New proposal for Novel Foods Regulation
Posted: January 10, 2014 Filed under: Authors, Food, novel food Leave a comment »
Introduction
Novel Foods (NF) are all foods that were not used for human consumption to a significant degree within the EU prior to 1997. One of the most well known examples is BECEL, a margarine containing plant sterols with a cholesterol lowering activity. So far, Novel Foods were covered by Regulations 258/97 and 1852/2001, but obtaining market access for a novel food within this regulatory framework could easily take three years. Therefore, between 2008 and 2011, a new proposal for the NF Regulation was discussed. This proposal has never been adopted by Union legislator, due to a number of bottlenecks including food produced from cloned animals. On 18 December 2013, the Commission has published a new proposal for a NF Regulation, which is the subject of this blog post. One of the aims is to shorten the authorisation procedure to 18 months. How? Continue reading.
Food from cloned animals no longer covered
In order to find a solution for the sensible issue of food from cloned animals, the current proposal for the NF Regulation simply no longer covers such food. Instead, two separate proposals have been prepared: (1) a Directive on the cloning of animals of various species kept and reproduced for farming purposes and (2) a Directive on the placing on the market of food from animal clones. These two proposals will – at least temporarily – ban the use of the cloning technique in the EU for farm animals and the imports of these animal clones. The marketing of food from animal clones, such as milk or meat, will also be prohibited. Cloning will however not be prohibited for purposes of research or conservation of rare breeds and endangered species. Furthermore, cloning will be allowed for the production of pharmaceuticals and medical devices, where the use of this technique can be justified.
Subject matter, scope and definitions
General criteria for the NF definition remain unchanged: they should be safe and not mislead the consumer. The definition of NF is however considerably changed, now that food from cloned animals is no longer included. Futhermore, only one out of four previous NF categories is maintained, namely food to which a new production process is applied. 3 new categories are introduced, being
(i) food containing of or consisting of engineered nano materials;
(ii) vitamins and minerals to which a new production process has been applied or consisting of or containing engineered nano materials; and
(iii) food used exclusively in food supplements prior to 1997, where it is intended to be used in foods other than food supplements.
It should be observed that it is unclear if this list of categories is of an exhaustive enumeration. Also, the introduction of nanomaterials may have huge implications for manufacturers of medical or baby foods. Those foods, although regulated by Regulation 609/2013 inter alia, could be covered by the NF definition, for instance when there was a significant change in the production process or particle size.
Three major changes
The new proposal for the NF Regulation aims to simplify and streamline the regulatory process, while it continues to ensure food safety. More concretely, three major changes are being proposed.
(1) There will be one centralized procedure for NF assessment and authorisation, aimed at the reduction of the authorization procedure from 3 years in average to 18 months.
(2) Introduction of simplified and more proportionate procedure for placing on the market of traditional foods from third countries.
(3) Introduction of a data protection regime covering newly developed scientific evidence and proprietary data during a maximum period of 5 years.
Ad (1) Central authorisation procedure
NF will continue to require pre-market authorisation. Currently, such authorisation is applied for at a national level. The Commission subsequently circulates initial national assessments to all Member States (MS). If these do not raise any reasoned safety objections, the NF can be marketed. However, in the majority of the 68 NF authorisations granted between 2000 and 2013, such objections were raised and an EFSA safety opinion was obtained. The current NF regulation does not set a time frame therefore and quite often, the 60 days term for the MS to provide their opinion is not enforced. This explains why authorisation procedures can last up to 6 years. Under the new NF Regulation, an application for a NF authorisation should be directly made to the Commission. Where the Commission requests a safety opinion, EFSA shall adopt such opinion within 9 months from the date of receipt of a valid application. Subsequently, the Commission shall publish a draft authorisation decision within 9 months from the date of publication of the EFSA opinion. The system of individual authorisations will be replaced by a system of generic authorisations and the “simplified procedure” based on substantial equivalence will cease to exist. Authorised NF will be included into a so-called Union list.
Ad (2) Simplified authorisation of traditional foods
The new NF Regulation introduces a simplified and more proportionate procedure for placing on the market traditional foods from third countries, provided that a history of safe use can be demonstrated. This should be confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a large part of the population of a third country. An applicant who intends to place on the EU-market a traditional food for a third country shall notify that intention to the Commission. When the Commission does not receive any reasoned safety objections within 4 months, the food applied for can be marketed in the EU. In case of any objections, the applicant can file a new application taking into account said objections, which the Commission forwards to EFSA. EFSA shall subsequently adopt, within 6 months from the date of a valid application, its safety opinion. Finally, the Commission shall publish a draft authorisation decision within 3 months from the date of publication of the EFSA opinion.
Ad (3) Data protection
On request of the applicant, data protection is available for newly developed scientific evidence or scientific data supporting the application. This measure was introduced in order to support innovation in the EU-food industry. A similar mechanism is also contained in the Health Claim Regulation for so-called “new function” claims under article 13.5. Under both Regulations, data protection implies that data covered may not be used for the benefit of a subsequent application during 5 years, in the case of a NF to be calculated from the inclusion of the NF in the Union list. Such individual authorisation should however not prevent other applicants from filing applications on the basis of their independently generated scientific data, which may be identical with or similar to the protected data.
Transitional measures, monitoring and timelines
NF that were authorized prior to the entry into force of the new NF Regulation, will be included in the Union list too. As a consequence, a food that was legally placed on the market prior to the application of the new NF Regulation may be further marketed. However, it is mandatory for those foods to undergo the authorisation procedure laid down in the new NF Regulation. Likewise, when a NF is authorized and included in the Union list, the Commission may introduce post-market requirements to monitor the use of the authorized NF, so to ensure that the food is within safe limits as established by EFSA. The new NF Regulation expected to enter into force in 2016 at the earliest, when the Council and the Parliament will have adopted their positions on this topic as well.
Evaluation
Over time many food business operators started to doubt if a new proposal for the NF Regulation would be published at all. The mere fact that this finally happened can be called a positive fact. Also, this proposal contains various positive elements, such as more defined timelines within the authorization procedure for EFSA. However, it should be noted that authorisation delays could still easily increase. For instance, if EFSA requests additional information from the applicant, the authorisation for sure will not make it within 18 months. Furthermore, the authorisation of traditional foods from third countries will take, as a very minimum, 13 months if an EFSA opinion is requested. In line with the number of times an EFSA opinion is requested for NF, it is not unrealistic to expect this will happen most of the times. The procedure provided is therefore not necessarily “simplified” in view of a food that in other parts of the world is considered safe. Also, the proposal still does not contain at all a fixed term in which the MS should provide their reasoned objections, if applicable. At any rate, many items covered by the NF Regulation are still open, since the NF definition does not seem to be of an exhaustive nature. Furthermore, the Commission has received implementing powers to (i) decide whether a particular food falls within the NF definition, (ii) design a procedure to collect information on human consumption of particular foods prior to 1997 and (iii) update the Union list. Finally, legal uncertainty is bound to arise regarding already authorized NF, as they will have to undergo the authorization procedure again under the new NF Regulation.
Image from Clinton Smith Design Consultants
How novel is your food?
Posted: September 6, 2013 Filed under: Food, novel food | Tags: food, guidance, novel, novel food Leave a comment »
If you like to add a new ingredient to – for example – a beverage or want to start selling ‘superberries’ or an exotic seed from Asia in the EU, you should always check whether the food is a so-called novel food. The producer, importer or any other person responsible for the placing of a product on the EU market is primarily responsible for compliance with the EU-legislation, including the Novel Foods Regulation.
According to this Regulation, novel foods require pre-market approval in the EU. But when is a food product actually a novel food? Based on a steady stream of questions, our firm has noticed clients struggle with this question. Good news: this guidance document, recently published by the European Commission brings some relief.
Novel Foods Regulation
Food products (including ingredients) that have not been used to a significant degree for human consumption within the EU prior to the entry into force of the Novel Foods Regulation on 15 May 1997, are, in general, considered novel foods and they should fall in one of the following categories:
- foods and food ingredients with a new or intentionally modified primary molecular structure;
- foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
- foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals (except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use);
- foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.
The Regulation does not apply to food additives, flavourings and extraction solvents used in the production of foodstuffs. Furthermore genetically modified organisms fall outside the scope of the Regulation since the Regulation on genetically modified food and feed that entered into force on 18 april 2004.
Human consumption to a significant degree
A food product is not a novel food within the meaning of the Regulation if it has been used for human consumption to a significant degree in the EU. What is a ‘significant degree’?
This is where the guidance document from the European Commission is helpful. It includes a decision tree and questionnaire to help you assess your product.
The facts to support that a food has already been used for human consumption to a significant degree within the European Union before 15 May 1997 should be based on robust, reliable information. Data must be taken from referenced sources and must relate to foods which have been legally on the Community market.
All available data and information should be taken into account in establishing whether the food product in question falls within the scope the Regulation. These could include for example, recipes, cookbooks, catalogues and sales data. Also (national) legislation regulating the food in question should be taken into account.
Food products commonly used and known in different EU Member States and in specific regions vary greatly. According to the EC guidance, an established history of food use to a significant degree in at least one EU Member State is sufficient to exclude the food from the scope of the Regulation. Obviously, the more a food has been used the easier it is to demonstrate ‘a significant degree’ of use.
Borderline products: Food/Drugs/Cosmetics
Products that have been used for their medicinal effects or as cosmetics are not considered novel foods. The food has to be used for the purpose of food, and not otherwise. Also, the classification of products as medicinal product or a food can differ across the EU because a food product can be classified as a medicinal product in one Member State and as food in another.
Use in food supplements
The Standing Committee on the Food Chain and Animal Health agreed in its meeting of 14 February 2005, that a use exclusively in food supplements before 15 May 1997 would not be considered as “human consumption to a significant degree”. Authorisation under the Regulation would be necessary if the food product has been exclusively used in food supplements.
Herbals considered as food
Significant use of a food product within Europe can be substantiated if the food product is listed on the ‘Inventory list of herbals considered as food’. This list has been drawn up by the European Herbal Infusions Association (EHIA), and is based on the habits, the traditions and/or the regulatory status of plants in different member states. EHIA’s list can be regarded as a compendium of the different histories of use all over Europe. This makes this list a useful resource because it helps to identify whether certain plant material has been used as food ingredient in Europe.
Novel Food Catalogue
In addition, the Novel Food Catalogue of the European Commission can be consulted. The Novel Food Catalogue is a non-exhaustive list of products of plant and animal origin and other substances subject to the Regulation. The list is a living document that is amended with novel foods earmarked by EU member states and the Commission in the Novel Food Working Group. The catalogue provides important guidance as to whether a product will require authorization under the Regulation. If a food product is not listed, this supports the conclusion that the product is not covered by the Regulation.
Useful documentation on Member State-level
Some EU countries have extensively documented which plants/herbs are considered safe and are allowed to be marketed as food. This documentation also gives insight into whether a food product is allowed and whether it is regarded as a novel food that is subject to the Regulation.
For example Belgium and Germany use detailed lists of allowed plants. The German list is helpful to determine whether a plant/herb is considered as food, drug or novel food.
Belgium has recently updated their indicative lists of plants, plant parts and substances and their novel food status. On the Belgian website you can also find a link to a convenient PDF-file named ‘Tools to prove that a food or food ingredient is not a novel food’.
In case of doubt, you may consider consulting the relevant competent authority for novel foods on the status of your food product. But you don’t want to spill the beans; always think it through before contacting authorities because they cannot un-know what you tell them about your product. An example of a review on the status of goji berries by UK’s Food Standards Agency can be found here.
Tools for the novel food toolbox
Are you familiar with similar lists such as the lists used in Belgium and Germany or other documents (preferable in English) that are helpful in the process of determining the status of a food product in the light of the Regulation or other convenient tools? Great! Your comment would be appreciated.
Best check before
Why do you have to check if the food product you are planning to sell on the EU market is a novel food? As mentioned in the beginning of this post, novel foods require pre-market approval. A non-compliant food product is illegal and liability-issues and/or fines might end up on your plate. Better check before you market, and use the tools mentioned in this post to help you find the answer.