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Food additives play crucial roles in food preservation, texture enhancement, and flavor improvement. But how does a substance like Potassium Bitartrate (CAS 868-14-4) become an approved food additive? Here’s a breakdown of the regulatory journey.
Region | Regulatory Authority | Key Standards |
---|---|---|
USA | FDA (Food & Drug Administration) | 21 CFR Part 172 |
EU | EFSA (European Food Safety Authority) | Regulation (EC) No 1333/2008 |
China | NHC (National Health Commission) | GB 2760 Standards |
Japan | MHLW (Ministry of Health, Labour and Welfare) | Food Sanitation Act |
Requirement | Description | Example (Potassium Bitartrate) |
---|---|---|
Safety Assessment | Toxicity studies, ADI* determination | Low toxicity, ADI "not specified" (JECFA) |
Functional Need | Purpose in food (e.g., stabilizer, leavening agent) | Acidity regulator, emulsifier in baked goods |
Technical Justification | Proof of effectiveness at intended use levels | Effective in stabilizing whipped creams |
Purity Specifications | Impurity limits, manufacturing process controls | ≥99% purity, heavy metals <3 ppm |
*ADI = Acceptable Daily Intake
Stage | Duration (Avg.) | Key Actions |
---|---|---|
Pre-submission Research | 1–3 years | Toxicology studies, efficacy trials |
Regulatory Submission | 6–18 months | Dossier preparation, agency review |
Public Consultation | 3–6 months | Stakeholder feedback, revisions |
Final Authorization | 3–12 months | Inclusion in permitted additives list |
Additive Function | Example Substances | Typical Applications |
---|---|---|
Preservatives | Sorbic acid, Potassium Bitartrate | Wine, baked goods, dairy |
Emulsifiers | Lecithin, Mono- and diglycerides | Ice cream, chocolate |
Antioxidants | Ascorbic acid, Tocopherols | Oils, processed meats |
Acidity Regulators | Citric acid, Potassium Bitartrate | Beverages, jellies |
This natural salt, derived from winemaking byproducts, gained approval as:
Its approval relied on:
Becoming a food additive requires rigorous safety proofs, functional validation, and compliance with regional regulations. Substances like Potassium Bitartrate exemplify how scientific and regulatory scrutiny ensures consumer safety while meeting industry needs.
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