Circular No. 03/2017/TT-BYT dated March 22, 2017 of the Ministry of Health on QCVN 5-1:2017/BYT - National Technical Regulation for fluid milk product

THE MINISTRY OF HEALTH 

Circular No.03/2017/TT-BYTdated March 22, 2017 of the Ministry of Health on QCVN 5-1:2017/BYT - National Technical Regulation for fluid milk product

Pursuant to theLaw on Technical Standards and Regulation dated June 29, 2006 and the Government’s DecreeNo. 127/2007/ND-CP datedAugust 01, 2007elaboratingthe implementation ofsome articlesof the Law on Technical Standards and Regulation;

Pursuant to the Law onFood Safety dated June 17, 2010 and the Government’s Decree No.38/2012/ND-CPdated April 25, 2012elaborating the implementation of some articles of the Law onFood Safety;

Pursuant to the Government’s Decree No. 75/2017/ND-CP datedJune 20, 2017defining functions, tasks, powers and organizational structure of the Ministry of National Defense;

At the requestof theDirector GeneralofVietnam Food Administration;

The Minister of Health promulgatesQCVN 5-1:2017/BYT -National technical regulation for fluid milk product.

Article 1.QCVN 5-1:2017/BYT - National technical regulation for fluid milk product issued with this Circular.

Article2.This Circular takes effect on March 01, 2018

QCVN 5-1:2010/BYT -National technical regulation for fluid milk productpromulgated together with the Circular No.30/2010/TT-BYTdated June 02, 1010 of the Minister of Health expires from the effective date of this Circular.

Article 3.The Director General of Vietnam Food Administration, heads of units affiliated to the Ministry of Health, units affiliated to the Ministry of Health; Directors of Departments of Health of provinces and central-affiliated cities and relevant authorities, organizations and individualsshall implementthis Circular./.

For the Minister

The Deputy Minister

Truong Quoc Cuong

QCVN 5-1:2017/BYT

NATIONAL TECHNICAL REGULATION FOR FLUID MILK PRODUCTS

Foreword

QCVN 5-1:2017/BYTis drafted by the Drafting Committee fornational technical regulation for fluid milk products,submitted by theVietnam Food Administrationfor approval and is promulgated together with the Circular No. 03/2017/TT-BYTdated March 22, 2017 of the Minister of Health.

NATIONAL TECHNICAL REGULATION FOR FLUID MILK PRODUCTS

I. GENERAL PROVISIONS

1.Scope of adjustment

This Regulation provides for the safety limits and management requirements for fluid milk products, including fresh milk (pasteurized/sterilizedfresh whole milk, pasteurized/sterilizedfresh skimmed whole milk, pasteurized/sterilizedfresh milk,pasteurized/sterilizedfresh skimmed milk),pasteurized/sterilizedreconstituted milk,pasteurized/sterilizedcomposite milk, condensed milk and sweetened condensed milk (condensed milk, sweetened condensed milk, a blend of evaporated skimmed milk and vegetable fat, a blend of sweetened condensed skimmed milk and vegetable fat).

This Regulation shall not apply to formula milk products for young children aged 36 months or below and formula milk for special medical purposes for infants, and functional food.

2.Subject of application

This Regulation shall apply to producers, sellers and importers of fluid milk products in Vietnam and relevant organizations and individuals.

3.Rules for formulation

This Regulation is formulatedaccording tothe following rules:

3.1. The safety of consumers health is ensured.

3.2. Condition of production, trading and import in Vietnam is conformed to.

3.3. National standards and regulations of Vietnam law are conformed to.

3.4. International standards and regulations are conformed to avoid creating barriers to trade exchange between Vietnam and other countries in the world.

3.5. Risk management recommendations from domestic and foreign competent authorities, Food and Agriculture Organization (FAO), World Health Organization (WHO) and Codex Alimentarius Commission(CODEX)are updated.

4.Definitions

For the purposes of this Regulation, the terms below are construed as follows:

4.1 “raw fresh milk”isfluid milk that is obtained from cows, buffaloes, goats and sheep without either addition to it or extraction from it is not processed by any method and used as an ingredient for processing.

4.2. “milk product”is a product obtained by any processing of milk, which may contain food additives, and other necessary ingredients functionally necessary for the processing.

4.3. “powdered milk”is a powdered product resulting from the removal of water from raw fresh milk. The fat and/or protein content of the milk may have been adjusted by the addition and/or removal of milk constituents in such a way as not to alter the whey protein to casein ratio of the milk being adjusted.

4.4. “milk fat”is the fat that is derived from milk or milk products and processed by a method that can remove most of the water and milk solids-non-fat.

4.5. “milk solids-non-fat”is a product resulting from removal of water and milk fat from raw fresh milk.

4.6. Fresh milk

4.6.1. “pasteurized/sterilizedfresh whole milk”is a product that is completely prepared from raw fresh milk without the addition or removal of any milk constituents and without the addition of any other constituent, and that has undergone pasteurization/sterilization.

4.6.2. “pasteurized/sterilizedfresh skimmed whole milk”is a product that is completely prepared from raw fresh milk, separated from milk fat without the addition or removal of any other milk constituent and without the addition of any other constituent, and that has undergone pasteurization/sterilization.

4.6.3. “pasteurized/sterilizedfresh milk”is a product that is mainly prepared from raw fresh milk (raw fresh milk accounts for at least 90% calculated according to the volume of the final product)

This product maybeadded withotherconstituentswithoutsubstituting the main constituentsand has undergonepasteurization/sterilization.

4.6.4. “pasteurized/sterilizedfresh skimmed milk”is a product that is mainly prepared from raw fresh milk separated from milk fat (raw fresh milk separated from milk fat accounts for at least 90% calculated according to the volume of the final product).

This product maybeadded withotherconstituentswithoutsubstituting the main constituentsand has undergonepasteurization/sterilization.

4.7. “pasteurized/sterilizedreconstituted milk”is the fluid that is obtained by adding water to powdered milk or condensed milk in the amount necessary to re-establish the appropriate water solids ratio or is obtained by mixing milk fat and milk solids-non-fat with or without the addition of water to achieve the appropriate milk product composition.

 This product maybeadded withotherconstituentswithoutsubstituting the main constituentsand has undergonepasteurization/sterilization.The constituents of reconstitutedmilkaccount for at least 90% calculated according to the volume of the final product.

4.8. “pasteurized/sterilizedcomposite milk”is a product that is prepared from the combination of raw fresh milk, milk products or milk constituents.

This product maybeadded withotherconstituentswithoutsubstituting the main constituentsand has undergonepasteurization/sterilization. Theconstituents of compositemilk account for at least 90% calculated according to the volume of the final product.

4.9. Condensed milk and sweetened condensed milk

4.9.1. “condensed milk”is a product that is obtainedby the partial removal of water from raw fresh milk by heat, or by any other process.The fat and/or protein content of the milk may have been adjusted by the addition and/or removal of milk constituents in such a way as not to alter the whey protein to casein ratio of the milk being adjusted.

This product maybeadded withother constituents withoutsubstituting the main constituents.

4.9.2.“sweetened condensed milk”is a product that is obtainedby the partial removal of water from raw fresh milk or addition of water to powdered milk, with the addition of sugar.The fat and/or protein content of the milk may have been adjusted by the addition and/or removal of milk constituents in such a way as not to alter the whey protein to casein ratio of the milk being adjusted.

This product maybeadded withother constituents withoutsubstituting the main constituents.

4.9.3.“a blend of evaporated skimmed milk and vegetable fat”is a product that is prepared by recombining skimmed milk and potable water, or by the partial removal of water, with the addition of vegetable fat.

This product maybeadded withother constituents withoutsubstituting the main constituents.

4.9.4. “a blend of condensed skimmed milk and vegetable fat”is a product that is prepared by recombining skimmed milk and potable water, or by the partial removal of water, with the addition of sugar and vegetable fat.

This product maybeadded withother constituents withoutsubstituting the main constituents.

II. TECHINCAL REQUIREMENTS

5.Requirements for raw fresh milk for production of fluid milk products

The raw fresh milk used for production of fluid milk products must satisfy quality and food safety requirements according to regulations of the Minister of Agriculture and Rural Development.

6.Physical and chemical andsafety criteria forfluidmilk products

6.1.Physical and chemical criteria are specified in Appendix I of this Regulation.

6.2.Maximum limits of pollutants are specified in Appendix II of this Regulation.

6.3.Maximum limits of microbial contaminationarespecified in Appendix II of this Regulation.

6.4.Food additives permitted for use in fluid milk products comply with regulations of the Circular No. 27/2012/TT-BYT dated November 30, 2012 of the Minister of Health providing guidance on the management of food additives and the Circular No. 08/2015/TT-BYT dated May 11, 2015 of the Minister of Health on amendments to some regulations of the Circular No. 27/2012/TT-BYT dated November 30, 2012 of the Minister of Health providing guidance on the management of food additives.

6.5.Test methods arespecified intheAppendix IVof this Regulation.

6.6.In the cases where test methods are yet to be specified in this Regulation, the Ministry of Health shall decide the test methods according to applicable domestic and foreign methods.

7.Labeling

7.1.The labeling of fluid milk products shall comply with regulations set forth in the Government’s Decree No.43/2017/ND-CPdated April 14, 2017 on goods labels, and other relevantlegislative documents.

7.2.The characteristics of the product must be specified on the front side of the product package in accordance with this Regulation.

III. MANAGEMENT REQUIREMENTS

8.Declaration of Conformity

8.1.Declarations of conformity of imported and domestic fluid milk products must be submitted in accordance with regulations of this document.

8.2.Methods and procedures for submission of declarations of conformity shall comply with the Government’s Decree No.38/2012/ND-CPdated April 25, 2012 elaborating the implementation of some articles of the Law on Food Safety, the Circular No.19/2012/TT-BYTdated September 11, 2012 of the Minister of Health providing guidance on submission of declarations of conformity and conformity with regulation on food safety and other relevant regulations.

9.Transitional provisions

9.1. Certificate of submission of Declaration of Conformity

The fluid milk product thathas been issued with a Certificate of submission of Declaration of Conformity according to the national technical regulation QCVN5-1:2010/BYTfor fluid milk products shall continue to use this Certificate for production, import and trading until the expiry date of the Certificate.

9.2. Product labels and commercial containers attached to the product labels

9.2.1.The fluid milk product thathas been labeled in accordance with thenational technical regulation QCVN 5-1:2010/BYT for fluid milk productsand produced, imported, sold and used before the effective date of this Regulationshall continue tobe sold and useduntil the expiry datespecified in such product label.

9.2.2.Theproduct labels and commercial containers attached to product labels in accordance withthe national technical regulation QCVN 5-1:2010/BYT for fluid milk productsthat have beenproducedand printedbefore the effective date of this Regulation shall continue to be usednot exceeding 06 months from the effective date of this Regulation.

9.2.3.Producers and importers of fluid milk products are responsible for declaring the number of products labeled in accordance with regulations of law before March 01, 2018 and informing the Ministry of Health (Vietnam Food Administration) thereof.

V. IMPLEMENTATION

10.Vietnam Food Administrationshall take charge and cooperate with relevant authorities in providing guidance and organizing the implementation of this Regulation.

11.Based on the management requirements,Vietnam Food Administrationis responsible for requesting the Ministry of Health to make amendments to this Regulation.

12.In the cases where the regulations on test methods in accordance with the national standard andlegislative documents referred to in this Regulation are amended or replaced, the regulations on new test methods and documents shall apply.

APPENDIX I

PHYSICAL AND CHEMICAL CRITERIA

APPENDIX II

MAXIMUM LIMITS OF POLLUTANTS

APPENDIX III

MAXIMUM LIMITS OF MICROBIAL CONTAMINATION

APPENDIX IV

LIST OF TEST METHODS

I. Sampling

1. TCVN 6400 (ISO 707) Milk and milk products - Guidance on sampling.

II. Methods of testing physical and chemical criteria

2. TCVN 5860:2007 Pasteurized fresh milk

3. TCVN 7028:2009 Sterilized fresh milk

4. TCVN 8099-1:2015 (ISO 8968-1:2014) Milk - Determination of nitrogen content - Part 1: Kjeldahlmethod

5. TCVN 8099-5:2009 (ISO 8968-5:2001) Milk - Determination of nitrogen content - Part 5: Kjeldahlmethod

III. Methods of testingpollutants

III.1. Heavy metals

6. TCVN 7933:2009 (ISO/TS 6733:2006) Milk and milk products - Determination of lead content - Graphite furnace atomic absorption spectrometric method

7. TCVN 7929:2008 (EN 14083:2003)Foodstuffs - Determination of trace elements - Determination of lead, cadmium, chromium and molybdenum by graphite furnace atomic absorption spectrometry (GFAAS) after pressure digestion

8. TCVN 10912:2015 (EN 15763:2009) Foodstuffs-Determination of trace elements-Determination of arsenic, cadmium, mercury and lead in foodstuffs by inductively coupled plasma mass spectrometry (ICP-MS) after pressure digestion

9. TCVN 7730:2007 (ISO/TS 9941:2005) Milk and canned evaporated milk - Determination of tin content - Spectrometric method

10. TCVN 7788:2007 Canned foods - Determination of tin content by atomic absorption spectrophotometric method

11. TCVN 10913:2015 (EN 15764:2009) Foodstuffs-Determination of trace elements-Determination of tin by flame and graphite furnace atomic absorption spectrometry (FAAS and GFAAS) after pressure digestion

12. TCVN 10914:2015 (EN 15765:2009) Foodstuffs - Determination of trace elements - Determination of tin by inductively coupled plasma mass spectrometry (ICP-MS) after pressure digestion

13. TCVN10643:2014Foodstuffs - Determination of lead, cadmium, copper, iron, and zinc - Atomic absorption spectrophotometric method after dry ashing

14. TCVN 8110:2009 (ISO 14377:2002) Canned evaporated milk-Determination of tin content - Method using graphite furnace atomic absorption spectrometry

III.2. Mycotoxins

15. TCVN 6685:2009 (ISO 14501:2007) Milk and milk powder – Determination fo aflatoxin M1 content – Clean-up by immunoaffinity chromatography and determination by high-performance liquid chromatography

III.3. Melamine

16. TCVN 9048:2012 (ISO/TS 15495:2010) Milk, milk products and infant formulae - Guidelines for the quantitative determination of melamine and cyanuric acidby liquid chromatography - tandem mass spectrometry (LC-MS/MS)

IV. Methods of testing microbiological criteria

17. TCVN 5518-2:2007 (ISO 21528-2:2004) Microbiology of food and animal feeding stuffs - Horizontal methods for the detection and enumeration of Enterobacteriaceae - Part 2: Colony-count method

18. TCVN 9980:2013 Microbiology of food and animal feeding stuffs – Enumeration of Enterobacteriaceae using Petrifilm™ count plate

19. TCVN 7700-2:2007 (ISO 11290-2:1998, With amd.1:2004) Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 2: Enumeration method

(Other test methods with equivalent accuracy may be used.)