Many individuals and companies, when making labels for health supplement, still face many problems such as: What is the content of the imported dietary supplement label? What content is required? Or are there any size requirements?
The following article of Khoi Nguyen will help you answer those problems.
1. The concept of product label
According to the joint circular No. 34/2014/TTLT-BYT-BNNPTNT-BCT dated October 27, 2014 guiding the labeling of food products, food additives and prepackaged food processing aids, regulation:
Product label are writings, prints, drawings, copies of words, drawings, images that are glued, printed, attached, molded, carved, engraved directly on products, commercial packaging of products or on other materials. Other products are attached to the product, the product’s commercial packaging to show the necessary information, mainly about that product.
2. Requirements on health supplement labels
The requirements on functional food labels are specified in Article 6 of Circular 43/2014/TT-BYT on functional food management as follows:
“In addition to having to comply with the labeling regulations for prepackaged foods in terms of product names, product composition and mandatory labeling contents specified in Chapter II, regulations on labeling and methods of labeling are required labeling of Joint Circular No. 34/2014/TTLT-BYT-BNNPTNT-BCT October 27, 2014 of the Minister of Health, Ministry of Agriculture and Rural Development, Ministry of Industry and Trade guiding the labeling of food, food additives and food processing aids available, the labeling of functional foods for each specific food group must also comply with the provisions of Articles 9, 11 and 13 of this Circular and the following regulations:
1. Disclose the hazard warning, if any.
2. The product name and the contents on the label must be consistent with the announced content and accompanying documents in the product announcement dossier.”
The requirements for product labels according to Article 3 – Joint Circular No. 34/2014/TTLT-BYT-BNNPTNT-BCT include:
1. The labeling or affixing on labels of all kinds of images, drawings and logos must be truthful and must not mislead, deceive or create an incorrect impression about the nature, characteristics, and uses of the product.
2. Do not write words, signs, motifs referring to or suggesting directly or indirectly to other products, misleading consumers to be other products.
3. For mandatory information inscribed on product labels, the letter height must not be lower than 1.2 mm. For the case where one side of the package used for labeling (excluding the edge of the seam) is less than 80 cm2, the letter height must not be lower than 0.9 mm. The color of the text must contrast with the background color of the label.
4. Goods labels must ensure long-term existence and must not be erased or erased without affecting product quality.
5. Organizations and individuals are encouraged to label nutritional information according to the guidelines of the International Committee for Food Standards (Codex).
At the same time, this joint circular also clearly states the mandatory contents and other contents in Article 5 as follows:
Article 5. Contents of the product label
1. Contents required to be labeled: product name; structural components; product quantification; date of manufacture; shelf life and storage instructions; User manual; the name and address of the organization or individual responsible for the product; origin; number of the Receipt of regulation conformity announcement or Certificate of publication of conformity with food safety regulations; food safety recommendations and warnings.
2. Other contents of product labels include words, drawings, images, symbols, numbers representing other information.
3. Label of imported goods
According to Clause 3, Article 7 of Decree No. 43/2017/ND-CP on goods labels has the following provisions:
3. Goods imported into Vietnam that have not been shown on the label or shown insufficiently the mandatory contents in Vietnamese must have an additional label showing the mandatory contents in Vietnamese and keep the original label of the goods. The content written in Vietnamese must correspond to the content written on the original label.
Secondary labels have the function of helping stakeholders such as management agencies (customs, police) and consumers to recognize the origin of goods and understand relevant information of such goods.
Clause 4, Article 8 of Decree No. 43/2017/ND-CP stipulates the contents of sub-labels as follows:
4. Contents written on auxiliary labels are contents translated into Vietnamese from the mandatory contents written on the original labels and supplemented with other missing mandatory contents according to the nature of the goods as prescribed in this Decree. Labeling organizations and individuals must take responsibility for the accuracy and truthfulness of the inscribed content. The content written on the supplementary label, including additional information, must not misrepresent the content on the original label and must accurately reflect the nature and origin of the goods.
Compulsory contents to be shown on the labels of imported health supplement are also specified in Clause 1, Article 10 of Decree No. 43/2017/ND-CP and Appendix I of this Decree as follows:
a) Name of goods;
b) Name and address of the organization or individual responsible for the goods;
c) Origin of goods;
đ) Date of manufacture;
e) Expiry date;
g) Ingredients, quantitative ingredients or nutritional value;
h) Instructions for use, instructions for preservation;
i) Publication of the hazard warning (if any);
k) Write the phrase: “Health supplement”;
l) Write the phrase: “This food is not a medicine and can not be replaced medicine.”
Because dietary supplements are a category that also has its own management sanctions compared to normal goods, in addition to the contents of the above Decree, the sub-label of imported food supplements must also add the number of Certificate of Receipt of the Declaration of Conformity. Regulations or Certificate of publication of conformity with food safety regulations (to be consistent with the required contents mentioned in Joint Circular No. 34/2014/TTLT-BYT-BNNPTNT-BCT)
Khoi Nguyen specializes in the import and export of dietary supplements, medical supplies and equipment with many different product groups. Not only that, Khoi Nguyen also provides a comprehensive service solution group for customers such as:
- Research & Development
- Regulatory Affairs
- Marketing consulting service
- Support after-sales activities
Please contact Khoi Nguyen immediately so we can help you with your related questions!
Tel: +84 982 574 391
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