By Lin Fang on Wednesday, 23 November 2016
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 be published on ANVISA’s website and be reviewed during the evaluation of their formulated products. For components not yet included into the list, companies will be required to submit the test reports or reference information on the components in accordance with the annex. The draft also provides a negative list of components assumed to have characteristics that prohibit them from registration. Totally 34 substances along with their CAS number and prohibitive characteristic were included in annex. These substances are banned from use in pesticides. Companies may also provide toxicological dossiers to justify non-classification and exclusion from this list.
Tests and Information Required
The tests and required information on technical product, formulated product, equivalence determination between technical products and components are separately provided in different annexes. The concepts of evidence strength, weight of evidence and endpoint are used to determine the strength of a registration application. As an important alternative method, structure-activity relationship analysis will be also widely encouraged to reduce in vivo tests and identify the endpoint:
Table 1- Comparison between Existing and Draft Regulations
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