Safety of the proposed amendment of the specifications for basic methacrylate copolymer (E 1205) as a food additive

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.