ImpARAS Improving Allergy Risk Assessment Strategy for new food proteins Kitty Verhoeckx, Scientist, TNO, The Netherlands
COST Action European network of scientists and researchers and is open to researchers from universities, public and private research institutions, industry and SMEs. COST Action has a four-year duration COST does not fund research itself COST Actions are active through a range of networking tools, such as meetings, workshops, conferences, training schools, short-term scientific missions (STSMs) and dissemination activities.
www.imparas.eu Aim: To build an interdisciplinary European network of scientists with a broad range of expertise to discuss, with an out-of-the-box view, new ideas and more predictive models and approaches to improve the current allergenicity risk assessment strategy
Background Growing world population > Sustainable food production > Alternative protein sources >
Solutions for food/energy problems Food Forward
Alternative protein sources Cultivated Meat Plants Algae Micro organisms Insects Legumes
Scenoprot Self sufficiency of Finland Search for novel protein sources New breeding and processing techniques Environmental impact/sustainability Health and risk effects Consumer perception & consumption patterns Vicia faba/ Faba bean Cannabis sativa Insects Mushrooms
General food law (EC regulation No 258/97 and EU recommendation 97/618) The law requires that safety is assured for all food ingredients placed on the market. Responsibility of the producers Novel food law: Comprehensive food safety assessment for novel foods introduced after 1997 Nutritional Microbial Toxicological Allergenic
Food allergy High prevalence 2-4 % (>20 million food allergic consumers in EU) Health impact (quality of life, lethality) Social impact (allergy sufferers and surrounding people) >80 million people confronted with food allergy on daily basis Economic impact (food incidents, recalls) No cure avoidance of allergenic food products
Food allergy mechanism IgE No clinical signs Sensitisation Clinical signs Allergic reaction
Allergy risk assessment strategy Is the novel protein able to elicit an allergic reaction in a food allergic population (cross reactivity)? Is the novel protein able to induce a new allergy (sensitization)? cross reactivity new allergy
Guidance novel foods (amending EC regulation No 97/618 and 2015/2283) Protein analysis Protein content in the Novel Food Immunological tests (e.g. Western blotting) Molecular weight of the potentially allergenic protein heat stability, sensitivity to ph, digestibility by gastrointestinal proteases, Degree of sequence homology with known allergens. Human testing Detection of specific IgE antibodies Skin prick testing Double blind placebo controlled food challenge studies
What makes a protein an allergen? 1) The pre-disposition of the individual (ifaam/europrevall) 2) Intrinsic properties of a protein (physical chemical and biological properties) 3) Timing, dosing and route of protein exposure 4) The context in which the protein is seen by the individual s immune system
Predictive parameters? Key events in food allergy Ingestion Allergen concentration, stability, processing, contact with oral mucosa Digestion Allergen stability, digestive capacity of the host, matrix Up take Transport kinetics, barrier function and activation Cellular events response of immune cells from innate and adaptive immune system Signs and symptoms Biological & physiological response induced by mediators Natuurwetenschap & techniek Ir Mieke Roth
Interdisciplinary European network Clinicians Food allergy experts Protein scientists Food technologists Analytical chemists Risk assessors Toxicologists immunologists biochemists In silico expert Gut physiologists Allergologists
www.imparas.eu Aim: To build an interdisciplinary European network of scientists with a broad range of expertise to discuss, with an out-of-the-box view, new ideas and more predictive models and approaches to improve the current allergenicity risk assessment strategy
www.imparas.eu Chair: Kitty Verhoeckx Working groups Vice Chair: René Crevel Working group 1 Physical chemical properties and Analysis Working group 2 In vitro methods Working group 3 In vivo methods Karin Hoffmann- Sommergruber Erwin Roggen Liam O Mahony Working group 4 Risks assessment and clinical perspectives Anne Constable
Working group 1: Physical chemical properties and Analysis Work group leader: Karin Hoffmann- Sommergruber Work group leader: Deputy Gabriel Mazzucchelli Questions Which physical chemical properties influence sensitisation? Effect of matrix, digestion, processing and bioavailability? How to purify allergens? How to quantify native and processed allergens?
Working group 2: In vitro models Work group leader: Erwin Roggen Work group leader: Deputy Edyta Sienkiewicz Questions Which in vitro model(s) can be used to predict allergenicity? What is the best test strategy (protocol, controls)? How can we harmonize and validate these models? Are there models for sensitising route? Test extract, purified or processed compounds?
Working group 3: In vivo models Work group leader: Liam O Mahony Work group leader: Deputy Katrine Lindholm Bøgh Questions How to extrapolate in vivo animal data to human? Which in vivo model(s) is suitable to predict allergenicity? How to harmonize and validate models? What is the role of microbiota? What are the sensitizing routes or proteins? Test extract, purified or processed compounds?
Working group 4: Risk assessment & clinical perspective Work group leader: Anne Constable Work group leader: Deputy Ben Remington Questions What are the gaps in the current risk assessment strategy? How can we implement the models defined in the other working groups? Can we rank allergens based on clinical data? How can we involve regulatory authorities?
European network Austria Belgium Bulgaria Czech Republic Croatia Cyprus Denmark France Germany Greece Hungary Ireland Italy Israel Luxembourg Malta Netherlands Norway Poland Portugal Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey United kingdom Inclusiveness Target Countries (13) COST Cooperating State (1) >250 scientists from 29 countries
Website: www.imparas.eu
Thank you for your attention Kitty Verhoeckx Scientist, TNO T: +31 (0)88 8665136 @: Kitty.verhoeckx@tno.nl