LGC Allergen Management in the Food Industry an introduction. Michael Walker LGC

Transcription

1 LGC Allergen Management in the Food Industry an introduction Michael Walker LGC 4005

2 Agenda Introduction what is food allergy? Managing allergens in the food industry The Food Information Regulation Thresholds & Action levels how much is too much Testing (briefly as this will be covered in another session) how to analyse for allergens Conclusions

3 What is Food Allergy? ADVERSE REACTIONS TO FOOD K PREDICTABLE REACTIONS [e.g. to pathogens or toxins] UNPREDICTABLE REACTIONS REPRODUCIBLE NON REPRODUCIBLE [e.g. food aversion] FOOD HYPERSENSITIVITY IMMUNE- MEDIATED food allergy OTHER MECHANISMS [e.g. coeliac condition & lactose intolerance]

4 Sensitisation ALLERGEN GASTRO INTESTINAL MUCOSA / DAMAGED DERMAL EPITHELIUM Aeroallergens DENDRITIC CELL ALLERGEN- SPECIFIC IgE Naive T CELL IL4 B CELL MAST CELL Th2 After De Leon et al. IL4, IL 13

5 ALLERGEN Challenge GASTRO INTESTINAL MUCOSA RELEASE OF INFLAMMATORY MEDIATORS GASTRO INTESTINAL SYMPTOMS Mouth Swelling Diarrhoea Vomiting EXTRA-INTESTINAL SYMPTOMS Pruritus Asthma Uriticaria Angioedema Anaphylaxis

6 And sometimes though rarely Belfast Telegraph 2006 Metro 2012

7 Food Allergy & Food Intolerance Estimated 2.5 million in UK affected Number of children with peanut allergy increasing Coeliac disease 0.5% - 1% of Irish population Over 180 known allergens 14 allergens subject to EU legislation and Codex & EU legislation on foodstuffs suitable for people intolerant to gluten

8 Oral or dermal exposure? Early exposure or avoidance? Why are some food proteins allergenic when others aren t? There are many unanswered questions Is it possible to identify thresholds of exposure to allergenic foods that are required for sensitisation and allergic reaction? What factors influence the severity of food allergic reactions? Integrated Approaches to Food Allergen and Allergy Risk Management (ifaam)

9 Allergens the challenges! (and in a financially difficult climate) Protection of the consumer by providing accurate information on labels minimising risks from allergens minimising unnecessary may contain labelling Securing compliance with current legal and retailer requirements Anticipating future legal and retailer requirements The Food Information Regulation Avoiding costly recalls The most common reason for recall in the UK is allergens Knowing what sampling & testing to do (due diligence) Realising opportunities

10 BRC V6 British Retail Consortium Global Standard for Food Safety Version 6 introduced on 01/01/2012 Management of Allergens a fundamental section (Section 5.2) Previously V5 8 clauses related to allergen control now 10 Clauses more prescriptive of what is expected BRC V6 Section 5.2: Statement of Intent: The company shall have a developed system for the management of allergenic materials which minimises the risk of allergen contamination of products and meets legal requirements for labelling.

11 IFST GMP 6 and IS IFST Food & Drink Good Manufacturing Practice A Guide to its responsible Management 6 th Ed Ch. 4 Food Allergens: Great care should be taken (a) to formulate foods so as to avoid, wherever possible, inclusion of major serious allergens as ingredients; (b) to provide appropriate warning, to potential purchasers, of the presence of a major serious allergen in a product; and (c) to organise production, production schedules and cleaning procedures so as to prevent cross-contamination of products by foreign allergens. IFST Information Statement (IS) Food Allergy ionals/foodsafetyandproductioninfostats/

12 Product Recalls / Withdrawals Cross contamination / Cross Contact is an issue and can occur at any stage in the supply and manufacturing chain BUT The vast majority of allergen recall incidents arise from a product that has been mislabelled either because The wrong product in the right label a component in the recipe has been changed without the label being changed a recipe component has unwittingly been substituted somewhere in the supply chain The right product in the wrong label A production line change has taken place without the appropriate label feed change A batch of wrong labels has been used for the label feed The wrong product in the wrong label The allergen was missed in formulating the product and designing the label

13 Obstacles to Successful Allergen Risk Management Lack of factual knowledge within companies Inadequate information from suppliers of raw materials Inaccurate / incomplete risk assessment Lack of staff training / complacency Lack of production controls Inaccurate labelling Source: Personal observations of audited manufacturers Christine Kane, LP Associates Lack of monitoring and review Plus Fraud

14 How do manufacturers need to approach allergen risk management? Methodically Logically HACCP based HACCP treats all allergens equally, which is not the case People awareness and training Raw materials Ingredients Storage segregation Production planning Cross contact/cross contamination control Cleaning Packing Labelling Validation Verification

15 Identification of Allergens Identify and map * the presence of intentional allergens, and assess the likelihood of unintentional allergens in: Raw materials Where claims are made on raw materials it may be important to confirm the allergen status of an ingredient To confirm that apparent cross contamination that cannot be reduced by controls in place is not actually due to raw material contamination Processing aids Work in progress and rework Finished product New product development Don t forget to consider how people, equipment and product flow through the plant * See the article by Simon Flanagan (RSSL) on the IFST website: onals/risk_assessment_and_allergen_management/

16 Risk Assessment - HACCP based Must be documented Risk assess (a) Likelihood and (b) Severity Likelihood is manufacturer/plant specific Severity is partly* allergen specific - 3 categories suggested: Risk of severe anaphylaxis and more prevalent in the population Peanuts, Nuts, Sesame, Crustaceans, Molluscs, Fish and Lupin Anaphylaxis risk in certain sections of the population; in the majority of cases symptoms are mild Milk, Egg (especially well cooked), Celery, Mustard, Sulphur Dioxide (depends on concentration care re excess) Anaphylaxis rarely encountered, prolonged exposure usually required for symptoms to appear Soya, Gluten (but note undiagnosed Coeliac condition can have insidious severe consequences) *see next slide

17 But the severity of allergic reaction depends on Genetics atopy, may be 10 6 difference between least & most sensitive Dose Matrix e.g. fat, ph, binding. Processing Exercise Medication (NSAIs) Alcohol Asthma Concurrent or recent infection Individual Age, knowledge experience Situation...

18 Identify: Target consumer Physical state of the allergenic material Powder, liquid, particulate Potential point of cross contamination in the process flow Risk of cross contamination at each process step Controls to reduce or eliminate the risk of cross contamination

19 Control: Segregation physical or time Production Planning Cleaning Personnel clothing, gloves, aprons, training Equipment identified, dedicated Systems to restrict airborne dust Waste handling & spillage controls Labelling See IFST GMP 6th Ed. Ch. 6 Manufacturing Activities Ch. 21 Reworking product Ch. 27 Labelling control

20 Segregation Separate areas in intake stores Consider risk of spillage Care re cleaning methods to avoid actually spreading risk Clear labelling of product Retain original labels of incoming material Consider risks with decanting Separate areas in WIP stores Closed / covered containers Guard against accidental use Separate Production Lines / time separation Separate rooms / areas Weigh up areas

21 Production Planning Group products according to the allergens each contains Those containing NO allergens should be produced first or those containing allergens that are present in all or most finished products Alter recipes where possible to remove allergens Consider rework procedures Waste control Traceability

22 Cleaning Cleaning between production runs containing allergenic materials Consider in cleaning schedules Use of appropriate detergents sanitising alone is not sufficient Ease of cleaning the equipment e.g. breaking down required Could traces of allergen contaminate during washing Validation typically includes Confirmation that correct methods and cleaning chemicals identified (e.g. by advice from knowledgeable cleaning chemical manufacturer) Visual assessment of cleaned line, before Swabs of surfaces and equipment for analysis Manufacture product that deliberately contains allergen, test as control, clean line and test the first non-allergen-containing product produced Analyse rinse water (RSSL have much experience in validation and testing of cleaning procedures)

23 Personnel Restrict numbers handling allergens Use of separate or additional protective clothing Handwashing procedures Training is vital Requirement under BRC that ALL RELEVANT personnel including engineers, temporary staff and contractors receive general allergen awareness training Relevant staff trained in company s allergen handling procedures Restrictions on food brought on site Make visitors aware On site catering facilities

24 Equipment The use of identified, dedicated equipment and utensils Colour coding useful Separate, lidded, colour coded or clearly labelled containers Thorough, validated, washing procedures if dedicated equipment not possible

25 Airborne contamination Consider carefully if powders used Airborne dust / aerosols Distance travelled Air flow Adequate Extraction System

26 Waste and Spillage Controls Segregation of allergenic waste Removal immediately from production areas Cleaning methods for spillages Who? How? Using what? Clean spillages immediately

27 Labelling other than retail Allergen labelling must be apparent at all stages in production Colour coding of labels helpful Clearly state allergens in material Raw materials WIP Finished Product Catering: display and service Reliant on consumer informing of allergy Risk with self service New Food Information Regulation, Regulation (EU) No 1169/2011, will require information on the 14 regulated allergens to be made available

28 End Product Labelling Legal Requirement: Where intentional presence of allergens they must be identified and labelled within the ingredient list There is currently no requirement for additional allergen alert Retailers may require specific formats 1169/2011 requirements in more detail below.

29 Unintentional inclusion May contain statements BRC: Where the nature of the production process is such that cross contamination from an allergen cannot be prevented, a warning should be included on the label Follow national guidelines or codes of practice e.g. Guidance on Allergen & Miscellaneous Labelling Provisions FSA March 2011

30 VALIDATION Key to ensuring controls are adequate Various methods Initial validation should be conducted at least 3 times At least 3 samples should be taken Worst case scenario If alterations are made to product, process or cleaning regime validation must be carried out again Repeat periodically at least annually

31 Validation may include: Final Product Important test the allergen containing product to ensure the allergen is detected using the method chosen First non-allergen containing products after the production of allergen containing on the same line and following appropriate cleandown Flushes Term used for flushes of dry ingredients where wet clean isn t suitable e.g. dry sauce mixes Flush material tested for allergen contamination from previous run

32 Validation may include: Surfaces Swabbing to test the efficacy of cleaning surfaces that come into direct contact with food Ensure swabs are taken from areas where the allergen is known to have been present Swab hard to reach areas / trouble spots Dismantle equipment Personnel Hand swabs After handling allergens but before hand-washing After hand-washing Protective clothing Assess the effectiveness of laundering After being in contact with allergens before laundering After laundering

33 Validation may include: Rinse Waters Air Can provide a method of monitoring cleaning especially CIP systems It may be useful to test successive samples to show decreasing levels of allergens Where powdered ingredients are used Using open, empty settle plates in the manufacturing environment for a defined time during production of an allergen containing product New settle plates then used during subsequent production runs to determine whether allergens are still settling into products This may be required to validate segregation of areas Look at the results

34 Documentation Ensure all risk assessments are documented Ensure a list is documented containing all allergen containing materials on site raw materials, WIP, finished product Ensure all procedures relating to allergen controls are well documented Ensure accurate training records are kept

35 Monitoring Cleaning records showing who has cleaned and who has verified (signatures) Pre-start hygiene audits prior to line start up / between line changes Line start-up documented checks following product changeover or changes in batches of packaging Label checks Production Records

36 VERIFICATION and REVIEW Verification Vital on an ongoing basis Record that the cleaning regime instigated has been completed Routine hygiene audits Assessment of staff competency Internal audits of allergen procedures Review Review is VITAL Changes occur frequently change in raw materials, supplier, production process, cleaning procedures Keep up to date on current guidance and legislation Review product recalls / withdrawals could this be you?

37 Food Information Regulation, (EU) No 1169/2011 New Food Information Regulation, Regulation (EU) No 1169/2011, will require additional information the most significant impact will be on the sale of non-prepacked foods and catering sales where allergen information will be required from 13 December 2014 Recitals indicate the intention of the regulation R 24. Member States should retain the right to lay down rules in respect of the provision of information concerning non-prepacked foods. Although in such cases the consumer demand for other information is limited, information on potential allergens is considered very important. Evidence suggests that most food allergy incidents can be traced back to non-prepacked food. Therefore information on potential allergens should always be provided to the consumer.

38 Food Information Regulation, Regulation (EU) No 1169/2011 R 24: important that information on the presence of food additives, processing aids and other substances or products with a scientifically proven allergenic or intolerance effect should be given to enable consumers, particularly those suffering from a food allergy or intolerance, to make informed choices which are safe for them. Article 9 Mandatory particulars any ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II causing allergies or intolerances used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; Article 21 Annex II substances shall be indicated in the list of ingredients with a clear reference to the name of the substance or product as listed in Annex II; and 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.

39 1169/2011 Manner of Marking Art. 13 mandatory food information shall be marked in a conspicuous place in such a way as to be easily visible, clearly legible and, where appropriate, indelible. It shall not in any way be hidden, obscured, detracted from or interrupted by any other written or pictorial matter or any other intervening material printed on the package or on the label in such a way as to ensure clear legibility, in characters using a font size where the x-height, as defined in Annex IV, is equal to or greater than 1.2 mm. For the purpose of achieving the objectives of this Regulation, the Commission shall, by means of delegated acts in accordance with Article 51, establish rules for legibility.

40 Regulation (EU) No 1169/2011 Art. 21 ctd Where several ingredients or processing aids of a food originate from a single substance or product listed in Annex II, the labelling shall make it clear for each ingredient or processing aid concerned. The indication of the particulars referred to [above] shall not be required in cases where the name of the food clearly refers to the substance or product concerned. In the absence of a list of ingredients, the indication of the particulars referred to [above] shall comprise the word contains followed by the name of the substance or product as listed in Annex II. the Commission shall systematically re- examine and, where necessary, update the list in Annex II by means of delegated acts, Art The Commission shall adopt implementing acts on the application of requirements [on] voluntary food information: (a) information on the possible and unintentional presence in food of substances or products causing allergies or intolerances;

41 1169/2011 Art. 44 Where foods are offered for sale to the final consumer or to mass caterers without prepackaging, or where foods are packed on the sales premises at the consumer s request or prepacked for direct sale: (a) the provision of the particulars specified in point (c) of Article 9(1) is mandatory; Article 9(1)(c) reads (c) any ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II causing allergies or intolerances used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; Unacceptable to say you don t know what s in the food Cover-all responses such as nuts used in our kitchen so we can t guarantee also unacceptable

42 1169/2011 Annex II EU 14 substances or products causing allergies or intolerances Previously Annex III(a) of Directive 2000/13/EC (as amended) 1. Cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof, except: [ingredients that do not contain sufficient allergen protein to elicit a reaction] - wheat/barley based glucose syrups, maltodextrins,& cereals used to make alcoholic distillates 2. Crustaceans and products thereof; 3. Eggs and products thereof; 4. Fish and products thereof, except fish gelatine (carrier for vitamin or carotenoid preparations) & fish gelatine or isinglass (fining beer and wine); 5. Peanuts and products thereof; 6. Soybeans and products thereof, except fully refined soybean oil/fat, natural mixed tocopherols etc from soybean sources; phytosterols / esters and stanol ester from soybean sources;

43 7. Milk and products thereof (including lactose), except whey used for making alcoholic distillates including ethyl alcohol of agricultural origin, lactitol; 8. Nuts, namely: almonds,hazelnuts, walnuts, cashews, pecan nuts, Brazil nuts, pistachio nuts, macadamia or Queensland nuts, and nut products except alcoholic distillates 9. Celery and products thereof; 10. Mustard and products thereof; 11. Sesame seeds and products thereof; 12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO 2 which are to be calculated for products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers; (underlined text is the only difference between the current Directive and the new Regulation) 13. Lupin and products thereof; 14. Molluscs and products thereof.

44 Allergen Box Widespread use of may contain unhelpful, But allergen boxes on food labels have proved more useful. Some confusion around the future permitted use of allergen boxes Essentially the new regulations do not permit the repetition of mandatory information, for example, ingredients, in such boxes. However, the allergen box may be used as a signpost for example, see ingredients list for highlighted allergy information, or to give voluntary information, for example, not suitable for anyone with a peanut allergy. EU website, including guidance: d_legislation_en.htm Latest BRC guidance on FIR olicy=food&ssubpolicy=labelling

45 Thresholds & Action Levels how much is too much? Important to bear in mind intra- and inter- individual variation, although this occurs in traditional toxicology also Would need to consider both the needs of allergic consumers for safe foods and analytical traceability German Society of Allergology & Clinical Immunology proposed upper limits of mg/kg of allergic food or 1 10 mg/kg of the protein fraction proposed Depending on allergenicity would protect most allergic consumers from severe reaction* Two other main sources of information: Europrevall and Allergen Bureau *R. W. R Crevel, B. K. Ballmer-Weber, T. Holzhauser, J. O_B. Hourihane, A. C. Knulst, A.R. Mackie, F. Timmermans, S. L. Taylor. Allergy 2008, 63, Part funded by EuroPrevall

46 Europrevall Studied interactions between food intake and metabolism, immune system, genetic background and socioeconomic factors to identify key risk factors and develop common European databases for food allergy. On-going data processing will, in the next 12 months, see published authoritative data on thresholds of elicitation Research Report gives an Overview (but not threshold data)

47 The Allergen Bureau VITAL grid Typical protein levels in allergenic foods and ACTION LEVELS with caveats

48 Options for Analysis? lateral flow devices designed for rapid on site testing ELISA DNA LCMS

49 Laboratory cross contamination precautions for a forensic sabotage investigation Dedicated area - step over barrier Segregation e.g., gowning-up, separate (colour coded) lab coats Air handling considerations Walker M J, Forensic investigation of a sabotage incident in a factory manufacturing nut-free ready meals in the UK, In: J Hoorfar ed. Case Studies in food safety and authenticity, Woodhead Publishing 2012, pp

50 Main laboratory techniques

51 Protein LC-MS/MS Enzymatic digestion Peptides released from protein Labelled peptide When thresholds/action levels adopted how do we analyse for allergens? Liquid chromatography with tandem mass spectrometry protein quantification T7: FESNFNTQATNR T16: GTDVQAWIR T5: HGLDNYR LC-MS/MS

52 LGC can offer Advice on incident and crisis management Training on method validation and statistics Advice on Allergen Bureau VITAL approach Interpretation of allergen results Metrological traceability Reference materials

53 Threat? Those at risk - Quality of life, death Health services Capacity Business - Reputation, litigation Regulators loss of trust

54 Or Opportunity? To work together To make children s, families and adults lives easier... To foster safer food for better business

55 The Network is where you will get the information and make the links to realise the opportunities. sources of further information Regulators & EHO s Caterers Public Analysts Media Food Industry FOOD ALLERGY OR INTOLERANCE SUFFERER Research & Analytical Scientists Detection Kit Manufacturers Clinicians & Health Care Support Groups

56 Acknowledgements Institute of Food Science & Technology With grateful thanks to the organisations listed here who have all helped with the preparation of this presentation APA Educational Trust Coming up allergen management in the - catering kitchen.videos