Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FRO
Abstract The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non‐genetically modified Rhizomucor miehei strain FRO by DSM Food Specialties B.V. The enzyme can be chemically modified to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It i...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-01-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2024.8512 |
| _version_ | 1797305039555919872 |
|---|---|
| author | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Lieve Herman Yrjö Roos Kyriaki Apergy Magdalena Andryszkiewicz Ana Criado Yi Liu Laura Sanmartin Andrew Chesson |
| author_facet | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Lieve Herman Yrjö Roos Kyriaki Apergy Magdalena Andryszkiewicz Ana Criado Yi Liu Laura Sanmartin Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non‐genetically modified Rhizomucor miehei strain FRO by DSM Food Specialties B.V. The enzyme can be chemically modified to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in three food manufacturing processes: processing of dairy products for the production of (1) cheese, (2) edible rennet casein, (3) fermented dairy products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to about 0.072 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 27,778. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and five matches were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but is considered low, except for individuals sensitised to mustard proteins, for whom the risk will not exceed that of mustard consumption. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. |
| first_indexed | 2024-03-08T00:19:10Z |
| format | Article |
| id | doaj.art-892daaf2cecb428c875f9d3ee4072749 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-08T00:19:10Z |
| publishDate | 2024-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-892daaf2cecb428c875f9d3ee40727492024-02-16T13:25:31ZengWileyEFSA Journal1831-47322024-01-01221n/an/a10.2903/j.efsa.2024.8512Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FROEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornLieve HermanYrjö RoosKyriaki ApergyMagdalena AndryszkiewiczAna CriadoYi LiuLaura SanmartinAndrew ChessonAbstract The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non‐genetically modified Rhizomucor miehei strain FRO by DSM Food Specialties B.V. The enzyme can be chemically modified to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in three food manufacturing processes: processing of dairy products for the production of (1) cheese, (2) edible rennet casein, (3) fermented dairy products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to about 0.072 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 27,778. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and five matches were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but is considered low, except for individuals sensitised to mustard proteins, for whom the risk will not exceed that of mustard consumption. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.https://doi.org/10.2903/j.efsa.2024.8512aspartic endopeptidaseEC 3.4.23.23food enzymemicrobial rennetmucorpepsinnon‐genetically modified microorganism |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Lieve Herman Yrjö Roos Kyriaki Apergy Magdalena Andryszkiewicz Ana Criado Yi Liu Laura Sanmartin Andrew Chesson Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FRO EFSA Journal aspartic endopeptidase EC 3.4.23.23 food enzyme microbial rennet mucorpepsin non‐genetically modified microorganism |
| title | Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FRO |
| title_full | Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FRO |
| title_fullStr | Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FRO |
| title_full_unstemmed | Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FRO |
| title_short | Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FRO |
| title_sort | safety evaluation of the food enzyme mucorpepsin from the non genetically modified rhizomucor miehei strain fro |
| topic | aspartic endopeptidase EC 3.4.23.23 food enzyme microbial rennet mucorpepsin non‐genetically modified microorganism |
| url | https://doi.org/10.2903/j.efsa.2024.8512 |
| work_keys_str_mv | AT efsapanelonfoodcontactmaterialsenzymesandprocessingaidscep safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT claudelambre safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT josemanuelbaratbaviera safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT claudiabolognesi safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT piersandrococconcelli safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT riccardocrebelli safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT davidmichaelgott safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT konradgrob safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT evgenialampi safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT marcelmengelers safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT alicjamortensen safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT gillesriviere safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT ingerlisesteffensen safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT christinatlustos safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT henkvanloveren safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT laurencevernis safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT holgerzorn safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT lieveherman safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT yrjoroos safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT kyriakiapergy safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT magdalenaandryszkiewicz safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT anacriado safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT yiliu safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT laurasanmartin safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro AT andrewchesson safetyevaluationofthefoodenzymemucorpepsinfromthenongeneticallymodifiedrhizomucormieheistrainfro |