Brussels, 14/01/2008 (Agence Europe) - The European Commission is proposing to revise Community legislation on new foodstuffs and food ingredients, in order to make it easier to put new foodstuffs on the market in the European Union. The objective is to encourage innovation by making life easier for companies which are prepared to invest in new food production, from new ideas in the field, “whilst maintaining a high level of consumer protection”, the Commission explains.
A proposed regulation to this end was adopted on 14 January by written procedure, with a view to revising Community assessment and authorisation rules for new foodstuffs within the EU.
New foodstuffs include all new food products, consumption of which within the EU remained negligible before 15 May 1997, the date on which the Community regulation 258/97 on new foodstuffs and food ingredients, the “Novel Food” regulation, entered into force.
The Commission means either foodstuffs which have resulted from biotechnology, such as products enriched with phytosterols/phytostanols which may help to reduce cholesterol levels in consumers, or conventional foods which are not well known in Europe, but are consumed in other parts of the world, and which have passed tests to prove their harmlessness, such as noni juice (a plant from Tahiti). Currently “in the pipeline” are: the Baobab (pulp of the dried tree fruit from Africa), concentrated Kiwiberri (commonly consumed in China, Japan, Korea and Siberia) and CLA (conjugated linoleic acid), which is reputed to be beneficial for health.
Central to the new proposed regulation is a centralised evaluation and authorisation procedure, which the European Commission believes will be “simpler and more effective”.
Regarding foodstuffs resulting from new technologies or techniques, the Commission is proposing to put an end to the current procedure, whereby an initial assessment must be carried out by a member state and sent to the other member states for their information.
In the future, under the proposed regulation, the request for authorisation will be sent to the European Commission. It will then be the responsibility of the European Food Safety Authority (EFSA) to carry out the scientific assessment of the product and return its opinion. If the product is judged to be safe, the Commission will put a proposal for the authorisation of sales of the product within the EU to the representatives of the member states on the Standing Committee for the Food Chain and Animal Health. “This centralisation will speed up and unify the authorisation procedure, whilst making it more transparent for applicants”, states the European Commission.
For conventional foodstuffs, consumption of which in third countries has demonstrated their harmlessness, the authorisation procedure will also be simplified. The applicant must send the Commission a notification together with a document attesting to the past safety of the product in the third country, but will not be obliged to provide a full dossier, as will be required for a newly developed product. This notification will be put to the EFSA and the member states. If no objections are raised, the applicant may sell the product within five months of the date of notification.
The proposed regulation also contains proposals aiming to protect data on innovative foodstuffs recently developed. These provisions will allow the initial applicant to sell the foodstuff for five years, whereupon it will become a generic foodstuff which can be produced and sold by others.
A step closer to the authorisation of foodstuffs produced from cloned animals?
As regards foodstuffs produced from cloned animals, the text provides that these must be the subject of a safety evaluation prior to placing them on the market, and of an authorisation procedure.
In answer to the press, which was surprised that the Commission was presenting a legislative proposal applicable to foodstuffs derived from cloned animals before it had even received the definitive opinion of EFSA on the guaranteed safety of such foodstuffs (see other article), Nina Papadoulaki, the spokesperson to Commissioner for Health Markos Kyprianou, invoked the timetable. At pains to reassure her audience, the spokesperson pledged that the Commission would wait for the definitive opinion of EFSA, which is anticipated for May 2008, the opinion of the European Group on Ethics in Science and New Technologies, and for the results of a Eurobarometer survey, which is planned to sound out the opinion of the citizens, in order to “reflect on possible measures to be taken”. Johannes Laitenberger, the chief spokesperson, added: “This text refers to the authorisation procedure, which does not prejudge the authorisation of products on a case-by-case basis”. The Commission has no response for those voicing their surprise that the Commission has opted, for new foodstuffs, for an authorisation procedure which is similar to that applicable to GMOs, just as this procedure is coming in for increasing levels of criticism. “This is a simplification of the procedures under an existing regulation, as a result of a consultation of all parties”, Ms Papadoulaki reiterated. (A.N.)