Regulatory Status & Safety Framework
Comprehensive regulatory approval and safety framework for cacao mucilage products worldwide
Category Safety Established
The cacao mucilage category has established safety precedent through multiple regulatory reviews globally, including FDA GRAS Notice 947 (2020).
Global Regulatory Recognition
United States
FDA reviewed cacao pulp, juice, and concentrate under GRAS Notice GRN-947 (2020), issuing a "no questions" letter establishing safety for food use.[1]
Maximum use levels: 20-65% depending on application
European Union
EFSA recognized Theobroma cacao L. pulp as a traditional food (2019), confirming history of safe use.[3]
Listed on EU authorized novel foods register
Brazil
Cacao pulp defined and regulated under Normative Instruction No. 01 (2000) with established quality standards.[2]
Minimum Brix: 14.0 for reconstituted juice
International Standards
Codex Alimentarius includes specifications for Theobroma cacao L. in fruit juice standards (CODEX STAN 247-2005).[4]
Minimum 50% juice content for nectars
Safety Assessment Framework
The FDA GRAS assessment evaluated cacao mucilage across multiple safety parameters:
- ✓Compositional analysis of macronutrients and micronutrients
- ✓Toxicological evaluation of methylxanthines (theobromine, caffeine)
- ✓Microbiological safety and stability studies
- ✓Estimated daily intake modeling across populations
- ✓Expert panel consensus on safety determination
Quality Standards
| Parameter | Specification | Reference |
|---|---|---|
| pH Range | 3.0 - 4.0 | GRAS Notice 947 |
| Minimum Brix | 14.0° | CODEX STAN 247 |
| Microbial Standards | <10 CFU/g yeast/mold | Industry Standard |
| Heavy Metals | Below detection limits | FDA/EU Standards |
Important Note
This page provides educational information about the regulatory status of the cacao mucilage category. Individual products should be evaluated based on their specific formulation and manufacturing processes. Always consult current regulations in your jurisdiction.