ICAMA Seeks Public Consultation on Registration Rules for Glyphosate and Glyphosate Salts

ICAMA CHINA

On Oct 8 2013, the Institute for the Control of Agrochemicals under the Ministry of Agriculture (ICAMA) issued a circular “Technical Opinion on Registration Management for Glyphosate and its Salts”, which will be available for public consultation until Oct 20, 2013.

As China's most important herbicide, glyphosate has been registered in China for over two decades. The active ingredient is usually present in final products as various types of glyphosate salts. Currently, the herbicide predominates in the salt forms of isopropylamine, ammonium, dimethylamine, potassium and sodium in China’s market. In order to facilitate the production of formulated products,Chinese producers are continually expanding the applications and uses of glyphosate and new salt compounds are continually being formulated.

However regulators have yet to decide on whether glyphosate salt derivatives should be individually registered or continue to be grouped under the umbrealla term glyphosate active ingredient products. Under Chinese national quality standards, the quality of the final product is indicated by the concentration of glyphosate other than based on individual assessment of the various salt compounds. Both the Joint Announcement 946 and Joint Announcement 1158 " Technical requirement on the concentration of active ingredient in the pesticide product" provided the maximum number of the content levels of the active ingredient in one type of final products. For example if the active ingredient present in a given formulation type is in an emulsion expressed as “emulsifiable concentration” or in an “aqueous solution” (EC, AS), or the active ingredient is mixed with other active ingredient with the same relative proportions in one type of formulated combination ( e.g. A 2%+ B 6% EC and A 10%+ B 30% in EC), for all instances the concentration of active ingredients used must conform to 5 arbitrarily set concentration levels. Pesticide products with concentration levels exceeding the standardized limits will not be approved for pesticide registration or granted a manufacturing permit. ICAMA currently groups all these salt compounds under the term “glyphosate active ingredient” in its registration management. Thus, the Institute only permits one type of glyphosate salt in different types of final products.

The original measures improved ICAMA’s efficiency as there was obviously less workload for regulators and also decreased the number of glyphosate registration applications. Global glyphosate market trends however have increasingly favored glyphosate salt products and there are fears that these regulations will damage China’s competitiveness in the global market. Furthermore, technological progress has seen development of new testing methods for glyphosate salts which will greatly help regulators to ensure both the quality and safety of these new products.

ICAMA announced the following suggestion on glyphosate registration for public consultation and hinted that the national quality standards for the herbicide would also be revised:

  • The salt compounds will be allowed to register as technical material (active ingredient): For salt compound if there is sufficient proof that the salt derivative has the same functions and metabolic activity  as its precursor exemptions for testing its sub-chronic toxicity, chronic toxicity and environmental impact assessment will be granted
  • The formulated salt products can be registered on the basis of their forms of salt compounds ICAMA will approve all types of salt products at specific concentrations in different types of formulation and the applicant should declare the concentration level of both glyphosate and its salt compound;
  • Certificate of origin of formulated glyphosate salts: If a company outsources any glyphosate materials the certificate of origin of these materials should be submitted when applying ICAMA registration for the formulated products.

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