Regulatory Updates

TITLE: Antifreeze AGENCY: Oklahoma Corporation Commission, State of Oklahoma ACTION: Permanent Final AdoptionsSUMMARY:  The proposed rules are amended to correct punctuation on a statutory cite, amend definitions to include language requested by the Office of Administrative Rules, update and clarify definitions to match the language used in OAC Chapters 15, 25, and 26, revise applicability of this chapter to include all entities subject to the requirements of Chapter 16 rules, outline and detail the authority of the PSTD pertaining to enforcing antifreeze, amend the rules to set forth the specific requirements for an application to sell antifreeze, correct rule citations, and outline the guidelines for obtaining antifreeze permits. Effective date: 11 September 2017 Vol. 34, No. 24, Oklahoma Register 1 September 2017: http://www.oar.state.ok.us Title 165 Corporation Commission Chapter 16 Antifreeze:  http://okrules.elaws.us/oac/title165_chapter16        

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Distribution date: 11 September 2017

Products Covered: Antifreeze

Regulation Type: Addendum to Regular Notification

Notification of updating the Annex of the adopted Animal Health Requirements for raw milk/milk products to be exported to Japan

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Distribution date: 06 September 2017

As was announced in G/SPS/N/JPN/471/Add.1 dated 14 November 2016, the revised Article 45 of "the Ministerial Ordinance for Enforcement of the Act on Domestic Animal Infectious Disease Control" will enter into force on 1 November 2017, and raw milk/milk products will be added to the list of items subject to animal health quarantine.   In G/SPS/N/JPN/471/Add.2 dated 16 February 2017, MAFF proposed the draft Animal Health Requirements to set out detailed import conditions including required statements in the health certificate to be applied to raw milk/milk products to be imported into Japan from 1 November 2017(*).   In G/SPS/N/JPN/471/Add.3 dated 1 May 2017, MAFF proposed the adopted Animal Health Requirements for raw milk/milk products to be exported to Japan and the model format of the health certificate.   This is to notify Indonesia is added on Listed countries of the Annex of the adopted Animal Health Requirements as attached: http://members.wto.org/crnattachments/2017/SPS/JPN/17_3945_00_e.pdf   (*) Note: Raw milk/milk products arriving in Japan on and after 1 November 2017, including products exported from exporting countries before 1 November 2017, will need to be accompanied by the health certificate issued by the competent authority of the exporting country in accordance with the AHRs.

Products Covered:

Regulation Type: Addendum to Regular Notification

Modification of content/scope of regulation

Resolución Ministerial Nº 649/017 (Ministerial Resolution No. 649/017)

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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

Veterinary drugs Animal health

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: 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

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: 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

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: 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

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: 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

Maximum residue limits (MRLs) Human health Pesticides 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: 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

Food safety Maximum residue limits (MRLs) Human health Pesticides

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:

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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

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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

Food safety Human health Food additives

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