GMP

+

-certificationscheme 2006 Production of feed

Product Board Animal Feed Dik Wolters and Els van der Boon

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)

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

Layout of the new GMP documents

A. Basic documents

participation

B. Standards + appendices

requirements

C. Control + Certification

certificate

Layout of the B documents: standards

B1 Production & Processing B2 QC (until 12/2008) B3 Trade B4 Transport 01, 02, 03, 04, 06, 09 13 01, 05 (02, 03, 09) 01,07,08A, 08B, 08C B5 Storage & transhipment 01, 06

Layout of the B documents: standards

B6 Cultivation of feed materials 11 B7 Feeding 12 B8 Petfood B9 grass-feed chickens/ free-range animals 17-2, 17-3 B10 Laboratory 19 10

Layout of the B documents: appendices

1. Products standards 2. DRV 3. Negative list 4. Inspections & verification 5. EWS 6. Management statement 7. Recall 8. Traceability GMP 14 & 21 GMP 26 GMP 25 GMP 18A & 18B GMP 22 GMP 23 GMP 24 GMP 27

Layout of the B documents: appendices

9. Conditionally non-compliant feed materials 10. Purchasing 11. Intermediary guarantees 12. Animal feed legislation 13. Taking samples 14. Road transport 15. HACCP manual GMP 29 GMP 00 art. 5A GMP 07 Appendices GMP 20

B documents: standards

B1 Production & processing B2 QC (until 12/2008) B3 Trade B4 Transport 01, 02, 03, 04, 06, 09 13 01, 05 (02, 03, 09) 01,07,08A, 08B, 08C B5 Storage & transhipment 01, 06

GMP B1: old to new



Merging of 4 production standards B1 Production and Processing GMP 01 GMP 02 GMP 04 GMP 03 GMP 09 GMP 05 GMP 06

 

No distinction by type of animal feed Also includes requirements for storage and trade



Transport remains separate

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



Also includes requirements for storage and trade



Transport remains separate Intended for producers!

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!

Summary: scope of the standards Standard Target group Scope of some standards B3 B1 ‘trader’ ‘producer’ B4 ‘transporter’ Activities Trade Production 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 If also transport



B4

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

What does this mean for a company?

(Art. 4.1) - cont'd

• •

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) - conclusions √ 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?

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

Specification of scope on certificate Activities Production / Processing Transport Cultivation Trade Storage and transhipment Analyse Products 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

Structure of GMP + B1 Production Based on:



HACCP Foodstuffs NL



ISO 9001-2000

}

≈ ISO 22000



Feed Hygiene Regulation



Experience with GMP + standards

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)

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

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

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

What else is different in the standard?

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?

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?

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)

What else is different in the standard?

Chapter 6: Management of resources

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

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

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!)

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)

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

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

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

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

What is new in the appendices?

1. Product standards 2. DRV 3. Negative list 4. Inspections & verification 5. EWS 6. Management statement 7. Recall 8. Traceability GMP 14 & 21 GMP 26 GMP 25 GMP 18A & 18B GMP 22 GMP 23 GMP 24 GMP 27

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)

Layout of the B documents: appendices

9. Conditionally non-compliant feed materials 10. Purchasing 11. Intermediary guarantees 12. Animal feed legislation 13. Taking samples 14. Road transport 15. HACCP manual GMP 29 GMP 00 art. 5A GMP 07 Appendices GMP 20

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)’

Definitions Relationship between products and feeds

-

Feeds

-

Compound feeds

-

Feed materials

-

Feed additives

-

Premixes

Products also include:

-

Feed medicines

-

Processing aids

-

Cleaning agents

-

etc.

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.

Appendix 10 Minimum requirements for purchasing: b) with equivalent / approved certificate (7.11.1b) Product / Service All Compound feed + feed material Feed material Standard Ovocom QS Femas, IFSA GTP FFCAT, GZP Remarks Only QS system partners Addtional requirements Grains, seeds and legumes Bakery waste product Graded potatoes Foodstuffs Analysis Hyg. Code ‘HACCP’ ISO 17025 (‘under construction’) Addtional requirements

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

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

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

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

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

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