MAFF Translation from German



Guidance on routine (supplementary/additional) monitoring required for United Kingdom establishments (Food Business Operators - FBOs) intending to export milk/milk products (used interchangeably, but herein after referred to as milk products) to the Russian Federation (RF). Although an EU harmonised certificate for exports to the Customs Union (CU) has not yet been agreed, this guidance can also be used for exports to the other two CU members (Belarus – BY and Kazakhstan - KZ).This document has been produced with the information and knowledge available at the time (see footer) and it may be further amended by Defra in light of new information, knowledge and any relevant experience gained following exports of milk products to the Russian Federation. CONTENTS Purpose Scope Listing of FBOsSupplying farmsRF requirementsMonitoring for complianceLaboratoriesAdverse resultsChain of supplyOfficial VeterinariansCommunicationsPURPOSE OF THIS DOCUMENTThis document aims to provide guidance to FBOs, exporters and AHVLA Official Veterinarians (OVs) on the monitoring required to provide evidence that milk products comply with the RF Maximum Residue Limits (MRLs) and microbiological standards and are therefore eligible for export to the RF. FBOs must demonstrate that they meet the specific microbiological, chemical-toxicological and radiological standards required by the RF to ultimately enable OVs to certify the following statement on the certificate:“Microbiological,?chemical-oxicological?and?radiological?characteristics?of?milk?and?milk?products?correspond?to?actual?veterinary?and?sanitary?rules and?requirements?of?Russian?Federation”FBOs intending to export unprocessed milk products (raw milk/cream, cheeses made from unpasteurised milk etc) to the RF (or any type of milk products to BY and KZ) are required to be listed - see section 3. Such FBOs must also comply with the general, hygienic and structural RF standards, at all times. In any case, the product or the product type intended for export must comply with the sanitary requirements (6409EHC / 6432EHC refer). Sanitary requirements include monitoring to ensure compliance with microbiological, chemical-toxicological and radiological standards, as stated above.As a minimum, all listed FBOs must undertake the routine monitoring detailed in this document at all times, regardless of whether actively exporting or not. If the FBO is not required to be listed, the batches intended for export must be monitored if routine monitoring - as explained in this document - of the product/type intended for export is not being carried out. SCOPE - THIS DOCUMENT APPLIES TO THE FOLLOWING DOCUMENTS6409EHC (Agreed 11/08/2006) - Direct exports to RF; 6432EHC (Agreed 20/10/2006) – Pre-export certificate, for dispatch to another EU MS before final export to RF; 6409IMC- Support Health attestation for the internal movement of milk products within the UK between establishments for ultimate exports to RF under certificates 6409EHC or 6432EHC. The milk products could be derived from cattle or small ruminants (sheep and goats).LISTING OF FBOs FOR EXPORT TO THE RFFollowing accession of the RF to the WTO, it is understood that FBOs intending to export milk products deemed to be ‘low-risk’ (eg pasteurised/processed milk products as opposed to raw milk products – raw milk/cream or raw milk cheeses, which are deemed ‘high-risk’) do not have to be listed on the RF website (see ) to be able to export to the RF (although they do for exports to BY and KZ). The intermediate FBOs for such products, therefore, do not have to be listed either. However, FBOs still have to comply with the norms of the RF, and an assessment by FSA will be required to establish this. At the moment, Defra will – out of courtesy – confirm compliance of the FBO to the RF, but would not recommend that the FBO be listed on the RF website if the product in question is low-risk; exporters can then export provided an import permit has been issued, subject to compliance with the requirements of the relevant certificate (6409EHC or 6432EHC), especially the microbiological and chemical-toxicological standards as explained in this guidance. RF has since indicated that a satisfactory ‘systems’ inspection of the exporting MS is a prerequisite for the listing requirement (for low-risk products) to be waived. An update will be provided on this when available.SUPPLYING FARMSThere is no requirement for the supplying farms (holdings) to be listed. However, as part of an inspection, RF normally ask to visit a supplying farm to ensure compliance with the RF norms which relate to raw milk and its storage, prior to processing. FBOs are therefore advised to discuss the special RF requirements with their supplying farms. The somatic cell count and the total plate count for raw milk are similar to that required under EU legislation, but it is important to ensure that these are met. However, the Maximum Residue Limits (MRLs) for antibiotics, particularly the tetracycline group, are much lower (close to zero tolerance). It is therefore recommended that suppliers meet a longer than the specified EU withdrawal period for antibiotics. This is equally important if the raw milk originates from another MS. RF REQUIREMENTSThe microbiological, chemical-toxicological and radiological requirements for milk products are detailed in RF Federal Law No. 88-Φ3 of 12 June 2008 (as amended) and summarised in the section 6 below. However, since becoming part of the Customs Union, RF requires CU norms to be followed – see . As the RF and CU microbiological, chemical-toxicological and radiological requirements are broadly similar, the summaries in section 6 continue to be appropriate for certification purposes. In many cases, the RF norms are more onerous (in terms of both the Maximum Residue Limits - MRLs – and the frequency of testing) than those envisaged by EU legislation and therefore, the monitoring carried out under the current National Surveillance Scheme (NSS) under Directive 96/23/EC is not adequate and/or sufficient to provide the guarantees expected for export to RF.For this reason, all FBOs must undertake supplementary/additional monitoring (sampling and testing) on a routine basis to ensure that the milk product/s intended for export comply with these requirements, with particular emphasis on antibiotic residues and microbiology levels. MONITORING FOR COMPLIANCE6.1 GENERAL PRINCIPLESThere are two options:Routine monitoring by FBO, at least for the product type/s intended for export (compulsory if the FBO has to be listed)Testing of the end product (batches intended for export)Unless impractical or wholly unjustified (eg exporting only now and again), FBOs are advised to undertake routine monitoring, regardless of whether listing is required or not. As a minimum, the FBO (preferably the last one in the UK supply chain, but if more appropriate, any preceding one) must adopt a monitoring protocol for the specific purpose of exporting milk products to RF, based on the guidance contained in this document and the export health certificate to be used (and its guidance notes – 6409NFG - and other associated documents - 6409IMC). There must be written procedures and instructions embedded in the Standard Operation Protocol (SOP) of the FBO for this purpose. These must be implemented and validated before consignments, other than those containing only batches tested with satisfactory results, can be certified (for final direct exports on 6409EHC, for movements to other MSs on a pre-export certificate 6432EHC, or - if appropriate - movements to other FBOs in the UK on 6409IMC). In the case of raw milk being moved from a UK farm to an FBO in another MS, the current understanding is that no pre-export certificate is required as the RF (microbiological/cellular and storage) requirements for raw milk are comparable to those in EU legislation: if raw milk takes more than 24hrs to reach the processor, EU legislation requires the TVC to be <100,000 cfu/ml on collection from the farm and <300,000 cfu/ml immediately before processing (Annex? III, Section IX of EU Regulation 853/2004 refers). EU animal health legislation will also ensure that that the raw milk cannot be moved unless the RF requirements are complied with (including that the animals from which the raw milk is derived have not shown a positive result to the tests for tuberculosis and brucellosis). It is for the exporting FBO to ensure compliance with the microbiological and chemico-toxicological requirements of the milk products.Where compliance with the RF norms is based on the equivalence with EU requirements (or where EU requirements exceed those of RF), this must be specified in the FBO’s protocol for export to RF and the relevant records of testing and results thereof must be available for inspection and for the purpose of providing the evidence needed by the Official Veterinarian for certification of the milk products for export to RF.Milk products from non-UK FBOsIf milk products intended for export originate from non-UK FBOs, it must be shown that the RF certificate requirements are met. FBOs which source milk/ products from other Member States must describe, in their SOP, how this is ensured. Milk products originating in another EU Member State with the intention of forward consignment to RF (with or without processing) must be accompanied by a pre-export certificate for this purpose and duly annotated in the main certificate (see notes for guidance of the relevant main certificate - direct export - for more information) – but see above for guidance in relation to raw milk.6.2WHERE TO TEST WHATWHEREWHATFBOs processing raw milk ANTIBIOTICSPESTICIDESHEAVY METALSMICROBIOLOGYMYCOTOXINSFBOs handling pre-processed milk productsHEAVY METALSMICROBIOLOGYCold stores (only liquid/fermented milk/products containing fat/cream)RANCIDITYN/A (can be certified on the basis of UK monitoring) N/A (only required following a contamination incident)N/A (antibiotic not licensed in the EU)RADIOCTIVITYDIOXINSGRISIN 6.3 FREQUENCY, MAXIMUM LIMIT AND TESTING METHODContaminant ANTIBIOTICSIncludesMaximum levelFrequencyTest method (or any other ISO 17025 accredited method)Levomycetin (Chloramphenicol)0.01 mg/kg4 times/yearLC-MSMSTetracyclines TetracyclineepiTetracyclineChlortetracyclineepiChlortetracyclineOxytetracycline epiOxytetracyclineDoxycycline0.01 mg/kg12 times/yearLC-MSMSStreptomycin0.2 mg/kg4 times/yearLC-MSMSPenicillinAmoxicillinAmpicillinBenzylpenicillin0.004 mg/kg4 times/yearLC-MSMSContaminant PESTICIDESIncludesMaximum levelFrequencyTest methodHexachloride cyclohexane (HCH) Alpha/Beta/Gamma0.05 mg/kg4 times per yearGC-MSDDTAll isomers pp-DDEpp-DDTop-DDTpp-TDE0.05 mg/kg4 times per yearGC-MSDieldrin, Aldrin, A-endosulphan, B-endosulphan, Endosulphan sulphatePCB 28, PCB 52, PCB 101, PCB 118, PCB 138, PCB 153,PCB 180NOT REGULATED BY CUN/AN/AN/AContaminant HEAVY METALSMaximum levelFrequencyTest methodLead1.0 mg/kg 4 times/yearICP-MSArsenic0.05 mg/kg 4 times/yearICP-MSCadmium0.03mg/kg 4 times/yearICP-MSMercury0.005 mg/kg 4 times/yearICP-MSContaminant MYCOTOXINSMaximum levelFrequencyTest methodAflatoxin M10.0005 mg/kg 4 times/yearHP-LCMICROBIOLOGYFrequency of testing:CriteriaSomatic cell count TVC (*QMAFAnM)Salmonellas Listeria monocytogenes(cells/cm3)(cfu/g)(absent in)(absent in)Processed milk(every 15 days)N/A<1x 10525 gram25 gramRaw milk/products(every 10 days)<4X 105(Highest grade)<1X 106 (Grade I)<1X 106(Grade II)<1x 105(Highest grade)<5x 105(Grade I)<4X 106(Grade I)25 gram25 gram*QMAFAnM (Quantity of Mesophilic Aerobic and Facultative Anaerobic Microorganisms) could be equated to TVC (total Viable Colony count) or to plate count as specified in Regulation (EC) No.853/2004, and can be a rolling geometric average over a two-month period, with at least two samples per monthRANCIDITYIncludesMaximum levelFrequency (1)Test methodRancidityLiquid/fermented milk products containing fat/cream4 millimole of active oxygen/kg fat4 times/yearPeroxide or TBARS test 6.4 PRODUCT SPECIFIC PARAMETERSCU Decision 299 must be consulted for further details as there is a requirement to comply with other parameters which vary depending on product type. An overview can be found below:ORGANISMPermissible Levels under Decision 299 of Customs UnionMesophilic and facultative aerobic andAnaerobic micro-organisms (TVC)As per technical annex depending on product typeColiformsAs per technical annex depending on product typeStaphlococcus aureusAs per technical annex for some product typesStaphlococcus enterotoxin Cheese (Absent in 5 samples of 25g of cheese with a ripening period of <45 days) Sulphite reducing Clostridia Edible caseinates: Absent in 0.01g/cm3Yeasts and mouldsAs per technical annex depending on product type6.5 DEFINITION OF A BATCHThere is no standard definition of what constitutes a batch. This could be a date of production or packing, a supplier etc. It is what will need to be traced for a recall of the product type.A consignment for export can be made up of different batches.FBOs must state in the establishment’s protocol how a batch of product is defined and made up. As a minimum, type of product, batch size and date of production must be stated. At least one batch of product must be subjected to the routine testing relevant for that product, as detailed in this document (establishment, contaminant, frequency etc.) before that product type (which could include the batch that was tested) can be certified for export. 6.6 PRODUCT TYPE TO BE TESTEDFBOs must include protocols in their SOP the routine monitoring to be carried out for each product type intended for export, or supplied to downstream FBOs if the product or products thereof are intended for export. Since the RF/CU norms contain requirements which are different for different product types, each particular product type (drinking milk, infant formula, yoghurt, cottage cheese, sour cream etc.) must be specifically named in the monitoring protocol and tested separately. If a particular product is not included but subjected to the monitoring programme, it is not eligible for export.6.7 WHENThe SOPs must be in place before the FBO can be assessed by FSA as compliant with the RF/CU norms. Three batches from every product type must be monitored initially to establish base line compliance. Only then can that product type be exported/supplied downstream on the back of routine monitoring. However, the actual batch/es that have been subjected to satisfactory testing can be certified as compliant for export/supply downstream.LABORATORIES The analyses to be conducted for the purpose of the monitoring scheme for RF/CU must be performed at a laboratory accredited to carry out the required specific test(s) to ISO 17025 standards with testing protocols validated to detect the MRLs prescribed by EU/CU. Such laboratories are required to perform proficiency testing for quality assurance purposes. Such laboratory(ies) may be outside the UK, including Russia. FBOs must obtain assurances directly from the laboratories to be used that they are accredited for the specific pathogen and test under ISO17025 standards.ADVERSE RESULTSNon-compliance with EU MRLs:If EU MRLs are exceeded, the certifying OV must be informed and FSA guidance at followed. Please note that if the product is not eligible to be placed on the EU market, then is not eligible for export, without exception.Non-compliance with RF/CU MRLs:If RF/CU MRLs are exceeded, FBOs must notify the certifying OV, the LA EHO or the DARD VO as appropriate.In turn, the OV/EHO/VO must inform and seek advice from the FSA OG/DARD regional lead.Affected batches must not be exported/supplied for export to RF/CU. Initial consideration is needed to assess if the product is eligible for EU trade.A full traceability exercise needs to be carried out and downstream establishments supplied with product from the failed batch need to be informed so that they can take appropriate action.FSA/LA/DARD will consider if further inquiries are needed to establish the reason and origin of the unsatisfactory results and if a risk assessment is required. If consignments containing product from the failed batch has been exported, then FSA/LA/FSA DARD (in coordination with AHVLA SCS Carlisle/DARD) must inform Defra of the incident with a list of the export health certificates in question. This notification should include advice to Defra whether the authorities of the importing country need to be contacted.In any case, at least an immediate follow-up test is needed for the specific product and parameter giving the adverse results to re-confirm compliance of that product with the RF/CU MRL for that specific parameter.Unless inquiries or the outcome of a risk assessment indicate otherwise, product not containing ingredients from the affected batch can continue to be exported/supplied for export (with or without further processing) to the RF/CU.CHAIN OF SUPPLYFor the purposes of exports to RF/CU, the milk products must comply with RF/CU standards/MRLs throughout the supply chain – from processing of the raw milk to final export. Co-ordination amongst the operators at the different stages of production is needed to provide traceability and evidence of compliance of the product with RF/CU norms. For this purpose and where the next FBO in the supply chain is not at the same location, milk products must be dispatched to the next FBO accompanied by a Support Health Attestation (6409IMC). FBOs must keep a record of such movements on/off the premises and copies of all the 6409IMC issued/received. These should be available for inspection and provided, as necessary, to the OV as supporting evidence for final veterinary certification for export. OFFICIAL VETERINARIANS (OVs)It is imperative that the Official Veterinarians (OV)/Authorised Veterinary Inspectors (AVI) responsible for the certification process are familiar with the FBO’s monitoring SOPs for export to the RF/CU. It is strongly advisable that they are consulted and involved in the development and implementation of the testing protocols at all stages. FBOs are responsible for ensuring that OVs have access to the relevant records and are informed of all the sampling and laboratory test results in order to facilitate the certification process.OV/AVI must strictly adhere to the principles of certification of the Royal College of Veterinary Surgeons (MRCVS) (link below) and AHVLA instructions to OVs and be satisfied that they are in possession of the necessary evidence for certification, including duly completed 6409IMCs containing the health attestations that the product complies with RF/CU standards on the basis of the routine monitoring guidance in this document when providing final certification.. COMMUNICATIONSFor general export certification matters Official Veterinarians should contact SSC Carlisle (AHVLA) on advice on the implementation of the routine testing for exports to RF/CU in this document, the following hierarchy should be followed to escalate issues: FBO ? OV/DARD VO/LA EHO ? Regional FSA/DARD VPHP DVO ? FSA OG/DARD TRADE DVO ? AHVLA VA Exports (Defra) ? ................
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