EFSA Offers Scientific Opinion on Basic Methacrylate Copolymer as a Food Additive

The petitioner provided studies on absorption, distribution, metabolim and excretion, acute and sub chronic oral toxicity, genotoxicity, and developmental toxicity of basic methacrylate copolymer.

17 Feb 2010 --- Following a request from the European Commission to the European Food Safety Authority (EFSA), the Scientific Panel on Additives and Nutrient Sources added to Food (ANS) was asked to provide a scientific opinion on the use of basic methacrylate copolymer as a glazing agent in solid food supplements as defined by European Parliament and Council Directive 2002/46/EC, and in solid foods for special medical purposes as defined by Commission Directive 1999/21/EC.
The technological function of the substance is to provide moisture protection and to mask the taste of various nutrients present in the treated products.

The Panel considered the identity of the test substances used in the toxicological studies submitted by the petitioner as compared to the commercial substance. From the information provided by the petitioner it is deduced that the proportion of monomers in the copolymer are either identical or very similar to the substance used in the ADME study and in the six month oral toxicity study.

The petitioner provided studies on absorption, distribution, metabolim and excretion, acute and sub chronic oral toxicity, genotoxicity, and developmental toxicity of basic methacrylate copolymer.

Basic methacrylate copolymer is virtually not absorbed from the gastrointestinal tract after oral administration. This is in line with it being a stable high-molecular compound.

Based on negative results derived from a gene mutation assay in Salmonella typhimurium, an in vitro mammalian cell gene mutation assay in L5178Y mouse lymphoma cells and an in vivo micronucleus assay, each performed according to current OECD guidelines and in compliance with GLP, the Panel concludes that basic methacrylate copolymer does not raise concern with respect to genotoxicity.

In a 26-week rat study, no treatment-related effects were noted on body weight, body weight gain, and food or water consumption. No clinical signs were apparent to indicate a treatment-related effect. No macroscopic or microscopic abnormalities were noted that were deemed to be a result of treatment. A NOAEL of 2000 mg/kg bw/day, the highest dose tested, was identified.

In the 28-day dog study, the NOAEL was regarded as being 750 mg/kg bw/day, the highest dose tested. The Panel however, considers that this study is less relevant for risk assessment due to its duration.

From the developmental toxicity study no evidence was found of an effect of treatment on maternal animals. There were also no effects on fetal survival, and fetal weights and placental weights were unaffected by the treatment. A NOAEL for both dams and fetuses of 1000 mg/kg bw/day (the only dose level tested) can be derived.

No data were provided on chronic toxicity, however, given the high-molecular-weight of the substance and its lack of absorption, the Panel considers that such data are not required.

The Panel based its exposure estimate on the worst case combined exposure for heavy users (assuming a coating level of 100 mg/tablet) to basic methacrylate copolymer from both its proposed use in food supplements and from its approved use in pharmaceuticals to be equal to 23.4 mg/kg bw/day for a 60 kg adult and to 16 mg/kg bw/day for children (4-18 years), whereas the petitioner estimated this exposure to be 20 mg/kg bw/day and 16 mg/kg bw/day respectively.

The Panel estimated the combined exposure for heavy users to basic methacrylate copolymer with a normal maximum coating level of 30 mg/tablet, from both its proposed use in food supplements and from its approved use in pharmaceuticals to 7 mg/kg bw/day for a 60 kg adult and to 4.8 mg/kg bw/day for a child. The respective estimates by the petitioner for these user groups are 6 mg/kg bw/day and 4.8 mg/kg bw/day.