Registration and Approvalof Establishments

(requirements according to Regulation 852/2004 and 853/2004/EC)

Study Visit on Registration and Approval of EstablishmentsRTP/STUD 42811

Düsseldorf, Germany, 04 – 06 July 2011

Rolf Kamphausen, MKULNV NRW

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

Regulation (EC) No 852/2004 on Food HygieneChapter II FBO’s obligationsArticle 6 …., registrationsparagraph 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

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)

National Legislation - Germanysmall 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

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

Regulation (EC) No 852/2004 on Food HygieneChapter II FBO’s obligationsArticle 6 …, approvalparagraph 3

Approval of Establishments should be ensured by FBO Member States regulation Regulation (EC) No 853/2004 Decision of Commission

Regulation (EC) No 853/2004 specific HygieneChapter 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: …

Regulation (EC) No 853/2004 Article 1 Scope

paragraph 1

Specific requirements for food of animal origin

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

Regulation (EC) No 853/2004 on specific hygiene rules for food of animal originChapter II Article 4 paragraph 2Approval 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)

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

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

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

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

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

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

Registration procedures and Responsibilities

of the Competent Authority(requirements according to Regulation 854/2004 and 882/2004/EC)

Rolf Kamphausen, MKULNV NRW

Regulation (EC) No. 882/2004 Chapter VIIArticle 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

Regulation (EC) No. 882/2004 Chapter VIIArticle 31 Registration No 1a

CA shall establish procedure for registrationSimple procedureCA is informed about

• address of establishment• activity carried out

Information available from other sources may be used

Regulation (EC) No. 882/2004 Chapter VIIArticle 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

Approval procedures and Responsibilities

of the Competent Authority(requirements according to Regulation 854/2004 and 882/2004/EC)

Rolf Kamphausen, MKULNV NRW

Regulation (EC) No. 854/2004 Chapter IIArticle 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

Regulation (EC) No. 882/2004 Chapter VIIArticle 31 Approval of EstablishmentsNo 2 Approval

a) CA shall establish procedures for business operators to follow when applying for Approval

b) CA shall make an on-site visit

c) CA approve for specified activities, if food business operator has demonstrated that it complies with relevant requirements

d) CA may grant conditional approval

e) CA shall keep approval under review

f) CA shall maintain up-to-date list of approved establishments and make them available to other Member States and to the public

Regulation (EC) No. 882/2004 Chapter VIIArticle 31 Approval of EstablishmentsNo 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)

Common administrative regulationPara. 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

Regulation (EC) No. 882/2004 Chapter VIIArticle 31 Approval of EstablishmentsNo 2 Approval

b) CA shall make an on-site visit

After checking documents on-site visit

Advising FBO asap (as soon as possible)

Regulation (EC) No. 882/2004 Chapter VIIArticle 31 Approval of EstablishmentsNo 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

Regulation (EC) No. 882/2004 Chapter VIIArticle 31 Approval of EstablishmentsNo 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

Regulation (EC) No. 882/2004 Chapter VIIArticle 31 Approval of EstablishmentsNo 2 Approval

e) CA shall keep approval under review

Reports from the local CA

Risk-based inspections on a regular term

Regulation (EC) No. 882/2004 Chapter VIIArticle 31 Approval of EstablishmentsNo 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

Regulation (EC) No. 854/2004 Chapter IIArticle 3 Approval of EstablishmentsNo 3 Approval Number

Approval Number for each establishment (ID / health mark)Different systems in Member StatesGermany:

general administrative regulation food hygieneDE NW 12345 EGolder ID / health mark stay valid

• Since 1986: Deutschland ES 1234 EWG• Since 1st May 1999: D NRW – ES 123 EWG

Master Lists – Technical Specifications ISection 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

Master Lists – Technical Specifications IISection 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

Master Lists – Codes and LegendsCategory / 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

…

Master Lists

EU Member Stateshttp://ec.europa.eu/food/food/biosafety/establishments/list_en.htm

EU Third Countrieshttp://ec.europa.eu/food/food/biosafety/establishments/third_country/index_en.htm

Turkeyhttps://sanco.ec.europa.eu/traces/output/listsPerCountry_en.htm#

Germanyhttp://btl.bvl.bund.de/btl/

any more questions …