FSA Consultation Letter, 28 April 2008
A copy of the FSA consultation document is available on this site - see: FSA Novel Foods Consultation. A copy of the Commission's proposal is also available - see COM(2007)872 - Novel Foods Proposal. See also:
The proposed regulation of the European Parliament and of the Council on novel foods intended to replace and repeal the current Novel Food Regulation (EC) No 258/97. Responses are requested by: 20 June 2008
The key proposals are to:
On 14 January the European Commission published a proposal to revise the Novel Foods Regulation with a view to simplifying the regulatory process therefore reducing the administrative burden and improving the competitiveness of the European food industry. The key elements of the proposal are set out below.
Centralise the authorisation procedure for novel foods
Under the current system, an application is made to individual Member States (MS) who have 90 days to provide an initial opinion. This opinion is then forwarded to MS who have an additional 60 days to comment on the initial opinion. The new proposal will involve a centralised procedure for the assessment and authorisation of novel foods. All applications for the approval of novel food will be submitted to the Commission and then directed to the European Food Safety Authority (EFSA) which will carry out the safety evaluations. Authorisation decisions will be addressed to the community in general. National administrative procedures and duplication will therefore be abolished.
Develop a simplified safety assessment system for traditional food from third countries
At present a uniform criteria apply for the safety assessment of all kinds of food, including traditional foods from third countries and newly developed innovative foods. However, the Commission considers that these requirements are not always proportional to the potential risks, which mean that the costs of application could be disproportionate. The new proposal makes provision for ‘traditional' food which has not been consumed in the EU, but which has a history of safe food use elsewhere to gain authorisation via a simplified assessment and authorisation process.
Clarify the definition of novel food
The new proposal includes an updated definition of a novel food to clarify that new technologies not currently being used in the food chain, such as nanotechnology and animal cloning, will require a pre-market safety assessment. A clearer definition of a novel food is intended to reduce the current ambiguity, where a food is considered novel only if the process was not used before 15 May 1997 and it results in significant changes in the composition or structure of the foods which affect their nutritional value, metabolism or level of undesirable substances compared with similar products from existing processes. The revised definition takes account of the general food law regulation 178/2002, which includes a general definition of 'food'.
Update the scope of the novel food regulation in relation to parallel legislation on specific categories of foods
At present separate applications need to be made within the respective legal frameworks for a substance with different food uses (such as additives, flavourings, extraction solvents or novel foods). The new proposal will facilitate a single application covering novel food and food uses regulated under various regulatory frameworks, therefore reducing the administrative burden. In addition, ingredients that are now regulated under certain other European Commission frameworks, such as sources of vitamins and minerals, will not be regarded as novel foods, removing the need for parallel authorisations.
Provide a degree of protection for innovative food
The current system of applicant-linked authorisations will be replaced by authorisation decisions addressed to the community in general. However, applicants of newly developed innovative foods would be eligible for an authorisation to market their product for five years through a system of data protection. If another company intends to market the same product within this time, they would be required to submit a separate novel food application using their own safety data. Alternatively, they could use the existing data with the permission of the original applicant.
The purpose of this consultation is to obtain your views on the new proposal, in particular your comments on the key differences between this and the current regulation as outlined above.
Preliminary discussions in Brussels are currently taking place at Council Working Party level under the Slovenian presidency. Responses received before the deadline would be particularly welcome as they will help to inform the UK contribution to these discussions. However, full account will be taken of all responses received before the consultation deadline of 20 June 2008.
Commission impact assessment
The European Commission's proposal is also accompanied by a detailed impact assessment that takes account of consultations with interested parties. The Food Standards Agency encouraged UK stakeholders to contribute to the Commission's assessment in June 2006. The Commission has identified a number of potential advantages associated with the changes it has proposed to the current regulatory framework for novel foods. This is available on the European Commission website.
FSA Impact Assessment
A draft Impact Assessment is included in the consultation documents. We would welcome comments on the draft Impact Assessment and any further evidence of the cost implications of this proposal. Some specific questions have been highlighted in the text.