Selling Skincare Worldwide: A Beginner's Map of Cosmetics Rules in 8 Markets
One of the joys of a small brand today is that a customer on the other side of the world can find you. One of the headaches is that every market has its own cosmetics rules. This post is a friendly starting map, not legal advice. Rules change, so always check the regulator's own pages (linked below) or work with a regulatory consultant before you launch.
A few ideas that appear almost everywhere
- A responsible party: a named company that's legally answerable for the product in that market.
- A safety assessment and a product information file.
- Notification or registration before (or shortly after) you start selling.
- Ingredient rules: lists of banned, restricted and permitted ingredients.
- Labelling rules, usually with INCI ingredient lists (see our guide to reading ingredient lists).
- Good manufacturing practice (GMP), often based on ISO 22716.
European Union
Under Regulation (EC) 1223/2009 you need an EU-based Responsible Person, a Cosmetic Product Safety Report (CPSR), a product information file, and an electronic notification before the product goes on sale (EUR-Lex). Notification is free through the CPNP portal, and one notification covers the whole EU (European Commission). Following ISO 22716 is the recognised route to showing GMP (harmonised standards).
United Kingdom
Great Britain uses its own version of the EU rules: a UK-based Responsible Person, a safety report, a product file kept for ten years, and notification through the UK's SCPN portal before sale (UK government guidance; how to notify). Northern Ireland has a separate process.
United States
The Modernization of Cosmetics Regulation Act (MoCRA) brought big changes. Facilities register (and renew every two years), products are listed with their ingredients, serious adverse events must be reported within 15 business days, and companies must keep records substantiating product safety. Some small businesses are exempt from certain requirements, and GMP and fragrance-allergen rules are still being finalised (FDA). Remember that sunscreens, antiperspirants and anti-dandruff products are regulated as drugs in the US.
Canada
Manufacturers and importers must notify Health Canada within ten days of first selling a cosmetic (Health Canada), and check ingredients against the Cosmetic Ingredient Hotlist of prohibited and restricted substances (Hotlist).
India
Cosmetics fall under the Drugs and Cosmetics Act and the Cosmetics Rules 2020. Manufacturing is licensed by State Licensing Authorities, while imported cosmetics need a registration certificate from the Central Licensing Authority (CDSCO).
Southeast Asia (ASEAN)
ASEAN member states follow the harmonised ASEAN Cosmetic Directive. Products are generally notified in each country before sale, and a product information file must be kept (ASEAN). Singapore's Health Sciences Authority has a clear overview (HSA).
Australia
Cosmetic ingredients are regulated through AICIS, the industrial chemicals regulator, and whether you need to register depends on what your business does (AICIS). A mandatory ingredient-labelling standard applies (ACCC Product Safety), and sunscreens that count as therapeutic goods are regulated by the TGA (AICIS).
China
Under China's cosmetics regulation (CSAR), "special" cosmetics and high-risk new ingredients need registration, while general cosmetics need filing. Overseas companies must appoint a responsible company in China (NMPA).
Where to start
- Pick one or two launch markets, not ten.
- Design your formula for your strictest target market, often the EU.
- Build a solid technical file: ingredient documents (CoA, SDS, technical data sheets, which we provide with every batch), stability data and challenge testing.
- Find your responsible person or importer in each market.
- Use our dictionary's regulatory notes as a first flag, then confirm the rules for each market.
Explore the Restricted & High-Diligence Materials collection to see ingredients that need extra checks, and every entry in our Ingredient Dictionary.
This article is a general overview for education. It is not legal or regulatory advice.