What is the current Novel Food legislation?
As of 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods (the new Regulation) is applicable. It repeals and replaces Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 which were in force until 31 December 2017.
The new Regulation improves conditions so that food businesses can easily bring new and innovative foods to the EU market, while maintaining a high level of food safety for European consumers.
The main features and improvements of the new Regulation are the following:
- Expanded categories of Novel Foods: The Novel Food definition describes the various situations of foods originating from plants, animals, microorganisms, cell cultures, minerals, etc., specific categories of foods (insects, vitamins, minerals, food supplements, etc.), foods resulting from production processes and practices, and state of the art technologies (e.g. intentionally modified or new molecular structure, nanomaterials), which were not produced or used before 1997 and thus may be considered to be as novel foods.
- Generic authorisations of Novel Foods: Under the new Regulation, all authorisations (new and old) are generic as opposed to the applicant-specific, restricted novel food authorisations under the old Novel Food regime. This means that any food business operator can place an authorised Novel Food on the European Union market, provided the authorised conditions of use, labelling requirements, and specifications are respected.
- Establishment of a Union list of authorised Novel Foods: This is a positive list containing all authorised novel foods. Novel Foods which will be authorised in the future will be added to the Union list by means of Commission Implementing Regulations. Once a novel food is added to the Union list, then it is automatically considered as being authorised and it can be placed in the European Union market.
- A simplified, centralised authorisation procedure manged by the European Commission using an online application submission system.
- Centralised, safety evaluation of the Novel Foods will be carried out by the European Food Safety Authority (EFSA). The European Commission consults EFSA on the applications and bases its authorisation decisions on the outcome of the EFSA's evaluation.
- Efficiency and transparency will be improved by establishing deadlines for the safety evaluation and authorisation procedure, thus reducing the overall time spent on approvals.
- A faster and structured notification system for traditional foods from third countries on the basis of a history of safe food use. To facilitate the marketing of traditional foods from countries outside the EU, which are considered novel foods in the EU, the new Regulation introduces a simplified assessment procedure for foods new to the EU. If the safety of the traditional food in question can be established on the basis of evidence of a history of consumption in the third country, and there are no safety concerns raised by the EU countries or EFSA, the traditional food will be allowed to be placed on the European Union market.
- Promotion of innovation by granting an individual authorisation for five years based on protected data. Data protection provisions are included in the new Regulation. That means that an applicant may be granted an individual authorisation for placing on the market of a novel food. This is based on newly developed scientific evidence and proprietary data and is limited in time to 5 years.
For further information:
Consultation process on novel food status
Article 4 of the novel food Regulation (EU) 2015/2283 requires food business operators to verify if the food they intend to place on the EU market falls within the scope of the novel food Regulation (EU) 2015/2283.; that is, if the food is novel or not.
If after considering all the information available food business operators are still unsure about a food as novel, they may consult the competent authorities of the EU country where they first intend to place the food (called ‘the recipient EU country’) on the market. Commission Implementing Regulation (EU) 2018/456 lays down the information requirements that need to be included in the consultation request, including provisions on the confidentiality of the request, and the procedural steps business operators must follow for the consultation process.
Once the recipient EU country reaches its conclusion on the novel food status of a food, the Commission will publish that information on the Commission's website.
- Contact details of the EU countries' authorities responsible for the consultation process on novel food status of a food.
Implementing acts and EFSA guidance
To facilitate the entry into force of the new Regulation, the Commission has adopted the following implementing acts:
- Commission Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.
This Implementing act sets out the administrative, technical and scientific requirements which should be included in a novel food application. In addition, specifically on the scientific requirements, the European Food Safety Authority (EFSA) has also issued detailed guidance. Both the legal text of the implementing act and the EFSA guidance are expected to assist food business operators and facilitate the preparation and submission of a Novel Food application.
- Commission Implementing Regulation (EU) 2017/2468 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. This Implementing act sets out the administrative, technical and scientific requirements which should be included in a notification of a traditional food from a third country and which is considered novel in the European Union. Also in this case, EFSA has issued detailed guidance on the information which should be included in the notification, in particular in relation to establishing the safe history of consumption of the traditional novel food in third countries.
- Commission Implementing Regulation (EU) 2017/2470 on establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods (see also chapter 3.3)
- Commission Implementing Regulation (EU) 2018/456 on the procedural steps of the consultation process for the determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods.
This Implementing act specifies the consultation process between a food business operator and an EU country for the determination of novel food status
The new Novel Food regulation does not apply in the following cases:
- Food enzymes within Regulation (EC) No 1332/2008.
- Food additives within Regulation (EC) No 1333/2008.
- Flavourings for use in foods within Regulation (EC) No 1334/2008.
- Extraction solvents used in the production of foods within Directive 2009/32/EC approximating EU countries' laws.
- GMOs for food and feed, covered by Regulation (EC) No 1829/2003.
- If foods and/or food ingredients were used exclusively in food supplements, new uses in other foods require an authorisation under the Novel Food Regulation e.g. food fortification requires an authorisation.