Cosmetics regulations are the legal rules that govern how cosmetic products are developed, tested, manufactured, labeled, notified to authorities, and sold in each jurisdiction.
Founders read that and file it under paperwork.
It decides whether you can launch your brand at all.
A great formula with a beautiful bottle that fails to meet the regulatory requirements of the market you want to sell in is inventory you cannot move. I have watched founders sit on warehouses full of finished goods for months because one document was missing.
After 30 years in the hair and beauty sector, most recently in private label cosmetics, with 14+ manufacturers across Europe, Turkey, China, and the US, I can say the single most underestimated cost area is regulatory. Founders budget for formulation and packaging. They rarely budget the real cost of compliance.
Important disclaimer: I am not a lawyer or regulatory affairs professional. This guide is practical industry perspective, not legal or regulatory advice. Every specific compliance question should be verified with a qualified Responsible Person, regulatory consultant, or attorney with current expertise in your target markets.
This guide covers how frameworks differ across major markets, what documentation is required everywhere, and how to plan a 2026 launch without getting trapped in paperwork.
Most first-time founders assume cosmetics regulations are roughly the same everywhere.
They are not.
At the highest level, cosmetic regulatory systems split into three philosophies.
Pre-market assessment systems require the brand to prove product safety and compile a complete dossier before the product can be sold. The dossier lives with a designated legal entity inside the jurisdiction. The EU is the canonical example. Great Britain now operates a parallel version. South Korea, Japan, and Taiwan all operate variations on this model. Canada does not: its notification is filed within ten days after the first sale, not before it, and no dossier is submitted to anyone.
Post-market surveillance systems allow products onto the market with minimal pre-clearance, and the authorities intervene reactively when problems surface. The United States has historically operated this way. MoCRA (the Modernization of Cosmetics Regulation Act of 2022) is moving the US toward a hybrid that still allows products onto the market quickly but requires facility registration, product listing, and safety substantiation on file.
Registration-based systems treat some or all cosmetics like drugs, requiring pre-approval before sale. China has historically operated here for "special cosmetics" such as sunscreens, whitening products, and hair dyes. General cosmetics moved to a faster notification track under the Cosmetic Supervision and Administration Regulation (CSAR) that took effect January 1, 2021.
For a founder, this distinction is the single most important planning input. The EU system front-loads cost and time. The US system allows faster launch but carries higher back-end liability. China runs both models at once: a general cosmetic is filed, while a special cosmetic cannot be manufactured or imported until NMPA has registered it (Article 17 of the CSAR). That pre-approval step, not the volume of paperwork, is the reason the special track is the slowest market entry I have worked on.
The EU Cosmetics Regulation 1223/2009 lists more than 1,700 entries of substances prohibited in cosmetic products, plus hundreds more permitted only with specific concentration limits, warnings, or conditions of use.
The United States bans roughly eleven.
That number sounds implausible until you see it in a formulation brief. An ingredient that is perfectly legal in a US product can be barred in the EU, either because the substance itself is prohibited under Annex II or because it is classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) under the EU CLP Regulation. The CMR route is a prohibition with a narrow door rather than an automatic one: Article 15 lets a category 2 substance be used where the SCCS has evaluated it and found it safe, and a category 1A or 1B substance only where four conditions are met together, so the practical question is whether your ingredient sits inside one of those exceptions.
The most recent example sits in my research log from this week. Commission Regulation (EU) 2025/877 of May 12, 2025 updated Annexes II and III to restrict additional CMR substances. A further amendment, Commission Regulation (EU) 2026/78 of 12 January 2026 (the "Omnibus VIII"), adds fifteen newly classified CMR substances to the Annex II prohibition list (with a few restricted-use entries also added to Annexes III to V), with application from May 1, 2026.
If your formula contains a US-legal substance that is banned in the EU, you cannot simply ship the US version to Europe.
You reformulate, re-test, re-notify.
The EU banned animal testing on finished cosmetic products in 2004 and on ingredients for cosmetic use in 2009. The ban on marketing cosmetics tested on animals, ingredient testing included, took effect on 11 March 2009 as well: only repeated-dose toxicity, reproductive toxicity and toxicokinetics were deferred to 11 March 2013, so that date closed the regime rather than opening it.
China never banned animal testing. It removed one document, on conditions. Since 1 May 2021 a general cosmetic can be filed without the product’s toxicology test report when two things hold together: the manufacturer already holds a production quality management system qualification issued by the government competent authority of the country or region where the plant sits, and the product’s safety risk assessment result confirms the product’s safety (Article 33(2) of the Provisions on the Management of Cosmetic Registration and Filing Dossiers). Three cases stay outside it: products claiming use on infants and children, products using a new cosmetic ingredient still inside its safety monitoring period, and filers, domestic responsible persons or manufacturers flagged as key supervision targets. Where several plants make the product, every one of them needs the qualification. On 29 July 2026 NMPA Announcement 2026 No. 70 opened the same route to three special cosmetics (perm products, non-oxidative hair dyes, and whitening products that work by physical covering only) and to general cosmetics using a new ingredient, children’s cosmetics excepted. Every other special cosmetic still files the toxicology test report.
The UK maintains the EU-aligned ban post-Brexit. The US has no federal ban, but an active patchwork of state-level bans now covers California, New York, Virginia, Nevada, Louisiana, Illinois, Maryland, Hawaii, and several others, with additional states advancing bills in 2025 and 2026.
For a multi-market brand, this means your whole supply chain, including any new raw material introduced into a formula, must be traceable to testing data that was not generated on animals for cosmetic purposes.
The mistake I see most often is founders who try to be globally compliant on day one.
They read a general overview, panic, and attempt to build a product that satisfies every jurisdiction simultaneously.
That approach is rarely efficient.
A better sequence: identify your real first market based on where you will actually sell revenue-producing volume in year one. Meet that market’s regulatory requirements fully. Plan the next market based on where extension of the brand makes commercial sense. Budget regulatory as a per-market cost, not a one-time expense.
For most European founders, that means EU compliance first, then Great Britain as the early expansion, then decide between US and select Asian markets based on the brand’s actual commercial traction.
Regardless of which first market you choose, several compliance artifacts are non-optional.
In the EU and UK systems, the Product Information File (PIF) is the master dossier for each cosmetic product. It is a structured collection of everything the authorities can ask you to produce.
Article 11(2) lists five things the PIF must contain: a description of the product that lets the file be attributed to it, the cosmetic product safety report, a description of the manufacturing method with a statement on compliance with Good Manufacturing Practice, proof of the effect claimed where the nature or effect of the product justifies it, and data on any animal testing performed. Most of what people picture in a PIF arrives through the second of those: the qualitative and quantitative formula in INCI names, raw material specifications, packaging characteristics, stability and preservation results and microbiological data are Annex I content, which the safety report carries into the file. Two details are worth holding onto. Proof of claims is conditional, not automatic, and cosmetovigilance records, although a real obligation under Article 23, are not listed as PIF content at all.
The PIF must be readily accessible, in electronic or other format, at the address of the Responsible Person shown on the label, and it is kept for a period of ten years following the date on which the last batch of the product was placed on the market.
Cost range for a first-time PIF: 500 to 1,800 EUR/USD per product, depending on the complexity of the formula, the claims made, and whether stability and microbiological testing are already complete or need to be commissioned as part of the PIF build. (All cost figures in this article are indicative estimates that vary by manufacturer, region, and project scope.)
The Cosmetic Product Safety Report (CPSR) is the specific safety-assessment component of the PIF, in both the EU and UK systems.
Part A is the compilation of safety information: the formula, the physical-chemical characteristics of ingredients, the microbiological quality, impurity data, normal and reasonably foreseeable use exposure, and the toxicological profile of each substance.
Part B is the assessor’s conclusion: a signed, reasoned statement that the product is safe for human health under the declared conditions of use.
The assessor must hold a diploma or other evidence of formal qualifications from a university course of theoretical and practical study in pharmacy, toxicology, medicine, or a similar discipline, or from a course a Member State recognizes as equivalent.
Cost range for a CPSR: 300 to 800 euros per product, depending on formula complexity and assessor.
This cost is bundled into the PIF in many regulatory consulting engagements.
The Responsible Person is a legal or natural person established inside the jurisdiction who takes on primary liability for the product’s compliance. Article 4(1) names both, so a sole trader established in the Union can hold the role personally without incorporating.
In the EU, the Responsible Person is named on the label and is the authorities' first point of contact for any compliance query. In the UK, a separate UK Responsible Person is required for the Great Britain market. Northern Ireland continues to use the EU framework and an EU Responsible Person. A brand selling into both the EU and Great Britain needs two Responsible Persons covering the two jurisdictions.
For a brand that has no natural in-jurisdiction legal entity, Responsible Person services are offered by specialized regulatory consultancies.
Typical cost runs 500 to 2,000 euros per year for a small catalog, scaling with the number of products and the complexity of the portfolio.
Once the PIF is complete and the Responsible Person is appointed, the product must be notified to the authorities before going on sale.
In the EU, notification happens on the Cosmetic Products Notification Portal (CPNP). The notification itself is free. The notification generates a reference number that is used for traceability and post-market surveillance.
In Great Britain, notification happens on the Submit Cosmetic Product Notification (SCPN) portal, managed by the Office for Product Safety and Standards (OPSS).
The SCPN and CPNP are operationally similar but are separate legal systems.
I once watched a client miss a 3.5 million euro retail distribution opportunity in France because her CPNP notifications were filed against the wrong product variant, and the reconciliation took six weeks. The product was safe. The assessment was correct. The paperwork was close to right but not exactly right. Close to right does not work with regulators.
The lesson from that episode is the lesson of the whole regulatory layer. Compliance runs on evidence, properly documented and readily accessible on demand.
Every cosmetic product requires evidence of shelf-life stability and microbiological safety under the normal conditions of use.
Accelerated stability testing, which subjects the product to elevated temperature conditions that simulate aging, typically costs 500 to 1,500 euros per formulation and takes three to six months. Real-time stability testing at ambient conditions costs 800 to 2,500 euros per formulation and is the gold standard for PIF documentation, though it obviously cannot be completed before launch. Challenge testing, which confirms the preservative system is effective against microbial contamination, adds 300 to 600 euros per product.
For a product going into the EU or UK, this testing is a PIF prerequisite. For the US, it is a safety substantiation record that must be producible on FDA request. Either way, the test is not optional.
Product labels are regulatory instruments.
In the EU and UK, labels must carry the Responsible Person’s name and address, the nominal content, the date of minimum durability, which Article 19(1)(c) replaces with the Period After Opening (PAO) symbol where minimum durability exceeds 30 months rather than leaving the two as a free choice, warnings where required, batch number, product function when not obvious from presentation, and the complete ingredient list, in descending order of weight at the time the ingredients are added, with ingredients present at less than 1 percent allowed in any order after those above 1 percent. The names used are the common ingredient names set out in the glossary provided for in Article 33, and a term from a generally accepted nomenclature where an ingredient has no common name. Allergens from the fragrance allergen list must be separately disclosed when present above the regulated thresholds.
In the US, labels must carry the manufacturer or distributor name and address, the net content, the ingredient declaration in descending order of predominance, warnings where required, and identification information sufficient to trace the batch.
The details diverge country by country.
For a full comparison of label requirements across EU, US, and Great Britain, there is a dedicated guide.
The EU Cosmetics Regulation 1223/2009 is, as of 2026, the most comprehensive and most frequently updated cosmetic regulation in the world.
The EU system rests on three operating principles.
Safety-first, by pre-market assessment. No cosmetic can be placed on the EU market without a complete PIF, a qualified safety assessor’s CPSR conclusion, a Responsible Person on record, and a completed CPNP notification. The burden is on the brand to demonstrate safety before sale.
A continuously updated substance control regime. Annexes II through VI of Regulation 1223/2009 list banned substances, restricted substances with conditions of use, permitted colorants, permitted preservatives, and permitted UV filters. These lists are updated by Commission Regulations issued on an ongoing basis. In the twelve months to April 2026 alone, the Commission issued Commission Regulation (EU) 2025/877 of May 12, 2025 adding CMR substance restrictions, and issued Commission Regulation (EU) 2026/78 (Omnibus VIII), adding fifteen newly classified CMR substances to the Annex II prohibition list with effect from May 1, 2026. Staying current means active monitoring, month after month.
GMP as a legal requirement. Article 8 of the regulation requires that cosmetic products be manufactured in compliance with Good Manufacturing Practice, and names no standard. Article 8(2) adds that compliance is presumed where manufacture follows the relevant harmonized standards whose references are published in the Official Journal, and the list for cosmetics holds a single entry, EN ISO 22716:2007. Any manufacturer producing for the EU market is expected to operate at that standard, and your manufacturer’s GMP certification is a commercial proof of GMP rather than a legal obligation: what Article 11(2)(c) requires inside the PIF is a statement on compliance with good manufacturing practice, not a certificate.
For a founder beginning from scratch with no prior regulatory infrastructure, a standard EU launch sequence runs as follows.
Month one to two: formulation finalization, manufacturer ISO 22716 verification, raw material documentation collection, initial stability testing begun.
Month three to four: PIF draft compilation, safety assessor engagement, CPSR development, microbiological testing completion, label design against regulatory requirements.
Month four to five: CPSR sign-off, PIF finalization, Responsible Person engagement (if not already secured), CPNP notification submission.
Month six: product goes on sale.
Most first-time brands exceed this timeline.
The most common overruns come from stability testing that takes longer than expected, formula changes that restart the testing clock, and label revisions required after safety assessor review.
Three developments sit on the near-term EU radar, and a brand launching in 2026 should watch all of them.
The CMR restriction package applying from May 1, 2026. Fifteen substances newly classified as CMR under the CLP Regulation are added to the Annex II prohibition list (Commission Regulation (EU) 2026/78; a few restricted-use entries are also added to Annexes III to V). Brands with legacy formulations should confirm their ingredient panels against the updated Annex II.
The fragrance allergen labeling expansion. Commission Regulation (EU) 2023/1545 of July 26, 2023 substantially expanded the list of fragrance allergens that must be separately disclosed on cosmetic labels. The transition runs on two dates and in one direction only: a product that does not meet the new entries could be placed on the Union market until July 31, 2026, and stock already placed may still be made available on the Union market until July 31, 2028. The supply chain implications for fragrance reformulation and relabeling run deeper than most founders expect.
The French PFAS ban. France’s Law No. 2025-188 of February 27, 2025, supplemented by implementing Decree 2025-1376 published in December 2025, entered into force on January 1, 2026. It prohibits the manufacture, import, export, and sale in France of cosmetic products containing per- and polyfluoroalkyl substances above thresholds specified in the decree, with a twelve-month transition period for pre-existing stock. France is the first EU country to ban PFAS in cosmetics. The European Chemicals Agency consultation on a bloc-wide PFAS restriction is ongoing, and the French law is widely expected to accelerate the EU-level decision.
The US regulatory environment for cosmetics is in the middle of its largest change in eighty years.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed in December 2022, imposed new federal requirements that were phased in from December 2023 through 2024.
Facility registration. Every facility that manufactures or processes cosmetic products for the US market must register with the FDA using Form FDA 5066, with biennial renewal, unless its owner or operator qualifies as a small business: under 1,000,000 dollars of average gross annual US cosmetic sales over the previous three years, adjusted for inflation, and none of the four product types listed in section 612(b). Those four are products that regularly come into contact with the mucus membrane of the eye under customary use, products that are injected, products intended for internal use, and products intended to alter appearance for more than 24 hours where removal by the consumer is not part of customary use. Facilities that initially registered by the July 1, 2024 deadline are in their first renewal cycle in 2026.
Product listing. Each cosmetic product sold in the US must be listed with the FDA using Form FDA 5067, and the same section 612 exemption applies. The listing provides formulation information, product category coding, and the identity of the responsible person (the brand name on the label).
Adverse event reporting. Serious adverse events must be reported to the FDA within fifteen business days of the responsible person receiving the report.
Safety substantiation records. The responsible person must maintain records supporting the safety substantiation of each product. These records are not submitted pre-market but must be producible on FDA request.
FDA enforcement powers. The FDA now has mandatory recall authority for cosmetics, expanded records access powers, and suspension authority over facility registrations.
The part most founders want to know is the part that remains least settled.
The GMP rule is delayed indefinitely. MoCRA required the FDA to issue a proposed GMP rule by December 29, 2024 and a final rule by December 29, 2025. Both statutory deadlines passed. The FDA’s Spring 2025 Unified Agenda moved the GMP rulemaking to the "Long-Term Actions" list, which signals that no Notice of Proposed Rulemaking is expected within twelve months. There is no published target date for either the proposed or final rule as of April 2026.
This does not create a compliance vacuum. The FDA has consistently signaled that ISO 22716 is the interim reference standard. The Federal Food, Drug, and Cosmetic Act’s adulteration provisions remain fully enforceable. FDA inspections continue. Brands whose manufacturers already operate to ISO 22716 standard are effectively ahead of the rule.
The fragrance allergen labeling rule is still unproposed. MoCRA required the FDA to issue a proposed rule on fragrance allergen disclosure by June 29, 2024. That deadline passed, and so did the May 2026 target the Unified Agenda set afterwards, with no proposed rule published. The FDA now points to a Notice of Proposed Rulemaking in November 2026. Even on that schedule, with a comment period and finalization still to come, an effective rule is unlikely before 2027 at the earliest.
The talc asbestos testing rule was withdrawn on November 28, 2025. The proposed rule requiring standardized detection methods for asbestos in talc-containing cosmetics was published in December 2024, then withdrawn (Federal Register 2025-21407), with the FDA saying it intends to reconsider the approach and republish. There is no pending proposal to track.
The formaldehyde restriction in hair smoothing products is in development. A proposed rule restricting formaldehyde and formaldehyde-releasing agents in hair straightening and smoothing products was on the FDA’s agenda with an originally expected December 2025 NPRM.
January 2026: records access draft guidance. The FDA released draft guidance in January 2026 clarifying its authority to access and copy cosmetic product records under MoCRA. The trigger is reasonable belief that a product is adulterated in a way posing a threat of serious adverse health consequences or death.
Federal MoCRA is not the full US compliance picture.
California Proposition 65 requires specific warnings when products contain substances that California has listed as known to cause cancer or reproductive toxicity. Compliance is complex, litigation is active, and brands selling into California without addressing Prop 65 carry genuine exposure.
State-level PFAS bans are active or coming. California’s ban on intentionally-added PFAS in cosmetics took effect in 2025. Colorado, Maryland, Minnesota, and Washington have enacted similar bans with varying effective dates. More states are advancing bills in 2026.
Animal testing bans at the state level now cover California, New York, Virginia, Illinois, Nevada, Louisiana, Hawaii, Maryland, New Jersey, Oregon, Maine, and a growing list.
A brand selling nationally must in effect operate to the most restrictive state standard.
The practical implication: a nationally distributed US cosmetic brand, in 2026, is working under federal MoCRA plus a fragmented but tightening state-level regulatory environment.
The total compliance burden is materially higher than it was even two years ago.
Federal MoCRA registrations are free.
Facility registration (handled by the manufacturer) and product listing (handled by the brand or the manufacturer depending on labeling) carry no filing fees.
The real US compliance cost sits in safety substantiation, Prop 65 review, state-by-state label and formula compliance, and ongoing legal review. Budget ranges I see in practice run from 1,000 to 3,000 euros per product for a first-time US launch with no state-specific complications, climbing to 5,000+ euros per product when California Prop 65 labeling and multiple state-level PFAS considerations are in play.
Compliance in 2026 is a structural cost, not a line item. Founders who treat it as a last-minute box-tick get stuck. The ones who treat it as one of the three legs of launch, alongside product and brand, are the ones who ship.
This is the mindset shift that distinguishes a brand that launches cleanly from a brand that lurches through enforcement letters and Amazon listing suspensions.
The EU and US command the most attention in industry content.
But a brand with any international ambition needs a view of what the rest of the regulatory map looks like in 2026.
The UK cosmetics regulation is a retained version of Regulation (EC) No 1223/2009, now operating as UK-domestic law. The framework is nearly identical in structure but increasingly independent in substance.
Key UK specifics. A Responsible Person established in the United Kingdom is required for any product placed on the GB market (England, Scotland, Wales). A GB-specific PIF is required, though its content largely mirrors the EU PIF. Notification happens through the SCPN portal, not the CPNP. Northern Ireland continues to follow the EU regulation and uses the EU CPNP under the terms of the Windsor Framework.
The drift is accelerating. The UK has begun issuing its own amendments independent of the EU track. The Cosmetic Products Regulation (EC) No 1223/2009 (Restriction of Chemical Substances) (Amendment and Transitional Provisions) Regulations 2026 (SI 2026/23) extend to England and Wales and Scotland, so they bind Great Britain and not Northern Ireland. They carry two dates: 4-MBC is prohibited from July 15, 2026, the sixteen CMR substances from August 15, 2026. UK amendment instruments SI 2022/659, SI 2023/836, SI 2024/1334, and SI 2025/901 show the pattern. Compliance with EU regulation no longer automatically means compliance in Great Britain.
Cost reality. A Great Britain-only launch runs roughly the same cost structure as EU. A brand selling into both markets carries dual infrastructure: two PIFs, two Responsible Persons, two notifications per product. Expect 30 to 50 percent incremental regulatory cost versus single-market launch.
Canada operates the Cosmetic Regulations under the Food and Drugs Act, enforced by Health Canada.
Cosmetic Notification Form (CNF). Every cosmetic sold in Canada must be notified to Health Canada via the CNF within ten days of the first sale. The CNF captures product identity, ingredients, company information, and, since March 5, 2025, a Canadian address for the manufacturer or importer. Filing is not clearance. Health Canada is explicit that submitting the CNF is not approval for sale, not agreement that the product counts as a cosmetic, and not confirmation that it complies with everything else. The form is free.
Cosmetic Ingredient Hotlist. Canada’s version of the EU Annexes II/III. The Hotlist identifies substances that are prohibited or restricted in cosmetics. The list is updated periodically. Pre-notification ingredient review against the Hotlist is the equivalent of EU CMR ingredient review.
Fragrance allergen disclosure from April 12, 2026. Subsection 21.4(4) of the Cosmetic Regulations requires a fragrance allergen to be named inside the ingredient list, outside the collective term parfum, when it is present above 0.01 percent in a rinse-off product or above 0.001 percent in a leave-on product. The same allergens go on the Cosmetic Notification Form, one per ingredient line, with the disclosure threshold box ticked. Below those levels the fragrance components can stay inside parfum on both the label and the form, and on the form you only have to give a concentration for an allergen line when the Hotlist attaches a concentration condition to that substance, although Health Canada encourages you to give it anyway. April 12, 2026 is not the day the whole European list lands. On that date you disclose the 24 allergens the EU already had, for new and existing products alike. The rest of the expanded list, 81 entries in total, follows the European clock: August 1, 2026 for new cosmetics and August 1, 2028 for products already on the market. Canada keeps no list of its own. It points at the EU annex as amended, so future European additions become Canadian requirements on the European timetable.
Bilingual labeling. Section 18 of the Cosmetic Regulations requires the information those Regulations mandate on a cosmetic label to appear in both English and French, with one exception written into the section itself: the INCI name. So the ingredient list does not get doubled, and neither does marketing copy, which section 18 never reaches, though provincial law can. The Consumer Packaging and Labelling Regulations add the same duty for the product identity and the net quantity, while the dealer’s identity and principal place of business may stay in one official language. Two catches. The 58 ingredients in the Schedule to the Cosmetic Regulations have a rule of their own: aqua on its own is fine, water on its own is not, because a Schedule ingredient’s INCI name has to travel with its French equivalent, as in water/eau. And Quebec adds French language requirements on top of the federal ones. Bilingual layout is still a design and printing constraint from day one, not an afterthought.
Cost profile. Canada is one of the most efficient jurisdictions to enter. Notification is free. Ingredient Hotlist review and bilingual label development typically run 200 to 600 euros per product for most formulations. Allow 2 to 4 months for end-to-end compliance.
China’s Cosmetic Supervision and Administration Regulation (CSAR) took effect January 1, 2021 and replaced the previous framework.
Two tracks. General cosmetics require filing (notification). Special cosmetics (sunscreens, hair dyes, perms, whitening products, anti-hair-loss products, and products with new efficacy claims) require full registration with the National Medical Products Administration (NMPA).
Domestic responsible person. The market calls this role the DRA, domestic responsible agent. NMPA’s own English name for it is domestic responsible person (境内责任人), and the difference is not cosmetic: an agent acts for you, while this entity carries a share of the liability itself. A company that registers or files a product in China from outside the country must designate an enterprise legal person established in China to fill the role. That entity files the registration or the notification in the overseas company’s name, assists it with adverse reaction monitoring and with recalls, cooperates with the drug regulatory authority’s inspections, and carries the share of product quality and safety liability their contract sets out (Article 23 of the CSAR, Article 8 of the Provisions for Registration and Filing of Cosmetics, SAMR Order No. 35). What it does not do is take the product over: the registration certificate is issued to the overseas registrant, it cannot be transferred, and the overseas company stays responsible for the product’s quality and safety. A brand that does not register or file in China itself, because a Chinese company does it or because the goods reach the consumer through cross-border e-commerce retail import, has no domestic responsible person to appoint.
Ingredient regime. China maintains an Inventory of Existing Cosmetic Ingredients in China (IECIC). Any ingredient not on the IECIC requires a separate new cosmetic ingredient registration or notification before it can appear in a finished product.
Animal testing update. Since 1 May 2021 an imported general cosmetic can be filed without the product’s toxicology test report when two conditions hold together: the manufacturer already holds a production quality management system qualification issued by the government competent authority of its own country or region, and the product’s safety risk assessment result confirms the product’s safety (Article 33(2) of the Provisions on the Management of Cosmetic Registration and Filing Dossiers). This is not a ban on animal testing, and the qualification is something the manufacturer must already hold, not something you supply. Products claiming use on infants and children stay outside it, as do products using a new ingredient still under safety monitoring and parties flagged as key supervision targets. From 29 July 2026, NMPA Announcement 2026 No. 70 opens the same route to perm products, non-oxidative hair dyes and whitening products that work by physical covering only. Every other special cosmetic still files the report.
Cost profile. Filing fees for general cosmetics run approximately RMB 2,000 (roughly 250 euros at April 2026 rates). Special cosmetics registration runs RMB 15,000 to 30,000 (approximately 1,800 to 3,600 euros) in official fees, with total compliance cost including DRA fees, testing, translations, and technical dossier preparation typically running 8,000 to 30,000 euros per product.
2026 reform signals. The NMPA issued reform guidelines in late 2025 and a draft announcement on March 31, 2026 introducing further simplification of cosmetic registration and filing processes. The E-Label Pilot Program (NMPA Cosmetics [2025] No. 16) launches February 1, 2026 in seven regions, testing digital labeling through QR codes. The Chinese regulatory environment is moving, and founders should consult current guidance at the point of market entry.
Japan regulates cosmetics under the Pharmaceuticals and Medical Devices Act (PMD Act). The authority is the Ministry of Health, Labour and Welfare, and the cosmetics work is delegated to prefectural governors, who issue the licenses and receive the filings. You need a Japanese marketing business license holder, and you notify each item before you market it. An ordinary cosmetic is not approved by anyone. The ingredient rules run the opposite way to a positive list: a prohibited list and a capped list cover ingredients in general, and true positive lists exist only for preservatives, UV absorbers and tar colors, so anything else may be used on your own responsibility. Item-by-item approval is the quasi-drug route, and what puts a product there is its intended purpose, not how strong the claim sounds. A plain cosmetic can still carry any of the 56 efficacies the ministry lists, including preventing sunburn. The Pharmaceuticals and Medical Devices Agency (PMDA) is not the cosmetics regulator, although adverse reaction reports on cosmetics do go to it.
South Korea operates the Cosmetics Act under the Ministry of Food and Drug Safety (MFDS). Functional cosmetics clear MFDS item by item, and the Act puts two routes on the same footing: a safety and efficacy review, or a report. If the active ingredient and its content, the efficacy, the dosage, the specification and the test method all match an item MFDS has already notified, you take the report route, which MFDS handles with no fee and usually on the same day. Both routes are filed with the National Institute of Food and Drug Safety Evaluation, and MFDS publishes 60 days and 189,000 KRW for the review. Neither route ends in a certificate: what you get is a notice of review result, and the status the Act confers is recognition as a functional cosmetic. To import, you need a cosmetics responsible distributor registered with MFDS, the role MFDS calls Responsible Seller in its own English pages. That registration is not a formality: it takes the quality control and post-sale safety standards, a named responsible distribution manager, and the full raw material list reported to MFDS before the product goes into distribution. Safety assessment data is owed for products marketed for infants or children, and Korean GMP is something MFDS recommends to manufacturers, not an entry requirement.
The GCC states (Gulf Cooperation Council, including UAE, Saudi Arabia, and others) operate a harmonized Technical Regulation for Cosmetic and Personal Care Products that requires conformity assessment and registration.
ASEAN operates the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS), with country-level notification systems.
For most small and mid-sized brands, these markets come after a multi-year EU and US track record. A brand planning serious entry into any of them should engage specialized regulatory consultancies in the target jurisdiction, not attempt self-compliance from a distance.
The practical approach I recommend to founders looks like this.
Start with a single primary market. Meet its requirements fully, end-to-end, before opening a second front. The cost of partial compliance in multiple markets is always higher than full compliance in one.
Build regulatory into your product development process from day one. A product development process that integrates regulatory review at the concept stage avoids the reformulation loops that kill launch timelines.
Budget realistically. For a line of three to five products launching into the EU, expect 3,000 to 5,000 euros in regulatory costs. For Great Britain, add 30 to 50 percent on top. For the US under MoCRA, budget 1,000 to 3,000 euros per product, rising with state-level complexity. For China as a single additional market, budget 8,000 to 30,000 euros per product for full compliance.
Treat regulatory as ongoing, not one-time. The EU publishes amendments throughout the year. MoCRA rulemaking is active. Divergence in Great Britain is accelerating. Someone, internally or contracted, needs to track these updates against your portfolio.
Verify the specifics at the point of launch, not before. The rules change fast enough that guidance written six months ago may be outdated in specific elements. For any concrete decision, confirm with a qualified Responsible Person or regulatory consultant with current expertise in your target market.
What are the main cosmetics regulations I need to know about as a new brand?
The main frameworks are EU Regulation 1223/2009 for the European Union, the UK Cosmetics Regulation (the retained and amended version of 1223/2009) for Great Britain, the FD&C Act as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for the United States, the Cosmetic Regulations under the Food and Drugs Act for Canada, and the Cosmetic Supervision and Administration Regulation (CSAR) for China. Every jurisdiction requires some form of safety documentation, product notification or registration, ingredient compliance, and labeling compliance. The EU system is the most demanding pre-market; the US is less demanding pre-market but carries serious post-market liability; Canada is the most efficient to enter; China is the only one of these five with a pre-approval step, since a special cosmetic cannot be manufactured or imported until NMPA has registered it.
How much does cosmetic regulatory compliance actually cost?
For a line of three to five products launching in the EU, budget 3,000 to 5,000 euros in regulatory costs, including CPSR, PIF preparation, Responsible Person services, and CPNP notification. Per-product cost runs 500 to 1,800 euros for the PIF and 300 to 800 euros for the CPSR. For Great Britain, add 30 to 50 percent on top if you are running parallel EU plus Great Britain compliance. For the US under MoCRA, expect 1,000 to 3,000 euros per product in substantiation, label compliance, and legal review, rising to 5,000+ euros per product when California Prop 65 and state-level PFAS concerns apply. For China, budget 8,000 to 30,000 euros per product for full compliance including DRA fees and testing. These numbers exclude ongoing monitoring and renewals.
What is the difference between PIF, CPSR, and CPNP notification?
The Product Information File (PIF) is the complete dossier on your cosmetic product: formulation, manufacturing, safety, claims, testing, and packaging documentation, all held at the Responsible Person’s address. The Cosmetic Product Safety Report (CPSR) is the specific safety-assessment component within the PIF, signed by a qualified safety assessor. The Cosmetic Products Notification Portal (CPNP) is the EU’s online notification system where each product is notified before sale. The PIF lives on file, the CPSR is inside the PIF, and the CPNP notification is submitted to the regulator and generates a reference number. All three are required for EU market entry.
Do I need a Responsible Person, and what does the role cover?
Yes, for sales in the EU and the UK. The Responsible Person is a legal or natural person established in the jurisdiction who takes on primary regulatory liability for the product. They hold the PIF, submit notifications, handle authority communications, manage adverse event reports, and are named on the label. Foreign brands typically contract with a specialized Responsible Person service. Typical cost is 500 to 2,000 euros per year for a small catalog. Separate Responsible Persons are required for the EU and Great Britain post-Brexit. China does not belong under the same heading. An overseas registrant or filer there must designate a domestic responsible person, but that entity acts in the registrant’s name, assists with adverse reaction monitoring rather than owning it, never appears on the label, and holds no Product Information File, because the Chinese system has none. Primary liability stays with the overseas registrant. Canada is a lighter case and worth keeping separate. The Cosmetic Regulations never use the term and nobody has to be formally appointed, but the definition of manufacturer only reaches a person in Canada, so a foreign brand owner either works through an importer or names someone in Canada to act on its behalf, and that Canadian address goes on the notification form. Health Canada calls that person the responsible person in Canada. They hold no dossier, and they do not have to be named on the label: an imported product can carry the foreign dealer’s address instead.
Is MoCRA the same as an EU-style regulation now?
No. MoCRA has materially expanded the FDA’s authority over cosmetics, but the US system is not equivalent to EU pre-market assessment. Under MoCRA, the owner or operator of the manufacturing facility registers it with the FDA and the responsible person named on the label files the product listing, unless the section 612 small business exemption applies (a sales threshold plus none of the four higher-risk product types), and in every case the responsible person maintains safety substantiation records on file and reports serious adverse events. There is no pre-market approval process, no equivalent of the CPSR-signed dossier, and no equivalent of the CPNP notification portal. The FDA proposed GMP rule is currently on the Long-Term Actions list with no 12-month horizon, while the fragrance allergen labeling proposed rule has still not been published and the FDA now indicates November 2026. MoCRA is best thought of as moving the US toward a mandatory facility and product registration system with FDA enforcement teeth, not toward full EU-equivalence.
What should I do about PFAS in my cosmetic formulations?
Plan for a PFAS-free formulation strategy across all target markets. France’s Law No. 2025-188 banned PFAS in cosmetics from January 1, 2026. California, Colorado, Maryland, Minnesota, and Washington all have PFAS restrictions in cosmetics now active or imminent, and the European Chemicals Agency is consulting on an EU-wide restriction. Even in markets without formal bans, major retailers and e-commerce platforms are increasingly requiring PFAS-free declarations. If your formulations currently use PFAS-containing ingredients (for texture, spreadability, or water resistance), engage your manufacturer on substitution now rather than waiting for the regulatory deadline in each market. The cost of reformulation ahead of the curve is materially lower than the cost of inventory write-offs when a market closes.
How do I plan a multi-market compliance strategy without getting overwhelmed?
Start with one market that represents real commercial volume in year one, and meet that market’s regulatory requirements fully before adding a second. Budget regulatory as a per-market cost, with ongoing monitoring as a fixed annual line item. Integrate regulatory review into your product development workflow at the concept stage, not the launch stage. Engage specialized Responsible Person services and regulatory consultants with current expertise in your target markets. Verify specifics at the point of launch, since regulations change frequently enough that secondary sources may be out of date. Treat the compliance layer as one of the three foundational elements of your brand, alongside product and positioning, not as a last-minute box-tick.
Keep reading
Complete independent guide to cosmetics import/export documentation in 2026. EU, USA, and Great Britain customs requirements, HS codes, certificates of free sale, IOSS changes, MoCRA obligations, and the operational traps that cost founders the most. From 30 years in the industry.
Complete independent guide to cosmetic brand trademark protection in 2026. EUIPO, USPTO, UKIPO, and the Madrid System compared, Nice classes 3 and 5 explained, costs and timelines. From 30 years in the industry. Not legal advice.
Complete independent comparison of cosmetic label requirements across the EU, USA, and Great Britain in 2026. Mandatory elements, symbols, language rules, printing technique constraints, and a pre-production checklist. From 30 years in the industry.
