The presence of peanut residues in some consignments of soy lecithin arriving from India has been reported in the RASFF (Rapid Alert System on Food and Feed) and deserves an in-depth analysis of the food safety risk analysis.
1) RASFF, peanut residues in Indian soy lecithin
Rasff - the European alert system on food safety, as well as feed and MOCA (Materials and Objects in Contact with Food) - reports two news items on the presence of peanut proteins (allergens) in soy lecithin arriving from India:
- notification 2022.2286. Notification from Germany, with the involvement of several Member States including Italy. Three liquid soy lecithin samples revealed the presence of 220, 110, 9,71 mg / kg (or ppm),
- notification 2022.2788. Notification by Spain on soya lecithin. The RASFF portal refers to 'serious risk', although no information is available on peanut levels detected in the samples.
1.1) Peanuts and soy, the source of the trouble
Contamination of soy lecithin with peanuts appears to have occurred in India upstream of the supply chain. Some Indian oil mills - in 2021, due to the shortage of soybeans - would have integrated their production by also working peanut seeds. Without, however, sanitizing the systems accurately, following the processing of the latter.
The extraction of lecithin from soybean oil has thus resulted in the entrainment of peanut protein residues in it. Following the alert, the suppliers involved should have stopped production for the accurate sanitization of the systems or the adaptation of technical data sheets and labels, in order to exclude the recurrence of contamination and in any case provide the necessary news.
2) EU rules
2.1) Food safety and allergens
Il General Food Law requires that all foods placed on the market comply with food safety requirements and fit for human consumption. The risk assessment must consider, among other things, the categories of vulnerable consumers and the information on the label (EC regulation 178/02, article 14).
The reg. CE 852/04 - milestone of the cd Hygiene package - establishes the requirements and criteria for hygiene and food safety, from farm to fork. The latest reform of him, intervened with the reg. 382/21, focuses on the culture of food safety and the proper management of allergen risk. (1)
2.2) Allergens on the label
Il Food Information Regulation in turn reports in Annex II the exhaustive list of allergens to be indicated on the label, with the appropriate methods indicated:
- the specific mandatory information concerns the ingredients or processing aids in Annex II or derived from substances or products listed therein, when used in the manufacture or preparation of a food and actually residues - albeit in an altered form - in the finished product,
- derivative substances expressly excluded as recognized (by the European legislator, on the basis of specific EFSA opinions) are not able to cause allergies or intolerances in sensitive consumers (EU regulation 1169/11, article 21 and Annex II) .
2.3) Risk management
Risk management in any case, regardless of the abstract assessment of any exceeding of legal limits or other non-conformities, as we have seen. (2) Risk analysis it is in fact aimed at ascertaining whether there is a concrete possibility, in the specific case, of exposing public health to a danger.
The comunication risk - through notification to health authorities, informing customers and consumers - as well as others corrective actions prescribed by General Food Law (commercial withdrawal and possible public recall of foods) in turn derive from the concrete analysis of an actual, possible manifestation of the danger. (3)
3) Risk analysis
Risk analysis to be performed - in the event of 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 can trigger an adverse reaction.
3.1) Allergens, eliciting dose (AND)
Numerous Oral Food Challenge (OFC) - tests for the diagnosis of food allergies, by means of controlled administrations of increasing doses of suspected allergens - have been conducted in the last decades in various parts of the world. In order to identify the levels of exposure at which the allergy occurs and its intensity (light, medium, severe. See notes 4,5).
The individuation of the cd eliciting dose (ED, or reaction dose), i.e. the dose that causes the appearance of allergic symptoms, is not simple due to the variables in individual sensitivity, also linked to genetic and environmental factors. The EFSA opinion (2014) indicates, among other things, 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 in Europe to date on peanut allergy, to follow:
- 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 on 63 children (Blumchen K. et al., 2014) identified an ED05 equal to 1,95 mg of peanut protein, (8)
- Denmark. 781 OFC tests on 487 patients (0,5 - 73,5 years) allowed to observe 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 their consequences, also linked to factors such as sleep deprivation and physical activity. (10)
3.3) Scientific literature, Canada and the USA
Studies Canada-Food Allergy Risk Management 1 (Canada-ARM1) and the Peanut Immunotherapy Starting in Canada, Evaluation and DiScovery (PISCES) allowed to establish an average ED01 value of 1,24 mg and 1,77 mg of peanut protein, respectively. (11)
In the USA, a scientific review (Zhu J. et al., 2015) focused on the identification of minimum eliciting dose (MED), equivalent to LOAEL, in people allergic to peanuts. (12) Subjects who experienced very violent adverse reactions have significantly higher MED and cut-off values (ED) than those who experienced mild and moderate reactions:
- MED (LOAEL). The median values identified are 25 mg of protein (range 0,05-2500 mg), 50 mg (range 0,1-5000 mg) and 250 mg (range 0,3-5000 mg). Respectively for light, moderate and violent reactions,
- ED10. The values identified are 0,09 mg of protein for subjects with mild reactions, 0,5 mg for subjects with moderate reactions, 3 mg of protein for subjects with violent reactions.
3.4) VITAL® 3.0
The system VITAL® (Voluntary Incidental Trace Allergen Labeling. Version 3.0, 2019), developed by Allergen desk (AUS-NZ), uses EDPs as reference doses to identify risk levels of allergens from cross contact.
BfR - the Federal Institute for Risk Assessments, in Germany - published a substantially favorable opinion on the approach and reference doses indicated in VITAL® 3.0 (0,2 mg for peanuts). (13)
3.5) Simulations and analyzes
The operators who receive notice of the possible presence of peanuts in the soy lecithin they use must:
- record the non-compliance within their food safety and quality management systems,
- perform a risk assessment related to their products, by:
- simulations to calculate possible contamination levels, assuming a worst-case scenario based on available data,
- sampling and analysis (to be entrusted to accredited laboratories for the method) on their finished products, to verify their compliance,
- decide on the corrective actions to be taken, where appropriate, in the sole hypothesis of well-founded fear of the safety of foods already placed on the market (EC regulation 178/02, articles 14 and 19).
4) Provisional conclusions
The risk food safety related to cross contamination allergens must always be taken into the utmost consideration by all operators in the agri-food chain. As unfortunately it does not happen, in the face of the wide diffusion of labels and outlawed news that the writer, alongside Food Allergy Italy, denounces in vain for three decades. (14)
The situation in question presents some peculiarities - different levels of accidental contamination, sometimes close to the detection limits (LoD, limit of detection), use of soy lecithin as an ingredient in other food products at <0,5% - which could reduce exposure margins. In any case, to be verified in the manner indicated.
(1) Dario Dongo. EU Reg. 2021/382. Allergen management, safety culture, food redistribution. GIFTS (Great Italian Food Trade). 9.3.21/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/sicurezza-alimentare/reg-ue-2081-382-cultura-della-sicurezza-redistribuzione-alimenti-gestione-allergeni/
(2) Dario Dongo. Mold in bread and baked goods, no food safety alarms. GIFTS (Great Italian Food Trade). 13.5.22/XNUMX/XNUMX, 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. CE 178/02 (articles 14,19) must therefore be updated in the light of the clarifications offered by reg. EU 2017/625 (Article 3, paragraphs 23 and 24)
(4) DO (Food Allergy Research & Education). Oral Food Challenge. https://www.foodallergy.org/resources/oral-food-challenge
(5) Casale TB 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:
(7) Hourihane JO'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 DK 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. Allergy to milk, one death and one recall. The 'lactose-free' issue. GIFTS (Great Italian Food Trade). 18.4.22/XNUMX/XNUMX, 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.