EC Directive 853/2004 Overview

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Questions and Answers

What is required for food business operators to market products of animal origin within the Community?

They only need to comply with general hygiene requirements.

They can sell products from any food establishment registered in any EU country.

They must be produced exclusively in establishments meeting the relevant food law requirements. (correct)

They must have approval from a regional department of health.

Which of the following operations does NOT require establishment approval according to Article 4?

Storage of products not requiring temperature control (correct)

Primary production (correct)

Manufacturing of refrigerated meat products

Transport operations (correct)

What authority must approve establishments handling specific products of animal origin as per Article 4?

Competent authority (correct)

Local government councils

Ministry of Agriculture

European Food Safety Authority

What does Article 11 of the regulation refer to?

Country specific rules on transport of meat and shellfish Signup and view all the answers

Under what circumstances may establishments that handle products of animal origin operate without approval?

If they only conduct primary production and retail operations Signup and view all the answers

What does Article 14 stipulate regarding reporting?

Regular audits must be reported to the EC Council and Parliament. Signup and view all the answers

Which of the following is NOT a factor considered in the approval process of establishments for food businesses?

Historical sales data of the establishment Signup and view all the answers

What role does the European Food Safety Authority play in this regulation?

They have a consultation role. Signup and view all the answers

What is the primary aim of national measures adopted by Member States under Article 10?

To enable traditional methods and accommodate geographical constraints Signup and view all the answers

What must Member States do before adopting national measures according to Article 10?

Notify the Commission and other Member States with details of the changes Signup and view all the answers

Which of the following products is an example of a geographically constrained product?

Champagne Signup and view all the answers

According to the EU regulations, what type of procedures must food business operators in slaughterhouses implement?

HACCP Based Procedures Signup and view all the answers

What should the details submitted by Member States include when notifying about adaptations?

Descriptions of adapted requirements and affected foodstuffs Signup and view all the answers

Which of the following best describes the requirement for food hygiene standards under EU regulations?

Standards must be based on HACCP and specific food processes. Signup and view all the answers

What fundamental objective should be preserved when national measures are adopted?

Achieving the objectives of existing EU regulations Signup and view all the answers

In terms of food safety, what is the role of HACCP-based procedures in food establishments?

To ensure safety and reduce hazards in food handling Signup and view all the answers

What must food business operators ensure when importing products of animal origin?

Products are made available for control upon importation. Signup and view all the answers

What is required when importing food that contains both products of plant origin and processed products of animal origin?

Processed products must satisfy specific requirements and compliance must be demonstrated. Signup and view all the answers

When food business operators are required to provide documentation for products of animal origin, what forms of documentation are acceptable?

Certificates or documents as specified in Annex II or III. Signup and view all the answers

Which of the following factors can lead to adaptations or updates of Annexes II and III?

Technological developments and their consumer implications. Signup and view all the answers

What is one of the possible exemptions from the regulations in Annex II and III?

Factors that do not affect the regulation's objectives. Signup and view all the answers

What does Article 6 of EC Directive 853/2004 primarily address?

Requirements for importing food with animal origin products. Signup and view all the answers

What kind of advice is particularly relevant for adaptations of food regulations according to Article 10?

Scientific advice, especially new risk assessments. Signup and view all the answers

What is an essential aspect of food hygiene that is highlighted in the directives?

Ensuring microbiological and temperature criteria for foodstuffs. Signup and view all the answers

Study Notes

EC Directive 853/2004: Key Provisions

Article 11 - Specific Decisions: Allows for country-specific regulations regarding meat transport and shellfish handling
Article 12 - Committee Procedure: Outlines the process for addressing specific issues related to food safety
Article 13 - Consultation with European Food Safety Authority: Establishes a mechanism for consulting with the European Food Safety Authority on matters related to food safety
Article 14 - Report to EC Council & Parliament: Requires regular reporting on food safety issues to the European Council and Parliament

Registration and Approval of Establishments (Article 4)

Requirement for Food Business Operators: Operators must ensure all products of animal origin are handled in registered or approved establishments.
Establishments Must Meet Requirements: These requirements include those outlined in Regulation (EC) No /2004, Annexes II and III of the Directive, and other relevant food safety legislation.
Requirement for Approval: Certain establishments handling products of animal origin (defined in Annex III) require specific approval from the competent authority.

Exceptions to Approval Requirement: Article 4

Primary Production: Approval not required for establishments engaged in primary production activities.
Transport Operations: Approval not required for establishments primarily involved in the transportation process.
Storage of Products: Approval not required for establishments storing products that do not require temperature-controlled storage conditions.
Retail Operations: Approval not required for retail operations excluding those specifically covered by the Directive.

Importation of Animal Products (Article 6)

Requirement for Food Business Operators: Operators importing products of animal origin must ensure these products are readily available for inspection upon importation, following the guidelines outlined in Directive 97/78/EC.

Documents for Animal Products (Article 7)

Requirements for Food Business Operators: Operators must provide certificates or other accompanying documentation for consignments of animal products, as mandated by Annexes II and III.
Model Documents and Electronic Documents: The procedure detailed in Article 12 allows for the creation of standardized documentation, including the use of electronic documents.

Annex II: HACCP Based Procedures

Requirements for Slaughterhouses: Operators of slaughterhouses must ensure their HACCP procedures meet the general requirements outlined in Regulation (EC) No 852/2004 and specific requirements detailed in Annex II.

Amendment and Adaption of Annex II and Annex III (Article 10)

Process for Adapting Annexes: Annexes II and III can be modified or updated based on:
- Developments in good practice guidelines
- Experiences with HACCP systems
- Technological advancements
- Scientific advice, including new risk assessments
- Microbiological and temperature criteria
- Changes in consumer preferences

Exemptions from Annexes (Article 10)

Process for Granting Exemptions: Exemptions from Annex II and III may be granted, ensuring that the objective of the regulation is maintained.

National Measures (Article 10)

Objective of National Measures: Member States can implement their own measures pertaining to Annex III, but they must uphold the overall objectives of the regulation.
Specific Aims of National Measures:
- Enabling the continued use of traditional methods in production, processing, or distribution.
- Accommodating the needs of businesses facing geographic constraints.
Scope of National Measures: These measures are primarily applied to the construction, layout, and equipment of establishments.

Notification Process for National Measures (Article 10)

Procedure for National Measures: Member States are required to notify the Commission and other Member States about any proposed national measures.
Content of Notification:
- Detailed description of the requirements to be adapted
- Nature of the proposed adaptation
- Foodstuffs and establishments involved

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Description

This quiz covers the key provisions of EC Directive 853/2004, focusing on regulations concerning meat transport, shellfish handling, and food safety mechanisms. Participants will also explore the registration and approval requirements for food business operators as outlined in the directive.