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danone withdraws marquee probiotic health claims (again)
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almost a year to the day after danone first withdrew submissions for its best-selling probiotic yoghurts from the european union health claims system, the french dairy giant has pulled its claims from the system once again. citing an ongoing lack of communication and clarity in the european food safety authority (efsa) process, danone announced the withdrawal of its article 13.5 claims for spoonable yoghurt, activia, and drinkable yoghurt, actimel in its q1 results this morning. the actimel immunity claim was only resubmitted by danone two months ago while its activia gut health claim was re-entered late in 2009. both dossiers contained more than 10 probiotic, strain-specific clinical trials. efsa’s health claims panel was due to deliver verdicts on danone’s claims in the “coming weeks”, but increasingly frustrated by efsa’s reluctance to communicate its scientific requirements, danone decided to pull the dossiers. danone vice president of external affairs and head of eu regulatory affairs, patrick o’quin, told nutraingredients.com the company had no idea how the claims assessment process was progressing, despite many attempts to gain status updates from efsa. “this complete lack of contact is one of the main issues we and the rest of the industry has. we now hope to take advantage of the upcoming stakeholders’ meeting,” o’quin said, in reference to a meeting efsa has called at its italian headquarters on june 1. danone gave similar reasons for withdrawing its activia and actimel claims in april last year ahead of a health claims meeting efsa held last june, but denied a sense of déjà vu as this time efsa had made clear its agenda. “the topics to be discussed are exactly those we want clarification on so we hope it will be a very positive meeting,” he said. “but in the meantime we are preparing for the worst-case scenario in terms of our marketing and communications although we are not as yet obliged to change anything.” for more on that meeting click here . an article 14, disease reduction diarrhoea claim remains in the system because it was not expected to be adjudicated on until after the june meeting, said chief financial officer, pierre-andre terisse in a press conference announcing the financial results this morning. meanwhile, a new group, the european health claims alliance, has sent a letter containing more than 350 signatures from concerned industry stakeholders to new ec president josé manuel barroso. the letter invites him to scrap the publication of health claim opinions in batches due to its distorting effect; unnecessary and disproportionate costs and creation of confusion. it can be found here . financial forecasts the q1 results included sales of €4bn for the quarter, with the dairy division showing 12.5 per cent growth. most analysts predict ongoing positive fortunes for the company despite danone stating that it is confronting a, "challenging financial, economic and social environment in 2010, with continued difficult consumption trends in western economies, weak emerging currencies and inflation of raw materials." those results showed growth of seven per cent for the whole group – quarter on quarter. senior research analyst, andrew wood, from sanford c bernstein in new york, expected danone’s withdrawal to have little effect on its financial fortunes. “we consider that the only development for bearish analysts/investors to focus on is the withdrawal of the efsa application for actimel and activia,” he said. “we consider that this was fairly well-flagged by management, and that there is still an intention to re-apply once the efsa process and requirements are clarified, hopefully in a new meeting announced for june 2010. our view remains that we see little short-term headwinds on volume momentum from withdrawing health claims.” wood said sales figures in the uk and france confirmed his observation. “if danone is struggling to understand the efsa process and obtain approval then it is very unlikely that others will suffer less. indeed, efsa might eventually prove to be a strong barrier to entry and strong competitive advantage for danone.”
Source :foodanddrinkeurope.com
Date :
15
April
2010
Category :
Food And Health
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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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