On November 1, 1993, the European Union (EU) was officially established, creating a single market among its Member States. This single market enables the free movement of goods, services, people, and capital across Europe, which has contributed to the region's economic growth and prosperity over time.

To eliminate trade barriers and promote the circulation of cosmetic products in the European market, EU issued the Directive 76/768/EEC (Cosmetic Directive) in July 1976. However, since it was only a framework agreement which requires Member States’ modification to adapt it to their own national conditions, the implementation of the Cosmetic Directive did not effectively reduce trade barriers within the EU. To address this issue, EU implemented the Regulation (EC) No 1223/2009 (Cosmetics Regulation) in 2013, repealing and fully replacing the Cosmetic Directive.

Unlike its predecessor, the Cosmetics Regulation is directly implemented as the law in each Member State, which helps avoid deviations during the transposition process. In addition, compared to its predecessor, the Cosmetics Regulation emphasizes the responsibilities of cosmetic manufacturers and operators, requires safety reporting before cosmetics are placed on the market, and establishes cosmetics responsible person system for the first time, which has successfully unified and strengthened the supervision of cosmetics among EU Member States.

Part 1 Regulatory Framework and the Competent Authority

1.1 Main Cosmetic Regulations

Regulation (EC) No 1223/2009 (Cosmetics Regulation) is the cornerstone of the EU's cosmetics regulatory system. In addition to it, this system encompasses a range of supportive regulations that further refine the provisions in the core regulation. The European Commission, the cosmetics regulatory authorities of all Member States, and the Scientific Committee on Consumer Safety (SCCS) have also issued explanatory or guiding documents, respectively. These documents are usually not legally binding, but provide practical guidelines for cosmetic manufacturers. 

1.2 Competent Authority

European Commission: The Commission is in charge of setting the legal framework of cosmetics, overseeing the safety of cosmetic products, ensuring cosmetics' compliance with regulations, and proposing revisions on regulations in light of scientific progress.

Scientific Committee on Consumer Safety (SCCS): SCCS plays a critical role in the cosmetics regulatory framework in the EU. On the one hand, it provides information and opinions based on particular issues identified by the Commission in the regulatory process of cosmetics, which are commonly referred to when revising the Cosmetics Regulation. On the other hand, SCCS consistently monitors the safety risks of cosmetic ingredients, including existing ingredients in the ingredient lists and those that may be used as cosmetic ingredients, and provides detailed guidance on the safety assessment methods of cosmetic ingredients.

Competent authorities of the Member States: Competent authorities of the Member States are responsible for establishing corresponding implementation systems based on the Cosmetics Regulation, ensuring that cosmetic products placed on the market are safe and comply with regulations. This includes conducting post-market surveillance of cosmetics, investigating and taking action against non-compliant products, and coordinating with other competent authorities in the EU to share information and best practices.

Part 2 Cosmetic Products

2.1 Definition

Cosmetic product refers to 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 the exclusive or main purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.

According to this definition, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered a cosmetic product. 

2.2 Responsible Person

Only cosmetic products with a legal or natural person who has been designated within the European Community as the "responsible person" can be placed on the market. The identity of this responsible person varies in different situations, and can be the product's manufacturer, importer, or distributor. 

2.3 Responsible Person's Obligations

Regardless of identity, the responsible person shall ensure cosmetic's compliance with the relevant obligations set out in the Cosmetics Regulation, covering aspects of manufacturing, safety assessment, notification, labelling, claims, etc. If the responsible person finds that a cosmetic product is not in conformity with the Cosmetics Regulations, he/she shall immediately take corrective measures to bring that product into conformity, withdraw it or recall it, as appropriate. 

2.3.1 Good Manufacturing Practice (GMP)

During the time when the Cosmetic Directive was in force, compliance with GMP was not mandatory for cosmetic manufacturers. Instead, they were only required to indicate whether or not they had followed GMP. To reduce the safety risks from purchasing ingredients to manufacturing, the Cosmetics Regulation now requires that cosmetic manufacturers abide by GMP to ensure cosmetic safety. Additionally, the Cosmetics Regulation clarifies that if manufacturers follow the harmonized standards of GMP recognized by the Commission, they are presumed to have fulfilled their obligation of GMP. Currently, the only harmonized standard recognized by the EU is the ISO 22716:2007 Cosmetics—Good Manufacturing Practices (GMP)—Guidelines on Good Manufacturing Practices issued by the International Organization for Standardization (ISO). 

2.3.2 Product Notification

In EU, cosmetic products do not require pre-market approval. Instead, they are subject to a centralized notification system, i.e., cosmetic products notification portal (CPNP), before being placed on the market. Once the product has been notified through the CPNP, there is no need for any further notification at the national level.

The obligation to notify a product through the CPNP falls on the responsible person, or the distributor under certain circumstances. Depending on the identity of the notifier, the documents to be submitted vary. But in either case, the notification shall include all necessary information about the product. 

The Cosmetics Regulation does not specify a particular moment for completing the product notification, but it shall be done before placing the product on the market. Exceptionally, for products containing nanomaterials, notification shall be completed six months before they are placed on the market. After receiving cosmetic's notification, the Commission will make them available electronically to all competent authorities, and poison centers or similar bodies of the Member States. The former will use the information received for the purposes of market surveillance, market analysis, evaluation and consumer information, while the latter will use it for necessary medical treatment.

Furthermore, it is worth mentioning that successful notification through the CPNP does not necessarily mean that a product fulfils all the requirements of the Cosmetics Regulation. The Commission does not review or assess the notification information collected through the CPNP. Instead, the national competent authorities are responsible to check whether a product complies with the Cosmetics Regulation. 

2.3.3 Production Information File (PIF)

The responsible person is required to maintain a PIF for any cosmetic product placed on the market, which shall include a description of the product and its manufacturing method, compliance statement with GMP, cosmetic product safety report, supporting evidence for any cosmetic claims made, and data on any animal testing performed.

The information contained in the PIF shall be available in a language easily understood by the competent authorities of the Member State. The responsible person shall keep the PIF at the address indicated on the label, update the information as needed, and keep it for ten years after the last batch of the cosmetic product was placed on the market. 

2.3.4 Safety Assessment  

Prior to placing a cosmetic product on the market, the responsible person shall ensure that the cosmetic product has undergone a safety assessment. As required, this assessment shall be carried out by a person with diploma or other evidence of formal qualifications awarded on the completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.

After the safety assessment is completed, a corresponding safety report shall be compiled. Consisting of two parts, each part shall at least contain the information listed below. Moreover, the report shall be up to date with any additional relevant information generated after the product is placed on the market. 

2.3.5 Animal Testing

To promote animal welfare, on March 11, 2013, EU officially implemented the full ban on animal testing for cosmetic reason. Subject to this ban, the following actions aimed at complying with the Cosmetics Regulation shall be prohibited:

1. the placing on the market of cosmetics whose final formulation has been tested on animals through a method other than a validated alternative one;

2. the placing on the market of cosmetics containing ingredients or ingredient combinations that have been tested on animals through a method other than a validated alternative one;

3. the performance of animal testing of finished products within the Community;

4. the performance of animal testing of ingredients or ingredient combinations within the Community, after the date by which such tests are required to be replaced by one or more alternative methods.  

In exceptional circumstances, where serious safety concerns arise regarding an existing cosmetic ingredient, a Member State may request the Commission to grant a derogation from the animal testing ban. In such cases, the Commission may authorize the derogation with conditions after consulting SCCS. A derogation may only be granted where:

• the ingredient is widely used and cannot be replaced by another ingredient that can perform a similar function;

• the specific human health problem is substantiated, and the need to conduct animal tests is justified by a detailed research protocol proposed for the evaluation.

2.3.6 Labelling

Consumers are the end users of cosmetics, while the vast majority of them lack professional knowledge about cosmetics. It is difficult for them to identify the performance and quality of cosmetics based solely on appearance. Considering this, the Commission strives to provide necessary and reliable information to consumers, protecting their right to know and choose through standardizing cosmetic labelling.

For cosmetics made available on the market, their container and packaging shall bear the following information in indelible, easily legible and visible lettering:

1. Name/registered name and the address of the responsible person;

2. Contents;

3. Date of minimum durability, or period of opening (for products with a minimum durability of more than 30 months);

4. Special precautions;

5. Batch number, or the reference for identifying the cosmetic product;

6. Function of the cosmetic product;

7. A list of ingredients. 

As per the Cosmetics Regulation, the ingredients shall be expressed by the common ingredient names in the Glossary of Common Ingredient Names. If a common ingredient name is not available, term from a generally accepted nomenclature shall be used. Regarding the language requirement, it shall be determined by the laws of the Member States in which the product is made available to the consumer.

If it is impractical to label the precautions and ingredients of a product, the information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card. Additionally, abbreviated information or the symbol given below shall be included on the container or packaging as a hint for the precautions information, and on the packaging as a hint for the ingredients information. 

Reference to enclosed or attached information

2.3.7 Claim

Cosmetic claims serve mainly to inform consumers about the characteristics and qualities of the product. They are essential for differentiating between products, and stimulating innovation and competition. As a general rule in EU, cosmetic claims shall not imply that the products have characteristics or functions which they do not possess through any form, including text, names, trademarks, pictures, and other signs.

To protect consumers from misleading claims in relation to cosmetics, after consulting the SCCS and other relevant authorities, the Commission has adopted a list of common criteria for claims in Commission Regulation (EC) No 655/2013 as follows:

In July 2017, the Working Group on Cosmetic Products issued the Technical Document on Cosmetic Claims, further providing practical guidance for the application of Commission Regulation (EC) No 655/2013. Based on the original six criteria, specific requirements for claims such as "free from" and "hypoallergenic" were added. For instance, "free from" claims should not be made for ingredients prohibited by the Cosmetics Regulation, or typically used in particular type of cosmetics. For products that claim to be hypoallergenic, the presence of known allergens and allergen precursors should be totally avoided. The responsible person should also provide evidence supporting the claim of low allergenic potential of the products. 

2.3.8 Serious Undesirable Effects (SUE)

An SUE refers to any undesirable effect resulting in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, an immediate vital risk, or death. In the event of SUEs, the responsible person shall report the following to the competent authority of the Member State where the SUE occurred within 20 calendar days from the date on which he/she becomes aware of the SUE:

1. all known SUEs, and those may reasonably be expected to be known;

2. the name of the cosmetic product concerned;

3. the corrective measures taken, if any.

To reduce the likelihood of the recurrence of an SUE, SUE Reporting Guidelines gives instructions on subsequent actions to be taken by the responsible person. Specifically, he/she should carry out a trend analysis of the nature, severity and/or frequency of the SUE, as well as possible predisposing factors on the end users who had experienced the undesirable effect. All available data on SUEs shall be included into the cosmetic product safety report, and made accessible to the public by appropriate means. Additionally, the responsible person should take corrective measures proportional to the nature and/or frequency of the SUE, which may include changing the usage instructions, labelling, warnings, formula, recalling or withdrawing the product, and taking any further action necessary to protect the health of the end users. 

2.4 Market Surveillance 

2.4.1 Product Monitoring

Member States shall conduct surveillance of their own markets to ensure the safety of cosmetics manufactured or imported into the EU. They shall monitor product's compliance with GMP principles, and perform appropriate checks on an adequate scale of cosmetic products and economic operators. These checks may include PIF reviews as well as physical and laboratory checks on adequate samples.

If there is non-compliance with a product, Member States shall require the responsible person to take corrective measures, such as bringing the product into conformity, as well as withdrawing or recalling it from the market, as appropriate. 

2.4.2 Communication of SUE

To ensure a coherent approach to cosmetics-related issues, the market surveillance authorities of all Member States established the Platform of European Market Surveillance Authorities in Cosmetics (PEMSAC). This network facilitates cooperation among the market surveillance authorities by coordinating their activities, exchanging information, developing and implementing joint projects, as well as sharing expertise and best practices in cosmetics market surveillance.

One area where Member States cooperate and exchange information is on SUEs attributable to cosmetics use. The Cosmetics Regulation established a foundation for a uniform approach for the communication of SUEs. It provides for：

1. reporting of SUEs to national authorities where the effect in question occurred;

2. reporting of any corrective measures taken by the responsible person or distributor.

Based on this foundation, the competent authority of the Member State where the effect occurred shall take appropriate measures, depending on the identity of the SUE reporter. To be specific,

• Where the responsible person reports SUEs, the competent authority shall immediately share the information received with the competent authorities of other Member States;

• Where distributors report SUEs, the competent authority shall immediately share the information received with the competent authorities of other Member States and with the responsible person.

• Where end users or health professionals report SUEs, the competent authority shall immediately share the information on the cosmetic product concerned with the competent authorities of other Member States and the responsible person.

Part 3 Cosmetic Ingredients

3.1 Ingredient Annexes to the Cosmetics Regulation

The safety of cosmetics depends on the safety of the ingredients used. Therefore, both the previous Cosmetic Directive and the current Cosmetics Regulation prioritize the safe use of cosmetic ingredients in cosmetic supervision. Following the Cosmetics Regulation, cosmetic ingredients shall be used in accordance with the use requirements laid down in the ingredient annexes. 

1. Annex II: List of Substances Prohibited in Cosmetic Products

2. Annex III: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions Laid down

3. Annex IV: List of Colorants Allowed in Cosmetic Products

4.  Annex V: List of Preservatives Allowed in Cosmetic Products

5. Annex VI: List of UV Filters Allowed in Cosmetic Products

Where there is a potential risk to human health arising from the use of certain cosmetic ingredients, which needs to be addressed on a Community-wide basis, the Commission shall request SCCS to provide its opinion on the safety of such ingredients for use in cosmetics, with reasonably foreseeable exposure conditions taken into account. Following the opinions of SCCS, the Commission may amend Annexes II to VI accordingly.

3.2 Glossary of Common Ingredient Names

The Cosmetics Regulation stipulates that cosmetic products made available on the market shall label ingredients' information on their container and packaging. To ensure uniform labelling and facilitate the identification of cosmetic ingredients, the Commission compiled the Glossary of Common Ingredient Names (the Glossary). If an ingredient has a corresponding name in the Glossary, it shall be used in the ingredient list.

In compiling and updating the Glossary, internationally recognized nomenclatures are considered, such as the International Nomenclature of Cosmetic Ingredients (INCI). For ingredients used in perfume and aromatic compositions without an INCI name, the Glossary provides the perfuming names that have been previously used for them. Besides, for colorants other than those intend to color the hair, the Glossary includes the Color Index (CI) numbers as their common ingredient names, as the CI nomenclature is used to label cosmetic products containing them.

It should be noted that the Glossary's function is different from that of the ingredient annexes to the Cosmetics Regulation. The Glossary is compiled and updated to make sure the cosmetic products on the Union market are labelled with the correct ingredient names. It is not a list of authorized or safe cosmetic ingredients, and does not provide information on the regulatory status or function of the ingredients. Regarding the regulatory status of ingredients, the ingredient annexes to the Cosmetics Regulation are the only legally binding references.