Health Scientific Committees Scientific Committee on Food Outcome of discussions

Minutes of the 118 ^th meeting of the Scientific Committee on Food held on 22 ^nd/23 ^rd September 1999 in Brussels

ATTENDANCE LIST/ LISTE DES PARTICIPANTS / TEILNEHMERLISTE

Members/Membres/Mitglieder

Mme. S. BARLOW, MM. D. BOSKOU, A. CARERE, I. ELMADFA (2 ^nd Vice-Chairman, Vice-President, Stellv. Vorsitzender), not present on 23 September, Mme. A. FERRO-LUZZI, MM. A. FLYNN, R. FRIES, W. GRUNOW, Mme. A. KNAAP (1 ^st Vice-Chairman, Vice-President, Stellv. Vorsitzender), MM. I. KNUDSEN (Chairman, President, Vorsitzender), not present on 23 September, B. MOSELEY, K-H. NAU, A. PALOU, W. SARIS, P. TOBBACK, J.-M. WAL, R. WALKER

Apologies/Excusés/Entschuldigt

M. S. LINDGREN

Experts

M. P. ELIAS

Commission/Kommission

M. F. VERSTRAETE (Health & Consumer Protection DG), Mme P. COLOMBO (Health & Consumer Protection DG), Mme K. SBIRRAZZUOLI (Health & Consumer Protection DG)

MM. A. KLEPSCH (Enterprise DG), G. SCHREIBER (Enterprise DG), M. MISCHENDAHL (Enterprise DG), Mme S. HEINIMAA (Enterprise DG)

M. R. BATES (Fisheries DG)

Secretariat/Secrétariat/Sekretariat

MM. M. A. GRANERO ROSELL (Health & Consumer Protection DG), D. PETTAUER (Health & Consumer Protection DG), Mme. J. THOLLEBEKE (Health & Consumer Protection DG)

1. Apologies for absence

The apologies for absence were noted.

2. Adoption of the agenda

The agenda was adopted.

3. Declarations of interest

No interests declared.

4. Matters arising from the minutes of the 117 ^th meeting

The minutes of the previous meeting held on 16/17 ^th June were adopted.

5. Requests for new opinions

5.1. Opinions on dioxins and PCBs

5.1.a. Opinion on measures taken by the European Commission during the management of the contamination of the Belgian food supply with PCBs and dioxins

5.1.b. Opinion on dioxins and PCBs

5.2. Evaluation of erythritol as food additive

5.3. Evaluation of exposure of the food additive nisin

5.4. Evaluation of a survey on dietary intake of di-2-(ethylhexyl) adipate (DEHA, PM/REF N. 31920) as food contact material

5.5. Ngali nuts as novel food

5.1.a. The Committee was asked, as a matter of urgency, to advise the Commission on the basis of consumer health considerations and available data, on the adequacy of the action levels set in Commission Decisions 1999/551/EC and 1999/449/EC for PCBs in food products. These action levels had been set by the Commission in the framework of the Belgian dioxin crisis and are intended to serve in this particular contamination case as a means to identify food products with high dioxin contamination (see item 6).

5.1.b. In addition, a request was submitted to the Committee to advise the Commission on the scientific elements necessary for the establishment of permanent limits and/or alternative measures, such as advice to consumers, relating to PCBs and dioxins in food. In response to the urgency of the request the Committee decided to set up a task force to elaborate a draft report. The Committee noted that the deadline for completion of this task would largely depend on the availability of the results of ongoing activities on data collection for PCBs and dioxins in foodstuffs in the EU.

5.2. The Committee was informed that the Commission services (DG III Industry) have received a request to use erythritol as a sweetener and as a miscellaneous food additive in foodstuffs in general. The Committee is asked to evaluate the safety of erythritol to be used as a food additive and to consider also its non-laxative effects and its energy value.

5.3. The SCF has evaluated the safety of nisin in 1990 (26 ^th series). The Commission services have received a request to use nisin for the preservation of pasteurised liquid egg products. The Committee is asked if it can confirm the estimation that permitting the use of nisin in liquid eggs at a level of 6.25 mg/kg will not lead to the exceeding of the ADI. The Committee is asked while reviewing this additive also to take into account the recent report on antimicrobial resistance of the Scientific Steering Committee.

5.4. In 1994, the SCF re-evaluated the hazards to human health arising from the migration into food of di-2-(ethylhexyl)adipate present in food contact material in 1994 ¹ . The Committee concluded that the very small intakes of DEHA from its uses in food contact materials would not pose any carcinogenic hazard for man. It established a TDI of 0.3 mg/kg bw, based on a NOEL of 30 mg/kg bw for foetotoxicity in a teratogenicity study in rats. The Committees is now asked to evaluate a survey relating to dietary intake of di-2-(ethylhexyl)adipate in three EU Member States, to determine whether the survey was designed and conducted correctly or not, whether the results of the survey confirm previous positions held by the SCF.

5.5. Within the framework of Regulation (EC) N° 258/97 on novel foods and novel food ingredients a request for authorisation has been submitted for the nuts of the ngali tree (Canarium indicum Linné) as Novel Food. Based on comments/objections from Member States to this request, and pursuant to Article 11 of Regulation (EC) 258/97, the Scientific Committee on Food is consulted to evaluate potential health concerns related to the food use of this product.

6. Follow -up of measures taken by the European Commission during the management of the contamination of the Belgian food supply with PCBs and dioxins

- Information from the Commission services

The Secretariat summarised the content of Commission Decisions 1999/449/EC and 1999/551/EC, which include action levels for PCBs in food products as indicators for contaminated samples.

- Request of opinion on measures taken by the European Commission during the management of the contamination of the Belgian food supply with PCBs and dioxins

The Committee discussed the request for an opinion on the adequacy in terms of consumer health protection of measures taken by the Commission during the management of the contamination of the Belgian food supply with PCBs and dioxins (see 5.1.a.).

The Committee issued the following statement regarding this question:

The Committee recognises that the available data do not provide a sound scientific basis to advise the Commission, on the basis of consumer health considerations, on the adequacy of the action levels set in the Commission Decisions ² for PCBs in food products (including concomitant exposure to dioxins). Those action levels were set by the Commission as an emergency measure in response to safety concerns and were intended to be applied for a limited period of time. However, the Committee stresses that they primarily serve as an indicator for highly contaminated animal products to manage the time-limited contamination episode in Belgium. Therefore, imposition of these pragmatic action levels serves the desirable purpose of identifying highly contaminated foodstuffs and thereby limiting levels of exposure.

7. Novel Foods

- Draft opinion on tomato fruit genetically modified to down-regulate the production of polygalacturonase (PG), and solely intended for processing

The rapporteur introduced the draft prepared by the working group on Novel Foods and Novel Food products. The opinion was adopted pending the inclusion of editorial comments. In discussing the opinion, the Committee emphasised the importance of having as complete a nutritional profile as is practicable in the evaluation of novel foods. The final text of the opinion is attached as Annex I.

8. Additives

- Draft updated opinion on coumarin

The Committee discussed the draft opinion prepared by the Working Group on additives which examined the new data existing since the evaluation of the Committee in 1994. After the discussions and some changes, the Committee adopted the opinion.

The full opinion appears in Annex II.

- Progress report from the Working Group

Lactoperoxydase has been previously authorised as a food additive in one Member State. An application has been made for EU wide authorisation to the Commission. Further information has been requested and the Committee will examine the safety of lactoperoxydase when that further information has been provided.

9. Flavourings - progress report of the Task Force

The chairman of the Task Force explained that agreement had been reached at the meeting on 21 September on the most important elements for the establishment of the evaluation program for flavouring substances. An additional meeting is scheduled for 19 October to finalise the draft evaluation program.

10. Contaminants

- Statement on aqueous solutions as acceptable previous cargoes for the bulk transport of fats and oils

In its previous opinion ³ the Committee considered aqueous solutions of calcium chloride, sodium hydroxide and potassium hydroxide only acceptable as previous cargoes where the immediate previous cargo to it is on the list and is not similarly restricted. The rationale behind this restriction and, if justified, why it is not applicable to other aqueous solutions, have subsequently been questioned.

The reason behind the restriction was originally based on advice that some organic chemicals, e.g. benzene, will dissolve in any paint used to coat the inner side of the tank. They cause the paint to swell and significant quantities can be involved, which might subsequently be removed by a potential subsequent edible oil.

As the aqueous solutions in question have a density higher than oils and fats the Committee was informed that the tanks would not be filled, thus leaving parts of the contaminated paint untouched by the aqueous solution.

The Committee has subsequently been advised that despite the higher density, this would not necessarily lead to a lower filling of the tank. Therefore the problem seems to be the filling of the tank rather than the type of the previous cargo.

The Committee therefore no longer finds it necessary to maintain the restriction on the 3 mentioned cargoes. Rather it should be specified, in order to wash out any residues of previous unacceptable cargoes which might have been absorbed into the paint of the tank, that any acceptable previous cargo should be of an acceptable filling depth to ensure contact with all parts of the tank liable to come into contact with a subsequent cargo of edible oil as fat. Furthermore, there should be a restriction relating to the minimum duration of the contact with the acceptable previous cargo.

The Committee felt that it is not the appropriate body to advise the Commission on the necessary depth of filling of tanks or on the minimum duration of contact with the acceptable previous cargo. The Committee recommended that the Commission seeks outside advice on these aspects.

These restrictions do not apply to tanks of stainless steel and other surfaces, which are unlikely to absorb material from unacceptable previous cargoes.

- Request for the opinion of the SCF on the adequacy of a proposed specification for gelatine in terms of protection of consumer health

The chairman of the SCF Working Group on Contaminants introduced a draft statement on specifications for heavy metals in gelatine. The Committee noted that hygienic specifications of gelatine were still under consideration by the SCF Working Group on Microbiology and Hygiene. It preferred to address all aspects of the request in a consolidated statement and decided to postpone the discussion until the draft hygienic specifications were available.

- Statement relating to the request for an opinion of the SCF concerning an update of the opinion on nitrate and nitrite ⁴ in the light of new information

The Committee considered the documents submitted by the Commission ⁵ . These data per se did not provide a basis for re-evaluation of the previous opinion. However, the Committee was aware of ongoing mechanistic and epidemiological studies and would wish to review the situation when the results of these studies become available.

11. Food Contact Materials

- Draft opinion on an additional list of monomers and additives for food contact materials

The draft assessments contained in the list together with the supporting documentation also prepared by the Working Group were introduced by the Chairperson of the Working Group. The Committee adopted the assessments proposed. The opinion is attached as Annex III.

12. Review of the SCF 1998-2000 Working Programme

Item deferred to next occasion.

13. Schedule of SCF meetings for 2000

The schedule of meetings for the next year was discussed. The following dates were provisionally retained for further consideration.

- 6-7 or 7-8 March

- 20-21 or 21-22 June

- 6-7 or 12-13 September

- 17-18 or 18 -19 October.

14. General information on matters relating to other Scientific Committees

- List of opinions in 1999 by the Scientific Committees other than the SCF

The Secretariat distributed the list opinions adopted in 1999 of the sister Scientific Committees and reported about the last Steering Committee meeting. An exchange of views about experience on how to better address subjects where more than one scientific committee could have expertise took place.

15. General information from the Commission services

The Secretariat reported briefly about the changes in the Commission. The new Commission was in office since last week. The new Commissioner responsible for Health and Consumer Protection is Mr. David Byrne. The present Directorate General XXIV will be merged with some services from DG VI (Directorate on veterinary and phytosanitary legislation) and DG V (directorate on Public Health) to become the Health and Consumer Protection Directorate General.

16. Any other business

No points were raised.

17. Adoption of these minutes

These minutes were adopted by written procedure.

ANNEXES

ANNEX I: Opinion on a request for consent to place on the market a tomato fruit genetically modified to down-regulate the production of polygalacturonase (PG), and solely intended for processing.

ANNEX II: Opinion on coumarin.

ANNEX III: Opinion on an additional list of monomers and additives for food contact materials.

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¹ Reports of the SCF, 36th series, 1997

² Commission Decisions 1999/551/EC and 1999/449/EC.

³ Opinion on the potential risk to human health arising from the transport in ships' tanks of oils and fats from substances proposed as acceptable previous cargoes, expressed on 20 September 1996.

⁴ Opinion on nitrate and nitrite, expressed by the SCF on 22 September 1995.

⁵ - R.S. Dykhuizen, R. Frazer, C. Duncan, C.C. Smith, M. Golden, N. Benjamin and C. Leifert (1996) Antimicrobial Effect of Acidified Nitrite on Gut Pathogens: Importance of Dietary Intake in Host Defense. Antimicrobial Agents and Chemotherapy, June 1996, p. 1422-1425.

- G.M. McKnight, L.M. Smith, R.S. Drummond, C.W. Duncan, M. Golden and N. Benjamin (1997) Chemical synthesis of nitric oxide in the stomach from dietary nitrate in humans, Gut 1997, 40,211-214.

- G. McKnight, L. Smith, M.N.H. Golden and N. Benjamin - Metabolism of dietary nitrate in the gastrointestinal tract in man, MAFF study FS2188 (1CO64).

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