Cosmetic Laws and Regulations
The regulatory requirements for placing cosmetics on the market in the EU, UK, US and Canada
Placing a cosmetic product on the market involves more than just a great concept, great formula or catchy headlines, it requires understanding the different cosmetic regulations for each market. Whether you’re launching in the UK, EU, USA, or Canada, this article outlines the key requirements to help ensure your product is compliant and ready for sale.
1. Does Your Product Fit the Definition of Cosmetic?
Before anything else, it’s crucial to ensure your product falls within the scope of the definition for a cosmetic product in the applicable markets. It is important not to misclassify your product, especially if you are marketing a product as a cosmetic that should be regulated as a medicine/drug.
2. Formula Compliance
To avoid setbacks, make sure your formulation adheres to the relevant regulations:
UK/EU: Ensure compliance to the UK/EU Cosmetic Regulation Annexes:
Annex II & III: List prohibited and restricted substances.
Annex IV, V, VI: Contain approved colourants, preservatives, and UV filters.
Canada: Ensure compliance with Health Canada’s Cosmetic Ingredient Hotlist, which outlines prohibited and restricted ingredients.
USA: Ensure compliance with Food and Drug Administration (FDA) prohibited ingredients and permitted colourants. Additionally, many individual states have restrictions and prohibition requirements for individual substances. It is also important if using ingredients listed on any OTC monograph to ensure that you have correctly classified your product as a cosmetic.
3. Responsible Person (RP)
In some markets, every cosmetic product must have a designated Responsible Person (RP), whose role is to ensure regulatory compliance.
UK and EU: The RP must be based in the UK and EU respectively, and their details must appear on the packaging. They must have access to the Product Information File (PIF) for the product.
USA: An RP may be located in the US or overseas. However, if using a foreign address on packaging, you must include a local contact or an email or website for adverse event reporting.
Canada: The RP does not need to be in Canada.
For more information on UK/EU Responsible Person, check out our article: Responsible Person Option Strategies.
4. Product Information File (PIF)
In the UK and EU, the RP must maintain a Product Information File (PIF) for each cosmetic product, available for inspection by the authorities. The PIF should include the product description, CPSR (see below), GMP-compliant manufacturing methods, evidence of claimed effects, and details of any animal testing.
A specific PIF is not required for the US and Canada.
5. Cosmetic Product Safety Report (CPSR)
Before placing a product on the UK/EU market, it must undergo a safety assessment by a qualified professional (usually a toxicologist). This report considers things like ingredient safety, product exposure, warnings and precautions for use. The full safety report must be included in the PIF.
In the US, under MoCRA, products must have “adequate substantiation” of safety. The RP must maintain supporting documentation to demonstrate that the product is safe under labelled or customary use. Many companies are currently using their UK/EU CPSR as evidence of how they meet this requirement.
In Canada, products must also be safe to be placed on the market and a valid CPSR can help provide due diligence proof that this is the case.
6. Labelling and Advertising
Labelling must be clear, legible, and indelible, and must include all mandatory requirements outlined in the relevant Cosmetic Regulations. Labelling requirements will vary depending on the market but will apply to both the primary and secondary packaging and include aspects such as contact details, ingredient listing, warnings and weight/volume indication.
All claims must be substantiated, true and honest. It is important to be cautious when using borderline medical claims to avoid your product being classified as a medicine based on the presentation of the product.
Check out our article on: Navigating cosmetic and medicinal borderlines in the EU and UK
Before placing a product on the market, the RP must notify the relevant authority:
EU: Submit via the Cosmetic Product Notification Portal
UK: Use the Submit Cosmetic Product Notification portal
Canada: Complete the Cosmetic Notification Form through Health Canada
USA: Submit via the Cosmetics Direct portal (please note facility registration with the FDA is also required for manufacturers).
At Bloom, we can support you at every stage of your cosmetics compliance journey and, whether taking our full compliance journey package or a tailored approach, our services are designed to meet your specific needs. If you require any support to ensure product compliance in any of these markets, please contact us and we will be happy to help!
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