The health claims approvals process has become a costly and time-consuming nightmare. Nick Hughes reveals which claims are getting through, which have been thrown out – and which are stuck in limbo
If only there were a food that cured headaches. Ever since the European Food Safety Authority (EFSA) published its first raft of adjudications on health claims last October, the industry has been banging its head against a brick wall, fighting a system it says not only lacks transparency, but is ill-conceived and ignorant of the realities of food processing.
This September, EFSA is expected to publish its decisions on a third batch of 'generic function' claims under the EU Health and Nutrition Claims regulation.
The industry isn't holding out much hope. Having whittled the 44,000 general function claims originally submitted by EU member states on behalf of manufacturers to fewer than 5,000, EFSA has so far examined just 900 80% of which have been rejected or are in limbo. Claims submitted by manufacturers regarding proprietary products and those relating to disease reduction and children's development haven't fared much better.
Some categories have been particularly hard hit. Incredibly, not one probiotic claim has been approved, prompting Danone to withdraw applications for Actimel and Activia rather than have them rejected.
Unsurprisingly, manufacturers are furious about the time and money they've wasted and the fact EFSA is demanding a similar level of scientific substantiation for foodstuff claims as it would for pharmaceuticals. Now they are directing that anger at the European Commission, which gave EFSA its mandate in the first place.
The commission admits that it underestimated the number of article 13.1 claims that would be submitted. That's not the only mistake it made, says Dairy Council director Judith Bryans.
"This legislation is hugely important to the food industry and yet, when tackled on the impracticalities of it, the commission described getting claims passed as a 'learning by doing' process for all involved," she says. "While we're all learning by doing it's costing the industry and EFSA a huge amount of money and time. No impact assessment has been done. It's maybe time for the commission to take a step back and do that."
Even EFSA isn't happy with the commission. It was only given the mandate to deal with 13.1 claims last year, by which point many applicants had already submitted their applications. To compound matters, as 13.1 claims are generic, contact between applicants and EFSA during the evaluation process is, by definition, limited. Last month, EFSA held a meeting for stakeholders in Parma.
One suggestion was to allow applicants to withdraw generic claim submissions and resubmit their applications where feasible under article 13.5 or article 14. This would allow applicants to present a rationale for the science they are presenting, and EFSA and the applicant to communicate more directly with one another.
It's a chink of light in a very dark tunnel for the likes of Danone, which will probably resubmit more detailed dossiers. For the moment, though, many manufacturers will just have to keep taking the aspirins.
The definite Articles
"General function" claims (article 13.1): These refer to the role of a nutrient or substance in growth, development and body functions, psychological and behavioural functions, slimming and weight control, satiety or reduction of available energy from the diet.
"New function" claims (article 13.5): Claims that are based on new scientific evidence or claims for which protection of proprietary data is requested. They require applicants to provide scientific evidence substantiating the claim.
Specific product or substance claims (article 14): Made in relation to disease risk reduction and child development or health, these claims require applicants to provide scientific evidence substantiating the claim.
Products affected: milk and dairy products
Claims relating to: calcium and bone health
The key applications relate to the role calcium in milk and dairy products has in maintaining bone health. Submissions have also been lodged for claims relating to nerve and muscle function and the maintenance of normal blood pressure. Generic statements such as "milk is good for your bones" are too vague to be submitted as a claim (although one specifically referring to calcium could be).
Approved: claims relating to the maintenance of bones and teeth; normal muscle function and neurotransmission; normal blood coagulation; normal energy-yielding metabolism and normal function of digestive enzymes (all under article 13.1).
Rejected: article 13.1 claims relating to the maintenance of normal blood pressure; and an article 14 application relating to dairy fresh cheese & bone health made by the Dairy Council of Ireland, which wanted approval for the claim that three portions of dairy foods a day promote a healthy body weight and dental health.
Products affected: Kinder chocolate
Claims relating to: children's growth
Ferrero wanted to describe a Kinder chocolate bar as aiding growth among those aged between four and 21 years.
Rejected: EFSA said the studies supplied to support its claim (submitted under article 14 of the regulation) were "of limited evidence" and ruled that no cause and effect had been established.
Products affected: Flora Pro-activ and BenecolClaims relating to: plant sterols/stanols and heart disease
Unilever's Flora Pro-activ and Raisio/McNeil Nutritionals' Benecol spreads are already marketed on the basis plant sterols and stanols lower cholesterol levels.
Approved: EFSA ruled cause and effect had been established between consumption and cholesterol lowering.
Products affected: sugar-free chewing gum
Claims relating to: oral health
Almost all chewing gum sold across Europe is sugar-free, and its oral health properties are well established. However, under the new regulation, simply claiming gum improves oral health will no longer be be sufficient as EFSA argues the description is "too general and non-specific".
Approved: Article 13.1 claims for plaque acid neutralisation, maintenance of tooth mineralisation and reductions of oral dryness.
Rejected: Those relating to weight management and to the reduction of dental plaque.
Products affected: energy drinks and energy bars containing taurine
Claims relating to: taurine and increased energy
Energy drinks and cereal bars are often sold on the basis that the taurine in them boosts athletic performance.
Article 13.1 applications were submitted to EFSA for permission to claim that the presence of taurine improves the protection of DNA; protects proteins and lipids from oxidative damage; increases energy; and delays the onset of fatigue while enhancing physical performance.
Rejected: EFSA could not establish cause and effect on any count cited in the article 13.1 applications.
Products affected: low-GI cereals, pasta, breadClaims relating to: carbohydrates and low GI
Low glycaemic index (GI) devotees follow a diet of particular carbohydrates that producers claim stimulate a reduced glycaemic response. Low-GI foods have been cited in relation to reducing the risk of heart disease and for helping with weight control.
Rejected: EFSA concluded that low-GI carbohydrates were "not sufficiently characterised" and that the health benefits of them had not been established.
Products affected: yoghurts and dairy shots
Claims relating to: probiotics and gut health
Danone withdrew article 13.5 applications for its Activia and Actimel products, claiming the bar had been set too high and that the human intervention studies requested by EFSA could take years to put together.
Withdrawn/rejected: No claim has been approved. Stakeholders in the probiotics industry held a regulatory workshop at a conference in Kosice, Slovakia, last month to discuss how best to deal with the raft of rejections.
Products affected: fish, fish oil supplements
Claims relating to: omega-3 and cholesterol/joint health
Omega-3 fatty acids, which occur naturally in oily fish and some meats, have been considered nutritionally important for years but only recently have manufacturers latched on to the possibility of marketing omega-3 on the basis of its health benefits, which are thought to include improved cardiovascular function and brain health. A mixture of article 13.1 and 14 claims have been submitted.
Approved: Generic claims that common strands of omega-3 (notably EPA, DHA and DPA) can reduce blood pressure.
Rejected: Claims linking omega-3 with the reduction of cholesterol and the maintenance of healthy joints; specific claims linking a Dutch omega-3 supplement with mental development and learning ability in children.
Products affected: honey, products containing honeycombClaims relating to: honey and respiratory health
Some member states submitted article 13.1 dossiers for honey, variously claiming that honey improves respiratory health through the presence of antioxidants, adds energy to the body and stimulates the whole metabolism and the immune system.
Rejected: EFSA ruled that from the references provided it was not possible to characterise the specific honey for which the claims should be made.
Products affected: Ocean Spray cranberry juiceClaims relating to: cranberry and risk reduction of urinary tract infection in women
Ocean Spray submitted a claim that its products containing cranberry sourced from North American cranberry plant Vaccinium macrocarpon Aiton reduced the risk of urinary tract infection in women.
Rejected: EFSA said the evidence provided failed to support a link between UTI reduction and consuming Ocean Spray cranberry products. It also dismissed a 13.1 claim that antioxidants including cranberry helped combat premature ageing.
If only there were a food that cured headaches. Ever since the European Food Safety Authority (EFSA) published its first raft of adjudications on health claims last October, the industry has been banging its head against a brick wall, fighting a system it says not only lacks transparency, but is ill-conceived and ignorant of the realities of food processing.
This September, EFSA is expected to publish its decisions on a third batch of 'generic function' claims under the EU Health and Nutrition Claims regulation.
The industry isn't holding out much hope. Having whittled the 44,000 general function claims originally submitted by EU member states on behalf of manufacturers to fewer than 5,000, EFSA has so far examined just 900 80% of which have been rejected or are in limbo. Claims submitted by manufacturers regarding proprietary products and those relating to disease reduction and children's development haven't fared much better.
Some categories have been particularly hard hit. Incredibly, not one probiotic claim has been approved, prompting Danone to withdraw applications for Actimel and Activia rather than have them rejected.
Unsurprisingly, manufacturers are furious about the time and money they've wasted and the fact EFSA is demanding a similar level of scientific substantiation for foodstuff claims as it would for pharmaceuticals. Now they are directing that anger at the European Commission, which gave EFSA its mandate in the first place.
The commission admits that it underestimated the number of article 13.1 claims that would be submitted. That's not the only mistake it made, says Dairy Council director Judith Bryans.
"This legislation is hugely important to the food industry and yet, when tackled on the impracticalities of it, the commission described getting claims passed as a 'learning by doing' process for all involved," she says. "While we're all learning by doing it's costing the industry and EFSA a huge amount of money and time. No impact assessment has been done. It's maybe time for the commission to take a step back and do that."
Even EFSA isn't happy with the commission. It was only given the mandate to deal with 13.1 claims last year, by which point many applicants had already submitted their applications. To compound matters, as 13.1 claims are generic, contact between applicants and EFSA during the evaluation process is, by definition, limited. Last month, EFSA held a meeting for stakeholders in Parma.
One suggestion was to allow applicants to withdraw generic claim submissions and resubmit their applications where feasible under article 13.5 or article 14. This would allow applicants to present a rationale for the science they are presenting, and EFSA and the applicant to communicate more directly with one another.
It's a chink of light in a very dark tunnel for the likes of Danone, which will probably resubmit more detailed dossiers. For the moment, though, many manufacturers will just have to keep taking the aspirins.
The definite Articles
"General function" claims (article 13.1): These refer to the role of a nutrient or substance in growth, development and body functions, psychological and behavioural functions, slimming and weight control, satiety or reduction of available energy from the diet.
"New function" claims (article 13.5): Claims that are based on new scientific evidence or claims for which protection of proprietary data is requested. They require applicants to provide scientific evidence substantiating the claim.
Specific product or substance claims (article 14): Made in relation to disease risk reduction and child development or health, these claims require applicants to provide scientific evidence substantiating the claim.
Products affected: milk and dairy products
Claims relating to: calcium and bone health
The key applications relate to the role calcium in milk and dairy products has in maintaining bone health. Submissions have also been lodged for claims relating to nerve and muscle function and the maintenance of normal blood pressure. Generic statements such as "milk is good for your bones" are too vague to be submitted as a claim (although one specifically referring to calcium could be).
Approved: claims relating to the maintenance of bones and teeth; normal muscle function and neurotransmission; normal blood coagulation; normal energy-yielding metabolism and normal function of digestive enzymes (all under article 13.1).
Rejected: article 13.1 claims relating to the maintenance of normal blood pressure; and an article 14 application relating to dairy fresh cheese & bone health made by the Dairy Council of Ireland, which wanted approval for the claim that three portions of dairy foods a day promote a healthy body weight and dental health.
Products affected: Kinder chocolate
Claims relating to: children's growth
Ferrero wanted to describe a Kinder chocolate bar as aiding growth among those aged between four and 21 years.
Rejected: EFSA said the studies supplied to support its claim (submitted under article 14 of the regulation) were "of limited evidence" and ruled that no cause and effect had been established.
Products affected: Flora Pro-activ and BenecolClaims relating to: plant sterols/stanols and heart disease
Unilever's Flora Pro-activ and Raisio/McNeil Nutritionals' Benecol spreads are already marketed on the basis plant sterols and stanols lower cholesterol levels.
Approved: EFSA ruled cause and effect had been established between consumption and cholesterol lowering.
Products affected: sugar-free chewing gum
Claims relating to: oral health
Almost all chewing gum sold across Europe is sugar-free, and its oral health properties are well established. However, under the new regulation, simply claiming gum improves oral health will no longer be be sufficient as EFSA argues the description is "too general and non-specific".
Approved: Article 13.1 claims for plaque acid neutralisation, maintenance of tooth mineralisation and reductions of oral dryness.
Rejected: Those relating to weight management and to the reduction of dental plaque.
Products affected: energy drinks and energy bars containing taurine
Claims relating to: taurine and increased energy
Energy drinks and cereal bars are often sold on the basis that the taurine in them boosts athletic performance.
Article 13.1 applications were submitted to EFSA for permission to claim that the presence of taurine improves the protection of DNA; protects proteins and lipids from oxidative damage; increases energy; and delays the onset of fatigue while enhancing physical performance.
Rejected: EFSA could not establish cause and effect on any count cited in the article 13.1 applications.
Products affected: low-GI cereals, pasta, breadClaims relating to: carbohydrates and low GI
Low glycaemic index (GI) devotees follow a diet of particular carbohydrates that producers claim stimulate a reduced glycaemic response. Low-GI foods have been cited in relation to reducing the risk of heart disease and for helping with weight control.
Rejected: EFSA concluded that low-GI carbohydrates were "not sufficiently characterised" and that the health benefits of them had not been established.
Products affected: yoghurts and dairy shots
Claims relating to: probiotics and gut health
Danone withdrew article 13.5 applications for its Activia and Actimel products, claiming the bar had been set too high and that the human intervention studies requested by EFSA could take years to put together.
Withdrawn/rejected: No claim has been approved. Stakeholders in the probiotics industry held a regulatory workshop at a conference in Kosice, Slovakia, last month to discuss how best to deal with the raft of rejections.
Products affected: fish, fish oil supplements
Claims relating to: omega-3 and cholesterol/joint health
Omega-3 fatty acids, which occur naturally in oily fish and some meats, have been considered nutritionally important for years but only recently have manufacturers latched on to the possibility of marketing omega-3 on the basis of its health benefits, which are thought to include improved cardiovascular function and brain health. A mixture of article 13.1 and 14 claims have been submitted.
Approved: Generic claims that common strands of omega-3 (notably EPA, DHA and DPA) can reduce blood pressure.
Rejected: Claims linking omega-3 with the reduction of cholesterol and the maintenance of healthy joints; specific claims linking a Dutch omega-3 supplement with mental development and learning ability in children.
Products affected: honey, products containing honeycombClaims relating to: honey and respiratory health
Some member states submitted article 13.1 dossiers for honey, variously claiming that honey improves respiratory health through the presence of antioxidants, adds energy to the body and stimulates the whole metabolism and the immune system.
Rejected: EFSA ruled that from the references provided it was not possible to characterise the specific honey for which the claims should be made.
Products affected: Ocean Spray cranberry juiceClaims relating to: cranberry and risk reduction of urinary tract infection in women
Ocean Spray submitted a claim that its products containing cranberry sourced from North American cranberry plant Vaccinium macrocarpon Aiton reduced the risk of urinary tract infection in women.
Rejected: EFSA said the evidence provided failed to support a link between UTI reduction and consuming Ocean Spray cranberry products. It also dismissed a 13.1 claim that antioxidants including cranberry helped combat premature ageing.
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