Newsletter Food Allergen Community

AOAC Food Allergen Community

NEWSLETTER Volume 6 | Issue 1

IN THIS ISSUE

Editorial Comment

Editorial Comment Changes... for good?

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News Implications and challenges of the Regulation 1169/2011 for retailers: an Italian perspective 2 New official definition of „gluten-free“ in Chile 3 Update food ingredients designated by Japanese food allergy labeling regulation4 Why your cumin spice can cause peanut allergy

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2015

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Changes... for good? This new year is bringing some fresh air in terms of changes to legislation in two different jurisdictions. Both of them have to do with consumer information. In Europe, the new consumer information regulation is in force. Does it bring real benefits to allergic consumers or is it just a costly burden to producers? In Chile, the updated food law permits the use of the “gluten-free” claim in a product if it contains no more than 3mg/kg gluten - a limit very few ELISA assays achieve reliably in any given matrix. Can that be enforced based on analytical methods? What will be the consequences? Even fewer products for people suffering from celiac disease, because food producers cannot control contamination reliably at such low level? In line with the regulatory changes mentioned above, we have included an article on the Japanese regulations, which explains how food ingredients get on the allergen list required or recommended for labeling. And last but not least, the article about one of the most widespread allergy-related recall in FDA history: the contamination of ground cumin with - partially - substantial amounts of peanut proteins. As of this issue, we include a New Feature. We think that our readers might be interested in knowing who are the contributors to the newsletter. For this reason, we are including links to the LinkedIn profiles of authors, when available. How to find those links? Look for the LinkedIn logo following the name of the author at the end of each article. All you have to do is to click on either the name or the logo. The only requirement is to have an internet connection and an account with LinkedIn (free).

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Carmen Diaz-Amigo Editor in Chief

Editorial Team

Editor in Chief: Carmen Diaz-Amigo 

Editorial Members:

Graphic Design:

Terry Koerner

Carmen Diaz-Amigo

Jupiter Yeung Michael Abbott James Roberts Bert Popping 

This newsletter is a public document and can be distributed. Partial reproduction is permitted with the proper indication of the author and its source. For questions contact us at [email protected].

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2015

News Implications and challenges of the Regulation 1169/2011 for retailers: an Italian perspective In this brief article I will touch upon two key aspects of the Food Information to Consumers Regulation (‘FIC Regulation’), which will have a significant impact on food retailers’ activity in the near future, whilst giving also some insights into the Italian legislation under preparation. The first issue concerns art. 8 of the FIC Regulation and namely the responsibility for the information provided on retailers own-brand products. Prior to the adoption of FIC Regulation, Member States competent authorities faced serious difficulties in determining which business operator was actually responsible for the information given on the label in such cases: therefore, in order to avoid fragmentation in the application of the new rules, the EU Commission deemed necessary to clarify, in accordance with the principles laid down in art. 17 of the Regulation (EC) No 178/2002, the responsibilities for the different operators. The primary responsibility (art. 8.1) lies now on the food business operator “under whose name or business name the food is marketed” (or, if that operator is not established in the EU, the importer into the EU). For both the EU Commission and the Italian authorities, notably the Ministry for the Economic Development, the “name or business name” covers also businesses’ trademarks, with the consequence that in case of own-brand products - e.g. Tesco’s beans but manufactured by another business operator - the retailer itself will be considered responsible for the accuracy and truthfulness of the food information on the label. This will require retailers a higher level of diligence in the food labelling conception, especially in cases where the non-compliance with the FIC could result in a fraud (i.e. omission of an allergen or an additive), sanctioned by the Criminal Code in some Member States (i.e. Italy, France, UK, etc…). The second aspect is related to the allergen information on non prepacked foods and their means of communication.

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According to art. 44.2 FIC, many EU Member States notified under the TRIS procedure (Directive 98/34) their projects of legislation in the last few months: what is important to stress is that the verbal communication, following the indication of the EU Commission, is never considered itself an effective means of communication, but is always considered complementary to the use of signs, posters, books of ingredients or other systems. In Italy, the existing food labeling legislation (Legislative Decree No 109/1992) is under review, to ensure the full compliance to the FIC Regulation. On this topic the draft of the new text adopts a peculiar distinction between the foods packed on the sales premises at the consumer’s request and the foods prepacked for direct sale. For the first shall be provided, with appropriate signboard or poster or other system equivalent, applied to counters or in the department of the store in which the products are exposed, the name of the food, the list of ingredients with emphasis on allergens in accordance with art. 21 FIC, the special conditions of storage (where appropriate) and specific provisions for particular products (i.e. fresh stuffed pasta, fishery products, etc..). For products prepacked for direct sale, in light of the fact that they bear a label, the mandatory information shall be put directly on the label or on the prepackage (namely the name of the food, the net quantity; the date on which the product was prepacked in the sales premise and the allergens as per art. 9.1, letter c) and art. 21 FIC). The draft is expected to be published in the first six months of 2015 and concerning foods prepacked for direct sale will be most likely provided a transitional period of 1 year. Cesare Varallo  | www.foodlawlatest.com

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2015

New official definition of „gluten-free“ in Chile As we reported in an earlier issue, in 2014, the Chilean Ministry of Health proposed a modification to the article 518 of Decree 977/96 of the Food Regulation and conducted a public hearing. The text proposed indicated that the “gluten-free” statement (“libre de gluten”) can only be used if the product doesn’t contain more 1 mg/kg prolamins of cereals listed in article 516 (wheat and its varieties, rye, barley and oat). Many of the comments expressed concern about the implications of such low gluten level:

Limited availability of detection methods sensitive enough

to provide reliable results. Limitation for the laboratories to provide reliable results considering that the majority of commercial and multilaboratory validated methods have limits of detection (LODs) around 3 mg/kg gluten. Financial and practical burden for the food industry to produce gluten-free products that comply with the updated regulation. Reduced availability of gluten-free products for celiac patients. Limitations to trade. It is important to highlight the situation of neighbouring South American countries with different definitions of gluten-free: Argentina: 10 mg/kg gluten; Brazil: all products have to be labelled as “contain” or “does not contain” gluten (no levels established); Ecuador: 20 mg/kg gluten; Colombia: doesn’t does not have a regulation but use 20 mg/kg gluten for practical reasons.

After the evaluation of all comments received, the final definition of “gluten-free” (published in the Official Journal on 14 January 2015) states that the “gluten-free” claim may be used if the analytical result indicates that the product does not contain more than 3 mg/kg gluten. The final cut off value is expressed as gluten content and not as “prolamins” to avoid confusion in the general population. The decree will come into force 180 days after its publication in the Official Journal, i.e. 13 July 2015. The determination of the amount of gluten present is done by the method implemented by the Chilean Institute of Public

Health. This technique is an ELISA using polyclonal antibodies, developed by Dr. Chirdo (University of La Plata, Argentina). It has a LOD of 1 mg/kg prolamin (equivalent to 2 mg/kg gluten). Such restrictive and challenging cut off values may have the opposite effect to what is intended. There is no question that establishing very low cut off values for gluten will protect the most sensitive consumers, but it will pose a very significant challenge to the food industry, leading to a decrease in the production of gluten-free products. The main reason is that the contamination of certain raw materials with gluten-containing cereals is not uncommon, difficult to control and unexpected in some instances. Many measures need to be in place to control the gluten level at concentrations below 3 mg/kg. This will pose additional economic burden on many producers, and many will consequently refrain from production of foods which can be labelled gluten-free under Chilean regulations. Moreover, from the analytical point of view, 3 mg/kg (ppm) gluten is a very ambitious limit. This concentration is around the detection limit (and about or lower than the limit of quantification) of commercial and internationally validated detection methods (r-Biopharm R5: LOD 3 ppm gluten, LOQ 5 ppm gluten; Romer Labs G12: LOD 2 ppm gluten, LOQ 4 ppm gluten; ELISA developed by Dr. Chirdo, implemented by the Chilean reference laboratory Institute of Public Health: LOD 2 ppm gluten). Analytical results should be accompanied by the measurement uncertainty, which is a requirement for laboratories with ISO 17025 accreditation. Considering that LOD of detection methods are so close to the regulated gluten cut off, it will be very difficult for the lab to issue a recommendation if a gluten-free claim can be made. Consequently, it will be equally difficult for management to make a decision as whether to label or not. For these reasons the establishment of maximum level of gluten should have considered an analytical safety margin to ensure the validity of analytical results for samples containing very low gluten content.  Public Hearing Document  Modification published in the Chilean Official Journal

129th AOAC Annual Meeting & Exposition September 27 - 30, 2015 Westin Bonaventure Hotel Los Angeles, California USA www.aoac.org

Carmen Diaz-Amigo  | Editor in Chief

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2015

Update food ingredients designated by Japanese food allergy labeling regulation In 2013, “cashew nuts” and “sesame” were designated as allergenic food ingredients, and were recommended to declare them on the product label. Consequently, the designated ingredients by the Japanese food allergen labeling regulation became as presented in Table 1. Table 1. Ingredients for food allergy labeling in Japan

Allergy Labeling

Food Ingredient

Mandatory

Egg, Milk, Wheat, Buckwheat, Peanut, Shrimp/Prawn*2 and Crab*2

Recommended Abalone, Squid, Salmon roe, Orange,

Cashew nuts*3, Kiwi fruit, Beef, Walnut, Sesame*3, Salmon, Mackerel, Soybean, Chicken, Banana*1, Pork, Matsutake mushroom, Peach, Yam, Apple and Gelatin

*1 Banana was designated as Recommended labeling food ingredients by the 2nd survey in 2004 - 2005.

Shrimp/Prawn and Crab were upgraded the classification from Recommended labeling to Mandatory labeling by the 3rd survey in 2007 - 2008. *2

Cashew nuts and Sesame were designated as Recommended labeling food ingredients by the 4th survey in 2011 - 2012.

causative food, allergic symptom etc. in order to collect the reliable data. The survey result reported 3,882 food allergy cases, and 395 anaphylaxis cases in 2 years (Table 2), and the observed causative allergenic food ingredients were mostly similar with those indicated in CODEX standard. Meanwhile, the result also demonstrated that Japanese food allergies depend on the country food intake habits, which include “Buckwheat” and “Salmon roe” cases. These are rarely consumed in Western countries. This finding indicated that it is important to take the food intake habit into account to designate food ingredients to be labeled. According to the first survey, in 2002, Japan included in the allergen labeling regulation 5 mandatory and 19 recommended food ingredients. Since then, the designated food ingredients have been revised and updated based on periodical clinical surveys (Table 1). Table 2. Occurrences of food allergy and anaphylaxis surveyed in 2001- 2002 (1)

Occurrence Food Allergy Food

*3

In the Japanese food allergen regulation, food ingredients for allergy labeling are revised based on the clinical survey of causative ingredients for food allergy (approximately every 3 years and following the first survey protocol as fixed-point observation) (1). Aiming to obtain the fundamental food allergy information for establishing food allergen labeling regulation, the first survey was investigated in 2001 – 2002. Although common food allergens had already been indicated in CODEX standard (2), food allergy is known to depend deeply on the food intake habit by the country, race and religion. Consequently, the Japanese government considered that the recognized CODEX standard is not an absolute reference to designate the food ingredient for the labeling regulation. To identify the ingredients responsible for triggering food allergic reactions at the time, the first survey was schemed in order to collect:

prospective data: retrospective research is less reliable than prospective one.

Occurrence of Anaphylaxis

No.

%

Food

No.

%

1

Egg

1486

38.3

1

Egg

109

27.6

2

Milk

616

15.9

2

Milk

93

23.5

3

Wheat

311

8.0

3

Wheat

70

17.7

4

Fruits

232

6.0

4

Buckwheat

28

7.1

5

Buckwheat

179

4.6

5

Peanuts

18

4.6

6

Fish

171

4.4

6

Shrimp

14

3.5

7

Shrimp

161

4.1

7 Salmon roe

8

2.0

8

Peanuts

110

2.8

9

Soybean

76

2.0

10

Meat

71

1.8

11

Others

469

12.1

9 11 13

Total 3882

100

Peach

8

2.0

Soybean

7

1.8

Kiwi

7

1.8

Banana

4

1.0

Yam

4

1.0

Other

25

6.3

Total

395

100

The Japanese food allergen labeling regulation is still evolving to match the real food allergy situation. (1) Akiyama, H., Imai, T., Ebisawa, M. (2011) Japan food allergen labeling regulation – History and evaluation. In Taylor, S. (Ed) Advances in Food and Nutrition Research. Vol. 62, 139-171 (2) General standard for the labeling of pre-packaged foods.

clinically-assured data by the collaboration with greater FAO/WHO Food standards: Codex Alimentarius Standard than 2,000 medical doctors: each food allergy case were examined by the medical doctor with respects to verify immediate-type allergic reaction, which is defined as the reaction elicits within 60 min after the relevant food intake,

1-1985

Masahiro Shoji  Morinaga Institute of Biological Science

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2015

Why your cumin spice can cause peanut allergy In December 2014, a US-based spice company performed a voluntary recall because it had been informed by one supplier that the ground cumin may contain peanuts which had not been declared. It initially appeared to be a small-scale recall. By now it has become clear that this problem affects hundreds of products on shelves nationwide. It led to the withdrawal of a variety of common products like hummus. But also large quantities of meat products were affected and some 160,000 kg were recalled. This has turned into the most widespread allergy-related recalls FDA ever conducted. According to unconfirmed sources, the contamination appears to have several origins and is not traceable to a single producer. The question is being asked if this is an intended, economically motivated adulteration, or an uncontrolled contamination issue. Levels that have been found by analysis range from low ppm to low percent levels. Even the high-level contamination would not lead to significant economic gain. So it has been surmised that this is more likely an uncontrolled contamination issue, which of course leads to the next question: how is the cumin seed production controlled? According to Wikipedia, the main producer of cumin is India with 70% of the world production. The country itself consumes 90% of its own production, i.e. 63% of the global production).

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Coincidentally, India is also the second largest producer of peanuts (after China and before the U.S.A.). So it is more than likely, that either in common storage areas or through the re-use of equipment (e.g. grinding, packaging, storage), this contamination has occurred. Other sources surmise the contamination originates from Turkey and that country is not known for its large peanut production. This would suggest a completely different scenario. The detection of this contamination is comparatively easy, either by protein-based methods (LC-MS/MS or ELISA) and PCR. At levels of up to 5000ppm and in marginally processed products, any of these methods will work. The whole issue of course begs another question: in order to better protect producers’ brand names and allergic consumers alike, should ingredient and finished-product testing go handin-hand with the analysis of information on – seemingly – unrelated products? And while we have seen a large number of recalls in the U.S.A., what actions have been taken by other countries that import cumin from India? Would it be prudent to assess products there for potential contamination, too? Bert Popping  Mérieux NutriSciences

AOAC Food Allergen Community Newsletter Contribute with articles, news items or suggestions. Submission deadline for the 2nd Issue of 2015: May 22, 2015 Send your articles to [email protected] 99 Regulatory Updates

99 Upcoming events

99 Food Industry Initiatives

99 Questions for our Experts

99 Regional developments

99 Interested in a topic?

99 Your research

The AOAC Food Allergen Community is a forum serving the scientific community working on Food Allergens: The community is aimed to help AOAC INTERNATIONAL in its consensus-based scientific and advisory capacity on methods of analysis for allergens in foods and other commodities. It is also meant to serve the broader Stakeholder Community whose objectives it is to enhance the protection of food allergic consumers worldwide. Contact us at [email protected]

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