Law Summary
Objectives of the Regulation
- Prescribes safe conditions and maximum allowable quantities for food additive use.
- Ensures food safety and harmonizes local regulations with international laws to facilitate market access.
- Updates the official list of permitted food additives and guidelines for their use in both local and imported foods.
Key Definitions
- Acceptable Daily Intake (ADI): The estimated safe daily amount of an additive based on a 60 kg person, as assessed by JECFA.
- Food Additive: Any substance that becomes part of food or affects its characteristics, used in manufacturing, packing, or processing, and scientifically proven safe.
- Good Manufacturing Practice (GMP): Using the minimal necessary quantity of additives to achieve the intended effect.
- Flavoring Substances: Substances primarily used to flavor food rather than for nutritional value.
- Other terms include FAO, FCC, IOFI, JECFA, WHO, and US FEMA definitions relevant to food additives.
General Guidelines for Food Additives
- Only additives found safe by JECFA or equivalent bodies and approved by DOH-BFAD are permitted.
- Use of additives must:
- Provide an advantage such as shelf life extension or nutritional enhancement.
- Not pose appreciable health risks.
- Not mislead consumers.
- Serve technological functions such as preserving nutrition, meeting special dietary needs, improving sensory properties, or aiding manufacturing processes without concealing defective practices.
- Maximum use levels are set to prevent exceeding ADI, based on scientific evaluations and international standards.
Good Manufacturing Practices (GMP)
- Additive quantity must be the lowest necessary to achieve desired effects.
- Carry-over residues not achieving any technical effect should be minimized.
- Additives must be food-grade quality and handled as food ingredients.
Specifications for Identity and Purity
- Food additives must meet Codex Alimentarius Commission, JECFA, or equivalent international specifications regarding identity and purity.
- Compliance is with overall safety and quality specifications, not just isolated criteria.
Treatment of Mislabeled or Adulterated Food
- Any non-compliance in use of food additives renders the food misbranded or adulterated.
- Violators are subject to sanctions under RA 3720, RA 7394, and related laws following due notice and hearing.
Carry-Over Principle of Food Additives
- Additives may appear in food indirectly via ingredients if:
- The additive is permitted in raw materials.
- The quantities in raw materials do not exceed permitted levels.
- The final food does not exceed allowed additive levels resulting from such carry-over.
Food Category System
- A hierarchical food category system allocates allowable additive uses.
- Permitted additive use in a general category extends to its sub-categories.
- Category descriptors are marketing-based and not for labeling.
- The system considers carry-over additives and does not require explicit mention of compound foods unless unauthorized additives are involved.
Format of Food Additive Listing
- Additives are grouped by major functional classes.
- Each additive’s maximum usage levels and conditions are specified.
Regulation of Flavoring Substances
- Flavoring additives must comply with US FEMA and IOFI regulations.
Review and Revision of Food Additive List
- The Technical Working Group on Food Additives and Contaminants (TWGFAC) regularly reviews and revises the food additive list.
- Amendments only take effect upon BFAD approval.
- Additives and functional classes adopted by Codex Alimentarius Commission are automatically included as addenda.