ICS Code(s): 13, 65 Pesticides

This Draft Resolution provides the criteria and procedures for toxicological reassesment of active ingredients of pesticides within the scope of the Brazilian Health Regulatory Agency (ANVISA) . The active ingredients of pesticides that show signs of altering risks to human health can be re-evaluated at any time. The toxicological re-evaluation process of active pesticide ingredients includes: indication of the active ingredients of pesticides for toxicological re-evaluation; selection and definition of the scope of the revaluation; disclosure of the beginning of the revaluation; public consultation; publication of the regulatory decision; elaboration of the final technical note. ANVISA will select the active ingredients of pesticides that will be submitted to the re-evaluation based on the risk of to human health and the list of the active ingredients selected to re-evaluation will be shared on Anvisa website. The toxicological re-evaluation of active ingredients shall follow the criteria for toxicological evaluation of technical and formulated products established by the technical regulation. A public consultation will be published with the proposed regulatory decision on the active ingredient. The Brazilian Health Regulatory Agency will publish the final decision about the revaluation process. This Resolution revokes Resolution RDC Nº 48 of 7 July 2008, published on 8 July 2008 on Brazilian Official Journal nº 129, section 1, pages 43 and 44.