Flexibility of the Hygiene Package

FLEXIBILITY OF THE HYGIENEPACKAGEFOOD HYGIENE & CONTROLS17-21 June 2013Lisbon, Portugalby Ron Dwinger

flexibilitygoal:‣ maintain European heritage in product diversity‣ reduction of administrative burdenssubjects:‣ food safety‣ consumer protectionbe aware:‣ flexibility is not a possibility to give derogation fromEU obligations at establishment level‣ no compromise to the goals of the hygiene legislation

flexibility – legal possibilitiesI derogations/exemptionsII adaptations of requirements in some AnnexesIII activities excluded from the scope

I - derogations/exemptionsonly Comitologypossibilities for Member States, e.g.- food with traditional characteristics- Trichinella-free holdings- regions with negligible risk of Trichinellapossibilities for competent authorities- „competent authority may authorise“- „if competent authority so permits“- „unless the competent authority considers…“

national measures for foods withtraditional characteristics 1(some examples)MS product derogationESPLDEcheese, sausages, bakeryprod., olive oil, alcoholicdrinkslist of products; register ofest.sausages, eintöpfe,fruchtaufstriche, milk prod.,etc.infrastructure, equipmentinfrastructure, equipmentinfrastructure, equipment1using Art. 7 (3) of Commission Regulation (EC) No 2074/2005

Regulation (EC) No 2074/2005- derogation – granted by Comitology- specified and limited scope of derogation- specific products- specific (simplified) notification procedure

II - adaptations• MS decision• defined situations when it is possible- traditional methods of production- special geographical constraints (DE)- construction, layout and equipment (CZ)• notification obligatory (the Hygienepackage procedure applies)• described content of notifications(description of requirements, description of foodstuffs andestablishments concerned, explanation of reasons, whererelevant – summary of the hazard analysis)

adaptations• adapt requirements on official controls:• continued use of traditional methods, at any of thestages of production, processing or distribution offood• establishments with low throughput• pilot projects (FR)concerning:• Food Chain Information• presence of Competent Authority

national measures taken by MSsome examples• AT and SI: small slaughterhouses• LU: slaughter on farm• FI and SE: reindeer meat• BG: raw-dried and raw-smoked meat products

national measures (AT, SI)- lairage facilities or waiting pens- cleaning & disinfection of transport vehicles- slaughter room and cutting room- storage of detained meat- minced meat at 4ºC (national market in AT)

national measures (LU)- slaughter on the farm- 30 well-equipped farms- slaughter of 1200 pigs/year- slaughter of 4500 piglets/year- slaughter of 250 calves/year

national measures (FI and SE)- local sale (“near food”)- without veterinary supervision (FI)- only in Lapland (Sami people)- sale directly to consumers- 200.000 kg of meat/year- national stamp (FI) or 3 villages (SE)

III - activities excluded from the scope• MS obligation to adopt national rules• Notification procedure according to Directive98/34/EC• Even if excluded from the scope of the HygienePackage, Regulations (EC) No 178/2002 andNo 882/2004 apply

activities excluded from the scope• public health protected by national law• close relationship between the producerand the consumerdirect supply of small quantities of:• primary products by farmers• products collected in the wild by individuals• meat of poultry and lagomorphs by farmers• wild game or wild game meat by hunters

direct sale of primary productsRegulation (EC) No 852/2004• by the producer• small quantities• to the final consumer or to local retailestablishment directly suppling the finalconsumerMS shall establish rules under national law

direct sale of other commoditiesRegulation (EC) No 853/2004• small quantities of meat form poultry andlagomorphs• small quantities of wild game or wild gamemeat• the same conditions as in previous slide• Regulation (EC) No 852/2004 appliesMS shall establish rules under national law

direct supply of small quantities ofpoultry meat• MS obligation to adopt national rules• notification procedure according toDirective 98/34/EC• excluded from the scope of Regulation(EC) No 853/2004• Regulations (EC) No(s) 178/2002,852/2004 and 882/2004 apply

localised, marginal, restrictedactivitiesArticle 1,5,b,ii to Regulation (EC) No 853/2004combination of three criteria:• localised – immediate vicinity• marginal – amount/percentage from theusual/daily/monthly/yearly production• restricted – certain products or establishmentsonlynotification procedure according to Directive98/34/EC

implementation of Article 1,5,b,ii 1MS marginal localised restrictedAT < 5 tons/week; 250tons/yearUK < 1000 LU; 5ton/week;250 ton/yearcounty 25%countyMax 25% (includes nonfood)IE < 1000 kg* 100 km* RTE, mince, < 25%*BE < 800 kg 80 km < 30%SE < 150 tons meat; 100tons milkDK< 3000 kg debonedmeatcountry < 50%region1Regulation (EC) No 853/2004; * still under discussion

national measures• Regulations, ordinances, decrees, administrativeRegulations, guidelines issued by the CAs• guidelines issued by professional organisations• guidance documents issued by CAs forimplementation by FBOs and for official controls

notification procedure- depending on the content• Directive No 98/34/EC• Hygiene Package- information flow between MS and Commission- TRIS system*- database available to public:• information available e.g. MS, draft, standstillperiod, comments and/or detailed opinion* http://ec.europa.eu/enterprise/tris/index_en.htm

• transparencyflexibility - benefits• national measures accepted by the Commissionand other Member States• mutual recognition – single EU market, crossbordertrade• preserve traditional products/production processes

flexibility - difficulties- contradictions• flexibility/harmonisation- misunderstandings• adaptation/derogation- notion of „local market“; „small quantities“;„localised, regional and restricted activity“- no notification, drafts changed after notification,unclear measures notified

flexibility - assistance- two documents explaining rules for flexibility (inaddition to the guidance documents)- FVO fact-finding missions carried out in theMember States- discussion document on small quantities andlocalised, marginal and restricted activities

guidelines for the competentauthorities*- legal provisions• derogations/exemptions• adaptations• excluded activities- guidance on understanding andapplicability of these provisions- notification procedure applicable* http://ec.europa.eu/food/food/biosafety/hygienelegislation/docs/faq_all_public_en.pdf

guidelines for food businessoperators*• questions and replies• principles- food business operators apply legislation- Member States and/or competent authorities areresponsible to verify, enforce and to use flexibility• examples: approval of butcher shops,sale of cheese produced at the farm* http://ec.europa.eu/food/food/biosafety/hygienelegislation/docs/faq_all_business_en.pdf

implementation of flexibilityhow?- food business operators apply legislation- Member States (Competent Authorities)are responsible to provide flexibility tofood business operators (if justified) andCA verify its applicationprocedure- notification to Commission- 3 months period

flexibility for microbiological criteria(Commission Regulation (EC) No 2073/2005) operator can choose frequency and method- based on risk- in the context of HACCP fixed frequency of sampling (carcases, etc.) once weekly fortnightly sampling reduced frequency for small establishments

flexibility for implementation ofHACCP• Art. 5 of Regulation (EC) No 852/2004• all food business operators shall:implement a “permanent procedure basedon the HACCP principles”

HACCP for small businessesflexibilityno HACCP, but general hygiene requirements: market stalls, mobile sale vehicles bars, coffee shops small retail shops (grocery shops) storage, transport (pre-packed foods)

HACCP for small businessesflexibility hazard analysis critical limits proportionate monitoring simplified recording (diary, checklist) verification, validation, certification

implementation in BEBusiness to business:> 2 personnel HACCP< 2 personnelno transformation GHPtransformation HACCP lightBusiness to consumer:surface area max 400 m 2 ormax 5 fteHACCP light

implementation in UKan example of flexibility‣ for retailers, caterers, take-aways & care homes‣ for Chinese, Indian, Pakistani, Bangladeshi& Sri Lankan cuisines‣ Over 360,000 packs distributedhttp://www.sfbbtraining.co.uk/

it is based upon 4 C’s4C’s are easy categories to remember1. Cross-contamination 3. Chilling2. Cleaning 4. Cooking- general controls for the general hazards in akitchen- each of the 4Cs has Safe Methods- practical methods control specific hazards in thebusiness- the manager can adapt these methods

what does SFBB pack contain?Safe methods refer to different topics:• important food safety issues• record how it is carried out• record what may have gone wrong• record any preventive action• diary – weekly and 4 weekly reviews• supplier records• cleaning schedule• training records

Safer food,better businessthe pack hasbeentranslatedin Chinese andotherlanguagesIf you would like to order an SFBB packor the DVD guidecall Food Standards Agency Publicationson 0845 606 0667or email foodstandards@ecgroup.co.uk

implementation in ATin small slaughterhouses defining small: < 1000 LU/year< 250 tons/year (cutting plant) no CCP control points (temperature) oval health mark

implementation in DK (BE, UK*)in the retail (restaurants, shops) food sold to the final consumer smiley system (4 grades plus elite) transparent (reports on internet) display clear to customer (fine) started in 2001* “scores on the doors”

flexibility – MS requestssome examples*• dangerous (semi-wild) cattle - farmed game• OV presence – farmed game• game handling establishments – plant staff• minced meat (2° C) - allow 4° C• Trichinella examination – laboratory accreditation* see DG(SANCO)/2010-6150 – MR Final

flexibilityFVO recommendations*• introduce flexibility more widely• notify national measures as required• uneven application at local level (give guidelines)• no documentation at local (establishment) levelwhich flexibility measures were applied• simplify notification procedure* see DG(SANCO)/2010-6150 – MR Final

THANK YOU FOR YOURATTENTIONRon DwingerNetherlands Food and Consumer ProductSafety Authority (NVWA)tel.: +31-652527828e-mail: ron.dwinger@vwa.nlAdditional info:http://ec.europa.eu/food/food/biosafety/hygienelegislation/index_en.htmhttp://europa.eu.int/eur-lex/lex/