The presence of peanut residues in some batches of soy lecithin arriving from India has been reported in theRapid Alert System on Food and Feed (RASFF) and warrants further investigation on food safety risk analysis.
1) RASFF, peanut residues in Indian soy lecithin.
RASFF-the European food, as well as feed and MOCA (Food Contact Materials and Objects) safety alert system-reports two reports of the presence of peanut protein (allergen) within soy lecithin arriving from India:
– notification 2022.2286. Notification from Germany, involving several member states including Italy. Three samples of liquid soy lecithin revealed the presence of 220, 110, 9.71 mg/kg (or ppm),
– notification 2022.2788. Notification from Spain on soy lecithin. The RASFF portal reports ‘serious risk,’ although no information is available on the levels of peanuts detected in the samples.
1.1) Peanuts and soybeans, the origin of the trouble
Contamination of soy lecithin with peanuts appears to have occurred in India upstream in the supply chain. Some Indian oil mills-in 2021, faced with a shortage of soybeans-would supplement their productions by also processing peanut seeds. However, without thoroughly sanitizing the facilities following their processing.
The extraction of lecithin from soybean oil thus resulted in the entrainment of peanut protein residues into it. As a result of the alert, the suppliers involved should have stopped production for the thorough sanitization of facilities or adjustment of data sheets and labels, so as to rule out the recurrence of contamination and provide the necessary news in any case.
2) EU Rules
2.1) Food safety and allergens
The General Food Law requires that all foods placed on the market comply with food safety requirements and be fit for human consumption. Risk assessment must consider, among other things, vulnerable consumer groups and label information (EC Reg. 178/02, Article 14).
Reg. EC 852/04 – cornerstone of the so-called Hygiene Package-establishes requirements and criteria to guard food hygiene and safety, from farm to fork. Its latest reform, which took place with Reg. 382/21, focuses on food safety culture and the dutiful management of allergen risk. (1)
2.2) Allergens in labeling
The Food Information Regulation in turn sets out in Annex II the exhaustive list of allergens to be listed on the label, with the appropriate modalities indicated:
– the specific mandatory information relates to ingredients or processing aids in Annex II or derived from substances or products listed therein, where used in the manufacture or preparation of a food and actually residing-even in an altered form-in the finished product,
– are subject to the derived substances expressly excluded because they have been recognized (by the European legislator, based on appropriate EFSA opinions) as not being capable of causing allergies or intolerances in sensitive consumers (EU reg. 1169/11, Article 21 and Annex II).
2.3) Risk management
Food safety risk management in any case prescinds from the abstract assessment of whether legal limits or other nonconformities have been exceeded, as noted above. (2) In fact, the purpose of risk analysis is to ascertain whether there is a real possibility, in the specific case, of exposing public health to a hazard.
Risk communication – through notification of health authorities, customer and consumer information – as well as other corrective actions prescribed by the General Food Law (commercial recall and possible public recall of food) are in turn derived from concrete analysis of an actual, possible manifestation of the hazard. (3)
3) Risk analysis
The risk analysis to be performed-assuming accidental contamination of food products with allergens not declared on the label-must therefore consider the possible presence of allergen proteins, in individual products, at a level that could trigger an adverse reaction.
3.1) Allergens, eliciting dose (ED)
Numerous Oral Food Challenge (OFC)-tests to diagnose food allergies by controlled administrations of increasing doses of the suspected allergens-have been conducted in recent decades in various parts of the world. For the purpose of identifying the levels of exposure at which the allergy occurs and its intensity (mild, medium, severe. See notes 4,5).
The identification of the so-called eliciting dose (ED, or reaction dose), that is, the dose that causes the onset of allergic symptoms, is not simple because of the variables in individual sensitivity, which is also linked to genetic and environmental factors. Among other things, EFSA opinion (2014) lists peanut allergy as one of the most problematic, as well as prevalent in children. (6)
3.2) European scientific literature
A brief review about the major studies conducted so far in Europe on peanut allergy follows:
– Ireland. The PATS study(Peanut Allergen Threshold Study. Hourihane et al., 2017) on 378 children, offered some interesting though not conclusive insights, (7)
– Germany. An OFC study of 63 children (Blumchen K. et al., 2014) found an ED05 of 1.95 mg of peanut protein, (8)
– Denmark. 781 OFC tests on 487 patients (0.5 – 73.5 years) yielded a Low Observed Adverse Effect Level (LOAEL) of 1 mg on the most sensitive patient (Eller et al., 2012), (9)
– England. The TRACE study(Threshold Reactivity and Clinical Evaluation. Dua et al., 2019) identified threshold values for peanut allergy and evaluated the consequences, which were also related to factors such as sleep deprivation and physical activity. (10)
3.3) Scientific literature, Canada and the U.S.
The Canada-Food Allergy Risk Management 1 (Canada-ARM1) and the Peanut Immunotherapy Starting in Canada, Evaluation and DiScovery (PISCES) studies established a mean ED01 value of 1.24 mg and 1.77 mg of peanut protein, respectively. (11)
In the U.S., a scientific review (Zhu J. et al., 2015) focused on identifying the minimum eliciting dose (MED), equivalent to LOAEL, in people allergic to peanuts. (12) Subjects who experienced very violent adverse reactions had significantly higher MED and threshold values (ED) than those who experienced mild and moderate reactions:
– MED (LOAEL). The median values identified are 25 mg protein (range 0.05-2500 mg), 50 mg (range 0.1-5000 mg) and 250 mg (range 0.3-5000 mg). Respectively for mild, moderate, and violent reactions,
– ED10. The identified values are 0.09 mg protein for subjects with mild reactions, 0.5 mg protein for subjects with moderate reactions, 3 mg protein for subjects with violent reactions.
3.4) VITAL® 3.0
The VITAL®(Voluntary Incidental Trace Allergen Labeling. Version 3.0, 2019) system, developed by Allergen Bureau (AUS-NZ), employs EDPs as reference doses to identify risk levels of cross-contact allergens.
BfR-the Federal Institute for Risk Assessment, Germany-published a substantially favorable opinion on the approach and reference doses given in VITAL® 3.0 (0.2 mg for peanuts). (13)
3.5) Simulations and analysis
Operators who receive notice of the possible presence of peanuts in the soy lecithin they use should:
– record non-compliance within their food quality and safety management systems,
– Perform a risk assessment referring to their products by:
- simulations to calculate possible contamination levels, assuming a worst-case scenario based on available data,
- sampling and testing (to be done by laboratories accredited for the method) on their finished products for compliance,
– decide on corrective actions to be taken, where appropriate, in the sole case of well-founded concern about the safety of food already placed on the market (EC Reg. 178/02, Articles 14 and 19).
4) Interim Conclusions
The food safety risk associated with allergen cross-contamination must always be given the utmost consideration by all operators in the food supply chain. As, unfortunately, is not the case, in the face of the widespread dissemination of outlawed labels and news that this writer, alongside Food Allergy Italia, has been denouncing in vain for three decades. (14)
The situation under review has some peculiarities-different levels of accidental contamination, sometimes close to the limit of detection(LoD), use of soy lecithin as an ingredient in other food products at < 0.5 percent-that could reduce the margins of exposure. In any case, to be verified in the manner indicated.
Dario Dongo
Notes
(1) Dario Dongo. Reg. EU 2021/382. Allergen management, safety culture, food redistribution. GIFT (Great Italian Food Trade). 9.3.21, https://www.greatitalianfoodtrade.it/sicurezza-alimentare/reg-ue-2081-382-cultura-della-sicurezza-redistribuzione-alimenti-gestione-allergeni/
(2) Dario Dongo. Molds in bread and baked goods, no food safety scare. GIFT(Great Italian Food Trade). 5/13/22, https://www.greatitalianfoodtrade.it/sicurezza-alimentare/muffe-nel-pane-e-nei-prodotti-da-forno-nessun-allarme-di-sicurezza-alimentare/
(3) The notion of risk referred to in reg. EC 178/02 (Articles 14,19) must therefore be updated in light of the clarifications offered by Reg. EU 2017/625 (Art. 3(23) and (24))
(4) FARE(Food Allergy Research & Education). Oral Food Challenge. https://www.foodallergy.org/resources/oral-food-challenge
(5) Casale T.B. et al. (2019). Harmonization of Terminology for Tolerated and Reactive Dose in Food Allergy Immunotherapy. J. Allergy Clin. Immunol. Pract. 7(2):389-392, https://doi.org/10.1016/j.jaip.2018.12.008
(6) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel). (2014). Scientific Opinion on the evaluation of allergenic foods and food ingredients for labeling purposes. doi:
https://doi.org/10.2903/j.efsa.2014.3894
(7) Hourihane J. O.’B. et al. (2017). Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy. J Allergy Clin. Immunol. 139:1583-90, http://doi.org/10.1016/j.jaci.2017.01.030
(8) Blumchen K. et al. (2014). Modified oral food challenge used with sensitization biomarkers provides more real-life clinical thresholds for peanut allergy. J. Allergy Clin. Immunol. 134:390-398, http://doi.org/10.1016/j.jaci.2014.03.035
(9) Eller et al. (2012). Clinical thresholds to egg, hazelnut, milk and peanut: results from a single-center study using standardized challenges. Ann. Allergy Asthma Immunol. 108:332-336, https://doi.org/10.1016/j.anai.2012.03.010
(10) Dua S. et al. (2019). Effect of sleep deprivation and exercise on reaction threshold in adults with peanut allergy: A randomized controlled study. J. Allergy Clin. Immunol. 144(6):1584–1594, https://doi.org/10.1016/j.jaci.2019.06.038
(11) Chu D.K. et al. (2021). Peanut allergen reaction thresholds during controlled food challenges in 2 Canadian randomized studies (Canada-ARM1 and PISCES). J. Allergy Clin. Immunol. Pract. 9(6):2524-2526, https://doi.org/10.1016/j.jaip.2021.02.009
(12) Zhu J. et al. (2015). A retrospective analysis of allergic reaction severities and minimal eliciting doses for peanut, milk, egg, and soy oral food challenges. Food and Chemical Toxicology 80:92-100, http://doi.org/10.1016/j.fct.2015.02.023
(13) BfR (2020). ‘VITAL 3.0’: New and updated proposals for reference doses of food allergens. doi: 10.17590/20200602-143608. https://mobil.bfr.bund.de/cm/349/vital-30-new-and-updated-proposals-for-reference-doses-of-food-allergens.pdf
(14) Dario Dongo. Milk allergy, one death and one recall. The ‘lactose-free’ issue. GIFT (Great Italian Food Trade). 18.4.22, https://www.greatitalianfoodtrade.it/sicurezza-alimentare/allergia-al-latte-un-decesso-e-un-richiamo-la-questione-senza-lattosio/
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
