Scientific Opinion on the use of high viscosity white mineral oils as a food additive

EFSA Journal

Volumn 7, Issue 11, 2009, Pages

[No Author Info available]

Author keywords

CAS Number 8042 47 5; High viscosity white mineral oils; Liquid paraffin; Paraffinum Liquidum

Indexed keywords

EID: 85022132888     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2009.1387     Document Type: Article

References (56)

1. AFSSA, 2005. Avis de l'Agence française de sécurité des aliments relatif à l'autorisation d'emploi en tant qu'auxiliaire technologique d'huiles minérales blanches obtenues par le procédé d'hydrocraquage et le procédé à l'oleum. 22 juin 2005. www.afssa.fr/Documents/AAAT2004sa0266.pdf.
2. Albro, PW and Fishbein L, 1970. Absorption of aliphatic hydrocarbons in rats. Biochim. Biophys. Acta 219, 437.
3. American Petroleum Institute (API), 1990. API Mineral oil review, CD8923902. Submitted on April 9, 1990 to FDA by API, Washington, D.C.
4. Biles, RW, McKee RH, Lewis SC, Scala RA, DePass LR, 1988. Dermal carcinogenic activity of petroleum-derived middle distillate fuels. Toxicology, 53, 301–314.
5. Boitnott JK and Margolis S, 1966. Mineral oil in human tissues. II. Oil droplets in lymph nodes of the Porta Hepatis. Bull. Johns Hopk. Hosp. 118, 414.
6. Boitnott, JK and Margolis S, 1970. Saturated hydrocarbons in human tissues. III. Oil droplets in the liver and spleen. Johns Hopkins Med. J., 127.
7. Carlton WW, Boitnott JK, Dungworth DL, Ernst H, Hayashi Y, Mohr U, Parodi AL, Pattengale PK, Rittinghausen S and Ward JM, 2001. Assessment of the morphology and significance of the lymph nodal and hepatic lesions produced in rats by feeding of certain mineral oils and waxes. Experimental and Toxicologic Pathology 53, 247–255.
8. Castle L, Kelly, M and Gilbert J, 1993a. Migration of mineral hydrocarbons into food. 2. Polystyrene, ABS and waxed paperboard containers for dairy products. Food Additives and Contaminants 10, 167–174.
9. Castle L, Kelly M and Gilbert J, 1993b. Migration of mineral hydrocarbons into food. 3. Cheese coatings and temporary casings for skinless sausages. Food Additives and Contaminants 10, 175–184.
10. Castle L, Kelly M and Gilbert J, 1994a. Migration of mineral hydrocarbons into food. 4. Waxed paper for packaging dry goods including bread, confectionery and for domestic use including microwave cooking. Food Additives and Contaminants 11, 79–89.
11. Castle L, Kelly M and Gilbert J, 1994b. Migration of mineral hydrocarbons into food. 5. Miscellaneous applications of mineral hydrocarbons in food materials. Food Additives and Contaminants 11, 333–341.
12. Castle L, Kelly M and Gilbert J, 1994c. Migration of mineral hydrocarbons into food. 6. Press lubricants used in food and beverage cans. Food Additives and Contaminants 11, 595–604.
13. CONCAWE (Conservation of Clean Air and Water in Europe), 1984. Assessment and comparison of the composition of food-grade white oils and waxes manufactured from petroleum by catalytic hydrogenation versus conventional treatment. CONCAWE report N°84/60. CONCAWE, Brussels, Belgium.
14. CONCAWE (Conservation of Clean Air and Water in Europe), 1993. White Oils and waxes-summary of 90-day studies. Concawe report N°93/56. CONCAWE, Brussels, Belgium.
15. Cruickshank B and Thomas MJ, 1984a. Mineral oil (follicular) lipidosis: Histologic studies of spleen, liver, lymph odes, and bone marrow. Hum. Pathol. 15, 731–737.
16. Cruickshank B, 1984b. Follicular (mineral oil) lipidosis: epidemiology studies of involvement of the spleen. Hum. Pathol. 15, 724–730.
17. Dincsoy HP, Weesner RE and MacGee J, 1982. Lipogranulomas in non-fatty human livers. Am. J. Clin. Pathol. 78(1), 35–41.
18. EFSA, 2004. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to Pullulan PI-20 for use as a new food additive' The EFSA Journal (2004) 85, 1–32.
19. EFSA, 2008. Scientific Opinion of the Panel on Contaminants in the Food Chain on a request from the European Commission on Polycyclic Aromatic Hydrocarbons in Food. The EFSA Journal (2008) 724, 1–114.
20. Esso Research, 1960. In ‘Petition by American Petroleum Institute on behalf of the manufacturers of white mineral oil to the US Food and Drug Administration to establish a regulation for the use of white mineral oil as a food additive under the Food Additives Amendment of 1958’, pp 28–29.
21. European Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs. OJ L 220/18, 15.8.2002.
22. European Pharmacopoeia, 2005. Liquid Paraffin Monograph, European Directorate for the Quality of Medicine, Strasbourg, France.
23. Exxon Biomedical Sciences, 2001. Combined chronic toxicity/carcinogenicity study of white oil in Fischer 344 rats. Unpublished report numbers 105970 and 106870. Submitted to WHO by CONCAWE, Brussels, Belgium.
24. Feich AG, 1998. Dietary Exposure assessment for direct and indirect food-use applications for mineral hydrocarbons, Unpublished report prepared for API by ENVIRON. Submitted to WHO.
25. Fleming KA, Zimmerman H and Shubik P, 1998. Granulomas in the Livers of Humans and Fischer Rats Associated with the Ingestion of Mineral Hydrocarbons: A Comparison. Reg. Tox & Pharm. 27, 75–81.
26. Gregory J, Tyler H and Wiseman M, 1990. The Dietary and Nutritional Survey of British Adults. Her Majesty's Stationery Office. London. England.
27. Gregory JR, Collins DL, Davies PSW, Hughes JM and Clarke PC, 1995. National Diet and Nutrition Survey; Children aged 1½ to 4½ years. Her Majesty's Stationery Office. London. England.
28. Gregory J, 2000. National Diet and Nutrition Survey: young people aged 4 to 18 years. Findings: Volume 1. The Stationery Office. London. England.
29. Grob K, Huber M, Boderius U, Bronz M, 1997. Mineral oil material in canned foods. Food Additives and Contaminants 14(1), 83–88.
30. Halladay JS, Mackerer CR, Twerdok LE, and Sipes IG, 2002. Comparative pharmacokinetic and disposition studies of [1–14C] 1-eicosanylcyclohexane, a surrogate mineral hydrocarbon (MHC), in female Fischer-344 and Sprague-Dawley rats. Drug Metab. Disp. 30, 1470–7.
31. Haenni EO, Joe FL, Howard JW, Leibel RL, 1962. A More Sensitive and Selective Ultraviolet Absorption Criterion for Mineral Oil. J.A.O.A.C. 45, N°1.
32. Heimbach JT, Bodor AR, Douglass JS, Barraj LM, Cohen SC, Biles RW and Faust HR, 2002. Dietary exposures to mineral hydrocarbons from food-use applications in the United States. Food Chem. Toxicol. 40:555–71.
33. Huntington Life Science, 2000. A Subchronic 90-Day Dietary Toxicity Study of A Low Melting Point Paraffin Wax in two Rat Stains. Prepared Under Contract for the White Oils and Waxes Research Group as Administered by the American Petroleum Institute.
34. JECFA (Joint Expert Committee for Food Additives), 1995. FAO/WHO, Monograph INS N° 905a.
35. JECFA (Joint Expert Committee for Food Additives), 2002. FAO/WHO, Monograph INS N° 905a.
36. Klatskin G, 1977. Hepatic granulomata: Problems in interpretation. Mt. Sinai J. Med. 44, 798–812.
37. Lanzon A, Albi T, Cert A and Gracián J, 1994. The hydrocarbons fraction of virgin olive oil and changes resulting from refining. J. Am. Oil. Chem. Soc. 71, 285.291.
38. Low LK, Stymanski PM, Komminini C, Naro PA and Mackerer CR, 1992. Oral absorption and pharmacokinetic studies of radio0labelled normal paraffinic, isoparaffinic and cycloparaffinic surrogates in white oil in Fischer-344 rats. In: Special Meeting on Mineral Hydrocarbons. The Toxicology Forum, Oxford. pp. 86–101.
39. Mackerer CR, Low, LK, Halladay JS and Freeman JJ (unpublished data submitted by the petitioner in its application). Pharmacokinetic and Disposition Studies of Radiolabelled Markers for Cycloparaffin, Isoparaffin and n-Paraffin Classes of White Oil Components in the Female Fischer 344 Rat.
40. McKee RH, Pasternak SJ and Traul KA, 1987a. Developmental toxicity of EDS recycle solvent and fuel oil. Toxicology 46, pp 205–215.
41. McKee RH, Plutnick RT and Traul KA, 1987b. Assessment of the potential reproductive and subchronic toxicity of EDS coal liquids in Sprague-Dawley rats. Toxicology Vol. 46, pp 267–280.
42. Rose HG and Liber AF, 1966. Accumulation of saturated hydrocarbons in human spleens. J. Lab. Clin. Med. 68, 475–483.
43. Scientific Committee on Food, 1995. Opinion on mineral synthetic hydrocarbons. Reports of the Scientific Committee for Food, (37th series published in 1997).
44. Schreiner C, Bui Q, Breglia R, Burnett D, Koschier F, Podhasky P, Lapadula L, White R, Feuston M, Krueger A and Rodriquez S, 1997. Toxicity evaluation of petroleum blending streams: Reproductive and developmental effects of hydrodesulfurized kerosine. J. Tox & Env Health 52(3), 211–229.
45. Scotter MJ, Castle L, Massey RC, Brantom PG and Cunninghame ME, 2003. A study of the toxicity of five mineral hydrocarbon waxes and oils in the F344 rat, with histological examination and tissue-specific chemical characterisation of accumulated hydrocarbon material. Food Chem. Tox. 41, 489–521.
46. Shoda T, Toyoda K, Uneyama C, Takada K and Takahashi M, 1997. Lack of carcinogenicity of medium-viscosity liquid paraffin given in the diet to Fischer 344 rats. Food Chem. Toxicol. 35, 1181–1190.
47. Smith JH, Mallett AK, Priston RAJ, Brantom PG, Worrell NR, Sexsmith C and Simpson B.J., 1996. Ninety-day feeding study in Fischer-344 rats of highly refined petroleum-derived food-grade white oils and waxes. Toxicol. Pathol. 24, 214–230.
48. Smith JH, Bird MG, Lewis SC, Freeman JJ, Hogan GK and Scala RA, 1995. Subchronic study of four white mineral oils in dogs and rats. Drug Chem. Toxicol. 18, 83–103.
49. Stryker WA, 1941. Absorption of liquid petrolatum (“Mineral oil”) from the intestine. Arch.* Pathol. 31, 670.
50. Tennant DR, 2001. The usage, occurrence and dietary intake of white mineral oils and waxes and naturally occurring hydrocarbons in Europe. Unpublished report prepared for CONCAWE and EWF by Food Chemical Risk Analysis, Brighton, England. Submitted to WHO by CONCAWE, Brussels, Belgium.
51. Trimmer GW, Freeman JJ, Priston RAJ and Urbanus J, 2004. Results of dietary chronic toxicity studies of high viscosity (P70 and P100) white mineral oils in Fischer 344 rats. Tox Path. 32, 439–447.
52. UK Food Standards Agency, 2003. Survey 34/03, Mineral Hydrocarbons in Food Contact Materials. London, England.
53. United States Pharmacopeia - The National Formulary, 2003. Page 1237. United States Pharmacopeial Convention, Rockville, Maryland.
54. USA Food Chemical Codex, 5th Edition, 2003. Monograph “Mineral Oil”. National Academies Press.
55. Volatier J-L, 2000. Enquête Individuelle et Nationale sur les Consommations Alimentaires (INCA). Technique & Documentation, Paris, France. ISBN: 2-7430-0426-6.
56. Wanless IR and Geddie WR, 1985. Mineral oil lipogranulomata in liver and spleen: A study of 465 autopsies. Arch. Pathol. Lab. Med. 109(3), 283–286.