EU Cosmetics Notification Guidance

1. Background Introduction

In 2013, the EU Cosmetics Regulation (EC) No 1223/2009 entered into force in the countries of European Economic Area (EEA), which includes countries of European Union and Norway, Iceland, and Liechtenstein. It sets out rules and requirements for cosmetic products to be sold within those countries, abrogating the local Directives. Thus, it ensures smooth functioning of the internal market for cosmetic products within the European Union. The regulation aims to ensure the safety of cosmetic products, protecting consumers’ health while providing clear information.

This guideline is based on the requirements of the EU Cosmetic Regulation (EC) No 1223/2009 and aims to assist cosmetic-related enterprises in standardizing the notification process, ensuring compliance with EU regulations, and facilitating smooth market entry.

2. Definition of Cosmetics

According to the the EU Cosmetics Regulation (EC) No 1223/2009, “‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.”

3. Classification of Cosmetics

According to the the EU Cosmetics Regulation (EC) No 1223/2009, the assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the product.

“Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, toilet waters and eau de Cologne, bath and shower preparations (salts, foams, oils, gels), depilatories, deodorantsand anti-perspirants, hair colorants, products for waving, straightening and fixing hair, hair-setting products, haircleansing products (lotions, powders, shampoos), hairconditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines), shaving products (creams, foams, lotions), make-up and products removing make-up, products intended for application to the lips, products for care of the teeth and the mouth, products for nail care and make-up, products for external intimate hygiene, sunbathing products, products for tanning without sun, skin-whitening products and anti-wrinkle products.”

The competent authorities of EU Member States are responsible for making the final determination on whether a product falls within the cosmetic product category. For products that exist on the borderline between cosmetics and other product categories, known as "borderline products", the European Commission has issued a series of guidance documents to provide clarification.

• Borderline products manual on the scope of application of the Cosmetics Regulation (EC) No 1223/2009
• Guidance document on the demarcation between the Cosmetic Products Directive 76/768 and the Medicinal Products Directive 2001/83

4. Cosmetics Regulatory Authorities

The regulatory bodies overseeing cosmetics in the EU include the European Commission (EC) and the competent authorities of EU Member States. To facilitate information exchange, enhance collaboration, and ensure a consistent approach to consumer product-related issues, the market surveillance authorities of these EU countries have also established the EU Working Group on Cosmetic Products Market Surveillance Authorities Platform.

5. Requirements for Placing Cosmetics on the EU Market

To place cosmetics on the EU market, they must comply with the EU Cosmetics Regulation (EC) No 1223/2009. Follows are the key compliance requirements and the listing process:

• Making sure the product is compliance with the definition of a cosmetic product
• Nominating a Responsible Person (RP)
• Ensuring the safety of the product
• Compliance of cosmetic product labeling
• Ensuring that cosmetic claims are truthful and not misleading
• Prohibiting animal testing of cosmetic products and their ingredients within the EU, as well as the import of products that have been tested on animals outside the EU
• Providing a complete Product Information File (PIF) kept by the Responsible Person (RP)
• Requiring companies to notify cosmetic products to a central database before placing them on the market
• Keeping the product compliant with regulatory evolution (monitore the regulatory and safety news and update the PIF accordingly) and reporting any adverse effects that occur once the product is on the market

6. Responsibilities and Qualification Requirements for Responsible Person

A Responsible Person (RP) is a natural or legal capable person who is designated by a cosmetic product manufacturer, importer, or distributor to be responsible for ensuring the safety of the cosmetic product they place on the market. The RP should have access to all relevant information about the cosmetic product, including the manufacturing process, formulation, and safety assessments.

6.1 Qualification Requirements for Responsible Person

The Responsible Person (RP) must be a legal entity or a natural person established within the EU. By default, the cosmetics manufacturer, importer, or distributor is considered the RP. However, through written authorization, a third-party legal entity or natural person can also assume this role.

6.2 Responsibilities for Responsible Person

The main duties of a RP include:

• Ensuring that the cosmetic product complies with all applicable regulations, including GMP;
• Ensuring that the cosmetic product has undergone a safety assessment by a qualified professional;
• Ensuring that the cosmetic product is labelled correctly with all necessary information, including ingredients, warnings, and instructions for use;
• Maintaining documentation of the safety assessment and product information for at least 10 years after the product is placed on the market, updated in case of any regulatory/toxicological evolution, undesirable effects raised by consumers, formula update, or any relevant change;
• Cooperating with authorities in the event of a product recall or safety concern.

7. Documentation Requirements for Cosmetics Notification

To sell cosmetics in the EU market, products must be registered in the Cosmetic Products Notification Portal (CPNP). Follows are the required documents for EU cosmetic product notification.

7.1 Cosmetic Products Notification Portal (CPNP) Notification

Before placing a cosmetic product on the market, the RP shall electronically submit the following information to the European Commission. Upon the product's launch, the RP must also archive images of the product's original packaging and labeling.

• Product category and product name
• Name and address of the RP, where the Product Information File (PIF) shall be kept and made available for inspection
• Country of origin for imported products
• Information on the Member State(s) where the product is placed on the market
• Contact details
• If the product contains nanomaterials, information on the substance and foreseeable exposure conditions under reasonable use must be provided
• Name and CAS number (or EC number) of substances classified as Category 1A or 1B Carcinogenic, Mutagenic, or Toxic for Reproduction (CMR)
• General formulation information (to facilitate emergency and appropriate medical response)

The competent authorities of the Member States and poison centers also have access to the simplified notification information in the CPNP.

7.2 Product Information File (PIF)

A Product Information File (PIF) is an essential document required for the registration of cosmetic products in the European Union (EU). It is a compilation of all the necessary information and data regarding the safety, quality, and efficacy of a cosmetic product. The PIF must be kept available at all times by the RP, up to ten years after market launch. The file should be updated regularly, as it is subject to inspection by the Authorities.

A PIF should include the following information:

• Product description
• Composition of ingredients
• Cosmetic Product Safety Report (CPSR)
• Description of the manufacturing process and a statement of compliance with Good Manufacturing Practices (GMP)
• Product packaging
• Evidence supporting product claims
• Product labeling
• Statement on animal testing data

Article 8.1 of the EU Cosmetic Regulation (EC) No 1223/2009 explicitly states that the manufacturing of cosmetic products must comply with Good Manufacturing Practices (GMP). The specific requirements for GMP compliance are published in the Official Journal of the European Union.

7.3 Cosmetic Product Safety Report (CPSR)

A CPSR is a report that outlines the safety information for each cosmetic product. This report is required by EU regulations and is an essential part of ensuring the safety of cosmetic products for human use. The CPSR is a comprehensive document that includes information on the formulation, manufacturing process, and safety assessment of each cosmetic product.

The CPSR should contain the following information:

8. Technical and Testing Requirements for Cosmetics Notification

The notification of cosmetic products in the EU must comply with Regulation (EC) No 1223/2009, ensuring that products are safe, effective, and meet market access requirements.

8.1 Ingredient Requirements

The EU Cosmetics Regulation (EC) No 1223/2009 stipulates the requirements for cosmetic ingredients, including:

• Prohibited substances (Annex II)
• Restricted substances (Annex III, including certain hair dyes)
• Permitted colorants (Annex IV)
• Permitted preservatives (Annex V)
• Permitted UV filters (Annex VI)

The ingredients used in cosmetic products must comply with the relevant requirements.

• EU Cosmetic Ingredients Database:

EU CosIng（https://ec.europa.eu/growth/tools-databases/cosing/）

8.2 Heavy Metal and Microbiological Testing Requirements

The EU Cosmetics Regulation (EC) No 1223/2009 classifies various heavy metal-containing substances as prohibited ingredients. However, the presence of trace amounts of these prohibited substances and their potential risks must be further assessed through cosmetic safety evaluation to ensure product safety.

In December 2016, the German Federal Office of Consumer Protection and Food Safety (BVL) (which replaced the role of the BGA in 2002) issued the guideline on "Technically Avoidable Heavy Metal Contents in Cosmetic Products". This guideline specifies the technically avoidable limits for heavy metals as a supplementary provision to the impurity limits of heavy metals under the EU Cosmetics Regulation (EC) No 1223/2009 and came into effect immediately.

*For face powders, lipsticks, eyeshadows, eyeliners, eyeliner gels, and cosmetic products used for theater, fan, or carnival purposes, the lead limit is 5 ppm.

**For cosmetic products used for theater, fan, or carnival purposes, the arsenic limit is 2.5 ppm.

In the EU Cosmetics Regulation (EC) No 1223/2009, the microbiological safety of cosmetic products is an integral part of the Cosmetic Product Safety Report (CPSR) and the Product Information File (PIF). Microbiological safety is typically assessed with reference to ISO 17516 and the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11th Edition. Manufacturers must ensure that their products are produced in a hygienic environment and undergo microbiological testing to confirm that they are free from harmful bacteria, fungi, and other microorganisms.

8.3 Toxicological Safety Testing

Cosmetic products and their ingredients must undergo toxicological evaluation to ensure their safety. The main tests include:

• Skin Irritation/Corrosion
• Eye Irritation
• Skin Sensitization
• Acute Toxicity
• Phototoxicity
• Genotoxicity
• Repeated Dose Toxicity
• Reproductive and Developmental Toxicity
• Carcinogenicity

Animal testing for cosmetics and their ingredients is banned in the EU, and alternative testing methods should be used.

9. Cosmetics Notification Timeline

When the product formulation contains ingredients with nanomaterials, if the ingredient is not a restricted substance under the EU Cosmetics Regulation (such as colorants, preservatives, UV filters, or other restricted ingredients), the Responsible Person (RP) must electronically notify the European Commission at least 6 months before the product is placed on the market.

10. Post-Market Supervision Requirements for Cosmetics

According to EU Cosmetics Regulation 1223/2009, once a cosmetic product is placed on the EU market, the Responsible Person (RP) and distributors must ensure continuous compliance with regulatory requirements and monitor products on the market to safeguard consumer safety.

10.1 Market Surveillance and EU Official Inspections

After a cosmetic product is placed on the market, it is subject to market surveillance and official inspections. The competent authorities of EU Member States are responsible for market supervision, assessing whether the product complies with safety requirements which includes Product Information File (PIF), labeling compliance, ingredient conformity, adverse reaction monitoring, etc. Authorities conduct random sampling, factory inspections, and may require the Responsible Person (RP) to provide the safety assessment report. In cases of non-compliance, enforcement measures may include product recalls, market bans, fines or other penalties.

10.2 Ongoing Obligations of the Responsible Person (RP) & Adverse Reaction Monitoring

The Responsible Person (RP) should retain the Product Information File (PIF) and safety assessment documents for at least 10 years after the product has been placed on the market. The PIF must be updated in case of regulatory or toxicological changes, consumer-reported adverse reactions, formula modifications and any other relevant updates.

The Responsible Person (RP) is also required to implement an adverse reaction monitoring system to ensure product safety on the market.

• Undesirable Effects (UE): Any adverse impact on human health under normal use, such as skin irritation or allergic reactions.
• Serious Undesirable Effects (SUE): Severe reactions, such as hospitalization or permanent damage, must be reported to the competent authority of the EU Member State within 20 days.

The Responsible Person (RP) should establish and maintain consumer complaint records, a database for adverse reactions and periodic safety evaluations.

Our services

• Responsible Person (RP)
• Preliminary review of formula and label
• Safety assessment
• Create an accurate PIF
• Labelling design
• CPNP submission

If you need any assistance or have any questions, please get in touch with us via cosmetic@cirs-group.com.