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On 6 June 2018, the Vietnam Food Administration (VFA), Ministry of Health (MOH) notified the World Trade Organization (WTO) of the draft Circular on Management and Use of Food Additives which amends the list of permitted food additives and maximum limits for food additives allowed for use in Vietnam. Once effective, the Circular will repeal and replace the two current keystone pieces of legislation, Circular No. 27/2012/TT-BYT and Circular No. 08/2015/TT-BYT, which regulate how food additives are used in Vietnam.
The final date for comment for WTO trading partners is 5 August 2018. The proposed date of adoption is 31 October 2018, and the expected date of entry to force of this draft Circular is 15 December 2018.
Verisk 3E Review
Food products imported or sold in Vietnam must comply with the provisions of the Law on Food Safety (FSL). This regulation outlines organizations' and individuals' roles and responsibilities to ensure food safety throughout the supply chain. For food additives, all food products may only contain food additives that are permitted by regulation (the Circular) currently enforced.
Additives used in food production must be recognized or confirmed to have met the national technical regulations/standards. At this time, food additives in Vietnam are governed by two pieces of legislation: Circular No. 27/2012/TT-BYT and Circular No. 8/2015/TT-BYT. Both documents regulate how food additives are used in Vietnam. Document 02/VBHN-BY, is a consolidated version of both Circulars and provides guidance for the management of food additives. In addition, there are 23 technical regulations on food additives according to function in Vietnam.
In September 2017, the Government of Vietnam (GVN) published a draft Circular replacing Circular 27/2012 TT- BYT on the management of food additives and sought public consultation. The comment period ended on 5 November 2017 and the GVN has yet to notify the WTO regarding this amendment.
Following this announcement, on 6 June 2018, VFA/MOH notified the WTO Committee on Sanitary and Phytosanitary Measure (SPS) of this draft Circular and invited comments from WTO trading partners through August 2018. The objective of the draft Circular is better regulation of the production and use of food additives, and to ensure safety for human consumption. Mirroring Codex Alimentarius 192-1995 (2017), this proposed draft regulation provides the most updated requirements for the permission and use of food additives, and the maximum limit for their use in food products. Once effective, the Circular will repeal and replace Circular Nos. 27/2012/TT-BYT and 08/2015/TT-BYT. Vietnam's MOH has proposed to review and amend this Circular annually (instead of every two years as originally proposed in 2017) in order to conform to the latest Codex Standard. Suggestions received from stakeholders/industries will also be taken into consideration for amendments.
The Draft Circular contains two lists of permitted food additives:
- List of food additives approved for use and their maximum use level; and
- List of additives permitted for use at GMP (Good Manufacturing Practice)
A food additive not directly added but introduced into the final product due to its presence in the ingredients or raw material used to produce the final product must also comply with the maximum limits set for that food additive as if it has been directly added. This requirement is not applicable for formulated nutrition products and supplemented food for infants and young children as the regulation does not allow food additives that have not been directly added to these products for children unless it is clearly specified for the maximum use level or GMP under this Circular.
Companies manufacturing and distributing food additives must comply with the requirement of a “product announcement” before using and/or placing products on the market. The procedure and implementation of this process are detailed in Decree No.15/2018/ND-CP (Guidance on the Implementation of a Few Articles of the Food Safety Law).
Food additives which have been mixed for a new use, those that are not currently on the permitted list under the Circular, or new additives that have not been approved for specific usage by MOH, are also subject to a registration requirement. Companies who wish to produce or trade these food additives in Vietnam must submit an application along with a required dossier to an authorized agency as part of the registration dossier. The order and procedures for this registration are detailed in Chapter 3 of Decree No. 15/2018/ND-CP.
Before introducing food additives, food flavors, and/or food products containing food additives into the Vietnamese market, companies must follow the specific requirements specified in the regulation. For food additives not found on the national list (Circular) but appearing on the latest CODEX list, the food products owners must submit their request form along with the referred CODEX standard to the MOH for evaluation. Food product owners of food additives neither found in this Circular or Codex must also submit their request form with documentation. The Circular specifies documentation requirements differently, depending on whether the food additives are domestically produced or imported.
This Circular applies to producers, traders, or importers of food additives and foods containing food additives for circulation in Vietnam and other relevant entities. In addition, organizations and individuals who are engaged in the business of dividing, extracting, filling, re-packing, and mixing of food additives must also comply with the requirements stipulated under this Circular.
Verisk 3E Analysis
This draft Circular signals the Vietnamese Government’s efforts to ensure a better national food safety regulatory system. Businesses who manufacture, import, and trade in food additives, food flavors, and food products including food additives and processing aids are strongly encouraged to consult the detailed requirements of the draft Circular as well as other relevant regulations in order to avoid noncompliance. If a product is not listed on the national list, companies should consult the CODEX list and ensure that they are in compliance with each different requirement under the Standard before introducing the product to the market.