1. 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

2. 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

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

4. 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

5. 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

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

7. 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)

8. 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.

9. 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.

10. 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

11. 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

12. 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

13. 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;

14. 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

15. 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.

16. 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.

17. 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.

18. 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.

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

20. 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

21. 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

22. 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

23. 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

24. 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