EFSA rejects Unilever black tea health claim

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18 Jan 2018 --- The European Food and Safety Authority (EFSA) has rejected a health claim regarding black tea’s effects on the maintenance of normal endothelium-dependent vasodilation in adults. The application, submitted for authorization of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 by Unilever, pertained to “black tea beverages, either freshly prepared or reconstituted from water extract powders of black tea, characterized by the content of flavanols (expressed as catechins plus theaflavins) of at least 30 mg per 200 ml serving.”

In its Scientific Opinion, published on 16 January, EFSA notes that, “on the basis of the data provided, the EFSA Panel on Dietetic Products, Nutrition and Allergies concludes that a cause and effect relationship has not been established between the consumption of black tea and maintenance of normal endothelium-dependent vasodilation.”

Of the five studies provided in the application to support the potential claim on the chronic effect of black tea consumption on endothelium-dependent vasodilation, EFSA notes that only two investigated the effect after regular consumption of black tea for a sufficiently long time period (i.e. at least 4 weeks). However, neither of these studies allowed an effect of black tea on endothelium-dependent vasodilation to be established.

Also in health claim related news, Lonza’s application for a health claim for L-carnitine’s contribution to normal lipid metabolism was also dismissed. The claimed effect of L-carnitine proposed by Lonza was “normal lipid metabolism,” with the claim submitted with this application based on the essentiality of a nutrient.

EFSA’s noted that although it acknowledged that L-carnitine is needed for the transport of long-chain fatty acids across the mitochondrial membrane, “the human body is able to synthesize L-carnitine from methionine and lysine, and that there is consensus that L-carnitine is not an essential nutrient. No dietary reference values have been set for L-carnitine.”

The panel notes that although L-carnitine is considered an indispensable nutrient for (both preterm and term) infants because of a temporarily insufficient synthesizing capacity – highlighting why a minimum L-carnitine content in infant formula has been established – this insufficient capacity to synthesize carnitine cannot be extrapolated to any other subgroup of the general healthy population, for which the claim is intended.

“Carnitine deficiency understood as clinical symptoms which can be corrected by carnitine administration has not been demonstrated in any other healthy population subgroup. In this context, the references submitted by the applicant on carnitine transporter deficiency syndromes do not provide evidence that dietary L-carnitine is required to maintain normal lipid metabolism in the target population for the claim (general healthy population),” the Scientific Opinion notes. 

It continues, “no evidence was provided that dietary carnitine could reverse the symptoms developed by the patient on long-term total parenteral nutrition and the supplementation studies with L-carnitine in healthy subjects do not provide information on whether dietary carnitine is required to maintain normal lipid metabolism (including normal fat oxidation), but rather on whether supplemental carnitine could modify the rate of fat oxidation under certain conditions.” 
 

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Lonza

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Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. As an integrated solutions provider, Lonza is boosting its value creation along and beyond the healthcare continuum with a strong focus on patient healthcare, consumer preventive healthcare and consumer's healthy environment. 

Lonza harnesses science and technology to create products that support safer and healthier living and that enhance the overall quality of life. With the recent Capsugel acquisition, Lonza now offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries. 

Benefiting from its regulatory expertise, Lonza is able to transfer its know-how from pharma to hygiene and fast-moving consumer goods all the way to coatings and composites and the preservation and protection of agricultural goods and other natural resources. 

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 14,500 full-time employees worldwide. The company generated sales of CHF 5.1 billion in 2017 with a CORE EBITDA of CHF 1.3 billion. Further information can be found at www.lonza.com.

Additional Information and Disclaimer

Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

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