FDA & International Regulations

All chemical substances manufactured or imported into the EU in quantities of 1 tonne or more per year must be registered with ECHA. Includes comprehensive safety assessments, substance identification, hazard classification, and safe use guidance. Tonnage bands determine data requirements: 1-10t, 10-100t, 100-1000t, and >1000t annually.

26 fragrance allergens must be declared on cosmetic product labels if present above 0.001% (10 ppm) in leave-on products or 0.01% (100 ppm) in rinse-off products. Includes: Amyl cinnamal, Amylcinnamyl alcohol, Anisyl alcohol, Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Cinnamyl alcohol, Cinnamal, Citral, Citronellol, Coumarin, Eugenol, Farnesol, Geraniol, Hexyl cinnamal, Hydroxycitronellal, Hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral), Isoeugenol, Lilial, d-Limonene, Linalool, Methyl 2-octynoate, g-Methylionone, Oakmoss extract, Treemoss extract.

Regulation of substances that may be safely used in food as flavoring agents. Includes GRAS (Generally Recognized As Safe) substances listed in 21 CFR Part 182 and approved food additives in 21 CFR Part 172. FEMA GRAS numbers provide industry consensus on safety. Maximum usage levels vary by food category. Electronic GRAS notification process required for new substances since 1997.

Latest amendment includes complete prohibition of Lilial (Butylphenyl Methylpropional) effective March 1, 2025, due to reproductive toxicity concerns. Updated restrictions on 180+ fragrance materials based on RIFM safety assessments. Applies to 12 product categories with different restriction levels. Includes specifications for purity, limits on impurities, and prohibited ingredients. Mandatory for IFRA members and widely adopted globally.

All cosmetic products must be notified to Thai FDA before importation, manufacturing, or sale in Thailand. Notification valid for 3 years, renewable. Requires: product formula disclosure, safety assessment, manufacturing site license, quality control data, labeling compliance. Special requirements for products containing restricted substances or making therapeutic claims. Separate notifications required for each formulation variant.

Requires chemical manufacturers and importers to classify chemicals, prepare labels and safety data sheets (SDS), and provide hazard information to downstream users. Aligned with UN GHS Rev. 3 classification criteria. Requires 16-section SDS format, standardized pictograms, signal words, and hazard/precautionary statements. All hazardous chemicals must be properly labeled and documented. Training required for all employees handling hazardous chemicals.

New registration system effective 2021 differentiates between ordinary and special cosmetics. Registration required for special cosmetics (including certain fragrances); notification for ordinary cosmetics. Imported products must have responsible person in China. Requires: safety assessment, formula disclosure, efficacy claims substantiation, animal testing data (for certain categories), toxicology reports. Annual reports mandatory for registered products.

Implements UN GHS in the EU for classification, labeling, and packaging of chemicals. Requires classification of substances and mixtures according to harmonized criteria. Mandatory use of standardized pictograms, signal words, hazard statements, and precautionary statements. Classification and Labeling (C&L) inventory notification required for all substances placed on EU market. Self-classification required for mixtures. Regularly updated with Adaptations to Technical Progress (ATP).

Pre-market notification required for new chemical substances manufactured or imported ≥1 tonne/year. Requires: biodegradability testing, bioaccumulation testing, toxicity data (acute, subacute, chronic as needed based on tonnage). Review period: 3-6 months. Existing substances listed in ENCS (Existing and New Chemical Substances) inventory exempt from notification. Joint notification possible for same substance from multiple companies.

Cosmetic Ingredient Hotlist lists prohibited and restricted ingredients in Canadian cosmetics. Over 600 substances prohibited or restricted based on health concerns. Mandatory reporting of serious adverse reactions. Product notification through CPNP Canada portal required. Labeling must include ingredient list in INCI format, bilingual (English/French) labeling required. Good Manufacturing Practices compliance expected.

Fragrance ingredients can be listed collectively as 'Fragrance' or 'Parfum' without individual disclosure, except for fragrance allergens if voluntarily disclosed. FDA does not pre-approve cosmetics or fragrances. Manufacturers responsible for safety substantiation. RIFM safety data and IFRA standards widely recognized. Trade secret protection for fragrance formulas. Adverse event reporting through MedWatch voluntary.

Harmonized cosmetics regulations across 10 ASEAN member states (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam). Includes: Annex II (Prohibited Substances), Annex III (Restricted Substances), Annex IV (Allowed Colorants), Annex V (Allowed Preservatives). Product Notification via ASEAN Cosmetic Online Notification (ACON) system. Mutual recognition of notifications among member states.

Formula approval required for alcohol-based perfumes, colognes, and fragrances containing specially denatured alcohol (SDA). TTB Form 5150.19 required for formula approval. Specific denaturants required (e.g., SDA 39-C for perfumes: ethanol denatured with tert-butyl alcohol and denatonium benzoate). Recordkeeping requirements for production volumes. Labeling must comply with TTB regulations.

Mandatory safety assessment by qualified safety assessor before placing cosmetic on EU market. CPSR must include: Part A (Product Safety Information - formula, physical/chemical properties, micro quality, impurity profile, normal/reasonably foreseeable use, exposure, substance exposure, toxicological profile, undesirable effects/serious undesirable effects, product information) and Part B (Safety Assessment Conclusion). Must be updated when new relevant information available. Required for all cosmetic products including fragrances.

Australian Industrial Chemicals Introduction Scheme (AICIS) replaced NICNAS in 2020. All introducers (importers/manufacturers) of industrial chemicals must register with AICIS. New chemicals require pre-introduction assessment. Existing chemicals on AICIS Inventory generally exempt. Three assessment categories based on risk and volume: Reported (low risk), Assessed (moderate risk), Commercial Evaluation (highest risk or high volume). Cosmetics and fragrances considered industrial chemicals.

RIFM conducts comprehensive safety evaluations of fragrance materials using risk-based methodology. Publishes safety assessments in peer-reviewed journals. Assessments consider: dermal sensitization, phototoxicity/photoallergenicity, skin irritation, eye irritation, repeated dose toxicity, reproductive/developmental toxicity, genotoxicity, carcinogenicity, environmental safety. QRA methodology determines safe use levels. Industry gold standard for fragrance safety data. Supports IFRA standards development.

Functional cosmetics (9 categories including skin whitening, wrinkle improvement, UV protection) require pre-market approval or notification. Efficacy and safety data required. Fragrance products making functional claims must undergo approval process. General cosmetics require online notification only. Ingredients must be approved in positive lists (preservatives, UV filters, colorants) or not prohibited in negative list. INCI naming required. Animal testing banned for finished products since 2018.

Cosmetics classified into Risk Grade 1 (minimal risk - notification) or Grade 2 (high risk - registration/petition). Fragrances generally Grade 1. Electronic notification via ANVISA system required. Technical Responsible (RT) - licensed professional in Brazil required. Must comply with prohibited/restricted substance lists (RDC 162/2001, updates). Labeling in Portuguese mandatory. GMP compliance expected. Product notification valid indefinitely unless formulation changes.

Nanomaterials in cosmetics require notification to European Commission 6 months before market placement. Definition: insoluble or biopersistent material where ≥50% particles have one or more dimensions in size range 1-100nm. Notification requires: specification of nanomaterial, estimated quantity, toxicological profile, safety data, reasonably foreseeable exposure conditions. Commission maintains public catalog of nanomaterials used in cosmetics. Applies to fragrances using nano-encapsulation or nano UV filters.

Requires warnings on products containing chemicals known to cause cancer, birth defects, or reproductive harm above safe harbor levels. Over 900 chemicals on Prop 65 list. Relevant to fragrances: styrene, benzene, formaldehyde, methanol, toluene, methyl eugenol, estragole, safrole, coumarin (above thresholds). Warning required if exposure exceeds Significant Risk Level (SRL) for carcinogens or Maximum Allowable Dose Level (MADL) for reproductive toxins. Private enforcement through lawsuits common.

Cosmetics import requires license from Drug Control authorities. Manufacturers must obtain manufacturing license (Form 32). List of prohibited ingredients in Rule 135 and restricted ingredients in Schedule S. No specific pre-market approval but post-market surveillance. Labeling must include: ingredients list, manufacturing license number, batch number, date of manufacture, best before date, country of origin. Fragrance allergens declaration not mandatory but recommended. Random testing by authorities common.

TSCA requires EPA notification before manufacturing or importing new chemicals. TSCA Inventory contains existing chemicals (86,000+ substances). New chemicals require Pre-Manufacture Notice (PMN) or applicable exemption. EPA reviews for environmental and health risks within 90 days (extendable). Low Volume Exemption (LVE) available for <10 tonnes/year. Section 5 Significant New Use Rules (SNURs) may apply to existing chemicals for new uses. Fragrance ingredients generally on TSCA Inventory but new uses may trigger notification.

Harmonized regulation for GCC member states (Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman). Alignment with EU cosmetics regulation. Prohibited/restricted substances follow EU Annexes II/III/IV/V/VI. Product notification required in each country. Saudi Arabia uses SFDA Cosmetics Platform (Tabuk). UAE uses MOHAP notification system. Shelf life testing required. Halal certification may be required for certain markets. Import permits necessary. Agent/distributor in country required.

UK-specific REACH regulation post-Brexit. Substances on EU REACH must be registered separately with UK REACH by October 2027 (tonnage-dependent deadlines). Downstream User Import Notification (DUIN) available for importers. UK HSE acts as competent authority. CLP regulation continues as UK CLP (GB CLP). Notification to Poison Centers required. Great Britain (England, Scotland, Wales) and Northern Ireland have different requirements - NI follows EU REACH. Transitional arrangements until full implementation.

Swiss cosmetics regulation largely aligned with EU Cosmetics Regulation EC 1223/2009 but legally independent. Product notification via Swiss CPNP required. Safety assessor must confirm product safety. Prohibited and restricted substances follow EU annexes with some Swiss-specific additions. Responsible person in Switzerland or EFTA required for non-EU products. Labeling in German, French, or Italian (depending on distribution region). Market surveillance by cantonal authorities. Animal testing ban in place.