EU Cosmetic Ingredient Regulations

The EU cosmetics regulatory framework puts emphasis on ingredient safety, as it directly impacts the overall safety of finished products. To ensure this safety, Regulation (EC) No 1223/2009 on Cosmetic Products (the Cosmetics Regulation) has established key compliance requirements for cosmetic ingredients, including use conditions, safety assessment, animal testing, and labelling. Additionally, for ingredients with specific characteristics, such as CMR substances, nanomaterials, and fragrance allergens, the regulation outlines extra compliance measures. These provisions work together to form a solid system to regulate the safe use of ingredients, thereby providing thorough protection for human health. 

Part 1 General Requirements for Cosmetic Ingredients

1.1 Use Conditions

Under the Cosmetics Regulation, cosmetic ingredients shall be used in accordance with the requirements specified in its 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

In compliance with these annexes, cosmetics shall not contain 1) annexed prohibited substances, 2) restricted substances, colorants, preservatives, or UV-filters that are not used in accordance with the specified conditions, and 3) colorants, preservatives, or UV-filters that are not listed in annexes. For the non-intended presence of a small quantity of a prohibited substance, if such presence is technically unavoidable following the good manufacturing practice, and does not endanger human health, it can be permitted.

The Scientific Committee on Consumer Safety (SCCS) plays a critical role in the EU cosmetics regulatory framework. It offers detailed guidance on the safety assessment methods for cosmetic ingredients, and consistently monitors their safety risks. When a potential risk to human health arises from the use of certain cosmetic ingredients, which requires a Community-wide basis, the European Commission shall request SCCS to assess the safety of these ingredients under reasonably foreseeable exposure conditions. Based on SCCS's opinions, the Commission may amend Annexes II to VI accordingly. 

1.2 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 demonstrating its safety for use, with a corresponding cosmetic product safety report (CPSR) compiled. In the assessment, the intended use of the product, and its anticipated systemic exposure to individual ingredients in the final formulation, shall be taken into account. Moreover, an appropriate weight-of-evidence approach shall be applied to evaluate data from all existing sources.

The safety assessments of cosmetic ingredients and products are based on risk evaluations. To support the industry in assessing ingredient risks, SCCS has developed a comprehensive guidance, The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation (the Notes of Guidance), which primarily addresses cosmetic ingredients, including essential information on various aspects of testing and safety evaluation of cosmetic ingredients, but also provides indirect guidance for finished products. Specifically, it outlines internationally recognized toxicological test procedures required to assess different human health-related toxicological endpoints, including hazard identification, exposure assessment, dose-response evaluation, and risk characterization. Additionally, in alignment with the full implementation of animal testing bans, the Notes of Guidance emphasizes the use of alternative methods, particularly non-animal approaches and new approach methodologies, for evaluating cosmetic ingredients.

For the safety evaluation of cosmetic ingredients, two functional channels are outlined in the diagram from the Notes of Guidance below. In principle, the guidance applies equally to safety evaluations conducted through both channels. 

• As illustrated in the left section of the diagram, the safety assessment of annexed substances is carried out under the responsibility of SCCS. Upon completing the assessment, SCCS issues its conclusions through SCCS Opinions. These opinions may serve as the basis for the Commission to consider amendments to ingredient annexes.

• As shown on the right side of the diagram, the safety evaluation of cosmetic products, including all ingredients contained, is carried out by enterprises placing them on the EU market. This responsibility lies with the responsible person. The conclusions from these evaluations shall be incorporated into the CPSR, and stored in the product information file (PIF).

1.3 Animal Testing

EU Cosmetics Regulation provides the most advanced protection against animal testing. Its predecessor, the former Directive 76/768/EEC (the Cosmetics Directive), established the regulatory framework of the phasing out of animal testing for cosmetic products. This directive implemented the ban on both testing and marketing of finished cosmetic products and ingredients tested on animals, with the following timelines:

• September 11, 2004: The ban on the performance of animal testing for cosmetic products (the "testing ban") came into force;

• March 11, 2009: The ban on the performance of animal testing for cosmetic ingredients came into force (the "testing ban"). Besides, the ban on the marketing of finished cosmetic products tested on animals (the "marketing ban") came into force, except for testing related to the most complex human effects, including repeated-dose toxicity, reproductive toxicity, and toxicokinetics;

• March 11, 2013: The full marketing ban on cosmetic products tested on animals came into force.

The same provisions are included in the new Cosmetics Regulation, which has replaced the Cosmetics Directive as from July 11, 2013. As per the Cosmetics Regulation, the marketing of cosmetic products is prohibited if the finished product, the final formulation, or any ingredients in the final formulation, have undergone animal testing.

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, which may only be granted with conditions where:

1. the ingredient is widely used and cannot be replaced by any other ingredient that can perform a similar function;

2. 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.

1.4 Labelling

For cosmetics made available on the EU market, their container and packaging shall bear the information specified in Article 19 of the Cosmetics Regulation, including a list of ingredients. This list shall be preceded by the word "ingredients", and can be presented solely on the packaging. In the context of labelling regulations, an "ingredient" refers to any substance or mixture intentionally used in the cosmetic product during manufacturing, excluding impurities in raw materials, and subsidiary technical materials that are not present in the final product.

The list shall follow the requirements below:

1. Ingredients shall be declared in descending order of weight at the time they are added. For those with concentrations less than 1%, they can be listed in any order after those with concentrations above 1%;

2. Ingredients shall be expressed by the names in the Glossary of Common Ingredient Names;

3. Perfume and aromatic compositions, and their raw materials, shall be referred to by the terms "parfum" or "aroma";

4. For nanomaterial ingredients, their names shall be followed by the word "nano" in brackets;

5. Colorants shall be listed using their Color Index (CI) numbers in any order after other ingredients. For decorative cosmetics with multiple color shades, all colorants used in the range may be listed (except those intended for hair coloring), provided that the phrase "may contain" or the symbol "+/-" is stated.

The Glossary of Common Ingredient Names, compiled by the Commission, serves as a mandatory reference list for ingredient names that shall be used for cosmetics labelling. However, it is important to note that the glossary neither constitutes a list of authorized or safe cosmetic ingredients, nor provides information on the regulatory status or function of the ingredients.

Part 2 Compliance in Specific Cosmetic Ingredients

2.1 CMR Substances

Within the European Community, Regulation 1272/2008 on Classification, Labelling and Packaging of Substances and Mixture (CLP Regulation) establishes a harmonized classification of hazardous chemicals, covering substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). Depending on their properties, the CLP Regulation further groups CMR substances under category 1A, category 1B, and category 2.

Article 15 of the Cosmetics Regulation sets rules on the use of CMR substances in cosmetics. To ensure comprehensive protection of human health, these substances are prohibited for use in cosmetics, unless an exemption has been granted by the Commission. Such an exemption can only happen if the industry submits an exemption application, and all criteria for exemption laid down in the Cosmetics Regulation are met.

2.2 Endocrine Disruptors

Endocrine disruptors (EDs), which may either be of synthetic or natural origin, are chemical substances that can alter the functioning of the endocrine system, and consequently produce adverse effects upon the human health. Compared to other toxicological chemicals, the property of EDs require attention to not only their toxic effects, but also the mechanism by which they interfere with the functioning of the hormonal system.

The Cosmetics Regulation does not include specific provisions for managing EDs. However, like other substances with concern for human health, substances identified as EDs are currently subject to safety assessment by SCCS. Upon SCCS's evaluation, the Commission will then implement appropriate measures to restrict or ban their use in cosmetic products.

In November 2018, the Commission reviewed the Cosmetics Regulation regarding substances with endocrine disrupting properties, and declared its commitment to creating a priority list of potential EDs not already covered by existing bans or restrictions in the Cosmetics Regulation for their subsequent safety assessment. After consultations with stakeholders, a list of 28 potential EDs was consolidated in early 2019. Based on their assessment status under the Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation), and available scientific evidence, the list was divided into the two following groups. SCCS has released opinions on most of them.

Group A: 14 Substances with Higher Priority for Assessment

Group B：14 Substances with Low Priority for Assessment

To comprehensively address the risks posed by harmful chemicals that may impact consumers and professional users similarly to CMR substances, the Commission revised the CLP Regulation on March 31, 2023, introducing EDs as well as persistent and mobile substances as new hazard categories. Following their formal inclusion, these substances will be identified as substances of very high concern (SVHCs) under the REACH Regulation, and may be prohibited for use in cosmetics similar to the existing ban of CMR substances under the Cosmetics Regulation.

2.3 Fragrance Allergens

Fragrance substances are organic compounds widely used in perfumes and other perfumed cosmetics. For sensitive consumers, their presence may trigger allergy symptoms, even at a much lower concentration than the maximum permitted levels. In order to ensure cosmetic's safe use, the Cosmetics Regulation considers it necessary to inform the sensitive consumers about the presence of fragrance allergens in cosmetics. Therefore, Article 19(1), point(g), of the Cosmetics Regulation stipulates that:

“Perfume and aromatic compositions, as well as their raw material, are to be referred to by the terms ‘parfum’ or ‘aroma’ in the list of ingredients. Moreover, the identified fragrance allergens shall be individually labelled on the package of cosmetics when their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products.”

To facilitate compliance, EU specified the fragrance allergens subject to the individual labelling requirement:

• On March 11, 2003, EU issued the Directive 2003/15/EC, introducing 26 fragrance allergens. However, with further scientific evidence, two of these allergens—hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) and butylphenyl methylpropional (Lilial)—were later banned from use in cosmetics. HICC was prohibited due to its link to allergic contact dermatitis, while Lilial was banned because of its reproductive toxicity.

• On July 27, 2023, EU published the Commission Regulation (EU) 2023/1545, identifying 57 additional fragrance allergens.

As a result, a total of 81 fragrance allergens are currently regulated in Annex III (the annex of restricted ingredients) of the Cosmetics Regulation. For the complete list of regulated fragrance allergens, please refer to the Cosme-list.

2.4 Nanomaterials

Within the EU's cosmetics regulatory framework, “nanomaterial” is defined as an intentionally manufactured material that is insoluble or biopersistent, with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.

Nanomaterials have various functions as cosmetic ingredients, such as UV filters, preservatives, colorants, etc. While bringing certain benefits to consumers, the nanoscale feature may also pose risks to consumers. As a result, ensuring the safety of nanomaterial ingredients has been an important focus in the Cosmetics Regulation.

According to the Cosmetics Regulation, cosmetics containing nanomaterials are subject to safety assessment, pre-market notification, and additional labelling.

2.4.1 Safety Assessment

For nanomaterials intended for cosmetic uses, cosmetic enterprises and risk assessors should follow the instructions outlined in the Guidance on the Safety Assessment of Nanomaterials in Cosmetics when carrying out the safety assessment. This guidance specifically addresses the safety aspects of nanomaterials, covering essential elements required in nanomaterial’s safety dossier, such as physicochemical characterization, exposure assessment, toxicological evaluation, and risk assessment. Besides, this guidance is complementary to the Notes of Guidance referenced to in section “1.2 Safety Assessment”, therefore should be used in conjunction with the latter.

In addition to assessments conducted by cosmetics enterprises, in the event that the Commission has concerns regarding the safety of a nanomaterial, it will request SCCS to assess their safety, and may amend ingredient annexes based on the assessment opinion.

2.4.2 Notification

In EU, cosmetic products have no need to gain a 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. Additionally, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person through CPNP six months prior to being placed on the market. Notably, this notification requirement only applies to nanomaterials that are not used as colorants, UV-filters, or preservatives that are regulated under the ingredient annexes to the Cosmetics Regulation.

The information required for the notification shall include at least the following:

1. The identification of the nanomaterial, including its chemical name, and other descriptors specified in point 2 of the “Preamble to Annexes II to VI”;

2. The specification of the nanomaterial, including its particle size, as well as physical and chemical properties;

3. An estimate of the quantity of nanomaterial contained in cosmetic products intended for market placement per year;

4. The toxicological profile of the nanomaterial;

5. The safety data of the nanomaterial relevant to the category of cosmetic product in which it is used;

6. The reasonably foreseeable exposure conditions.

2.4.3 Labelling

To enable consumers to identify whether their cosmetic products contain nanomaterials, EU has set additional labelling requirements for ingredients present in the form of nanomaterials. As mentioned in section “1.4 Labelling”, these ingredients shall be labelled with the word “nano” in brackets after the ingredient name, e.g., Zinc Oxide [nano].

2.5 Microplastics

In September 2023, EU released the Commission Regulation (EU) 2023/2055 to impose restrictions on products containing intentionally-added microplastics, including cosmetics. These restrictions apply to synthetic polymer microparticles that meet specific criteria:

1. They are present in particles and constitute at least 1% by weight of those particles, or form a continuous surface coating on particles;

2. At least 1% by weight of the particles referred to in "point a" fulfill either of the following conditions:

1. All dimensions of the particles are equal to or less than 5 mm;

2. The length of the particles is equal to or less than 15 mm, and their length-to-diameter ratio is greater than 3.

It is important to note that natural, degradable, and soluble polymers, as well as polymers without carbon atoms, fall outside the scope of the restrictions.

In addition, the restrictions require that, starting from October 17, 2023, synthetic polymer microparticles within the above scope shall not be placed on the market as individual substances. Additionally, if they are present in mixtures to confer a sought-after characteristic, their concentrations shall be below 0.01% by weight. To facilitate a smooth transition, specific transitional periods have been provided for the affected industries. For the cosmetics sector, the following transitional provisions apply:  

2.6 Formaldehyde Releasers

Formaldehyde releasers refer to certain preservatives that are gradually releases formaldehyde to fulfil their preserving function in finished cosmetic products. Since formaldehyde may trigger allergic reactions in consumers who are sensitized to it, products containing formaldehyde releasers are required to be labelled with the warning "contains formaldehyde" if the formaldehyde’s concentration in the finished product exceeds a specified level.

Previously, this threshold was set at 0.05% (500 ppm). However, in its scientific advice (SCCS/1632/21), SCCS concluded that this threshold could not adequately protect consumers sensitized to formaldehyde, and recommended lowering the labelling threshold to 0.001% (10 ppm) for total formaldehyde released, regardless of whether the product contains one or more formaldehyde releasers. In light of this advice, EU introduced the Commission Regulation (EU) 2022/1181 in July 2022, amending the Cosmetics Regulation to lower the labelling threshold for formaldehyde releasers listed in Annex V (the annex of permitted preservatives). Cosmetics in compliance with the prior threshold could be placed on the EU market until July 31, 2024, and remain available until July 31, 2026.