Vietnam: What are the amendments to the requirements for health claims for functional foods?

“What are the amendments to the requirements for health claims for functional foods in Vietnam?” - asked Ms. T.H (Dong Nai)

What are the amendments to the requirements for health claims for functional foods in Vietnam?

Pursuant to the current provisions in Clause 2, Article 10 of Circular 43/2014/TT-BYT as follows:

Claim contents
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2. Health claims:
a) Health claims must reflect the product nature, the claim about effects of ingredients having main or combined effects shall be made only when there is scientific evidence, the effects of ingredients must not be enumerated as effects of the product;
b) Claims about health, dosage, suitable users and suitable usage must be consistent and in conformity with the documents;
c) The effects of the vitamins, minerals and active ingredients of which the contents are smaller than those in the scientific documents shall not be claimed;
c) The effects of vitamins, minerals and active ingredients of which the contents are the same as those in the scientific documents shall be claimed, provided suitable users and doses are specified;
dd) Scientific evidence of effects of ingredients and recommended intakes must be provided if such ingredients do not have RNI.
...

Pursuant to the new provisions in Clause 7 Article 4 of Circular 17/2023/TT-BYT amending and supplementing Clause 2 Article 10 of Circular 43/2014/TT-BYT follows:

Amending and supplementing a number of articles in Circular No. 43/2014/TT-BYT dated November 24, 11 of the Minister of Health regulating the management of functional foods
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7. Points d and dd, Clause 2, Article 10 are amended as follows:
"d) When the daily dose of vitamins and minerals in a product reaches at least 15% of RNI or reaches at least 15% of the use of such ingredient stated in scientific documents, the use of the product shall be claimed, provided suitable users and doses are specified;
dd) For an ingredient that does not yet have an RNI as prescribed, when the daily dose reaches at least 15% of the use of that ingredient stated in scientific documents, the use of the product shall be claimed, provided suitable users and doses are specified."
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Thus, based on the above-mentioned regulations, the requirement for health claims for functional foods under the new regulations has specified the percentage of vitamins, minerals, and active ingredients to be claimed for use, provided acceptable users and dosages are given.

- For an ingredient that does not yet have an RNI as prescribed, when the daily dose reaches at least 15% of the use of that ingredient stated in scientific documents, the use of the product shall be claimed, provided acceptable users and dosages are given.

What are the cases of recalling functional foods in Vietnam?

Pursuant to the provisions of Article 16 of Circular 43/2014/TT-BYT, the cases of recalling functional foods in Vietnam are:

Recalling functional foods
1. Functional foods must be recalled in the following cases:
a) The products have expired;
The products are not conformable to the Ministry of Health’s technical standards or regulations on food safety.
c) The information on the products sold on the market is inconsistent with the claims confirmed by the agency granting the Certificate of Declaration of Conformity or inconsistent with the Certificate of Declaration of Conformity with the food safety regulations or violates other laws;
d) The products are sold on the market without conformity certification or confirmation of satisfying food safety regulations;
dd) There is a safety warning of the product from competent authorities of the countries or international organizations and confirmation from Vietnam Food Administration- the Ministry of Health

However, this regulation will be annulled on November 9, 2023.

What are the regulations on the traceability of infringing products in Vietnam?

Pursuant to the provisions of Article 18 of Circular 43/2014/TT-BYT as follows:

Tracing the origins of infringing products
1. Origins tracing shall be carried out at the final packaging place. Manufacturers and sellers of functional foods have a responsibility to provide sufficient information about the origin, quality, material safety, manufacturing process, processing, preserving to the competent State management agencies during inspection.
2. Origins of materials threatening food safety shall be investigated at the facilities considered origins of such materials in order to identify the supplier of such materials or the area where such materials are produced.

Thus, based on the above provisions, the traceability of infringing products in Vietnam is carried out as follows:

- Origins tracing shall be carried out at the final packaging place. Manufacturers and sellers of functional foods have a responsibility to provide sufficient information about the origin, quality, material safety, manufacturing process, processing, and preservation to the competent State management agencies during inspection.

- Origins of materials threatening food safety shall be investigated at the facilities considered origins of such materials in order to identify the supplier of such materials or the area where such materials are produced.

However, this regulation will be annulled on November 9, 2023.

Circular 17/2023/TT-BYT will take effect from November 9, 2023.

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