E1205 (Basic methacrylate copolymer) is a chemical compound produced through a controlled thermal polymerisation process involving butyl methacrylate, methyl methacrylate monomers and dimethylaminoethyl methacrylate. An alkylmercaptan is used as a chain modifying agent.
It appears in the form of a white powder.
What it is used for and where
Food
Ingredient included in the list of European food additives as E1205 as a coating agent
Safety
EFSA's Scientific Panel on Food Additives and Nutrient Sources Added to Food did not consider an ADI (Acceptable Daily Intake) necessary as basic methacrylate copolymer does not raise safety concerns at the proposed use levels (1).
- Molecular Formula C21H37NO6
- Molecular Weight 399.5
- CAS 24938-16-7
- UNII 905HNO1SIH
- EC Number
Synonyms:
- Eudragit E
- Eudragit E 100
- Amino Methacrylate Copolymer
References_____________________________________________________________________
(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.
E1205 
