The European Union:
On 14 January 2008, the European Commission adopted a proposal revising the current “Novel Foods” Regulation (no. 258/97) in order to simplify the regulatory process and reduce the current national administrative burdens. Novel foods are currently defined as:
- foodstuffs produced by means of new techniques and technologies;
- foodstuffs comprising an ingredient whose origin is not food related; or
- foodstuffs that have no history within the European Union (“EU”), but have been traditionally consumed elsewhere.
The European Commission aims with the new proposal to facilitate the access and trade of new and innovative foodstuffs and ingredients into the European market. In the process of achieving these aims, the European Commission will also continue to strive for a high level of consumer protection.
One of the elements introduced by the European Commission to facilitate the access into the European market is the “one door – one key” procedure which is to simplify procedures for assessing and authorising novel foods. The proposal introduces one centralised procedure for assessing and authorising a novel food. The centralised procedure will be conducted by the European Food Safety Authority (“EFSA”).
In the current Novel Foods Regulation, the application for an authorisation of foodstuffs, which have no history of safe consumption within the EU before 15 May 1997, is made to the individual Member States’ administrative procedures for a prior safety assessment. The new proposal abolishes the national administrative procedures and sets the EFSA as the responsible authority to assess the application of novel foods. However, the Member States retain some involvement since the final outcome of the EFSA’s assessment m ust be submitted to the Member States for additional comments. In addition to the described procedure, the new proposal introduces a simplified (faster) safety assessment procedure for products which have been safely consumed outside the EU, in other words, products which have been traditionally used in third (non-EU) countries (“traditional products”).
At this point of time, the proposal of the European Commission has been submitted to the Environment Commission of the European Parliament (“EP”), which is to review the proposal and take a decision in December 2008. Moreover, the proposal has been supplemented with the proposed amendments of Zuzana Roithová, Rapporteur of the European Parliament, which will also be taken into account by the Environment Commission.
The proposed amendments by the EP Rapporteur are, in a general context, aiming at increasing the legal certainty of undertakings operating in the European food industry. In the proposed amendments the EP Rapporteur specifically emphasises the importance of:
- the objectives of the new proposal for Novel Foods – Regulation;
- the definition and classification of a “novel food” and traditional products of third countries;
- the protection of the innovator; and
- the information process.
With the proposed amendments the EP Rapporteur envisages more clarity regarding the different criteria stated in the new proposed Novel Foods - Regulation. As an example, it can be referred to the definition of “traditional products” where the EP Rapporteur proposed a “clear cut” amendment with regard to the abstract definition of the words “one generation”:
“Text proposed by the Commission:
(a) “traditional food from a third country” means novel food with a history of food use in a third country, meaning that the food in question has been and continues to be part of the normal diet for at least one generation in a large part of the population of the country;
(b) “traditional food from a third country” means novel food with a history of food use in a third country, meaning that the food in question has been part of the normal diet for a period of at least 20 years in a large part of the population of the country;”
On 9 September 2008 the Dutch Association regarding Legislation of Foodstuffs (Nederlandse Vereniging voor Levensmiddelenrecht) organised a study session regarding the proposal’s process of realisation and content. EP Rapporteur Zuzana Roithová was also present at this study session in order to elucidate her proposed amendments.
During the study session, it has been voiced from members operating in the food sector that it would be desirable to clarify the definition of “novel foods” in the most extensive way. The members of the study session stated that the current proposal of the European Commission does not provide an unequivocal definition. Moreover, definitions such as “additives”, “food cloning” and the use of “nanotechnology”, which can be interacted with “novel foods”, raise various questions regarding the classification of “novel foods”. Therefore, the members stated that the proposal cannot be seen as contributing to the legal certainty desired by the undertakings.
It is to be seen to what extent the proposal and EP Rapporteur’s amendments will be adopted by the EP Environment Commission. Moreover, the EP Environment Commission can propose additional amendments based on its own review of the proposal. The EP Commission’s decision will be revealed at the end of December of 2008.
At this point, the conclusion can be drawn that the proposed Novel Foods - Regulation of the European Commission, in its current form, will not meet the expectations desired by the undertakings operating in the European food sector.