BASIC SPECIFICATIONS FORMAT:

Transcription

1 BASIC SPECIFICATIONS FORMAT: Formatting requirements are detailed and vary depending on the nature of the food, its nutritional profile, whether nutrient content claims or statements are made, the nature of the packaging or any special consideration offered in the regulations. Formatting is described in greater detail in the following section of this guide. TYPE/RULES/BOX: Generally the presentation of nutrition facts must be in black or dark contrasting print on a white or neutral background. Reverse printing (light on dark), is discouraged but would not be object too where it is not possible to print otherwise. The information however needs to be legible and may thus need special attention to enhance the graphic display of reverse printing. LETTERS & LINES: The following are key considerations. Please refer to graphic enhancements as suggested by FDA. A single easy-to-read type style Upper and lower case letters At least one point leading (i.e. space between two lines of text) except that at least four points leading shall be utilized for the information related to vitamins and minerals as demonstrated in the standard nutrition facts panel format. Letters should never touch. Highlighting of any kind, other than as required is prohibited. HEADING: The heading Nutrition Facts must, other than Calories, be the largest text no less than 16 point bold or extra bold. Where it is reasonable to do so it should be fully justified. CALORIES (NUMERICAL VALUE): Must be at least 22 point bold or extra bold. CALORIES: Must be at least 16 point bold or extra bold. 6 POINT TYPE: The following information should be in a size no less than a 6 point type: % Daily Value, Footnote, Amount Per Serving (bold or extra bold). 8 POINT TYPE: Essentially all other nutrient that do not have specific type requirements. 10 POINT TYPE: The following information should be in a size no less than a 10 point type: Servings per container, Serving size and amount (right justified) in bold or extra bold. BOLD: The following need to appear in bold type, headings: Nutrition Facts, Serving Size, servings per container, % Daily Value*. principal nutrients: Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrate and Protein. percent DVs: The numerical portion of the percent DVs for macronutrients, except that that the percent DV s for all other vitamins and minerals (below protein) would be in a regular type face. BOX: The box that sets out the nutrition facts information should be a hairline box. Figure 1: Standard NFP HAIRLINE RULE: A hairline rule centered between lines of text must separate Nutrition Facts from information below, % Daily Value from information below and must separate each nutrient from the nutrients above and below. BAR: A bar (think line) must separate Calories and vitamins & minerals from information below. A thick bar should separate Serving Size and Protein from information below. LOCATION: Information panel, grouped together with other mandatory information, (e.g. domicile statement, ingredients, etc.). The declaration may be on the PDP. Only where space is limited can the NFP appear on other panels. Foods in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers. The space needed for vignettes, designs, and other non-mandatory label information on the principal display panel may be considered in determining the sufficiency of available space on the principal display panel for the placement of the nutrition label. Nonmandatory label information on the information panel shall not be considered in determining the sufficiency of available space for the placement of the nutrition label. LANGUAGE: English. If however a second language is required, a separated nutrition fact panel in that language may be included in addition to one in English or a bilingual version can be presented with that language and English. Page 1 of 6

2 ROUNDING RULES FOR DECLARING ELEMENTS WITH THE NFP (Including revised rules for Total Sugars, Added Sugars, Vitamin D, Calcium, Iron and Potassium, other Vitamins and Minerals - FR Vol. 81 N0. 103) NUTRIENT/ SERVING (M) (V) CORE UNITS ROUNDING*** INSIGNIFICANT RELEVANT INFORMATION Calories M cal < 5 cal - express as zero 50 cal - express to nearest 5 cal increment > 50 cal - express to nearest 10 cal increment Calories from saturated fat V cal < 5 cal - express as zero 50 express to nearest 5 cal increment > 50 cal - express to nearest 10 cal increment Total fat M g < 0.5g - express as zero < 5g - express in nearest 0.5g increment 5g - express to nearest 1g increment Saturated fat M g < 0.5g - express as zero < 5g - express to nearest 0.5g increment 5g - express to nearest 1g increment Trans fat M g < 0.5g - express as zero < 5g - express to nearest 0.5g increment 5g - express to nearest 1g increment Polyunsaturated & Monounsaturated fat V g < 0.5g - express as zero < 5g -express to nearest 0.5g increment 5 g - express to nearest 1g increment Cholesterol M mg < 2 mg - express as zero 2-5 mg - express as "less than 5 mg > 5 mg - express to nearest 5 mg increment Sodium M mg < 5 mg - express as zero mg - express to nearest 5 mg increment > 140 mg - express to nearest 10 mg increment Fluoride V mg < 0.1 mg - express as zero mg - express to nearest 0.1 mg increment > 0.8 mg - express to nearest 0.2 mg increment Total carbohydrate M g < 0.5g - express as zero Dietary fiber M g < 0.5g - express as zero NOTE: Must meet the definition of dietary fiber as recognized by FDA. Soluble & Insoluble fiber V g < 0.5g - express as zero NOTE: Must meet the definition of dietary fiber as recognized by FDA. Sugars M g < 0.5g - express as zero NOTE: When less than 1 gram and no claims are made about sweeteners, sugars, or sugar alcohol content, may Not a significant source of total sugars would be placed at the bottom of the NFP in the same type size. < 5 cal 101.9(c)(1)(i) < 5 cal 101.9(c)(1)(ii) < 0.5 g 101.9(c)(2) < 0.5 g 101.9(c)(2)(i) < 0.5 g 101.9(c)(2)(ii) < 0.5 g 101.9(c)(2)(iii)&(iv) < 2 mg 101.9(c)(3) < 5 mg 101.9(c)(4) < 5 mg 101.9(c)(5) < 1 g 101.9(c)(6) < 1 g 101.9(c)(6)(i) < 1 g 101.9(c)(6)(i)(A) & (B) < 1 g 101.9(c)(6)(ii) Page 2 of 6

3 ROUNDING RULES FOR DECLARING ELEMENTS WITH THE NFP (Including revised rules for Total Sugars, Added Sugars, Vitamin D, Calcium, Iron and Potassium, other Vitamins and Minerals - FR Vol. 81 N0. 103) Added Sugars M g < 0.5g - express as zero NOTE: When less than 1 gram and no claims are made about sweeteners, sugars, or sugar alcohol content, may Not a significant source of added sugars would be placed at the bottom of the NFP in the same type size. Sugar alcohol V g < 0.5g - express as zero< 1g - express as "Contains less than 1g" OR "less than 1g" 1g - express to nearest 1g increment Protein M X g < 0.5g - express as zero Vitamins & Minerals M % DV < 2% of RDI - may be expressed as (1) zero (2) an asterisk that refers to statement "Contains less than 2% of the Daily Value of this (these) nutrient (nutrients) (3) for Vit D, calcium, iron & potassium: statement "Not a significant source of (listing the vitamins or minerals omitted) 10% of RDI - express to nearest 2% increment > 10% - 50% of RDI - express to nearest 5% increment > 50% of RDI - express to nearest 10% increment Vitamins & Minerals M Q Mandatory for vit D, calcium, iron, potassium and where fluoride is include. Optional in all other cases. NOTE: Fluoride does not have a RDI established and as such would not show a percent DV in the NFP. Express in applicable units of mg or mcg. Round to the degree of significance in 101.9(c)(8)(iv). Additional degree of significance may be warranted, (i.e. declare zinc to nearest 10 th of a gram. If < 2% of RDI - may be expressed as zero when declared as 0% of the DV, as above. Beta-carotene V % Vit A *** NOTES FOR ROUNDING % Daily Value (DV): (1) To calculate % DV, divide either the actual (unrounded) quantitative amount or the declared (rounded) amount by the appropriate RDI or DRV. Use whichever amount will provide the greatest consistency on the food label and prevent unnecessary consumer confusion 109.9(d)(7)(2). (2) When %DV values fall between two whole numbers, rounding shall be as follows: - for values exactly halfway between two whole numbers or higher (e.g. 2.5 to the values shall round up (e.g. 3%) - for values less than halfway between two whole numbers (e.g to 2.49) the values shall round down (e.g. 2%). 10% of Vit. A - express to nearest 2% increment > 10% - 50% of Vit A - express to nearest 5% increment > 50% of Vit A - express to nearest 10% increment < 1 g 101.9(c)(6)(iii) < 1 g 101.9(c)(6)(iv) < 1 g 101.9(c)(7) < 2% RDI Vitamins and minerals other than vit D, calcium, iron & potassium, listed in (8)(iv), are mandatory if added as nutrient supplement in food or if claim is made 101.9(c)(8)(iii) & (iv) < 2% RDI Vitamins and minerals other than vit D, calcium, iron & potassium, listed in (8)(iv), are mandatory if added as nutrient supplement in food or if claim is made 101.9(c)(8)(iii) & (iv) N/A Energy Values (21 CFR 101.9(c)(1)(i)(f)) 101.9(c)(8)(vi) POLYOLS CALORIES PER GRAM erythritol 0 mannitol 1.6 isomalt 2.0 lactitol 2.0 maltitol 2.1 xylitol 2.4 sorbitol 2.6 hydrogenated starch hydrolysates 3.0 Compared to 4 Calories per gram generally used for carbohydrates, 9 Calories per gram for fat & 4 Calories per gram protein. Page 3 of 6

4 ROUNDING RULES FOR DECLARING SERVING SIZE & NUMBER OF SERVING (Including revisions as per FR Vol. 81 N MEASUREMENT TYPE UNIT RELEVANT INFORMATION*** Discrete Units Servings 50% of the Reference Amount (RA): number of units closest to the RA = 1 serving Common Household Measures Metric Measure Number of Servings / Container ABBREVIATIONS VOLUME: Cup (cup) Tablespoon (Tbsp) Teaspoon (tsp) Fluid Ounce (fl oz) WEIGHT: Ounce (oz) VOLUME: Milliliters (ml) WEIGHT: Gram (g) Milligram (mg) Numbers DAILY REFERENCE VALUES (DRV) > 50% to < 67% of RA: then, 1 unit = 1 serving OR 2 units = 1 serving 67% to < 200% of RA: then, 1 unit = 1 serving 200% up to and including 300% of RA: The serving size shall be the amount that approximates the reference amount. In addition, the manufacturer shall provide a column within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values per individual unit, (dual format). The exemptions in paragraphs 21 CFR (b)(12)(i)(a), (B), and (C) of this section apply to this provision. Use cup in 1/3 or 1/4 cup increments, except may use fl oz for beverages 2 Tbsp & < 114 cup whole Tbsp Between 1 & 2 Tbsp, may use the increments of: 1, 1 1/3, 1 1/2, 1 2/3, 2 1 tsp & < 1 Tbsp whole tsp < 1 tsp = 1/4 tsp increments Ounce (oz) measures = 0.5 oz increments Fluid ounce (fi oz) = whole number increments Serving sizes that fall half-way between two serving sizes, manufacturers shall round up to the next incremental size. > 5 = nearest whole number 2 and < 5 = nearest 0.5 < 2 = nearest 0.1 Round to the nearest whole number except for servings between 2 and 5 servings. Between 2 and 5 servings = nearest 0.5 serving Roundings should be indicated by the term about ABBREVIATIONS MAY BE USED WHEN <40 IN 2 LABEL AREA NFP ITEM ABBREVIATION NFP ITEM ABBREVIATION Serving size Serv size Dietary fiber Fiber Servings per container Servings Soluble fiber Sol fiber Calories from saturated fat Sat fat cal Insoluble fiber Insol fiber Saturated fat Sat fat Sugar alcohol Sugar alc Monounsaturated fat Monounsat fat Potassium Potas Polyunsaturated fat Polyunsat fat Includes* Incl. Cholesterol Cholest Vitamin* Vit Total carbohydrate Total carb * Abbreviation can also be used on dual-column displays. FOOD COMPONENT UNIT OF MEASURE ADULTS AND CHILDREN 4 YEARS INFANTS THROUGH 12 MONTHS CHILDREN 1 THROUGH 3 YEARS PREGNANT WOMEN AND LACTATING WOMEN Fat Grams (g) Saturated fat Grams (g) 1 20 N/A Cholesterol Milligrams (mg) 300 N/A Total carbohydrate Grams (g) Sodium Milligrams (mg) 2,300 N/A 1,500 2,300 Dietary Fiber Grams (g) 1 28 N/A Protein Grams (g) 1 50 N/A 2 13 N/A Added Sugars Grams (g) 1 50 N/A Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women 2 - Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age. Page 4 of 6

5 REFERENCE DAILY INTAKES (RDI) Nutrient Unit of measure RDI Adults and children 4 yrs Infants 1 through 12 months Children 1 through 3 yrs Pregnant women and lactating women Vitamin A Micrograms RAE 2 (mcg) ,300 Vitamin C Milligrams (mg) Calcium Milligrams (mg) 1, ,300 Iron Milligrams (mg) Vitamin D Micrograms (mcg) Vitamin E Milligrams (mg) Vitamin K Micrograms (mcg) Thiamin Milligrams (mg) Riboflavin Milligrams (mg) Niacin Milligrams NE 5 (mg) Vitamin B 6 Milligrams (mg) Folate 6 Micrograms DFE 7 (mcg) Vitamin B 12 Micrograms (mcg) Biotin Micrograms (mcg) Pantothenic acid Milligrams (mg) Phosphorus Milligrams (mg) 1, ,250 Iodine Micrograms (mcg) Magnesium Milligrams (mg) Zinc Milligrams (mg) Selenium Micrograms (mcg) Copper Milligrams (mg) Manganese Milligrams (mg) Chromium Micrograms (mcg) Molybdenum Micrograms (mcg) Chloride Milligrams (mg) 2, ,500 2,300 Potassium Milligrams (mg) 4, ,000 5,100 Choline Milligrams (mg) Protein Grams (g) N/A 11 N/A RDIs are based on dietary reference intake recommendations for infants through 12 months of age. 2 - AE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental β-carotene, 12 micrograms β-carotene, or 24 micrograms α- carotene, or 24 micrograms β-cryptoxanthin. 3 - The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in parentheses after the declaration of the amount of vitamin D in mcg. 4-1 mg α-tocopherol (label claim) = 1 mg α-tocopherol = 1 mg RRR- α-tocopherol = 2 mg all rac-α-tocopherol. 5 - NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan. 6 - Folate and Folic Acid must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid. 7 - DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid. 8 - Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women. US VS CANADA NUTRIENT DAILY VALUE Canada 1 (current) US 2 (current) Canada Proposed US New 3 Fat 65 g 4 65 g 75 g 78 g Saturated Fat 20 g 20 g 20 g 20 g Trans Fat (sum of saturated + trans fat) no DV (the sum of saturated + trans fat) no DV Cholesterol 300 mg (Optional declaration) 300 mg 300 mg (Optional declaration) 300 mg Sodium 2,400 mg 2,400 mg 2,300 mg 2,300 mg Carbohydrates 300 g 300 g no DV 275 g Fibre 25 g 25 g no DV 28 g Sugars no DV no DV 100 g no DV Added Sugars no DV (Not listed) no DV (Not listed) no DV (Not listed) 50 g Protein no DV 50 g 5 no DV 50 g Based on the reference standards published in Section B of the FDR. 2 - Based on the US Reference Daily Intakes published in Code of Federal Regulations, 101.9(c)(8)(iv). 3 - As per final regulations 81 FR Based on a 2,000-Calorie diet 5 - In the US, the % DV for protein is only required when a protein claim is made for the product or if the product is to be used by infants or children under 4 years of age. Page 5 of 6

6 FIGURE 2: STANDARD SIDE BY SIDE FIGURE 3: DUAL COLUMN FIGURE 4: SIMPLIFIED NFP WHEN 8 OR MORE CORE NUTRIENTS ARE AT A LEVEL CONSIDERED INSIGNIFICANT. FIGURE 5: TABULAR NFP WHEN AVAILABLE LABEL AREA IS LESS THAN 40 IN 2. FIGURE 6: LINEAR NFP WHEN AVAILABLE LABEL AREA IS LESS THAN 12 IN 2. FIGURE 7: TABULAR NFP WHEN LESS THAN ABOUT 3 INCHES IN HEIGHT FOR STANDARD FORMAT. FIGURE 8: CHILDREN 1 THROUGH 3 YEARS NOTE: IMAGES ARE NOT TO SCALE WHEN SHOWN IN HIS DOCUMENT. Page 6 of 6