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1. FOOD SAFETY – EU food law requirementsJozef Kerekréty, Slovenský živnostenský zväz
2. Introduction Case study: Slovakia and the Czech Republic
Where were we? Where are we? Where are we going?
Outline of EU food laws
Comments on SMEs To Do List
Your questions and comments
3. Economy transformation
5. Previous legal system
6. New legal system
7. Quality ladder
8. EC food law – the aim protect public health (human, animal and plant)
provide consumers with information to enable informed choices and protect consumer interests
assure fair trading and competitive conditions of food business operators
provide for the adequate and necessary official controls of foodstuffs
9. Food safety issues
10. The structure of EU food law Horizontal
Hygiene package – Regulations
852/2004 on food hygiene
853/2004 on food of animal origin
854/2004 rules for official controls on products of animal origin
183/2005 on feed hygiene
882/2004 on official controls – feed and food law
Microbiological criteria for foodstuffs Commission Regulation EC 2073/2005.
11. Horizontal EU food legislation Food labelling – Directive 2000/13
GMO regulations – Regulation 1829/2003 and 1830/2003
Packaging and food contact materials – Regulation 1935/2004
Food additives, colours and sweeteners – Directives 89/107, 94/35, 94/36 EEC and 95/2/EEC
Maximum levels for certain contaminants in foodstuffs - Regulation 1881/2006/EC
Foodstuffs intended for particular nutritional uses Directive 89/398/EEC and Foods for special medical purposes Directive 1999/21/EEC
12. The structure of EU food law Vertical – not the food safety issues
Chocolate
Fruit juices and nectars
Sugars
Poultry meat
Eggs
Honey
Preserved milks
....
14. General food law Regulation (EC) N°178/2002
laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
Food laws
EFSA
Rapid alert system
Import – export equivalence
15. General food law high level of protection of human health and consumers' interest in relation to food
applies to all stages of production, processing and distribution of food and feed
except the primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption
16. General food law Article 14
food shall not be placed on the market if it is unsafe
if it is
injurious to health
and/or
unfit for human consumption
Taking account on conditions of use
and information given to the consumer
17. General food law food business operator
ensure that foods/feeds satisfy relevant law requirements;
verify that such requirements are met;
assure the product traceability;
withdraw and/or recall food/feed which is not in compliance with the food/feed safety requirements;
notify consumers and/or the competent authorities
non conforming product may have reached the consumer
food placed on the market may be injurious to health
cooperate with the competent authorities
18. General food law Traceability the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed (‘product’), through all stages of production, processing and distribution.
at all stages of production, processing and distribution
downstream traceability
upstream traceability
19. Usptream traceability
20. Downstream traceability
21. General food hygiene measures Regulation 852/2004 procedures necessary to achieve the targets laid down in
Annex I General hygiene measures for the primary production
Annex II General hygiene measures for all other stages of food chain
procedures according the HACCP principles
temperature control requirements (pasteurization, freezing to kill parazites)
microbiological criteria for foodstuffs
maintain of the cold chain (transport, loading, storage)
product sampling and analysis
22. Hazard? – Risk? HAZARD = agent (salmonella, glass) having a potential to cause adverse health effect
Hazard analysis – HACCP - Codex Alimentarius
RISK = combination of the probability of hazard occurrence and the severity of health effect
Risk analysis – Regulation 178/2002
23. Risk analysis (no SMEs)
25. HACCP application Regulation 852/2004 Conduct hazard analysis
Learn the HACCP principles and the way of its application – HACCP team
Review the product/raw material characteristics
Review the production and storage processes
Identify hazards and assess the risk level
Determine the control mesusres: prerequisite programms and/or CCPs where the hazards can be prevented, eliminated or minimalized
26. HACCP application Regulation 852/2004 For each CCP determine:
Critical limits
Monitoring procedures
Corrective action plan
Responsibility
Establish verification procedures
Laboratory testing
Hygiene checks
Data analysis
Internal audits, HA review, product description, flow charts
27. HACCP application Regulation 852/2004 Establish documentation
plans, procedures, instructions
records
Establish retaining time of documents
28. Foods of animal origin Regulation 853/2004 Registration or approval of establishments
Health and identification marking Annex II
Import of products of animal origin
Annex I
Annex III
29. Foods of animal origin Regulation 853/2004 Annex III Requirements for production and harvesting
Transport and handling of live animals
Health standards, e. g. maximum toxin content of fishery products, microbial and somatic cell counts in raw milk
Requirements for slaughterhouses or processing premises
Requirements for raw material
Process hygiene requirements
Heat treatment requirements – equipment and temperatures
Temperature control criteria – chilling, cold storage
Ante mortem and post mortem inspections
Specific wrapping, packaging and labelling requirements
Storage and transport of products
30. Microbiological criteria for foodstuffs Only microbiological analyses themselves will never guarantee the safety of a foodstuff tested
31. Microbiological criteria for foodstuffs Food safety criterion
32. Microbiological criteria for foodstuffs Process hygiene criterion
33. Microbiological criteria for foodstuffs
34. Microbiological criteria for foodstuffs
35. Microbiological criteria for foodstuffs Food business operators shall:
Test against the values set for the criteria - take samples
Conduct studies in order to investigate compliance with the criteria throughout the shelf-life (ready-to-eat foods that are able to support the growth of Listeria monocytogenes)
Implement corrective actions - HACCP plan, food law and/or the instructions given by the competent authority
Take measures to find the cause of an unsatisfactory result in order to prevent the reoccurrence of unacceptable microbiological contamination.
36. Official controls on foodstuffs and feed Regulation (EC) 882/2004 Hygiene audits, taking samples, tests, inspections etc.
If non conformance competent authority may:
Impose of sanitation procedures
Restrict or prohibit of the placing on the market
Impose the recall, withdrawal, and destruction of products
Authorize to use products for other purposes
Suspend or withdraw of an establishment’s approval
Suspend, close a part or the whole premise
Impose the seizure, destruction or re-dispatch of lots from third countries
Take other measures that are appropriate to ensure food safety
37. Official controls on products of animal origin Food hygiene audits Regulation (EC) 854/2004
Food-chain information – product origin or treatment (documents);
Design and maintenance of premises and equipment
Pre-operational and post-operational hygiene
Personnel hygiene
Training (hygiene, HACCP procedures)
Pest control
Water quality
Temperature control
38. Official controls on products of animal origin HACCP audits on Regulation (EC) 854/2004
Continuous and proper application of procedures
Conformity of microbiological criteria
Conformity regarding residues, contamination, prohibited substances
Absence of physical hazards
39. Food labelling Directive 2000/13
Food safety meaning have
40. Allergens labelling Cereals containing gluten
Crustaceans
Eggs
Fish
Peanuts
Soybeans
Milk
Nuts
Celery
Mustard
41. Food contact materials and articles intended to come into contact directly or indirectly with food must be sufficiently inert
No danger to human health
No cause an unacceptable change in the composition of the food
No deterioration in its organoleptic properties
42. Food contact materials and articles made of authorized substances
purity requirements
not exceed the overall and/or specific migration limit
written declaration
43. Genetically modiefied organisms Regulation 1829/2003
Regulation 1830/2003
Food safety, labeling and traceability
Genetically modified organisms (GMO) for food uses
Food containing or consisting of GMOs
Food produced from or containing ingredients produced from GMOs
44. Food additives any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food
the intentionally added to food for a technological purpose
results, or may be reasonably expected to result in its or its by-products becoming directly or indirectly a component of such foods.
Authorized, purity criteria, food and quantity measures
Processing aids are not food additives
Sweeteners - Directive 94/35/EC
Colors - Directive 94/36/EC
Other additives – Directive 95/2/EC
45. Contaminants
46. Contaminants Product containing contaminants exceeding the maximum levels should not be placed on the market.
Mixing of such a product with other food or its use as an ingredient in other food is prohibited.
Practices
Provide concentration and dilution factors
Sorting and other physical treatments - adequate labeling
47. To-do-list for (SMEs) Define the scope of the food business
Nominate persons responsible for food safety
Identify and study applicable legislation
In site verification of its implementation
Notify, apply for approval, registration
Identify the relevance of microbiological criteria
Conduct hazard analysis (HACCP)
Establish a control measures plan (HACCP plan)
Establish documentation + recordkeeping practices
Write internal standards
48. To-do-list for (SMEs) 11. Allergen risk assessment/CM implementation
12. GMO risk assessment/CM implementation
13. Packaging and articles coming into contact validation
14. Food additives policy/validation
15. Laboratory testing plans
16. Define and introduce the traceability system
17. Implementation of all food safety procedures (trainings)
18. Validation of implemented procedures
19. Establish a crisis plan
20. Maintenance of the food safety system
49. Thank you!Any questions, comments?Food Safety - IntroductionJozef Kerekréty, Slovenský živnostenský zväz