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Food Safety

- Regulatory Committees - Standing Committee on Foodstuffs

Summary record of the 78 th meeting held in Brussels on the 18 th and 19 th of October 2000

Chairman : Mr Deboyser (except agenda items 3 to 12 and 14 : Mrs Brunko)

1. Opinion on a Commission Decision refusing the placing on the market of "Nangai nuts (Canarium indicum L.)" as a novel food or novel food ingredient under Regulation (EC) No. 258/97 of the European parliament and of the Council.

The Committee delivered a favourable opinion on the draft Commission Decision refusing the placing on the market of Ngali nuts (77 votes in favour; 10 votes against, no abstentions).

During the discussion it was pointed out that the Novel Food Regulation puts a high burden to demonstrate the safety of the product on the applicants. On the other hand it was also acknowledged that the safety of products that are alien to the diet in Europe cannot be taken for granted. The guidelines on the assessment of Novel Foods might need to be revised in this respect.

It was suggested that the criteria for deciding whether or not a product falls under the Novel Food Regulation should be clarified and made available for applicants

2. Opinion on a draft Commission Decision on the decree of the President of the Council of Ministers of Italy of the 4 th of August 2000 suspending the trade and the use of products from genetically modified maize.

The Commission representative presented the draft Decision. The Italian Decree was based on Article 12 of Regulation (EC) N° 258/97; therefore the Commission had to apply the procedure laid down in that provision. To this end the Scientific Committee for Foods (SCF) had been asked whether Italy had provided grounds for considering that the products concerned endanger human health. On September 7 th, the Scientific Committee on Food issued its opinion that "the information provided by the Italian Authorities does not provide detailed scientific grounds for considering that the use of the novel foods in question endangers human health". The draft Commission decision was in accordance with this opinion.

Italy presented their view and stressed that their main concern was that the products derived from the 4 varieties of maize were not 'substantially equivalent' in the meaning of Article 3 (4) of Regulation (EC) No 258/97. Therefore the products concerned were not eligible for the simplified procedure and they should only be authorised following after a full assessment of their safety. Italy further requested that the SCF be consulted on whether the products at stake should be considered as "substantially equivalent".

All other Member had proceeded in accordance with the provisions of Regulation (EC) No 258/97. However, a number of Member States expressed concerns about the application of the simplified procedure to products derived from GMOs and insisted that this problem should be addressed before a Decision on the Italian Decree could be taken. Clarification of the application of substantial equivalence to GM derived products such as GM maize products was needed, and this could be done, it was noted, under Article 3.4 of the Regulation. Several Member States indicated that they would not support the Commission proposal at this stage. On the other hand all Member States, apart from Italy, agreed that the products at stake did not raise safety concerns.

The representative of the Commission announced that, in view of the lack of support for the Commission draft Decision, the Committee would not be asked to deliver an opinion. The matter would be reconsidered in the context of the overall strategy on GMOs

2a. Discussion on "substantial equivalence" in the context of Regulation (EC) No 258/97 on Novel Foods

This item had been added to the Agenda at the request of Italy.

The Italian representative introduced the discussion. The concept of "substantial equivalence" was flawed, in particular in the way it had been applied to products which, such as the 4 varieties of maize authorised under Regulation (EC) No 258/97, still contained DNA or protein. Furthermore, it was unacceptable that GMO derived products were placed on the EU market under the simplified procedure, without undergoing a full safety assessment.

This view was shared by several delegations. Others noted that the validity of the concept of substantial equivalence as a starting point of a safety assessment had been recognised by the recent Joint FAO/WHO Expert Consultation on "Safety aspects of genetically modified foods of plant origin". Identifying similarities and differences between the GM food and a comparator with a history of safe food use was an appropriate guide for starting a safety assessment process.

The Commission representative concluded that it did not seem appropriate to ask the Scientific Committee on Food about the concept of "substantial equivalence". Indeed, the main criticism levelled against this concept related to the perception - particularly in the context of the notification procedure - that it was the end point of a safety assessment. This was a procedural problem which should better be addressed in the context of the review of Regulation (EC) No 258/97. The Commission had already announced that it intended to advance this review to 2001. However, products having benefited from the notification procedure were lawfully on the market. It was likely that the provisions of Regulation (EC) No 258/97 would be aligned on the revised 90/220/EEC Directive, thus providing for time-limited authorisations. This might allow for a review of all authorisations, including - as the case may be - authorisations granted prior to the coming into force of Regulation (EC) No 258/97 and authorisations granted under the notification procedure

3. a) Draft Commission Regulation amending Commission Regulation (EC) N° 194/97 of 31 January 1997 setting maximum limits for certain contaminants (Ochratoxin A)

The draft Commission Regulation proposes to establish a maximum limit for ochratoxin A of 5 µg/kg for raw cereal grains and of 3 µg/kg for derived cereal products (including cereal grains intended for direct human consumption) and to establish provisionally a maximum limit of 10 µg/kg for dried vine fruit (currants, raisins and sultanas), the latter to be reviewed before 31 December 2002.

The presence of ochratoxin A has also been observed in coffee, wine, beer, grape juice, cocoa and spices. Investigations and research have to be undertaken to determine the different factors involved in the formation of ochratoxin A and to determine the prevention measures to be taken to reduce the presence of Ochratoxin A in these foodstuffs. It is foreseen to review the provisions with a view to include a maximum limit for ochratoxin A for these products taking into account the outcome of the investigations and the prevention measures taken.

The Committee could in general support the proposed measures but comments were raised by some delegations concerning:

- the limited scope of the draft Regulation (in particular concerning the absence of a limit for coffee)

- the proposed limit for dried vine fruit

- the procedure to communicate the results of investigations by interested parties.

The Committee accepted the measures to be notified to WTO for comments.

b) Draft Commission Directive laying down the sampling methods and the methods of analysis for the official control of the levels of Ochratoxin A in foodstuffs

The draft Commission Directive lays down the sampling method and the method of analysis for the official control of the levels of Ochratoxin A in cereals and dried vine fruit. The sampling regime is based on what is foreseen for the control of aflatoxin but lower sample weights are required (10 kg samples instead of 30 kg). Concerning the methods of analysis, following a criteria-based approach, a set of performance characteristics are proposed.

The problem of practical application of different sampling procedures to control different contaminants in the same foodstuffs has been raised and a plea has been made to establish more harmonised control procedures. The Commission representative has indicated to share this concern and that the Commission is currently preparing a proposal containing an unique set of control provisions across the whole food chain.

The Committee accepted the measures to be notified to WTO for comments.

4. a) Daft Commission Regulation amending Commission Regulation (EC) N° 194/97 of 31 January 1997 setting maximum limits for certain contaminants (Aflatoxins in spices).

b) Draft Commission Directive amending Commission Directive 98/53/EC of 16 July 1998 laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs (Aflatoxins in spices).

The draft Commission Regulation proposes to establish a maximum limit of 5 µg/kg for aflatoxin B1 and of 10 µg/kg aflatoxin total for some species of spices i.e. Capsicum spp. (dried fruit thereof, whole or ground, including chillies, chilli powder, cayenne and paprika), Piper spp. (fruits thereof, including white and black pepper), Myristica fragrans (nutmeg), Zingiber officinale (ginger), Curcuma longa (turmeric).

The measures have been notified to the WTO. One comment has been received which does not necessitate modifying the proposal. A reply justifying this position will be made.

Some Member States were of the opinion that the proposed levels were too high.

The vote has taken place and a favourable opinion has been expressed.

The draft Commission Directive lays down sampling provisions for the control of the level of aflatoxins in spices. The comment on difficulties related to different sampling procedures has again been made (cf. point 3)

In addition, some minor amendments have been proposed which have been accepted. The vote has taken place and a favourable opinion by unanimity has been expressed.

5. Draft Commission Regulation amending Commission Regulation (EC) N° 194/97 of 31 January 1997 setting maximum limits for certain contaminants (Patulin in apple products).

A working document outlining the discussions at international level and the status of the discussions at EU level concerning the presence of patulin in apple juice were presented. Different views have been expressed on the appropriate level for patulin in apple juice taking into account the need to reduce the exposure for high-risk groups of the population in particular infants and children in the light of the feasibility of achieving these levels. Patulin has also been found in solid apple based products, blueberries, pear products, grape juice and apple cider where apple juice was added after fermentation.

The Committee was informed that a SCOOP (scientific co-operation) will start soon on the assessment of dietary intake by the population of EU member States, with particular emphasis on the exposure of high risk sub-groups of the populations.

The matter has been referred again to the Expert Committee for further discussion.

6. a) Draft Commission Regulation amending Commission Regulation (EC) N° 194/97 of 31 January 1997 setting maximum levels for certain contaminants in foodstuffs. (Lead, cadmium, mercury and 3-MCPD).

The proposal had been intensively discussed in the WG which achieved agreement on most of the proposed maximum levels. Following the advice of the Legal Service of the Commission, it is proposed to recast the Regulation since it has been amended already several times. As a new element, it is proposed to apply the levels also to baby foods and to establish specific levels for these products within the next 3 years.

Some issues could not be solved, so far: EP and Council Directive 96/23/EC lays down that the whole animal has to be declared unfit for human consumption if the maximum level for a part of the animal, e.g. offal, is exceeded. This provision seems to be unjustified in the case of heavy metals but it can only be changed by an amendment to Directive 96/23 and not by this Regulation. Concerning the proposed levels, ES provided data to show that higher levels of Pb and Cd would be justified for some fish species. For Hg levels in tuna, ES and FR provided data to show that the level (1 mg/kg) currently established by Decision 93/351/EEC seems to be justified. For 3-MCPD, toxicological in vivo studies have been recently completed in UK which indicate that the substance is non-genotoxic. The Commission has already informed the SCF and requested a new opinion. However, it cannot be expected that the SCF will deliver this opinion within a few months. If the SCF would consider the substance as non-genotoxic, a TDI needs to be set. It is questionable if the data needed for a TDI are already available. There seems to be no doubt that the substance is cancerogenic. Therefore, a level should be set to protect the health of consumers. In light of these new toxicological studies, it seems to be justified to raise the level from 0,01 to 0,02 mg/kg which would cause less problems for the producers to comply with and which ensures the protection of the health of consumers. In parallel, the SCF should arrive at a new opinon as soon as possible.

Most delegations indicated agreement to the above-indicated amendments of the proposal

6. b) Sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs (Lead, cadmium, mercury and 3-MCPD)

This proposal had been intensively discussed in the WG and agreement could be found on most of the issues. Several delegations were of the opinion that the proposed Horrat value of 1 is too strict and cannot be fulfilled by a number of available methods. BE asked for a harmonised approach in the area of methods of sampling and analysis and requested to delete all parts of the proposal which are already covered by Community legislation, in particular chapter 2.5.3 of the Annex. The exception for sampling of wine should be extended to all liquid products for which a homogeneous distribution of substances can be assumed. IT indicated that the number of packages to be taken from a lot seems to be too high.

7. Consultation on a draft Commission Recommendation on the reduction of the presence of deoxynivalenol (DON) in cereals and cereal products.

The scientific Committee has expressed an opinion on Deoxynivalenol (DON) and derived a temporary TDI of 1 µg/kg bw. Preliminary intake assessments indicate that the exposure is found to be in the order of tTDI. The Scientific Committee concluded that more accurate information on the exposure to DON is necessary. There are indications that, besides the climatic conditions, certain production techniques influence the development of the Fusarium toxins.

The Committee has been consulted on a working document outlining recommendations for action.

The Committee agreed that it was appropriate to undertake urgently investigations and research to determine the different factors involved in the formation of Fusarium toxins and to determine the prevention measures or control measures to be taken to reduce the presence of Fusarium toxins in cereals and cereal products as much as possible.

The Committee furthermore endorsed the recommendation on an increased monitoring on the presence of DON in cereals and cereal products across the European Union in order to obtain more accurate information. Also guidance values for actions have been discussed for cereal products as consumed and for flour.

Following observations have been made:

- the preference of legal measures instead of recommendations

- the need for validated methods of analysis.

8. Information by the Italian authorities on the results of the investigations on the source of contamination by benzo(a)pyrene of sunflower oil originating from Italy.

The Netherlands reported on 28 April 2000 through the Rapid Alert System for Food the finding a high level of benzo(a)pyrene in sunflower oil originating from Italy. The contaminated batches of sunflower oil had been seized in order to avoid entering the food chain. The Italian authorities were requested to report on the investigations undertaken in order to trace the origin of contamination in order to avoid such contamination in the future.

The Italian delegation reported that several investigations have been undertaken to trace the origin of the contamination including the origin of sunflower seed and the possible ways of contamination during processing of the seeds. No final conclusion on the source could be drawn but one of the likely hypothesis is the drying/roasting of the sunflower seeds prior to extraction of the oil by a direct heating/roasting system, using improper burning material. A more extensive report will be transmitted to the Commission in writing.

9. Information by the Commission on follow-up of the opinion of the SCF. (Zearalenone). Exchange of views.

The Scientific Committee on Food expressed on 22 June 2000 an opinion on Zearalenone (ZEA). The Committee established a temporary TDI for ZEA of 0.2 µg/kg of body weight. Preliminary intake calculations indicate that the human exposure is well below (one order of magnitude) the temporary TDI.

The Committee accepted therefore that it is appropriate to wait for considering legal measures to reduce the presence of zearalenone in food until more analytical data on the presence of ZEA have become available and until the SCF has assessed the general toxicological aspects of the Fusarium toxins as a group.

In the meantime it is recommended to take prevention measures aimed at reducing the levels of zearalenone in cereals (maize), to support research on methods and techniques to prevent fungal contamination and to continue to monitor the presence of zearalenone in food.

10. Exchange of views on future priorities, concerning industrial and environmental contaminants.

A document containing the working programme for the next few years concerning contaminants in food was presented. Besides the continuous updating of existing legislation and the continuation of current ongoing discussions, following possible new items were presented : Polycyclic aromatic hydrocarbons (PAH) in particular benzo(a)pyrene, tributyltin, arsenic and tin. A short discussion indicated that the Committee welcomed these proposals but the matter could not be discussed in detail, due to a lack of time. Delegations were asked to comment in writing.

11. Exchange of views on the request of France concerning labelling of irradiated foods.

This proposal had been intensively discussed in the WG and agreement could be found on most of the issues. Several delegations were of the opinion that the proposed Horrat value of 1 is too strict and cannot be fulfilled by a number of available methods. BE asked for a harmonised approach in the area of methods of sampling and analysis and requested to delete all parts of the proposal which are already covered by Community legislation, in particular chapter 2.5.3 of the Annex. The exception for sampling of wine should be extended to all liquid products for which a homogeneous distribution of substances can be assumed. IT indicated that the number of packages to be taken from a lot seems to be too high.

12. Exchange of views on the conclusions of the Working Group on Additives concerning

The Committee endorsed the conclusions of the Working Group on Additives. It however underlined that:

  • Sodium metabisulphite in table grapes : According to Directive 95/2/EC Annex III Part B an SO 2 content of not more than 10 mg/kg or 10 mg/ml is not considered to be present.
  • Sodium hydroxide in coffee infusion : The labelling of the coffee infusion may not mislead the consumer as to the coffee content of the product and not create an unfair competition to coffee and coffee extracts.
  • Status of Aspartame-Acesulfame salt : this salt has to be authorised under Directive 94/35/EC on sweeteners for use in foodstuffs, attributed a separate E-number and labelled accordingly.
  • Status of smoked fish : The request of Austria was send back to the Working Group for further discussion. Further information on the need to use preservatives in smoked fish and to their usefulness in that product was requested.

13. Exchange of views on a request from Austria concerning honey with pollen from GM rape seed.

Austria introduced the topic. As explained in a letter to the Commission of 10 July 2000, a study commissioned by an environmental organisation into certain types of organically produced Canadian rape-clover honey found that they contained GM rape seed pollen due to environmental contamination. There was agreement that the amounts were so small (<< 1%) that there is no legal basis for labelling.

The Commission representative suggested that this issue should be considered in the context of the forthcoming review of the GM labelling provisions. The problem of adventitious contamination from non-authorised varieties was a particular sensitive matter which would have to be addressed.

14. Exchange of views on the request of the United Kingdom on Commission Directive 92/1/EEC : Quick Frozen Foods.

Discussion of this item was postponed until the next meeting of the Committee.

15. Exchange of views on the request of the Spanish concerning Directive 96/84/EC of the European Parliament and of the Council of 19/12/1996 amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses.

By letter of 28 July 2000 the Spanish authorities had asked for a discussion on an infant formula marketed in several Member States including Spain.

The product in question contains fructo-oligosacchardides (FOS) and galacto-oligosaccharides (GOS) which, according to the Spanish authorities, belong to the category of carbohydrates covered by Annex I. These substances not being included in the list of permitted carbohydrates listed in that Annex, the Spanish authorities consider that the product should not be marketed until an authorisation had been obtained for the use of these substances as provided for in Directive 96/84/EC amending Directive 89/398/EEC.

The Committee did not endorse the view that FOS and GOS where carbohydrates which - as such - could not be used in the manufacture of infant formulae. It however agreed that the concern of the Spanish authorities, shared by some Member States, over the allowed use of FOS and GOS in infant formulae under current EU legislation needed further discussion.

Some Member States questioned whether FOS and GOS belonged to other substances having a particular nutritional purpose mentioned in Article 5.1 of Directive 91/321/EEC and as such they should be listed in Annex III of that directive prior to their use. Others would consider FOS and GOS as other ingredients covered by Article 3 of Directive 91/321/EEC, which in turn raised questions about whether these ingredients were suitable for particular nutritional use by infants.

The Committee agreed that the above points needed to be further considered by an expert working group, which the Commission was asked to convene as soon as possible. The Committee noted however that there were no immediate safety concerns regarding the product in question

16. Exchange of views on General Food Law.

The Commission representative presented a draft working document on a Regulation on General Food Law, explaining that this would form part of a package with other proposals including, most notably, a proposal for a European Food Authority.

Although most delegations welcomed the proposal, several delegations expressed the view that it would have been desirable to have more time to discuss the text, and that the proposed timetable for adoption by the Commission was unfortunate, particularly as the general food law part of the proposal would have a tremendous impact on food law in Member States.

All Member States who expressed a view called for the Commission to ensure cohesion between the proposals currently under discussion in the Council, and in particular the General Product Safety Directive and the recast of the hygiene legislation. Some Member States expressed the view that tap water should be included in the definition of food, and there were conflicting views concerning the inclusion of feed.

Member States were requested to make their views available to the Commission in writing.

17. Exchange of views on Commission discussion papers laying down a definition of the term "meat" for labelling purposes.

The Commission representative presented the first draft of a Commission Directive laying down a definition of the term "meat" for labelling purpose and a discussion paper explaining the need for such a Directive and how it would apply.

All delegations welcomed the initiative, though most of them indicated that there had been little time for consulting interested parties, and a final position could therefore not be communicated. Member States were invited to send further comments by November 20 th, 2000. Depending on these comments, the Commission would either convene an expert working group or present a new draft directly to the Committee

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- Regulatory Committees - Standing Committee on Foodstuffs

FOOD SAFETY | PUBLIC HEALTH | CONSUMER PROTECTION | DIRECTORATE GENERAL "HEALTH & CONSUMER PROTECTION"

 
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