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danone awaits efsa guidance on probiotic health claims
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french dairy giant danone has withdrawn claims from the controversial eu nutrition and health claim process because it is waiting for procedural guidance from the claims assessment agency, the european food safety authority (efsa). danone issued a statement to that effect on friday evening after nutraingredients.com revealed it had pulled from the process two article 13.5 gut health claims for its spoonable probiotic yoghurt, actimel, and one 13.5 immunity claim for its drinkable yoghurt, activia. still learning danone said companies were still in a “learning stage” about the “new and complex procedure” and that, while it remained confident about the strength of its claims, it decided it was better to remove the claims from the process until further guidance was issued by efsa, due by mid-may. groupe danone corporate communications director in health, nature and external communication, agnès berthet-d'anthonay, said the regulation was not clear in its demands on companies and that it was, “better to know the rules before playing the game”. she said once this clarification occurred the company would resubmit its dossiers, with potential changes occurring in claim wording. “we will not change the studies that are in the dossiers but it may be that the way the information is presented needs to be changed and the wording may have to be modified,” berthet-d'anthonay told nutraingredients.com this morning. “it is a difficult thing to find the correct wording and that has contributed to the fact no article 13.5 claims have as yet been accepted by efsa. but we are very confident about the strength of our science.” the three withdrawn claims are: . improves digestive comfort (activia) . improves slow transit (activia) . helps to strengthen the body’s natural defences (actimel) these claims are already employed on its products so to have this communication tool stripped from it would be a massive body blow for danone, not to mention the bad publicity that could follow any efsa negative opinion. danone said its dossiers contained 24 scientific publications for actimel, and 16 for activia, published in “highly reputed scientific journals”. further guidance from efsa efsa is holding a health claims summit in brussels on june 15 and is in the process of publishing a faq (frequently asked questions) document, but when contacted by nutraingredients.com this morning would not reveal any detail about the kind of clarification that would be forthcoming in both the faq and the brussels meeting. in a statement on its website, efsa said: “in the light of the experience gained with the evaluation of health claims applications, efsa will provide further guidance to applicants for the preparation and presentation of applications for article 14 and 13.5 claims in the form of a document outlining answers to faq.” that statement can be viewed here . “efsa has recently decided to call a meeting in order to provide further guidance to applicants for the preparation and presentation of applications for article 14 and 13.5 claims,” danone said in friday’s statement. “in this context, groupe danone has - like several other industry players - decided to withdraw three applications... we welcome the new process and remain committed to working with efsa.” danone is not the first major food or ingredients supplier to pull out of the european claims process. in the article 14 disease reduction and children’s claims list, something like 10 claims have been withdrawn from the likes of nestle, unilever and valio as well as the irish dairy council and the france-based association of the food industries for particular nutritional uses of the european union (idace). the 2006 nutrition and health claims regulation aims to formulate a centralised health claims list under the nutrition and health claims regulation that is due for completion in january, 2010. activia and actimel, and versions of them that sell under different names in different markets, are some of the most successful functional foods in the world, with sales in the billions of euros. us 'misleading' claims case meanwhile, last week it emerged that dannon, the us arm of danone, is settling class actions mounted against it for making misleading probiotic health claims. dannon spokesperson, michael neuwirth told nutraingredients-usa.com that “we stand by our claims and will continue to defend them ” but refused to deny that dannon was settling out-of-court in class actions that sought at least $300m.
Source :Food Safety, HACCP, Food Quality, Food Microbiology, Hygiene
Date :
20
April
2009
Category :
Dairy Products
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global probiotics leader danone has paid an undisclosed sum to swedish dairy skånemejerier for a 51 per cent stake in its probiotic juice brand, proviva. expanding the €40m brand beyond its swedish core is high on the agenda, as is confirmation of its digestive health claims that are approved in sweden, but not as yet by the european food safety authority (efsa). fellow swedish company, probi the supplier of the lp299v strain used in the beverage launched in 1994, has also benefitted in the deal with 10-year supply contracts affirmed.
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nine months after the european food safety authority (efsa) handed in a positive safety assessment for conjugated linoleic acid (cla), the weight management ingredient will be assessed by the european commission as it continues its protracted journey to attain eu novel foods status. body shaping and toning is the predominate cla claim, although to date, efsa\'s health claims panel has not accepted cla claim-backing science february 21 will see the ec’s standing committee on the food chain and animal health (scofcah) entertain member state views on draft opinions for the use of proprietary versions of cla owned by market leaders lipid nutrition and basf-owned cognis in foodstuffs across the eu.
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danone has resubmitted an article 13.5 gut health claim for its flagship probiotic product, activia, to the european food safety authority (efsa). the company said it had refined its approach in the wake of meetings with efsa and the experience of others in the process and come up with a submission it is “fully confident” of. “we have redrafted the whole dossier, including rewording of the scientific claim, to take aboard elements coming from the june 15 stakeholder meeting [with efsa],” danone vice president of external affairs and head of eu regulatory affairs, patrick o’quin, told nutraingredients this morning.
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after taking part in a pharmanager seminar at vitafoods in geneva, dr jean-michel antoine, a 30-year research and development veteran at danone, tells shane starling why the french dairy firm has pulled three article 13.5 probiotic yoghurt claims from the european union nutrition and health claims process. you must have javascript enabled. download podcastdr jean-michel antoinesenior scientistdanone 04:01 subscribe to podcast: rss he said danone remained confident its immunity and gut health claims would be approved by the european food safety authority (efsa), but it wanted to wait until further guidance, due this month, was issued by the assessor.
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the european food safety authority (efsa) has repeatedly emphasised that the 2006 eu nutrition and health claims regulation is a learning experience for everyone involved – from its health claims assessment panel to industry stakeholders, to the member states and the european commission. that may be so, but it is a highly expensive learning process, with the greatest burden of cost being borne by industry players like danone, the company’s vice president of research and development in its dairy division, frederic rené, said after efsa’s gut/immune function meeting in amsterdam last week.
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global probiotics leader danone says its withdrawn probiotic health claim dossiers will remain untouched on its shelves at least until it attends a gut and immune health claim workshop to be hosted by efsa this year. danone for the second time in a year withdrew its article 13.5 immune and gut health claims from the european union health claims process in april, citing a lack of clarity about dossier requirements which it hoped would be at least in part be resolved at the european food safety authority (efsa) stakeholder’s meeting held tuesday in parma, italy.
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the world\'s largest yoghurt maker in april withdrew applications for the benefits of activia and actimel, saying there was confusion about what kind of scientific evidence the european food safety authority (efsa) required. health claims are keenly followed by investors because they are a powerful marketing tool and allow companies like danone to charge more for well-differentiated products. several brokers had voiced concern the efsa might reject danone\'s health claims, a move that could hurt the group\'s image and stock price.
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