Circular 35 2015 TT BYT QCVN 12 4 glass ceramic porcelain enameled food contact packaging

LEGAL DOCUMENT • MINISTRY OF HEALTH • FOOD SAFETY

Circular 35/2015/TT-BYT: QCVN 12-4:2015/BYT for glass, ceramic, porcelain and enameled food-contact packaging

Circular 35/2015/TT-BYT promulgates QCVN 12-4:2015/BYT, controlling lead and cadmium migration and management requirements for glass, ceramic, porcelain and enameled food-contact implements, containers and packaging. For import shipments, wrong material grouping or missing conformity/testing files may delay customs clearance and create post-clearance risks.

QUICK SUMMARY

Effective date

Issued on 28 October 2015 and effective from 01 May 2016; the national database records it as still effective.

Affected goods

Glass bottles/jars, bowls, cups, plates, ceramic/porcelain ware, enameled utensils and food-contact packaging.

Immediate action

Review material, use case, flat/hollow shape, capacity, drinking rim, lead/cadmium test reports and food safety declaration files before ETA.

Lưu ý / Note: Nội dung áp dụng phụ thuộc hồ sơ thực tế, vật liệu, công năng, dung tích và mục đích sử dụng của từng lô hàng.

DOCUMENT INFORMATION

Information field Content Operational note
Legal document Circular 35/2015/TT-BYT promulgating QCVN 12-4:2015/BYT. Applies to glass, ceramic, porcelain and enameled food-contact implements, containers and packaging.
Reference number 35/2015/TT-BYT Use the exact reference in conformity and testing dossiers.
Issuing authority Ministry of Health Specialized food safety regulator.
Date of issuance 28 October 2015 As published on the Government Official Gazette.
Effective date 01 May 2016 The national database records the document as still effective.
Signatory Nguyen Thanh Long Signed as Deputy Minister, for the Minister.
Scope Technical limits, labeling, sampling/testing methods, management requirements and responsibilities. The key controls are migration limits for lead and cadmium.
Regulated entities Importers, producers and sellers in Vietnam and relevant state authorities. Importers should review this before finalizing HS classification, technical files and test reports.

KEY POINTS TO NOTE

  • QCVN 12-4:2015/BYT is issued for glass, ceramic, porcelain and enameled food-contact products.
  • Main technical focus: migration limits for lead and cadmium by material, shape, capacity and use case.
  • Labeling: labels must comply with goods-labeling regulations and other relevant laws.
  • Management requirement: imported, produced and traded goods must complete conformity declaration according to the regulation and effective laws at the time of filing.
  • Partial repeal: Sections 4.1 and 4.2, Part 4 of Decision 46/2007/QD-BYT are repealed from the effective date of this Circular.

AFFECTED BUSINESSES / PRODUCT GROUPS

Analysis group How to identify Risk if misidentified
Business group Importers, distributors, packaging producers, F&B chains, logistics providers. Wrong food safety dossier, missing testing or incorrect declaration scope.
Product group Glass jars/bottles, cups, bowls, plates, cookware, ceramic/porcelain ware, enameled food-contact articles. A generic product name may trigger wrong technical regulation.
Trigger condition Direct food contact; material, flat/hollow shape, capacity, drinking rim and use case. Incorrect lead/cadmium limit selected.
Documents to check Catalogue, datasheet, product photos, original labels, test report, invoice, packing list and material list. Commercial documents may not match technical documents.

IMPORT-EXPORT / LOGISTICS IMPACT

  • Customs declaration: describe material, function, capacity, product set and food-contact use clearly.
  • Technical documents: maintain catalogue/datasheet showing material, capacity, temperature use, enameled surface and food-contact surface.
  • Testing: check lead/cadmium criteria and test method by product group.
  • Timeline: late food-safety dossiers or test reports may cause storage, warehousing and additional explanations.
  • Post-clearance: retain shipment dossiers for future food-safety and quality inspections.

BUSINESS DOSSIER CHECKLIST

Dossier group Documents to review Operational note
Commercial documents Invoice, Packing List, B/L or AWB, contract/PO, C/O where applicable. Product name must match material, function and actual quantity.
Technical files Catalogue, datasheet, label photos, model list, material and capacity description. Distinguish glass, ceramic, glass-ceramic, porcelain and enameled ware.
Testing files Lead/cadmium test report, test method, sample scope and extraction conditions. Match flatware/hollowware, cups/mugs and drinking rim correctly.
Food safety filing Self-declaration/conformity or equivalent dossier under current law. Review Decree 15/2018/ND-CP and applicable amended/replacement documents.
Labeling Original label, Vietnamese supplementary label, use instructions, temperature warnings if any. Labels should not conflict with technical files and use case.

RELATED LEGAL DOCUMENTS TO REVIEW

Document group Document Role Review note
Law Law on Food Safety 55/2010/QH12 Legal basis for food safety management. Basis document for Circular 35/2015/TT-BYT.
Law Law on Standards and Technical Regulations 68/2006/QH11 Basis for issuing national technical regulations. Relevant to QCVN application.
Decree Decree 38/2012/ND-CP Referenced in the Circular. Review against Decree 15/2018/ND-CP, which replaced Decree 38/2012/ND-CP in food safety management.
Decree Decree 15/2018/ND-CP Current framework for food safety declaration, inspection and labeling. Must be checked for current filings.
Circular Circular 19/2012/TT-BYT Referenced for declaration procedures. Apply only after reviewing current validity.
Circular Circular 26/2012/TT-BKHCN Sampling reference. Referenced in the QCVN sampling section.
Decision Decision 46/2007/QD-BYT Partially repealed document. Sections 4.1 and 4.2, Part 4 are repealed.

VIEW / DOWNLOAD ORIGINAL SOURCES

BẢN GỐC / ORIGINAL SOURCE

This block uses source buttons only and does not embed an iframe, to avoid blocked PDF viewers in WordPress/browser environments. Nguồn ưu tiên: Công báo điện tử Chính phủ và Cơ sở dữ liệu quốc gia về văn bản pháp luật; PDF QCVN dùng để đối chiếu định dạng kỹ thuật.

FULL LEGAL TEXT – OPERATIONAL TRANSLATION

This English version is an operational reference translation only and is not an official legal translation.

MINISTRY OF HEALTH
No. 35/2015/TT-BYT
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
Hanoi, 28 October 2015
CIRCULAR
PROMULGATING THE NATIONAL TECHNICAL REGULATION ON SAFETY AND HYGIENE FOR GLASS, CERAMIC, PORCELAIN AND ENAMELED IMPLEMENTS, CONTAINERS AND PACKAGING IN DIRECT CONTACT WITH FOOD

Pursuant to the Law on Food Safety dated 17 June 2010 and Decree No. 38/2012/ND-CP dated 25 April 2012 elaborating several articles of the Law on Food Safety;

Pursuant to the Law on Standards and Technical Regulations dated 29 June 2006 and Decree No. 127/2007/ND-CP dated 01 August 2007;

Pursuant to Decree No. 63/2012/ND-CP dated 31 August 2012 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director General of the Vietnam Food Administration, the Minister of Health promulgates this Circular.

Article 1. QCVN 12-4:2015/BYT – National technical regulation on safety and hygiene for glass, ceramic, porcelain and enameled implements, containers and packaging in direct contact with food is promulgated together with this Circular. From the effective date of this Circular, Section 4.1 and Section 4.2, Part 4 of the food-contact packaging and implements hygiene requirements issued with Decision No. 46/2007/QD-BYT are repealed.

Article 2. This Circular takes effect on 01 May 2016.

Article 3. The Director General of the Vietnam Food Administration, heads of units under the Ministry of Health, Directors of provincial Departments of Health and relevant organizations and individuals are responsible for implementation.

FOR THE MINISTER
DEPUTY MINISTER

Nguyen Thanh Long

QCVN 12-4:2015/BYT
NATIONAL TECHNICAL REGULATION ON SAFETY AND HYGIENE FOR GLASS, CERAMIC, PORCELAIN AND ENAMELED IMPLEMENTS, CONTAINERS AND PACKAGING IN DIRECT CONTACT WITH FOOD

Foreword. QCVN 12-4:2015/BYT was prepared by the drafting committee, submitted by the Vietnam Food Administration and issued together with Circular No. 35/2015/TT-BYT dated 28 October 2015 of the Minister of Health.

I. GENERAL PROVISIONS

1. Scope. This regulation provides technical and management requirements for food safety and hygiene of glass, ceramic, porcelain and enameled implements, containers and packaging in direct contact with food.

2. Regulated entities. This regulation applies to importers, producers and sellers of such products in Vietnam and relevant state authorities.

3. Definitions. Flatware means products whose internal depth is not greater than 25 mm. Hollowware means products whose internal depth is greater than 25 mm. Enameled ware means glass, ceramic, glass-ceramic, porcelain or metal articles coated with vitreous or porcelain enamel. Drinking rim means the 20 mm wide external surface measured from the vessel mouth downward along the wall.

II. SPECIFICATIONS

1.1. Technical requirements for glass implements, containers and packaging

No. Product group Use case Testing criteria Maximum limit
1 Flatware For containing and heating/cooking food Cadmium (mg/dm²)
Lead (mg/dm²)
0.07
0.8
2.1.1 Hollowware For containing food, volume below 600 ml Cadmium (mg/l)
Lead (mg/l)
0.5
1.5
2.1.2 Hollowware For containing food, 600 ml to under 3,000 ml Cadmium (mg/l)
Lead (mg/l)
0.25
0.75
2.1.3 Hollowware For containing food, 3,000 ml or more Cadmium (mg/l)
Lead (mg/l)
0.25
0.5
2.2 Hollowware For heating/cooking food Cadmium (mg/l)
Lead (mg/l)
0.05
0.5
3 Cups and mugs For containing/serving food or drinks Cadmium (mg/l)
Lead (mg/l)
0.25
0.5

Note: units are mg/l of the extraction solution, or mg/dm² of the food-contact surface area, as applicable.

1.2. Technical requirements for ceramic and glass-ceramic implements, containers and packaging

No. Product group Use case Testing criteria Maximum limit
1 Flatware For containing and heating/cooking food Cadmium (mg/dm²)
Lead (mg/dm²)
0.07
0.8
2.1.1 Hollowware For containing food, volume below 1,100 ml Cadmium (mg/l)
Lead (mg/l)
0.5
2.0
2.1.2 Hollowware For containing food, 1,100 ml to under 3,000 ml Cadmium (mg/l)
Lead (mg/l)
0.25
1.0
2.1.3 Hollowware For containing food, 3,000 ml or more Cadmium (mg/l)
Lead (mg/l)
0.25
0.5
2.2 Hollowware For heating/cooking food Cadmium (mg/l)
Lead (mg/l)
0.05
0.5
3 Cups and mugs For containing/serving food or drinks Cadmium (mg/l)
Lead (mg/l)
0.25
0.5

Note: units are mg/l of the extraction solution, or mg/dm² of the food-contact surface area, as applicable.

1.3. Technical requirements for enameled ware, including cups and mugs

No. Product group Use case Testing criteria Maximum limit
1.1 Flatware For containing food Cadmium (mg/dm²)
Lead (mg/dm²)
0.07
0.8
1.2 Flatware For heating/cooking food Cadmium (mg/dm²)
Lead (mg/dm²)
0.05
0.1
2.1.1 Hollowware Volume below 3,000 ml, for containing food Cadmium (mg/l)
Lead (mg/l)
0.07
0.8
2.1.2 Hollowware Volume below 3,000 ml, for heating/cooking food Cadmium (mg/l)
Lead (mg/l)
0.07
0.4
2.2 Hollowware Volume 3,000 ml or more, for containing and heating/cooking food Cadmium (mg/dm²)
Lead (mg/dm²)
0.05
0.1

Note: units are mg/l of the extraction solution, or mg/dm² of the food-contact surface area, as applicable.

1.4. Technical requirements for the drinking rim of enameled ware

No. Testing criteria Maximum limit
1 Cadmium (mg/drinking rim) 0.2
2 Lead (mg/drinking rim) 2.0

Note: the unit is mg/drinking rim of the implement, container or packaging.

2. Labeling requirements. Implements, containers and packaging shall be labeled in accordance with Decree No. 89/2006/ND-CP on goods labels and other relevant laws.

III. SAMPLING AND TEST METHODS

1. Sampling. Sampling shall follow Circular No. 26/2012/TT-BKHCN of the Ministry of Science and Technology and relevant laws.

2. Testing. The technical requirements in this regulation are tested under Appendix 01. The methods listed in Appendix 01 are not mandatory if another method of equivalent accuracy is used.

IV. MANAGEMENT REQUIREMENTS

1. Declaration of conformity. Imported, domestically produced and traded products must be declared conforming to this regulation. Procedures are implemented under Decree No. 38/2012/ND-CP and Circular No. 19/2012/TT-BYT and relevant laws; in current practice, effective replacement or amended regulations must also be checked.

2. Inspection and handling of violations. Competent authorities carry out inspection and handling against importers, producers and sellers violating technical and management requirements.

V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

1. Importers, producers and sellers of food-contact implements, containers and packaging must declare conformity with the requirements of this Regulation.

2. Organizations and individuals may import, produce and trade such products only after obtaining the Certificate of Receipt of Declaration of Conformity from the Vietnam Food Administration and satisfying other applicable legal requirements.

VI. IMPLEMENTATION

1. The Vietnam Food Administration shall take the lead and coordinate with relevant competent agencies to provide guidance and organize implementation of this Regulation.

2. Based on management requirements, the Vietnam Food Administration shall propose amendments and supplements to this Regulation to the Ministry of Health.

3. Where standards or legal documents referenced in this Regulation are amended, supplemented or replaced, the new documents shall apply.

APPENDIX 01 – TEST METHODS

1. Test methods for glass implements, containers and packaging, including cups and mugs: 1.1. For glass flatware: TCVN 7146-1:2002 / ISO 6486-1:1999. 1.2. For glass hollowware: TCVN 7146-1:2002 / ISO 7086-1:2000.

2. Test method for ceramic and glass-ceramic implements, containers and packaging, including cups and mugs: TCVN 7146-1:2002 / ISO 6486-1:1999.

3. Test method for enameled implements, containers and packaging, including cups and mugs: TCVN 7542-1:2005 / ISO 4531-1:1998.

4. Test method for the drinking rim of enameled implements, containers and packaging: TCVN 7542-1:2005 / ISO 4531-1:1998.

FAQ

When does Circular 35/2015/TT-BYT take effect?

It takes effect on 01 May 2016 and is recorded as still effective.

Which goods should be reviewed?

Glass, ceramic, porcelain and enameled food-contact packaging, containers and implements.

What should be tested?

Lead and cadmium migration limits by material, shape, capacity, use case and drinking rim.

Is conformity declaration required?

The QCVN states that imported, produced and traded products must be declared conforming; current filing must be reviewed under effective food-safety laws.

Does it determine HS codes?

No, but material and use case descriptions can affect HS classification and specialized management.

Should documents be prepared before ETA?

Yes. Review catalogues, test reports, labels and declaration files before ETA to reduce storage and clearance delays.

OPERATIONAL SUPPORT FROM TGIMEX

Legal review

Check QCVN 12-4:2015/BYT, validity status, amended/replacement documents and product-specific triggering conditions.

Document control

Review Invoice, Packing List, B/L/AWB, catalogue, datasheet, test report, label and C/O for consistency.

Operational coordination

Plan before ETA, identify testing/declaration points, coordinate customs, warehouse/port and domestic delivery.

Post-clearance readiness

Retain shipment dossiers, prepare data for inspection, review supplementary labeling and market circulation obligations.

Businesses should review the applicable legal documents before finalizing commercial documents and before ETA to reduce the risk of storage charges, customs channel changes, additional dossier requests or delivery delays.

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