Copolimero di metacrilato neutro (NMC) è un composto chimico prodotto attraverso un processo di polimerizzazione in emulsione dei monomeri etil-acrilato e metil-metacrilato e successiva purificazione con distillazione a vapore acqueo. Per la rimozione dei monomeri residuali viene effettuata una filtrazione.
Si presenta in forma di polvere bianca.
A cosa serve e dove si usa
Alimentazione
Ingrediente inserito nella lista degli additivi alimentari europei come E1206 con funzione di agente di rivestimento negli integratori alimentari solidi e negli alimenti solidi a fini medici speciali
Medicina
Copolimero di metacrilato neutro è un copolimero completamente polimerizzato utilizzato nell'industria farmaceutica per consentire il rilascio ritardato di principi attivi (1).
Sicurezza
Il Gruppo di esperti scientifici dell'EFSA sugli additivi alimentari e le fonti di nutrienti aggiunti agli alimenti ha valutato nel 2010 che per il Copolimero di metacrilato neutro non possono essere esclusi effetti cronici sul tratto gastrointestinale dopo somministrazione orale, tuttavia il suo uso negli integratori alimentari solidi ai livelli d'uso e d'uso proposti non desta preoccupazioni per la sicurezza (2).
Un successivo studio del 2020 (FAO/WHO) ha confermato le conclusioni del precedente studio rilevando che le valutazioni dell'esposizione alimentare al metacrilato di metile e all'acrilato di etile a causa della loro presenza residua nei NMC metacrilato e all'acrilato di etile a causa della loro presenza residua nel NMC, suggeriscono che l'esposizione a questi monomeri derivanti dall'uso di NMC non costituisce un problema di sicurezza (3).
- Formula molecolare C10H16O4
- Peso molecolare 200.23
- CAS 9010-88-2
- UNII XRK36F13ZZ
- EC Number 618-459-6
Sinonimi:
- ethyl acrylate methyl methacrylate polymer
- Ethyl acrylate methyl methacrylate
- methyl methacrylate ethyl acrylate polymer
Bibliografia_____________________________________________________________________
(1) Eisele, J., Haynes, G., Kreuzer, K. and Rosamilia, T., 2013. Characterisation and toxicological assessment of Neutral Methacrylate Copolymer for GRAS evaluation. Regulatory Toxicology and Pharmacology, 67(3), pp.392-408.
Abstract. Neutral Methacrylate Copolymer is a fully polymerised copolymer used in the pharmaceutical industry to permit pH-independent delayed release of active ingredients from oral dosage forms. This function has potential use with food supplements and this article describes available information on the safety of the substance. Oral administration of radiolabelled copolymer to rats resulted in the detection of chemically unchanged copolymer in the faeces, with negligible absorption. Safety studies revealed no adverse toxicity following repeated administration at doses of up to 2000 mg/kg bw/d in a sub-chronic study in rats or 250 mg/kg bw/d in a sub-chronic study in dogs. No reproductive toxicity occurred at up to 2000 mg/kg bw/d in rats or rabbits. The substance shows no evidence of genotoxicity, has low acute toxicity and no irritation or sensitisation potential. An ADI value of 20 mg/kg bw was concluded from two alternative approaches. Daily exposure from use in dietary supplements is estimated as up to 10.0 mg/kg bw in adults and 13.3 mg/kg bw in children. There would therefore appear to be no safety concerns under the intended conditions of use. The information provided is intended to support an evaluation that the substance may be “generally recognized as safe” (GRAS).
(2) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), 2010. Scientific Opinion on the safety of neutral methacrylate copolymer for the proposed uses as a food additive. EFSA Journal, 8(7), p.1655.
Abstract. The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of neutral methacrylate copolymer (NMC, a 30% dispersion of the dry copolymer in water) as a glazing agent in solid food supplements and solid foods for special medical purposes (FSMPs). The dispersion contains 0.7% of polyethylene glycol monostearyl ether, which is not a authorised food additive; the opinion does not include a safety evaluation of this substance. From studies on metabolism/toxicokinetics, acute and subchronic oral toxicity, genotoxicity, and developmental toxicity it is concluded that NMC is essentially not absorbed and that any absorbed material is not retained in the tissues. No data on reproductive toxicity, chronic toxicity and carcinogenicity are provided. In the absence of such data, chronic effects on the gastrointestinal tract following oral administration cannot be excluded. Therefore, the Panel considers that an ADI should not be established and that a margin of safety (MOS) approach is appropriate. Data from in vitro Ames and mammalian cell mutation assays and an in vivo micronucleus assay show that NMC does not raise concern with respect to genotoxicity. The calculated anticipated exposure (coating level 200 mg/tablet) to NMC from both its proposed use in food supplements and its approved use in pharmaceuticals is 46.7 mg/kg bw/day for high consumer adults, and 32 mg/kg bw/day for children. Two subchronic toxicity studies in rats and a developmental study in rabbits revealed NOAELs of 2000 mg/kg/bw/day (highest dose level tested) resulting in a MOS of at least 43 for adults and at least 63 for children. The Panel considers these margins of safety sufficient given the lack of absorption and that the exposure estimates are based on worst case assumptions. The Panel concludes that the use of NMC in solid food supplements at the proposed use and use levels is not of safety concern. The Panel could not assess the safety of neutral methacrylate copolymer for uses in solid foods for special medical purposes.
(3) World Health Organization, 2020. Safety evaluation of certain food additives: prepared by the eighty-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
