What is a novel food in the EU?

An Overview Of Food Innovation In The EU

In the EU regulatory system, there is a raft of regulations that relate to innovation in terms of new or novel ingredients in food stuffs. These have been developed over a number of years – at least 30. The most pertinent has been the novel food regulation (EU) no. 2283/2015 which superseded regulation No 258/1997. As well as the novel food regulations we also see a variety of other EU or EC regulations which impact on food innovation. These are:-

• Food Additives regulation (EC) no. 1333/2008 and Food Improvement Agents Regulation (EC) no. 1331/2008
• Enzyme Regulation (EC) No. 1332/2008
• Flavouring Substances Regulation (EC) No. 1334/2008
• GMOs Regulation (EC) No. 1829/2003 and 1830/2003 

For the purposes of this article only the novel food regulations will be looked at.

The Rationale For The Old Regulation (EC) no. 258/1997

The year 1997 is an important one in the EU calendar because it defines from a regulatory point, whether a food product and a food ingredient is ‘novel’ or not. It’s perhaps the most pertinent feature of the Novel Food Regs.

The Definition Of A Novel Food

A ‘Novel Food’ according to the EU is:-

–‘a food that was not used for human consumption to a significant degree within the EU before 15 May 1997; and is a novel food by falling into one of the following categories:- 

I. food with a new or intentionally modified primary molecular structure, examples include fat replacers and tagatose.

II. food consisting of, isolated from or produced from microorganisms, fungi or algae; this would include oil rich in DHA from microalgae.

III. food consisting of, isolated from or produced from material of mineral origin;

IV. food consisting of, isolated from or produced from plants or their parts; this would include chia seed and rapeseed protein

V. food consisting of, isolated from or produced from new animals or their parts; an example is the lipid extract from the Antarctic Krill Euphausia superba.

VI. food consisting of, isolated from or produced from new cell culture or tissue culture derived from animals, plants, micro organisms, fungi or algae

VII. food from a novel production process and 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 (e.g. UVC treated milk)

VIII refers to food consisting of engineered nanomaterials

IX refers to vitamins, minerals and other substances which are produced by novel production processes

X refers to a food exclusively in food supplements before 15th May 1997.

It would not include foods or food ingredients obtained by traditional propagating or breeding practices and already have a history of safe food use.

The idea of novelty in a food is important because it helps define the type of regulations that are needed to be put in place for that food or ingredient.  It even goes as far as to include newly developed foods that could have been made from established extracts and nutrients that are produced from existing food, from foods that are prepared using a new manufacturing process and foods that are traditionally eaten outside of the EU.

If a food ingredient has not been consumed to any significant level within the EU before May 1997 then there is a regulation known as Regulation (EC) Nº 258/1997 which considers it ‘novel’. 

The implication if you have a novel food or a novel food ingredient is that neither can be sold on the open market within the European Union. The ingredient must undergo a thorough assessment proving that it is safe for human consumption. Once its safety has been confirmed does it receive pre-market authorization from the European Commission (EC) which allows it to be sold.

In the old days, Regulation (EC) no. 258/1997 was in operation for just over 20 years. Under that regulation, the new introduction of a food ingredient was required if it did not have a history of use in the European Union generally. Getting a new food approved took some time – at least 2 years if not more. It also meant that assessment from a safety point of view was duplicated because there was an MS safety review and and EFSA evaluation with the European Commission then making the decision. The authorization for the new food was addressed only to the applicants which meant that any other applicants who wanted to use the same ingredient, had to file a ‘substantial equivalence petition’. Unfortunately, evidence gathering was not straightforward and there was often confusion over the history of use. It meant there were substantial barriers to introducing novel foods from countries outside the EU which were undeserved. Clearly botanicals and plants which had a long history of safe use outside the EU were penalised because of the length of time it took for their approval.

The Current Situation: Regulation (EU) 2283/2015

The old process under regulation no. 258/1997 took too long for a new ingredient to be introduced. There was also the need to address the issues of cloning and the emergence of nano-materials. This process of developing new regulations began in 2008 and followed the impasse between the European Council and the European parliament over the meaning of cloning and what types of new food this was creating. 

To ensure a better formulation of the process, there was much wider stakeholder participation. The European Commission consulted many organisations from industry and from consumers. 

The goals of the new regulation which became 2283/2015 was to significantly shorten the time for authorization, to encourage a better process for innovation and reduce the barriers to Novel Foods which were traditional foods in non-EU countries.

The year 2018 marks an important point in the regulatory process. From the 1^st January 2018, all the processes for submissions and evaluation of a novel food change. A new novel food, Regulation (EU) Nº 2015/2283 has brought in a centralized authorization procedure. This new procedure is designed to reduce the time to get a novel food to market by simplifying the process. It now means that all applications will be submitted to the European Commission instead of to a Member State under the old process. If the food needs a scientific safety assessment then the European Food Safety Authority (EFSA) will conduct it. This body rigorously evaluates information from a number of sources to ensure the product is safe for consumers.

Traditional Foods And Novel Food Regulations

Traditional food according to the EFSA web-site is in EU law, treated as a subset of novel foods. EFSA assesses the safe use of traditional foods in parallel with Member States. It relies on information provided by the applicant. the applicant must provide evidence that demonstrates the safe use of a traditional food in at least one country outside the EU for a period of at least 25 years.

It is not up to EFSA to decide whether a food is a novel food or a traditional food coming from a third country. That is a responsibility of the EU risk managers. These risk managers have the key responsibility of deciding whether a novel food or a traditional food from any third country can be placed on the EU market and this also includes its authorised conditions of use.

The General Process For Assessing a Novel Food

Based on the guidelines gleaned from EFSA, when ever you are presented with a new ingredient or foodstuff, the first question to be answered is – is it novel?  It means examining its regulatory status and defining the most appropriate regulatory pathway to take before the product is placed on the market.

Part of the process means finding, collecting and bringing together any information available which supports the fact that the ingredient/foodstuff has been significantly consumed in the European Union before 15^th May 1997. It can also mean finding out if the food has been consumed without safety issues in another country outside the EU for at least 25 years.

A consultancy business will not only gather this data but evaluate it. The idea is to prepare an all encompassing novel food dossier which means it will contain existing information and data on safety, identify any gaps and offer expert opinion to gather and secure additional information, and offer any justifications if data is not available. A lot of data is contained in journals, including ones associated with EFSA itself, in studies that are world-wide and ones which may need translation.

The novel food dossier is a compilation of all this material which is then submitted to EFSA for examination.

Following submission of the report, it is likely EFSA and the European Commission will require additional and supplementary data to consolidate viewpoints. These bodies will also make suggestions and offer regulatory support to help smooth the path of progression of the dossier.

What Do You Look For In The Novel Foods Regulations

Having discussed the development of the novel foods regulations in Europe, it’s worth touching on the information about approved novel food ingredients in databases and documents that can be accessed. We’ll discuss the issues around this information even though it is an extremely useful resource for anyone trying to establish knowledge about such ingredients.

The European Union List

There is now one generic list of approved novel food ingredients in the European Union. It consists of just 2 tables:

Table 1 contains:-

• A specified food category and maximum levels
• Additional specific labelling requirements
• Other requirements

Table 2:

• The specification

Table 1 Definitions

Table 1 is relatively straightforward to understand in most cases. However, compromises have been made that relate to the previous multiple approvals for the same ingredients. One of the most notorious examples of this is krill oil as there are 4 approvals under the old regulation. In other instances, previous approvals of a novel food were rather ambiguous. One of the worst examples was the description of potato protein hydrolysates.

Krill Oil is worth discussing. The Union list identifies the novel ingredient in the first column. This is defined as  ‘Antarctic Krill oil from Euphausia superba’ and this is column one. In the 2nd column are all the specified food categories that this ingredient may be used in such as ‘dairy analogues except drinks’ for example. This column also includes foods which are defined for particular references. For each particular food category there is a 3rd corresponding column which establishes the maximum levels of combined DHA and EPA in this example. So for a specific food category such as ‘cooking fats’ say, the maximum level is 360 mg per 100g.

The 4th column defines the ingredient name for labelling which is ‘Lipid extract from the crustacean Antartic Krill (Euphausia superba).’

For potato protein hydrolysates, the specified food category is not specified. The designation of the novel food on the label of any foodstuff shall be ‘Potato protein’ and nothing more.

These two ingredients illustrate the range of information in the Union list.

Table 2 Specifications

The format for Table 2 has been standardized to a greater degree, including ‘Description’. It is one of those categories where many complex compromises have had to be made on specifications. For example 2′-fucosyllactose has one set of approved used and 3 specifications. So, the ingredient is defined, described, levels of purity established and a number of other quality parameters are described, the heavy metal content that is permitted and a microbiological specification set for bacteria, yeasts and molds.

Novel Food Regulations In Other Parts Of The World

There is no Codex Standard that exist for new food applications with the exception of GMOs anywhere in the rest of the world. All countries or regions have review processes for new ingredients. The FDA in the USA uses GRAS, whilst Health Canada, ANVISA (South America) and FSANZ (Australia/New Zealand) has their own Novel Food regs. in China there is the Nutrition fortifier (CFDA- China Food & Drug Administration)) and the new raw Material (NHFPC). 

Note: EU – European Union and EC – European Commission.