Regulatory Requirements
Track and manage regulatory requirements across different regions
Total Requirements
Active
Upcoming
Compliance Rate
IFRA Amendment 53 Implementation
Deadline: March 1, 2025
Thailand Cosmetic Re-notification
Deadline: November 30, 2024
FDA GRAS Portal Migration
Deadline: January 1, 2025
Registration, Evaluation, Authorisation and Restriction of Chemicals (EC 1907/2006)
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.
EC 1223/2009 - Fragrance Allergen Declaration Requirements
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.
21 CFR Part 172 & 21 CFR Part 182 - Food Flavoring Substances
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.
Cosmetic Control Act B.E. 2558 (2015) - Notification Requirements
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.
29 CFR 1910.1200 - HCS 2012 (GHS-aligned)
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.
Cosmetic Supervision and Administration Regulation (CSAR 2021)
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.
EC 1272/2008 - Classification, Labelling and Packaging of Substances and Mixtures
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).
ISHA - Notification of New Chemical Substances
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.
C.R.C., c. 869 - Cosmetic Ingredient Hotlist and Notification
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.
21 CFR Part 701 - Cosmetic Labeling Regulations
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.
ACD 2022 - Harmonized Cosmetic Regulations
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.
27 CFR Part 21 - Formulas for Denatured Alcohol and Rum
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.
Cosmetic Product Safety Report (CPSR) Requirements
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.
Industrial Chemicals Act 2019 - AICIS Registration
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 Safety Assessments and QRA (Quantitative Risk Assessment)
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.
Cosmetics Act - Functional Cosmetics Approval
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.
RDC 07/2015 - Cosmetic Products Regularization
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.
Cosmetics Regulation Annex III - Nanomaterials Notification
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.
Safe Drinking Water and Toxic Enforcement Act of 1986
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.
Drugs & Cosmetics Rules 1945 - Cosmetics Import and Manufacturing
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.
Toxic Substances Control Act - Chemical Substance Inventory
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.
GSO 1943/2016 - Technical Regulation for Cosmetic Products
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.
REACH (Amendment etc.) (EU Exit) Regulations 2020
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.
Cosmetic Products Ordinance (VKos) SR 817.023.31
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.