Cosmetic Safety Obligations are important in keeping consumers, the environment and the general population safe. In this series, we will delve into the safety obligations across the globe.
Safety obligations of Cosmetic Products Series
To learn more about the differences in safety obligations across regional regulations, explore our safety obligations of cosmetic products series:
REACH Safety Obligations
The REACH Regulation No. 1907/2006 (Registration, Evaluation, Authorisation, and Restriction of Chemicals) was adopted by the European Union in 2006. REACH is not specific to cosmetics, its provisions have a direct and profound impact on the cosmetic industry, ensuring that ingredients used in these products are safe for both human health and the environment.
What Is REACH Regulation?
The REACH Regulation (EC No. 1907/2006) governs the manufacturing, importation, and use of chemical substances within the EU. Its primary aim is to protect human health and the environment from risks posed by chemicals while enhancing the competitiveness of the EU chemicals industry. REACH applies to all chemical substances, whether they are used in industrial processes, household products, or cosmetics.
Under REACH, companies must:
- Register their chemicals with the European Chemicals Agency (ECHA).
- Evaluate the risks of chemicals to human health and the environment.
- Obtain authorisation for substances of very high concern (SVHCs).
- Comply with restrictions on hazardous chemicals.
Ingredient Safety Assessment
Under REACH, manufacturers and importers must submit detailed toxicological data for each chemical. This data includes studies on carcinogenicity, reproductive toxicity, skin irritation, and other potential health hazards. For cosmetics, this information is important in ensuring that ingredients meet the safety obligations outlined in the Cosmetics Regulation.
REACH data helps evaluate whether an ingredient in a face cream or lipstick could cause allergic reactions, sensitization, or long-term health risks.
Prohibition of Hazardous Substances
Some chemicals are classified as substances of very high concern (SVHCs) under REACH, including carcinogens, mutagens, or reproductive toxins (CMRs). Many of these substances are either restricted or banned from use in cosmetics under the Cosmetics Regulation.
Alternative Testing Methods
REACH promotes the use of alternative methods to animal testing, a priority also emphasized in the cosmetics industry. Since 2013, the EU has prohibited the marketing of cosmetics tested on animals. REACH supports this goal by validating non-animal testing methods, ensuring that safety data for cosmetic ingredients can be obtained without violating ethical standards. Although some data used in the classification process uses animal testing data. Therefore, although the products are not tested on animals, the ingredients used in cosmetic products may have been due to REACH obligations. If the ingredient use was solely cosmetic, then it wouldn’t have been tested on animals, but ingredients used in cosmetics are also often used in detergents, pharmaceuticals and household preparations.
Environmental Considerations
Many cosmetic products, such as shampoos, scrubs, and makeup removers, eventually enter the environment through wastewater systems. REACH evaluates the environmental impact of chemical substances, including their biodegradability and potential to bioaccumulate in aquatic ecosystems. This ensures that cosmetic ingredients do not pose excessive risks to wildlife or contribute to pollution.
Practical Implications for the Cosmetic Industry
The intersection of REACH and cosmetic safety imposes strict obligations on manufacturers and importers:
- Pre-market testing: Cosmetic companies must rely on REACH data to validate the safety of their ingredients.
- Supply chain transparency: Companies must ensure that suppliers comply with REACH requirements, providing complete safety information for raw materials.
- Ongoing vigilance: As new scientific data emerges, substances previously deemed safe may become restricted under REACH. Cosmetic manufacturers must stay updated to maintain compliance.
CLP Safety Obligations
The CLP Regulation (Classification, Labelling, and Packaging) plays a role in the assessment and communication of chemical hazards for cosmetic ingredients. Although cosmetics are primarily governed by the EU Cosmetics Regulation (EC No. 1223/2009), the CLP Regulation ensures that hazardous ingredients used in their formulation are properly identified and managed.
What Is the CLP Regulation?
The CLP Regulation (EC No. 1272/2008) implements the United Nations’ Globally Harmonized System (GHS) of classification and labelling of chemicals within the EU. It provides a standardized system to:
- Classify chemicals based on their physical, health, and environmental hazards.
- Label hazardous substances and mixtures with appropriate warnings (e.g., pictograms, hazard statements).
- Package chemicals safely to reduce risks during handling and use.
The CLP Regulation ensures that manufacturers, importers, and downstream users provide clear information about the hazards of chemical substances and mixtures, helping protect human health and the environment.
Classification of Cosmetic Ingredients
Under the CLP Regulation, manufacturers and importers must classify the ingredients used in cosmetics based on their potential hazards. This includes evaluating whether a substance is:
- A carcinogen, mutagen, or reproductive toxin (CMR).
- A skin sensitizer, irritant, or allergen.
- Harmful to the environment, such as aquatic toxicity.
For example, if a cosmetic ingredient is classified as a CMR substance, its use in cosmetics is generally prohibited under the EU Cosmetics Regulation unless specific exemptions apply. This ensures that hazardous substances are identified and restricted before they pose risks to consumers. The classification of skin sensitisers, irritants and allergens help safety assessors determine the overall safety of the cosmetic product in the cosmetic product safety report (CPSR).
Harmonized Classification
Certain hazardous substances used in cosmetics, such as preservatives, fragrances, or colorants, may have a harmonized classification under the CLP Regulation. Harmonized classification means that all manufacturers must follow the same hazard classification for a specific substance, ensuring consistent safety standards across the EU.
Hazard Communication in the Supply Chain
Even though finished cosmetic products are exempt from CLP labelling, the regulation plays a key role in ensuring the safe use of raw materials. Through Safety Data Sheets (SDS), chemical suppliers provide vital information about the hazards of substances and mixtures to downstream users, including cosmetic manufacturers. This helps companies:
- Identify risks during the formulation process.
- Implement safe handling practices for workers.
Impact on Worker Safety
The CLP Regulation contributes to the safety of workers involved in the production of cosmetics. By requiring clear labelling of hazardous raw materials, the regulation ensures that workers can take necessary precautions, such as using personal protective equipment (PPE) or implementing safe storage practices.
Environmental Protection
Cosmetic ingredients that may pose environmental risks, such as microplastics or persistent chemicals, are evaluated under the CLP Regulation for their ecological impact. This ensures that hazardous substances are managed responsibly, reducing their potential to harm aquatic ecosystems or accumulate in the environment.
Cosmetic Regulation Safety Obligations
Adopted in 2009 and enforced since 2013, the EU Cosmetic Regulation replaced the earlier Cosmetics Directive (76/768/EEC). The regulation provides a harmonized approach to cosmetic safety across all EU member states, ensuring that products meet the same high standards regardless of where they are sold or manufactured.
Key aspects of the regulation include:
- Strict requirements for ingredient safety.
- Clear labeling and product information for consumers.
- A ban on animal testing for cosmetic products and their ingredients.
Safety Assessment and Product Information File (PIF)
Before a cosmetic product can be placed on the market, it must undergo a thorough safety assessment conducted by a qualified safety assessor. This evaluation considers:
- The toxicological profile of each ingredient.
- The intended use of the product (e.g., rinse-off or leave-on).
- The potential exposure to consumers.
The results of this assessment are documented in a Product Information File (PIF), which must be readily available to regulatory authorities. The PIF includes:
- A cosmetic product safety report (CPSR).
- Detailed descriptions of the product’s formulation.
- Substantiation of claims (e.g., “anti-aging” or “hypoallergenic”).
- Data on animal testing or alternative methods.
Prohibited and Restricted Substances
The regulation includes annexes listing substances that are:
- Prohibited: Ingredients that are banned due to their potential harm to human health (Annex II).
- Restricted: Ingredients that can only be used under specific conditions, such as limited concentrations or restrictions on usage (Annex III).
For instance, heavy metals like lead and mercury are prohibited, while preservatives like parabens are restricted to safe concentrations.
Ban on Animal Testing
The EU is a global leader in ethical cosmetics. Since 2013, the Cosmetic Regulation has prohibited:
- Animal testing for finished cosmetic products.
- Animal testing for cosmetic ingredients or raw materials.
- The marketing of cosmetic products that have been tested on animals.
This has led to significant advancements in alternative testing methods, such as in vitro testing and computer modeling, ensuring that products are safe without compromising animal welfare.
Good Manufacturing Practices (GMP)
Cosmetic products must be manufactured according to Good Manufacturing Practices (GMP). This ensures that products are consistently produced and controlled to meet quality standards. GMP requirements minimize the risk of contamination, ensure accurate labeling, and guarantee the stability of products over their shelf life. The third party company International Organization for Standards helps to standardise GMP approaches through the Standard ISO 22716:2007.
Notification
All cosmetic products must be registered with the Cosmetic Products Notification Portal (CPNP) before being placed on the market. This centralized database allows EU authorities to monitor products and take swift action if safety concerns arise.
Labeling Requirements
The Cosmetics Regulation mandates clear and transparent labeling, including:
- A list of ingredients using the International Nomenclature of Cosmetic Ingredients (INCI) system.
- Warnings or usage instructions for specific products (e.g., hair dyes).
- The name and address of the Responsible Person (RP).
- An expiration date or period after opening (PAO) symbol.
This helps consumers make informed choices, use products safely and know where to seek help in the case of undesirable effects.
Regulatory Bodies Mandating Safety Obligations
European Commission
The European Commission is the primary regulatory body responsible for overseeing the implementation of the EU Cosmetics Regulation. Its roles include:
- Drafting and updating cosmetic regulations.
- Managing the Cosmetic Products Notification Portal (CPNP), where all cosmetic products must be registered before being placed on the EU market.
- Developing guidelines for manufacturers, distributors, and importers to ensure compliance.
Scientific Committee on Consumer Safety (SCCS)
The SCCS is an advisory body composed of independent experts. It provides scientific opinions on the safety of cosmetic ingredients, particularly in cases of:
- Substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances).
- Ingredients for which new safety concerns have emerged.
The SCCS evaluates data submitted by manufacturers or stakeholders and issues recommendations to the European Commission. These opinions often influence regulatory decisions, such as banning or restricting certain ingredients.
National Competent Authorities (NCAs)
Each EU member state has its own National Competent Authority (NCA) responsible for enforcing the EU Cosmetics Regulation within its territory. NCAs play a crucial role in:
- Monitoring compliance with cosmetic safety obligations.
- Conducting market surveillance and inspections.
- Investigating consumer complaints and adverse reactions to cosmetics.
- Taking enforcement actions, such as product recalls or fines, for non-compliance.
Examples of NCAs include:
European Chemicals Agency (ECHA)
While the ECHA primarily oversees the implementation of the REACH Regulation and CLP Regulation, its work has a significant impact on cosmetics.
- The ECHA evaluates the safety of chemicals used in cosmetics, including their environmental impact.
- Substances of Very High Concern (SVHCs) identified by ECHA under REACH are often restricted or banned from use in cosmetics.
Border Control and Customs Authorities
Customs authorities in each member state are responsible for checking cosmetic products imported from outside the EU. They ensure compliance with the EU Cosmetics Regulation by verifying product documentation, labeling, and safety.
Consumer Protection Agencies and Rapid Alert System (RAPEX)
The RAPEX system (Rapid Alert System for Dangerous Non-Food Products) is a network that allows EU member states and the European Commission to share information about dangerous cosmetic products found on the market.
- If a product is deemed unsafe, it can be recalled or withdrawn from the market across the EU.
