5 Key Cosmetic Ingredient Compliance Checks Before Product Launch

Cosmetic ingredient compliance requirements can vary significantly across global markets. An accepted ingredient in one market may be restricted or banned in another. Furthermore, there may be variances in allowable concentration levels and formats of safety data.  

Before finalizing formulations and artwork, cosmetic companies must evaluate the following ingredient compliance checks:  

1. Check Prohibited and Restricted Ingredients

The first step is to check if every ingredient in the formulation is allowed in the target market and whether there are any conditions that apply to its use. Cosmetic ingredient regulations vary across countries, making it essential for manufacturers to assess cosmetic ingredient compliance against the applicable regulatory requirements. 

In the European Union, Regulation (EC) No 1223/2009 bans substances listed in Annex II. Substances listed in Annex III may only be used under restrictions, such as limits on concentration, certain product types, or required labeling warnings. Other rules apply to permitted colorants, preservatives, and UV filters under Annex IV, V, and VI. 

Health Canada’s Cosmetic Ingredient Hotlist also shows substances that are prohibited or restricted in cosmetics. Restrictions can include limits on concentration, allowed product types, conditions of use, and required cautionary statements. 

Under the ASEAN Cosmetic Directive (ACD), cosmetic ingredients are regulated through the ASEAN Cosmetic Ingredient Listings. Substances listed in Annex II are prohibited from use in cosmetic products, while substances listed in Annex III may be used only under specified restrictions, such as concentration limits, permitted product types, conditions of use, and mandatory warning statements on labeling. Additional requirements apply to approved colorants, preservatives, and UV filters, which are regulated under Annexes IV, VI, and VII, respectively. Compliance with these annexes must be demonstrated to support the safe marketing of cosmetic products within ASEAN member states. Similarly, India follows BIS standards, while countries such as Colombia, Brazil, and others have their own cosmetic product regulations and compliance requirements. 

For manufacturers, the key is to review each ingredient’s concentration, the product type, and the intended use of the ingredient. 

2. Confirm Ingredient Nomenclature and Label Declaration Requirements

In Canada, cosmetic labels must list ingredients using the International Nomenclature for Cosmetic Ingredients. This means every ingredient must be named in a way that consumers can understand what they are using. For certain ingredients listed in the Schedule to the Cosmetic Regulations, the prescribed trivial name should be used. Health Canada also specifies that labels must include warnings or cautions when needed.  

In the United States, the FDA requires ingredients to be declared using their International Nomenclature for Cosmetic Ingredients, generally in descending order of predominance.  

Manufacturers should always check the accepted ingredient names, the order in which ingredients are listed, and cosmetic ingredient labeling requirements for the market they are selling in and should not simply copy ingredient lists from another country. 

3. Review Allergens, Impurities and Contaminants

The EU has expanded mandatory fragrance allergen labeling rules with Regulation (EU) 2023/1545. Fragrance allergens must appear on the ingredient lists when their concentration is above 0.001 % in leave‑on products or 0.01 % in rinse‑off products under Annex III. 

These rules help consumers who're sensitive to fragrance allergens to find and avoid products that contain those substances. 

Health Canada has issued guidance on heavy-metal impurities in cosmetics and sets limits, such as 10 ppm for lead, 3 ppm for arsenic, 3 ppm for cadmium, 1 ppm for mercury, and 5 ppm for antimony. 

Manufacturers must check ingredient composition, fragrance allergen data, raw‑material specifications, impurities, contaminants, and test results before launch. 

4. Validate Ingredient Categorization & Risk Classification

In some markets, cosmetic ingredient assessment is an essential step in determining whether ingredients require specific classification, categorization, or regulatory approval before they can be used in cosmetic products. 

For example, in Australia, AICIS controls the import and manufacture of chemicals used as ingredients. Every industrial chemical used in care, skin care, makeup, and cosmetic products must be categorized in one of five categories: Listed, Exempted, Reported, Assessed, and Commercial Evaluation. 

Regulations for each category depend on the risk to health and the environment that the chemical poses. Manufacturers must find the category for each ingredient and make sure the regulatory requirements are met before the product enters the market. 

In certain countries, such as China and Japan, novel ingredients may require specific ingredient registration or approval before they can be used in cosmetic products. Therefore, ingredient novelty and country-specific registration requirements should also be assessed as part of the regulatory review. 

5. Verify Safety Data and Regulatory Documentation

Cosmetic manufacturers must make sure that all cosmetic ingredient safety data and regulatory documents are complete and correct. This means having data on every raw material used and on the finished product.  

Depending on the market, this can include toxicology data, exposure data, safety reviews, test results, and other documents that prove the final product is safe for how it's meant to be used. For instance, in the EU, the Responsible Person is required to keep a Product Information File (PIF). This file includes the Cosmetic Product Safety Report (CPSR) details, manufacturing and GMP information, and any proof needed to support product claims. 

Dernières réflexions

Cosmetic Ingredient compliance can differ a lot from one market to another. That is why it is important to do ingredient and formulation reviews early on. From restricted substances to ingredient classification, safety data, and any supporting documents, early checks at all stages help lower the chances of regulatory delays when entering a new market. 

Freyr helps manufacturers with product formulation and cosmetic ingredient review, safety and compliance checks, labeling and claims review, as well as market‑specific regulatory guidance to make product launches smoother in all markets. 

Consult Freyr for expert Regulatory guidance and support!