February 2012 Whole Grain Claims in the Marketplace Canada’s agri-food sector is interested in promoting the nutritional and health benefits of food products through the use of health claims, nutrient content claims and other nutrition information provided on food labels. Recently there has been interest in products containing whole grains because the dietary guidelines recommend increasing their consumption, other jurisdictions have approved health claims and consumer demand is rising. This report examines market penetration and communication of whole grain claims on the labels of food products sold in Canada and in other jurisdictions, their importance to consumers and potential opportunities for promoting the health benefits of whole grains. This information has been compiled from a variety of sources and is supported by data on new product launches bearing whole grain claims entering the market since 2006. 1 Defining Whole Grains The American Association of Cereal Chemists International (AACC) defines whole grains as consisting of the “intact, ground, cracked or flaked caryopsis [grain], whose principal components— the starchy endosperm, germ and bran—are present in the same relative proportions as they exist in the intact caryopsis” (AACC, 1999). To be considered whole grain, a food may contain intact grains, minimally processed grains, or milled grains from which no component has been removed during the milling process. Grains considered to be a true cereal or pseudocereal by AACC are listed in Table 1. Currently AACC is developing guidance related to the interpretation and application of the whole grain definition when components of the same grain are recombined or when the whole grain is reconstituted from components of different grains. Table 1: Common Whole Grains True cereals Pseudocereals Wheat including spelt, emmer, farro, einkorn, kamut, durums Rice, African rice* Barley Corn (maize, popcorn) Rye Oats Millets Sorghum Teff (tef) Triticale Canary Seed Job’s Tears Fonio, Black Fonio, Asian Millet Wild Rice Amaranth Buckwheat, Tartar Buckwheat Quinoa Source: adapted from official correspondence from AACC International to Health Canada, February 12, 2007; www.aaccnet.org/definitions/pdfs/AACCIntlResponseToHealthCanadaFeb07.pdf *Brown and coloured rices (e.g. black, red) are whole grain. 1 Source: Mintel Global New Products Database 2011. New product launches only (which can include an existing product re-launched with a claim); does not represent the total number of products on the market February 2012 The AACC definition of whole grain has been adopted by several countries, including the U.S., U.K., Sweden and Denmark. Each country has a list of qualifying grains and a list of permitted processing methods. They allow for minor losses of components through traditional processing methods and natural variations that exist between batches of grains. Health Canada has also proposed to adopt the AACC definition into the Canadian Food and Drug Regulations (Health Canada, 2006) and is participating on the AACC committee that is developing the guidance on the interpretation of the definition. Dietary Importance of Whole Grains Dietary guidelines in Canada and in other countries recommend consuming whole grain products as a component of healthy eating (Table 2). Table 2: Some Whole Grain Dietary Recommendations Around the World Country Guideline Recommendations Canada Eating Well with “Make at least half of your grain products whole grain each day. Canada’s Food Guide Eat a variety of whole grains such as barley, brown rice, oats, quinoa and wild rice. Enjoy whole grain breads, oatmeal or (2007) Australia Australian Dietary Guidelines (2003) China Dietary Guide for Chinese Citizens (2008) National Food Institute report on the health benefits of whole grains (2008) Eatwell Plate (2011) Denmark United Kingdom United States World Health Organization Dietary Guidelines for Americans (2010) Global Strategy on Diet, Physical Activity and Health (2004) whole wheat pasta.” “Eat plenty of cereals (including breads, rice, pasta and noodles), preferably wholegrain.” Updated guidelines are expected to indicate “mostly whole grain” instead of “preferably whole grain”. The Chinese Ministry of Health and the Chinese Nutrition Society recommend that adults consume a daily average of 50 g of coarse grain, and that the elderly consume 100 g.* Danes should consume a minimum of 75 g of whole grains daily (based on a 2400 calorie diet; about 63 g daily for a 2000 calorie diet), emphasizing a variety of whole grain products.† “Try to eat…plenty of bread, rice, potatoes, pasta and other starchy foods – choose wholegrain varieties whenever you can.” “Consume at least half of all grains as whole grains. Increase whole-grain intake by replacing refined grains with whole grains.” “For diet, recommendations for populations and individuals should include the following: … increase consumption of fruits and vegetables, and legumes, whole grains and nuts…”. *http://english1.people.com.cn/90001/90782/90880/6867310.html † based on an English summary of the report’s recommendations, www.wholegrainscouncil.org/whole-grains-101/whole-grain-guidelines-worldwide Marketplace Trends for Whole Grains Consumers are aware of dietary recommendations for whole grains and they are interested in consuming whole grains for health. In fact, “whole grain” was the most sought-after claim on food labels in 2010 in the U.S., followed by high fibre and low sodium (IFT, 2011). Baby boomers, the largest generational group in Canada, will continue to be a big driver in the demand for whole grain products as they look to manage their health and improve or maintain their quality of life through nutrition. They are actively looking for products containing whole grains. As a result, many companies are introducing whole grain products and identifying “whole grain” on product labels. Whole Grain Claims in the Marketplace Food Regulatory Issues Division, Agriculture and Agri-Food Canada 2 February 2012 Figure 1: Number of New Products in the Global Market Bearing “Whole Grain” Claims Whole Grain Claims in the Marketplace # of new product launches with whole grain claims 300 250 200 2007 2008 150 2009 2010 100 50 0 Globally Canada US EU AUS/NZ Others* Region * “Others” include Brazil, China, India, Mexico, South Korea, Russia combined Source: Mintel Global New Products Database (January 1 to April 20, 2011) The general increase since 2007 in the number of new product launches in the market bearing whole grain claims (Figure 1) indicates that industry is responding to consumer demand for whole grain products. New product launches bearing whole grain claims were most prevalent in North America. In Canada, manufacturers of cold cereals, cereal bars and bread and bread products are the most frequent users of whole grain claims (Table 3); these three sub-categories accounted for 74% of Canadian product launches with whole grain claims. The 49 cold cereal products with whole grain claims represent just over one quarter (26%) of the cold cereal category. Table 3: Product Categories with Whole Grain Claims in Canada, 2007–2011 Number of Products Sub-Category With whole Total grain claims Baby Snacks Baking Ingredients & Mixes Bread & Bread Products Cakes, Pastries & Sweet Goods Cold Cereals Fruit Snacks Hot Cereals Pasta Savoury Biscuits/Crackers Shelf-stable Desserts Snack/Cereal/Energy Bars Sweet Biscuits/Cookies Wheat & Other Grain Based Snacks Total 18 14 153 39 186 4 27 51 53 1 97 57 10 710 3 1 22 2 49 2 7 1 5 1 49 15 4 161 Source: Mintel Global New Products Database 2011 There appears to be a continuing trend to add whole grain claims to product labels both globally and in Canada, as indicated by the increase in the number of new product launches over time (Figure 1). Data for the first quarter of 2011 show that 19 new products with whole grain claims have been launched in Canada, 51 in the U.S., and 88 globally (Mintel, 2011). Whole Grain Claims in the Marketplace Food Regulatory Issues Division, Agriculture and Agri-Food Canada 3 February 2012 Figure 2 indicates the total percentage market value growth in the bakery and cereal product category as a whole between 2006 and 2011, including products with and without whole grain claims. The market value of bakery and cereal products has increased every year since 2006 for each country presented and this category appears to have the greatest potential to bear whole grain claims, depending on the formulation. Figure 2: Market Value Growth of Bakery and Cereal Products, 2006–2011 Market Value Growth since 2006 18% 16% 14% 12% 10% % Growth 8% Bakery and Cereal Products 6% 4% 2% 0% United States Canada Germany United Kingdon France Country Source: Datamonitor Market Data Analytics 2011 Helping Consumers Identify Whole Grains Variations in the existing global definitions for whole grain and whole wheat have made it difficult for consumers to understand food labels and determine what is meant by the terms “whole grain”, “multi-grain” and “whole wheat”, as well as the various names used for processed grains identified on ingredient lists (Miller Jones, 2010). For example, the standard for whole wheat flour in Canada’s Food and Drug Regulations permits up to 5% of the wheat kernel to be removed—which includes much of the germ and some of the bran—to help reduce rancidity and prolong the shelf life of whole wheat flour. Such flour would comply with the Canadian regulations but would not be considered whole grain by the AACC definition. As Canada moves toward adopting the AACC definition, further action will likely be required on flour standards to ensure options are available. Currently, many companies identify whole grain content by using their own unique logos or by using label claims such as “contains whole grains” and “made with 100% whole grains”. The CFIA Guide to Food Labelling and Advertising (section 4.2.3) recommends that when the presence of an ingredient, component or substance is emphasized, the label should include a statement regarding the amount present in the food. Furthermore, care should be taken when claims are made about whole grains, when the whole grain is not intact, so that consumers are not misled about the composition of the food. The Whole Grains Council (WGC) and its internationally affiliated groups have developed a logo to identify products containing significant amounts of whole grains. There are two types of Whole Grain Stamp, each showing the amount of whole grains per serving in compliance with the recommendation in the CFIA Guide. The basic Whole Grain Stamp can be used on products containing a minimum of 8 g of whole grains per serving. In Canada, the 100% Whole Grain Stamp can only be used on products that are made entirely with whole grains and that contain a minimum of 16 g of whole grains per serving. The Canadian stamps are also bilingual. To use the stamp, a company must be a paid member of the WGC. The Whole Grain Stamp appeared Whole Grain Claims in the Marketplace Food Regulatory Issues Division, Agriculture and Agri-Food Canada 4 February 2012 on 5,800 different products in 23 countries as of August 2011. 2 In Canada, where it was introduced in 2008, 779 products are registered to use the Whole Grain Stamp. 3 Health Claim Opportunities Health claims on product labels and in advertising convey information about food characteristics and related health benefits. This information can be used by consumers to choose foods that may help reduce their risk of developing nutrition-related chronic diseases. Manufacturers have some options for supporting informed choice among consumers who are interested in being able to identify whole grains. Whole Grain Claims in Other Jurisdictions Some jurisdictions have approved health claims related to whole grain consumption. However, more recently, as the definition for whole grains established by AACC in 1999 has received increasing support from the scientific and regulatory community, other jurisdictions have reviewed the evidence and some of them have rejected health claims for whole grains, sometimes in favour of grain-specific claims. Previously accepted health claims In 1999, the U.S. was the first country to allow a whole grain health claim: "Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers." In 2003, the U.S. permitted a variant of this claim: “Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.” In 2002, the U.K accepted: “People with a healthy heart tend to eat more whole grain foods as a part of a healthy lifestyle”. In 2003, Sweden approved: “A healthy lifestyle and a balanced diet rich in whole grain products reduce the risk of heart disease”. New evidence challenges whole grain health claims When Food Standards Australia New Zealand (FSANZ) and the European Food Safety Authority (EFSA) each reviewed the evidence for a health claim (in 2007 and 2010, respectively), many of the studies that supported the above health claims were not considered because the measurement of whole grains was not consistent with the AACC definition. Both FSANZ and EFSA concluded that the evidence provided did not support a claim for whole grains and heart disease risk reduction (FSANZ, 2007; EFSA, 2010). A Cochrane Review on whole grain cereals for coronary heart disease (CHD) in people with existing CHD or risk factors for CHD found evidence supporting the effects of "whole grain oats" on blood lipids. The reviewers did not find supporting evidence for other whole grains because of a lack of well-designed, long-term randomised controlled trials on whole grain foods and diets other than oats (Kelly et al., 2007). Whole Grain Claims in Canada In Canada, references to Canada’s Food Guide are permitted for use on labels and in advertising, provided principles for their use are followed. 4 This includes a general health claim stating that “Canada’s Food Guide recommends making at least half of your grain products whole grain each day.” General health claims promote health through healthy eating or provide dietary guidance; they do not refer to a health effect, disease, or health condition. 2 www.wholegrainscouncil.org/newsroom/whole-grain-statistics 3 Information provided by Cynthia Harriman, Whole Grains Council, December 20, 2011.The stamp, customized for Canada, received a “letter of no objection” from CFIA in December 2007. 4 General Principles for the Use of Content from Canada's Food Guide Resources in Labelling and Advertising www.hc-sc.gc.ca/fn-an/food-guide-aliment/gen_prin-eng.php Whole Grain Claims in the Marketplace Food Regulatory Issues Division, Agriculture and Agri-Food Canada 5 February 2012 To date, a disease risk reduction health claim for whole grains has not been accepted for use in Canada. However, in 2012-13, Health Canada expects to publish the results of a systematic review undertaken to determine whether the evidence from intervention and prospective cohort studies supports a health claim for whole grains and cardiovascular disease risk reduction in generally healthy populations. In 2010, Health Canada accepted a therapeutic health claim that links the consumption of betaglucan oat fibre to a reduction in blood cholesterol, a risk factor for heart disease. For example: "X g (x cup) of [naming the food] supplies X% of the daily amount of the fibres shown to help reduce cholesterol." Eligible sources of beta-glucan oat fibre are oat bran, rolled oats (or oatmeal), and whole oat flour, either as the foods themselves or as ingredients in formulated foods. The conditions of use and the claim wording are prescribed in the assessment (Health Canada, 2010). For a health claim to be approved in Canada, it is necessary to submit a pre-market application prepared according to Health Canada’s Guidance Document for Preparing a Submission for Food Health Claims. In response to industry’s concern about the level of resources required to meet health claim substantiation standards, Health Canada has developed the Guidance Document for Preparing a Submission for Food Health Claims Using an Existing Systematic Review. This guidance document outlines the requirements for a complete health claim submission based on an existing literature review. Health Canada has identified five regulatory or scientific organizations with standards of evidence similar to Canada’s standards, including FSANZ, EFSA and the Cochrane Collaboration. The results of the reviews undertaken by these organizations suggest that additional research gaps need to be addressed prior to making a submission on whole grains. The Food Regulatory Issues Division (FRID) of Agriculture and Agri-Food Canada provides assistance to Canada’s agri-food sector in navigating Canada’s regulatory system for health claims, novel foods and ingredients. FRID can provide mentoring and guidance in the health claim and novel food submission process. References American Association of Cereal Chemists International. (1999): AACC members agree on definition of whole grain. www.aaccnet.org/news/pdfs/wgPR.pdf Datamonitor (2011): Market Data Analytics. Retrieved April 5, 2011 European Food Safety Authority [EFSA] (2010): Scientific Opinion on the substantiation of health claims related to whole grain (ID 831, 832, 833, 1126, 1268, 1269, 1270, 1271, 1431) pursuant to Article 13(1) of Regulation (EC) No 1924/20061. EFSA Journal 8(10):1766. www.efsa.europa.eu/en/efsajournal/pub/1766.htm Food Standards Australia New Zealand (2007): Wholegrains and coronary heart disease – FSANZ consideration of a commissioned review. www.foodstandards.gov.au/consumerinformation/nutritionhealthandrelatedclaims/reviewsforhighlevelc3090.cfm Health Canada (2010): Oat Products and Blood Cholesterol Lowering: Summary of Assessment of a Health Claim about Oat Products and Blood Cholesterol Lowering. www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assessevalu/oat-avoine-eng.php Health Canada (2006): Position Paper on Five US Health Claims Considered for Use in Canada. (Part A, A.2 Definition of whole grain). www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/position_paper-enonce_position-eng.php Institute of Food Technologists [IFT] (2011). Top 10 Food Trends for 2011. www.foodproductdesign.com/news/2011/04/top-10-food-trends-for-2011.aspx Kelly SAM, Summerbell CD, Brynes A, Whittaker V, Frost G (2007): Wholegrain cereals for coronary heart disease. Cochrane Database of Systematic Reviews. Issue 2. Art. No.: CD005051. DOI: 10.1002/14651858.CD005051.pub2 www2.cochrane.org/reviews/en/ab005051.html Miller Jones, J. (2010): Regulatory Aspects of Whole Grain and Whole Grain Foods: Definitions and Labelling. Cereal Chem. 87(2):150–154 Mintel (2011): Global New Products Database. Retrieved April 2011 Whole Grain Claims in the Marketplace Food Regulatory Issues Division, Agriculture and Agri-Food Canada 6 February 2012 Select Resources Agriculture and Agri-Food Canada - Canada’s Regulatory System for Foods with Health Benefits—At a Glance www.agr.gc.ca/food-regulatory-issues - Promising Health Claim Opportunities for Canada’s Agri-Food Sector www.agr.gc.ca/food-regulatory-issues (select “Reports and Reviews”) - Best Practices in Promoting Food Health Benefits www.agr.gc.ca/food-regulatory-issues (select “Reports and Reviews”) Health Canada - Position Paper on Five US Health Claims Considered for Use in Canada; A.2 Definition of Whole Grain www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/position_paper-enonce_position-eng.php#a2 - Whole Grains—Get The Facts www.hc-sc.gc.ca/fn-an/nutrition/whole-grain-entiers-eng.php - Canada’s Food Guide to Healthy Eating www.hc-sc.gc.ca/fn-an/food-guide-aliment/index-eng.php - General Principles for the Use of Content from Canada's Food Guide Resources in Labelling and Advertising www.hc-sc.gc.ca/fn-an/food-guide-aliment/gen_prin-eng.php - Guidance Document for Preparing a Submission for Food Health Claims www.hc-sc.gc.ca/fn-an/legislation/guide-ld/health-claims_guidance-orientation_allegations-sante-eng.php - Guidance Document for Preparing a Submission for Food Health Claims Using an Existing Systematic Review www.hc-sc.gc.ca/fn-an/legislation/guide-ld/systemat-revi-sub-eng.php Canadian Food Inspection Agency - Guide to Food Labelling and Advertising Section 4.2.3: Stressing or Highlighting Particular Ingredients. www.inspection.gc.ca/english/fssa/labeti/guide/ch4e.shtml#a4_2 Chapter 8: Health Claims. www.inspection.gc.ca/english/fssa/labeti/guide/tab8e.shtml Contact us to learn more about regulations for health claims, novel foods and ingredients. Food Regulatory Issues Division Agriculture and Agri-Food Canada 1341 Baseline Road, Tower 5, 2nd Floor Ottawa, Ontario K1A 0C5 Email: [email protected] www.agr.gc.ca/food-regulatory-issues The Government of Canada has prepared this report based on primary and secondary sources of information. Although every effort has been made to ensure that the information is accurate, Agriculture and Agri-Food Canada assumes no liability for any actions taken based on the information contained herein. © Her Majesty the Queen in Right of Canada, 2012 Cat. No. A72-108/2011E-PDF ISBN 978-1-100-19326-7 AAFC No. 11629E Electronic version available at www.agr.gc.ca/food-regulatory-issues Aussi offert en français sous le titre : Les allégations concernant les grains entiers sur le marché This publication may be reproduced in its entirety without permission provided the source is fully acknowledged. Whole Grain Claims in the Marketplace Food Regulatory Issues Division, Agriculture and Agri-Food Canada 7
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