Joerg Gruenwald, analyze & realize GmbH04.01.14
As the food and health industry has had to learn during the past few years, getting a health claim application through the European Food Safety Authority’s (EFSA) approval process is a lengthy, costly and nerve-wracking task.
Many applications have been refused, often on grounds that seem trivial. However, the industry has learned from mistakes, guidance documents have been published, and it seems that filing an application nowadays has a much better chance of success than it did five years ago.
However, in some cases, even earning a positive opinion from EFSA does not necessarily allow you to use the health claim.
The EU Commission is required to adopt EFSA’s opinion first, and member states have a say in that—at which point political considerations may enter into what, up until then, had been purely scientific evaluations based on substantiation of cause and effect.
Caffeine Case Study
Some of these political considerations are safety concerns.
In the case of caffeine, EFSA gave positive opinions on several claim applications for caffeine and increased alertness, improved concentration and endurance.
However, some EU member states (and the U.S. FDA) voiced concerns about caffeine levels increasing in energy drinks, as well as in other food products such as chewing gums, which might lead to overconsumption and health issues up to and including death. Discussions ensued on maximum daily intakes of caffeine for sub-groups of the population (e.g., athletes, pregnant and breastfeeding women, children, adolescents, etc.).
EFSA was once again called in to give opinions on this issue, and to advise the Commission on links between caffeine intake and adverse health effects and the feasibility of imposing upper intake levels. The body is expected to present its findings in 2014 when discussions will resume.
Meanwhile, however, EFSA’s positive opinion was not adopted by the Commission, and manufacturers cannot use the claim.
The Pharmacological Hurdle
There are similar cases where EFSA issued a positive opinion and the Commission adopted it, yet the claim can still not be used in some EU countries.
This happens when the condition of use (i.e., the required uptake level) for the claim in question would mean that intake of the substance is within the pharmacological range.
A similar situation exists when the substance in question is considered a pharmacological (drug) substance in some countries. An example of this involves Monacolin K, a constituent of red yeast rice. EFSA approved a claim for Monacolin K and cholesterol lowering, provided 10 mg of Monacolin K are consumed daily However, Monacolin K is identical to Lovastatin, a substance with drug status in Germany.
At the intake levels required to use the health claim, any product containing Monacolin K (and thus Lovastatin) would automatically be considered a drug, and not a food product, and thus require drug authorization.
Court rulings on this issue are already in place, with the net result that the Monacolin K claim cannot be used in Germany. A similar situation exists with melatonin. Two health claims have been approved by the Commission (one on reduction of sleep onset time and one on reduction of jet lag), but the conditions of use elevate the substance into the area of pharmacological effect—at least in Germany, where until recently the ruling was that melatonin, being a hormone, is a drug substance.
This has since been changed, and melatonin intake of up to 0.5 mg per day is permissible in dietary supplements. Unfortunately, the condition of use for the sleep claim is 1 mg, moving the health claim out of reach for the supplement industry in Germany.
As these examples show, a successful health claim application culminating in a positive opinion from EFSA may only be the first hurdle, and the only part of the health claim process that a manufacturer really has any control over. For most health claim applications, the application itself will be the full extent of the problem, and after EFSA issues a positive opinion, it is usually smooth sailing from there on out.
However, for some rare cases, it is still necessary to consider what may come next. A unifying strategy is required in order to anticipate whether the desired health claim will be successful beyond EFSA’s opinion. Many factors need to be taken into account, ranging from consumer understanding of the claim to possible political impact of the claim adoption across the EU.
Experienced consultancies such as analyze & realize can help manufacturers evaluate both the financial risk of the study expenses necessary for the application itself, and also whether the claim will be adopted and used in all of the EU, should the claim application go through.
Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@analyze-realize.com; Website: www.analyze-realize.com
Many applications have been refused, often on grounds that seem trivial. However, the industry has learned from mistakes, guidance documents have been published, and it seems that filing an application nowadays has a much better chance of success than it did five years ago.
However, in some cases, even earning a positive opinion from EFSA does not necessarily allow you to use the health claim.
The EU Commission is required to adopt EFSA’s opinion first, and member states have a say in that—at which point political considerations may enter into what, up until then, had been purely scientific evaluations based on substantiation of cause and effect.
Caffeine Case Study
Some of these political considerations are safety concerns.
In the case of caffeine, EFSA gave positive opinions on several claim applications for caffeine and increased alertness, improved concentration and endurance.
However, some EU member states (and the U.S. FDA) voiced concerns about caffeine levels increasing in energy drinks, as well as in other food products such as chewing gums, which might lead to overconsumption and health issues up to and including death. Discussions ensued on maximum daily intakes of caffeine for sub-groups of the population (e.g., athletes, pregnant and breastfeeding women, children, adolescents, etc.).
EFSA was once again called in to give opinions on this issue, and to advise the Commission on links between caffeine intake and adverse health effects and the feasibility of imposing upper intake levels. The body is expected to present its findings in 2014 when discussions will resume.
Meanwhile, however, EFSA’s positive opinion was not adopted by the Commission, and manufacturers cannot use the claim.
The Pharmacological Hurdle
There are similar cases where EFSA issued a positive opinion and the Commission adopted it, yet the claim can still not be used in some EU countries.
This happens when the condition of use (i.e., the required uptake level) for the claim in question would mean that intake of the substance is within the pharmacological range.
A similar situation exists when the substance in question is considered a pharmacological (drug) substance in some countries. An example of this involves Monacolin K, a constituent of red yeast rice. EFSA approved a claim for Monacolin K and cholesterol lowering, provided 10 mg of Monacolin K are consumed daily However, Monacolin K is identical to Lovastatin, a substance with drug status in Germany.
At the intake levels required to use the health claim, any product containing Monacolin K (and thus Lovastatin) would automatically be considered a drug, and not a food product, and thus require drug authorization.
Court rulings on this issue are already in place, with the net result that the Monacolin K claim cannot be used in Germany. A similar situation exists with melatonin. Two health claims have been approved by the Commission (one on reduction of sleep onset time and one on reduction of jet lag), but the conditions of use elevate the substance into the area of pharmacological effect—at least in Germany, where until recently the ruling was that melatonin, being a hormone, is a drug substance.
This has since been changed, and melatonin intake of up to 0.5 mg per day is permissible in dietary supplements. Unfortunately, the condition of use for the sleep claim is 1 mg, moving the health claim out of reach for the supplement industry in Germany.
As these examples show, a successful health claim application culminating in a positive opinion from EFSA may only be the first hurdle, and the only part of the health claim process that a manufacturer really has any control over. For most health claim applications, the application itself will be the full extent of the problem, and after EFSA issues a positive opinion, it is usually smooth sailing from there on out.
However, for some rare cases, it is still necessary to consider what may come next. A unifying strategy is required in order to anticipate whether the desired health claim will be successful beyond EFSA’s opinion. Many factors need to be taken into account, ranging from consumer understanding of the claim to possible political impact of the claim adoption across the EU.
Experienced consultancies such as analyze & realize can help manufacturers evaluate both the financial risk of the study expenses necessary for the application itself, and also whether the claim will be adopted and used in all of the EU, should the claim application go through.
Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@analyze-realize.com; Website: www.analyze-realize.com
