Thông tư 41/2010/TT-BYT Quy chuẩn kỹ thuật quốc gia các sản phẩm sữa

• Số hiệu: 41/2010/TT-BYT
• Loại văn bản: Thông tư
• Nơi ban hành: Bộ Y tế
• Người ký: Trịnh Quân Huấn
• Ngày ban hành: 18/11/2010

BỘ Y TẾ -------	CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc ---------
Số: 41/2010/TT-BYT	Hà Nội, ngày 18 tháng 11 năm 2010

THÔNG TƯ

BAN HÀNH QUY CHUẨN KỸ THUẬT QUỐC GIA ĐỐI VỚI CÁC SẢN PHẨM SỮA LÊN MEN

BỘ TRƯỞNG BỘ Y TẾ

Căn cứ Luật Tiêu chuẩn và Quy chuẩn kỹ thuật ngày 29 tháng 6 năm 2006 và Nghị định số 127/2007/NĐ-CP ngày 01 tháng 8 năm 2007 của Chính phủ quy định chi tiết thi hành một số điều của Luật Tiêu chuẩn và Quy chuẩn kỹ thuật;
Căn cứ Pháp lệnh Vệ sinh an toàn thực phẩm ngày 26 tháng 7 năm 2003 và Nghị định số 163/2004/NĐ-CP ngày 07 tháng 9 năm 2004 của Chính phủ quy định chi tiết thi hành một số điều của Pháp lệnh Vệ sinh an toàn thực phẩm;
Căn cứ Nghị định số 188/2007/NĐ-CP ngày 27 tháng 12 năm 2007 của Chính phủ quy định chức năng, nhiệm vụ, quyền hạn và cơ cấu tổ chức của Bộ Y tế;
Theo đề nghị của Cục trưởng Cục An toàn vệ sinh thực phẩm, Vụ trưởng Vụ Khoa học và Đào tạo, Vụ trưởng Vụ Pháp chế,

QUY ĐỊNH:

Điều 1. Ban hành kèm theo Thông tư này:

QCVN 5-5:2010/BYT - Quy chuẩn kỹ thuật quốc gia đối với các sản phẩm sữa lên men.

Điều 2. Thông tư này có hiệu lực từ ngày 01 tháng 06 năm 2011.

Điều 3. Cục trưởng Cục An toàn vệ sinh thực phẩm, Thủ trưởng các đơn vị thuộc Bộ Y tế, các đơn vị trực thuộc Bộ Y tế; Giám đốc Sở Y tế các tỉnh, thành phố trực thuộc trung ương và các tổ chức, cá nhân có liên quan chịu trách nhiệm thi hành Thông tư này. /.

Nơi nhận: - VPCP (Văn xã, Công báo, Cổng TTĐT Chính phủ); - Các Bộ, cơ quan ngang Bộ, cơ quan thuộc CP; - Bộ Tư pháp (Cục Kiểm tra VBQPPL); - Bộ trưởng Nguyễn Quốc Triệu (để báo cáo); - UBND các tỉnh, thành phố trực thuộc TW; - Viện Kiểm sát nhân dân tối cao; - Toà án nhân dân tối cao; - Sở Y tế các tỉnh, thành phố trực thuộc TW; - Chi cục ATTP các tỉnh, thành phố trực thuộc TW; - TTYTDP các tỉnh, thành phố trực thuộc TW; - Các cơ quan KTNN về thực phẩm nhập khẩu; - Tổng Cục Tiêu chuẩn - Đo lường - Chất lượng; - Website Bộ Y tế; - Lưu: VT, K2ĐT, PC, ATTP.

KT. BỘ TRƯỞNG THỨ TRƯỞNG Trịnh Quân Huấn

FILE ĐƯỢC ĐÍNH KÈM THEO VĂN BẢN

Tiếng Anh (English)

MINISTRY OF HEALTH --------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 41/2010/TT-BYT	Hanoi, 18 November 2010

CIRCULAR

ON PROMULGATION OF NATIONAL TECHNICAL REGULATION FOR FERMENTED MILK PRODUCTS

MINISTER OF HEALTH

Pursuant to the Law on Technical standards and regulations dated 29 June 2006 and the Government's Decree No. 127/2007/ND-CP dated 01 August 2007 on details for the enforcement of certain articles of the Law on Technical standards and regulations;

Pursuant to the Ordinance on Food hygiene and safety dated 26 July 2003 and the Government’s Decree No. 163/2004/ND-CP dated 07 September 2004 on details for the enforcement of certain articles of the Ordinance on Food hygiene and safety;

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

At the requests of the Head of the Food Hygiene and Safety Administration, Head of the Science and Education Department, and Head of the Legal Department.

REGULATES:

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Article 2. This Circular comes into force as of 01 June 2011.

Article 3. Head of the Food Hygiene and Safety Administration, Heads of agencies under the Ministry of Health, agencies of the Ministry of Health, Directors of Health Departments of provinces and centrally affiliated cities and concerned entities are responsible for enforcing this Circular. /.

FOR THE MINISTER
DEPUTY MINISTER




Trinh Quan Huan

QCVN 5-5:2010/BYT

NATIONAL TECHNICAL REGULATION FOR FERMENTED MILK PRODUCTS

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QCVN 5-5:2010/BYT is compiled by the Committee for drafting of National technical regulations for food hygiene and safety for milk and milk products, is presented by the Food Hygiene and Safety Administration, and is promulgated under the Circular No. 41/2010/TT-BYT dated 18 November 2010 by Minister of Health.

NATIONAL TECHNICAL REGULATION FOR FERMENTED MILK PRODUCTS

I. GENERAL

1. Scope of regulation

This Regulation governs food safety norms and administrative requirements for fermented milk products.

2. Regulated entities

This Regulation shall apply to:

a) Organizations and individuals importing, producing and selling fermented milk products in Vietnam;

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3. Terminology

In this Regulation, the following words and phrases are construed as follows:

Ferment milk refers to milk products that undergo fermentation or refers to dairy products with or without changes in regulated constituents, with pH level lowered by felicitous microorganisms, with or without coagulation.

Flavored fermented milk contains a maximum of 50% of non-dairy ingredients (such as nutritive and non-nutritive sweeteners, fruits, vegetables, juices, purees, pulps, preparations and preserves derived thereof, cereals, honey, chocolate, nuts, coffee, spices and other harmless natural flavoring foods) and/or flavors. Non-dairy ingredients can be mixed before or after fermentation.

II. TECHNICAL REQUIREMENTS

1. Food safety norms for fermented milk products

1.1. Physicochemical norms are defined in Annex I of this Regulation.

1.2. Maximum limit of contaminants is specified in Annex II of this Regulation.

1.3. Microbial norms are prescribed in Annex III of this Regulation.

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1.5 It is permissible to employ testing measures with precision equivalent to that of methods defined by norm in Annex I, Annex II and Annex III of this Regulation.

1.6. Codes and full names of sampling approaches and testing methods are indicated in Annex IV of this Regulation.

1.7. Ministry of Health shall regulate tests for norms, whose testing methods are not available in this Regulation, according to accredited measures being employed locally or abroad.

2. Labeling 

The labeling of fermented milk products must conform to the Government's Decree No. 89/2006/ND-CP dated 30 August 2006 on product label and written guidelines. 

III. MANAGEMENT REGULATIONS

1. Announcement of conformity

1.1. The conformity of fermented milk products imported, produced and sold domestically must be announced according to this Regulation prior to their circulation in the market.

1.2. Methods and procedures for announcement of conformity shall be governed by the regulation on certification and announcement of conformity and conformance under the Decision No. 24/2007/QĐ-BKHCN dated 28 September 2007 by Minister of Science and Technology and the laws.

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The inspection of the quality and safety of fermented milk products must abide by the laws.

IV. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

1. Importers and producers of fermented milk products must announce their conformity to technical requirements in this Regulation and register such announcements with competent government authorities as specified by the Ministry of Health. Quality and safety of the products must be maintained according to such announcements.

2. Entities can only import, produce and sell fermented milk products when they complete the registration of the announcement of conformity with competent government authorities and maintain quality, hygiene, safety and labeling according to the laws.

V. ENFORCEMENT

1. Food Hygiene and Safety Administration shall lead and coordinate with relevant authorities to guide and organize the enforcement of this Regulation.

2. Food Hygiene and Safety Administration, according to its managerial devoirs, shall be responsible for proposing to the Ministry of Health the amendments and supplements to this Regulation.

3. If amendments, supplements or replacements of standards and regulations stated in this Regulation occur, such revisions shall govern. 

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PHYSICOCHEMICAL NORMS FOR FERMENTED MILK PRODUCTS

Entry

Regulated limit

Testing method

Category of norms ^*)

1. Milk protein content in unheated fermented milk products, % by weight, not lower than

2.7

TCVN 7774:2007 (ISO 5542:1984), TCVN 8099-1:2009 (ISO 8968-1:2001), TCVN 8099-5:2009 (ISO 8968-5:2001)

A

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ANNEX II

LIMITATION OF CONTAMINANTS IN FERMENTED MILK PRODUCTS

Entry

Maximum limit

Testing method

Category of norms ^*)

I. Heavy metal

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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

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...

...

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)

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...

6. Mercury, mg/kg

0.05

TCVN 7993:2008 (EN 13806:2002)

B

II. Mycotoxin

1. Aflatoxin M1, mg/kg

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...

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)

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IV. Residue of veterinary medicines, mg/kg

1. Benzylpenicillin/ Procaine benzylpenicillin

4

TCVN 8106:2009 (ISO/TS 26844:2006); AOAC 988.08

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...

2. Clortetracyclline/ 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

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...

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)

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7. Clenbuterol

50

B

8. Cyfluthrin ^1)

40

TCVN 8101:2009 (ISO 8260:2008)

B

9. Cyhalothrin ^1)

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...

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 ^1)

30

TCVN 8101:2009 (ISO 8260:2008)

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12. Diminazen

150

B

13. Doramectin

15

B

14. Eprinomectin

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B

15. Febantel/ Fenbendazole/ Oxfendazole

100

B

16. Imidocarb

50

...

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...

17. Isometamidium

100

B

18. Ivermectin

10

B

19. Lincomycin

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...

AOAC 988.08

B

20. Neomycin

1500

TCVN 8106:2009 (ISO/TS 26844:2006)

B

21. Pirlimycin

200

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...

22. Spectinomycin

200

B

23. Sulfadimidine

25

AOAC 992.21

B

24. Thiabendazole ^1)

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B

25. Triclorfon (Metrifonate) ^1)

50

B

V. Residue of pesticides ^1) 2), mg/kg

V.1. Pesticides soluble in water or partially soluble in fat

1. Endosulfan

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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

...

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...

4. Acephate

0.02

AOAC 970.52

B

5. Aldicarb

0.01

US FDA PAM, Vol. I, Section 401, E1+DL1

B

6. Aminopyralid

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B

7. Amitraz

0.01

B

8. Bentazon

0.05

...

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...

9. Bifenazate

0.01

B

10. Bifenthrin

0.05

AOAC 970.52

B

11. Bitertanol

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B

12. Carbaryl

0.05

AOAC 964.18; US FDA PAM, Vol. I, Section 401, E1+DL1

B

13. Carbendazim

0.05

...

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B

14. Carbofuran

0.05

US FDA PAM, Vol. I, Section 401, E1, DL1

B

15. Carbosulfan

0.03

B

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0.5

B

17. Chlorpropham

0.0005

US FDA PAM, Vol. I, Section 304, E4, C1-C4

B

18. Chlorpyrifos

0.02

...

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B

19. Chlorpyrifos-methyl

0.01

TCVN 8101:2009 (ISO 8260:2008)

B

20. Clethodim

0.05

B

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0.05

B

22. Cyhexatin

0.05

B

23. Cyprodinil

0.0004

...

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B

24. Cyromazine

0.01

B

25. Dichlorvos

0.02

TCVN 8101:2009 (ISO 8260:2008)

B

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0.005

B

27. Dimethenamid-p

0.01

B

28. Dimethipin

0.01

...

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B

29. Dimethoate

0.05

AOAC 970.52

B

30. Dimethomorph

0.01

B

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0.01

B

32. Disulfoton

0.01

B

33. Dithiocarbamate

0.05

...

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B

34. Ethephon

0.05

B

35. Ethoprophos

0.01

US FDA PAM, Vol. I, Section 304, E4, C1, C3

B

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0.005

B

37. Fenbuconazole

0.05

B

38. Fenbutatin-oxide

0.05

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B

39. Fenpropimorph

0.01

B

40. Fipronil

0.02

US FDA PAM, Vol. I, Section 304, E4, C1-C4

B

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0.01

B

42. Flutolanil

0.05

B

43. Glufosinate ammonium

0.02

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B

44. Imidacloprid

0.02

B

45. Indoxacarb

0.1

B

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0.01

B

47. Lindane

0.01

AOAC 970.52

B

48. Methamidophos

0.02

...

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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

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0.01

B

52. Myclobutanil

0.01

B

53. Novaluron

0.4

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B

54. Oxamyl

0.02

US FDA PAM, Vol. I, Section 401, E1, DL1

B

55. Oxydemeton-methyl

0.01

B

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0.005

B

57. Penconazole

0.01

B

58. Pirimicarb

0.01

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B

59. Pirimiphos-methyl

0.01

TCVN 8101:2009 (ISO 8260:2008)

B

60. Prochloraz

0.05

B

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0.01

US FDA PAM, Vol. I, Section 304, E4, C1, C3

B

62. Propamocarb

0.01

B

63. Propiconazole

0.01

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B

64. Pyraclostrobin

0.03

B

65. Pyrimethanil

0.01

US FDA PAM, Vol. I, Section 304, E4, C1-C4<0}

B

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0.01

B

67. Spinosad

1

B

68. Tebuconazole

0.01

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B

69. Tebufenozide

0.01

B

70. Terbufos

0.01

US FDA PAM, Vol. I, Section 304, C1-C4

B

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0.05

B

72. Triadimefon

0.01

US FDA PAM, Vol. I, Section 304, C1, C3

B

73. Triadimenol

0.01

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B

74. Trifloxystrobin

0.02

B

75. Vinclozolin

0.05

US FDA PAM, Vol. I, Section 304, C1-C3; E1-E5+C6

B

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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 ^4)

0.04

TCVN 8101:2009 (ISO 8260:2008)

A

3. Chlordane

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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

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A

6. Deltamethrin ^5)

0.05

TCVN 8101:2009 (ISO 8260:2008)

B

7. Diazinon

0.02

TCVN 8101:2009 (ISO 8260:2008)

B

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0.1

TCVN 8101:2009 (ISO 8260:2008)

B

9. Diflubenzuron

0.02

B

10. Diphenylamine

0.0004

...

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B

11. Famoxadone

0.03

B

12. Fenhexamid

0.01

B

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0.1

US FDA PAM Vol. I, Section 304, E4, C1-C4

B

14. Fenpyroximate

0.005

B

15. Fenvalerate

0.1

...

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B

16. Flumethrin

0.05

B

17. Flusilazole

0.05

B

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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

...

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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

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0.1

US FDA PAM Vol. I, Section 304, E4+C6

B

ANNEX III

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Entry

Maximum allowable limit

Testing method

Category of norms ^10)

n ^6)

c ^7)

m ^8)

M ^9)

I. Heat-treated fermented milk products

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5

2

< 1 CFU/g

5 CFU/g

TCVN 5518-1:2007  (ISO 21528-1:2004)

A

2. Listeria monocytogenes (for instant milk products)

5

0

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

A

II. Unheated fermented milk products

1. Listeria monocytogenes (for instant milk products)

5

0

100 CFU/g

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

A

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^7)c: maximum number of samples with test results ranging from m to M, total quantity of unqualified samples exceeding c despite their test results ranging from m to M.

^8)m: test results below these limits are qualified and those above such limits may be qualified or failed.

^9)M: maximum limits that none of the samples can exceed.

^10)Category A: tests are required for assessment of conformity.

ANNEX IV

LIST OF TESTING METHODS FOR FOOD SAFETY NORMS FOR FERMENTED MILK PRODUCTS

I. Sampling

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

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1. TCVN 6508:2007 (ISO 1211:1999) Milk - Determination of fat content - Gravimetric method (Reference method)

2. TCVN 7774:2007 (ISO 5542:1984) Milk - Determination of protein content - Amido black dye-binding method (Routine method)

3. TCVN 8099-1:2009 (ISO 8968-1:2001) Milk - Determination of nitrogen content - Part 1: Kjeldahl method

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

III. Testing methods for contaminants

III.1. Heavy metal

1. TCVN 7601:2007 Foodstuffs – Determination of arsenic content by silver diethyldithiocarbamate method

2. TCVN 7603:2007 Foods – Determination of cadmium content by atomic absorption spectrophotometric method

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

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5. 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

6. TCVN 7933:2008 (ISO 6733:2006) Milk and milk products - Determination of lead content - Graphite furnace atomic absorption spectrometric method

7. TCVN 7993:2008 (EN 13806:2002) Foodstuffs - Determination of trace elements - Determination of mercury by cold-vapour atomic absorption spectrometry (CVAAS) after pressure digestion

III.2. Mycotoxin

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

III.3. Melamine

1. Common technical regulation on enumeration of melamine in foodstuffs, as enclosed to the Decision No. 4143/QĐ-BYT dated 22 October 2008

III.4. Residue of veterinary medicines

1. TCVN 8101:2009 (ISO 8260:2008) Milk and milk products - Determination of organochlorine pesticides and polychlorobiphenyls - Method using capillary gas-liquid chromatography with electron-capture detection

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3. AOAC 988.08 Antimicrobial Drugs in Milk. Microbial Receptor Assay

4. AOAC 992.21 Sulfamethazine Residues in Raw Bovine Milk

5. AOAC 995.04 Multiple Tetracycline Residues in Milk Metal Chelate Affinity-Liquid Chromatographic Method

6. AOAC 995.09 Chlortetracycline, Oxytetracycline, and Tetracycline in Edible Animal Tissues. Liquid Chromatographic Method

7. AOAC 998.01 Synthetic Pyrethroids in Agricultural Products Multiresidue. GC Method

8. Pesticide Analytical Manual (PAM), Food and Drug Administration, Washington, D.C., USA, Vol. I, 3rd edition, Section 304

9. Pesticide Analytical Manual (PAM), Food and Drug Administration, Washington, D.C., USA, Vol. I, 3rd edition, Section 401

10. Pesticide Analytical Manual (PAM), Food and Drug Administration, Washington, D.C., USA, Vol. I, 3rd edition, Section 402

III.5. Residue of pesticides

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2. TCVN 7082-1:2002 (ISO 3890-1:2000) Milk and milk products - Determination of residues of organochlorine compounds (pesticides) - Part 1: General considerations and extraction methods

3. TCVN 7082-2:2002 (ISO 3890-2:2000) Milk and milk products - Determination of residues of organochlorine compounds (pesticides) - Part 2: Test methods for crude extract purification and confirmation

4. TCVN 8101:2009 (ISO 8260:2008) Milk and milk products - Determination of organochlorine pesticides and polychlorobiphenyls - Method using capillary gas-liquid chromatography with electron-capture detection

5. TCVN 8170-1:2009 (EN 1528-1:1996) Fatty food - Determination of pesticides and polychlorinated biphenyls (PCBs) - Part 1: General

6. TCVN 8170-2:2009 (EN 1528-2:1996) Fatty food - Determination of pesticides and polychlorinated biphenyls (PCBs) - Part 2: Extraction of fat, pesticides and PCBs, and determination of fat content

7. TCVN 8170-3:2009 (EN 1528-3:1996) Fatty food - Determination of pesticides and polychlorinated biphenyls (PCBs) - Part 3: Clean-up methods

8. TCVN 8170-4:2009 (EN 1528-4:1996) Fatty food - Determination of pesticides and polychlorinated biphenyls (PCBs) - Part 4: Determination, confirmatory tests, miscellaneous

9. AOAC 964.18 Carbaryl Pesticide Residues. Colorimetric Method

10. AOAC 970.52 Organochlorine and Organophosphorus Pesticide Residues. General Multiresidue Method

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1. 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

2. TCVN 5518-1:2007 (ISO 21528-1:2004) Microbiology of food and animal feeding stuffs -Horizontal methods for the detection and enumeration of Enterobacteriaceae - Part 1: Detection and enumeration by MPN technique with pre-enrichment