FSA Letter, 29 July 2003

CONTAMINANTS - Mycotoxins - EC Permitted Levels

Discussions on harmonized controls for mycotoxins were continued at meetings of the Working Group on Agricultural Contaminants on 23 June and 18 July and a meeting of the Standing Committee on the Food Chain and Animal Health on 17 July.

Aflatoxins

Aflatoxins in maize

At the meeting of the Standing Committee the Commission produced a revised draft Regulation setting maximum limits for aflatoxins in maize intended for further sorting or physical treatment before human consumption. It also produced a revised draft Directive on sampling and analysis of such maize, which now indicates that the measurement of uncertainty should be taken into account when assessing the analytical result to decide whether a lot is acceptable or not. After some minor discussion on the documents the Committee unanimously agreed that both documents should be notified to the World Trade Organization (WTO) for member country's comments.

Brazil nuts in-shell from Brazil

A Commission Decision (2003/493/EC) imposing special conditions on the import into the EU of in-shell Brazil nuts from Brazil came into force on 5 July. This Decision has been implemented in England by The Food (Brazil Nuts from Brazil) (Emergency Control) (England) Regulations 2003 [S.I. 2003 No. 1722] which came into force on 11 July.

Pistachios from Iran, peanuts from China and dried figs, hazelnuts and pistachios from Turkey

Commission Decisions amending the special conditions on the import of Pistachios from Iran (Commission Decision 2003/551/EC), peanuts from China (Commission Decision 2003/550/EC) and dried figs, hazelnuts and pistachios from Turkey (Commission Decision 2003/552/EC) were published in the Official Journal on 26 July. In addition to the initial measures imposed, the amending Decisions specify that consignments to be subjected to sampling and analysis can only be detained for a maximum of 15 working days from the point of entry into the Community before release onto the market and that Member States should submit to the Commission a three monthly report of all analytical results of these official controls. They also detail the procedure to be followed for any consignments which are subsequently split.

These Decisions will be implemented in England by:

• The Food (Pistachios from Iran) (Emergency Control) (England) Regulations 2003
  
• The Food (Peanuts from China) (Emergency Control) (England) (No.2) (Amendment) Regulations 2003
  
• The Food (Figs, Hazelnuts and Pistachios from Turkey) (Emergency Control) (England) (No. 2) (Amendment) Regulations 2003
  

These Regulations are due to come into force in England on 31 July.

Guidance document for competent authorities for the control of compliance with the EU-legislation on aflatoxins

This preliminary draft document was introduced by the Commission to assist Member States in meeting the enforcement requirements laid down in the aflatoxin Regulations. The Commission requested information from Member States to help in the drafting process. Points of clarification were raised on imported foodstuffs that should be addressed in the document, which were recognised by the Commission. The Commission also explained that the document will give guidance on sampling at the retail stage, by recommending necessary actions under a series of 'standard' retail situations. The UK agreed to send to the Commission the results of a current research project on retail sampling when the project was complete. The Commission stated that an 'enforcement' meeting on the guidance document would be scheduled for the Autumn. The FSA would be grateful for any suggestions of areas where such guidance would be useful.

Patulin

The Commission introduced a slightly amended version of the draft Regulation setting maximum limits for patulin in various foodstuffs indicating that it had been notified to the WTO for member country's comments. The UK noted that no formal consultation of industry or professional organizations had taken place to date. The Commission responded by stating that procedures for formal consultation had yet to be finalized. After extensive discussion on points of clarification in the text, a formal vote was taken and the draft Regulation was adopted.

At the meeting of the Working Group on 18 July the organizer of the collaborative trial on the analysis of patulin in infant foods summarised the progress of the trial to date. Two methods had been identified as suitable; the first being a modification of a UK Central Science Laboratory method and the second being a shorter method developed in-house at EC's Joint Research Centre. The analytical methodology would be sent out during the week beginning 21/07/03. The limits of detection (LOD) and quantification (LOQ) indicate that quantifying a level of 10 µg/kg should not be a problem, however, methodological difficulties exist regarding mixed matrices, especially with mixtures containing mango. Participating laboratories would have to conduct pre-trial tests on their own samples and the actual trial samples would be sent out in the second week of September, with a response time for results of 3 to 4 weeks. Two matrices would be tested: apple juice and a complex mixture containing blueberries and cereals. The analysis time per sample should be one to two days.

The Commission introduced an amended version of the Directive for the sampling and analysis for patulin, which now includes reference to the measurement of uncertainty. There was extensive discussion on the text, particularly the paragraph dealing with the compliance of the lot or sub-lot with the specification. The Commission reworded the text to the satisfaction of Member States, where the relevant paragraph was based on a similar paragraph in the dioxins sampling Directive. The Commission then called for a vote on the Directive, which was agreed.

There was general support for a draft Commission Recommendation on the reduction of patulin contamination in apple juice and apple juice ingredients in other beverages, this document is basically the same as the Codex Code of Practice produced by the UK. There was a request for further clarification in relation to the document's legal status and also that its status should be made clear to the Food and Veterinary Office (FVO) so that these measures are not seen as compulsory during missions. The Commission agreed to clarify this with the FVO. There was also an objection to the recommendation relating to the use of ozone as a decontaminating agent as this is not a European practice and the Commission agreed to delete this reference. The Commission agreed to make the necessary amendments and circulate the amended text.

Aflatoxin B1, aflatoxin M1 and ochratoxin A in foods for infants and young children

No discussion of the draft Regulation took place at the Standing Committee since the Commission recognised that majority support had not been obtained in the Working Group. The Commission referred the issue back to the Working Group, but noted that it had not received any real evidence to show that the limits proposed were not achievable. At the meeting of the Working Group on 18 July the Commission indicated that the proposed limits were appropriate if analytical methods were available and if proposed levels were technologically feasible. The Commission stated that it believed that this was the case but it recognised that such a measure may not provide the same level of protection for children fed non-specialised foods. The majority of Member States supported the Commissions proposals, but they also agreed that the difference between the levels for baby foods and for general foods could not be too great. The UK also stated that further consultation was required. The Commission stated that it would formally consult professional organisations and consumers, requesting industry to give views, supported by data, on the feasibility of proposed levels. Further discussions would then begin again in the Autumn.

Ochratoxin A

At the Working Group meeting on 23 June discussion centred on a document from the Commission outlining a list of commodities that are under consideration, with accompanying proposed maximum levels.

• Roasted coffee - The discussion centred around the need to follow the ALARA principle versus the consideration that there wasn't a problem from an exposure viewpoint, and that very stringent controls could penalise Third World economies, as the majority of coffee comes from developing countries. The Commission summarised the position by stating that a figure of 3 or 4 µg/kg seemed realistic, but that Member States required more time for consultation.
  
• Soluble coffee (instant coffee) - There was some discussion about the value of the ochratoxin A concentration factor relating to roasted coffee, with the Commission concluding that a value of 2 was supported by the data. Thus, the proposed limits of 6-8 µg/kg remained in the proposal.
• Table wine - After some discussion, the Commission summarised the position by stating that a level of 2 µg/kg was deemed acceptable for all wines (red, white and rose) as a proposed maximum limit for further consultation with professional organisations. Cider and perry were deleted from the proposals as there was no evidence of ochratoxin A contamination in these commodities and it was agreed that the levels should apply to all wines, not just table wines. The Commission agreed to clarify the applicability of maximum levels to 'aromatised' wines and to drinks containing wine.
• Juices - A lower limit of 1 µg/kg for ochratoxin A in grape juice was put forward as it is consumed in quantity by children. After further discussion, with other Member States commenting that they have had insufficient time for consultation, the Commission decided to amend the wording of the proposal so that a figure of 2 µg/kg applied only to grape juice and all other juices containing grape juice.
• Dried vine fruit - Written comments from industry on the proposals for lowering the limit from 10 µg/kg to 5 µg/kg stated that achieving these lower limits, especially for raisins, would be difficult in years with unfavourable climatic conditions, a view supported by some Member States. An extensive discussion followed, centred around the definition of currants, sultanas and raisins, with a number of Member States noting that they do not distinguish between raisins and sultanas. The Commission noted that further discussion was necessary to clarify definitions and to obtain more data on levels in varying types of dried vine fruit (especially from industry). The Commission concluded by suggesting that a lower limit of 5 µg/kg would be proposed for raisins and sultanas, but that the limit of 10 µg/kg would remain for currants. This would then be reviewed in future.
• Green coffee - Divergent views existed between Member States on the need to set maximum levels for this commodity. Discussions also took place on how best to sample green coffee, and the Commission stated that a sampling directive would be provided if levels were set in future. The Commission agreed with Member States that further discussions on this commodity were necessary.
• Beer - The Commission summarised by stating that no consensus existed on the need for limits, so the figure of 0.2 µg/kg would be kept in the proposal.
• Cocoa and cocoa products (including chocolate) - Extensive discussions took place, but with no real consensus. All Member States that commented stated that they had no firm position and further consultation was necessary, especially regarding the need to set limits on cocoa beans, as well as on retail products such as chocolate and cocoa powder. Again, the impact of setting maximum limits on the economies of the less developed countries was raised, this time by the Commission. The Commission stated that proposed levels would be retained for further consideration by professional organisations over the summer.
• Dried fruits other than dried vine fruits - The Commission decided to keep maximum levels in the proposal for further consultation by professional organisations.
• Spices - After minor discussion, the Commission decided to retain maximum levels for further consultation to 'send out a clear message' that the issue of ochratoxin A contamination of spices needed to be addressed by the industry.
• Liquorice - Germany raised this commodity as a specific concern and presented data to support their request for maximum limits. The Commission and Member States recognised that the exposure to ochratoxin A via this commodity was likely to be low, but that it may be of concern for high consumers of liquorice. The majority of Member States did not have a position, having divergent views about the usefulness of limits for this commodity. The Commission kept liquorice within the proposal, but recognised that more data was needed before limits could be proposed.

The Commission indicated that it would adapt the ochratoxin A proposal and submit it to the Standing Committee. The amended proposal was discussed at the meeting of the Standing Committee on 17th July. After minor points of clarification, the Committee agreed that the Commission should send out the amended draft for formal consultation.

Fusarium toxins

At the meeting of the Working Group on 23 June the discussions centred on which commodities should be covered by maximum limits. There was extensive, and sometimes confused, discussion on the definition of 'raw cereals', with Member States having divergent views. The Commission stated that the definition would be clarified in a later draft of the proposals, but indicated that 'raw cereals' would define a commodity that was sent to a processing facility, after initial storage/cleaning. The Commission summarised views by indicating a number of actions that it will take regarding the future of the proposals on maximum limits for Fusarium toxins, namely:

• The 'list' of foods covered will be shortened by deleting some categories.
• Methods of analysis would be assured to allow limits to be enforceable.
• The SCOOP report would be published 'soon' and professional organisations would be formally consulted regarding the tractability of proposed limits.
• The points in the food chain where limits would apply would be defined, since it appeared that having limits at only one point in the chain would not satisfy the needs of a number of Member States.

At the meeting of the Standing Committee the Commission stated that, due to the preliminary nature of discussions on limits for Fusarium toxins in foods, it would not yet ask the Committee to agree to submit the proposals for formal consultation. Further discussions are needed at Working Group before any proposals could be submitted for consultation.

At the Working Group on 18 July the aim of the discussions was to refine the proposed levels in light of the SCOOP report, which was now available. However, the Commission indicated that further minor amendments were necessary before the report could be published on the EC website, but Member States could assess the report as the substance of the report would not be amended. Unfortunately the report is over 600 pages long and it is, therefore, not possible to send it out to interested parties. However, summary tables giving the exposure data are available from the FSA. It was anticipated that maximum limits agreed by the Working Group would be circulated by the Commission to professional organisations for consultation later in the year.

The discussion proceeded by examining proposals for each individual Fusarium toxin.

• Deoxynivalenol: There was a discussion on the stages in the food chain where levels could be set, i.e. at the raw cereal stage, the intermediate stage (e.g. flour) or on processed products. Member States recognised that it may not be necessary to set limits for all three stages. The majority of Member States that commented on specific levels stated that the maximum limit for raw cereals (1500 µg/kg) was too high. Some Member States also commented that the level for processed products was also too high (500 µg/kg). The Commission indicated that the proposals should not be overcomplicated by setting limits on very specific commodities. There was general agreement with the Commission on this.
• T-2 and HT-2 toxins: The Commission stated that there would be extensive discussion on analytical methodology at the next meeting of the Working Group. One Member State commented that the maximum limits proposed were very high in relation to the temporary tolerable daily intake (t-TDI) and the Commission recognised that of all the Fusarium toxins, T-2 and HT-2 toxins were the toxins of highest concerns from a 'TDI-exceedence' perspective. It was recognised, however, that there was limited occurrence data on T-2 and HT-2 toxins.
• Zearalenone: After some discussion, the need for limits for this toxin at all was queried, due to the low levels of exposure to zearalenone, as defined in the SCOOP report. However, other Member States considered that limits were necessary due to the oestrogenic activity of zearalenone. The Commission noted that the exposure calculations in the SCOOP task involved replacing a large number of 'non-detects' with 'LOD/2' values, which may have artificially elevated intake estimates. The Commission noted that zearalenone could be seen as the toxin of lowest priority when setting maximum limits.
• Fumonisins: Very limited discussion took place in relation to these toxins, with the Commission again noting that the SCOOP exposures may be artificially high due to the replacement of 'non-detects' (as for zearalenone).

The Commission concluded that the position paper would be updated and circulated again for comment.

Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions in EU legislation concerning contaminants

At the meeting of the Standing Committee there was a general positive view of the proposals, which were circulated with my letter of 18 June 2003, from Member States, although much work remained to be done. Some Member States were uneasy about the application of the measurement of uncertainty principles to the microbiology field. The Commission stated that it was in discussion with its colleagues responsible for microbiology to assess applicability of the measurement of uncertainty proposals to other areas and that harmonizing measurement of uncertainty calculations would be difficult as they are calculated in different ways under different circumstances. However, the Commission and Member States agreed that the principles of the document should be taken forward with a view to applying them to all contaminants. The Commission concluded by stating that it would revise the draft proposals and circulate them for further comment. There will be a meeting to discuss this issue in the Autumn.

Future meetings

• 8th - 9th September: Working Group meeting to include major discussion on Fusarium toxins.
• 17th September: Standing Committee meeting.
• 8th - 10th October: Ochratoxin A Forum, Forum on Fusarium toxins and a 5th Framework mycotoxin cluster stakeholders meeting.