Dossier to register a product declaration for imported functional food products

1. Business establishments must register product declarations for which products?

According to Article 6 of Decree 15/2018/ND-CP, organizations and individuals producing and trading food must register product declarations for the following products:

– Health protection foods, medical nutritional foods, and dietary foods special.

– Nutritional products for children up to 36 months old.

– Mixed food additives with new uses, food additives that are not on the list of additives allowed to be used in food or are not for the right users as prescribed by the Ministry of Health.

2. What does the product declaration registration dossier for imported functional food products include?

According to Clause 1, Article 7 of Decree 15/2018/ND-CP, the product declaration registration dossier for imported products includes:

– The product declaration is specified in Form No. 02 Appendix I issued with the Decree This;

– Certificate of Free Sale or Certificate of Export or Health Certificate issued by the competent authority of the country of origin/export with content ensuring safety for users or sold freely in the market of the country of production/export (consular legalization);

– Conclusion slip Food safety testing results of the product within 12 months up to the date of submission of documents issued by a designated testing laboratory or testing laboratory recognized in accordance with ISO 17025 including safety criteria issued by the Ministry of Health according to risk management principles in accordance with international regulations or safety criteria according to corresponding regulations and standards announced by organizations and individuals in case there are no regulations of the Ministry of Health (original or certified copy);

– Scientific evidence proving the uses of the product or the ingredients that create the announced uses (original or copy certified by the organization or individual). When using scientific evidence about the uses of a product’s ingredients to make use of the product, the daily dose of the product must be at least greater than or equal to 15% of the amount of use of that ingredient stated in the document;

– Certificate of establishment meeting food safety conditions meeting Good Manufacturing Practices (GMP) requirements or equivalent certification in case the imported product is health protection food applicable from July 1, 2019 (copy certified by the organization or individual).

3. What conditions are required for functional food business?

According to Article 9 of Decree 67/2016/ND-CP the conditions for functional food businesses are specified as follows:

– Comply with the conditions specified in Articles 6 and 7 of this Decree.

– For import facilities, there must be a separate warehouse or storage area in accordance with the manufacturer’s storage requirements.

– The business of functional foods in drug retail establishments must have a separate display area, area instructions and nameplates for functional foods.

According to Article 6 of Decree 67/2016/ND-CP the conditions for business establishments include:

– There is enough space to arrange food display areas, storage and preservation areas, and convenient transportation of raw materials and food products.

– Do not flood or stagnate water.

– Not affected by animals, insects and other sources of pollution.

– Business establishment structure appropriate to nature and scale; Built with materials that ensure hygiene and safety.

– Walls and ceilings are smooth, brightly colored, made of durable, strong materials that do not leak, absorb water, do not crack, mold, accumulate water and adhere to dirt.

– The restroom area must be separated from the food business area; Toilet doors must not open into the food storage area.

– Have a bookkeeping system or food management software throughout the business process.

According to Article 7 of this Decree, conditions for equipment and tools include:

– Have enough equipment to serve business, preserve and control appropriate food safety factors according to the manufacturer’s requirements; There are regulations on cleaning procedures and regimes for the facility.

– There are enough tools to collect waste and garbage, have lids and are cleaned regularly.

Thus, for a functional food business that imports and sells, in addition to registering for the functional food business code, it must also meet the conditions for a functional food business, equipment conditions, tools.