(1)

Regulation (EC) No 1333/2008 requires the Commission to set up a programme for the re-evaluation, by the European Food Safety Authority (hereinafter referred to as ‘EFSA’), of the safety of food additives that were already permitted in the Union before 20 January 2009.

(2)

In 2007, the Commission presented a report to the European Parliament and the Council on the progress of the re-evaluation of food additives (2). That report provides a summary of the recent additive re-evaluations undertaken by the Scientific Committee on Food (‘SCF’) and EFSA and describes the related actions taken by the European Commission on the basis of the scientific opinions.

(3)

The re-evaluation of food colours has already been started with priority, since these food additives have the oldest evaluations by the SCF. The re-evaluation of certain colours (namely E 102 Tartrazine, E 104 Quinoline Yellow, E 110 Sunset Yellow FCF, E 124 Ponceau 4R, E 129 Allura Red AC and E 122 Carmoisine, E 160d lycopene) has already been completed. In addition, some food additives such as E 234 Nisin and E 214–219 Para-hydroxybenzoates were re-evaluated in recent years since new scientific data was requested or became otherwise available. As a consequence, those additives do not need to be re-evaluated again.

(4)

Taking into account that sweeteners have the most recent evaluations they should be re-evaluated the last.

(5)

The order of priorities for the re-evaluation of the currently approved food additives should be set on the basis of the following criteria: the time since the last evaluation of a food additive by the SCF or by EFSA, the availability of new scientific evidence, the extent of use of a food additive in food and the human exposure to the food additive taking also into account the outcome of the Report from the Commission on Dietary Food Additive Intake in the EU (3) of 2001. The report ‘Food additives in Europe 2000 (4)’ submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re-evaluation.

(6)

For efficiency and practical purposes, the re-evaluation should, as far as possible, be conducted by group of food additives according to the main functional class to which they belong. EFSA should however be in a position to start the re-evaluation of a food additive or a group of food additives with higher priority, on a request from the Commission or on its own initiative, if new scientific evidence emerges that indicates a possible risk for human health or which in any way may affect the assessment of the safety of a food additive.

(7)

Deadlines for the re-evaluation should be established in accordance with that order of priorities. In duly justified cases and only when such re-evaluation may delay substantially the re-evaluation of other food additives, the deadlines laid down in this Regulation may be revised.

(8)

More specific deadlines for individual food additives or groups of food additives may be set in the future, in order to allow the smooth running of the re-evaluation process or in case of emerging concern.

(9)

In order for the re-evaluation procedure to be effective, it is important that EFSA acquires from the interested parties all data relevant to the re-evaluation and that the interested parties are informed well in advance when additional data is necessary for the completion of the re-evaluation of a food additive.

(10)

Business operators interested in the continuity of the approval of a food additive under re-evaluation should submit any data relevant to the re-evaluation of the food additive. Where possible, business operators should take steps to submit information collectively.

(11)

EFSA should make public one or more open calls for data on all food additives to be re-evaluated. Any technical and scientific information about a food additive which is necessary for its re-evaluation, in particular toxicological data and data relevant for the estimation of the human exposure to the relevant food additive, should be submitted by the interested parties to EFSA within the set time limits.

(12)

The food additives to be re-evaluated by EFSA have been previously assessed for their safety by the SCF and many of them have been used since long time. The information to be submitted for their re-evaluation should include existing data on which the previous evaluation of a food additive was based and any new data relevant to the food additive made available since its last evaluation by the SCF. That information should be as comprehensive as possible in order to allow EFSA to complete its re-evaluation and form an up-to-date opinion and should be submitted following to the extent possible the applicable guidance on submissions for food additive evaluations (currently the guidance established by the SCF on 11 July 2001 (5)).

(13)

EFSA may require additional information in order to complete the re-evaluation of a food additive. In that case EFSA should request the necessary data in good time either by an open call for data or by contacting the parties that submitted data on the food additive. The interested parties should submit the requested information within a time period that is set by EFSA having considered, where relevant, the views of the interested parties.

(14)

Regulation (EC) No 1333/2008 provides that the approval of food additives should also take into account environmental factors. Therefore, in the framework of the re-evaluation of a food additive the interested parties should inform the Commission and EFSA of any information relevant to any environmental risks from the production, use or waste of that additive.

(15)

Where the requested information necessary for the completion of the re-evaluation of a particular food additive is not provided, the food additive may be removed from the Union list of approved food additives.

(16)

The re-evaluation procedure of food additives must fulfil transparency and public information requirements while guaranteeing the confidentiality of certain information.

(17)

By the date of entry into force of this Regulation, the Commission will make available to the public a list of approved food additives that are being re-evaluated with the date of their latest evaluation by the ‘SCF’ or EFSA.

(18)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council opposed them,

(a)

‘approved food additive’ means a food additive authorised before 20 January 2009 and listed in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs (6), Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (7) or in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (8);

(b)

‘business operator’ means any natural or legal person responsible for ensuring that the requirements of Regulation (EC) No 1333/2008 are met within the food business under its control;

(c)

‘interested business operator’ means a business operator interested in the continuity of the authorisation of one or more approved food additives;

(d)

‘original dossier’ means a dossier on the basis of which the food additive was evaluated and permitted for use in food before 20 January 2009.

(a)

examine the original opinion and the working documents of the Scientific Committee on Food (‘SCF’) or EFSA;

(b)

examine, where available, the original dossier;

(c)

examine the data submitted by the interested business operator(s) and/or any other interested party;

(d)

examine any data made available by the Commission and Member States;

(e)

identify any relevant literature published since the last evaluation of each food additive.