Joerg Gruenwald, President, analyze & realize ag11.01.13
New product development currently faces many regulatory hurdles—certainly more than it did 10 years ago. Not only is it difficult to claim new health-related effects without going to considerable lengths for substantiation, but even the mere inclusion of new ingredients presents challenges.
In Europe, the Novel Food Regulation stipulates that ingredients extracted from natural sources, such as plants or animals, and that were not consumed in significant amounts in Europe before 1997, are considered novel and need to apply for novel food approval. This process involves, in effect, a safety assessment including all relevant studies such as toxicity and mutagenicity—a costly and time-consuming evaluation if no meaningful data is available in the public domain.
The safety data, together with the intended use and projected uptake estimates for the substance in question, are then submitted to the European Food Safety Authority (EFSA) for review, ideally following a pre-assessment meeting with a competent national authority. According to the current Novel Food Regulation, the full assessment procedure takes quite a while, since all EU Member States have to give their approval, and the applicant may be required to file additional data. All in all, it is not unusual for applicants to wait a year or longer before finally being able to use the new ingredient.
An amendment to the current Novel Food Regulation has been under discussion for years. Currently, this amended version of the regulation—scheduled to be published at the beginning of next year—will include, among other things, a faster review process by the Member States. Furthermore, a simplified authorization procedure for exotic fruits that are traditionally used outside of the EU is being discussed. During the course of this amendment, the Substantial Equivalence Procedure will be changed as well, and may be dropped completely.
What’s Novel?
It is not just exotic fruits or herbs that may trigger the novel food process. Production processes that change familiar ingredients sufficiently (e.g., through concentration of certain constituents during extraction), resulting in greater uptake of the substance than through normal food use, may also result in a novel food. For example, a green tea extract with its EGCG content concentrated above a certain threshold runs a great novel food risk.
A look at the Novel Food Regulation reveals two conditions for novel food risk: 1) the substance in question must be extracted from a natural matrix, and 2) it must be new. Purely synthetic substances are not extracted from a natural matrix, therefore, only one condition for novel food consideration is met. Does that mean such a synthetic substance isn’t a novel food? Of course it does not. The issue now becomes: if the synthetic substance isn’t a food at all, then it no longer falls under the purview of the Novel Food Regulation—or any food-related regulations for that matter—and instead falls into the realm of pharmaceuticals.
What about purely synthetic ingredients that are identical to naturally occurring food substances? Since the substances themselves aren’t novel—having natural counterparts—it is mainly the production process that makes them so. They are, for the most part, the equivalent of isolated substances, but even sourcing a single substance from a natural source makes that substance, in all probability, a novel food. The earlier green tea/EGCG example still applies. Therefore, isolated substances, whether synthetic or isolated from nature, run a high novel food risk, resulting in the need to apply for a full novel food authorization.
However, if the synthetic substance in question is fully equivalent to its natural counterpart, there may be an alternative strategy available. If substantial structural equivalence to a naturally occurring substance with proven safety can be proven, then a simplified authorization procedure for the synthetic substance is possible.
This route is especially promising if other safety records exist (e.g., a Generally Recognized As Safe statement). The presence of safety data required even for self-affirmed GRAS status goes a long way toward paving the road for the simplified novel food authorization procedure.
This saves a lot of time and effort—and therefore cost—and all that is required is proof that the substance in question is structurally equivalent to a known and safe food substance. Such proof is not very costly compared to the full novel food procedure, which makes investigating whether or note it is a feasible alternative worthwhile.
Novel food approval, contrary to popular opinion, is not an administrative chicanery; rather, it proves the safe consumption and harmlessness of a food substance. Such a safety assessment is essential for manufacturers in order to market a new ingredient successfully.
Drawing up a novel food dossier requires in-depth knowledge of food production processes, good toxicological knowledge and regulatory know-how. These three aspects can be provided by analyze & realize due to its 20 years of experience.
Dr. Joerg Gruenwald is president of analyze & realize ag, 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 ag, Waldseeweg 6, 13467 Berlin, Germany, Tel: 49-30-40008100; Fax: 49-30-40008500; E-mail: jgruenwald@analyze-realize.com; Website: www.analyze-realize.com.
In Europe, the Novel Food Regulation stipulates that ingredients extracted from natural sources, such as plants or animals, and that were not consumed in significant amounts in Europe before 1997, are considered novel and need to apply for novel food approval. This process involves, in effect, a safety assessment including all relevant studies such as toxicity and mutagenicity—a costly and time-consuming evaluation if no meaningful data is available in the public domain.
The safety data, together with the intended use and projected uptake estimates for the substance in question, are then submitted to the European Food Safety Authority (EFSA) for review, ideally following a pre-assessment meeting with a competent national authority. According to the current Novel Food Regulation, the full assessment procedure takes quite a while, since all EU Member States have to give their approval, and the applicant may be required to file additional data. All in all, it is not unusual for applicants to wait a year or longer before finally being able to use the new ingredient.
An amendment to the current Novel Food Regulation has been under discussion for years. Currently, this amended version of the regulation—scheduled to be published at the beginning of next year—will include, among other things, a faster review process by the Member States. Furthermore, a simplified authorization procedure for exotic fruits that are traditionally used outside of the EU is being discussed. During the course of this amendment, the Substantial Equivalence Procedure will be changed as well, and may be dropped completely.
What’s Novel?
It is not just exotic fruits or herbs that may trigger the novel food process. Production processes that change familiar ingredients sufficiently (e.g., through concentration of certain constituents during extraction), resulting in greater uptake of the substance than through normal food use, may also result in a novel food. For example, a green tea extract with its EGCG content concentrated above a certain threshold runs a great novel food risk.
A look at the Novel Food Regulation reveals two conditions for novel food risk: 1) the substance in question must be extracted from a natural matrix, and 2) it must be new. Purely synthetic substances are not extracted from a natural matrix, therefore, only one condition for novel food consideration is met. Does that mean such a synthetic substance isn’t a novel food? Of course it does not. The issue now becomes: if the synthetic substance isn’t a food at all, then it no longer falls under the purview of the Novel Food Regulation—or any food-related regulations for that matter—and instead falls into the realm of pharmaceuticals.
What about purely synthetic ingredients that are identical to naturally occurring food substances? Since the substances themselves aren’t novel—having natural counterparts—it is mainly the production process that makes them so. They are, for the most part, the equivalent of isolated substances, but even sourcing a single substance from a natural source makes that substance, in all probability, a novel food. The earlier green tea/EGCG example still applies. Therefore, isolated substances, whether synthetic or isolated from nature, run a high novel food risk, resulting in the need to apply for a full novel food authorization.
However, if the synthetic substance in question is fully equivalent to its natural counterpart, there may be an alternative strategy available. If substantial structural equivalence to a naturally occurring substance with proven safety can be proven, then a simplified authorization procedure for the synthetic substance is possible.
This route is especially promising if other safety records exist (e.g., a Generally Recognized As Safe statement). The presence of safety data required even for self-affirmed GRAS status goes a long way toward paving the road for the simplified novel food authorization procedure.
This saves a lot of time and effort—and therefore cost—and all that is required is proof that the substance in question is structurally equivalent to a known and safe food substance. Such proof is not very costly compared to the full novel food procedure, which makes investigating whether or note it is a feasible alternative worthwhile.
Novel food approval, contrary to popular opinion, is not an administrative chicanery; rather, it proves the safe consumption and harmlessness of a food substance. Such a safety assessment is essential for manufacturers in order to market a new ingredient successfully.
Drawing up a novel food dossier requires in-depth knowledge of food production processes, good toxicological knowledge and regulatory know-how. These three aspects can be provided by analyze & realize due to its 20 years of experience.
Dr. Joerg Gruenwald is president of analyze & realize ag, 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 ag, Waldseeweg 6, 13467 Berlin, Germany, Tel: 49-30-40008100; Fax: 49-30-40008500; E-mail: jgruenwald@analyze-realize.com; Website: www.analyze-realize.com.
