food credit 1+ 1

Define therm: official veterinarian & auxillary

under the responsibility on the official veterinarian, under the supervision of the official veterinarian

official vet: a vet appointed by the competent authorieties as staff or otherwise. they must be qualified to perform official controls and other official activities following regulation No 2017/625

auxillary: person representing the competent authorities who have ewceiveed trainign according to the establishment requirements to perform official controls of products of animal origin ontended for human consamption. they can perform offoc control tasks or other activities

respons of vet: the official vet assigns performanceof an action to an official auxillary

supervis vet: in a trained person is performing actions while the official vet os preseent to look after those actions, the official vat is responsible for those actionswhat

what r\are the requirements for financing of official controls?

what types of costs need to be taken into account when calculating the amount of fees for official controls

Regulation 2017/625 requires member states to ensure that they have wnough financial resources to perform official controls. The compitent authorities will collect fees or charges for the official controls, either via general taxation or by collecting fees or charges

the fees and changes are determined on the basis of salary and cost of stuff innvolved in official controls, including cost of facilities, equipment, consumables tools, training, travels …. and the cost of sampling and lab analysis, testing and diagnosis charged by official laboratories.

1. what is food premises registration? who needs to register , explain the procedure for food buisness establishments

2. what is regulation No 2017/625 anout? what are official controls and who does carry them

3. what are competent authrities? describe obligations of the competent authorities

4. what are the health and identification marks? Describe thee technical requirements of the health and identification mark and the practical arrangements for their application

1.What is food premises registration? Who needs to register? Explain the procedures for registration of food business establishments

Food businesses (FBOs) must register and be approved by the competent authority under Regulation No 852/2004 so official hygiene controls can be maintained.

Key Registration Rules

• Mandatory Listing: Authorities must maintain an updated list of all registered food businesses.

• Deadline: Operators must submit the registration form at least 28 days before starting food operations.

• Operators must register every establishment under their control and notify the local authority of all premises used to store, sell, prepare, or distribute food.

Who Must Register?

• The food business operators have to ask the local authority for registration and of each establishment being under their contro

• Supermarkets, restaurants, cafes, and ice cream vans.

• Establishments handling food of animal origin, + primary production and connected activities.

• Small-Scale Producers: of primary animal products directly to final consumers or local retail operations.

• Primary Production

Required Application Details

• Business name, registered seat, + company registration number.

• Natural Persons / Entrepreneurs: name, surname, company ID number, and place of business.

• Hygiene Responsible:

  First name, surname, and contact details of the person in charge of operational hygiene.

• Activity Details: The specific type and scope of the food activities being registered.

• The FBOs must inform the local authority of the following: The premises used for storing, selling, preparing and distribution of the food. About establishments performing only primary production, operations and activities which are associated the primary production or operations and activities which are only marginal, localized and restricted activity of retail establishment

• The establishments which needs to register are: Food premises (supermarkets, restaurants, cafes, ice cream cans and others). Food establishments which handle food of animal origin with the primary production or with operations and activities which is in connection with the primary production. Other producers which supply final consumers, local establishments and retail operations a small quantity of primary products of animal origin must also register.

• This form must be submitted to the food authority at least 28 days before commencing food operations. If it is approved, the FBO will get registration number from the LA. This allows them to have updated list and they can visit them when needed. This list should also be available for other competent authorities.

2. What is the Administrative Assistance and Cooperation (AAC) system and how does it operate?

The Administrative Assistance and Cooperation (AAC) system enables EU and national authorities to share information to detect, investigate, and punish violations of agri-food chain legislation.

Member States must work together - on-the-spot official controls and quickly share information from law enforcement, prosecutors, and courts about non-compliance cases involving health risks or fraud.

• AAC system has a Rapid Alert System for Food and Feed (RASFF)

• How does it operate? 2 parts

  • 1. Dedicated to every request for AAC, - requests that do not involve health risks (to humans or animals) or suspected violations of EU food laws.

  • 2. Food Fraud Network - intentional violation of the EU food and feed legislation

• Types of non-compliance in the request: Mislabeling, documents that are not updated, replacement/dilution, unapproved treatments, IPR infringement.

• AAC works with the Food Fraud (FF) network - 4 key criterias to be put in the case of food fraud or non-compliance

1. Breaking EU food chain laws listed in Article 1(2) of Regulation (EU) 2017/625.

2. lie to Customer →hiding true quality of a product

3. Direct or indirect economic gain for the perpetrator

4. Deliberate intent, backed by strong evidence that the violation was not an accident.

3.What is an annual report? What information does the annual report contain? When is the deadline for its submission?

- yearly report which should be given by member states to the Commission. → include information on the implementation of the multi-annual national control plans (this provides a basis for how the commission inspections are carried out in the member states)

• report should give results from the official controls and audits done within year and if anything should be update in the control plan as effected by these results.

• include → type and number of cases of non-compliance. + information of that official control that found the non-compliance (like what measures were performed). Can also include what type of penality was chosen and the number fo these penalties.

• include the possibility for where the FBO found of non-compliance can comment this

• finished + send reports within 31. August (within 8 months)

• Based on national control plans (MANCPs), the Commission must publish a public annual report by January 31 summarizing official controls, results, and recommendations for the previous year. This report must be sent to the European Parliament and the Council, and made fully available to the public.

4. What are the general rules and main principles for performing official control

Regulation 2017/625 -the rules for official controls, which are done by competent authorities or authorized persons.

Core Control Logistics

• Frequency & Notice: regularly and frequently. →unannounced, except for audits or specific decisions where advance warning to the FBO is required.

• Evidence Check: must look all relevant documentation, traceability data, and operational records to evaluate compliance.

The 5 Essential Control Methods

• Verification: Checking whether all regulatory requirements are actively being met.

• Inspection: Examining feed, food, and animal health/welfare—including comprehensive antemortem and postmortem animal inspections.

• Monitoring:

  Observing and measuring long-term metrics like antibiotic (Ab) use, drinking water safety, food of animal origin, growth indicators, and heavy metal contamination.

• Audits: Systems-level evaluations to verify if existing safety programs—such as control plans and HACCP frameworks—are effective.

• Sampling & Analysis: Testing raw, processing, or distribution samples of food and feed to scientifically verify law compliance.

The rules of the official controls are decided/laid down by the Regulation (EU) 2017/625

• Official controls meand activities that are performed either by the competent authority itself or by delegated bodies or persons.

• Official controls are carried out frequently on a regular basis. The control must be carried out without a warning but in cases of audits or decisions the FBO should be warned in addition to the control

• During the official control it should be used control methods and techniques for the purpose of:

• Verification: examine if the requirements are being fulfilled

• Inspection: Make sure that the examination of both feed, food and animal health and welfare are in accordance to the requirements of the rules and laws. This inspection include both post mortem and antemortem inspection of the animals.

• Monitoring: Get an overview of the observations and measurement when it comes to the use of Ab, drinking water, food of animal origin, growth and also when it comes to the contamination and amount of heavy metals.

• Audits: Examination to determine whether the arrangement are affectively and suitable to achieve the objectives. This is associated with the evaluation systems, like control and safety system and HACCP.

• Sampling for analysis: Taking samples of the feed or food relevant to the production, processing and distribution of feed or food. This is to make sure that animal health rules and feed or food laws are in compliance by checking the analysis.

• Documents, traceability records and other records which may be relevant to assessments of compliance with the rules must be examined.

5. How are fees or charges calculated? What are the main methods for calculating fees or charges? In which sectors are fees mandatory?

Food premises registration mandatory requirement - Regulation (EC) No 852/2004 - enables authorities to maintain oversight and execute official hygiene controls.

Core Rules & Deadlines

• Operators must give all sites used to store, sell, prepare, or distribute food.

• Live Registry: Local authorities need maintain up-to-date master list of all registered Food Business Operators (FBOs).

• Multi-Site: A separate registration must be submitted for every individual establishment under an operator's control.

Who Must Register?

• Shops, supermarkets, market stalls, restaurants, cafes, ice cream vans, delivery vehicles, and train buffet carts.

• Animal Origin Handlers: Facilities dealing with animal products, including transport operations and primary production.

• Small Producers: Primary producers supplying small amounts of animal products directly to local retailers or final consumers.

• Minor Operations: Establishments handling primary production, associated activities, or marginal, highly localized retail functions.

Required Application Details

• Legal Corporations: Corporate name, registered seat, and company registration number.

• Sole Traders / Entrepreneurs: First name, surname, business ID number, and place of enterprise.

• Hygiene Manager: First name, surname, and direct contact details of the person accountable for operational hygiene at the site.

• Scope of Business: The specific type and exact scale of food operations being conducted.

What are health and identification marks? Describe the technical requirements of the health and identification marks and the practical arrangements for their application?

Applied exclusively to large mammal carcasses by an official veterinarian (or an official assistant under the vet's direct supervision) to certify the meat is fit for human consumption.

• Prerequisites: Requires passing both ante-mortem and post-mortem inspections.

• Format: An oval-shaped stamp.

• Placement: Applied to the external surface of the carcass. Every individual piece must bear the mark if the carcass is cut.

• Required Info: Country name, slaughterhouse approval number, slaughterhouse location, and the inspector's ID.

🏷 Identification Mark

Applied directly by the Food Business Operator (FBO) to processed food products of animal origin to confirm legal compliance.

• Placement: Applied to the packaging outside of the food wrapping.

• Required Content:

  • Product name and complete ingredient list (with quantities).

  • Net quantity and minimum durability date (expiry).

  • Manufacturer/packager name, address, and place of origin.

  • Special storage conditions and clear instructions for use.

What is Regulation (EU) No 2017/625 about? What are official controls and who does carry them out

What are the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs?

Describe the specific rules for the performance of official controls of milk production holding. What are the decisions taken by the official veterinarian in cases of non-compliance

Official controls on milk and colostrum holdings ensure raw milk is safe by verifying animal health, farm hygiene, and strict regulatory compliance.

Core Control & Audit Areas

• Animal Health Checks: Verifying that dairy animals are in a healthy general state, free of infectious diseases, and show no signs of udder illness that could contaminate milk.

• Chemical & Drug Screening: Monitoring for unauthorized substances, pesticides, contaminants, and residues of veterinary medicines.

• Premises & Equipment: Auditing that milking equipment and storage facilities are built to prevent contamination, with surfaces that are easy to clean and disinfect.

• Hygiene Observation: Assessing the cleanliness of staff, their work clothing, and the hygienic execution of milking, collection, and transport.

• System Audits: Reviewing farm-level Good Hygiene Practices (GHP) and HACCP compliance.

Enforcement & Vet Decisions for Non-Compliance

• Testing Metrics: Raw milk is tested at collection for plate counts, somatic cell counts, and antibiotic residues.

• Immediate Suspension: If milk fails to meet mandatory safety criteria, the official veterinarian suspends all milk deliveries, declaring the product unfit for human consumption.

• Reinstatement: The suspension remains active until the operator proves compliance with official safety criteria through a clean follow-up sample.

What is food premises approval? who needs to approval? Explain the procedure for approval of food business establishments

Food Business Operators (FBOs) supplying or selling products of animal origin must be approved by the competent authority under Regulations (EC) No 852/2004 and 853/2004, which requires a mandatory on-site visit by the authority before approval is granted.

Establishments Requiring Approval

• Slaughterhouses and meat cutting plants.

• Game-handling establishments.

• Collection centers for animal products.

• Facilities manufacturing meat preparations (such as minced meat).

Approval Procedure & Application Requirements

• Local Notification: Operators must apply to the local authority for each individual establishment under their control.

• Corporate Details: Business name and company registration number for legal entities.

• Sole Traders: First name, surname, company ID number, and place of enterprise for natural person-entrepreneurs.

• Site Location: Exact address where the food business activity takes place.

• Operational Scope: The specific type of food business activity being performed.

• Accountable Personnel: Full name and address of the persons responsible for the operations.

• Technical Dossier: Structural, technical, material, and staffing documents proving facility readiness.

• Outcome: Successfully approved establishments receive a unique, official approval number.

What are competent authorities? Describe obligations of the competent authorities

Competent Authorities (CAs) are central or national bodies responsible for organizing official food safety controls within an EU Member State.

Core Obligations of a Competent Authority

• Laboratory Capacity: Must have direct access to fully compliant testing laboratories staffed by a sufficient number of qualified, experienced personnel.

• Infrastructure: Must provide and maintain proper facilities that allow staff to perform official controls safely, efficiently, and effectively.

• Legal Authority: Must possess the explicit legal powers required to execute official controls and enforce regulatory measures.

• Emergency Preparedness: Must establish operational control plans and ready-to-use contingency plans for emergency situations.

• Quality & Consistency: Must implement formal procedures to guarantee the effectiveness, impartiality, quality, and consistency of all control activities.

What is a multi-annual national control plan? What information does the multi-annual national control plan contain? When is the deadline for its submission?

A Multi-Annual National Control Plan (MANCP) is a mandatory master blueprint that each EU Member State must establish and regularly update to detail the structure, organization, and long-term planning of its official control systems.

Core Architecture & Contents

• Past Performance: Includes complete results from official controls and audits executed during previous years.

• Agency Framework: Designates specific local and central competent authorities, outlining their tasks and available resources.

• Management Hierarchy: Maps the organization of official controls at national, regional, and local levels—including site-specific establishment inspections.

• Sector Controls: Defines the distinct inspection systems applied across different agricultural and food sectors.

• Staffing & Operations: Outlines staff training programs and standardized, documented operational procedures.

• Emergency Preparedness: Details the organization of contingency plans for food-borne illnesses, animal diseases, feed contamination, and public health risks.

• System Integration: Coordinates the framework for mutual assistance and inter-agency cooperation.

Submission Deadline

• Strict Timeline: Member States must finalize and submit their updated MANCP to the European Commission by August 31st each year.

What is the Integrated Management System for Official Controls (IMSOC) and how does it operate?

IMSOC (Information Management System for Official Controls) is an integrated EU computer system designed for rapid, real-time data exchange between Member States to block safety violations at the border.

System Integration

• All-in-One Network: Merges all existing food safety systems into a single hub, including TRACES, BOVEX, Europhyt, and iRASFF.

How it Operates (Example Workflow)

• Detection: The TRACES component identifies a health risk at an EU border.

• Instant Sharing: IMSOC instantly routes this alert to necessary networks like the iRASFF alert system and the AAC.

• Enforcement: Border customs authorities immediately receive the data and intercept the non-compliant shipment before it enters any Member State.

Regulation (EC) No 178/2002 as amended (scope, general principles of food law, EFSA, procedures relating to food safety, food safety requirements

Scope

• Framework for food/feed law within the EU

• Imposes obligations on Member States & on food/feed business operators

• Applies -stages of production, processing & distribution of food/feed but not primary production for private domestic use

General principles of food law are:

1. Protection of human life/health + consumers’ interests with regards to the protection of animal health/welfare, plant health and the environment

2. EU-wide free movement of safe and wholesome human food

3. Consideration of existing or planned international technical and sanitary standards for food

European Food Safety Authority (EFSA):

•   Provides advice & scientific/technical support in all areas on food safety

•   Independent source of info on all matters in this field

• Ensures public kept informed

• Participation open to Member States of EU & other countries applying EU food safety law

Procedures relating to food safety

• Relates to direct/indirect impact on food safety & elimination of risk to human health

• Rapid alert system (identifies emerging risks) – effective tool to exchange info relating to existence of a serious direct/indirect risk to human health

• Looks at risk analysis – risk assessment, risk management, risk communication

Food safety requirements

• Food not placed on market if unsafe (injury to health/unfit for consumption)

. Regulation (EC) No 882/2004 as amended (subject matter & scope, main elements of this Regulation

Lays down general rules for performance of official controls to verify compliance aiming at:

1. Preventing, eliminating or reducing risk to humans/animals to acceptable levels (directly/indirectly through enviro)

2. Guaranteeing fair practices in food trade & protecting consumer interests (incl. food labelling & other info)

• ‘official control’ - any form of control that the competent authority or EU performs for verification of compliance with feed/food law, animal health & animal welfare rules

• Official controls must be carried out:

  •   Without prior warning (except in audits)

Organisation of official control:

• Carried out regularly & in accordance with risk-based approach

• Without prior warning to business concerned

• At all stages of production, processing & distribution

• On feed/food produced & sold in EU

• On feed/food for export & import

 

Requirements for competent authority

1. Have sufficient no. of qualified/experienced staff

2. Ensure all staff receive training

3. Carry out external/internal audits

4. Ensure specific conditions are met if any control task is delegated to an independent third party – ‘control body’

5.  Be transparent about enforcement activity

6. Prepare reports of individual controls & provide copies to businesses

7. Have, use & update documented procedures for carrying out controls

8. Ensure effective & efficient coordination with other competent authorities

9. Have procedures in place for registration & approval of premises

10. Take appropriate action where businesses are infringing the law

 

Requirements for sampling, analysis & official labs

• Methods of sampling chemical analysis & microbiological examination used for official control purposes should be recognised by international organisations

• These should also be validated in accordance with EU legislation or internally accepted protocols

• Labs shall be appointed by competent authorities to undertake chemical analysis or microbiological examination of samples that have been taken for official control purposes

 

Official controls of third country imports of feed/food

• Checks carried out at Border Inspection Posts (BIP)

• All consignments are subject to documentary, identity checks and physical checks

• Checks on labelling and composition

• Checks on compliance with feed and food law

 

Administrative assistance and cooperation with other Member States and with the Commission

• Competent authorities of different Member States (MS) may work together and with the commission

• Results of enforcement controls indicate that action needed in more than one country

• Each MS required to designate ‘liaison body

• This can be used as first point of communication for transmission and reception of requests for assistance

 

National control plans and annual reports to Commission

•   Each MS required to prepare a ‘multi-annual’ national control plan

• Plan must be a single integrated plan

• Covers arrangements for enforcement of feed/food law, animal health/welfare rules and plant health controls

• Plan must be updated regularly

 

Community controls in MS and in third world countries

• Audits of the national control plans and annual reports

• Supplementary or specific audits (where there’s emerging or recurring problems)

EU Hygiene Package

Covers:

1.     Food hygiene

2.     Hygiene for food of animal origin

3.     Official controls on products of animal origin intended for human consumption

 

HP is the collection of legislation consisting of 3 Regulations and 2 Directives:

1.     Regulation (EC) No 852/2004 on the hygiene of foodstuffs as amended – general food hygiene rules (H1)

2.     Regulation (EC) No 853/2004 laying down specific rules for food of animal origin as amended – Special hygiene rules for food of animal origin (H2)

3.     Regulation (EC) No 854/2004 laying down specific hygiene rules for the organisation of official controls on products of animal origin intended for human consumption as amended – Additional control rules on food of animal origin (H3)

4.     Directive 2002/99/EC laying down animal health rules governing the prod, processing, distribution and introduction of products of animal origin for human consumption – Animal health rules related to food of animal origin intended for human consumption (H4)

5.     Directive 2004/41/EC repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (H5)

 

Principles of HP:

1.     Food business operator has primary responsibility of food safety

2.     Food safety ensured throughout the food chain starting with primary production (from farm to fork, stable to table)

3.     Implementation of procedures based on the HACCP principles

4.     Application of basic common hygiene requirements

5.     Registration for certain food establishments

6.     Development of guides to good hygiene practice (GHP) or for the application of HACCP principles

. Regulation (EC) No 852/2004 as amended - Registration of food business establishments (who needs to register, registration procedure, small quantities of primary products)

Who needs to register?

1.     Food premises: shops, supermarkets, restaurants, cafes, etc)

2.     Food Establishments for Feedstuffs of Animal Origin

a)     Primary production

­        Production, rearing or growing of primary products of animal origin

­        Harvesting or primary products of animal origin

­        Milking

­        Farmed animal production prior to slaughter, hunting, fishing and harvesting of wild products

b)     Operations and activities associated with primary production ie transport operations

­        Transport, storage and handling primary products of animal origin at their place of production

­        Transport of food-producing animals to a market, slaughterhouse or between farms

­        Transport operations for the supply of primary products of animal origin, the nature of which substantially altered, from their place of production to the first establishment of destination, in the case of fishery products and wild game

c)     Primary producers directly supplying small quantities of primary products of animal origin or meat from poultry/lagomorphs slaughtered on the farm

d)     Storage of products not requiring temperature-controlled storage conditions

e)     Retail operations

­        Transport/delivery of foodstuffs of animal origin to other establishments

­        This delivery is only marginal, localised and restricted activity of retail establishment in question

Registration procedure

­        Ask the local authority for registration of each establishment

­        Application for registration contains:

a)     Business name, seat, company registration number

b)     Name, surname, company ID number and place of enterprise

c)     Name, surname and address or contact to a person responsible for hygiene of operations in each establishment

d)     Type and extent of activity performed in the establishment

e)     Local authority records application for registration

­        Local authority assigns registration number

­        Registered establishments list available on website of the competent authority of each MS

­        Registration allows local authorities to keep an up-to-date list of all premises which they can visit when needed

­        Frequency of visits will depend on degree of risk involved

Small quantities of primary producers

­        These are supplied directly by the food business operator producing them to the final consumer or to a local retail establishment

­        Appropriate to protect public health through national law

­        Especially due to the close relationship between the producer and consumer

. Regulation (EC) No 853/2004 as amended - Approval of food business establishments (who needs to approval, approval procedure)

Who needs to approval?

1.     Slaughterhouses

2.     Meat cutting plants

3.     Establishments manufacturing meat preparations, minced meat, mechanically separated meat and meat products

4.     Game-handling establishments

5.     Raw milk collection centres

6.     Establishments manufacturing milk products

7.     Collection of eggs from primary producers

8.     Establishments manufacturing egg products

9.     Establishment handling fishery products

10.  Establishments preparing frog's legs and snails

11.  Establishments manufacturing rendered animal fats

12.  Establishments treating bladders, stomachs and intestines

13.  Establishments manufacturing gelatine

14.  Establishments manufacturing collagen

15.  Establishments performing collection and wrapping and/or packing of honey

16.  Establishments for storage of products of animal origin requiring temperature-controlled storage conditions

17.  Retail establishments that perform production operations such as cutting up meat, production of minced meat and meat preparations

18.  Retail establishments that perform activities and operations for the purpose of delivery of foodstuffs of animal origin to other establishments (This delivery is not only marginal, localised and restricted activity of retail establishment in question)

19.  Other establishments

 

Approval procedure

 

*Registration procedure as above

 

Upon receipt of application for approval from a food business operator, the competent authority makes local visit

­        Establishment shall not operate unless the competent authority has:

a)     Granted approval to operate following on-site visit

b)     Provided establishment with conditional approval

c)     Approval based on an application of a natural person-entrepreneur or legal person if it meets the structural, technical, material, staffing and other conditions for the requested type and scope of activities laid down

­        Authority assigns approval number

­        Decision shall take effect as of the day of delivery of the decision on approval or authorisation

­        Competent authority keeps list of establishments, facilities and activities that have been approved

­        Food business operators shall ensure that an establishment ceases to operate if:

a)     Competent authority withdraws approval

b)     Fails to prolong or grant full approval (if under conditional approval)

. Regulation (EC) No 854/2004 as amended (subject matter and scope, auditing and inspection tasks of the competent authority and the official veterinarians

Regulation (EC) No 854/2004 relates to the organisation of official controls on products of animal origin intended for human consumption to verify compliance with Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004

The official controls carried out in accordance with this regulation include:

1. Audits of food business operators’ activities & inspections, including checks on food business operators’ own controls

2. Audits of good hygiene practices and hazard analysis and critical control point (HACCP)-based procedures

3. Audits and inspections of slaughterhouses, game handling establishments and certain cutting plants

4. Official controls on the production of meat

5. Official controls on the production of live bivalve molluscs and fishery products

6. Official controls on the production of raw milk

 

Audits of good hygiene practices shall verify that food business operators apply procedures continuously and properly concerning at least:

1. Checks on food-chain information

2. Design and maintenance of premises and equipment

3. Pre-operational, operational and post-operational hygiene

4. Personal hygiene

5. Training in hygiene and in work procedures

6. Pest control

7. Water quality

8. Temperature control

9. Controls on food entering and leaving establishment

10. Any accompanying documentation

 

When carrying out auditing tasks, the competent authority (official veterinarian) shall take special care to:

1. Determine whether staff in the establishment at all stages of production comply with the relevant requirements of the Regulations

2. Verify the food business operator's relevant records

3. Take samples for laboratory analysis when necessary

4. Document elements taken into account and the findings of the audit

Council Directive 2002/99/EC as amended (scope, general animal health requirements, derogations, veterinary certificates

This directive lays down the general animal health rules governing all stages of production, processing, distribution, and third-country imports of live animals and products of animal origin intended for human consumption.

General Health Requirements & Bans

• Disease Prevention: Member States (MS) must ensure food operations do not spread transmissible animal diseases and are responsible for disease eradication.

• Zoning Restrictions: Products are banned if they originate from an area subject to official animal health restrictions.

• Legality: All products must come from animals that fully comply with EU health standards.

Derogations (Exceptions for Restricted Areas)

MS may authorize products from a restricted zone only if they do not come from an infected or suspected holding, and meet these strict conditions:

• Separation: Handled, stored, and transported separately or at different times from fully compliant products.

• Approval: Transport out of the restricted zone must be officially approved by the competent authority.

• Treatment: Products must be clearly identified and undergo an approved risk-elimination treatment at a designated facility.

• Special Marking: Treated products must carry a special identification mark (Directive 2002/99/EC) or alternative mark (Decision 2007/118/EC).

Veterinary Certificate Rules

• Mandatory Paperwork: Shipments must be accompanied by an official veterinary certificate containing an official stamp and signature from the dispatch authority.

• Language: Must be written in the official language of the destination/border MS, or accompanied by a certified translation.

• Format Standards: Must be the original version, consisting of a single sheet, multiple pages from a single sheet, or sequentially numbered pages (e.g., "page 2 of 4").

• Timing: Must be issued before the consignment leaves the control of the dispatch country's competent authority.

Commission Regulation (EC) No 2073/2005 as amended (subject matter and scope, microbiological criterion, food safety criteria, process hygiene criteria

­        Microbiological criteria are used to measure the safety of foodstuffs based on absence, presence or number of m/o per unit of mass/vol/area/batch

­        Criteria set for certain bacteria (salmonella, listeria, etc) in the main food categories

­        Food operators have primary responsibility for ensuring criteria are met at a specific point of the food chain determined in the regulation

­        National authorities verify that the rules are complied with

­        New microbiological criteria are used to test whether good hygiene practices and HACCP principles are properly applied

­        New criteria cover:

a)     Food safety: criteria for foodborne bacteria, toxins and metabolites

b)     Process hygiene: criteria during the production process

­        When the results of testing against the criteria are unsatisfactory, food business operators find the cause of the unsatisfactory results with the corrective actions defined in their HACCP-based procedures

­        If unsatisfactory the product shall be withdrawn

­        Products placed on the market which do not fulfil the food safety criteria may be submitted to further processing by a treatment eliminating the hazard in question

Commission Regulation (EC) No 2075/2005 as amended (scope, sampling of carcases, Trichinella examination, import health requirements /health certificates

­        This regulation requires the examination for the presence of Trichinella in all slaughtered pigs, wild boar and horses (except for pigs originating from Trichinella-free farms)

 

Sampling of carcasses

­        Domestic pig systematically sampled in slaughterhouses as part of PM examination (same with wild boar and horses)

­        Sample examined in a lab designated by the competent authority using one of these methods of detection:

1.     Reference method of detection set out in Chapter I of Annex I

a)     Magnetic stirrer method for pooled sample digestion

2.     An equivalent method of detection set out in Chapter II of Annex I

a)     Mechanically assisted pooled sample digestion method/sedimentation tech

b)     Mechanically assisted pooled sample digestion method/on filter isolation tech

c)     Automatic digestion method for pooled samples of up to 35g

Trichinella examination and application of health mark

1.     Whole carcass/parts of animal may not leave premises before Trichinella exam negative

2.     Other parts of the animal intended for human/animal consumption that contain striated muscle tissue may not leave premises until exam negative

3.     Animal waste and by-products not intended for human consumption and not containing striated muscle may leave before results are available

Import health requirements

­        Meat of animals that may be carriers of Trichinella, containing striated muscle or from a third country can only be imported if examined in that country

­        Such exam is carried out in accordance with this regulation

­        Meat of domestic pig may be imported without being examined if it comes from a holding in a third country that is recognised by the EU as free from Trichinella

­        Meat of domestic pig can also be imported if it has undergone freezing treatment under the supervision of the competent authority in the third country

­        Freezing must be at recommended temp and time combinations set out in regulation

­        Health cert accompanying imports shall have a statement by the official vet stating ‘the meat has been examined in the third country of origin in accordance with this regulation’

. Directive 2000/13/EC as amended (purpose, compulsory
indication of the labelling of food of animal origin, identification marking)

­        Aim to ensure consumer gets all essential info regarding composition of product, manufacturer, methods of storage and prep, durability, etc

­        Producers and manufacturers are free to provide any additional info they wish provided it doesn’t mislead consumer

­        Must be waterproof

­        Must have ID mark

­        Info on food label:

1. Name under which the product is sold

2. List of ingredients

3. Quantity of certain ingredients

4. Net quantity (in the case of pre-packaged foodstuffs)

5. Date of minimum durability (in the case of foodstuffs that are highly perishable have ‘use by’ date)

6. Any special storage conditions

7. Name and address of the manufacturer or packager (or of a seller established within the EU)

8. Place of origin

9. Instructions for use

10. Alcoholic strength by volume (when beverages have more than 1.2% vol of alcohol)

In live-bivalve products, following info must be on label:

1.     Species of bivalve mollusc (common and scientific)

2.     Date of packaging

3.     By way of derogation from Directive 2000/13/EC as amended, date of minimum durability may be replaced by entry ‘these animals must be alive when sold’

­        If products are made with raw milk: ‘made with raw milk’ must be on label

­        If products are made with gelatine or collagen: ‘gelatine fit for human consumption’ and must indicate date of min durability

Commission Decision No 2006/677/EC (purpose and scope, nature of audit process, implementation of audit process, definitions relating to
the audit process)

­        This regulation provides guidance on the nature and implementation of audit systems by national competent authorities

1.     Audits of competent authorities should be:

­        Systematic in planning, conduct, follow-up and management

­        Transparent (documented procedures with clearly defined planning process, audit criteria and audit report approval)

­        Independent (audit bodies should be free from any commercial, financial, hierarchical, political pressures that may affect outcome of audit process)

2.     Implementation of audit process

­        Guiding principles:

a)     Verification of compliance with planned arrangements to provide assurances

b)     Verification of effective implementation of planned arrangements

c)     Assess whether planned arrangements are suitable to achieve objectives of Regulation (EC) No 882/2004

­        Audit reporting should have clear conclusions stemming from audit findings

­        Follow-up audit results with corrective and preventive actions

­        Resources (MS should ensure that competent authority have sufficient powers and resources to establish, implement and maintain an effective audit system)

­        Auditor competence (generic knowledge and skills, specific technical knowledge and skills, education, etc)

Definitions

•   Audit criteria: set of policies, procedures or requirements used as a reference against which audit evidence is compared

• Audit plan: description of the activities and arrangements for an audit

• Audit programme: set of one or more audits planned for a specific time frame and directed towards a specific purpose

• Audit team: one or more auditors conducting an audit supported if needed by technical experts

• Auditee: organisation being audited

• Auditor: person with the competence to conduct an audit

• Technical expert: person who provides specific knowledge/expertise to the audit team

• Audit body: body that carries out the audit process (may be internal/external)

• Audit process: set of activities (Systematic Approach)

• Audit system: combination of one or more audit bodies carrying out an audit process within or across competent authorities

• Corrective action: action to eliminate the cause of a detected non-conformity or other undesirable situation

• Preventive action: action to eliminate the cause of a potential non-conformity or other undesirable situation

• Production chain: whole production chain incorporating all "stages of production, processing and distribution"

 

Rapid Alert System for Food and Feed (RASFF). Legal basis. Scope. RASFF notifications

The Rapid Alert System for Food and Feed (RASFF) is a real-time network connecting Member States, the Commission, and the EFSA Authority to exchange information and coordinate rapid responses to serious food or feed health threats.

System Management & Reporting Triggers

• Network Management: The European Commission manages the network and instantly transmits received alerts to all members.

• Mandatory MS Notifications: Member States (MS) must immediately notify the Commission of:

  • Official measures restricting or withdrawing products from the market.

  • Voluntary operator agreements aimed at limiting high-risk products.

  • Consignment rejections at EU border posts due to health risks.

• Global Alerts: If an import cargo is blocked at an EU border, the Commission immediately warns all other EU border posts and the third country of origin.

The 4 Types of RASFF Notifications

All notifications are publicly queryable via the online RASFF Portal database and fall into two main categories:

1. Market Notifications (Risk found on the active market)

• Alert Notifications: Triggered when a product presenting a serious health risk is actively on the market, requiring immediate, rapid containment action from other MS.

• Information Notifications: Used when a risk is identified on the market, but other members do not need to take immediate action (e.g., the product hasn't reached their market or is already removed).

2. Border Rejections (Risk intercepted at the perimeter)

• Border Rejection Notifications: Triggered when a non-compliant food or feed consignment fails testing and is blocked at the external EU border.

• Third-Country Dispatches: Triggered when a contaminated product under a rapid alert has already been shipped out to a country outside the EU.

Definitions of official food control. General obligations. Competent authorities

Official control - any form of control that the competent authority or EU performs for verification of compliance with feed and food law, animal health and animal welfare rules

Official controls must be carried out:

1.     Without prior warning (except in audits)

2.     On an ad hoc basis

3.     At any stages of production, processing and distribution of food, animals and animal products

Obligations with regards to the organisation of official control

·       Carried out regularly and in accordance with risk-based approach

·       Without prior warning to business concerned

·       At all stages of production, processing and distribution

·       On feed/food produced and sold in EU

·       On feed/food for export and import

Official controls shall be applied:

­        To exports outside the EU

­        To the placing on the market in the EU

­        To introductions from third countries into the EU

Competent authority = central authority of a MS competent organisation of official controls to carry out veterinary checks or any other authority to which that competence has been conferred

­        Also includes the corresponding authority of a third country

CA ensure:

1.     Effectiveness and appropriateness of official controls on live animals, feed and food at all stages of production, processing and distribution and on the use of feed

2.     Staff carrying out official controls are free from any conflict of interest

3.     Adequate lab for testing and a sufficient number of suitably qualified/experienced staff

4.     Appropriate and maintained facilities/equipment

5.     Have legal powers to carry out official controls and take measures provided for in the regulation

6.     Have control plans and prepared to operate such plans in the event of an emergency

7.     Feed/food business operators are obliged to undergo any inspection carried out in accordance with the regulation and to assist staff of the competent authority in the accomplishment of their tasks

Control staff. Official veterinarian. Approved veterinarian. Official auxiliary. Professional qualification

Control body - an independent third party to which the competent authority has delegated certain control tasks

Competent authority shall ensure that all of its staff are performing official controls:

­        Receive appropriate training enabling them to undertake their duties competently and to carry out official controls in a consistent manner

­        Keep up to date in their area of competence and receive regular training as necessary

­        Have aptitude for multidisciplinary cooperation

­        Official controls should be carried out using appropriate techniques developed for that purpose, including routine surveillance checks and more intensive controls such as inspections, verifications, audits, sampling and the testing of samples

­        These techniques require appropriate training of the staff performing official controls

­        Training also required in order to ensure staff take decisions in a uniform way, in particular with regard to the implementation HACCP principles

­        Training of control staff:

a)     Commission organise training courses for staff of competent authorities of MS

b)     Training courses may be open to participants from third countries, particularly developing

Official veterinarian: veterinarian qualified, accordance with regulations, to act in such a capacity and appointed by the competent authority

Approved veterinarian: veterinarian designated by the competent authority to carry out specific official controls on holdings on its behalf

­        The official veterinarian shall carry out inspection tasks:

a)     In slaughterhouses, game handling establishments and cutting plants placing fresh meat on the market

b)     In production and relaying areas of live bivalve molluscs, pectinidae and live marine gastropods

c)     In the production of fishery products

d)     In milk production and colostrum holdings

­        Competent authority may appoint only veterinarians who have passed a test meeting the requirements as official veterinarians

­        Candidates may need the required knowledge as part of their basic veterinary training or professional experience acquired, after qualifying as veterinarians

­        Each official veterinarian is to undergo practical training for a probationary period of at least 200 hours before starting to work independently

­        During this period the probationer is to work under the supervision of existing official veterinarians

­        The official veterinarian is to maintain up-to-date knowledge through regular continuing education activities

Official auxiliary: person qualified, in accordance with this Regulation, to act in such a capacity, appointed by the competent authority and working under the authority and responsibility of an official veterinarian

­        Competent authority may appoint as official auxiliaries only persons who have undergone training and passed a test in accordance with the following requirements

­        Each official auxiliary must receive at least 500 hours of theoretical training and at least 400 hours of practical training

­        The practical training is to take place in slaughterhouses and cutting plants under the supervision of an official veterinarian

­        The official auxiliary is to maintain up-to-date knowledge through regular continuing education activities

Control activities, methods and techniques. Control plans. Annual reports. Financing of official control

The official controls should be carried out using appropriate techniques developed for that purpose, including

1.     Routine surveillance checks (careful observation of one or more feed or food businesses, feed or food business operators or their activities)

2.     More intensive controls such as:

a)     Verifications - checking, by examination and the consideration of objective evidence, whether specified requirements have been fulfilled

b)     Inspections - examination of any aspect of feed, food, animal health and animal welfare in order to verify that such aspects comply with the legal requirements of feed and food law and animal health and animal welfare rules

c)     Monitoring - conducting a planned sequence of observations with a view to obtaining an overview of the state of compliance with feed or food law, animal health and animal welfare rules

d)     Audits – a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these are implemented effectively and are suitable to achieve objectives

e)     Sampling - taking feed or food or any other substance relevant to the production, processing and distribution of feed or food or to the health of animals, in order to verify through analysis compliance with feed or food law or animal health rules

f)      Testing of samples - analysis of official samples by methods and analysis validated in accordance with internationally approved procedures

 

The national control plans should be regularly updated with new developments:

­        New legislation

­        New diseases or other health risks

­        Significant changes to the structure, management or operation of the competent national authorities

­        Results of MS official controls

­        Results of Commission controls

­        Scientific findings

 

Annual report – presented by MS to the Commission with info on the implementation of the multi-annual control plans

­        Provides results of the official controls and audits carried out during the previous year and an update of the initial control plan in response to these results

­        Provides the type and number of cases of non-compliance identified and the actions to ensure the effective operation of multi-annual national control plans, including enforcement action and its results

­        MS finalise their reports and transmit them to the Commission within 6 months of the end of year

­        Commission establishes an annual report on the overall operation of official controls in MS

­        Commission submits report to European Parliament and the Council and make available to public

­        MS ensure adequate financial resources are available to provide the necessary staff and other resources for official control

 

Fees/charges

­        MS collect fees/charges to cover costs by official controls

­        MS make public the method of calculation of fees and communicate it to the Commission

 

Criteria to be taken into consideration for calculation of fees

­        Salaries of the staff involved in the official controls

­        Costs for the staff involved in the official controls, including facilities, tools, equipment, training, travel and associated costs

­        Laboratory analysis and sampling costs

Sampling and analysis of samples (purpose, basic principles, supplementary expert opinion). Official laboratories

Basic principles that must be addressed in food sampling

1.     Sample should represent the food as sold to the consumer and each part of a divided sample should be truly representative of the original

2.     Where divided, all parts of the sample must individually be representative of the food and of each other

3.     Sampling process must not alter the sample in any way that might affect the analysis

4.     Storage and transportation of the sample must not alter it in any significant way – whether through contamination, loss, deterioration or other means

The quantity and nature of any sample should be such as to enable the required analysis to be made

–       Nature of the samples that are appropriate will depend on the purpose for which the analysis is undertaken

–       Quantity will vary according to the product and the type of analysis to be carried out

Scope of the investigation of food samples:

–       Sensory evaluation

–       Physico-chemical examination

–       Microbiological examination

–       Contaminants

–       Food additives

–       Residues

–       Allergens

–       Labelling

–       Other specific examinations

Supplementary expert opinion

­        Competent authorities:

­        Establish adequate producers to guarantee the right of feed and food business operators whose products are subject to sampling and analysis to apply for a supplementary expert opinion

­        Ensure that feed and food business operators can obtain sufficient numbers of samples for a supplementary expert opinion (unless impossible eg highly perishable products)

Competent authorities may only designate labs that operate and are accredited in accordance with the following European standards:

–       EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories

–       EN 45002 on ‘General criteria for the assessment of testing laboratories

–       EN 45003 on ‘Calibration and testing laboratory accreditation system – General requirements for operation and recognition taking into account criteria

­        Statutory role of official labs is to test food for compliance with the relevant legislation and guidelines

­        Labs should be accredited for individual tests used

­        Labs involved in analysis of official samples should work in accordance with internationally approved procedures and use methods of analysis that have been validated

­        Official labs should have equipment enabling the correct determination of standards fixed by the EU and national law

The EU's network of laboratories includes:

-        EU Reference Laboratories (EU-RLs) designated by the Commission

-        National Reference Laboratories (NRLs) designated by each EU-countries

-        Official control laboratories under the responsibility of EU-countries

 

Official control of fresh meat (food chain information, ante-mortem inspection, post-mortem inspections, laboratory testing)

Food chain information (FCI)

FCI document must be completed and supplied to the slaughterhouses and game handling establishments by:

−      Person responsible of the animals to be slaughtered

−      Official/approved veterinarian carrying out the AM inspection of animals before slaughter

−      Hunter: trained person responsible for the initial examination of the body and viscera of the hunted wild game

The official veterinarian has to:

−      Check and analyse relevant information from the records of the holding of origin of animals intended for slaughter

−      Take account of the documented results of this check and analysis when carrying out AM and PM inspection

−      Take account of official certificates accompanying animals and any declarations made by veterinarians or trained persons carrying out controls at the level of primary production

 

Ante-mortem inspection

­        Official vet must carry out AM inspection of all animals before slaughter

­        Carried out at the holding where the animals are kept

­        If not carried out at the holding, it must be carried out at the slaughterhouse

­        Must take place within 24 hours of arrival of the animals at the slaughterhouse and less than 24 hours before slaughter

­        Vet is to verify that animals accepted for slaughter for human consumption are properly identified

­        Must determine whether, as regards the animal inspected, there is any sign:

o   Welfare has been compromised

o   Any condition which might adversely affect human/animal health, especially zoonotic diseases and diseases on List of the Office International des Epizooties (World organisation for animal health/OIE)

­        After AM inspection of animals before slaughter, veterinarian must complete and sign a health certificate

­        Certificate must declare the animals healthy, free of symptoms of infectious, transmissible or contagious disease and without the risk of residues of veterinary medicinal products in excess of the levels allowed or residues of forbidden substances

­        Live animals transported from the holding to the slaughterhouse must be accompanied by a valid health certificate. (Validity of health certificate is 3 days)

­        If not slaughtered within the three days, animals must be re-examined and a new health certificate issued

­        If the animals show clinical symptoms of a disease or suspected of the presence of residues, they may not be slaughtered for human consumption

­        However, killing of animals showing clinical symptoms may take place at the end of the normal slaughter process, if precautions are taken to avoid the risk of spreading pathogenic organisms and to clean/disinfect facilities after killing

Post-mortem inspection

•        Carcasses and accompanying offal are to be subjected without delay after slaughter to PM inspection:

-        All external surfaces are to be viewed

-        Minimal handling of the carcass and offal or special technical facilities may be required

-        Particular attention to be paid to the detection of zoonotic diseases and diseases on OIE List

•        Additional examinations, such as palpation and incision of parts of the carcass and laboratory tests, are to take place, considered necessary:

-        To reach a definitive diagnosis,

-        To detect the presence of

Ø  Animal disease,

Ø  Residues or contaminants in excess of the levels laid down under EU legislation

Ø  Non-compliance with microbiological criteria

Ø  Other factors that might require the meat to be declared unfit for human consumption

Official Control of live bivalve molluscs and fishery products (filter feeders, classification of production and relaying areas, monitoring, not filter feeders, health standards, checks & inspection of fishery products)

Filter-Feeders

·       Filter-feeding marine animals are animals fed by pumping water through their bodies and straining plankton from it.

o   Bivalve molluscs (oysters, mussels, clams, cockles and scallops).

o   Echinoderms are either filter feeders, substrate eaters or carnivores (starfish, sea cucumbers or urchins)

o   Tunicates (sea squirts)

·       They are susceptible to accumulating toxins or bacterial contaminants from their environment. Consumption of contaminated products could be a risk to human health.

·       Therefore these animals can only be commercially harvested from approved production areas that are monitored to ensure they meet the toxin and MO criteria

·       The CA must fix the location and boundaries of the production and relaying areas and must classify these areas based on their level of faecal contamination:

o   Class A areas – live bivalve molluscs may be collected for direct human consumption (already the health standards for live bivalve molluscs and E. coli)

o   Class B areas -  BV molluscs may be collected and placed on market for human consumption only after treatment in a purification centre or after relaying (so they meet these health standards)

o   Class C areas – BV mollusc may be collected and placed on market only after relaying for long period of time (< 2 months), so as to meet these health standards.

·       The CA must make a list of sources of pollution (animal or human origin) that may contaminate production area

Monitoring of Classified Relaying and Production Areas

These areas are monitored periodically to check

1.     There’s no malpractice regarding origin, current location and destination of live BV molluscs

2.     The microbiological quality of these molluscs in relation to production and relaying areas (check faecal contam)

3.     Presence of toxin-producing plankton in production and relaying waters and biotoxins in molluscs

4.     Presence of chemical contaminants (e.g. heavy metals ) in molluscs

Non-filter feeders

·       Pectinidae family – BV molluscs incl the scallop closely related to the clam and oyster

·       Official controls of Pectinidae and live marine gastropods that are not filter feeders and harvested outside of production areas are to be carried out in fish auctions, dispatch centres and processing establishments

·       These controls verify compliance with health standards for live BV molluscs

a)     Must have organoleptic properties assoc with freshness and viability (e.g. clean shells, normal response to percussion)

b)     Not contain marine biotoxins that exceed permitted limits.

·       Official controls on the production and placing of fishery products on the market incl:

a)     Regular checks on hygiene of landings

b)     Regular inspections of vessels and land establishments to see

·       Conditions for approval are fulfilled

·       Fishery products are handled correctly

·       Compliance of hygiene and temp requirements

·       Cleanliness of establishments incl vessels, facilities, equipment and staff

c)     Checks of storage and transport conditions

Official controls of fishery products must be carried out at all stages of production, processing and distribution. These include:

a)     Organoleptic examinations – compliance with freshness criteria in accordance with EU leg

b)     Freshness indicators – determine total levels of total volatile basic nitrogen (TVB-N) and Trimetheylamine nitrogen (TMA-N)

c)     Histamine – levels comply with EU leg

d)     Residues and contaminants – levels comply with EU leg

e)     Microbial checks  - compliance of relevant rules and criteria laid down by EU leg

f)      Parasites – comply with EU leg. Can check by visual inspec.

Poison fishery products – ensure products from poisonous fish or those containing biotoxins harmful to human health are not placed on the market

Official control of raw milk and dairy products (milk collection holdings, raw milk upon collection, food safety criteria, processed dairy products)

Control of milk producing holdings

Animals are subject to official controls to check

·       Animal has no symptoms of infectious zoonotic diseases

·       Animal has good state of health and no sign of disease that would affect milk

·       The use of veterinary products are being complied with (respect of withdrawal period and no admin of unauthorised substances)

·       Theses checks can be done by approved vet

Holdings undergo official controls regularly and without prior notice to verify hygiene requirements are being complied with:

·       Milking equipment and premises of storage, handling and cooling are located and build so as to minimize risk of contamination

·       Storage area must protect against vermin

·       Surface areas that may come into contact with milk must be easy to clean and disinfect.

·       Milking, collection and transport must be carried out hygienically and cold temperatures must be maintained.

·       People milking and or handling raw milk must wear appropriate, clean clothes and have a high level of personal hygiene.

Official control may also include monitoring for controls the FBO performs

If hygiene levels are inadequate the CA must tell the operator the steps to take to fix the situation

Control of Raw milk upon collection

·       CA organises official controls to ensure compliance with standards raw milk

a)     Plate count (≤100,000/ml cowls milk, ≤1,500,00/ml or ≤500,000/ml other species)

b)     Somatic cell count (≤100,000/ml cow’s milk)

c)     Antibiotic residues (levels in Reg (EU) No 37/2010)

·       Representative no. of samples of raw milk collected from the holdings should be taken by random sampling

·       If raw milk fails to meet the mandatory food safety criteria, the CA may suspend delivery of milk and ask farmer to fix the issue (suspended until FBO proves it now meets the criteria)

·       The CA can organise controls to ensure compliance of requirements that apply to dairy products

a)     Temp – not >6 °C

b)     Heat treatment and ultra high heat treatment

c)     Plate count (<300,000/ml)

d)     Wrapping and packaging

e)     Labelling

f)      Identification marking

·       Official controls also include audits of good hygiene practices (GHP) and HACCP.

Official control of eggs, gelatine, collagen (raw materials, processed products, health and hygienic requirements, marketing standards)

FBOs placing eggs on the market must ensure that:

1.     Eggs are kept clean, dry, free of external odours and protected from shocks and direct sunshine.

2.     Eggs are stored and transported at a constant temp optimal for conservation of  quality and hygiene

3.     Eggs are delivered to the consumer within 21 days of laying (max time limit)

4.     Eggs meet highest standards of cleanliness, freshness and quality

5.     Consignments originate from flocks tested with negative results in accordance to EU leg for salmonella. Each consignment must be accompanied by a certificate stating the test was carried out

The CA must organise official controls of the FBO to check

1.     Facilities and equipment used for egg production (houses and hens should be checked for cleanliness)

2.     Facilities and equipment for egg collection (check all surfaces inside poultry house keep egg clean and dry)

3.     Egg equipment for storage (check pallets, containers, crates and vehicles are clean and protect from physical damage, sunlight and pest contamination)

4.     Egg storage and packaging materials (check if store keeps eggs at suitable temp, dry, clean etc)

5.     Personal hygiene and handling (check that staff are in good health and undergo training on health risks and eggs are handled hygienically)

6.     Record keeping (FBO must keep account of samples taken and measures put in place to control hazards, e.g. checks on hens or eggs, info on disease occurrence and veterinary products used incl withdrawal, etc)

The CA must check eggs at all stage of marketing

Animal Collagen and Gelatine

·       Animal collagen: Protein based product derived from animal bones, hides, skins and tendons

·       Gelatine: Natural, soluble protein obtained by partial hydrolysis of collagen.

Raw materials used for collagen/gelatine production intended for use in food:

·       Bones

·       Hides and skins of farmed Ruminants and wild game

·       Pig and poultry skins

·       Fish skin and bones

·       Must derive from animal carcases slaughtered in slaughterhouse and found fit for human consumption, or wild game found fit for human consumption

The CA must carry out audits on collection centres, tanneries and carry out audits on GHP and HACCP-based principles

The Ca must organise official controls to check

·       Storage of raw materials (rooms or premises are clean, hygienic, at correct temp, etc)

·       Production process of collagen (finished product is fit for human consumption)

Labelling (Date of min durability, ID mark and “collagen/gelatine fit for human consumption”)

. Official control of products of animal origin entering the EU from the third countries (Council Directive 97/78/EC as amended / veterinary checks, border inspection posts, certificates

This directive applies to imports from third countries such as:

a)     Food products of animal origin

b)     Animal feed

c)     Plant products which increase risk of spreading infectious or contagious animal diseases

d)     By-products not intended for human consumption

All products from third countries are subject to veterinary checks before introduction into the EU. These are carried out at a border inspection post by an OV of the CA. Checks include:

a)     Documentary check of veterinary certificates and other documents accompanying consignment

b)     Identity check by visual inspection to ensure products correspond with info on documents

c)     Physical check (sensory eval, simple physical or chemical tests) on the product to ensure it meets requirements of EU leg (packaging, temp, sampling, etc)

·       After completion of required checks the OV issues a certificate to say the consignment complies with regulations

·       If the OV or CA suspects legislation was not complied with, it must remain under supervision of the CA until the results of further checks are received.

·       If something that may cause a serious threat to animal/human health is suspected the CA may suspend or set special conditions for imports coming from part or all of the country concerned.

·       Reg (EC) No 882/2004 – if the product doesn’t meet the conditions of EU leg, measures must be applied incl. the possibility of destruction, returning or treatment of products in question.

·       FBOs and CAs worldwide can use the Trade Control and Expert System (TRACES) to trace animal and animal product movement. It is a web-based trans-Europe veterinary network.

. Official controls of food premises (verification of FBOs compliance with the requirements of Regulation (EC) No 852/2004 as amended and the Regulation (EC) No 853/2004 as amended).

Official controls include audits of GPH and HACCP-based procedures

Audits of GHP verify FBOs apply procedures properly and consistently. Checks include:

a)     checks on food chain info

b)     design and maintenance of premises and equipment

c)     pre-operational, op and post-op hygiene

d)     personal hygiene

e)     work hygiene and procedures

f)      pest control

g)     water quality

h)     temp control

i)        controls on food entering and leaving the establishment

j)       Any accompanying documentation

Audits of HACCP based procedures shall verify FBOs apply procedures:

·       Continuously and properly

·       Guarantee products of animal origin comply with

o   Community legislation on Microbiological criteria

o   Community leg on residues, contaminants and prohibited substances

o   Doesn’t contain physical hazards (E.g. foreign bodies)

11. Official controls of audits of Good Hygiene Practice (GHP) and Hazard Analysis and Critical Control Points (HACCP) system

Food operators must:

a)     Offer assistance needed to make sure official controls carried out by the CA can be done efficiently

b)     Give access to all buildings, installations, premises and other infrastructure

c)     Make any documents and records required by regulation or considered necessary available

Audits of GHP ensure FBOs apply procedures properly and consistently. Checks include:

a)     checks on food chain info

b)     design and maintenance of premises and equipment

c)     pre-operational, op and post-op hygiene

d)     personal hygiene

e)     work hygiene and procedures

f)      pest control

g)     water quality

h)     temp control

i)       controls on food entering and leaving the establishment

j)       Any accompanying documentation

Audits of HACCP based procedures shall verify FBOs apply procedures:

·       Continuously and properly

·       Guarantee products of animal origin comply with

o   Community legislation on Microbiological criteria

o   Community leg on residues, contaminants and prohibited substances

o   Doesn’t contain physical hazards (E.g. foreign bodies)

·       When carrying out auditing the CA (official vet) makes sure:

o   Staff and staff activities comply with relevant regulations at all times

o   To verify the FBOs relevant records

o   To take samples for lab analysis where necessary

o   To document findings of audit

1. Decision following the official controls of products of animal origin. Enforcement measures. Action in case of non compliance. Sanctions

Regulation (EC) No 882/2004 of European parliament and of the Council of 29^th April 2004

·       On controls performed to ensure compliance with feed and food law, animal health and animal welfare rules

·       Decision taken by competent authority (CA) due to official controls

Enforcement measures

·       Action in case of non-compliance – CA will take action to make sure operator fixes situation. Must take into consideration the nature of non-compliance and operators past record.

·       Such action shall include the following measures:

a)     Put in place sanitation procedures etc to ensure safety of food or compliance with food law

b)     Restriction/prohibition of placing on the market, importing or exporting food

c)     Monitoring, recalling, with drawing and/or destroying food if necessary

d)     Authorisation to use food for purposes other than they were originally intended

e)     Suspension/withdrawal of establishment’s approval

f)      Any other measure the CA deem appropriate

·       The CA shall provide the operator, or representative with:

a)     Written notification of its decision on action and the reasons behind this

b)     Info on rights for appeal

·       All expenditure is the responsibility of the business operator

Sanctions

·       Member states lay down rules on sanctions applicable to infringement of food law and other EU provisions relating to animal health and welfare.

·       They must take all measures necessary to ensure these are implemented.

·       Sanctions must be effective, proportionate and dissuasive

2. Decisions following official control of fresh meat (food chain info, live animals, animal welfare, meat)

FCI documents must be completed and supplied to slaughter house and game handling establishment by:

a)     Keeper/person person responsible for animals to be slaughtered

b)     Official/approved vet carrying out AM inspection of animal before slaughter

c)     Hunter – trained person responsible for initial exam of body and viscera in wild game

Official vet shall

a)     Check relevant info from records of original holdings of animals for slaughter

b)     Take into account these documents during AM and PM inspection

c)     Look at all official documents accompanying animas and declarations of vet or trained person inspection wild game on the spot.

Decisions concerning food chain info

·       Official vet must verify the animal is not slaughtered unless slaughterhouse operator has been given the relevant food chain info

·       OV may allow animas to undergo slaughter if this info is not available (but info must be given before carcass approved for human consumption, and carcass stored separately until then)

Decision concerning live animals

·       OV must confirm animals send for human consumption are correctly identified

·       If animal can’t be IDed, must be killed separately and declared unfit for human consumption.

Decisions concerning animal welfare

·       OV must ensure food business operators (FBOs) take immediate action if rules about protection of animals during transport is broken.

·       Includes corrective measure and preventative measures.

Decisions concerning meat

Meat must be declared:

a)     fit for human consumption

o   PM reveals no abnormality and there is no other reason to prevent meat entering the food chain

o   OV must apply health mark

b)     unfit for human consumption

o   PM reveal abnormalities or there are other reasons to prevent meat entering the food chain

o   Reasons include things like inedible by-products

No health mark may be applied

3. Decisions following official control of live bivalve molluscs and fishery products (decisions after monitoring, decisions after controls)

Decisions after monitoring

·       If results of sampling show health standards for molluscs do not comply with regulation or a risk to human health the CA must close or reclassify the production area.

·       CA may reopen or reclassify this area if health standards once again comply with EU legislation.

Decisions after controls

Fishery products often declared unfit for human consump if:

·       Checks on organoleptic, chemical or physical properties, MO or parasites do not comply with EU leg

·       The contain contaminants/residues exceeding limits  in EU leg

·       They derive from:

a)     Poisonous fish

b)     Fishery products containing too much biotoxins

c)     Bivalve molluscs, marine gastropods etc with biotoxins exceeding limits in Reg (EC) No 853/2004.

·       CA feels they are a risk to human/animal health or are unfit for human consumption.

4. Decisions following the official control of raw milk and dairy products, eggs, gelatine and collagen

Raw milk

If it doesn’t meet the mandatory food safety criteria the CA may:

·       may suspend the delivery of milk

·       ask the farmer to take necessary measures

·       suspend it until the FBO proves the milk complies again to the criteria

Gelatine/collagen – failure to meet legal requirements

·       CA audits collection centres and tanneries

·       Does audits of good hygiene practices (GHP) and hazard analysis and critical control points (HACCP) in manufacturer of collagen and gelatine producing establishments.

·       Organises official controls in order to check

a)     Storage of raw materials (hygiene conditions, cleanliness, temperature etc)

b)     Production process for collagen and gelatine (compliance with MO and contaminant criteria)

c)     Labelling of collagen and gelatine (ID mark, date of min durability, “collagen or gelatine fit for human consumption

5. Health marking (health mark, special health mark, special identification mark or other identification mark)

Health Marking

·       Meat declared fit for human consumption

·       Only applied to animal after AM and PM inspection, where there’s no grounds for declaring it unfit for human consumption

·       OV must supervise marking and marks used

Health Mark

·       Ink or hot branding on external surface of carcass

·      

If the animal is cut into halves, quarters, etc. must mark all pieces.

·       Oval mark at least 6.5 cm X 4.5 cm, with letters 0.8cm high and figures 1 cm high. Must indicate:

a)     Name of country establishment is located in (2 letter code e.g. UK,)

b)     Approval number of slaughterhouse (eg 2468)

c)     Location of slaughterhouse within the EY (the abbreviation eg EC)

d)     May also include indication of OV who carried out health inspection.

Special Health Mark

·       On meat from animals which underwent emergency slaughter.

·       May be placed on market only in member state the slaughter takes place in

·       The form and indications of this mark are decided by the law of each member state.

Special Health Identification Mark (SPIM)

·       Products of animal origin treated in approved establishment

·       For meat from a territory or part of a territory

·       Council Directive 2002/99/EC laying down animal health rules governing production, processing, distribution and introduction of products of animal origin for human consumption.

·       Stamp must be oval, at least 6.5 cm x 4.5 cm bearing a diagonal cross and the following info:

a)     The country the establishment is in (2 letter code eg UK)

b)     Approval no. of slaughter house within the EU

c)     Identification of OV who carried out inspection

Alternative Identification mark

·      

May be used instead of a SPIM – must have the following dimensions:

o   Square with outer diam of not <30 mm

o   Relevant country code = 8mm

o   Approval no of establishment = 11mm

6. Decisions following the official control of products of animal origin entering the EU from third countries (Action in the case of suspicion, action following official control, special treatment, redispatch of consignment, notifications)

Action following official controls from third countries

The CA can place under official detention food from third countries that doesn’t comply with food law and may take the following measures with that food:

·       Order it to be destroyed, re-dispatched or subject to special treatment

·       Monitor or recall/withdraw food if it has already been placed on the market

·       Verify the food doesn’t cause any adverse effects on human health (directly or through environment) while these measures are being carried out.

·       If official controls indicate the consignment is bad for human health or unsafe, the CA must place it under detention pending its destruction to protect human health

·       The CA will notify the Commission or Member States of its findings and of the identification of the products, and of its decisions and info on the final destination of the consignment to customs.

·       The CA provides the operator or representative with written notification of its decision, the reasoning behind it and info on their rights to appeal (all decisions are subject to the right of appeal).

Special treatment

·       May include

a)     Treatment or processing to bring the food into line with EU law, including decontamination but not including dilution.

b)     Processing in any other suitable manner other than for purposes other than human or animal consumption.

·       CA must ensure this treatment occurs in an establishment under its control, or the control of another Member State in accordance with national rules.

Re-dispatch of Consignments

·       The CA allows for re-dispatch of consignments only if:

a)     The destination has been agreed with the FBO responsible for the consignment

b)     The FBO has already informed the CA of the third country of origin or destination of the reasons preventing the placement of food on the market within the EU.

c)     If the third country of destination is not the country of origin, the CA of the destination country must agree to accept the consignment.

·       Re-dispatch must take no more that 60 days after the CA decided on the destination of the consignment. After this, unless legal action is taken it shall be destroyed.

·       Pending this re-dispatch the CA must place the consignment under official detention.

Official certification

·       Official certification of each consignment is the responsibility of the CA of the third country and is checked before entry into one of the territories of the member states.

·       Official certification must:

a)     Have an existing link between the certificate and consignment

b)     Contain accurate and authentic information

7. Verification of official controls and procedures performed by the competent authority of Member States (audit, internal and external audits, purpose).

Audit

·       Systematic and independent examination to determine whether activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives.

·       Requirements:

a)     Member States designated a CA for performing these audits

b)     These authorities must comply with criteria ensuring the are effective and impartial

c)     Reg (EC) No 882/2004 = the CA of Member States must also carry out internal audits or have external audits carried out to ensure they achieve their objectives

Internal audits – Professional work of the OV or inspector in that region is supervised by the head/chief in the district or by the central CA; Carried out in accordance with internal rules established by the centre for control activities (internal audit programmes, plans and manuals)

External audits – Professional work of the CA/OV or inspector is supervised by Commission experts

Purpose of audits

·       To verify whether official controls relating to feed or food law and animal health and welfare rules are being implemented.

·       To verify if they are suitable to achieve the objectives of relevant legislation.

·       Subject to independent scrutiny and carried out in transparent manner.

8. EU control of official controls and procedures in Member States and the third countries (external audit, purpose)

Purpose

·       To verify official controls take place in Member States in accordance with multi-annual national control plans and EU law

·       Specific audits in specific areas may supplement general audits, in particular:

a)     Verify the implementation of the multi-annual control plan, feed and food law and animal health and welfare legislation.

b)     Verify functioning and organisation of CAs

c)     Investigate important or recurring problems in Member States

d)     Investigate emergency situations or emerging problems in Member States

e)     Report on findings of each control carried out, with recommendations on improvement of compliance. These reports are publicly available.

f)      Inspections may be on-the-spot of official services or facilities of sector being audited.

g)     The commission establishes an annual control programme, inform the Member state and report of its results.

Member States shall:

a)     Take appropriate action in light of recommendations from EU controls

b)     Give all necessary assistances and provide all required documentation and other support requested by the commission experts to allow them to work efficiently and effectively

c)     Ensure the commission experts have access to all premises and information relevant to their audit.

EU controls in third countries (non-EU member countries)

·       Commission experts may carry out official controls in third countries to verify compliance or equivalence of the country’s legislation and systems with EU feed and food law and EU health legislation.

·       If during these controls serious risk to human/animal health is found the Commission must act immediately and take any necessary emergency measures in accordance with EU leg.

·       The commission must report on these findings and where appropriate, make recommendations. These reports should be publicly available.

·       These controls look in particular at:

a)     Legislation of the third country

b)     Organisation of the third country’s CAs, their powers and independence, the authority they have to enforce legislation effectively and their supervision.

c)     Training of staff performing official controls

d)     Resources available to CA (eg diagnostic facilities)

e)     Existence and use of documented control procedures and control systems

f)      Extent and operation of official controls of animals and their products

g)     The third country’s assurance of compliance and equivalence to EU requirements

9. Notification of direct or indirect risk to human health deriving from food. Implementing measures of RASFF

Notification of a Direct or Indirect risk to human health

The Member states immediately notify the commission via the raid alert system of:

·       Any measures used to restrict placement of food/feed on the market or forcing withdrawal from the market or recall to protect human health.

·       Any agreement with the operator (voluntary or obligatory), aimed at preventing, limiting or imposing specific conditions on placing food/feed on the market due to risk of human health

·       Any rejection of a consignment due to direct or indirect risk to human health by a CA at a border post within the EU (the commission must then immediately notify all other border posts within the EU, and the third country of origin)

·       Notifications must be accompanied by reasoning for the actions taken by the CA of that member state and followed up with supplementary info.

·       If the food/feed that is subject of a notification under the RAS is dispatched to third country, the commission must provide that country with the appropriate info.

·       Participation in the RAS may be opened up to applicant countries, third countries and international organisations if they agree with the Community on specific procedures

RASSF Legal Basis:

·       Reg (EC) No178/202 of the European Parliament – general principles and requirements of food law, and establishment of European Food Safety Authority (EFSA).

·       Commission Ref (EU) No 16/2011 – implementing measures for the rapid alert system (RAS) of food and feed.

Amendment to Reg No 178/2002:

·       RAS for notification of direct or indirect risk to human health from food or feed established as a network involving the Member States, Commission and the Authority.

·       Each must designate a contact point (a member from the network)

·       The commission is responsible for running the network and shall transmit info rapidly to other members of the network

·       If a member of the network has any info on the existence of a serious direct or indirect risk to human health from food or feed, they must immediately notify the commission by the rapid RAS.

·       The Authority may supplement this info with any scientific or technical info to assist in action by the Member States.

Implementing measures

·       Measures are adopted by the Commission after discussion with the Authority

·       These measures specify specific conditions and procedures applicable to the transmission of notifications and supplementary information.