A certification roadmap for global cosmetics export
Why this matters right now
Korea exported USD 11.4 billion of cosmetics in 2025, taking second place worldwide behind France (USD 24.3 billion) and passing the United States (USD 10.8 billion) for the first time. The trade surplus reached USD 10.1 billion, crossing USD 10 billion for the first time, and domestic production came to KRW 17.94 trillion. Skincare accounted for 74.7% of exports and colour cosmetics 13.2% — 87.9% between them. The largest destination also changed: the United States rose 15% year on year to USD 2.2 billion and took first place, while China fell 19% to USD 2.0 billion (Ministry of Food and Drug Safety, 2025 cosmetics production, export and import statistics).
The more markets a brand enters, the harder regulatory work becomes. Every country runs its own registration or notification regime, and in the last two years the US, EU, China and Indonesia have all changed theirs. What follows is where each market actually stands as of August 2026.
United States — MoCRA
Under the Modernization of Cosmetics Regulation Act of 2022, cosmetics distributed in the US require facility registration and product listing. Submissions go through Cosmetics Direct, the FDA's electronic portal. As of 6 January 2026 the system held 14,299 active facility registrations and 992,907 active product listings.
What teams miss most often is not the initial filing but the renewal. Facility registration must be renewed every two years, and the clock runs from each facility's own first submission rather than a single industry-wide date — register in February 2024 and your renewal falls due in February 2026. Product listings are updated annually to confirm formulation and facility linkage, and any newly launched product must be listed within 120 days of entering the market.
Beyond registration and listing, MoCRA also requires a designated Responsible Person, safety substantiation records, and reporting of serious adverse events. In an OEM/ODM arrangement the manufacturer typically carries facility registration while the brand owner carries product listing and the Responsible Person role, so the split should be settled at contract stage.
European Union — notification, not registration
The terminology matters. The EU does not operate a registration scheme; it operates a notification scheme. Under Regulation (EC) No 1223/2009 you appoint a Responsible Person established in the EU and notify the product through CPNP, the Cosmetic Products Notification Portal, before it is placed on the market.
The Responsible Person holds and maintains the Product Information File (PIF), which contains the product description, the Cosmetic Product Safety Report (CPSR Parts A and B), a description of the manufacturing method, a declaration of GMP compliance, evidence for any claimed effect, and data on animal testing. The PIF must be kept for ten years after the last batch is placed on the market and made available to authorities on request.
The standard behind that GMP declaration is EN ISO 22716:2007. Article 8 requires GMP compliance and ISO 22716 serves as the applicable standard — which makes it a practical precondition for EU export rather than an optional credential.
The most time-sensitive recent change is fragrance allergen labelling. Regulation (EU) 2023/1545 added 56 substances that must be declared individually. The deadline for placing new products on the market was 31 July 2026 and has already passed; existing stock must be brought into line by 31 July 2028. Anything shipping to the EU now needs labels that already reflect the expanded list.
Claim wording needs preparing too. The Empowering Consumers for the Green Transition Directive (EmpCo, Directive (EU) 2024/825) becomes enforceable in member states from 27 September 2026, restricting unsubstantiated environmental and vegan-adjacent claims, and the omnibus amendments clearing CMR substances continue (Regulation (EU) 2026/78, 12 January 2026).
China — the bar dropped sharply in July 2026
China's CSAR framework splits products into special cosmetics, which require registration, and general cosmetics, which require filing. That two-track structure is unchanged, but the practical burden eased considerably when the NMPA issued its Announcement on Matters Relating to Cosmetics Registration and Filing (No. 70 of 2026) on 29 July 2026.
The most significant change is a wider animal testing exemption. It now extends to certain special cosmetics — perm products, non-oxidative hair dyes, and whitening products that work purely by physical coverage — as well as general cosmetics containing novel ingredients. The conditions are that the manufacturer holds a CGMP certificate issued by its own government and that the safety assessment covers stability, preservative efficacy and packaging compatibility. Children's cosmetics remain excluded.
This is where Korean manufacturers gain concrete ground: a domestic CGMP certificate stops being a nice-to-have credential and becomes a working condition of market entry in China.
Other provisions ease the paperwork further. The requirement to submit raw material safety dossiers and ingredient registration codes has been removed — suppliers need only be named, with safety data retained internally for inspection. Registrants using the same brand may run testing on one representative product and extend the results to similar formulations through equivalency documentation. And for claims other than spot correction/whitening, UV protection and anti-hair-loss, companies may now choose their own efficacy evaluation methods where the scientific basis is sufficient. With fewer documents submitted, the completeness of internal records and the safety assessment itself carries more weight than before.
Japan and Southeast Asia
Japan operates under the Pharmaceutical and Medical Device Act administered by the Ministry of Health, Labour and Welfare. A domestic entity holding a marketing authorisation licence takes final responsibility for quality and safety and files the cosmetic marketing notification. Claiming an effect such as brightening or anti-wrinkle moves the product out of the cosmetic category into quasi-drugs, which requires separate approval and, for overseas manufacturers, a foreign manufacturer accreditation that adds significant time and cost. The line between cosmetics and quasi-drugs is drawn more strictly than in Korea, and packaging and advertising copy are correspondingly constrained.
In Southeast Asia the nearest deadline is Indonesia. On top of existing BPOM registration, halal certification becomes mandatory for cosmetics from 17 October 2026, and the authorities have stated publicly that there will be no further extension. Even with a clean ingredient position the certification process runs three to six months, which makes the timeline tight at this point. Other ASEAN markets run notification schemes under the ASEAN Cosmetic Directive, with ingredient restriction lists that differ by country — so compliance review has to come first.
The documents every market asks for
The schemes differ, but the paperwork converges. A quality system under ISO 22716 or Korean CGMP, batch test reports, stability data, microbiological and heavy metal results, a full ingredient list with raw material origin statements, BSE-free declarations, and a Certificate of Free Sale form the base set.
As above, the EU treats ISO 22716 as the reference standard for GMP compliance and China now treats a CGMP certificate as a condition of the animal testing exemption. A quality system certification pays for itself across several markets at once.
The order to work in
In practice the sequence is: confirm target markets, review ingredient compliance country by country, run the required testing (stability, microbiological, safety, efficacy), complete each market's registration or notification, then verify labels and claims. Ingredient compliance review belongs first — deferring it is what forces a formulation to be rebuilt from scratch.
HBMIC settles target markets with clients at the start of development and designs the formulation and testing plan against those markets' ingredient rules and documentation requirements.