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The application of post-market monitoring to novel foods

Autor: John Howlett, A. Davi, B. Moseley, Andrew Cockburn, P.A Hepburn, H. Boeing, N. de Jong, J.-M. Wal, Regina Oberdörfer, F. Samuels, Anne Constable, Claire E. Robertson

Publikováno v: Food and Chemical Toxicology. 46:9-33

The role of post-market monitoring (PMM) in the safety assessment of novel foods is critically discussed in order to derive guidelines as to in which situations the application of PMM might be warranted. Available data sources on food consumption and

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0d3242ef4fca8a33b42607e78378e721
https://doi.org/10.1016/j.fct.2007.09.008

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Post-market surveillance of GM foods: applicability and limitations of schemes used with pharmaceuticals and some non-GM novel foods

Autor: R.W.R. Crevel, L.J Lea, P.A Hepburn, J.-M. Wal

Publikováno v: Regulatory Toxicology and Pharmacology. 38:98-104

Post-market surveillance (PMS) is increasingly required by some regulatory authorities for the marketing approval of GM-Novel Foods. This requirement, in addition to a complete conventional safety assessment, aims to show that unexpected (adverse) ef

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::28959b76603491d02826e0f133acbac7
https://doi.org/10.1016/s0273-2300(03)00079-5

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The safety assessment of novel foods and concepts to determine their safety in use

Autor: Morten Poulsen, D.J.G. Müller, J. Kleiner, R. Walker, Ad A. C. M. Peijnenburg, D.G. Edwards, I. Perrin, J. Howlett, P.A Hepburn, G. Kozianowski, A. Cockburn, Dietrich Knorr

Publikováno v: International Journal of Food Sciences and Nutrition 54 (2003) 1 suppl. 5
International Journal of Food Sciences and Nutrition, 54(1 suppl. 5), S1-S32
Technical University of Denmark Orbit

(2003). The safety assessment of Novel Foods and concepts to determine their safety in use. International Journal of Food Sciences and Nutrition: Vol. 54, No. 5, pp. 1-32.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ba7de54785bb33d99f96d1114cd0ce60
https://doi.org/10.1080/09637480310001610308

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A 13-Week Feeding Study in the Rat with Shea Oleine and Hardened Shea Oleine

Autor: P.A Hepburn, Lesley K. Earl, Paul Baldrick

Publikováno v: International Journal of Toxicology. 21:13-22

Shea oleine is an oil fraction derived from the nut of the tree, Butyrospermum parkii, which grows in central and western Africa. There are several uses of shea oleine, including its use as a cooking oil and, after hardening, in margarine and toffee

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0c7a0ec99d0b8d4c16b3c5d83ee214dc
https://doi.org/10.1080/10915810252825984

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Safety evaluation of phytosterol esters. Part 5. Faecal short-chain fatty acid and microflora content, faecal bacterial enzyme activity and serum female sex hormones in healthy normolipidaemic volunteers consuming a controlled diet either with or without a phytosterol ester-enriched margarine

Autor: J.A Weststrate, P.A Hepburn, P.N Drewitt, R Ayesh

Publikováno v: Food and Chemical Toxicology. 37:1127-1138

A study was conducted in 12 healthy males and 12 healthy females (mean age 36 years, mean body mass index 24 kg/m2), to determine the effect of a margarine enriched with phytosterol esters on faecal short-chain fatty acids (SCFAs) and faecal bacteria

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7568e94b78c10907f245a53e46310c2f
https://doi.org/10.1016/s0278-6915(99)00109-x

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Approaches to the safety assessment of engineered nanomaterials (ENM) in food

Autor: Susan Wijnhoven, Anne Constable, Christoph Klein, Roberta Bradford, Andrew Cockburn, Gareth Edwards, Neil Robert Buck, Tanja Wildemann, Hermann Stamm, P.A Hepburn, Marek W. Radomski, Frans W.H. Kampers, Bernd Haber, John Howlett

Publikováno v: Food and Chemical Toxicology 50 (2012) 6
Food and Chemical Toxicology, 50(6), 2224-2242

A systematic, tiered approach to assess the safety of engineered nanomaterials (ENMs) in foods is presented. The ENM is first compared to its non-nano form counterpart to determine if ENM-specific assessment is required. Of highest concern from a tox

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4af5174417ea5fc1a7b6f64a1ae01397
https://research.wur.nl/en/publications/approaches-to-the-safety-assessment-of-engineered-nanomaterials-e

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Safety evaluation of phytosterol-esters. Part 9: Results of a European post-launch monitoring programme

Autor: L.J. Lea, P.A. Hepburn

Publikováno v: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 44(8)

Phytosterol-esters were developed by Unilever as a cholesterol lowering novel food ingredient for use initially in vegetable oil spreads. In addition to an extensive package of safety studies and clinical studies a programme of post-launch monitoring

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::79a1d90ce69a0249ea72fb0a65caecee
https://pubmed.ncbi.nlm.nih.gov/16542769

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An investigation of the general, reproductive and postnatal developmental toxicity of Betapol, a human milk fat equivalent

Autor: A.K Palmer, P.A Hepburn, M.J Spurgeon

Publikováno v: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 41(10)

Betapol consists of triglyceride fatty acids commonly found in vegetable and animal fats. A similarity to human milk fat indicated a potential use in infant formulae as well as for food use in general. To test the potential for substantial equivalenc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::39ed3db0d6d1ed0f37b48129edfcf585
https://pubmed.ncbi.nlm.nih.gov/12909269

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Safety evaluation of phytosterol esters. Part 8. Lack of genotoxicity and subchronic toxicity with phytosterol oxides

Autor: A.M Wolfreys, L.J Lea, Paul Baldrick, P.A Hepburn

Publikováno v: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 42(5)

Vegetable oil spreads containing phytosterol-esters are marketed as a cholesterol-lowering functional food in more than 20 countries worldwide. An extensive package of safety data has shown phytosterol-esters to be safe for human use. However, even t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::53a12485557b144a13564ed16aafb6de
https://pubmed.ncbi.nlm.nih.gov/15046823

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Safety evaluation of phytosterol esters. Part 7. Assessment of mutagenic activity of phytosterols, phytosterol esters and the cholesterol derivative, 4-cholesten-3-one

Autor: A.M. Wolfreys, P.A. Hepburn

Publikováno v: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 40(4)

Phytosterol esters are phytosterols derived from vegetable oils following esterification to fatty acids. When phytosterols are added to foods, they inhibit the absorption of dietary and endogenous cholesterol and thereby reduce blood cholesterol conc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::238f0710b9fc7c325c36f0d584525c0f
https://pubmed.ncbi.nlm.nih.gov/11893405

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