Top 6 Cosmetic Artwork Regulatory Risks & How to Avoid Them

Top 6 Regulatory Risks in Cosmetic Artwork & How to Mitigate Them

1. Non-Compliant Product Claims

Risk: Misleading or drug-like claims (e.g., “treats acne,” “heals skin,” “permanently stops hair fall”) may:

• Reclassify your product as a drug/therapeutic good

• Trigger regulatory investigations, recalls, or lawsuits

Mitigation:

• Cross-check claims with market-specific regulations

• Involve Regulatory & Legal experts in label approvals

• Train marketing teams on compliant, non-therapeutic language

2. Lack of Claims Substantiation

Risk: Claims like “anti-aging,” “hypoallergenic,” “dermatologist tested” require scientific proof. Without substantiation:

• Products may be deemed deceptive

• Companies face fines, consumer complaints, or brand damage

Mitigation:

• Maintain a claims substantiation file with clinical or lab data

• Ensure evidence is scientifically valid, product-specific, and current

3. Incorrect Ingredient Listing

Risk: Non-compliance with ingredient labeling rules (e.g., INCI names, allergen declarations) can lead to:

• Enforcement actions or product bans in key markets

• Consumer trust issues

Mitigation:

• Use Regulatory databases (e.g., CosIng, PCPC) to validate ingredients

• Leverage Regulatory software for automation and accuracy

• Stay up to date on regional ingredient disclosure requirements (e.g., EU’s allergen expansion)

4. Language & Translation Errors

Risk: Poor translations = unclear usage, regulatory breaches, or safety issues in multilingual markets (e.g., Canada, EU, Japan, Brazil, GCC).

Mitigation:

• Use professional translators with regulatory experience

• Conduct Regulatory review of all translated artwork

• Consider cultural sensitivities and legal nuances in local markets

5. Omission of Mandatory Information

Risk: Missing details like:

• Net content

• Batch/Lot number

• Expiry date

• Responsible Person or distributor info

Can lead to:

• Immediate non-compliance

• Product seizure or recalls

Mitigation:

• Maintain market-specific compliance checklists

• Perform regular internal audits of artwork elements

• Align with Regulatory intelligence updates

6. Failure to Adapt to Regulatory Changes

Risk: Regulations evolve quickly (e.g., EU allergen rule changes, USA MoCRA updates, ASEAN harmonization). Outdated artwork may:

• Prevent market entry

• Incur retroactive penalties

Mitigation:

• Set up a Regulatory monitoring system

• Subscribe to official updates and trade association alerts

• Work with Regulatory partners to track and act on changes globally

Final Takeaway

Navigating cosmetic artwork compliance requires more than regulatory knowledge—it demands proactive processes, cross-functional collaboration, and constant vigilance across multiple jurisdictions.

Your Compliance Strategy Should Include:

• ✅ Pre-market artwork checks by Regulatory experts

• ✅ Real-time tracking of evolving global regulations

• ✅ Automated ingredient and claims validation tools

• ✅ Regular training for marketing, R&D, and packaging teams

• ✅ Strategic support from partners like Freyr for labeling, compliance, and audits