A new Novel Food Regulation (EU) 2015/2283 (“Regulation”) was published in the Official Journal of the European Union on 11 December 2015. The Regulation aims to make it easier for food business operators to place novel foods and food ingredients on the EU market, while ensuring high level of consumer protection.
Under the Regulation, novel food is defined as food that has not been consumed to any significant degree in the EU before May 1997 (when the first novel food legislation entered into force). This can be newly developed, innovative food or food produced using new technologies and production processes as well as food traditionally eaten outside of the EU. The definition now also includes food consisting of engineered nanomaterials and derived from animal clones. The Regulation also makes it clear that insects can fall under the definition of a novel food. The Regulation introduces the following main changes:
- The Regulation creates a centralised authorisation system, which is intended to allow greater certainty for applicants seeking an authorisation for novel food and simplify and speed up the authorisation process. Under the old rules, applications were submitted to an individual Member State for an initial opinion followed by further assessment by the remaining 27 Member States of the EU with input from the European Food Safety Authority in the event of any reasoned objections. This meant that the application process took on average three and a half years. It is expected that the new procedure will cut the average time down to less than half of that, but it remains to be seen whether this will be achieved.
- The European Food Safety Authority (EFSA) will conduct a scientific risk assessment for the novel food application, while the Commission will manage the files of each applicant and put forward a proposal for the authorisation of a novel food which is found to be safe.
- To facilitate trade of traditional food from non-EU countries, which are considered novel foods in the EU, the new Regulation also introduces a “more appropriate assessment procedure for food new to the EU”. If the traditional food in question can historically be demonstrated as being safe and there are no safety concerns raised by EU Member States or EFSA, that traditional food will be allowed to be placed on the market on the basis of a notification from the food business operator.
- The Regulation also provides a procedure for establishing whether a product is novel or not, which has been a difficult exercise in many cases. As part of the procedure, food business operators shall seek clarification from the Member State in which they intend to first market the product.
- To encourage innovation, data protection provisions are also included in the new Regulation. Newly developed scientific evidence and proprietary data will not be able to be used for the benefit of another application for 5 years after the novel food has been authorised.
Overall, the changes made by the new Regulation have been welcomed by the food industry and they are expected to result in a faster, cheaper and more efficient and consistent procedure, removing unnecessary barriers to trade and encouraging innovation.
The Regulation repeals the original novel food Regulation (EC) No 258/97 and takes effect from 1 January 2018, subject to certain administrative provisions that apply from 31 December 2015. The Regulation will also apply to any applications received prior to 1 January 2018, but not finalised before 1 January 2018.