Follow-up of unwarranted alerts on impurities (peanut residues) in Indian soy lecithin-used as an additive in millions of tons of food products-has triggered a European blackout on allergen risk analysis and management of theRapid Alert System on Food and Feed (RASFF).
1) Allergen risk analysis and management, the great chaos
24 member states, between April and July 2022, took sometimes antithetical positions on almost identical situations, and stakeholders-representing the operators involved and the 17 million allergic consumers in the EU-in vain urged the European Commission to do its duty. All the way to turning to the European Ombudsman.
The proper application of EU regulations could have prevented an escalation of contradictory measures whose disastrous effects, amid unjust damage and procured alarm, highlight the need for EFSA intervention. Not to mention the results of scientific research in this area, funded by the EU and EFSA with 24 million euros in recent years.
1.1) Lower risk, more drastic measure?
The first paradox noted in the cacophonous handling of three entirely similar alerts (1,2,3) concerns:
– orders drastic corrective measures (public recall of products) on food products that contained minimal portions (0.1-0.2%) of the additive soy lecithin with the lowest cross-contact levels (<2.3 ppm peanut protein). As was the case in Italy where the Ministry of Health tried to justify its abuses, more than a month late, by producing an ISS (Istituto Superiore di Sanità) page marked ‘zero tolerance’ (see section 2.1 below),
– no corrective action was conversely imposed on food products that contained higher amounts (0.5 percent) of soy lecithin from India with significantly more significant levels of cross-contamination (>200 ppm). As was the case in Germany and Belgium, whose authorities implemented the Vital® 3.0 method recognized by FAO/WHO and ILSI(International Life Science Institute), among others. (4) As well as by the European Federation of Allergy and Airways Diseases Patient’s Associations (EFA. See Annex 1).
2) Reference Dose and VITAL® 3.0
The system of VITAL® 3.0 risk analysis – developed by Allergen Bureau from more than 3,400 clinical trials of Oral Food Challenge (OFC)-has been recognized as the best example of an allergen risk analysis system available to the international community by FAO and WHO. The expert panels assembled by the two UN agencies, as noted above, also confirmed the suitability of the Reference Dose (RD) identified by Vital® 3.0 to protect the health of the most sensitive allergic consumers. (4)
2.1) Italy, the unsolved riddles of ISS.
The ISS – in its cryptic notes on the subject (see Annex 2) – denied the possibility of excluding the risk of allergic reactions in cases of contributions of indefinite ‘traces’ of allergens in foods containing an additive (soy lecithin) with impurities (peanut residues). However, without clarifying the possible relevance of ‘traces’ below Lod(Limit of Detection), nor to which analysis methods to refer. ISS’s point of view remains enigmatic because:
– completely ignores both the scientific literature (referred to by FAO and WHO, among others) and the assessments made over the years by risk analysis authorities in Germany, Belgium, Germany (see next paragraphs),
– cites only two studies, pediatric (5,6), which on closer inspection express favor toward the Reference Doses approach adopted in the Vital® system. Referring the former to the need for additional evidence, compared to the Vital® 2.0 edition, indeed then offered in its latest version 3.0 (2019).
2.3) Belgium, FASFC’s views on VITAL®.
In 2017, the SciCom(Scientific Committee) of FASFC(Federal Agency for the Safety of the Food Chain) in Belgium had published an initial opinion favoring the use of Reference Dose in allergen risk analysis and management. For this purpose FASFC had been inspired by the Vital® recommended reference doses, with a less conservative approach (ED05 instead of ED01 as RD), and a higher value for peanut protein (1.1 mg FASFC v. 0.2 mg Vital®). (7)
In 2022 , SciCom updated the Reference doses, based on new scientific evidence from the literature and recommendations from FAO and WHO. (4) FASFC therefore decided to adopt the FAO-proposed values (10 times higher than Vital® 3.0) and-despite some uncertainties in the models suggested by the FAO/WHO group and varying individual sensitivities-considered this approach suitable to protect 97-98% of the allergic population. (8)
2.4) FASFC, peanuts as a ‘reference allergen‘
FASFC evaluated, among various scientific publications, a very recent meta-analysis, (Turner et al., 2022) that considers the possibility of using peanuts as a ‘reference allergen‘ for risk assessment. The cited study-in reporting at an ED01 of 1 mg (5 times that of Vital®)-indicates <1 in 1,000,000 suspected cases of fatal anaphylaxis.
All other reactions are mainly mild or moderate. Even in cases of anaphylaxis, 80% are mild and 97% regress with one adrenaline treatment. And despite the theoretical prediction of possible fatality, no case of death has ever been found at the proposed doses. (9)
2.5) Germany, Vital® 3.0 is the official system.
Germany currently uses the Vital® 3.0 system as part of official controls. Also following the scientific opinion published by the Federal Institute for Risk Assessment (BfR, 2020) to review the very values of internal assessment. And reconfirm, for peanuts, the Reference Dose already recommended at the time by Vital® 2.0 and unchanged in its latest edition. (10)
The food allergy working group of the German Society for Allergology and Clinical Immunology, among others, had already published a position paper as a result of the iFAAM project (see section 3 below), highlighting the important contribution of Vital® in implementing an allergen management system in Germany. Supported by, among others, EEACI(European Academy on Allergy and Clinical Immunology). (11)
2.6) Holland. BuRO, Vital® and Reference Doses
Back in 2016 , the director of BuRO(Office for Risk Assessment and Research) called on the Dutch Ministry of Health, Welfare and Sport to consider using the Vital® system for effective management of the allergen risk that the ‘zero tolerance’ approach cannot solve.
The BuRO had thus proposed the adoption of Reference Doses inspired by Vital®, but 10 times lower. A prudential decision related to BuRo’s unavailability of free access to Vital® and TNO(Netherlands Organization for Applied Scientific Research) databases.(11)
3) European Commission, DG SANTE. The Stone Convitee
European Food Allergy
and the writer, as early as 6/21/22, have repeatedly urged the European Commission to fulfill its duties as defined in the General Food Law (EC Reg. 178/02) and the Official Controls Regulation (EU Reg. 2017/625). That is, take urgent action to coordinate the great chaos mentioned in the introduction (see supra, para. 1).
However, the Eurocrats have failed to fulfill their duties. As well as failing to dignify with a response a benefit company, duly registered in the EU Transparency Register, which exposed the risk of crisis for a Campania industry with 130 workers and more than 800 clients-which in turn serve more than 10,000 operators-because of unfair damage caused by a false alert. (3)
3.1) European Commission, violation of EU rules.
The European Commission is responsible for coordinating the National Contact Points participating in the RASFF and the European Food Safety Risk Analysis Network (EC Reg. 178/02, Article 50). DG Sante’s omissions in the three impurity cases on soy lecithin from India, on the other hand, resulted in unfounded, disproportionate, and inconsistent corrective measures across Europe. Causing serious and unjust damage to all involved, but also:
– false alarms. Seventeen million consumers with food allergies residing in the EU (12) were exposed to the stress of false alarms and the frustration of seeing their shelf availability of safe foods further reduced,
– unjustified food waste, in amounts 500-1,000 times higher than the amount of lecithin powder under alert (used at 0.1-0.2%, or 1/500-1/1000).
4) ALLERGENS, EUROPEAN BLACKOUT
The European Ombudsman has been briefed by this writer regarding the European blackout in risk analysis and its management, with specific regard to the matter at hand.
4.1) Risk analysis and management
The Kafkaesque affair under consideration highlights that:
– national authorities participating in the European Risk Analysis Network do not apply harmonized or transparent risk analysis and management criteria. Neither in the general approach, nor on lab test protocols (method, sensitivity) to be applied to the qualitative and quantitative analysis of allergens in food products,
– regional and local authorities in the 24 EU countries, following a (sometimes unwarranted) alert notification in the RASFF system, tend to uncritically execute the indications proposed by the member state, without performing in turn an effective risk analysis and assessment of the necessity, suitability and proportionality of the proposed measures,
– the European Commission, DG Sante, plays the mere role of a paper-pusher in the management of the RASFF system. Without verifying the actual substantiation of the member states’ notifications, let alone verifying the consistency of the indicated risk levels with the general and specific precedents recorded in the same system,
– even more serious, the European Commission does not respond to substantiated requests with factual and scientific arguments regarding alerts with significant impact on businesses and consumers. Thus deliberately ignoring the damage that their indifference can cause on economic operators, workers and citizens in the EU.
4.2) Possible solutions
The complaint to the European Ombudsman (Emily O’Reilly) therefore aspires to get the European Commission, DG Sante, to proceed without further delay to:
– Immediately review the inconsistent risk classifications proposed in the three alerts under review, the impact of which on the domestic market, trade relations with India and competition is most serious,
– Update the management procedures of the RASFF system so that each notification is effectively verified by the European Commission on the basis of shared, objective and transparent criteria that also consider the history of similar situations and experience,
– Take a transparent, accountable and harmonized position on allergen risk analysis and management, in agreement with member states meeting in the PAFF Standing Committee (Plants, Animals, Food and Feed), so that identical criteria are adopted and applied with transparency in the 27 countries and can be shared with non-EU partners,
– request EFSA to verify the suitability of the Vital® 3.0 method to pragmatically and reasonably manage risks related to the presence of trace amounts of allergens in food, while ensuring the food safety and health of consumers allergic and intolerant to the substances listed in Annex 2 to reg. EU 1169/11,
– 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). Binding the use of claims such as ‘may contain … (allergen)‘ to a preliminary cross-contact risk analysis, at the self-control stage, to be performed through the Vital® 3.0 system following its validation also by EFSA.
5) EU, EFSA. 24 million euros in public funding for research on RD and Vital®.
Ironically, the Vital® system was also developed thanks to the results of projects funded by European citizens-through the European Commission and EFSA-with more than 20 million euros. And Vital® has been used as a model for developing new systems, managing OFC data and identifying allergens in food. The Joint Research Center (JRC) of the European Commission and several research institutes including the Dutch TNO, which is itself a member of the Vital® scientific panel, participated in this work.
5.1) Europrevall, iFAAM, ThrALL
The most prominent EU research projects on Reference Dose and Vital® are:
– Europrevall(The prevalence, cost and basis of food allergy across Europe). The European Union has funded with €14,329,838 the first European wide-ranging research project on food allergies, in which the Italian CNR also participated. Europrevall results contributed to the development of Vital®, (13)
– iFAAM(Integrated Approaches to Food Allergen and Allergy Risk Management) is perhaps the largest research project on allergen risk analysis and management, to which the EU has contributed €8,999,969 in funding. (14) This project-which also involved the participation of EAACI(European Academy of Allergy and Clinical Immunology)-has enabled TNO to create the ‘Contamination Estimate Calculator,’ along the lines of Vital®, for risk analysis, (15)
– ThrALL (Detection and quantification of allergens in food and minimum eliciting doses in food allergic individuals). Co-funded at 50% (€ 375,000) by EFSA, ThrALL took up and revised the results of iFAAM and Europrevall and also extended the results (so far) obtained by VITAL for other allergens not considered. CNR-ISPA of Bari, among others, are participating. (16)
6) EFSA wanted
EFSA is ‘the recipient of messages passing through the Early Warning System, the content of which it analyzes in order to provide the Commission and Member States with all the information necessary for risk analysis.’ Tasked, among other things, with ‘promoting and coordinating the establishment of uniform risk assessment methods in the areas within its competence‘ (EC Reg. 178/02, Art. 35 and 23.1.b).
‘The testofa first-rate intelligence is the ability to hold two opposing ideas in mind at the same time and, at the same time, retain the ability to function‘ (Francis Scott Fitzgerald).
Dario Dongo
Cover image from Bizarro comics (2013)
Attachments
(1) European Federation of Allergy and Airways Diseases Patient’s Associations (EFA). Letter 7.7.22 to the European Commission.
(2) ISS. Note on allergen risk analysis in foods containing soy lecithin additive with peanut residues, 7.7.22
Notes
(1) Dario Dongo. RASFF, peanuts in soy lecithin from India. Risk analysis. GIFT (Great Italian Food Trade). 3.6.22
(2) Dario Dongo. Allergen contamination risk analysis. The unresolved knot. GIFT (Great Italian Food Trade). 21.6.22
(3) Dario Dongo. False alerts. Scarcity, abuse of power and disasters. GIFT (Great Italian Food Trade). 2.7.22,
(4) Dario Dongo. Allergen risk analysis. FAO, WHO and ILSI Confirm Vital 3.0. GIFT (Great Italian Food Trade). 4.7.22,
(5) Sicherer et al. (2017). Critical Issues in Food Allergy: A National Academies Consensus Report. Pediatrics 140(2) :e20170194 , https://doi.org/10.1542/peds.2017-0194
(6) Carboni et al. (2019). Food safety: labels and trigger doses. Journal of Pediatric Immunology and Allergology. https://www.riaponline.it/article/sicurezza-alimentare-etichette-e-dosi-scatenanti/
(7) SciCom (2017). Advice 24-2017 of the Scientific Committee of the FASFC on the reference doses for the allergens mentioned in Annex II of Regulation (EU) N° 1169/2011. https://www.favv-afsca.be/scientificcommittee/opinions/2017/_documents/Advice24-2017.pdf
(8) SciCom (2022). Opinion 08-2022 of the Scientific Committee established at the FASFC on reference doses for allergens (update SciCom opinion 24-2017). https://bit.ly/3PaSmjW
(9) Turner et al. (2022). Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis. J. Allergy Clin. Immunol. Pract.10(1):59-70, https://doi.org/10.1016/j.jaip.2021.08.008
(10) Reese et al. (2015). Allergen and allergy risk assessment, allergen management, and gaps in the European Food Information Regulation (FIR) – Are allergic consumers adequately protected by current statutory food safety and labeling regulations? Allergo. J. Int. 24:180-184, https://doi.org/10.1007/s40629-015-0066-0
(11) BuRO. Advice of BuRO on preliminary reference doses for food allergens. 2.6.16. https://english.nvwa.nl/documents/consumers/food/safety/documents/advice-of-buro-on-preliminary-reference-doses-for-food-allergens
(12) European Academy on Allergy and Clinical Immunology, EAACI (2013). Food Allergy & Anaphylaxis Public Declaration. https://bit.ly/3IBilyn
(13) Europrevall. The prevalence, cost and basis of food allergy across Europe. https://cordis.europa.eu/project/id/514000/it
(14) iFAAM. Integrated Approaches to Food Allergen and Allergy Risk Management. https://cordis.europa.eu/project/id/312147/it
(15) TNO. Contamination Estimate Calculator. https://diamonds.tno.nl/info/191
(16) CRN-ISPA. ThrALL Project – Detection and quantification of allergens in food and minimum eliciting doses in food allergic individuals. https://www.ispacnr.it/thrall-project/
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
