Based on the above analysis of banned substances, we can infer the registration trend of the following popular products.
❶ Glufosinate
Glufosinate-ammonium is the levorotatory isomer of glufosinate-ammonium. Glufosinate itself is a racemate composed of a mixture of L-Glufosinate-ammonium and D-Glufosinate-ammonium.
Studies have shown that among the mixed isomers, the real herbicidal activity is L-glufosinate, namely glufosinate essence. After enriching the isomers that really exert herbicidal activity, the same effect will be exerted, the dosage of glufosinate-ammonium will be greatly reduced, and the risk of application will also be reduced.
Since glufosinate-ammonium is banned in the EU, can glufosinate-ammonium continue to apply for EU registration?
The main reason for the ban of glufosinate-ammonium is that it is classified as reproductive and developmental toxicity category 1B, which meets the EU substance ban standard, and the applicant no longer supports it. Therefore, if glufosinate-ammonium has different hazard classifications, it is entirely possible to submit an application for substance approval to the EU again. Such an example has actually happened in the EU. For example, metolachlor is banned in the EU, but metolachlor sperm is approved.
Current research shows that the metabolic pathway of glufosinate-ammonium may be different from glufosinate-ammonium, and the classification of glufosinate-ammonium is likely to be inconsistent with glufosinate-ammonium. Therefore, before an enterprise submits a registration application, the key point to be confirmed in the research and development and pre-risk assessment is the reproductive and developmental toxicity of glufosinate-ammonium.
❷ Glyphosate
In the last re-evaluation, for various reasons, glyphosate was only granted a 5-year validity period.
After approval, the next round of re-evaluation work began immediately. The EU sent France, Hungary, the Netherlands and Sweden to form a strong glyphosate evaluation team, which completed the evaluation draft last year.
Although the draft assessment found that glyphosate fully met the approval requirements, most people still felt that there was still a lot of uncertainty about whether glyphosate was approved. Controversy continues over whether glyphosate is carcinogenic. Although the review of glyphosate has not yet ended, the German government has passed regulations stating that glyphosate will be completely banned from 2024.
This year, however, there is good news for the approval of glyphosate, which is the final conclusion of the CLP classification of glyphosate. That is, in May of this year, ECHA officially announced the final conclusion of the hazard classification of glyphosate, confirming that glyphosate has no carcinogenic classification.
The focus of previous discussions on glyphosate is carcinogenicity. This classification is undoubtedly good news for the approval of glyphosate. The current hazard classification of glyphosate fully meets the basic conditions for EU substance approval. If the follow-up goes well, in the near future. In the future, we can look forward to the smooth approval of glyphosate in the EU.
❸ Candidate Substitute Substances
Candidate substitute substances are the substances that everyone is most worried about being banned. Is there a high probability that such substances will be banned?
Based on the approval information of EU active substances, there are currently 91 candidate alternative substances in the EU, of which 53 substances are approved, accounting for 11.2% of all approved substances, and 38 substances are in unapproved status, accounting for 0.04% of all unapproved substances .
It can be seen that most of the candidate substitute substances are not banned in absolute quantity or relative quantity, but most of them are in the approved state, so there is no need to worry too much about the risk of candidate substances being banned.
Candidate substitute substances are relatively harmful substances, but they do not meet the prohibition standards. For the registration of such substances, additional attention should be paid to the risk assessment of the product. When the use risks are controllable, they will generally not be banned.
In general, the EU pesticide regulation is not only a risk-oriented regulation, but also a hazard-oriented regulation. When the hazard of the active substance reaches a certain level, the risk assessment is no longer carried out, and the corresponding active substance is directly banned. Under the condition that the harm is OK, each product still needs to ensure that the risk of use is controllable before it can be approved.
