Scientific Opinion on the safety of neutral methacrylate copolymer for the proposed uses as a food additive

EFSA Journal

Volumn 8, Issue 7, 2010, Pages

[No Author Info available]

Author keywords

ethyl acryl; ethyl acrylate; ethyl acrylate (CAS No: 140 88 5); ethyl acrylate methyl methacrylate polymer; methyl methacrylate (CAS No: 80 62 6); methyl methacrylate polymer; Neutral methacrylate copolymer; poly(ethyl acrylate co methyl methacrylate) 2:1

Indexed keywords

EID: 85016110783     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2010.1655     Document Type: Article

References (32)

1. Ames BN, McCann J and Yamasaki E, 1975. Methods for detecting carcinogens and mutagens with the Salmonella/mammalian microsome mutagenicity test. Mutation Research 31, 347–364.
2. Bootman J, 1977. Eudragit E30D: Assessment of Mutagenic Potential by the “Ames Test”. Life Science Research (LSR) Report No: 77/RGC21/255. LSR, Stock, Essex CM4 9PE, England. Unpublished report submitted by the petitioner.
3. Ciliutti P, 2007. EUDRAGIT® NE 40 D: Micronucleus test in mice (Study 54000, Research Toxicology Centre S.p.A., Via Tito Speri 12, 00040 Pomezia (RM), Italy). Unpublished report submitted by the petitioner.
4. Cowie JMG, 1976. Chemie und Physik der Polymeren, Verlag Chemie, Weinheim, 49ff. Date 2008-08-20. Page 124 of 133. Basic Methacrylate Copolymer Evonik Röhm GmbH.
5. ChemIdplusAdvanced. chem.sis.nlm.nih.gov/chemidplus/ProxyServlet?objectHandle=eBMaint&actionHandle=eefault&nextPage=esp/chemidheavy/ResultScreen.jsp&ROW_NUM=0&TXTSUPERLISTID=009010882zn.
6. Elias HG, 1990. Makromoleküle Grundlagen. 5 Ed, Hüthig und Wepf Verlag, Heidelberg, 441ff.
7. EFSA, 2004. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Materials in Contact with Food (AFC) on a request fromw the Commission related to Ethyl as a food additive. The EFSA Journal 35, 1–6. Available at: www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/opinion_afc_08_en1.pdf.
8. EFSA, 2005. Opinion of the Scientific Committee on request from EFSA related to Exposure Assessments. The EFSA Journal 249, 1–26. Available at: www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/sc_op_ej249_exposure_en2,1.pdf.
9. European Pharmacopoeia, 6th Edition, Volume 2, Monographs A-J (2008).
10. European Pharmacopoeia, 6th Edition, Volume 3, Monographs A-J (2009).
11. European Union Risk Assessment Report on methyl methacrylate ISBN 92-894-1253-4.
12. French Vidal, 2005. BIAM 2000 – 2002 (Banque de Données Automatisée sur les Médicaments).
13. FDA, 1966. Drug review branch division of toxicological evaluation. Bureau of Science, FDA, March 1966.
14. Gregory J, 2000. National Diet and Nutrition Survey: young people aged 4 to 18 years. The Stationary Office. London.
15. Henderson L, Gregory J and Swan G, 2002. The national diet and nutrition survey: adults aged 19 to 64 years, Types and quantities of foods consumed, volume 1, Crown.
16. Hirakawa T, 1981. Subacute toxicity study of EUDRAGIT® E30D with rats by oral administration for one month, and the recovery study (Bozo Research Center Co. Ltd., Japan.). Unpublished report submitted by the petitioner.
17. Houben-Weyl, 1987. Polymeric materials. Methoden der organischen Chemie (Methods of Organic Chemistry), 4th Edition, Vol. E 14, Part 1, Georg Thieme Verlag, Stuttgart, pp. 133 ff.
18. Lehmann K and Dreher D, 1973. Drugs made in Germany XVI, 126–136.
19. Leuschner F, 1971a. The acute toxicity of Preparations 2807 B and 2837 B on oral administration in rats Laboratorium f$ur Pharmacologie und Toxicologie, Bredengrund 31, Hamburg-Hausbruch, Germany. Unpublished report submitted by the petitioner.
20. Leuschner F, 1971b. The acute toxicity of Preparations 2807 C and 2837 C in cross-bred dogs when administered in the feedstuff. Laboratorium f$ur Pharmacologie und Toxicologie, Bredengrund 31, Hamburg-Hausbruch, Germany. Unpublished report submitted by the petitioner.
21. Leuschner F, 1972. 6-Month toxicity of 2837 D in Sprague-Dawley rats by administration in the diet (Report 100692, Laboratory for Pharmacology and Toxicology, Redderweg 8, 2104 Hamburg 92, Germany). Unpublished report submitted by the petitioner.
22. Leuschner F, 1974a. Investigation of the effect of 2837 D administered in the food on the pregnant rat and the foetus (Laboratorium f$ur Pharmacologie und Toxicologie, Bredengrund 31, 2104 Hamburg-Hausbruch, Germany). Unpublished report submitted by the petitioner.
23. Leuschner F, 1974b. Investigation of the effect of 2837 E administered in the food on the pregnant rabbit and the foetus (Laboratorium f$ur Pharmacologie und Toxicologie, Bredengrund 31, 2104 Hamburg-Hausbruch, Germany). Unpublished report submitted by the petitioner.
24. LSC Report, 1974. [14C] – EUDRAGIT®-E-30-D: The excretion and tissue distribution of radioactivity after oral administration to rats (Report No. 74/RGC1/174, Life Science Research, Stock, Essex, CM4 9PE, UK). Unpublished report submitted by the petitioner.
25. Ocké MC, Buurma-Rethans EJM and Fransen HP, 2005. RIVM report 350100001/2005. Dietary supplement use in the Netherlands, Current data and recommendations for future assessment. Available at: rivm.openrepository.com/rivm/bitstream/10029/7347/1/350100001.pdf.
26. Rossiello E, 2006. EUDRAGIT® NE 30 D: 4-Week oral toxicity study in minipigs (Study No. 31030, Research Toxicology Centre S.p.A., Via Tito Speri 12, 00040 Pomezia (RM), Italy). Unpublished report submitted by the petitioner.
27. Rossiello E, 2007. EUDRAGIT® NE 40 D: 26-Week oral toxicity study in dogs followed by a 3-Week recovery period (Study No. 53990, Research Toxicology Centre S.p.A., Via Tito Speri 12, 00040 Pomezia (RM), Italy). Unpublished report submitted by the petitioner.
28. Rote Liste® Service GmbH, Mainzer Landstr. 55, 60329 Frankfurt/Main 2009. www.rote-liste.de.
29. SCF, 1998. Opinion on an additional list of monomers and additives intended to be used for food contact materials (23 compounds) (expressed on 10 December 1998).
30. SCF, 1999. Reports of the Scientific Committee for Food, 42nd Series. Available at: ec.europa.eu/food/fs/sc/scf/reports/scf_reports_42.pdf.
31. Sokolowski A, 2005. Salmonella typhimurium reverse mutation assay with Eudragit NE 40 D (Study No. 901500, RCC Cytotest Cell Research GmbH, In den Leppsteinswiesen 19, 64380 Roßdorf, Germany). Unpublished report submitted by the petitioner.
32. Wollny HE, 2004. Cell mutation assay at the thymidine kinase locus (TK±) in mouse lymphoma L5178Y cells with EUDRAGIT NE 40 D (Study 855500, RCC Cytotest Cell Research GmbH, In den Leppsteinswiesen 19, 64380 Roßdorf, Germany). Unpublished report submitted by the petitioner.