Regulatory Updates
Resolución Ministerial Nº 649/017 (Ministerial Resolution No. 649/017)
Distribution date: 05 September 2017 | Final date for Comment: 03 November 2017
The notified Ministerial Resolution prohibits the use throughout national territory of ethion-based veterinary products, such as anti-fly, anti-larval, anti-mange, anti-lice and anti-tick products, as pour-ons or for environmental application. The use of ethion is permitted exclusively in anti-tick products administered by dipping or spraying.
Products Covered: Veterinary products containing ethion
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 05 September 2017 | Final date for Comment: 03 November 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Pyraclostrobin.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - 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 fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 05 September 2017 | Final date for Comment: 03 November 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Triforine.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - 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 fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 05 September 2017 | Final date for Comment: 03 November 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Fosetyl (also knows as "Fosetyl-aluminium").
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08) - Products of animal origin (HS Code: 05.04) - 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 fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)- Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 05 September 2017 | Final date for Comment: 03 November 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Pyribencarb.
Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.13) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01 and 10.06)- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 05 September 2017 | Final date for Comment: 03 November 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: DCIP.
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 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.04, 12.05, 12.06 and 12.07)
Regulation Type: Regular notification
This addendum aims to informing that the Brazilian Health Regulatory Agency (ANVISA) issued the Normative Instruction Nº 17 and Nº 18, both of 22 August 2017, in order to clarify the implementation of the Resolution – RDC nº 157, 11 May 2017, notified through G/TBT/N/BRA/707/Add1. The full text of the Normative Instruction Nº 17 is available in Portuguese and can be downloaded at: The full text of the Normative Instruction Nº 18 is available in Portuguese and can be downloaded at:
Distribution date: 31 August 2017
Products Covered: Medicines
Regulation Type: Addendum to Regular Notification
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lipase from Candida cylindracea AE-LAYH in Bread, Flour, Whole Wheat Flour, Unstandardized Bakery Products, Dairy-based Flavouring Preparations and Modified Fats and Oils – Reference Number: NOM/ADM-0100
Distribution date: 28 August 2017 | Final date for Comment: 31 October 2017
Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of lipase from the yeast Candida cylindracea AE-LAYH in bread, flour, whole wheat flour, unstandardized bakery products, dairy-based flavouring preparations and modified fats and oils. This enzyme is intended to function as a dough conditioner in bakery applications; to help in the development of flavour in enzyme-modified cheese paste and enzyme-modified dairy paste which are in turn used to flavour certain foods; and it would also be used in the manufacture of modified fats and oils, in particular, docosahexaenoic acid (DHA)-eicosapentaenoic acid (EPA) fish oil concentrates. The List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html) already permits the use of lipase from other source organisms in the manufacture of the foods of interest to the petitioner. Lipase from Candida rugosa in particular is permitted in "dairy-based flavouring preparations", a food category that includes enzyme-modified cheese paste and enzyme-modified dairy paste. As no safety concerns were raised through Health Canada's assessment the Department has enabled the food additive use of lipase from C. cylindracea AE-LAYH described in the information document below by updating the List of Permitted Food Enzymes, effective 18 August 2017. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food additive.
Products Covered: Lipase (ICS Codes: 67.220.20)
Regulation Type: Regular notification
The draft Circular amending and supplementing a number of articles of Circular No.34/2014/TT-BNNPTNT Guiding quality inspection of imported salt
Distribution date: 28 August 2017 | Final date for Comment: 27 October 2017
This Circular provides the contents of and procedures for the quality inspection of imported salt within the state management of the Ministry of Agriculture and Rural Development. The import of salt in the following cases is not regulated by this Circular but must comply with current management regulations: a) Temporary import for re-export, border-gate transfer or transit; b) Import for export production or goods processing for foreign traders; c) Personal luggage, sample goods for testing or research, goods for exhibitions or fairs, refined salts (Pa) used as reagents in chemical analysis, salt in donations, and cosmetic salt, salt for feeding aquarium. Articles to be amended and supplemented in this draft Circular includes: - Clause 2, Clause 3 and Clause 4 of Article 3 - Clause 1 of Article 4 - Clause 1 and Clause 2 of Article 6 - Clause 2 and Clause 4 of Article 8 - Clause 3 of Article 9 - Amending some terms in Article 11, Article 15 and Article 16
Products Covered: Sodium chloride salt
Regulation Type: Regular notification
Proyecto de Resolución de la Superintendencia de Industria y Comercio "Por la cual se adiciona el Capítulo Noveno en el Título VI de la Circular Única y se reglamenta el control metrológico aplicable a alcoholímetros, etilómetros o alcohosensores evidenciales" (Draft Resolution of the Supervisory Authority for Industry and Trade "Adding an ninth chapter to Title VI of the Single Circular, and regulating the metrological control of evidential breathalysers") (55 pages, in Spanish)
Distribution date: 25 August 2017 | Final date for Comment: 23 November 2017
The notified text establishes the technical and metrological requirements to be met by evidential breathalysers used in expert assessments and judicial or administrative activities that determine the concentration of alcohol in the blood by measuring the amount of alcohol in exhaled air. The text covers the following: Purpose; Scope; Definitions; Technical and metrological requirements; Breathalyser labelling; Instructions for use; Electronic seals; Tests and trials; Documents demonstrating conformity; Prohibition on the marketing and use of breathalysers; Inspection, monitoring and control authority; Metrological control phase for breathalysers already in use; Successful metrological verification; Failed metrological verification; Security seals; Obligations of owners of breathalysers already in use; Transitional provisions concerning the metrological control of breathalysers already in use; Penalties; Transitional regime; and Period of validity. Annex No. 1 contains a model declaration of conformity for evidential breathalysers.
Products Covered: Breathalysers (90.27.80.90.00 and 90.27.10.90.00)
Regulation Type: Regular notification
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