Circular No. 44/2015/TT-BYT stipulates the list of nutrient fortifiers used in foods and management requirements for the use of nutrient fortifiers, applicable to food production and business establishments. This circular does not apply to infant formula products.
适用范围
Food production and business establishments; National Food Safety Authority - Ministry of Health
要点
- Nutrient fortifier production and business establishments must declare conformity or declare compliance with food safety regulations before circulating on the market.
- Nutrient fortifiers and food products using nutrient fortifiers that have been issued a Certificate of Acceptance for Declaration of Conformity or a Confirmation of Declaration of Compliance before this circular takes effect may continue to be used until their validity period as stated on the Certificate of Acceptance or Confirmation.
- Nutrient fortifiers and food products must meet national technical standards and other corresponding regulations when using nutrient fortifiers in foods.
- Nutrient fortifier production and business establishments must comply with all conditions prescribed in Circular No. 16/2012/TT-BYT of the Ministry of Health.
- Management and use of nutrient fortifiers will be reviewed, amended, and supplemented when there is a change in the list of the Codex Alimentarius Commission or when permitted for use in the country of production.
🌐 本文件的社会影响
- Positive impact: Ensuring the safety and quality of nutrient fortifiers in foods, helping consumers have full information about nutritional components.
- Negative impact: May increase costs for food manufacturing enterprises due to conformity declaration requirements and labeling.
- Food manufacturing enterprises will have to comply with new regulations, which may encounter difficulties during the transition process.
❓ 常见问题
How should nutrient fortifiers be declared?
Nutrient fortifiers must be declared for conformity or declared compliant with food safety regulations before circulating on the market. The procedures and application documents shall be carried out according to Article 6 and Article 7 of Decree No. 38/2012/NĐ-CP.
Nutrient fortifiers that have been issued a Certificate of Acceptance for Declaration of Conformity can be used until when?
Nutrient fortifiers and food products using nutrient fortifiers that have been issued a Certificate of Acceptance for Declaration of Conformity or a Confirmation of Declaration of Compliance before this circular takes effect may continue to be used until their validity period as stated on the Certificate of Acceptance or Confirmation.
What conditions must nutrient fortifier production and business establishments meet?
Nutrient fortifier production and business establishments must comply with all conditions prescribed in Circular No. 16/2012/TT-BYT of the Ministry of Health regarding food safety conditions for food production and business establishments.
Does this circular apply to infant formula products?
No. This circular does not apply to infant formula products. The use of nutrient fortifiers for these products is carried out in accordance with corresponding technical standards and legal provisions governing the sale and use of infant nutrition products.
When will the management of nutrient fortifiers be reviewed and amended?
Management and use of nutrient fortifiers will be reviewed, amended, and supplemented when there is a change in the list of the Codex Alimentarius Commission or when permitted for use in the country of production.
全文
CIRCULAR
Issuing "Domestic air passenger transport service on regular basic economy classon micronutrients for use in food
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Pursuant to the Food Safety Law dated June 17, 2010 and Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain articles of the Food Safety Law;
Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Health;
At the proposal of the Director of the Food Safety Administration;
The Minister of Health issues this Circular on "List of Micronutrients for Use in Food".
Article 1. Scope of Regulation
1. This Circular specifies the list of vitamins, minerals, and management requirements for micronutrients used to fortify or enhance foods.
2. This Circular does not apply to infant formula products. The use of micronutrients in these products shall be carried out according to corresponding technical regulations and legal provisions governing the sale and use of infant formula products.
Article 2. List of vitamins and minerals for use in food
The list of vitamins and minerals for use in food is specified in the Appendix attached to this Circular.
Article 3. Management requirements for the use of micronutrients
1. Micronutrients must be declared compliant with regulations or declared compliant with food safety regulations before being put into circulation on the market. The procedures and documentation for declaring compliance with regulations or food safety regulations are implemented in accordance with Article 6, Article 7 of Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain articles of the Food Safety Law and Articles 4, 5, 7, and 9 of Circular No. 19/2012/TT-BYT dated November 9, 2012 issued by the Minister of Health guiding the declaration of compliance with regulations and food safety regulations.
2. Labeling of micronutrients shall be conducted in accordance with Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labeling, Joint Circular No. 34/2014/TTLT-BYT-BNNPTNT-BCT dated October 27, 2014 of the Ministers of Health, Agriculture and Rural Development, and Industry and Trade on guidelines for labeling of food, food additives, and food processing aids for pre-packaged foods, and other relevant provisions.
3. The use of micronutrients in food must comply with national technical standards and other corresponding regulations.
4. Production and business establishments of micronutrients must meet all conditions prescribed in Circular No. 16/2012/TT-BYT dated October 22, 2012 of the Minister of Health on food safety conditions for production and business establishments of food, food packaging materials, and containers under the jurisdiction of the Ministry of Health.
Article 4. Transitional Provisions
Micronutrients and food products using micronutrients that have been granted a Certificate of Acceptance of Declaration of Compliance or a Confirmation of Declaration of Compliance prior to the effective date of this Circular may continue to be used until the expiration date stated on the Certificate of Acceptance or Confirmation.
Article 5. Review, amendment, supplementation
For micronutrients not included in the list attached to this Circular but listed in the International Food Standards Committee (CODEX) or permitted for use in the country of production, the Food Safety Administration will review and compile proposals for the Minister to issue a revised and supplementary Circular.
Article 6. Reference Provisions
In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.
Article 7. Implementation Provisions
1. This Circular takes effect from March 1, 2016.
2. The Food Safety Administration under the Ministry of Health shall be responsible for leading and coordinating with relevant agencies to guide implementation and organize the enforcement of this Circular. Any difficulties encountered during implementation should be reported to the Food Safety Administration for review and resolution./.
DEPUTY MINISTER
原始文件（PDF）
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