Thailand has introduced new regulatory controls on Enzymes used in food production, targeting specific enzyme types including protease, amylase, and lipase.
Thailand Restricts Enzymes in Food Production
New controls target specific enzyme types used in food manufacturing.
What changed
New regulatory controls on enzymes used in food production under the Food Act B.E. 2522.
Specific enzymes targeted including protease, amylase, lipase, and cellulase.
HS code 350790 now subject to regulatory oversight for food processing enzymes.
Applies to all imports and domestic production of enzymes within Thailand.
Who it affects
Enzyme importers must comply with new regulatory controls for HS code 350790 products.
Domestic enzyme producers subject to the same controls as importers.
Food manufacturers using protease, amylase, lipase, or cellulase must source compliant enzymes.
Regulation Analysis: Thailand’s New Controls on Enzymes in Food Production
Thailand has introduced updated regulatory controls on enzymes used in food production, including protease, amylase, and lipase, through a Draft Notification of the Ministry of Public Health (MOPH) issued under the Food Act B.E. 2522 (1979). The new rules repeal and replace the previous enzyme lists under Notification No. 443 B.E. 2566 (2023) and align with international safety assessments by the Thai FDA and JECFA (Joint FAO/WHO Expert Committee on Food Additives). Below is a structured breakdown of the key requirements, authorities, and timelines.
1. Regulatory Framework and Scope
The draft notification applies to food enzymes (HS code: 3507) used in food production, including but not limited to:
The regulation is issued under the Food Act B.E. 2522 (1979), which empowers the MOPH to set safety standards for food additives and processing aids1.
2. Key Requirements
A. Updated List of Permitted Enzymes
- The draft repeals and replaces Schedule 1 of Notification No. 443 B.E. 2566 (2023), which previously listed approved enzymes. The new list includes only enzymes that have passed safety assessments by the Thai FDA or JECFA1, 2.
- Silicon dioxide (INS 551) is explicitly added to Schedule 4 as a permitted food additive for enzyme preparations1.
B. Compliance with International Standards
- The draft aligns with Codex Alimentarius standards, specifically the General Specifications and Considerations for Enzyme Preparations (JECFA)1, 2.
- Risk assessments follow FAO/WHO Principles and Methods for the Risk Assessment of Chemicals in Food (Environmental Health Criteria 240, Section 9.1.4.2)2.
C. Enforcement and Entry into Force
- The regulation will take effect the day after publication in the Government Gazette1, 2.
- No transition period is specified; compliance is required immediately upon enforcement1.
3. Regulatory Table: Key Provisions
| Regulation | Key Requirement | Deadline/Threshold | Authority |
|---|---|---|---|
| Draft MOPH Notification (Enzymes Used in Food Production No. 2) | Updates permitted enzyme list (Schedule 1) based on Thai FDA/JECFA safety assessments1, 2. | Effective day after Gazette publication1. | Thai FDA (MOPH) |
| Repeal of Notification No. 443 B.E. 2566 (2023) | Replaces prior enzyme lists; no grandfathering for unlisted enzymes1. | Same as above. | Thai FDA (MOPH) |
| Addition of Silicon Dioxide (INS 551) to Schedule 4 | Permits use as a food additive in enzyme preparations1. | Same as above. | Thai FDA (MOPH) |
| Alignment with Codex/JECFA Standards | Enzymes must comply with General Specifications for Enzyme Preparations1, 2. | N/A (ongoing compliance). | Thai FDA (MOPH) |
| Public Comment Period | Stakeholders may submit feedback until 28 August 2026 (60 days from notification)1, 2. | 28 August 2026. | ACFS (National Enquiry Point) |
4. Authorities and Stakeholder Engagement
- Thai FDA (Food and Drug Administration): Primary regulator responsible for enforcement and safety assessments1.
- National Bureau of Agricultural Commodity and Food Standards (ACFS): Handles public comments and serves as the National Notification Authority and National Enquiry Point1, 2.
- Contact for Comments:
- Email: `spsthailand@acfs.go.th` / `spsthailand@gmail.com`
- Tel: +(662) 561 4204
- Deadline: 28 August 20261.
5. Urgency and Rationale
The regulation aims to protect human health by ensuring only safety-assessed enzymes are used in food production. The update addresses gaps in the previous list (Notification No. 443) and incorporates recent JECFA evaluations1, 2.
Summary Answer
Thailand’s Draft Notification of the Ministry of Public Health (Enzymes Used in Food Production No. 2) introduces stricter controls on food enzymes, including protease, amylase, and lipase, by replacing the previous list under Notification No. 443 B.E. 2566 (2023) with enzymes approved by the Thai FDA or JECFA1, 2. The regulation adds silicon dioxide (INS 551) as a permitted additive for enzyme preparations1, aligns with Codex/JECFA standards2, and takes effect the day after publication in the Government Gazette1. Stakeholders may submit comments to the ACFS until 28 August 20261. Compliance is mandatory upon enforcement, with no transition period specified.
Sources
- ↩ Draft Notification of the Ministry of Public Health (MOPH), (No. …) B.E. …. issued by virtue of the Food Act B.E. 2522 Re: Enzyme Used in Food Production (No. 2) https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/T/G/SPS/NTHA811.docx
- ↩ Draft Notification of the Ministry of Public Health (MOPH), (No. …) B.E. …. issued by virtue of the Food Act B.E. 2522 Re: Enzyme Used in Food Production (No.2) https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/T/G/TBTN26/THA810.docx