Label compliance articles

Each article explains one labelling regulation in full, cites the provisions it relies on, and states who reviewed it and when.

Food

US
What must be on a US food label?
Principal display panel
1
5
Bottom 30%
2Net Wt 24 oz (1 lb 8 oz) 680 g
Information panel
3
6Contains: …
8
Nutrition Facts
7
On the principal display panel
1Statement of identityBold, parallel to the base of the package
2Net quantity of contentsBottom 30% of the PDP (except PDPs of 5 sq in or less); customary and metric units side by side
5Characterizing flavorWhere applicable; at least half the height of the food’s name
On the PDP or the information panel
3Ingredient listDescending order by weight
6Major food allergensIn or next to the ingredient list
8Nutrition FactsServing size (9) from the RACC
7Name and place of businessCorporate name, street, city, state, ZIP
Schematic, not to scale. Numbers match the checklist below. The information panel is the panel immediately to the right of the PDP (21 CFR 101.2(a)).
A US food label needs identity, net quantity, ingredients, allergens, firm name and address, and Nutrition Facts. One checklist with 21 CFR 101 citations.
Reviewed 12 Oct 2026 · Alan Huang
EU
What must be on a food label in the EU?
An x-height, not a point size
Annex IV measures it from the baseline to the mean line.
Same field of vision
Name of the food
Net quantity
Alcoholic strength, where relevant
Same field of vision
Front
Name
Back
250 g
Not in the same field of vision
A field of vision is all the surfaces readable from a single viewing point, so front and back panels are normally not one.
Article 13(5); Article 2(2)(k); Annex IV. Article 13(6) excludes glass bottles intended for reuse that are indelibly marked and therefore bear no label, ring or collar, and packages whose largest surface is less than 10 cm² (Article 16(1) and (2)).
An EU food label must carry 12 mandatory particulars under Article 9(1) of Regulation (EU) No 1169/2011. A cited checklist, from allergens to QUID.
Reviewed 12 Oct 2026 · Alan Huang
USDietary supplements
What must be on a dietary supplement label in the US?
1
Supplement Facts
2
Serving Size
Servings Per Container
% Daily Value
3
Calcium (as calcium carbonate)
4
Garlic (bulb)
†
5
Proprietary Blend
†
† Daily Value not established
6
Other ingredients:
What the panel shows
1“Supplement Facts”Larger than all other print in the panel and bold; runs its full width unless impractical
2Serving SizeDirectly under the title, in a unit suited to the form; then Servings Per Container, unless the net quantity already states it
3Ingredients with a Daily ValueAmount of the nutrient itself and % Daily Value, in the set order; omitted when absent. A source may be named with “as” or “from”
4Ingredients without a Daily ValueCommon or usual name and metric amount; a symbol in the % Daily Value column leads to “Daily Value not established”. Botanicals name the part of the plant
5Proprietary blendBlend name and total weight; the ingredients without a Daily Value indented beneath, in descending order by weight
6Ingredient listImmediately below the panel, or to the right where space is insufficient; headed “Other ingredients” when some sources are already named in the panel
Schematic, not to scale; the panel is boxed with hairlines. The regulation's example symbol is an asterisk; many labels use a dagger (†) instead. 21 CFR 101.36(b)–(e); 101.4(g), (h).
A US supplement label needs a Supplement Facts panel (21 CFR 101.36), “dietary supplement” in its name, plant parts, the claim disclaimer and a US contact.
Reviewed 12 Oct 2026 · Alan Huang
US vs EU
How do US and EU allergen labelling rules differ?
United States
9 allergens
Two methods; a label may use either or both.
Within the ingredient list
whey (milk)
The source follows the ingredient in parentheses.
“Contains” statement
Contains: milk, egg, peanuts
Printed immediately after or next to the ingredient list. If used, it must name every major allergen in the food.
No emphasis required.
European Union
14 allergens
Within the list of ingredients, emphasised.
Emphasised so that it clearly stands out
whey (milk)Bold
whey (MILK)Capitals
whey (milk)Underlining
whey (milk)Background colour
For example by bold, capitals, underlining or a background colour; the method is left to the business.
Name the cereal; name the nut in derived ingredients too
wheat (spelt), flavourings (almond)
“Spelt” or “khorasan” needs a reference to wheat.
“Contains” only where there is no list of ingredients.
FD&C Act § 403(w)(1); Regulation (EU) No 1169/2011, Article 21(1); Commission Notice 2017/C 428/01, points 8–11, 13 and 15.
The US requires 9 major allergens in the ingredient list or a "Contains" statement. The EU requires 14, emphasised in the ingredient list.
Reviewed 12 Oct 2026 · Alan Huang
US vs EU
Which food claims are allowed in the US and the EU?
United States: three kinds of claim
Defines claim categories and attaches conditions to each
Nutrient content claims
Only as defined in Subpart D (21 CFR 101.54–101.69) or another applicable FDA rule
Some are instead notified to FDA under FDAMA on the basis of an authoritative statement
Health claims
Authorised by regulation, listed in 21 CFR 101.72–101.83
Notified under FDAMA on the basis of an authoritative statement
Qualified health claims: covered by an FDA letter of enforcement discretion, which is not an approval
Structure/function claims
No prior approval
Dietary supplement: the 21 CFR 101.93 disclaimer, and FDA notified within 30 days of first marketing
Conventional food: the effect must derive from nutritive value; no disclaimer or notification
European Union: a closed list
A positive list: a claim is prohibited unless it is listed
Nutrition claims
Only claims in the Annex to Regulation (EC) No 1924/2006 are permitted
Conditions are generally set per 100 g, per 100 ml or as a share of energy, not per serving
Health claims
Prohibited unless authorised and listed
Article 13(1) function claims: listed in Regulation (EU) No 432/2012
Article 14(1) reduction of disease risk claims and children’s development claims: authorised individually
Botanical claims “on hold”: may continue to be used under Article 28(5) and (6)
A label carrying a health claim must include the Article 10(2) statements
US: 21 CFR 101.13(b), 101.14, 101.54–101.69, 101.72–101.83, 101.93. EU: Regulation (EC) No 1924/2006, Articles 8(1), 10(1), 10(2), 13(1), 14(1), 28(5) and (6); Regulation (EU) No 432/2012. Psychological or behavioural botanical claims need Article 28(6) (Case C‑386/23).
The US allows defined nutrient content, health and structure/function claims; the EU allows only listed claims. Ten common claims compared.
Reviewed 12 Oct 2026 · Alan Huang
Taiwan → US
Exporting food and supplements from Taiwan to the US: what changes on the label?
Single-serving containers
500 mL tea, about 139%
0%100%200%300%
of the RACC in the package
One serving
A package sold individually that contains less than 200% of the RACC (101.9(b)(6))
Dual columns, per serving and per package
A package that contains 200% to 300% of the RACC (101.9(b)(12)(i))
For sweetened tea drinks and other beverages, the RACC is 360 mL. So a 500 mL bottle of Taiwanese tea (about 139% of the RACC) must be labeled in the US with the whole 500 mL bottle as one serving.
Required nutrients
Taiwan requires
Calories
Protein
Fat
Saturated fat
Trans fat
Carbohydrate
Sugars
Sodium
The US also requires
Cholesterol
Dietary fiber
Added sugars, under total sugars
Vitamin D
Calcium
Iron
Potassium
If these values were never tested, test or calculate them first.
21 CFR 101.9(b)(6), (b)(12)(i), (c); serving sizes derived from the RACC in 21 CFR 101.12(b).
A Taiwan label cannot just be translated for the US. Redo Nutrition Facts under 21 CFR 101, use RACC servings, declare 9 allergens incl. sesame; supplements need Supplement Facts and the 101.93 disclaimer.
Reviewed 12 Oct 2026 · Alan Huang

Cosmetics

US
What does MoCRA require on a cosmetic label?
Adverse-event contact on the label
Cosmetic (MoCRA)Required since 29 Dec 2024Dietary supplement
Domestic addressEnoughEnough
Domestic phone numberEnoughEnough
Electronic contact information, such as a websiteEnoughAlone is not enough
Cosmetic: any one of the three is enough. “Domestic” qualifies the address and the phone number.
A foreign address and foreign phone number alone do not comply.
FD&C Act § 609(a) (21 U.S.C. 364e(a)). A label without the contact is misbranded under FD&C Act § 602(b)(3).
MoCRA adds an adverse-event contact (US address, US phone or website) to every US cosmetic label and a licensed-professional statement for salon products. Full checklist inside.
Reviewed 12 Oct 2026 · Alan Huang
EU
What must appear on a cosmetic label in the EU?
The 30-month line decides the date format
Minimum durability: 30 months or less
Date of minimum durability
Preceded by the hourglass symbol (Annex VII, point 3) or the words “best used before the end of”
Month and year, or day, month and year, in that order
Storage conditions if needed to guarantee it
Minimum durability: More than 30 months
Period after opening (PAO)
The open-jar symbol (Annex VII, point 2) followed by the period in months and/or years
Not required where durability after opening is not relevant
Article 19(1)(c) of Regulation (EC) No 1223/2009; Annex VII, points 2 and 3.
An EU cosmetic label must carry the Article 19 particulars of Regulation 1223/2009. Line-by-line checklist, fragrance allergen dates and claim rules.
Reviewed 12 Oct 2026 · Alan Huang
US vs EU
Selling cosmetics in both the EU and the US: how do the labels differ?
One artwork for both?
Yes
Responsible person
Country of origin
Net quantity of contents
Shelf life
Batch number
Fragrance allergens
Professional-use statement
Mostly
Function
The local EU language is a separate matter
Ingredient list
The wording needs adjusting
Combine
Precautions and warnings
Print each market’s prescribed wording in full; one does not replace the other
Take care
Language
Adding French or German claims to the US version triggers the full foreign-language requirement of 701.2(b)(2)
EU: Regulation (EC) No 1223/2009; Directive 80/181/EEC. US: 21 CFR Parts 701 and 740; FD&C Act § 609 (MoCRA); FPLA § 4(a)(2); 19 U.S.C. 1304, 19 CFR Part 134.
The EU requires the Responsible Person's address, origin, durability date or PAO, batch number, function and fragrance allergens; the US requires English, metric and inch/pound net quantity and a MoCRA adverse-event contact. Side-by-side table with provisions.
Reviewed 12 Oct 2026 · Alan Huang

See every regulation RegaaS checks against