1. The European Feed Manufacturers’ Guide: new chapters on medicated feed and HACCP guidance Alexander Döring FEFAC Secretary General

2. The EFMC ….
Is the first Community guide to good practice for the EU industrial compound feed and premixtures manufacturing sector for food-producing animals
Meets the demands of EU Feed/Food legislation harmonisation (Jan. 2006, Feed Hygiene Reg. (EC) No 183/2005)
Only covers safety related issues
Help ensure safety of food through adherence to good Manufacturing practice during purchase, handling, storage, processing and distribution of feed for food producing animals
16 September 2010
TAIEX Sofia, Bulgaria

3. Building up an HACCP-based QA system all along the feed chain:
Full traceability Recall procedure
Sourcing of feed ingredients
System certified by an independent body
FEFAC
EFMC
Pro-
cessor
Con-
sumers
Farm
Re-
tailers
Feed
supply

4. European Feed Manufacturers Code Key points
Building up an HACCP-based QA system all along the feed chain:
Scope
Full traceability
Recall procedure
Sourcing of feed materials
System certified by an independent body
Making sure that all operators in the feed chain are under control (role of the legislator)
Collaboration with downstream partners
Collaboration with upstream partners

5. Development of the European Feed Manufacturers Code (EFMC)
July 2005 – FEFAC expert group evaluation of EFMC with regard to possible accreditation
January/October 2005 – 1st National Benchmarking of Codes against EFMC and development of national Codes on basis of EFMC (22 national codes)
November 2005 – Public launch event of EFMC with participation of European Commission (DG SANCO)
January 2007 – EFMC positive assessment by Standing Committee (SCOFCAH)
March 2007 – Publication of the EFMC in the OJ C 64
November 2009 – 1st EFMC review : positive SCOFCAH assessment on new chapters medicated feed and HACCP guidance
16 September 2010
TAIEX Sofia, Bulgaria

6. Country (association) Scope of national scheme *
Accreditation possible
Certification system available
Governmental endorsement
Austria (VFÖ) M
YES
Belgium (OVOCOM)
PM, RM, M, T, FA
Croatia (CFIA)
M, PM
Cyprus (CFA)
Czech Republic
(CSMO ZZN)
PM, M
Denmark (DAKOFO)
Yes
Finland (FFDIF)
France (SNIA/SYNCOPAC)
Germany (QS)
M, T, RM
Ireland (IGFA) – integration of UK’s code
M, PM, RM, T NO
Italy (ASSALZOO)
M, PM, T
March 2008
* M = Feed manufacturing PM = Pre-mixtures RM = Raw materials T= Transport FA = Feed additives
16 September 2010
TAIEX Sofia, Bulgaria

7. Country (association) Scope of national scheme *
Accreditation possible
Certification system available
Governmental endorsement
Lithuania (LGPA)
Luxembourg (OVOCOM)
PM, M, T
YES
Netherlands (PDV)
RM, PM, M, T
Poland (IZBA Gospodarcza) M
Portugal (IACA)
PM, M
Slovakia (AFPWTC)
Slovenia (GZS)
Spain (CESFAC)
Sweden
Code not requested at the moment _
Switzerland
M, PM, RM, T
United Kingdom (AIC)
* M = Feed manufacturing PM = Pre-mixtures RM = Raw materials T= Transport FA = Feed additives
16 September 2010
TAIEX Sofia, Bulgaria

8. Responsibilities of feed business operators
Article 17 of GFL (178/2002): “Food and feed business operators at all stage of production, processing and distribution within the businesses under their control, shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met.” Art (4) of Feed Hygiene Reg 183/2005: “1. Feed business operators shall ensure that all stages of production, processing and distribution under their control are carried out in accordance with Community legislation, national law compatible therewith, and good practice. They shall ensure in particular that they satisfy the relevant hygiene requirements laid down in this Regulation. 2. When feeding food-producing animals, farmers shall take measures and adopt procedures to keep the risk of biological, chemical and physical contamination of feed, animals and animal products as low as reasonably achievable.”
16 September 2010
TAIEX Sofia, Bulgaria

9. The EFMC …
Covers all stages for manufacturing of premixtures, compound feedingstuffs and medicated feed from intake of feed ingredients to distribution of final products
Provides practical information for benchmarking of Codes of Practice to facilitate mutual recognition of national Codes of Practice
Ensures that coexistence of nationally developed Quality Assurance Systems does not lead to unjustified EU trade barriers
TAIEX Sofia, Bulgaria
16 September 2010

10. European Feed Manufacturers Guide Key points
Building up an HACCP-based QA system all along the feed chain:
Scope
Full traceability
Recall procedure
Sourcing of feed materials
System certified by an independent body
Making sure that all operators in the feed chain are under control (role of the legislator)
Collaboration with downstream partners
Collaboration with upstream partners
16 September 2010
TAIEX Sofia, Bulgaria

11. Outcome of the Standing Committee (SC) assessment of the EFMC
Positive assessment of the EFMC on 29 January 2007
Minor corrections requested by the SC before publication already integrated in a revised version of the EFMC
The section dedicated to medicated feed shall be reviewed and developed in collaboration with Member States
Publication of the references of the EFMC in the OJ C 64 (2007)
16 September 2010
TAIEX Sofia, Bulgaria

12. Hygiene requirements for the manufacturing of medicated feed: 2 sets of legal provisions
Feed Hygiene Regulation (EC) No 183/2005:
Regulation covering …
Common feed safety/hygiene requirements, with …
Voluntary …
European / national…
Guides to good practice
Medicated Feed Directive 90/167/EC:
Directive covering …
Medicated feed, with …
Mandatory compliance with …
National …
Good Practice rules
16 September 2010
TAIEX Sofia, Bulgaria

13. Principles of the new EFMC version regarding medicated feed
Introduction:
Medicated feed is a feed (ref. to summary record of the Veterinary Pharmaceutical Committee – 20 March 2007)
National codes of practice take precedence over EFMC
Core part of EFMC:
Withdrawal of all references to medicated feed from the previous version of the core part of EFMC
New Annex 1: Sector note medicated feed
Development of a specific annex mirroring the structure of the EFMC and providing specific requirements for medicated feed
16 September 2010
TAIEX Sofia, Bulgaria

14. Sector note on medicated feed: key principles
Based on existing national good practices for medicated feed
In case provisions in national implementing rules are significantly divergent or the Directive leaves it to MS to derogate from basic rules, the wording of the Directive was used, e.g.:
Derogation for intermediate products,
Storage of medicated feed and premixtures,
Derogation for manufacturing before emission of a prescription,
Period of validity of the prescription (max. 3 months),
Derogation for medicated feed produced from several medicated premixtures,
Rules for medicated feed for placing on the market of another MS,
Period of record keeping (at least three years),
Derogation for delivery via retailers,
Transport of medicated feed
16 September 2010
TAIEX Sofia, Bulgaria

15. Key principles (1)
Designation of a Medicated Feed Manager responsible for
control of orders of medicated premixtures
list of authorised medicated premixtures,
list of approved suppliers,
scheduling programme,
approval of reworks of internal returns
validation of the register
Management of risk of carry-over
Control plan (criteria, record keeping, actions in case of non-conformity)
Avoiding manufacturing of “finisher” feed or feed for continuously producing animals after medicated feed
Cleaning procedures
16 September 2010
TAIEX Sofia, Bulgaria

16. Key principles (2) Reworks Prescription
Returns from farms not accepted
Internal return may be reworked after approval by Medicated Feed Manager
Prescription
Delivery of medicated feed only if accompanied by prescription
Prescription valid for no more than 3 months
16 September 2010
TAIEX Sofia, Bulgaria

17. FEFAC approach on EFMC review (1)
Practical examples of HACCP in feed production
Reviewed section A of EFMC containing a separate Guide to assist operators in applying a HACCP system
Detailing principles and not examples
Danger that examples are used exclusively
Operators must apply the principles to every different application
Training is the key to successful HACCP (EUFETEC HACCP training module)
16 September 2010
TAIEX Sofia, Bulgaria

18. FEFAC approach on EFMC review (2)
Responsibilities of feed business operators
Inclusion in the introduction of the Guide, of an explicit reference to the General Food Law guidance document and in particular on article 17 dedicated to the responsibilities of Feed Business Operators
a Code of Practice should not repeat the law (but requires/explains how to comply with it)
16 September 2010
TAIEX Sofia, Bulgaria

19. FEFAC approach on EFMC review (3)
Risk-based analysis of best practice to ensure effective tracing of products
EFMC already requires product traceability
HACCP deals with cross contamination
Internal traceability provisions in the EFMC have been further improved
Specific requirements have been added to each relevant chapter of EFMC
16 September 2010
TAIEX Sofia, Bulgaria

20. FEFAC approach on EFMC review (4)
Other hazards, such as fertilisers and plant protection products
EFMC requires
Raw Material Approval
Raw Material Supplier Evaluation
Raw Material Checking at Intake
HACCP
Together these requirements should address “other hazards” (pesticides mentioned in guidance for HACCP
16 September 2010
TAIEX Sofia, Bulgaria

21. EFMC Committee Working programme for 2010
EU feed hygiene workshop, 18 November 2010 :
Review of FVO Mission results on implementation of Reg 183/2005
Leadership of the EFMC Committee
International harmonization of feed safety approaches (CODEX code of good practice for animal feeding, new CODEX Task Force)
Monitoring of implementation of national codes of practices
Review of the EFMC on Standing Committee request
Co-leadership of the EFMC Committee
Microbiological risk management for feed with EU feed chain partners
Consultation & Dialogue with EU feed chain partners on EU guides of good manufacturing practice
Establishment of a voluntary and non-exhaustive EU Catalogue of feed materials
16 September 2010
TAIEX Sofia, Bulgaria

22. Thank you for your attention