USA – FDA to Redefine “Healthy” Claim for Food Labeling

The U.S. Food and Drug Administration (FDA) today announced that it has started a public process to redefine the “healthy” nutrient content claim for food labeling. Redefining “healthy” is part of an overall plan to provide consumers with information and tools to enable them to easily and quickly make food choices consistent with public health recommendations and to encourage the development of healthier foods by the industry.

While FDA is considering how to redefine the term “healthy” as a nutrient content claim, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition. FDA is also issuing a guidance document stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.

For readers which are not very practical with US legislation, it is useful to outline that “healthy” – while in many country is a not regulated term – is considered in USA a nutrient content claim, and it can be used exclusively when some compositional criteria related to specific nutrients are met. In that sense, you can check two recent warning letters to food business operators, where you can find relevant reference to legislation and examples of non compliance:

http://www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm437839.htm

http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm425102.htm

Public health recommendations for various nutrients have evolved, as reflected by the 2015-2020 Dietary Guidelines for Americans and the updated Nutrition Facts label. For example, healthy dietary patterns now focus on food groups, the type of fat rather than the total amount of fat consumed and now address added sugars in the diet. Also, the nutrients of public health concern that consumers aren’t getting enough of have changed.

FDA is publishing a “request for information” to solicit public input as it redefines the term “healthy.” In addition, the Agency is planning other public forums to receive additional public input.

For more information:

Federal Register Notice for the Guidance for Industry
Federal Register Notice for the Request for Information
Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
Blog: Making Sure ‘Healthy’ Means What It Says on Food Packages
“Healthy” on Food Labeling

(Source: FDA website)

QeA to EU Commission – Allergy to apples ?!

In EU, as well as in USA and other countries with different allergens requirements (e.g. Japan), the choice of the legislator is to specifically consider as “allergens” – for labeling purposes – only the so called “major allergens”: substances which account for the major % of food allergies found in the local population. 

It could happen that some allergies are not considered (think of garlic, strawberries…) by the legislator, so it is up to the consumer to check the ingredient list (where everything should be declared).

Those evaluations could nonetheless change in time, as explained by the EU Commission.

Question for written answer to the Commission

Tomáš Zdechovský (PPE) – 15th June 2016

Subject: Allergy to apples

Allergy to apples is affecting more and more people. It is an allergy which can manifest itself at any age.

The most common symptoms include tingling lips and itching or sore throat, as well as swelling or sneezing. A research project called SAFE was conducted across Europe to explore the occurrence of combined apple-pollen allergies. The research shows that the new varieties of apple have a greater impact on those affected.

The research also suggests that there is a geographical division between south and north, and that there are two specific types of apple allergy. In the north there are people allergic to raw apple pulp, while people from the south are allergic to the skin in all of its forms, whether raw or cooked.

The research shows that the form the allergy takes is influenced not only by the amount of the allergen in the apple, but also by the variety of apple and the storage conditions.

Has the Commission conducted any research into apple allergy and its impact on European consumers or is it planning to conduct such a research?

How is the EU protecting its consumers against this allergy?

Answer given by  Mr Moedas on behalf of the Commission – 1st September 2016

Research on allergies has been supported by the European Commission since the 5th Framework Programme, when the Safe project was funded. Currently, five projects are dealing with allergies to apples (Safe, Fast, Caramel, iFAAM, Europrevall) with total EU funding of more than EUR 28 million. Horizon 2020 also offers the possibility to receive funding to carry out research on apple allergy (see Horizon 2020 Research and Innovation Participant Portal).

Regulation (EU) No 1169/2011 requires, for all food, the mandatory provision of information on the presence of allergens whenever they are used in food as an ingredient. It also requires that such information must be emphasised on food labels through a typeset that clearly distinguishes it from the rest of the list of ingredients. The EU list of allergens is provided in its Annex II and has been established on the basis of a scientific opinion adopted by the European Food Safety Authority. According to this, the substances of Annex II are considered as part of the most common food allergens and there is ample evidence to support their inclusion into the list.

The regulation foresees a systematic re-examination of the allergen list and, when necessary, it is updated on the basis of the most recent scientific knowledge. At this stage, there are no available scientific data to support the inclusion of apples into the allergen list.

Nevertheless, when apple has been used as an ingredient in food, its present products, used in the production or preparation of food and still present in the finished product, must be stated in the list of ingredients

(Source: EU Parliament)