Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 06 December 2019

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Fenpicoxamid.

Products Covered: - Edible fruit (HS Code: 08.03)- Cereals (HS Codes: 10.01 and 10.02)

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 06 December 2019 | Final date for Comment: 04 February 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Prothiofos.

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.03, 07.04, 07.06, 07.09, 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.02, 08.03, 08.05, 08.06, 08.08, 08.10, 08.11 and 08.14) - Tea and spices (HS Codes: 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)- Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07 and 12.12)

Regulation Type: Regular notification

Human health Pesticides Maximum residue limits (MRLs) Food safety

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 06 December 2019 | Final date for Comment: 04 February 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Flutianil.

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.07, 07.08, 07.09 and 07.10)- Edible fruit (HS Codes: 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11)

Regulation Type: Regular notification

Human health Pesticides Maximum residue limits (MRLs) Food safety

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 06 December 2019

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Cephapirin.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02 and 02.06) - Dairy produce (HS Code: 04.01) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Code: 15.02)

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs) Veterinary drugs

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 06 December 2019

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Chloropicrin.

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruit (HS Codes: 08.07, 08.08, 08.10 and 08.11) - Mate and spices (HS Codes: 09.03 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08)- Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02 and 12.12)

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 06 December 2019

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Dichlobentiazox.

Products Covered: Cereals (HS Code: 10.06)

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Proyecto de Reglamento que Regula los Cambios de Importancia Mayor de los Productos Farmacéuticos con Registro Sanitario (Draft Regulations governing major changes to pharmaceutical products in the sanitary register) (22 pages, in Spanish)

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Distribution date: 05 December 2019 | Final date for Comment: 17 December 2019

The notified draft Regulations provide for major changes in the sanitary register, as they may have repercussions on the quality, safety and effectiveness of pharmaceutical products, and establish the conditions and documents required for such changes.

Products Covered: Pharmaceutical products; Fish, fresh or chilled, excluding fish fillets and other fish meat of heading 03.04 (HS 0302); Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included (HS 3001); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Pharmaceutical goods specified in Note 4 to this Chapter (HS 3006)

Regulation Type: Regular notification

Instructivo Nacional SENASAG/NAL/DN/N° 053/2019 (National Directive SENASAG/NAL/DN/No. 053/2019)

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Distribution date: 03 December 2019 | Final date for Comment: 23 December 2019

The notified Directive has been issued in response to the need for measures that reduce, prevent or eliminate risks to public health arising from the presence of chemical residues and contaminants in meat products imported into the Plurinational State of Bolivia.

Products Covered: HS codes: 0201, 0202, 0203 and 0206

Regulation Type: Regular notification

Contaminants Human health Food safety

Draft Resolution number 735, 7 November 2019. Number of pages: 4; Language(s): Portuguese. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=52117

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Distribution date: 02 December 2019 | Final date for Comment: 03 January 2020

This Draft Resolution establishes criteria for the changing of information of medical devices after its market authorization and provides other measures.

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Regular notification

Hydraulic brake fluid Extension of the comment period for draft Technical Regulation PRTE INEN No. 031 (2R) "Hydraulic brake fluid". In accordance with the provisions of the Agreement on Technical Barriers to Trade and Andean Community Decision No. 827, Ecuador hereby advises that the comment period for draft second revision (2R) of Technical Regulation PRTE INEN No. 031 "Hydraulic brake fluid", notified in document G/TBT/N/ECU/398/Rev.1 of 30 October 2019, has been extended. Comments must be received on or before 29 December 2019. Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries) Subsecretaría de Calidad (Under-Secretariat for Quality) TBT enquiry point: Andrés Ramón Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito - Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: [email protected] [email protected] [email protected] [email protected] [email protected] www.normalizacion.gob.ec

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Distribution date: 02 December 2019

Products Covered: Hydraulic brake fluids and other prepared liquids for hydraulic transmission not containing petroleum oil or bituminous mineral oil, or containing < 70% petroleum oil or bituminous mineral oil by weight (HS code(s): 3819); Hydraulic brake fluids and other prepared liquids for hydraulic transmission not containing petroleum oil or bituminous mineral oil, or containing < 70% petroleum oil or bituminous mineral oil by weight (HS code(s): 381900); Braking systems (ICS code(s): 43.040.40)

Regulation Type: Addendum to Regular Notification

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