Novel or Not Novel? Commission Draft Implementing Regulation on the Consultation Procedure for Assessing the Novel Food Status

03 August 2017

Francesca Lotta

The new Novel Food Regulation (i.e. Regulation (EU) 2015/2283), entered into force on January 2016, will become applicable on January 1, 2018. Among the innovations triggered by the Regulation, there is the provision of a consultation procedure aimed at assessing whether or not the food falls within the scope of the Novel Food Regulation.

Article 4(4) of Novel Food Regulation expressly requires the Commission to adopt implementing acts laying down the procedural steps of consultation process for the determination of novel food status.

On July 19, 2017, pursuant Articles 4(4) of Novel Food Regulation, the European Commission published a draft regulation (hereinafter the “Draft”) setting forth the procedure that food operators are required to follow to assess the novel food status of a new product. The Draft is open to consultation until August 16, 2017.

1. Procedural Steps of the Consultation Process for the Determination of Novel Food Status

Article 4 of Novel Food Regulation requires food business operators to verify whether or not the food, which they intend to place on the market, fall within the scope of Novel Food Regulation.

While under Regulation (EC) no 258/1997 (hereafter the “Old Novel Food Regulation”) this assessment was performed on informal basis by national authorities of the Member State in which the food operator intended to place the product on the market, the new Novel Food Regulation provides a consultation procedure which involves both the Commission and the other Member States.

The Draft Implementing Regulation sets forth detailed rules as concerns both the content of consultation request and the procedures Member States have to follow to assess the novel food status.

1.1. Content of consultation request

Article 3 of the Draft Regulation provides that the food business operator shall submit a consultation request to the Member State where he intends to place the food on the market for the first time (hereinafter the “Recipient Member State”).

The consultation request, which shall be submitted electronically to the Recipient Member State, shall consist of: a) a cover letter; b) a technical dossier; c) the supporting documentation; d) an explanatory note clarifying the purpose and relevance of the submitted documentation.

The cover letter shall contain the elements specified in Annex I, which includes the name of the company and its contact details, while the content of technical dossier is specified within Annex II. The content of the technical dossier varies accordingly to the type of food which novel food status shall be assessed and somehow mirrors the outline of the dossier for a new novel food application proposed in the other Draft implementing regulations. In addition to this, whenever a food is an extract or it results from a production process not used for food production within the Union before May 15, 1997, additional information is requested.

The technical dossier shall contain: 1) description of the food; 2) further characterisation of the food and/or source of the food (where relevant); 3) conditions of use; 4) production process; 5) history of human consumption of the food within the Union before May 15, 1997; 6) outcome of consultations on availability in the Union; 7) additional information. Beside this information, when the food is an extract, the food operator shall specify whether the intake of any extract components in the new food is higher than the intake of these components from the original food source. When food results from a production process not used for food production within the Union before May 15, 1997, the food business operator shall provide a detailed description of the production process, specifying whether the structure or composition of the food affects its nutritional value.

1.3. Procedures for evaluating the consultation request and notification of novel food status

According to Article 5 of the Draft Regulation, the recipient Member State shall without delay verify whether the consultation request complies with the requirements of Article 4. Where the recipient Member State deems the consultation request incomplete, it shall request the food business operator to provide additional information. The consultation request shall be considered not valid where: a) the food business operator does not provide requested additional information or b) the submitted additional information is insufficient to conclude that the consultation request is valid.

The recipient Member State shall decide on the validity of consultation request and, where the consultation request is considered not valid, it shall provide the reason for that conclusion, informing the food business operator, the other Member States and the Commission.

Article 6 of the Draft Regulation provides that in case of valid consultation request, the recipient Member State shall conclude on the novel food status within four months from the date on which it decided on the validity of the consultation request. Within the same deadline, the recipient Member State may request the food business operator to provide additional information where it does not have sufficient evidence to decide on the status of a novel food.

The recipient Member State shall notify to the food business operator, the other Member States and the Commission the status of the novel food. The Commission shall without delay make the information on the novel food status publicly available on the Commission’s website.

2. Short Notes

The system shaped by the Draft Regulation presents several grey areas that the Commission should address before passing the act. Although one of the goals of the Novel Food Regulation is to facilitate the placing on the market of innovative food products, this implementing measure seems to introduce disproportionate burdens upon food business operators.

First, even though food business operators are not required to submit studies and analysis to prove food safety, they are in any case required to draft a complete technical dossier in a phase in which they are simply evaluating the opportunity whether or not to place the product on the market. Gathering information on the history of human consumption could be costly and time consuming and requiring in any case the submission of technical dossier for assessing the novel food status, might lead food operators to limit food innovation to avoid falling into “border-line cases”, in which this type of assessment could be required.

Secondly, while under the old Novel Food Regulation, the novel food status was assessed on informal and often anonymous basis by Member States national authorities, the cover letter template expressly requires the food operator to disclose its name and its contact details. This might jeopardise its competitive position, especially when he does not want to make its competitors aware that is working on a specific ingredient or recipe. This is especially true if one considers that the same template also requests the food business operator to consult with industry associations and/or other food business operators.

Moreover, since the Draft Regulation does not provide the possibility to request the confidential treatment of information submitted, it is unclear whether the technical dossier can benefit or not of confidentiality provided by Article 23 of the Novel Food Regulation. The confidential treatment of information submitted through the consultation request needs to be expressly addressed since food operators are required to submit very sensitive information such as the production process and the flow process chart.

Finally the procedure – which basically leaves the decision on the novel food status solely to the recipient Member State – recreates the fragmented system that the new Novel Food Regulation aims to overcome. The edible insects case clearly demonstrates how the European Member States may adopt very different approaches to the novel food status, strongly affecting the developing of this new business that is currently allowed in some Countries (Belgium, France, The Netherlands, U.K. and Denmark) and forbidden in others.

Conclusions

This short analysis highlights that the Draft Regulation presents several “grey areas” that may strongly affect the food operators’ activity. Organizations interested to provide a feedback can submit their comments by August 16, 2017 using the Commission web page.

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