Joanna Cosgrove07.14.11
The European Food Safety Authority (EFSA), the European Union (EU) agency tasked with food safety risk assessment, has been hard at work in recent years evaluating food health claims. The EFSA recently published a fifth collection of Article 13 approved “general function” health claims allowable for use on food labels. And just as structure/function claims here in the U.S. have incited debate, so too have the rulings in the EU.
According to "Targeted Botanical and Herbal Food and Drinks in Europe," a report from Business Insights, among the various claims made on new product launches made through to August 2010, 49% were targeted at the metabolic/endocrinology therapeutic area, with weight management being the main area of focus.
Other than probiotics, botanicals and herbs have proven least successful in securing positive approvals from EFSA. Of the 67 opinions published pertaining to botanicals and herbs in the first two batches, 66 were rejected.
Botanicals were temporarily removed from EFSA’s assessment process, leading to uncertainty over the future regulatory environment. However, Business Insights found that with the European Commission contemplating the adoption of an alternative assessment procedure, previously rejected health claims could still successfully reach the market via an updated evaluation process.
A total of 4,637 claims were submitted to EFSA by the European Commission between July 2008 and March 2010. The European Commission asked EFSA to evaluate 2,758 claims by June 2011, 331 claims were withdrawn and 1,548 claims on “botanicals” have been placed on hold by the Commission pending further consideration on how to proceed.
In April, EFSA’s fourth collection of claims included 442 claims opinions on a range of ingredients, including minerals, probiotics, fatty acids, amino acids and specific plant extracts, covering areas such as antioxidative, cognitive and bowel function and blood cholesterol.
The most recent fifth batch of approved health claims pertained to the relationship of dietary fiber to blood cholesterol; cereal fiber and bowel function; carbohydrate-electrolyte drinks and endurance performance; low sodium and blood pressure; dietary fiber and blood glucose benefit after meals; melatonin and sleep onset; and low calorie diet in relation to body weight.
A handful of claims relating to women’s health and mental energy were panned after experts concluded that they were not “sufficiently specific.” Similarly, other claims were declined because they were not supported by evidentiary human studies.
A sixth collection of general function health claim evaluations are scheduled to be released in September.
Last month the European Parliament, Council and European Commission capped off 10 weeks of intensive negotiations to outline agreements on the remaining issues in the way of an overall political agreement on the new EU legislation on food labeling. The agreements still need to be endorsed by Member States and Parliament political groups.
If all goes to pass, the resulting label will be a unified presence on pre-packaged foods and will features concise information disclosing any of the 14 food allergens currently recognized by the EFSA, “best-by” or “use-by” dates, energy value, and amounts of fat, saturated fats, carbohydrates, sugars, proteins and salt. The prevailing hope is that the new label will better inform consumers without being overburdening for businesses to deliver.
That said, there is concern among business about meeting the new expectations. To address how food businesses can benefit from what has already been learned in the claims evaluation process, and to help companies offset possible challenges, European Advisory Services (EAS) a group located in Brussels, Belgium, held a workshop designed to arm those involved in the labeling process with information on how to handle claims regulations.
The workshop, titled “Claims: Dealing with the Present, Planning for the Future,” gave attendees insight into the European Commission’s new policy for the adoption of the Article 13 list and strategies on how to best benefit from the Article 13 transition period, and the European Commission’s plans relating to claims for botanicals.
“The claims regulation has fundamentally changed the marketing rules for communicating health messages on food products,” stated EAS regulatory affairs Manager, Stefanie Geiser. “Besides watching and drawing conclusions from the general trend so far, it is now important to follow the next three EFSA public consultations on technical guidelines, which last from now until the end of August. These relate specifically to bone, joint or oral health, antioxidants or cardiovascular health, and weight management, satiety, and blood glucose concentrations.”
At the workshop EAS advisers also clarified the steps for companies wanting to submit further information on Article 13 claims that are still on the gray list, such as probiotics and “insufficient” claims, gave tips toward the best chance of a successful claims application to EFSA, and laid out the future playing field for claims in the EU.
Ms. Geiser commented that companies can learn a lot “from the opinions EFSA has given so far and incorporate this into new marketing strategies.”
She went on to say that the trend in recent health function opinions showed “rejections related particularly to immune response or natural defenses, digestive and intestinal health, vitality anti-aging effects of plant extracts and many unfavorable opinions for a range of amino acids and other substances. At the same time, there is trend of positive assessments for fatty acid heart claims and chewing gum/sweetener dental health claims, as well as new positive claims for activated charcoal, betaine, caffeine, choline, resistant starch, l-arginine, olive polyphenols, meat/fish, walnuts and water.”
Although EFSA has worked hard to separate the proverbial wheat from the chaff, the agency’s rejection of volumes of nutritional science has riled the nutritional industry and related academia, prompting a public expressed of outrage with many of the EFSA’s conclusions, even inspiring the formation of groups such as "Gut Health," which has openly protested the EFSA’s views on pre- and probiotic submissions.
According to "Targeted Botanical and Herbal Food and Drinks in Europe," a report from Business Insights, among the various claims made on new product launches made through to August 2010, 49% were targeted at the metabolic/endocrinology therapeutic area, with weight management being the main area of focus.
Other than probiotics, botanicals and herbs have proven least successful in securing positive approvals from EFSA. Of the 67 opinions published pertaining to botanicals and herbs in the first two batches, 66 were rejected.
Botanicals were temporarily removed from EFSA’s assessment process, leading to uncertainty over the future regulatory environment. However, Business Insights found that with the European Commission contemplating the adoption of an alternative assessment procedure, previously rejected health claims could still successfully reach the market via an updated evaluation process.
A total of 4,637 claims were submitted to EFSA by the European Commission between July 2008 and March 2010. The European Commission asked EFSA to evaluate 2,758 claims by June 2011, 331 claims were withdrawn and 1,548 claims on “botanicals” have been placed on hold by the Commission pending further consideration on how to proceed.
In April, EFSA’s fourth collection of claims included 442 claims opinions on a range of ingredients, including minerals, probiotics, fatty acids, amino acids and specific plant extracts, covering areas such as antioxidative, cognitive and bowel function and blood cholesterol.
The most recent fifth batch of approved health claims pertained to the relationship of dietary fiber to blood cholesterol; cereal fiber and bowel function; carbohydrate-electrolyte drinks and endurance performance; low sodium and blood pressure; dietary fiber and blood glucose benefit after meals; melatonin and sleep onset; and low calorie diet in relation to body weight.
A handful of claims relating to women’s health and mental energy were panned after experts concluded that they were not “sufficiently specific.” Similarly, other claims were declined because they were not supported by evidentiary human studies.
A sixth collection of general function health claim evaluations are scheduled to be released in September.
Last month the European Parliament, Council and European Commission capped off 10 weeks of intensive negotiations to outline agreements on the remaining issues in the way of an overall political agreement on the new EU legislation on food labeling. The agreements still need to be endorsed by Member States and Parliament political groups.
If all goes to pass, the resulting label will be a unified presence on pre-packaged foods and will features concise information disclosing any of the 14 food allergens currently recognized by the EFSA, “best-by” or “use-by” dates, energy value, and amounts of fat, saturated fats, carbohydrates, sugars, proteins and salt. The prevailing hope is that the new label will better inform consumers without being overburdening for businesses to deliver.
That said, there is concern among business about meeting the new expectations. To address how food businesses can benefit from what has already been learned in the claims evaluation process, and to help companies offset possible challenges, European Advisory Services (EAS) a group located in Brussels, Belgium, held a workshop designed to arm those involved in the labeling process with information on how to handle claims regulations.
The workshop, titled “Claims: Dealing with the Present, Planning for the Future,” gave attendees insight into the European Commission’s new policy for the adoption of the Article 13 list and strategies on how to best benefit from the Article 13 transition period, and the European Commission’s plans relating to claims for botanicals.
“The claims regulation has fundamentally changed the marketing rules for communicating health messages on food products,” stated EAS regulatory affairs Manager, Stefanie Geiser. “Besides watching and drawing conclusions from the general trend so far, it is now important to follow the next three EFSA public consultations on technical guidelines, which last from now until the end of August. These relate specifically to bone, joint or oral health, antioxidants or cardiovascular health, and weight management, satiety, and blood glucose concentrations.”
At the workshop EAS advisers also clarified the steps for companies wanting to submit further information on Article 13 claims that are still on the gray list, such as probiotics and “insufficient” claims, gave tips toward the best chance of a successful claims application to EFSA, and laid out the future playing field for claims in the EU.
Ms. Geiser commented that companies can learn a lot “from the opinions EFSA has given so far and incorporate this into new marketing strategies.”
She went on to say that the trend in recent health function opinions showed “rejections related particularly to immune response or natural defenses, digestive and intestinal health, vitality anti-aging effects of plant extracts and many unfavorable opinions for a range of amino acids and other substances. At the same time, there is trend of positive assessments for fatty acid heart claims and chewing gum/sweetener dental health claims, as well as new positive claims for activated charcoal, betaine, caffeine, choline, resistant starch, l-arginine, olive polyphenols, meat/fish, walnuts and water.”
Although EFSA has worked hard to separate the proverbial wheat from the chaff, the agency’s rejection of volumes of nutritional science has riled the nutritional industry and related academia, prompting a public expressed of outrage with many of the EFSA’s conclusions, even inspiring the formation of groups such as "Gut Health," which has openly protested the EFSA’s views on pre- and probiotic submissions.
