The documents you need to legally sell a perfume
A little while ago I took a call from a founder whose entire first run, some three thousand bottles of a genuinely lovely woody floral, was sitting on a pallet in a bonded warehouse in New Jersey, going absolutely nowhere. The forwarder had asked for a safety data sheet. She had one. Or thought she did. What she actually had was an SDS for the concentrate rather than for the finished juice, which meant the flash point printed on it bore no useful relationship to what was in the bottles. Two weeks and a considerable sum of money later, the pallet moved.
I mention this not to be gloomy, but because it is so completely typical. Nobody sets out to get the paperwork wrong. What happens is that the paperwork simply isn't thought about until something stops moving, and by then the run has been made and the options have narrowed dramatically.
So. Here is the whole set, for a fine fragrance sold in the United States and Europe. What each document is, who actually produces it, and, perhaps most usefully, when in a development program it ought to be made. None of it is difficult. Very nearly all of it is easier before you have three thousand bottles sitting somewhere.
| Document | Where it applies | Who issues it | When |
|---|---|---|---|
| IFRA Certificate of Conformity | Global, contractual | Fragrance house | At formula approval |
| Allergen declaration | EU, UK, eventually US | Fragrance house | At formula approval |
| Safety Data Sheet (GHS) | US, EU, all transport | Maker of the finished good | Before first shipment |
| Certificate of Analysis | Contractual, per batch | Filler or manufacturer | Every production batch |
| MoCRA registration and listing | United States | You, via the FDA portal | Before marketing |
| Label artwork, 21 CFR 701 | United States | You | Before print |
| PIF and CPSR | European Union | Qualified safety assessor | Before notification |
| CPNP and SCPN notifications | EU and UK separately | Responsible Person | Before placing on market |
| UN1266 transport paperwork | All freight | Shipper | Every shipment |
ONE GLOBAL
The IFRA Certificate of Conformity
Let us start with the document everybody has heard of and rather fewer have actually read.
It comes from whoever compounded your concentrate, and it states that the compound has been assessed against the IFRA Standards, with a maximum use level given for each of twelve product categories. Fine fragrance is Category 4, covering hydroalcoholic products applied to the skin, and for most of you it is the only line on the certificate that will ever matter. A certificate reading "Category 4, 20%" means exactly what it appears to mean. You may dose that compound up to twenty percent in an eau de parfum and remain within the Standards.
Where a category reads "not supported", the compound simply hasn't been assessed for that use. Which is not at all the same thing as unsafe. It is, however, precisely the same thing as having no document to show, and as far as a retailer's compliance team is concerned those two states are indistinguishable. Semantics, I'm afraid. There will be more of it.
The point I would press hardest, though, is that the Standards move. IFRA is currently on its 51st Amendment. The 52nd went out to consultation and closed in June of this year, and has yet to publish. Each amendment prohibits or restricts materials on a staged clock: prohibitions bind new creations two months after notification and existing ones at thirteen months, whilst restrictions and specifications run to nine and twenty-eight months respectively. All of which means a certificate issued three years ago against a superseded amendment is evidence of very little. Look for the amendment number on the face of the document. If it isn't there, ask.
And one clarification, because I have seen this misunderstood energetically in both directions. IFRA compliance is not law in the United States. It is a voluntary industry standard, nothing more. It is also the thing that every serious retailer, insurer, filler and freight partner will ask you for. Meanwhile, in the European Union, a good many IFRA restrictions are mirrored in Annexes II and III of the Cosmetics Regulation, where they most certainly are law.
TWO EU, UK
The allergen declaration
Now for the one that actually changed. Four weeks ago. In late July, when a great many people who needed to know about it were on a beach.
CHANGED 31 JULY 2026
Under Commission Regulation (EU) 2023/1545, the list of fragrance allergens requiring individual declaration on EU labels has gone from 26 substances to 82. Product placed on the EU market from 31 July 2026 must comply. Stock already on the market before that date may be sold through until 31 July 2028.
The thresholds themselves are unchanged. An allergen must be named in the ingredient declaration where it exceeds 0.001% in a leave-on product, or 0.01% in a rinse-off. Fine fragrance is leave-on, so we are talking about ten parts per million in the finished juice, which is not very much at all.
At ten parts per million, naturals declare, and they declare enthusiastically. Bergamot brings limonene and linalool along with it. Ylang arrives with benzyl benzoate and benzyl salicylate. A rose absolute at a few percent can put four or five names on your carton entirely by itself. The expansion has therefore not landed evenly: a naturals-forward composition picked up considerably more names in July than an aromachemical-forward one did, which is an irony I suspect nobody intended and everybody has noticed.
The declaration itself comes from your compounder, calculated from the formula at your finished dosage. It is a list of allergen names with their percentages in the finished product, and your ingredient list is derived from it. Never, and I do mean never, the other way round.
Two consequences worth acting on. The first is that an allergen statement built against the old twenty-six is no longer a compliant basis for EU label copy, and if yours was issued before the middle of last year you should assume it needs reissuing. The second is subtler, and it is the one I would raise with any perfumer you are working with: allergen load has quietly become a formulation decision with packaging consequences. If a brief is heading for Europe and the carton is already tight, that is a conversation for submission stage. Not for artwork.
An allergen statement built against the old twenty-six is no longer a compliant basis for EU label copy.
THREE US, EU, TRANSPORT
The Safety Data Sheet
Sixteen sections, in a fixed order, under the Globally Harmonised System as adopted by OSHA in 29 CFR 1910.1200. In practice three of those sections do nearly all the work: Section 2 carries the hazard classification and signal word, Section 9 carries the flash point, and Section 14 carries the transport classification.
Which brings us back to that pallet in New Jersey. An SDS for your concentrate is not an SDS for your product. I realise this sounds like the sort of distinction only a pedant would insist upon, and I accept the charge cheerfully, but it is also the single most common documentary error I see. You need an SDS for the finished good at its final ethanol content, because the finished good is what is actually in the box.
Flash point is the number that governs everything downstream. An eau de parfum at eighteen to twenty percent in denatured alcohol will typically flash somewhere in the low twenties Celsius, which puts it in Class 3, Packing Group II. That one figure determines your packing requirements, your carrier options, your air freight surcharges, and in one or two lanes whether the shipment moves at all. Your forwarder reads it before anything else. So should you.
FOUR CONTRACTUAL
The Certificate of Analysis
Per batch. Not per product. I labour the distinction because it catches people out with some regularity, usually when a second delivery arrives and the retailer asks for a CoA that nobody has thought to produce.
A CoA covers the specific lot in front of you: batch number, date of manufacture, appearance, colour, odour conformity against a retained standard, specific gravity, refractive index, ethanol content, and a straightforward pass or fail against the agreed specification. It is what demonstrates that the bottles on this pallet are the same as the ones you approved.
It is also, and I would put this rather higher than most people do, the only meaningful defence you have if a batch is questioned six months later. Which is why the retained reference sample matters at least as much as the certificate. Keep a sealed one from every single run. It costs you nothing and one day it will be the most valuable object you own.
FIVE UNITED STATES
MoCRA, and what America now asks of you
The United States spent the better part of eighty-five years not regulating cosmetics terribly much, and then, on 29 December 2023, the Modernization of Cosmetics Regulation Act came into force. The FDA began enforcing facility registration and product listing in July 2024. It is the most substantial expansion of American cosmetics oversight since 1938, and, as you would expect of something that new, it is still settling.
What is live now:
Facility registration. Whoever manufactures or processes the product registers the facility, updates within sixty days of any change, and renews every two years.
Product listing. The responsible person lists each marketed product with its ingredients, updated annually.
Safety substantiation. You must hold adequate evidence of safety. No format is prescribed, which is very probably why this is the obligation most widely ignored. A CPSR prepared for Europe satisfies it comfortably, and if you are launching in both markets it is much the most efficient route.
Adverse event records. Kept for six years, with serious events reported to the FDA within fifteen business days.
And what is not. The GMP rule has been postponed and shunted onto the FDA's long-term actions list. The talc testing rule was withdrawn in November of last year. The fragrance allergen labelling rule, which is the one that would bring American disclosure somewhere nearer the European position, remains a notice of proposed rulemaking and has slipped more than once.
My own guess, for whatever it is worth, is that the United States converges on something resembling the EU list eventually. Building your allergen data now is therefore not wasted effort. It is simply early.
There is a small business exemption from registration and listing below the revenue threshold, though it does not extend to eye-area products, injectables, products for internal use, or anything that alters appearance for more than twenty-four hours. Most fine fragrance qualifies. The safety substantiation and adverse event duties apply to everyone regardless of size, which is a detail worth reading twice.
SIX UNITED STATES
What has to be on an American label
21 CFR 701, and it is more prescriptive than most people expect. The principal display panel carries the identity of the product and the net quantity of contents, the latter sitting in the bottom thirty percent of the panel and running parallel to the base. The information panel carries the name and place of business, with a street address unless the firm appears in a current directory, qualified by "Manufactured for" or "Distributed by" where you are not in fact the manufacturer.
Ingredients run in descending order of predominance, except that anything present at one percent or below, along with colour additives at any level, may be listed without regard to order. Type must be conspicuous and no smaller than a sixteenth of an inch.
The fragrance exemption is the part that gets misread, and I would say misread optimistically. Composition may be declared simply as "fragrance", or "parfum" if you prefer the French, which protects your formula and is a genuinely useful concession. But it covers composition. It does not cover allergens. And it is precisely the exemption that the pending FDA rule is expected to narrow.
SEVEN EUROPEAN UNION
Responsible Person, PIF, CPSR
"Responsible Person" is one of those phrases that sounds like a description and is in fact a legal term of art. You cannot place a cosmetic on the EU market without one, they must be established in the Union, and their name and address must appear on your label. This is a role carrying real liability, not a forwarding address. In practice it is either your EU distributor or a contracted RP service, and I would think carefully before choosing the former: an RP tied to a distribution agreement becomes awkward at precisely the moment the distribution agreement ends.
The RP holds the Product Information File. In it: the product description, the Cosmetic Product Safety Report, evidence of Good Manufacturing Practice, substantiation for every claim you have made, and a statement on animal testing. It must remain available to the authorities for ten years after the last batch was placed on the market, which is longer than a good many brands last.
The CPSR comes in two parts. Part A is the data: composition, physicochemical characteristics, microbiological quality, impurities and traces, packaging, exposure calculations, and the toxicological profile of every substance. Part B is the assessment and the reasoned conclusion, signed by a qualified safety assessor holding a recognised qualification in pharmacy, toxicology or dermatology.
You do not write Part B. Nor does your fragrance house, whatever it may imply. It is signed work by a named professional putting their qualification behind a conclusion, and anybody suggesting otherwise is describing a different document.
Notification then runs through the Cosmetic Product Notification Portal before the product goes on sale: product name and category, RP details, country of origin, frame formulation, label artwork and a product image.
EIGHT UNITED KINGDOM
And the UK is a separate filing entirely
Since Brexit, Britain runs its own version of all of the above. You will need a UK Responsible Person established in the UK, a UK address on the label, and notification through the Submit Cosmetic Product Notification service, administered by the Office for Product Safety and Standards.
It is a parallel filing rather than a copy of the European one, and it is not free. Northern Ireland, meanwhile, remains aligned with EU rules, so product destined there needs both notifications. Brands tend to discover all of this at the moment a London stockist places an order, which is very much the worst moment available.
NINE ALL FREIGHT
UN1266, or actually moving the things
Perfume, whatever else it may be, is a flammable liquid. The proper shipping name is UN1266, Perfumery products, Class 3, Packing Group II or III depending on that flash point we discussed earlier. Every carrier, warehouse and third-party logistics provider you deal with will treat it accordingly, and a surprising number will simply decline it.
Ground, domestic. Most retail perfume moves under Limited Quantity provisions. Special Provision 149 allows inner receptacles of up to five litres irrespective of packing group, with the limited quantity diamond mark and no shipper's declaration. This is how direct-to-consumer perfume ships in America, and it is refreshingly straightforward.
Air. Retail-packaged personal care goods can travel as Consumer Commodity, ID8000, Class 9, with a shipper's declaration. Air tightens further on passenger aircraft and into several Gulf and Asian markets.
Training. Hazmat training is mandatory for anyone preparing shipments, recertified every three years under 49 CFR and every two under IATA. Your filler holding it does not cover you.
Overpacks. Shrink-wrap your cartons to a pallet and that pallet becomes an overpack, requiring the marks and labels duplicated on the outside. This is the most common finding at freight inspection I am aware of, and it is what strands pallets.
Above a few hundred kilos into Europe, ocean is very nearly always the answer. Air freight on Class 3 is expensive, and the surcharges have a habit of not appearing on the original quotation.
TWO ASIDES UNITED STATES
Two things I am asked about constantly
There is no such thing as an FDA-approved perfume
The FDA does not approve cosmetics and never has. MoCRA introduced registration, listing and substantiation duties; it did not introduce pre-market approval, and the distinction is not a small one. Any supplier describing their fragrance as FDA approved is telling you a good deal about themselves and nothing whatsoever about the product.
You need a federal permit simply to buy the alcohol
Specially denatured alcohol, the SDA 40-B that carries very nearly all fine fragrance, cannot simply be purchased. It requires an Industrial Alcohol User Permit from the TTB, with formula-specific use authorisation, bonded storage and recordkeeping to match. This is one of the genuine barriers to compounding perfume at any scale in the United States, and it is a large part of why a great deal of fragrance described as American is compounded elsewhere and merely filled here.
Which makes it, I would suggest, a rather good question to put to any prospective partner. Do you hold one?
FINALLY SEQUENCE
When each of these ought to be made
| Stage | What gets produced |
|---|---|
| Formula approval | IFRA Certificate of Conformity, allergen declaration |
| Pre-production | Safety Data Sheet, CPSR, stability and compatibility data |
| Pre-market | MoCRA registration and listing, CPNP, SCPN, approved label artwork |
| Every batch | Certificate of Analysis, retained reference sample |
| Every shipment | UN1266 marks and declarations as required |
Sequenced properly into a development program, the complete set for one SKU into America and Europe costs a few thousand dollars and adds no time at all, for the simple reason that it runs alongside componentry lead times, which are slower anyway.
Reconstructed after a run has been made, it costs considerably more. And some of it cannot be produced retrospectively at all: a CoA needs a batch that exists, a CPSR needs the finished formulation, and label copy needs allergen data before the artwork goes to print rather than after, at which point your options are a sticker or a reprint. Neither is a happy conversation.
Anyway. If you take one thing from all of this, let it be a question rather than a fact. Ask any development partner, in writing, which of these nine they produce and which they expect you to source yourself. The answer will tell you a great deal more about what you are buying than the price does.
And if I have got any of it wrong, or if something has moved since I wrote this, do please let me know. In this particular corner of the business, things move rather more often than one would like.
[Regulatory information current as of August 2026, written for founders and brand teams scoping a first fragrance program. General guidance rather than legal advice; requirements vary by market, product type and the claims you choose to make.]
