Thailand has updated its list of approved enzymes for food use, including lactase, amylase, protease, cellulase, and other enzyme preparations, by issuing a draft notification that replaces prior safety assessments and includes silicon dioxide as a permitted additive in enzyme preparations.
Thailand Updates Approved Food Enzyme Safety Lists
New draft notification replaces 2023 list and permits silicon dioxide in enzyme preparations.
What changed
Updated enzyme approvals for lactase, amylase, protease, cellulase and other preparations under HS code 3507.
Silicon dioxide (INS 551) permitted as a food additive in enzyme preparations under Schedule 4.
Previous notification repealed and replaced, establishing new regulatory baseline for enzyme use.
Who it affects
Food manufacturers must ensure enzymes used are on the updated approved list.
Enzyme preparation producers can now include silicon dioxide in formulations.
Importers of enzyme products must verify compliance with the new safety evaluations.
Compliance Analysis: Thailand’s Updated List of Approved Enzymes for Food Use
Thailand has updated its regulatory framework for enzymes used in food production through a draft notification that replaces prior safety assessments. The updated list includes specific enzymes such as lactase, amylase, protease, cellulase, and other enzyme preparations, with silicon dioxide now permitted as an additive in enzyme preparations1, 2. The following analysis outlines the approved enzymes, their sources, permitted uses, and conditions under regulatory compliance in Thailand.
1. Approved Enzymes and Their Regulatory Specifications
The draft notification categorizes enzymes by their Enzyme Commission (EC) number, source organism, permitted food applications, and usage conditions. Below is a structured summary of key enzymes and their regulatory requirements:
A. Carbohydrases (EC 3.2.1.x)
| Enzyme | EC Number | Source Organism(s) | Permitted Use | Usage Condition |
|---|---|---|---|---|
| Alpha-amylase | EC 3.2.1.1 | Bacillus subtilis, Bacillus licheniformis, Aspergillus oryzae, Rhizopus oryzae | Hydrolysis of starch/glycogen in food/beverages (e.g., syrups, alcoholic beverages, bakery products, glucose, malt extract)1, 2. | "Appropriate quantity"1, 2. |
| Beta-amylase | EC 3.2.1.2 | Sweet potato (Ipomoea batatas), Bacillus licheniformis (genetically modified) | Hydrolysis of (1→4)-alpha-D-glucosidic bonds in amylose/amylopectin for maltose syrups, bakery products, alcoholic beverages, and rice-based foods2. | "Appropriate quantity"2. |
| Glucoamylase | EC 3.2.1.3 | Aspergillus niger (genetically modified), Aspergillus oryzae | Hydrolysis of starch in cereal-based beverages, bakery products, sweets, and alcoholic beverages2. | "Appropriate quantity"2. |
| Cellulase | EC 3.2.1.4 | Trichoderma longibrachiatum, Penicillium funiculosum, Aspergillus niger | Hydrolysis of beta-1,3/1,4-glycosidic bonds in cellulose for fruit juices, vegetable oils, malt extracts, alcoholic beverages, and ethanol production1, 2. | "Appropriate quantity"1, 2. |
| Beta-galactosidase (Lactase) | EC 3.2.1.23 | Kluyveromyces lactis, Bacillus circulans, Papiliotrema terrestris | (1) Lactose hydrolysis in dairy products; (2) Transgalactosylation to produce galacto-oligosaccharides (GOS)2. | "Appropriate quantity"2. |
| Isoamylase | EC 3.2.1.68 | Pseudomonas amyloderamosa | Hydrolysis of glycogen, amylopectin, and dextrins in starch-based foods2. | "Appropriate quantity"2. |
| Pullulanase | EC 3.2.1.41 | Not specified | Hydrolysis of alpha-1,6-glucosidic bonds in pullulan/starch2. | "Appropriate quantity"2. |
B. Proteases (EC 3.4.x.x)
| Enzyme | EC Number | Source Organism(s) | Permitted Use | Usage Condition |
|---|---|---|---|---|
| Microbial serine protease | EC 3.4.21.14 | Bacillus amyloliquefaciens | Hydrolysis of polypeptides in food production (e.g., protein hydrolysates, bakery products, meat/fish products)1. | "Appropriate quantity"1. |
| Subtilisin | EC 3.4.21.62 | Bacillus subtilis (genetically modified) | Hydrolysis of peptide bonds in proteins for dairy products, plant-based milks, meat products, and flavor enhancers1, 2. | "Appropriate quantity"1, 2. |
| Thermolysin | EC 3.4.24.27 | Geobacillus stearothermophilus | Hydrolysis of peptide bonds in proteins for cheese, sauces, plant-based milks, meat/fish products, and protein hydrolysates2. | "Appropriate quantity"2. |
| Chymosin | EC 3.4.23.4 | Escherichia coli K-12 (genetically modified), Aspergillus niger, Kluyveromyces lactis, calf/ovine rennet | Hydrolysis of casein in milk for cheese production2. | "Appropriate quantity"2. |
| Mucorpepsin | EC 3.4.23.23 | Rhizomucor species | Hydrolysis of casein in cheese production2. | "Appropriate quantity"2. |
| Bacillolysin | EC 3.4.24.28 | Bacillus amyloliquefaciens | Hydrolysis of peptide bonds for yeast extract, dairy products, plant-based milks, flavor enhancers, and bakery products2. | "Appropriate quantity"2. |
C. Other Enzymes
| Enzyme | EC Number | Source Organism(s) | Permitted Use | Usage Condition |
|---|---|---|---|---|
| Asparaginase | EC 3.5.1.1 | Bacillus subtilis (genetically modified) | Hydrolysis of asparagine in starchy foods (e.g., bakery products, cereal-based beverages, ethanol) to reduce acrylamide formation2. | "Appropriate quantity"2. |
| Triacylglycerol lipase | EC 3.1.1.3 | Rhizopus niveus, Streptomyces violaceoruber | (1) Modification of phospholipids/lecithin in bakery products, egg yolk, emulsified sauces, and dairy; (2) Degumming in vegetable oil production2. | "Appropriate quantity"2. |
| Microbial collagenase | EC 3.4.24.3 | Streptomyces violaceoruber (genetically modified) | Hydrolysis of collagen for meat/fish products and collagen hydrolysates2. | "Appropriate quantity"2. |
2. Key Regulatory Requirements
A. Permitted Additives in Enzyme Preparations
- Silicon dioxide is explicitly permitted as an additive in enzyme preparations under the draft notification.
- No maximum limit is specified; usage must be "appropriate" for the intended application1, 2.
B. Genetically Modified Organisms (GMOs)
- Enzymes derived from genetically modified microorganisms (GMOs) are permitted if the source organism is listed (e.g., Bacillus subtilis with Bifidobacterium bifidum genes for lactase production)2.
- No additional safety assessment is required beyond the draft notification’s approval.
C. Labeling and Usage Conditions
- Enzymes must be used only as processing aids unless otherwise specified (e.g., lactase for lactose hydrolysis in dairy products)2.
- No residual enzyme activity is permitted in the final food product unless the enzyme is explicitly approved as a food additive (e.g., chymosin in cheese)2.
- No maximum limits are prescribed for most enzymes; the draft notification states "appropriate quantity" for all listed enzymes1, 2.
3. Comparison with Prior Regulations
The draft notification replaces prior safety assessments with a pre-approved list of enzymes, streamlining compliance for food manufacturers. Key changes include:
- Expanded Scope: Addition of enzymes like asparaginase (for acrylamide reduction) and microbial collagenase (for meat/fish products)2.
- GMO Clarity: Explicit approval of enzymes from genetically modified sources (e.g., Bacillus licheniformis with Geobacillus stearothermophilus genes)2.
- Additive Inclusion: Silicon dioxide is now permitted as an additive in enzyme preparations.
Summary Answer
Thailand’s draft notification updates the list of approved enzymes for food use, including lactase, amylase, protease, cellulase, and others, with silicon dioxide permitted as an additive in enzyme preparations. Enzymes are categorized by EC number, source organism, and permitted applications, with usage limited to "appropriate quantities"1, 2. The notification replaces prior safety assessments, streamlining compliance for genetically modified and traditional enzyme sources. Key enzymes like chymosin (for cheese), thermolysin (for protein hydrolysates), and asparaginase (for acrylamide reduction) are explicitly approved, while no maximum limits are prescribed for most enzymes2. Manufacturers must ensure enzymes are used as processing aids unless otherwise specified1, 2. All sources1, 2 are cited in this analysis.
Sources
- ↩ WTO SPS notification 26-03319 — Thailand https://members.wto.org/crnattachments/2026/SPS/THA/26_03319_00_x.pdf
- ↩ WTO TBT notification 26-03320 — Thailand https://members.wto.org/crnattachments/2026/TBT/THA/26_03320_00_e.pdf