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)
Modernization of Cosmetics Regulation Act (MoCRA) – United States
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
Modernization of Cosmetics Regulation Act (MoCRA) – United States
For cosmetics imported into the United States, MoCRA turns cosmetics oversight into a more formal compliance system.
MoCRA is a paradigm shift in U.S. cosmetics regulation. For importers, compliance is not optional - it is essential for market access. By registering facilities, listing products, substantiating safety, reporting adverse events, updating labels, and preparing for GMPs, importers can ensure smooth entry into the U.S. market.
1.1 Mandatory facility registration and product listing
• Facility registration: facilities that manufacture or process cosmetics for distribution in the U.S. must register with FDA.
• Facility registration renewal: must be renewed every two years.
• Product listing: a responsible person must list each marketed cosmetic product with FDA, including ingredients, and provide updates annually.
• FDA introduced / uses 'Cosmetics Direct' as the system for registration / listing submission.
Why this matters for imports: if your product is manufactured abroad but distributed into the U.S., the foreign manufacturer / processor (and the importer establishment, depending on how it’s structured) typically still triggers the 'facility' and 'responsible person' obligations. The compliance work cannot stop at the customs entry - it must be supported by the regulated parties.
‘Responsible Person’ means: The manufacturer, packer, or distributor whose name appears on the label.
Importers must designate a U.S. Responsible Person or Agent. Non-U.S. manufacturers must appoint a U.S. Agent to liaise with FDA.
1.2 Adverse event reporting (serious adverse events)
• A responsible person must report serious adverse events associated with cosmetic use to FDA within 15 business days of becoming aware.
• Reports include information such as a copy of the label on or within the retail packaging.
• If additional medical / other information is received within 1 year of the initial report, it must be submitted within 15 business days.
• Adverse event records are maintained for 6 years (and fewer years for some small businesses).
1.3 Safety substantiation (record-based duty)
Cosmetics generally do not require FDA pre-approval to be marketed (with some color additive exceptions), but the manufacturer / marketer must ensure safety.
MoCRA requires adequate safety substantiation:
• The responsible person must ensure and maintain records supporting safety.
• “adequate substantiation” includes tests, studies, research, analyses, or other information that experts consider sufficient to support a reasonable certainty of safety.
• Animal testing is not a requirement for marketing, but the data must be scientifically robust.
Why this matters for imports: U.S. safety substantiation must be supported by data you can stand behind for the specific products and claims marketed in the U.S. You may be able to rely on existing data, but the “record readiness” becomes essential because FDA can access records under MoCRA.
‘Responsible Person’ means: The manufacturer, packer, or distributor whose name appears on the label.
Importers must designate a U.S. Responsible Person or Agent. Non-U.S. manufacturers must appoint a U.S. Agent to liaise with FDA.
1.4 Good Manufacturing Practice (GMP) establishment and enforcement consequences
MoCRA directs FDA to establish regulatory GMPs consistent with national / international standards. FDA is expected to issue proposed and final rules over time. Importantly, the industry-facing explanation highlights the consequence: if products are manufactured / processed under conditions that fail to meet GMP requirements, the products can be deemed adulterated, meaning they cannot legally be sold in the U.S., and non-compliance may lead to severe penalties.
• MoCRA requires FDA to establish GMP regulations for facilities that manufacture cosmetic products, and it references a GMP draft guidance.
• MoCRA also requires additional science-based rulemaking (e.g., fragrance allergen labeling and standardized test methods for asbestos in talc-containing products).
Why this matters for imports: GMP compliance must cover the actual manufacturing / processing environment -often outside the U.S. - not just the U.S. labeling operation. You need supplier and factory documentation, training, SOPs, and records that align with the eventual GMP rule expectations.
1.5 Labeling and fragrance allergen transparency
MoCRA requires cosmetics labeling changes, including:
• Contact information for reporting potential adverse events (address / phone / electronic means as applicable).
• Identification of each fragrance allergen in the product.
• For professional products: additional labeling related to professional use (e.g., only licensed professionals may use the product).
1.6 New FDA enforcement tools (recalls, suspension, records access)
MoCRA gives FDA new authorities that change compliance risk:
• Records access: if certain conditions are met, FDA can access / copy certain records related to a cosmetic product, including safety records.
• Facility suspension: FDA can suspend a facility’s registration if FDA determines there’s a reasonable probability that products from the facility may cause serious adverse health consequences or death.
• Mandatory recall authority: if FDA determines a cosmetic is adulterated or misbranded and exposure will cause serious adverse health consequences or death, FDA can order a mandatory recall if a responsible person refuses voluntary recall.
Why this matters for imports: enforcement risk is no longer limited to U.S.-based manufacturing operations; FDA can act against imported products through the record trail and the regulated facility / responsible person chain.
2. Facility registration & product listing requirements (importer-specific workflow)
2.1 Facility registration
• Manufacturers and processors must register facilities with FDA.
• Registration must be renewed every two years.
• FDA can suspend a facility’s registration if serious adverse health consequences or death are reasonably probable from products manufactured / processed there.
2.2 Product listing
• A responsible person must list each marketed cosmetic product, including ingredients, and provide updates annually.
• It highlights the importance of FEI (FDA Establishment Identifier) and using FDA’s platform and deadlines for existing / new facilities.
• It describes that companies may verify / obtain FEI and handle registration/listing support.
MoCRA replaced a previously voluntary registration program (VCRP) with required registration / listing.
2.3 Cosmetics Direct
FDA is using Systems (including 'Cosmetics Direct') for registration / listing submissions.
3. Safety substantiation: testing & documentation expectations
3.1 Safety substantiation
• FDA does not require pre-market approval of cosmetics (with some exceptions).
• But MoCRA requires companies to maintain records supporting adequate safety substantiation.
• MoCRA does not require animal testing.
• Data should come from scientifically robust methods.
3.2 Adequate substantiation
Adequate safety substantiation includes tests, studies, research, analyses, or other information that experts consider sufficient to support reasonable certainty that a product is safe.
The responsible person must keep records proving safety, including tests, studies, and other expert-approved evidence.
3.3 The types of testing and safety evidence typically involved
• Acceptable evidence includes:
- Toxicological profiles of ingredients
- Microbiological testing (challenge tests, preservative efficacy)
- Analytical chemistry
- Stability testing (shelf life, packaging compatibility)
- Dermatological / allergen testing (patch tests, HRIPT)
- and other types of tests
• Align with ISO 10993 (biocompatibility) and OECD toxicology guidelines
3.4 Documentation
Importer implications:
• Build a product-specific safety file that includes ingredient specifications, toxicological / risk assessments, and relevant test results.
• Ensure your U.S. claims and intended use align with your safety substantiation evidence.
• Ensure you can produce the records during FDA inspection or under FDA records access authority.
3.5 Testing Standards
Importers should align with internationally recognized testing standards:
• Microbiological safety: USP <61>, USP <62>, ISO 18415
• Preservative efficacy: ISO 11930 (Challenge Test)
• Stability testing: ICH Q1A(R2) guidelines
• Heavy metals & contaminants: ICP-MS testing per FDA guidance
• Allergen testing: HRIPT (Human Repeat Insult Patch Test)
• Packaging compatibility: ASTM standards for migration / leaching
4. Labeling and fragrance allergen transparency
Labels must include:
• Contact information (address, phone, email, or website) for adverse event reporting
• Fragrance allergen disclosure
• Professional use labeling (e.g., salon-only products)
MoCRA requires labeling changes including:
• Direct contact information for adverse event reporting
• Fragrance allergen identification in the product
• Professional products: professional-use statements
Labels not listing fragrance allergens can be considered misbranded. Products without proper labeling may be deemed misbranded.
Fragrance allergen labeling requires you to know:
• which fragrance allergens are present above applicable threshold conditions;
• you must be able to support that allergen list with formulation knowledge and / or validated analytical support.
5 Small business exemptions
MoCRA provides exemptions for certain small businesses:
• Small businesses can have simplified requirements and a longer compliance period.
• Small businesses may be exempt from GMP and facility / product registration requirements if average gross sales are below $1M over the prior three years (and other conditions).
• Exemptions do not apply to certain products (mucus membrane of the eye contact products, injected products, internal use products, and products intended to alter appearance for more than 24 hours, and certain drug / device related products).
Importer implications:
• If you are not a qualifying small business, you need full MoCRA compliance.
• If you are a qualifying small business, ensure your product category doesn’t fall into exemption exclusions.
6. MoCRA compliance for imported cosmetics
For cosmetics imported into the United States, MoCRA turns cosmetics oversight into a more formal compliance system with:
• Mandatory facility registration and product listing (with FDA systems),
• Mandatory serious adverse event reporting within 15 business days and defined serious-event criteria,
• Safety substantiation recordkeeping (no premarket approval required, but safety must be demonstrably supported),
• GMP rulemaking leading to potential adulteration determinations if facilities fail to meet requirements,
• Labeling updates including adverse event contact information and fragrance allergen transparency,
• Expanded FDA enforcement tools: records access, facility suspension, and mandatory recall authority,
• Exemptions for certain small businesses, with exclusions,
• And a growing regulatory focus on safety science topics like PFAS and standardized asbestos-in-talc testing methods.
