The risk of contamination of Italian wheat with the mustard allergen and its disgraceful handling by some large operators prompted the Ministry of Health to clarify what to do, with circular 10.12.21 signed by the director general for Food Hygiene and Safety and Nutrition, Massimo Casciello. Analysis and brief notes to follow.
Mustard allergen in wheat, causes
The use of mustard in agriculture has become widespread in recent years. Both in green manure and in intercropping with other plants, including wheat and legumes. Due to its biofumigant and nematicidal, corroborative and phytodepuration actions, mustard has been included in ‘integrated’ agriculture specifications, among others.
The commodities at greatest risk of contamination are precisely wheat and other grains, due to the substantial inability to (identify and) separate mustard grains by sieving and sorting. Other crops affected are potatoes, sugar (and seed) beets, IV Gamma, strawberries.
Mustard contamination, early signs
Contamination of wheat and its derivatives with the mustard allergen was not detected in time either by industrial operators or control authorities. (1) The Italian Ministry of Health-in the first circular on the subject by DG Massimo Casciello, 8.9.21-disclosed the news on the record, as a result of concerns expressed by the Irish point of contact in the European Risk Management Network (which, moreover, were not registered in the EU Rapid Alert System on Food and Feed, RASFF).
‘Considering that wheat is used in a wide range of food products from pasta to bread, baked goods, etc., (…) and being that mustard is listed as an allergen under EU Regulation 1169/2011, it is recommended (…) the invitation to adopt the preventive actionsto eliminate the risk of contamination in the grain, such as a pass through a suitable screen to separate the mustard from the grain, or corrective action such as labeling possible traces of mustard and otherwise any other action deemed appropriate.’
European alert, unhinged reactions
Inexplicably, public inspections conducted in Ireland, although mentioned already in the Ministry of Health circular, did not lead to any notification in theRapid Alert System on Food and Feed (RASFF). Only one alert–of the 19 recorded, between 1.1.21 and 15.12.21, for contamination by mustard not declared on the label–in fact concerns pasta food, and the alert comes from Italy.
However, Prof. Paolo Borghi’s bad advice , echoed in a circular from industry trade association ItalMoPa, has exposed food safety and public health to serious risk. So much so that the Great Italian Mills have gone so far as to falsely communicate that they do not have to recall in cases of established contamination. Food Allergy Italy has therefore asked the Ministry of Health for clarity. (2)
Circular Min. Sal. 10.12.21
The circular Min. Sal. 10.12.21 to the Regions and Autonomous Provinces – and, p.c., to the most representative associations in the sector, the ISS, the Experimental Zooprophylactic Institute of Piedmont, Liguria and Valle d’Aosta – CRENARIA, the Carabinieri Command for the Protection of Health NAS, the ICQRF – highlights the existence of a problem on ‘Wheat produced in Italy, harvested in 2021, cited as “heavily contaminated” with mustard‘. According to reports from the Irish authorities.
Consumer information
Consumer information is essential and should always be carried out on the label, with the words ‘may contain mustard‘. (3) A transitional safe-conduct is introduced, ‘in view of the difficulty ofdealing with contamination that is as sudden as it is widespread, and the difficulty of providing for the printing of new labels in a timely manner, (…) with a view to the gradual adjustment of labels.’
On ‘in-stock cases already purchased,’ ministry recommends ‘the introduction, via inkjet (a system that can usually be used in the area dedicated to the minimum shelf life) of a phrase about the possible presence of mustard, e.g., “may contain traces of mustard” [better yet, ‘may contain mustard,’ ed. See footnote 3] and possibly in addition the cross-reference to a special page on the company’s website where allergens accidentally present are listed‘.
Systemic crisis management. Point-of-sale alert, in Italy and abroad
For products already on the shelf, the Ministry of Health has agreed with trade associations on an innovative tool to manage the ongoing systemic crisis. Instead of providing commercial recall and/or public recall of products,as prescribed by the General Food Law (4),
‘Promptly inform the consumer about the possible presence of the mustard allergen in the specific product through point-of-sale notices with appropriate signage and possibly, in addition, additional information to be included in social media, company websites, etc.
This form of communication must also take place for products already marketed abroad.
The above information must also apply to flours sold as such to consumers.”
Available methods of analysis
‘To date , no reference methods are available nationwide for detecting mustard allergen in food,’ the ministry reports. Samples taken as part of official controls by must be analyzed by official laboratories with internally validated methods accredited by Accredia in accordance with ISO/IEC 17025:2018.
ISS and the National Reference Center for the Detection in Food of Substances and Products Causing Allergies or Intolerances (CRENARIA, at the Experimental Zooprophylactic Institute of Piedmont, Liguria and Valle d’Aosta) report on the use of enzyme immunoassay (ELISA) and molecular biology (PCR) techniques.
Possible analytical uncertainties
The two analytical models, according to the ministry, would not be superimposable because the ELISA test detects the presence of potentially allergenic proteins while the PCR analysis can detect the presence of specific DNA. With potential critical issues in terms of ‘false positives’ and possible cross-reactions with proteins from other plants in the Brassicaceae family, to which mustard belongs.
The national reference center CRENARIA and the Department of Food Safety, Nutrition and Public Health of the ISS (Istituto Superiore di Sanità) ‘becameavailable to conduct an evaluation
experimental of commercially available ELISA and PCR kits for the detection of mustard in cereal matrices, in order to prepare a suitable methodological protocol.’
Experimental analysis
ISS and IZS Piedmont, Liguria, and Aosta Valley will therefore work under the coordination of the ministry, for at least six months, on the development and validation of ‘A certain and accredited procedure and methodology to increase the specificity and sensitivity of analytical methods‘ of the presence of mustard in wheat and its derivatives.
The ‘ most representative associations have pledged, through a pool of member companies,’ to:
– ‘send samples of hard and soft wheat flours to CRENARIA CoR and ISS‘ for a ‘experimental evaluation. These samples are mainly from the batches already processed and share of those undergoing processing and must be in sufficient numbers to credit the methods‘,
– ‘financial support for the costs of experimental verifications at the above-mentioned laboratories, subject to verification and approval of the relevant cost estimates.’
Den free all?
‘Pending of CoR studies and evaluations on analytical methods, it is suggested that official sampling for mustard in flour and wheat products be avoided in order to avoid predictable and unnecessary litigation;
‘Obviously, the detection of mustard seeds in the grain can be done visually, and this would avoid processing and the subsequent impossibility, except by analysis, of verifying the presence or absence of mustard.’ (Min. Sal. Circ. 10.12.21)
Screening, optical verification and visual inspection
Milling enterprises should in any case:
– perform ‘mechanical screening operations to reveal the presence of mustard that has been separated from the grain‘,
– proceed to verification, on mechanically screened grain, ‘with optical equipment based on the different color of the seeds.’
– check however, ‘even after optical screening, through visual checks carried out visually by staff, that no mustard seeds similar in color to wheat remain in the grain.’
Issues of law
The risk management strategy adopted by the Ministry of Health addresses matters subject to European regulations (reg. EC 178/02, reg. EU 1169/11, reg. EU 2017/625) and acts having the force of state law, which, among other things, contemplate duties of official controls (on a matter, food safety, that is under the concurrent jurisdiction of the state, regions and autonomous provinces of Trento and Bolzano).
A ministerial circular-although inspired by the need to balance the needs of saving the milling, pasta and bakery industries with those of mustard-allergic consumers-cannot justify the disapplication of the above-mentioned mandatory regulations. The aforementioned analytical uncertainties, moreover, certainly do not invalidate analyses performed in accordance with administrative procedures and accredited methods. (5)
Responsibility
Risk management, in the logic introduced by the General Food Law, is entrusted to the primary responsibility of the food business operator. As a logical extension of its duty to ensure food safety through self-control based on good hygienic practices and HACCP. (6) The ministerial ‘safe-conduct’ may perhaps absolve operators of the duty to recall to Italy unsafe products that have left their direct availability, but without releasing them from the duties of:
– Timely notification to the ASL, information to customers and consumers, specifying the identified safety defect and the measures to be taken, (7)
– recall and/or recall of products distributed abroad, in addition to the above activities. Subject only to the assumption, to be verified, of assent from the authorities of the respective countries.
Criminal or administrative as well as civil liability, in the different systems, in turn, cannot be elided in cases of adverse reactions by allergic consumers. Member States in turn have a duty to immediately notify ‘information about the existence of a serious direct or indirect risk to human health from food or feed (…) under the rapid alert system‘. (8)
Dario Dongo
Notes
(1) Dario Dongo, Andrea Adelmo Della Penna. Mustard. Allergy prevalence, agricultural uses, contamination risks. GIFT (Great Italian Food Trade). 9/19/21, https://www.greatitalianfoodtrade.it/sicurezza/senape-prevalenza-allergie-usi-in-agricoltura-rischi-di-contaminazione
(2) Dario Dongo. Mustard alert in wheat. The reminder is timely and urgent. GIFT (Great Italian Food Trade). 22.11.21, https://www.greatitalianfoodtrade.it/sicurezza/allerta-senape-nel-grano-richiamo-doveroso-e-urgente/
(3) The ministry refers to ‘traces of,’ a wording not accepted by the scientific community nor by allergy patient associations for three essential reasons:
– there is no legal definition of ‘trace’ allergens, since
– no scientific consensus has been reached on thresholds of allergenic substances below which an allergic reaction can be ruled out,
– the wording ‘traces’ is therefore ambiguous, contrary to the provision in Article 36 of Reg. EU 1169/11, and exposes allergic consumers to unnecessary risk. See previous article
(4) Reg. EC 178/02, Article 19. For more details see theebook ‘Food Safety, Mandatory Rules and Voluntary Standards‘
(5) The RASFF portal database reports 33 notifications to undeclared mustard between 1.1.20 and 15.12.21. The risk was classified as serious (severe) in all but one undefined case. No concerns appear to have been raised about tests that have been in use for decades.
In any case, it is EFSA’s task to ‘promote and coordinate the establishment of uniform risk assessment methods in areas of its competence‘ such as the one under consideration. And it is in fact the Authority ‘the recipient of messages passing through the Early Warning System, the content of which it analyzes in order to provide the Commission and the Member States with all the information necessary for risk analysis‘ (EC Reg. 178/02, Art. 23.1.b and 35)
(6) Reg. EC 178/02, Articles 19 and 14
(7) See previous article
(8) Reg. EC 178/02, Article 50.2(early warning system). Omissions and delays in notifications to the RASFF-with historical examples from the UK(hepatitis E in pork, 2011-2017), Belgium(eggs with Fipronil, 2017), France(salmonella in infants, 2018), and Spain(listeria in meat, 2019)-are one of the primary causes of system dysfunction. And of the inability, among other things, to deal with food fraud in the EU
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
