Скачать презентацию Marko Mahne dr vet med Beograd 27 Скачать презентацию Marko Mahne dr vet med Beograd 27

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 Marko Mahne, dr. vet. med. Beograd, 27. 3. 2012 1 Marko Mahne, dr. vet. med. Beograd, 27. 3. 2012 1

General principles and goals • • • Categorisation Keeping the categories separate Processing of General principles and goals • • • Categorisation Keeping the categories separate Processing of the material to reduce risk And/or sending them to disposal or safe use Authorisation of all ABP establishments between start and end point / disposal / use 2

Regulation (EC) No 1069/2009 Article 3 - Definitions 3 Regulation (EC) No 1069/2009 Article 3 - Definitions 3

Regulation (EC) No 1069/2009 Article 23 – Registration • • Required for all operators, Regulation (EC) No 1069/2009 Article 23 – Registration • • Required for all operators, establishments or plants until the end point Operations: – – – Generation Transport Handling Processing Storage Placing on the market – also establishments complying with Reg. 853/2004 – – Distribution Use Disposal Traders and putting on the market derived products not intended for human consumption 4

Regulation (EC) No 1069/2009 Article 23 – Registration • Operator Competent authority: – Before Regulation (EC) No 1069/2009 Article 23 – Registration • Operator Competent authority: – Before commencing operations, notify CA – Operator shall provide the information on: • Category of ABP or DP • Nature of the operations – Operator shall provide CA with up-to-date information, including any significant change (e. g. closure) • Derogations: – Establishments already approved or registered in accordance with 852/2004 or 853/2004 (such as slaughterhouses) – Activities involving the generation of ABPs on site only, which are carried out on farms or other premises where animals are kept, bred or taken care of – Approved establishments or plants (art. 24) 5

Procedure for registration – national rules 1. step: Written application for registration to the Procedure for registration – national rules 1. step: Written application for registration to the competent authority 2. step: Preliminary inspection of application 2. 1. step: Request for additional information (missing data) 3. step: Registration decision + official number or Certificate of registration + official number (transporters) 4. step: Entering into list of establishments 6

Regulation (EC) No 1069/2009 Article 24 - Approval • Approval required for certain activities Regulation (EC) No 1069/2009 Article 24 - Approval • Approval required for certain activities in link with following destination § § § § Processing of animal by-products (with standard processing methods or alternative methods) Incineration and co-incineration, excluding plant permitted in accordance with Directive 2000/76 Combustion Manufacturing of pet food Manufacturing of organic fertilisers and soil improvers Transformation into biogas and compost Handling and storage of animal by-products, after their collection Storage of certain derived products intended to be disposed, used as fuel for combustion, used as feed or as organic fertilisers and soil improvers 7

Commision Regulation (EU) No 142/2011 Annex 1 - Definitions 8 Commision Regulation (EU) No 142/2011 Annex 1 - Definitions 8

Regulation (EC) No 1069/2009 Article 24 - Approval • Operator shall ensure that establishments Regulation (EC) No 1069/2009 Article 24 - Approval • Operator shall ensure that establishments or plants under their control are approved by CA – prior to start-up of any activity • The approval shall specify if the establishment or plant is approved for operations with ABP/DP of: – Particular category – More than one category • Permanently – strict separation • Temporarily – Outbreak of an epizootic disease – Extraordinary and unforeseen circumstances 9

Regulation (EU) No 142/2011 Article 33 • Reapproval of plants and establishments after the Regulation (EU) No 142/2011 Article 33 • Reapproval of plants and establishments after the grant of a temporary approval Cat 3 plant for Cat 1 or Cat 2 – Before recommencing the processing of Cat 3 material: APPROVAL OF CA • Cat 2 plant for Cat 1 – Before recommencing the processing of Cat 2 material: APPROVAL OF CA 10

Procedure for approval – national rules 1. step: Written application for approval to the Procedure for approval – national rules 1. step: Written application for approval to the competent authority 2. step: Preliminary inspection of required documents • HACCP plan (when required) • layout of the plant (equipment and charted routes of production) 2. 1. step: Request for additional information and missing documents 3. step: Appointed is a commission to verify on-site compliance with the conditions laid down in legislation 11

Procedure for approval – national rules 4. step: On-site visit Requirements are not fully Procedure for approval – national rules 4. step: On-site visit Requirements are not fully met 4. 1 Conditional approval 3 months Requirements are not met 4. 2 On-site visit 4. 3 Extension of conditional approval Requirements are met 3 months 4. 4 Documental inspection / On-site visit 5. step: Approval decision + official number 6. step: Entering into the list of establishments 12

Regulation (EC) No 1069/2009 Article 44 – Conditional approval • CA may grant conditional Regulation (EC) No 1069/2009 Article 44 – Conditional approval • CA may grant conditional approval if establishment or plant meets all the infrastructure and equipment requirements with a view to ensuring the application of the operational procedures in compliance with this Regulation • For 3 months • Full approval: another on site visit and all requirements are met • If clear progress has been made, but the establishment or plant still does not meet all requirements, CA may extend conditional approval • Conditional approval shall not exceed a total of 6 months Operators shall ensure that an establishment or plant ceases to operate if the competent authority withdraws its approval or in the case of conditional approval fails to extend it or to grant full approval. 13

Requirements for establishments and plants • • Art. 25 of 1069/2009 – General hygiene Requirements for establishments and plants • • Art. 25 of 1069/2009 – General hygiene requirements Processing and ˝intermediate˝ plants Constructed for effective cleaning and desinfection, and fitted with drainage for liquids Access to adequate facilities for staff personal hygiene; changing rooms, lavatories and washbasins Appropriate protection against pests (insects, rodents, birds) Keep installations and equipment in good condition – regular calibration of measuring equipment arrangements for the cleaning and desinfection of containers and vehicles to avoid contamination Suitable, clean and protective (if necessary) clothing for staff 14

Requirements for establishments and plants • • Art. 25 of 1069/2009 - continued Separation Requirements for establishments and plants • • Art. 25 of 1069/2009 - continued Separation of clean and unclean sector – from the unclean sector to the clean sector: • changing of work clothes and shoes, or • disinfection – equipment and machinery moved from the unclean to the clean sector must be first cleaned and disinfected – established a procedure relating to the movements of persons – description of the correct use of footbaths and wheel baths • Additional requirements for processing plants – – Contamination Temperature treatment Check regurarly the applicable parameters Cleaning procedures 15

Requirements for establishments and plants • • Art. 25 of 1069/2009 - continued Separation Requirements for establishments and plants • • Art. 25 of 1069/2009 - continued Separation of clean and unclean sector – from the unclean sector to the clean sector: • changing of work clothes and shoes, or • disinfection – equipment and machinery moved from the unclean to the clean sector must be first cleaned and disinfected – established a procedure relating to the movements of persons – description of the correct use of footbaths and wheel baths • Additional requirements for processing plants – – Contamination Temperature treatment Check regurarly the applicable parameters Cleaning procedures 16

Requirements for establishments and plants • • Reg. 142/2011 Hygienic requirements Processing methods Articles Requirements for establishments and plants • • Reg. 142/2011 Hygienic requirements Processing methods Articles + Annexes 17

Own checks, HACCP • Article 28 of Reg. 1069/2009 – Obligation of operator – Own checks, HACCP • Article 28 of Reg. 1069/2009 – Obligation of operator – Own checks – Make sure no non-compliant ABPs/DP leave establishment/plant, unless for disposal • Article 29 of Reg. 1069/2009 - HACCP – Processing / biogas & compost / pet food / more than one category 18

Own checks, HACCP 19 Own checks, HACCP 19

Regulation (EC) No 1069/2009 Article 45 – Official controls • • CA shall at Regulation (EC) No 1069/2009 Article 45 – Official controls • • CA shall at regular intervals carry out official controls and supervision of the handling of ABPs and DP Articles 41 and 42 of Regulation (EC) No 882/2004 – MANCP • • CA may take into account guides to good practice 142/2011 – Annex XV 20

Official controls • Risk based approach • Evaluation form: Criteria for determination of minimum Official controls • Risk based approach • Evaluation form: Criteria for determination of minimum frequency of official controls in approved plant/establishment • 3 groups: – High risk: 2 / year – Medium risk: 1 / year – Low risk: 1 / 2 years • CRITERIA: • Activity: • : more than one activity, processing, petfood • : OF/SI, biogas/composting, handling • : storage (ABPs/DP) • + additional points: feed/food/derogations 21

Official controls • Category: • : more than one category • : category 1, Official controls • Category: • : more than one category • : category 1, 2 • : category 3 • Origin of material • : third country • : EU • : Slovenia • Hygiene requirements / technical state • : barely met • : good • : very good / excellent 22

Official controls • Operator (cooperation): • : deficinecies or sanction in last year • Official controls • Operator (cooperation): • : deficinecies or sanction in last year • : minor deficiencies in last year and were rectified • : any deficiencies are rectified instantly and with self-initiative • Internal controls and traceability: • : veterinary documents are not compliant, system of controls is deficient and unreliable, traceability is incomlete • : veterinary documents are compliant, but not properly completed, system of controls is in place, but not carried out properly, traceability is not always complete • : complete documents, traceability and internal controls • Placing on the market • : authorisation for storing material in line with R 853/2004, OF/SI (waiting period), feed for farmed animals • : petfood • : tehnical use 23

Regulation (EC) No 1069/2009 Article 45 – Suspensions, withdrawals and prohibitions on operations • Regulation (EC) No 1069/2009 Article 45 – Suspensions, withdrawals and prohibitions on operations • Suspension of approval – Conditions for approving/operating are no longer fulfilled, but: • Operator can be expected to remedy the deficiencies within reasonable period • Potential risks for public/animal health are not severe • Withdrawal of approval – Conditions for approving/operating are no longer fulfilled, and: • Operator cannot be expected to remedy the deficiencies in reasonable period of time because: – Reasons to the infrastructure – Reasons relating to personal capacity (operator or staff) – Serious risks to public/animal health • Specific conditions to rectify existing deficiencies 24

Regulation (EC) No 1069/2009 Article 45 – Suspensions, withdrawals and prohibitions on operations • Regulation (EC) No 1069/2009 Article 45 – Suspensions, withdrawals and prohibitions on operations • Temporary or permanent prohibition from carrying out operations – For registered and approved – Requirements of legislation are not met – Potential risks to public/animal health 25

Regulation (EC) No 1069/2009 Article 47 - Lists Official number assigned to each approved Regulation (EC) No 1069/2009 Article 47 - Lists Official number assigned to each approved or registered establishment, plant or operator TECHNICAL SPECIFICATIONS FOR THE FORMAT FOR THE LISTS OF APPROVED OR REGISTERED ESTABLISHMENTS, PLANTS OR OPERATORS HANDLING ANIMAL BY-PRODUCTS INSIDE THE EUROPEAN UNION AND IN THIRD COUNTRIES http: //ec. europa. eu/food/biosafety/establishments/animal_byproducts_en. htm 26

 • Thank you for your attention 27 • Thank you for your attention 27