The RASFF alert related to the presence of peanut residues in soy lecithin arriving from India-used in infinitesimally small proportions in millions of tons of food products (1)-provides useful food for tackling an unresolved issue at the EU level, the risk analysis of food contamination with allergens.
1) Peanuts in Indian soy lecithin, cross-contact.
Lecithin is a naturally occurring emulsifier derived from soybean plant membranes that break down during the extraction of oil from the seed. It has endless applications in the food (emulsifying additive E 322), animal husbandry, cosmetic, pharmaceutical, chemical and technical (agricultural, textile, construction, etc.) sectors. India is one of the top exporters of soy lecithin, as it is the only country to guarantee non-GMO products (unlike the US, Brazil, Argentina). Indian industries that export lecithins for use in food supply chains apply FSSC 22000-certified food safety management systems.
The Covid era and the resulting commodity supply discontinuities, however, has led to serious supply problems for Indian oil mills as early as 2021. Who, faced with the shortage of soybeans, shredded oilseeds of different kinds in the same plants. And the objective difficulties of sanitizing plants 1000%, after each processing cycle, have caused cross-contact (accidental and/or technically unavoidable contamination) of soybean oils with protein residues from other seeds.
2) Oilseeds, potential cross-contact risks.
Cross-contact (or cross-contamination) in oilseed crushing plants-i.e., downstream, including in oil transport tanks-can potentially affect four allergens mentioned in Codex Alimentarius and so in Annex II to reg. EU 1169/11:
– soybean,
– peanuts,
– sesame,
– mustard.
Soybean oils and fats refined-as well as natural tocopherols, vegetable oils derived from phytosterols, soy-based phytosterol esters, and stanol esters produced from them-are, however, exempt from the specific information requirements in relation to soy, as they lack its proteins. (2)
3) Cross-contact, possible extension of the phenomenon.
The above news and considerations lead one to abstractly believe that widespread contamination of soy lecithin produced throughout India in the past 12 months, perhaps even in earlier periods, with the four commodities mentioned in the previous paragraph is possible. Which are actually grown and marketed in that country.
The three alerts registered so far in the EU in the RASFF system (Rapid Alert System on Food and Feed) – notification 2022.2286 (Germany, 19.4.22), 2022.2788(Spain, 11.5.22), 2022.3272(Italy, 2.6.22), with follow-ups in 24 EU countries (3) and 39 non-EU countries-on some batches of Indian soybean lecithin with accidental peanut contamination could thus be only the tip of theiceberg. (4)
4) Total absence of adverse reactions
No allergic or otherwise adverse reactions were reported in the files for the three RASFF notifications mentioned above. Which involved, it should be noted, 63 countries on five continents. The probable absence of risk associated with the consumption of foods containing an additive (E 322) contaminated with peanut residues thus finds initial, empirical but not therefore negligible confirmation.
All the more so where one considers that:
– almost all food products containing soy lecithin distributed in Europe in the last two years could be affected by accidental contamination, precisely because its origin is almost exclusively Indian (except for cases of foods labeled as GMO, which are very rare in the Old Continent),
– peanut allergy is prevalent and widespread planet-wide, to the point that it has been deemed by EFSA as ‘one of the most critical,’ especially in young age groups. (5) Reasoning the other way around, if the risk had been real, there would have been a real carnage. Instead, not a single case was recorded.
5) Risk Analysis
5.1) General Criteria
The General Food Law, reg. EC 178/02, introduced the principle of risk analysis as the cornerstone of all policy, legislative and administrative decisions, as well as responsible choices by operators in self-control and risk management.
Food safety risk analysis must consider concrete situations and not abstract facts, as reflected in Article 14 of the GFL, which defines the prerequisites for triggering corrective actions in Article 19 below.
5.2) Cross-contact risk analysis
The risk from cross-contact-in this case related to the use of the additive soy lecithin with incidental contamination by peanut (or mustard, or sesame) residues-must therefore be verified, specifically, on individual foods. And the mere finding of the presence, in an ingredient and/or additive, of a few (or even a few dozen) ppm (mg/kg) of peanuts is neither sufficient nor fit for purpose. Instead, one must:
– Perform analysis on final products intended for sale and/or administration to the final consumer. Using different methods (PCR and ELISA), possibly to be repeated in several laboratories to check their reliability, depending on the sensitivity chosen. Still waiting for an on the official harmonized method in the EU,
– Classify risk by scientific method. Which is now (only) the VITAL® system(Voluntary Incidental Trace Allergen Labelling. Allergen Bureau. Version 3.0, 2019), developed by some of the world’s leading food allergy experts and validated by the German Federal Institute for Risk Assessment (BfR), among others.
5.3) European mess
The total absence of coordination among member state authorities and between them and the European Commission-which in the present case merely ‘validated’ uncritically the three notifications to the RASFF, without even noting the heterogeneous risk classification of almost identical cases (6)-is now causing serious problems for all supply chains involved in any allergen risk analysis and management situation, From farm to fork:
– national authorities participating in the European Risk Analysis Network apply lab test protocols (method, sensitivity) and evaluation and management criteria that are neither harmonized nor transparent. As seen in the recent case of the mustard alert in wheat, (7)
– the regional and local health authorities in the 24 countries involved in the alerts under review, on the sole basis of an (often unwarranted) national alert, find themselves constrained to take varied measures that are independent of effective risk analysis,
– the operators involved, in their tens of thousands in the EU, are in turn groping in the dark in the absence of harmonized criteria on risk analysis (which must be adopted as early as self-control. See footnote 8). Also because of the uncoordinated interventions of the authorities,
– allergic consumers, some millions in the EU, find themselves exposed to a redundancy of often unwarranted alerts, generating unnecessary stress and further reducing their food choices. Already unfairly restricted by thoughtless use without harmonized criteria of so-calledPrecautionary Allergens Labeling (PAL). (9,10)
6) Risk management
Ensuring food safety and the health of vulnerable consumers is a pre-requisite to food production, distribution, and serving in the EU and every country in the world. This pre-requisite must also be met in risk management related to unintentional allergen contamination, which must be harmonized and consistent with EU rules (EC Reg. 178/02, Articles 14 and 19).
It is neither justified nor justifiable to take drastic corrective action (recall, recall), let alone require the re-labeling of foods just because, due to cross-contact, they may contain a few hundred parts per billion (e.g., 0.2 ppm = 200 ppb) of allergens. That is, levels that are sometimes even lower than the LoDs(Level of Detection) of analytical methods (except by amplifying them to levels that may compromise their reliability) and still harmless. (11)
7) Harmonization needed
The international scientific community, allergy patient associations, and the more pragmatic authorities in risk analysis (e.g., BfR in Germany, FSA in the UK) have validated an approach in allergen risk analysis and management (inspired by VITAL 3.0) that obviously goes beyond mere analytical detection. Precisely because the risk, as clarified in reg. EU 2017/625, expresses ‘a function of the likelihood and severity of a harmful effect on human health.’ (12)
Allergic consumers, supply chain operators and authorities in the 27 member states can no longer wait for a decisive intervention by the European Commission to unravel a tangle that today, in the case of soy lecithin, also exposes, among other things, risks of unjustified food waste and problems of food security. In the face of the current unavailability of raw materials guaranteed to be 1000% free of traces of allergen DNA strands.
8) Interim Conclusions.
Alarmist news of alerts that are baseless because they are based on false risk analysis, on a par with the abuse of may contain on food labels, produce the opposite effect of lowering the guard in the vulnerable population, which tends to resign itself to taking some risk (albeit, potentially lethal in about 1 percent of people diagnosed with allergies) in order to continue living without falling prey to obsessions.
Therefore, the European Commission must:
– Immediately review the inconsistent risk classifications proposed in the three alerts under review, the impact of which on the domestic market is potentially enormous as noted above(see supra, para. 3)
– Take a transparent and responsible position on allergen risk analysis and management, in agreement with member states meeting in the PAFF(Plants, Animals, Food and Feed) Standing Committee, so that identical criteria are adopted in the 27 countries and can be shared with non-EU partners,
– exercise the delegation of authority given to it by the legislature (reg. EU 1169/11, Article 36.3.a) to define detailed rules regarding the use ofPrecautionary Allergens Labelling (PAL). In all cases, ‘may contain… (allergen)’ type claims must follow a cross-contact, self-check risk analysis inspired by Allergens Bureau‘s Vital 3.0 system.
Dario Dongo
Notes
(1) Dario Dongo. RASFF, peanuts in soy lecithin from India. Risk analysis. GIFT (Great Italian Food Trade). 3.6.22,
(2) Reg. EU 1169/11, Annex II, point 6, letters a,b,c,d
(3) The member states listed for follow-up in the three aforementioned notifications to the RASFF-in addition to the notifying countries (Germany, Spain, France)-are Austria, Belgium, Bulgaria, Czech Republic, Croatia, Cyprus, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, and Sweden. Non-EU countries in the European macro-region include UK, Switzerland, Albania, Serbia, Moldova, Ukraine, Russia
(4) The RASFF also reports on numerous other accidental peanut contaminations not declared on the label over the past 2 years on a wide variety of products (e.g., “peanut chocolate, rice cakes, protein bars, confectionery) where soy lecithin, perhaps not surprisingly, is routinely used as an emulsifying additive (E 322)
(5) See scientific literature cited in the previous article referred to in footnote 1
(6) Paradoxically, Germany, where peanut residue levels in soy lecithin were found to be higher, declassified the risk from ‘serious‘ to ‘undecided‘. Where Italy – where peanut contamination has been the lowest – persists in qualifying the risk as ‘serious,’ in defiance of all logic and reasoning in the administrative act
(7) Dario Dongo. Mustard allergen alert in wheat, health ministry circular. Analysis. GIFT (Great Italian Food Trade). 17.12.21,
(8) Dario Dongo. https://www.greatitalianfoodtrade.it/sicurezza/reg-ue-2081-382-cultura-della-sicurezza-redistribuzione-alimenti-gestione-allergeni/. GIFT(Great Italian Food Trade). 3.6.21,
(9) Dario Dongo.
May contain allergens, ABC
. GIFT (Great Italian Food Trade). 24.6.18,
(10) Dario Dongo.
Food Allergies and PAL, Codex Alimentarius.
. GIFT (Great Italian Food Trade). 28.11.18,
(11) It is precisely for this reason that ‘information regarding the possible and unintended presence in food of substances or products causing allergies or intolerance‘ is framed in the Food Information Regulation as voluntary label information (EU Reg. 1169/11, Article 36.3.a). Unlike those related to the deliberate use of allergens in the formulation and/or preparation of products (reg. cit., articles 9.1.c and 21)
(12) See definition of ‘hazard‘ and ‘risk‘ in reg. EU 2017/625. V. Dario Dongo.
Official public controls, EU Regulation 2017/625 kicks off.
. GIFT (Great Italian Food Trade). 18.12.19
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
