Changes to novel foods law aim to simplify application process
product innovation in the industry, and make cross-border trading
easier, the European Commission says in a consultative document.
The online public consultation was launched on revising the Novel Food Regulation by the Commission's health and consumer protection section as a means of gauging the impact the changes would have on the industry and consumers.
Revisions to the directive are necessary to reflect an EU decision to exclude genetically modified (GM) foods from the scope of the legislation, the Commission stated.
"Novel foods" are defined as those products that were not consumed to significant degree in the EU before 15 May 1997, the date the original legislation came into force. Such foods thus go under a pre-market safety assessment and authorisation process before being allowed to go on sale in the 25-member bloc.
Novel foods are divided in three main groups. One group coverse traditional foods, such as noni juice, sourced from outside the bloc. A second group covers newly developed innovative foods such as phytosterols. A third group covers food produced by new technologies with impact on food, such as fruit juice produced using high pressure processing.
"The consumer would also benefit from a wider choice of safe novel foods," the consultative document stated. The Commission wants to create a more streamlined authorisation procedure.
The changes would take into account issues such as the particular needs of traditional exotic food from third countries and applications that cover several food uses.
Under the currently legislation traditional foods, which were not on the EU market before 1997, goes through the same rigorous safety assessment as any newly developed innovative food. This is perceived by third countries as unjustified barriers to trade for their traditional foods, the Commission noted.
"The data on safe food use outside the EU should be taken better into account," the Commission stated.
The changes would also make it easier to trade in the EU's internal market by streamlining the authorisation procedure, by developing a more adjusted safety assessment system and by clarifying the definition of 'novel'. The use of new technologies that have an impact on food would also be covered by the proposals.
One proposal would require product makers to disclose to consumers specific information about novel foods.
"The product authorisation procedure takes too long," the Commission stated. "It is also in some cases difficult to predict for the applicants due to the lengthy decentralised system."
The authorisation decision is presently only addressed to the applicant, so that others do not have the right to market the product. Therefore, an additional separate but simplified procedure is needed for others to market the same food.
Another proposal would allow an applicant to make one submission when applying for approval of a novel food and at the same time for uses covered by other sectoral legislation, such as additives, flavourings, and extractions solvents.
"The advantage would be one application and risk assessment submitted in conformity with the future common authorisation procedure in the food area to be laid down in a horizontal legal act," the Commission stated. "The requirements and criteria of the specific sectoral legal frameworks would be respected."
The changes would fit into the current Commission policy, contained in proposals to the European Parliament and Council calling for the bloc to establish a common authorisation procedure for food additives, food enzymes and food flavourings.
A common authorisation procedure for these food categories would be the first building block of a cross-industry legal act. Such an act would harmonise the authorisation procedures for all the approvals in the food sector.
The original Novel Foods regulation came into force in 1997. A consultation with industry and regulators along with an independent review by a consultation company were carried out between 2002 to 2003.
A previous consultation and an independent review of the legislation set out different policy options for the issues involved in bringing novel foods to the market.
Since implementation in 1997 the European Commission has received about 65 applications for approval under the legislation. About seven to 10 applications are submitted for a decision per year.
The consultation will run for eight weeks, until 1 August 2006.
