The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world
In: Beneficial MicrobesSearch for other papers by T.M.G. Dronkers in
Current site
Google Scholar
Search for other papers by L. Krist in
Current site
Google Scholar
Search for other papers by F.J. Van Overveld in
Current site
Google Scholar
Search for other papers by G.T. Rijkers in
Current site
Google Scholar
The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.
Purchase
Buy instant access (PDF download and unlimited online access):
Institutional Login
Log in with Open Athens, Shibboleth, or your institutional credentials
Personal login
Log in with your brill.com account
-
Amagase, H., 2008. Current marketplace for probiotics: a Japanese perspective. Clinical and Infectious Diseases 46, Suppl. 2: S73-75.
'Current marketplace for probiotics: a Japanese perspective ' () 46 Clinical and Infectious Diseases : S73 -75.
-
Arroyo, R., Martín, V., Maldonado, A., Jiménez, E., Fernández, L. and Rodríguez, J.M., 2010. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clinical and Infectious Diseases 50: 1551-1558.
'Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk ' () 50 Clinical and Infectious Diseases : 1551 -1558.
-
Asp, N.-G. and Bryngelsson, S., 2008 Health claims in Europe: new legislation and PASSCLAIM for substantiation. Journal of Nutrition 138: 1210S-1215S.
'Health claims in Europe: new legislation and PASSCLAIM for substantiation ' () 138 Journal of Nutrition : 1210S -1215S.
-
Binnendijk, K.H. and Rijkers, G.T., 2013. What is a health benefit? An evaluation of EFSA opinions on health benefits with reference to probiotics. Beneficial Microbes 4: 223-230.
'What is a health benefit? An evaluation of EFSA opinions on health benefits with reference to probiotics ' () 4 Beneficial Microbes : 223 -230.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2010. Scientific Opinion on the substantiation of health claims related to live yoghurt cultures and improved lactose digestion (ID 1143, 2976) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 8: 1763.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2013a. Scientific Opinion on the substantiation of a health claim related to Yestimun® and defence against pathogens in the upper respiratory tract pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 11: 3159.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2013b. Scientific Opinion on the substantiation of a health claim related to Lactobacillus rhamnosus GG and maintenance of normal defecation during antibiotic treatment pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 11: 3256.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2013c. Scientific Opinion on the substantiation of a health claim related to Transitech® and improvement of bowel function which is maintained after cessation of consumption of the food pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 11: 3258.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2013d. Scientific Opinion on the substantiation of a health claim related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 11: 3412.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2014a. Scientific Opinion on the substantiation of a health claim related to a combination of Bifidobacterium longum LA 101, Lactobacillus helveticus LA 102, Lactococcus lactis LA 103 and Streptococcus thermophilus LA 104 and reducing intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 12: 3658.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2014b. Scientific Opinion on the substantiation of a health claim related to a combination of Bifidobacterium longum LA 101, Lactobacillus helveticus LA 102, Lactococcus lactis LA 103 and Streptococcus thermophilus LA 104 and improvement of bowel function by increasing stool frequency pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 12: 3659.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2014c. Scientific Opinion on the substantiation of a health claim related to ‘ Lactobacillus plantarum TENSIA® in the semi-hard Edam-type “heart cheese” of Harmony™’ and maintenance of normal blood pressure pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 12: 3842.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2015a. Scientific Opinion on the substantiation of a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 13: 4094.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2015b. Scientific Opinion on the substantiation of a health claim related to SYNBIO®, a combination of Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®, and maintenance of normal defecation pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 13: 4095.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2016a. Lactobacillus plantarum 299v and an increase of non-haem iron absorption: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 14: 4550.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2016b. Scientific opinion on low-fat fermented milk with a combination of fructo-oligosaccharides and live Lactobacillus rhamnosus GG (ATCC 53103), Streptococcus thermophilus(Z57) and Lactobacillus bulgaricus(LB2), and defence against reactivation of Herpes simplex virus in the orolabial epithelia: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 14: 4538.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2017. Scientific Opinion on ‘Nutrimune®’ and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 15: 4679.
-
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 2017a. Scientific Opinion on the Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 15: 4917.
-
European Commission (EC), 2017. EU Register of nutrition and health claims made on foods. Available at: https://tinyurl.com/y7sauo7d.
-
European Food Safety Authority (EFSA), 2015. Shaping the future of food safety, together: proceedings of the 2nd EFSA Scientific Conference. Milan, Italy, 14-16 October 2015. EFSA Journal 13: s1310.
-
European Food Safety Authority (EFSA), 2017. Outcome of a public consultation on the draft scientific and technical guidance for the preparation and presentation of a health claim application. EFSA Supporting Publication 2017: EN-1159.
-
Fernández, L., Cárdenas, N., Arroyo, R., Manzano, S., Jiménez, E., Martín, V. and Rodríguez, J.M., 2016. Prevention of infectious mastitis by oral administration of Lactobacillus salivarius PS2 during late pregnancy. Clinical and Infectious Diseases 62: 568-573.
'Prevention of infectious mastitis by oral administration of Lactobacillus salivarius PS2 during late pregnancy ' () 62 Clinical and Infectious Diseases : 568 -573.
-
Food Directorate, Health Products and Food Branch, 2009. Guidance document – the use of probiotic microorganisms in food. Available at: https://tinyurl.com/ydgtjgag.
-
Health Canada, 2009. Accepted Claims about the Nature of Probiotic Microorganisms in Food. Available at: http://tinyurl.com/ya3w96gn.
-
Hoffmann, D.E., Fraser, C.M., Palumbo, F., Ravel, J., Rowthorn, V. and Schwartz, J., 2014. Probiotics: achieving a better regulatory fit. Food Drug Law Journal 69: 237-272.
'Probiotics: achieving a better regulatory fit ' () 69 Food Drug Law Journal : 237 -272.
-
Hoffmann, D.E., Fraser, C.M., Palumbo, F., Ravel, J., Rowthorn, V. and Schwartz, J., 2016. Final report federal regulation of probiotics: an analysis of the existing regulatory framework and recommendations for alternative frameworks, November 15, 2012. Available at: https://tinyurl.com/y93325mb.
-
Hoffmann, D.E., Fraser, C.M., Palumbo, F.B., Ravel, J., Rothenberg, K., Rowthorn, V. and Schwartz, J., 2013. Probiotics: finding the right regulatory balance. Science 342: 314-315.
'Probiotics: finding the right regulatory balance ' () 342 Science : 314 -315.
-
Indian Council of Medical Research, 2011. ICMR-DBT guidelines for evaluation of probiotics in food. Available at: http://tinyurl.com/ycbkph86.
-
Jahanfar, S., Ng, C.J. and Teng, C.L., 2013. Antibiotics for mastitis in breastfeeding women. Cochrane Database Systematic Reviews 28: CD005458.
'Antibiotics for mastitis in breastfeeding women ' () 28 Cochrane Database Systematic Reviews : CD005458.
-
Kamioka, H., Tsutani, K., Origasa, H., Yoshizaki, T., Kitayuguchi, J., Shimada, M., Tang, W. and Takano-Ohmuro, H., 2017. Quality of systematic reviews of the foods with function claims registered at the consumer affairs agency web site in Japan: a prospective systematic review. Nutrition Research 40: 21-31.
'Quality of systematic reviews of the foods with function claims registered at the consumer affairs agency web site in Japan: a prospective systematic review ' () 40 Nutrition Research : 21 -31.
-
Kondo, J., Xiao, J.Z., Shirahata, A., Baba, M., Abe, A., Ogawa, K. and Shimoda, T., 2013. Modulatory effects of Bifidobacterium longum BB536 on defecation in elderly patients receiving enteral feeding. World Journal of Gastroenterology 19: 2162-2170.
'Modulatory effects of Bifidobacterium longum BB536 on defecation in elderly patients receiving enteral feeding ' () 19 World Journal of Gastroenterology : 2162 -2170.
-
Lee, Y.K., Conway, P., Pettersson, S., Nair, G.B., Surono, I., Egayanti, Y. and Amarra, M.S., 2017. ILSI Southeast Asia Region conference proceedings: the gut, its microbes and health: relevance for Asia. Asia Pacific Journal of Clinical Nutrition 26: 957-971.
'ILSI Southeast Asia Region conference proceedings: the gut, its microbes and health: relevance for Asia ' () 26 Asia Pacific Journal of Clinical Nutrition : 957 -971.
-
Ministry for Primary Industries, 2016. Global regulatory environment of health claims on foods. MPI Technical Paper No. 2016/16. Available at: https://tinyurl.com/yaoeooh6.
-
Patro, J.N., Ramachandran, P., Barnaba, T., Mammel, M.K., Lewis, J.L. and Elkins, C.A., 2016. Culture-independent metagenomic surveillance of commercially available probiotics with high-throughput next-generation sequencing. mSphere 1: e00057-16.
'Culture-independent metagenomic surveillance of commercially available probiotics with high-throughput next-generation sequencing ' () 1 mSphere : e00057 -16.
-
Saldanha, L.G., 2008. US Food and Drug Administration regulations governing label claims for food products, including probiotics. Clinical Infectious Diseases 46, Suppl. 2: S119-121.
'US Food and Drug Administration regulations governing label claims for food products, including probiotics ' () 46 Clinical Infectious Diseases : S119 -121.
-
Schweizerische Bundesamt für Lebensmittelsicherheit und Veterinärwesen (FSVO/BLV), 2018. Zugelassene gesundheitsbezogene Angaben gemäss Art. 29g der Verordnung über die Kennzeichnung und Anpreisung von Lebensmitteln (LKV). (LKV; SR 817.022.21). Available at: https://tinyurl.com/ycvkylld.
-
Shimizu, M., 2012. Functional food in Japan: current status and future of gut-modulating food. Journal of Food and Drug Analysis 20, Suppl. 1: 213-216.
'Functional food in Japan: current status and future of gut-modulating food ' () 20 Journal of Food and Drug Analysis : 213 -216.
-
Stringueta, P.S., Da Penha Henriques do Amaral, M., Brumano, L.P., Santana Pereira, M.C. and De Oliveira Pinto, M.A., 2012. Public health policies and functional property claims for food in Brazil. In: Eissa, A.A. (ed.) Structure and function of food engineering agricultural and biological sciences. Intech Publisher, Rijeka, Croatia, pp. 307-336.
'Public health policies and functional property claims for food in Brazil ', in Intech Publisher, Rijeka, Croatia , () 307 -336.
-
US Food and Drug Administration (FDA), 2017. Authorized health claims that meet the Significant Scientific Agreement (SSA) standard. Available at: https://tinyurl.com/y6w2cjxg.
-
Yang, Y., 2008. Scientific substantiation of functional food health claims in China. Journal of Nutrition 138: 1199-1205S.
'Scientific substantiation of functional food health claims in China ' () 138 Journal of Nutrition : 1199 -1205S.
| All Time | Past 365 days | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 653 | 171 | 12 |
| Full Text Views | 35 | 14 | 0 |
| PDF Views & Downloads | 58 | 19 | 0 |
The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world
In: Beneficial MicrobesSearch for other papers by T.M.G. Dronkers in
Current site
Google Scholar
PubMed
Search for other papers by L. Krist in
Current site
Google Scholar
PubMed
Search for other papers by F.J. Van Overveld in
Current site
Google Scholar
PubMed
Search for other papers by G.T. Rijkers in
Current site
Google Scholar
PubMed
The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.
| All Time | Past 365 days | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 653 | 171 | 12 |
| Full Text Views | 35 | 14 | 0 |
| PDF Views & Downloads | 58 | 19 | 0 |
