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Common cosmetic compliance gaps and how to avoid them
Staying compliant is not just a legal necessity but also a safeguard for company credibility and consumer trust. Failing to meet Regulation (EC) No 1223/2009 can lead to product recalls, legal penalties, and reputational damage. Here are some of the most common compliance gaps and how to avoid them.
Lack of a properly documented PIF
A Product Information File (PIF) is a critical regulatory requirement in the European Union (EU). Every cosmetic product placed on the EU market must have a PIF and it must contain comprehensive details about the product, including formulation, labelling, manufacturing and safety data.
Moreover, the PIF must be readily accessible to competent authorities and must be kept for a period of 10 years after the last batch of the cosmetic product was placed on the market.
It is thus important to:
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Ensure that each product has a PIF compiled before it reaches the market;
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Ensure all required information is included;
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Keep the PIF updated with any formulation or regulatory changes and accessible to the authorities.
Non-compliant formulation
Cosmetic formulations must comply with regulatory requirements regarding ingredient safety and concentration limits. Some ingredients are banned or restricted in certain markets, and exceeding allowable limits or using ingredients that have been prohibited is a serious compliance issue.
It is thus important to:
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Carefully assess formulations;
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Regularly review and comply with the ingredient restrictions in target markets;
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Use an ingredient screening tool or database to verify formulation compliance.
Incorrect labelling
Labelling errors are also a common compliance issue, often including incorrect ingredient lists and non-compliant claims.
Before placing a cosmetic product into the market, it is important to:
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Verify all labelling requirements and ensure that all necessary information, such as the ingredient list and responsible person details, is included;
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Ensure mandatory details are clear and compliant with language requirements in each market.
Unsubstantiated claims
Cosmetic claims are also closely regulated and monitored in the EU through Regulation (EU) No 655/2013. Terms such as “hypoallergenic” or "dermatologist tested" must be supported by scientific evidence.
To avoid compliance issues regarding cosmetic claims:
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Ensure all claims are backed by scientific data or appropriate testing;
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Avoid vague or absolute terms without proof.
Achieving cosmetic compliance requires attention to detail and adherence to regulatory requirements. By proactively addressing these common mistakes—ensuring a well-documented PIF, using compliant formulations, properly labelling products and substantiating claims, you can mitigate risks and establish consumer trust. Investing in compliance not only prevents legal issues but also strengthens your company credibility in the competitive cosmetics market.