Regulations covered

RegaaS applies the rules below when it reviews a food, dietary supplement or cosmetic product label, and cites the specific provision behind every finding.

Rule set reviewed 6 October 2026 · Nine instruments

Food — United States

FDA, 21 CFR Part 101

Food labelling under the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act and the Nutrition Labeling and Education Act, as implemented by FDA in Part 101: Nutrition Facts, ingredient declarations, name and place of business, net quantity, serving sizes derived from the Reference Amount Customarily Consumed, mandatory warning statements, the rules on flavourings and colourings, and the conditions attached to nutrient content claims, to authorised and qualified health claims, and to “gluten-free” and structure/function claims. The redefined “healthy” claim and the proposed front-of-package nutrition box are each applied with the date on which they were checked.

Read more: What must be on a US food label?

Food allergens — United States

FD&C Act § 403(w), FALCPA as amended by the FASTER Act

Declaration of the nine major food allergens, in the ingredient list or a “Contains” statement. FALCPA identified eight in 2004; the FASTER Act of 2021 added sesame as the ninth, applying to food introduced or delivered for introduction into interstate commerce on or after 1 January 2023. The requirement sits in the statute rather than in the labelling regulations and is cited that way — and FDA’s Food Labeling Guide has not been updated and still lists eight.

Read more: How do US and EU allergen labelling rules differ?

Dietary supplements — United States

Supplement Facts, 21 CFR 101.36

A third regime rather than a variant of the food rules: a Supplement Facts panel in place of Nutrition Facts, a separate basis for the ingredient declaration, “supplement” as part of the statement of identity, the part of the plant named for botanical ingredients, and the mandatory disclaimer that accompanies a structure/function claim, with its own placement, framing and type-size rules. The adverse-event contact also differs from cosmetics: a supplement needs a domestic address or domestic telephone number, and a website alone is not enough.

Read more: What must be on a dietary supplement label in the US? · Exporting food and supplements from Taiwan to the US: what changes on the label?

Cosmetics — United States

Fair Packaging and Labeling Act, 21 CFR Parts 701 and 740

The principal source of United States cosmetic labelling requirements, resting on the misbranding provisions of the Federal Food, Drug, and Cosmetic Act and on the Fair Packaging and Labeling Act: statement of identity, net quantity of contents, name and place of business of the responsible firm, the ingredient declaration and the names it must use, and the mandatory warning statements. The list need not be one descending sequence — ingredients at or below one per cent may appear in any order after the rest, colour additives in any order after those, fragrance and flavour may be declared by function, and an ingredient accepted as a trade secret may be replaced by “and other ingredients”.

Read more: What does MoCRA require on a cosmetic label? · Selling cosmetics in both the EU and the US: how do the labels differ?

Cosmetics — United States

MoCRA, the Modernization of Cosmetics Regulation Act of 2022

Enacted at the end of 2022. On the label: contact information — a domestic address, domestic telephone number or electronic contact, which may include a website — through which the responsible person can receive adverse event reports, and a clear statement on products intended to be used only by licensed professionals. Fragrance allergen labelling still awaits FDA rulemaking and is raised as a watch item, not as a finding. Facility registration, product listing, safety substantiation, good manufacturing practice and adverse event reporting leave no trace on a label, so a label review cannot confirm them; the responsible person has to check them separately.

Read more: What does MoCRA require on a cosmetic label?

Cosmetics — European Union

Regulation (EC) No 1223/2009

The particulars required on the container and outer packaging — responsible person and address, country of origin for imported products, nominal content, date of minimum durability or period after opening, precautions for use, batch number, product function and the ingredient list — along with the alternatives available where the label has no room, the prohibited and restricted substances, colorants, preservatives and UV filters of the annexes, and product claims against the six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. The ingredient list follows descending order of weight, with latitude below one per cent and for colorants, perfume compositions declared as “parfum” or “aroma”, and nanomaterials marked “(nano)”. Individual fragrance allergen labelling was substantially expanded in 2023 by Regulation (EU) 2023/1545: non-compliant products could be placed on the Union market only until 31 July 2026 and may be made available until 31 July 2028. Citral is the exception — Regulation (EU) 2026/909 replaced its entry, and products not complying with it may be placed on the market until 31 December 2026 and made available until 30 June 2028, or 31 July 2028 for geranial and neral. The responsible person, the product information file, the safety report and notification through the CPNP are not visible on a label, so a label review cannot confirm them; the responsible person has to check them separately.

Read more: What must appear on a cosmetic label in the EU? · Selling cosmetics in both the EU and the US: how do the labels differ?

Food labelling — European Union

Regulation (EU) No 1169/2011

Provision of food information to consumers: the twelve mandatory particulars, emphasis of the fourteen listed allergens within the ingredient list, name, net quantity and alcoholic strength in the same field of vision, the nutrition declaration, quantitative ingredient declaration, origin including the origin of the primary ingredient, legibility at an x-height of at least 1.2 mm — 0.9 mm on surfaces under 80 cm² — and the rules on voluntary information. Food supplements sit outside the nutrition declaration altogether, so a per-100 g table is not the required format for them.

Read more: What must be on a food label in the EU? · How do US and EU allergen labelling rules differ?

Nutrition and health claims — European Union

Regulation (EC) No 1924/2006

Claims made on foods: only authorised claims, with the conditions of use met and the four mandatory accompanying statements present. Wording need not be reproduced verbatim — a nutrition claim extends to any claim likely to have the same meaning for the consumer, and the same principle applies to health claims. RegaaS assesses meaning and conditions of use rather than literal wording, so a lawful paraphrase is not reported as a violation.

Read more: Which food claims are allowed in the US and the EU?

Novel foods — European Union

Regulation (EU) 2015/2283

Authorisation of novel foods — food not used for human consumption to a significant degree within the Union before 15 May 1997 and falling within one of the listed categories — and conformity with the Union list: the designation to be used in labelling, the conditions of use, the specification, and any additional labelling condition attached to the individual authorisation. Traditional foods from third countries follow a separate notification procedure.