Vietnam’s Ministry of Health (MOH) has just issued a draft amendment to the QCVN 8-1:2011/BYT- National Technical Regulation on the Limits of Mycotoxins Contamination in Food, which sets maximum limits for several contaminants in foods, including Aflatoxin, Ochratoxin A, Patulin, Deoxynivalenol, Zearalenone and Fumonisin.

According to the explanatory document of the MOH, the main changes in QCVN 8-1:2025/BYT based on changes in contaminant regulations of Codex and EU. Compared to QCVN QCVN 8-1:2011/BYT, the draft includes the following changes:

1. Adding Maximum Limit (ML) for new contaminant including Ergot Sclerotia, Ergot alkaloids, T-2 and HT-2 toxins in specific samples
2. Adjusting ML of existing contaminating toxins in certain sample matrices, particularly:

                      2.1. Aflatoxin:

• Setting new ML for Brazil nut, dried figs for direct use
• Setting new ML for each sample of corn, rice and sorghum grains and flours
• Amending the scope of Aflatoxin M1 regulations, only regulating the raw milk group.

                      2.2. Ochratoxin A:

• Reducing ML in raisins, coffee and instant coffee, dried spices group
• Setting new ML for dried figs and other dried fruits, date syrup, dried chestnuts, dried herbs, dried ginger, oilseeds, cocoa powder
• Revising and adding ML for each type of licorice product.

                       2.3. Deoxynivalenol:

• Increasing ML in wheat, barley and corn cereals for further processing
• Adding ML to flours derived from wheat, barley and corn.

                      2.4. Fumonisin:

• Adding ML to corn flour (2000 µg/kg).

3. Adding notes on ML calculations for different types of products in each oxin category prescribed ML.
4. Updating testmethods (these methods are not mandatory, other equivalent testing methods can be used)

Expected official issuance date in October 2025.

Also according to the circular, the transitional provisions are as follows:

1. Products that have self-declared or have been granted a certificate of registration for product declaration produced before the effective date of the circular, if not in accordance with QCVN 8-1:2025/BYT, organizations and individuals are allowed to continue to import, trade, and circulate until the expiry date of the product, except in cases where there is a warning about food safety
2. Product declaration/self-declaration registration dossiers submitted before the effective date of the Circular will continue to be processed according to the regulations at the time of submission
3. From the effective date of the Circular, for Products that have been granted a Certificate of Acceptance of Product Declaration Registration or have self-declared products, if the Manufacturer's Standards are not in accordance with the regulations issued with this Circular, the organization or individual shall adjust the Manufacturer's Standards to be in accordance with the regulations and make a notification according to the provisions of Clause 4, Article 5, Clause 4, Article 8 of Decree No. 15/2018/ND-CP dated February 2, 2018 of the Government detailing the implementation of a number of articles of the Law on Food Safety.

Thus, when the Circular takes effect, products that have been previously registered for declaration/self-declaration and are not in accordance with QCVN 8-1:2025/BYT will still be circulated in cases where there are no violations of food safety. At the same time, individuals/enterprises must adjust the Manufacturer's Standards to be in accordance with the Regulation and send a notification to their product management agency.

Individuals and Stakeholders who have comments on this draft can send feedback via the Ministry of Health's website until February 15, 2025 at the link :see details here.

Please see the detail of the draft QCVN 8-1:2025/BYT at link: see details here.