City of Buenos Aires, 06/26/2024
HAVING SEEN File No. EX-2024-63136548- -APN-DGTYA#SENASA; Law No. 27,233; Decree-Law No. 3,489 of March 24, 1958; Regulatory Decree No. DECTO-2019-776-APN-PTE of November 19, 2019; Decree No. 5,769 of May 12, 1959; Resolution No. 350 of August 30, 1999 of the then SECRETARIAT OF AGRICULTURE, LIVESTOCK, FISHING AND FOOD and its amendments, and
CONSIDERING:
That by Decree-Law No. 3,489 of March 24, 1958, it is established that the sale throughout the Territory of the Nation of chemical or biological products, intended for the treatment and destruction of animal and plant enemies of cultivated or useful plants, as well as the adjuvants of such products, is subject to the control of the then MINISTRY OF AGRICULTURE AND LIVESTOCK.
That by Decree No. 5,769 of May 12, 1959, the National Registry of Plant Therapeutics is created, where both the phytosanitary products that are used and marketed throughout the country for the control of pests in the agricultural field, as well as the human or legal persons that market, import or export phytosanitary products, and the establishments that synthesize or formulate these products.
That by Law No. 27,233, the health of animals and plants is declared of national interest, as well as the prevention, control and eradication of diseases and pests that affect national forestry and agricultural production, flora and fauna, quality of raw materials produced by forestry-agricultural, livestock and fishing activities, the production, safety and quality of agri-food, specific agricultural inputs and the control of chemical residues and chemical and microbiological contaminants in food and national and international trade of said products and by-products, with the NATIONAL SERVICE OF AGRI-FOOD HEALTH AND QUALITY (SENASA) being the enforcement authority and in charge of planning, executing and controlling the development of the actions provided for in the aforementioned law.
Which, likewise, establishes the primary and unavoidable responsibility of any human or legal person linked to the production, obtaining or industrialization of products, by-products and derivatives of forestry-agricultural origin, whose activity is subject to the control of SENASA, to ensure and respond. for the health, safety, hygiene and quality of its production, in accordance with current regulations and those established in the future.
Which, to this end, determines that said responsibility extends to those who produce, prepare, divide, conserve, deposit, concentrate, transport, market, sell, import or export animals, plants, foods, raw materials, food additives, reproductive material, animal food and its raw materials, fishery products and other products of animal and/or plant origin that act individually, jointly or successively, in the agri-food chain.
That, in such a context, it establishes that the intervention of the competent health authorities, insofar as it corresponds to their control activity, does not exempt the direct or joint responsibility of the different actors in the agri-food chain with respect to risks, dangers or damages to third parties. that derive from the activity carried out by them.
That through Resolution No. 350 of August 30, 1999 of the then SECRETARIAT OF AGRICULTURE, LIVESTOCK, FISHING AND FOOD, the Manual of Procedures, Criteria and Scope for the Registration of Phytosanitary Products in the ARGENTINE REPUBLIC is approved.
That, currently, the Directorate of Agrochemicals and Biologicals, dependent on the National Directorate of Plant Protection of the aforementioned National Service, administers the National Registry of Plant Therapeutics.
That the ARGENTINE REPUBLIC has incorporated into its current regulations the determination of the equivalence between technical grade active substances based on the “MANUAL ON THE PREPARATION AND USE OF FAO AND WHO SPECIFICATIONS FOR PESTICIDES” of 1999.
That at present, said criteria and procedure have been adopted by the Competent Authorities of countries or groups of countries considered to be of high sanitary and phytosanitary surveillance by the ARGENTINE REPUBLIC.
That the reports and opinions issued by said Authorities are based on procedures and scientific knowledge, as established by the WORLD TRADE ORGANIZATION (WTO) and the Agreement on the Application of Sanitary and Phytosanitary Measures of said Organization, as well as those issued by Argentina.
That, likewise, the agencies and organizations that make up the Competent Authorities of the UNITED STATES OF AMERICA, the UNITED MEXICAN STATES, the EUROPEAN UNION, the UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND, AUSTRALIA, NEW ZEALAND and the FEDERATIVE REPUBLIC OF BRAZIL are considered as a reference as an observatory of the decisions that may be adopted for the risk analysis of phytosanitary products.
That, by virtue of this, it is advisable to recognize the evaluation and authorization of leading countries or regions in the regulatory field of phytosanitary products and, particularly, their agencies, among which are the ENVIRONMENTAL PROTECTION AGENCY (United States Environmental Protection Agency –US EPA–) of the UNITED STATES OF AMERICA, the EUROPEAN FOOD SAFETY AUTHORITY (EFSA–) of the EUROPEAN UNION and the AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY (APVMA– ) from Australia.
That, in this regard, it is appropriate to establish a scheme for recognition of the authorization or registration that the UNITED STATES OF AMERICA, the UNITED MEXICAN STATES, the EUROPEAN UNION, the UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND, AUSTRALIA, NEW ZEALAND and the REPUBLIC FEDERATIVE OF BRAZIL grant the active substance technical grade, in the case of satisfactory results in terms of equivalence of active substances.
That, in this sense, it becomes necessary to formalize this recognition scheme as a special authorization and specify the requirements and documentation required for its compliance.
That the recognition scheme promoted maintains the conditions for demanding requirements provided for in the aforementioned Resolution No. 350/99, as well as the standards agreed upon by the Common Market Group of the SOUTHERN COMMON MARKET (MERCOSUR) and the WTO.
That the National Directorate of Plant Protection and its dependent directorates with jurisdiction in the matter have taken the appropriate intervention.
That the Directorate of Legal Affairs has taken the intervention that corresponds to it.
That this measure is issued in accordance with the powers conferred by Article 8, paragraph f), of Decree No. 1,585 of December 19, 1996 and its amendments.
Thus,
THE PRESIDENT OF THE NATIONAL SERVICE OF HEALTH AND AGRI-FOOD QUALITY
RESOLVES:
ARTICLE 1.- Recognition of equivalence of technical grade active substances. The conditions and requirements are established to request the recognition of equivalence of technical grade active substances, approved by the Competent Authorities of the countries or groups of countries that make up the list that, as Annex (IF-2024-66957000-APN-DAYB# SENASA), forms an integral part of this resolution.
To this end, it is established that equivalence will only be recognized in those cases in which the technical grade active substance to be registered comes from the same manufacturing establishment and has the same minimum or higher purity than that registered in the countries that make up the aforementioned Annex.
ARTICLE 2°.- Requirements to request recognition of equivalence. To request the recognition of equivalence established in this regulation, within the framework of the application for registration of an equivalent technical grade active substance on the SIGTrámites platform of the NATIONAL SERVICE FOR AGRO-FOOD HEALTH AND QUALITY (SENASA), the registering company must:
Section a) Submit all the information required in Chapter 7 “REGISTRATION OF EQUIVALENT CHEMICAL OR BIOCHEMICAL ACTIVE SUBSTANCES” of the Annex of Resolution No. 350 of August 30, 1999 of the then SECRETARIAT OF AGRICULTURE, LIVESTOCK, FISHERIES AND FOOD and its amendments.
Section b) Present the official document issued by the Competent Authority of one of the countries or groups of countries mentioned in the aforementioned Annex, stating the name of the technical grade active substance, the minimum purity expressed in PERCENTAGE WEIGHT BY WEIGHT (% w/w), the name and address of the synthesising establishment.
Subsection c) Manage, as an Affidavit, the presentation of the documentation required in the preceding subsections, through the SIGTrámites platform.
ARTICLE 3.- Post-registration control of the equivalent technical grade active substance. SENASA may carry out post-registration inspections of the equivalent technical grade active substance. In the event that the inspection demonstrates inconsistencies between the declared information and the analyzes carried out on the official samples, the aforementioned National Service will cancel the registration in accordance with the procedures established in the current regulations, without prejudice to the sanctions that may apply. in accordance with the provisions of Chapter V of Law No. 27,233 and its Regulatory Decree No. DECTO-2019-776-APN-PTE of November 19, 2019, and the eventual application of the relevant preventive measures.
ARTICLE 4.- Post-registration documentary inspection of the equivalent technical grade active substance. SENASA may carry out post-registration documentary inspections of the equivalent technical grade active substance. In the event that the inspection reveals inconsistencies between the information declared and that presented when requesting registration by equivalence of the active substance for the plant in question, the aforementioned National Service will request the corresponding correction, without prejudice to any sanctions that may apply in accordance with the provisions of Chapter V of the aforementioned Law No. 27,233 and its regulatory decree.
ARTICLE 5.- Equivalence of office. SENASA may resolve the equivalence ex officio if the information required in Article 2 of this standard is public and available.
ARTICLE 6.- “Recognition of equivalence. List of recognized countries or groups of countries. Exhibit. Approval. The List “RECOGNIZATION OF EQUIVALENCE” is approved. LIST OF RECOGNIZED COUNTRIES OR GROUPS OF COUNTRIES” which, as an Annex (IF-2024-66957000-APN-DAYB#SENASA), forms an integral part of this measure.
ARTICLE 7.- Power. The National Directorate of Plant Protection of the NATIONAL SERVICE FOR AGRO-FOOD HEALTH AND QUALITY is empowered to modify the list in the aforementioned Annex.
ARTICLE 8.- Non-compliance. Sanctions. Non-compliance or violations of this rule will be subject to the sanctions established in Chapter V of Law No. 27,233 and its Regulatory Decree No. DECTO-2019-776-APN-PTE of November 19, 2019, without prejudice to the preventive actions that may be adopted pursuant to the provisions of Resolution No. 38 of February 3, 2012 of the then MINISTRY OF AGRICULTURE, LIVESTOCK AND FISHERIES and its amendment, or any other resolution which replaces it in the future.
ARTICLE 9.- Incorporation. This resolution is incorporated into the Third Book, Part Four, Title I, Chapter II, of the Thematic Index of the Regulatory Digest of the NATIONAL AGRI-FOOD HEALTH AND QUALITY SERVICE, approved by Resolution No. 401 of June 14, 2010 and its complementary N ° 913 of December 22, 2010, both from the aforementioned National Service.
ARTICLE 10.- Validity. This rule comes into force upon its publication in the Official Gazette.
ARTICLE 11.- Communicate, publish, give to the NATIONAL DIRECTORATE OF THE OFFICIAL REGISTRY and archive.
Pablo Cortese
NOTE: The Annex(es) that make up this Resolution are published in the BORA web edition -www.boletinoficial.gob.ar-
and. 06/28/2024 No. 41078/24 v. 06/28/2024
