Since 1 January 2018, the new EU Novel Foods Regulation, No. 2015/2283, has come into force. This Regulation sets rules for new foods and new food ingredients, the so-called novel foods. These novel foods have received a new definition (see article 3, sub 2a). The new regulation takes into account a high level of protection of human health, environment and consumers' interests and the effective functioning of the internal market i.e. the free movement of safe and wholesome food. Both the old EC Novel Foods Regulation, No. 258/97, and EC Novel Food Labeling Regulation No. 1852/2001, which were valid until 1 January 2018 (see below), have been repealed as from this date.
New categories for novel foods have been introduced, like ‘food consisting of engineered nanomaterials’. Food intended to be used for technological purposes and genetically modified food which is already covered by other Union acts (see article 2) do, however, still not fall within the scope of this Regulation.
Union list of authorised novel foods
Novel foods may not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). In that list are included the novel foods already authorised or notified in accordance with Regulation (EC) No 258/97, including any existing authorisation conditions. For the most recent Union list, as established by Commission Implementing Regulation (EU) 2017/2470 and valid on 1 January 2018, click here.
On this list, one may find the next oils and fats related (authorised) novel foods and food ingredients:
|Decision 2000/500/EC||yellow fat spreads with added phytosterol esters|
|Decision 2008/559||refined allanblackia seed oil (for use in yellow fat and cream-based spreads)|
|Decision 2008/558||refined echium oil (for use in various products, including spreadable fat products)|
|Decision 2009/752 and Implementing Decision (EU) 2016/598||lipid extract from the Antarctic Krill Euphausia superba crustaceans (for use in various products, including spreadable fats and dressings) and DHA and EPA-rich oil from Antarctic Krill (for use in food supplements)|
|Decision 2009/777, Implementing Decision (EU) 2015/545 and Implementing Decision (EU) 2015/546||algal oil from the micro-algae Ulkenia sp. (for use in bakery products, cereal bars and non-alcoholic beverages) and DHA and EPA-rich oil from the micro-algae Schizochytrium sp. (for use in spreadable fats and dressings, cooking fats, various foods and food supplements)|
|Decision 2011/513||phosphatidylserine from soya phospholipids (for use in chocolate-based confectionery, cereal bars, foods and beverages based on yoghurt, and powders based on milk powder)|
|Implementing Decision 2014/155/EU||coriander seed oil (for use in specific food supplements subject to conditions)|
|Implementing Decision 2014/424/EU||rapeseed oil (for use in foods)|
|Implementing Decision 2014/463||algal oil from the micro-algae Schizochytrium sp (for use in various products, including spreadable fats and dressings, dairy products, bakery products, breakfast cereals, cereal bars and cooking fats)|
|Implementing Decision 2014/890/EU||cold-pressed chia oil (for use in oils and fats, as well as in food supplements)|
|Implementing Decision (EU) 2015/1290||refined oil from the seeds of Buglossoides arvensis (for use in butter and other oil and fat emulsions, including spreadable products, and in other foods and food supplements)|
|Implementing Decision (EU) 2017/2373||hydroxytyrosol, a polyphenol from olives (for use in fish and vegetable oils (maximum content 0.215 g / kg) and spreadable fat products (maximum content 0.175 g / kg); the ingredient is intended for the general population, with the exception of children younger than three years, pregnant women and breastfeeding women)|
|Implementing Decision (EU) 2017/115||fermented (non-genetically modified) soybean extract (for use in food supplements subject to conditions)|
This Union list will function as a starting point, in so far as novel foods authorised according to the criteria of the new EU Novel Food Regulation will be added to this list.
According to article 7, the Commission shall only authorise and include a novel food in the Union list if it complies with the following conditions:
(a) the food does not, on the basis of the scientific evidence available, pose a safety risk to human health;
(b) the food's intended use does not mislead the consumer, especially when the food is intended to replace another food and there is a significant change in the nutritional value;
(c) where the food is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
The authorisation procedures for a novel food may be found in article 10, the requirements for the European Food Safety Authority’s assessment of the safety risks arising from a novel food in article 11. The EFSA is subjected to a deadline (maximum of nine months after receiving the Commission’s request for an Opinion) to guarantee a smooth processing of applications, although this may be extended in certain cases (like insufficient information). After the publication of a (positive) EFSA Opinion, the Commission in its turn according to article 12 has a maximum of seven month to come up with a draft implementing act for the authorisation of the novel food concerned. Where the Commission has not requested an Opinion from EFSA, the seven-month period starts from the date on which a valid application is received by the Commission.
Traditional foods from third countries which comply with certain criteria, may benefit from a fast-track authorisation procedure. Articles 14 to 20 lay down the specific requirements for this category of novel foods.
When a novel food is authorised and included in the Union list, the Commission may introduce post-market monitoring requirements to monitor the use of the authorised novel food to ensure that the use is within safe limits as established in the risk assessment by EFSA (article 24). Scientific data provided by an applicant who requests confidential treatment of (certain) data, may benefit from an overall five-year period of data protection (see articles 23, 26, 27 and 28).
Pending applications and widening scope
For those applications which have been submitted under Regulation (EC) No 258/97 and for which a final decision has not been taken before 1 January 2018 risk assessment and authorisation procedures should be concluded in accordance with this new Regulation. Furthermore, a food not falling within the scope of Regulation (EC) No 258/97 which was lawfully placed on the market before the date of application of this Regulation and which now falls under the scope of this Regulation, may in principle continue to be placed on the market until the risk assessment and authorisation procedures under this Regulation have been concluded.
In order to adjust faster to new technological and scientific developments, the European Commission is given mandate to adopt delegated acts under certain conditions (see articles 31 and 32).
Situation before 1 January 2018
Novel Foods Regulation (EC) no. 258/97 regulated the authorisation of new foods and new food ingredients until the entry into force of the new regulation per 1 January 2018. In a certain way, this old Novel Foods Regulation still bears influence, since its coming into effect on 16 May 1997 still serves as a marking point when considering foods and processes which have or not te be judged novel foods or novel food ingredients. ,To determine whether the old Novel Foods Regulation applied to a product, the following flowchart could be used. New foods had to be analysed for potential population health problems due to the consumption of the relevant food.
If a producer or merchant wanted to bring a product of this nature onto the European market, it had to go through an authorisation procedure. The application for the authorisation of a novel food or a notification of a novel food that had already been placed on the market by another producer had to be made with the Ministry of Health, Welfare and Sport (VWS) and had to be accompanied with a safety dossier on the relevant food. The applicant at the same time sent a copy of the application to the European Commission. The Health Council evaluated the dossier on behalf of the Ministry of VWS and sent its recommendation to the European Commission, which distributed it among member states. The member states subsequently had 60 days within which to submit any objections. If an additional evaluation was required or if an objection was submitted, the member state was not permitted to approve the product for trade. A special authorisation decision from the European Commission was then required in accordance with the procedure of the Permanent Committee for the Food Chain and Animal Health. If a product was ruled essentially equivalent to an existing product on the European market, the product, following notification, could be placed on the market without any further safety assessment (Article 5 Application).
The Commission maintained various Novel Foods Lists. There was a list with applications for authorisation, a list with notifications and a list with authorised products. To view these full lists visit the EU Novel foods Catalogue. It was also possible to consult a catalogue to find out whether anything was said about a specific product in the past and what the status of that product was. The actions required to be allowed to use the product could then be determined on this basis. It should be noted that even when a substance was not new, some member states had nevertheless imposed legislative restrictions on its use. Even when a substance was used in food supplements, its use in other foods was only possible after going through an authorisation procedure that produced a positive result.