The false alerts on non-existent allergen risks in products made with non-GMO Indian soy lecithin additive and their Kafkaesque management - including omissions, blame and abuse of power, in the various levels of Eurocratic and ministerial, regional and local bureaucracy - are causing serious damage to food supply chains and social disasters in Italy and in the EU.
The widespread presence of minimal residues of allergens in the emulsifying additive E 322 has already been described in previous articles, highlighting the need to ensure coordination of risk analysis both at European level and within the Member States (1,2, 3). Also underlining the need to limit corrective actions only to cases of actual public health risk. (XNUMX)
Bureaucrats in every button room, however, indulge in the blame game, (4) declassifying their role from public executives to stolid paper passers, rather than declassifying risk from 'serious' to 'nonexistent'. And from hour to hour the workers of the industries involved risk unemployment caused by the crisis of a procured alarm, which allergic consumers live with infinite stress.
Indian soy lecithin, false alerts
False alerts on the presence of impurities consisting of peanut residues in soy lecithin produced in India have occurred since April 2022. The only Member State not to report to 'serious risk'food safety was Germany. Spain and Italy, on the other hand, have deployed the sirens, without however carrying out the necessary risk analysis that is the prerequisite for any alert. To follow the chronology of the facts.
Italy, the silly alert
The Italian alert on Indian soy lecithin was taken in Lombardy on 28.5.22, following the self-report of a distributor to the local ASL. Which - instead of asking the responsible importer for an initial risk analysis - has generated alarm for the possible presence of peanut residues at levels close to the detection limits of the analytical methods available. (5)
the 31.5.22 the Lombard ASL, without carrying out official sampling or risk analysis suitable for assessing the effective exposure margin of consumers who eat food where this lecithin powder is used in a minimal amount (0,1-0,2%), has notified aserious risk' in the Rapid Alert System on Food and Feed (RASFF).
Analyzes available, however, revealed additive impurities in the order of 0,2-2,5 ppm of the peanut protein allergen (therefore impossible to find in the final products, without the need for further analysis thanks to a simple arithmetic operation). In fact, Germany, albeit in the face of 300 times higher residue levels, had notified RASFF a simple information for attention (instead of an alert).
Scientific risk analysis
the 3.6.22 the importer of the alerted lecithin - one of the greatest lecithin experts of the Old Continent - delivered to the distributor a scientific risk analysis - drawn up by our team of DO and shared with the association representing allergic patients, Food Allergy Italia - aimed at ascertaining the possible existence of any risk on any food matrix where the use of soy lecithin (emulsifying additive E 322) has been used.
The aforementioned analysis - performed with the Vital 3.0 method, prepared by Allergen Bureau and validated both by the international scientific community and by various institutions responsible for risk analysis (eg BfR in Germany), it has shown the absence of any risk for vulnerable groups of the population. Even if simulating a worst-case scenario, i.e. levels of contamination far higher than those detected, as well as the use of the additive lecithin to an extent 3 times higher than industrial practices.
Communication of (the absence of) risk
the 9.6.22 the writer shared the aforementioned analysis with the head of the Office of the Ministry of Health appointed to 'Crisis management and food emergencies', with the explicit requests of:
- verify the correctness of their technical-legal opinion pro-veritate, thus ascertaining the absence of any food safety and public health risk that constitutes the conditio sine qua non for the activation of the corrective actions prescribed by General Food Law (EC reg. 178/02, article 19),
- thus proceed with the due assessment of (absence of) risk on all foods that contain the additive soy lecithin subject to the alert at <0,5% in the formula / recipe of the products,
- update the communication in the national and European rapid alert systems on food and feed (iRASFF, RASFF) accordingly.
Second risk analysis
the 16.6.22 a Campania industry leader in the production of ingredients for bakery and pastry companies and industries, after having received notification of the alert in question, in turn transmitted a scientific analysis - carried out by the writer and shared with Food Allergy Italia - which demonstrates the absolute absence of risks of food safety on its batches of products where the soy lecithin in question had been used as a food additive, in a share not exceeding 0,2%.
This analysis, like the previous one, was conducted using the Vital 3.0 method (using the VITAL Calculator 3.1.4), on the basis of the product data sheets certified by numerous international certifications. Assuming, with a prudent approach, the presence of peanuts in the additive at an altitude of 60 times higher than the concentration detected in the batches of lecithin from which the alert was triggered. In support of the mathematical simulations, both analyzes included a brief supporting scientific review.
Second sharing of (the absence of) risk
the 16.6.22 the writer shared the concrete analysis of the non-existence of any risk on the products of the Campania industry to the same ministerial manager who should be in charge of managing food alerts. With a further reminder to verify its correctness and assume responsibility for one's assignment.
Activation of alert in numerous Regions and territorial health authorities and the concrete risk of uncoordinated interventions - based on the risk analysis that each body should in turn carry out but is often lacking the necessary skills and resources - in fact postulates the duty of coordination of the aforementioned office.
That office is by the way is the National Point of Contact in the European Food and Feed Alert System (RASFF) and is responsible for classifying the risk, as well as providing timely updates (follow-up) to about. (6)
Request for coordination from the European Commission
the 21.6.22 the writer therefore addressed the director general of DG Sante (Directorate-General for Food Safety and Public Health) at the European Commission, and to the Head of its Unit G.4 (Food Hygiene & Fraud) responsible for alerts in the EU, so that in turn:
- having taken note of the presence on RASFF of one notification for information (Germany) and two for alert (Spain, Italy), all relating to the presence of peanut residues in soy lecithin food additive produced in India and used in a very wide variety of foodstuffs,
- acknowledging the substantial difference in approach between the 24 Member States involved in these notifications, where the Member State that recorded the highest levels of peanut in lecithin (Germany,> 200 ppm) assessed the non-existence of risk on products that contain it as an additive, precisely by applying the only international standard validated to perform this analysis (Vital 3.0), and several other countries (e.g. Belgium, Holland, Bulgaria, UK) have followed the same concrete risk-free assessment approach for allergic consumers associated with the consumption of foods that contain infinitesimal quantities of additives with impurities not even detectable by analysis,
- acknowledged the unacceptable delay of National Point of Contact Italian in carrying out the necessary concrete analysis of the safety risk of food produced using soy lecithin imported into Italy, whose levels of impurities with peanuts are also the lowest so far recorded in the EU,
coordinated risk analysis and management in the internal market, where 2021 tons of Indian soy lecithin potentially affected by impurities and yet harmless for allergic patients were imported in 25.000 alone, without prejudice to a concrete risk analysis, when used as an additive in 5 million tons of food that only in 2021 (the year to which the principle of cross contact) were produced and consumed throughout the EU and various other countries (63 those involved so far for follow-up in the three RASFF notifications). Without ever having been recorded even an allergic reaction to this.
Abuses of power, first act
the 23.6.22 an ASL from Campania transmitted to the glorious industry based there, 'For your information', a Email where generic indications of withdrawal and recall of products were referred to, without having carried out the analysis of the risk which is a prerequisite for the adoption of the corrective actions provided for by reg. CE 178/02 to article 19. This regulation, it should be noted, has supra-constitutional rank in the hierarchy of sources of law and its non-application certainly cannot be justified by referring to a guideline adopted in the State-Regions Conference.
The uncertain communication said is the point of fall of a systemic blame game, where
- the competent authority for the area omits the necessary risk analysis. Without taking any account of the scientific analysis promptly notified to it by the industry in question, nor carrying out official sampling of the products nor having collected reports of allergic reactions of any kind. It is emphasized that the timely evaluation of the analysis and subsequent actions of the food business operator (pursuant to EC regulation 178/02, article 19) constitutes the prerequisite for justifying the administrative act if the authority decides to challenge the operator management,
- instead of justifying its act with the necessary risk analysis that is incumbent on it, the territorial ASL reported that it had turned to the regional node. Which in turn, instead of evaluating the risk analysis produced by the operator, had asked the alert office for guidance (name ipsum) of the Ministry of Health,
- the ministerial manager of the alert office in turn, instead of examining the data offered by the Campania industry as proof of the guarantee of the absolute safety of its products, denied his competence by asserting the hypothetical responsibility of another office that instead deals with labels . As if the analysis of the risk of an immune reaction to the intake of 0,05 ppm of allergenic protein (equal to 0,2 ppm of peanut, not even detectable by CERN) by an allergic patient had anything to do with the product labeling.
Beware first
the 28.6.22 the writer notified the Campania ASL of the warning to annul his provision in self-defense 23.6.22. Highlighting how the same was devoid of any reason and the uncertain order of withdrawal and / or recall of safe foods mentioned therein is the cause of a unjustified damage of a millionaire value that jeopardizes the survival of a Campania industry with 130 workers. Industry that has given excellent proof of its irreproachable responsibility.
The Campania industry had in fact activated a temporary block of the batches where the additive was used, through instant communication to its distributors and customers made possible by an optimal traceability system, certified among other things for compliance with international food safety management schemes ( IFS, BRC). And it lifted this block only after receiving scientific confirmation and mathematical proof of the safety of its products.
Coordination reminder to the European Commission
On 29 and 30.6.22 the writer updated the European Commission on theescalation of the alert caused by the Campania ASL, which in turn caused the activation of the health authorities of Spain, Romania, Bulgaria and Croatia. The importer of Indian soy lecithin in Italy was also informed of the activation of the alert in France. In addition to that of numerous ASLs in every region of Italy, in pursuit of customers from the Campania industry.
The 'responsible' authorities of the various territories all in turn have given execution to the recall notice for an alert based on a false ideological in public deed, having been identified as seriously risky instead safe foods. However, DG Sante has not deigned to reply to the two petitions written in the interest of over 800 companies overwhelmed by the collective delirium of bureaucrats, nor has it yet fulfilled its duties of coordinating the European network of risk analysis.
Political intervention
On 29 and 30.6.22 the writer then submitted the matter to the Undersecretary of State at the Ministry of Health Prof. Pierpaolo Sileri, whose Secretariat responded immediately by communicating the registration of the urgent practice 'Omission of official acts in the analysis and management of food alerts'with the specific protocol SSS.AOP.MM.1059.
The 1.7.22 the Secretariat of Undersecretary Sileri confirmed that it had immediately interested the competent ministerial offices. In any case, the writer also involved Undersecretary Paolo Costa and the Governor of the Campania Region Vincenzo De Luca. Having regard to the delegation of the Undersecretary and the concurrent jurisdiction of the Regions in matters of food safety.
Abuses of power, second act
The 1.7.22 the director of the Prevention Department and the 'business node manager' of the Campania ASL replied to the warning 28.6.22 of the writer with the rhetoric already noted in the previous communication of the same ASL. And therefore, instead of finally examining the scientific analysis of the risk and transmitted to the aforementioned ASL the now distant 16.6.22, and expressing, where appropriate, specific concerns about specific topics that may be worthy of further study:
- dismissed the aforementioned analysis as'arbitrary', clearly ignoring its content (since the Vital 3.0 scientific system does not allow any margins of discretion in interpreting the results of mathematical calculations) and international recognition,
- omitted the necessary risk analysis, an activity that had to be carried out urgently on 16.6.22 for public health reasons (however non-existent),
- attached e-mail exchanges between the various ministerial offices, confirming the blame game in progress on the three local, regional and national levels,
- alleged the need to calmly carry out, in the following five days, an official sampling of the products of the innocent and diligent company in Campania at the sole expense of the same,
- stressed that 'only following the detection process described above
any further and different determinations may be adopted, failing which the provisions already put in place will remain in force'.
Emergency in progress
The grotesque management of this alert by the 'competent' offices of the ASL, the Regions, the Ministry of Health and the European Commission is worsening, day by day, the terrible damage to an industry in Campania on which the existence of hundreds of families, also considering the induced activity generated by its activities, and the over 800 customers who were provided with safe food, both for the general population and for the community of allergic patients. (7)
Direct damage which include the continuous subtraction of human resources from their ordinary tasks to reassure and support customers and their customers, speak with the authorities, manage collection operations and face the costs of logistics. But above all indirect damage, linked to the damage to international reputation after customers, due to abuses of power, found themselves under siege by the authorities with the threat of having to block goods and in turn activate withdrawals and recalls. With the consequent risk of significant loss of customers and market shares.
Added to this are the damage suffered by the importer in Italy, a company in turn certified IFS (International Food Standard) which for twenty years has been selecting the best high quality soy lecithin for its customers. Lecithin produced by an Indian industrial group leader industry, certified FSSC 22000 (international standard ISO 22000: 2018), in one factory hi-tech that packages the products in a 'clean room' (maximum level of protection from contaminants).
False alarm for allergic consumers
Even more serious damage is caused by the 'blame' of the health authorities ai several million allergic consumers in Italy and in the European Union. Which
- are already afflicted by the systematic illegitimacy of redundant labels of voluntary and generic indications such as'may contain traces of ... (allergens)', (8)
often added to labels without prior analysis of the actual risk of food contamination (which in turn should follow the Vital 3.0 method),
- cannot buy food in bulk or eat meals away from home, due to the ubiquitous violation of consumer information rules that health authorities persist in tolerating in many EU Member States, (9)
and now they are frustrated by false warnings about safe food and risk further unavailability of tens of thousands of products on the shelf.
Food waste
Withdrawal and recall generalized and unjustified of tens of thousands of safe foods is also the cause of unjustified food waste which, in the absence of a responsible decision on the analysis and management of allergen risk, could be extended to tens of millions of tons of healthy and safe foods on Italy and in the EU.
Last warning
the 2.7.22 the writer has notified the last warning to the managers in charge of the ASL Campania, so that they cancel in self-defense and without further delay their unjustified, therefore illegitimate orders 23.6.22 and 1.7.22 for the withdrawal and recall of the products of the industry mentioned several times, consequently updating the alert communication system at national and European level.
The Minister of Health Roberto Speranza and the Commissioner for Health and Food Safety Stella Kyriakides are invited to intervene immediately to put an end to an event that has highlighted the complete irresponsibility of the officials in charge of coordinating the analysis and management of food safety risk. Who perhaps are not up to managing such delicate tasks, where the ability to is crucial risk management tragically shipwrecked here.
The Commissioner Stella Kyriakides is also requested to contact EFSA, in order to assess the suitability and completeness of the Vital 3.0 allergen risk analysis method, which is emphasized to have been prepared and updated by the greatest experts in the field of food allergies, already members of FARE (Food Allergy Research and Education). In order for its use to be imposed on all food sector operators already in the self-control phase, in execution of reg. EU 2021/382. (10)
Justice
The damaged operators from this bad management of false alerts they will be able to obtain protection from the competent judicial authorities, in Italy and in Luxembourg, also for the purposes of compensation for damages from the administrations and managers responsible. Our team is available to support these actions, so that justice is done once and for all.
An investigating magistrate In the meantime, he was informed of the actions perpetrated by the managers of the ASL to the detriment of primary Campania industry, so that he would acquire the documents of the administrative procedure still pending and evaluate the possible existence of offenses that can be prosecuted ex officio.
'How miserable life is among the abuses of power'(quoted by Franco Battiato, Up patriots to arms).
Dario Dongo
Cover elaborated on cartoon © 2021 CartoonStock Ltd, license 1.7.22
Footnotes to the story
(1) Dario Dongo. RASFF, peanuts in soy lecithin from India. Risk analysis. GIFTS (Great Italian Food Trade). one
(2) Dario Dongo. Analysis of the risk of allergen contamination, the unsolved problem. GIFTS (Great Italian Food Trade). 21.6.22/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/sicurezza/analisi-del-rischio-contaminazione-allergeni-il-nodo-irrisolto
(3) Safe food withdrawal and recall? The lawyer Dario Dongo answers. DO (Food and Agriculture Requirements). 28.6.22/XNUMX/XNUMX, https://www.foodagriculturerequirements.com/sicurezza/ritiro-e-richiamo-di-alimenti-sicuri-risponde-lavvocato-dario-dongo/
(4) Anna Maria Testa. Scaricabarile, the game of blaming someone else. New and useful. 14.7.19, https://nuovoeutile.it/scaricabarile-il-brutto-gioco-di-incolpare-qualcun-altro/
(5) He Limit of Detection (LoD) of most of the accredited laboratories is 10 ppm = mg / kg, for the consolidated PCR method, and 0,75 ppm for the ELISA method which, however, has not negligible margins of uncertainty on complex matrices such as lecithin. Indeed, the European Commission has not established an official method of analysis
(6) European Commission, DG Sante. Direction G, Crisis management in food, animals and plants. DDG2.G5 unit, Alerts, traceability and committees Standard operating procedures of the Rapid Alert System for Food and Feed. Version 1, revision 6. V. RASFF SOP 5: Transmitting a notification to the ECCP. Section 5, Classification (page 30). On https://bit.ly/3ui7ymA
(7) Assuming by default that each of the 800 customers of the Campania industry - in turn industries and / or food companies or wholesale distributors - has distributed the falsely classified products as dangerous to an average of 12,5 of their professional customers ( e.g. public establishments, food service, supermarkets, shops), the number of companies involved in this Kafkaesque affair is 10.000,
(9) Martha Strinati. Allergen labeling, the great chaos. The Utrecht studio. GIFTS (Great Italian Food Trade). 9.8.21/XNUMX/XNUMX,
(9) Dario Dongo. Allergies in the restaurant, guaranteed danger. I study German. GIFTS (Great Italian Food Trade). 26.5.19/XNUMX/XNUMX,
(10) Dario Dongo. https://www.greatitalianfoodtrade.it/sicurezza/reg-ue-2081-382-cultura-della-sicurezza-redistribuzione-alimenti-gestione-allergeni/. GIFTS (Great Italian Food Trade). 9.3.21/XNUMX/XNUMX,
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
