GMP+ Feed Safety Assurance scheme BA Product standards GMP+ BA1 1 Version: 1st January 2010 Estffective from: 1 January 2010 Identical with version 5 November 2009 of GMP+:2006 EN ' GMP+ International . All rights reserved. The information in this publica-tion may be consulted on the screen, downloaded and printed as long as this is done for your own, non-commercial use. For other desired uses, prior written permission should be obtained from the GMP+ International .
TABLE OF CONTENTS 1 INTRODUCTION.............................................................................................4 GENERAL...................................................................................................4 STRUCTURE OF THE GMP+ FSA SCHEME....................................................4 PART A: PRODUCT STANDARDS.......................................................................6 1 INTRODUCTION TO THE PRODUCT STANDARDS.....................................6 2 CONDITIONS..................................................................................................6 3 SUMMARY GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR................................................................................................................8 4 RESIDUE LEVELS OF PESTICIDES IN FEEDS...........................................40 INTRODUCTION.........................................................................................40 THE ESTABLISHMENT OF AN MRL..............................................................40 General...............................................................................................40 Questionnaire for basic products.........................................................42 Questionnaire for by-products.............................................................43 Questionaire for compound feeds.......................................................45 Fumigators..........................................................................................46 SPECIAL REQUIREMENTS..........................................................................46 PART B: RESIDUE STANDARDS.......................................................................47 1 INTRODUCTION...........................................................................................47 2 ADDITIONAL PROVISIONS.........................................................................48 GENERAL.................................................................................................48 COMPOUND FEED.....................................................................................49 Installation Carry-over level:................................................................49 . The coefficient.................................................................................49 . Carry-over and flush batches...........................................................50 Items for attention and other remarks..................................................50 PREMIX...................................................................................................51 General...............................................................................................51 Direct contamination...........................................................................51 Indirect contamination.........................................................................51 3 RESIDUE STANDARDS FOR CRITICAL ADDITIVES..................................52 Summary of residue standards for coccidiostats and histomonostats.....52 GMP+ BA1 Product Standards 2/61 1st January 2010 GMP+ International
Additional information for some coccidiostats and histomonostats *.......57 4 RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL PRODUCTS.........................................................................................................58 Summary of residue standards for critical veterinary medical products...58 Additional information per critical veterinary medical product..................59 GMP+ BA1 Product Standards 3/61 1st January 2010 GMP+ International
1 Introduction General The GMP+ Feed Safety Assurance scheme (GMP+ FSA) has been developed sin-ce 1992. It was managed from 1992 up until 2009 by the Product Board Animal Feed, The Hague, The Netherlands. Since 2010, this scheme is managed by GMP+ International. It is a scheme for assuring feed safety in all the links in the feed chain. It is also an international scheme, applicable worldwide. The establishment and development of the scheme was primarily the result of de-mand from the subsequent links in the animal production chain for better control of feed safety. Another contributory factor was the damage caused by more and less serious contamination incidents. In the initial phase the demand arose for better differentiation in an increasingly saturated European sales market for animal products. Since 1999, feed & food safety has been a top issue internationally both politically and commercially, be-cause of serious incidents in the feed sector. Because of this, demonstrable assur-ance of feed safety has become a sales prerequisite. The basic principle of the GMP+ FSA scheme is that the feed chain is part of the whole animal production chain. Proper assurance of feed safety worldwide is a high priority. Companies must live up to their responsibilities and respond properly and convincingly to the needs of animal production. The GMP+ FSA scheme is an aid to realise this. Structure of the GMP+ FSA scheme The documents within the GMP+ FSA scheme are subdivided into a number of series. A description follows of these: These documents contain the requirements for Aparticipation in the certification scheme for com- Gpanies and certification bodies (framework regu-eneral (framework) docu-mlation, the use of logo s, etc.). This series also in-ents cludes a general list of definitions and abbrevia-tions. These documents contain the international stan-dards and additional country notes for use by Bcompanies with respect to the various feed prod- Sucts and production phases including cultivation tandardative documents. and industrial production, treatment and process- ing, collection, trade, means of transport, storage and transhipment. GMP+ BA1 Product Standards 4/61 1st January 2010 GMP+ International
These documents are divided in several subgroups, with a code and a name Document Code Name ⇒ Standard GMP+ Bxx ⇒ Appendix GMP+ BAxx . GMP+ BA1 Product Standards ⇒ Country Note GMP+ BCNxx These documents contain the Rules of Certifica-tion including those for the approval of certifica-tion bodies and auditors, the frequency of audits, C minimum audit time, assessment criteria, check-Certification requirements lists, etc. There is also an explanation of how the supervision by certification bodies is implemented and of how GMP+ International supervises the certification process. In addition to the above-mentioned standardative D documents, there are also supporting documents Interpretations and accompa-in the D series including a list of frequently-asked nying texts questions, manuals and guidances with additional information. All these documents are available through the website of GMP+ International (). The document in the present case is referred to as appendix GMP+ BA1 Product Standards and is part of the GMP+ FSA scheme. It has a structure of its own. GMP+ Appendices (GMP+ BAxx), to which there are also references, are separate GMP+ documents within the B segment of the GMP+ FSA Scheme. If there is a reference to such a GMP+ BAxx-appendix, then it applies within the framework of this standard. GMP+ BAxx-appendices are indicated as such. Next to this, also reference to a number of other appendices may be made. These appendices are in that case only part of this document, and are attached to it. To indicate them, only the word appendix is used. GMP+ BA1 Product Standards 5/61 1st January 2010 GMP+ International
PART A: PRODUCT STANDARDS 1 Introduction to the product standards There are references in the various GMP+ standards to the product standards. This part of this appendix contains the statutory and GMP+ standards with respect to contaminants. The product standards included in this appendix are a. based on the statutory standards for products in the European Union or na-tionally (the Netherlands), or b. as determined within the framework of the GMP+ FSA scheme in consulta-tion with the subsequent links in the animal production chain. The following standards apply in addition to those in the tables: the list of permitted additives in the Netherlands in accordance with Directive (EC) No. 1831/2003 and the residue standards in part B of this appendix. DISCLAIMER: The GMP+ International has adopted this list in order to inform in-terested parties with respect to the standards in the legislation (European Union and national) and additional GMP+ standards. The list will be regularly updated. The GMP+ International is not liable for any errors in this list. 2 Conditions In arriving at the standards a distinction has been made between action and rejec-tion limits. The action limits for undesirable contaminants is appreciably lower than the rejection limit. Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. Where the action limit is exceeded an investigation must be carried out into the: - source of the contamination and measures must be taken to - remove or limit the source of the contamination. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If the rejection limit is exceeded then the product is not suitable for use as a feed material or animal feed. In the various GMP+ standards it is stated that the participant must ensure that deviations (in the product or process) from the requirements in this standard are recorded and controlled in order to prevent unintentional use or delivery of the product. GMP+ BA1 Product Standards 6/61 1st January 2010 GMP+ International
Standard for mixes of feed materials which are marketed as feed material on car-rier : The standard for the maximum level of undesirable substances is calculated pro-portionately from the standard for the individual components. This calculation prin-ciple is also applied for the calculation of the standard for pesticides for compound feeds (see section question ). GMP+ BA1 Product Standards 7/61 1st January 2010 GMP+ International
3 Summary GMP+ product standards for the animal feed sector Contaminant Product Action(1) limit Rejection lim(1)it Source Supplementary require-Analysis method7 ments Microbiological M1 Antibacterial inhibition - Feed materials - < 15 mm GMP+ According to the 5-plate OZM Part 1; O-1 test MB003, derived from EG-4-plate test, product basis (RIVM report no. 206; Archiv fur Lebensmit-telhygiene 31 (1981) page 97-140. - Wet mixes M3 Enterobacteriaceae Feed for pets and dog bones - 300 kve/gram Reg. 1774/2002 n = 5, c = 2, m = 10, M = OZM Part 2; M-3 300 in 1 gram14 , Tinned feed for pets which has been subjected to heat treatment with a Fc value of at least 3 does not necessarily have to be sampled and tested for Salmonella and En- terobacteriaceae. M4a Salmonella Consumption chick feed: end products GMP+ OZM Part 2; M-2a and feed materials for: to M2e - Top breeding consumption chicks - 0+%20 (approaching 0%) - Breeding increase consumption chicks0 - 0+%2 (approaching 0%) GMP+ BA1 Product Standards 8/61 1st January 2010 GMP+ International
Contaminan)t Product Action lim(1it Rejection(1) limit Source Supplementary require-Analysis method7 ments Microbiological - Increase consumption chicks - 0+%20 (approaching 0%) - Consumption chicks - 0+%20 (approaching 0%) Laying poultry feed: end products and GMP+ feed materials for: - Top breeding laying poultry - 0+%20 (approaching 0%) Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary Analysis requirements method7 - Raising20 increase laying poultry - 0+% (approaching 0%) - Increase laying poultry - 0+%20 (approaching 0%) - Laying-hens and breeding hens 1% 0+%20 (approaching 0%) for S. enteritidus and S. typhimurium Turkey feed: end products and feed GMP+ materials for: - Raising increase turkeys - 0+%20 (approaching 0%) - Increase turkeys - 0+%20 (approaching 0%) - Consumption turkeys0 - 0+%2 (approaching 0%) Other animal feeds, feed materials and - Absent in 25 gr GMP+ wet mixes intended for cattle farms (except for poultry feeds). Feed for pets and dog bones - Absent in 25 gr Reg. 1774/2002 n = 5, c = 0, m = 0, M = 0 14 Tinned feed for pets which has been subjected to heat treatment with a Fc value of at least 3 GMP+ BA1 Product Standards 9/61 1st January 2010 GMP+ International
Contaminan(1)t Product Action lim(1)it Rejection limit Source Supplementary require-Analysis method7 ments Microbiological does not necessarily have to be sampled and tested for Salmonella and En-terobacteriaceae. Mion can be 4b Salmonella preservation - Feed materials for delivery to cattle Maximum pH for guar-GMPIf preservat+ aOZM Part 2; M-5 chieved at a higher pH determined through pH farms, and antee: then this should be sup-ported with data. - Wet mixes for delivery to livestock farmers on the basis of: - Spontaneous lactic acid fermentation - These standards do not apply if the products are - Add organic acids 4 supplied at a temperature of at least 60 C and the - Add anorganic acids 3,5 supplier is demonstrably informed of the storage conditions. The absence of Salmo-nella can also be shown in heat-treated wet mixes and feed materials (<13% moisture) through compli-ance with the standards for Enterobacteriaceae, M5 Moulds - Feed materials for delivery to cattle - 10,000 kve/gram GMP+ OZM Part 2; M-4 farms, and - Wet mixes for delivery to cattle farm- ers with an Aw value > (if this is not known then a moisture content > 13%) GMP+ BA1 Product Standards 10/61 1st January 2010 GMP+ International
Contam(1)inant Product Action limit Rejection) lim(1it Source Supplementary require-Analysis method7 ments Chemical C1 Aflatoxin B1 Feed materials intended for (direct) - mg/kg GMP+ OZM Part 2; delivery to dairy farmers OSP1a to 1e All feed materials - mg/kg Directive 2003/100/EEG Complete animal feeds for cattle, sheep - mg/kg amending Directive and goats with the exception of: 2002/32/EEG - dairy cattle - mg/kg - calves and lambs - mg/kg Complete animal feeds for pigs and - mg/kg poultry (with the exception of young animals) Chemical Other complete animal feeds - mg/kg Supplementary animal feeds for cattle, - mg/kg sheep and goats (with the exception of supplementary animal feeds for dairy cattle, calves, lambs) Supplementary animal feeds for pigs - mg/kg and poultry (with the exception of young animals) Other supplementary animal feeds - mg/kg GMP+ BA1 Product Standards 11/61 1st January 2010 GMP+ International
Contaminan(1)1)t Product Action limit Rejection lim(it Source Supplementary require-Analysis method7 ments Chemical C2 Aldrin } separately a l l a n i m a l f e e d s , w i t h t h e e x c e p t ion of: - mg/kg Directive OZM Part 2; OSP- } or 2002/32/EG 11 } jointly } expressed in D- fats and oils, 0,1 mg/kg ieldrin }dieDirectiveldrin - fish feed mg/kg 2006/77/EEG amending Directive 2002/32/EEG C3 Arsenic16 Feed materials, with the exception of: - 2 mg/kg Directive OZM Part 2; OSP-2003/100/EEG 26 - ground grass meal, alfalfa meal and - 4 mg/kg amending Directive clover meal and also molassed and 2002/32/EEG unmolassed dried sugar beet pulp - Palm kernel flakes - 4 mg/kg15 - phosphates and limestone - 10 mg/kg - calcium carbonate - 15 mg/kg - magnesium oxide - 20 mg/kg - animal feeds obtained by processing - 15 mg/kg15 fish or other sea creatures - ground dried seaweed and feed mate-- 40 mg/kg15 rials on the basis of seaweed GMP+ BA1 Product Standards 12/61 1st January 2010 GMP+ International
Contaminan(1)t Product Action limit Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical complete animal feeds, with the excep-- 2 mg/kg tion of: - complete fish feed and complete ani-- 6 mg/kg15 mal feed for fur-bearing animals complete animal feeds, with the excep-- 4 mg/kg tion of: - mineral mixes - 12 mg/kg C4 Prussic acid Feed materials, with the exception of: - 50 mg/kg Directive OZM Part 2; OSP-9 2002/32/EG - linseed - 250 mg/kg - linseed cake - 350 mg/kg - cassava products and almond cake, - 100 mg/kg complete animal feeds, with the excep-- 50 mg/kg tion of: - complete animal feeds for chicks - 10 mg/kg C5 Biogenic amines* - Animal feeds> 30% crude protein - 4,000 mg/kg. protein GMP+ * In as far as these are OZM Part 2; OSP-created by decay due to 23 protein decay and are not the consequence of the standardal processing of the product C6 Cadmium2 Feed materials of vegetable origin, - 1 mg/kg Directive OZM Part 2; OSP-2005/87/EEG 27 Feed materials of animal origin - 2 mg/kg amending Directive 2002/32/EEG Feed materials of mineral origin, with the 2 mg/kg exception of: - phosphates - 10 mg/kg GMP+ BA1 Product Standards 13/61 1st January 2010 GMP+ International
Contaminan)t Product Action lim(1it Rejection(1) limit Source Supplementary require-Analysis method7 ments Chemical Feed additives, belonging to the func-- 10 mg/kg tional group "Compounds of trace elements", with the exception of: - copper oxide, manganese8 (II)oxide, - 30 mg/kg zinc oxide and manganese (II) sulphate-monohydrate Feed additives belonging to the func-- 2 mg/kg tional group "Binding agents and thin-ners" Premixes - 15 mg/kg8 Mineral mixes - containing < 7% phosphorus - 5 mg/kg - containing> 7% phosphorus - mg/kg per 1% phosphorus, with a maximum of mg/kg Additional animal feeds for pets - 2 mg/kg Other supplementary animal feeds - mg/kg Complete animal feeds for cattle, sheep - 1 mg/kg and goats and fish feed with the excep-tion of: - complete pet feeds - 2 mg/kg - complete animal feeds for calves, - mg/kg lambs and goat lambs and other com-plete animal feeds Con limit is ex-7 Chloride - Feed materials for delivery to cattle 10 g/kg (dry 10x the action limit (dry GMPIf the acti+ ceeded then a warning oOZM deel 2; OSP-r farms, and matter) ma21tter) processing advice must 22 be demonstrably commu-nicated to the customer. GMP+ BA1 Product Standards 14/61 1st January 2010 GMP+ International
Contaminan)t Product Action lim(1it Rejection(1) limit Source Supplementary require-Analysis method7 ments Chemical - Wet mixes for delivery to cattle farm- ers. C8 Chlorocamphene Fish, other sea creatures and - mg/kg Directive OZM Part 2; OSP-(toxaphene) sum of (by)products thereof with the exception 2005/86/EEG 11 the indicators CHB 26, of fish oil amending Directive 50 and 627 2002/32/EEG - fish o8il - mg/kg - fish food8 - mg/kg C9 Chlordane (sum of cis- all animal feeds, with the exception of: - mg/kg Directive OZM Part 2; OSP-en transisomers and of 2002/32/EG 11 oxychlordane expressed in Chlordane) - fats and oils - mg/kg Directive 2006/77/EEG amending Directive 2002/32/EEG CMicroscopic deter-10 Crotalaria spp. All animal feeds - 100 mg/kg Directive mination in accor-2002/32/EG dance with the instructions of the manufacturer C11 DDT (sum of DDT-, all animal feeds, with the exception of: - mg/kg Directive OZM Part 2; OSP-DDD- (or TDE-) and 2008/76/EEG 11 DDE-isomers, ex-amending Directive pressed in DDT) 2002/32/EEG - fats en oils - mg/kg C12 Animal proteins Animal feeds for productive livestock - 0 Regulation (EC) See GMP+ Appendix 3: OZM Part 2; OSP-no. 1234/2003 to Negative list 12 amend 999/2001/EG GMP+ BA1 Product Standards 15/61 1st January 2010 GMP+ International
Contaminan1)t Product Action lim(it Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical C13a Dioxin 11 + 18 Feed materials of vegetable origin with ng ng WHO-PCDD/F-Directive In the event of exceeding OZM Part 2; OSP-the exception of vegetable oils and their PCDD/F-TEQ/kg4 + 5 2006/13/EG to the action limit: Determi-18 by4 + 17-products TEQ/kg amend Directive nation of the source of the 2002/32/EEG contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Vegetable oils and their by-products ng ng WHO-PCDD/F- In the event of exceeding PCDD/F-TEQ+ 5/kg4 the action limit: Determi-TEQ+ 17/kg4 nation of the source of the contamina-tion. Once the source of the contamination has been established take, if possible, suitable meas-ures to reduce or elimi-nate this Feed materials of mineral origin ng ng WHOIn the event of ex-PCDDceeding /F- the action lim it: Determi-PCDD/F-TEQ/kg4 + 5 nation of the source of the TEQ7contamination. Once the /kg4 + 1 source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this GMP+ BA1 Product Standards 16/61 1st January 2010 GMP+ International
Contaminant Product Ac(1)tion limit Rejec(1)tion limit Source Supplementary require-Analysis method7 ments Chemical Animal fat including milk fat and egg fat ng WHO-2,0 ng WHO-PCDD/F- In the event of exceeding PCDD/F-TEQ5/kg4 + the action limit: Determi-TEQ/kg4 + 17 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Products from other than land animals 0,5 ng WHO-0,75 ng WHO-PCDD/F- In the event of exceeding including milk, milk products, eggs and PCDD/F-TEQ/kg4 + 5 the action limit: Determi-productsTEQ 17/kg4 + from eggs nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Fish oil ng ng WHO-PCDD/F- In the event of exceeding PCDD/F-TEQ/kg4 + 5 the action limit: In many TEQ/kg4 + 17 cases it may perhaps not be necessary to carry out an investigation into the source of the contamina-tion as the background level in some areas is close or above the action level. GMP+ BA1 Product Standards 17/61 1st January 2010 GMP+ International
Contaminant Product Action lim(1)it Rejection lim(1)it Source Supplementary requ7ire-Analysis method ments Chemical Fish, other sea creatures and their ng ng WHO-PCDD/F- If the action limit is really (subsidiary) products , with the exception PCDD/F-TEQ/kg4 + 5 exceeded then all the of fish oil and fish protein hydrolysates TEQ/kg4 + 17 details such as the sam-which contain more6 than 20% fat pling period, geogrpahical origin, fish species, Fish protein hydrolysates which contain ng ng WHO-PCDD/F- etc., should be recorded mo re6 than 20% fat PCDD/F-TEQ/kg4 + 5 with a view to future TEQ 17/kg4 + measures for the pres-ence of dioxins Fish food 1 . 7 5 ng ng WHO-PCDD/F- and dioxin-like com- Feeds for pets PCDD/F-TEQ + 5/kg4 pounds in these animal TEQ+ 17/kg4 feeds The feed additives kaolinite-bearing clay, ng WHO-PCDD/F- calcium sulphate hydrate, vermiculite, TEQ/kg4 + 5 natrolite phonolite, synthetic calcium aluminates and clinoptilolite of sedimen-tary origin, belonging to the functional group "Binding agents and thinners" Feed additives belonging to the ng WHO- In the event of exceeding tional group "Binding agents and thin-PCDD/F-the action limit: Determi-ners" TEQ/kg4 + 17 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this GMP+ BA1 Product Standards 18/61 1st January 2010 GMP+ International
Contaminant Produc(1)t Action limit Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical Feed additives belonging to the ng ng WHO-PCDD/F- In the event of exceeding PCDD/F-TEQ+ 5/kg4 tional group "Trace elements com- the action limit: Determi-pounds" TEQ7/kg4 + 1 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Premixes ng ng WHO-PCDD/F- In the event of exceeding PCDD/F-TEQ/kg4 + 5 the action limit: Determi-TEQ/kg4 + 17 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Compound feeds with the exception of ng ng WHO-PCDD/F- In the event of exceeding feeds for fur-bearing animals and pets PCDD/F-TEQ + 5/kg4 the action limit: Determi-and of fishfeed TEQ/kg4 + 17 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this C13b Sum of dioxins and Feed materials of vegetable origin with ng WHO-PCDD/F- OZM Part 2; OSP-d2 +18ioxin-like PCBs1 the exception of vegetable oils and their PCB-TEQ/kg4 18 by-products GMP+ BA1 Product Standards 19/61 1st January 2010 GMP+ International
Contaminant Product Action(1) limit Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical Vegetable oils and their by-products ng WHO-PCDD/F- PCB-TEQ/kg4 Feed materials of mineral origin ng WHO-PCDD/F- PCB-TEQ/kg4 Animal fat including milk fat and egg fat ng WHO-PCDD/F- PCB-TEQ4 /kg Products from other than land animals ng WHO-PCDD/F- including milk, milk products, eggs and PCB-TEQ4 /kg products from eggs Fish oil ng WHO-PCDD/F- PCB-TEQ/kg4 Fish, other sea creatures and their ng WHO-PCDD/F- (subsidiary) products , with the exception PCB-TEQ/kg4 of fish oil and fish protein hydrolysates which contain morea6 than 20% ft Fish protein hydrolysates which contain 11 ng WHO-PCDD/F- more than 20% fa t PCB-TEQ/kg4 Feed additives belonging to the func- ng WHO-PCDD/F- tional group "Binding agents and thin-PCB-TEQ/kg4 ners" Feed additives belonging to the func- ng WHO-PCDD/F- tional group "Trace elements com-PCB -TEQ/kg4 pounds" Premixes ng WHO-PCDD/F- PCB4 -TEQ/kg Compound feed with the exception of ng WHO-PCDD/F- feeds for fur-bearing animals and pets PCB-TEQ/kg4 and of fishfeed GMP+ BA1 Product Standards 20/61 1st January 2010 GMP+ International
Contaminan1)t Product Action lim(it Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical Fish food ng WHO-PCDD/F- Feeds for pets PCB-TEQ/kg4 C13c Dioxin-like PCBs19 +18 Feed materials of vegetable origin with ng WHO- In the event of exceeding OZM Part 2; OSP-the exception of vegePCB-TEQ/kg4 table oils and their the action limit: Determi-18 by+ 17-products nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Vegetable oils and their by-products ng WHO- In the event of exceeding PCB-TEQ/kg4 the action limit: Determi-+ 17 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Feed materials of mineral origin ng WHO- In the event of exceeding PCB4 -TEQ/kg the action limit: Determi-+ 17 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this GMP+ BA1 Product Standards 21/61 1st January 2010 GMP+ International
Contam1)(1)inant Product Action lim(it Rejection limit Source Supplementary require-Analysis method7 ments Chemical Animal fat including milk fat and egg fat ng WHO- In the event of exceeding PCB-TEQ/kg4 the action limit: Determi-+ 17 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Chemical Products from other than land animals ng WHO- In the event of exceeding including milk, milk products, eggs and PCB-TEQ/kg4 the action limit: Determi-p+ 17roducts from eggs nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Fish oil ng WHO- In the event of exceeding PCB-TEQ/kg4 the action limit: In many + 17 cases it may perhaps not be necessary to carry out an investigation into the source of the contamina-tion as the background level in some areas is close or above the action level. GMP+ BA1 Product Standards 22/61 1st January 2010 GMP+ International
Contaminan(1)(1)t Product Action limit Rejection limit Source Supplementary require-Analysis method7 ments Chemical Fish, other sea creatures and their ng WHO- If the action limit is really (subsidiary) products , with the exception PCB-TEQ/kg4 exceeded then all the o+ 17f fish oil and fish protein hydrolysates details such as the sam-which contain more than 20% fat pling period, geogrpahical origin, fish species, etc., should be recorded with Fish protein hydrolysates which contain ng WHO- a view to future measures more than 20% fa 4 t PCB-TEQ/kg for the presence of dioxins + 17 Fish food 3 . 5 ng WHO- and dioxin-like com- Feeds for pets PCB-TEQ/kg4 pounds in these animal + 17 feeds Feed additives belonging to the ng WHO- In the event of exceeding tional group "Binding agents and thin-PCB4 -TEQ/kg the action limit: Determi-ne+ 17rs" nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this In the event of exceeding Feed additives belonging to the ng WHO- the action limit: Determi-tional group "Trace elements com-PCB-TEQ/kg4 nation of the source of the contamination. Once the pounds+ 17" source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this GMP+ BA1 Product Standards 23/61 1st January 2010 GMP+ International
Contam)1)inant Product Action lim(1it Rejection lim(it Source Supplementary require-Analysis method7 ments Chemical Premixes ng WHO- In the event of exceeding PCB4 -TEQ/kg the action limit: Determi-+ 17 nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this Compound feed with the exception of ng WHO- In the event of exceeding feeds for fur-bearing animals and pets PCB-TEQ/kg4 the action limit: Determi-and+ 17 of fishfeed nation of the source of the contamination. Once the source of the contamina-tion has been established take, if possible, suitable measures to reduce or eliminate this C15 DON Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-19 (Deoxynivalenol) - Pigs mg/kg 1 mg/kg - Cattle 4 mg/kg 5 mg/kg - Calves up to 4 months mg/kg 2 mg/kg - Dairy cattle mg/kg 3 mg/kg - Poultry mg/kg 4 mg/kg GMP+ BA1 Product Standards 24/61 1st January 2010 GMP+ International
Contaminant Product Action(1) limit Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical Feed material (supplied to the cattle GMP+ The supplier provides farmer for immediate feeding) for information to the cattle - Pigs 1 mg/kg 5 mg/kg farmer in the event of - Cattle 5 mg/kg 15 mg/kg infringement of the action limit for the level of the - Calves up to 4 months 2 mg/kg 6 mg/kg undesirable substance - Dairy cattle 3 mg/kg 9 mg/kg and provides advice on processing the product in - Poultry 4 mg/kg 12 mg/kg the days ration C16 Endosulfan (sum of alfa all animal feeds, with the exception of: mg/kg Directive OZM Part 2; OSP-and bŁta-isomers and of 2003/100/EEG 11 endosulfan sulphate, - maize and derived products - mg/kg amending Directive expressed in endosul-2002/32/EEG fan) - oil-bearing seeds and derived products - mg/kg Directive with the exception of crude vegetable oil 2006/77/EEG amending Directive 2002/32/EEG - crude vegetable oil - 1,0 mg/kg - complete fish food - mg/kg C17 Endrin (sum of endrin All animal feeds, with the exception of: - mg/kg Directive OZM Part 2; OSP-and deltaketo-endrin, 2002/32/EG 11 expressed in endrin) - fats and oils - mg/kg Directive 2006/77/EEG amending Directive 2002/32/EEG C19 Fluorine3 Feed materials, with the exception of: - 150 mg/kg Directive OZM Part 2; OSP-6 2005/87/EEG amending Directive 2002/32/EEG GMP+ BA1 Product Standards 25/61 1st January 2010 GMP+ International
Contaminant Produc(1)t Action limit Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical - animal feeds of animal origin with the - 500 mg/kg exception of sea water shellfish such as krill - seawater shellfish such as krill - 3,000 mg/kg - phosphates - 2,000 mg/kg - calcium carbonate - 350 mg/kg - magnesium oxide - 600 mg/kg - calcareous marine algae - 1,000 mg/kg Vermiculite (E 561) - 3,000 mg/kg8 Directive 2008/76/EEG amending Annex I to Directive 2002/32/EEG Supplementary animal feeds - containing> 4% phosphorus - 500 mg/kg - containing > 4% phosphorus - 125 mg/kg per 1% phosphorus complete animal feeds, with the excep-- 150 mg/kg tion of: - complete animal feeds for cattle, sheep and goats - which suck - 30 mg/kg - others - 50 mg/kg - complete animal feeds for pigs - 100 mg/kg - complete animal feeds for poultry - 350 mg/kg - complete animal feeds for chicks - 250 mg/kg GMP+ BA1 Product Standards 26/61 1st January 2010 GMP+ International
Con)taminant Product Action lim(1)it Rejection lim(1it Source Supplementary require-Analysis method7 ments Chemical - complete animal feeds for fish - 350 mg/kg Directive 2008/76/EEG amending Annex I to Directive 2002/32/EEG C20 Heptachlor (sum of All animal feeds, with the exception of: - mg/kg Directive OZM Part 2; OSP-heptachlor and hepta-2002/32/EG 11 chlor epoxyd, expressed - fats and oils - mg/kg Directive in heptachlor) 2006/77/EEG amending Directive 2002/32/EEG C21 Hexachlorobenzene All animal feeds, with the exception of: - mg/kg Directive OZM Part 2; OSP-(HCB) 2002/32/EG 11 - fats and oils - mg/kg Directive 2006/77/EEG amending Directive 2002/32/EEG C22 Hexachlorocyclohexane - Directive OZM Part 2; OSP-(HCH): 2002/32/EG 11 - Alfa-isomer All animal feeds, with the exception of: - mg/kg - fats and oils - mg/kg Directive 2006/77/EEG amending Directive 2002/32/EEG - Beta-isomer Compound feeds with the exception of: - mg/kg - feeds for dairy cattle - mg/kg GMP+ BA1 Product Standards 27/61 1st January 2010 GMP+ International
Contaminant Product Ac(1)tion limit Rejec(1)tion limit Source Supplementary require-Analysis method7 ments Chemical Feed materials, with the exception of: - mg/kg - fats and oils - mg/kg Directive 2006/77/EEG amending Directive 2002/32/EEG - Gamma-isomer (lin-All animal feeds, with the exception of: - mg/kg dane) - fats and oils - mg/kg Directive 2006/77/EEG amending Directive 2002/32/EEG C23 Potassium - Feed materials for delivery to cattle 60 g/kg (dry 10x the action limit (dry GMP+ If the action limit is OZM deel 3; WM-farms, and matter) ma21tter) exceeded then a warning 08 - Wet mixes for delivery to cattle farm- or processing advice must ers be demonstrably commu-nicated to the customer. C24 Hydrocarbons (C10-Animal fat, with the exception of: - 400 mg/kg (on product GMP+ OZM Part 2; OSP-C40) basic) 15a - crude fish oil - 3,000 mg/kg (on product basic) Vegetable oil (with the exception of - 400 mg/kg (on product sunflower oil) basic) Sunflower oil and sunflower fatty acids - 1,000 mg/kg (on product basic) GMP+ BA1 Product Standards 28/61 1st January 2010 GMP+ International
Contaminan)t Product Action lim(1)it Rejection lim(1it Source Supplementary require-Analysis method7 ments Chemical Vegetable fatty acids incl. Mixes of fatty - 3,000 mg/kg (on product acids (with the exception of sunflower basic) fatty acids) Palm oil - 25 mg/kg calculated as This standard applies if OZM Part 2; OSP-diesel oil the hydrocarbons (calcu-15b lated as diesel oil) are determined via the GC-MS method. If use is made of the GC-FID method, then the standard for vegetable oil applies Hydrocarbons (mineral Sunflower oil originating in or consigned 50 mg/kg (on product Commission Deci-Temporary standard. In The method of oil) (C10-C56/C20-C56 from Ukraine basic) sion 2008/388/EC one year the situation will detection GC-FID minus C27 + C29 +C31) of 23 May 2008 be re-assessed. The (flame ionisation batch must be accompa-detector) is prefer-nied by a report of analy-able, but the GC-sis MS can be used as well. C25 Copper (E4) Free-range consumption pig feed - 25 mg/kg total GMP+ Only for free-range con-OZM Part 1; TVM-sumption pig feed I-2 Pigs13: - Commission Regu- lation (EC) No - Piglets to 12 weeks 13 - 170 mg/kg total 1334/2003 amend- - Other p3ing the conditions igs1 - 25 mg/kg total for authorisation of Ca13ttle: a number of addi-tives in feed-ingstuffs belonging to the group of trace elements GMP+ BA1 Product Standards 29/61 1st January 2010 GMP+ International
Contaminant Product Action lim(1)it Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical 1. Cattle before they start with rumina- tion: - Milk replace13r - 15 mg/kg total - Other complete animal feeds13 - 15 mg/kg total 2. Othe13r pigs - 35 mg/kg total - Sheep13 - 15 mg/kg Total - Fish13 - 25 mg/kg total - Shellfish13 - 50 mg/kg total - Other animals13 - 25 mg/kg total C26 Mercury Feed materials, with the exception of: - mg/kg Directive OZM Part 2; OSP-5 2005/8/EEG - animal feeds obtained by processing - mg/kg amend ing Directive fish or other sea creatures 2002/32/EEG - calcium carbonate - mg/kg complete animal feeds, with the excep-- mg/kg tion of: - complete animal feeds for dogs and - mg/kg cats complete animal feeds, with the excep-- mg/kg tion of: - supplementary animal feeds for dogs - - and cats C27 Lead10 Feed materials, with the exception of: - 10 mg/kg Directive OZM Part 2; OSP-2005/87/EEG 28 amending Directive 2002/32/EEG GMP+ BA1 Product Standards 30/61 1st January 2010 GMP+ International
Contaminant Produc(1)t Action limit Rejection lim(1)it Source Supplementary require-Analysis method7 ments Chemical - green fodde9r - 30 mg/kg8 - phosphates and limestone - 15 mg/kg - calcium carbonate - 20 mg/kg - yeast - 5 mg/kg Feed additives, belonging to the func- 100 mg/kg tional group "Compounds of trace elements", with the exception of: - zinc oxide 400 mg/kg8 - manganese (II)oxide, ferrous carbon- 200 mg/kg8 ate, copper carbonate Feed additives, belonging to the func- 30 mg/kg8 tional group "Binding agents and thin-ners", with the exception of: - clinoptilolite of vulcanic origin 60 mg/kg8 Premixes 200 mg/kg8 complete animal feeds, with the excep-- 10 mg/kg tion of: - mineral mixes - 15 mg/kg Complete animal feeds - 5 mg/kg C28 Ergot of rye (Claviceps All animal feeds which contain unground - 1,000 mg/kg Directive OZM Part 2; OSP-purpurea) grain 2002/32/EG 32 C29 Sodium - Feed materials for delivery to cattle 8 g/kg (dry 10x the action limit (dry GMP+ If the action limit is OZM deel 3; WM-matte21farms, and matter) r) exceeded then a warning 09 or processing advice must - Wet mixes for delivery to cattle farm- be demonstrably commu-ers nicated to the customer. GMP+ BA1 Product Standards 31/61 1st January 2010 GMP+ International
Contam1)inant Product Action lim(it Rejection1) lim(it Source Supplementary require-Analysis method7 ments Chemical C30 Nickel Feed fats 20 mg / kg (on 50 mg / kg (on a fat GMP+ OZM Part 2; OSP-a fat basis) basis) 29 C31 Nitrite Fish meal - 60 mg/kg (expressed in Directive OZM Part 2; OSP-7 sodium nitrite) 2002/32/EG complete animal feeds, with the excep-- 15 mg/kg (expressed in tion of: sodium nitrite) - feeds for pets with the exception of - - birds and aquarium fish C32 Weed seeds and un-All animal feeds - 3,000 mg/kg Directive Microscopic deter-ground or pulverised 2002/32/EG mination in accor-fruits which contain dance with the alkaloids, glucosides or instructions of the other poisonous sub-manufacturer stances separately or jointly, including: - Datura stramonium L. - 1,000 mg/kg C33 Insoluble impurities Melted fats from ruminants - 0,15% Regulation OZM Part 2; OSP-1774/2002 16 C34 Ochratoxin A Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-19 - sows and consumption pigs and piglets mg/kg mg/kg - poultry mg/kg mg/kg GMP+ BA1 Product Standards 32/61 1st January 2010 GMP+ International
Contaminan))t Product Action lim(1it Rejection lim(1it Source Supplementary require-Analysis method7 ments Chemical Feed material (supplied to the cattle The supplier provides farmer for immediate feeding) for information to the cattle farmer in the event of infringement of the action - Sows and pigs and piglets mg/kg mg/kg limit for the level of the - Poultry mg/kg mg/kg undesirable substance and provides advice on processing the product in the days ration C35 Polycyclic Aromatic Feed fats 15 µg/kg 50 µg/kg BaPEQ GMP+ BaPEQ = Benzo(a)pyrene OZM Part 2; OSP-Hydrocarbons (PAHs) BaPEQ equivalent 33 (on fat basis) (on fat basis) C38 Ricinus-Ricinus commu-All animal feeds - 10 mg/kg (expressed in Directive Microscopic deter-nis L. ricinus husks) 2002/32/EG mination in accor-dance with the instructions of the manufacturer C39 Sulphate - Feed materials for delivery to cattle 8 g/kg (dry 10x the action limit (dry GMP+ If the action limit is ex-OZM deel 2; OSP-farms, and matter) ma21tter) ceeded then a warning or 24 - Wet mixes for delivery to cattle farm- processing advice must ers which are preserved with sulphuric be demonstrably commu-acid and not for products which by nicated to the customer. nature are rich in sulphur C40 Theobromine complete animal feeds, with the excep-- 300 mg/kg Directive OZM Part 2; OSP-8 tion of: 2002/32/EG - complete animal feeds for full-grown - 700 mg/kg cattle C41 Vinylthiooxazolidon Complete animal feeds for poultry with - 1,000 mg/kg Directive OZM Part 2; OSP-the exception of: 2002/32/EG 31 GMP+ BA1 Product Standards 33/61 1st January 2010 GMP+ International
Contaminan1)t Product Action lim(it Rejection(1) limit Source Supplementary require-Analysis method7 ments Chemical (Vinyloxazolidine thion) - complete animal feeds for laying poul-- 500 mg/kg try C42 Volatile mustard oil Feed materials, with the exception of: - 100 mg/kg Directive OZM Part 2; OSP-2002/32/EG 20 - colza cakes - 4,000 mg/kg (calculated as allylisothiocyanate) complete animal feeds, with the excep-- 150 mg/kg (calculated tion of: as allylisothiocyanate) - Complete animal feeds for cattle, - 1,000 mg/kg (calculated sheep and goats (with the exception of as allylisothiocyanate) young animals) - Complete animal feeds for pigs (with - 500 mg/kg (calculated the exception of piglets) and poultry as allylisothiocyanate) C43 Free gossypol Feed materials, with the exception of: - 20 mg/kg Directive OZM Part 2; OSP-2003/100/EEG 21 - cotton seed - 5,000 mg/kg amending Directive 2002/32/EEG - cotton seed cake and cotton seed meal - 1,200 mg/kg complete animal feeds, with the excep-- 20 mg/kg tion of: - complete animal feeds for cattle, sheep - 500 mg/kg and goats - complete animal feeds for poultry - 100 mg/kg (except laying hens) and calves - complete animal feeds for rabbits and - 60 mg/kg pigs (except piglets) C44 Zearalenon Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-19 GMP+ BA1 Product Standards 34/61 1st January 2010 GMP+ International
Contaminant Product Action lim(1)it Rejection(1) limit Source Supplementary require-Analysis method7 ments Chemical - sows and consumption pigs mg/kg mg/kg - young pigs mg/kg mg/kg - young cattle and dairy cattle mg/kg mg/kg The supplier provides Feed material (supplied to the cattle information to the cattle farmer for immediate feeding) for farmer in the event of infringement of the action limit for the level of the - sows and pigs mg/kg undesirable substance and provides advice on - young pigs mg/kg mg/kg processing the product in the days ration - young cattle and dairy cattle mg/kg mg/kg C45 Zinc (E6) Free-range consumption pig feed - 90 mg/kg total GMP+ Only for free-range con-OZM Part 1; TVM-sumption pig feed I-4 Commission Regu- Pets13 - 250 mg/kg total lation (EC) No 1334/2003 amend-ing the conditions Fish13 - 200 mg/kg total for authorisation of a number of addi- Mtives in feed-ilk replace13r - 200 mg/kg total ingstuffs belonging to the group of Other animals13 - 150 mg/kg total trace elements C46 Melamine - All feeds which contain milk and milk - 2,5 mg/kg Commission Deci-All batches from China or products, soya or soya products originat-sion 2008/921/EC of feeds sent from China ing from or sent from China. 9 December 2008 which contain milk and amending Commis-milk products, soya or sion Decision soya products must be 2008/798/EG of 14 tested for Melamine. See October 2008. Commission Decision 2008/798/EC for complete information. - Ammonium bicarbonate intended for - 2,5 mg/kg - All batches from China use in feeds or ammonium bicarbonate from China intended for use in feeds must be tested for Melamine. GMP+ BA1 Product Standards 35/61 1st January 2010 GMP+ International
Contaminan)t Product Action lim(1)it Rejection lim(1it Source Supplementary require-Analysis method7 ments - All other feeds originating in China - 2,5 mg/kg Random checks may be which have a high protein content. carried out on other feeds which have originated in China and which have a high protein content before the products are imported into the EU. Physical F1 Plastics - Feed materials for delivery to cattle - g/kg (dry matter GMP+ Via manual separation Microscopic deter-farms, and basis) and weighing mination in accor-dance with the instructions of the manufacturer - Wet mixes for delivery to cattle farm- This standard was in-ers cluded subject to the outcome of the discussion taking place in the Euro-pean Commission. F2 Polyethylene - Feed materials for delivery to cattle g/kg (on g/kg (on fat basis) GMP+ OZM Part 2; OSP-farms, and fat basis) 13 - Wet mix for delivery to cattle farmers F5 Beech, unpeeled seeds - - Fagus silvatica (L.) F6 ChineseSeeds mu and fruits of the stard All animal feeds - Directive adjacent plant types Brassica juncea (L.) and the by-products 2002/32/EG Czernobtianed from process-. and Coss. ssp. ing may not appear in juncea var. lutea Batalin animal feeds unless as F7 Ethiopian mustardtraces which can not - be qunaititatively Brassica carinata A. determijned Braun GMP+ BA1 Product Standards 36/61 1st January 2010 GMP+ International
Contaminan)t Product Action lim(1)it Rejection lim(1it Source Supplementary require-Analysis method7 ments Chemical F8 Indian brown mustard - - Brassica juncea (L.) Czern. and Coss. ssp. integrifolia (West.) Thell. F9 Mowrah, Bassia, Mad- - huca Madhuca longifo-lia (L.) Macbr. (=Bassia longifolia L. = Illipe malabrorum Engl.) Madhuca indica Gmelin (= Bassia latifolia (Roxb.) = Illipe latifolia (Roscb.) F. Mueller) Physical F10 Physic nut - Jatropha - curcas L. F11 Physic croton - Croton - tiglium L. F12 Sarepta mustard - - Brassica juncea (L.) Czern. and Coss. ssp. juncea F14 Black mustard Bras- - sica nigra (L.) Koch GMP+ BA1 Product Standards 37/61 1st January 2010 GMP+ International
*[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned diifferently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [2] The maximum levels refer to an analytical determination of cadmium where the extraction is done for 30 minutes a boiling temperature in Nitric acid (5% m/m). Equivalent extraction procedures may be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency [3] The maximum levels refer to an analytical determination of fluorine where the extraction is done for 20 minutes at an ambient temperature with hydrochloric acid 1 N. Equivalent extraction procedures may be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency [4] Upper limit concentrations; in the calculation of upper limit concentrations it must be assumed that values lying under the detection limits for the various congenors are equal to the detection limit. [5] The individual maximum level for dioxins (PCDD/Fs) remains temporarily applicable. The values specified in item C13a for products intended for feeding to animals must correspond in this period to the maxi-mum levels for dioxins and the maximum levels for the sum of dioxins and dioxin-like PCBs. [6] Fresh fish which is supplied directly without any further processing and used for the production of feeds for fur-bearing animals gebruikt, is exempted from the maximum level, and for fresh fish which is used for the direct feeding of pets, zoo animals and circus animals there is a maximum level of ng WHO-PCDD/F-TEQ/kg product and ng WHO-PCDD/F-TEQ/kg product. The products, processed animal proteins from these animals (fur-bearing animals, pets, zoo animals and circus animals), may not get into the feed chain and the feeding of them to productive livestock which are kept for the production foodstuffs, are being fattened up or bred, is forbidden. [7] The research methods (OZM) can be found via the ; quality; research methods) [8] The levels will be reviewed before 31 December 2007 with a view to lowering the maximum levels [9] Green fodder includes products which are intended for feeding to animals such as hay, silage, fresh grass, etc. [10] The maximum levels refer to an analytical determination of leadwhere the extraction is done for 30 minutes a boiling temperature in Nitric acid (5% m/m). Equivalent extraction procedures may be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency [11] (sum of the polychlorinated dibenzo-para dioxins (PCDDs) and the polychlorinated dibenzofurans (PCDFs) expressed in toxicity equivalents established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997) [12] (sum of the polychlorinated dibenzo-para dioxins (PCDDs) and the polychlorinated dibenzofurans (PCDFs) and the polychlorinated biphenyls (PCBs) expressed in toxicity equivalents established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997) [13] If the GMP+ standard for this product and the animal type in question is lower than the standard specified here, then the GMP+ standard applies. In complete animal feed [14] n = number of samples to be tested; m = threshold value for the number of bacteria; the results will be considered to be satisfactory if the number of bacteria in none of the samples is greater than m, M = maximum value for the number of bacteria in one or more samples is equal to or greater than M, c = number of samples for which the bacteria count gives a result between m and M and where the sample is still considered acceptable if the result of the bacteria for the other samples is not higher than m. [15] At the request of the competent authorities the responsible operator must carry out an analysis to show that the level of anorganic arsenic is lower than 2 ppm. This analysis is especially important for the Hizikia fusiforme seaweed [16] The maximum levels refer to the total level of arsenic [17] The Commission will evaluate these action limits at the same time as the maximum levels for the sum of dioxins and dioxin-like PCBs before 31 December 2008. GMP+ BA1 Product Standards 38/61 1st January 2010 GMP+ International
[18] TEF’s from the WHO for the assessment of the risks to humans based on the conclusions of the meeting of the World Health Organisation in Stockholm, Sweden, 15-18 June 1997 (van den Berg et al., (1998) Toxic Equivalence Factors (TEF’s) for PCB’s, PCDD’s, PCFD’s for Humans and for Wildlife Environmental Health Perspectives, 106(12), 775). Congenor TEF Value Congenor TEF Value Dibenzo-p-dioxins (PCDDs) Dioxin-like PCBs 2,3,7,8-TCDD 1 Non-ortho-PCBs + mono-ortho-PCBs 1,2,3,7,8-PeCDD 1 Non-ortho-PCB’ 1,2,3,4,7,8-HxCDD PCB 77 0,0001 1,2,3,4,7,8-HxCDD PCB 81 0,0001 1,2,3,4,7,8-HxCDD PCB 126 0,1 1,2,3,4,6,7,8-HpCDD PCB 169 0,01 OCDD Mono-ortho-PCBs Dibenzofuranes (PCDFs) PCB 105 0,0001 2,3,7,8-TCDF PCB 114 0,0005 1,2,3,7,8-PeCDF PCB 118 0,0001 2,3,4,7,8-PeCDF PCB 123 0,0001 1,2,3,4,7,8-HxCDF PCB 156 0,0005 1,2,3,6,7,8-HxCDF PCB 157 0,0005 1,2,3,7,8,9-HxCDF PCB 167 0,00001 2,3,4,7,8-HxCDF PCB 189 0,0001 1,2,3,4,6,7,8-HpCDF 1,2,3,4,7,8,9-HpCDF OCDF Key to abbreviations: T= tetra; Pe= penta; Hx=hexa; Hp= hepta; O= octa; CDD= chlordibenzodioxin; CDF= chlordibenzofuran; CB= chlorbiphenyl [19] (sum of the polychlorinated biphenyls (PCBs) expressed in toxicity equivalents established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997) [20] Explanation of 0+: this standard does not apply to each individual sample. In a particular period of time the Salmonella incidence at company level should approach 0% (= 0+). [21]The rejection limits do not apply to feeds such as salt or mineral licks which are deliberately supplied with high mineral levels. GMP+ BA1 Product Standards 39/61 1st January 2010 GMP+ International
4 Residue levels of pesticides in feeds Introduction A start was made in April 2005 in the EU on the revision of the community legisla-tion with respect to the permitted maximum levels of residues of pesticides by way of Regulation (EG) No. 396/2005. This regulation includes the maximum residue levels (MRL) for simple products of vegetable and animal origin intended for human consumption and for feeds. In as much as the MRLs apply to feeds they are appli-cable to both feeds for food-producing animals and for non-food-producing animals. The layout of the standard is such that in many cases it is not possible immediately to indicate a standard for a certain combination of feed / pesticide. This chapter indicates: a. How the correct standard for a simple, untreated/unprocessed product can be out-of-date; b. How the correct standard for a derived product can be determined; c. How the correct standard for a compound feed can be determined; d. Which special requirements apply. The establishment of and MRL General The MRLs (maximum residue levels) are established for simple products. Many of these MRLs are to be found on Pesticides Web , a database which was created by the EC. ( This is almost always the untreated form of a product. This means that a number of calculations must be carried out both for the determination of the MRL in a derived product (for example, sunflower oil, maize gluten meal) and for the de-termination in compound products (compound feeds, supplementary feeds). The correct standard can be determined using the enclosed questionnaires. The basic principle of the questionnaires is that there is a known pesticide and that the associated residue standard must be found for a particular feed. The questionnaires have been drawn up so that you always are led to a result. The following questionnaires are available. a. Questionnaire for basic products. This questionnaire helps you determine the MRL for basic products. b. Questionnaire for by-products. This questionnaire helps you determine the MRL for auxiliary products. c. Questionnaire for compound feeds. This questionnaire helps you determine the MRL for compound feeds. It is of great importance to note here that Regulation (EC) No. 396/2005 only ap-plies to products of vegetable or animal origin! If this is not the case then any stan-dards in Directive 2002/32/EG still apply. GMP+ BA1 Product standards 40/61 1st January 2010 GMP+ International
To make this chapter easier to read the questionnaire makes use of the definitions in the following table. Table 1: Definitions and questionnaires Product group Definition Questionnaire Basic product Simple, unprocessed product of vegetable or animal origin (wheat, . barley, linseed, sunflower seeds, soya bean, peas, shrimps) Auxiliary products Simple, treated/processed or derived product, originating from an basic product. (flour, semolina pellets, potato press fibres, soya flakes, linseed oil, peapod meal, fish meal) Compound feed Compound product consisting of at least two components being basic . products, by-products and/or feed additives. (complete feed, supple-mentary feed, petfood, grain mixes, premixes) NOTE: These definitions have only been drawn up to improve the readability of Chapter 4 and have no value or legitimacy outside this chapter. The questionnaires help you to determine the standard. You are not always imme-diately led to a number or value. It could be that you are referred to another point in a table or to another table. It may also be possible that you have to carry out a few calculations. For a limited number of products (table 2) the MRL in Regulation (EC) No. 396/2005 may not (yet) apply if for parts of these products are given the exclusive destination animal feed. For these products the MRLs for pesticides therefore still apply as specified in the Directive 2002/32/EG. Table 2: Product (groups) of which parts with the exclusive destination animal feed are not (yet) covered under Reg. 396/2005 Product (groups) Fish, fish products, crus-Kohl-rabi foliage Palm hearts Palm kernels taceans and shellfish and other products from salt and fresh water creatures* Only for crops used for Garden cress Fungi Palm fruits feed* Loquats Winter cress Seaweed Kapok Cherimoya s Rucola Lupines (dried) Millet Guavas Red amsoi Shells, seeds and possi-Sorghum bly skins of oil-retaining seeds and fruits (such as soya hulls) Bread fruits Leaves and sprouts of Borage Coffee beans Brassica spp. Durians Purslain Pumpkin seed Herbal tea Soursops (durian blanda) Vine leaves Hemp seed Cacao bean Arrowroot Herbs (sage, rosemary, Camelina Carob thym, basi, laurel, tarra-gon) Nut shells Lentils (fresh) Safflower seed Spices Sprouts stems Bamboo shoots Olives (oil recovery) Sugar crops * : The standards of Reg. 396/2005 apply neither to feeds nor to foodstuffs for (parts of) products in these groups. For all other products of vegetable or animal origin, Regulation (EC) No. 396/2005 applies. GMP+ BA1 Product standards 41/61 1st January 2010 GMP+ International
Questionnaire for basic products 1. Is your basic product in Table 2 and does it have the exclusive destination animal feed? Yes This new regulation does not yet apply to your basic product. Check if Directive 2002/32/EG contains a standard for your basic product / pesticide combination (end). No Go to question 2. 2. Is your basic product included in Appendix I of Reg. 396/2005, either as an Individual product (column 3, 4 and 5) or as a group of products (column 2)? Yes Go to question 3. No Your basic product is probably not a simple untreated / Un-processed product of vegetable or animal origin. Check your product using the definitions in Table 1. Consult your sup-plier. 3. Is your basic product individually included in Appendix I of Reg. 396/2005, (column 3, 4 and 5) Yes Go to question 4. No Go to question 7. 4. Is the pesticide for which you are looking for a standard included in Pesticides Web , the online EU pesticides database? Yes Go to question 5. No Go to question 6. 5. On Pesticides Web select the languiage you want, your basic product and the pesticide for which you want the MRL. Click on the button Search cur-rent MRL . You have found the standard. Place the mouse cursor on the MRL or click on the pesticide for additional information (end). 6. Is the pesticide included in Appendix V of Reg. 396/2005? Yes You have found the standard for the pesticide. Carefully read any footnotes which apply to the standard (end). No The pesticide is not standard amounts to mg/kg for basic products. (end) Note: At the time of the first publication of this document Appendix V was not yet completed 7. Is the pesticide for which you are looking for a standard included in Pesticides Web , the online EU pesticides database? Yes Go to question 8. No Go to question 9. 8. On Pesticides Web select the languiage you want, the (sub) group of prod-ucts to which your basic product belongs and the pesticide for which you want the MRL. Click on the button Search current MRL . You have found the standard. Place the mouse cursor on the MRL or click on the pesticide for additional information (end). GMP+ BA1 Product standards 42/61 1st January 2010 GMP+ International
9. Is the pesticide included in Appendix V of Reg. 396/2005? Yes You have found the standard for the pesticide. Carefully read any footnotes which apply to the standard (end). No The pesticide is not standard amounts to mg/kg for basic products. (end) NOTE: At the time of the first publication of this document Appendix V was not yet completed Questionnaire for by-products 1. Is your by-product from a product / product group in table 2 and does it have the exclusive destination animal feed? Yes This new regulation does not yet apply to your basic product. Check if Directive 2002/32/EG contains a standard for your basic product / pesticide combination (end). No Go to question 2. 2. Is your by-product included in Appendix I of Reg. 396/2005, either as a by-product (column 2 in combination with 3, 4 or 5) or as a group of products (column 2) or in the form of the original product? Yes Go to question 3. No Your by-product is probably not a product of vegetable or animal origin. Check your product using the definitions in Ta-ble 1. Consult your supplier. 3. Is your by-product from that part of the (derived) product or the product group for which the MRL applies (Reg. 396/2005, Appendix I, column 6)? Yes The standards in this regulation apply to your by-product. Go to question 4. No This new regulation does not yet apply to your by-product. Check if Directive 2002/32/EG contains a standard for your by-product/pesticide combination (end). You have established that the standards from this regulation apply to your by-product. You then use the questionnaire for basic products (.) question 3 and further, to determine the standard for your individually-specified by-product, the origi-nal product or the relevant product group. Now proceed with question 4 in this questionnaire. 4. Is the by-product for which the standard is established equal to the by-product for which you are looking for a standard? Yes The standard you have found is the standard for this by-product / pesticide combination. (end) No Go to question 5. 5. In Reg. 396/2005, Appendix VI, is there a concentration or dilution factor established for your by-product or for the treatment / processing which is the basis for your by-product? Yes Use this factor to determine the final standard for this by-product / pesticide combination. (end) GMP+ BA1 Product standards 43/61 1st January 2010 GMP+ International
No Go to question 6. NOTE: At the time of the first publication of this document Appendix VI was not yet completed 6. Is the treatment / processing for this by-product based on the separation of a fat and water fraction? Yes Go to question 7. No The processing / treatment has no effect on the residue level, the standard which you have found is the final standard for this by-product/pesticide combination. (end) Your by-product has been created as a result of the separation of a fat-oil fraction and a fat-oil free fraction (pressing, extraction). In the rest of this questionnaire you determine if there is an accummulation of residues in the fat fraction or in the fat-free fraction 7. Does the name of the pesticide in Pesticiden Web have the suffix (F)? Yes The pesticide is soluble in fat. Determine, using the fat per-centage in the original product and in your by-product, the di-lution or concentration factor (see table 3) and divide or mul-tiply this by the standard found for the original product(group) in order to determine the final standard.(end) Table 3: Concentration factors for many vegetable oils which are used Concentration Oil-retaining basic product Avg. oil level factor in oil Palm fruit 50 2 Sheanut 50 2 Coconut 50 2 Palm kernel 49 2 Sesame seed 49 2 Peanut 48 2 Rapeseed 40 2 Linseed 45 2 Sunflower seeds 32 3 Kardi / Safflower seed 31 3 Cotton seed 20 5 Soya bean 19 5 Grape seed 15 6 Source: Product Board for Margarine, Fats and Oils (MVO), Memorandum Crude Oils MRLs, Sept. 2003 No Go to question 8. 8. Search on International Chemical Safety Cards (ICSCs) for the pesticide in question and note the Octanol/water partition coefficient (log Pow) which you will find in the chapter Physical properties . The log Pow is a measure of the solubility in water or fat of the pesticide. Is the log Pow greater than 4? GMP+ BA1 Product standards 44/61 1st January 2010 GMP+ International
Yes The pesticide is soluble in fat. Determine, using the fat per-centage in the original product and in your by-product, the di-lution or concentration factor and divide or multiply this by the standard found for the original product(group) in order to de-termine the final orm.(end) No Go to question 9. 9. Is the log Pow between 3 and 4? Yes The pesticide is not specifically soluble in water or fat. There is no Dilution or concentration of the pesticide residue as a Result of the treatment to which the original product was sub-jected. The standard which you found in the Pesticides Web also applies to your by-product. (end) No Go to question 10. 10. The log Pow is less than 3. The pesticide is soluble in water. Use the fat percentage in the original product and your by-product to determine the dilu-tion or concentration factor and divide or multiply this by the the standard you found for the original product or product group in order to determine the final standard.(end). Note: In this case, where there is a pesticide which is soluble in water, there is dilution of the fat fraction and concentration of the fat-free fraction! NOTE: the method described in this section for the determination of maximum resi-due limits (MRL) in fats and oils also applies to fatty acids. Questionaire for compound feeds 1. Specify the individual components of your compound feed. In Reg. 396/2005, Appendix VI, has a concentration or dilution factor has been es-tablished for your compound feed, A certain fraction of your compound feed. A by-product that is part of your copound feed? Yes Use this factor or factors to determine the final standard for this specific part of your compound feed and to determine the pesticide in ques-tion. Go to question 2 . No Go to question 2. NOTE: At the time of the first publication of this document Appendix VI was not yet completed 2. Does your compound feed contain basic products among other things? Yes For each of these components go through the questionnaire in par. . In order to determine the standards for these components. Go to question 3 No Go to question 3. 3. Your compound feed contains (among other things) by-products. For each of these components go through the questionnaire in par. . In order to determine the standards for these components. Go to question 4. GMP+ BA1 Product standards 45/61 1st January 2010 GMP+ International
4. Have you determined a standard for all the components for which a stan-dard has been set and have you taken account of the factors laid down in question 1? Yes Go to question 5. No Go through this questionnaire again starting at question 1 5. Now determine the MRL for the specific pesticide in the compound feed in the following way MRLx = {(NxC1 * C1) + (NxC2 * C2) . + (NxCn * Cn)}/ ΣC1:Cn Where: MRLx : Is the maximum residue standard for pesticide X in the compound feed NxCn : The standard found for the component / group of components C (1 to n) Cn : The percentage in the compound feed for compo-nent / group of components C (1 to n) ΣC1:Cn: The sum of the percentages of components for which an MRL for pesticide X actually applies Fumigators It is permitted to trade feeds which at the moment of sale exceed an MRL for a pes-ticide specified in Appendix II or III of Reg. 396/2005. This relates to an excess as a result of treatment of feeds with gaseous pesticides (gas generation, fumigation) after harvesting. The pesticides for which this permission applies and also the products involved are specified in Appendix VII of Reg. 396/2005. Special requirements In addition to the standards for undesirable substances which have a broad validity within the feed chain, some specific measures are announced with some regularity for precisely-defined products or product groups. These are often temporary meas-ures as a result of very specific contamination. The following measures are cur-rently in force. • Decision 2008/352/EG of 29/04/08 adopting special requirements for guar flour originating or sent from India due to the risks of contamination of this product with pentachlorophenol and dioxins. GMP+ BA1 Product standards 46/61 1st January 2010 GMP+ International
PART B: RESIDUE STANDARDS 1 INTRODUCTION In addition to compliance with the adopted standards in appendix 1, part A, the participant must also comply with the (residue) levels of additives and veterinary medical products. Please refer to the definition of feed safety as laid down in the list of definitions for the GMP+ Feed Safety Assurance scheme. The participant must ensure that a. the correct additives and veterinary medical products get into the right feed in the right dosage (GMP+ B1, section ). b. (residues of) additives and veterinary medical products are not present or are under set maximum limits (the so-called residue standards) in feeds in which they should not be present (GMP+ B1, section ). In order to be able to control the residue levels the participant should, among other things, measure carry-over in the installations (see Appendix 4) and establish production sequences. In chapter 2 of part B of this appendix there are further instructions for this. Chapter 3 of part B of this appendix states the maximum residue standards for coccidiostats, histomonostats and critical veterinary medical products. These standards apply to compound feeds, semi-manufactured products, feed materials and premixtures and are applicable to producers of these products. GMP+ BA1 Product standards 47/61 1st January 2010 GMP+ International
2 Additional provisions General The control of residue levels using the production sequence is shown in diagram form in the following table. Carry-over Wall adhesion factor measurement measurement instruction instruction(Appendix 4) Relative wall adhesion factor measurementCoefficient factor Installation internal (Appendix 1, Part B, carry-overChapter 3)Coefficient (=carry-over x factor)Carry-over percentageMax. residue norm (Appendix 1, Part B, Chapter 3Calculation)Production sequence / flush batches GMP+ BA1 Product standards 48/61 1st January 2010 GMP+ International Carried out by TNO-Nutrition
Compound feed Installation Carry-over level: The installation s own carry-over is the carry-over measured using an inspection procedure as laid down in GMP+BA4 Minimum Requirements for Sampling and Analysis. The frequency at which the carry-over must be measured is determined as follows: a. If the participant processes or transports (animal feed containing) feed ad-ditives for which a residue standard has been determined in the table in Chapter 3 or veterinary medical products then the degree of carry-over must be known for the lines on which these products are processed. b. If the participant has relevan1t lines then he must measure carry-over at least once per two years. c. The minimum frequency for the measurement of carry-over may be low-ered to once per year on condition that: 1. the carry over measured is less than 10% and 2. as soon as the last measurement is over two years old, the participant must assume the degree of carry over of the line in question is 15%. The carry-over must be re-established in the event of major changes to the installa-tion. . The coefficient The coefficient is intended to take account of an extra carry-over in addition to the installation carry-over, as a consequence of the processing properties of the addi-tive or veterinary medicine. A factor of 1 means that the product contains no proc-essing properties other than those of a standard measurement substance. The ac-tual carry-over of the product therefore corresponds to the installation carry-over. If the factor is greater than 1, this means that the product has anomalous processing properties, such that the actual carry-over will be higher than the installation carry-over. The coefficient is determined on the basis of a so-called relative wall adhesion fac-tor using a method specially developed for this purpose. Refer to TNO report I-96-31006 Carry-over of a number of critical substances in cattle feed and the relation-ship to their characteristic properties. 1 Relevant lines are lines on which (products with) feed additives for which a residue norm has been determined in the table in Chapter 3 or veterinary medical products and also products with a de-termined residue norm are produced and/or transported. GMP+ BA1 Product standards 49/61 1st January 2010 GMP+ International
The relationship between the relative wall adhesion factor and the co-efficient is shown in the following table. Relative wall adhesive factor according to the Coefficient established method. < 1 1 > 1 and < 2 2 > 2 and < 3 2,5 unknown, > 3 3 . Carry-over and flush batches The actual carry-over of additives and carry-over or veterinary medical products must be calculated in order to establish the number of flushes. This carry-over can be calculated by multiplying the installation carry-over by the coefficient. This coefficient can be used to calculate how many flush batches are minimally required to remain under the established residue standards. A sample calculation follows. Example: Broiler feed with nicarbazine : 80 ppm Company s own carry-over in installation: : 5 % Coefficient : "1" Maximum residue standard for broiler feed for the last five days: : ppm Calculation of actual carry-over = company s own carry-over x coefficient = (5%) x 1 = Calculation: calculated level of nicarbazine - batch a broiler feed 80 ppm - batch a+1 follow-on feed 4 ppm (= x 80) - batch a+2 follow-on feed ppm (= x 4) The second batch complies with the residue standard for broiler feed in the final fattening phase. Therefore a first flush batch must be produced with a non-critical feed. Items for attention and other remarks The supplementary instructions for use relate to the sequence of production opera-tions in the installation. It is also necessary for the participant to establish company requirements and procedures in order to comply with the residue standards for: a. transport (sequence) and storage (sequence) b. intake of premixes, additives and veterinary medical products. The participant must check that the prescribed residue standards are not ex-ceeded. If an infringement of these residue standards is detected, the instructions for use and procedures must be modified. The coefficients and the minimum carry-over levels calculated from them may be deviated from provided that the carry-over is measured using the relevant product itself. GMP+ BA1 Product standards 50/61 1st January 2010 GMP+ International
Premix General The objective of these supplementary instructions is that compound feed producers must be able to use premixes from GMP+-certified manufacturers in producing compound feeds, without exceeding the maximum carry-over levels. Carry-over of critical additives and veterinary medicines also occurs in the prepara-tion of premixes. In order to prevent GMP+-certified compound feed mixers from exceeding the standards for coccidiostats, histomonostats and critical veterinary medical products because of excessive levels in premixes, a general rule of thumb is that no more than 50% of the residue standard as stated for compound feed may be used up as a result of the premixes used. The maximum level in the premix must be derived from the dosage of the premix in the compound feed. Carry-over of coccidiostats, histomonostats and critical veteri-nary medical products may take place via direct and indirect contamination. Direct contamination Direct contamination is possible through use of a premix destined for an animal feed for which a maximum residual level has been established. The premix pro-ducer is to ensure through his GMP+ feed safety system that no more than 50% of the residue standard as stated for that compound feed is used up via the premix. For any flush batches required, the relevant coefficient as established for that prod-uct should be adopted. Indirect contamination In order to achieve extremely low residue standards in premixes, producers of pre-mixes will have to first produce a number of batches for a non-critical use following the production of premixes with coccidiostats, histomonostats and critical veterinary medicines. A premix which is produced subsequent to one prepared with a coc-cidiostats or histomonostats (a so-called flush batch) may still contain such high levels of coccidiostats or histomonostats that this can cause problems for the com-pound feed producer. Compound feed manufacturers use these premixes mainly in animal feeds which are also used to flush an installation clean. In certain cases the level of critical addi-tives is so high that, together with the company s own carry-over levels, the residue standards in compound feeds are exceeded. GMP+ BA1 Product standards 51/61 1st January 2010 GMP+ International
3 Residue standards for critical additives Summary of residue standards for coccidiostats and histomonostats according to Directive 2002/32/EC amending Annex I to Directive 2002/32/EC Additives Products intended for animal feed2 () Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % Lasalocid Feed materials 1,25 sodium Compound feed for: - dogs, calves, rabbits, equine species, dairy 1,25 animals, laying birds, turkeys (> 12 weeks) and chickens reared for laying (> 16 weeks) - chickens for fattening, chickens reared for 1,25 laying (< 16 weeks) and turkeys (< 12 weeks) for the period before slaughter in which the use of lasalocid sodium is prohibited (with-drawal feed) - other animal species 3,75 3 Premixtures for use in feed in which the use () of lasalocid sodium is not authorised Narasin Feed materials 0,7 Compound feed for: - turkeys, rabbits, equine species, laying birds 0,7 and chickens reared for laying (> 16 weeks) - chickens for fattening for the period before 0,7 slaughter in which the use of narasin is pro-hibited (withdrawal feed) - other animal species 2,1 2 Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutri-tion. 3 The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50 % of the maximum levels established in the feed when the instructions for use of the premixture are followed. GMP+ BA1 Product standards 52/61 1st January 2010 GMP+ International
Additives Products2 intended for animal feed () Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % 3 Premixtures for use in feed in which the use () of narasin is not authorised. Salinomycin Feed materials 0,7 sodium Compound feed for: - equine species, turkeys, laying birds and 0,7 chickens reared for laying (> 12 weeks) - chickens for fattening, chickens reared for 0,7 laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed) - other animal species 2,1 Premixtures for use in feed in which the3 use () of salinomycin sodium is not authorised. Monensin Feed materials 1,25 sodium Compound feed for: - equine species, dogs, small ruminants 1,25 (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 16 weeks) - chickens for fattening, chickens reared for 1,25 laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (with-drawal feed) - other animal species Premixtures for use in feed in which3 the use () of monensin sodium is not authorised. SemduramiciFeed materials n sodium Compound feed for: - laying birds and chickens reared for laying 0,25 (> 16 weeks) GMP+ BA1 Product standards 53/61 1st January 2010 GMP+ International
Additives Products2 intended for animal feed () Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % - chickens for fattening for the period before 0,25 slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed) - other animal species 0,75 Premixtures for use in feed in wh3ich the use () of semduramicin sodium is not authorised. Maduramicin Feed materials 0,05 ammonium alpha Compound feed for: - equine species, rabbits, turkeys (> 16 0,05 weeks), laying birds and chickens reared for laying (> 16 weeks) - chickens for fattening and turkeys (< 16 0,05 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed) - other animal species 0,15 Premixtures for use in feed in which the3 use () of maduramicin ammonium alpha is not authorised. Robenidine Feed materials 0,7 hydro- chloride Compound feed for: - laying birds and chickens reared for laying 0,7 (> 16 weeks) - chickens for fattening, rabbits for fattening 0,7 and breeding and turkeys for the period be-fore slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed) - other animal species 2,1 Premixtures for use in feed in which the use () of robenidine hydrochloride is not authorised. Decoquinate Feed materials 0,4 Compound feed for: GMP+ BA1 Product standards 54/61 1st January 2010 GMP+ International
Additives Products2 intended for animal feed () Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % - laying birds and chickens reared for laying 0,4 (> 16 weeks) - chickens for fattening for the period before 0,4 slaughter in which the use of decoquinate is prohibited (withdrawal feed) - other animal species 1,2 3 Premixtures for use in feed in which the use () of decoquinate is not authorised Halofuginone Feed materials 0,03 hydro- bromide Compound feed for: - laying birds, chickens reared for laying (> 16 0,03 weeks) and turkeys (> 12 weeks) - chickens for fattening and turkeys (< 12 0,03 weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed) - other animal species other than chickens 0,09 reared for laying (< 16 weeks) 3 Premixtures for use in feed in which the use () of halofuginone hydrobromide is not author-ised Nicarbazin Feed materials 0,5 Compound feed for: - equine species, laying birds and chickens 0,5 reared for laying (> 16 weeks) - chickens for fattening for the period before 0,5 slaughter in which the use of nicarbazin (in combination with narasin) is prohibited (with-drawal feed) - other animal species 1,5 3 Premixtures for use in feed in which the use () of nicarbazin (in combination with narasin) is not authorised GMP+ BA1 Product standards 55/61 1st January 2010 GMP+ International
Add2itives Products intended for animal feed () Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % Diclazuril Feed materials 0,01 Compound feed for: - laying birds, chickens reared for laying (> 16 0,01 weeks) and turkeys for fattening (> 12 weeks) - rabbits for fattening and breeding for the 0,01 period before slaughter in which the use of diclazuril is prohibited (withdrawal feed). - other animal species other than chickens 0,03 reared for laying (< 16 weeks), chickens for fattening and turkeys for fattening (< 12 weeks) Premixtures for u3se in feed in which the use () of diclazuril is not authorised. Feed All feeds intended for marketing within the EU. 1 additives not registered in the EU which are intended for use in feeds for export out-side the EU. GMP+ BA1 Product standards 56/61 1st January 2010 GMP+ International
Additional information for some coccidiostats and histomonostats * Trade name Manufacturer Importer Concentration Coefficient Pigs Other Compound of narasin and nicarbazine (E 772) Maxiban G 160 premix Eli Lilly Eli Lilly Nederland BV 80 g/kg narasin 5 1 80 g/kg nicarbazine Lasalocid sodium (E 763) Avatec 15% CC Roche Alpharma 15g/100g Lasalocide-sodium 1 1 Robenidine-hydrochloride (E758) Cycostat 66G Roche Alpharma 66g/kg Robenidine-1 1 hydrochloride Monensin-sodium (E757) Elancoban G200 premix Eli Lilly Eli Lilly Nederland BV 200g/kg monensin sodium 1 1 Coxidin (5 1 701) Huvepharma Huvepharma NV 200g/kg monensin natrium 1 1 Narasin (E765) Monteban G100 premix Eli Lilly Eli Lilly Nederland BV 100g/kg narasin 1 1 Halofuginone-hydrobromine (764) Stenorol Huvepharma Huvepharma NV 6 g/kg halofuginone 1 1 hydrobromide Diclazuril (E 771) Clinacox 0,5 % Premix Janssen Janssen diclazuril 2 2 Pharmaceutica nv Pharmaceutica nv Salinomycin-sodium (E 766) Sacox 120 microGranulate Huvepharma Huvepharma NV 120g/kg salinomycine 1 1 Other Other Other N/a 3 3 *: This list can be extended at new available data of relative wall adhesion test GMP+ BA1 Product standards 57/61 1st January 2010 GMP+ International
4 Residue standards for critical veterinary medical prod-ucts Summary of residue standards for critical veterinary medical products Veterinary medical Established maximum residue standards Established product in an4imal feeds in ppm precautionary measure for dairy cattle laying slaughter pigs7 dairy hens5 chickens6 cattle8 fattening turkeys6 Sulfadiazine sodium 5 8 1 1 Sulfamethoxazol 5 8 1 1 Doxycycline 8 8 109 - 1 batch10 Oxytetracycline 1 109 10 - 1 batch10 Ivermectine - 1 batch10 Tiamuline 1 89 10 - 1 charge10 Tilmicosine 1 4 109 - 1 charge10 Trimethoprim Linked to Sulfadiazine and therefore sufficiently guaranteed for export (not in NL 1 1 1 1 for animal feed registered materials) and for any new registrations in the Netherlands 4 The max. residue norms for premixes amount to maximum. 50% of the indicated residue norms for animal feeds calculated on an animal feed basis 5 feed given to laying animals 6 feed given from 5 days before slaughter 7 feed given from 28 days before slaughter 8 feed given to milk-producing cows, goats and sheep 9 At this moment there is insufficient knowledge available in order to be able to establish a carry-over norm for this additive for these categories. 10 Dairy cow feed may not immediately be produced on a production line which has just produced feed with these additives. GMP+ BA1 Product standards 58/61 1st January 2010 GMP+ International
Additional information per critical veterinary medical product Trade name Registration holder Registration number Concentration Coefficient max dosing Sulphadiazine sodium Pigs Other (trimethoprim) Feedmix Trim/sul 80/420 Aesculaap BV RegNL 1808 77 g/kg 5 3 385 ppm (5kg/t) Trimethosulf premix Eurovet RegNL 7589 g/kg 5 2 312 ppm ( 5kg/t) 625 ppm ( 10kg/t) Feedmix sulfatrim Dopharma RegNL 8541 60 g/kg 5 3 480 ppm ( 8kg/t) 600 ppm ( 10kg/t) Sulphamethoxazol (trimethoprim) Feedmix TS Dopharma RegNL 8674 50 g/kg 5 3 250 ppm (5kg/t) 500 ppm (10kg/t) Bromine hexine hydrochloride/doxycyclinehyclate Feedmix Doxy-B Dopharma RegNL 2588 20 g/kg 2,5 2,5 100 ppm (5kg/t) 300 ppm (15kg/t) Pulmodox 5% Premix Virbac Laboratories RegNL 9826 50g/kg 2,5 2,5 250 ppm (5kg/t) Doxyprex Industrial Veterinaria S. A. RegNL 10393 100g/kg 2,5 2,5 250 ppm (2,5kg/t) Oxytetracycline Feedmix V4 Dopharma RegNL 2158 80g/kg 3 3 400 ppm (5kg/t) 800 ppm (10kg/t) Feedmix Oxy 10% Dopharma RegNL 2004 100g/kg 3 3 300 ppm (3kg/t) 700 ppm (7kg/t) OTC-400 Framelco . RegNL 7254 80g/kg 3 3 400 ppm (5kg/t) OXY-400 V4 Eurovet RegNL 7277 80g/kg 3 3 400 ppm (5kg/t) GMP+ BA1 Product standards 59/61 1st January 2010 GMP+ International
Trade name Registration holder Registration number Concentration Coefficient max dosing Ivermectine Ivomec Premix Merial RegNL 8731 6/kg11 3 3 10 ppm12 Noromectin Premix 0,6% G/G Norbrook Laboratories RegNL 10465 6g/kg11 3 3 10 ppm12 voor varkens Ltd Tiamulin Tiamutin 10% premix Novartis RegNL 8015 100g/kg 3 3 30-40ppm Denagard 2% premix Novartis RegNL 8016 20g/kg 3 3 30-40ppm Tialin 10% premix Eurovet RegNL 10178 100g/kg 3 3 30-40ppm Tialin 2% premix Eurovet RegNL 10177 20g/kg 3 3 30-40ppm Vetmulin 2% premix Huvepharma . RegNL 100731 20g/kg 3 3 175ppm Vetmulin 10% premix for Huvepharma . RegNL 101337 100g/kg 3 3 175ppm medicated feed Tilmicosine Pulmotil G40 PREMIX Eli Lilly/Elanco Health RegNL 9166 40g/kg 3 3 tot 400 ppm Pulmotil G100 PREMIX Eli Lilly/Elanco Health RegNL 9167 100g/kg 3 3 tot 400 ppm Pulmotil G200 PREMIX Eli Lilly/Elanco Health RegNL 9168 200g/kg 3 3 tot 400 ppm Pneumotil G40 PREMIX Eli Lilly/Elanco Health RegNL 10368 40g/kg 3 3 tot 400 ppm Tilmovet 10%, premix for Huvepharma . RegNL 100528 100g/kg 3 3 400 ppm medicated feed for pigs Tilmovet 4% Huvepharma . RegNL 100739 40g/kg 3 3 400 ppm Tilmovet 20%, premix for Huvepharma . RegNL 100742 200g/kg 3 3 400 ppm medicated feed for pigs 11 The product is made by mixing kg premix (concentration 6 g/kg) in 5 kg premix. 12 Dosing for sow feed, calculated on the basis of dosing 100 microgrammes ivermectine per kg delivered weight. GMP+ BA1 Product standards 60/61 1st January 2010 GMP+ International
Trade name Registration holder Registration number Concentration Coefficient max dosing for export (not in NL for animal Reg NL .... .... 3 3 . feed registered materials) and for any new registrations in the Netherlands GMP+ BA1 Product standards 61/61 1st January 2010 GMP+ International
