Scientific Opinion on the safety of a “novel chewing gum base (Rev‐7?)” as a Novel Food ingredient

摘要

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of a ‘novel chewing gum base (Rev‐7?)’. The novel food ingredient (NI) is a synthetic polymer intended to be used in the formulation of chewing gum, with the aim of reducing its adhesive properties compared with conventional chewing gum. It consists of branched polymers of monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene‐graft‐maleic anhydride (PIP‐g‐MA), and unreacted MPEG (<35 %). The NI and its main ingredients have no history of use in foods within the EU. A detailed specification has been provided, including the toxicologically relevant compounds potentially present in the end product. The applicant intends to use a maximum of 8 % Rev‐7? in the formulation of chewing gums. The maximum daily intake was calculated to occur in male teenagers at a level of 1.16 g/person per day. The specification sets limits for monomer residues, (heavy) metals, solvent residues, additives (BHT and lactic acid), and other impurities from the starting materials. The theoretical maximum exposures to these substances are below established safety limits. A maximum of 50 mg/kg for MPEG oligomers of <1000 Da has been set in the specification. The calculated maximum intake of MPEG oligomers is <0.058 mg. No genotoxicity or toxicity data on MPEG oligomers were provided, but because of its structural similarity to low molecular weight PEG, the exposure to MPEG oligomers causes no concern at the proposed use level. The toxicological data show that Rev‐7? has low oral toxicity in rats after short‐term administration (28 days) and is not genotoxic. Rev‐7? is unlikely to cause food allergic reactions. The Panel concludes that the novel ingredient Rev‐7? is safe at the proposed conditions of use and the proposed levels of intake.