The European Commission has adopted a proposal to revise Regulation EC 258/97, concerning novel foods and novel food ingredients ("foodstuffs"), with the aim of improving EU market access to new and innovative foodstuffs whilst still ensuring consumer protection.
"Novel foods" are foodstuffs that have not been used, to any significant degree, for human consumption within the European Community before the 15 May 1997. Any foodstuffs entering the EU market after this date must undergo a safety assessment and must be deemed to be safe for human consumption before they can be legally placed on the EU market.
One of the key complaints made against Regulation EC 258/97 is that the application for assessment and approval is often complex and involves a considerable length of time, with some applications taking several years before a decision is reached. Under the proposed Regulations the Commission hope to streamline and simplify the application and authorisation procedure and thereby enable novel foodstuffs to enter the EU market more quickly.
Centralised authorisation system
Under the proposals there will be one centralised procedure for assessment and authorisation. Applications are submitted to the Commission, who will ask the European Food Safety Authority (the "EFSA") to undertake scientific and safety assessments. The Commission will include those products deemed to be safe for human consumption by the EFSA in an approved Community list of novel foodstuffs.
Traditional food from a third country
Traditional foods from a third country are defined in the proposed Regulations as meaning "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".
Under the current Regulations traditional foods are subject to exactly the same assessment and authorisation procedures as new and innovative foodstuffs. Under the new proposals the procedures for traditional foods will be simplified and the history of safe use will be taken into account. The third country will send a notification to the Commission, together with a dossier of data on the food, which will be provided by the Commission to the EFSA and each Member State, who have the right to raise objections. If no objections are raised the traditional food can be placed on the EU market five months after the date of notification to the Commission.
Data protection
In order to encourage investment in new food technologies the Commission are proposing provisions whereby a period of data protection will be granted to protect newly developed scientific evidence and proprietary data that has been provided in support of an application for authorisation of a new and innovative foodstuff. The applicant afforded the protection will be able to prevent the use of the protected data by third parties as part of other applications, without its prior consent, for a period of five years from the date of inclusion of the novel foodstuff in the Community list.
