Claims and Warnings in the EU and the UK Cosmetic Regulations: A Comprehensive Guide to Compliance

Cosmetic products are subject to strict regulations in the European Union (EU) and the United Kingdom (UK) to ensure consumer safety and prevent misleading information.

Understanding Claims and Warnings

Claims

Claims refer to statements made by cosmetic product manufacturers or sellers regarding the benefits, characteristics, or properties of a product. These claims can range from general descriptions to specific performance attributes. Examples include "hydrates skin," "reduces wrinkles," or "improves hair strength."

Warnings

Warnings are cautionary statements that alert consumers to potential risks, hazards, or specific safety precautions associated with the use of a cosmetic product. Warnings are aimed at ensuring consumer safety and informing them about any potential adverse effects or specific usage instructions. These risks may arise from specific ingredients, usage instructions, or potential side effects. Examples of warnings include "avoid contact with eyes," "patch test before use," or "not suitable for children under three years."

Different types of claims and warnings

It is important to note that while claims focus on the positive aspects and benefits of a cosmetic product, warnings address potential risks and precautionary measures to mitigate them. Both claims and warnings are subject to regulations to prevent misleading information, protect consumer safety, and ensure that the products are used appropriately.

Types of claims

a) Efficacy claims: These claims describe the positive effects or results that can be expected from using a product. Examples include "brightens skin tone" or "strengthens nails."

b) Comparative claims: These claims compare the performance or characteristics of one product to another. They should be supported by scientifically valid evidence and should not be misleading.

c) Cosmetic function claims: These claims highlight the intended cosmetic purpose or function of the product. Examples include "moisturizes lips" or "soothes sensitive skin."

Types of warnings

a) Allergy warnings: These warnings are necessary when a product contains known allergens or ingredients that may cause allergic reactions in certain individuals.

b) Usage warnings: These warnings inform consumers about specific precautions or instructions for the safe use of a product. They may include directions for patch testing, avoiding contact with sensitive areas, or using the product as directed.

c) Sun protection warnings: These warnings are mandatory for cosmetic products that provide sun protection. They inform consumers about the level of sun protection offered and emphasize the importance of reapplication.

Ensuring Compliance with Regulations

EU Cosmetic Regulation

a) EU Regulation 1223/2009: This regulation sets out the requirements for claims and warnings in the EU. It mandates that claims must be truthful, substantiated by evidence, not misleading, and comply with specific restrictions.

b) Cosmetic Product Safety Report (CPSR): Manufacturers must prepare a CPSR, which includes an assessment of the safety and compliance of the product, including claims and warnings.

UK Cosmetics Regulation

The UK has adopted similar regulations to the EU, specifically the EU Regulation 1223/2009, with some modifications to align with the UK legislation after Brexit. The key principles for claims and warnings remain the same.

Compliance Requirements

To ensure compliance with the EU and the UK cosmetic regulations, manufacturers and sellers must:

a) Substantiate claims: All claims must be supported by scientific evidence or data. Manufacturers should conduct appropriate tests, studies, or trials to validate the claimed benefits or properties of their products.

b) Avoid misleading claims: Claims must not be false, ambiguous, exaggerated, or likely to mislead consumers. They should accurately reflect the product's characteristics and performance.

c) Comply with specific restrictions: Certain types of claims, such as medical claims or claims related to the prevention or treatment of diseases, are prohibited for cosmetic products. Manufacturers should familiarize themselves with the specific restrictions outlined in the regulations.

d) Provide clear and conspicuous warnings: Warnings should be clearly stated on the product packaging or accompanying literature. They should be easily understandable, visible, and accessible to consumers.

Warning requirements

The definition of a cosmetic product within regulatory frameworks can have implications for the warnings that need to be provided. Here's how the definition can impact warnings:

a) Scope: The definition of a cosmetic product determines the areas of the body with which the product is intended to come into contact. Warnings are typically related to the proper and safe use of the product on those specific areas. For example, if a cosmetic product is intended for application to the skin, warnings may include instructions to avoid contact with eyes, to conduct a patch test before use, or to discontinue use if irritation occurs.

b) Potential risks: Warnings are aimed at informing consumers about potential risks associated with the use of a cosmetic product. The definition helps identify the specific risks that may be relevant. For instance, if a cosmetic product is intended for use on the lips, warnings may include statements to avoid ingestion and to discontinue use if any adverse reactions or symptoms occur.

c) Allergens: If a cosmetic product contains known allergens or ingredients that may cause allergic reactions in some individuals, warnings may be required to alert consumers who are susceptible to such allergies. The definition helps identify the substances or ingredients that may require specific warnings to ensure consumer safety.

d) Mucous membranes: If a cosmetic product is intended for use on or near mucous membranes (such as the oral cavity), warnings may be necessary to inform consumers about potential risks specific to those areas. For example, warnings may include statements to avoid swallowing the product or to rinse thoroughly after use.

e) Precautionary statements: Warnings can also include precautionary statements related to specific usage instructions or circumstances. For instance, if a cosmetic product provides sun protection, warnings may include recommendations to reapply the product frequently for sustained protection against UV radiation.

By considering the definition of a cosmetic product, manufacturers and sellers can identify the appropriate warnings to communicate to consumers. This helps ensure that consumers are well-informed about potential risks, usage instructions, and precautions associated with the cosmetic product, enabling them to use it safely and responsibly.

Claims requirements

The definition of a cosmetic product within the EU and the UK regulations has a significant impact on the claims that can be made about the product. Claims made about a cosmetic product must align with its defined purpose and intended use as stated in the regulation.

Cosmetic definition

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 aim of exclusively or mainly cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or correcting body odours.

Here are some key impacts:

a) Scope: Claims must relate to the specific functions and effects defined in the regulation, such as cleaning, perfuming, changing appearance, protecting, maintaining, or correcting body odors. Any claims that go beyond these intended purposes may be considered non-compliant.

b) Substantiation: Claims made about a cosmetic product must be substantiated by evidence. Manufacturers must possess scientific data or appropriate studies to support the claims they make. This ensures that claims are truthful, accurate, and not misleading to consumers.

c) Prohibited claims: The EU regulation prohibits claims that imply the product has a pharmaceutical effect or can treat or prevent diseases. Cosmetic products cannot make medical claims, as they are not classified as medicinal products. Claims suggesting therapeutic or curative properties are not allowed.

d) Comparative claims: Comparative claims, where a cosmetic product is compared to another product, are allowed as long as they are truthful, substantiated, and do not denigrate competitors. Comparative claims should not mislead or create confusion for consumers.

e) Precautionary Statements: Depending on the nature of the product and its ingredients, certain precautionary statements or warnings may be required. These warnings inform consumers about potential risks, proper usage, or specific precautions associated with the cosmetic product.

f) Language and Clarity: Claims must be clear, understandable, and presented in a language that the target consumer can easily comprehend. Claims should not be ambiguous or open to multiple interpretations, ensuring that consumers can make informed decisions.

It is important for manufacturers and marketers to ensure that the claims they make about their cosmetic products align with the defined purpose, are supported by scientific evidence, comply with the regulatory restrictions, and are communicated clearly and transparently to consumers. Failure to comply with these requirements can lead to regulatory issues, penalties, or legal consequences.

Examples of Non-Compliant Claims and Warnings

Regulatory authorities continue to closely monitor the industry and take action against non-compliance to protect consumers and maintain fair practices within the cosmetics market.

Non-compliant claims and warnings can lead to penalties and legal consequences for companies.

Some notable examples include:

The United Kingdom's Advertising Standards Authority (ASA) ruled against a multinational company for an advertisement promoting its foundation. The ASA found that the advertisement, featuring an actress, misleadingly exaggerated the product's ability to provide flawless skin and reduce the appearance of wrinkles. The claims were deemed to be unsubstantiated and in breach of advertising rules. As a result of this ruling, the company was required to withdraw the advertisement and discontinue the claims. While specific financial penalties were not disclosed, it serves as an example of a prominent cosmetic company facing regulatory action and being compelled to alter or withdraw non-compliant claims.

ASA ruled against a famous brand for claims made on its website regarding the effectiveness of its products against COVID-19. The ASA found the claims to be misleading and unsubstantiated, as they implied that the products could provide protection or prevent the spread of the virus. It was required to remove the claims and ensure future compliance with advertising rules.

A well-known cosmetics brand, faced scrutiny from French authorities regarding the presence of sensitizing ingredients. The Directorate-General for Competition, Consumer Affairs, and Fraud Control (DGCCRF) found that some products contained allergenic substances without the required warning labels to alert consumers who may be sensitive or allergic to those ingredients. As a result, the brand was fined €30,000 and required to modify its product labeling to comply with regulations.

Please note that the specific penalties and enforcement actions can vary depending on the jurisdiction and the severity of the non-compliance. Here are some potential consequences:

a) Financial penalties: Regulatory authorities can impose fines or monetary penalties on companies found to be in violation of cosmetic regulations. The amount of the penalty may vary based on factors such as the nature and extent of the violation.

b) Product recalls: In cases where a cosmetic product poses a significant risk to consumer safety or does not comply with regulatory requirements, authorities may require the company to initiate a product recall. This involves removing the non-compliant product from the market and notifying consumers who have purchased the product.

d) Corrective actions: Companies may be required to take corrective actions, such as reformulating the product, revising labeling or packaging, or modifying claims and warnings to ensure compliance with regulations. These actions are aimed at rectifying the non-compliance and bringing the product in line with regulatory requirements.

e) Market withdrawal: Regulatory authorities may request companies to withdraw non-compliant products from the market voluntarily. This may involve the removal of products from store shelves or the discontinuation of the product's production and distribution.

f) Reputational damage: Non-compliance with claims and warnings regulations can lead to reputational damage for a company. Negative publicity, consumer distrust, and loss of market share are potential consequences that can significantly impact a company's brand reputation.

It is important to note that regulatory enforcement actions and penalties can vary on a case-by-case basis, and specific details of such cases may not always be readily available in the public domain.

Compliance with EU and UK cosmetic regulations regarding claims and warnings is crucial for manufacturers and sellers to ensure consumer safety and prevent misleading information. Understanding the definitions, types, and requirements of claims and warnings is essential. By working with consulting firms specializing in cosmetic regulations, businesses can navigate the complex regulatory landscape, substantiate claims, provide accurate warnings, and ultimately maintain compliance with the regulations.

Our services

a) Regulatory Analysis: We can help businesses understand the specific requirements and restrictions related to claims and warnings in the EU and the UK regulations.

b) Claims Substantiation: We would be happy to assist in gathering scientific evidence, conducting tests or trials, and preparing robust documentation to substantiate product claims.

c) Labeling and Packaging Review: We review product labels, packaging materials, and accompanying literature to ensure that warnings are clear, conspicuous, and compliant with regulations.

d) Compliance Audits: If needed, we can conduct comprehensive audits of a company's product portfolio to identify any non-compliant claims or warnings and provide recommendations for corrective actions.

e) Training and Education: We can offer training programs and workshops to educate company staff on the regulations, best practices, and recent updates related to claims and warnings.