Beauty and Personal Care
Prime Testing Group Ltd. offers the following testing / evaluation services related to cosmetics:
Cosmetic Products Regulation EC 1223/2009
Cosmetic Product Safety Report (CPSR)
Heavy Metals Test
Microbiological Test
Formaldehyde Content
1,4 dioxane
Steroid Test (Glucocorticoids)
European Union
When importing cosmetics into the European Union (EU), compliance with a comprehensive set of regulations and safety standards is essential. The EU has established rigorous requirements to ensure consumer safety and product efficacy. Below is a detailed overview of the key regulations, testing requirements, and safety standards for cosmetics in the EU.
1. Regulatory Framework
1.1. Regulation (EC) No. 1223/2009
This regulation is the cornerstone of cosmetic product regulation in the EU. It covers:
• Definition of Cosmetics: A cosmetic product is defined as any substance or mixture intended to be placed in contact with the external parts of the human body.
• Safety Assessment: All cosmetic products must undergo a safety assessment before being placed on the market. This assessment must be conducted by a qualified safety assessor.
1.2. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)
• Chemical Safety: Imports must comply with REACH, which regulates the use of chemicals in products. Companies must register chemical substances used in cosmetics.
• Substances of Very High Concern (SVHC): Products containing SVHCs must be disclosed, and appropriate risk management measures must be implemented.
1.3. CLP Regulation (Classification, Labelling and Packaging)
• Labeling Requirements: The CLP Regulation requires that all chemicals, including those in cosmetics, be classified and labeled according to their hazards.
2. Safety Testing Requirements
2.1. Safety Assessment
• Cosmetic Product Safety Report (CPSR): A CPSR must be prepared for each cosmetic product, including:
- Physical and Chemical Properties: Data on the stability and compatibility of the product.
- Microbiological Quality: Testing for contamination and stability.
- Toxicological Profile: Evaluation of ingredients for potential toxicity.
2.2. Testing Methods
• In Vitro Testing: The use of alternative methods, such as in vitro assays, is encouraged to assess safety without animal testing.
• Dermal Irritation: Testing for skin irritation potential is mandatory.
• Sensitization Testing: Products must be tested for potential allergic reactions.
2.3. Product Stability Testing
• Shelf Life: Stability testing must be conducted to determine the shelf life and efficacy of the product over time.
• Storage Conditions: Testing under various storage conditions to evaluate product performance.
3. Ingredient Restrictions and Prohibitions
3.1. Annex II of Regulation (EC) No. 1223/2009
• Prohibited Substances: A list of substances that are banned from use in cosmetic products, such as certain heavy metals and harmful chemicals.
3.2. Annex III
• Restricted Substances: Ingredients that may be used only under certain conditions or in specific concentrations.
3.3. Annex IV and Annex V
• Coloring Agents and Preservatives: Lists of approved colorants and preservatives, including their permitted uses.
4. Labeling Requirements
4.1. Information on Labels
• Product Identity: The name and function of the cosmetic product.
• Ingredients List: All ingredients must be listed in descending order of concentration.
• Warnings: Any necessary warnings or precautions for safe use.
• Batch Number: Identification of the batch for traceability.
4.2. Multilingual Labels
• Language Requirements: Labels must be in the language(s) of the country where the product is sold, ensuring consumers understand the information.
5. Good Manufacturing Practices (GMP)
• ISO 22716: Compliance with international standards for GMP is essential. This includes:
- Quality Control: Ensuring that products are consistently produced and controlled according to quality standards.
- Documentation: Maintaining records of manufacturing processes and quality checks.
6. Notification Requirements
6.1. Cosmetic Product Notification Portal (CPNP)
• Pre-Market Notification: Before placing a cosmetic product on the EU market, it must be notified through the CPNP, providing essential information such as:
- Product Details: Name, category, and intended use.
- Responsible Person: The entity responsible for product compliance.
7. Animal Testing Regulations
• Ban on Animal Testing: The EU has a strict prohibition on the testing of finished cosmetic products and their ingredients on animals.
• Alternative Methods: Promotion of non-animal testing methods for safety assessments.
8. Enforcement and Compliance
8.1. Market Surveillance
• Inspections: Member States are responsible for conducting market surveillance to ensure compliance with cosmetic regulations.
• Penalties: Non-compliance can lead to penalties, product recalls, or bans.
9. Claims and Advertising
9.1. Substantiation of Claims
• Truthful Advertising: Any claims made about the product must be substantiated by evidence, ensuring that they are not misleading.
9.2. Claims Regulation
• Cosmetic Claims: Claims about effectiveness, safety, and benefits must comply with EU regulations, ensuring transparency and honesty.
10. Specific Considerations for Natural and Organic Cosmetics
10.1. Certification Standards
• Organic Certification: Products claiming to be organic may need to comply with specific standards from recognized certification bodies.
• Natural Ingredients: Clear definitions of what constitutes a "natural" product may vary by certification body.
Additional Information
Product Information File (PIF)
A Product Information File (PIF) should be established. The PIF must be kept for 10 years after the last batch of the product is placed on the market.
The PIF must include at least, but not limited to, the following data:
• Product description
• Product name
• Unique Internal formulation reference
• Language variations
• Product function
• Finished product specification
• Primary and secondary artwork
• Cosmetic Product Safety Report
• Method of manufacture / GMP statement
• Proof of effect
• Historic animal testing data
• Ingredient Material Safety Data Sheets (MSDS)
Notification via the European Electronic Portal (Cosmetic Product Notification Portal, CPNP)
The cosmetic products should be notified on the new portal. The product notification process is simplified with the introduction of a single harmonized ‘e-notification‘ system (Cosmetic Product Notification Portal, CPNP) for all markets in which the product is sold.
This should be done by an E.U. Responsible Person (RP).
The followings show the neccessary information (but not limited to) to be included:
• Category of product
• Name of product
• Name and address of Responsible Person
• Contact person in case of necessity
• Country of origin (imports only)
• Member state where placed on the market
• Nanomaterials information
• CMRs identification
• Original packaging, or photograph of original packaging
• Frame formulation for emergencies
United States
Regulatory Framework
1. Federal Food, Drug, and Cosmetic Act (FDCA)
- The primary legislation governing the safety and labeling of cosmetics in the U.S.
- Cosmetics must be safe for use and properly labeled.
2. Food and Drug Administration (FDA)
- The FDA oversees the regulation of cosmetics under the FDCA.
- The agency requires that cosmetics be safe for consumers when used as intended.
3. Cosmetic Ingredient Review (CIR)
- An independent panel that assesses the safety of cosmetic ingredients.
- Manufacturers can submit their products for evaluation.
Safety Standards
1. Safety Assessments
- Pre-Market Safety Testing: Manufacturers are responsible for ensuring their products are safe before marketing.
- Cosmetic Safety Data: Companies should maintain safety data for each ingredient, including toxicological data.
2. Good Manufacturing Practices (GMP)
- While not mandatory, following GMP is recommended to ensure product quality and safety.
- Includes proper sanitation, quality control, and personnel training.
3. Adverse Event Reporting
- Manufacturers must report any serious adverse events related to their cosmetics to the FDA.
- A system for monitoring consumer complaints and injuries is essential.
4. Ingredient Restrictions
- Certain ingredients are prohibited or restricted under FDA regulations (e.g., mercury, certain color additives).
- The FDA maintains a list of banned substances.
Labeling Requirements
1. Ingredient Labeling
- Ingredients must be listed in descending order of predominance.
- Common or usual names must be used.
2. Product Claims
- Claims made on labels must be truthful and not misleading.
- Specific terms like "hypoallergenic" or "non-comedogenic" must be substantiated.
3. Warning Labels
- Products that pose risks must include appropriate warning labels.
- For example, products containing certain allergens may require cautionary statements.
Specific Testing Requirements
1. Microbial Testing
- Testing for microbial contamination is crucial, especially for water-based products.
- Common tests include total aerobic microbial count (TAMC) and total yeast and mold count (TYMC).
2. Stability Testing
- Products should undergo stability testing to ensure they remain safe and effective throughout their shelf life.
- Testing should include various conditions (temperature, light exposure).
3. Allergy Testing
- Patch testing may be conducted to identify potential allergens in products.
- Products must be formulated to minimize the risk of allergic reactions.
4. Toxicological Testing
- Various tests may be conducted, including skin irritation, eye irritation, and sensitization tests.
- In vitro methods are increasingly used to reduce animal testing.
International Regulations
1. European Union (EU) Standards
- Many U.S. companies comply with EU regulations for international markets, which may influence U.S. standards.
- The EU has stricter regulations regarding safety assessments and ingredient restrictions.
2. Global Harmonization
- Efforts are underway to harmonize cosmetic regulations internationally (e.g., through the International Organization for Standardization - ISO).
