DRAFT CONSULTATION - Scotch Whisky Association

1.0IntroductionThis Industry Guide has been drawn up toassist Spirit Drinks producers comply withtwo key pieces of legislation;Regulation (EC) No 852/2004 on the Hygiene of Foodstuffs (852/2004)The Food Hygiene (Scotland) Regulations 2006 and the equivalent Regulations inEngland, Wales and Northern Ireland respectively. Referred to as “the UK HygieneRegulations” throughout this guidance.The development of national guides for specific food groups is outlined inRegulation (EC) No 852/2004, Articles 7 and 8. This Industry Guide has beenrecognised by the UK Food Standards Agency (FSA) as having been developedin accordance with Article 8 of Regulation (EC) No 852/2004 and it follows theguidance published in “Guidelines for the development of national voluntary guidesto good hygiene practice…” issued by the Food Standards Agency, SecondEdition, February 2007.The Guide has special status under law and may be used by enforcement officersundertaking a compliance assessment of hygiene requirements at the premisesof a spirit drinks producer. However, use of the Guide is entirely voluntary andcompanies are free to demonstrate compliance with the legislation in other ways.It is hoped that the information in this Guide will be adopted and used to assistbusinesses to meet their legal obligations and ensure food safety.The Guide replaces the Spirit Drinks coverage of a previous drinks industry hygieneguide - The Guide to Good Hygiene Practice for the Beer, Wines and Spirits DrinksIndustries, issued in June 1995.DRAFT CONSULTATIONPhysical, chemical and microbiological hazards should be considered whenevaluating food safety risks.It is worth noting that the antiseptic properties of ethyl alcohol are an importantfeature when considering food safety as these properties minimise the likelihoodof microbiological hazard in spirit drinks. This fact has been confirmed by scientificevidence and in light of this microbiological hazards can be considered as low riskin products with more than 15% abv.However, alcoholic beverages with an alcohol content of less than 15% abv willhave a higher potential likelihood of microbiological growth and the risk should bewell researched and controlled through the HACCP process to ensure food safetyis maintained.3

1.3GlossaryFor the purpose of this document, the following definitions are used:ABV – Alcohol by volume is a standard measure of how much alcohol(ethanol) is contained in an alcoholic beverageAir Blowing – method for rinsing bottles before the filling operation.Allergen – is any substance that can cause an allergy.Bacteriocidal – is a substance that kills bacteria.Blending – the mixing of different types of spirit to produce a specific brand,product or quality.Bloom –• a deposit of micro-organisms, including yeast, found on the skins of fruit,most commonly grapes.• a white coating usually found on glass bottles after a prolonged period ofstorage. The main constituent is calcium and this can cause a reaction withthe beverage.Botanicals – is a plant or plant part valued for its flavour and/or scent.BRC – British Retail Consortium.Brown Spirits – general term for spirits, principally brandy, rum and whisky,which have extracted colour from the cask during maturation.By-Product – is a secondary product deriving from a manufacturing process,chemical reaction, and is not the primary product or service being produced. Aby-product can be useful and marketable or if intentionally discarded it can beconsidered as a waste.DRAFT CONSULTATIONCased Goods – is the finished product in final packaging for distribution.Cask – a barrel used to store and to mature spirits.CCP – Critical control point is a point, step or procedure at which controls canbe applied and a food safety hazard can be prevented, eliminated or reduced toacceptable (critical) levels.Chill filtration – a production step in the preparation for bottling phase –filtration at reduced temperature (4 deg C to -4 deg C) enhances the removal ofnatural fatty acid compounds which can cause precipitation or haze formationduring storage in market.CIP – Cleaning in place.Codex Alimentarious – is a collection of internationally recognised standards,codes of practice, guidelines and other recommendations relating to foods,food production and food safety.7

Glossary (Continued)Mashing – the process of mixing grist (usually milled malt) with hot water toactivate enzymes which convert starch to fermentable sugars and to solubilisethe sugars.Maturation – storage of spirit in oak casks to allow removal of unwantedflavours components and to develop an improved flavour by chemical reactionsbetween flavour components of the spirit and the wood of the cask, also byreaction with atmospheric oxygen diffusing into the cask.Methanol – (methyl alcohol) Toxic alcohol, of lower molecular weight than ethylalcohol, which is produced in small amount during fermentation of cereal.NDMA – Nitrosodimethylamine is a semi-volatile organic chemical that is highlytoxic and is a suspected human carcinogen.PAS – Publicly Available Specification is a consultative document where thedevelopment process and written format is based on the British Standardmodel. Any organisation, association or group who wish to documentstandardised best practice on a specific subject, can commission a PAS,subject to the BSI acceptance process.PET – Polyethylene terephthalate - resin of the polyester family and is used insynthetic fibers; beverage, food and other liquid containers.Potable Spirit – distilled spirit, usually at least 37.5% alcohol by volume, whichis approved for human consumption.Raw Materials – the material of agricultural origin from which fermentableextracts are made.Reduction – dilution of spirit with water. Distilled spirit is too strong formaturation and reduction to 63 – 70% alcohol by volume is necessary.DRAFT CONSULTATIONReverse Osmosis - process for water purification.Rousing – mixing the contents of a vat by injection of air or by a paddle.RTD and RTS – ready to drink or ready to serve, sub 15% alcoholic beveragessold in bottles, cans or other packs and typically in smaller quantities, 200 ml orless.Steeping – part of the malting process, barley is put in to a vessel and coveredwith water to initiate the germination process.SWRI – The Scotch Whisky Research Institute.UV Radiation – a form of sterilisation for water systems - exposure to UVwavelength of light.White Spirit – potable spirits which have not been matured in cask andtherefore retain the water-clear appearance of the new distillate.Yeast – a micro-organism used to ferment wort, must or molasses.9

Prerequisites (continued)c) clarify the boundaries of thehazard analysis (i.e. whetherprocess specific, productspecific, or designed to cover aspecific range of products)Construct a flow diagram showingall the process steps (see AppendixB)Identify the following:Describe the producta) Consider relevant safetyinformation like raw materialsand product composition andchemical composition. Identifyif your product has a high orlow microbiological risk. (Spiritsof 37.5% abv can generally beconsidered low risk. Other loweralcohol strength spirits especiallycream liqueurs may be higherrisk)b) Consider the Processing (egdistilling, heating, cooling) andthe extent of eachc) Identify intended use anddistribution channels. i.e.consumer target groupd) Shelf life datae) Consider the packaging usedto distribute your productsi.e. bottles, bulk shipment,containers etc.DRAFT CONSULTATIONf) Describe the storage conditionsa) Associated inputs e.g. rawmaterials, maturation containers,compressed air usage, reducingwaterb) Packaging materialsc) Process activitiesd) Equipment design featurese) Reworkf) Storage conditionsg) Steps before and after thespecific operation should beconsideredh) DistributionOn site confirmation of the flowdiagrama) Confirm the processingoperation against the flowdiagram. Amend if appropriateAdvice on Best PracticeAllergens are not considered to be a significant risk in distilled products asdistillation itself acts as barrier to allergenic material from the raw materials.However, anything which is added to the spirit post distillation, or any allergenicmaterials which have the potential to cross contaminate the product postdistillation, must be considered. Allergens can be considered as a hazard ontheir own or as part of the chemical hazard analysis.PAS 220:2008 Prerequisite Programmes on food safety for food manufacturing.13

VerificationLegal RequirementsArticle 5 para 2 (f) Regulation (EC) No 852/2004– HACCP• The HACCP principles referred to inparagraph 1 of this section shall include:establishing procedures, which shall becarried out regularly, to verify that themeasures outlined in subparagraphs (a)to (e) are working effectively. (See CodexPrinciple 6 – Establish procedures forverification to confirm the HACCP system isworking effectively)Definition:Verification is the application of methods,procedures tests and other evaluations,in addition to monitoring, to determinecompliance with the HACCP plan. (CodexAlimentarius Commission 2003).Verification activities are required to ensurethat the HACCP system and supportingprogrammes are being maintained and areeffective in delivering hygienic and safeproducts. These activities are in additionto monitoring and validation processes.Verification activities and any corrective actionsshall be documented.Guide to ComplianceProcedures for Verification shall bein place to ensure that the HACCPsystem is working correctlyVerification activities such asauditing, procedures and tests,including sampling and analysis, willenable trends to be identified andallow improvements to be madeVerification should be carried out bysomeone other than the person whois responsible for the monitoring andundertaking corrective actionsAdvice on Best PracticeVerification activities should includeactions to confirm that all elementsof the HACCP system are efficient.If change is required the systemshould be reviewed to ensure it isstill validExternal experts or qualified thirdparties may perform verificationactivities if these cannot beperformed in houseThe frequency of verification should be sufficient to confirm that HACCP isworking effectivelyIt is good practice to document all verification plansVerification is not confined to data from the monitoring points it may includeother data e.g. from HACCP team meetings, customer complaints and internal/external audits, reviews of the HACCP system and plan, dispositions andconfirmation that CCPs are under controlThe HACCP team should specify the methods and procedures to be used fordetermining if HACCP is working correctlyDRAFT CONSULTATIONMethods for verification may include random sampling and analysis, tests atselected critical points, intensified analysis of final products, surveys on actualconditions during storage, distribution and sale, internal audits20

DocumentationLegal RequirementsArticle 5 para 2 (g) Regulation (EC) No852/2004 – HACCP• The HACCP principles referred to inparagraph 1 of this section shall include:establishing documents and recordscommensurate with the nature and sizeof the food business to demonstrate theeffective application of the measuresoutlined in subparagraphs (a) to (f).(See Codex Principle 7 – Establishdocumentation concerning all proceduresand records appropriate to the principlesand their application)Guide to ComplianceAll documentation relating to theestablishment and maintenanceof the HACCP system shall be inaccordance with the nature and sizeof that business and procedures andpolicies applying to that businessAdvice on Best PracticeAll documents should be sufficientto assist in the verification of HACCPcontrolsRetention time for documents may be related to shelf life or HM Revenue &Customs requirements or may be stipulated within the internal procedures andpolices of that businessA simple record keeping system can be effective and easily communicated. Itmay use existing paperwork, such as delivery invoices and checklists to record,for example, product temperatures or volumesCo-operation between primary producer, industry and responsible authoritiesis of vital importance. Opportunities to encourage and maintain a continuousdialogue and create a climate of understanding in the practical application ofHACCP should be providedDocuments should be approved and signed by members of senior managementin the companyTo assist in training to support a HACCP plan, work instructions and proceduresshould be developed which define the tasks of the operating personnel to bestationed at each CCPFor more information and links to further guidance please refer to Appendix H.DRAFT CONSULTATION21

2.2Potential Hazards within theSpirit Drinks IndustryThis is an introductory sample of hazards andfurther details can be found in the followingsections of the document. The table belowprovides readers with the key areas in whichoperators should be aware of, and thepossible risks of contamination.The table is a guide and not exhaustive or exclusive. Producers should carry out thenecessary risk assessments to identify food safety hazards and controls within theirown operations.DRAFT CONSULTATION22

Typical examples of hazard types and theircontrols:Source ofHazardType ofHazardExample of Potential Hazard & ControlHazard Control Measure Control PointsRaw Materials Physical Foreign objects Supplier QA & ContractsDressing Equipment & MetalDetection Equipment MagnetsMaintenance SchedulesCereals intakeCereal and Botanicalpreparation roomRodent infestationWater Chemical Contamination atSpring Water SourceCleaningAgentsPhysicalChemicalParticulate material in thewaterContamination of bottles byuse on filling machineContamination withCleaning in Place (CIP)chemicalsPackaging Physical Glass breakage resulting incontaminationPest Control andCleaning ProgrammeQuality control testingSensory AssessmentQuality Control Process ControlMaintenanceCleaning ProgrammeSpecificationsCleaning ProgrammeSpecificationsGlass Breakage Proceduresand Training – Air Blowers, SpiritRinsers and FiltrationMalt storageSpring water sourceand Water Intake pointWater Intake pointWater Storage and/ orTreatmentPoint of useQC spirit checks – inprocess and finishedproduct testingAnalysis of rinse waterIntake, Storage andbottling process –inspection and operatortrainingDRAFT CONSULTATIONChemicalTaints from packaging orclosuresSupplier specificationsGoods inward inspectionIntake, storageconditions anduse of materials23

3.0Spirit Drinks IndustryGuidanceThe following chapters focus on the key topicareas for the spirit drinks sector providing thereader with guidance on complying with thelegislation and advice on best practice.The full list of requirements under thislegislation can be found in Appendix A.DRAFT CONSULTATION24

3.1Official Controls, Registrationand ApprovalLegal RequirementsRegulation 852/2004 Article 6 (2)Every food business operator shall notify theappropriate competent authority, in the mannerthe latter requires, of each establishmentunder its control that carries out any stagesof production, processing and distribution offood, with a view to the registration of eachestablishment.Food business operators shall also ensurethat the competent authority always has up todate information on establishments, includingnotifying any significant change in activitiesand any closure of an existing establishment.The spirit drinks sector and individual companies must engage withtheir competent authority e.g. Local Authorities to ensure they havea good understanding of the key business activities.Guide to ComplianceFood premises must be registeredwith the Competent AuthorityAdvice on Best PracticeCurrently no adviceAny significant change to the productrange or plant operation should benotified to the Competent AuthorityDRAFT CONSULTATION25

3.2Plant Design, Infrastructureand EquipmentLegal RequirementsRegulation (EC) No 852/2004 on the Hygiene ofFoodstuffs, Annex II Chapter I (2)Plant Design2) The layout, design, construction, siting andsize of food premises are to:a) Permit adequate maintenance, cleaningand/or disinfection, avoid or minimise airborne contamination, and provide adequateworking space to allow for the hygienicperformance of all operations;b) Be such as to protect against theaccumulation of dirt, contact with toxicmaterials, the shedding of particles intofood and the formation of condensation orundesirable mould on surfaces;c) Permit good food hygiene practicesincluding protection against contaminationand in particular pest control; andd) Where necessary, provide suitabletemperature-controlled handling andstorage conditions of sufficient capacityfor maintaining foodstuffs at appropriatetemperatures and designed to allow thosetemperatures to be monitored and, wherenecessary, recordedRegulation (EC) No 852/2004 on the Hygiene ofFoodstuffs, Annex II Chapter V(1)Equipment RequirementsThe design, construction, and location of equipment andinfrastructure for food premises are of paramount importance toensure hygienic operations. During the initial project planning phaseof any new or modified building work or process re-engineering,sufficient consideration should be given to hygiene issues to ensurethe delivery of a cost-effective and hygienic operation.In the case of existing premises or equipment, the constraints andlimitations need to be identified and appropriate hygiene proceduresadopted. Historical evidence demonstrates that older premises usedfor primary production, without sealed floors and tiled walls can bemaintained in a hygienic condition and these conditions will not impingeon the hygiene of the subsequent bottled products.Guide to ComplianceReduction of hygiene risk includinginference risks to the product andbusiness are key goals of good plantdesign. The key process areas for thespirit drinks industry is from distillationonwards. When designing or modifyingthe premises and installing newequipment, consideration shall be givento the following areas where appropriate:Plant DesignWhen designing in and aroundpremises, minimise the accumulationof inaccessible dirtDRAFT CONSULTATION1) All articles, fittings and equipment withwhich food comes into contact are to:a) Be effectively cleaned and, wherenecessary, disinfected. Cleaning anddisinfection are to take place at a frequencysufficient to avoid any risk of contamination;Good design allows for easyinspection and auditing ofhousekeeping standards e.g. pipesmust run and drain effectivelyA finished goods storagearea should be identified andcondensation minimised to ensurethat transit cases are not spoiledor damaged which may lead to theproduction of taintsPreventing ingress of pests andharbourage of pests and maintaindry low humidity storage areas.This is particularly important for thestorage of cerealsAdequate security measures shouldbe taken to ensure unauthorisedentry to the production premises isavoidedb) Be so constructed, be of such materialsand be kept in such good order, repairand condition as to minimise any risk ofcontamination;c) With the exception of non-returnablecontainers and packaging, be soconstructed, be of such materials andbe kept in such good order, repair andcondition as to enable them to be keptclean and, where necessary disinfected;andd) Be installed in such a manner as to allowadequate cleaning of the equipment andthe surrounding areaElimination of contamination risksthrough the separation of low & highrisk processes e.g. cleaning pipesseparate to production pipeworkWhere chemicals are used to preventcorrosion e.g. chill filtration plants,they should be used in accordancewith the manufactures instructions26

Plant Design, Infrastructureand Equipment (Continued)InfrastructureEquipmentAll changes and modificationsshall be reviewed for impact via theHACCP planAppropriate to level of risk and bemaintainedThe construction materials procuredshould be appropriate to thelevel of risk such as sealed floorsand smooth impervious walls forpost distillation areas where highhygiene standards are needed tobe maintained e.g. filling stores,disgorging, blending and bottlingareasSurface water and foul drainageshould be free flowing and not besituated under any of the buildingsFloors should be drainable to avoidstanding water and open drainsshould be covered where possibleAdvice on Best PracticeWhere the plant and equipmentrequires cleaning and sterilisation ,adequate working space to allow fullaccess for maintenance is required.This is particularly important forfermentation, compounding andbottling plant equipmentMaterials coming in contact withthe product must not imparttoxic substances, taste or taint.Companies must identify the correctspecification or grades of materialto ensure compliance with theEuropean Food Contact Materiallegislation e.g. grade of copper forstills; high strength spirit rubber,hoses, gaskets and plastic pipesDue to the nature of the old buildings that many distilleries are housed in,a bespoke approach to cleaning and maintenance programme is required.Measures should be proportionate to the risks identifiedDRAFT CONSULTATIONAll investment decisions in plant and equipment should be assessed at an earlystage for any potential impact on food safety, hygiene and qualityWhere possible open containers and product should be covered to themaximum extent. Particularity in the bottling line, which should be covered upto the filling stage. Any lighting above open systems e.g. open man-doors, vatsand bottles should be covered to prevent glass contamination and inspectedregularly for damageWhere you have open systems, restrict access to minimise risks ofcontaminationSegregate dry and wet goods from bottling and packaging areas where possible27

3.4Water SupplyLegal RequirementsPrivate Water Supplies (Scotland) Regulations2006Water systems must be maintained to ensure that water used forfood production is of the stipulated quality - this includes waterused as an ingredient, as a process aid and for washing purposes.The Private Water Supplies Regulations(Northern Ireland) 1994Private Water Supplies Regulations 1991 (to bereplaced by Private water supplies (England)Regulations 2008)• Water supplied to any premises from aprivate supply for drinking, washing orcooking or for food production purposesshall be fit for human consumptionDistillery water supplies are exempt from thePrivate Water Supplies (Scotland) Regulations2006 where they are used for the mashingprocess or cleaning of plant during thedistillation process where the water used doesnot either directly or indirectly affect the fitnessfor human consumption of the spirits in theirfinished formRegulation (EC) No. 852/2004 on the Hygieneof Foodstuffs – Chapter VII Water Supply• You must have an adequate supply of‘potable’ (drinking quality) water, which is tobe used whenever necessary to ensure thatfoods are not contaminated• Where ‘non-potable’ water (i.e. not ofdrinking quality) is used in your business,for example for fire control, steamproduction, refrigeration and other similarpurposes, it must circulate in a separate,identified system. It must not connectwith, or be able to get into, the systems for‘potable’ (drinking quality) waterThe industry considers that primary production up to and includingdistillation is not a concern, since bacteria would not survive the hightemperatures of distillation. There is a low potential biological risk ifcontaminated reducing water is used. However, evaluation of such a riskshould take into account post-distillation processes such as maturation,filtration, UV radiation and reverse osmosis. Particular considerationshould also be given to the bacteriocidal effect of alcohol at the variousstages of production and bottling.Guide to ComplianceCompanies must have evidenceof water supplies being analysedon a regular basis to confirm it is fitfor purpose and poses no risk e.g.review of Scottish Water reports onpublic water supplyAny on-site storage and distributionmust be such that the water remainsfit for purpose to the point of use.Stored water shall be protected fromanything which could contaminateit – physically, chemically andmicrobiologicallyDRAFT CONSULTATION• If recycled water is used in processing oras an ingredient, it must not present a riskof contamination. It must be of the samestandard as potable (drinking quality) water,unless you can satisfy your local authoritythat the quality of the water cannot affecthow safe the food is to eat in its finishedformAll hoses/pipes for the transfer ofpotable water shall be of food gradequalityAny water treatment plants (e.g.De-mineralisation /Reverse Osmosis)shall be maintained and serviced inline with manufacturer’s guidelinesNon-potable water (e.g. for thegeneration of steam, fire controlor cooling systems) shall have atotally separate system which mustbe readily identifiable and not haveany physical connection with or anypossibility of cross contaminationinto potable water systems. It shallonly be used where it does not affectthe hygiene of the productRecycled water must be assessedto ensure it does not introducecontamination into the productionprocessAll materials in contact with the watersupply must be of suitable quality setout in the water fittings and materialsdirectory http://www. wras.co.uk/Directory/Non-potable water may be usedin the mashing process duringthe distillation of spirits and forthe washing of plant during thedistillation of spiritsWater of potable standard shall beused for spirit reduction, subjectto any amendments of futureregulationsSteam used directly in contact withfood shall not contain any substancewhich presents a hazard to health, oris likely to contaminate the productAll water sources must have agreedspecifications. A regular samplingand review of the water suppliedshould be carried out in house orcontracted out to a 3rd party29

Water Supply (Continued)Advice on Best PracticeA good working relationship with your water provider should be sought. Part ofthis will be regular reviews of their specification and water analysisWater specifications should be maintained for all sources. Set a samplingregime appropriate to risk that should be implemented and any deviation outwithstated parameters should trigger investigation into possible contaminationDRAFT CONSULTATION30

3.5Compressed Air QualityLegal RequirementsISO8573-1:2010 Part 1This standard specifies the amount ofcontamination allowable in each cubic meterof compressed air for three categories ofcontaminants – solid particles, water and oil.Depending on the intended use of thecompressed air the level of each of the abovecontaminants may need to be specified.In the case of food and beverages the BRC(British Retail Consortium) and BCAS (BritishCompressed Air Society) have published acode of practice that specifies the allowableamounts of contaminants for different useswithin the food and beverage industries.Compressed air is widely used in the spirit drinks industry for mixingvats of liquids, moving liquids from vat to vat or purging pipeworkand in some companies blowing debris from bottles prior to filling.For these uses the compressed air will be in contact with the productand so its purity and cleanliness should be assessed and systemsdesigned to supply compressed air should be maintained against adefined standard.The International Air Quality Standard, ISO8573 consists of nine parts.Part 1 specifies the quality requirements for compressed air and parts2-9 specify the methods of testing the three categories detailed in thestandard;solid particles,water andoil.ISO 8573-1:2010 does not specify the purity level required for specificuses. Users of compressed air need to determine the level of purity thatis appropriate for their application. However, a code of practice has beendrawn up by BRC and BCAS for food and beverage users and three usesof air and corresponding recommended purity limits are listed;direct contact with food,non-contact high risk, andnon-contact low risk, see table below.Guide to ComplianceCompanies should ensure that aircompressing equipment is correctlyspecified for the grade of air to beused taking the BRC and BCAS codeof practice in to account.DRAFT CONSULTATIONThe details of the air qualityspecification should be agreed withthe plant supply company and themaintenance company that willservice the equipment.The air quality specification willonly be met if the supply air tothe compressor is of appropriatequality, so siting the compressorand its air intake should be carefullyconsidered.Careful consideration should begiven to the grade of air requiredat different points throughout thecompressed air supply system. Itmay not be necessary to have thesame grade available at all pointsdepending on the intended use.31Solid ParticlesWater• Defined as the number of particlesper cubic meter and they aremeasured over three size ranges,see table below.• Microbial contamination – noneshould be detected, see testmethod ISO8573-7.• The amount of water incompressed air is defined by thepressure dew point of the dryingsystem.• In food contact applications itmust be -40°C or lower.• Older refrigerant driers typicallyonly reach 3°C dew points andshould only be used in noncontactair supplies since there istoo much water remaining in theair at this temperature.

Compressed Air Quality (Continued)Oil & Oil Vapour• Oil quality specifications aremore stringent than the other twocategories regardless of contactor non-contact use.Maintenance schedules should beset at six monthly intervals althoughdaily inspection of filters, dryers andpipework should be a routine part ofthe plant operator’s duties.• Oil contamination wouldconstitute a major contaminationissue in a food productionoperation and therefore oil shouldnot be found in compressed airused in food operations.Advice on Best PracticeOil free compressors are widely available and should be considered when newor replacement compressors are being installed.Filtration of the compressed air is important to achieving the desired final qualitybut in some instances filtration of the intake air may need to be considered if sitedesign cannot accommodate large quantities of clean air.Modern air compressors are air cooled but in cases when liquid coolant is usedthe grade of coolant should be compatible with food use.Table – Specification for Air QualityFood contact & non-food contact with high risk recommendationCompressed air coming into direct contact with food shall meet or exceed thefollowing recommendation;DRAFT CONSULTATIONISO8573 – 1:2010 Class 1.2.1Pipework – smooth bore pipeshould be used wherever possibleand carbon steel pipework avoidedbecause it is prone to corrosion.- Dirt (solid particles) the maximum number of particles in the following size rangesshall not exceed;Particle size, d µm 0,10 < d ≤ 0,5 0,5 < d ≤ 1,0 1,0 < d ≤ 5,0Maximum number of particles; per m 3 100 000 1000 10- humidity ≤-40°C PDP (at air line pressure)- Total oil < 0.01 mg/m 3Non-contact low risk recommendationSame as contact grade except, humidity ≤+3°C PDP (at air line pressure), ISO8573 –1:2010 Class 1.4.1Where the HACCP shows the air may be used in a process that has a high risk offood contact occurring then the air purity shall be the same specification as the foodcontact grade above, ISO8573 – 1:2010 Class 1.2.132

3.6CleaningLegal RequirementsRegulation (EC) No 852/2004 on the Hygieneof Foodstuffs: Annex II Chapter I – Generalrequirements for food premises1) Food premises are to be kept clean andmaintained in good repair and condition.2) a) b) The layout, design, construction,siting and size of food premises are topermit adequate maintenance cleaningand /or disinfection to protect against theaccumulation of dirt.10) Cleaning agents and disinfectants arenot to be stored in areas where food ishandled.Chapter II – Specific requirements in roomswhere foodstuffs are prepared, treated orprocessed.1) In rooms where food is prepared, treatedor processed the design and layout areto permit good food hygiene practices,including protection against contaminationbetween and during operations. Inparticular floor surfaces, wall surfaces,ceilings and overhead fixtures, windowsand doors are to be maintained in asound condition and be easy to clean.This will require the use of impervious,non-absorbent, washable and non-toxicmaterials unless food business operatorscan satisfy the competent authority thatother materials used are appropriate.Where appropriate, floors are to allowadequate surface drainage.Guide to ComplianceEach location shall havedocumented cleaning schedulescovering all areas as a means ofmaintaining a hygienic productionenvironment. Cleaning schedulesshall detail areas to be cleaned,frequency of cleaning, method ofcleaning, responsibility for cleaning,cleaning assessments and recordsto be maintainedNew buildings for the manufacture,processing and storage of spiritdrinks shall be located, designedand constructed to allow for effectivecleaning and disinfectionFloors in post distillation, particularlyprocessing and packaging areasshall be non-porous, smooth, freeof potholes, easy to clean and ofa non-slip surface. Floors shall bemaintained in a clean, hygienic andsafe condition. Walls, ceilings andother internal structures shall beconstructed and finished to requireminimal or easy maintenance andcleaning. Windows and doors shallbe close fitting and allow for effectivecleaning. Where external windowsare used for ventilation, they shallbe fitted with insect-proof screens toprevent ingress of insects and pests.The design of screens shall enableeasy cleaningEquipment shall be maintained in aclean, tidy and hygienic conditionand cleaning records shall be keptCleaning agents shall be storedaway from production areas e.g. stillhouses, blending and bottling areasMeasures should be taken to ensurethat prior to filling and sealing,bottles are free from contaminationi.e. bottle rinsing or blowingSteam pipes used for sterilisationshould be free from rust or fitted withsuitable filters to eliminate possiblecontamination of the plant andequipmentDRAFT CONSULTATION2) Adequate facilities are to be provided,where necessary, for the cleaning,disinfecting and storage of workingutensils and equipment. These facilities areto be constructed of corrosion-resistantmaterials, be easy to clean and have anadequate supply of hot and cold water.Effective cleaning is crucial to maintaining hygienic conditions inany food premises. The design and construction of new premisesand equipment shall permit adequate cleaning and protect againstthe accumulation of dirt. The walls, floors, ceilings and surfacesin areas post distillation shall be maintained in a sound conditionand be easy to clean. Post distillation, bottling halls and fillersare identified as priority areas in Spirit production. Cleaning ismore than the removal of dirt. Effective cleaning also ensures theavoidance of contamination with chemicals.Chemicals should be approvedand a list maintained. Chemicalsmust not endanger the product orintroduce any contamination or taint.COSHH records will be part of thisprocessWhere chemicals are usedprocedures should be put in placeso that no residues are left tocontaminate the productsCompanies should develop a glassbreakage clean up procedure toeliminate the risk of contamination33

Pest Control (Continued)All areas, including external areasclose to manufacturing units, mustbe kept free of debris, buildingmaterials, defunct equipment,pallets or wooden boxes which mayattract pests or provide harbourage.Accumulations of refuse shall beavoided in all areasDomestic animals shall be excludedfrom production areas by keepingdoorways and entrances closedAdvice on Best PracticeIncoming materials and ingredients should be inspected prior to storage forsigns of pest infestation. These checks should be part of the pre-requisiteprogrammeMaterials should be stacked at least 50cm away from walls to allow sufficientspace for cleaning and pest control activities. External vegetation should be keptshort and should not be allowed to grow close to buildingsExternal perimeter baits should be heavy duty lockable boxes firmly secured tothe substrateGrain intake and storage areas are high priority areas for ingress of pests.Appropriate maintenance and cleaning should be sufficient if they are wellmanagedDry goods such as herbs and spices used for compounding with spirits andmanufacturing of low alcohol beverages require extra vigilance for pests andinfestation. Any fumigants or pesticides used must meet legal requirements asdefined in Regulation (EC) No 396/2005 Pesticide Residues (and subsequentamendments)DRAFT CONSULTATIONEnsure all external waste storage is enclosed so as not to encourage pestsEnsure adjoining land does not have signs of infestation or activities that mayattract infestationRodent baits should be in tamperproof boxesTo minimise the ingress of pests, casks stored externally should have storagebung in place and bulk storage containers should be sealed appropriately39

3.11TrainingLegal RequirementsRegulation (EC) No 852/2004 on the Hygiene ofFoodstuffs: Annex II – Chapter XIIFood business operators are to ensure;1) that all food handlers are supervised andinstructed and/or trained in food hygienematters commensurate with their workinstruction.A food business operator/proprietor must address the supervisionand instruction and/or training of both food hygiene and foodsafety management. All spirit drinks are classified as foodstuffsand are consequently covered by the Hygiene of Foodstuffslegislation. Food safety is the responsibility of everyone involvedin the manufacture, transport and packaging of spirit drinks or lowalcohol beverages and all relevant staff must have an appropriateunderstanding of good food hygiene and food safety hazards.2) that those responsible for the developmentand maintenance of the procedure referredto in Article 5(1) of this regulation or for theoperation of relevant guides have receivedadequate training in the application of theHACCP principles; and3) compliance with any requirementsof national law concerning trainingprogrammes for persons working in certainfood sectors.Guide to ComplianceThe aim of food hygiene and safetytraining is to ensure the productionof safe food, by using competentfood handlers, who have beenadequately trainedThe food business has aresponsibility to determine thelevel of training, instruction, andsupervision of food handlers. Thistraining should form an importantpart of the basis of the hazardanalysis systemFor training to be effective, it mustbe;a) Relevant to the job roleb) Clearly linked to food safetyhazards and controlsDRAFT CONSULTATIONc) Capably delivered, understood,assessed, supervised andresourcedFor those handlers whose firstlanguage is not English, suitableprovision should be made to supportthem and additionally any employeesidentified with learning difficultiesWhere staff have a responsibilityfor, development of, maintenanceof HACCP (or related) food safetymanagement principles, suitabletraining must be demonstratedManagement must ensure that thetraining is effective by monitoringthe trained staff, and confirmingthat work is being carried out safelyand hygienically in line with thecompany’s food safety procedures.Legislation does not identify arequirement for staff to attend aformal training course or obtain aqualificationTraining shall cover food safetyessentials such as;a) Overview of company’s foodsafety policy, commitment tohygiene etcb) Personal health and hygiene,responsibilities of food handlers,reporting of illnessc) Prevention of contaminationd) Cleaning procedures and storagee) Awareness of pest activityf) Awareness of goodmanufacturing (GMP)42

Training (Continued)Advice on Best PracticePersonnel working in the food processing areas either as an operator orcontractor should be trained and the training should be completed prior to themcommencing workThe company should put in place documented programmes coveringthe training needs of relevant personnel. These should include necessarycompetencies for specific roles; providing training or other action to ensure staffhave the necessary competencies; review and auditing the implementation oftraining and competency of the trainerRecords of training should be available and should contain date/duration,training provider, name of trainee and confirmation of attendanceThe company should regularly review the competencies of staff and providerelevant training as appropriate (including refresher training)DRAFT CONSULTATION43

3.12Packaging Materials inContact with the ProductLegal RequirementsRegulation (EC) No. 2023/2006 on GoodManufacturing Practice for Materials andArticles intended to come into contact withFoodPackaging is items used for the protection, transportation,preservation and presentation of finished products. Packaging hasto comply with relevant food safety legislation and must not bea source of contamination to the food which it contains. By theirnature packaging materials should be inert.• Materials and articles in contact with foodshould be of appropriate quality so asnot to endanger human health or causeunacceptable change in the compositionof the food or causing deterioration in theorganoleptic characteristics• EC Directive 2005/79/EC - amends the ECDirective 2002/72/EC relating to plasticmaterials and articles intended to come intocontact with foodRegulation (EC) No 852/2004 on the Hygieneof Foodstuffs: Annex II; Chapter X - Provisionsapplicable to the wrapping and packaging offoodstuffs• Material used for wrapping and packagingare not to be a source of contamination• Wrapping materials are to be stored in sucha manner that they are not exposed to a riskof contamination• Wrapping and packaging operations are tobe carried out so as to avoid contaminationof the products. Where appropriate and inparticular in the case of cans and glass jars,the integrity of the container’s constructionand its cleanliness is to be assuredPrimary packaging is directly in contact with the spirit - glass or PET bottles,cans, ceramics, caps, closures, corks and others. Also included in this categoryare items such as wax used on cork or coating/ varnishes found on closures andplastic fitments/wads inside non refillable closures.Secondary packaging is not in direct contact with the spirit but protects theprimary pack from damage or may add value to the presentation. These itemsmust not introduce contamination to the product but it is acknowledged that therisk is much lower than with primary packaging for our industry.Other materials in contact with the spirit should be considered such as pipework, gaskets, pumps, promotional materials etc. For more information refer toPlant section 3.2.Casks used for maturation or storage are not considered to be packaging. Theyare fundamental to spirit drinks production processes and by their nature theyare not inert. Their purpose is to change the characteristics of the product albeitin a positive way. For more information on the risks related to cask use pleaserefer to Appendix E: Allergens.Guide to CompliancePackaging specifications shall beadequate to prevent contaminationand meet legal obligationsDRAFT CONSULTATION• Wrapping and packaging material re-usedfor foodstuffs is to be easy to clean and,where necessary, to disinfectPackaging shall not introduce anytype of contamination into theproductPackaging shall comply withregulations for food contact materialand food safetyFinished goods for sale shall betamper evident to prevent accidentalcontaminationThe organisation shall verify this isthe case and keep recordsAll packaging shall be covered untilrequired for usePrinted surfaces shall not come intocontact with foodContainers must be cleaned beforeuse – blowing , rinsing or othermeans may be employedPrimary packaging shall be storedunder conditions that ensure it is fitfor purpose at point of useGlass breakage procedures shallbe in place to prevent accidentalcontamination during packagingClosures shall be debagged awayfrom high risk areas44

Packaging Materials in Contactwith the Product (Continued)Advice on Best PracticeA packaging supplier audit programme should be employed which coversselection and ongoing appraisalPackaging should be designed to ensure the risk of contamination is eliminatedwhere possibleBottles should be designed to minimise breakageFragile containers should be designed to minimise impact during packingoperationsEquipment controls such as neck guides should be assessed to minimiseimpact and reduce breakage, ie plastic nozzles of suitable material could beusedStore packaging in clean, ventilated, dry places which are free from odoursGlass should be used in rotation and stored under conditions that preventformation of ‘bloom’Obtain compliance certificate from supplierDRAFT CONSULTATION45

Documents and Record3.13 KeepingLegal RequirementsRegulation (EC) No 852/2004 on the Hygiene ofFoodstuffs: Article 5 (2)g) Establishing documents and recordscommensurate with the nature and sizeof the food business to demonstrate theeffective application of the measuresoutlined in subparagraphs (a) to (f).Effective documentation and record keeping is an essential andintegral part of any food safety and hygiene system. There is a legalrequirement to document and maintain the HACCP system. Thisincludes keeping records of hazard analysis, monitoring records,corrective actions, verification reports and system review activities.The key benefits of a robust documentation and record system are:1) They demonstrate that the business is operating responsibly and iscommitted to meeting the legal requirements2) They provide evidence to demonstrate food hazards have been identifiedand are being controlled (due diligence)3) They assist in identification of areas for improvement of the food safetymanagement systemGuide to ComplianceAs a minimum, the documents andrecords needed to comply with legalrequirements for food hygiene are -a) A procedure(s) detailing theresponsibilities and key elementsof the operation of the food safetysystemb) A hazard analysis based onCodex Alimentarius principles(HACCP)c) Records of monitoring andverification activitiesDRAFT CONSULTATIONd) Records of non conformancesand subsequent actions takene) Records of review of the foodsafety system and HACCPprocessesf) Evidence of training andcompetence on food hygieneissuesRecording of checks carried out toverify CCPs are being controlledRecords of monitoring shall not bealtered or any alterations must beauthorisedIt is essential that any records thatare kept are accurate and truly reflectwhat is happening in the businessThe records shall be reviewedto ensure controls are operatingeffectively and if not, relevantcorrective actions must be taken.These actions must be recordedThe records shall be retainedfor a defined period, from dateof manufacturing i.e. bottledHMRC requirements shall also beconsidered when determining recordomissionEvidence of cleaning regimes andplant maintenance documentationsuch as procedures, specifications,work instructions which containinformation to ensure control of foodhazards should be authorised andmanaged to ensure information iscurrent, legible, unambiguous andrelevant46

Documents and RecordKeeping (Continued)Advice on Best PracticeFurther guidance on document and record control for management systems canbe found within BS EN ISO 9000 or BS EN ISO 22000. Companies who producespirit drinks for retailers may find the British Retail Consortium (BRC) standardcan assist in clarifying documentation and record keeping requirementsA formalised approach to document and record control is useful in complex orlarge multi-site organisations. A document control process should include stepswhich cover:Creation: documents which communicate clearly and unambiguouslyReview: to validate the information contained in the documentApproval: by nominated authorised personIssue: to users and remove old editions, train users on changesDocumentation control software package is a useful tool to consider. Electronicrecords must have an adequate backup system in place to prevent loss. Bothpaper management systems and electronic document management systemsshould be tested periodically to ensure they are effectiveIn addition to the minimum legal requirements outlined there are benefits incapturing evidence on activities which support good hygiene practises todemonstrate they are being controlledThe benefits of controlling additional documentation will be dependent on thesize and complexity of the organisation and the products made. Appendix Dcontains a detailed list of documents that are commonly found in thoroughHACCP systemsDRAFT CONSULTATION47

Appendix AOverview of (EC) No 852/2004Regulations on the Hygiene of FoodstuffsDRAFT CONSULTATION48

1Food PremisesPremises of food businesses should be keptclean, and in good repair and condition.The following table sets out more specific requirements for premises.Subject What you must do Part of theRegulationLayout, design,construction and sizeToiletsHand washing facilitiesand washbasinsVentilationMake sure the premises permit adequate maintenance, goodhygiene practice and cleaning and /or disinfection, and protectfood against external sources of contamination, such asaccumulation of dirt, contact with toxic materials, shedding ofparticles of food, formation of condensation or undesirable mouldon surfaces and also pests and that there are, where necessary,suitable temperature-controlled handling and storage conditionsof sufficient capacity for maintaining foodstuffs at appropriatetemperatures and designed to allow those temperatures to bemonitored and, where necessary, recorded.There must also be an adequate number of toilets connected toan adequate drainage system and these must not lead directlyinto rooms in which food is handled.Make sure there are an adequate number of washbasinsavailable, designated for cleaning hands. Make sure that basinshave hot and cold (or appropriately mixed) running water. Youmust provide materials for cleaning and hygienically dryinghands. Where necessary, facilities for washing food must beseparate from hand washing facilities.Annex IIChapter I.2Annex IIChapter I.3DRAFT CONSULTATIONMake sure there is suitable and sufficient ventilation, eithernatural or mechanical. Ventilation systems must be accessible forcleaning and/ or replacement of parts.Annex IIChapter I.4Annex IIChapter I.5RelevantSection ofthis Guide3.2N/A3.103.6Ventilation of toiletsAll toilets inside food premises must have adequate ventilation,either natural or mechanical.Annex IIChapter I.6N/ALightingMake sure the premises have adequate natural and/or artificiallighting.Annex IIChapter I.73.2DrainageMake sure there are adequate drainage facilities. Where drainagechannels are open, waste must not flow from a contaminated areatowards or into a clean area.Annex IIChapter I.83.2, 3.6Changing facilitiesWhere necessary, you must provide adequate changing facilitiesfor staff.Annex IIChapter I.93.10Cleaning agents anddisinfectantsMake sure these are not stored in areas where food is handled.Annex IIChapter I.103.2, 3.649

2Food RoomsThe design and layout of rooms where food isprepared, treated or processed, excluding foodstorage rooms, packaging areas for wrappedfood, dining areas but including roomscontained in means of transport, must permitgood hygiene, including protection againstcontamination between and during operations.Subject What you must do Part of theRegulationFloors, walls andsurfacesCeilingsWindowsMake sure floors, walls and surfaces in contact with food aremaintained in a sound condition. They must be easy to cleanand, where necessary, to disinfect. They should be constructedof impervious, non absorbent, washable, corrosion resistant andnon toxic materials unless the component authority agrees thatother materials are appropriate.The design and construction of ceilings should preventaccumulation of dirt, condensation, growth of moulds andshedding of particles.Windows must be constructed to prevent the accumulation of dirt.Where necessary, windows that can be opened to the outsidemust be fitted with insect-proof screens or remain closed.Annex IIChapter II.1 (a)(b) and (fAnnex IIChapter II.1(c)Annex IIChapter II.1 (d)DRAFT CONSULTATIONDoors Doors must be easy to clean and, where necessary, to disinfect. Annex IIChapter II.1 (e)RelevantSection ofthis Guide3.2, 3.63.2, 3.63.2, 3.6,3.93.6Ventilation of toiletsAll toilets inside food premises must have adequate ventilation,either natural or mechanical.Annex IIChapter I.63.6Cleaning, disinfectingand storage of tools,utensils and equipmentYou must provide adequate facilities for cleaning, disinfectingand storing tools, utensils and equipment, where necessary.There must be an adequate supply of hot and cold water and thefacilities must be constructed of corrosion resistant materials andeasy to clean.Annex IIChapter II.23.2, 3.6Washing foodWhere appropriate, you must provide adequate facilities forwashing food, including a supply of hot and/or cold potable(drinking) water as required.Annex IIChapter II.3N/A50

3Moveable/temporary PremisesThere are different requirements for:• movable and/or temporary premises e.g. marquees, market stalls etc.• vending machines• domestic premises used primarily as a “private dwelling house”• premises used occasionally for catering purposesMovable and/or temporary premises include marquees, market stalls and mobilesales vehicles.Subject What you must do Part of theRegulationPremises and vendingmachinesPersonal hygienefacilitiesSurfacesCleaning of utensils andequipmentCleaning of foodstuffsHot and cold runningwaterMake sure that these are sited, designed, constructed, keptclean and maintained in good repair, so as to avoid the risk ofcontaminating food, especially by animals and pests.There must be appropriate facilities to maintain adequatepersonal hygiene, where necessary.Where necessary, make sure that surfaces in contact with foodare easy to clean and, where necessary, to disinfect.All toilets inside food premises must have adequate ventilation,either natural or mechanical.You must make adequate provision for the cleaning of foodstuffs,where necessary.Annex IIChapter III.1Annex IIChapter III.2(a)Annex IIChapter III.2(b)Annex IIChapter III.2(c)DRAFT CONSULTATIONMake available an adequate supply of hot and/or cold potable(drinking) water, where necessary.Annex IIChapter III.2(d)Annex IIChapter III.2(e)RelevantSection ofthis Guide3.2, 3.6,3.93.103.2, 3.63.6N/A3.4Waste storage anddisposalMake adequate arrangements for storage and disposal of waste,where necessary.Annex IIChapter III.2 (f)3.8Temperature controlYou must have adequate facilities for maintaining and monitoringsuitable temperature conditions.Annex IIChapter III.2(g)N/AAvoidingContaminationPlace foods where the risk of contamination will be avoided, as faras is practical.Annex IIChapter III.2(h)3.8, 3.1251

4TransportFood must always be transported in a waythat minimises the risk of contamination.Subject What you must do Part of theRegulationContainers and vehiclesused for transport offoodDedicated containersContainers or vehiclesused for differentfoodstuffs or for bothfood and non-foodproducts at the sametimeBulk transport of foodin liquid, granulated orpowder formContainers or vehiclesused forAny container or vehicle used for transporting foodstuffs must bekept clean and maintained in good repair to protect food fromcontamination. Where necessary, the container or vehicle mustbe designed and constructed to permit adequate cleaning and/ordisinfection.Receptacles in vehicles and/or containers must not be used fortransporting anything other than foodstuffs, where this may resultin contamination of foodstuffs.You must separate products effectively, where necessary, toprotect against the risk of contamination.Bulk foodstuffs in liquid, granulated or powder form must betransported in receptacles and/or containers/tankers reservedfor the transport of foodstuffs, if otherwise there is a risk ofcontamination. Containers reserved for foodstuffs must bemarked ‘for foodstuffs only’.Annex IIChapter IV.1Annex IIChapter IV.2Annex IIChapter IV.3Annex IIChapter IV.4DRAFT CONSULTATIONYou must separate products effectively, where necessary, toprotect against the risk of contamination.Annex IIChapter IV.5RelevantSection ofthis Guide3.73.73.73.73.7Minimises the risk ofcontaminationFoodstuffs in conveyances or containers must be placed andprotected in a way that minimises the risk of contamination.Annex IIChapter IV.63.7Maintaining andmonitoring temperaturesWhere necessary, vehicles and/or containers used fortransporting foodstuffs must be capable of keeping foodstuffs atappropriate temperatures. Where necessary,the vehicle and/or container must be designed to allow thosetemperatures to be monitored.Annex IIChapter IV.73.752

5EquipmentAll articles, fittings and equipment that comeinto contact with food must be kept clean.Subject What you must do Part of theRegulationCleaning of equipmentMinimisingcontaminationConstruction toallow cleaning anddisinfectionInstallationControl devicesChemical additivesEquipment, articles and fittings must be effectively cleanedand, where necessary, disinfected. Cleaning and disinfectionare to take place at a frequency sufficient to avoid any risk ofcontamination.Make sure that all articles, fittings and equipment that comeinto contact with food are constructed, made of such materialsand kept in good repair, so as to minimise the risk of anycontamination of the food.All articles, fittings and equipment that come into contact withfood must be constructed, made of such materials and kept ingood repair, so as to enable them to be kept thoroughly cleanedand, where necessary, disinfected.All articles, fittings and equipment that come into contact withfood must be installed in a way that allows adequate cleaning ofthe surrounding area.Where necessary, equipment is to be fitted with any appropriatecontrol device to guarantee fulfillment of this Hygiene ofFoodstuffs Regulation’s objectives.Annex IIChapter V.1(a)Annex IIChapter V.1 (b)Annex IIChapter V.1 (b)Annex IIChapter V.1 (d)DRAFT CONSULTATIONWhere chemical additives have to be used to prevent corrosionof equipment and containers, they are to be used in accordancewith good practice.Annex IIChapter V.2Annex IIChapter V.3RelevantSection ofthis Guide3.63.2, 3.3 &3.123.2, 3.63.2, 3.3 &3.6N/A3.353

6WasteThe storage and disposal of waste canpresent a risk of contaminating food, so youmust make sure you follow the requirementsof the Regulation.Subject What you must do Part of theRegulationFood and other wasteContainers for wasteArrangements for thestorage and removal ofwasteFood waste, non-edible by-products and other refuse are tobe removed from rooms where food is present as quickly aspossible, so as to avoid their accumulationMake sure that containers can be closed, unless theenvironmental health services are satisfied that this is notappropriate. The containers must be kept in a sound conditionand be capable of being cleaned and, where necessary,disinfected.You must make adequate provision for storage and disposal, ina hygienic and environmentally friendly way, of waste. The latteris not to constitute a direct or indirect source of contamination.Refuse stores must be designed and managed so as to enablethem to be kept clean and, where necessary, free of animals andpests.Annex IIChapter VI.1Annex IIChapter VI.2Annex IIChapter VI.3and 4DRAFT CONSULTATIONRelevantSection ofthis Guide3.83.83.854

7Water SupplySubject What you must do Part of theRegulationWater supplyThere must be an adequate supply of potable (drinking) water.Use potable water in food preparation so that the food is notcontaminated.Annex IIChapterVII.1(a)RelevantSection ofthis Guide3.4Water unfit for drinkingRecycled waterSteamWater unfit for drinking, e.g. for fire control, must be conductedseparately from potable water.Recycled water used in processing or as an ingredient is not topresent a risk of contamination. It is to be of the same standardas potable water, unless the environmental health servicesare satisfied that the quality of the water cannot affect thewholesomeness of the foodstuff in its finished form.Steam used directly in contact with food must not containsubstances hazardous to health or likely to contaminate theproduct.Annex IIChapter VII.2Annex IIChapter VII.3Annex IIChapter VII.5DRAFT CONSULTATION3.43.43.3 & 3.455

8StaffSubject What you must do Part of theRegulationPersonal hygieneEveryone working in a food handling area must maintain a highdegree of personal cleanliness. They must wear suitable, cleanand, where necessary, protective clothing.Annex IIChapter VIII.1RelevantSection ofthis Guide3.10Infected food handlersAnyone suffering from or being a carrier of a disease likely to betransmitted through food or afflicted, for example, with infectedwounds, skin infections, sores or diarrhoea must not be permittedto handle food or enter any food handling area in any capacityif there is any likelihood of direct or indirect contamination. Anyperson so affected and employed in a food business and whois likely to come into contact with food is to report immediatelythe illness or symptoms, and if possible their causes, to the foodbusiness operator.Annex IIChapter VIII.2DRAFT CONSULTATION3.1056

9Provisions Applicable toFoodstuffsSubject What you must do Part of theRegulationAccepting raw MaterialsDo not accept any raw materials or ingredients if you know orsuspect that they are contaminated and would still be unfit afternormal sorting or processing.Annex IIChapter IX.1RelevantSection ofthis Guide3.13Annex F& HStoring raw materialsProtecting againstcontaminationControl of animals andpestsHazardous and/orinedible substancesRaw materials and ingredients must be stored in appropriateconditions designed to prevent harmful deterioration and protectthem from contamination.At all stages of production, processing and distribution, food is tobe protected against any contamination likely to render the foodunfit for human consumption, injurious to health or contaminatedin such a way that it would be unreasonable to expect it to beconsumed in that state.There must be adequate procedures to control pests and toprevent domestic animals from having access to places wherefood is prepared, handled or stored, unless the environmentalhealth services permit special cases.Hazardous and/or inedible substances, including animal feeds,must be adequately labelled and stored in separate and securecontainers.Annex IIChapter IX.2Annex IIChapter IX.3Annex IIChapter IX.4Annex IIChapter IX.8DRAFT CONSULTATION3.23.133.9N/A57

10Wrapping and packaging offoodstuffsSubject What you must do Part of theRegulationPackaging materials IngeneralMaterial used for packaging and wrapping is not to be a source ofcontamination.Annex IIChapter X.1RelevantSection ofthis Guide3.12Storage of wrapping/packaging materialsWrapping andpackaging operationsRe-usable materialPackaging materials are to be stored in such a manner that theyare not exposed to a risk of contamination.Packaging and wrapping operations are to be carried out soas to avoid contamination of the products. Where appropriateand in particular in the case of glass bottles, the integrity of thecontainer’s construction and its cleanliness is to be assured.Wrapping and packaging material re-used for foodstuffs is to beeasy to clean and, where necessary, to disinfect.Annex IIChapter X.2Annex IIChapter X.3Annex IIChapter X.4DRAFT CONSULTATION3.2 & 3.123.12N/A58

12TrainingFood business operators must ensure thefollowing:Subject What you must do Part of theRegulationSupervision, instructionand trainingTraining in HACCPPrinciplesSector specific trainingAll food handlers are supervised and instructed and/or trained infood hygiene matters to a level appropriate to their job.Those responsible for the development and maintenance ofthe food safety management procedure based on the HACCPprinciples, required by this Regulation (Article 5), or the operationof relevant guides must have received adequate training in theapplication of the HACCP principles.Compliance with any requirements of UK national law concerningtraining programmes for persons working in certain food sectors.Annex IIChapter XII.1Annex IIChapter XII.2Annex IIChapter XII.3DRAFT CONSULTATIONRelevantSection ofthis Guide3.113.113.1160

Appendix B -– Brown Spirit Flowcharts ChartsExample of a Whisky FlowchartCerealsProcess Raw WaterSteamMashingAirSupplyCasksFiltrationRousingFermentationDistillationCask FillingMaturationDisgorgingBlendingDRAFT CONSULTATIONYeastCaramelReductionWaterCoolantAttemperationChill FiltrationPrimingFilterMediaAirSupplyBottle CleaningBottling & PackagingPackaging ComponentsORProductCased Goods55 61

Appendix Appendix B - White B Spirit – White Flow Spirit Chart FlowchartsExample of a Gin FlowchartGrain NeutralSpirits (GNS)SteepingBotanicalsSteamDistillationRaw WaterOption:Unfl avoured whitespirit production GrainNeutral Spirits (GNS) +compounding agentsDRAFT CONSULTATIONRousingFiltrationTanker FillingBlendingReductionFilter MediaOption: Dilution of theconcentrated botanicalextract with Grain NeutralSpirits (GNS)Demineralised WaterAirSupplyORProductFiltration orCarbon TreatmentFilter MediaBottle CleaningBottling& PackagingPackagingComponentsCased Goods62

Appendix C – C Codex - Codex Decision Tree TreeDo preventative controlmeasures exist?YesNoModify steps in the processor productIs the step specifi cally designedto eliminate or reduce the likelyoccurrence of a hazard to anacceptable level?NoIs control at this step necessaryfor safety?NoCould contamination with identifi edhazard(s) occur in excess ofacceptable level(s) or could theseincrease to unacceptable levels?Not a CCPDRAFT CONSULTATIONYesStopYesYesNoNot a CCPWill a subsequent stop eliminateidentifi ed hazard(s) or reduce likelyoccurrence to acceptable level(s)?StopYesNoCritical Control Point(CCP)Not a CCPStop6357

Appendix D – Documents and RecordsAs a guide to companies setting up new hygiene systems orauditing existing systems this list of documents and records may beuseful. Each company must determine the level of controls requireddependant on the activities being carried out.European and UK Regulatory GuidancePolicies/StandardsFood safety policyPersonal hygiene policyGlass breakage policyRisk analysis food hazardsRisk analysis allergensCorrective and preventative actionsStandards/InformationRaw material specificationsIngredient specificationsDry goods specificationsIn-process specifications By- product specifications(FEMAS)Finished product specificationsDRAFT CONSULTATION64Preventative maintenancePest controlInternal auditChange controlRecall or withdrawal proceduresCrisis managementRecordsIncoming goods and materialsinspectionsPest controlQC recordsMaintenance records (planned andreactive) Equipment specifications andCCP monitoring recordsoperating manualsCalibration recordsCustomer requirements/contracts External audit Chemical data sheets (MSDS’s – Allergen registerMaterial Safety Data Sheets)Process recordsCleaning programmes/instructions COSHH register Product withdrawal or recallProcedures or Pre requisiterecordsProgrammesInternal auditsCustomer ordering processesWeight and content controlProcurement procedurerecordsSupplier approvalTraceability recordsTraining and induction Alcohol accounting and volumeprogrammeschecksChemical approval processCleaning records Defect control procedures e.g.Customer complaintglass breakageCleaning procedures

Appendix E – AllergensLegal RequirementsEU Directive 2000/13/EC – on the labelling,presentation and advertising of foodstuffs andthe following amendments to this Directive:EU Directive 2003/89/EC – indication of theingredients present in foodstuffs (introduced alist of 12 food allergens and labelling of theseallergens and their derivatives in pre packedfoods and alcoholic drinks)EU Directive 2006/142/EC – added mollusksand lupin to the list of food allergensEU Directive 2007/68/EC - replaces the listof food allergens to include information onpermanent exemptionsThese Directives are implemented by The FoodLabelling Regulations 1996 (as amended)Allergens are substances (normally proteins) in a food whichsensitive individuals can have an undesirable reaction to. Therecent changes to the Food Labelling Regulations covering thisissue have brought the topic into public awareness. In general forthe spirit drinks industry this is a food safety, quality and labellingissue rather than a hygiene topic and this is the reason for it beingincluded as an Appendix.Although allergens are not hazardous to all consumers, a susceptibleindividual’s response can range from minor discomfort to serious illness andin extreme circumstances even death. Therefore, we need to be responsible inthe manufacture of our products. We should treat allergens as a serious issuewhen considering the consumer safety of our products and where relevantprovide the required information on our product labels.In distilled spirits the cereals used as raw materials are exempt from labellingbecause they have been shown to be excluded from the process by distillation.This is also true for spirits distilled from other allergenic rawmaterials as detailed in Annex IIIa of Commission Directive 2007/68/EC. Theuse of any materials that may contain an allergen post distillation must beconsidered as it could remain in the product that is consumed. Spirit caramelproduced from glucose syrups manufactured from wheat based raw materialshave also been exempt from the allergen labelling although this exemptionis within the EU only, but may not be applicable in markets out with the EU.Users should confirm market requirements relevant to their customers.Guide to ComplianceDirective 2007/68/EC containsinformation on permanentexemptions from labelling and usersof this guide should consult the fulllist within the DirectiveThe comprehensive list ofrecognised allergens can be found inthe Directives specifically amendingDirective 2007/68/EC but includesthe following:-DRAFT CONSULTATIONIdentify allergens which areintentionally used in your productsProducts containing recognisedallergens (or their derivatives) as anintentional ingredient shall requiremandatory labelling to be appliedDetails of the labelling requirement(e.g. wording, legibility) can befound in the Directive 2000/13/EC (asamended)• Cereals containing gluten (i.e.wheat, rye, oats, barley, spelt,kamut (or their hybridised strains)and products thereof• Eggs and products thereof• Milk and products thereof(including lactose)• Nuts i.e. almond, hazelnut, walnut,cashew, pecan, brazil, pistachio,macadamia and queensland65

Allergens (Continued)• Sulphur dioxide and sulphitesat concentrations of more than10mg/ kg or 10ml/litre expressedas SO 2• Others as indicated in theDirectiveCompanies using allergenicingredients in some of their productsmust consider and apply appropriatecontrols to ensure no crosscontaminationAdvice on Best PracticeWhere casks are used for storage or maturation of spirit, companies shouldensure no wheat pastes have been used on the cask or allergenic finingmaterials used within the cask. Presence of these items would indicate anallergen concernA best practice guideline is published by the FSA – Guidance on allergenmanagement and consumer information. This guidance provides advice onthe management of allergens in the manufacturing of food products and theadoption of a risk based approach to avoid allergen cross contaminationDistilled spirits made from cereals are exempt from requirements for allergenlabelling, as the allergenic components are not carried over through distillation.Evidence should be documented to ensure risks in relation to allergens arebeing controlledConsideration should also be given to employees who have known allergenicsensitivities and to ensure they are not exposed to the risk during processing orhandling of allergenic materialsSite visitors should be made aware of any allergen risks when visiting a sensitiveareaDRAFT CONSULTATION66

Allergens (Continued)The following topics should be considered if allergens are present in any product:Eliminate AllergensBest practice would be to avoid the use of allergens completely by formulatingspirit drinks so as far as possible to avoid inclusion of allergens. This aspectshould be considered at the product design and product formulation stageReduce the total number of allergensIf possible a substitute non-allergenic alternative should be considered. Areduction in the number of allergens on site should reduce the risks to theorganisationEnsure suppliers are aware of the need to advise on materials containingallergens to the business in advance of supply. Purchasing and internalspecifications are recommended for ingredients used in product formulationsPrevent accidental mis-formulationThe accidental presence of an allergen in a product can occur by errors informulation - producers should organise and control production activities andpersonnel to prevent cross contamination of allergen containing materials/products, with non allergen containing materials/productsThis can be prevented by control of manufacturing activities and operatorawareness. Approve work methods to ensure correct formulation should bevalidated and written into policies, procedures and work instructionsOperators should be trained on the relevant instructions and training should berecorded. Supervision should be provided where high risk activities are carriedout. (Management Controls)DRAFT CONSULTATIONPrevent cross contamination with a food allergen from a different productProducts which ‘may contain’ allergens could be labelled as part of bestpractice. Advice on advisory labelling is set out in the FSA ‘Guidance on allergenmanagement and consumer information’. Controls should be considered toisolate potential contaminants like allergens from products which do not containallergens. Controls may include identified, dedicated raw material intake, pipesand vats, equipment and production lines where allergen contain products aremade or cross contamination can occurCleaning schedules and CIP programmes should be utilised to ensure areaswhere potential for cross contamination exists are effectively cleanedCleaning regimes should be validated to ensure they are efficient and methodsand schedules for cleaning should be documented. Records should be keptConsideration should be given to airborne dust from allergenic materials crosscontaminating other products. One solution would be a dust extraction systemConsideration should be given to ensuring the packaging and related labellingis also correct67

Appendix F - Ethyl Carbamate andNitroso DimethylamineLegal RequirementsNo legislation to date.Ethyl carbamate (EC) and Nitroso dimethylamine (NDMA) arecompounds that have been found in alcoholic beverages in tracequantities (parts per billion). Their mechanisms of formation havebeen well researched and their concentration can be controlledby correct specification of raw materials and process handlingconditions.Ethyl CarbamateEthyl carbamate is a naturally-occurring compound present in many fermentedfoods and beverages. To minimise levels in distilled spirits and to maintainthe current low levels of this compound which is well below current standardsset by some countries, the SWA has produced a Guidance for their membercompanies on the Control of Ethyl Carbamate which is available from the SWA’sMembers only DRAMS Reference Library (under the topic “Food Safety”).Routine monitoring by spirit drinks companies of the EC content of theirproducts continues to manage the levels of EC well below the standard set bysome countries.The primary area of control for EC is minimisation of the precursor in rawmaterials. The main precursor of Ethyl Carbamate is epiheterodendrin (EPH),which originates from the malted barley. Research in to barley varieties hasidentified a class of barleys which have low levels of the precursor and aredescribed as “low GN” (Glycosidic Nitrile). In addition to choosing suitable rawmaterials, careful monitoring of the distillation will ensure any precursors areremoved from the process and the distilled spirit will not subsequently developany EC.Nitroso Dimethylamine (NDMA)DRAFT CONSULTATIONNitroso Dimethylamine is a combustion compound that is formed as maltedbarley is dried using traditional direct fired kilns. Since the source andmechanism were identified, indirect heating methods have been widely adopted,effectively removing the contamination. In cases where direct kilning is neededto transfer the ‘peated aroma’ to malted barley a small amount of sulphur, inthe form of a sulphur candle, is burnt along with the peat and this reduces thecontamination. Since the widespread adoption of these two methods of control,companies continue to monitor NDMA levels as part of their due diligenceproduct checks.68

Appendix G – Product Recall and TraceabilityLegal RequirementsEU Directive 178/2002 Article 14 – Food SafetyRequirementsEU Directive 178/2002 Article 18 – TraceabilityEU Directive 178/2002 Article 19 –Responsibilities of food business operatorsTraceability is a requirement of EU food law. In simple terms thelaw requires manufacturers of food products to know where foodingredients came from, the processing history and who the finishedgoods were sent to. This information can assist in the event of afood safety incident which would impact on a consumer or brand byenabling the producers to identify and isolate any problem materialsor products.EU Directive 89/396/EEC – Lot CodingGuide to ComplianceArticle 14 Food Safety requirementsFood shall not be placed on market ifunsafeFood shall be deemed to be unsafe ifit is considered injurious to health orunfit for human consumptionWhere unsafe food is part of a batchthe whole batch shall be consideredunsafeEU Directive 89/336/EECrequirementsA lot code which meets the legaldefinition shall be applied. ‘Lot’means a batch of sales units of afoodstuff produced, manufactured orpackaged under practically the sameconditions. Lot codes starts with theletter ‘L’Records shall be maintainedThe organisation shall have in placesystems and procedures which canidentify any businesses to which theirproducts have been supplied. Thisinformation must be made availableto competent authorities on demandThe organisation is required toensure the flow of goods can betraced from supplier to site, throughoperations and to the customer(excluding final consumer). Systemsand procedures must be in place toallow for this information to be madeavailable to the competent authoritieson request eg. Environmental HealthOfficerDRAFT CONSULTATIONFoods placed on the market must beadequately labelled or identified tofacilitate its traceabilityArticle 18 TraceabilityTraceability shall be established atall stages of production, processingand distribution (minimum one up /one down)The organisation shall be able toidentify any person or company fromwhom they have been supplied witha food or any substance intended tobe or expected to be incorporatedinto a foodArticle 19 - Responsibilities of foodbusiness operatorsIf the organisation considers orhas reason to believe a product isnot in compliance with food safetyrequirements it shall immediatelyinitiate procedure to withdraw orrecall the products in questionIf the product has reached the finalconsumer, the operator shall informthe consumers of the reason for tsrecall69

Appendix G – Product Recall and Traceability(Continued)The relevant local authority mustbe immediately informed of thewithdrawal/ recallThey shall also notify the FSA via thealert form on the FSA website or bytelephone and follow up with formcompletion which can be sourcedfrom the websiteAdvice on Best PracticeIn event of an incident which would affect spirit drink products, any tradeassociation of which you are a member should be advised. Relevant tradeassociations in the spirit drinks sector are:Companies should maintain product recall proceduresThe above applies when the producthas left the immediate control of theinitial food business operator. Foodis not considered to have left thecontrol of the initial food businessoperator if it was being held, forexample, on behalf of the operatorby a third party and the ownerretained control over that food. In thiscase, an internal withdrawal wouldbe appropriate and there would beno requirement to inform the localauthority or FSAAssociation Website TelephoneScotch WhiskyAssociationwww.scotch-whisky.org.uk 0131 222 9200 (Edinburgh)020 7629 4384 (London)Wine & Spirit TradeAssociationwww.wsta.co.uk 020 7089 3877This procedure should indicate types of incidents which may lead to recall.These include customer and consumer complaints, internal production issues,supplier notifications, media contact, malicious threats and governmentnotifications etc.DRAFT CONSULTATIONTo determine the classification and provide evidence to support decisions it isrecommended a risk assessment process is followed and documented whendetermining the severity of the issueA log should be maintained during an incident detailing decisions and actionstakenMember of recall teams should have defined roles and responsibilities andtraining of team members should be carried out70

Appendix G – Product Recall and Traceability(Continued)Companies should maintain and test traceability systems to verify allcomponents of products and primary packaging can be traced backward tosuppliers and forward to customers within an effective timeframeThe procedures should be tested at least annually and include an effectivenesscheck on traceability systemsThe regulations only require traceability one step backward to the supplierand one step forward to your customer. It is good practice to be able to traceproducts through the process. In many instances there is a requirement forinternal traceability from HMRC for revenue purposesDefinitionsWithdrawal – removal of an unsafe product from supply chain – excluding theconsumer.Consumer Recall – removal of an unsafe product from supply chain – includingthose in the possession of the consumer.DRAFT CONSULTATION71

Appendix H- Reference of further guidance– Code of Practice/Advice/LegislationOther Useful Guidance• Malting HACCP Guidance• BRC Product Recall Guidelines (Issue 22007)In addition to the information provided in the main body of thedocument, supplementary on this topic area can be found below:At time of print these references were correct• CCRFA Crisis prevention through incidentmanagement: being prepared andresponding effectively CCFRA GuidelineNo. 49 (2006)• The BRC Global Standard - Food: A Guideto a Successful Evaluation• Food and Drink - Good ManufacturingPractice: A Guide to its ResponsibleManagement (5th Edition) 2007• EFWSID (The European Federation ofWine and Spirit Importers and Distributors)- a voluntary code of practice relating tothe transportation of wines, spirits andconcentrated grape must in bulk• Supplier Agreements for raw materialsshould include standards in terms ofpesticide and toxin levels• The Department of Food Biosciences, TheUniversity of Reading, UK – Overview ofFood Law• FEMAS – animal feed standards the HACCPapproach appliesEuropean and UK Regulatory GuidanceGuidance on the Implementation ofArticles 11, 12, 16, 17, 18, 19 and 20of Regulation (EC) N° 178/2002 onGeneral Food Law (www.ec.europa.eu/food/ food/foodlaw/guidance/guidance_rev8_en.pdf)Principles for Preventing andResponding to Food IncidentsAdequate security measures shouldbe taken to ensure unauthorisedentry to the production premisesis avoided (www. food.gov.uk/multimedia/pdfs/ incidentsprinciples.pdf)Guidance On The Plastic MaterialsAnd Articles In Contact With Food(Scotland) Regulations 2009; Version1 January 2009FSA Food Handlers: Fitness to WorkRegulatory Guidance and BestPractice Advice For Food BusinessOperators 2009Water Regulatory Advisory schemedirectory of approved water fittinghttp://www.wras.co.uk/ Directory/• ISO 22000 Food SafetyManagement System• ISO 9000 Quality ManagementSystem StandardsCODEX AlimentariusDRAFT CONSULTATIONLegistlation Title Year SI Number OwnerConsumer SafetyRegulation (EC) 178/2002Food LawRegulation (EC) 852/2004 onHygiene of FoodstuffsEU Spirit Drinks Regulations110/2008The General Food Regulations2004Materials and Articles Intendedto Come into Contact withFood Regulations 1935/2004The Private Water Supplies(Scotland) Regulations 20062002 2004 No 2990 EuropeanUnion2004 SSI No. 2006/3 EuropeanUnion2008 2008 No. 3206 EuropeanUnion2004 2004 No. 3279 UK Parliament2004 2007 No. 471 EuropeanUnion2006 SSI 2006 No. 209 Scotland72