Joerg Gruenwald, analyze & realize ag01.05.16
The new Novel Food Regulation is ready and has been signed and printed. Following a 24-month transitional period during which Delegated Acts will be added to it, the regulation will be in force at the beginning of 2018. The industry has eagerly anticipated this new regulation, since marketing novel foods is one of the major ways to innovate. Novel food authorizations via the old regulation have been time-consuming above all, and a major hurdle on the way to market. Companies are hoping are the size of this hurdle is going to be reduced.
There are indeed several, well, novelties in the Novel Food Regulation. One of those is the new Union List, a compilation of all the authorized Novel Foods past and future. Similar to the EU Register for Health and Nutrition Claims, and different from the Novel Food Catalogue, this new Union List will be legally binding. If a food or food ingredient is considered novel and not on that list, then it will require a novel food authorization of some sort before it can be marketed.
New Procedures
Speaking of novel food authorizations, industry operators will be pleased to find that the time span for the full authorization has been shortened and the procedure itself has been simplified.
According to the new regulation, the novel food application dossier is sent to the European Commission (EC), which then has one month to decide whether to pass the application on to the European Food Safety Authority (EFSA). During these four weeks, the Commission may consult Member States at its discretion, and only if no decision can be reached at this level will EFSA become involved. Thus, the EC can decide to grant or reject a Novel Food Authorization without the involvement of EFSA, or even without consulting individual Member States.
If EFSA does become involved, then it has nine months to evaluate the data submitted with the application. Similar to health claim applications, a stop-clock process is involved at this point in case there are remaining questions to be cleared up with the applicant. Following this, EFSA is expected to give its recommendation to the EC.
The EC then either grants the approval and actualizes the Union List to contain the new novel food, or rejects the application. This decision will take another 7 months. Thus, all in all, a full novel food application can be accepted within 18 to 24 months.
Traditional Foods from Non-EU Countries
Also new for novel foods is the opportunity to market a traditional food from third (non-EU) countries. Any food that has a history of safe and significant food use for 25 years in a third country is eligible for notification based on this history of use.
The notification is filed to the EC. Within one month, the EC makes this notification public for all Member States and EFSA. They have four months to raise objections. If there are none, the food will be granted Novel Food status and will be included in the Union List.
If there are objections, the traditional food can apply for a novel food authorization by filing a dossier containing all safety data required to erase the raised safety doubts. Again, the application is filed with the EC, which passes it on to EFSA within one month. Within six months, EFSA evaluates the application and gives its recommendation to the EC. Following another three months, the Union List will be actualized if the food is authorized as novel.
These simplified procedures seem to indicate the EC wishes to facilitate approval of traditional foods from non-EU countries.
In case a food operator is in doubt whether a certain product falls under the scope of the Novel Food Regulation, the company can consult with the national authorities of the target market. National authorities then decide whether a food is novel or not. As before, this includes proof or lack of history of food use before 1997. If the food is deemed novel and not on the Union List—which may be because either there has been no application before, or because an application is in progress but under data protection—then the food operator needs to file an application.
Data Protection
Another new aspect of the regulation is data protection. An applicant can mark data used in the dossier as proprietary. This data is then protected for five years and can only be used by other applicants if the first applicant approves.
This point is still under discussion and will be clarified later by Delegated Acts. But the interesting thing is that applicants can, in fact, use data already used by a previous applicant. This opens up the route to two or more food operators using the same toxicity data, reducing the number of animal studies that need to be conducted if several applications concern the same food.
It is not clear at this time whether joint applications by two or more applicants will be accepted; it is currently looking like this will in fact be the case. Therefore, collaboration is not only possible but also advisable.
The new regulation, thus, significantly shortens the time required for novel food authorizations and facilitates market entry for non-EU traditional foods. In most cases, the basis still is a safety assessment—something qualified consultancies such as analyze & realize can assist food operators with.
Joerg Gruenwald
analyze & realize ag
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@a-r.com; Website: www.analyze-realize.com.
There are indeed several, well, novelties in the Novel Food Regulation. One of those is the new Union List, a compilation of all the authorized Novel Foods past and future. Similar to the EU Register for Health and Nutrition Claims, and different from the Novel Food Catalogue, this new Union List will be legally binding. If a food or food ingredient is considered novel and not on that list, then it will require a novel food authorization of some sort before it can be marketed.
New Procedures
Speaking of novel food authorizations, industry operators will be pleased to find that the time span for the full authorization has been shortened and the procedure itself has been simplified.
According to the new regulation, the novel food application dossier is sent to the European Commission (EC), which then has one month to decide whether to pass the application on to the European Food Safety Authority (EFSA). During these four weeks, the Commission may consult Member States at its discretion, and only if no decision can be reached at this level will EFSA become involved. Thus, the EC can decide to grant or reject a Novel Food Authorization without the involvement of EFSA, or even without consulting individual Member States.
If EFSA does become involved, then it has nine months to evaluate the data submitted with the application. Similar to health claim applications, a stop-clock process is involved at this point in case there are remaining questions to be cleared up with the applicant. Following this, EFSA is expected to give its recommendation to the EC.
The EC then either grants the approval and actualizes the Union List to contain the new novel food, or rejects the application. This decision will take another 7 months. Thus, all in all, a full novel food application can be accepted within 18 to 24 months.
Traditional Foods from Non-EU Countries
Also new for novel foods is the opportunity to market a traditional food from third (non-EU) countries. Any food that has a history of safe and significant food use for 25 years in a third country is eligible for notification based on this history of use.
The notification is filed to the EC. Within one month, the EC makes this notification public for all Member States and EFSA. They have four months to raise objections. If there are none, the food will be granted Novel Food status and will be included in the Union List.
If there are objections, the traditional food can apply for a novel food authorization by filing a dossier containing all safety data required to erase the raised safety doubts. Again, the application is filed with the EC, which passes it on to EFSA within one month. Within six months, EFSA evaluates the application and gives its recommendation to the EC. Following another three months, the Union List will be actualized if the food is authorized as novel.
These simplified procedures seem to indicate the EC wishes to facilitate approval of traditional foods from non-EU countries.
In case a food operator is in doubt whether a certain product falls under the scope of the Novel Food Regulation, the company can consult with the national authorities of the target market. National authorities then decide whether a food is novel or not. As before, this includes proof or lack of history of food use before 1997. If the food is deemed novel and not on the Union List—which may be because either there has been no application before, or because an application is in progress but under data protection—then the food operator needs to file an application.
Data Protection
Another new aspect of the regulation is data protection. An applicant can mark data used in the dossier as proprietary. This data is then protected for five years and can only be used by other applicants if the first applicant approves.
This point is still under discussion and will be clarified later by Delegated Acts. But the interesting thing is that applicants can, in fact, use data already used by a previous applicant. This opens up the route to two or more food operators using the same toxicity data, reducing the number of animal studies that need to be conducted if several applications concern the same food.
It is not clear at this time whether joint applications by two or more applicants will be accepted; it is currently looking like this will in fact be the case. Therefore, collaboration is not only possible but also advisable.
The new regulation, thus, significantly shortens the time required for novel food authorizations and facilitates market entry for non-EU traditional foods. In most cases, the basis still is a safety assessment—something qualified consultancies such as analyze & realize can assist food operators with.
Joerg Gruenwald
analyze & realize ag
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@a-r.com; Website: www.analyze-realize.com.
