Commission Regulation (EU) No 231/2012Show full title

Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (Text with EEA relevance)

E 1205 BASIC METHACRYLATE COPOLYMER

SynonymsBasic butylated methacrylate copolymer; amino methacrylate copolymer; aminoalkyl methacrylate copolymer E; butyl methacrylate, dimethylaminoethyl methacrylate, methyl methacrylate polymer; butyl methacrylate, methyl methacrylate, dimethylaminoethyl methacrylate polymer
DefinitionBasic methacrylate copolymer is manufactured by thermic controlled polymerisation of the monomers methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate, dissolved in propan-2-ol) by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The solid polymer is milled (first milling step) and extruded and granulated under vacuum to remove residual volatile components. The granules resulting are commercialised as such or undergo a second milling step (micronisation).
Chemical namePoly(butyl methacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate) 1:2:1
Chemical formulaPoly[(CH2:C(CH3)CO2(CH2)2N(CH3)2)-co-(CH2:C(CH3)CO2CH3)-co-(CH2:C(CH3)CO2(CH2)3CH3)]
Weight average molecular weight estimated by gel permeation chromatographyApproximately 47 000 g/mol
Particle size of powder (when used forms a film)

< 50 μm more than 50 %

< 0,1 μm 5,1-5,5 %

Assay

(according to Ph. Eur. 2.2.20 ‘potentiometric titration’)

20,8-25,5 % dimethylaminoethyl (DMAE) groups on dry substance
DescriptionGranules are colourless to yellow tinged, the powder is white
Identification
Infrared absorption spectroscopyTo be identified
Viscosity of a 12,5 % solution in 60:40 (w/w/) propan-2-ol to acetone3-6 mPa.s
Refractive index[n]D 20 1,380-1,385
Solubility

1 g dissolves in 7 g Methanol, Ethanol, propan-2-ol, dichloromethane, aqueous Hydrochloric acid 1N.

Not soluble in petroleum ether.

Purity
Loss of dryingNot more than 2,0 % (105 °C, 3H)
Alkali value162-198 mg KOH/g of dried substance
Sulphated ashNot more than 0,1 %
Residual monomers

Butylmethacrylate < 1 000 mg/kg

Methyl methacrylate < 1 000 mg/kg

Dimethylaminoethyl methacrylate < 1 000 mg/kg

Solvent residues

propan-2-ol < 0,5 %

Butanol < 0,5 %

Methanol < 0,1 %

ArsenicNot more than 2 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 2 mg/kg
CopperNot more than 10 mg/kg