Acrylamide evaluations in EU and USA – FDA Final Guidance on reduction in certain foods

On 4 June 2015, the European Food Safety Authority (EFSA) published its first full risk assessment of acrylamide in food. Experts from EFSA’s Panel on Contaminants in the Food Chain (CONTAM) reconfirmed previous evaluations that acrylamide in food potentially increases the risk of developing cancer for consumers in all age groups.

Evidence from animal studies shows that acrylamide and its metabolite glycidamide are genotoxic and carcinogenic: they damage DNA and cause cancer. Evidence from human studies that dietary exposure to acrylamide causes cancer is currently limited and inconclusive. To know more about the situation in EU click here or download EFSA’s infographic.

Last week the U.S. Food and Drug Administration (FDA) has issued final guidance to the food industry to help growers, manufacturers and food service operators take steps to reduce levels of acrylamide in certain foods.

Acrylamide is a chemical that may form in certain foods during high-temperature cooking, such as frying, roasting and baking. The National Toxicology Program (an interagency program that evaluates possible health risks associated with exposure to certain chemicals) characterizes the substance as “reasonably anticipated to be a human carcinogen.” And efforts to reduce acrylamide levels are already underway in many sectors of the food industry.

To help mitigate potential human health risks, the FDA’s guidance recommends that companies be aware of the levels of acrylamide in the foods they produce and consider adopting approaches, if feasible, that reduce acrylamide in their products. The guidance also offers a range of steps that growers, manufacturers, and food service operators may take to help reduce acrylamide levels.

For instance, for french fries, the recommended maximum cooking temperature for frying is 345-350 ºF/approximately 170-175 ºC (Refs. 30, 43). Providing appropriate cooking instructions on frozen french fry packages may help reduce acrylamide formation safely during final preparation by consumers and food service operators. Examples of such instructions (which may not be applicable to all products) are:

• Cook to a light golden color. Avoid browning fries.

• Avoid overcooking or undercooking.

• Avoid cooking in a toaster oven to prevent overcooking.

• Reduce cooking time when cooking small amounts.

Through this guidance and various research activities, the FDA is helping companies reduce acrylamide and reduce any potential risks to human health. The focus of this non-binding guidance is on raw materials, processing practices, and ingredients pertaining to potato-based foods (such as french fries and potato chips), cereal-based foods (such as cookies, crackers, breakfast cereals and toasted bread), and coffee, all sources of acrylamide exposure.

Because acrylamide is found primarily in potato-based foods, cereal-based foods, and coffee, the FDA’s best advice for consumers to help limit acrylamide intake is to adopt a healthy eating plan, consistent with the Dietary Guidelines for Americans, that:

• Emphasizes fruits, vegetables, whole grains, and fat-free or low-fat milk and milk products;
• Includes lean meats, poultry, fish, beans, eggs, and nuts; and
• Limits saturated fats, trans fats, cholesterol, salt (sodium) and added sugars.

Additional advice to consumers pertaining to acrylamide, including recommended food storage and preparation methods, is available on FDA website.

See also: Acrylamide – Nothing seems to help on focusonfoodsafety.wordpress.com, by Stefan Fabiansson.

“Just Mayo” without eggs? FDA warning letter to Hampton Creek Foods

On 20th August 2015 the U.S. Food and Drug Administration published the following warning letter, after reviewing Hampton Creek Foods’ Just Mayo and Just Mayo Sriracha labels.

The FDA concludes that these products are in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and its implementing regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Basically, for 4 different reasons:

1-2 Health claims: the presence on the labels and on advertising materials of an unauthorised health claim (“cholesterol-free”, “Your Heart Matters. When your heart is healthy, well, we’re happy. You’ll never find cholesterol in our products.” or equivalent wordings);

3. Misbranding: products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that they purport to be the standardized food mayonnaise due to the misleading name and imagery used on the label, but do not qualify as the standardized food mayonnaise as described under 21 CFR 169.140. The name “Just Mayo” and an image of an egg are prominently featured on the labels for these products. The term “mayo” has long been used and understood as shorthand or slang for mayonnaise. The use of the term “mayo” in the product names and the image of an egg may be misleading to consumers because it may lead them to believe that the products are the standardized food, mayonnaise, which must contain eggs as described under 21 CFR 169.140(c). Additionally, the use of the term “Just” together with “Mayo” reinforces the impression that the products are real mayonnaise by suggesting that they are “all mayonnaise” or “nothing but” mayonnaise. However, Just Mayo and Just Mayo Sriracha do not meet the definition of the standard for mayonnaise. According to the labels for these products, neither product contains eggs.

4. Non compliance with the related standard of identity: products are misbranded within the meaning of section 403(g) of the Act [21 U.S.C. § 343(g)] in that they purport to be a food for which a definition and standard of identity has been prescribed by regulation, but they fail to conform to such definition and standard. Specifically, these products purport to be mayonnaise by prominently featuring the word “Mayo” on the labels, which has long been used to refer to mayonnaise. Mayonnaise is a food for which a definition and standard of identity has been prescribed by regulation (see 21 CFR 169.140). According to the standard of identity for mayonnaise, egg is a required ingredient (21 CFR 169.140(c)); however, based on the ingredient information on the labels, these products do not contain eggs. We also note that these products contain additional ingredients that are not permitted by the standard, such as modified food starch, pea protein, and beta-carotene, which may be used to impart color simulating egg yolk.

It will be extremely interesting to see how the company will react, trying to defend a really difficult position.

In October 2014 Unilever filed a lawsuit against Hampton Creek, raising more or less the same arguments. Few months later, anyway, they drop the action without any reason. Probably, they prefer to wait the enforcement action by the FDA, in light of the fact that a petition on Change.org calling on Unilever to “stop bullying sustainable food companies” gathered more than 112.000 signature in few days.

Sustainable or not (that’s completely another matter), the Hampton Creek position in my opinion is quite critical because:

  1. in US there is a standard of identity for mayonnaise and they don’t meet it;
  2. they suggest both by wording and pictorial of eggs that their products are mayonnaise;
  3. “mayo” is commonly understand all over the world as a synonym of mayonnaise and the egg is a characterizing ingredient of such a product.

Therefore, also in case you remove from the equation the standard of identity, the product could still be considered misleading.

It is interesting to stress that in EU, one of the innovation brought by the Food Information to Consumers Regulation (or “FIC”, Reg. (EU) n. 1169/2011, entered in application on 13th December 2014) considered specifically the ingredient’s substitution.

The art. 7 on Fair information practices provides that food information shall not be misleading, particularly:

“(d) by suggesting, by means of the appearance, the description or pictorial representations, the presence of a particular food or an ingredient, while in reality a component naturally present or an ingredient normally used in that food has been substituted with a different component or a different ingredient.”

Moreover, the Annex VI, point 4, establishes a positive obligation to label this kind of ingredients, with specific rules for positioning and font size:

“In the case of foods in which a component or ingredient that consumers expect to be normally used or naturally present has been substituted with a different component or ingredient, the labelling shall bear — in addition to the list of ingredients — a clear indication of the component or the ingredient that has been used for the partial or whole substitution:

(a) in close proximity to the name of the product; and

(b) using a font size which has an x-height of at least 75 % of the x-height of the name of the product and which is not smaller than the minimum font size required in Article 13(2) of this Regulation.”