Scientific Opinion on the safety of refined Buglossoides oil as a novel food ingredient
2015; Wiley; Volume: 13; Issue: 2 Linguagem: Inglês
10.2903/j.efsa.2015.4029
ISSN1831-4732
Tópico(s)Agricultural safety and regulations
ResumoEFSA JournalVolume 13, Issue 2 4029 OpinionOpen Access Scientific Opinion on the safety of refined Buglossoides oil as a novel food ingredient EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)Search for more papers by this author EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)Search for more papers by this author First published: 25 February 2015 https://doi.org/10.2903/j.efsa.2015.4029Citations: 1 Panel members: Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen Correspondence: nda@efsa.europa.eu Acknowledgement: The Panel wishes to thank the members of the Working Group on Novel Foods: Paul Brantom, Karl-Heinz Engel, Marina Heinonen, Hannu Korhonen, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Seppo Salminen, Josef Schlatter, Hendrik Van Loveren and Hans Verhagen for the preparatory work on this scientific opinion. Adoption date: 5 February 2015 Published date: 25 February 2015 Question number: EFSA-Q-2014-00444 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on refined Buglossoides oil as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is produced from the seeds of Buglossoides arvensis (L.) I. M. Johnst, using processes conventionally used for edible oil production. The main fatty acids (FAs) contained in the NFI are alpha-linolenic acid (ALA), stearidonic acid (SDA) and linoleic acid, with smaller amounts of oleic acid, gamma-linolenic acid (GLA) and saturated FAs. With the exceptions of SDA and GLA, these FAs are widely present in common foods. The NFI is intended to be used in a range of foods and food supplements to provide approximately 200 mg of SDA per day. Upon digestion, FAs are used primarily as an energy source. ALA and SDA can be elongated and desaturated to produce eicosapentaenoic acid. In human studies using various sources of SDA, no increase or small increases in SDA were observed in blood cell membranes or in total plasma. The proposed specifications for pyrrolizidine alkaloids and erucic acid, which are undesirable substances, do not give rise to concern in view of the proposed conditions of use. The available information does not give concerns as regards other undesirable substances in the NFI. Available animal studies provide only limited information on the safety of the NFI. Human studies that investigated different plant oils or fatty acid ethyl esters as sources of SDA, GLA and ALA found no adverse effects with up to 4 200 mg SDA/day for 12 weeks, up to 1 700 mg GLA/day for 28 days and 9 100 mg ALA/day for four weeks. The Panel concludes that the NFI is safe for the proposed uses and use levels. References ACNFP (Advisory Committee on Novel Foods and Processes), 2011. Proteins in novel foods: issues for consideration. 5 pp. Barzanti V, Pregnolato P, Maranesi M, Bosi I, Baracco A, Solaini G and Turchetto E, 1995. Effect of dietary oils containing graded amounts of 18:3 n-6 and 18:4 n-3 on cell plasma membranes. Journal of Nutritional Biochemistry, 6(1), 21– 26. Brigham LA, Michaels PJ and Flores HE, 1999. Cell-specific production and antimicrobial activity of naphthoquinones in roots of lithospermum erythrorhizon. Plant Physiology, 119, 417– 428. Clapham AR, Tutin TG and Warburg EF, 1962. Flora of the British Isles ( 2nd Ed.). Cambridge University Press, Cambridge, UK. Codex Alimentarius, 1999. Codex standard for named vegetable oils. CODEX STAN 210-1999. Adopted 1999. Revisions 2001, 2003, 2009. Amendment 2005, 2011, 2013. 16 pp. Cramer L, Schiebel HM, Ernst L and Beuerle T, 2013. Pyrrolizidine alkaloids in the food chain: development, validation, and application of a new HPLC-ESI-MS/MS sum parameter method. Journal of Agricultural and Food Chemistry, 61, 11382– 11391. Cramer L, Fleck G, Horn G and Beuerle T, 2014. Process Development of Lappula squarrosa Oil Refinement: Monitoring of Pyrrolizidine Alkaloids in Boraginaceae Seed Oils. Journal of the American Oil Chemists' Society, 91, 721– 731. Croda Chemicals Europe Ltd., 2006. Application for the approval of refined Echium oil (stearidonic acid-rich oil from Echium plantagineum). 50 pp. Crozier GL, Fleith M, Traitler H and Finot PA, 1989. Black currant seed oil feeding and fatty acids in liver lipid classes of guinea pigs. Lipids, 24, 460– 466. Dinan L, Savchenko T and Whiting P, 2001. On the distribution of phytoecdysteroids in plants. Cellular and Molecular Life Sciences, 58, 1121– 1132. EFSA (European Food Safety Authority), 2009. Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other substances of concern on request of EFSA. EFSA Journal 2009; 7(9): 281, 100 pp. doi:10.2903/j.efsa.2009.281. EFSA (European Food Safety Authority), 2012. Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health when used in food and food supplements. EFSA Journal 2012; 10(5): 2663, 60 pp. doi:10.2903/j.efsa.2012.2663. EFSA Panel on Contaminants in the Food Chain (CONTAM), 2011. Scientific Opinion on Pyrrolizidine alkaloids in food and feed. EFSA Journal 2011; 9(11): 2406, 134 pp. doi:10.2903/j.efsa.2011.2406. EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2014. Scientific Opinion on application (EFSA-GMO-UK-2009-76) for the placing on the market of soybean MON 87769 genetically modified to contain stearidonic acid, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal 2014; 12(5): 3644, 41 pp. doi:10.2903/j.efsa.2014.3644. EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA), 2010. Scientific Opinion on Dietary Reference Values for fats, including saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, trans fatty acids, and cholesterol. EFSA Journal 2010; 8(3): 1461, 107 pp., doi:10.2903/j.efsa.2010.1461. Engler MM, 1993. Comparative study of diets enriched with evening primrose, black currant, borage or fungal oils on blood pressure and pressor responses in spontaneously hypertensive rats. Prostaglandins, Leukotrienes and Essential Fatty Acids, 49, 809– 814. Everett DJ, Greenough RJ, Perry CJ, McDonald P and Bayliss P, 1988. Chronic toxicity studies of Efamol evening primrose oil in rats and dogs. Medical Science Research, 16(16), 863– 864. Findley WE and Jacobs BR, 1980. The antigonadotropic activity of Lithospermum ruderale I. The lack of steroid-like activity at the receptor level. Contraception, 21, 199– 205. Gracious BL, Chirieac MC, Costescu S, Finucane TL, Youngstrom EA and Hibbeln JR, 2010. Randomized, placebo-controlled trial of flax oil in pediatric bipolar disorder. Bipolar Disorders, 12, 142– 154. Hammond BG, Lemen JK, Ahmed G, Miller KD, Kirkpatrick J and Fleeman T, 2008. Safety assessment of SDA soybean oil: results of a 28-day gavage study and a 90-day/one generation reproduction feeding study in rats. Regulatory Toxicology and Pharmacology, 52, 311– 323. Harris WS, DiRienzo MA, Sands SA, George C, Jones PG and Eapen AK, 2007. Stearidonic acid increases the red blood cell and heart eicosapentaenoic acid content in dogs. Lipids, 42, 325– 333. Harris WS, Lemke SL, Hansen SN, Goldstein DA, DiRienzo MA, Su H, Nemeth MA, Taylor ML, Ahmed G and George C, 2008. Stearidonic acid-enriched soybean oil increased the omega-3 index, an emerging cardiovascular risk marker. Lipids, 43, 805– 811. Huang YS, Smith RS, Redden PR, Cantrill RC and Horrobin DF, 1991. Modification of liver fatty acid metabolism in mice by n-3 and n-6 delta 6-desaturase substrates and products. Biochimica et Biophysica Acta: Protein Structure and Molecular Enzymology, 1082, 319– 327. Ilarionov I, 1989. Androgenic and aphrodesiac action of the medicinal plant Lithospermum arvense [Bulgarian]. Eksperimentalna Meditsina i Morfologiya, 28, 28– 33. Ishihara K, Komatsu W, Saito H and Shinohara K, 2002. Comparison of the effects of dietary alpha-linolenic, stearidonic, and eicosapentaenoic acids on production of inflammatory mediators in mice. Lipids, 37, 481– 486. James MJ, Ursin VM and Cleland LG, 2003. Metabolism of stearidonic acid in human subjects: comparison with the metabolism of other n-3 fatty acids. American Journal of Clinical Nutrition, 77, 1140– 1145. Kelley DS, Nelson GJ, Love JE, Branch LB, Taylor PC, Schmidt PC, Mackey BE and Iacono JM, 1993. Dietary alpha-linolenic acid alters tissue fatty acid composition, but not blood lipids, lipoproteins or coagulation status in humans. Lipids, 28, 533– 537. Lemke SL, Vicini JL, Su H, Goldstein DA, Nemeth MA, Krul ES and Harris WS, 2010. Dietary intake of stearidonic acid-enriched soybean oil increases the omega-3 index: randomized, double-blind clinical study of efficacy and safety. American Journal of Clinical Nutrition, 92, 766– 775. Linnaeus C, 1753. Species plantarum. Tomus 1. p. 132. Miles EA, Banerjee T, Dooper MM, M'Rabet L, Graus YM and Calder PC, 2004a. The influence of different combinations of gamma-linolenic acid, stearidonic acid and EPA on immune function in healthy young male subjects. British Journal of Nutrition, 91, 893– 903. Miles EA, Banerjee T and Calder PC, 2004b. The influence of different combinations of gamma-linolenic, stearidonic and eicosapentaenoic acids on the fatty acid composition of blood lipids and mononuclear cells in human volunteers. Prostaglandins, Leukotrienes and Essential Fatty Acids, 70, 529– 538. Miles EA, Banerjee T and Calder PC, 2006. Self-reported health problems in young male subjects supplementing their diet with oils rich in eicosapentaenoic, gamma-linolenic and stearidonic acids. Prostaglandins, Leukotrienes and Essential Fatty Acids, 75, 57– 60. Papageorgiou VP, Assimopoulou AN and Couladouros EA, 1999. The chemistry and biology of alkannin, shikonin, and related naphthazarin natural products. Angewandte Chemie International Edition, 38, 270– 300. Plante S and Surette M, 2012. Feeding trial #1. Comparison of the nutritional properties of Buglossoides arvensis oil versus herring oil in Atlantic salmon (Salmo salar) fry. Unpublished study report. 3 pp. Rigby NM, Sancho AI, Salt LJ, Foxall R, Taylor S, Raczynski A, Cochrane SA, Crevel RW and Mills EN, 2011. Quantification and partial characterization of the residual protein in fully and partially refined commercial soybean oils. Journal of Agricultural and Food Chemistry, 59, 1752– 1759. Sandroni P, 2001. Aphrodisiacs past and present: a historical review. Clinical Autonomic Research, 11, 303– 307. Su L, Liu L, Wang Y, Yan G and Zhang Y, 2013. Long-term systemic toxicity of shikonin derivatives in Wistar rats. Pharmaceutical Biology. Surette M and Matar C, 2012. Evaluation of dietary Buglossoides oil and milk protein hydrolysates. Unpublished study report. Unpublished, 20 pp. Surette ME, Edens M, Chilton FH and Tramposch KM, 2004. Dietary echium oil increases plasma and neutrophil long-chain (n-3) fatty acids and lowers serum triacylglycerols in hypertriglyceridemic humans. Journal of Nutrition, 134, 1406– 1411. Surette ME, 2013. Dietary omega-3 PUFA and health: stearidonic acid-containing seed oils as effective and sustainable alternatives to traditional marine oils. Molecular Nutrition & Food Research, 57, 748– 759. Takeuchi H, Sakurai C, Noda R, Sekine S, Murano Y, Wanaka K, Kasai M, Watanabe S, Aoyama T and Kondo K, 2007. Antihypertensive effect and safety of dietary alpha-linolenic acid in subjects with high-normal blood pressure and mild hypertension. J Oleo Sci, 56, 347– 360. Wainwright PE, Huang YS, DeMichele SJ, Xing H, Liu JW, Chuang LT and Biederman J, 2003. Effects of high-gamma-linolenic acid canola oil compared with borage oil on reproduction, growth, and brain and behavioral development in mice. Lipids, 38, 171– 178. Weston PA, Weston LA and Hildebrand S, 2012. Environmental impact on biocontrol agents and secondary chemistry of Paterson's curse (Echium plantagineum). Eighteenth Australasian Weeds Conference, 203– 207. Whelan J, 2009. Dietary stearidonic acid is a long chain (n-3) polyunsaturated fatty acid with potential health benefits. Journal of Nutrition, 139, 5– 10. Yamazaki K, Fujikawa M, Hamazaki T, Yano S and Shono T, 1992. Comparison of the conversion rates of alpha-linolenic acid (18:3(n - 3)) and stearidonic acid (18:4(n - 3)) to longer polyunsaturated fatty acids in rats. Biochimica et Biophysica Acta: Protein Structure and Molecular Enzymology, 1123, 18– 26. Yazaki K, Matsuoka H, Shimomura K, Bechthold A and Sato F, 2001. A novel dark-inducible protein, LeDI-2, and its involvement in root-specific secondary metabolism in Lithospermum erythrorhizon. Plant Physiology, 125, 1831– 1841. Citing Literature Volume13, Issue2February 20154029 ReferencesRelatedInformation
Referência(s)