Cosmetic Regulations

We offer comprehensive support to ensure your products meet all EU Regulation 1223/2009 requirements. This includes:

• Conducting a Cosmetic Product Safety Report (CPSR) to guarantee that your product is safe for consumers.
• Creating and maintaining your Product Information File (PIF), which is a mandatory dossier containing all regulatory documentation.
• Managing Label and Claims Reviews to ensure your packaging complies with the EU’s strict standards.
• Submitting product notifications to the Cosmetic Products Notification Portal (CPNP) and acting as your Responsible Person in the EU, ensuring your products are legally placed on the market.

Our team of regulatory experts, toxicologists, and chemists will manage the entire process, giving you peace of mind that your products are fully compliant.

Yes, the UK Cosmetics Regulation requires separate compliance, and Biorius can handle this for you. Our services include:

• Updating your PIF and submitting product notifications through the UK SCPN Portal.
• Appointing a UK Responsible Person to handle all compliance issues and represent your brand in the UK.
• Ensuring your labels meet the requirements specific to both the EU and UK markets.

With offices in both the EU and UK, we simplify the process by providing full compliance services for both regions.

In the US, we help you navigate the Federal Food, Drug, and Cosmetic Act and the newly introduced Modernization of Cosmetic Regulation Act (MoCRA). Our services include:

• Reviewing your product formulas, labels, and marketing claims to ensure compliance with federal and state laws.
• Offering optional Voluntary Cosmetic Registration Program (VCRP) assistance to make future inspections smoother.
• Helping brands comply with California-specific laws like Proposition 65 and the California Safe Cosmetics Program, which are among the most stringent in the US.

Canada regulates cosmetics under the Food and Drugs Act and the Cosmetic Regulations. The regulatory framework is overseen by Health Canada, which ensures that all cosmetic products sold in the country are safe and properly labeled. Key aspects include:

• Cosmetic Ingredient Review: Similar to the EU, Canada has a list of restricted and prohibited ingredients that must be adhered to. Biorius helps by reviewing your formulations to ensure they meet Canada’s safety requirements.
• Notification of Cosmetics: All cosmetic products sold in Canada must be notified to Health Canada via a Cosmetic Notification Form (CNF) within 10 days of being sold. This process confirms that the product meets the standards set by Health Canada.
• Labeling Requirements: Canadian cosmetics must comply with specific labeling regulations, including bilingual labeling (English and French), ingredient lists using the INCI nomenclature, and ensuring that all health and safety warnings are properly included on the packaging. We help ensure that your labels are fully compliant with these standards.
• Restricted Substances: Canada has a Hotlist, which is a list of ingredients that are restricted or banned in cosmetics. Biorius conducts an in-depth ingredient review to ensure your formulations do not contain any prohibited substances.

Our Formula Review Service ensures that your product formulation complies with local and international regulations, including restrictions on ingredients and their usage levels. The process involves:

• Toxicological assessments to confirm that each ingredient is safe at the concentration used.
• Verifying that your formulation doesn’t contain any prohibited substances or ingredients that exceed maximum allowed concentrations.
• Ensuring compliance with additional regulations such as the REACH Regulation in Europe and the FDA rules in the USA.

A Free Sales Certificate (FSC) is often required when exporting cosmetics to certain countries. It confirms that your product is legally sold in its home market. Biorius can obtain an FSC for you, ensuring smooth export processes and legal compliance in your target markets.

Biorius offers a comprehensive review of every ingredient in your formulation. This includes:

• Safety evaluations, ensuring that each ingredient is safe for use in the intended quantities.
• Regulatory checks against international regulatory databases, ensuring compliance with market-specific regulations such as the EU’s Regulation 1223/2009, Canada’s Hotlist, and the US FDA’s regulations.
• Toxicological assessment to identify potential health risks, such as skin irritation or sensitization, as well as long-term effects like carcinogenicity or reproductive toxicity.
• Trace impurities analysis to ensure that the final product does not contain any unwanted contaminants.