Comparing cosmetic regulations in the US and EU quickly reveals just how different the two really are. Have you ever wondered why certain ingredients banned in the EU are perfectly fine to use in the US? Or why product labeling requirements seem far more complex across the Atlantic?

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In the US, the FDA only bans or restricts around 11 ingredients in cosmetics, while the EU has prohibited over 1300. The result? Cosmetic products formulated for the European market often look quite different from their American counterparts, not just in terms of ingredients but also in how they're labeled and marketed.

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Whether you're developing a product for one or both markets, understanding these differences between US and EU cosmetic regulations is crucial to ensuring regulatory compliance and avoiding costly mistakes. 

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Let’s break down the key distinctions that could make or break your product’s launch.

Differences between US and EU cosmetic regulations

1. Ingredient listing order

• EU: Ingredients must be listed in descending order of concentration, with any ingredient under 1% allowed to be listed in any order at the end of the list. Additionally, colorants can be listed at the end of the ingredients, regardless of concentration.
• US: Similar to the EU, the US cosmetic regulations require ingredients to be listed in descending order of concentration. However, there’s no flexibility for ingredients under 1% to be listed out of order unless specifically approved by the FDA.

2. Allergen labeling

• EU: The EU cosmetic regulations mandate that 26 specific fragrance allergens (commonly found in perfumes and essential oils) must be listed on the cosmetic product label if present above certain thresholds.
• US: The US allows companies to list "fragrance" or "flavor" as a generic term without identifying specific ingredients, which may include potential allergens.

3. Product expiry and shelf life

• EU: The EU mandates that cosmetic products must include a "period after opening" symbol if the product's shelf life exceeds 30 months, indicating how long the product can be used after being opened. Otherwise, an expiration date is required.

• US: In the US, cosmetics are not required to carry expiration dates or PAO symbols, except for products that make drug claims (like SPF). Manufacturers can choose to include this information, but it's not legally mandated.

4. Language requirements

• EU: Cosmetic labels in the EU must be in the official language(s) of the country where the product is being sold. This includes all required information, such as ingredient lists and safety warnings.
• US: In the US, cosmetic labeling must be in English, unless the product is sold in Puerto Rico, where Spanish must be included. This can create language barriers for non-English speakers.

5. Responsible person information

• EU: The EU cosmetics regulation requires the name and address of the "Responsible Person" (the individual or company responsible for product safety and compliance) to be listed on the label.
• US: In the US, cosmetic labels must include the name and address of the manufacturer, distributor, or packer, but there’s no legal obligation to name a "Responsible Person" as in the EU system.

6. Country of origin

• EU: The EU requires that the product's country of origin be listed on the label if it’s manufactured outside of the EU. This provides clarity for consumers regarding where the product was made.
• US: In the US, there is no mandatory requirement to declare the country of origin on cosmetic labels unless the product is imported. However, the product’s label must comply with the Federal Trade Commission’s (FTC) "Made in USA" guidelines if it claims to be manufactured in the US.

7. Batch number

• EU: The EU cosmetics regulation requires all cosmetic products to display a batch number or lot code on the label, which helps with product traceability in case of recalls or safety issues.
• US: In the US, there is no legal requirement for a batch number on cosmetic products, although many companies include it voluntarily for traceability and internal tracking purposes.

8. Good Manufacturing Practices (GMP)

• EU: Cosmetic products sold in the EU must be manufactured following Good Manufacturing Practices (GMP), ensuring consistent quality and safety throughout production.
• US: In the US, GMP guidelines exist, but adherence is voluntary. This can lead to variations in product quality if standards are not rigorously followed.

9. Packaging symbols

• EU: The EU uses several standardized packaging symbols, such as the "e-mark" (which indicates volume or weight accuracy), the "period after opening" symbol, and recycling symbols, all of which must appear on the label where relevant.
• US: In the US, these symbols are not mandatory. Some packaging may include voluntary symbols like the "leaping bunny" for cruelty-free certification, but these are not regulated or required by law.

10. Warning labels and precautionary statements

• EU: The EU cosmetic regulations require that specific warnings or precautionary statements be listed on the label for cosmetic products that pose any risk, such as hair dyes or products containing certain chemicals. These warnings must be visible and clear.
• US: In the US, precautionary statements are only required if the product contains a known hazardous ingredient. This generally applies to products regulated as drugs (e.g., sunscreen) or products like hair dyes, but the requirements are less extensive than in the EU.

11. Claims substantiation

• EU: In the EU, any claims of cosmetic products, such as "anti-aging" or "skin firming," must be substantiated with evidence. Authorities may request proof to verify the legitimacy of the claims.
• US: In the US, while claims must not be misleading, the FDA is less likely to intervene unless the claim causes a public health risk. However, the Federal Trade Commission (FTC) regulates false advertising, and companies may face penalties if claims are proven misleading.

12. Animal testing regulations

• EU: The EU has banned animal testing for cosmetics, and no cosmetic product that has been tested on animals after 2013 can be sold in the EU. Additionally, the use of animal-tested ingredients is prohibited.
• US: In the US, there is no federal ban on animal testing for cosmetics. While many brands voluntarily avoid animal testing, it remains legal, and products tested on animals can still be sold without restriction.

13. Natural or organic claims

• EU: The EU tightly regulates marketing claims made on cosmetic packaging. Terms like "organic" or "natural" are strictly defined, and brands must provide proof for any claims made.
• US: In the US, marketing claims are more loosely regulated. While the FDA monitors "misleading" claims, terms like "organic" and "natural" do not have standardized definitions, allowing brands more flexibility in their marketing.

14. Nanomaterial labeling

• EU: In the EU, any cosmetic product containing nanomaterials must clearly label them in the ingredient list, with the word "nano" in parentheses next to the ingredient (e.g., titanium dioxide [nano]).

• US: In the US, there is no mandatory labeling requirement for nanomaterials. However, the FDA encourages companies to consider labeling if they believe it’s necessary for consumer safety.

‍15. Sunscreen products

• EU: In the EU, sunscreens are classified as cosmetics, and their labeling must meet specific requirements, including UVA and UVB protection indicators. The SPF labeling must adhere to EU guidelines.
• US: In the US, sunscreens are regulated as over-the-counter (OTC) drugs by the FDA. This means they must comply with drug labeling regulations, including Drug Facts panels, dosage instructions, and active ingredient listings.

16. Cosmetic vs. drug labeling

• EU: The EU cosmetic regulations strictly distinguish between cosmetics and drugs, with different labeling requirements for each. Cosmetics cannot make medicinal claims (e.g., "treats eczema") unless classified as a drug or therapeutic product.

• US: In the US, products that make both cosmetic and drug claims (e.g., acne treatments) must comply with drug labeling laws, including detailed information on active ingredients, warnings, and instructions for use. The FDA closely monitors such products to ensure compliance.

17. Environmental claims

• EU: The EU cosmetic regulation requires that any environmental claims (e.g., "biodegradable," "eco-friendly") be substantiated and non-misleading. Products making green claims must provide proof that their product has a reduced environmental impact.
• US: The US FTC oversees environmental marketing claims. While the FTC provides guidelines (known as "Green Guides"), the regulations are less strict compared to the EU, leading to varying interpretations of terms like "eco-friendly" or "sustainable".

18. Cosmetic notification portal

• EU: Before being sold in the EU, cosmetic products must be notified through the EU Cosmetic Products Notification Portal (CPNP). This includes uploading all relevant product information, including labeling details, to ensure compliance.
• US: The US has no equivalent notification system for cosmetics. Manufacturers are not required to notify the FDA about new products or upload detailed product information, except for products classified as drugs.

19. Pre-market approval

• EU: In the EU, every cosmetic product must be reviewed for safety before it can hit the shelves. This involves a strict assessment by a designated safety assessor who ensures that the product complies with EU regulations.
• US: The US does not require pre-market approval for most cosmetics, aside from color additives. While the FDA monitors products for safety, the responsibility lies heavily on the manufacturers to ensure compliance before selling their products.

20. Cosmetic product labeling

• EU: The EU cosmetic regulation mandates that product labels must include a full list of ingredients, an expiration date or a "period after opening" symbol, and information about any allergens present in the product.
• US: In the US, cosmetic labels must list ingredients in descending order of concentration, but there is no requirement to list allergens or expiration dates unless the product makes drug claims (like anti-aging or SPF).

Meet US and EU cosmetic regulations with AI-led label compliance

Meeting cosmetic regulations for a single region can be challenging, let alone across multiple regions. Keeping up with the EU, US, or even Canada can be tricky when each region has its own nuances for cosmetic labeling. Artwork Flow’s ComplyAI helps automate label compliance, so you don’t miss out on any critical details or risk going to market with error-prone labels. 

Here’s how it works:

• Create rulebooks for each region with multiple rulesets, whether it’s for ingredients, allergens, text size, and more.
• Once your rulebook is set, run compliance checks for all rulesets in one go.
• ComplyAI will quickly flag any errors or discrepancies in the label.
• Easily make corrections and ensure your final label is error-free and 100% compliant with cosmetic regulations.

Curious to see it in action? Book a demo with us today!