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Allergens and RASFF, European blackout

Il follow-up unjustified warnings about impurities (peanut residues) in Indian soy lecithin - used as an additive in millions of tons of food products - triggered a Blackout European Union on allergen risk analysis and management of the RASFF system (Rapid Alert System on Food and Feed).

1) Analysis and management of allergen risk, the great chaos

24 Member States, between April and July 2022, took sometimes antithetical positions on almost identical situations and the stakeholders - representing the operators involved and the 17 million allergic consumers in the EU - have unsuccessfully urged the European Commission to carry out its duty. Until you contact the European Ombudsman.

Correct application of EU regulations could have prevented a escalation of contradictory measures whose disastrous effects, including unjust damage and alarms, highlight the need for EFSA intervention. Without neglecting 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 which can be seen in the cacophonous management of three completely similar alerts (1,2,3) concerns:

- orders for drastic corrective measures (public recall of products) on food products that contained minimal quotas (0,1-0,2%) of the soy lecithin additive with levels of cross-contact lower (<2,3 ppm of peanut protein). As happened in Italy where the Ministry of Health tried to justify its abuses, with more than a month delay, producing a page of ISS (Istituto Superiore di Sanità) based on 'zero tolerance' (see next paragraph 2.1),

- no corrective action was instead imposed on food products that contained higher quantities (0,5%) of soy lecithin from India with levels of cross-contamination decidedly more significant (> 200 ppm). As happened in Germany and Belgium, whose authorities have applied the Vital® 3.0 method recognized, among others, by FAO / WHO and ILSI (International Life Science Institute). (4) In addition to 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 - elaborated by Allergen Bureau starting from over 3.400 clinical tests 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 groups of experts brought together by the two UN agencies, as we have seen, 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 his cryptic notes on the subject (see Annex 2) - he denied the possibility of excluding the risk of allergic reactions in cases of indefinite 'traces' of allergens in foods that contain an additive (soy lecithin) with impurities ( peanut residues). Without, however, clarifying the possible relevance of 'traces' lower than Lods (Limit of Detection), nor to which methods of analysis to refer. ISS's point of view remains enigmatic, as:

- completely ignores both the scientific literature (referred to, among others, by FAO and WHO), and the assessments expressed over the years by the authorities responsible for risk analysis in Germany, Belgium, Germany (see following paragraphs),

- cites only two studies, pediatric (5,6), which in hindsight express favor towards the per approach Reference Doses adopted in the Vital® system. Referring the first to the need for further evidence, compared to the Vital® 2.0 edition, actually offered in its latest version 3.0 (2019).

2.3) Belgium, the opinions of FASFC on VITAL®

in 2017 the SciCom (Scientific Committee) by FASFC (Federal Agency for the Safety of the Food Chain), in Belgium, had published an initial opinion in favor of using Reference Dose in the analysis and management of allergen risk. To this end, FASFC was inspired by the reference doses recommended by Vital®, with a less conservative approach (ED05 instead of ED01 as RD), and a higher value for peanut proteins (1,1 mg FASFC v. 0.2 mg Vital ®). (7)

in 2022 SciCom has 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 values ​​proposed by FAO (10 times higher than Vital® 3.0) and - despite some uncertainties in the models suggested by the FAO / WHO group and the individual sensitivity variables - considered this approach suitable for protecting the 97-98% of the allergic population. (8)

2.4) FASFC, peanuts like 'reference allergen'

FASFC evaluated, among the various scientific publications, a very recent meta-analysis, (Turner et al., 2022) which considers the possibility of using peanuts as'reference allergen'for risk assessment. The study cited - in reporting an ED01 of 1 mg (5 times higher than that of Vital®) - indicates <1 in 1.000.000 suspected cases of fatal anaphylaxis.

All other reactions they are mostly mild or moderate. Even in cases of anaphylaxis, 80% are mild and 97% regress with just 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 Federal Institute for Risk Assessment (BfR, 2020) to review the internal evaluation values. And reconfirm, for peanuts, the Reference Dose already recommended by Vital® 2.0 and unchanged in its latest edition. (10)

The working group on food allergies of the German Society for Allergology and Clinical Immunology among other things, already following the outcome of the iFAAM project (see next paragraph 3), had published a position paper where the important contribution of Vital® in implementing an allergen management system in Germany was highlighted. With the support, among others, of EEACI (European Academy on Allergy and Clinical Immunology). (11)

2.6) Holland. BuRO, Vital® e Reference Doses

Already in the 2016 the director of the BuRO (Office for Risk Assessment and Research) had invited the Dutch Ministry of Health, Welfare and Sport to consider using the Vital® system for effective management of 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 less. A prudential decision linked to the BuRo's unavailability of free access to   by Vital® e TNO (Netherlands Organization for Applied Scientific Research). (11)

3) European Commission, DG SANTE. The stone guest

European Food Allergy and the writer, starting from 21.6.22, have repeatedly urged the European Commission to fulfill its duties, as defined in the General Food Law (reg. CE 178/02) and in Official Controls Regulation (EU reg. 2017/625). That is to say, to intervene urgently to coordinate the great chaos referred to in the introduction (v. supra, paragraph 1).

The Eurocrats however, they failed to fulfill their duties. In addition to not deigning to answer a benefit company, regularly registered in the EU transparency register, which exposed the risk of crisis for a Campania industry with 130 workers and over 800 customers - who in turn serve more than 10 thousand operators - due to the unfair harm 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). Instead, DG Sante's omissions in the three cases of soy lecithin impurities from India resulted in unjustified, disproportionate and inconsistent corrective measures across Europe. Causing serious and unfair damage to all the operators involved, but also:

- false alarms. 17 million consumers with food allergies residing in the EU (12) have been exposed to the stress of false alarms and the frustration of seeing their availability on the shelf of safe food further reduced,

- food waste unjustified, in quantities 500-1.000 times higher than that of lecithin powder subject to the alert (used in a share of 0,1-0,2%, equal to 1 / 500-1 / 1000).

4) ALLERGENS, BLACKOUT EUROPE

Lo European Ombudsman was informed by the writer regarding the Blackout European in risk analysis and its management, with specific regard to the matter in question.

4.1) Risk analysis and management

The Kafkaesque story under examination highlights that:

- the 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 the protocols of lab test (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 an (sometimes unjustified) alert notification in the RASFF system, they tend to uncritically carry out the indications proposed by the Member State, without in turn carrying out an actual risk analysis and assessment of the necessity, suitability and proportionality of the proposed measures,

- the European Commission, DG Sante, plays the mere role of paper passer in the management of the RASFF system. Without verifying the actual validity of the notifications of the Member States nor verifying the consistency of the levels of risk indicated with the previous ones, general and specific, registered in the same system,

- even more serious, the European Commission does not respond to motivated requests with factual and scientific arguments relating to alerts with a 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 exposed the European Ombudsman (Emily O'Reilly) therefore aspires to have the European Commission, DG Sante, proceed without further delay to:

- immediately review the inconsistent risk classifications proposed in the three alerts in question, whose impact on the internal market, trade relations with India and competition is very 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 precedents of similar situations and the experience gained,

- take a transparent, responsible and harmonized position on allergen risk analysis and management, in agreement with the Member States gathered in the PAFF Standing Committee (Plants, Animals, Food and Feed), so that identical criteria are adopted and applied transparently in the 27 countries and can be shared with non-EU partners,

- ask EFSA to verify the suitability of the Vital® 3.0 method to manage with pragmatism and reasonableness the risks related to the presence of traces of allergens in food, while ensuring the food safety and health of consumers who are allergic and intolerant to the substances indicated in the Annex 2 to reg. EU 1169/11,

- exercise the delegation conferred by the legislator (EU regulation 1169/11, article 36.3.a) to define detailed rules regarding the use of PAL (Precautionary Allergens Labeling). By constraining the use of indications of the type 'may contain… (allergen)'to a preliminary risk analysis of cross-contact, in the self-check phase, to be performed through the Vital® 3.0 system following its validation also by EFSA.

5) EU, EFSA. 24 million euros of public funding for research on RD and Vital®

Irony of fate, the Vital® system was also developed thanks to the results of projects financed by European citizens - through the European Commission and EFSA - with over 20 million euros. And Vital® was used as a model to develop new systems, manage OFC data and identify 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 panel science of Vital®.

5.1) Europrevall, iFAAM, ThrALL

EU research projects most prominent on Reference Dose and Vital® are:

- Europrevall (The prevalence, cost and basis of food allergy across Europe). The European Union financed the first European wide-ranging research project on food allergies with € 14.329.838, 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 most important research project on allergen risk analysis and management, to which the EU has contributed with € 8.999.969 in funding. (14) This project - which also saw the participation of EAACI (European Academy of Allergy and Clinical Immunology) - allowed TNO to realize the 'Contamination Estimate Calculator', in the wake 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 has taken over and reviewed the results of iFAAM and Europrevall, also expanding the results (so far) obtained by VITAL for other allergens not considered. The CNR-ISPA of Bari participates among others. (16)

6) EFSA wanted

EFSA is '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'. With the task, among other things, saypromote and coordinate the definition of uniform risk assessment methods in the areas of its competence'(EC reg. 178/02, art. 35 and 23.1.b).

'The test bed of first-rate intelligence is the ability to hold two opposing ideas in mind at the same time and, together, to 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 that contain 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). one

(2) Dario Dongo. Allergen contamination risk analysis. The unsolved knot. GIFT (Great Italian Food Trade). one

(3) Dario Dongo. False alert. Scaricabarile, 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. Practice 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? Allergy. 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 individualshttps://www.ispacnr.it/thrall-project/

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

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