It has made changes to areas concerning definitions, data protection, traditional foods from third countries, penalties imposed by member states, and the authorisation procedure. Europe's novel foods regulation (EC No 258/97) was introduced in 1997 and requires any food not commonly consumed in the EU prior to May 1997 to undergo rigorous safety assessment before it can be brought to market. The amendments were proposed by the European Commission to simplify and centralise the novel foods authorisation process and foster industry innovation. The European Parliament (EP) agreed new regulation was necessary to ensure high levels of food safety, consumer protection, environmental protection and protection of animal health, however made additional changes to further achieve this. European Parliament's alterations The Commission's proposed changes sought to clarify the definition of novel foods and associated definitions, but the EP said "the Commission has negligently fallen short in achieving it". It therefore suggested there be individual definitions for foods deriving from cloned animals, as "no democratic decision has yet been reached on the desirability of these foods," and those produced using nanotechnology should be added. The EP also said the Commission has "got ahead of itself" in seeking to make the authorisation procedure more effective and transparent, by thinking the regulation should be governed by the common authorisation procedure for food additives, food enzymes and flavourings. The EP and the Council has therefore proposed an authorisation procedure based on that used for genetically modified food and feed, "which was carefully drafted with a view to consumer protection and environmental protection", and also the most recently devised specific procedure for novel foods. The EP has said a precise period of safe use of traditional foods from third countries should be established - one that is long enough to guarantee the safety of the product. It proposed a period of 50 years, as opposed to the 'one generation' suggested by the Commission, which is difficult to define. Additionally, while the Commission proposals foresee member states having to impose penalties on violators of the novel foods regulation, the EP said criminal law is always a matter for the member states and they should be able to decide whether a penalty is to be imposed. Data protection A major concern for the novel foods regulation has been on whether it adequately supports innovation and competitiveness by protection novel procedures and products. The Commission proposal aimed to achieve a certain level of data protection for a five-year period for applications, which the EP said it found surprising. "The Commission adduced a completely different line of argument during the consideration of the uniform authorisation procedure in the European Parliament," it said. "The Commission claimed there that a data protection system would result in an increase in regulation and would render monitoring systems and administrative procedures more complex. In addition, a data protection system would constitute an obstacle to free movement of goods which are safe and meet the criteria of the relevant legislation." It therefore lay down rules for making certain information available to the public and for the protection of submitted information. Scope for further change The CIAA (The Confederation of the Food and Drink Industries of the EU) said: "We are pleased to see that she introduced definitions, including for nanotechnology and a uniform authorisation procedure. Details of course need to be further reviewed." CIAA maintains that the revision of the regulation needs to ensure that the competitiveness of the food and drink industry is safeguarded and that particularly SMEs can in the future profit from easier procedures, thereby encouraging them to invest in innovation: However, criticisms remain, and the CIAA would like to see more provisions to ensure the competitiveness of the food and drink industry and to encourage SMEs to invest in innovation, such as:
Establishing a more explicit link between a novel food authorisation and the applicant company
Providing appropriate transitional mechanisms for pending novel food applications
Ensuring an operable relationship between the Novel Foods and Health Claims Regulation
Introducing a simplified notification procedure for foods and ingredients with a history of safe use, such as foods and ingredients that are used in food supplements, which are intended to be used in a novel food
The draft report will now be debated in the environment committee on 14 July, and the deadline for amendments has been set as 8 October. Following this, there will be a debate on the amendments, which is currently scheduled for 4 November. There will be a vote in the environment committee regarding the proposal in early December, shortly followed by a vote in the plenary.