European Union: The re-evaluation of prochlorfenacil was finally approved, and the changes and impacts associated with it

Recently, the European Union issued an official announcement (Commission Implementing Regulation (EU) 2022/43) announcing that the re-evaluation of Flumioxazin was approved, and the validity period was updated from March 1, 2022 to February 28, 2037
.
 

Flumioxazin is a phthalimide herbicide developed by Sumitomo Chemical Industry Co.
, Ltd.
and first listed in Japan in 1993
.
According to the mechanism of action, it is a protoporphyrinogen oxidase (PPO) inhibitor and is a contact selective herbicide
.

Flumioxazin was first approved under the old EU regulation and is listed in the second group AIR-2 programme in the EU Active Substance Reassessment Scheme
.
The applicant, Sumitomo Chemical, submitted an application for re-evaluation in 2012, and the substance was finally approved earlier this year after more than a dozen extensions
.

Although the specifications of active substances and related impurities have not changed since the approval, a major change worthy of our attention is that after the re-evaluation, prochlorfenapyr is no longer listed as a candidate substitute substance, and the EU has removed it from the candidate substitute substance.
removed from the list
.

Why is it no longer a candidate for replacement?

In 2015, the European Union first issued a list of candidate alternative substances.
According to the then Regulation (EC) No 1272/2008, Flumioxazin was classified as reproductive toxicity 1B, so it was listed as a candidate alternative substance
.

According to the revised Regulation (EC) No 1272/2008 issued in March last year, the reproductive toxicity classification of Flumioxazin was reduced to Category 2, so it no longer meets the requirements for being listed as a candidate alternative substance
.

What are the implications of being removed from the Candidate Alternative Substances List?

Approval period

Article 24 of Regulation (EC) No 1107/2009 clearly stipulates that the approval period of candidate alternative substances for the first time and after re-evaluation shall not exceed 7 years
.
After this re-evaluation, Flumioxazin obtained the longest approval period allowed by the EU after the re-evaluation of active substances - a validity period of 15 years, which greatly delayed the second re-evaluation.
time
.

The delay of the second re-evaluation time will not only ensure the long-term and stable sales of prochlorfenazone products in the EU market, but also greatly benefit the subsequent registration of preparation products at the level of each member state, and also prolong the process of preparation products.
Best time to register
.

Formulation product registration

After the re-evaluation and approval of Flumioxazin, the preparation products containing Flumioxazin that have been approved by each member state need to submit a product renewal application within 3 months, and according to the specific renewal approval of each member state.
To calculate the protection period (30 months) of the data submitted during the substance re-evaluation phase
.

Due to the current workload of EU member states, delays in product renewals are also common, and the free citation time for data submitted during the substance re-evaluation phase will also be extended accordingly
.
For substances with a longer approval period, even if they choose to wait for the data protection period before submitting, it can ensure that there is still a considerable amount of time before the next substance re-evaluation.
Applicants are especially friendly
.