A novel food is a food or ingredient that was not yet sold as a food by the EU prior to 15 May 1997. Novel foods include newly developed foodstuffs, foodstuffs that have been produced using new technologies and production processes and exotic products, such as insects that are only consumed outside the EU. A new European Novel Food Regulation was adopted on 25 November 2015. It will come into effect on 1 January 2018.
The provisions of the prevailing Regulation (EC) no. 258/97 are twenty years old. The technological developments and scientific recommendations have meanwhile changed considerably. In order to shorten the duration of the application procedure (3.5 years on average), the rules and regulations needed to be adjusted. The European Commission put forward an amendment proposal in 2008, but it was not passed due to a lack of consensus between the European Council and the European Parliament. The new proposal was officially agreed upon in November 2015.
The European Commission of the European Union is considered to be the executive committee of the EU. The members are referred to as members of the European Commission. There are presently 28 members of the European Commission, one for each member state. It is the responsibility of the members of the European Commission to promote the interest of the European Union as a whole.
The most significant change with the introduction of the new legislation concerns the more efficient authorisation procedure, which makes it easier to launch new and innovating products in the market subject to the same high food safety standards. A centralised authorisation procedure has been set up to that end.
The Regulation also includes a new procedure to facilitate trading in traditional foodstuffs from non-EU countries that are considered novel foods in EU countries. If it can be demonstrated that a traditional foodstuff has never led to safety problems and the European Food Safety Authority (EFSA) or the EU member states have not ascertained any safety risks, then the product may be introduced on the market in the EU with a notification from the food company.
The members of the European Parliament are elected every five years by the citizens of the European Union. The European Parliament therefore represents the 28 countries that participate in the European Union. It debates on the proposals of the European Commission and comes to a decision, together with the European Council, regarding these proposals.
The EFSA conducts a risk analysis whenever a novel food application is submitted. If the EFSA considers the product to be safe, then the European Commission will conduct the next step in the process. The conditions for use and the labelling requirements are laid down in the permit.
There are a number of conditions that a novel food must meet in order to be eligible for approval within the EU:
1. The product may not pose a threat to public health.
2. The product may not be unfavourable in a nutritional sense when it is to replace a similar product.
3. The product may not be misleading to the consumer.
The governments of the 28 member states of the EU are represented in the Council of the European Union, also called ‘the Council of Ministers’ or ‘the Council’. The Council, together with the European Parliament, is responsible for the legislative and budgetary tasks. This means that the Council must grant its approval of any legislative proposal from the European Commission and every proposed EU-budget.
A number of requests for approval have been submitted during the past years, some of which are yet to be approved as of 1 January 2018. The European Commission will see to winding up these applications per 1 January 2018.