Cosmetic Label Compliance

Cosmetic product definitions and labeling regulations vary across countries, making compliance a critical aspect of international distribution. What meets regulatory requirements in one market may not be accepted in another.

At Nexreg, we provide expert cosmetic regulatory compliance services, ensuring that your products adhere to the necessary regulations for shipping and sale in your target market.

To support businesses in navigating these requirements, we have compiled a detailed breakdown of cosmetic labeling regulations for the most frequently requested countries.

If the country you are interested in is not listed, or if you require further guidance, our regulatory compliance experts are available to assist you. Contact Nexreg today to ensure your products meet all necessary compliance standards.

US Cosmetics Regulations Canada Cosmetics Regulations EU Cosmetics Regulations

The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body or any part thereof, for cleansing, beautifying, promoting attractiveness or altering appearance.”

A cosmetic is a product that is intended to create a physical effect on the human body, not a physiological effect, like a drug.

Why the service is needed?

Cosmetic products are required to be correctly labelled before being placed on the market. The cosmetic labeling review service will ensure that your label is compliant with region-specific regulations regarding the ingredients list, and any necessary warnings or precautions that may be required. We currently offer services for the US, EU, and Canada cosmetic label reviews.

All cosmetic companies are required to market safe, and properly labeled products, without the use of prohibited ingredients. It is considered good practice to follow all industry safety recommendations and guidelines. The US regulations do not specify a certain type of Safety Assessment testing for cosmetic products or ingredients; however, it is the company’s responsibility to ensure that the product and its ingredients are safe prior to being sold on the market.

What is the service we provide?

Any new cosmetic products in the United States do not legally have to be reported to the FDA but companies are encouraged to report product formulations through the Voluntary Cosmetic Registration Program (VCRP).

Nexreg will check all ingredients for safety against the required lists (ex: Ingredients Prohibited & Restricted, Color Additives, Prop 65, EPA, etc.) and determine the order of ingredients for declaration on the label. Ingredients should be listed by their INCI name, unless otherwise specified.

Note: According to the FDA Labeling Requirements for Cosmetics- The FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are appropriate to substantiate the safety of their cosmetics.

Nexreg can provide the information for vendors that will be able to complete the Safety Assessment Testing. Based on the testing results, and upon determining if any safety warnings will apply to the product; then Nexreg will select the appropriate label warning template for the cosmetic product.

Once the label artwork has been completed by the manufacturer or distributor, Nexreg can compare this to the cosmetic label review report. The label artwork will be checked to ensure that all necessary label elements and information are present, and the statements follow the proper sizing requirements.

Cosmetics sold in Canada must meet the requirements of the Cosmetic Regulations and the Food and Drugs Act. The Food and Drugs Act defines cosmetics as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.”

The regulations state that a cosmetic that is sold in Canada must be manufactured, prepared, preserved, packed, and stored within sanitary conditions. The manufacturer and importer must notify Health Canada that it will be selling the product and provide a list of ingredients through the Health Canada Cosmetic Notification Form.

Why the service is needed?

All cosmetic companies are required to market safe, and properly labeled products, without the use of prohibited ingredients. It is considered good practice to follow all industry safety recommendations and guidelines. The Canadian regulations state that all products must be submitted through the online Cosmetic Notification form within 10 days after you first sell your cosmetic product in Canada.

What is the service we provide?

Nexreg will check that all ingredients are listed on the Cosmetic Notification form and if any ingredients are found on the Cosmetic Ingredient Hotlist. Ingredients can be searched using the CAS# or INCI names. Note that some INCI names can be listed under an alternative name. If any ingredient(s) are found on the Hotlist, then the restriction or prohibition for the ingredient(s) will be identified.

Upon determining if any precautions or warnings are required to be listed, Nexreg will then select the appropriate label warning template for the cosmetic product. The ingredients on the label should be listed from highest % to lowest % in the product. Note that based on the regulations, some names must be listed either as their ‘EU trivial name’ or ‘English/French equivalent name.’

Nexreg will provide you with a list of information needed that is required to properly complete the Cosmetic Notification form. Once received, we will fill in the sections of the form with this information. All sections must be properly completed prior to submitting the form to Health Canada for approval. Nexreg will submit the Notification form on your behalf and provide a link to the completed form with instructions on any next steps, if needed.

The EU Cosmetics Safety Regulations (EC) No 1223/2009 for cosmetic products ensures that there is a high level of standard for products being placed on the EU market. Manufacturers and distributors are responsible for following the requirements to ensure these products being used by the consumers will meet the safety standards.

Cosmetic products being placed on the market in the EU/UK require a legal or natural person that is designated within the EU or UK to act as the ‘Responsible Person’ (RP). This person will act as the representative for the product to ensure it follows all regulations and is marketed for safe use.

Why the service is needed?

Cosmetic labeling is an important aspect in the marketing of the products. The purpose is to provide consumers with the necessary information about the product they will be using which includes the ingredients, usage directions, warning text & precautionary statements (if applicable), manufacturing details, etc. Each region has its own cosmetics labeling regulations and requirements, so it is important that your product will be compliant.

All cosmetic companies are required to market safe, and properly labeled products, without the use of prohibited ingredients. It is considered good practice to follow all industry safety recommendations and guidelines. The EU regulations state that an appointed Responsible Person (RP) will need to guarantee the safety of the cosmetic product, ensure the quality of the manufacturing process, confirm the compliance of the cosmetic label and packaging, and other obligations.

What is the service we provide?

Prior to placing the product on the market, the Responsible Person will need to submit the product information through the Cosmetic Product Notification Portal (CPNP). Nexreg can provide the information for vendors that will be able to act as the Responsible Person in the EU/UK for your product.

Nexreg will check all ingredients against the required lists (ex: Annexes II-VI, etc.) using the CAS# or INCI names, and determine the order of ingredients for declaration on the label. If any ingredients are found on the Annexes, then the restrictions, conditions, or prohibitions for these ingredient(s) will be identified.

Upon determining if any precautions or warnings are required to be listed for the product, Nexreg will then select the appropriate label warning template for the cosmetic product. The ingredients on the label must be listed in order of decreasing weight for those ≥ 1%. Ingredients < 1% do not need to be listed in order. Once the label artwork has been completed by the manufacturer or distributor, Nexreg can compare this to the cosmetic label review report. The label artwork will be checked to ensure that all necessary label elements and information are present, and the statements follow the proper sizing requirements.

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I am very satisfied with the work provided by Nexreg. The work has been through, timely and reasonable. Additionally, both Mike Harvey and Nazifa Beganovic are very knowledgeable. Mike and Nazifa’s efforts have been an essential part of getting our MSDS program on track and positioned for the Global Harmonized System.

Jack CoverBonsal American, Inc.

We’re often asked by our clients to meet next-to-impossible deadlines, which means that we’re often forced to ask our vendors for the impossible. Working with Nexreg makes my job easier. They are experts at what they do, they pay attention to detail, and they make suggestions and offer advice – which makes us look like the experts. For regulatory compliance and translations, Nexreg ranks as one of the strategic partners we can always count on.

John S. WolowiecZoltun Design