Community Food Safety Legislation, in particular Food Hygiene. Maaria Hackzell European Commission, DG SANCO OIE, Sofia, 22 April 2009
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1 Community Food Safety Legislation, in particular Food Hygiene Maaria Hackzell European Commission, DG SANCO OIE, Sofia, 22 April 2009
2 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
3 Community Food Safety Legislation Regulation (EC) No 178/2002, GFL Regulation (EC) No 882/2004: official controls Regulation (EC) No 852/2004: the hygiene of foodstuffs Regulation (EC) No 853/2004: the hygiene of food of animal origin Regulation (EC) No 854/2004: official controls on products of animal origin
4 Contaminants, residues, pesticides Regulation (EC) No 1881/2006: max levels for contaminants in foodstuffs Regulation (EEC) No 2377/90: MRLs for veterinary medicines Directive 96/22/EC: prohibition of certain substances Directive 96/23/EC: monitoring of substances and residues Directive 91/414/EC: pesticides Reg. (EC) No 396/2005: MRLs for pestic.
5 Other Food Safety Legislation Directive 2000/13/EC: labelling of food Directive 90/496/EEC: nutrition labelling Regulation (EC) No 1935/2004: food contact materials Regulation (EC) No 258/97: novel food Reg. (EC) No 1333/2008: food additives Reg. (EC) No 1332/2008: food enzymes Reg. (EC) No 1334/2008: food flavourings
6 General Food Law 178/2002 basic law objectives: protection of human health and consumers interests food safety requirements presentation of products responsibilities (food business operators!) traceability
7 Reg. 882/2004: official controls risk-based official controls of all food, feed and live animals national competent authorities control the correct implementation of legislation by operators Community (FVO) controls verify the correct implementation of EU legislation in Member States principles and general requirements: documented procedures, training, enforcement
8 Hygiene Regulation 852/2004 hygiene requirements for all food including primary production HACCP requirement (not in primary production) registration of all food businesses national and Community guides to good practice
9 Reg. 852/2004, Article 4 general and specific hygiene requirements microbiological criteria temperature control requirements cold chain sampling and analysis Annex I for primary production, Annex II for other stages
10 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 principles HACCP for small businesses: flexibility
11 Reg. 852/2004 HACCP principles identify hazards identify CCPs establish critical limits establish monitoring procedures establish corrective actions establish verification procedures documentation and records
12 Regulation 853/2004 specific 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 products not applicable to direct retail approval of establishments identification mark by FBO food chain information FCI
13 Regulation 854/2004 official controls on products of animal origin responsibilities of competent authorities approval of establishments meat inspection: ante and post mortem health mark for red meat, large wild and farmed game meat by CA identification mark for poultry meat, small wild and farmed game meat by FBO
14 Regulation 854/2004 flexibility for official inspections in cutting plants possibility for slaughterhouse staff to take over some activities with regard to the production of poultry and rabbit meat possibility to implement visual inspection for fattening pigs as a part of risk-based inspection system under certain conditions
15 Implementation of hygiene package Regulation (EC) No 2073/2005: microbiological criteria Regulation (EC) No 2074/2005: implementing measures Regulation (EC) No 2075/2005: Trichinella testing Regulation (EC) No 2076/2005: transitional measures
16 Regulation 2073/2005 Main objectives: to ensure a high level of human health protection to verify the HACCP measures to harmonise microbiological criteria in EU FBOs responsible sampling plans, sampling frequencies, analytical methods
17 Regulation 2073/2005 food safety criteria: the acceptability of the product / batch products placed on the market actions when unsatisfactory results process hygiene criteria: the acceptable functioning of production process during the processing actions when unsatisfactory results
18 Regulation 2074/2005 Main objectives to lay down implementing measures: food chain information (FCI) mechanically separated meat (MSM) model health certificates for import food with traditional characteristics lists of establishments
19 Regs 2075/2005 and 2076/2005 Regulation (EC) No 2075/2005: specific rules on official controls for Trichinella in meat Regulation (EC) No 2076/2005: transitional measures for the implementation until 31 December 2009
20 Guidance documents Regulation 178/2002 Regulation 852/2004 Regulation 853/2004 HACCP import requirements Regulation 2073/2005 (sampling and testing) multi-annual control plans / auditing
21 Future report to the European Parliament and to the Council by 20 May 2009: reviewing the experience gained from the implementation of the hygiene package possible amendments of the hygiene package
22 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 MRL Annex II: no MRL necessary Annex III: temporary MRL Annex IV: forbidden substances
23 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
24 Residue monitoring plan + results general information production figures of previous year group-substances: banned, veterinary medicines, contaminants laboratories analytical methods animal species/ matrixes/ number of samples RESULTS and follow-up actions
25 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/EC Decision 2007/407/EC: Salmonella isolates in poultry populations and pigs Decision 2007/516/EC: Campylobacter isolates from survey in broilers in 2008 Decision 2008/55/EC: MRSA prevalence survey in breeding pigs in 2008 EFSA recommendations on AMR indicators E. coli and Enterococci harmonised with monitoring in humans (EUCAST)
26 Example: Commission Decision 2007/407/EC on a harmonised monitoring of AMR in Salmonella Year All Salmonella serovars, up to 170 isolates per population Laying hens X X X X X Broilers X X X X Turkeys X X X X Slaughter pigs X X X
27 Results will be published by European Food Safety Authority (EFSA) during 2009 from the 2006 EFSA/ECDC annual monitoring report Ciprofloxacine resistance in Campylobacter isolates from poultry, pigs and cattle: 31-57% nearly 40% of S. Typhimurium isolates in humans were resistant to 4 or more antimicrobials tested
28 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 animals from 2010 Estimation of correlation between use and prevalence of resistant strains
29 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 hygiene animals: Regulation (EC) No 2160/2003 and implementing provisions food: Regulation (EC) No 2073/2005 on microbiological criteria in foodstuffs
30 Regulation (EC) No 2160/2003: Approach baseline surveys: reference values setting targets for reduction submission/approval control programmes of Member States and third countries at start of the programmes: restrictions of trade of live animals (+ hatching eggs) harmonised monitoring equivalent guarantees from third countries
31 Salmonella prevalence (% infected flocks) during baseline surveys (or first year of control programme) Breeding hens Laying hens Broilers Slaughter turkeys Breeding turkeys Slaughter pigs Breeding pigs Target serotypes 1.4 (0-15.4) 20.4 (0-62.5) 11.0 (0-39.3) 3.8 (0-18.4) 1.7 (0-8.3) - - All serotypes 2.9 (0-26.3) 30.8 (0-79.5) 23.7 (0-68.2) 30.7 (0-78.5) 13.6 (0-82.1) 10.3 (0-29.0) Not available yet
32 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 2009 laying hens: a defined annual reduction until 2% or less of remaining positive for top 2 : S. Enteritidis, S. Typhimurium broilers: 1% or less remaining positive for top 2 by the end of 2011 turkeys: 1% or less remaining positive for top 2 by the end of 2012 slaughter and breeding pigs: not decided yet
33 Minimum requirements in control programmes: overview for poultry and pigs: general requirements for poultry: specific measures for all poultry: vaccination, use of antibiotics per poultry population (breeding hens, laying hens, broilers, turkeys): minimum monitoring requirements: by FBOs / by CAs trade restrictions for pigs: no specific measures yet equivalent guarantees expected in control programmes from third countries
34 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 chicks laying hens: immediately stops placing on the market of table eggs no import of these products from such flocks allowed
35 The end Thank you for your attention!
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