European Union renews approval of active substance metalaxyl-M

Recently, the European Union issued Regulation (EU) 2020/616 to update and approve the active substance metalaxyl-M. This Regulation takes effect on the twentieth day from the date of promulgation and will come into effect on June 1, 2020, and will restrict the use of seed treatment plant protection products containing this ingredient from June 1, 2021.
 
EU Regulation (EU) No 540/2011 Annex Part A deletes the corresponding entry, Part B adds the corresponding entry, the number is 140. The specific approval information is as follows:

Metalaxyl-M CAS number: 70630-17-0 (R) CIPAC number: 580CAS number: 70630-17-0 (R) CIPAC number: 580

N- (methoxyacetyl) -N- (2,6-xylyl) -D-alanine methyl ester

≥920g / kg

  The following toxic impurities shall not be exceeded in the original drug:

2,6-DIMETHYLANILINE: up to 0.5g / kg;

4-Methoxy-5-methyl-5H- [1,2] thiol 2,2-dioxide: up to 1g / kg;

2-[((2,6-dimethyl-phenyl)-(2-methoxyacetyl) -amino] -propionic acid 1-methoxycarbonyl-ethyl ester: up to 0.18g / kg

When used for seed treatment, only seed treatment sown in the greenhouse can be approved.

In order to implement the unified principles of Article 29 (6) of Regulation (EC) No 1107/2009, the conclusion of Jinghuashuangling's updated report must be taken into consideration, especially Annexes I and II.

In the overall assessment, Member States should pay special attention to:

—Technical parameters of commercial production of original drugs;

—Protect operators and workers, and ensure that the conditions of use specify the use of appropriate personal protective equipment under appropriate circumstances;

-Protect the groundwater when using the substance in areas with fragile soil and / or climatic conditions;

—Protect non-target arthropods, birds and mammals.

Conditions of use should include appropriate risk mitigation measures.

Applicants should also confirm that Jingjiashuangling is not an endocrine disrupting substance according to (EC) No 1107/2009 Annex II 3.6.5 and 3.8.2 as revised by (EU) 2018/605 before May 6, 2022 Update assessment confirmation information.