Labelling soap: US, EU, UK and Canada

A soap label has to do two jobs at once: tell the customer what they are buying, and satisfy the rules of the place it is sold. The second job is the harder one, because the rules change at every border, and they all start from a question only the maker can answer: in law, what is this bar?

What your soap is in law

A drug or disease claim changes the answer in every one of these markets: see the section on claims below.

The United States is the odd one out. Its food and drug law defines a cosmetic and then says the term “shall not include soap”, and FDA treats a product as soap only when two conditions hold: “the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds”, and the product “is labeled, sold, and represented only as soap” (21 CFR 701.20). A cold-process or hot-process bar made from oils and lye normally meets the first condition; a syndet bar, whose detergents are not soap, never does. The label decides the second. A true soap is regulated by the Consumer Product Safety Commission, not by FDA.

Everywhere else, cleansing the skin is one of the things that makes a product a cosmetic. The EU’s definition covers anything applied to the body “with a view exclusively or mainly to cleaning” it, and Canada’s covers anything “for use in cleansing, improving or altering the complexion, skin, hair or teeth”. Health Canada lists soap among its examples of cosmetics.

United States

A true soap

A true soap is a consumer commodity under the Fair Packaging and Labeling Act, and the Federal Trade Commission’s rules in 16 CFR 500 ask for three things.

1. What it is, on the principal display panel: the face a shopper sees. “Soap” does it, or another plain descriptive name (500.4).
2. Who made or sells it, and where: the business name, street address, city, state and ZIP code, with “Manufactured for” or “Distributed by” if someone else made it. The street address may be left off if it is listed in a widely published resource such as a directory or a website (500.5).
3. The net quantity, in both ounces and grams, as a separate item in the bottom 30 % of the principal display panel (unless the panel is 5 square inches or smaller), with no qualifying words such as “when packed” (500.6, 500.8, 500.9).

No ingredient list is required for a true soap, though nothing stops you printing one. The net quantity’s lettering grows with the face of the package: at least 1/16 inch on a panel of 5 square inches or less, 1/8 inch above that up to 25 square inches, and so on (500.21). A bar face of 70 × 50 mm is 5.4 square inches, so its net weight needs lower-case letters at least 1/8 inch high, which the rule gives as 3.1 mm.

A soap that is a cosmetic

Add a cosmetic claim and FDA’s cosmetic labelling rules apply instead, in 21 CFR 701. The identity goes on the front in bold type (701.11), the name and place of business conspicuously anywhere on the label (701.12), and the net weight in ounces in the bottom 30 % of the front (701.13), with the grams alongside if you wish. Three further things become necessary.

• An ingredient list, in descending order of predominance, in letters at least 1/16 inch high. As an alternative, ingredients above 1 % go in descending order, then those at 1 % or less in any order, then colour additives in any order. A fragrance may be listed simply as “fragrance” (701.3).
• A contact for reports of reactions. Since 29 December 2024 every cosmetic’s label must carry a domestic address, a domestic phone number, or electronic contact information, which may be a website, through which the responsible person can receive adverse event reports (21 U.S.C. 364e(a), added by the Modernization of Cosmetics Regulation Act of 2022, MoCRA).
• Colours FDA has approved for cosmetics. “All color additives used in cosmetics … must be approved by FDA”, and that includes the mineral and plant colours FDA lists as exempt from certification: they are exempt from batch certification, not from approval.

MoCRA brings duties beyond the label. A responsible person must report a serious adverse event to FDA within 15 business days and keep records of every adverse event report for six years, or three for a small business. A small business, one whose average gross annual US sales of cosmetics over the previous three years are under 1 million dollars (adjusted for inflation), is exempt from facility registration, product listing and the good manufacturing practice rules FDA has yet to make, unless it makes certain products, such as those used around the eye. MoCRA also tells FDA to require fragrance allergens on labels, but no such rule had been published when this guide was written; the regulatory calendar tracks it.

Net weight that never overstates

A net weight is a promise about what is in the pack, so convert down, never up. A bar that weighs 128 g after cure is 4.515 oz, which rounds to 4.52 but must be printed as 4.51: “Net wt. 4.51 oz. (128 g)”. The FTC’s own example does the same, printing “453 g” for a pound of 453.592 g. Weigh bars after they have cured, since a bar weighed at cutting has water still to lose. The rules recognise reasonable variations “caused by loss or gain of moisture during the course of good distribution practice” (21 CFR 701.13(s); 16 CFR 500.25 says much the same), which is a different thing from labelling a bar that has not finished curing.

Worked by the label maker: ounces truncated to two decimals, grams to three figures. One ounce is 28.349523125 g exactly.

European Union

Article 19(1) of Regulation 1223/2009 lists seven particulars, in “indelible, easily legible and visible lettering”, on the container and the packaging.

The durability, the precautions and whether a period after opening applies all come from the product’s safety assessment, covered in the safety assessment guide.

The language of the quantity, the date, the precautions and the function is set by each country where the soap is sold (Article 19(5)); the INCI names in the ingredient list stay the same in every language. A date in month-and-year form promises the whole month, so the label maker prints the last month that ends inside the durability: a bar made on 23 September 2026 with twelve months’ durability is good until 23 September 2027, and its label says “best used before the end of 08/2027”. The batch number is covered in the batch records guide.

Two provisions matter to soap in particular. Where a label, tag, tape, card or leaflet is impossible for practical reasons, “in the case of soap, bath balls and other small products”, the ingredient list may appear “on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale” (Article 19(3)). And for products that are not pre-packaged, or are wrapped at the counter, each country makes its own rules for the rest of the label (Article 19(4)). An unwrapped bar at a market stall therefore answers to the law of the country the stall is in.

The ingredient list, two ways

The Regulation’s words are that the list goes “in descending order of weight of the ingredients at the time they are added”. Ingredients below 1 % may follow in any order, colourants go last by their CI numbers, a perfume is written “parfum”, and a nanomaterial is followed by “(nano)”.

For soap there are two defensible ways to read that. The as-added list names what went into the pot: the oils, the water and the sodium hydroxide. The as-saponified list names what is in the bar once the reaction is done: the soaps, the glycerin the reaction made, the superfat as the oils it is made of, and the water. The Regulation does not count as ingredients “subsidiary technical materials used in the mixture but not present in the final product”, which is the reading an as-saponified list relies on to leave the sodium hydroxide off, and the soap names it uses are entries in CosIng, the EU’s own database of cosmetic ingredients. Here is one recipe both ways, worked by the engine.

700 g of olive oil and 300 g of coconut oil at a 5 % superfat, with the calculator’s 142.2 g of sodium hydroxide in 288.7 g of water. The superfat is shared between the oils in proportion to their weight, which is an assumption: no calculator can know which oil stays unsaponified.

Which list your label uses is a question for your safety assessor, and the site writes both, each saying which rule it follows. The as-saponified list also changes as the bar cures: water leaves, and every other ingredient’s share rises. The lye calculator’s ingredient list shows the bar as made unless you enter the weight a bar lost in cure, which the batch log records when you weigh bars as they dry.

Fragrance allergens

The fragrance goes into the list as “Parfum”, in its place by weight, and certain substances in it are named in the list as well once they pass a threshold: above 0.01 % of the product in a rinse-off product such as soap, and above 0.001 % in a leave-on product.

Which substances has just changed. The original list had 24 entries. Regulation (EU) 2023/1545 gave the same labelling condition to 57 more, 81 entries in all: 45 new entries in Annex III and 12 existing ones that gained the condition. Some entries are groups, and a group counts once: all lavender and lavandin oils, for instance, are one entry, named on the label as “Lavandula Oil/Extract”. A product that does not name them may be placed on the EU market until 31 July 2026 and made available until 31 July 2028. So a bar first supplied in the EU on or after 1 August 2026 must name all 81 wherever they pass the threshold, while bars placed on the market before then may sell out under their old labels until 31 July 2028.

The arithmetic is simpler than it looks. In a bar whose fragrance is 2 % of its weight, an allergen passes 0.01 % once it is more than half a percent of the fragrance. The percentages come from your supplier’s allergen declaration, and the fragrance and allergen check does the sums, including the rise in each allergen’s share as the bar dries. The scenting guide covers choosing and dosing the fragrance itself.

Great Britain and Northern Ireland

Great Britain kept its own copy of Regulation 1223/2009 when the UK left the EU, so a GB label carries the same seven particulars, with three differences.

• The responsible person must be established in the United Kingdom, at an address that is not a PO box or a mail-forwarding service. Until the end of 2027, though, the label itself may still carry the name and address of the product’s EU responsible person (Article 19(1)(ab) of the GB text).
• English. The quantity, the date, the precautions and the function must be in English, “whether or not” another language is there too (Cosmetic Products Enforcement Regulations 2013, regulation 5(3)).
• 24 allergens, not 81. Great Britain has not taken up Regulation 2023/1545, so its Annex III still names the original 24. A lavender soap sold in the EU names Lavandula Oil/Extract and Linalyl Acetate when they pass the threshold; in Great Britain they stay inside “Parfum”, and only the original 24, such as Linalool and Limonene, are named.

For unwrapped soap the GB rule is specific and useful. Where cosmetics “are not pre-packaged, or are packaged at the point of sale at the purchaser’s request”, the information Article 19(1) requires “must appear on the container in which the product is exposed for supply or on a notice in immediate proximity to that container” (regulation 5(1)). A crate of bare bars at a market can carry its whole label on a card beside it.

Northern Ireland follows the EU rules, including the 81 allergens, and its responsible person must be established in Northern Ireland or the EU.

Canada

In Canada soap is a cosmetic, and two sets of rules meet on its label.

The Consumer Packaging and Labelling Regulations put the identity and the net quantity on the principal display panel, in English and in French, the net quantity in grams with its figures in bold at a height set by the size of the display surface. Your name and principal place of business go anywhere but the bottom, in either language, and a product made abroad and sold under a Canadian dealer’s name says “imported by” or “importé par” before it, unless the label states where the product was made.

The Cosmetic Regulations add the ingredient list by INCI name, in descending order of predominance by weight, with those at 1 % or less in any order and “parfum” for the fragrance; a contact on the inner label, which can be a telephone number, an email address, a website or a postal address, for questions about the product; and directions for safe use, in both languages, where the product presents a hazard. For 58 ingredients Canada accepts the EU’s Latin names, such as “Aqua” and “Mel” for honey, and the label maker uses them.

Canada’s fragrance allergens follow the EU list on their own timetable. Since 12 April 2026 every cosmetic must name the original 24 above the thresholds. From 1 August 2026 new cosmetics must name the rest of the list too, and from 1 August 2028 so must existing ones. Separately from the label, a maker must notify Health Canada of each cosmetic within 10 days of first selling it, and that includes handmade soap sold at craft sales.

Claims that turn soap into a medicine

In every market here, a product presented as treating or preventing disease is a medicine, whatever it is made of. US law defines a drug as an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”, EU law a medicinal product as a substance “presented as having properties for treating or preventing disease in human beings”, and Canadian law a drug as one “represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state”. In Canada, a natural ingredient with a therapeutic claim makes a natural health product.

FDA draws the soap lines plainly: a cleanser “intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body” is a cosmetic, and one “intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema” is a drug. The intended use is read from more than the label: FDA looks at “claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials”. A product page, a market sign or a post about what your soap did for someone’s eczema all count.

In the EU, Great Britain and Canada the first two rows are both cosmetics. A claim to treat a disease, such as acne or eczema, makes a medicine in all four markets; how the others treat a germ-killing claim is a question to put to your assessor or regulator before you make one.

The label maker’s claims check reads the product name, identity and tagline on a US label and flags words FDA’s examples point to, from “moisturising” and “exfoliating” to “antibacterial”, “acne” and “heals”. It matches words and cannot judge intent, so it points at wording to reread; a label it passes can still make a claim in other words.

Using the label maker

The label maker takes a market and your product’s details and lays out the label at true size, for the EU, Great Britain, a US true soap or cosmetic, Canada or Australia.

• The net weight comes out in each market’s units, converted down, at the minimum height the market’s rule sets for your pack.
• The date is worked from the durability your assessment gave, and never promises a month more than it.
• A checklist shows each particular the market asks for, the provision it comes from, and whether it is on the label, missing, or something only you and your assessor can settle.
• The ingredient list is written in the market’s own terms: Aqua or Water, Parfum or Fragrance, the EU’s Latin names in Canada.
• Every ingredient is checked against the EU’s and Great Britain’s annexes of restricted and prohibited substances, Health Canada’s Cosmetic Ingredient Hotlist and California’s law, with each list’s own words for what it restricts.

It checks that the particulars are there. Whether what is written is right, from the responsible person’s address to the durability and any precaution, is for you and your safety assessor to settle.