| European Union / EEA |
Mandatory compliance
A cosmetic product must comply with Regulation (EC) No. 1223/2009 before being placed on the market.
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Packaging must support required label information, including product identity, nominal content, durability or period-after-opening information, precautions, batch number, responsible person, and ingredient declaration. Materials must also be assessed for safety and relevant chemical restrictions.
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Cosmetic Product Safety Report; Product Information File; packaging specifications; artwork approval; ingredient list; stability and compatibility evidence; supplier declarations; evidence for restricted substances under REACH where applicable.
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No general packaging certificate
CE marking does not generally apply to ordinary cosmetic packaging.
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ISO 22716 for cosmetic GMP; ISO 9001 for quality management; FSC or PEFC for paper-based components; recycled-content or chain-of-custody evidence where environmental claims are made.
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Prioritize legal label review and packaging-product compatibility. Use ISO 22716 as supporting manufacturing evidence, not as a substitute for the EU safety assessment.
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| United Kingdom |
Mandatory compliance
Cosmetics must comply with the UK Cosmetics Regulation and require a UK Responsible Person when placed on the Great Britain market.
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Packaging must carry the required UK label information and support traceability. Products placed on the Great Britain market require notification through the UK Submit Cosmetic Product Notification system.
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Product Information File; Cosmetic Product Safety Report; label artwork; ingredient and fragrance documentation; manufacturing and batch records; notification confirmation.
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No general packaging certificate
Notification and safety documentation are regulatory obligations, not certifications.
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ISO 22716; ISO 9001; FSC or PEFC for qualifying paper packaging; recycled-content verification for substantiated claims.
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Treat Great Britain and the EU/EEA as separate notification and responsible-person pathways. Check whether the product is also entering Northern Ireland under applicable EU rules.
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| United States |
Risk-based obligations
Most cosmetics do not require premarket approval, but color additives generally require FDA approval for their intended use. MoCRA introduced additional duties for covered facilities and responsible persons.
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Packaging and labeling must comply with the Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act. Claims must not make the product an unapproved drug. Packaging should be evaluated for adulteration, contamination, migration, and tamper-related risks where relevant.
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Facility registration where required; cosmetic product listing where required; responsible-person information; safety substantiation; ingredient and color-additive records; adverse-event procedures; label review.
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No general FDA cosmetic certificate
FDA registration or listing is not an FDA approval or certification.
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ISO 22716; ISO 9001; supplier certificates of analysis; packaging migration or extractables data; FSC or recycled-content certification for environmental claims.
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Do not present facility registration or product listing as “FDA certified.” Verify MoCRA duties, state requirements, claim wording, and special rules for products containing color additives.
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| China Mainland |
Registration or filing
Special cosmetics generally require registration; ordinary cosmetics generally require filing under the applicable NMPA framework.
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Packaging and labels must meet Chinese cosmetic labeling requirements, including product name, registrant or filer information, ingredients, net content, usage, warnings, shelf-life information, and other required particulars. Imported products need appropriate Chinese-language labeling.
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Product registration or filing record; safety assessment; formula and ingredient documentation; packaging artwork; testing or evaluation materials; qualified domestic responsible-person information where applicable.
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Regulatory record required
NMPA registration or filing is a market-access procedure, not a general packaging certification.
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ISO 22716; ISO 9001; packaging material specifications; supplier compliance declarations; FSC or recycled-content evidence for substantiated claims.
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Confirm whether the product is special or ordinary, then align the packaging artwork and technical dossier with the current NMPA portal and Chinese labeling rules.
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| Japan |
Category-dependent
Ordinary cosmetics are regulated under the Pharmaceutical and Medical Device Act. Products making quasi-drug claims may require a different approval or notification route.
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Packaging must support Japanese labeling requirements, including product name, responsible marketing authorization holder information, net quantity, use directions, precautions, expiration information where required, and full ingredient labeling.
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Ingredient and safety data; Japanese label review; manufacturing and quality records; notification or approval documents for products falling into quasi-drug categories.
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No universal packaging certificate
The regulatory route depends strongly on product classification and claims.
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ISO 22716; ISO 9001; packaging compatibility data; documentation for material safety and quality control.
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Review claims before selecting packaging evidence. A claim that changes a cosmetic into a quasi-drug can change the market-entry requirements.
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| ASEAN Member States |
Notification-based framework
ASEAN Cosmetic Directive principles are implemented through national systems, with country-specific procedures and enforcement.
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Packaging must comply with the applicable national implementation of ASEAN cosmetic labeling requirements, including product information, ingredients, warnings, responsible company details, and net contents.
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Product Information File; notification confirmation; ingredient compliance review; safety and quality information; label artwork; manufacturing evidence.
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Notification is not certification
Individual countries may impose additional documentary or language requirements.
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ISO 22716; ISO 9001; packaging specifications; supplier declarations; FSC or PEFC for paper packaging when relevant.
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Use one core technical file where possible, but validate each destination country’s notification process, language rules, responsible-person requirements, and prohibited-ingredient list.
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| Canada |
Notification required
Cosmetic products generally require a Cosmetic Notification Form, while products with therapeutic claims may be regulated differently.
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Packaging and labels must comply with Canadian cosmetic labeling rules, including ingredient declaration using the accepted nomenclature, product identity, net quantity, dealer information, and required warnings.
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Cosmetic Notification Form; bilingual English and French label review where applicable; ingredient and safety records; claim substantiation; packaging specifications.
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No general packaging certificate
Notification is a legal filing rather than a certification.
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ISO 22716; ISO 9001; packaging safety and compatibility testing; FSC or recycled-content evidence for environmental claims.
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Confirm bilingual packaging requirements and ensure that therapeutic or drug-like claims do not change the product’s regulatory classification.
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| Australia |
Product-classification dependent
Most cosmetics are regulated as consumer goods, but therapeutic claims or active ingredients can bring the product under therapeutic-goods controls.
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Packaging must be safe, accurately labeled, and consistent with the product category. Ingredient disclosure, warnings, quantity statements, and claims should be reviewed against Australian requirements.
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Ingredient and safety records; label and claim substantiation; import documentation; therapeutic-goods evidence where the product is classified as a therapeutic good.
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No universal cosmetic packaging certificate
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ISO 22716; ISO 9001; packaging compatibility and transport testing; sustainable-material certifications for substantiated claims.
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Classify the product from its claims and ingredients first. Do not assume that a cosmetic label remains cosmetic if it claims to treat, prevent, or modify a health condition.
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| Gulf Cooperation Council Markets |
National implementation
GCC technical requirements provide a regional reference, but import, registration, language, and conformity procedures can vary by country.
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Packaging commonly needs Arabic labeling or bilingual labeling, product identity, ingredients, country of origin, net content, batch information, expiry or durability information, responsible party details, and precautions.
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Product registration or conformity documents where required; ingredient list; Certificate of Free Sale or equivalent commercial evidence where requested; label artwork; safety and quality documents.
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Country-specific documentation
A requested conformity document is not automatically a universal GCC packaging certification.
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ISO 22716; ISO 9001; Arabic label validation; packaging specifications; transport and climate-resistance testing.
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Confirm the destination country’s authority, importer requirements, Arabic labeling rules, shelf-life expectations, and document legalization requirements before printing packaging.
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