EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 29 NOVEMBER 2013

Transcription

1 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Brussels, SANCO G (2013) SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 29 NOVEMBER 2013 Chairman: Michael Flueh (Section Toxicological Safety of the Food Chain) 25 Member States were present. Portugal was absent but represented by Belgium, Cyprus was absent but represented by Latvia and Hungary was partly absent but represented by Luxembourg. A.01 Discussion and possible endorsement on a draft Commission Recommendation on the reduction of the presence of cadmium in foodstuffs. See point B4. A.02 Discussion and possible endorsement on a draft Commission Recommendation on the monitoring of brominated flame retardants in food. In June 2009, the European Commission requested EFSA to deliver a scientific opinion on brominated flame retardants in food. As a result, EFSA has adopted 6 opinions: 5 opinions each dealing with a specific subclass of these substances and the last one dealing with the class of emerging and novel brominated flame retardants. As occurrence data in food are scarce, the first step is to organise an EU wide monitoring. A draft recommendation agreed in the relevant experts committee was presented for endorsement. This proposal recommends monitoring during 2014 and 2015 of all relevant classes of brominated flame retardants in the relevant food commodities. The recommendation specifies the provisions related to sampling and analysis. Member States are recommended to report to EFSA. At the end of the monitoring exercise, EFSA will compile an occurrence and exposure report, which should allow us all to have a better view on what would be the future steps related to these substances. The draft recommendation was endorsed by all Member States.

2 A.03 Guidance notes on the classification of food extracts with colouring properties - endorsement. The document which objective is to give guidance for classifying food extracts as colours (food additives) or foods with colouring properties (also called 'colouring foods ) was presented. It describes the criteria that determine the difference between selective and non-selective extraction (especially the Enrichment factor) and proposes a decision tree (Annex I) and a checklist (Annex II) to facilitate the classification. Furthermore, Annex IV provides a practical example of a classification and Annex III, once established, will provide reference values for the source materials. The following concerns were raised by a few Member States: The guidance note does not reflect the traditional interpretation of the food additives legislation and therefore will have a considerable impact on food manufacturers across Europe. In addition it considered that the interpretation is unjustifiably more favourable towards water based extracts compared to oil based extracts. The note will lead to an increased use of extracts that have not been assessed for their safe use at the cost of food additive that have been evaluated and which use must comply with conditions of the food additives legislation such as not misleading the consumer. It is not clear how pulp will be included in the reference value of the source materials. Further clarification is requested about the status of extracts produced from novel food in particular when novel foods would be authorised of which the sole purpose would be to use these food for colouring purposes. The Commission explained that the guidance note was the best compromise taking into account the divergent views of some Member States. The key decision factor is the threshold value for a selective extraction (> 6). A transition period of 18 months is foreseen. The Guidance note can be updated based on the practical experience with their implementation and reflecting the development in the colouring food area The guidance note was endorsed by large majority of MS. It is recommended that all food products placed on the market after 29 November 2015 should be in line with the Guidance notes. The UK requested that the following statement should be included in the minutes of this meeting: The UK appreciates the need for guidance which clarifies the boundary between food additives which require approval and colouring foods which do not. However we regret this proposed guidance will, in the future, require approval of certain long-used spice extracts despite no safety concerns having been identified. This will increase the regulatory burden on business with no discernible benefit to the consumer.

3 A.04 Approval of the national residue control plans for The approval of the Member States' residue monitoring plans is an annual exercise and obligation according to Article 8(2) of Directive 96/23/EC. The 2013 evaluation has been relatively straightforward thanks to the progress made by the Member States in addressing issues identified by the Food and Veterinary Office (FVO) and by the relevant European Union Reference Laboratories (EURLs) in In many cases, only relatively minor clarifications were required following the initial FVO evaluations. These typically concerned correcting discrepancies in the information provided, providing explanations for not testing certain substance groups and confirming that specific sampling criteria for aquaculture and eggs were fulfilled. In the last year, progress has been made in ensuring that the laboratories testing Residue Monitoring Plans samples are accredited to ISO and use appropriately validated methods as required. In those Member States where this is not the case (for a relatively small number of matrix-analyte combinations), adequate assurances have been given where necessary or the analysis of Residue Monitoring Plans samples has been outsourced to other laboratories which operate in accordance with EU requirements. Overall, the 2013 RMPs for all MS are considered to conform to the requirements of Council Directive 96/23/EC and, on that basis, the Commission services propose that they be approved accordingly. All Member States have been invited on 21 November 2013 to examine all of the plans and associated documentation, including the individual assessments. It is worth noting that the Croatian plan was assessed as a third country plan already prior to accession. As the procedure in Article 8(2) of Council Directive 96/23/EC describes, the Member State have ten working days in which to provide comments on the plans of the other Member States. If no comments are received, the plans will be approved on Friday 13 December A.05 Union Guidelines on Regulation (EU) No 10/2011 as regards information in the supply chain. The Guidelines were welcomed by the Member States. Comments received from some Member States were discussed. These covered the availability of a declaration of compliance at the retail stage, and the way this is referred to in the GL. It was raised that the GL may pose difficulties for certain business operators in the retail sector, in particular small business operators. One delegation considered that these difficulties make the implementation of the GL impossible. The Commission clarified that these issues must be clarified in the legislative text itself. Discussions are currently on-going in the Working Group on food contact materials in order to improve the legal text with a view to clarify the obligations on

4 the availability of a declaration of compliance for small businesses and the retail stage. Editorial comments raised by the Member States were noted and will be incorporated before publication of the guidelines. On the request for availability of the guidelines in all EU languages the Commission services acknowledged the importance of different language versions and will make translations available provided available resources allow for this. Outcome of the discussion: The Guideline was endorsed by the Committee with the reservation that the legal text should clarify the availability of Declaration of compliance at the retail stage taking into account in particular the feasibility and burden for small businesses. A.06 Application of Regulation (EC) No 1333/2008 on food additives regarding table-top sweeteners containing sugar. The Commission presented and further explained its point of view on the subject of application of Regulation (EC) No 1333/2008 on food additives regarding tabletop sweeteners containing sugar. At the request of several Member States this topic will be discussed further within the Working Group of Governmental Experts on Food Additives on 16 December A.07 Discussion on the review of Commission Implementing Regulation (EU) No 996/2012 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station as amended by Regulation (EU) No 495/2013 of 29 May The current restrictive measures as regards the import of certain feed and food from Japan as provided for in Regulation (EU) No 996/2012 expire on 31 March A review of the measures is foreseen before that date. The Committee was informed of the controls performed in 2013 on feed and food by the Japanese authorities. From 1 January 2013 until 20 November 2013, in total controls have been performed, 748 were found to be above the Japanese maximum level controls were on livestock products, on agricultural products, on fishery products, 3016 on milk products, 930 on meat from wild animals and 907 on drinking water. As regards findings of non-compliance, there were 235 findings (of which 127 from the prefecture Fukushima) on agricultural products, 8 on livestock, 229 on fishery products (of which 187 of the Fukushima prefecture). As regards controls at import in EU, there were no findings of non-compliance in

5 2013 (neither in 2012). Several delegations expressed their view as regards the foreseen review of the measures. All delegations which have expressed their view indicated to be in favour of a further alleviation of the measures. However there were divergent views as regards the extent of the alleviation: from a very significant alleviation of the restrictive measures up to a limitation of the feed and food products to be controlled before export based upon the data whilst maintaining the measures unchanged as regards feed and food from the prefecture of Fukushima. The Commission representative indicated to elaborate a proposal for the review taking into account the views expressed. If needed an ad hoc working group meeting could be organised in the second half of January to discuss the proposal in more detail before submission for opinion at the next meeting of the Committee. A.08 Feedback on topics discussed in the Expert Committees on contaminants. Mineral oil: End of April 2008, sunflower oil contaminated with mineral oil was exported from Ukraine to the European Union, resulting in the adoption of a safeguard decision in May This decision was amended to reflect the evolution of the situation in 2008 and in Following discussions in the expert Committee on industrial and environmental contaminants during and in the aftermath of this incident, EFSA was requested in March 2010 to deliver an opinion on mineral hydrocarbons in food. This opinion was adopted in June 2012 and indicated a number of important pathways of mineral oil entering in the food chain: the use as de-dusting agent on cereals to prevent explosions of silos, the use as glazing agent for confectionery and fruit, the use as an ingredient in pesticides, the migration from printing inks to the packaged food and the contamination of the food during harvesting or further processing. As only the last route is strictly spoken a subject for the expert committee on environmental and industrial contaminants, and taking into account that this is only a minor contributor to the total consumer exposure, the conclusion of the discussions in the expert committee on environmental and industrial contaminants was that no urgent action was needed in relation to mineral oil under the contaminants legislation. PFAS:

6 The 2008 EFSA Opinion on PFOS and PFOA and their salts resulted in Commission Recommendation 2010/161/EU to perform monitoring of PFASs during 2010 and Data submitted by the MSs were compiled by EFSA in the report on PFAS occurrence and exposure issued June This report concluded "that dietary exposure to PFOS and PFOA is highly unlikely to exceed healthbased guidance values." Taking into account the fact that the monitoring recommendation is no longer applicable and the conclusion and recommendations of EFSA's occurrence and exposure report, no specific action is envisaged at this moment at EU level. Member States continuing the monitoring of perfluorinated substances are invited to further provide their data to EFSA. EFSA will update the occurrence and exposure report in due time and in case of substantial new data. * Trade in fish from the Baltic region The Committee was informed of the discussions which have taken place in the Expert Committee POPs in Food on 18 November 2013 as regards the follow up to be given on the findings of trade of Baltic salmon within EU without evidence of compliance with EU legislation as regards dioxins and PCBs and the findings of the recent Food and Veterinary Office (FVO) audits to the Member States neighbouring the Baltic sea. The Committee agreed to reconvene the Baltic working group (composed of the representatives of the 8 Member States neighbouring the Baltic Sea and chaired by a representative of the European Commission) with the following terms of reference: - to discuss the establishment of a common database of all occurrence data on dioxins, dioxin-like PCBs and non-dioxin-like PCBs in fish species from the Baltic, with indication insofar available of the age, size, weight and the geographical origin (ICES zone) - to come to common conclusions as regards the presence of dioxins, dioxin-like PCBs and non-dioxin like PCBs in certain fish species from a certain age, size and geographical region (ICES zone) and in particular as regards their compliance with the maximum level established in Regulation (EC) 1881/ to conclude on common risk management measures to ensure that fish placed on the market in the EU complies with the maximum levels as established in Regulation (EC) 1881/2006 The outcome of the discussions will be presented to the Expert Committee "POPs in Food" for discussion and subsequently to the this Committee at the latest at the scheduled meeting in July *The setting of separate maximum levels for dioxin-like PCBs The request of a delegation to consider the setting of separate maximum levels for dioxin-like PCBs in view of ensuring a better management in case of contamination incidents, the issue was discussed in detail in the Expert Committee

7 "POPs in Food". The Committee agreed with the conclusion of the Expert Committee that setting of a maximum level for dioxin-like PCBs separately is not appropriate. B.01 Exchange of views and possible opinion of the Committee on a draft Commission Regulation correcting the Spanish version of Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. The Spanish language version of the Regulation states in Annex III, chapter 3, table 2, reference in column 2: Concentrated extracts of an alcoholic strength equal to or lower than 6 % vol. The other language versions read: Concentrated extracts of an alcoholic strength equal to or exceeding 6 % vol., which is the correct text. Therefore, the Spanish language version of the Regulation should be corrected accordingly. The other language versions are not affected. Vote taken: unanimous in favour. B.02 Exchange of views and possible opinion of the Committee on a draft Commission Regulation amending Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. The amendment adds FCM substances 872 and 988 to the Union List in Annex I of the Regulation, introduces a change to the specification of FCM substance 421 and corrects a mistake in the specification of FCM substance 340. Vote taken: unanimous in favour. B.03 Exchange of views and possible opinion of the Committee on a draft Commission Regulation amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards Ethyl lauroyl arginate as a preservative in certain heat-treated meat products. The Commission received an application for authorisation of the use of Ethyl lauroyl arginate as a preservative in several food categories. The European Food Safety Authority evaluated the safety of the use of Ethyl lauroyl arginate as a food preservative and allocated an Acceptable Daily Intake (ADI) of 0.5 mg/kg body weight. Conservative estimates of exposure to the substance, suggested that it was likely that the ADI would be exceeded. Following these conclusions, the applicant revised its uses and use levels and requested an authorisation of the use in heat-treated meat products. The Authority

8 published a statement on a refined exposure assessment of Ethyl lauroyl arginate based on its revised proposed uses as a food additive, and concluded that the exposure for all population groups is below the ADI. There is a technological need to use Ethyl lauroyl arginate as a preservative in heat-treated meat products in order to improve the microbiological quality of those food products, including inhibiting the growth of harmful micro-organisms such as Listeria monocytogenes. As the use of Ethyl lauroyl arginate in heat treated meat products will help maintaining their quality and safety, it is appropriate to authorise its use in heat-treated meat products and to assign number E 243 to that food additive. The specifications for Ethyl lauroyl arginate (E 243) should be included in Regulation (EU) No 231/2012 when it is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time. Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly. Vote taken: favourable opinion with qualified majority (323 in favour, 29 abstention) B.04 Exchange of views and possible opinion of the Committee on a draft Commission Regulation (EU) amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs as regards cadmium. Maximum levels for cadmium exist in EU legislation since In its 2009 opinion on cadmium in food, EFSA concluded that the mean exposure for adults is close to or slightly exceeding the tolerable weekly intake and that vegetarians and children might exceed their tolerable weekly intake by about twofold. EFSA further concluded that the current exposure to cadmium at the population levels should be reduced. Taking into account these conclusions, the Commission started work in the relevant expert group and with stakeholders. Discussions have been lengthy and difficult and demonstrated that an immediate reduction of the existing maximum levels for a number of major contributors would be difficult to achieve at this moment. A solution was finally found in an amendment of the existing maximum levels in combination with a recommendation to progressively implement available mitigation measures for reduction of cadmium in food (point A1 of the current agenda). In the proposal for a Regulation, additional maximum levels are proposed for two new commodities. The first commodity is chocolate and cocoa products as sold to the consumer. Different maximum levels are proposed for different categories of products depending on the cocoa content. The lowest maximum levels are proposed for the categories of chocolate containing lowest percentage of cocoa solids. The maximum levels for this group will only be applicable from 1 January 2019 onwards. The second group of commodities covers food destined specifically to infants and young children and covers infant formulae, follow-on formulae and processed cereal based foods and other baby foods for infants and young children. The maximum levels for this group will only become applicable from 1 January 2015 onwards.

9 Finally, there was also some fine-tuning of existing MLs for a number of vegetables and fish species. These adjustments will enter into force the 20th day following publication. The recommendation aims at a progressive implementation of available mitigation measures by farmers and food business operators and focuses on the commodities for which a reduction would have a substantial beneficial effect on consumer exposure but for which a reduction of the existing maximum levels is difficult to achieve at this moment. Commodities that are explicitly mentioned in the recommendation are cereals, vegetables and potatoes. The recommendation covers a four-year period from 2014 to As usual, MSs are invited to submit their data to EFSA. Member States are recommended to submit a progress report in December 2015 and a final report at the latest in February Based on all this information, the Commission will re-assess the situation by 31 December 2018 with a view to deciding about further appropriate measures. A declaration of Germany is annexed at the end of the minutes. Belgium made the following declaration on point A2, which was dealt with under this point: Belgium is disappointed that the emphasis of the cadmium review doesn t include the main contributors to the exposure. Stimulation to put in use already available mitigation methods and further research is indeed necessary. However, we fear that a recommendation will mean a standstill, especially as research and promotion in the agricultural field might belong to the competences of other competent authorities. So we hope that the Commission will liaise with colleagues from other fields such as agriculture and fertilisers. Given the current economic situation, the primary sector might not be proactive or willing to follow a simple recommendation for available methods of cadmium reduction and even less if these methods are not fully efficient and/or costly. In our experience, legal limits are stronger incentives than recommendations. Belgium takes note of the fact that the Commission will reassess the situation by 31 December 2018 with a view to deciding about further appropriate measures. Vote taken: favourable opinion by qualified majority (323 in favour, 29 abstention) B.05 Exchange of views and possible opinion of the Committee on a draft Commission Regulation granting derogation from certain provisions of Regulation (EC) No 852/2004 on the hygiene of foodstuffs as regards the transport of liquid oils and fats by sea. As a general rule established by Regulation (EC) No 852/2004, foodstuffs are to be transported in receptacles that are exclusively reserved for the transport of foodstuffs. Directive 96/3/EG grants derogation to this general principle applicable only to the transport in seagoing vessels of liquid oils and fats intended for or likely to be used for human consumption provided that conditions related to the structure of the tanks, to the record keeping of the cleaning procedures and to the nature of the previous cargoes are respected. Following a proposal in Codex on criteria related to the acceptability of the previous cargoes and a favourable evaluation of these criteria by EFSA, the

10 Commission requested EFSA to evaluate the acceptability as previous cargo of the substances on the list annexed to Directive 96/3/EC plus some additional candidate substances, resulting in three opinions. The proposal presented for vote take into account the outcome of the EFSA scientific opinions. In the interests of clarity of Union legislation, Directive 96/3EC is repealed and replaced by the proposed Regulation. As no changes have been introduced to the conditions related to this exception scheme, the system of the derogation fundamentally remains unchanged. The draft received a unanimous favourable vote. Vote taken: unanimous in favour. B.06 Exchange of views and possible opinion of the Committee on a draft Commission Implementing Regulation (EU) imposing special conditions governing the import of certain feed and food from certain third countries due to contamination risk by aflatoxins and repealing Regulation (EC) 1152/2009. Given the late availability of the document, the document was presented and only shortly discussed. Several delegations highlighted the importance of providing legal solutions to problems occurring in practice when implementing the provisions of the Regulation and welcomed the clarifications provided in the draft. No major objections were raised but it was requested to review some of the control frequencies to take into account the most recent control results. Member States were invited to submit their comments in writing. Vote postponed B.07 Exchange of views and possible opinion of the Committee on a draft Commission Implementing Regulation (EU) laying down specific conditions applicable to the import of okra and curry leaves from India repealing Commission Implementing Regulation (EU) No 91/2013. Given the integration of the provisions of Commission Implementing Regulation (EU) No 91/2013 related to aflatoxins into the draft Regulation discussed under agenda item 5, Commission Implementing Regulation (EU) No 91/2013 needs to be replaced by this draft which covers now only the commodities subject to a safeguard measure because of the presence of excessive levels of pesticide residues. The measures as regards the import of okra and curry leaves from India remain unchanged compared to what is currently foreseen in Regulation (EU) N0 91/2013. Vote postponed B.08 Exchange of views and possible opinion of the Committee on a draft

11 Commission Regulation amending Regulation (EC) No 401/2006 as regards methods of sampling of large lots, spices and food supplements, performance criteria for T-2, HT-2 toxin and citrinin and screening methods of analysis. The proposed amendments for the control on the presence of mycotoxins to Regulation (EC) 401/2006 relate to the establishment of - specific sampling procedures of very large lots; - sampling procedure for spices with a large particle size; - sampling procedure for food supplements; - performance criteria for the analysis of T-2, HT-2 toxin and citrinin; - criteria for screening methods of analysis. The proposed changes have been extensively discussed in the EURL/NRL network and the Expert Committee Agricultural and additional comments made at the previous meeting have been taken into account. Vote taken: unanimous in favour. B.09 Exchange of views and possible opinion of the Committee on a draft Commission Regulation (EU) laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) 252/2012. This draft Commission Regulation provides that the analytical method with GC- MS/MS can be used as confirmatory method for checking compliance with maximum levels in addition to the HRGC/ HRMS for the analysis of dioxins and PCBs in food. The method has demonstrated to have a similar level of reliability at the range of levels of the maximum levels than the HRGC/HRMS and is cheaper as regards equipment and analysis. As this modification requires many changes on many places in the text, it is appropriate for reasons of clarity to replace Regulation (EU) 252/2012. Furthermore, following the experience gained with the application of the rules currently in place, minor changes or clarifications are proposed as regards the necessity of duplicate analysis, the compliance in case of duplicate analysis and the requirement as regards the acceptable difference between upper-bound and lowerbound results. Following comments made at the meeting the explicit reference to the applicability of the criteria for the method of analysis for the auto-control performed by food business operators has been deleted pending further discussions with stakeholder organisations. Vote taken: unanimous in favour. B.10 Exchange of views and possible opinion of the Committee on a draft Commission Regulation (EU) amending Regulation (EC) No 1881/2006 as

12 regards erucic acid. Given the late availability of the document, the document was presented and only shortly discussed. The draft Regulation provides in view of simplifying EU legislation for the integration in Regulation (EC) 1881/2006 [1] of the existing maximum levels for erucic acid in oils and fats intended as such for human consumption and in foodstuffs containing added oils and fats has been established by Council Directive 76/621/EEC [2] and the stricter maximum level for erucic acid in infant formulae and follow-on formulae which has been established by Commission Directive 2006/141/EC [3]. Consequently, Council Directive 76/621 will be repealed subsequently. The Committee welcomed the approach. [1] Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, , p. 5 ) [2] Council Directive 76/621/EEC [2] of 20 July 1976 relating to the fixing of the maximum level of erucic acid in oils and fats intended as such for human consumption and in foodstuffs containing added oils and fats (OJ L 202, , p. 35) [3] Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, , p. 1) Vote postponed M.01 Any Other Business France responded to questions raised by some Member States concerning the implementation of the two French measures on BPA covering the ban on BPA and transitional labelling of BPA. French services are currently studying the comments raised by these Member States and will reply in detail later. Preliminary answers to the main points raised were given by the French representative during the meeting, and are detailed below. Regarding the scope of the law: - Materials manufactured with BPA such as polycarbonate plastics and epoxy resins are primarily in the scope of the law; - Industrial equipment used for food production, transport or storage such as fixed or mobile large storage tanks, silos, and pipes, are not included in the scope of the law; - The extent to which materials and articles not manufactured with BPA but containing BPA (in particular because of printing inks, adhesives, or recycled raw materials) are included in the scope of the law, will be specified later. The introduction of a maximum residual content for BPA is also considered and analytical methods are being developed. Regarding both the scope of the law and the decree: - Materials and articles not yet and already in contact with food are covered; - Materials behind a barrier material would not be affected (such as metal or aluminium foil, glass..);

13 - France intends to publish a guideline to clarify the implementation. Regarding the scope of the decree - For exported products the rules of the destination country will apply; - Labelling should be attached to materials and articles already in contact with food. For materials and articles intended to the final consumer not yet in contact with food, it will be accepted that the health warning is displayed in the immediate vicinity of the materials and articles. France intends to provide additional clarification during the Working Group Meeting of Governmental Experts on Food Contact Materials on 16 December M.02 Use of food additives in meat preparations On request of a Member State, the Commission provided a short feedback about the discussions on 22 November 2013 in the Working Group of the Advisory Group on the Food Chain, Animal and Plant Health on the use of food additives in meat preparations.