Food Allergen Management 2015 the impact of the new EC regulation

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1 EDITORIAL Increasing public awareness of food allergies is driving allergen labelling requirements in more and more countries worldwide. The new EC Directive 1169/2011 on food information to customers is, for instance, a further addition to allergen labelling regulations in Europe. It applies from December The biggest challenge in allergen testing is the lack of threshold levels for the majority of food allergens (exceptions: gluten and sulfite). Without these, food producers struggle to set internal thresholds for allergen management that are sufficient to protect allergenic customers and, thus, safeguard their brands. Food producers are keen to comply with EC allergen labelling regulations, despite all the hurdles they face and are, therefore, not only looking for reliable and fast test kit systems, but also experienced consultants. Romer Labs with its more than 30 years of experience, combines both fast and reliable allergen test kits, as well as indepth knowledge to consult customers looking to find optimal solutions making the worlds food safer. Food Allergen Management 2015 the impact of the new EC regulation Food allergy has become a topic of major consumer concern during the last few years. They are one of the potential causes of an adverse reaction to food. Underlying the rise in diagnosed cases of food allergy there is an increased awareness and the need to better inform sufferers on a restricted diet. Labelling regulations are in place in many regions around the world designed to protect allergenic suffers from adverse reactions to foodstuffs. In Europe, new legislation, which applies from December 2014, is making big waves by extending existing labelling regulations. From now on, allergenic substances must be highlighted in the ingredients list and the labelling requirements extended further to nonprepacked food. Still, no threshold level applies to allergens, with the exception of gluten and sulphites. Thus, a reduction in the misleading may contain statements made by producers can only be achieved by highly aware food makers, using efficient allergen management.

2 Adverse reaction to foods Several mechanisms can lead to undesired reactions to food. The different possible causes are depicted in Figure 1 below. in cereals. Allergens, which are mainly proteins, typically cause a reaction in the immune system. On contact with an allergen, specific white blood cells, B-lymphocytes, produce allergen specific antibodies (IgE). These antibodies will be presented Adverse Reaction to Food Psychosomatic Toxic Non-Toxic Immunological Reaction Food Allergy Non-Immunological Reaction Food Intolerance IgE induced non-ige induced enzympopathy pharmacological not defined Figure 1. Adverse Reactions to Food (Bruijnzeel-Koomen C, Ortolani C, Aas K, Bindslev-Jensen C, Bjorksten B, Moneret- Vautrin D, Wuthrich B. Adverse reactions to food. European Academy of Allergology and Clinical Immunology Subcommittee. Allergy 1995, 50: ) Toxic reactions, for example to aflatoxins in foods, will affect everybody and will occur with immediate exposure to the toxin. A special situation exists with psychosomatic reactions, as there can be no known objective mechanism or cause found. Non-toxic reactions will not affect everybody and the severity of reactions might differ strongly between individuals. Again, this category can be divided into reactions involving the immune system and others without, generally called food intolerances. Both are markedly different in cause, severity and spectrum of reactions. They may involve enzymes (e.g. lacking ß-galactosidase resulting in lactose intolerance) or can be caused by pharmacologically active substances. Food allergy itself is an immunological reaction that can either be immunoglobulin E (IgE) mediated or be a non-ige response. Most common food allergies, e.g. to peanut, milk, egg, etc., are caused by elevated levels of specific IgE in the patients. An example of non- IgE induced food allergy would be Coeliac disease, a hypersensitivity to gluten, a protein fraction to mast cells which contain histamine. On second contact with the same allergen the proteins bind to the antibodies and in order to protect the body, mast cells will release histamine. This mechanism explains, why on a first contact with an allergen no allergic reaction will occur, but any subsequent exposure will lead to allergic symptoms. Symptoms can include reactions in the skin (itching, swelling, urticaria, etc.), eyes, the respiratory tract (from running nose to asthma bronchiale), gastrointestinal tract (vomiting, diarrhoea, etc.) to the cardiovascular system (anaphylactic shock). Definitive diagnosis of a food allergy is quite difficult and mainly done by anamnesis, skin tests, IgE determination or double blind placebo controlled food challenges (DBPCFC). As symptoms are not readily identifiable, not everything that looks like an allergy is really an allergy. Food intolerances, featuring nonimmunological reactions and showing comparable symptoms, are more frequently found than food allergies.

3 The new European food information to consumers (FIC) Regulation and regulations around the world To protect consumers it became mandatory in many countries around the world to label the presence of certain food allergens in packaged food. EUROPEAN LEGISLATION following Commission Directive 2000/13/EC on the labelling, presentation and advertising of foodstuffs was amended to include Commission Directive 2003/89/EC indicating ingredients present in foodstuffs. It was further amended by Commission Directive 2005/26/EC establishing a list of food ingredients or substances provisionally excluded from Annex IIIa and corrected by Commission Directive 2005/63/EC concerning the list of food ingredients or substances provisionally excluded from Annex IIIa. Commission Directive 2007/68/EC once more amended Annex IIIa, which now lists a total of 14 allergenic substances. In addition the Europe Union published Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten defining threshold levels for foodstuffs with reduced gluten content (level of gluten not exceeding 100 mg/kg) and foodstuffs that shall be labelled as "gluten-free" (level of gluten not exceeding 20 mg/kg). These levels were adopted from Codex Standard To Date, November 2014, there are now 13 food categories (cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame, lupines, molluscs) and one chemical (sulphur dioxide and sulphite), which are included in these labelling directives. The latest amendment to allergen labelling rules is regulation No 1169/2011 on the provision of food information to consumers (FIC) an detailed update is given on the next page. All substances listed in Annex II of 2011/1169/ EC (or respectively Annex IIIa of Commission Directive 2007/68/EC) must be labelled for foods and beverages. Substances which are not additives but are used in the same way and with the same purpose as processing aids and are still present in the finished product, even if in altered form shall be labelled. Any ingredients used in production of a food stuff and still present in the finished product, even if in altered form, and listed in Annex II or originating from an ingredient listed in Annex II shall be indicated on the label. Annex II will be systematically re-examined and, where necessary, updated on the basis of the most recent scientific knowledge. US LEGISLATION is laid down in the Food Allergen Labeling and Consumer Protection Act (FALCPA). There the term major food allergens means any of the following: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. Also included is any food containing protein from a food specified as an allergen, except any highly refined oil and ingredient derived from such highly refined oil. If any of the major food allergens or proteins derived from any of these major food allergens is an ingredient, packaged foods must comply with the FALCPA s food allergen labelling requirements. In 2013, the FDA issued a final ruling defining the term "gluten-free" taking over the 20mg/kg threshold defined by Codex Standard JAPANESE LEGISLATION lists potentially allergenic ingredients which require labelling. Where labelling is mandatory those ingredients are eggs, milk, wheat, buckwheat and peanuts.

4 The new EC regulation 1169/2011 on the provision of food information to consumers The Food Information to Consumers (FIC) regulation, which applies from 13 December 2014 with the exception of provisions relating to nutrition declarations (which will apply from 13 December 2016), modifies the existing food labelling provisions in the European Union to allow consumers to make informed choices and make safe use of food, while at the same time, ensure the free movement of legally produced and marketed food. In addition to defining important parameters for prepacked food labelling such as mandatory food information and minimum font size, the FIC regulations further expand allergen labelling regulations in Article 21 (1) (b): the name of the substance or product as listed in Annex II shall be emphasised through a typeset that clearly distinguishes it from the rest of the list of ingredients, for example by means of the font, style or background colour This means that the part of the name of the ingredient that corresponds to the substances or products listed in Annex II should be highlighted. Highlighting the entire name of the ingredient involved would also be seen as complying with these legal requirements. An example would be the German word milk powder, which could be highlighted either as Milchpulver or as Milchpulver. Furthermore the new regulations state: In the absence of a list of ingredients, the indication of the particulars referred to in point (c) of Article 9 (1) shall comprise the word 'contains' followed by the name of the substance or product as listed in Annex II. This applies if the largest surface of a product is less than 10 cm 2 and the list of ingredients can, therefore, be omitted. Even in the absence of a list of ingredients, it is mandatory to indicate the presence of substances or products causing allergies or intolerances in the food concerned by including the word contains followed by the name of the substance or product causing allergies or intolerances. In Article 44 of these new regulations, allergen labelling rules are further expanded to nonprepacked food. Information about allergenic substances specified in Annex II and used in the manufacture or preparation of non-prepacked food must be available and easily accessible to consumers either by means of a label, other accompanying material or any other means including modern technology tools or verbal communication. This information is mandatory and, therefore, it is not possible to provide such information only upon request by the customer. Substances or products causing allergies or intolerances a short summary of Annex II: 1) Cereals containing gluten* 2) Crustaceans and products thereof 3) Eggs and products thereof 4) Fish and products thereof* 5) Peanut and products thereof 6) Soybeans and products thereof* 7) Milk and products thereof* 8) Nuts and products thereof* 9) Celery and products thereof 10) Mustard and products thereof 11) Sesame seeds and products thereof 12) Sulphur dioxides and sulphites 13) Lupin and products thereof 14) Molluscs and products thereof * for a more detailed list with more comprehensive definitions and exceptions please see Regulation (EC) No 1169/2011 ATTENTION: The list of substances or products causing allergies or intolerances which was previously defined in Annex IIIa of every EC directive is now defined in Annex II.

5 In addition a list of ingredients where labelling is recommended is also published, containing abalone, squid, salmon roe, shrimp/prawn, oranges, crab, kiwi fruit, beef, tree nuts, salmon, mackerel, soybeans, chicken (poultry), pork, mushrooms, peaches, yams, apples and gelatine. The five products subject to mandatory labelling must be labelled even in the case of carry-over or processing aids. The main difference of Japanese to European and US labelling regulations is that indicating May contain (name of allergen) on the food label is not allowed. In AUSTRALIA and NEW ZEALAND the standards in the Australia New Zealand Food Standards Code are legislative instruments under the Legislative Instruments Act In Standard in the mandatory warning and advisory statements and declarations, 10 allergenic substances are listed that must be declared on food labels when present as an ingredient, an ingredient of a compound ingredient, a food additive or component of a food additive or as a processing aid or component of a processing aid. These include: sulphites (in concentrations more than 10 mg/kg or more), cereals containing gluten, crustaceans, egg, fish, milk, peanuts, sesame, soybeans and tree nuts. Furthermore, food containing the bee product royal jelly is required to have a warning statement. A new way of labelling allergens in food products is being promoted by the Allergen Bureau, organised by Australian Food & Grocery Council Allergen Forum. They promote a concept called VITAL (Voluntary Incidental Trace Allergen Labelling) as an essential standardised allergen risk assessment tool for food producers. VITAL allows food producers to assess the impact of allergen cross contact and provide appropriate precautionary allergen labelling on their products using different action levels relying on concentration ranges for different allergens. In general, besides gluten and sulphite in the European legislation and gluten in the US legislation, there are Food Allergen Labelling & Consumer Protection Act of 2004 Directive 2007/68/EC: The "big 14" Ordinance No. 23 of 2001 of the Ministry of Health, Labour and Welfare Joint Australian New Zealand Food Standards Code (Standard: 1.2.3) Bee pollen Buckwheat Celery Crustacea Egg Fish Lupins Milk Mulluscs Mustard Peanut Propolis Royal Jelly Sesame Soy Sulphite Tree nuts Wheat Figure 2. Summary of allergen labelling regulations in the 4 main markets United States, Europe, Japan and Australia/New Zealand. The four major allergens that are regulated in all of the four markets are egg, peanut, milk and gluten.

6 no threshold levels defined in the regulations, creating major challenges for analysts. Ideally, specific thresholds for different allergens should be defined which would help development of methods and give analysts guidelines for results to comply with regulations. The absence of limits makes it impossible to identify foods with regard to a safe residual allergen content, a problem especially for highly sensitive allergy sufferers. Another situation exists with gluten. Where the Codex Alimentarius recommends limits for labelling food "gluten-free". This threshold concentration is 20 ppm gluten in the finished food. The European Union adopted the recommendation in the Commission Regulation 2009/41/EC. This legislation is completely separate and cannot be applied to any labelling requirements under Commission Directive 2003/89/ EC. The FDA also adopted the CODEX threshold in their final rule defining the term "gluten-free". Since there are many regulations on allergen labelling in place there is a need for appropriate detection methods. Several technologies like specific antibody based tests e.g. enzyme linked immunosorbent assays (ELISA) or lateral flow assays, polymerase chain reaction (PCR) methods and mass spectrometry are available, all with varying degrees of commercialisation, giving both qualitative and quantitative results. Antibody based tests (e.g. ELISA) will directly detect proteins from the foodstuff, whereas the DNA methods (e.g. PCR) will give an indirect result since they detect DNA specific to the foodstuff rather than the protein. Both methods are commercially available and used in routine analysis. Detection and quantification limits of those methods vary greatly depending on the test, allergen and food matrix. Decisions on which method should be used for the determination of the allergen are dependant on when and where the testing has to be performed. Cross contamination of production equipment might need a fast and easy method, like lateral flow tests, whereas analysing a final food product in a quality control lab or governmental lab will use more advanced and quantitative methods. Mass spectrometry methods are not currently used in routine testing due to prohibitive costs of equipment and the complexity of the analysis and interpretation. The lack of reference methods as well as reference materials for food allergens makes comparison of different analytical methods extremely difficult, if not impossible. The fact that every method uses different calibrants and may target different components adds to this complexity. Although there are certain allergenic proteins which are well characterised the labelling regulations do not demand analysing specific allergens instead stating that the presence of the food itself which can cause the allergy needs to be labelled. In addition, proteins can change their structure during processing (e.g. by heat and pressure treatment) which can therefore lead to issues with detection. A similar problem is found with DNA which can be broken down during processing into small pieces and therefore may not be detected any more. This situation might be overcome to some extent by amplifying only very small fragments of the target gene. It cannot be stated that protein is more stable than DNA or vice versa, but combining these two techniques can be useful as a confirmatory approach, because they detect different molecular targets. ELISA methods are at the moment the most widely used technology in quality control and government labs as a quantitative screening tool for on-site control and has become more popular in the manufacturing environment. Until the time when new technologies, such as gene cloning or immunotherapy, will end food intolerance and allergy, patients have to rely on manufacturers allergen control practices. However, it would seem that enforcement of allergen labelling legislation globally is still not as effective as it could be and is still absent in many places. Therefore, there is the danger that this ignorance of the importance of testing could lead to a higher risk of undeclared contaminated food and further product recalls, not to mention the risk to the allergic consumer. Food allergy must be taken seriously since it can be life threatening!

7 Food Allergen Management So how do food allergens find their way into food products? Food allergens are regular food components and so part of many recipes and formulations. They are often added as an ingredient or as part of a premixed ingredient e.g. a herb mixture. In this case, manufacturers are aware of the presence of an allergen and can react accordingly by labelling the ingredient on the ingredients list. However, more problematic are cross contaminations of food with allergens. For example, this can happen during storage of ingredients when allergen containing foods are located next to ingredients without the respective allergens. Also, during food production itself there are several ways of transferring traces of one allergen to another product, e.g. when sharing utensils for mixing or weighing ingredients or when using an inadequately cleaned production line or piece of equipment. Inadequate cleaning can also cause so-called carryover, transmitting allergens via cleaning water or cleaning procedures. Even production staff can cross contaminate food by dirty clothing. Another possible cause could be the use of rework materials. Cross contamination often leads to uneven distribution of an allergen in the food product, making finding this small or singular contamination a real challenge, e.g. one small piece of peanut in a chocolate bar amongst a large batch of chocolate bars. An extremely important part of allergen management and control practices is the documentation of every aspect of the food manufacturing process. Such documentation serves the need for traceability in the event of future problems and potential product recalls. However, documentation cannot be relied upon alone without audits, inspection and testing to demonstrate that the control systems are working. Any agreed specifications require validation and this may include manufacturing, cleaning and analytical testing. Auditing the supply chain is the first important step for proper ingredient management, and needs to occur before incoming goods are warehoused. It can then be followed by confirmation of the supplier specifications and certificates which could be verified by analysing the goods with a rapid method (ELISA or lateral flow test). After the ingredients get a green light for compliance proper storage and correct ingredient separation is crucial to avoid cross contamination. Before the actual manufacturing process can start it is fundamental that the equipment should be clean. The cleaning procedure should be validated in advance to ensure the cleaning techniques employed remove the specific food allergens and that it is checked to ensure that it has been effective. A convenient method to do so would be by surface swabbing particular parts of the equipment that are tricky to clean. The swabs can be analysed using AgraQuant and AgraQuant PLUS Allergen ELISA test kits and AgraStrip Allergen lateral flow test kits. Rinse water testing is also an option to ensure the effectiveness of cleaning in terms of allergen contamination. Spillages of any materials in a factory need to be avoided at all times but when they do happen it is important that the cleaning is checked e.g. by swabbing and specific allergen testing. When the manufacturing process has started it can be monitored for cross contaminations by using on-site detection methods like AgraStrip Allergen lateral flow test. At any stage of production it can happen that in-process materials or finished products are used as rework to minimise wastage. Great care has to be taken with such practises to ensure that correct separation and re-use of these materials. Possible cross contaminations by rework material entering the process can be detected with AgraQuant and AgraQuant PLUS Allergen ELISA test kits or AgraStrip Allergen lateral flow tests.

8 Once a product is finished it is vital to ensure that the packaging displays the correct labels. Labelling claims can be checked against specifications and verified with analytical methods like AgraQuant and AgraQuant PLUS Allergen ELISA test kits or AgraStrip Allergen lateral flow test kits. This is one important step towards reduction of may contain labelling and product recalls. Once all of this has been done in a satisfactory manner correct product separation during distribution of the packaged product is equally important. It is beneficial to use AgraQuant and AgraQuant PLUS Allergen ELISA test kits and/or AgraStrip Allergen lateral flow device to establish and enforce allergen management practise because of the increased confidence in product safety derived from testing. Sufficient sampling is an important aspect underlying the successful tracking of hidden food allergens in the manufacturing process when they are often distributed unevenly. This means both for the supply chain and process so that control can be verified by testing at the critical control points. Real time testing using on-site lateral flow methods like AgraStrip Allergen lateral flow tests can allow both testing and decisions to be made expediently especially when fast turnaround or trouble shooting is necessary. Everything is supplied within the test kit (no equipment is required) and being stored at ambient temperatures means it can be used straight away. The tests are easy to use, require few skills and only a minimal amount of training. Training certificates which document that instruction on the correct use of the test has been provided is prudent when such trainings are given. In conclusion, so called rapid methods are very cost effective analytical tools because of the simplicity and real-time decision making capability of the AgraStrip Allergen lateral flow tests and the quantitative, break-apart strip format of the AgraQuant and AgraQuant PLUS Allergen ELISA test kits allows the best flexibility. Romer Labs, Inc. - America Union, MO, USA T F E office@romerlabs.com Romer Labs Diagnostic GmbH - Europe Tulln, Austria T F E office-europe@romerlabs.com Romer Labs Singapore Pte. Ltd. - Asia Singapore T F E salesasia@romerlabs.com