1. GMP + -certificationscheme 2006 Production of feed Product Board Animal Feed Dik Wolters and Els van der Boon

2. Why redesign the GMP programme? Reasons:  ISO 9001:1994  ISO 9001:2000  NL-HACCP Food has been updated  Improve accessibility  more logical sequence, remove duplicates  National focus  international (EU)  Ready for accreditation  Change to Feed Hygiene Regulation (Reg. (EG) 183/2005)

3. Final result The GMP + certification scheme is:  Up-to-date  Applicable internationally  Covers complete animal feed sector  Is supported by the animal production chain  'Feed Hygiene Regulation'-proof

4. Layout of the new GMP documents participation requirements certificate

5. Layout of the B documents: standards

7. Layout of the B documents: appendices

9. B documents: standards

10. B1 Production and Processing  No distinction by type of animal feed GMP B1: old to new  Merging of 4 production standards  Transport remains separate  Also includes requirements for storage and trade

11. Scope GMP B1: Production & Processing of Feeds  All forms of physical interaction with animal feed  grinding, mixing, pelletizing  extrusion, expansion  cleaning, drying  bagging / packing  internal storage and internal transport  etc.  All types of feed Intended for producers!  Transport remains separate  Also includes requirements for storage and trade

12. Scope GMP B3: Trade in animal feeds  All trade (= purchasing and selling)  administrative  ‘paper office’  All types of feed  No requirements for production & processing  Storage & simple processing  B1 Intended for traders!

13. Summary: scope of the standards Scope of some standards StandardB3B1B4 Target group‘trader’‘producer’‘transporter’ ActivitiesTradeProduction and Processing Transport If in addition to production also trade or storage  no problem, requirements included in B1 If in addition to trade also storage or simple processing   B1 If also transport  B4

14. What does this mean for a company? (Art. 4.1) 1.Describe the feeds + the activities related to the feeds All feeds and activities for which there is a standard must be in system 2.Describe the locations All locations where the feed activities take place must be in the system 3.Describe other activities May not influence safety

15. 4. Establish exceptions ‘Paper’ trade in non-GMP feeds Pet foods 5. Establish contracted out work All activities for which there is a standard: GMP All other matters: under own control What does this mean for a company? (Art. 4.1) - cont'd

16. What is the scope of my system?  Activities/feeds & locations Which standard(s) must I apply? Which requirements must I apply? What is on the certificate? What does this mean for a company? (Art. 4.1) - conclusions √ √ √ √

17. Specification of scope on certificate  In accordance with fixed terminology  Combination of activities and feeds  Activities  Derived from names of standards  Animal feeds  All animal feeds  Goes on PDV website  In free section you can specify

18. ActivitiesProducts Production / Processing Transport Cultivation Trade Storage and transhipment Analyse Feed materials Premixes Feed additives Compound feed Pet foods in accordance with standards B1 and B4.1 ( or another standard) In the free section you can specify, for example  Production of poultry feeds  Production of calves milk  Collection and drying of grains Specification of scope on certificate

19. Structure of GMP + B1 Production  Feed Hygiene Regulation  Experience with GMP + standards } ≈ ISO 22000 Based on:  HACCP Foodstuffs NL  ISO 9001-2000

20. Amendments to the content  New HACCP system  Prerequisite programme integrated  New ISO 9001:2000 content/structure  Chapter layout  Description changed in accordance with feed safety (instead of quality)

21. Amendments to the content  Addition of new requirements from the Feed Hygiene Regulation  Requirements from Appendix II included  Experience with GMP standards  Basic quality  feed safety  Less administration such as procedures, lists and overviews

22. General structure of the standard 8 chapters, as in ISO9001 1 to 3:Scope, definitions, etc. 4: Feed Safety System 5: Management Responsibility 6: Management of resources 7: HACCP + Process control 8: Measurement, analysis and improvement

23. What else is different in the standard? Specification of major changes per chapter Chapter 1 Subject and scope … Chapter 2 Normative references …. Chapter 3 Terms and definitions ….. …. have already been discussed

24. Chapter 4 Feed safety system Scope of the system (4.1): has already been discussed Fewer prescribed procedures (4.2):  Control of calibration / maintenance of measuring devices  Handling, storage and packaging  Statistical techniques What else is different in the standard?

25. Fewer mandatory lists (4.2):  No list of suppliers  No quarterly overview of analyses carried out  No list of analyses carried out per laboratory Management statement no longer has to be send to certification body Keeping period for records (4.2)  from 2  3 years What else is different in the standard?

26. Chapter 5 Management responsibility More emphasis as a result of HACCP and the General Food Law Management review (5.5)  more explicity summary of input (5.5.2) and output (5.5.3)

27. What else is different in the standard? Chapter 6: Management of resources

28. What else is different in the standard? Chapter 6: Management of resources Personnel (6.2)  Good care because of feed safety  Protective clothing if necessary  Rules with respect to eating, drinking and smoking

29. What else is different in the standard? Environment, buildings, production areas, equipment (6.3) Environment/terrain (6.3.1/6.3.2.1)  Awareness of risks from the environment Production facilities (6.3.2.2)  More explicit control of vermin  Water which is used is safe for animals  Sufficient light  No admittance for unauthorised persons  Visitors' regulations

30. What else is different in the standard? Working environment (6.4)  Covers the daily work activities cleaning and disinfection, vermin control, maintenance, waste control (new!)

31. What else is different in the standard? Summary of Chapter 6 Care for: Good personnel Good facilities (including rooms, equipment) Work tidy and clean  prerequisites for successful application of HACCP (Chapter 7) √ √ √

32. What else is different in the standard? Chapter 7 HACCP + Process control Prerequisite programme (7.1)  included more explicitly in B1  requirements can be found in chapters 6+7 Control measures (7.6)  General control measures: part of prerequisite programme not linked to CCP previously point of attention

33. What else is different in the standard? Control measures (7.6)  Specific linked to CCP often measurable such as time and temp. supported by standards, monitoring and corrective actions

34. What else is different in the standard? Validation (7.10) Does the HACCP system work?  Verification: assessment after  Validation (new):rassessment before  Hazards founded and complete  Risk classification founded  Control measures sufficient  Monitoring plan adequate  Corrective actions adequate  by validation team  HACCP team + independent members

35. What else is different in the standard? Chapter 8 Measurement, analysis and improvement  More attention for continuious improvement  Follows HACCP  Consciously engaged  compliance with chain requirements and legislation  Corrective measure  prevention of non conformities  Corrective action (7.9)  correcting non conformities

36. What is new in the appendices?

37. Appendix 4 Minimum requirements for inspection and control  Merging of GMP 18a & b and action plans  Protocols with standard layout  Duplicates removed  Report analyses results to the Undesirable Substances (DOS) Database  Analysis obligation on feed materials for livestock companies has lapsed (except for Salmonella) Cross-reference table as aid (www.pdv.nl)

38. Layout of the B documents: appendices

39. Appendix 10 Minimum Requirements for Purchasing  Linked to 7.11 Purchasing  Make sure you get what you ordered  Strict requirements based on(7.11.1): ‘Purchase animal feeds and services from GMP + - certified companies’ + ‘Risk assessment published in Feed Materials Risk Assessment (DRV) database (= feed material can be controlled)’

40. Definitions Relationship between products and feeds  Feeds  Compound feeds  Feed materials  Feed additives  Premixes Products also include:  Feed medicines  Processing aids  Cleaning agents  etc.

41. Appendix 10 Minimum requirements for purchasing a) with GMP + -certificate (7.11.1a)  Compound feeds, premixes, feed materials and feed additives  O&O, transport, production & processing, analyses  Also: bagging, packaging, contract production, storage, etc.

42. Appendix 10 Minimum requirements for purchasing: b) with equivalent / approved certificate (7.11.1b) Product / ServiceStandardRemarks AllOvocom Compound feed + feed material QSOnly QS system partners Feed materialFemas, IFSA GTP Addtional requirements Grains, seeds and legumes FFCAT, GZP Bakery waste product Graded potatoes Hyg. Code Foodstuffs‘HACCP’(‘under construction’) AnalysisISO 17025Addtional requirements

43. Appendix 10 Minimum requirements purchasing: c) as Gatekeeper (7.11.1c)  Producer is not GMP + -certified  As client you ct as guarantor  Policy = case by case (per type of animal feed and/or origin)  Gatekeeper on extra conditions  Checking takes place during audit at customer  At this moment concrete requirements for  Feed additives  Products from grower (grain, seeds, legumes but also straw and hay)  Some feed materials: entry check

44. Appendix 10 Minimum requirements purchasing: c) as Gatekeeper (7.11.1c) Feed materialStandardRemarks Intervention powder dairy-- Intervention grain-entry check Dairy powders (food grade)-‘oval’ Straw-Entry check palm oil-Requirements + entry check Grains, seeds and legumes-Requirements + entry check

45. Appendix 10 Minimum requirements purchasing: c) other products/services (7.11.1d)  self assessment and check  assess and control the risks  Silo cleaning  Vermin control  Cleaning and disinfection agents

46. Practical consequences of the transition Manuals:  In accordance with new GMP B1 and/or  By way of good cross-reference table Cross-reference tables as aids www.pdv.nl

47. Transitional period GMP + 2003 - 2006  Per 1 January 2006  GMP + 2006 replaces GMP + 2003  2006 transition year  the two schemes run alongside one another in 2006  GMP participant & certification body: contract GMP + 2006  Audit on the basis of GMP + 2006  Certificate GMP 2003 Certificate GMP 2006

48. What is still to be changed or developed?  Some GMP standards (cultivation, feeding)  Residue norms (MRLs) and carry-over  Uniformity of mixing  Monitoring  Gatekeeper for food  Supplier assessment and selection  Sampling protocols  HACCP manual