Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Parenti, Marco; Santoro, Aurelia; Río, Alberto Del; Franceschi, Claudio

doi:10.2903/sp.efsa.2019.en-1551

Cited by 22 publications

(22 citation statements)

References 263 publications

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“…The Panel has previously evaluated the safety of Cry1A.105, Cry2Ab2 and Cry1Ac proteins, and no concerns on adjuvanticity were identified in the context of the applications assessed (see Table ). More recently, this aspect has been discussed in detail by EFSA (EFSA et al., ; Parenti et al., ). The levels of the individual Bt proteins in the four‐event stack soybean are comparable to those in the respective single soybean events (see Section 3.4.3).…”

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

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Soybean MON 87751 9 MON 87701 9 MON 87708 9 MON 89788 (four-event stack soybean) was produced by conventional crossing to combine four single events: MON 87751, MON 87701, MON 87708 and MON 89788. The GMO Panel previously assessed the four single events and did not identify safety concerns. No new data on the single events have been identified that would lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological and allergenicity assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the four-event stack soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack soybean, as described in this application, is as safe as and nutritionally equivalent to the non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable seeds of the four-event stack soybean into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the four-event stack soybean. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four-event stack soybean is as safe as the non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

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Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

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“…The Panel has previously evaluated the safety of Cry1A.105, Cry2Ab2, Vip3Aa20 and Cry3Bb1 proteins, and no concerns on adjuvanticity were identified in the context of the applications assessed (see Table ). More recently, this aspect has been discussed in detail by EFSA (EFSA, ; Parenti et al., ). The levels of the individual Bt proteins in the four‐event stack maize are comparable to those in the respective single maize events (see Section 3.4.1.4).…”

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐144)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

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Maize MON 87427 × MON 89034 × MIR162 × MON 87411 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and MON 87411. The genetically modified organism (GMO) Panel previously assessed the four single maize events and four of the subcombinations and did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA in the four‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

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“…Thus, in addition to cytotoxicity, the incidence of allergic reactions following novel protein consumption (e.g., from insect origin) has been assessed (Parenti, Santoro, Del Rio, & Franceschi, 2019). The majority of studies explored the proteins' immunomodulatory properties and their influence on inflammatory cytokine production, antibodies production, and lymphocyte activity and proliferation (Parenti et al, 2019). One study reported that oral administration of carp egg protein hydrolysates (CEPHs) (pepsin hydrolyzed) to female BALB/c mice significantly enhanced humoral immune response because immunoglobulin A (IgA) antibody production increase in serum.…”

Section: Allergenicitymentioning

confidence: 99%

“…Furthermore, a complete allergenicity risk assessment is needed (according to the European Food Safety Authority (EFSA) legislation) to approve novel protein sources as potential food ingredients taking into consideration various aspects such as route (e.g., oral) and dose of protein exposure, protein properties (e.g., physicochemical properties) and how protein is perceived by each person's immune system (Parenti et al, 2019). Different strategies can be used to assess allergenicity risks (Crevel et al, 2014;Fernandez, Mills, Koning, & Moreno, 2019).…”

Section: Allergenicitymentioning

confidence: 99%

Emergent food proteins – Towards sustainability, health and innovation

Fasolin

Pereira

Pinheiro

et al. 2019

Food Research International

177

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There is an increasing demand for alternative and sustainable protein sources, such as vegetables, insects and microorganisms, that can meet the nutritional and sensory pleasantness needs of consumers. This emergent interest for novel protein sources, allied with "green" and cost-effective processing technologies, such as high hydrostatic pressure, ohmic heating and pulsed electric fields, can be used as strategies to improve the consumption of proteins from sustainable sources without compromising food security. In addition to their nutritional value, these novel proteins present several technological-functional properties that can be used to create various protein systems in different scales (i.e., macro, micro and nano scale), which can be tailored for a specific application in innovative food products. However, in order for these novel protein sources to be broadly used in future food products, their fate in the human gastrointestinal tract (e.g., digestion and bioavailability) must be assessed, as well as their safety for consumers must be clearly demonstrated. In particular, these proteins may become novel allergens triggering adverse reactions and, therefore, a comprehensive allergenicity risk assessment is needed. This review presents an overview of the most promising alternative protein sources, their application in the production of innovative food systems, as well as their potential effects on human health. In addition, new insights on sustainable processing strategies are given.

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Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Cited by 22 publications

References 263 publications

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

Assessment of genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2017‐144)

Emergent food proteins – Towards sustainability, health and innovation

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