Regulations covered

Regulatory coverage for US and EU labels: food (including dietary supplements in the US and food supplements in the EU) and cosmetics. RegaaS selects requirements relevant to the product and market and reports findings with supporting regulatory sources. Explore the requirements covered, applicable conditions and exclusions before starting a review.

Rule set reviewed October 26, 2026 · Fifteen core instruments

Parts 701 and 740 count as one instrument, as do 19 CFR Parts 134 and 102, § 403(w) and § 403(y) of the FD&C Act, and Directive 2002/46/EC with Regulation (EC) No 1170/2009, which replaced its annexes. US dietary supplements are reviewed within the US food review. These are the core instruments; further EU rule areas are listed below.

Food — United States

FDA, 21 CFR Part 101

Food labeling 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 flavorings and colorings, and the conditions attached to nutrient content claims, to authorized and qualified health claims, and to “gluten-free” and structure/function claims. Requirements adopted but not yet mandatory, such as the redefined “healthy” claim before its compliance date of February 25, 2028, are flagged with that date; proposals such as the front-of-package Nutrition Info box are raised only as watch items, not reported as findings.

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

Dietary supplements — United States (reviewed with food)

21 CFR Part 101 (§§ 101.36, 101.3(g), 101.4(g)–(h), 101.93, 101.17(e), 101.7) and FD&C Act § 403(y) and (w)

Within the food review, supplements follow rules of their own: a Supplement Facts panel in place of Nutrition Facts (§ 101.36), a separate basis for the ingredient declaration (§ 101.4(g) and (h)), “supplement” as part of the statement of identity (§ 101.3(g)), the part of the plant named for botanical ingredients, the mandatory disclaimer that accompanies a structure/function claim, with its own placement, framing and type-size rules (§ 101.93), and the accidental-overdose warning on iron-containing products (§ 101.17(e)). Net quantity of contents (§ 101.7) and the major food allergens (FD&C Act § 403(w)) apply as for any food. The adverse-event contact also differs from cosmetics: a supplement needs a domestic address or a domestic telephone number with area code under § 403(y), 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?

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 January 1, 2023. The requirement sits in the statute rather than in the labeling 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?

Country of origin — United States (food)

19 CFR Parts 134 and 102

Customs marking of imported food: the English name of the country of origin, marked legibly, indelibly and permanently in a conspicuous place, as the nature of the article permits (§ 134.11, with the methods and manner of marking in § 134.41); the general and J-List exceptions (§§ 134.32 and 134.33); marking where a US address or the name of another country or locality on the label could mislead about origin (§ 134.46); and, under Part 102, how the country of origin is determined for goods made from materials of more than one country. For cosmetics, the review checks only that an imported product names its country of origin in English, the Tariff Act requirement noted in FDA's Cosmetics Labeling Guide.

Food and cosmetics — United States

Fair Packaging and Labeling Act

The federal packaging statute behind the basic package statements on food and cosmetics, administered for those products by FDA: the identity of the commodity and the name and place of business of the manufacturer, packer or distributor; the net quantity of contents, stated separately and accurately in a uniform location on the principal display panel, in both inch/pound and SI metric units, in a type size set by the area of that panel and in lines generally parallel to the base on which the package rests; and, where the label states a number of servings, the net quantity of each serving. FDA implements these requirements for food in 21 CFR Part 101 and for cosmetics in Part 701.

Net quantity and weights and measures — United States (food and cosmetics)

NIST Handbook 130 (2026 edition)

The uniform weights-and-measures laws and regulations NIST publishes for states to adopt, read alongside the Fair Packaging and Labeling Act and FDA's net-quantity rules: the Uniform Packaging and Labeling Regulation's declarations of identity, responsible party and net quantity — units, placement on the principal display panel, type size and the inch-pound and SI statements — and the Uniform Regulation for the Method of Sale of Commodities. Handbook 130 is a model: whether and how each state has adopted it, and any state-specific variation, are outside the review.

Cosmetics — United States

21 CFR Parts 701 and 740

The principal source of United States cosmetic labeling 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 percent may appear in any order after the rest, color additives in any order after those, fragrance and flavor 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 labeling 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 they fall outside a label review.

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

Cosmetics — European Union

Regulation (EC) No 1223/2009

The particulars Article 19 requires on the container and packaging — the name and address of the responsible person, the country of origin for imported products, the nominal content, the date of minimum durability or, for products that keep for more than 30 months, the period after opening, the precautions for use, the batch number, the product’s function where its presentation does not make it clear, and the ingredient list — along with the leaflet or tag allowed where precautions or ingredients cannot fit on the label, the prohibited and restricted substances, colorants, preservatives and UV filters of Annexes II to VI, and product claims under Article 20, judged against the common criteria of Regulation (EU) No 655/2013. The ingredient list follows descending order of weight, with latitude below one percent and for colorants, perfume compositions declared as “parfum” or “aroma”, and nanomaterials marked “(nano)”. Individual fragrance allergen labeling was substantially expanded in 2023 by Regulation (EU) 2023/1545: non-compliant products could be placed on the Union market only until July 31, 2026, and may be made available until July 31, 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 December 31, 2026, and made available until June 30, 2028, or July 31, 2028, for geranial and neral. The responsible person’s other obligations — the product information file, the safety report and notification through the CPNP — leave no trace on a label, so they fall outside a label review.

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?

Cosmetic claims — European Union

Commission Regulation (EU) No 655/2013

Common criteria for the justification of claims made for cosmetic products, applying since July 11, 2013, to claims in the labeling, the making available on the market and the advertising of cosmetic products, whatever the medium: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. A claim that a product has been authorized or approved by a competent authority within the Union is not allowed, and the responsible person must ensure the wording of each claim meets the criteria and matches the product information file.

Food labeling — 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. For food supplements, the nutrition declaration does not apply (Article 29(1)(a)); see Directive 2002/46/EC below.

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

Food supplements — European Union

Directive 2002/46/EC

The specific rules for food supplements, read with the general food rules. Permitted vitamins and minerals, and their forms, are listed in Annexes I and II as replaced by Regulation (EC) No 1170/2009. The product is sold as a “food supplement” (Article 6(1)). Article 6(3) adds five mandatory particulars: the names of the categories of nutrients or substances that characterize the product, the recommended daily portion, a warning not to exceed it, a statement that food supplements should not be used as a substitute for a varied diet, and a statement that the product should be stored out of the reach of young children. Under Article 8, each nutrient or substance with a nutritional or physiological effect is declared per recommended daily portion, with vitamins and minerals also given as a percentage of the reference values. The nutrition declaration of Regulation (EU) No 1169/2011 does not apply (Article 29(1)(a)); its other labeling requirements do. Claims follow Regulation (EC) No 1924/2006, including the four accompanying statements of Article 10(2), and Regulation (EU) No 432/2012.

Nutrition and health claims — European Union

Regulation (EC) No 1924/2006

Claims made on foods: only authorized 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?

Health claims — European Union

Commission Regulation (EU) No 432/2012

The Union list of permitted health claims made on foods, other than claims referring to the reduction of disease risk or to children’s development and health, applying since December 14, 2012. For each nutrient, substance, food or food category the list sets out the authorized claim, the conditions of use of the claim and any conditions or restrictions of use of the food or additional statement or warning. A health claim on a label is checked against its entry: whether the claim is listed, whether the food meets the conditions of use, and whether a required statement or warning is present.

Novel foods — European Union

Regulation (EU) 2015/2283

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

Novel foods — European Union

Commission Implementing Regulation (EU) 2017/2470

The Union list of novel foods authorized under Regulation (EU) 2015/2283, set out in its Annex and amended with each new authorization. Table 1 gives, for every authorized novel food, the food categories and maximum levels at which it may be used, the additional specific labeling requirements — including the designation to be used on the label — and any other requirements; Table 2 gives its specifications. A novel food on a label is checked against its entry in the list.