EU Cosmetic Products Regulation: An Essential Guide

The Cosmetic Products Regulation establishes requirements for cosmetic products in the European Union, such as makeup, hair care products, skin care products, and more. In this guide we break down the requirements of the Cosmetic Products Regulation, including substance restrictions, safety assessment, labelling, and documentation.

In addition, we also list other regulations that are relevant to cosmetics, such as the REACH regulation and CLP regulation.

What is the Cosmetic Products Regulation?

This regulation sets requirements for cosmetic products to ensure the protection of human health. It includes provisions concerning:

• Safety assessment
• Substance restrictions
• Responsible persons
• Good manufacturing practice
• Notifications
• Documentation
• Labelling and claims
• Testing

The Cosmetic Products Regulation also includes specific provisions (e.g., substance restrictions and warnings) for:

• Colorants
• Preservatives
• UV filters
• Nanomaterials

Product scope

The Cosmetic Products Regulation covers cosmetic products, which are defined as substances and mixtures meant to contact the outside parts of the human body (e.g. the skin, hair, or lips) or inside the mouth (e.g. the teeth). These substances and mixtures are meant for purposes such as the following:

• Cleaning or perfuming parts of the body
• Altering the look of body parts
• Protecting parts of the body

Product examples

Here are some examples of cosmetic products (taken from Annexes III to VI, which set provisions for specific products):

• Eyelash colouring products
• Tooth whitening products
• Hair lotions and shampoos
• Rinse-off products
• Eye products
• Products for application on mucous membranes
• Oral products
• Leave-on products
• Shower gels
• Face, hand, and lip products
• Body pump spray products
• Propellant spray products

Exemptions

Cosmetic products do not include mixtures or substances that are meant to enter the human body by way of:

• Swallowing
• Breathing in
• Injection
• Implantation

Overview

Type	Requirements
Responsible person	1. Manufacturer in the EU 2. Importer in the EU 3. Distributor in the EU, or 4. A person in the EU designated by the manufacturer or importer
Substance restrictions	Substance restrictions are listed in Chapter IV
Safety assessment	Safety assessment requirements are listed in Article 10
Notification	1. Notification via the Cosmetic Products Notification Portal (CPNP) is required 2. Additional notification requirements apply to nanomaterials
Documentation	1. Cosmetic product safety report 2. Product information file 3. Test reports
Labelling	Must contain the information listed in Article 19
Good manufacturing practice (GMP)	Compliance with GMP is presumed when the product is manufactured per EN ISO 22716 requirements
Product claims	Labels, products, and product advertising must not contain false claims
Instructions and warnings	1. Use and disposal 2. Condition of use and warnings as listed in Annexes III to VI
Presentation	The product’s purpose must be clear for consumers

Who can act as the responsible person?

In order to place a cosmetic product on the market, there must be a responsible person who must ensure that the products comply with the relevant obligations, as listed in Article 5.

The responsible person can be:

• The manufacturer based in the EU
• The importer based in the EU
• The distributor based in the EU
• A person established in the EU that is designated by either the manufacturer or importer

Substance restrictions

The regulation sets different restrictions for different types of substances.

While some substances are prohibited (Annex II) or restricted to a certain amount (Annex III), others are only allowed for specific use (e.g., colorants, preservatives, and UV filters) and under certain conditions (e.g., body parts, maximum concentration).

In the table below, we list examples of several substances, their restriction types, and some conditions of restriction. You can find the complete list in Annexes II to VI.

Substance name	Restriction type	Conditions
Trichloroacetic acid	Annex II: Prohibited	Prohibited
Allyl isothiocyanate	Annex II: Prohibited	Prohibited
Thioglycolic acid and its salts	Annex III: Restricted	Hair waving or straightening products: a. Maximum 8%, with a general use ready for use pH of 7–9.5 b. Maximum 11%, with a professional use ready for use pH of 7–9.5
Chlorates of alkali metals	Annex III: Restricted	Toothpaste: maximum 5% Other: maximum 3%
Polychloro copper phthalocyanine	Annex IV: Only allowed in colorants	Not to be used in eye products
Sulfonated nigrosine color	Annex IV: Only allowed in colorants	Not to be used in products applied on mucous membranes
Benzoic acid and its sodium salt	Annex V: Only allowed in preservatives	Oral products: maximum 1.7% (acid)
Chlorobutanol	Annex V: Only allowed in preservatives	Maximum 0.5% Must not be used in aerosol dispensers (sprays)
2-Cyano-3,3-diphenyl acrylic acid, 2- ethylhexyl ester/Octocrylene	Annex VI: Only allowed in UV filters	Propellant spray products: maximum 9%
Benzoic acid, 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester/Homosalate	Annex VI: Only allowed in UV filters	Face products (except propellent spray products): maximum 7.34%

Finally, Article 15 sets restrictions for some type of substances listed in the Classification, Labelling and Packaging (CLP) Regulation.

Safety assessment

Before placing a cosmetic product on the market, the responsible person must demonstrate that the cosmetic product complies with relevant requirements. The responsible person must ensure that:

a. The cosmetic product in question has undergone a safety assessment.

b. The safety assessment accounts for the cosmetic product’s intended use as well as foreseeable systemic exposure to individual ingredients in the final product.

c. The safety assessment uses a suitable weight-of-evidence approach to review data from existing sources.

d. The cosmetic product’s safety report is kept up to date before placing the product on the market.

Lab testing

In practice, the responsible person should seek the help of a testing company which can perform the necessary testing (e.g. ingredient analysis, toxicology testing) and provide a qualified safety assessor that must perform the cosmetic product safety assessment and produce:

a. A statement on the cosmetic product’s safety, as well as why the product is deemed safe for sale

b. A statement on the necessity of providing warnings and usage instructions

c. Their name and address

d. Their proof of qualification

e. The date and their signature

Following the cosmetic product safety assessment and necessary testing, the responsible person can complete the necessary documentation (e.g. Cosmetic product safety report, Product information file).

Test methods

Here are a few examples of test methods relevant to cosmetics products:

• Dermatological testing
• Toxicokinetic testing
• Bacterial aerobic plate counts
• Stability and shelf life testing

Where can I find a safety assessor?

Some testing companies can provide safety assessment services. We list below several testing companies and some of their services.

SGS

• Physical and chemical characteristics and stability testing
• Microbial quality testing
• Exposure testing
• Toxicological profile testing
• Safety assessor’s expert opinion on product’s safety

Intertek

• Physicochemical characteristics and stability testing
• Microbiological quality testing
• Impurity testing
• Normal and reasonably foreseeable use testing
• Assessor’s evaluation of product’s safety

TÜV Rheinland

• Chemical analyses of cosmetic products
• Microbiological quality and challenge testing
• Storage stability testing
• Packaging material testing
• Safety assessment

Eurofins

• Toxicology services
• Physico-chemical analyses
• Ecotoxicity and biodegradability services
• Microbiology services
• Safety assessment

TÜV SÜD

• Microbiological and chemical contamination testing
• Toxicological testing
• Stability testing
• Chemical analysis

Animal testing

The regulation prohibits the sale of cosmetic products if the final formulation or its ingredients were subject to animal testing.

There are some cases in which animal testing is allowed. You can learn more in Article 18 of the regulation.

Notification requirements

Article 13 of the regulation sets notification requirements. For instance, the responsible person must submit the following information via the cosmetic products notification portal (CPNP):

• The cosmetic product’s category and name
• The responsible person’s name and address
• The country of origin in the case of import
• The EU member state where the cosmetic product is to be sold
• A physical person’s contact details
• Presence of substances in nanomaterial form (IUPAC and foreseeable exposure conditions)
• Substance names and CAS/EC numbers

Article 16 sets additional notification requirements regarding nanomaterials. The notification submitted to the CPNP must include:

• The nanomaterial identification (IUPAC) and other descriptors
• The nanomaterial’s size, physical, and chemical properties
• An estimate of the annual quantity of nanomaterial placed on the market
• The nanomaterial’s toxicological profile
• The nanomaterial’s safety data
• The reasonably foreseeable conditions of exposure.

Documentation requirements

The responsible persons must be able to provide a cosmetic product safety report and a product information file.

Cosmetic product safety report

According to Annex I of the regulation, the cosmetic product safety report consists of two parts – Part A (Cosmetic product safety information) and Part B (Cosmetic product safety assessment).

Part A

Part A of the report must contain the following:

• The cosmetic product’s quantitative and qualitative composition
• The cosmetic product’s stability and chemical or physical characteristics
• Microbiological quality
• Information about the packaging material’s impurities and traces
• The cosmetic product’s normal and foreseeable use.
• Data on the exposure to the cosmetic product
• Data on the exposure to the cosmetic product’s substances
• The cosmetic product’s toxicological profile
• The cosmetic product’s serious undesirable side effects
• Other relevant information regarding the cosmetic product

Part B

A safety assessor, who is generally a qualified individual from a lab testing company such as SGS or Intertek, must perform the assessment stated in Part B of the report, which must contain:

• A statement on the cosmetic product’s safety
• A statement on labelled warnings and usage instructions
• Explanations of the scientific reasoning for the assessment conclusion
• Assessor’s credentials (name, address, proof of qualification, date, and signature) and approval

Product information file

Article 11 of the regulation requires the responsible person to keep a product information file for each cosmetic product. The file must contain the following:

a. A product description, enabling the attribution of the file to the product

b. The cosmetic product safety report

c. A description of the manufacturing method and statement of compliance with good manufacturing practice

d. Evidence of effect claimed for the cosmetic product

e. Data on animal testing performed

The responsible person must:

• Keep the file for 10 years
• Ensure it is electronically accessible
• Ensure the file is written in an easily-understood language

Labelling requirements

Article 19 of the regulation requires containers and packaging of cosmetic products to clearly, permanently, and visibly carry labelling information such as the following:

• The responsible person’s name and address
• The nominal content at the time of packaging, by weight or by volume
• Date of minimum durability
• Precautions to be observed in use
• Batch number of manufacture or reference number
• The cosmetic product’s function
• List of ingredients

Note that specific precautions (eg. conditions of use and warnings) are set in Annexes III to VI for different cosmetic products.

For instance, according to Annex III, general-use oxidative hair dye products must bear the mixing ratio, a warning symbol, as well as the following text on the label:

---

“Hair colourants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on persons under the age of 16.

Temporary “black henna” tattoos may increase your risk of allergy.

Do not colour your hair if:

— you have a rash on your face or sensitive, irritated and damaged scalp,

— you have ever experienced any reaction after colouring your hair,

— you have experienced a reaction to a temporary “black henna” tattoo in the past.

Contains phenylenediamines.

Do not use to dye eyelashes or eyebrows”

---

Good Manufacturing Practice (GMP)

Good manufacturing practice is required to ensure that products are consistently controlled and produced according to quality standards relevant to the product’s intended use.

Per Article 8, compliance with the requirements of the following standard provides a presumption of conformity with the GMP requirements:

EN ISO 22716:2007 — Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices

Product claims

Labels on cosmetic products and their advertising shouldn’t contain information concerning characteristics or functions that the product doesn’t have. This includes information contained in:

• Text
• Names
• Trademarks
• Pictures
• Other figurative signs

Commission Regulation (EU) No 655/2013 sets criteria for the justification of claims for cosmetic products.

Instructions and warnings

Article 3 of the regulation requires instructions for use and disposal to accompany cosmetic products on sale.

Annexes III to VI also set requirements regarding the provision of use and warnings for specific substances. For instance, according to Annex III, hydrogen peroxide in hair products necessitates the provision of the following instructions:

• “Avoid contact with eyes”
• “Rinse immediately if product comes into contact with them”

Presentation

Article 3 of the regulation requires cosmetic products for sale to account for their presentation, including conformity with Directive 87/357/EEC, which concerns products that endanger the health and safety of consumers because said products appear to be other than they are.

Other regulations relevant to cosmetics

We list below some regulations that are relevant to cosmetic products. Note that additional regulations may be relevant to cosmetic products.

REACH

The REACH regulation restricts substances contained in both mixtures and products. Substances listed under Annex XVII are subject to bans and restrictions, while certain conditions apply to substances classed as SVHCs.

The regulation is also relevant for substances that can be found in cosmetics, such as microplastics.

Specifically, Regulation (EU) 2023/2055 amends Annex XVII to REACH by establishing restrictions on the use of microplastics, including when contained in some types of cosmetics. The regulation prohibits sales of covered products when microparticles are present in concentrations over 0.01% by weight.

Here are a few examples of cosmetics listed in the regulation’s Annex, which corresponds to entry 78 of Annex XVII to REACH, and the dates from which the restriction takes effect:

• Fragrances – 17 October 2029
• Leave-on products – 17 October 2029
• Rinse-off products – 17 October 2027
• Lip products – 17 October 2035
• Nail products – 17 October 2035
• Make-up products – 17 October 2035

Some products containing microplastics must comply with certain labelling requirements by specific dates. For example, the following products must carry the labelling statement “This product contains microplastics” from 17 October 2031 until 16 October 2035:

• Lip products
• Nail products
• Make-up products

Our understanding is that the labelling requirements only apply before the restrictions take effect, in 2035.

CLP Regulation

According to our research, the CLP Regulation does not directly cover cosmetics. However, the Cosmetic Products Regulation uses ECHA’s C&L Inventory as the basis for some of its listed substance restrictions.

Aerosol Dispenser Directive

The Aerosol Dispenser Directive covers products, including cosmetics, that are packaged in aerosol dispensers.

General Product Safety Regulation (GPSR)

The General Product Safety Regulation generally applies to products for safety aspects that other existing regulations do not cover (e.g., flammability).