FDA – Final Guidance on Menu Labeling published

The U.S. Food and Drug Administration (FDA) announced on 29th April the publication of its final guidance for industry, “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11).”

The FDA intends to begin enforcing the menu labeling final rule one year from the date that the Notice of Availability (NOA) is published in the Federal Register. The NOA for the guidance is expected to be published in early May 2016.

This guidance responds to many frequently asked questions that the agency has received to date. It differs from the draft guidance by providing additional examples and new or revised questions and answers on topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and record keeping requirements.

In 2010, section 4205 of the Patient Protection and Affordable Care Act amended 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(5)(H)) to require that restaurants and similar retail food establishments that are part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items, provide calorie information for standard menu items (including food on display and self-service food) and provide, upon request, additional written nutrition information for standard menu items.

This guidance document describes nutrition labeling that is required for foods sold in covered establishments, how this information (calorie and nutrition labeling) may be presented, and when exempt foods, as defined further below, must provide nutrition labeling. The guidance also describes means (reasonable basis) by which nutrient values may be derived.

You can download the PDF file here.

(Source: FDA website)

Food Labeling Contrast between China and EU Regulations (Part II)

In case you have not spotted the first part, here you can find the link. This is an invaluable comparison between the Chinese food labeling standards and the Regulation (EU) No 1169/2011. The part II is more focused on nutrition labeling requirements.

Nutrition declaration (Nutrition labeling)

1,Mandatory information

Reg. (EU) No 1169/2011 GB7718-2011
1+6

 

  Reference intake 1+4

 

  NRV
Energy value 8400 kJ/2000 kcal Energy value 8400 kJ/2000 kcal
Fat (Total fat)70 g Protein 60 g
Saturates 20 g Fat 60g
Carbohydrate 260 g Carbohydrate 300 g
Sugars 90 g Sodium 2000 mg
Protein 50 g Note: In (EU) No 1169/2011, salt =sodium×2.5
Salt 6 g
None

If any nutrition claim or functional claim is made about nutrition component besides energy and the core nutrients, the content of such nutrition component and its corresponding NRV% should be indicated on the nutrition labeling.

None

If any nutritional fortification substances are used in pre-packed food, the content of the fortified nutrition component and its corresponding NRV% should be indicated on the nutrition labeling.

None

The content of trans fatty acid should be indicated if any hydrogenated oil and fat or partially hydrogenated oil and fat is used as an ingredient or in the manufacturing process.

Not mandatory NRV%

Note: In GB7718-2011, NRV% ×100%

In the formula, x stands for the content of one nutrient.

 

2, Supplements

Reg. (EU) No 1169/2011 GB 28050-2011
Fat Reference intake Fat NRV
Mono-unsaturates (Total fat)70 g Saturates(acid) ≦20g
Polyunsaturates Trans fats(acid)  
Mono-unsaturates(acid)  
Polyunsaturates(acid)  
Cholesterol ≦300 mg
Carbohydrate   Carbohydrate  
Polyols (Carbohydrate)260g Sugar(lactose)  
Fibre Dietary fibre (monomer component, soluble or insoluble dietary fibre) 25g
Starch

 

3Exemptions

Reg. (EU) No 1169/2011 GB7718-2011
Where the labeling of beverages containing more than 1.2% by volume of alcohol provides a nutrition declaration, the content of the declaration may be limited to the energy value only. For beverages containing more than 0.5% by volume of ethanol, a nutrition labeling is not required.
Where food are offered for sale to the final consumer or to mass caterers without prepackaging, or where foods are packed on the sales premises at the consumer’s request or prepacked for direct sale, the content of the nutrition declaration may be limited to:

(a)    the energy value; or

(b)    the energy value together with the amounts of fat, saturates, sugars, and salt.

 
  For fresh produce such as meat, fish, vegetables and fruits, eggs etc, a nutrition labeling is not required.
Food in packaging or containers the largest surface of which has an area of less than 25 cm².

For foods which have a total surface area less than 100 cm²or a maximum surface area less than 20 cm², a nutrition labeling is not required.

Food, including handcrafted food, directly supplied by the manufacturer of small quantities of products to the final consumer or to local retail establishments directly supplying the final consumer.

For site-selling foods, a nutrition labeling is not required.

Waters intended for human consumption, including those where the only added ingredients are carbon dioxide and/or flavorings.

For packed water, a nutrition labeling is not required.
  For prepacked foods of which daily consumption are less than 10 g or 10 ml, a nutrition labeling is not required.

Other foods stipulated in ANNEX V

 

 

4, Vitamins and minerals

Reg. (EU) No 1169/2011 GB 28050-2011
  NRV   NRV
Vitamin A 800μg Vitamin A 800μgRE
Vitamin D 5μg Vitamin D 5μg
Vitamin E 12mg Vitamin E 14mgα-TE
Vitamin K 75μg Vitamin K 80μg
Thiamin 1,1mg Thiamin 1.4mg
Riboflavin 1,4mg Riboflavin 1.4mg
Vitamin B6 1,4mg Vitamin B6 1.4mg
Vitamin B12 2,5μg Vitamin B12 2.4μg
Vitamin C 80mg Vitamin C 100mg
Niacin 16mg Niacin 14mg
Folic acid 200μg Folic acid 400μg DFE
Pantothenic acid 6mg Pantothenic acid 5mg
Biotin 50μg Biotin 30μg
None Choline 450mg
Phosphorus 700mg Phosphorus 700mg
Potassium 2 000mg Potassium 2000mg
Chloride 800mg None
Magnesium 375mg Magnesium 300mg
Calcium 800mg Calcium 800mg
Iron 14mg Iron 15mg
Zinc 10mg Zinc 15mg
Iodine 150μg Iodine 150μg
Selenium 55μg Selenium 50μg
Chromium 40μg None
Molybdenum 50μg None
Copper 1mg Copper 1.5mg
Fluoride 3,5mg Fluoride 1mg
Manganese 2mg Manganese 3mg

 

5, Expression of the content of nutrients

Reg. (EU) No 1169/2011 GB7718-2011
Per 100g or per 100ml Per 100g or per 100ml
Per portion or per consumption unit Per portion

6Notes

A much more detailed Questions and Answers of GB 28050-2011 (Revised Version) has been provided by National Health and Family Planning Commission of the People’s Republic of China and acts as an inseparable supplement to GB 28050-2011. It gives the basic introduction of GB 28050-2011 and clarifies relevant definitions, while elaborating on the most important parts and elements in making a nutrition labeling. It’s more intricate than GB 28050-2011 and requires more patience if one wants to master the Chinese regulations in food nutrition labeling.