Brazil proposed toxicological information of pesticides, related products and wooden preservatives Brazilian Health Regulatory Agency (Anvisa) proposed following: 1) Toxicological information for labels and leaflets of pesticides, related products and wooden preservatives: This Resolution provides for toxicological information for labels and leaflets of pesticides, related products and wooden preservatives, within Anvisa. The guidelines for the preparation of toxicological information for labels and leaflets of pesticides, related products and wooden preservatives are approved within Anvisa. The purpose of this Resolution is to establish: I - the obligatory information related to the protection of human health that must be included in pesticide labels and leaflets, similar products and wooden preservatives; and II - the adoption of the labeling guidelines of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The company is responsible for all labeling and package leaflet information, and must present it clearly and ensure that it is adequate and sufficient for health protection purposes. ANVISA may, at its discretion and with a reasoned technical justification, require the company that holds the record to change the texts of labels and package leaflets. The labels and package inserts of biological products and wooden preservatives must follow the provisions of this Resolution and the determinations provided in other specific devices and norms, and the necessary adaptations must be made to the peculiarities of the product. For information on appropriate poisoning prevention or risk minimization measures, the pictograms recommended by the Food and Agriculture Organization of the United Nations (FAO) should be used on pesticide labels and leaflets, as well as on wood preservatives. ANVISA may make available on the ANVISA website the latest version of the package leaflets and approved labels in relation to health information. Companies with already registered models of labels and pesticides, wood preservatives and preservatives must comply with this Resolution by means of a notification, with protocol under a specific subject code, and submit electronically to ANVISA all relevant documentation, up to 360 (three hundred and sixty) days after the validity of this Resolution, and may implement the labels and package inserts, without prior authorization from ANVISA. It revokes item 2 of the "Guidelines and Requirements of the Ministry of Health, Registration Authorization, Renewal of Registration and Extension of Use of Agrochemicals and Related", approved by the Product Divisions, Human Ecology and Environmental Health and Risk Assessment as "Guidelines and Requirements Regarding the
Authorization of Records, Renewal of Registration and Extension of Use of Agrotóxicos and Afins Products – n° 01, 09 December 1991", published in the Federal Official Gazette on 13 December 1991 and Ratified by Administrative Rule 03, 16 January 1992, of the Technical Department of Normative of the Health Surveillance Secretariat of the Ministry of Health. Click Here for Notification 2) Criteria for the evaluation and toxicological classification of pesticides, components, related products and wooden preservatives: Resolution establishes the criteria for the evaluation and toxicological classification of pesticides, components, related products and wooden preservatives, within ANVISA. The process of toxicological evaluation of products must be instructed with all the documentation established in Decree No. 4,074, of January 4, 2002, its updates or other specific legislation. The documentation required for the toxicological evaluation for product registration and post-registration shall be in accordance with specific legislation and standards. In order to instruct or justify the granting of registration to third parties, ANVISA may use data or information related to the results of studies submitted by another company. All toxicological studies submitted to comply with this Resolution shall be carried out in accordance with current protocols published by the Organization for Economic Co‑operation and Development (OECD) or other authorities having similarity of requirements and validation. Without prejudice to the provisions of Decree No. 4,074 of 4 January, 2002, for the studies of corrosion/skin irritation and ocular corrosion/irritation, the toxicological profile of a technical product is considered equivalent to the profile of the technical reference product, when does not fall into a category of greater danger, in accordance with specific legislation and in accordance with the equivalence criteria of the Food and Agriculture Organization of the United Nations (FAO). For purposes of toxicological classification, the criteria based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) are adopted in this Resolution. For pesticides, related and preservatives of wood already registered, the company must evaluate its toxicological dossier and verify the need for toxicological reclassification, considering the provisions of this Resolution. The company is responsible for evaluating the composition/formulation of its registered products and checking for the presence of unauthorized components. It revokes item "l", "m", 1.3 and 1.4 of "Guidelines and Requirements Ministry of Health, Regarding the Authorization of Registration and Extension of Use of Agrochemicals and Related ", approved by the Divisions of Human Ecology and Health Environment and Risk Assessment as "Guidelines and Requirements of the Ministry of Safety,
Regarding the Authorization to Register and Extend Use of Agrotóxicos and Afins N°. 01, of 09 December 1991", published in the Official Gazette of the Union on 13 December 1991 and ratified by Administrative Rule 03, of 16 January 1992, of the Technical-Normative Department of the Health Surveillance Secretariat of the Ministry of Health. Click Here for Notification Products covered: Pesticides HS code: 3808 Proposed date of adoption: NA Proposed date of entry into force: NA Final date for comments: 24-04-2018 | 
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