1. Registration and Approval of Establishments (requirements according to Regulation 852/2004 and 853/2004/EC)
Rolf Kamphausen, MKULNV NRW
Study Visit on Registration and Approval of Establishments
RTP/STUD 42811
Düsseldorf, Germany, 04 – 06 July 2011

2. Registration of Establishments (requirements according to Regulation 852/2004)
Guidance document on the implementation of certain provisions of Regulation (EC) No. 852/2004 on the hygiene of foodstuffs
Rolf Kamphausen, MKULNV NRW

3. Regulation (EC) No 852/2004 on Food Hygiene
Chapter II FBO’s obligations
Article 6 …., registrations
paragraph 2
Requires FBO to be registered CA
to know where FB are situated
to know what their activities are
to carry out official controls
FBO shall update information on establishment, including significant change in activities and any closure of an existing establishment

4. No Obligation for Registration
Food business operator?
Occasional handling, preparation, storage and serving of food by private person, e.g. in school or village fairs; organised charities cannot be considered as “undertaking”
Broker only if they meet the definition of FB or FBO
Internet sales only if they meet the definition of FB or FBO
Regulation (EC) No 852/2004 does not cover:
Primary production, domestic preparation, handling or storage for private domestic use
Direct supply by producer of small quantities of primary products to final consumer or to local retail - final consumer (to be specified by national legislation)

5. National Legislation - Germany small quantities of primary products
Hygiene Regulation Food of Animal Origin
Local establishments – up to 100 km
Small quantities fish and mussels
to final consumer – household quantities
to local establishment – daily selling quantities
Small quantities of eggs
less than 350 laying hens
Game
products of hunting of one day

6. Approval of Establishments (requirements according to Regulation 853/2004)
Guidance Document Implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin
Rolf Kamphausen, MKULNV NRW

7. Regulation (EC) No 852/2004 on Food Hygiene Chapter II FBO’s obligations Article 6 …, approval paragraph 3
Approval of Establishments should be ensured by FBO
Member States regulation
Regulation (EC) No 853/2004
Decision of Commission

8. Regulation (EC) No 853/2004 specific Hygiene Chapter II FBO’s obligations Article 4 Registration and Approval
Basically: FBO shall place products of animal origin only on the market when the establishment is approved by CA
In detail: …

9. Regulation (EC) No 853/2004 Article 1 Scope
paragraph 1
Specific requirements for food of animal origin

10. Regulation (EC) No 853/2004 Not covered by regulation:
Composed food, plant origin and processed food animal origin
Primary production
Primary production, domestic preparation, handling or storage for private domestic use
Direct supply by producer of small quantities of primary products to final consumer or to local retail - final consumer
Direct supply by producer of small quantities of meat from poultry and lagomorphs shlaugtered on the farm, to final consumer or local retail to final consumer as fresh meat
Hunters supply small quantities of wild game / wild game meat to final consumer or local retail to final consumer as fresh meat
Retail, unless food animal origin supplied to other establishments; exception: transport, storage without specific temperature requirements in accordance with national law: marginal, localised, restricted

11. Regulation (EC) No 853/2004 on specific hygiene rules for food of animal origin Chapter II Article 4 paragraph 2
Approval is not demanded for FB
Not any requirements for the products in Annex III
Primary production
Transport operations
Storage of Food not requiring temperature-controlled storage conditions
Retail operations (with exception Art. 1 para 5 letter b)
Not any requirements for the products in Annex III:
- honey – no requierements, no approval, no ID mark
Distribution terminals
Catering operations
Factory canteens
Institutional catering
Restaurants
Shops
Supermarket distribution centres
Wholesale outlets

12. Case Studies / Examples
Primary production
transport living animals – no approval
products as eggs or milk – no approval
Retail
Production, processing, storage of food at the point of sail – no approval (e.g. retail shops, supermarkets, kiosk, restaurant)
Supply of other FB on retail level – approval (a branch is also an establishment) – unless marginal, localised, restricted

13. Case Studies / Examples
Composed food (plant origin and animal origin)
Non processed food of animal origin – approval (minced meat for Gözleme)
Processed food of animal origin – non approval (heated cheese for Börek)
Catering - Approval, not retail level
Slaughtering - Approval
Approval for Export to EU
- Mea Products
- Live bivalve molluscs
- Fishery products
- Treated stomachs, bladders and intestines: casing only

14. Case Studies / Examples
Cutting and Processing
Distribution only to final consumer, point of sale is production point – no approval
All other cases approval
Poultry and Lagomorphs
Slaughtering, Cutting, Processing basically as red meat
Slaughtering on the farm, cutting processing … No approval
Turkish establishments with approval for Export to EU
Kayseri establishment 38-B-01 for Treated stomachs, bladders and intestines: casing only

15. Case Studies / Examples
Farmed Game
Distribution to final consumer, point of sale is production point – No approval
All other cases – approval
Wild game / game meat
Hunting, supplying final consumer – no approval, no registration
Hunting, cutting the carcass – registration
Wild meat cutting or processing plant - approval

16. Case Studies / Examples
Milk
Raw milk, selling on the farm – no approval
Raw milk transport to dairy plant – no approval
Dairy products, also pasteurised, selling on the farm – no approval
Dairy plants – approval
Honey
No requirements in Annex III, no approval, no ID mark

17. Case Studies / Examples
Fish
Slaughtering, cutting, deboning, small amount, final consumer, .. No registration, no approval
Fish product factory – approval
Eggs
Egg supply locally to final consumer on the farm – no registration, no approval
Production of bakery products with pasteurised egg products – no approval
Egg products pasteurising - approval

18. Registration procedures and Responsibilities of the Competent Authority (requirements according to Regulation 854/2004 and 882/2004/EC)
Rolf Kamphausen, MKULNV NRW

19. Regulation (EC) No. 882/2004 Chapter VII Article 31 Registration of Establishments
Article 31 No 1 a … competent authorities shall establish procedure for registration
Article 3 No 1 b … competent authorities shall draw up and keep up to date a list of food business operators

20. Regulation (EC) No. 882/2004 Chapter VII Article 31 Registration No 1a
CA shall establish procedure for registration
Simple procedure
CA is informed about
address of establishment
activity carried out
Information available from other sources may be used

21. Regulation (EC) No. 882/2004 Chapter VII Article 31 Registration No 1b
CA shall draw up and keep up to date a list of food business operators
List can be drawn and kept up at the
Local CA
Regional CA or
Central CA
Turkish Law No.: 5179 – Law on Adoption of the Amended Decree By-Law on the Production, COnsumption and Inspection of Food
Art. 4
Businesses that produce foodstuffs – food business working permit / registry number
Which Authority is responsible?
Only for producing? – What is about selling (Definition Art. 3) places? What is about primary producer?

22. Approval procedures and Responsibilities of the Competent Authority (requirements according to Regulation 854/2004 and 882/2004/EC)
Rolf Kamphausen, MKULNV NRW

23. Regulation (EC) No. 854/2004 Chapter II Article 3 Approval of Establishments
Article 3 No 1 … competent authorities shall approve as specified in Article 31 (2) of regulation (EC) No. 882/2004
Article 3 No 3 … competent authority shall give an approval number

24. Regulation (EC) No. 882/2004 Chapter VII Article 31 Approval of Establishments No 2 Approval
CA shall establish procedures for business operators to follow when applying for Approval
CA shall make an on-site visit
CA approve for specified activities, if food business operator has demonstrated that it complies with relevant requirements
CA may grant conditional approval
CA shall keep approval under review
CA shall maintain up-to-date list of approved establishments and make them available to other Member States and to the public

25. Regulation (EC) No. 882/2004 Chapter VII Article 31 Approval of Establishments No 2 Approval
a) CA shall establish procedures for business operators to follow when applying for Approval
Common administrative regulation food hygiene Paragraph 2 and Annex I – Approval Procedure
Official Announcement – risk based requirements for approval of establishments (OJ No 149 1st Oct. 2008, p. 3541)

26. Common administrative regulation Para. 2, Annex I – Approval Procedure
Application
Basic data of the establishment
Establishment plan, layout plan
Water supply
C+D plan
Pest control plan
Certificates of health
Training programs
Temperature registration system
Registration system for receiving goods / slaughtering animals
Registration system for delivering goods
Documentation of Animal By-Products
Risk analysis
System to control the use of labels with ID / health mark

27. Regulation (EC) No. 882/2004 Chapter VII Article 31 Approval of Establishments No 2 Approval
CA shall make an on-site visit
After checking documents on-site visit
Advising FBO asap (as soon as possible)

28. Regulation (EC) No. 882/2004 Chapter VII Article 31 Approval of Establishments No 2 Approval
c) CA approve for specified activities, if food business operator has demonstrated that it complies with relevant requirements
Specification of activities / category, species, amount numbers, e.g.:
Slaughtering of 10 sheep / week
Cutting beef 50t / day
… for category and activities s. technical specifications ANNEX V

29. Regulation (EC) No. 882/2004 Chapter VII Article 31 Approval of Establishments No 2 Approval
d) CA may grant conditional approval
If e.g. requirements only partly met
Conditional approval for 3m
On-site visit
Possibility to extend conditional approval for another 3m

30. Regulation (EC) No. 882/2004 Chapter VII Article 31 Approval of Establishments No 2 Approval
e) CA shall keep approval under review
Reports from the local CA
Risk-based inspections on a regular term

31. Regulation (EC) No. 882/2004 Chapter VII Article 31 Approval of Establishments No 2 Approval
f) CA shall maintain up-to-date list of approved establishments and make them available to other Member States and to the public
ID / health mark
Technical documents for master lists
Master lists

32. Regulation (EC) No. 854/2004 Chapter II Article 3 Approval of Establishments No 3 Approval Number
Approval Number for each establishment (ID / health mark)
Different systems in Member States
Germany: general administrative regulation food hygiene
DE NW EG
older ID / health mark stay valid
Since 1986: Deutschland ES 1234 EWG
Since 1st May 1999: D NRW – ES 123 EWG

33. Master Lists – Technical Specifications I
Section 0
Section I
Section II
Section III
Section IV
Section V
Section VI
Section VII
Section VIII
General activity establishment
Meat of domestic ungulates
Meat from poultry and lagomorphs
Meat of farmed game
Wild game meat
Minced meat, meat preparations and MSM
Meat products
Live bivalve molluscs
Fishery products

34. Master Lists – Technical Specifications II
Section IX
Section X
Section XI
Section XII
Section XIII
Section XIV
Section XV
Raw milk and dairy products
Eggs and egg products
Frogs’ legs and snails
Rendered animal fats and greaves
Treated stomachs, bladders and intestines
Gelatine
Collagen
Specified: SANCO/2179/2005 Revisions 5

35. Master Lists – Codes and Legends
Category / Activity
AH = auction hall
CC = collection centre
CP = cutting plant …
ZV = freezer vessel
Species Remarks
A = poultry bl = blood products
B = bovine mp = meat products
C = caprine
… …
R = ratite fl = frogs’ legs
wA = wild birds sn = snails …

36. Master Lists EU Member States EU Third Countries Turkey Germany
EU Third Countries
Turkey
Germany

37. any more questions …