Vietnam Sanitary and Phytosanitary Notification Authority and Enquiry Point

This draft amends some articles of Decree No 15/2018/NĐ-CP dated 2 February 2018 of the Government detailing the implementation of a number of articles of the Food Safety Law: I. Administrative procedure reform 1. Eliminating the regulation on translating and notarizing English legal documents after consular legalization and acceptance of electronic copies of legal documents; 2. Allowing the use of the Testing Result for health supplement of production facilities that meet Good Manufacturing Practices (GMP) without having to send samples for testing at designated testing laboratories or recognized testing laboratories; 3. Stipulating the number of times enterprises can submit additional request documents (maximum three times) and the time limit for enterprises to submit additional request documents (30 days) for the sequence of food groups that must register product declarations according to the recommendation of the Government Inspectorate; 4. Adding regulation on importing food donated by organizations and individuals for charity purposes, not for business purposes, in the direction of simplifying the process and procedures compared to the case of food business; 5. Supplementing regulations assigning ministries to develop unified management software from central to local levels to handle administrative procedures and manage food safety according to assigned management areas; 6. Adding regulation on product declaration registration for mixed food additives with new uses, food additives not on the list of additives permitted for use in food or not for the right users as prescribed by the Ministry of Health; 7. Reducing and simplifying some administrative procedures:  Simplifying procedures for registration of advertising confirmation, issuance of Certificate of food safety qualified facilities;  Adding one procedure on exemption from periodic inspection and supervision of testing facilities;  Simplifying requirements on registration dossiers for designating testing facilities currently regulated in Joint Circular 20/2013/TTLT-BYT-BCT-BNNPTNT stipulating conditions, procedures for designating food testing facilities for state management. II. Strengthening decentralization and delegation of authority Decentralizing granting Certificates of Free Sale for food products, except health supplement; Health Certificate and other relevant certificates for exported foods to local authorities. III. Strengthening post-inspection 1. Regulations on only the manufacturing facility or product owner being allowed to be named in the declaration dossier. In case it is not the above two entities, the organization or individual responsible for bringing the product to the market must have a letter of authorization from the manufacturing facility or product owner; 2. Controlling changes to products after announcement: adding cases where reannouncement is required if there is a change in the organization or individual responsible for bringing the product to the market; manufacturing facility, origin; product name; ingredients; uses, subjects; dosage; concentration, content, volume of ingredients that create the product's uses, dosage form; quality and safety indicators; 3. Adding provisions on the withdrawal and suspension of the acceptance of the Certificate of registration of product declaration, Certificate of confirmation of food advertising content, withdrawal of the Certificate of food safety qualified facility, in which specific provisions are made on the cases of withdrawal and the authority to withdraw; 4. Organizations and individuals responsible for bringing products to market must keep records as prescribed in Point g, Clause 2, Article 7 and Point d, Clause 1, Article 19 of the Food Safety Law and in accordance with the provisions of Good Manufacturing Practice (GMP) for health protection foods, Hazard Analysis and Critical Control Points (HACCP) system, ISO 22000 Food Safety Management System, International Food Standards (IFS), Global Food Safety Standards (BRC), Food Safety System Certification (FSSC 22000) or equivalent if they apply and are certified for this system to serve inspection and examination work and present it when requested by competent inspection and examination agencies; 5. Requiring organizations and individuals to provide Standards including testing methods for safety indicators and quality indicators of the product in the registration dossier of the declaration so that the dossier receiving agency can provide them to public testing units to deploy sampling for monitoring on the market; 6. Adding regulations on Food Testing for State Management (including conditions for food testing facilities for State Management and verification testing facilities; registration dossier for designating testing facilities; procedures for designation and cases of recall. IV. Implement the recommendations of Ministries, including the Government Inspectorate 1. Adding and clarify the concept of functional foods introduced to the market for the first time; 2. Amending and adding the concept of scientific evidence proving the product's uses. V. Some other contents 1. Amending and adding the concept of dietary supplements to control the features and uses of this product; 2. Regarding self-declaration procedures for food products: clearly stipulate the responsibilities of the competent state management agency designated by the Provincial People's Committee to post the self-declaration dossier on the unit's electronic information page within seven days from the date of receiving the dossier; At the same time, the records must be reviewed within three months after the organization or individual selfdeclares (regarding product classification, uses, users, ingredients) to ensure that the product is declared correctly in nature and in accordance with regulations.