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2 min read
In the competitive world of Cosmetics, product artwork is more than just a creative expression — it is a crucial compliance requirement. Every detail on a Cosmetic label, from ingredient lists to claims, is regulated differently across global markets. Non-compliance can result in product recalls, fines, reputational damage, and market entry delays. Here are the top six Regulatory risks in Cosmetic artwork and practical strategies to mitigate them effectively.
Non-Compliant Product Claims
Making claims that are not compliant with the cosmetic product category, as medical or drug-like claims (e.g., “treats acne” or “heals skin”) or making unrealistic and exaggerated claims (e.g., 100% guaranteed to make you look 10 years younger, Permanently stops hair fall after one use)on cosmetics can lead to regulatory enforcement, product recalls, or legal action, and trigger different product classification. These claims may also mislead consumers and damage brand credibility.
Mitigation Strategy:
Collaborate with Regulatory experts who can cross-check claims against market-specific guidelines. Train marketing teams on compliant language and have legal or regulatory experts review labelling before release.
Lack of relevant claims substantiation
One of the most common pitfalls in Cosmetic artwork is making unsubstantiated claims. Terms like “hypoallergenic,” “anti-aging,” or “dermatologically tested” or Comedogenic require scientific evidence and can be interpreted differently in the EU, US, Asia or GCC. Without appropriate scientific or clinical evidence, claims can be considered deceptive and lead to regulatory penalties, consumer complaints, or reputational harm.
Mitigation Strategy:
Conduct a thorough claims substantiation process and ensure that valid scientific evidence supports all claims. Maintain proper documentation and ensure the evidence is relevant to the specific claim and product formulation.
Incorrect Ingredient Listing
Different regions have specific requirements for ingredient nomenclature, listing order, and allergens disclosure, among others. For instance, the EU mandates using INCI (International Nomenclature of Cosmetic Ingredients) names and requires 26 (and soon, 82!) allergens to be highlighted if present above certain thresholds. While allergen listing is not explicitly mandated in some ASEAN countries, such as Singapore and Malaysia, allergens are generally covered under the term "fragrance”.
Mitigation Strategy:
Ensure your ingredient list is updated and verified against the latest Regulatory databases for each market of interest. Automating ingredient checks using Regulatory software can minimize errors and speed up compliance reviews.
Language and Translation Errors
Cosmetic products sold in multilingual markets like Canada, Thailand, Japan, Mexico, Brazil, GCC or the EU require artwork in multiple languages. Poor translations can lead to misinterpretation, non-compliance, or even safety risks if unclear usage instructions are used.
Mitigation Strategy:
Work with professional translators familiar with Cosmetic regulations and ensure every translation undergoes a Regulatory review. Regulatory experts can validate translations for linguistic accuracy, cultural relevance, and legal compliance.
Omission of Mandatory Information
Markets often mandate the inclusion of critical details such as net quantity, batch number, expiry date, and the Responsible Person’s name and address. Missing any of the required elements can result in Regulatory action.
Mitigation Strategy:
Develop a standardized checklist based on market-specific regulations to ensure all required elements are included. Regular audits of artwork against updated checklists help maintain compliance over time.
Failure to Adapt to Regulatory Changes
Regulatory requirements are constantly evolving. Compliant artwork today may not meet new requirements tomorrow, such as updated allergen disclosure rules in the EU, USA, or any new labeling requirements in Asia.
Mitigation Strategy:
Implement a robust Regulatory monitoring process to stay ahead of changes. Partnering with Regulatory experts ensures your team is always informed and your artwork remains compliant globally.
Navigating cosmetic artwork compliance across diverse and evolving Regulatory environments is complex but essential for global success. By proactively addressing these risks, cosmetic brands can protect their reputation and streamline market entry.
Partner with a Regulatory expert like Freyr to safeguard your cosmetic artwork compliance and stay ahead of global regulations.
