The risk of contamination of Italian wheat with the mustard allergen and its ignoble management by some large operators has led the Ministry of Health to clarify what to do, with circular 10.12.21 signed by the Director General for Hygiene and Food Safety and Nutrition, Massimo Casciello. Analysis and brief notes to follow.
Mustard allergen in wheat, causes
The use of mustard in agriculture it has spread in recent years. Both in green manure and in association with other plants, including wheat and legumes. Thanks to its biofumigant and nematocide, invigorating and phytodepuration actions, mustard has been included in the regulations of 'integrated' agriculture.
Foods at greatest risk of contamination are precisely the wheat and other cereals, due to the substantial impossibility of (identifying and) separating the mustard grains by sieving and sorting. Other crops involved are potatoes, sugar beets (and seed), IV range, strawberries.
Mustard contamination, first signs
Contamination of wheat and its derivatives with the mustard allergen was not detected in time by either the industrial operators or the control authorities. (1) The Italian Ministry of Health - in the first circular on the subject by DG Massimo Casciello, on 8.9.21 - officially disclosed the news, following the concerns expressed by the Irish contact point in the European risk management network (however 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 since mustard is listed as an allergen under EU regulation 1169/2011, it is recommended (...) the invitation to adopt the preventive actionsand to eliminate the risk of contamination in the grain, such as passing through a suitable sieve to separate the mustard from the grain, or corrective such as for example the indication on the label of possible traces of mustard and in any case any other action considered suitable. '
European alert, mixed reactions
Inexplicably the public audits conducted in Ireland, although already mentioned in the circular from the Ministry of Health, did not lead to any notification in the RASFF (Rapid Alert System on Food and Feed). Only one alert - of the 19 registered, between 1.1.21 and 15.12.21, for contamination from mustard not declared on the label - concerns pasta, and the report comes from Italy.
Bad advice by prof. Paolo Borghi, reproduced in a circular of the industrial association of the ItalMoPa category, however, exposed food safety and public health to serious risk. To the point that the Great Italian Mills have come to falsely communicate the non-dutifulness of the withdrawal in the event of proven contamination. Food Allergy Italia therefore asked the Ministry of Health to clarify. (2)
Circular Min. Sal. 10.12.21
The circular Min. Sal. 10.12.21 to the Regions and Autonomous Provinces - and, pc, to the most representative associations in the sector, to the ISS, to the Experimental Zooprophylactic Institute of Piedmont, Liguria and Valle d'Aosta - CRENARIA, to the Carabinieri Command for the Protection of Health NAS, to the ICQRF - highlights the existence of a problem on 'wheat produced in Italy, harvested in 2021, cited as "heavily contaminated" by mustard'. According to reports from the Irish authorities.
Consumer information it is essential and must always be performed on the label, with the words'may contain mustard'. (3) A transitional safe conduct is introduced, 'taking into account the difficult management of a contamination as sudden as it is widespread, and the difficulty in quickly printing new labels, (...) in view of the progressive adaptation of the labels'.
On 'already purchased wrappers in stock', the ministry recommends'the introduction, through the ink jet (a system usually used in the area dedicated to the minimum shelf life) of a sentence on the possible presence of mustard, eg. “It may contain traces of mustard” [better yet, 'it may contain mustard', ed. See note 3] and possibly in addition the reference to a specific page of the company website which lists the allergens accidentally present'.
Systemic crisis management. Alert in points of sale, in Italy and abroad
For products already on the shelf, the Ministry of Health has agreed with the trade associations an innovative tool for managing the systemic crisis in place. Instead of providing for the commercial recall and / or public recall of the 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 by means of notices in the points of sale with appropriate signs and possibly, in addition, further information to be included in the social networks, corporate sites, etc.
This form of communication must also take place for products already marketed abroad.
The above information should also apply to flours sold as is to consumers. '
Analysis methods available
'To date there are no reference methods available on the national territory for the detection of the mustard allergen in food'reports the ministry. The samples taken as part of the official controls by must be analyzed by official laboratories with methods validated internally and accredited by Accredia in accordance with the ISO / IEC 17025: 2018 standard.
The ISS and the Reference Center National for the detection in foods of substances and products that cause allergies or intolerances (CRENARIA, at the Experimental Zooprophylactic Institute of Piedmont, Liguria and Valle d'Aosta) refer to the use of immunoenzymatic techniques (ELISA) and molecular biology (PCR ).
Possible analytical uncertainties
The two analytical models, according to the ministry, they would not be overlapping since the ELISA test detects the presence of potentially allergenic proteins while the PCR analysis can detect the presence of specific DNA. With potential criticalities in terms of 'false positives' and possible cross reactions with the proteins of other plants of the family of Brassicaceae, to which mustard belongs.
The reference center national CRENARIA and the Department of Food Safety, Nutrition and Public Health of the ISS (Istituto Superiore di Sanità) 'have made themselves available to carry out an evaluation
test of commercially available KITs both ELISA and PCR for the search for mustard in cereal matrices, in order to prepare a suitable methodological protocol. '
ISS and IZS Piedmont, Liguria, Valle d'Aosta 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 the methods of analysis'of the presence of mustard in wheat and its derivatives.
The associations most representative have committed themselves, through a pool associated companies', to:
- 'send samples of durum and soft wheat flours to the CRENARIA Committee and the ISS' for a 'experimental evaluation. These samples are mainly from batches already transformed and a portion of those in transformation and must be in a sufficient number to accredit the methods’,
- 'economic support for the costs of experimental tests at the aforementioned laboratories, subject to verification and approval of the related cost estimates. '
All free lair?
'On hold from the studies and evaluations of the CoR on analytical methods, it is suggested to avoid official sampling for the research of mustard in flour and in products derived from wheat in order to avoid predictable and useless disputes;
obviously the comparison in the grain of mustard seeds can take place visually and this would avoid the transformation and the subsequent impossibility, if not through analysis, the verification of the presence or absence of mustard. ' (Circ. Min. Sal. 10.12.21)
Screening, optical verification and visual inspection
The milling companies in any case they should:
- to execute 'mechanical screening operations to highlight the presence of mustard which has been separated from the grain’,
- proceed with the verification, on the mechanically screened grain, 'with optical equipment based on the different color of the seeds’,
- check anyway, 'even after optical screening, through visual checks carried out by the staff, that no mustard seeds of a color similar to wheat remain in the grain'.
Issues of law
The risk management strategy adopted by the Ministry of Health deals with matters subject to European regulations (reg. CE 178/02, reg. UE 1169/11, reg. EU 2017/625) and acts having the force of the law of the State, which among other things include duties of official controls (on one matter, food safety, referred to the concurrent jurisdiction of the State, Regions and Autonomous Provinces of Trento and Bolzano).
A ministerial circular - although inspired by the need to reconcile the need to save the milling, pasta and bakery products industries with those of consumers allergic to mustard - it cannot justify the non-application of the aforementioned mandatory rules. Moreover, the aforementioned analytical uncertainties certainly do not invalidate analyzes carried out in compliance with administrative procedures and accredited methods. (5)
Risk management, in the logic introduced by General Food Law, is entrusted to the primary responsibility of the food business operator. As a logical extension of its duty to guarantee food safety, through self-control based on good hygiene practices and HACCP. (6) The ministerial 'safe conduct' can perhaps absolve operators from the duty to recall in Italy risky products that have come out of their direct availability, without however freeing them from the duties of:
- timely notification to the ASL, information to customers and consumers, specifying the identified security defect and the measures to be taken, (7)
- collection and / or recall of products distributed abroad, in addition to the above activities. Without prejudice to the hypothesis, to be verified, of the consent of the authorities of the respective countries.
Criminal or administrative liability as well as civil, in the various legal systems, it cannot in turn be eliminated in the event of adverse reactions by allergic consumers. Member States in turn have the duty of immediate notification ofinformation relating to the existence of a serious risk, direct or indirect, to human health from food or feed (...) in the context of the rapid alert system'. (8)
(1) Dario Dongo, Andrea Adelmo Della Penna. Mustard. Prevalence of allergies, uses in agriculture, risk of contamination. GIFTS (Great Italian Food Trade). 19.9.21/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/sicurezza/senape-prevalenza-allergie-usi-in-agricoltura-rischi-di-contaminazione
(2) Dario Dongo. Mustard alert in wheat. The recall is necessary and urgent. GIFTS (Great Italian Food Trade). 22.11.21/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/sicurezza/allerta-senape-nel-grano-richiamo-doveroso-e-urgente/
(3) The ministry refers to 'traces of', a term not accepted by the scientific community or by the associations of allergic patients for three essential reasons:
- there is no legal definition of 'traces' of allergens, since
- scientific consensus has not been reached on the thresholds for allergenic substances below which an allergic reaction can be excluded,
- the wording 'traces' is therefore ambiguous, in contrast to the provisions of article 36 of the reg. 1169/11, and exposes allergic consumers to unnecessary risk. V. previous article
(4) EC Reg. 178/02, article 19. For further information see theebook 'Food safety, mandatory rules and voluntary standards'
(5) The RASFF portal database reports 33 notifications a undeclared mustard (mustard) between 1.1.20 and 15.12.21. The risk was classified as serious (severe) in all cases except one indefinite. No doubts have been raised about tests that have been in use for decades.
In any case, it is the task of EFSA 'promote and coordinate the definition of uniform risk assessment methods in the areas of its competence'like the one under consideration. And it is in fact the Authority 'the recipient of messages passing through the rapid alert system, the content of which is analyzed in order to provide the Commission and the Member States with all the information necessary for the risk analysis'(EC reg. 178/02, art. 23.1.b and 35)
(6) EC Reg. 178/02, articles 19 and 14
(7) See previous article
(8) EC Reg. 178/02, article 50.2 (early warning system). Omissions and delays in notifications to RASFF - with historical examples from UK (hepatitis E in pork, 2011-2017), Belgium (Fipronil eggs, 2017), France (salmonella to newborns, 2018), Spain (listeria in meats, 2019) - are one of the prime causes of system dysfunction. And the inability, among other things, to deal with food fraud in the EU