Thông tư 34/2011/TT-BYT Quy chuẩn kỹ thuật quốc gia an toàn vệ sinh

CIRCULAR

PROMULGATING NATIONAL TECHNICAL REGULATIONS ON CONTAINERS AND PACKAGING IN DIRECT CONTACT WITH FOODS

THE MINISTER OF HEALTH

Pursuant to the Law on Food Safety dated June 17, 2010;

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

Pursuant to the Law on Product and Goods Quality dated November 21, 2007 and Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 elaborating some articles of the Law on Product and Goods Quality;

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 Director General of Vietnam Food Administration, Director of Department of Science and Training and Director of Department of Legal Affairs;

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Article 1. National technical regulations on containers and packaging in direct contact with foods are promulgated together with this Circular.

QCVN 12-1:2011/BYT - National technical regulations on synthetic resin implement, containers and packaging in direct contact with foods;

QCVN 12-2:2011/BYT - National technical regulation on safety and hygiene for rubber implements, containers and packaging in direct contact with foods;

QCVN 12-3:2011/BYT - National technical regulation on safety and hygiene for metallic containers in direct contact with foods.

Article 2. This Circular comes into force from March 01, 2012

Article 3. Director General of 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

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QCVN 12-1:2011/BYT

NATIONAL TECHNICAL REGULATION ON SAFETY AND HYGIENE FOR SYNTHETIC RESIN IMPLEMENTS, CONTAINERS AND PACKAGING IN DIRECT CONTACT WITH FOODS

Foreword

QCVN 12-1:2011/BYT is drafted by the Drafting Committee for national technical regulation on containers and packaging in direct contact with foods, submitted by the Vietnam Food Administration for approval and promulgated together with the Circular No. 34/2011/TT-BYT dated August 30, 2011 of the Minister of Health.

NATIONAL TECHNICAL REGULATION ON SAFETY AND HYGIENE FOR SYNTHETIC RESIN IMPLEMENT, CONTAINERS AND PACKAGING IN DIRECT CONTACT WITH FOODS

I. GENERAL PROVISIONS

1. Scope

This document provides for specifications and requirements for management of safety and hygiene for synthetic resin implements, containers and packaging in direct contact with foods (hereinafter referred to as “synthetic resin implements, containers and packaging”).

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This document applies to:

2.1. Importers, producers, sellers and users of synthetic resin implements, containers and packaging.

2.2. Regulatory authorities and relevant organizations and individuals.

3. Definitions

3.1 Leaching solution is a solution used to immerse samples.

II. SPECIFICATIONS

1. Specifications for synthetic resin implements, containers and packaging

Synthetic resin implements, containers and packaging must meet the specifications provided in Table 1:

Table 1. Specifications for synthetic resin implements, containers and packaging

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Elution test

Testing criteria

Maximum limit

Testing criteria

Leaching condition

Leaching solution

Maximum limit

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100 µg/g

Heavy metal

60⁰C hold for 30 minutes ^[7]

Acetic acid 4%

1 µg/ml

Volume of KMnO₄ used^[1]

Water

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Cadmium

100 µg/g

2. Specifications for phenol, melamine and urea resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, phenol, melamine and urea resin implements, containers and packaging must meet the specifications provided in Table 2:

Table 2: Specifications for phenol, melamine and urea resin implements, containers and packaging

Elution test

Testing criteria

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Leaching solution

Maximum limit

Phenol

60⁰C hold for 30 minutes^[7]

Water

5 µg/ml

Formaldehyde

Negative

Evaporation residue

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Heptane

30 µg/ml

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

60⁰C hold for 30 minutes^[7]

Water

Acetic acid 4%

3. Specifications for formaldehyde resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, formaldehyde resin implements, containers and packaging must meet the specifications provided in Table 3:

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Elution test

Testing criteria

Leaching condition

Leaching solution

Maximum limit

Phenol

60⁰C  hold for 30 minutes^[7]

Water

Negative

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Negative

Evaporation residue

Acetic acid 4%

30 µg/ml

4. Specifications for Polyvinyl Chloride (PVC) resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, Polyvinyl Chloride (PVC) resin implements, containers and packaging must meet the specifications provided in Table 4:

Table 4: Specifications for Polyvinyl Chloride (PVC) resin implements, containers and packaging

Material testing

Elution test

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Testing criteria

Maximum limit

Testing criteria

Leaching condition

Leaching solution

Maximum limit

Vinyl chloride

1µg/g

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25^oC hold for 1 hour

Heptane^[3]

150 µg/ml

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

30 µg/ml

Cresyl phosphate

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Dibutyltin compounds

50µ/g

60⁰C hold for 30 minutes

Water ^[5]

Acetic acid 4%

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In addition to the specifications provided in Clause II, section 1, Polyethylene and Polypropylene (PE and PP) resin implements, containers and packaging must meet the specifications provided in Table 5:

Table 5: Specifications for Polyethylene and Polypropylene (PE and PP) resin implements, containers and packaging

Elution test

Testing criteria

Leaching condition

Leaching solution

Maximum limit

Evaporation residue

25^oC hold for 1 hour

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30 µg/ml ^[a]

60^oC hold for 30 minutes

Ethanol 20% ^[4]

30 µg/ml

60⁰C hold for 30 minutes^[7]

Water^[5]

Acetic acid 4%^[6]

6. Specifications for Polystyrene (PS) resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, Polystyrene (PS) resin implements, containers and packaging must meet the specifications provided in Table 6:

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Material testing

Elution test

Testing criteria

Maximum limit

Testing criteria

Leaching condition

Leaching solution

Maximum limit

▪Total volatile substances (styrene, touluene, ethybenzene, n-propyl benzene)

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Evaporation residue

25^oC hold for 1 hour

Heptane^[3]

240 µg/ml

Expanded Polystyrenee (upon use of boiling water) 

2mg/g

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

30 µg/ml

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Water^[5]

Styrene and Ethybenzene

1mg/g

Acetic acid 4%^[6]

7. Specifications for Polyvinylidene chloride (PVDC) resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, Polyvinylidene chloride (PVDC) resin implements, containers and packaging must meet the specifications provided in Table 7:

Table 7: Specifications for Polyvinylidene chloride (PVDC) resin implements, containers and packaging

Material testing

Elution test

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Maximum limit

Testing criteria

Leaching condition

Leaching solution

Maximum limit

Barium

100 µg/g

Evaporation residue

25^oC hold for 1 hour

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30 µg/ml

Vinylidene chloride

Not exceeding 6 µg/g

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

60⁰C hold for 30 minutes^[7]

Water^[5]

Acetic acid 4%^[6]

8. Specifications for Polyethylene terephthalate (PET) resin implements, containers and packaging

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Table 8: Specifications for Polyethylene terephthalate (PET) resin implements, containers and packaging

Elution test

Testing criteria

Leaching condition

Leaching solution

Maximum limit

Antimony

60⁰C hold for 30 minutes ^[7]

Acetic acid 4%

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Germani

0.1 µg/ml

Evaporation residue

25⁰C hold for 1 hour

Heptane^[3]

30 µg/ml

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

60⁰C hold for 30 minutes ^[7]

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Acetic acid 4%^[6]

9. Specifications for Polymethyl Metacrylate (PMMA) resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, Polymethyl Metacrylate (PMMA) resin implements, containers and packaging must meet the specifications provided in Table 9:

Table 9: Specifications for Polymethyl Metacrylate (PMMA) resin implements, containers and packaging

Elution test

Testing criteria

Leaching condition

Leaching solution

Maximum limit

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60⁰C hold for 30 minutes

Ethanol 20%

15 µg/ml

Evaporation residue

25⁰C hold for 1 hour

Heptane^[3]

30 µg/ml

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

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Water^[5]

Acetic acid 4%^[6]

10. Specifications for Nylon (PA) resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, Nylon (PA) resin implements, containers and packaging must meet the specifications provided in Table 10:

Table 10: Specifications for Nylon (PA) resin implements, containers and packaging

Elution test

Testing criteria

Leaching condition

Leaching solution

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Caprolactam

60⁰C hold for 30 minutes

Ethanol 20%

15 µg/ml

Evaporation residue

25⁰C hold for 1 hour

Heptane^[3]

30 µg/ml

60⁰C hold for 30 minutes

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60⁰C hold for 30 minutes ^[7]

Water^[5]

Acetic acid 4%^[6]

11. Specifications for Polymethyl Pentene (PMP) resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, Polymethyl Pentene (PMP) resin implements, containers and packaging must meet the specifications provided in Table 11:

Table 11: Specifications for Polymethyl Pentene (PMP) resin implements, containers and packaging

Elution test

Testing criteria

Leaching condition

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Maximum limit

Evaporation residue

25⁰C hold for 1 hour

Heptane^[3]

120 µg/ml

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

30 µg/m l

60⁰C hold for 30 minutes ^[7]

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Acetic acid 4%^[6]

12.  Specifications for Polycarbonate (PC) resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, Polycarbonate (PC) resin implements, containers and packaging must meet the specifications provided in Table 12:

Table 12: Specifications for Polycarbonate (PC) resin implements, containers and packaging

Material testing

Elution test

Testing criteria

Maximum limit

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Leaching condition

Leaching solution

Maximum limit

Bis-phenol A (Phenol,P-t-butylphenol)^[8]

Not exceeding 500µg/g

Bisphenol A (Phenol,P-t-butylphenol)

25⁰C hold for 1 hour

Heptane^[3]

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60⁰C hold for 30 minutes

Ethanol 20% ^[4]

60⁰C hold for 30 minutes ^[7]

Water^[5]

Acetic acid 4%^[6]

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Not exceeding 500µg/g

Evaporation residue

25⁰C hold for 1 hour

Heptane^[3]

30 µg/ml

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

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60⁰C hold for 30 minutes ^[7]

Water^[5]

Amine (triethylamine and tributylamine)

Not exceeding 1µg/g

Acetic acid 4%^[6]

13. Specifications for Polylactic Acid (PLA) resin implements, containers and packaging

In addition to the specifications provided in Clause II, section 1, Polylactic Acid (PLA) resin implements, containers and packaging must meet the specifications provided in Table 13:

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Elution test

Testing criteria

Leaching condition

Leaching solution

Maximum limit

Total lactic acid

60⁰C hold for 30 minutes

Water

30 µg/ml

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25⁰C hold for 1 hour

Heptane^[3]

30 µg/ml

60⁰C hold for 30 minutes

Ethanol 20% ^[4]

60⁰C hold for 30 minutes ^[7]

Water^[5]

Acetic acid 4%^[6]

14. Specifications for Polyvinyl Alcohol (PVA) resin implements, containers and packaging

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Table 14: Specifications for Polyvinyl Alcohol (PVA) resin implements, containers and packaging

Elution test

Testing criteria

Leaching condition

Leaching solution

Maximum limit

Evaporation residue

25⁰C hold for 1 hour

Water^[3]

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60⁰C hold for 30 minutes

Ethanol 20% ^[4]

60⁰C hold for 30 minutes ^[7]

Water^[5]

Acetic acid 4%^[6]

Note

^[1] Except for phenol, melamine and urea resin implements, containers and packaging.

^[2] Applied to cooking ware and dinnerware.

^[3] Applied to implements, containers and packaging containing fat, cooking oil and fatty foods.

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^[5] Applied to implements, containers and packaging containing foods with a pH greater than 5.

^[6] Applied to implements, containers and packaging containing foods with a pH less than or equal to 5.

^[7] Applied to implements used at a temperature of greater than 100⁰C, the leaching condition is 95⁰C hold for 30 minutes.

^[8] Not contained in implements, containers and packaging for kids.

III. TEST AND SAMPLING METHODS

Test and sampling methods are provided in the Appendices promulgated together with this document. To be specific:

1. Appendix 1: Material test methods

2. Appendix 2: Elution test methods.

IV. MANAGEMENT REQUIREMENTS

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1.1. Declarations of conformity of imported and domestic resin implements, containers and packaging must be submitted in accordance with regulations of this document.

1.2. Methods and procedures for submission of declarations of conformity shall be compliant with the Regulation on declaration of standard conformity and technical-regulation conformity promulgated together with the Decision No. 24/2007/QD BKHCN dated September 28, 2007 of the Minister of Science and Technology and regulations of law.

2. State inspection of resin implements, containers and packaging

The state inspection of resin implements, containers and packaging shall be carried out as prescribed by law.

V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

1. Importers and producers of resin implements, containers and packaging must submit declarations of conformity according to the specifications specified in this document, register the declarations of conformity at the Vietnam Food Administration and ensure fulfillment of food quality and safety requirements specified in the declarations.

2. Importers, producers, sellers and users shall be only allowed to import, produce, sell and use metallic containers after registering the declarations of conformity and ensuring food quality and safety as prescribed by law.

VI. IMPLEMENTATION

1. The Vietnam Food Administration shall take charge and cooperate with relevant authorities in providing guidance and organizing the implementation of this document.

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APPENDIX 1

TESTING METHODS FOR PLASTIC MATERIALS

1. Determination of lead and cadmium in plastic materials

1.1. Prepare test solution

Take 1.0 g of sample in a platinum, quartz or heat-resistant glass evaporating dish, add 2ml of sulfuric acid, gradually heat, and continue heating until white smoke has mostly stopped coming from the sulfuric acid and most of the material has carbonized. Heat this in an electric furnace at approximately 450°C to carbonize. Until it completely carbonizes, repeat the process of moistening the content of the evaporation dish with sulfuric acid and reheating. Add 5ml of hydrochloric acid (1→2) to the residue, mix, and evaporate and harden on a water bath. After cooling, add 20 ml of 0.1 mol/l nitric acid, dissolve, filter away any undissolved matter, and use the liquid as test solution.

1.2. Prepare standard solution

1.2.1 Cadmium

- Cadmium standard undiluted solution: Measure out 100 mg of cadmium dissolve in 50 ml of 10% nitric acid, evaporate and harden on a water bath. Then add 0.1 mol/l nitric acid to the residue to bring the total volume to 100 ml. 1 ml of this liquid contains 1 mg of cadmium.

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1.2.2 Lead

- Lead standard undiluted solution: Dissolve 159.8 mg of lead (II) nitrate in 10 ml of 10% nitric acid and add water to bring the total volume to 100 ml. 1 ml of this solution contains 1 mg of lead.

- Lead standard solution: Take 1 ml of lead standard undiluted solution, add 0.1 mol/l nitric acid to bring the total volume to 200 ml. 1 ml of this liquid contains 5 μg of cadmium.

1.3 Test

Determine the concentration of cadmium and lead respectively in the test solution by atomic absorption spectrometry or inductively coupled plasma emission spectroscopic.

2. Determination of dibutyltin compounds

2.1. Prepare test solution

Finely slice or crush a sample, measure out 0.5 g and place in a stoppered flask. Add 20 ml of a 3:7 mixture of acetone and hexane and one drop of hydrochloric acid, seal tightly and leave overnight at approximately 40°C, occasionally shaking to mix. After cooling, filter out this liquid, mix the filtered liquid and wash liquid, and use a vacuum concentrator to concentrate to approximately 1 ml at no more than 40°C. Next, using hexane, transfer to a 25-ml measuring flask and add hexane to make 25.0 ml. Centrifuge the mixture for approximately 10 minutes at 2,500 rpm and use the supernatant as test solution. Add acetone and two or three drops of hydrochloric acid to 100 ml of dibutyltin dichloride and dissolve, then add acetone to bring the total volume to 100 ml. Take 1 ml of this and add hexane and two or three drops of hydrochloric acid to bring the total volume to 1,000 ml. 1 ml of this liquid contains 1 μg of dibutyltin dichloride.

2.2 Test

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Column

Use a 30 m long silicate-glass column with an inner diameter of 0.25 mm and with a 0.25 μm thick dimethylpolysiloxane coating containing up to 5% diphenylpolysiloxane

Column temperature

Heat the column at 45°C for 4 minutes, then raise the temperature by 15°C every minute until 300°C is reached, then maintain at that temperature for 10 minutes.

Sample solution inlet temperature

250⁰C

Detector

Use a mass spectrometer set to an atomic mass number of 263

Carrier gas

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3. Determination of tricresyl phosphate in PVC

3.1. Prepare test solution

Finely slice or crush a sample, measure out 0.5 g and place in a stoppered flask. Add 15ml acetonitrile, seal tightly and leave overnight at about 40°C. Afterwards, filter this liquid, mix the filtered liquid with the wash liquid, add acetonitrile to make 25 ml and use this as the acetonitrile extract.

Mix 5 ml of acetonitrile extract with 5 ml of water and inject into octadecyl silylate silica gel minicolumn into which 5 ml of acetonitrile and 5ml of a 1:1 acetonitrile and water mixture have each been previously injected.

Elute in a 2:1 mixture of acetonitrile and water and take 10 ml of the elution.

3.2 Prepare standard solution

Take 100 mg of tricresyl phosphate precisely, add acetonitrile and dissolve to bring the total volume to 100 ml. Take 1 ml of this and add 60 ml of acetonitrile, then add water to bring the total volume to 100 ml. 1 ml of this liquid contains 10 μg of tricresyl phosphate.

3.3 Test 

Use 20 ml each of test solution and tricresyl phosphate standard solution. Perform liquid chromatrography according to the procedure and conditions described below.

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Use a stainless-steel tube 250 mm long and with an inner diameter of 4.6 mm

Column temperature

50⁰C

Detector

Use an ultraviolet spectrophotometric detector. Operate at a wavelength of 264 nm.

Moving phase

Use a 2:1 mixture of acetonitrile and water. Adjust the flow rate so that the tricresyl phosphate flows out in approximately 9 minutes.

4. Determination of Vinyl chloride in PVC

4.1 Prepare test solution

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4.2 Vinyl chloride standard solution

Place approximately 190 ml of ethanol in a 200 ml measuring flask, plug with a silicon rubber stopper and weigh. Cool the measuring flask in a methanol-dry ice bath and inject 200 mg of already liquefied vinyl chloride. Inject the ethanol chilled in the methanol-dry ice bath to bring the total volume to 200 ml. Next, cool this in the methanol-dry ice bath. Take 1 ml, and add ethanol chilled in the methanol-dry ice bath to bring the total volume to 100 ml. Store in a methanol-dry ice bath. 1 ml of this liquid contains 10 μg of vinyl chloride. Ethanol (99.5), when testing for vinyl chloride, confirm that no substances that interfere with testing are contained.

4.3 Test

Pour 50 ml of vinyl chloride standard solution into a septum-stoppered glass bottle already containing 2.5 ml of N,N-dimethylacetamide, and immediately seal. Do the same for the test sample. Next, heat sealed glass bottles containing the sample solution and standard solution for 1 hour, shaking occasionally while maintaining at 90°C. Next, use 0.5 ml of vapor from each, perform gas chromatography under the procedure and conditions specified below.

Column

Use a 25 m long silicate-glass column with an inner diameter of 0.25 mm and with a 3 μm thick coating of porous styrene divinylbenzene resin.

Column temperature

Heat the column at 80°C for 1 minute, then raise the temperature by 10°C every minute until 250°C is reached, then maintain at that temperature for 10 minutes.

Sample solution inlet temperature

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Detector

Use a hydrogen flame ionization detector. Operate at or near 250°C. Adjust the flow of air and hydrogen for maximum detection sensitivity.

Carrier gas

Use nitrogen or helium. Adjust the flow rate so that the vinyl chloride flows out in approximately 5 minutes.

5. Determination of volatile substances in PS

5.1 Prepare test solution

Measure out 0.5 g of sample precisely, place in a 20 ml measuring flask and add an appropriate amount of tetrahydrofuran. After the sample has dissolved, add 1 ml of diethylbenzene test solution, and then add tetrahydrofuran to make 20 ml.

5.2 Prepare standard solution

Place 90 ml of tetrahydrofuran in a 100 ml measuring flask. Accurately measure and add 50 mg each of styrene, toluene, ethylbenzene, isopropyl benzene, and propyl benzene, then add enough tetrahydrofuran to bring the total volume to 100 ml. In separate 20 ml measuring flasks, place 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml of this solution, and add 1 ml of diethylbenzene test solution and enough tetrahydrofuran to bring the total volume to 20 ml.

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Add tetrahydrofuran to 1 ml of diethylbenzene to bring the total volume to 100 ml. Take 10 ml of this and add more tetrahydrofuran to bring the total volume to 100 ml.

5.4 Plot an analytical curve

Use 1 ml of each standard solution, perform gas chromatography according to the procedure and conditions specified below. Use the resultant gas chromatogram to calculate the ratio of the each peak area of styrene, toluene, ethylbenzene, isopropyl benzene and propyl benzene to that of diethylbenzene, then plot an analytical curve for each.

Column

Use a 30 m long silicate-glass column with an inner diameter of 0,25 mm and  with a 0.5 μm thick  coating of polyethylene  glycol

Column temperature

From a temperature of 60°C, raise the temperature at a rate of 4°C per minute until 100°C is reached, then continue raising the temperature at a rate of 10°C per minute until 150°C is reached.

Sample solution inlet temperature

220⁰C

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Use a hydrogen flame ionization detector. Operate at or near 220°C. Adjust the flow of air and hydrogen for maximum detection sensitivity.

Carrier gas

Use nitrogen or helium. Adjust the flow rate so that the diethylbenzene flows out in approximately 11 minutes.

5.5 Test

Using 1 ml of the test solution, perform gas chromatography according to the same procedure and conditions as described above. Use the resultant gas chromatogram to calculate the ratio of each peak area to that of diethylbenzene. Next, use the respective analytical lines to determine the concentration of styrene, toluene, ethylbenzene, isopropyl benzene, and propyl benzene, then use the following equation to determine the content of each.

Content (mg/g) = sample solution concentration (mg/ml) ´ 20 (ml) / sample weight (g)

6. Determination of barium in PVDC

6.1 Prepare test solution

Measure out 0.5 g of sample into a platinum, quartz or heat-resistant glass evaporation dish; gradually carbonize directly over a flame at approximately 300°C, then heat at approximately 450°C to turn to ash. Add 50 ml of 0.1 mol/l nitric acid to the residue and dissolve.

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- Barium standard undiluted solution : Dissolve 190.3 mg of barium nitrate in 0.1 mol/l nitric acid to bring the total volume to 100 ml.  1 ml of the liquid contains 1 mg of barium.

- Barium standard solution : Take 1 ml of barium standard undiluted solution and add 0.1 mol/l nitric acid to bring the total volume to 1,000 ml. 1 ml of this liquid contains 1μg of barium.

6.3 Test

Analyze barium in the test solution with atomic absorption spectrometry or inductively coupled plasma photoemission spectroscopy.

7. Determination of vinylidene chloride in PVDC

7.1 Prepare test solution

Finely slice a sample, measure out 0.5 g and place in a 20 ml glass bottle with a septum cap. Next, add 2.5 ml of N,N-dimethyl acetamide and immediately seal.

7.2 Standard solution

Place approximately 98 ml of N,N-dimethyl acetamid in a 100 ml measuring flask, plug with a silicon rubber stopper. Inject 250 ml of vinylidene chloride into  this measuring flask. Then inject N,N-dimethyl acetamide through the silicon rubber stopper to bring the total volume to 100 ml. Take 1 ml of this liquid and add N,N-dimethyl acetamide to bring the total volume to 50 ml. 1 ml of this liquid contains 60 μg of vinylidene chloride. Vinylidene chloride standard solution has a content of 60 µg/ml.

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Pour 50 ml of vinylidene chloride standard solution into a septum-stoppered glass bottle already containing 2.5 ml of N,N-dimethylacetamide, and immediately seal. Do the same for test sample. Next, heat sealed glass bottles containing the sample solution and standard solution for 1 hour, shaking occasionally while maintaining at 90°C. Next, use 0.5 ml of vapor from each, perform gas chromatography under the procedure and conditions specified below.

Column

Use a 25 m long silicate-glass column with an inner diameter of 0.25 mm and with a 3 μm thick coating of porous styrene divinylbenzene resin.

Column temperature

Heat the column at 80°C for 1 minute, then raise the temperature by 10°C every minute until 250°C is reached, then maintain at that temperature for 10 minutes.

Sample solution inlet temperature

200⁰C

Detector

Use a hydrogen flame ionization detector. Operate at or near 250°C. Adjust the flow of air and hydrogen for maximum detection sensitivity.

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Use nitrogen or helium. Adjust the flow rate so that the vinylidene chloride flows out in approximately 9 minutes.

8. Determination of bisphenol A in PC

8.1 Prepare test solution

Place 1.0 g of sample in a 200 ml Erlenmeyer flask and add 20 ml of dichloromethane. After the sample has dissolved, add 100 ml of acetone by droplets while mixing well and centrifuge the mixture for approximately 10 minutes at 3,000rpm. Use a vacuum concentrator to concentrate the supernatant to approximately 2 ml. Next, add 10 ml of acetonitrile, and then add water to make 20 ml. Take 1 ml of this and filter through a membrane filter with pores of no more than 0.5 μm.

8.2 Prepare standard solution

Accurately measure 10 mg each of bisphenol A, phenol, and p-tert-butylphenol and place in a 100 ml measuring flask, then add enough methanol to bring the total volume to 100 ml. In separate 20 ml measuring flasks, place 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml of this solution, then add enough water to bring the total volume to 20 ml. These are the standard solutions (5 µg/ml, 10 µg/ml, 15 µg/ml, 20 µg/ml, and 25 µg/ml).

8.3 Plot an analytical curve

Using 20 ml of each standard solution, perform liquid chromatography according to the procedure and conditions specified below. Use the resultant liquid chromatogram to calculate the height and area of the peak of bisphenol A, phenol, and p-tert-butylphenol, then plot an analytical curve for each.

Column filler

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Column

Use a stainless-steel tube 250 mm long and with an inner diameter of 4.6 mm

Column temperature

40^oC

Detector

Use an ultraviolet spectrophotometric detector. Operate at a wavelength of 217 nm.

Moving phase

A = acetonitrile ; B = water.

Concentration gradient

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8.4 Test

Use 20 μl of the sample solution, perform liquid chromatography according to the same procedure and conditions as described above. Next, use the analytical curve to determine the concentration of bisphenol A, phenol and p-tert-butylphenol in the sample solution, then use the following equation to determine the content in the material:

Content (mg/g) = sample solution concentration (mg/ml) ´ 20 (ml) / sample weight (g)

9. Determination of diphenyl carbonate in PC

9.1 Prepare test solution

Place 1.0 g of sample in a 200 ml Erlenmeyer flask and add 20 ml of dichloromethane. After the sample has dissolved, add 100 ml of acetone by droplets while mixing well and centrifuge the mixture for approximately 10 minutes at 3,000rpm. Use a vacuum concentrator to concentrate the supernatant to approximately 2 ml. Next, add 10ml of acetonitrile, and then add water to make 20 ml. Take 1 ml of this and filter through a membrane filter with pores of no more than 0.5 μm.

9.2 Prepare standard solution

Take 10 mg of diphenyl carbonate, add enough methanol to bring the total volume to 100 ml. In separate 20 ml measuring flasks, place 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml of this solution, then add enough water to bring the total volume to 20 ml.

9.3 Plot an analytical curve

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Column filler

Use octadecylsilyl silica gel

Column

Use a stainless-steel tube 250 mm long and with an inner diameter of 4.6 mm

Column temperature

40^oC

Detector

Use an ultraviolet spectrophotometric detector. Operate at a wavelength of 217 nm.

Moving phase

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Concentration gradient

After conducting a linear concentration gradient from A:B (3:07) to (100:0) for 35 minutes, let the acetonitrile flow for 10 minutes.

9.4 Test

Use 20 ml of the test solution, perform gas chromatography according to the same procedure and conditions as described above. Use the resultant liquid chromatogram to calculate the height and area of the peak. Next, use the analytical curve to determine the concentration of diphenyl carbonate in the test solution, then use the following equation to determine the content in the material:

Content (mg/g) = sample solution concentration (mg/ml) ´ 20 (ml) / sample weight (g)

10. Determination of amines in PC

10.1 Prepare test solution

Place 1.0 g of sample in a 200 ml Erlenmeyer flask and add 20 ml of dichloromethane. After the sample has dissolved, add 100 ml of acetone by droplets while mixing well and centrifuge the mixture for approximately 10 minutes at 3,000rpm. Use a vacuum concentrator to concentrate the supernatant to approximately 2 ml. Using this as the test solution (only applies to triethylamine and tributylamine).

10.2 Prepare standard solution

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10.3 Plot an analytical curve

Using 1 ml of each standard solution, perform liquid chromatography according to the procedure and conditions specified below. Use the resultant liquid chromatogram to calculate the height and area of the peak of triethylamine and tributylamine, then plot an analytical curve for each.

Column

Use a 30 m long silicate-glass column with an inner diameter of 0,32 mm and with a 0.5 μm thick coating of dimethylpolysiloxane.

Column temperature

Heat the column at 150°C for 5 minute, then raise the temperature by 20°C every minute until 250°C is reached, then maintain at that temperature for 5 minutes.

Sample solution inlet temperature

200⁰C

Detector

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Carrier gas

Use helium. Adjust the flow rate so that the triethylamine flows out in 3–4 minutes.

10.4 Test

Using 1 ml of the test solution, perform gas chromatography according to the same procedure and conditions as described above. Use the resultant gas chromatogram to calculate the height and area of each peak. Next, use the respective analytical lines to determine the concentration of triethylamine and tributylamine in the sample solution, and use the following equation to determine the content of each in the material:

Content (mg/g) = sample solution concentration (mg/ml) ´ 20 (ml) / sample weight (g)

QCVN 12-2 : 2011/BYT

NATIONAL TECHNICAL REGULATION ON SAFETY AND HYGIENE FOR RUBBER IMPLEMENTS, CONTAINER AND PACKAGING IN DIRECT CONTACT WITH FOODS

Foreword

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NATIONAL TECHNICAL REGULATION ON SAFETY AND HYGIENE FOR RUBBER IMPLEMENTS, CONTAINER AND PACKAGING IN DIRECT CONTACT WITH FOODS

I. GENERAL

1. Scope

This document provides for specifications and requirements for management of safety and hygiene for rubber implements, containers and packaging in direct contact with foods (hereinafter referred to as “rubber implements, containers and packaging”).

2. Regulated entities

This document applies to:

2.1. Importers, producers, sellers and users of rubber implements, containers and packaging.

2.2. Regulatory authorities and other relevant organizations and individuals.

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3.1 “leaching solution” refers to a solution used to immerse test samples.

II. SPECIFICATIONS

1. Specifications for rubber implements, containers and packaging (not intended for use by kids)

Rubber implements, containers and packaging must meet the specifications provided in Table 1 below:

Table 1. Specifications for rubber implements, containers and packaging (not intended for use by kids)

Materials testing

Elution testing

 Provision

Maximum limit

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Leaching condition

Leaching solution

Maximum limit

Cadmium

100µg/g

Phenol

60⁰C hold for 30 minutes ^[5]

Water

5 µg/ml

...

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...

100µg/g

2-Mercaptoimidazoline (containing Chlor)

Negative

Formaldehyde

Negative

Zinc

Acetic acid 4%

15 µg/ml

Heavy metal

...

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...

1 µg/ml

Evaporation residue

Water^{[3] , [6]}

60 µg/ml

Acetic acid 4%^[4]

60⁰C hold for 30 minutes

Ethanol 20% ^{[1] [2]}

2. Specifications for rubber implements, containers and packaging (intended for use by kids)

Rubber implements, containers and packaging must meet the specifications provided in Table 2 below:

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Materials testing

Elution testing

Provision

Maximum limit

Provision

Leaching condition

Leaching solution

Maximum limit

Cadmium

...

...

...

Phenol

40⁰C hold for 24 hours

Water

5 µg/ml

Lead

10µg/g

Formaldehyde

Negative

Zinc

...

...

...

Heavy metal

Acetic acid 4%

1 µg/ml

Evaporation residue

Water

40 µg/ml

Note

^[1] Applicable to implements, containers and packaging containing fat, cooking oil and fatty foods.

^[2] Applicable to implements, containers and packaging containing alcoholic drinks.^.

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^[4] Applicable to implements, containers and packaging containing foods with a pH less than or equal to 5.

^[5] Applicable to implements used at a temperature of greater than 100⁰C, the leaching condition is 95⁰C hold for 30 minutes.

^[6] Dedicated to implements.

III. TESTING AND SAMPLING METHODS

Testing and sampling methods are provided in the Appendices promulgated together with this document. To be specific

1. Appendix 1: Materials testing methods

2. Appendix 2: Elution testing methods

IV. MANAGEMENT

1. Declaration of conformity

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1.2 Methods and procedures for submission of declarations of conformity shall comply with the Regulation on declaration of standard conformity and technical-regulation conformity promulgated together with the Decision No. 24/2007/QD-BKHCN dated September 28, 2007 of the Minister of Science and Technology and regulations of law.

2. State inspection of rubber implements, containers and packaging

The state inspection of rubber implements, containers and packaging shall be carried out as prescribed by law.

V. RESPONSIBILITIES OF ORGANZIATIONS AND INDIVIDUALS

1. Importers, producers, sellers and users of rubber implements, containers and packaging shall submit the declarations of conformity according to the specifications specified in this document, register the declarations of conformity with the Vietnam Food Administration and ensure food quality and safety according to the declarations.

2. Importers, producers, sellers and users shall be only allowed to import, produce, sell and use rubber implements, containers and packaging after registering the declarations of conformity and ensuring food quality and safety as prescribed by law.

VI. IMPLEMENTATION

1. The Vietnam Food Administration shall take charge and cooperate with relevant competent authorities in providing instructions and organizing the implementation of this document.

2. The Vietnam Food Administration shall, according to management requirements, request the Ministry of Health to amend this document.

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APPENDIX 1

MATERIALS TESTING METHODS

1. Determination of Lead and Cadmium

1.1 Prepare test solution :

Take 1.0 g of sample in a platinum, quartz or heat-resistant glass evaporating dish, add 2ml of sulfuric acid, gradually heat, and continue heating until white smoke has mostly stopped coming from  the  sulfuric  acid  and  most  of  the  material  has  carbonized. Heat this in an electric furnace at approximately 450°C to carbonize. Until it completely carbonizes, repeat the process of moistening the content of the evaporation dish with sulfuric acid and reheating. Add 5ml of hydrochloric acid (1/2) to the residue, mix, and evaporate and harden on a water bath. After cooling, add 20 ml of 0.1 mol/l nitric acid, dissolve, filter away any undissolved matter, and use the liquid as test solution.

1.2 Prepare standard solution :

1.2.1 Cadmium

+ Cadmium standard undiluted solution :

Measure out 100 mg of cadmium, dissolve it in 50 ml of 10% nitric acid, evaporate and harden on a water bath. Then add 0.1 mol/l nitric acid to the residue to bring the total volume to 100 ml. 1 ml of this liquid contains 1 mg of cadmium.

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Take 1 ml of cadmium standard undiluted solution, add 0.1 mol/l nitric acid to bring the total volume to 200 ml. 1 ml of this liquid contains 5 μg of cadmium.

+ Cadmium standard solution (of a kind not intended for use by kids)

Take 1 ml of cadmium standard undiluted solution, add 0.1 mol/l nitric acid to bring the total volume to 200 ml. Take 10 ml of the abovementioned solution, add 0.1 mol/l nitric acid to bring the total volume to 100 ml. 1 ml of this liquid contains 0.5 μg of cadmium.

1.2.2 Lead

+ Lead standard undiluted solution:

Dissolve 159.8 mg of lead (II) nitrate in 10 ml of 10% nitric acid and add water to bring the total volume to 100 ml.  1 ml of this solution contains 1 mg of lead.

+ Lead standard solution (of a kind not intended for use by kids)

Take 1 ml of lead standard undiluted solution, add 0.1 mol/l nitric acid to bring the total volume to 200 ml. 1 ml of this liquid contains 5 μg of lead.

+ Lead standard solution (of a kind not intended for use by kids)

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1.3 Test

Determine the concentration of cadmium and lead respectively in the test solution by atomic absorption spectrometry or inductively coupled plasma emission spectroscopic.

2. Determination of 2-mercaptoimidazoline

2.1 Prepare test solution :

Place 1.0 g of sample in cylindrical filter paper and use a Soxhlet extractor and extract for 8 hours with approximately 45 ml methanol. Condense this extract to approximately 1 ml, and use 10 μl of this as the test solution.

2.2 Prepare standard solution :

Take 200 mg of 2-mercaptoimidazoline and dissolve it in methanol to bring the total volume to 100 ml. Take 1 ml of this liquid and add methanol to bring the total volume to 100 ml. 1 ml of this liquid contains 20 μg of 2-mercaptoimidazoline.

2.3 Dissolve 100 mg of 2,6-dichloroquinone chlorimide in ethanol to bring the total volume to 10 ml.

2.4 Test

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Use each of a 5:1 mixture of ethyl acetate and benzene and a 30:2:1:1 mixture of ethyl acetate, methanol, ammonia solution and water as developing. With a thin layer plate as the carrier, use thin layer chromatography silica gel and dry for 1 hour at 120°C.

When the leading end of the developing solvent has reached a height approximately 10 cm, stop developing and allow to air-dry. Then, atomize 2,6-dichloroquinone chlorimide ethanol sample solution, heat for 10 minutes at 120°C and observe.

APPENDIX 2

ELUTION TESTING METHODS

1. Determination of heavy metals

1.1 Prepare test solution:

Wash the sample well with  water, use the specified leaching solution at a ratio of 2 ml per cm² of sample surface area (of a kind not intended for use by kids) and 20 ml per gram of sample (of a kind intended for use by kids) under the specified leaching condition.

1.2 Prepare standard solution:

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Dissolve 159.8 mg of lead (II) nitrate in 10 ml of 10% nitric acid and add water to bring the total volume to 100 ml. 1 ml of this solution contains 1 mg of lead.

+ Lead standard solution (of a kind not intended for use by kids)

Take 1 ml of lead standard undiluted solution, add water to bring the total volume to 100 ml. 1 ml of this liquid contains 10 μg of lead.

+ Lead standard solution (of a kind intended for use by kids)

Take 1 ml of lead standard undiluted solution, add 0.1 mol/l nitric acid to bring the total volume to 100 ml. 1 ml of this liquid contains 0.5 μg of lead.

1.3 Test

Test tube: Place 20 ml of test solution into a Nessler tube, and to this add enough water to bring the total volume to 50 ml.

Contrast tube: also perform the test for the test solution, place 2 ml of lead standard solution, add 20 ml of 4% acetic acid and then add enough water to bring the total volume to 50 ml.

To both solutions add 2 drops each of sodium sulfide reagent and leave for 5 minutes, then view both Nessler tubes from the top and sides against a white background.

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2. Determination of phenol

2.1 Prepare test solution:

Wash the sample well with water, use the specified leaching solution at a ratio of 2 ml per cm² of sample surface area (of a kind not intended for use by kids) and 20 ml per gram of sample (of a kind intended for use by kids) under the specified leaching condition.

2.2 Prepare standard solution :

Phenol standard undiluted solution: Weigh 1.0 g of phenol and dissolve it in 100 ml of water.

Phenol intermediate standard solution: place 1 ml of standard undiluted solution into a volumetric flask, and add water to bring the total volume to 100 ml.

Phenol standard solution: take 1 ml of intermediate standard solution, and add water to bring the total volume to 20 ml. 1 ml of this liquid contains 5 μg of phenol.

2.3 Prepare boric acid buffer solution

Prepare 2 solutions:

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+ Solution 2: Dissolve 6.2 g of boric acid in water and add enough water to bring the total volume to 100 ml.

Take equal amounts of each solution and shake well.

2.4 Test:

Add 20 ml of test solution with 3 ml of boric acid buffer solution and mix well, then add 5 ml of 4-amino antipyrine and 2.5 ml of potassium hexacyanoferrate (III) and enough water to bring the total volume to 100 ml. Mix well and leave for 10 minutes at room temperature.

Also prepare 20 ml of phenol standard solution according to the same procedure.

When measured at a wavelength of 510 nm, the spectral absorbance of the sample solution must not exceed that of the phenol standard solution.

3. Determination of formaldehyde

3.1 Prepare test solution:

Wash the sample well with water, use the specified leaching solution at a ratio of 2 ml per cm² of sample surface area (of a kind not intended for use by kids) and 20 ml per gram of sample (of a kind intended for use by kids) under the specified leaching condition.

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Add 10 ml of sample solution with 1 ml of 20% phosphoric acid, then place 5–10 ml of water in a 200 ml measuring cylinder and conduct steam distillation with the cooling unit adapter submerged in water. When the volume of distillate reaches approximately 190 ml, stop distillation and add enough water to bring the total volume to 200 ml. Place 5 ml of this solution in a 15 mm inner-diameter test tube and add 5 ml of acetylacetone reagent. Mix and then heat in a boiling water bath for 10 minutes.

Contrast solution: In a separate 15 mm inner-diameter test tube, place 5 ml of water and 5 ml of acetylacetone reagent. Mix and then heat in a boiling water bath for 10 minutes. When viewed from the side against a white background, the test solution must not appear darker in color than the contrast solution.

4. Determination of zinc

4.1 Prepare test solution:

Wash the sample well with water, use the specified leaching solution at a ratio of 2 ml per cm² of sample surface area (of a kind not intended for use by kids) and 20 ml per gram of sample (of a kind intended for use by kids) under the specified leaching condition.

a) Take 1 ml of test solution and add 4% of acetic acid to bring the total volume to 15 ml (of a kind not intended for use by kids)

b) Take 20 ml of test solution and add 5 drops of acetic acid (of a kind intended for use by kids)

4.2 Prepare standard solution:

Measure out 1.0 g of zinc, dissolve it in 6 mol/l hydrochloric acid and evaporate and harden on a water bath. Add 1 mol/l hydrochloric acid to the residue to bring the total volume to 1,000 ml. 1 ml of this solution contains 1 mg of zinc.

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Take 1 ml of zinc standard undiluted solution and add enough water to bring the total volume to 50 ml. Take 1 ml of this solution and add enough water to bring the total volume to 20 ml. 1 ml of this liquid contains 1 μg of zinc.

4.3 Test:

When performing the zinc test with atomic absorption spectrometry or inductively coupled plasma photoemission spectroscopy on the test solution, the results must conform to the standards thereof.

5. Evaporation residue

5.1 Prepare test solution:

Wash the sample well with water, use the specified leaching solution at a ratio of 2 ml per cm2 of sample surface area (of a kind not intended for use by kids) and 20 ml per gram of sample (of a kind intended for use by kids) under the specified leaching condition.

5.2 Test:

Place 200-300 ml of test solution then heat it on a water bath until the solution evaporates and the residue hardens. After drying for 2 hours at 105^oC, let cool in a desiccater. After cooling, weigh the evaporation dish and determine the weight difference before and after evaporation.

Conduct a blank test. The same amount of water must be used in place of the amount of test solution.

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Evaporation residue (µg/ml) = [(a-b) x1,000] / amount of test solution used

Where:

a (mg) = weight difference before and after evaporation.

b (mg) = blank test value obtained for the same amount of leaching solution as the test solution.

QCVN 12-3 : 2011/BYT

NATIONAL TECHNICAL REGULATION ON SAFETY AND HYGIENE FOR METALLIC CONTAINERS IN DIRECT CONTACT WITH FOODS

Foreword

QCVN 12-3:2011/BYT is drafted by Drafting Committee for national technical regulation on safety and hygiene for metallic containers in direct contact with foods, submitted by Vietnam Food Administration for approval and promulgated together with the Circular No. 34/2011/TT-BYT dated August 30, 2011 of the Minister of Health.

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NATIONAL TECHNICAL REGULATION ON SAFETY AND HYGIENE FOR METALLIC CONTAINERS IN DIRECT CONTACT WITH FOODS

I. GENERAL PROVISIONS

1. Scope

This document provides for specifications and management requirements for safety and hygiene for metallic containers in direct contact with foods (hereinafter referred to as “metallic containers”).

2. Regulated entities

This document applies to:

2.1. Importers, producers, sellers and users of metallic containers.

2.2. Regulatory authorities and relevant organizations and individuals.

3. Definitions

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II. SPECIFICATIONS

Elution test

Testing criteria

Leaching condition

Leaching solution

Maximum limit

Arsenic

60⁰C hold for 30 minutes^[5]

Water^[3]

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60⁰C hold for 30 minutes

Citric acid 0.5%^[4]

Cadmium

60⁰C hold for 30 minutes^[5]

Water^[3]

0.1 μg/ml

60⁰C hold for 30 minutes

Citric acid 0.5%^[4]

Lead

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Water^[3]

0.4 μg/ml

60⁰C hold for 30 minutes

Citric acid 0.5%^[4]

Phenol

60⁰C hold for 30 minutes^[5]

Water

5 μg/ml ^[8]

Formaldehyde

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 Evaporation residue

25⁰C hold for 1 hour

Heptane^{[1] , [6]}

30 µg/ml ^[8]

60⁰C hold for 30 minutes

Ethanol 20% ^[2]

60⁰C hold for 30 minutes^[5]

Water^{[3] , [7]}

Acetic acid 4% ^[4]

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25⁰C hold for 2 hours

Pentane

0.5 μg/ml ^{[8] , [9]}

Vinyl chloride

not more than 5⁰C hold for 24 hours

Ethanol 20%

0.05 μg/ml ^[8]

Notes

^[1] The sample is used to contain fat, cooking oil and fatty foods.

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^[3] The sample is used to contain foods having a pH of greater than 5.

^[4] The sample is used to contain foods having a pH of less than or equal to 5.

^[5] For the instruments used at a temperature of greater than 100⁰C, the leaching condition is 95⁰C hold for 30 minutes.

 ^[6] The evaporation residue must not exceed 90 µg/ml in case where the sample is a can that has been coated on the inside with a coating whose main raw material is natural oils or fats and the content of zinc oxide in the coating is greater than 3%.

^[7] The amount of a chloroform-soluble substance (30μg/ml or less) is determined when a sample may be used similarly to ^[6] with an amount exceeding 30μg/ml.

^[8] It is not applicable to metallic containers that are not coated with a plastic layer in direct contact with foods.

^[9] The eluting solution is concentrated 5 times though the concentration of the solution is not more than 25μg/ml.

III. TEST AND SAMPLING METHODS

Test and sampling methods are provided in the Appendix enclosed herewith.

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1. Declaration of conformity

1.1 Declarations of conformity of imported and domestic metallic containers must be submitted in accordance with regulations of this document.

1.2 Methods and procedures for submission of declarations of conformity shall be compliant with Regulation on declaration of standard conformity and technical-regulation conformity issued together with the Decision No. 24/2007/QD BKHCN dated September 28, 2007 of the Minister of Science and Technology and regulations of law.

2. State inspection of metallic containers

The state inspection of metallic containers shall be carried out in accordance with regulations of law.

V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

1. Importers and producers of metallic containers must submit declarations of conformity according to the specifications provided in this document at the Vietnam Food Administration and ensure fulfillment of food quality and safety requirements specified in the declarations.

2. Importers, producers and sellers shall be only allowed to import, produce, sell and use metallic containers after registering the declarations of conformity and ensuring food quality and safety in accordance with regulations of law.

VI. IMPLEMENTATION

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2. According to the management requirements, the Vietnam Food Administration is responsible for requesting the Ministry of Health to make amendments to this document.