The European Council’s Permanent Representatives Committee approved a draft regulation on novel foods last week, which will make it easier and cheaper to get approval to put the foods on the market. Additionally, the high level of protection of human health will be preserved by this legislation. Novel foods are foods not consumed in the EU to a significant degree before May 1997, when the first novel food legislation entered into force. This distinction includes foods to which a new production process is applied.
The main changes:
- Current rules mean that novel foods take about three years to authorize. In the past 20 years, technological developments and scientific advice have evolved considerably … therefore, under the new rules, the authorization procedure should only take around 18 months. The draft regulation also provides for generic authorizations, which helps reduce administrative burdens — once authorized and added to the EU list, a novel food is able to be put on the market by any food business operator. This means that other companies will not have to re-submit a new application for the same novel food.
- The regulation creates a centralized authorization system, to allow greater certainty for applicants seeking an authorization for novel food and to make the authorization process quicker and easier.
- The European Food Safety Authority (EFSA) will conduct a scientific risk assessment for the novel food application. Meanwhile, the Commission will manage the files of each applicant and put forward a proposal for the authorization of a novel food which is found to be safe.
- In order to enable trade of traditional food from non-EU countries (these 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.
- Data protection provisions — new scientific evidence and proprietary data has to wait five years after the novel food has been authorised in order to be used for the benefit of another application.
These rules specifically cover food containing engineered nanomaterials. According to the European Council’s website, “The Commission is mandated to adapt the definition of engineered nanomaterials to technical progress or the definitions agreed at international level.” The rules also cover insects, and food from cloned animals.
The International Life Sciences Institute states that new technologies, such as nanotechnology, impact many aspects of food science — the production of food, packaging materials, and developing new ingredients with new functionalities. The Novel Foods and Nanotechnology Task Force has been at the leading edge in terms of developing the safety risk assessment approaches for novel foods (including biotechnology) over the years.
As new technologies are being developed, for delivering benefits to consumers the task force considers and evaluates how risk assessment approaches will need to be adapted in order to support future innovation in the food industry.
