Cosmetics Export Regulations by Country: EU, US, Asia Compared

Europe and the UK: a local Responsible Person and a notification

In the EU, Regulation (EC) No 1223/2009 lets only cosmetics with a Responsible Person (RP) established in the EU be placed on the market; a company outside the EU cannot be the RP. For imports the importer is the RP unless it appoints another EU-established person by written mandate. Before first placing a product on the market, the RP notifies it in the Cosmetic Products Notification Portal (CPNP), one free notification for the whole EU, and keeps the Product Information File (PIF), with its safety report, for 10 years after the last batch.

Great Britain (England, Wales and Scotland) is separate. A UK-established RP, with a real UK address rather than a PO box or mail-forwarding service, notifies each product to the Office for Product Safety and Standards (OPSS) through the free SCPN service before sale; an EU CPNP notification does not cover Great Britain. Since 2021 GB has changed its ingredient lists by its own statutory instruments and on its own dates, so a product sold in both markets must meet both. Northern Ireland follows EU rules: an RP in Northern Ireland or the EU, and a CPNP notification.

Labels carry the RP's name and address and, for imports, the country of origin. In GB a label meeting the EU rule is accepted for the RP details until 31 December 2027; from 1 January 2028 it must name the UK RP. Products placed on the EU market from 31 July 2026 must name the expanded list of fragrance allergens, and earlier stock may be sold until 31 July 2028. For detail, see Triplicate's notes on exporting cosmetics to the EU and to the UK.

The Americas: FDA listing in the US, CNF in Canada, ANVISA in Brazil, no registration in Mexico

The US has no pre-market approval for cosmetics, except color additives. Under the Modernization of Cosmetics Regulation Act (MoCRA), each facility that manufactures or processes cosmetics for the US registers with FDA and renews every two years, and a foreign factory names a US agent. The responsible person, the company named on the label, can be a foreign brand owner or a US importer; it lists each product within 120 days of first US marketing, reports serious adverse events and keeps safety evidence. Filing in Cosmetics Direct is free, FDA issues no registration certificates, and required label statements must be in English. Sunscreens, SPF moisturizers and makeup, anti-dandruff shampoos and antiperspirants are drugs as well as cosmetics and follow OTC drug rules.

Canada does not approve cosmetics before sale either, but the manufacturer or importer in Canada must file a Cosmetic Notification Form (CNF) with Health Canada within 10 days after the first sale, online and free. Since 5 March 2025 the form needs a Canadian address, so a foreign brand notifies through its Canadian importer or a person in Canada it authorises. Products must respect the Cosmetic Ingredient Hotlist and carry English and French labels with an INCI ingredient list and, since 12 April 2026, named fragrance allergens. Every sunscreen, SPF make-up included, needs a Drug Identification Number (DIN) or Natural Product Number (NPN).

In Brazil, cosmetics must be notified to ANVISA under RDC 907/2024 before they are imported for sale, and sunscreens, bronzers, hair straighteners and wavers, insect repellents, antiseptic hand gel and hair pomades need registration, which ANVISA assesses before sale. Only a Brazilian company with an ANVISA operating authorization (AFE) and a local sanitary licence can hold the notification and import the goods: your distributor or a separate regulatory holder. Mandatory label items go in Brazilian Portuguese, with the holder's name, CNPJ and AFE number. See Triplicate's notes on exporting cosmetics to the US, Canada and Brazil.

Mexico has no product registration or notification for cosmetics. The Mexican importer files COFEPRIS's operating notice (aviso de funcionamiento), runs a quality system under NOM-259-SSA1-2022 and keeps safety studies on file; formulas must meet the Secretaría de Salud's list of prohibited and restricted substances, and labels must follow NOM-141-SSA1/SCFI-2012 in Spanish, which customs checks at entry. Under a decree published on 29 December 2025, most chapter 33 lines pay 25% import duty, plus 16% IVA.

North-East Asia: Japan, China, Taiwan and Hong Kong

Japan's PMD Act requires a Japanese company with a cosmetics marketing licence, the Marketing Authorization Holder (MAH), to notify each product to its prefecture before sale; it is legally responsible for the product. For imports the MAH also files a foreign manufacturer notification through PMDA, at no fee. No pre-approval is needed if the formula meets the Standards for Cosmetics and the label lists all ingredients in Japanese. Products with medicated claims, such as whitening by suppressing melanin or preventing acne, are quasi-drugs that need product approval, and cosmetics may use only MHLW's 56 permitted claims, plus makeup effects.

In mainland China, imported general cosmetics are filed online with the National Medical Products Administration (NMPA) before import, and special cosmetics, such as hair dyes, perms, sunscreens, whitening and anti-hair-loss products, must be registered first; the registration certificate is valid for 5 years. The overseas brand owner or manufacturer holds the filing or registration but must appoint an enterprise legal person in China as its domestic responsible person, whose name and address go on the Chinese label. A Chinese sticker is allowed if it matches the original label. Cross-border e-commerce retail imports follow separate rules.

Taiwan requires a manufacturer or importer registered in Taiwan to register each product online with TFDA before it is supplied and, since 1 July 2026, to hold a Product Information File with a signed safety assessment; the permits for sunscreens, hair dyes and other specific-purpose cosmetics ended on 1 July 2024. Hong Kong has no registration, notification, import licence or local responsible person for ordinary cosmetics: the manufacturer, importer and supplier must make sure each product is reasonably safe under the Consumer Goods Safety Ordinance (Cap. 456), and products with drug ingredients or medicinal claims must be registered as pharmaceutical products. Goods re-exported from Hong Kong to the mainland still need NMPA filing or registration. See Triplicate's notes on exporting cosmetics to Japan, China, Taiwan and Hong Kong.

South-East Asia: notification through a local company

Vietnam, Thailand, Indonesia, Malaysia, the Philippines, Singapore and Cambodia all require each cosmetic to be notified before it is imported or sold, and only a local company can file. A foreign brand works through its importer, distributor or a local subsidiary, usually authorising it with a letter of authorisation or appointment, and that company holds the notification and is named on the label. In Indonesia, Malaysia, Singapore and the Philippines a new distributor must notify the products again, so agree in the contract who holds each notification. Triplicate has a separate note on each of these markets.

Each country applies the ASEAN Cosmetic Directive annexes (prohibited and restricted substances, permitted colourants, preservatives and UV filters), last updated in June 2026, through its own notices and deadlines, and claims to treat or prevent disease are not allowed. The main differences are the filing system, fees, validity and import steps:

• Vietnam: notification to the Drug Administration of Vietnam (DAV) by a company with cosmetics in its business scope; VND 500,000 per product, valid 5 years; usually a Certificate of Free Sale (CFS), legalised unless exempt.
• Thailand: Thai FDA notification in e-Submission by a company registered in Thailand whose place of import has passed FDA inspection; receipt in about 3 working days, valid 3 years; a License per Invoice (LPI) for each shipment.
• Indonesia: BPOM notification in Notifkos by an importer with BPOM's recommendation; IDR 1,500,000 per item made outside ASEAN, valid 3 years; a halal certificate or non-halal statement from 18 October 2026; an SKI Border for each shipment.
• Malaysia: NPRA notification in QUEST3+ by a company registered with SSM; RM 50 per product, valid 2 years; halal certification is voluntary, and NPRA issues no separate import permit.
• Philippines: Certificate of Product Notification (CPN) filed in the FDA ePortal by a company with an FDA License to Operate; PHP 500 per year of validity, for 1, 2 or 3 years; about 23 working days.
• Singapore: HSA notification in PRISM by a company registered with ACRA; S$13 or S$28 per product, acknowledged at once, valid 1 year; no HSA import licence.
• Cambodia: notification number from the Ministry of Health through CamPORS, filed by a Cambodian importer registered with the MOH; fees and validity are not published online.

Australia, New Zealand, the UAE and Saudi Arabia

Australia has no pre-market approval or product notification for cosmetics. The business that imports them registers with the Australian Industrial Chemicals Introduction Scheme (AICIS) before the first import and renews by 31 August every year, and makes sure each ingredient is on the Australian Inventory of Industrial Chemicals or categorised; a foreign company that sells directly to Australian customers may itself be the introducer, with an ARBN. Labels list ingredients in English or INCI names under the ACCC's information standard, and primary sunscreens and moisturisers above SPF 15 are medicines regulated by the TGA. New Zealand applies the EPA's Cosmetic Products Group Standard, also with no pre-market approval, so Australian compliance does not cover it.

In the UAE, cosmetics need a conformity certificate under the federal MoIAT scheme against UAE.S GSO 1943, and products for Dubai must also be registered in Dubai Municipality's Montaji system before import, valid for 5 years. A UAE company with a trade licence applies, normally the importer or distributor, while the exporter supplies the free sale certificate, formula, test reports and labels. The Emirates Drug Establishment (EDE) deals only with cosmetics that have a medical effect, and a UAE registration does not cover the other GCC countries. See Triplicate's notes on exporting cosmetics to Australia and to the UAE.

In Saudi Arabia the Saudi Food and Drug Authority (SFDA), not SASO's SABER platform, regulates cosmetics. A Saudi company whose commercial registration covers cosmetics lists each product in SFDA's Ghad system before import; products must meet SFDA.CO/GSO 1943:2024 and the claims rule SFDA.CO/GSO 2528:2024, and every commercial shipment needs a certificate of conformity issued through SFDA's FASEH system before it is shipped.

Across markets: sunscreens, ingredients, labels, HS codes and shipping

The same product can be a cosmetic in one market and a drug in another. Sunscreens are OTC drugs in the US, need a DIN or NPN in Canada, are TGA medicines in Australia when they are primary sunscreens, need ANVISA registration in Brazil and are special cosmetics registered with NMPA in China; in Japan a sunscreen sold as a cosmetic needs no approval if its UV filters are on Annex 4, and Taiwan no longer issues permits. Whitening, anti-acne and anti-hair-loss claims raise the same question, for example as quasi-drugs in Japan or special cosmetics in China, so check every claim for each market before printing labels.

Ingredient lists differ: the EU and GB annexes change on separate dates, Canada uses its Hotlist, Japan its Standards for Cosmetics, China its Inventory of Existing Cosmetic Ingredients, Australia its Inventory of Industrial Chemicals and South-East Asia the ASEAN annexes. Animal testing rules also differ. The EU bans selling cosmetics tested on animals to meet its Regulation, and GB applies the same rule; Taiwan has banned animal testing for safety assessment since 9 November 2019, with narrow exceptions; Brazil has banned testing cosmetics on live vertebrate animals since 31 July 2025; Australia does not let data from animal tests done on or after 1 July 2020 be used to categorise unlisted cosmetic ingredients, except in narrow cases; and China lets most general cosmetics be filed without toxicology tests if every manufacturing site holds a government-issued GMP certificate and the safety assessment confirms safety.

At the border, most cosmetics fall in HS Chapter 33: perfumes 3303, make-up and skin care, sunscreens included, 3304, hair products 3305 and shaving, deodorant and bath products 3307, while surfactant face washes and body washes usually go to 3401.30; regulatory status, such as a US OTC sunscreen, does not decide the heading (see Triplicate's note on HS codes for cosmetics, and its free HS code lookup). Alcohol-based perfume ships as dangerous goods under UN1266 and spray cans under UN1950, usually as limited quantities, and they cannot go by international mail (see Triplicate's note on shipping perfume, aerosols and nail polish). Rules change often, and each Triplicate country note shows the month it was checked; this is practical guidance, not legal advice, so confirm with the regulator, your local holder or a licensed customs broker. Label languages:

• EU: each Member State sets the language for content, durability, precautions and function; Great Britain needs these in English.
• US: required statements in English. Canada: English and French, with ingredients in INCI names.
• Brazil: mandatory items in Brazilian Portuguese, plus the composition in Portuguese.
• Japan: Japanese, with JCIA ingredient names. China: a Chinese label or a sticker matching the original. Taiwan: Chinese, though ingredient names may be in English.
• Hong Kong: warnings and cautions in English and Chinese. UAE: at least name, use, warnings and storage in Arabic and English (GSO 1943).
• Australia: ingredient list in English or INCI names.
• Vietnam: a Vietnamese sub-label. Thailand: Thai. Indonesia: Bahasa Indonesia for benefits, directions and warnings. Cambodia: Khmer.
• Malaysia: Bahasa Malaysia and/or English. Philippines: English and/or Filipino. Singapore: English.
• Mexico: Spanish under NOM-141-SSA1/SCFI-2012; only the importer's name and address may be added in Mexico after clearance. Saudi Arabia: labels under SFDA.CO/GSO 1943; a bilingual Arabic and English label is the safe choice.