Food claims
Guidance on product declaration procedures for food
According to the current law, organizations and individuals producing and trading food before putting their products on the market must carry out procedures for self-declaration or registration of product proclamation. Members are invited to follow up the detailed procedures in the following article.
I. Case 1: Self-declaration of product
1. When to perform the product self-declaration procedure?
Pursuant to Article 4 of Decree No. 15/2018 / ND-CP , food producers and traders will have to carry out the procedures for self-declaration of food for:
Pre-packaged processed food;
- Food Additives;
- Food processing aids;
- Food containers, packaging materials in direct contact with food.
Note: Food producers and traders are exempt from the self-declaration procedure if the products and raw materials manufactured or imported are used only for the production or processing of export goods or for restoration. for internal production of organizations and individuals not for consumption in the domestic market.
2. The product self-declaration dossier includes:
- The product self-declaration according to Form No. 01, Appendix I, issued together with Decree No. 15/2018 / ND-CP ;
- The results of food safety testing of products within 12 months to the date of submission.
3. Order of product announcement
Pursuant to Clause 2, Article 5 of Decree 15/2018 / ND-CP and Clause 1 Article 3 of Decree 155/2018 / ND-CP , product self-declaration is made in the following order:
- Organizations and individuals that self-publish products on the mass media or their website or publicly post them at the headquarters of organizations and individuals and publish on the information and data system updates on food safety;
- If there is no updated information and data system on food safety , the organization or individual shall submit 01 copy by post or directly to a competent state management agency issued by the provincial People's Committee. centrally designated city to record and post the names of organizations, individuals and self-declared products on the website of the receiving agency;
- Immediately after self-declaration of the product, the organization or individual is entitled to manufacture and trade the product and take full responsibility for the safety of that product.
Note:
- In case organizations or individuals have 02 or more manufacturing establishments that produce the same product, the organization or individual shall only submit their application to one state management agency in the locality where the manufacturing facility is produced. selected organizations and individuals;
- When a state management agency is selected to submit the dossier, the subsequent self-declaration must submit the dossier to the previously selected agency;
- Documents in the self-declaration dossier must be in Vietnamese; In cases where a document is in a foreign language, it must be translated into Vietnamese and notarized. The document must remain valid at the time of self-publication;
- In case the product has any change in product name, origin, composition, the organization or individual must self-declare the product. In other cases of changes, organizations and individuals shall notify in writing the content of changes to competent state management agencies and may produce and trade in products right after sending such notices.
II. Case 2: Register the product proclamation
1. When do I carry out the registration procedure for a product proclamation?
Pursuant to Article 6 of Decree No. 15/2018 / ND-CP , organizations and individuals will have to carry out the product declaration registration procedures for:
- Food for health protection, food for medical nutrition, food for special diets;
- Nutrition products for children up to 36 months old;
Mixed food additives with new uses, food additives that are not on the list of food additives permitted for use or not subject to use as prescribed by the Ministry of Health.
2. Product proclamation registration dossier
2.1. For imported products, the application includes:
- The product declaration according to Form No. 02, Appendix I issued together with Decree No. 15/2018 / ND-CP ;
- certificate of free sale (certificate of free sale) or certificate of export (Certificate of exportation) or Certificate of Health (Health Certificate) of the competent authority of the country of origin / export levels content to ensure user safety or is freely sold in the market of the country of manufacture / export (consular legalization);
- Results of food safety testing of products within 12 months to the date of submission;
- Scientific evidence proving the use of the product or the ingredients that make up the declared effect (the original or a copy certified by the organization or individual);
- Certificate of establishment satisfying the requirements of Good Manufacturing Practice (GMP) or equivalent certificate in case of imported products as health protection food, applied from July 1. / 2019 (certified by organization or individual).
2.2. For domestically manufactured products, the application includes:
- The product declaration according to Form No. 02, Appendix I issued together with Decree No. 15/2018 / ND-CP ;
- Results of food safety testing of products within 12 months to the date of submission;
- Scientific evidence proving the use of the product or the ingredients that make up the declared effect (the original or a copy certified by the organization or individual);
- Certificate of establishment meeting the conditions of food safety in case the establishment is required to issue a certificate of eligibility for food safety as prescribed (a copy certified by the organization or individual. );
- Certificate of establishment satisfying the requirements of Good Manufacturing Practice (GMP) in case the product is domestically produced as a health protection food, applied from July 1, 2019 ( copies certified by organization or individual).
Note: Documents in the application for the product proclamation must be presented in Vietnamese; In cases where a document is in a foreign language, it must be translated into Vietnamese and notarized. The document must be valid at the time of submission of registration dossier for the product proclamation.
3. Order of registration of product announcement
Pursuant to Article 8 of Decree No. 15/2018 / ND-CP , the registration of product announcement is done in the following order:
- Food producers and traders shall submit their dossiers via the online public service system or by post or directly to the receiving agency;
- Within: 21 working days from the date of receipt of the complete application for health food and 07 working days for other cases, the receiving agency is responsible for examining the application and issuing the certificate. receiving registration of product announcement;
- In case of disagreeing with the product announcement of organizations or individuals or request for amendment or supplementation, the dossier-receiving agency must issue a written document stating the reason and legal basis for the request. bridge. The dossier-receiving agency is only allowed to request amendments and supplements once;
- The agency receiving the product announcement registration dossier is responsible for publicly announcing the names and products of the organization or individual that has been accepted for registration of the product announcement on the website (website its and its food safety database;
- The organizations and individuals that manufacture and trade in products are responsible for paying fees for the examination of the application for registration of the product announcement in accordance with the law on fees and charges.
Note:
- Receiving body:
+ Submit to the Ministry of Health for: health protection foods, mixed food additives with new uses, food additives not included in the list of approved food additives approved by the Minister of Health. medical regulations;
+ Submit to a competent state management agency designated by the People's Committee of the province for: medical nutritional foods, foods for special diets, nutritional products for children up to 36 month old.
- If organizations or individuals that produce a variety of foods are within the competence to receive product declaration registration dossiers from both the Ministry of Health and the competent state management agencies are only authorized by the provincial-level People's Committees. According to the plan, the organization or individual has the right to choose to submit the dossier to one of the two receiving agencies;
- If the organization or individual has 02 (two) or more manufacturing facilities that produce the same product, they shall only carry out the product declaration registration procedures at a local state management agency. Production departments are selected by organizations or individuals (except for products registered at the Ministry of Health). When a state management agency is selected for registration, the subsequent registration times must be registered at the selected agency;
- In case the product has any change in product name, origin, composition, the organization or individual must re-announce the product. In other cases of changes, organizations and individuals shall notify in writing the content of the changes to the above-mentioned dossier-receiving agency and may manufacture and trade in products right after sending the notice.
Legal grounds: