Copolimero di metacrilato basico è un composto chimico prodotto attraverso un processo di polimerizzazione termica controllata in cui sono coinvolti metacrilato di butile, monomeri di metilmetacrilato, metacrilato di dimetilaminoetile. Un alchilmercaptano è utilizzato come agente modificatore della catena.
Si presenta in forma di polvere bianca.
A cosa serve e dove si usa
Alimentazione
Ingrediente inserito nella lista degli additivi alimentari europei come E1205 con funzione di agente di rivestimento
Sicurezza
Il Gruppo di esperti scientifici dell'EFSA sugli additivi alimentari e le fonti di nutrienti aggiunti agli alimenti non ha ritenuto necessaria una DGA (Dose Giornaliera Ammissibile) in quanto il Copolimero di metacrilato basico non desta preoccupazioni per la sicurezza ai livelli d'uso proposti (1).
- Formula molecolare C21H37NO6
- Peso molecolare 399.5
- CAS 24938-16-7
- UNII 905HNO1SIH
- EC Number
Sinonimi:
- Eudragit E
- Eudragit E 100
- Amino Methacrylate Copolymer
Bibliografia_____________________________________________________________________
(1) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), 2016. Safety of the proposed amendment of the specifications for basic methacrylate copolymer (E 1205) as a food additive. EFSA Journal, 14(5), p.e04490.
Abstract. Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver an opinion to amend the specifications regarding the ‘definition’ and the ‘particle size’ limits of basic methacrylate copolymer (BMC – E 1205) listed in Commission Regulation (EU) No 231/2012. The request resulted from the change of the manufacturing process from a bulk polymerisation process to a solution polymerisation process and that the specifications for the particle size of < 0.1 μm are set at limits of ‘between 5.1% and 5.5%’. These limits were never met and could be interpreted as requesting a defined percentage of nanoparticles in the powder. The specifications were amended as follows: at least 95% of the particles have a size below 50 μm; at least 50% have a size below 20 μm; not more than 10% have a size below 3 μm. Particles with a diameter of 0.1 μm (100 nm) or below were never observed in the batches analysed. A detailed description of the solution polymerisation process was provided together with data on residual solvents, residual monomers, stability and reaction and fate in food. No new or additional biological and toxicological data were submitted. The ANS Panel taking into account the available information and as BMC was recently evaluated by EFSA (EFSA ANS Panel, 2010), considered this conclusion would still be valid for BMC produced by the new manufacturing procedure and that the request for amending the specification can be accepted. Therefore, the Panel concluded that there is no safety concern from the proposed amendments in the specifications resulting from the changes in the manufacturing process for the food additive BMC.
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), 2010. Scientific Opinion on the use of Basic Methacrylate Copolymer as a food additive. EFSA Journal, 8(2), p.1513.
Abstract. The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of basic methacrylate copolymer (BMC) as a glazing agent in solid food supplements and in solid foods for special medical purposes. The NOAELs derived from the main studies are 1000 mg/kg bw/day (developmental study in rat, the only dose level tested) and 2000 mg/kg bw/day (26-week feeding study in rat, highest dose tested). BMC does not raise concern with respect to genotoxicity. No studies on reproductive toxicity were available and the database on developmental toxicity was limited. Therefore no ADI was derived. The estimated combined exposure for heavy users to BMC from both its use in food supplements and in pharmaceuticals is equal to 23.4 mg/kg bw/day for a 60 kg adult and 16 mg/kg bw/day for children (4–18 years). The calculated worst case exposure to the monomers (MMA, BMA, and DMAEMA) is < 50 µg/kg bw/day for adults and < 32 µg/kg bw/day for children, being significantly below the group TDI of 0.1 mg/kg bw/day (as methacrylic acid) set by the SCF. Using the above NOAELs, given a coating level of 100 mg/tablet and a combined exposure from food supplements and pharmaceuticals, the calculated margin of safety (MOS) for heavy users varies from at least 43 to 85 for adults and from 63 to 125 for children. The MOS from the exposure only from food supplements ranges from 85 to 171 for adults and from 125 to 250 for children. In the light of the high molecular weight of the substance, its lack of absorption and its low toxicity profile, the Panel considers these margins of safety adequate. In conclusion the use of BMC as a glazing agent/coating agent in solid food supplements is not of safety concern at the proposed use levels.
