Tiếng Việt
中文 (中国)
CIRCULAR 27/2012/TT-BYT: FOOD ADDITIVES MANAGEMENT AND IMPORT COMPLIANCE NOTES
Circular 27/2012/TT-BYT was a foundational document on food additive management, affecting producers, traders, importers of food additives and food products containing additives. It has fully expired, but remains useful for historical legal review and must be compared with Circular 24/2019/TT-BYT for current dossiers. This article places the regulation in the practical context of import-export operations, clarifying its scope, affected parties, and the checks required before it is relied on for a shipment dossier. Before implementation, businesses should verify the effective date, amendments, and relevant official guidance applicable to the transaction, while retaining the source and document version used for later explanation or audit.
Operational reference for import-export, logistics, compliance and operations teams.
DOCUMENT INFORMATION
| Field | Content |
|---|---|
| Document title | Circular guiding the management of food additives |
| Number | 27/2012/TT-BYT |
| Issuing authority | Ministry of Health |
| Issued date | 30 November 2012 |
| Effective date | 1 February 2013 |
| Expired date | 16 October 2019 |
| Legal status | Fully expired |
| Scope | Permitted food additive list, maximum limits and management requirements for food additives. |
| Signer | Nguyen Thanh Long |
EFFECTIVE STATUS AND APPLICATION NOTES
KEY POINTS TO NOTE
| Key point | Operational note |
|---|---|
| Regulatory scope | Article 1 covered two groups: permitted food additives and management requirements for food additives. |
| Permitted list | Article 4 referred to Appendix 1. Review should be based on substance name, INS code, technological function and food category, not trade name only. |
| Maximum limits | Article 5 referred to Appendix 2. The same additive may be permitted for one food category but not another. |
| Prohibited acts | Article 3 prohibited additives outside the list, excess limits, wrong food categories, non-compliant use, unclear origin or expired additives. |
| Declaration before import/trading | Article 6 required conformity declaration or declaration of conformity with food-safety regulations before production, trading, importation and use. |
| GMP principle | Article 6 required additive use at the minimum level necessary and not changing the nature of food during production, preservation, packaging and transportation. |
| Labelling | Article 6 required food additive labels to comply with applicable law. Importers should check original label, Vietnamese sub-label, composition, INS code, shelf life and origin. |
| Transitional and historical effect | Article 7 allowed products with pre-effective product standard certificates to be used until the certificate expired; however, the Circular is now fully expired. |
AFFECTED BUSINESSES / PRODUCT GROUPS
| Affected group | Affected stage | Documents to cross-check |
|---|---|---|
| Food additive importer | Before import / before ETA | Substance name, INS, technological function, COA, MSDS if any, labels, declaration dossier, origin documents, invoice, packing list and transport documents. |
| Importer of food containing additives | Before purchase order and product declaration | Check additive composition, food category, maximum use level and declaration/self-declaration dossier under current law. |
| Food factory / FDI / EPE | Before production, storage and material use | Control formulation, batch record, COA, raw material standards and traceability file by lot. |
| Logistics / customs broker | During customs clearance and delivery | Check product description, HS code, label, food-safety dossier, storage conditions and lot data before customs declaration. |
IMPACT ON IMPORT-EXPORT / LOGISTICS OPERATIONS
| Impact point | Operational meaning |
|---|---|
| Customs declaration | Product description should show food additive, substance/mixture name, powder/liquid form, function, INS code if any and product status. |
| Commercial documents | Invoice, Packing List, B/L/AWB, catalogue, COA, C/O, original label and declaration dossier should match substance name, lot number, quantity, origin and shelf life. |
| Food-safety control | Food additives and foods containing additives may require review of food-safety policy, product declaration, import conditions and current replacement texts. |
| Storage and transport | Check storage conditions, packaging, cross-contamination risk, temperature/humidity if any and shelf life during international transport. |
| Cost exposure | Missing declaration, wrong label or inconsistent additive composition may cause storage costs, extra testing or delivery delays. |
| Post-clearance | Maintain lot-based files: declaration/self-declaration, COA, labels, import documents, batch data and distribution records. |
BUSINESS REVIEW CHECKLIST
| Dossier group | Documents to review | Control note |
|---|---|---|
| Legal basis | Circular 27 status, Circular 24/2019/TT-BYT, latest consolidated text | Avoid using an expired text as current legal basis. |
| Additive details | Substance name, INS, technological function, physical form and mixture composition | Basis for checking permitted list and limits. |
| Food category | Food category, product formula and use level | Limits may vary by food category. |
| Shipment documents | Invoice, Packing List, B/L/AWB, COA, C/O, original label, catalogue/datasheet | Cross-check name, lot, shelf life and origin. |
| Food-safety dossier | Declaration/self-declaration, test result, label dossier, quality documents | Review under current regulations, not only Circular 27. |
| Logistics plan | ETA, shelf life, storage condition, sampling/testing plan if any | Reduce storage and delay risks. |
TECHNICAL TERM NOTES
| Term | Short explanation |
|---|---|
| Food additive | A substance intentionally used for technological functions in food processing, preservation, structure, colour, flavour or other functions. |
| CAC | Codex Alimentarius Committee. |
| GMP | Good Manufacturing Practices; for additives, using the minimum necessary amount for the technical purpose. |
| ML | Maximum Level of an additive in food, often expressed as mg/kg. |
| INS | International Numbering System for food additives. |
| Food Category Number | Food category code used to determine permitted additives and corresponding limits. |
RELATED LEGAL DOCUMENTS TO REVIEW
| Document group | Name/Number | Authority | Status/Timing | Role | Review note |
|---|---|---|---|---|---|
| Law | Law on Food Safety 55/2010/QH12 | National Assembly | Effective from 1 July 2011 | General legal basis for food safety and additives. | Check the latest consolidated version. |
| Decree | Decree 38/2012/ND-CP | Government | Expired | Legal basis cited when Circular 27 was issued. | Now replaced in the food safety regime. |
| Circular | Circular 08/2015/TT-BYT | Ministry of Health | Effective 1 July 2015; later expired under Circular 24/2019 | Amended Circular 27. | For historical review. |
| Replacement circular | Circular 24/2019/TT-BYT | Ministry of Health | Effective from 16 October 2019 | Repealed Circular 27 and Circular 08 and regulated food additive management/use at the replacement date. | Review together with latest consolidated text. |
| Consolidated text | Consolidated Text 09/VBHN-BYT 2024 | Ministry of Health | Consolidated text | Consolidates regulations on food additive management and use. | Preferred reference for current dossiers. |
| Repealed decisions | Decision 3742/2001/QD-BYT; Decision 928/2002/QD-BYT | Ministry of Health | Partially repealed from 1 February 2013 | Former rules on permitted additive list and hygiene conditions. | Historical reference only. |
VIEW / DOWNLOAD ORIGINAL LEGAL DOCUMENTS
Prioritize the National Legal Database/Ministry of Health source and current replacement text.
FULL TEXT OF THE LEGAL DOCUMENT
The translated full text below is for operational reference only. Appendices and current replacement texts should be checked against the original file and the latest effective legal text.
No. 27/2012/TT-BYT
Independence – Freedom – Happiness
Hanoi, 30 November 2012
CIRCULAR
Guiding the management of food additives
This English version is an operational reference translation only and is not an official legal translation.
Pursuant to the Law on Food Safety dated 17 June 2010;
Pursuant to Decree No. 38/2012/ND-CP dated 25 April 2012 of the Government detailing the implementation of a number of articles of the Law on Food Safety;
Pursuant to Decree No. 63/2012/ND-CP dated 31 August 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;
At the proposal of the Director of the Vietnam Food Administration, the Minister of Health promulgates this Circular guiding the management of food additives.
Article 1. Scope of regulation
This Circular provides for:
1. The list of food additives permitted for use in food production, processing and trading, and maximum limits of additives in food products;
2. Management requirements applicable to food additives.
Article 2. Interpretation of terms and abbreviations
For the purposes of this Circular, the following terms and abbreviations are understood as follows:
1. CAC (Codex Alimentarius Committee): the international food standards committee.
2. GMP (Good Manufacturing Practices): good manufacturing practices.
3. ML (Maximum Level) means the maximum content of a food additive determined to be effective and safe for use in each food or food group. The maximum level is calculated in mg of additive per kg of food (mg/kg).
4. INS (International Numbering System) means the numbering system developed by CAC for each additive.
5. Food Category Number means the number assigned to each food type or group under the CAC food classification system for the management of food additives.
6. Use of food additives includes: (a) manufacturing, processing, trading and import of food additives; and (b) manufacturing, processing, trading and use of food products containing food additives.
Article 3. Prohibited acts in the use of food additives
1. Using food additives not included in the list of permitted additives in Appendix 1 to this Circular.
2. Using food additives above the permitted limits or for food objects other than those specified in Appendix 2 to this Circular.
3. Using food additives that do not fully satisfy the management requirements specified in Article 6 of this Circular.
4. Using food additives of unknown origin or source, or beyond their expiry date.
Article 4. List of food additives permitted for use in food
The list of food additives permitted for use in food is specified in Appendix 1 to this Circular.
Article 5. Maximum limits for food additives in food
The maximum limits for food additives in food are specified in Appendix 2 to this Circular.
Article 6. Management requirements for food additives
1. Food additive manufacturing and trading establishments must fully satisfy the requirements prescribed in Circular No. 16/2012/TT-BYT dated 22 October 2012 of the Ministry of Health on food safety conditions for establishments manufacturing and trading food, food tools, packaging materials and containers under the management of the Ministry of Health.
2. Food additives must be subject to regulation conformity announcement or announcement of conformity with food safety regulations before being manufactured, traded, imported or used for food production and processing.
The procedures for regulation conformity announcement or announcement of conformity with food safety regulations follow Circular No. 19/2012/TT-BYT dated 09 November 2012 of the Ministry of Health guiding such announcement procedures.
3. Application of GMP in food production and processing must comply with the following principles:
a) The quantity of food additives used must be minimized to the lowest level necessary to meet technical requirements;
b) The quantity of additives used during production, processing, preservation, packaging and transportation of food must not alter the nature of the food.
4. Labelling of food additives must comply with current law.
Article 7. Transitional provision
Food additives and food products using food additives for which product standard certificates were granted before the effective date of this Circular may continue to be used until the expiry date stated in such certificates.
Article 8. Review, amendment and supplementation
Based on management needs from time to time, product standards or CAC guidelines, the Vietnam Food Administration shall review and propose amendments or supplements to the Ministry of Health in order to support domestic production and align with international practice.
Article 9. Reference clause
Where legal documents or provisions referenced in this Circular are amended, supplemented or replaced, the new legal document shall apply.
Article 10. Implementation provision
1. This Circular took effect on 1 February 2013.
Regulations relating to food additives, excluding flavoring substances permitted for use in food, under Decision No. 3742/2001/QD-BYT and Decision No. 928/2002/QD-BYT were repealed from the effective date of this Circular.
2. The Vietnam Food Administration was responsible for taking the lead and coordinating with relevant authorities to guide and organize implementation of this Circular.
FOR THE MINISTER
DEPUTY MINISTER
Nguyen Thanh Long
APPENDICES ATTACHED TO THE DOCUMENT
| Appendix | Content | How to review correctly |
|---|---|---|
| Appendix 1 | List of food additives permitted for use in food. | Check the original DOC file on the National Legal Database/VFA and note that this Circular has fully expired. |
| Appendix 2 | Maximum limits for food additives in food. | Review by additive, food category, ML/GMP and the currently effective replacement regulations. |
Presentation note: Appendices 1 and 2 are long tabular lists. To avoid an incomplete or misleading HTML reconstruction, this page keeps the operative articles in text form and provides source buttons for the original DOC file. Practical application must be based on current regulations, especially Circular 24/2019/TT-BYT and the latest consolidated text.
FAQ
Is Circular 27/2012/TT-BYT still effective?
No. The National Legal Database records it as fully expired from 16 October 2019.
Which document should be reviewed now?
Companies should review Circular 24/2019/TT-BYT and the latest consolidated text of the Ministry of Health.
What did Circular 27 regulate?
Permitted additive list, maximum limits by food category and management requirements for food additive production, trading, importation and use.
Should imported additives be reviewed by product name or HS code?
Review substance name, INS, function, food category, use level, HS code, label, COA and declaration dossier together.
Did Circular 27 change import duty?
No. HS and duty should be determined under tariff schedules, product description, composition, form and C/O if any.
What if additives are part of a food product formula?
Check composition, use level, food category, declaration/self-declaration dossier, label and testing criteria under current law.
What should logistics teams check before ETA?
Labels, additive composition, food-safety dossier, document description, shelf life, storage conditions and product declaration readiness.
NEED TO REVIEW IMPORT PROCEDURES OR A SHIPPING PLAN?
Send us the product name, shipping route, current dossier, or implementation request in advance so we can suggest a suitable approach that is practical, focused, and aligned with your shipment.
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