What Your Label Says About Fragrance: Europe vs. the U.S.
I will admit I had not read the back of a bottle properly until I started importing them. Pick up almost any lotion made in Europe and look at the end of the ingredient list. After "Parfum (Fragrance)" there is usually a short run of Latin-sounding words (Linalool, Limonene, Geraniol, that sort of thing). I assumed those were just more ingredients, and in a sense they are, but they are on the label for a different reason than the glycerin is: European law makes the brand spell out the parts of its fragrance that enough people are allergic to.
Now pick up a lotion made here. The same spot on the label usually says "fragrance." One word, and the law lets it stand in for everything the perfumer put in. It is a small example of the gap I wrote about in 11 vs. 1,700, and it is about to get more interesting, because the FDA's own schedule now says it will publish a proposed fragrance-allergen rule next month. I will get to why I am not holding my breath.
Why One Word Is Allowed at All
It is fair to ask why either side lets a company write "fragrance" or "parfum" and stop there, when every other ingredient has to be named. The answer is the same in both places and it comes down to two things. The first is that a perfume is not one ingredient. A finished fragrance is a few to several hundred separate materials blended in a particular order and proportion, and a label that listed all of them would run to a second box. The second is that the blend is the perfumer's property. In the U.S., the Fair Packaging and Labeling Act is what gives the FDA the power to require an ingredient list in the first place, and the same law bars the agency from using that power to force a company to reveal a trade secret. The FDA's own explanation is that fragrance formulas are complex mixtures of many natural and synthetic chemicals, which is why the 1974 regulation let the whole composition hide behind one word.
Europe made the same bargain. The EU Cosmetics Regulation says in so many words that perfume and aromatic compositions "shall be referred to by the terms 'Parfum' or 'Aroma'" on the ingredient list. So the secrecy is not the difference between the two systems. The difference is that Europe decided, back in the mid-2000s, that the materials people are allergic to do not get to stay hidden: whatever else the perfumer keeps to himself, those names come out onto the label once they pass a threshold. The U.S. has not made that carve-out yet, which is what the rest of this post is about.
What a Fragrance Allergen Is
A fragrance allergen is a scent material that the skin's immune system can learn to react against. The allergy develops after exposure to a certain minimum dose, for example through regular use of a scented product, and once it has developed then it is typically life-long. The reaction is delayed: redness, swelling and small blisters about a day after you used the product.
How common is it? The European Commission's estimate, drawn from its scientific committee's work, is that 1 to 3 percent of Europeans have a skin allergy to fragrance. That figure holds up when you look at the population studies as well. A 2019 analysis that pooled 19 of them, covering 19,440 people, found 3.5 percent sensitized to the standard fragrance mix, and a random sample of 3,119 adults in five European countries put clinically relevant fragrance allergy at about 2 percent, roughly twice as common in women as in men. For the U.S. there is no equivalent, because nobody has patch tested a random sample of Americans (if you know of a study that did, write to me). I do not think that changes the picture much. The same fragrance materials are in the same products on both sides of the Atlantic, so a figure in the low single digits is the honest guess for here as well, and among Americans who are referred to a dermatologist for patch testing the rate runs well above that.
How Europe Built Its List
The European rule did not start at 81 labeled allergens. In 1999 the Commission's scientific committee of the day (the SCCNFP, before it was renamed) sorted the fragrance allergens reported at the time into two lists: 13 substances that were "most frequently reported and well-recognised consumer allergens," 11 that were "less frequently reported and thus less documented," plus two natural mixtures, oak moss and tree moss. That made 26. The seventh amendment to the Cosmetics Directive, 2003/15/EC, wrote them into law, and ever since, any of the 26 present above a small threshold had to be named on the pack.
The thresholds are worth a moment because they were not scientific. The committee said plainly that no safe-use level had been established, so 0.01 percent for rinse-off products (a cleanser, a shampoo) and 0.001 percent, which is 10 parts per million, for leave-on products (a cream, a serum) were set as an administrative decision. Somebody had to pick a line and those are the lines they picked, and they are still the lines today.
In 2012 the committee, by then called the SCCS, did the exercise again with more data. It screened the clinical and animal evidence, and based on the clinical experience alone it classified 82 substances as established contact allergens in humans: 54 single chemicals and 28 natural extracts, including all 26 from 1999. Within those, 12 chemicals and 8 extracts had at least 100 reported cases each and were marked as of special concern.
So why 81 on the label and not every allergen known to dermatology? Because the committee only listed what the evidence supported at the time. Some materials had been patch tested in too few patients to call either way. Others had passed the laboratory screening that is supposed to flag an allergen before it goes to market, went into wide use on the strength of that, and only then started showing up in dermatologists’ case reports; the committee itself admitted that its lab methods had missed a few that later proved significant. And a handful were banned outright, so labeling them was moot. The list covers the documented cases, and since the Commission has rewritten it once already I expect it will do so again.
It took eleven years to get from that opinion to a regulation. Regulation (EU) 2023/1545, published in July 2023, takes the label list from 26 entries to 81, keeps the same two thresholds, and it gave the industry a long runway: anything placed on the EU market from 31 July 2026 has to carry the new labels, and stock already on shelves has until 31 July 2028 to sell through. So a box bought in Europe this winter may be on either system for a while yet.
What surprised me when I read the new list is how much of it is not lab-made at all. Rose flower oil, lavender oil, jasmine, lemon peel oil, bergamot, peppermint, eucalyptus, sandalwood and ylang-ylang are all on it now. If a Greek brand scents a lotion with orange blossom, that goes on the label by name the same as a synthetic would.
What the U.S. Requires, and Has Since 1974
The U.S. ingredient-labeling rule, 21 CFR 701.3, says every ingredient goes on the label in descending order, "except that fragrance or flavor may be listed as fragrance or flavor." The same section also allows "and other ingredients" at the end of a list when the FDA has agreed that something is a trade secret. The source note on that section still cites the rule as issued in March 1974, which is well before I was born, for what it is worth.
Whilst the EU was expanding its list, one state did move. California's SB 312 has, since January 2022, required manufacturers to report fragrance allergens to the state's Department of Public Health when they exceed 10 parts per million in a leave-on product or 100 in a rinse-off product. Those are the EU's numbers (10 parts per million is 0.001 percent). The difference is where the information goes, because the law does not require any new disclosure on the label itself. In other words the state has the data, and the person holding the bottle would have to go looking for it.
What the FDA Has Scheduled for November
The Modernization of Cosmetics Regulation Act (MoCRA), signed in December 2022, added a fragrance-allergen section to the Food, Drug and Cosmetic Act and gave the FDA 18 months to publish a proposed rule, so the deadline was 29 June 2024. The law also told the agency what to do in that rule: identify the substances that count as fragrance allergens, consider international, state and local requirements (the EU list is named), and, if it chooses, set threshold levels below which no disclosure is needed. Once a proposal is out and comments close, the FDA has 180 days to finalize it.
Then the dates started moving. The June 2024 deadline passed with nothing. The FDA's Fall 2024 regulatory agenda said January 2025; that passed too. In April 2025 a group of House members wrote to the FDA Commissioner asking where the rule was. The Spring 2025 agenda, published that September, said May 2026. The agenda released this July says November 2026. That is three agency target dates on top of the deadline Congress wrote, and we are almost two and a half years past that deadline.
As for what will be in it, I do not know and neither does anyone outside the agency. The agenda entry says only that the rule "would identify substances that must be disclosed as fragrance allergens on cosmetic product labels." Whether that means the EU's 81, the older 26, or an American list of its own, and what the threshold will be, we find out when the document is published. And a proposed rule is a draft: after it come comments, the final rule, and a compliance date the final rule sets. None of that exists today, so I would not expect American labels to change for a while even if November holds.
What This Means for You
If you buy European skincare, the names after "Parfum" are the allergen list at work. If you have ever reacted to a scented product, write down the names on the one that caused it and look for them on the next label, and if it keeps happening, the test dermatologists use for this is called a patch test (the population figures above come from patch-test studies). If you have never reacted to anything, the names are just information. Lemon peel oil and lavender oil are on the list themselves, and seeing a name on a label does not by itself make a product a problem for you.
If you buy American-made products and the label says "fragrance" and nothing else, you have fewer options. You can choose products with no added fragrance, with the caveats in our earlier post on why "fragrance-free" isn't always better. Or you can email the brand and ask which of the EU's 81 its fragrance contains. A brand that also sells in Europe has that answer on file for anything above the threshold, because it had to print it there, and whether it is willing to tell an American customer is a fair thing to find out about a brand.
What I Will Be Watching in November
I wrote in July, about the new sunscreen filter, that what frustrates me about U.S. cosmetics regulation is how reactive it is, and this rule has the same shape. Europe's committee did its homework in 2012 and the law followed, slowly but it followed. Here, Congress wrote the FDA a deadline in 2022 and the deadline came and went. Even so, a late proposal beats no proposal, and I will read it the week it lands. My hope is a modest one. The FDA was told to consider the EU list, and the simplest good outcome I can picture is that it adopts most of it instead of spending another decade assembling an American one, since a person allergic to geraniol in Texas is reacting to the same molecule as one in Lyon, and the Europeans have already done the work of writing it down.
Cheers,
Chase
Founder of Relterra
