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Circular 33/2010/TT-BYT promulgating the National Technical Regulation on dairy fat products issued by the Minister of Health

Số hiệu	33/2010/TT-BYT
Loại văn bản	Thông tư
Cơ quan	Bộ Y tế
Ngày ban hành	02/06/2010
Người ký	Trịnh Quân Huấn
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MINISTRY OF HEALTH -------	THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------
No. 33/2010/TT-BYT	Hanoi, June 02, 2010

CIRCULAR

PROMULGATING NATIONAL TECHNICAL REGULATION FOR DAIRY FAT PRODUCTS

THE MINISTER OF HEALTH

Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006 and Government’s Decree No. 127/2007/ND-CP dated August 01, 2007 on elaboration of some Articles of the Law on Technical Standards and Regulations;

Pursuant to the Ordinance on Food Safety and Hygiene dated August 08, 2003 and Government’s Decree No. 163/2004/ND-CP dated September 07, 2004 on elaboration of some Articles of the Ordinance on Food Safety and Hygiene;

Pursuant to the Government’s Decree No. 188/2007/ND-CP dated December 27, 2007 defining functions, tasks, entitlements and organizational structure of the Ministry of Health;

At the request of the Director of the Vietnam Food Administration, the Director of the Department of Science and Training and the Director of the Department of Legal Affairs,

HEREBY DECIDES:

Article 1. QCVN 5-4:2010/BYT National technical regulation for dairy fat products is promulgated together with this Circular.

Article 2. This Circular comes into force from January 01, 2011.

Article 3. The Director of the Vietnam Food Administration, heads of affiliates of the Ministry of Health, affiliates of the Ministry of Health; Directors of Departments of Health of provinces and central-affiliated cities and relevant organizations and individuals are responsible for the implementation of this Circular./.

PP. THE MINISTER
THE DEPUTY MINISTER

Trinh Quan Huan

Foreword

QCVN 5-4:2010/BYT is prepared by the Drafting Committee for national technical regulation on food safety and hygiene for milk and milk products, is presented by the Vietnam Food Administration, and is promulgated together with the Circular No. 33/2010/TT-BYT dated June 02, 2010 by the Minister of Health.

NATIONAL TECHNICAL REGULATION FOR DAIRY FAT PRODUCTS

1. GENERAL

1.1. Scope

This document provides for food safety criteria and requirements for management of dairy fat products, including cream products (except cream powder), butter, butteroil, milk fat products and dairy fat spreads.

1.2. Regulated entities

This document applies to:

a) Importers, producers and sellers of dairy fat products in Vietnam;

b) Relevant organizations and individuals.

1.3. Definitions

For the purposes of this document, the terms below shall be construed as follows:

1.3.1. Liquid cream

refers to a milk product, rich in fat, in the form of an emulsion, obtained by physical separation from milk.

1.3.2. Butter

refers to a fatty product derived exclusively from milk or milk products principally in the form of an emulsion.

1.3.3. Milkfat and butteroil; anhydrous milkfat and anhydrous butteroil

refer to fatty products derived exclusively from milk or milk products obtained from milk by means of processes which result in almost total removal of water and non-fat solids.

1.3.4. Dairy fat spreads

refer to fatty products derived exclusively from milk, in the form of an emulsion or spreadable emulsion.

2. SPECIFICATIONS

2.1. Food safety criteria for dairy fat products

2.1.1. Physicochemical criteria are provided in the Appendix I of this document.

2.1.2. Maximum levels for contaminants are provided in the Appendix II of this document.

2.1.3. Microbiological criteria are provided in the Appendix III of this document.

2.1.4. The list of permitted food additives is pertinent to applicable regulations.

2.1.5. It is permissible to employ test methods with precision equivalent to that of methods defined by criteria specified in the Appendix I, Appendix II and Appendix III of this document.

2.1.6. Codes and full names of sampling methods and test methods are provided in the Appendix IV of this document.

2.1.7. The Ministry of Health shall regulate tests for criteria whose test methods are not available in this document according to accredited methods being employed locally or abroad.

2.2. Labeling

The labeling of dairy fat products shall comply with regulations in the Government's Decree No. 89/2006/ND-CP dated August 30, 2006 and relevant written guidelines.

3. MANAGEMENT REGULATIONS

3.1. Declaration of conformity

3.1.1. Declarations of conformity of imported and domestic dairy fat products must be submitted in accordance with regulations of this document.

3.1.2. Methods and procedures for submission of declarations of conformity shall comply with the Regulation on certification and declaration of conformity and conformance under the Decision No. 24/2007/QD-BKHCN dated September 28, 2007 by Minister of Science and Technology and the laws.

3.2. Inspection of dairy fat products

The inspection of the quality, hygiene and safety of dairy fat products must abide by the laws.

4. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

4.1. Importers and producers of dairy fat products shall declare conformity according to the specifications mentioned in this document and register such declarations of conformity with competent authorities defined by the Ministry of Health. Quality, hygiene and safety of the products shall be maintained according to such declarations of conformity.

4.2. Organizations and individuals can only import, produce and sell dairy fat products when they complete the registration of the declaration of conformity and ensure that the quality, food safety and hygiene, and labeling thereof are conformable to prevailing laws.

5. IMPLEMENTATION

5.1. The Vietnam Food Administration shall take charge and coordinate with relevant authorities to provide guidance and organize the implementation of this document.

5.2. The Vietnam Food Administration shall, according to its managerial duties, recommend the Ministry of Health to make amendments to this document.

5.3. In the cases where any of the standards and regulations referred to in this document is amended or replaced, the newest one shall apply.

APPENDIX I

PHYSICOCHEMICAL CRITERIA FOR DAIRY FAT PRODUCTS

Entry	Regulated limit	Test method	Category of criteria 1)
I. Liquid cream				I. Liquid cream	I. Liquid cream	I. Liquid cream
1. Milkfat content, % by weight, not less than	10	ISO 2450:1999	A
II. Butter
1. Moisture content, % by weight, not more than	16	TCVN 8151-1:2009 (ISO 3727-1:2001)	A
2. Milkfat content, % by weight, not less than	80	TCVN 8151-3:2009 (ISO 3727-3:2003); TCVN 8154:2009 (ISO 17189:2003)	B
3. Peroxide value, milli-equivalents of active oxygen/kg fat	0,3	ISO 3976:2006	A
III. Milkfat and butter oil				III. Milkfat and butter oil	III. Milkfat and butter oil	III. Milkfat and butter oil
1. Milkfat content, % by weight, not less than	99,6	TCVN 8154:2009 (ISO 17189:2003)	A
2. Peroxide value, milli-equivalents of active oxygen/kg fat	0,6	ISO 3976:2006	A
IV. Anhydrous milkfat and anhydrous butter oil				IV. Anhydrous milkfat and anhydrous butter oil	IV. Anhydrous milkfat and anhydrous butter oil	IV. Anhydrous milkfat and anhydrous butter oil
1. Water content, % by weight, not more than	0,1	TCVN 7728:2007 (ISO 5536:2002)	A
2. Milkfat content, % by weight, not less than	99,8	TCVN 8154:2009 (ISO 17189:2003)	A
3. Peroxide value, milli-equivalents of active oxygen/kg fat	0,3	ISO 3976:2006	A
V. Dairy fat spreads				V. Dairy fat spreads	V. Dairy fat spreads	V. Dairy fat spreads
1. Milkfat content, % by weight	from 10 to less than 80	TCVN 8154:2009 (ISO 17189:2003)	A
1) Category A: tests are required for assessment of conformity. Category B: though tests are not required for assessment of conformity, producers, importers or processors of liquid milk products must meet specifications for Category B.				1) Category A: tests are required for assessment of conformity. Category B: though tests are not required for assessment of conformity, producers, importers or processors of liquid milk products must meet specifications for Category B.	1) Category A: tests are required for assessment of conformity. Category B: though tests are not required for assessment of conformity, producers, importers or processors of liquid milk products must meet specifications for Category B.	1) Category A: tests are required for assessment of conformity. Category B: though tests are not required for assessment of conformity, producers, importers or processors of liquid milk products must meet specifications for Category B.

APPENDIX II

MAXIMUM LEVELS FOR CONTAMINANTS FOR CREAM AND DAIRY FAT PRODUCTS

Entry	Maximum level	Test method	Category of criteria 2)
I. Heavy metal
1. Lead, mg/kg	0,02	TCVN 7933:2008 (ISO 6733:2006), TCVN 7929:2008 (EN 14083:2003)	A
2. Tin (for products stored in tin coated containers), mg/kg	250	TCVN 7730:2007 (ISO/TS 9941:2005), TCVN 8110:2009 (ISO 14377:2002), TCVN 7788:2007	A
3. Antimony, mg/kg	1,0	TCVN 8132:2009	B
4. Arsenic, mg/kg	0,5	TCVN 7601:2007	B
5. Cadmium, mg/kg	1,0	TCVN 7603:2007, TCVN 7929:2008 (EN 14083:2003)	B
6. Mercury, mg/kg	0,05	TCVN 7993:2008 (EN 13806:2002)	B
II. Mycotoxin
1. Aflatoxin M1, mg/kg	0,5	TCVN 6685:2009 (ISO 14501:2007)	A
III. Melamine
1. Melamine, mg/kg	2,5	Common technical regulation for enumeration of melamine in foodstuffs (Decision No. 4143/QD-BYT)	B
IV. Residues of veterinary drugs, mg/kg		IV. Residues of veterinary drugs, mg/kg
1. Benzylpenicilin/Procaine benzylpenicilin	4	TCVN 8106:2009 (ISO/TS 26844:2006); AOAC 988.08	A
2. Clortetracycline/Oxytetracycline/ Tetracycline	100	TCVN 8106:2009 (ISO/TS 26844:2006); AOAC 995.04	A
3. Dihydrostreptomycin/Streptomycin	200	TCVN 8106:2009 (ISO/TS 26844:2006); AOAC 988.08;	A
4. Gentamicin	200	TCVN 8106:2009 (ISO/TS 26844:2006)	A
5. Spiramycin	200	TCVN 8106:2009 (ISO/TS 26844:2006)	A
6. Ceftiofur	100	TCVN 8106:2009 (ISO/TS 26844:2006)	B
7. Clenbuterol	50		B
8. Cyfluthrin 3)	40	TCVN 8101:2009 (ISO 8260:2008)	B
9. Cyhalothrin 3)	30	AOAC 998.01	B
10. Cypermethrin and alpha-cypermethrin	100	US FDA PAM, Vol. I, Section 304, E4/C2, C4; TCVN 8101:2009 (ISO 8260:2008)	B
11. Deltamethrin 3)	30	TCVN 8101:2009 (ISO 8260:2008)	B
12. Diminazene	150		B
13. Doramectin	15		B
14. Eprinomectin	20		B
15. Febantel/ Fenbendazole/ Oxfendazole	100		B
16. Imidocarb	50		B
17. Isometamidium	100		B
18. Ivermectin	10		B
19. Lincomycin	150	AOAC 988.08	B
20. Neomycin	1500	TCVN 8106:2009 (ISO/TS 26844:2006)	B
21. Pirlimycin	200		B
22. Spectinomycin	200		B
23. Sulfadimidine	25	AOAC 992.21	B
24. Thiabendazole 3)	100		B
25. Triclorfon (Metrifonate) 3)	50		B
V. Residues of pesticides 4), mg/kg				V. Residues of pesticides 4), mg/kg	V. Residues of pesticides 4), mg/kg	V. Residues of pesticides 4), mg/kg
V.1. Pesticides soluble in water or partially soluble in fat				V.1. Pesticides soluble in water or partially soluble in fat	V.1. Pesticides soluble in water or partially soluble in fat	V.1. Pesticides soluble in water or partially soluble in fat
1. Endosulfan	0,01	TCVN 7082:2002 (ISO 3890:2000), part 1 and part 2; TCVN 8170:2009 (EN 1528:1996), parts 1, 2, 3 and 4	A
2. 2,4-D	0,01	US FDA PAM, Vol. I, Section 402, E1	B
3. Abamectin	0,005		B
4. Acephate	0,02	AOAC 970.52	B
5. Aldicarb	0,01	US FDA PAM, Vol. I, Section 401, E1+DL1	B
6. Aminopyralid	0,02		B
7. Amitraz	0,01		B
8. Bentazon	0,05		B
9. Bifenazate	0,01		B
10. Bifenthrin	0,05	AOAC 970.52	B
11. Bitertanol	0,05		B
12. Carbaryl	0,05	AOAC 964.18; US FDA PAM, Vol. I, Section 401, E1+DL1	B
13. Carbendazim	0,05		B
14. Carbofuran	0,05	US FDA PAM, Vol. I, Section 401, E1, DL1	B
15. Carbosulfan	0,03		B
16. Clormequat	0,5		B
17. Clorpropham	0,0005	US FDA PAM, Vol. I, Section 304, E4, C1-C4	B
18. Clorpyrifos	0,02	TCVN 8101:2009 (ISO 8260:2008)	B
19. Clorpyrifos-methyl	0,01	TCVN 8101:2009 (ISO 8260:2008)	B
20. Clethodim	0,05		B
21. Clofentezin	0,05		B
22. Cyhexatin	0,05		B
23. Cyprodinil	0,0004		B
24. Cyromazine	0,01		B
25. Diclorvos	0,02	TCVN 8101:2009 (ISO 8260:2008)	B
26. Difenoconazole	0,005		B
27. Dimethenamid-p	0,01		B
28. Dimethipin	0,01		B
29. Dimethoate	0,05	AOAC 970.52	B
30. Dimethomorph	0,01		B
31. Diquat	0,01		B
32. Disulfoton	0,01		B
33. Dithiocarbamate	0,05		B
34. Ethephon	0,05		B
35. Ethoprophos	0,01	US FDA PAM, Vol. I, Section 304, E4, C1, C3	B
36. Fenamiphos	0,005		B
37. Fenbuconazol	0,05		B
38. Fenbutatin oxid	0,05		B
39. Fenpropimorph	0,01		B
40. Fipronil	0,02	US FDA PAM, Vol. I, Section 304, E4, C1-C4	B
41. Fludioxonil	0,01		B
42. Flutolanil	0,05		B
43. Glufosinat-amoni	0,02		B
44. Imidacloprid	0,02		B
45. Indoxacarb	0,1		B
46. Kresoxim-methyl	0,01		B
47. Lindan	0,01	AOAC 970.52	B
48. Methamidophos	0,02		B
49. Methidathion	0,001	US FDA PAM, Vol. I, Section 304, E4, C2, C4	B
50. Methomyl	0,02	US FDA PAM, Vol. I, Section 401, E1, DL1	B
51. Methoxyfenozide	0,01		B
52. Myclobutanil	0,01		B
53. Novaluron	0,4		B
54. Oxamyl	0,02	US FDA PAM, Vol. I, Section 401, E1, DL1	B
55. Oxydemeton-methyl	0,01		B
56. Paraquat	0,005		B
57. Penconazole	0,01		B
58. Pirimicarb	0,01		B
59. Pirimiphos-methyl	0,01	TCVN 8101:2009 (ISO 8260:2008)	B
60. Procloraz	0,05		B
61. Profenofos	0,01	US FDA PAM, Vol. I, Section 304, E4, C1, C3	B
62. Propamocarb	0,01		B
63. Propiconazol	0,01		B
64. Pyraclostrobin	0,03		B
65. Pyrimethanil	0,01	US FDA PAM, Vol. I, Section 304, E4, C1-C4	B
66. Quinoxyfen	0,01		B
67. Spinosad	1		B
68. Tebuconazole	0,01		B
69. Tebufenozide	0,01		B
70. Terbufos	0,01	US FDA PAM, Vol. I, Section 304, C1-C4	B
71. Thiacloprid	0,05		B
72. Triadimefon	0,01	US FDA PAM, Vol. I, Section 304, C1, C3	B
73. Triadimenol	0,01		B
74. Trifloxystrobin	0,02		B
75. Vinclozolin	0,05	US FDA PAM, Vol. I, Section 304, C1-C3; E1-E5+C6	B
V.2. Pesticides soluble in fat 5)				V.2. Pesticides soluble in fat 5)	V.2. Pesticides soluble in fat 5)	V.2. Pesticides soluble in fat 5)
1. Aldrin and dieldrin	0,006	TCVN 7082:2002 (ISO 3890:2000), part 1 and part 2; TCVN 8101:2009 (ISO 8260:2008); TCVN 8170:2009 (EN 1528:1996), parts 1, 2, 3 and 4	A
2. Cyfluthrin 6)	0,04	TCVN 8101:2009 (ISO 8260:2008)	A
3. Clordane	0,002	TCVN 7082:2002 (ISO 3890:2000), part 1 and part 2; TCVN 8170:2009 (EN 1528:1996), parts 1, 2, 3 and 4	B
4. Cypermethrin	0,05	US FDA PAM, Vol. I, Section 304, E4/C2, C4; TCVN 8101:2009 (ISO 8260:2008)	B
5. DDT	0,02	TCVN 7082:2002 (ISO 3890:2000), part 1 and part 2; TCVN 8170:2009 (EN 1528:1996), parts 1, 2, 3 and 4	A
6. Deltamethrin 6)	0,05	TCVN 8101:2009 (ISO 8260:2008)	B
7. Diazinon	0,02	TCVN 8101:2009 (ISO 8260:2008)	B
8. Dicofol	0,1	TCVN 8101:2009 (ISO 8260:2008)	B
9. Diflubenzuron	0,02		B
10. Diphenylamine	0,0004		B
11. Famoxadine	0,03		B
12. Fenhexamid	0,01		B
13. Fenpropathrin	0,1	US FDA PAM Vol. I, Section 304, E4, C1-C4	B
14. Fenpyroximate	0,005		B
15. Fenvalerate	0,1	TCVN 8101:2009 (ISO 8260:2008); AOAC 998.01	B
16. Flumethrin	0,05		B
17. Flusilazole	0,05		B
18. Heptaclor	0,006	TCVN 7082:2002 (ISO 3890:2000), part 1 and part 2; TCVN 8170:2009 (EN 1528:1996), parts 1, 2, 3 and 4	B
19. Methoprene	0,1		B
20. Permethrin	0,1	TCVN 8101:2009 (ISO 8260:2008)	B
21. Phorate	0,01	US FDA PAM Vol. I, Section 304, C2, C4	B
22. Piperonyl butoxide	0,05	US FDA PAM Vol. I, Section 401, E1, DL2	B
23. Propargite	0,1	US FDA PAM Vol. I, Section 304, E4+C6	B
2) Category A: tests are required for assessment of conformity. Category B: though tests are not required for assessment of conformity, producers, importers or processors of liquid milk products must meet specifications for Category B. 3) Also used as pesticides. 4) By reference to test methods mentioned in TCVN 5142:2008 (CODEX STAN 229-1993, Rev.1-2003) Analysis of Pesticide Residues - Recommended Methods. 5) This limit applies to pasteurized and sterilized milk products. With regard to cream and dairy fat products, the limit shall be 25 times the regulated one according to the fat content in milk products. 6) Also used as veterinary drugs.				2) Category A: tests are required for assessment of conformity. Category B: though tests are not required for assessment of conformity, producers, importers or processors of liquid milk products must meet specifications for Category B. 3) Also used as pesticides. 4) By reference to test methods mentioned in TCVN 5142:2008 (CODEX STAN 229-1993, Rev.1-2003) Analysis of Pesticide Residues - Recommended Methods. 5) This limit applies to pasteurized and sterilized milk products. With regard to cream and dairy fat products, the limit shall be 25 times the regulated one according to the fat content in milk products. 6) Also used as veterinary drugs.	2) Category A: tests are required for assessment of conformity. Category B: though tests are not required for assessment of conformity, producers, importers or processors of liquid milk products must meet specifications for Category B. 3) Also used as pesticides. 4) By reference to test methods mentioned in TCVN 5142:2008 (CODEX STAN 229-1993, Rev.1-2003) Analysis of Pesticide Residues - Recommended Methods. 5) This limit applies to pasteurized and sterilized milk products. With regard to cream and dairy fat products, the limit shall be 25 times the regulated one according to the fat content in milk products. 6) Also used as veterinary drugs.	2) Category A: tests are required for assessment of conformity. Category B: though tests are not required for assessment of conformity, producers, importers or processors of liquid milk products must meet specifications for Category B. 3) Also used as pesticides. 4) By reference to test methods mentioned in TCVN 5142:2008 (CODEX STAN 229-1993, Rev.1-2003) Analysis of Pesticide Residues - Recommended Methods. 5) This limit applies to pasteurized and sterilized milk products. With regard to cream and dairy fat products, the limit shall be 25 times the regulated one according to the fat content in milk products. 6) Also used as veterinary drugs.

APPENDIX III

MICROBIOLOGICAL CRITERIA FOR DAIRY FAT PRODUCTS

Entry

Sampling plan

Limit

Test method

Category of criteria 11)

n 7)

c 8)

m 9)

M 10)

I. Cream and butter

1. E. coli

10 CFU/g

100 CFU/g

TCVN 7924-1:2008 (ISO 16649-1:2001); TCVN 7924-2:2008 (ISO 16649-2:2001)

2. L. monocytogenes (for instant products)

100 CFU/g

TCVN 7700-2:2007 (ISO 11290-2:1998, With amd.1:2004)

3. Salmonella

No salmonella detected in 25 grams

TCVN 4829:2005 (ISO 6579:2002, With amd.1:2004)

II. Milkfat and butteroil; anhydrous milkfat and anhydrous butteroil and dairy fat spreads

L. monocytogenes (for instant products)

100 CFU/g

TCVN 7700-2:2007 (ISO 11290-2:1998, With amd.1:2004)

7) n: number of sampling units taken from the batch/shipment to be inspected.

8) c: maximum number of sampling units acceptable or permissible to exceed the “m” microbiological criterion. If the maximum number of sampling units stated herein is exceeded, the batch/shipment is considered failed.

9) m: number or maximum limit of bacteria in 1 gram of product; test results exceeding these limits may be qualified or failed.

10) M: maximum limits used for deciding that product's quality is qualified or failed.

11) Category A: tests are required for assessment of conformity.