Required Documentation & Testing Standards for Cosmetics in the EU and US Markets

Entering the European and American cosmetics markets requires strict compliance with regulatory documentation and testing standards. These requirements are designed to ensure product safety, ingredient transparency, and consumer protection.
Below is a comprehensive overview of the key documents and testing standards required for cosmetics and packaging materials in the EU and US markets.

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1. Documents Required to Be Provided to Clients

To support regulatory review, product registration, and brand compliance, the following documentation must be prepared and provided:

1.1 Detailed Formula Sheet

Bilingual version (Chinese & English)

Includes:

INCI Name

CAS Number

Percentage of each ingredient

Ensures full ingredient traceability and regulatory transparency.

1.2 Raw Material Documentation

For each individual ingredient, the following are required:

MSDS (Material Safety Data Sheet)

COA (Certificate of Analysis)

These documents confirm the safety specifications and quality consistency of all raw materials.

1.3 Finished Product Documentation

Product MSDS

Product COA

Demonstrates the safety profile and batch conformity of the final formulation.

1.4 Fragrance Compliance Documents

If fragrance is used, additional documentation is mandatory:

Fragrance MSDS

Fragrance COA

26 Allergens Report (as required by EU regulations)

IFRA Certificate (International Fragrance Association compliance)

1.5 REACH Registration (If Applicable)

If the product contains high-risk or restricted substances, a valid REACH registration number must be provided in accordance with EU chemical regulations.

1.6 Compliance with Prohibited Ingredient Lists

The formulation must not contain banned or restricted substances.

Requirements are strictly aligned with EU and US regulations, based on the official prohibited ingredient lists.

1.7 Colorant Compliance

All pigments and colorants must comply with:

European cosmetic regulations

United States cosmetic color additive requirements

 

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2. EU & US Cosmetic Product Testing Requirements

To ensure consumer safety and regulatory approval, cosmetic products must pass the following testing standards:

2.1 Microbiological Testing

Evaluation of microbial contamination

Conducted according to:

EU and US standards

Southeast Asian market standards (where applicable)

2.2 Heavy Metal Testing

Testing for the following six heavy metals:

Lead (Pb)

Cadmium (Cd)

Mercury (Hg)

Arsenic (As)

Antimony (Sb)

Nickel (Ni)

2.3 Preservative Efficacy Test (Challenge Test)

Conducted according to:

ISO 11930:2012

ASEAN testing methods

Verifies the effectiveness of the preservative system throughout product use.

2.4 Free Formaldehyde Test

Ensures formaldehyde levels meet regulatory safety limits.

2.5 NDELA Analysis

Detects N-Nitrosodiethanolamine (NDELA), a potential carcinogenic impurity.

2.6 Dioxane (1,4-Dioxane) Test

Confirms the absence or safe levels of this processing by-product.

2.7 Phthalates Test

Must comply with EC No. 1223/2009 and Taiwan standards

Plasticizer screening includes:

DBP, DEHP, BBP, DMEP

DnPP, DiPP, PiPP, DNOP

2.8 26 Allergens Testing

Mandatory for fragrance-containing products sold in the EU

Supports accurate ingredient labeling and allergen disclosure.

2.9 Stability Testing

Evaluates product performance under different temperature and storage conditions

Confirms shelf life and packaging compatibility.

2.10 Skin Safety Testing

Assesses skin irritation and compatibility

Ensures products are safe for topical application.

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3. EU Testing Standards for Packaging & Accessories

In addition to the cosmetic formula, primary and secondary packaging materials must also meet EU safety standards:

3.1 Phthalates Testing

In accordance with EC No. 1223/2009 and Taiwan regulations

Covers the same plasticizers:

DBP, DEHP, BBP, DMEP, DnPP, DiPP, PiPP, DNOP

3.2 Polycyclic Aromatic Hydrocarbons (PAH) Content

Ensures packaging materials do not release harmful PAH substances.

3.3 Heavy Metal Testing

Screening for:

Lead, Cadmium, Mercury, Arsenic, Antimony, Nickel

3.4 Packaging Waste Compliance

Meets EU environmental and recycling requirements for packaging materials.

3.5 EN 71 Part 1 – Mechanical & Physical Properties

Ensures packaging safety, especially for products that may be used by children.

3.6 EN 71 Part 2 – Flammability

Evaluates fire safety risks related to packaging components.

3.7 General Product Safety

Confirms overall packaging safety under EU General Product Safety standards.

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Conclusion

Compliance with EU and US cosmetic regulations requires systematic documentation, rigorous testing, and strict ingredient control. From raw materials and finished formulations to fragrances and packaging components, every element must meet established safety and regulatory standards.

By preparing complete documentation and conducting the required testing, brands can:

• Reduce regulatory risks
• Accelerate market entry
• Build trust with distributors, retailers, and consumers
• For brands targeting Europe and the United States, working with a manufacturer experienced in EU & US cosmetic compliance is essential for long-term success.