Community Food Safety Legislation,

in particular Food Hygiene

Maaria HackzellEuropean Commission, DG SANCO

OIE, Sofia, 22 April 2009

Community Food Safety Legislation

white paper on food safety in 2000

from farm to fork / from stable to table

all food: animal and plant origin

all feed intended for food-producing animals

all stages of production, processing and distribution of food

Community Food Safety Legislation

Regulation (EC) No 178/2002, GFLRegulation (EC) No 882/2004: official controlsRegulation (EC) No 852/2004: the hygiene of foodstuffsRegulation (EC) No 853/2004: the hygiene of food of animal origin Regulation (EC) No 854/2004: official controls on products of animal origin

Contaminants, residues, pesticides

Regulation (EC) No 1881/2006: max levels for contaminants in foodstuffsRegulation (EEC) No 2377/90: MRLs for veterinary medicines Directive 96/22/EC: prohibition of certain substancesDirective 96/23/EC: monitoring of substances and residuesDirective 91/414/EC: pesticidesReg. (EC) No 396/2005: MRLs for pestic.

Other Food Safety Legislation

Directive 2000/13/EC: labelling of foodDirective 90/496/EEC: nutrition labellingRegulation (EC) No 1935/2004: food contact materialsRegulation (EC) No 258/97: novel foodReg. (EC) No 1333/2008: food additivesReg. (EC) No 1332/2008: food enzymesReg. (EC) No 1334/2008: food flavourings

General Food Law 178/2002

basic law

objectives: protection of human health and consumers’ interests

food safety requirementspresentation of productsresponsibilities (food business operators!)traceability

Reg. 882/2004: official controlsrisk-based official controls of all food, feed and live animalsnational competent authorities control the correct implementation of legislation by operatorsCommunity (FVO) controls verify the correct implementation of EU legislation in Member Statesprinciples and general requirements: documented procedures, training, enforcement

Hygiene Regulation 852/2004hygiene requirements for all food including primary production HACCP requirement (not in primary production)registration of all food businessesnational and Community guides to good practice

Reg. 852/2004, Article 4general and specific hygiene requirementsmicrobiological criteriatemperature control requirementscold chainsampling and analysisAnnex I for primary production, Annex II for other stages

Reg. 852/2004, Article 5

HACCP requirements: food business operators shall put in place, implement and maintain a permanent procedure(s) based on the HACCP principlesHACCP for small businesses: flexibility

Reg. 852/2004 HACCP principlesidentify hazardsidentify CCPsestablish critical limitsestablish monitoring proceduresestablish corrective actionsestablish verification proceduresdocumentation and records

Regulation 853/2004specific hygiene rules for food of animal origin: meat (red meat, poultry meat, farmed and wild game meat), live bivalve molluscs, fishery products, milk, eggs etc. and processed productsnot applicable to direct retailapproval of establishmentsidentification mark by FBOfood chain information FCI

Regulation 854/2004official controls on products of animal originresponsibilities of competent authorities approval of establishmentsmeat inspection: ante and post mortemhealth mark for red meat, large wild and farmed game meat by CAidentification mark for poultry meat, small wild and farmed game meat by FBO

Regulation 854/2004flexibility for official inspections in cutting plantspossibility for slaughterhouse staff to take over some activities with regard to the production of poultry and rabbit meatpossibility to implement visual inspection for fattening pigs as a part of risk-based inspection system under certain conditions

Implementation of hygiene package

Regulation (EC) No 2073/2005: microbiological criteriaRegulation (EC) No 2074/2005: implementing measuresRegulation (EC) No 2075/2005: Trichinella testingRegulation (EC) No 2076/2005: transitional measures

Regulation 2073/2005Main objectives:

to ensure a high level of human health protectionto verify the HACCP measuresto harmonise microbiological criteria in EU

FBOs responsiblesampling plans, sampling frequencies, analytical methods

Regulation 2073/2005

food safety criteria:the acceptability of the product / batchproducts placed on the marketactions when unsatisfactory results

process hygiene criteria:the acceptable functioning of production processduring the processingactions when unsatisfactory results

Regulation 2074/2005Main objectivesto lay down implementing measures:

food chain information (FCI)mechanically separated meat (MSM) model health certificates for importfood with traditional characteristicslists of establishments

Regs 2075/2005 and 2076/2005Regulation (EC) No 2075/2005:

specific rules on official controls for Trichinella in meat

Regulation (EC) No 2076/2005: transitional measures for the implementationuntil 31 December 2009

Guidance documents

Regulation 178/2002Regulation 852/2004Regulation 853/2004HACCPimport requirementsRegulation 2073/2005 (sampling and testing)multi-annual control plans / auditing

Future

report to the European Parliament and to the Council by 20 May 2009: reviewing the experience gained from the implementation of the hygiene packagepossible amendments of the hygiene package

Residue control in live animals and animal products

Directive 96/22/EC: prohibition of certain substances having hormonal or thyrostatic action and of beta-agonists

Regulation 2377/90: MRLs for veterinary medicines and animal species

Annex I: definitive MRLAnnex II: no MRL necessaryAnnex III: temporary MRLAnnex IV: forbidden substances

Residue control in live animals and animal products

Directive 96/23/EC: measures to monitor certain substances and residues in live animals and animal products (residue monitoring plans)

national residue monitoring plans to be sent annually to the European Commission together with the results of the previous year

Residue monitoring plan + results

general information production figures of previous yeargroup-substances: banned, veterinary medicines, contaminantslaboratoriesanalytical methodsanimal species/ matrixes/ number of samplesRESULTS and follow-up actions

Monitoring of antimicrobial resistance in animals

prevalence of resistant bacteria in food and animals. Since 2007: EU harmonisation

legal acts:Frame work: zoonoses monitoring Directive 2003/99/ECDecision 2007/407/EC: Salmonella isolates in poultry populations and pigsDecision 2007/516/EC: Campylobacter isolates from survey in broilers in 2008Decision 2008/55/EC: MRSA prevalence survey in breeding pigs in 2008

EFSA recommendations on AMR indicators E. coli and Enterococciharmonised with monitoring in humans (EUCAST)

Example: Commission Decision 2007/407/EC on a harmonised monitoring of AMR in Salmonella

XXXX2012

XXXX2011

XXX2010

XX2009

X2008

XX2007

Slaughterpigs

TurkeysBroilersLayinghens

All Salmonella serovars, up to 170 isolates per population

Year

Resultswill be published by European Food Safety Authority (EFSA) during 2009from the 2006 EFSA/ECDC annual monitoring report

Ciprofloxacine resistance in Campylobacterisolates from poultry, pigs and cattle: 31-57%nearly 40% of S. Typhimurium isolates in humans were resistant to 4 or more antimicrobials tested

Monitoring of the use of antibiotics in animals

new requests to the European Medicinal Agency (EMEA): Proposal of the EU approach on the collection of data and to manage a data base on the use of antibiotics in animalsfrom 2010

Estimation of correlation between use and prevalence of resistant strains

Integrated EU approach on zoonoses(Salmonella) control

General hygiene measures: the hygiene package

Specific measures for the control of Salmonella:feed: Art. 5 of Regulation (EC) No 183/2005 laying down requirements for feed hygieneanimals: Regulation (EC) No 2160/2003 and implementing provisionsfood: Regulation (EC) No 2073/2005 on microbiological criteria in foodstuffs

Regulation (EC) No 2160/2003: Approach

baseline surveys: reference valuessetting targets for reductionsubmission/approval control programmes of Member States and third countriesat start of the programmes:

restrictions of trade of live animals (+ hatching eggs)harmonised monitoringequivalent guarantees from third countries

Salmonella prevalence (% infected flocks) during baseline surveys (or first year of control programme)

Not available yet-Breeding pigs

10.3 (0-29.0)-Slaughter pigs

13.6 (0-82.1)1.7 (0-8.3)Breeding turkeys

30.7 (0-78.5)3.8 (0-18.4)Slaughter turkeys

23.7 (0-68.2)11.0 (0-39.3)Broilers

30.8 (0-79.5)20.4 (0-62.5)Laying hens

2.9 (0-26.3)1.4 (0-15.4)Breeding hens

All serotypesTarget serotypes

EU targets for reduction of Salmonella for each Member State

breeding hens (fowl): 1% or less remaining positive for “top 5” serotypes by the end of 2009laying hens: a defined annual reduction until 2% or less of remaining positive for “top 2”: S. Enteritidis, S. Typhimuriumbroilers: 1% or less remaining positive for “top 2” by the end of 2011turkeys: 1% or less remaining positive for “top 2” by the end of 2012slaughter and breeding pigs: not decided yet

Minimum requirements in control programmes: overview

for poultry and pigs: general requirements for poultry: specific measures

for all poultry: vaccination, use of antibioticsper poultry population (breeding hens, laying hens, broilers, turkeys):

minimum monitoring requirements: by FBOs / by CAstrade restrictions

for pigs: no specific measures yetequivalent guarantees expected in control programmes from third countries

Trade restrictions

Detection of S. Enteritidis and S.Typhimurium in flocks of: breeding hens and breeding turkeys: immediately stops placing on the market of hatching eggs or day-old chickslaying hens: immediately stops placing on the market of table eggs no import of these products from such flocks allowed

The end

Thank you for your attention!