An implementing Regulation adopted on 19 March 2018 determines the procedure for the ´consultation process´ regarding the novel food status of foods and food ingredients. Under the Novel Food Regulation (Regulation 2015/2283), food business operators are responsible to consider the novel food status of the foods and ingredients they use. In order to assist in the assessment a request may be directed to the Member States. The Regulation formalizes the procedure for the concerned requests.
The consultation request should be directed to the Member State where the operator intends to first market the food, and the request should also be limited to that Member State. Further, the implementing Regulation imposes formal and material requirements. Following the submission, the Member State shall decide on its validity.
Following the validity of the request, the Member State shall conclude on the novel food status within 4 months. The concerned Member State shall notify the operator, the other Member States and the European Commission. The Commission shall make the decision and related information publicly available on its website.
Food business operators can request confidential treatment of – a part of – the information they provide to the Member State in their consultation request. Important however is that confidentiality shall not affect the exchange of information between the Commission and the Member States necessary to consider the consultation requests.
Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods