Novel foods

The Committee on the Environment, Public Health and Food Safety adopted the report by James NICHOLSON (ECR, UK) on the proposal for a regulation of the European Parliament and of the Council on novel foods.

The committee recommended that Parliament’s position adopted in first reading following the ordinary legislative procedure should amend the Commission proposal as follows :

Purpose and scope: Members stated that the primary objective of the Regulation should be to ensure a high level of protection of human health, consumers’ interests and of the environment and the effective functioning of the internal market.

In order to adapt the Regulation to technological progress and new kinds of food entering the Union marketplace, Members adopted amendments aiming to reintroduce food categories and introduce new categories for:

·        food with a new or intentionally modified primary molecular structure;

·        food containing, consisting of, or produced from microorganisms, fungi and algae;

·        new foods containing, consisting of, or produced from plants or animals;

·        food derived from cloned animals or their descendants ;

·        food containing, consisting of, or obtained from cellular or tissue cultures.

Marketing of novel foods in the Union: food business operators shall consult the Member State in which they first intend to place the novel food. They shall provide the necessary information to the Member State to enable it to determine whether or not a food falls within the scope of the Regulation. With a view to determining that assessment, the Member State may consult the Commission and other Member States.

Union list: the Commission shall only authorise a novel food in the Union list if: (a) it does not pose a safety risk to human health, nor to animal welfare and where applicable to the environment; (ii) its intended use, presentation and labelling do not mislead the consumer, especially when there is a significant change in the nutritional value of a food intended to replace another food; (iii) it is possible to ensure the traceability of the materials used in its manufacture.

Foods to which production processes have been applied that require specific risk assessment methods (for example, foods produced using nanotechnologies) may not be included in the Union list until such specific methods have been approved by EFSA for use.

Streamlining the authorisation procedure: Members were concerned that the Commission’s proposals did not go far enough in reducing the delays applicants might face. One amendment stated that the Commission should make the application available to Member States without delay and verify the validity of the application within one month of receipt of the latter. Where the Commission requested an opinion from EFSA, it should forward a valid novel food application to EFSA within one month, rather than an unspecified period of time.

The Commission will be empowered to adopt delegated acts in order to update the list of novel foods within six months from EFSA giving its opinion.

In general, the extensions of time limits should be exceptional and appropriate. The applicant is to be the first to be informed about the extension.

Data protection: Members wanted to specify that if an applicant requested data protection on the same food both under this Regulation and Regulation (EC) 1924/2006, the Commission should endeavour to align the timing of both authorisation procedures to let the data protection periods run concurrently. In addition to this alignment of intellectual property protection periods, health claim and novel food evaluation and authorisation procedures shall, where possible, also be synchronised.

Under the Commission proposal, an applicant could obtain protection for data for five years for innovative products. Members want this period to be seven years from the date of authorisation of the novel food.

Monitoring: the Commission shall, for food safety reasons and in line with the precautionary principle impose a requirement for postmarked monitoring for all novel food, in order to ensure that the use of the authorised novel food is within safe limits.

Migration limits for constituents of food contact materials: as the Regulation deals with nanomaterials in food, Members stressed that it was important to ensure that nanoparticles that might accidentally migrate into food be taken into account.

Privileges of Member States: where a Member State had detailed grounds for considering that the use of a food complying with the Regulation endangered human health or the environment, that Member State might  either temporarily restrict or suspend the trade in that food  in its territory.

Cloned animals: until specific legislation on food derived from cloned animals and their descendants entered into force, this food should be accompanied by the following information for the final consumer: "Food derived from cloned animals/descendants of cloned animals."