Brazil Consults on GHS for Pesticide Classification and Labeling
On 3 Nov 2016, Brazil ANVISA hosted a public hearing regarding three daft rules on toxicological evaluation, labeling and toxicological ratings of pesticides and components (adjuvants). Currently, the evaluation and classification are made under ANVISA Ordinance 3 of 1992, which is now incompatible with the technical and scientific developments made over the last 3 decades since its implementation. The proposed replacement of Ordinance 3 and the release of the latest draft rules reflect the desire of Brazilian authorities to align its national standards with global best practices and the current state of the art. In addition to the new data requirements and criterion, the adoption of GHS is one of the major innovations in the new drafts.
Data Waiving and Prioritization
The drafts emphasize administrative and data requirements for toxicological evaluation of technical product, formulated products and components and offer clear criteria for data waiving and prioritization of certain products:
The toxicological study report of biological products can be replaced by relevant scientific literature or studies conducted by public or private research institutions demonstrating adequate safety
If the technical product or component has been evaluated/registered with another Brazilian authority which has similar measures and criterion on toxicological evaluation, the results can be used during ANVISA’s evaluation
The analysis of low toxicity products (non-skin sensitization, non-skin/eye corrosive/irritating, non-carcinogenicity, non-mutagenicity, non-teratogenic and non-endocrine disruption) will be expedited and prioritized by ANVISA and biological agent, semi -chemicals and microbiological products will be generally considered as low toxicity products. Applicants may apply for the prioritization exclusively through electronic submission;
Negative List of Pesticide Components
A list of components subject to toxicological evaluation will
2016-11-13
China ICAMA Consults on 3 Pesticide Registration Test Guidelines
On 28 Nov 2016, China ICAMA released an announcement opening three draft guidelines on pesticide residue study to public consultation and will solicit public opinion until 12 Nov. The guidelines include:
2016-09-30
China ICAMA Consults on 6 Pesticide Environmental Risk Assessment Draft Guidelines
On 23 Sep 2016, China ICAMA released 6 draft guidelines for pesticide environmental risk assessment and will solicit public opinion until 23 Oct. All guidelines are compiled as agricultural standards including:
3 test guidelines to assess pesticide environmental behavior and impact
2 guidelines on the validation, calculation and determination of degradation kinetics in environmental medium
1 consolidated guidance on the pesticide risk to soil organisms.
2016-09-12
China Institutes Bans on 2,4-D butylate and Paraquat
On 7 Sep 2016, China MoA issued Announcement 2445 to terminate the domestic use of 2,4-D butylate, paraquat dicofol as well as restriction of flubendiamide and 4 other active ingredients.
2016-09-12
China MoA Newly Grants GLP Accreditation to 12 Pesticide Testing Labs
On 31 Aug 2016, China MoA issued Announcement 2443 regarding the GLP accreditation of testing facilities for pesticide registration. 12 laboratories were newly approved, 9 existing GLP labs were approved for expanded study scope and 5 labs were approved for name change.
2016-09-12
Brazil Institutes Ban on Methyl Parathion
On 29 Aug 2016, Brazil ANVISA published Resolution 2297 on the Official Gazette to cancel the approval of methyl parathion pesticides from the 1st of Sep 2016.
2016-09-08
197 Products to be Approved under China Pesticide Registration in 2016
On 1 and 5 September 2016, China ICAMA issued the 8th and 9th Batches of pesticide registration to be approved in 2016 for public consultation until 7 and 11 September.
China Pesticide Registration: Assessment of Risk to Aquatic Ecosystems
Pesticides are wildly used in agricultural production in China. The use of pesticides affects the environment significantly. Pesticides are introduced to the aquatic ecosystem in a variety of ways such as, leaching, evaporation and precipitation cycles, surface runoff etc. Chinese manufacturers produce a large amount of pesticides every year. Technical material production accounts for about 60% of global production capacity. This article will briefly introduce assessment of risk to aquatic ecosystems in China. Pesticide registration in China is based on tiered assessment whereby increased production volume incurs increased regulatory compliance requirements including the evaluation of pesticide impact to aquatic ecosystems. If primary evaluation is unacceptable, senior assessment is necessary. Environmental risk assessment consists of:
Exposure assessment (predicted environmental concentration, PEC)
Effect assessment (predicted no effect concentration, PNEC)
Risk characterization (risk quotient, RQ).
Exposure Assessment
Exposure assessment is made up of primary exposure assessment and senior exposure assessment. For primary exposure assessment, a model is used to predict the surface water exposure level in which worst case scenarios are chosen for model parameters. Generally, the PEC is the maximal predicted environmental concentration, or the weighted predicted environmental concentration.
For senior exposure assessment, modified parameters or field test data are often used in the exposure model, to find parameters similar to the actual situation. Actual monitoring data of common pesticides is also used as the exposure level. When using a model to analyze the exposure concentration, the areas of use, sites of application and methods of application should be considered to obtain the final PEC. During the exposure analysis, we need to find the appropriate endpoint, including soil adsorption coefficient, hydrolysis half-life, photolysis hal
2016-08-30
11 New Active Ingredients to be Fully Approved in China
On 25 Aug 2016, China MoA released the meeting-minutes of the 19th session of the 8 National Expert Committee of Pesticide Registration, which was held on 26 Jul in Beijing. A total of 43 pesticides using 21 new active ingredients were reviewed for full registration. 20 pesticides using 11 new active ingredients were approved, of which 3 were submitted by MNCs: halauxifen-methyl herbicide by Dow Agroscience, fluoxastrobin fungicide and amicarbazone herbicide by Arysta.
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