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)

FDA Warning Letter – “Healthy” products

This is an interesting example of warning letter issued by the FDA. It gives not only some indications about the use of the term “healthy”, but examines also other profiles of non compliance about allergens (“Contains…”).
“The Food and Drug Administration (FDA) reviewed the label for your Dark Chocolate PlumSweets product in July 2014. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 343) and regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA’s home page athttp://www.fda.gov.
 
Your Dark Chocolate PlumSweets product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim.
 
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the labeling of a food product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
 
Specifically, the label of your Dark Chocolate PlumSweets product bears an implied nutrient content claim, because it bears statements suggesting that the product may be useful in maintaining healthy dietary practices and those statements are made in connection with claims or statements about nutrients. Specifically, the label of your Dark Chocolate PlumSweets product bears the claim “deliciously sweet and healthy diced plums…” in connection with the statements “Indulge in the Ultimate Antioxidant treat…” and “Dried Plum Whole Fruit Antioxidants + Decadent Dark Chocolate Goodness = The Ultimate Antioxidant Snack.” In the context of this label, FDA considers the claim “deliciously sweet and healthy diced plums…” to be an implied claim about the food itself. However, this product does not meet the requirements for use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d)(2).
 
In accordance with 21 CFR 101.65(d)(2), you may use the term “healthy” as an implied nutrient content claim on the label or in the labeling of a food provided that the food, among other things, is “low saturated fat” as defined in 21 CFR 101.62(c)(2) (i.e., the food has a saturated fat content of 1 g or less per Reference Amount Customarily Consumed (RACC) and no more than 15 percent of the calories are from saturated fat).
 
According to the Nutrition Facts panel, your product contains 5 g of saturated fat per 40 g serving of the food. This amount exceeds the maximum of 1 g of saturated fat per RACC for the food and the maximum of 15% of calories from saturated fat in the “low saturated fat” definition. Accordingly, your product does not meet the requirements for use of the nutrient content claim “healthy” on a food label [21 CFR 101.65(d)(2)]. Your product is thus misbranded within the meaning of section 403(r)(1)(A) of the Act.
 
The above violations are not meant to be an all-inclusive list of violations that may exist in connection with your products or their labeling. It is your responsibility to ensure that your products comply with the Act and its implementing regulations. You should take prompt action to correct the violations. Failure to promptly correct the violations may result in regulatory action without further notice, including seizure and/or injunction. 
 
In addition, in accordance with section 403(w) of the Act, when a food manufacturer opts to use the word “Contains” followed by the name of the food source from which the major food allergen is derived, this information must be placed immediately after or adjacent to the list of ingredients. The “Contains” statement on your product label is placed at the bottom of the information panel after various printed information such as how to store the product and other non-mandatory labeling information.
 
Please respond to this letter within 15 working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction”.
(Source: FDA Website)