For enterprises trading in food and food-related products, it is mandatory to carry out product circulation procedures, which is also the “permit to circulate products”.
DHP Law introduces to readers the product circulation procedures as follows:
- LEGAL BASIS
- Decree 15/2018/ND-CP dated February 2, 2018 detailing a number of articles of the Law on Food Safety.
- Decree 155/2018/ND-CP dated November 12, 2018 amending and supplementing a number of regulations related to business investment conditions under the scope of state management of the Ministry of Health.
II . SELF-DISCLOSURE OF PRODUCTS
Self-declaration of product circulation means that enterprises self-announce the circulation of products without having to carry out registration procedures with competent State agencies.
first. Subjects self-declared product circulation
- Pre-packaged processed foods;
- Food Additives;
- Food processing aids;
- Food containers;
- Packaging materials that come into direct contact with food.
- Profile composition
- Self-declaration of products made according to Form No. 01, Appendix I issued together with Decree 15/2018/ND-CP;
- The certificate of results of food safety testing of the product within 12 months from the date of application is issued by a designated testing laboratory or a laboratory accredited in accordance with ISO 17025 including the safety criteria issued by the manufacturer. The Ministry of Health promulgates according to the principles of risk management in accordance with international regulations or safety criteria according to relevant regulations and standards announced by organizations and individuals in case there are no regulations. of the Ministry of Health (original or certified true copy).
- Order and procedures for self-declaration of product circulation
- Organizations and individuals self-declare their products on the mass media or their website or publicly post them at the headquarters of the organization or individual and publish them on the updated data information system. Update on food safety (In case there is no updated system of information and data on food safety, the organization or individual shall submit 01 copy by post or directly to the competent state management agency). the authority appointed by the People’s Committee of the province or centrally run city to keep records and publish the names of organizations and individuals and the names of self-proclaimed products on the website of the receiving agency, In case an organization or individual has 02 or more production facilities that produce the same product, the organization or individual only submits the application at a local state management agency where the production facility is located. Once the state management agency has been selected to submit the dossier, the subsequent self-declaration must submit the dossier at the previously selected agency).
- Immediately after self-announcing products, organizations and individuals are entitled to manufacture and trade products and take full responsibility for the safety of such products;
III. REGISTERED PRODUCT PUBLICATION
Is the procedure for product circulation registration at a competent State agency. For this procedure, the enterprise prepares a dossier and submits it to a competent State agency for a certificate of completion of the product circulation procedure.
- Subjects registering the product circulation announcement
- Food for health protection, food for medical nutrition, food for special diet.
- 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 prescribed by the Ministry of Health.
- Dossier for registration of product circulation announcement
2.1 For domestically produced products
- The product announcement is specified in Form No. 02, Appendix I issued together with Decree 15/2018/ND-CP guiding the Law on Food Safety;
- The certificate of results of food safety testing of the product within 12 months from the date of application is issued by a designated testing laboratory or a laboratory accredited in accordance with ISO 17025 including the safety criteria issued by the manufacturer. The Ministry of Health promulgates according to the principles of risk management in accordance with international regulations or safety criteria according to relevant regulations and standards announced by organizations and individuals in case there are no regulations. of the Ministry of Health (original or certified true copy);
- Scientific evidence proving the use of the product or the ingredients creating the announced use (original or copy certified by the organization or individual). When using scientific evidence about the use of a product’s ingredient for the product’s use, the daily dose of the product must be at least 15% greater than or equal to 15% of the use of that ingredient stated in the brochure. Whether;
- Certificate of eligibility for food safety in case the establishment is subject to the issuance of a certificate of eligibility for food safety as prescribed (a copy certified by the organization or individual) ;
- The certificate of food safety conditions satisfying the requirements of Good Manufacturing Practice (GMP) in case the domestically produced product is a health protection food, applied from July 1, 2019 (copy). certified copy of the organization or individual).
2.2 For imported products
- The product announcement is specified in Form No. 02, Appendix I issued together with Decree 15/2018/ND-CP guiding the Law on Food Safety;
- Certificate of Free Sale or Certificate of Exportation or Health Certificate issued by a competent authority of the country of origin/export with contents content to ensure safety for users or be freely sold in the market of the producing/exporting country (consular legalization);
- The certificate of results of food safety testing of the product within 12 months from the date of application is issued by a designated testing laboratory or a laboratory accredited in accordance with ISO 17025 including the safety criteria issued by the manufacturer. The Ministry of Health promulgates according to the principles of risk management in accordance with international regulations or safety criteria according to relevant regulations and standards announced by organizations and individuals in case there are no regulations. of the Ministry of Health (original or certified true copy);
- Scientific evidence proving the use of the product or the ingredients creating the announced use (original or copy certified by the organization or individual). When using scientific evidence about the use of a product’s ingredient for the product’s use, the daily dose of the product must be at least 15% greater than or equal to 15% of the use of that ingredient stated in the brochure. Whether;
- Certificate of eligibility for food safety and meeting the requirements of Good Manufacturing Practice (GMP) or an equivalent certificate in case the imported product is a health food applied from July 1, 2019 (copy certified by the organization or individual).
- Order and procedures for registration of the product circulation announcement
- Organizations and individuals producing and trading food shall submit an application for registration of a product announcement via the online public service system or by post or directly to a dossier-receiving agency according to the following regulations: :
- Submit to the Ministry of Health for health foods, mixed food additives with new uses, and food additives that are not included in the list of additives permitted for use in food prescribed by the Minister of Health. determined
- Submit to the competent state management agency designated by the People’s Committee of the province for medical nutrition food, food for special diets, nutritional products for children up to 36 months old ;
- In case organizations or individuals producing many types of food fall under the competence of receiving dossiers of registration of product announcements from both the Ministry of Health and the competent state management agencies approved by the provincial People’s Committees. If designated, organizations or individuals have the right to choose whether to submit dossiers to the Ministry of Health or products under the authority to receive registration dossiers of which agencies shall submit registration dossiers to such receiving agencies.
- In case an organization or individual has 02 or more production facilities that produce the same product, the organization or individual only carries out the procedures for registration of the product announcement at a local state management agency. The locality has a production facility selected by an organization or individual (except for products registered at the Ministry of Health). Once a state management agency has been selected for registration, subsequent registrations must be made at the selected agency.
- Within 07 working days from the date of receipt of a complete application for registration of the product announcement, for a mixed food additive with new uses, a food additive that is not on the list of permitted additives, or not suitable for use in foods prescribed by the Minister of Health, medical nutritional foods, foods for special diets, nutritional products for children up to 36 months old and 21 working days old. For health foods, the receiving authority is responsible for verifying the application and issuing a certificate of registration of the product announcement using Form No. 03, Appendix I issued together with Decree 15. /2018/ND-CP guiding the Law on Food Safety.
- In case of disagreement with the product announcement dossier of the organization or individual or request for amendment, supplement, the dossier-receiving agency must make a document clearly stating the reasons and legal grounds for the request. bridge. The application-receiving agency may only request amendments and supplements once.
- Within 07 working days from the date of receipt of the amended and supplemented dossier, the dossier-receiving agency shall appraise the dossier and give a written reply. After 90 working days from the date of receipt of a written request for amendment and supplementation, if the organization or individual does not amend or supplement, the dossier is no longer valid.
- In case a product has a change in product name, origin, or composition, the organization or individual must re-announce the product. In case of other changes, the organization or individual shall notify in writing of the changed content to the agency competent to receive the dossier and be allowed to manufacture and trade products immediately after sending the notice.
- The agency that receives the application for registration of the product announcement shall publicly announce the name and product of the organization or individual that has received the registration of the product announcement on the website. and its food safety database.
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