Navigating Cosmetic New Ingredient Registration: Key Considerations for Scenario 5 - "History of Safe Use in Food"

In the journey of cosmetic new ingredient registration and filing, Scenario 5—demonstrating a history of safe use in food—offers applicants a potential "fast track." However, while this pathway appears straightforward, it is laden with nuanced requirements and hidden challenges. This article provides an in-depth analysis of Scenario 5’s definition, common rejection reasons, and actionable guidance based on the latest official regulations.

I. Core Interpretation of Scenario 5: Bridging "Safe to Eat" and "Safe to Apply"

What is Scenario 5?
Per Annex 3 of the Regulations on the Management of Cosmetic New Ingredient Registration and Filing Documentation, cosmetic new ingredients are categorized into six scenarios. Scenario 5 refers to "cosmetic new ingredients with a history of safe use in food (the used part of the ingredient must match the edible part)."

Key Requirements (as clarified in the Guidelines for Research and Determination of Safe Food Use History for Cosmetic New Ingredients (Trial) issued by NIFDC on June 24, 2025):

• The ingredient must have authoritative, scientific, and complete evidence of safe food use.

• The cosmetic ingredient must demonstrate consistency or relevance with the food ingredient in terms of source, production process, and safety indicators.

• The dietary habits, consumption limits, and exposure levels of the food ingredient must be considered.

Critical Analysis:

1. "Food Use History" as the Foundation

• Evidence must be detailed, substantiated, and credible, sourced from regulatory bodies or authoritative institutions (e.g., conventional foods, regional food ingredients, novel foods, health food ingredients, GRAS, WHO food additive databases).

2. Scientific "Transfer" of Safety

• Safety assessments must bridge food and cosmetic use, accounting for dermal irritation, eye irritation, and sensitization risks.

• Exposure comparison: Is the dermal absorption rate significantly lower than the safe oral dose? Are additional toxicity studies needed?

II. Common Rejection Reasons: Pitfalls in Scenario 5 Applications

Failures to meet the above requirements often lead to rejections. Typical issues include:

1. Insufficient Evidence of Food Use History

• Lack of authoritative sources or incomplete data.

2. Weak Safety "Transfer" Argument

• Inadequate justification for extrapolating oral safety to topical use.

3. Unclear Ingredient Definition or Source

• Mismatch between the cosmetic ingredient and its food counterpart (e.g., extraction method, plant part used).

III. Accepted Evidence for Safe Food Use History

• Regulatory approvals: Novel food certifications, health food registrations.

• Scientific literature: Peer-reviewed studies on toxicity and consumption patterns.

• Traditional use: Documentation of long-term dietary use in specific populations.

Conclusion

Scenario 5 opens a streamlined pathway for ingredients with robust "food-safe" credentials, but it is not a free pass. Success hinges on:

1. Ironclad food-use evidence as the starting point.

2. Scientific bridging of oral-to-topical safety.

3. Cosmetic-specific assessments (e.g., local toxicity, quality control).

For companies, Scenario 5 remains a cost-effective route, but meticulous attention to detail is paramount. ZOOP’s regulatory team offers end-to-end support, from evidence compilation to dossier submission, ensuring compliance at every step.

ZOOP’s New Ingredient Services

✅ Safety risk monitoring & evaluation system setup
✅ R&D report preparation
✅ Manufacturing process & quality standard guidance
✅ Toxicology & efficacy data compilation
✅ Full-cycle registration/filing agency