EFSA Journal (Apr 2022)

Safety evaluation of the food enzyme containing trypsin, chymotrypsin, α‐amylase and triacylglycerol lipase from porcine pancreas

  • 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,
  • Boet Glandorf,
  • Ursula Gundert‐Remy,
  • Lieve Herman,
  • Dominique Turck,
  • Magdalena Andryszkiewicz,
  • Natália Kovalkovičová,
  • Joaquim Maia,
  • Yi Liu,
  • Rainieri Sandra,
  • Andrew Chesson

DOI
https://doi.org/10.2903/j.efsa.2022.7239
Journal volume & issue
Vol. 20, no. 4
pp. n/a – n/a

Abstract

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Abstract The food enzyme complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), α‐amylase (1,4‐α‐d‐glucan glucanohydrolase, EC 3.2.1.1) and triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3), is obtained from porcine pancreas by American Laboratories, Inc., USA. The food enzyme is intended primarily for the hydrolysis of milk proteins to be used in foods for special medical or nutritional dietary management. ■■■■■ is extensively used in the manufacturing process, and residual amounts of the solvent remain in the food enzyme. The applicant estimates a typical range of ■■■■■ in the food enzyme to be 10,000–13,000 mg/kg. Directive 2009/32/EC sets a maximum residue level of 10 mg/kg for foods and food ingredients produced in the EU or imported into the EU. The use of ■■■■■ for the production of a food enzyme falls within the scope of Directive 2009/32/EC. Consequently, the food enzyme does not comply with the existing requirements within the EU governing residual amount of solvent.

Keywords