The Commission has proposed speeding up market authorisation for foods ranging from cloned meat to exotic products from third countries. But the proposed centralised authorisation system is raising questions at a time when the safety of GMOs is back under the spotlight.
The Commission adopted, on 14 January 2008, its proposal to amend the current novel foods regulation. The aim, according to the EU executive, is to allow “for safe and innovative foods to reach the EU market faster” and encourage the development of “new types of foods and food production techniques”.
The novel foods covered by the revised regulation would include “foods derived from plants and animals, produced by non-traditional breeding techniques, and foods modified by new production processes, such as nanotechnology and nanoscience, which might have an impact on food”, with “non-traditional breeding techniques” standing for ‘cloning of animals’ in this case.
Novel food qualification covers food groups such as plant algae, fungi microorganisms and animal-derived foods, as well as food that has an altered compositional structure or contains oils and dairy products enriched with cholesterol-reducing chemicals.
The Commission proposed the creation of a centralised authorisation system, which would simplify and speed up the process of authorisation for novel foods. The European Food Safety Authority (EFSA) would be responsible for carrying out the risk assessment on the novel food applications. The Commission would then propose authorisation if a food was judged safe by EFSA.
The centralised authorisation system, which is currently applied to GM products, is contested by several member states, which criticise EFSA’s GMO bias in its approval of new GMOs and would prefer their national experts to have more say on the matter. Presenting the novel foods proposal and answering journalists’ questions, a Commission spokeswoman admitted that “the timing of the proposal was not perfect”.
Regarding traditional food from third countries, which have no history of consumption in the EU, “a more proportional safety assessment and management for food with a history of safe food use” is proposed. This means that if a history of safe use of the food in a third country can be demonstrated, and there are no objections from member states or EFSA, the food will be allowed to be placed on the market on the basis of a notification from the third country operator.
The proposal also sets out data protection rules to allow companies to benefit from newly developed scientific evidence and proprietary data once authorised. A five-year market authorisation exclusivity on new types of foods and food production techniques is proposed to encourage innovation.
"This proposal aims to create a more efficient and practical system for regulating novel foods, which will offer EU consumers the benefit of the most up-to-date choice of foodstuffs possible and provide a favourable environment for the food industry in Europe," said Commissioner for Health, Markos Kyprianou.
According to the European Advisory Service, changes to the European novel food regulation could bring the waiting time for approval of new products and food producing techniques down from around three years to just one for the applicants. "The draft of the revision, which is being prepared by the Commission, would reduce the amount of assessment an application has to go through. Instead, EFSA will immediately assess the application and not the member state," it explained.
The European association of consumer cooperatives (Euro Coop) calls for more scientific data and further research on cloning but "would not like to see the scientific dimension outweigh the highly political and ethical dimension of the matter" and calls on a "thorough public debate" on the issue.
"Lessons from the past should be heeded. The EU cannot afford to wait until food resulting from cloned animals is on supermarket shelves to start a dialogue with the general public. More than ever, communicating to consumers is key," said Euro Coop’s Secretary General, Rodrigo Gouveia.
The European Consumers' Organisation (BEUC), in its response to the consultation, strongly supported the need to apply uniform criteria for the assessment of novel foods, but is concerned that any different approach to the safety assessment of "traditional foods from third countries" could result in a relaxation in the safety assessment with a consequent loss of trust in "new" ingredients by European consumers.
BEUC also stated: "We understand the arguments in favour of a centralised assessment and authorisation procedure but we would like to see opportunities for member states and stakeholders to fully comment and contribute to all authorisations [...] We believe that the EFSA should make the initial risk assessment for a novel food in close consultation with experts from member states."
The current EU novel foods regulation dates back to May 1997 and does not cover innovative foods developed since then, nor foods that are being consumed in quantities outside the EU that are not traditionally consumed in Europe.
A stakeholder consultation on the regulation, carried out in 2002, "showed the need to update the current provisions for novel food, in line with new technological developments and scientific advice". The 1997 regulation also needs to be revised as it no longer covers genetically modified organisms (GMOs), which have been covered by separate legislation since 2003.
The revised rules will, once adopted, not apply to biotech foods, food additives, flavourings, enzymes, vitamins or minerals, which are also covered by separate laws.
An impact assessment on the major changes was carried out by the Commission in 2006.
- 11 Jan. 2008: The European Food Safety Authority (EFSA) adopted a draft scientific opinion on the implications of animal cloning on food safety, animal welfare and the environment. It states that "it is very unlikely that any difference exists in terms of food safety between food products from clones and their progeny compared with conventionally-bred animals."
- 16 Jan. 2008: The European Group of Ethics in Science and New Technologies (EGE) is to adopt an opinion on the ethical aspects of animal cloning for food supply.
- 25 Feb. 2008: Consultation on the EFSA draft opinion on animal cloning closes.
- May 2008: Final opinion of EFSA on animal cloning.
- 2008: Eurobarometer on citizens' views on novel foods.
EU official documents
- Commission:Proposal for a regulation on novel foods and amending(14 January 2008) [draft report on impact assessment] [draft report on impact assessment] [summary of impact assessment]
- Commission:Responses to the Online Consultation on the revision of Novel Food regulation [consultation]
- Commission:Novel Foods - Review of Regulation (EC) 258/97
- EurLex:Regulation concerning novel foods and novel food ingredients(27 January 1997) [FR] [FR] [DE]
- Commission press release:Commission proposes measures to encourage safe novel foods in the EU(14 January 2008) [FR] [FR] [DE]
- Commission memo:Questions and Answers on Novel Food(14 January 2008)
- Commission:Novel Foods
- European Food Safety Authority (EFSA):EFSA launches its draft opinion on animal cloning for public consultation(11 January 2008)
- European Group of Ethics in Science and New Technologies (EGE)
- UK Institute of Food Science & Technology:Nanotechnology(February 2006)
- UK Institute of Food Science & Technology:Phytosterol Esters (Plant Sterol and Stanol Esters)(January 2005)
EU Actors positions
- Euro Coop -European Association of Consumer Cooperatives press release:Animal cloning: Euro Coop call for more research and an open debate(January 2008)
Business & Industry
- European Advisory Service:Article 13.5 fast track decision will nourish competitive market(11 January 2008)