Tunde KoltaiAOECS Board, Chair

European Licensing System

A harmonised symbol for Europe

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

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

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

Researchers, University

centres

Food industry, Retailers,Caterers

Insurance CompaniesNational Health Services

Governmental institutions and

bodies

Doctors, Dietetitians

Coeliac societyand

coeliac members

Gluten withdrawal

Gluten consumption

Healthy villi Villous atrophy of coeliac patients

Coeliac disease is a medical, lifelong

condition

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”

COMMISSION REGULATION (EC) No 41/2009 of 20

January 2009

concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten

EU regulations

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 ‘gluten-free’ foods are fully regulated only by this regulation

“Big 14” food allergens Annex II

Gluten containing cereals

Crustaceans

Egg

Fish

Peanuts

Soybeans

Milk (casein and lactose)

Nuts

Celery

Mustard

Sesame seed

SO2 and sulfits

Lupin

Molluscs

Food for gluten-intolerant people

Types of products

and gluten content

Gluten content <20 mg/kg

Gluten content between

21-100 mg/kg

Gluten content >100 mg/kg

Food for gluten intolerant people Gluten-free NOT suitable 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

Gluten-free Very low gluten

Oats „pure” oats = NOT contaminated with gluten-containing cereals

Gluten-free NOT suitable for gluten-intolerant

people

NOT suitable for gluten-intolerant

people

Coeliacs need and wish

- Safe- Good- Cheap- Available

products which comply with the international and local standards

http://images.google.co.uk/imgres?imgurl=http://www.allergy-details.com/files/gluten-free-list.jpg&imgrefurl=http://www.allergy-details.com/&usg=__ckTzD1IJi0i8AGvrxk95wpIaqhI=&h=251&w=250&sz=28&hl=en&start=16&tbnid=aQj-6ZrAeR91PM:&tbnh=111&tbnw=111&prev=/images%3Fq%3Dsuitable%2Bfor%2Bpeople%2Bon%2Bgluten%2Bfree%2Bdiet%26gbv%3D2%26hl%3Den

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 partnersDefinitionsTechnical requirementsQuality criteria

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)

European Licensing System

(ELS)

CZ-100-001OATS-CZ-100-001

License numberingCountry code-license code-product code

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

• 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

European Licensing System (ELS)

Our aim is common: Our aim is common: the happy and satisfied coeliac the happy and satisfied coeliac

customer/patient/guestcustomer/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 the contracts can be signed and the products register

6. step: inform AOECSinform socety’s members via magazin and webpage

7.step: License fee- information from the company- invoicing the amount- paying the invoice

8. step:Sharing the money with AOECS

HACCP guidanceFLOUR, FLOUR MIXTURE AND MILL

PROCESS PHASE

HAZARD PREVENTION CORRECTION INSTRUCTIONS/ CP/CCP

PERSON IN CHARGE

Suppliers qualification

Gluten contamination in raw material

Assessment of suppliers (audit, questionnaire, etc.)

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.

QM

Quality of raw material

Gluten contamination in raw material

Hazard analysis of the raw materials and association with a critical level (meaning a risk that the raw material might be contamined)

To change raw material / supplier CCP - List of suitable raw materials - Supplier documentation

QM

Receiving raw material

Gluten in raw material or surroundings / wrong (not GF) 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)

Refuse the acceptance of the materials or Separated storage of the raw material (identified as not-to-be-used) waiting: to receive documents from supplier / to receive analytical testing result or Use of the raw material in another with-gluten production

CCP - Certificate of gluten analysis from the producer and / or - Declaration / documentation by the supplier

Leader of production, QM

Foods not to be licensedUNPROCESSED 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 licensedMILK 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 licensedNUTS 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 licensedSWEETS

• 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

Gluten related disorders

http://image.slidesharecdn.com/finalfreefrompp-130530053441-phpapp02/95/free-from-presentation-9-638.jpg?cb=1369892133

The gluten-free market is growing

Value Per capita Value Per capita Value Per capita CAGR 04-09 CAGR 09-14France 105.7 1.7 158.4 2.5 233.1 3.5 8.4% 8.0%Germany 100.6 1.2 191.5 2.3 324.0 3.9 13.7% 11.1%Italy 145.5 2.5 205.5 3.5 273.2 4.7 7.1% 5.9%Netherlands 35.6 2.2 46.7 2.8 57.2 3.4 5.6% 4.1%Russia 40.0 0.3 57.9 0.4 63.4 0.5 7.7% 1.8%Spain 77.6 1.8 134.5 3.0 200.8 4.3 11.6% 8.3%Sweden 16.5 1.8 24.6 2.7 34.2 3.7 8.3% 6.8%UK 113.8 1.9 228.3 3.7 374.2 6.0 14.9% 10.4%

Brazil 22.3 0.1 55.5 0.3 100.7 0.5 20.0% 12.7%US 1,134.0 3.9 1,754.3 5.7 2,298.5 7.1 9.1% 5.6%

Australia 38.4 1.9 69.9 3.3 98.6 4.4 12.7% 7.1%China 22.0 0.0 34.6 0.0 44.4 0.0 9.5% 5.1%India 24.3 0.0 47.3 0.0 69.1 0.1 14.2% 7.9%Japan 21.6 0.2 40.1 0.3 58.0 0.5 13.2% 7.7%Korea 25.1 0.5 63.9 1.3 114.1 2.3 20.6% 12.3%

Overall 1,923.3 0.5 3,113.1 0.8 4,343.4 1.1 10.1% 6.9%

2004 2009 2014

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 awarenessFoods/ingredients avoided, UK, July 2013

Forrás: Mintel 2014

New products

Gluten-free and lactose-free new products

LOW/NO LACTOSE NPD IS UP 93% BETWEEN 2009 AND 2013

Forrás: Mintel 2014

Our common challenge

Coeliac disease

Our common challenge

Coeliac disease