
(iii) eugenol, geraniol and thymol;
(iv) Trichoderma atroviride (strain I 1237) and Trichoderma asperellum (strain T34);
(v)  benzovindiflupyr and isopyrazam.

As for all renewal endeavours, the applicant must submit an application to be granted an extension of the expiry date of the a.s. (SANTE-2019-13022).

And the 6th renewal programme? Is being discussed and the EU Commission has started its work. It will call upon a.s. expiring from 2025 to 2028 and the allocation of Rapporteur Member States is currently ongoing. It will take into account issues such as the latest amendments to the General Food Law, i.e. access to study reports.

Bernd Brielbeck