Food business operators (FBOs) are required, under the Novel Food Regulation (Regulation 2015/2283, Article 4), to check if the food which they intend to place on the EU market falls within the scope of that Regulation. In cases where they are unsure of the status of the food, they are obliged to consult Member States. The recently adopted Commission Implementing Regulation 2018/456, determines the procedure of the consultation process.
The consultation request has to be submitted and is limited (in cases of several Member States) to the Member State where the FBO first intends to place the food (Recipient Member State). The FBO has to provide all the required information to enable the Recipient Member State to determine the novel food status. If the information submitted by the FBO is insufficient, the Recipient Member State requests additional information. The decision on the validity of the consultation request must be communicated without delay to the FBO, the other Member States and the Commission.
Starting from the date of the decision validating the request, the Recipient Member State has 4 months to conclude on the novel food status. If needed, the Recipient Member State may request additional information to the FBO, consult the other Member States and the Commission. Once the decision on the novel food status is taken, it must be notified, together with a justification, to the FBO, the other Member States and the Commission. The Commission has to publish the decision on its website.
Finally, FBOs can request the Recipient Member State to treat certain information with confidentiality. In case of consultation with the other Member States, the Recipient Member State must inform them and the Commission about confidentiality of the consultation request. The Commission and the Member States remain bound by confidentiality.
The Implementing Regulation applies from 9 April 2018.