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European Licensing System A harmonised symbol for Europe Tunde Koltai AOECS Board, Chair Questions • 1 who produces only GF • 2 who doesn’t have HACCP • 3 who has Quality management for GF production (IFS, BRC, AHA, …) • 4 who had last year a turnover over 100 000 EUR • 5 who had last year export sales > 15% and where? • 6 who uses now the Czech symbol and when the contract will expire • 7 who was asked already to join ELS • 8 who has a reps for HU AOECS European umbrella organisation of national coeliac societies in Europe Independent NGO Established in 1988 Registered seat in Brussels 5 Board members 35 members from 29 European countries Represents more than 300.000 coeliacs across Europe AOECS Member of International networks: European Patients’ Forum (EPF), International Alliance of Patients’ Organisations (IAPO), International Society for the Study of Celiac Disease (ISSCD) Partner scientific projects: PREVENTCD, CDMEDICS, TRAFOON, MEDICEL, ProCeDE Partner of EU and national institutions AOECS Aims to increase awareness of coeliac disease to facilitate the exchange of information relating to the coeliac condition to increase the availability and easily identifiable labelling of gluten-free products Food industry, Retailers, Caterers Insurance Companies National Health Services Doctors, Dietetitians Coeliac society and coeliac members Governmental institutions and bodies Researchers, University centres Coeliac disease is a medical, lifelong condition Gluten withdrawal Gluten consumption Healthy villi Villous atrophy of coeliac patients Treatment The unique and evidence based treatment: Lifelong and strict gluten-free diet Never start a gluten-free diet before the diagnosis or exclusion of coeliac disease or cereal (protein) allergy Medication? Gluten related disorders Gluten Storage protein of cereals: wheat, rye, barley and [oats*] Can cause • Intolerance Threshold: 10 mg/day • Allergy (is species specific) Threshold: 0 (?!)/different sensitivity levels * Oats can be tolerated by most but not all people who are intolerant to gluten. Therefore, the allowance of oats that are not contaminated with wheat, rye or barley in foods covered by this standard may be determined at the national level. Gluten Storage protein of cereals: wheat, rye, barley and [oats*] Can cause • Intolerance Threshold: 10 mg/day • Allergy (is species specific) Threshold: 0 (?!)/different sensitivity levels * Oats can be tolerated by most but not all people who are intolerant to gluten. Therefore, the allowance of oats that are not contaminated with wheat, rye or barley in foods covered by this standard may be determined at the national level. Gluten-free regulation Gluten-free foods Gluten content < 20 mg/kg 2008: Codex Standard 118-1979 World-wide „Codex Standard for foods for special dietary use for persons intolerant to gluten” EU regulations COMMISSION REGULATION (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten 1169/2011 regulation (FIC) Regulation (EU) 1169/2011 of the European Parliament and the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 1169/2011 regulation (FIC) Brings together existing regulations regarding • Labelling • Nutrition • Allergen information Not only for pre-packed food 1169/2011 regulation (FIC) Regulation (EU) 1169/2011 of the European Parliament and the Council of 25 October 2011 Starting from 20 July 2016 the ‘glutenfree’ foods are fully regulated only by this regulation “Big 14” food allergens Annex II Gluten containing cereals Crustaceans Nuts Celery Egg Mustard Fish Peanuts Soybeans Milk (casein and lactose) Sesame seed Lupin Molluscs SO2 and sulfits Food for gluten-intolerant people Types of products and gluten content Food for gluten intolerant people Food consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been specially processed to reduce the gluten content, contains no more than 100 mg/kg of gluten in the food as sold to the final consumer Oats „pure” oats = NOT contaminated with gluten-containing cereals Gluten content <20 mg/kg Gluten-free Gluten content between 21-100 mg/kg NOT suitable for gluten-intolerant people Gluten-free Very low gluten Gluten-free NOT suitable for gluten-intolerant people Gluten content >100 mg/kg NOT suitable for gluten-intolerant people Coeliacs need and wish - Safe Good Cheap Available products which comply with the international and local standards What is the Crossed Grain Symbol? • Created in 1969 by a member of Coeliac UK • Today it is the internationally recognised symbol for gluten-free food needed by people with coeliac disease • Registered by coeliac societies at national and European levels • Outside Europe: contact to Coeliac UK International Trade Mark • Harmonised system for equal quality in Europe • Trust/confidence of the customers • Guidelines for the local/small producers • Advises for local/small producers For quality and safe gluten-free products European Charta Determines Obligations of all the partners Definitions Technical requirements Quality criteria European Licensing System (ELS) ELS components consist of: • AOECS Standard • AOECS Charta • AOECS-Member society license contract for the sub-licensing of the Crossed Grain symbol • AOECS Member-Producer license contract for the use of the Crossed Grain symbol European Licensing System (ELS) License numbering Country code-license code-product code CZ-100-001 OATS-CZ-100-001 European Licensing System (ELS) The ELS Charta was accepted by the AOECS General Assembly in Malta in 2009 Regulates the use of the Crossed Grain Symbol on gf food products across all countries in which AOECS Member societies are located (AOECS territory) Permits the use of the Symbol across the entire AOECS territory with one license contract European Licensing System (ELS) The Crossed Grain symbol conveys a safety guarantee for coeliacs by communicating that licensed gluten-free products must comply with the AOECS Standard Provides unified licensing conditions across AOECS territory Increases availability of gluten-free food products featuring the Symbol across Europe European Licensing System (ELS) • One licencor in each AOECS-member countries (= national societies) • International producers: • Sales of licenced products > 100.001 € and • Export sales > 15 % •Local producers: • Sales of licenced products <100.000 € and/or • Export sales < 15 % European Licensing System (ELS) Data as per 31 December 2014 • 21 Member societies have signed the AOECS Charta • +300 producer contracts signed • +5000 gluten-free products licensed Our aim is common: the happy and satisfied coeliac customer/patient/guest Certification procedure 1. step: contact of CS and a producer, information 2. step: application - Certificate of gluten analysis Packaging/labelling to place on the symbol Proving documentation 3. step: - Audit of the production site(s) Certification procedure 4. Audit can be fulfilled - by employing qualified staff of the society - by deploying a service provider - by using the existing/acceptable assurance scheme of the producer (recognising the AOECS Standard too) The minimum quality criteria from the producer: to have an appropriate HACCP System The main goal: to avoid/prevent gluten contamination Certification procedure 5. Step 6. step: 7.step: 8. step: the contracts can be signed and the products register inform AOECS inform socety’s members via magazin and webpage License fee - information from the company - invoicing the amount - paying the invoice Sharing the money with AOECS HACCP guidance FLOUR, FLOUR MIXTURE AND MILL PROCESS PHASE HAZARD PREVENTION Suppliers qualification Gluten Assessment of suppliers (audit, contamination questionnaire, etc.) in raw material CORRECTION INSTRUCTIONS/ CP/CCP To choose another supplier / to make aware the supplier of gluten contamination risk - List of qualified suppliers -Supplier documentation - Audit of supplier report, questionnaire, etc. CCP - List of suitable raw materials - Supplier documentation CCP - Certificate of gluten analysis from the producer and / or - Declaration / documentation by the supplier Quality of raw Gluten material contamination in raw material Hazard analysis of the raw materials To change raw material / supplier and association with a critical level (meaning a risk that the raw material might be contamined) Receiving raw material Inspection at the delivery, control of documents: - Certificate of gluten analysis from the producer and / or other documentation by the supplier - Documents identifying the cargo (product, GF nature, lot number, quantity, source, destination) - Random sampling (analytical plan) Gluten in raw material or surroundings / wrong (not GF) raw material Refuse the acceptance of the materials or Separated storage of the raw material (identified as not-to-beused) waiting: to receive documents from supplier / to receive analytical testing result or Use of the raw material in another with-gluten production PERSON IN CHARGE QM QM Leader of production, QM Foods not to be licensed UNPROCESSED CEREAL GRAINS AND PSEUDOCEREALS • Rice • Maize MEAT, FISH AND EGGS • All sorts of fresh or frozen meat and fish not processed • Tinned or canned fish with water/vegetable oil and salt, without additives or other • substances • Eggs Foods not to be licensed MILK AND MILK-DERIVATES • Fresh milk, UHT milk, sterilized milk without additives, vitamins or other substances • Infant formula • Yogurt without additives, vitamins or other substances • Fresh milk cream and UHT milk cream • Cheese VEGETABLES AND LEGUMES • All sorts of plain, fresh, frozen, canned or dried vegetables and legumes Foods not to be licensed NUTS AND SEEDS All sorts of nuts and seeds, with or without shells, not processed FRUITS All sorts of plain, fresh, frozen, canned or dried fruits DRINKS • Fruit juices • Soft drinks • Mineral waters • Tea, pure coffee • Wine • Distillates for spirits Foods not to be licensed SWEETS • Honey, sugar • Marmalade and jam DRESSINGS AND OTHERS • • • • Butter, bacon fat, lard Vegetable Oil Vinegar Spices and aromatic herbs not processed GOOD GLUTEN-FREE Majority of (daily) gluten-free products contain more salt, sugar and fat than regular products Food allergy across EUROPE − Up to 25% of European population reacts to food − About 17 million Europeans suffer from food allergies, 3.5 million aged less than 25 − 8% of allergic patients produce acute anaphylaxis considered potentially fatal − Over the past ten years, number of allergic children younger than 5 years has redoubled + emergency room visits for anaphylactic reactions have increased seven-fold * * Source: European Academy of Allergy and Clinical Immunology (EAACI) Gluten related disorders http://image.slidesharecdn.com/finalfreefrompp-130530053441-phpapp02/95/free-from-presentation-9638.jpg?cb=1369892133 The gluten-free market is growing France Germany Italy Netherlands Russia Spain Sweden UK 2004 Value Per capita 105.7 1.7 100.6 1.2 145.5 2.5 35.6 2.2 40.0 0.3 77.6 1.8 16.5 1.8 113.8 1.9 2009 Value Per capita 158.4 2.5 191.5 2.3 205.5 3.5 46.7 2.8 57.9 0.4 134.5 3.0 24.6 2.7 228.3 3.7 2014 Value Per capita CAGR 04-09 CAGR 09-14 233.1 3.5 8.4% 8.0% 324.0 3.9 13.7% 11.1% 273.2 4.7 7.1% 5.9% 57.2 3.4 5.6% 4.1% 63.4 0.5 7.7% 1.8% 200.8 4.3 11.6% 8.3% 34.2 3.7 8.3% 6.8% 374.2 6.0 14.9% 10.4% Brazil US 22.3 1,134.0 0.1 3.9 55.5 1,754.3 0.3 5.7 100.7 2,298.5 0.5 7.1 20.0% 9.1% 12.7% 5.6% 38.4 22.0 24.3 21.6 25.1 1.9 0.0 0.0 0.2 0.5 69.9 34.6 47.3 40.1 63.9 3.3 0.0 0.0 0.3 1.3 98.6 44.4 69.1 58.0 114.1 4.4 0.0 0.1 0.5 2.3 12.7% 9.5% 14.2% 13.2% 20.6% 7.1% 5.1% 7.9% 7.7% 12.3% 1,923.3 0.5 3,113.1 0.8 4,343.4 1.1 10.1% 6.9% Australia China India Japan Korea Overall Values in millions US Dollars Source Datamonitor Increasing sales Types of free-from foods bought (last six months), UK, 2012 vs. 2013 Forrás: Mintel 2014 Increasing awareness Foods/ingredients avoided, UK, July 2013 Forrás: Mintel 2014 New products Gluten-free and lactose-free new products 8000 LOW/NO LACTOSE NPD IS UP 93% BETWEEN 2009 AND 2013 7000 6000 5000 4000 3000 2000 1000 0 Q1 - Q2 - Q3 - Q4 - Q1 - Q2 - Q3 - Q4 - Q1 - Q2 - Q3 - Q4 - Q1 - Q2 - Q3 - Q4 - Q1 - Q2 - Q3 - Q4 2009 2009 2009 2009 2010 2010 2010 2010 2011 2011 2011 2011 2012 2012 2012 2012 2013 2013 2013 2013 Forrás: Mintel 2014 Gluten-Free Low/No/Red. Lactose Coeliac disease Our common challenge Coeliac disease Our common challenge