WRITTEN QUESTION E-2131/97 by Hiltrud Breyer (V) to the Commission (23 June 1997)

Subject: Novel food regulation No 258/97 - Requirements for authorization

What exactly are the test criteria, in accordance with which applications for authorization for products under the novel food regulation ((OJ L 43, 14.2.1997, p. 1. )) have to be assessed to see whether permission is required or whether simple registration will be deemed to be sufficient if the manufacturer has not applied for permission?

Supplementary joint answer to Written Questions E-2113/97, E-2115/97, E-2117/97, E-2119/97, E-2121/97, E-2123/97, E-2127/97, E-2129/97, E-2131/97, E-2133/97, E-2135/97, E-2137/97, E-2139/97, E-2141/97, E-2143/97, E-2145/97, E-2147/97, E-2149/97, E-2151/97, E-2153/97, E-2155/97, E-2157/97, E-2159/97, E-2161/97, E-2163/97, E-2165/97, E-2167/97, E-2169/97, E-2171/97, E-2173/97, E-2175/97, E-2177/97, E-2179/97, E-2181/97, E-2183/97, E-2185/97, E-2187/97, E-2189/97, E-2191/97, E-2193/97, E-2195/97, E-2197/97, E-2199/97, E-2201/97, E-2203/97 and E-2205/97 given by Mr Bangemann on behalf of the Commission (11 November 1997)

Further to its answer of 17 September 1997 ((OJ C 60, 25.2.1998, p. 109. )), the Commission can now provide the following information.

E-2113/97, E-2115/97, E-2117/97, E-2119/97, E-2123/97, E-2149/97

At the present time, seeds covered by Directives 70/457/EEC and 70/458/EEC, be they genetically modified organisms (GMOs) or not, must be registered in the common catalogue of varieties before being placed on the market within the Community. Before being registered, it must be established that they are distinct, stable and sufficiently uniform. Where seeds are GMOs, they must, in addition, undergo a human safety and environmental risk assessment under Council Directive No 90/220/EC of 23 April 1990 concerning the deliberate release of genetically modified organisms into the environment. The labelling of such products, ie transgenic seeds, must be carried out in accordance with Annex III to that directive.

Furthermore, since 15 May 1997, all foods and food ingredients containing, consisting of, or derived from GMOs, which have not hitherto been consumed to a significant degree within the Community, must follow the procedures laid down in Regulation (EC) 258/97 concerning novel foods and novel food ingredients. Article 8 of that Regulation also lays down the labelling rules that apply to such products.

As the Honourable Member is aware, Regulation (EC) 258/97 initiates the so-called 'one-stop' policy. This means that it is possible to carry out the risk assessment relating to Directive 90/220/EC in the framework of the Regulation.

Moreover, the Commission has submitted a proposal to amend the directives relating to the marketing of seeds ((COM(93) 598. )). This proposal, on which Parliament has given its opinion, stipulates that an applicant must have the environmental risks pursuant to Directive 90/220/EC assessed within the framework of the seeds directive, and also stipulates the possibility of having novel food characteristics analysed, in order to simplify administrative procedures, again in accordance with the 'one-stop' principle. This possibility, envisaged in Article 3(2) of Regulation (EC) 258/97, has not yet been implemented, pending the adoption of the new rules on seeds.

E-2121/97

Normally, the safety evaluation of a novel food will cover all uses of the foodstuff concerned. Thus the safety evaluation of a genetically modified tomato would cover tomato concentrate, and processed foods containing that concentrate. However, in certain cases, a separate evaluation of secondary products may be required.

For example, if ready-made pizza was imported from a third country containing tomato concentrate produced from a variety of genetically modified tomato which was not authorised in the Community, then a separate authorisation or notification procedure under Regulation (EC) 258/97 would be required.

E-2127/97, E-2129/97, E-2131/97

Novel foods or novel food ingredients which fall within the scope of Regulation (EC) 258/97 may only be placed on the market in accordance with the provisions of the Regulation. In accordance with Article 3 (4) and Article 5 of the Regulation, a simplified notification procedure is available for novel foods or novel food ingredients which are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the number of undesirable substances contained therein.

The person placing the food or food ingredient on the market is required to notify the Commission, which forwards the notification to the Member States. The applicant must accompany the notification with the relevant details provided for in Article 3(4). The labelling requirement of Article 8 of the Regulation applies to products covered by the Article 3(4) procedure. The information supplied in accordance with Article 5 of the Regulation, namely the relevant details provided for in Article 3(4) accompanying the notification, can be used to assess which labelling obligations arise pursuant to Article 8. If necessary additional information may be requested.

As regards the evidence necessary to demonstrate substantial equivalence, the Honourable Member is referred to the Commission Recommendation of 29 July 1997 ((SEC(97) 1452. )) concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) 258/97.

E-2133/97, E-2135/97

For the scientific aspects of the evaluation of applications for novel foods and novel food ingredients, the Honourable Member is referred to the abovementioned Commission Recommendation of 29 July 1997.

This data is subject to an independent evaluation in accordance with the procedures laid down in Regulation (EC) 258/97. As part of this evaluation, the competent authorities may decide to verify certain of the results presented by the applicant.

E-2137/97

The Commission would refer the Honourable Member to the published statement it made in respect of Article 2 at the time of the adoption of the Regulation ((OJ L 43, 14.2.1997. )).

E-2139/97, E-2157/97

For some years, the Commission has been engaged in extensive consultations with Member States and representative organisations established at Community level on all aspects concerning novel foods, including labelling questions.

In accordance with the procedure laid down in Article 13 of Regulation (EC) 258/97, decisions on its implementation are taken by the Commission following the opinion of the Standing Committee for Foodstuffs, which was established by Council Decision 69/414/EEC of 13 November 1969 ((OJ L 291, 19.11.1969. )). The committee consists of representatives of the Member States, with a representative of the Commission as chairman. There is no possibility for representatives of non-governmental organisations to participate in the deliberations of the committee.

E-2141/97

Pursuant to Article 8(1) of Regulation (EC) 258/97, the label must indicate the modified characteristics or properties, together with the method by which that characteristic or property was obtained.

E-2143/97

It is true that the labelling of products, for which applications for authorisation were subject to Directive 90/220/EC and presented before the amendment of Annex III, is voluntary. The Commission would however draw the Honourable Member's attention to the fact that under Directive 90/220/EC it has received voluntary labelling proposals from applicants. In addition, all novel foods and food ingredients, as defined in Article 1 of Regulation (EC) 258/97, are subject to the provisions of that Regulation, including the labelling rules laid down in Article 8.

E-2145/97

The Commission would refer the Honourable Member to Council Directive 89/397/EEC on the official control of foodstuffs ((OJ L 186, 30.6.1989. )) and Council Directive 93/99/EEC on additional measures on the official control of foodstuffs ((OJ L 290, 24.11.1993. )).

E-2147/97

Responsibility for deciding on the sanctions applicable in case of non-respect of the Regulation lies with the Member States.

E-2151/97

A novel food or food ingredient is deemed to be Longer equivalent for the purpose of Article 8 of Regulation (EC) 258/97, if a scientific assessment, based upon an appropriate analysis of existing data, can demonstrate that the characteristics assessed are different in comparison with a conventional food or food ingredient, having regard to the accepted limits of natural variations for such characteristics. In this case, the labelling must indicate the modified characteristics or properties, together with the method by which that characteristic or property was obtained.

E-2153/97

Yes. The above mentioned Commission Recommendation of 29 July 1997 makes it clear in paragraph 3.4 that analytical studies of the composition of the novel food are of crucial importance and so should be included in the request referred to in Article 4(1) of Regulation (CE) 258/97.

E-2155/97

1. In such circumstances, the Commission considers that a notice displayed prominently at the point of sale would be appropriate to ensure the proper information of the consumer. However, since no application has yet been submitted under the Regulation for genetically modified fruit and vegetables which are intended to be sold loose to the consumer, no final decision has yet been made on this matter.

2. - 4. The questions raised by the Honourable Member are currently under active consideration by the Commission in the framework of the preparation of detailed Community rules for the labelling of foods and food ingredients produced from genetically modified soya and maize.

E-2159/97

The possibility of the unintentional transfer of elements derived from genetically modified organisms into other crops or products is considered during the environmental risk assessment which is provided for in Regulation (EC) 258/97 and in Directive 90/220/EEC. This risk assessment includes human safety aspects.

On the basis of the information currently available, the Commission considers that honey unintentionally containing pollen transferred by bees from genetically modified crops does not constitute a novel food within the meaning of the Regulation. Therefore, the labelling provisions of the Regulation do not apply.

E-2161/97, E-2163/97

Article 8(1)(a) of Regulation (EC) 258/97 requires the final consumer to be informed of any characteristic or food property such as composition, nutritional value or nutritional effects, or the intended use of a food which renders a novel food or a novel food ingredient Longer equivalent to an existing food or food ingredient.

A novel food or food ingredient is deemed to be Longer equivalent for the purposes of that Article if a scientific assessment, based on an appropriate analysis of existing data, can demonstrate that the characteristics assessed are different in comparison with a conventional food or food ingredient, having regard to the acceptable limits of natural variations for such characteristics.

In this context, the reference to an appropriate analysis of existing data requires an evaluation of all the relevant information in order to determine whether the characteristics assessed are in fact different. It is not possible to determine in advance which analytical methods will be used to define whether or not there is a difference between a novel food and a conventional food.

E-2165/97, E-2167/97, E-2171/97, E-2173/97

The primary responsibility for the control and enforcement of the requirements of Regulation (EC) 258/97, including the development of analytical control methods, lies with the official control authorities of the Member States in accordance with Directives 89/397/EEC and 93/99/EEC. The financing and staffing of the national official control bodies is a matter for the Member States.

In accordance with Article 5 of Directive 93/99/EEC, the Commission may undertake missions to the Member States to report on the equivalence and effectiveness of the official control systems of the Member States, including questions relating to the implementation of Regulation (EC) 258/97.

The Commission has presented a draft supplementary budget with a view to increasing the resources available for food control activities at the Community level. Since the official control of foodstuffs is an ongoing activity, there is no date for the completion of these activities.

E-2169/97, E-2187/97

The Commission would refer the Honourable Member to Article 3 of Directive 93/99/EEC which sets out in detail the requirements to be met by the official control laboratories for the monitoring of foodstuffs.

E-2175/97

1. In accordance with the general Community rules on food labelling, producers may include claims on the labelling that particular foods do not contain material which has been produced from genetically modified organisms, provided that such a claim is true. Before making such a claim, the producer will need to take the steps necessary to ensure the claim is true. These may include arranging for analyses to be undertaken by independent laboratories.

2. The arrangements for payment for such analyses will be the responsibility of the parties concerned.

3. Control tests on all foods on the market may be carried out by the official control authorities as part of their general enforcement programmes.

E-2177/97, E-2179/97, E-2181/97

The Commission considers that there is no single criterion which can be used to decide on appropriate analytical methods for genetically modified foods. The choice of appropriate methods must be made on a case by case basis, having regard to all relevant factors.

E-2183/97

The analytical methods used by the official control authorities of the Member States are kept under constant review. However, the choice of methods used for enforcement purposes depends on a variety of factors including not only the sensitivity of the method, but its reliability, accuracy, robustness and cost.

E-2185/97

The primary responsibility for the development of appropriate enforcement methods lies with Member States. Where appropriate, standardised methods may be developed at Community level. In addition, Community research programmes may support research projects aimed at improving methods for the assessment of novel foods and novel food ingredients.

E-2189/97, E-2191/97

In accordance with Article 4 of the Regulation, the applicant is required to submit a dossier which demonstrates that the product meets the requirements for authorisation set out in Article 3. The need for the provision of samples by the applicant is determined on a case by case basis during the authorisation procedure.

E-2193/97

The authorities of the Member States and the Commission will keep records of all novel foods and novel food ingredients which have been placed on the market in accordance with the regulation.

As regards product recalls, the Commission would refer the Honourable Member to Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs ((OJ L 186, 30.6.1989. )).

E-2195/97

There is no formal obligation in Community law for manufacturers to keep detailed records of the origin of all ingredients used in food production. However, appropriate record-keeping is an important part of the obligations of food businesses, and will be verified by the official control authorities during inspections.

E-2197/97

In its opinion on the safety evaluation of novel foods, the Scientific Committee for Food drew attention to the fact that scientific knowledge in the field is evolving rapidly, and that there is a need for any guidelines to be kept under review. The committee identified certain specific areas where the information currently available is incomplete. In the section of the guidelines dealing with intake, it also indicated that the inclusion of novel foods in the diet may cause major changes in consumption patterns, which should be the subject of monitoring.

Having regard to these recommendations, the Commission does not consider that it is necessary at this stage to set up a formal monitoring programme covering all novel foods. Where appropriate, specific monitoring programmes will be part of the conditions of authorisation of a novel food.

E-2199/97, E-2201/97 E-2205/97

There is no obligation under Regulation (EC) 258/97 to establish a data base on novel foods, and the Commission does not envisage setting up such a data base at present.

In accordance with the Regulation, authorisation decisions and summaries of notifications received are to be published in the Official journal.

E-2203/97

In accordance with the principles announced in the Commission's communication on consumer health and food safety ((COM(97) 183 final. )), safety evaluations of novel foods which have been undertaken by the Scientific Committee for Food will be published together with bibliographical references to the data evaluated by the committee.