EU Food Safety Requirements: - Hygiene of Foodstuffs - Achim Seiler, Trade Consultant and Capacity Building Specialist, Kathmandu EU Food Safety Requirements: - Hygiene of Foodstuffs - EU-Project: Trade and Private Sector Development (TPSD) TPSD is implemented by in cooperation with and

The legal and institutional context Verification of Import Control Requirements Food Safety and Quality Requirements in Target Countries National Standards and Technical Regulations Int. Standards (SPS and TBT): CAC, IPPC, OIE WTO-SPS and TBT Rights and Obligations

Regulation (EC) No 852/2004 Regulation (EC) No 852/2004 of the European Parliament and of the Council on the Hygiene of Foodstuffs

Regulation (EC) No 852/2004 (I) Chapter 1: General Provisions Chapter 2: Food Business Operators´ Obligations Chapter 3: Guides to Good Practice Chapter 4: Imports and Exports Chapter 5: Final Provisions Annex 1: Primary Production Annex 2: General Hygiene Requirements

Regulation (EC) No 852/2004 (II) Chapter 1: General Provisions Chapter 2: Food Business Operators´ Obligations Chapter 3: Guides to Good Practice Chapter 4: Imports and Exports Chapter 5: Final Provisions Annex1: Primary Production Annex 2: General Hygiene Requirements

Regulation (EC) No 852/2004 (III) Chapter 1 Chapter 2 Chapter 3 Chapter 4 Annex 1 Chapter 5 Annex 2

Regulation (EC) No 852/2004 (IV) Chapter 4: Imports and Exports As regards the hygiene of imported food, the relevant requirements of food law referred to in Article 11 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation. (Art. 10)

Regulation (EC) No 852/2004 (V) General Food Law (EC 178/2002), Art. 11: Food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognized by the Community to be at least equivalent thereto or, where a specific agreement exists between the Community and the exporting country, with requirements contained therein.

Regulation (EC) No 852/2004 (VI) Chapter 2: Food Business Operator´s Obligations Article 3: General Obligation Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.

Regulation (EC) No 852/2004 (VII) Chapter 2: Food Business Operator´s Obligations Article 4: General and Specifc Hygiene Requirements 1. Food business operators carrying out primary production and those associated operations listed in Annex 1 shall comply with the general hygiene provisions laid down in part A of Annex 1 and any specific requirements provided for in Regulation (EC) No 853/2004

Regulation (EC) No 852/2004 (VIII) Chapter 2: Food Business Operator´s Obligations Article 4: General and Specifc Hygiene Requirements 2. Food business operators carrying out any stage of production, processing and distribution of food after those stages to which paragraph 1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements provided for in Regulation (EC) No 853/2004

Regulation (EC) No 852/2004 (IX) Chapter 2: Food Business Operator´s Obligations Article 4: General and Specifc Hygiene Requirements 3. Food business operators shall, as appropriate, adopt the following specific hygiene measures: compliance with microbiological criteria for foodstuffs procedures necessary to meet targets set to achieve the objectives of this Regulation compliance with temperature control maintenance of the cold chain sampling and analysis

Regulation (EC) No 852/2004 (X) Chapter 2: Food Business Operator´s Obligations Article 5: Hazard analysis and critical control points Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles. The HACCP principles referred to in paragraph 1 consist of the following: a): identifying any hazards that must be prevented, eliminated or reduced to acceptable levels; b) identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;

Regulation (EC) No 852/2004 (XI) Chapter 2: Food Business Operator´s Obligations Article 5: Hazard analysis and critical control points c): establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, eliminnation or reduction of identified hazards; d): establishing and implementing effective monitoring procedures at critical control points; e): establishing corrective actions when monitoring indicates that a critical control point is not under control f): establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively; and

Regulation (EC) No 852/2004 (XII) Chapter 2: Food Business Operator´s Obligations Article 5: Hazard analysis and critical control points g): establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f) When any modification is made in the product, process, any step, food business operators shall review the procedure and make the necessary changes to it.

Regulation (EC) No 852/2004 (XIII) Chapter 2: Food Business Operator´s Obligations Article 5: Hazard analysis and critical control points 3. Paragraph 1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex 1.

Regulation (EC) No 852/2004 (XIV) Chapter 2: Food Business Operator´s Obligations Article 5: Hazard analysis and critical control points 4. Food business operators shall: Provide the competent authority with evidence of their compliance (…); Ensure that any documents describing the procedures developed in accordance with this Article are up-to-date at all times; Retain any other documents and records for an appropriate period.

Regulation (EC) No 852/2004 (XV) Chapter 2: Food Business Operator´s Obligations Article 6: Official Controls, Registration and Approval 1. Food business operators shall cooperate with the competent authorities in accordance with other applicable Community legislation or, if it does not exist, with national law.

Regulation (EC) No 852/2004 (XVI) Annex 1: Primary Production Scope Hygiene Provisions Record-Keeping Part B: Recommendations for Guides to Good Hygiene Practice

Regulation (EC) No 852/2004 (XVII) Annex 2: General Hygiene Requirements for All Food Business Operators (Except when Annex 1 Applies) General Requirements for Food Premises Specific Requirements in Rooms where Foodstuffs are Prepared, Treated or Processed Requirements for Movable and/or Temporary Premises Transport Equipment Requirements Food Waste Water Supply Personal Hygiene

Regulation (EC) No 852/2004 (XVIII) Annex 2: General Hygiene Requirements for All Food Business Operators (Except when Annex 1 Applies) Provisions Applicable to Foodstuffs Provisions Applicable to the Wrapping and Packaging of Foodstuffs 11. Heat Treatment 12. Training

Comparison of EU import controls for products of animal and non-animal origin Control Measure Non-animal Origin Animal Origin Exporting country must be on an EU list of approved countries NO Yes Exporting country must have EU approved competent authorities No, but must provide evidence of competent authority for phytosanitary measures No, but must provide evidence of competent authority for veterinary measures Exporting country must submit a control plan prior to export No No, but must provide information on certain zoonotic diseases, veterinary medicines and other pharmacologically active substances Exporting food business (establishment) must be on an EU list of approved establishments

Cont.d (I) Comparison of EU import controls for products of animal and non-animal origin Control Measure Non-animal Origin Animal Origin Exporting country must have EU approved reference laboratories No No, but laboratories that verify compliance to EU standards must be accredited. Exporting countries national food control systems are subject to inspection by EU inspectors from the food and and veterinary office (FVO) New guidance was issued by the EU in 2006 Yes HACCP required for primary production No, but is mandatory for animal feed producers HACCP required for post-harvest handling Yes, for processing of fresh cut products

Cont.d (II) Comparison of EU import controls for products of animal and non-animal origin Control Measure Non-animal Origin Animal Origin Prior notification of export must be given for each consignment No Yes Certific ates must be supplied with each consignment Yes, plant health certificate required Yes, animal health certificates and health and identification marks Source: A. Graffham