GMP+ BA1 Product Standards

BA

1

EN

Module: Feed Safety Assurance

GMP+ BA1 GMP BA1 Product standards

Version: June 2014

© GMP+ International B.V.

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Version: 30-10-2014 08:37Product Standards EN

© GMP+ International B.V.1 / 109

History of the document

Revision nr./ Date of approval

Amendment Concers Final implemen-

tation date

0.0 / 01-01-2010 Overgang van de documenten van Previous versions can be found in History 01-01-2010

0.1 / 17-03-2010 17-03-2010

0.2 / 29-09-2010 25-11-2010

0.3 / 14-11-2011 20-12-2011

0.4 / 01-10-2012 01-11-2012

0.4 / 11-2012 01-03-2013

05 / 03-2014 Changes in feed legislation: - maximum levels for melamine in

canned pet food - special conditions on the imports of

guar gum originating in or con-signed from India

- maximum levels for arsenic, cad-mium, lead, nitrites, volatile mus-tard oil and harmful botanical impu-rities

- maximum levels for radioactivity

New action limits for Fumonisin B1 +B2 and T-2 and HT-2- toxins New limit for Moulds and yeast

Summary of residue standards for coccidiostats and histomonostats: mi-nor corrections

Part A, par. 3

Part A, par. 3

Part A, par. 3

Part B, par. 3.1



INDEX

1 INTRODUCTION 5

1.1 GENERAL 5

1.2 STRUCTURE OF THE GMP+ FEED CERTIFICATION SCHEME 5

PART A: PRODUCT STANDARDS 7

1 INTRODUCTION TO THE PRODUCT STANDARDS 7

2 CONDITIONS 7

3 SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANI-MAL FEED SECTOR 8

4 RESIDUE LEVELS OF PESTICIDES IN FEEDS 83

4.1 INTRODUCTION 83

4.2 THE ESTABLISHMENT OF AND MRL 83

4.2.1 General 83 4.2.2 Questionnaire for basic products 85

4.2.3 Questionnaire for by-products 86

4.2.4 Questionnaire for compound feeds 86

4.2.5 Fumigators 86

4.3 SPECIAL REQUIREMENTS 89

PART B: RESIDUE STANDARDS 90

1 INTRODUCTION 90

2

ADDITIONAL PROVISIONS

91

2.1 GENERAL 91

2.2 COMPOUND FEED 92

2.2.1 Installation Carry-over level 92 2.2.2. The coefficient 92

2.2.3. Carry-over and flush batches 93

2.2.4 Items for attention and other remarks 93

2.3 PREMIX 94

2.3.1 General 94

2.3.2 Direct contamination 94

2.3.3 Indirect contamination 94

3 RESIDUE STANDARDS FOR COCCIDIOSTATS AND HISTO-MONOSTATS 95

3.1 SUMMARY OF RESIDUE STANDARDS 95

3.2 ADDITIONAL INFORMATION FOR SOME COCCIDIOSTATS AND

HISTOMONOSTATS * 100



4 RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL PRODUCTS 101

4.1 SUMMARY OF RESIDUE STANDARDS FOR CRITICAL VETERINARY

MEDICAL PRODUCTS 101

4.2 OVERVIEW OF ADMISSIBLE MEDICATED PREMIXES 102

4.3 Product standards GMP+ BCN-NL1 Antibiotics free feed 108



1 Introduction

1.1 General

The GMP+ Feed Certification scheme was initiated and developed in 1992 by the Dutch feed industry in response to various more or less serious incidents involving contamination in feed materials. Although it started as a national scheme, it has developed to become an international scheme that is managed by GMP+ International in collaboration with various international stakeholders.

Even though the GMP+ Feed Certification scheme originated from a feed safety

perspective, in 2013 the first feed responsibility standard has been published. For

this purpose, two modules are created: GMP+ Feed Safety Assurance (focussed

on feed safety) and GMP+ Feed Responsibility Assurance (focussed on responsi-

ble feed).

GMP+ Feed Safety Assurance is a complete module with standards for the assur-

ance of feed safety in all the links of the feed chain. Demonstrable assurance of

feed safety is a 'license to sell’ in many countries and markets and participation in

the GMP+ FSA module can facilitate this excellently. Based on needs in practice,

multiple components have been integrated into the GMP+ FSA standards, such as

requirements for a feed safety management system, for application of HACCP prin-

ciples, to traceability, monitoring, prerequisites programmes, chain approach and

the Early Warning System.

With the development of the GMP+ Feed Responsibility Assurance module, GMP+

International is responding to requests from GMP+ participants. The animal feed

sector is confronted with requests to operate more responsible. This includes, for

example, the sourcing of soy and fishmeal which are produced and traded with

respect for humans, animals and the environment. In order to demonstrate respon-

sible production and trade, a company can get certified for the GMP+ Feed Re-

sponsibility Assurance. GMP+ International facilitates via independent certification

the demands from the market.

Together with the GMP+ partners, GMP+ International transparently lays down

clear requirements in the Feed Certification scheme. Certification bodies are able to

carry out GMP+ certification independently.

GMP+ International supports the GMP+ participants with useful and practical infor-mation by way of a number of guidance documents, databases, newsletters, Q&A lists and seminars.

1.2 Structure of the GMP+ Feed Certification scheme

The documents within the GMP+ Feed Certification scheme are subdivided into a number of series. The next page shows a schematic representation of the content of the GMP+ Feed Certification scheme:



B – documentsNormative documents, appendices and country notes

A – documentsGeneral requirements for participation in the GMP+ FC scheme

GMP+ Feed Certification scheme

Feed Safety Assurance Feed Responsibility Assurance

C – documentsCertification requirements of the GMP+ FC scheme

D – documentsGuidelines to help companies with the implementation

of the GMP+ requirements

All these documents are available via the website of GMP+ International

(www.gmpplus.org).

This document is referred to as GMP+ BA1 Product standards and is part of the GMP+ FSA module.



PART A: PRODUCT STANDARDS

Introduction to the product standards

There are references in the various GMP+ standards to the product standards. This

part of this appendix contains the legal and a number of additional GMP+ product

standards with respect to contaminants. The product standards included in

this appendix are:

a. the product standards as laid down in the European Union feed legislation, or

b. a number of product standards, as determined within the framework of the

GMP+ FSA scheme in consultation with the subsequent links in the animal pro-

duction chain.

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 additional GMP+ standards). The list will be regularly updated. The GMP+ In-

ternational is not liable for any errors in this list.

2 Conditions

In arriving at the product standards a distinction has been made between action and rejection 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 de-

viations (in the product or process) from the requirements in this standard are rec-

orded and controlled in order to prevent unintentional use or delivery of the product.

Product standards for mixes of feed materials (semi-manufactured product) which

are marketed as such

The product standards for the maximum level of undesirable substances is calcu-

lated proportionately from the product standard for the individual components. This calculation principle is also applied for the calculation of the product standard for pesticides for compound feeds (see section 4.2.4 question no.5).



SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR

Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary

requirements Analysis method7

Microbiological: Other undesirable substances and products

M1 Antibacterial inhibition - Feed materials - < 15 mm GMP+ According to the 5-plate test MB003, derived from EG-4-plate test, product basis (RIVM report no. 206; Archiv fur Lebensmittelhygiene 31 (1981) page 97-140.

OZM Part 1; O-1

- Wet mixes

[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 differently.

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.

[7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods)






Microbiological

M3 Enterobacteriaceae From animal by-products derived products, with the exception of canned petfood and raw petfood

300 kve/g Commission Regulation (EU) 142/2011, annex XIII, chapter 2

n = 5, c = 2, m = 10, M = 300 14

OZM Part 2; M-3

From animal by-products derived raw petfood 5.000 kve/g Commission Regulation (EU) 142/2011, annex XIII, chapter 2

n = 5, c = 0, m = 0, M =5.000 14

From animal by-products derived canned petfood - Commission Regulation (EU) 142/2011, annex XIII, chapter 2

Canned petfood which has been subjected to heat treatment with a Fc value of at least 3




[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; the result shall be considered unsatisfactory if the number of bacteria in one or more samples is M or more; 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.






Microbiological: Microbiological contamination

M4a Salmonella Consumption chick feed: end products and feed materials for:

GMP+ OZM Part 2; M-2a to M2e

- Top breeding consumption chicks - 0+% 20(approaching

0%)

- Breeding increase consumption chicks - 0+% 20(approaching

0%)

- Increase consumption chicks - 0+% 20(approaching

0%)

- Consumption chicks - 0+% 20(approaching

0%)

Laying poultry feed: end products and feed materials for:

GMP+

- Top breeding laying poultry - 0+% 20(approaching

0%)

- Raising increase laying poultry - 0+% 20(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 materials for: GMP+

- Raising increase turkeys - 0+% 20(approaching

0%)

- Increase turkeys - 0+% 20(approaching

0%)

- Consumption turkeys - 0+% 20(approaching

0%)

Other animal feeds, feed materials and wet mixes intended for cattle farms (except for poultry feeds).

- Absent in 25 gr GMP+

From animal by-products derived products with the exception of canned petfood

- Absent in 25 gr Commission Regulation (EU) 142/2011, annex XIII, chapter 2

n = 5, c = 0, m = 0, M = 0 14



Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements

Analysis method7

From animal by-products derived canned petfood - Commission Regulation (EU) 142/2011, annex XIII, chapter 2

Canned petfood which has been subjected to heat treatment with a Fc value of at least 3

M4b Salmonella preservation determined through pH

- Feed materials for delivery to cattle farms, and Maximum pH for guarantee:

GMP+ If preservation can be achieved at a higher pH then this should be supported with data.

OZM Part 2; M-5

- Wet mixes for delivery to livestock farmers on the basis of:

- Spontaneous lactic acid fermentation - Add organic acids - Add inorganic acids

- 4.5 4 3,5

These norms do not apply if the products are supplied at a temperature of at least 60°C and the supplier is demonstrably informed of the storage conditions. The absence of Salmonella can also be shown in heat-treated wet mixes and feed materials (<13% moisture) through compliance with the norms for Enterobacteriaceae.




[20] Explanation of 0+: this norm does not apply to each individual sample. In a particular period of time the Salmonella incidence at company level should approach 0% (= 0+).

[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; the result shall be considered unsatisfactory if the number of bacteria in one or more samples is M or more; 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.





requirements Suggestion for analysis method

Microbiological: Microbiological contamination

M5a Moulds - Feed materials for delivery to cattle farms, and - 10,000 kve/gram GMP+ OZM Part 2; M-4

- Wet mixes for delivery to livestock farmers

with an Aw value > 0.75 (if this is not known then a moisture content > 13%)

Feed materials 106 CFU/g In the TNO report “Norm

for fungal load in animal feed (D4.16)“ you can read the foundation of the new standards and the suggestions for analysis methods.

Enumeration NEN-ISO 21527-1:2008 Enumeration NEN-ISO 21527-2:2008 (if aw-value ≥ 0.95)

M5b Yeast Feed materials≤ 12% moisture content or aw-value ≤ 0.95

106 CFU/g Enumeration NEN-

ISO 21527-1:2008

Feed materials ≥ 12% moisture content or aw-value ≥ 0.95

-









Chemical: Mycotoxin

C1 Aflatoxin B1 Feed materials intended for (direct) delivery to dairy farmers

- 0.005 mg/kg GMP+ OZM Part 2; OSP1a to 1e

Feed materials - 0.02 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

Complementary and complete feed with the exception of:

- 0.01 mg/kg

- compound feed for dairy cattle and calves, dairy sheep and lambs, dairy goats and kids, piglets and young poultry animals.

- 0.005 mg/kg

- compound feed for cattle (except dairy cattle and calves), sheep (except dairy sheep and lambs), goats (except dairy goats and kids), pigs (except piglets) and poultry (except young animals).

- 0,02 mg/kg









Chemical: Crop protection agents (Pesticides which are not permitted in the EU)

C2 Aldrin Dieldrin (Singly or combined expressed as dieldrin)

Feed materials and compound feed, with the exception of:

- 0.01 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

Maximum level for aldrin and dieldrin, singly or combined, expressed as dieldrin.

OZM Part 2; OSP-11

- fats and oils, 0,1 mg/kg

- compound feed for fish 0.2 mg/kg









Chemical: Heavy metals

C3 Arsenic16 Feed materials, with the exception of:

- 2 mg/kg Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC Commission Regulation (EU) No 1275/2013 amending Annex I and II to Directive 2002/32/EC

OZM Part 2; OSP-26

- meal made from grass, from dried lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp,

- 4 mg/kg

- palm kernel expeller, - 4 mg/kg15

- phosphates and calcareous marine algae - 10 mg/kg

- calcium carbonate; calcium and magnesium carbonate 11

- 15 mg/kg

- magnesium oxide and magnesium carbonate - 20 mg/kg

- fish, other aquatic animals and products derived thereof,

- 25 mg/kg15

- seaweed meal and feed materials derived from seaweed

- 40 mg/kg15

Iron particles used as tracer - 50 mg/kg

Feed additives belonging to the functional group of compounds of trace elements except:

- 30 mg/kg

- cupric sulphate pentahydrate; cupric carbonate; di copper chloride trihydroxide; ferrous carbonate,

- 50 mg/kg

- zinc oxide, manganous oxide and cupric oxide - 100 mg/kg

Complete feed, with the exception of: - 2 mg/kg

- complete feed for fish and fur animals. - 10 mg/kg15

- complete feed for pet animals containing fish, other aquatic animals and products derived thereof and/or seaweed meal and feed materials derived from seaweed.

- 10 mg/kg15

Complementary feed, with the exception of: - 4 mg/kg

- mineral feed - 12 mg/kg




Analysis method7

- complementary feed for pet animals containing fish, other aquatic animals and products derived thereof and/or seaweed meal and feed materials derived from seaweed.

10 mg/kg 15

- long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed.

30 mg/kg




[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 / mercury respectively

[11] Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25)






Chemical: Other undesirable substances and products

C4 Hydrocyanic acid Feed materials, with the exception of: - 50 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-9

- linseed - 250 mg/kg

- linseed cakes - 350 mg/kg - manioc products and almond cake. - 100 mg/kg


- complete feed for young chickens (< 6 weeks) - 10 mg/kg










C5 Biogenic amines* - Animal feeds> 30% crude protein - 4,000 mg/kg protein

GMP+ * In as far as these are created by decay due to protein decay and are not the consequence of the normal processing of the product

OZM Part 2; OSP-23










C6 Cadmium Feed materials of vegetable origin - 1 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 1275/2013 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-27

Feed materials of animal origin - 2 mg/kg

Feed materials of mineral origin, with the exception of:

2 mg/kg

- phosphates - 10 mg/kg

Feed additives, belonging to the functional group "Compounds of trace elements", with the exception of:

- 10 mg/kg

- cupric oxide, manganous oxide, zinc oxide and manganous sulphate-monohydrate

- 30 mg/kg

Feed additives belonging to the functional groups of binders and anti-caking agents

- 2 mg/kg

Premixtureses - 15 mg/kg2

Complementary feed with the exception of: - 0,5 mg/kg

Mineral feed

- containing < 7% phosphorus 8 - 5 mg/kg

- containing> 7% phosphorus 8 - 0,75 mg/kg per 1% phosphorus 8, with a maximum of 7,5 mg/kg

Complementary feed for pet animals - 2 mg/kg

Long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed.

- 15 mg/kg

Complete feed with the exception of: - complete feed for cattle (except calves), sheep (except lambs) goats (except kids) and fish feed

- 0,5 mg/kg 1 mg/kg




Analysis method7

- complete feed for pet animals - 2 mg/kg



[2]The maximum level established for premixtures takes into account the additives with the highest level of lead and cadmium and not the sensitivity of the different animal species to lead and cadmium. As provided in Article 16 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29), in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feed.


[8] The % of phosphorus is relative to a feed with a moisture content of 12 %.






Chemical: Salts

C7 Chloride - Feed materials for delivery to livestock farms, and

10 g/kg (dry matter)

GMP+ If the action limit is exceeded then a warning or processing advice must be demonstrably communicated to the customer. Supply of additional water to the animals is also important to avoid health problems. More recommendations in the event of excess of the action limit can be found in GMP+ D4.13 Salts in rations with wet feeds for fattening pigs and sows

OZM deel 2; OSP-22

- Wet mixes for delivery to livestock farmers










C8 Camphechlor (toxaphene) – sum of the indicators CHB 26, 50 and 6222

Fish, other aquatic animals and products thereof with the exception of fish oil


OZM Part 2; OSP-11

- fish oi - 0.2 mg/kg

Complete feed for fish - 0.05 mg/kg




[22] Numbering system according to Parlar, prefixed by either CHB or "Parlar": - CHB 26: 2-endo,3-exo,5-endo,6-exo,8,8,10,10-octochlorobornane, - CHB 50: 2-endo,3-exo,5-endo,6-exo,8,8,9,10,10-nonachlorobornane, - CHB 62: 2,2,5,5,8,9,9,10,10-nonachlorobornane.







C9 Chlordane (sum of cis- en transisomers and of oxychlordane expressed chlordane)

Feed materials and compound feed with the exception of:


OZM Part 2; OSP-11

- fats and oils - 0.05 mg/kg








requirements Analysis method

Chemical: Botanical impurities

C10 Crotalaria spp. Feed materials and compound feed - 100 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 1275/2013 amending Annex I to Directive 2002/32/EC

Microscopic determination in accordance with the instructions of the laboratory








Chemical: Crop protection agents and biocides (permitted in the EU)

C11 DDT (sum of DDT-, DDD- (or TDE-) and DDE-isomers, expressed as DDT)



OZM Part 2; OSP-11

- fats en oils - 0.5 mg/kg










C12 Prohibited Animal proteins (Restricted animal proteins)

Animal feeds for productive livestock - 0 Regulation 999/2001, art. 7 and Appendix IV

See GMP+ BA 3: Negative list

OZM Part 2; OSP-12







Contaminant Product Action limit(1)

(4)

Rejection limit(1)(4) Source Supplementary requirements Analysis method7

Chemical: Toxic substances

C13a Dioxin 18

(sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005))

Feed materials of plant origin with the exception of vegetable oils and their by-products

0,5 ng WHO-PCDD/F-TEQ/kg


Commission Regulation (EU) No 277/2012 and 744/2012 amending Annex I and II to Directive 2002/32/EC

In the event of exceeding the action limit: Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

OZM Part 2; OSP-18

Vegetable oils and their by-products 0,5 ng WHO-PCDD/F-TEQ/kg


Feed materials of mineral origin 0,5 ng WHO-PCDD/F-TEQ/kg


Feed materials of animal origin:

Animal fat including milk fat and egg fat 0,75 ng WHO-PCDD/F-TEQ/kg


Other land animal products including milk and milk products and eggs and egg products.



Fish oil 4,0 ng WHO-PCDD/F-TEQ/kg


In the event of exceeding the action limit: In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species, etc., shall be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in the materials for animal nutrition.

Fish, other aquatic animals and products derived thereof, with the exception of fish oil and hydrolysed fish protein containing more than 20% fat6 and crustacean meal.



Hydrolysed fish protein containing more than 20% fat ; crustacean meal.






(4)


Feed additives belonging to the functional groups of binders and anti-caking agents



The feed additives kaolinitic clay, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin, belonging to the functional groups of binders and anti-caking agents


Feed additives belonging to the functional group of compounds of trace elements.



Premixes 0,5 ng WHO-PCDD/F-TEQ/kg


Compound feeds with the exception of: 0,5 ng WHO-PCDD/F-TEQ/kg


- compound feed for pet animals and fish 1,25 ng WHO-PCDD/F-TEQ/kg



- compound feed for fur animals - -

C13b Sum of dioxins and dioxin-like PCBs18 (sum of polychlorinated dibenzo- para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) expressed in World Health Organisation


1.25 ng WHO-PCDD/F-PCB-TEQ/kg

OZM Part 2; OSP-18

Vegetable oils and their by-products 1.5 ng WHO-PCDD/F-PCB-




(4)


(WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005))

TEQ/kg

Feed materials of mineral origin 1,0 ng WHO-PCDD/F-PCB-TEQ/kg


- Animal fat including milk fat and egg fat 2,0 ng WHO-PCDD/F-PCB-TEQ/kg

- Other land animal products including milk and milk products and eggs and egg products


- Fish oil 20,0 ng WHO-PCDD/F-PCB-TEQ/kg

- Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20% fat6

4,0 ng WHO-PCDD/F-PCB-TEQ/kg

- Fish protein hydrolysates containing more than 20% fat

9,0 ng WHO-PCDD/F-PCB-TEQ/kg

The feed additives kaolinitic clay, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin, belonging to the functional groups of binders and anti-caking agents


Feed additives belonging to the functional group of compound of trace elements.


Premixtures 1.5 ng WHO-PCDD/F-PCB-TEQ/kg

Compound feed with the exception of: 1.5 ng WHO-PCDD/F-PCB-TEQ/kg

- Compound feed for pet animals and fish 5,0 ng WHO-PCDD/F-PCB-TEQ/kg

- Compound feed for fur animals -




(4)


C13c Dioxin-like PCBs18 (sum of polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO- TEFs (toxic equivalency factors, 2005)


0.35 ng WHO-PCB-TEQ/kg


OZM Part 2; OSP-18

Vegetable oils and their by-products 0.5 ng WHO-PCB-TEQ/kg

Feed materials of mineral origin 0.35 ng WHO-PCB-TEQ/kg


- Animal fat including milk fat and egg fat 0.75 ng WHO-PCB-TEQ/kg



- Fish oil 11,0 ng WHO-PCB-TEQ/kg


- Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20% fat 6

2,0 ng WHO-PCB-TEQ/kg

- Fish protein, hydrolysed, containing more than 20% fat

5,0 ng WHO-PCB-TEQ/kg

Feed additives belonging to the functional groups of binders and anti-caking



Feed additives belonging to the functional group of compounds of trace elements





(4)


Premixtures 0.35 ng WHO-PCB-TEQ/kg

Compound feed with the exception of: 0.5 ng WHO-PCB-TEQ/kg

- Compound feed for pet animals and fish, 2,5 ng WHO-PCB-TEQ/kg


- Compound feed for fur animals -

C13d Non-dioxin-like PCBs (sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (ICES – 6))

Feed materials of plant origin 10 μg/kg (ppb)

Feed materials of mineral origin 10 μg/kg (ppb)

Feed materials of animal origin: 10 μg/kg (ppb)

- Animal fat, including milk fat and egg fat 10 μg/kg (ppb)


10 μg/kg (ppb)

- Fish oil 175 μg/kg (ppb)

- Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat 5

30 μg/kg (ppb)

- Fish protein, hydrolysed, containing more than 20 % fat

50 μg/kg (ppb)

The feed additives kaolinitic clay, vermiculite, natrolite- phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to

10 μg/kg (ppb)




(4)


the functional groups of binders and anti-caking agents

Feed additives belonging to the functional group of compounds of trace elements

10 μg/kg (ppb)

Premixture 10 μg/kg (ppb)

Compound feed with the exception of: 10 μg/kg (ppb)

- compound feed for pet animals and fish 40 μg/kg (ppb)

- compound feed for fur animals -



[4] Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

[5] Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 75 μg/kg product are

applicable to fresh fish and 200 μg/kg product are applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.

[6] Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 3,5 ng WHO-PCDD/F-TEQ/kg product and 6,5 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20,0 ng WHO-PCDD/F-PCB-TEQ/kg product is applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.


[18] Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs: WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on

Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin- like Compounds. Toxicological Sciences 93(2), 223–241 (2006))

Congener TEF value Congener TEF value

Dibenzo-p-dioxins (PCDDs) Dioxin-like PCBs:

2,3,7,8-TCDD 1

1,2,3,7,8-PeCDD 1 Non-ortho-PCBs

1,2,3,4,7,8-HxCDD 0.1 PCB 77 0,0001

1,2,3,6,7,8-HxCDD 0.1 PCB 81 0,0003

1,2,3,7,8, 9-HxCDD 0.1 PCB 126 0,1

1,2,3,4,6,7,8-HpCDD 0.01 PCB 169 0,03

OCDD 0,0003

Mono-ortho-PCBs



Dibenzofuranes (PCDFs) PCB 105 0,00003

2,3,7,8-TCDF 0.1 PCB 114 0,00003

1,2,3,7,8-PeCDF 0,03 PCB 118 0,00003

2,3,4,7,8-PeCDF 0,3 PCB 123 0,00003

1,2,3,4,7,8-HxCDF 0.1 PCB 156 0,00003

1,2,3,6,7,8-HxCDF 0.1 PCB 157 0,00003

1,2,3,7,8,9-HxCDF 0.1 PCB 167 0,00003

2,3,4,6,7,8-HxCDF 0.1 PCB 189 0,00003

1,2,3,4,6,7,8-HpCDF 0.01

1,2,3,4,7,8,9-HpCDF 0.01

OCDF 0,0003

Abbreviations used: T= tetra; Pe= penta; Hx=hexa; Hp= hepta; O= octa; CDD= chlorodibenzodioxin; CDF= chlorodibenzofuran; CB= chlorobiphenyl






Chemical: Mycotoxin

C15 DON Animal feed on full ration basis for: GMP+

(*) The supplier provides information to the livestock farmer in the event of infringement of the action limit for the level of the undesirable substance and provides advice on processing the product in the days ration The European Commission has published “Recommendation 2006/576/EC” regarding the guidance values for this mycotoxin. GMP+ International has established other values to comply.

OZM Part 2; OSP-19 ELISA, Lateral flow analysis

(Deoxynivalenol) - Pigs 0.8 mg/kg 1 mg/kg

- Cattle 4 mg/kg 5 mg/kg

- Calves up to 4 months 1.6 mg/kg 2 mg/kg

- Dairy cattle 2.4 mg/kg 3 mg/kg

- Poultry 3.2 mg/kg 4 mg/kg

Feed material (supplied to the livestock farmer for immediate feeding) for (*)

- Pigs 1 mg/kg 5 mg/kg

- Cattle 5 mg/kg 15 mg/kg

- Calves up to 4 months 2 mg/kg 6 mg/kg

- Dairy cattle 3 mg/kg 9 mg/kg

- Poultry 4 mg/kg 12 mg/kg










C16 Endosulfan (sum of alfa and bèta-isomers and of endosulfan sulphate, expressed as endosulfan)


0,1 mg/kg Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC

OZM Part 2; OSP-11

- maize and maize products derived from the processing thereof

- 0,2 mg/kg

- oilseeds and products derived from the processing thereof, except crude vegetable oil,

- 0,5 mg/kg

- crude vegetable oil, - 1,0 mg/kg

- complete feed for fish except for Salmonids, - 0,005 mg/kg

- complete feed for Salmonids - 0,05 mg/kg










C17 Endrin (sum of endrin and deltaketo-endrin, expressed as endrin)



OZM Part 2; OSP-11










Chemical: Salts

C19 Fluorine 3 Feed materials, with the exception of: - 150 mg/kg Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC

OZM Part 2; OSP-6

- Feed materials of animal origin except marine crustaceans such as marine krill

- 500 mg/kg

- marine crustaceans such as marine krill

- 3 000 mg/kg

- phosphates

- 2 000 mg/kg


- 350 mg/kg

- magnesium oxide - 600 mg/kg

- calcareous marine algae - 1,000 mg/kg

Vermiculite (E 561) - 3 000 mg/kg

Complementary feed

- containing < 4% phosphorus 8 - 500 mg/kg

- containing > 4% phosphorus 8 - 125 mg/kg per 1% phosphorus 8


- complete feed for cattle, sheep and goats

- in lactation - 30 mg/kg

- others - 50 mg/kg

- complete feed for pigs - 100 mg/kg

- complete feed for poultry (except chicks) and fish - 350 mg/kg

- complete feed for chicks - 250 mg/kg





[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


[8] The % of phosphorus is relative to a feed with a moisture content of 12 %.








C20 Heptachlor (sum of heptachlor and heptachlor epoxyd, expressed as heptachlor)

Feed materials and compound feed, with the exception of:


OZM Part 2; OSP-11











C21 Hexachlorobenzene (HCB) Feed materials and compound feed, with the exception of:


OZM Part 2; OSP-11











C22a Hexachlorocyclohexane (HCH): Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-11

- Alfa-isomer Feed materials and compound feed, with the exception of:

- 0.02 mg/kg











C22b Hexachlorocyclohexane (HCH): - Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-11

- Beta-isomer Compound feeds with the exception of: - 0.01 mg/kg

- compound feed for dairy cattle - 0.005 mg/kg

Feed materials, with the exception of: - 0.01 mg/kg











C22c Hexachlorocyclohexane (HCH): - Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-11

- Gamma-isomer (lindane) Feed materials and compound feed, with the exception of:

- 0.2 mg/kg










Chemical: Salts

C23 Potassium - Feed materials for delivery to cattle farms, and 60 g/kg (dry matter)


OZM deel 3; WM-08

- Wet mixes for delivery to cattle farmers







Contaminant Product Action limit

(1) Rejection limit

(1) Source Supplementary

requirements

Analysis method7


C24 Hydrocarbons (C10-C40) Animal fat, with the exception of: - 400 mg/kg (on product basic)

GMP+ OZM Part 2; OSP-15a

- crude fish oil - 3,000 mg/kg (on product basic)

Vegetable oil (with the exception of sunflower oil) - 400 mg/kg (on product basic)

Sunflower oil and sunflower fatty acids - 1,000 mg/kg (on

product basic)

Vegetable fatty acids incl. Mixes of fatty acids (with

the exception of sunflower fatty acids)

- 3,000 mg/kg (on

product basic)

Palm oil - 25 mg/kg

calculated as diesel oil

This norm applies if the

hydrocarbons (calculated as diesel oil) are

determined via the GC-MS method. If use is

made of the GC-FID method, then the norm for

vegetable oil applies

OZM Part 2; OSP-

15b

Hydrocarbons (mineral paraffin/oil) : saturated

hydrocarbons in the range C10-C56 from external sources minus

the alkanes C27, C29 and C31

Sunflower oil (falling within CN code 15121191 or TARIC Code 1512199010) originating in or

consigned from Ukraine

50 mg/kg (on product basic)

Commission Regulation (EC)

1151/2009 of 27 November 2009

The batch must be accompanied by a report

of analysis and a Health certificate

The sampling has to be performed in

accordance with Commission

Regulation (EC) No 333/2007 and the

standard ISO5555:2003 and

the analysis by a laboratory

accredited according to EN

ISO/IEC 17025

[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 differently.



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.





Contaminant Product (complete feedingstuff) Action limit(1) Rejection limit(1) Source Supplementary



C25 Copper (E4) Pigs: Commission Regulation (EC) No 1334/2003 amending the conditions for authorisation of a number of additives in feedingstuffs belonging to the group of trace elements

OZM Part 1; TVM-I-2

- Piglets up to 12 weeks - 170 mg/kg total

- Other pigs - 25 mg/kg total

Bovine:

1. Bovine before the start of rumination:

- Milk replace - 15 mg/kg total

- Other complete feeingstuffs - 15 mg/kg total

2. Other bovine - 35 mg/kg total

Ovine - 15 mg/kg Total

Fish - 25 mg/kg total

Crustaceans - 50 mg/kg total

Other species - 25 mg/kg total










C26 Mercury 16 Feed materials, with the exception of: - 0.1 mg/kg Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC

OZM Part 2; OSP-5

- fish, other aquatic animals and products derived thereof,

- 0.5 mg/kg

- calcium carbonate; ; calcium and magnesium carbonate 11

- 0.3 mg/kg

Compound feed, with the exception of: - 0.1 mg/kg

- mineral feed - 0.2 mg/kg

- compound feed for fish - 0,2 mg/kg

- compound feed for dogs, cats and fur animals - 0,3 mg/kg




[16] The maximum levels refer to the total level of arsenic / mercury respectively.








C27 Lead * Feed materials, with the exception of: - 10 mg/kg Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 002/32/EC

Commission Regulation (EU) No 1275/2013 amending Annex I and II to Directive 2002/32/EC

OZM Part 2; OSP-28

- forage 9 - 30 mg/kg

- phosphates and calcareous marine algae - 15 mg/kg


- 20 mg/kg

- yeast - 5 mg/kg

Feed additives belonging to the functional group of compounds of trace elements, with the exception of:

100 mg/kg

- zinc oxide 400 mg/kg

- manganous oxide, ferrous carbonate, cupric carbonate

200 mg/kg

Feed additives belonging to the functional group of binders and anti-caking agents, with the exception of:

30 mg/kg

- clinoptilolite of vulcanic origin; natrolite-phonolite 60 mg/kg

Premixtures 2 200 mg/kg

Complementary feed, with the exception of: - 10 mg/kg

- mineral feed - 15 mg/kg

- long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed.

- 60 mg/kg

Complete feed - 5 mg/kg




[9] Green fodder includes products which are intended for feeding to animals such as hay, silage, fresh grass, etc.

[2]The maximum level established for premixtures takes into account the additives with the highest level of lead and cadmium and not the sensitivity of the different animal species to lead and cadmium. As provided



in Article 16 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJL 268, 18.10.2003, p. 29), in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feed.

[11] Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials.

* for the determination of lead in kaolinitic clay and in feed containing kaolinitic clay, the maximum level refers to an analytical determination of lead, whereby extraction is performed in nitric acid (5 % w/w) for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.






Chemical: Mycotoxin

C28 Rye ergot (Claviceps purpurea) Feed materials and compound feed containing unground cereals

- 1,000 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-32









Chemical: Salts

C29 Sodium - Feed materials for delivery to cattle farms, and 8 g/kg (dry matter)


OZM deel 3; WM-09

- Wet mixes for delivery to cattle farmers








(1) Rejection limit


requirements

Analysis method7


C30 Nickel Feed fats 20 mg / kg (on

a fat basis)

50 mg / kg (on a fat

basis)

GMP+ OZM Part 2; OSP-

29


taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a mo isture content of 12% unless mentioned differently.

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. Ma ximum levels in mg/kg

(ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently.








C31 Nitrites Feed materials, with the exception of: - 15 mg/kg (expressed in sodium nitrite)

Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 1275/2013 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-7

- Fish meal - 30 mg/kg (expressed in sodium nitrite)

- silage -

- Products and by-products from sugar beet and sugarcane and from starch production and alcoholic drink production.

- -

Complete feed, with the exception of: - 15 mg/kg (expressed in sodium nitrite)

- complete feed for dogs and cats with a moisture content exceeding 20 %.

- -










C32 Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including

Feed material and compound feed - 3,000 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 1275/2013 amending Annex I to Directive 2002/32/EC










C32a - Datura sp. Feed material and compound feed - 1,000 mg/kg










C33 Insoluble impurities Rendered fats from ruminants - 0,15% Commission Regulation (EU) 142/2011, Annex X, Chapter II, Section 3

OZM Part 2; OSP-16









Chemical: Mycotoxin

C34 Ochratoxin A Animal feed on full ration basis for: GMP+

(*) The supplier provides information to the livestock farmer in the event of infringement of the action limit for the level of the undesirable substance and provides advice on processing the product in the days ration The European Commission has published recommendation 2006/576/EC regarding the guidance values for this mycotoxin. GMP+ International has established other values to comply.

OZM Part 2; OSP-19 HPLC, ELISA, Lateral flow analysis

- sows and consumption pigs and piglets 0.04 mg/kg 0.05 mg/kg

- poultry 0.16 mg/kg 0.2 mg/kg


- Sows and pigs and piglets 0.05 mg/kg 0.15 mg/kg

- Poultry 0.2 mg/kg 0.6 mg/kg







Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method


C35a Polycyclic Aromatic Hydrocarbons (PAH4)

Oils and fats (excluding palm(kernel)-, coconutoil and products derived thereof)

160 μg/kg (on fat basis)


GMP+ (PAH4=sum of benzo(a)pyrene, benzo(a)anthracene, benzo(b)fluoranthene and chrysene

Palm(kernel)-, coconutoil and and products derived thereof)



See the GMP+ D documents: - GMP+ D4.14 - GMP+ D415 http://www.gmpplus.org/nl/gmp+_fsa/D-documenten.php

See the GMP+ D documents: - GMP+ D4.14 - GMP+ D415

[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.

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.






Chemical: Antinutritional factors: Glucosides

C38 Seeds and husks from Ricinus communis L., Croton tiglium L. and Abrus precatorius L. as well as their processed derivatives (in so far determinable by analytical microscopy), separately or in combination

Feed materials and compound feed. - 10 mg/kg 23 Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 1275/2013 amending Annex I to Directive 2002/32/EC





[23] Includes also seed husk fragments.






Chemical: Salts

C39 Sulphate - Feed materials for delivery to cattle farms, and 8 g/kg (dry matter)


OZM deel 2; OSP-24

- Wet mixes for delivery to cattle farmers which are preserved with sulphuric acid and not for products which by nature are rich in sulphur









Chemical: Antinutritional factors: Alkaloids

C40 Theobromine Complete feed, with the exception of: - 300 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-8

- complete feed for pigs - 200 mg/kg

- complete feed for dogs, rabbits, horses and fur animals

- 50 mg/kg










C41 Vinyl thiooxazolidone (5-vinyloxazolidine-2-thione)

Complete feed for poultry with the exception of:

- 1,000 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-31

- complete feed for laying hens - 500 mg/kg










C42 Volatile mustard oil Feed materials, with the exception of: - 100 mg/kg (calculated as allylisothiocyanate)


OZM Part 2; OSP-20

- rapeseed cakes - Camelina seed and products derived thereof (*), products derived from mustard seed (*), rape seed and products derived thereof.

- 4,000 mg/kg (calculated as allylisothiocyanate)

Complete feed, with the exception of: - 150 mg/kg (calculated as allylisothiocyanate)

- Complete feeds for cattle (except calves), sheep (except lambs) and goats (except kids)

- 1,000 mg/kg (calculated as allylisothiocyanate)

- Complete feeds for pigs (except with the exception of piglets) and poultry

- 500 mg/kg (calculated as allylisothiocyanate)




* : Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of total glucosinolates is lower than 30 mmol/kg. The method of analysis of reference is EN-ISO 9167-1:1995






Chemical: Antinutritional factors: Other

C43 Free gossypol Feed materials, with the exception of: - 20 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC

OZM Part 2; OSP-21

- cotton seed - 5,000 mg/kg

- cotton seed cake and cotton seed meal - 1,200 mg/kg


- complete feed for cattle (except calves) - 500 mg/kg

- complete feed for sheep (except lambs) and goats (except kids),

- 300 mg/kg

- complete feed for poultry (except laying hens) and calves

- 100 mg/kg

- complete feed for rabbits, lambs, kids and pigs (except piglets)

- 60 mg/kg









Chemical: Mycotoxin

C44 Zearalenon Animal feed on full ration basis for: GMP+

(*) The supplier provides information to the livestock farmer in the event of infringement of the action limit for the level of the undesirable substance and provides advice on processing the product in the days ration The European Commission has published “Recommendation 2006/576/EC” regarding the guidance values for this mycotoxin. GMP+ International has established other values to comply.

OZM Part 2; OSP-19 HPLC, ELISA, Lateral flow analysis

- sows and consumption pigs 0.2 mg/kg 0.25 mg/kg

- young pigs 0.08 mg/kg 0.1 mg/kg

- young cattle and dairy cattle 0.4 mg/kg 0.5 mg/kg


- sows and pigs 0.25 mg/kg 0.75mg/kg

- young pigs 0.1 mg/kg 0.3 mg/kg

- young cattle and dairy cattle 0.2 mg/kg 1.5 mg/kg








(1) Rejection limit


requirements

Analysis method7


C45 Zinc (E6) Pets13

- 250 mg/kg total Commission

Regulation (EC) No 1334/2003

amending the conditions for

authorisation of a number of additives

in feedingstuffs belonging to the

group of trace elements

OZM Part 1; TVM-

I-4

Fish13

- 200 mg/kg total

Milk replacer13

- 200 mg/kg total

Other animals13

- 150 mg/kg total


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 differently.

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, deri ved to a moisture content of 12% unless mentioned differently.


[13] If the GMP norm for this product and the animal type in question is lower than the norm specified here, then the GMP no rm applies. In complete animal feed







C46 Melamine 24 Feed, with the exception of 2,5 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 107/2013 amending Annex I to Directive 2002/32/EC

EFSA recommendation: LC-MS/MS (liquid chromatography coupled to mass spectrometry

- canned pet food

2,5 mg/kg *

- the following feed additives:

- guanidino acetic acid (GAA), -

- urea -

- biuret -



[24] The maximum level refers to melamine only. The inclusion of the structurally related compounds cyanuric acid, ammeline and ammelide in the maximum level will be considered at a later stage.

*: The maximum level is applicable to canned pet food as sold.






Chemical: Mycotoxin

C109 Fumonisin B1 + B2 Feed materials GMP+ (Commission Recommendation No 2006/576/EC)

Particular attention has to be paid to cereals and cereals products fed directly to the animals that their use in a daily ration should not lead to the animal being exposed to a higher level of these mycotoxins than the corresponding levels of exposure where only the complete feedingstuffs are used in a daily ration.

HPLC, Lateral flow analysis

- maize and maize products * 60 mg/kg

Complementary and complete feedingstuffs for:

- pigs, horses (Equidae), rabbits and pet animals 5 mg/kg

- fish 10 mg/kg

- poultry, calves (< 4 months), lambs and kids 20 mg/kg

- adult ruminants (> 4 months) and mink 50 mg/kg



[*]The term ‘Maize and maize products’ includes not only the feed materials derived from maize listed under heading 1 ‘Cereal grains, their products and by-products’ of the non-exclusive list of main feed materials referred to in the Annex, part B of Directive 96/25/EC but also other feed materials derived from maize in particular maize forages and roughages. (note: Directive 96/25/EC is replaced by the Catalogue of feed materials)




Contaminant Product Action limit Rejection limit Source Supplementary


Chemical: Mycotoxin

C113 T-2 and HT-2 toxin, Sum of Unprocessed cereals: GMP+ (Commission Recommendation No 2013/165/EC)

Unprocessed cereals are cereals which have not undergone any physical or thermal treatment other than drying, cleaning and sorting.

HPLC, ELISA, Lateral flow analysis

- barley (including malting barley) and maize 200 μg/kg (on product basis) *

- oats (with husk) 1000 μg/kg(on product basis) *

- wheat, rye and other cereals 100 μg/kg(on product basis) *

Cereal products for feed and compound feed

- oat milling products (husks) 2000 μg/kg *1

- other cereal products 500 μg/kg *1

- compound feed, with the exception of feed for cats

250 μg/kg *1

Compound feed for cats 0,05 mg/kg *1 GMP+ (Commission Recommendation No 2013/637/EC)



[*]The levels referred to in this Annex are indicative levels above which, certainly in the case of repetitive findings, investigations should be performed on the factors leading to the presence of T-2 and HT-2 toxin or on the effects of feed and food processing. The indicative levels are based on the occurrence data available in the EFSA database as presented in the EFSA opinion. The indicative levels are not feed and food safety levels.






Fysical: Bodies foreign to the product

F1 Plastics - Feed materials for delivery to cattle farms, and - 1.5 g/kg (dry matter basis)

GMP+ Via manual separation and weighing See GMP+ BA 3: Negative list

Microscopic determination in accordance with the instructions of the laboratory.

- Wet mixes for delivery to livestock farmers This norm was included subject to the outcome of the discussion taking place in the European Commission.








Fysical: Bodies foreign to the product

F2 Polyethylene - Feed materials for delivery to cattle farms, and 0.25 g/kg (on fat basis)

0.5 g/kg (on fat basis)

GMP+ See GMP+ BA 3: Negative list.

OZM Part 2; OSP-13

- Wet mix for delivery to livestock farmers









Fysical: Botanical impurities

F5 Unhusked beech mast - Fagus siylvatica L.

Feed materials and compound feed - Seeds and fruits of the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable






SUMMARY OF GMP+ PRODUCT STANDARDSNORMS FOR THE ANIMAL FEED SECTOR




F6 Chinese mustard – Brassica juncea (L.) Czern. and Coss. ssp. juncea var. lutea Batalin











F7 Ethiopian mustard – Brassica carinata A. Braun











F8 Indian brown mustard - Brassica juncea (L.) Czern. and Coss. ssp. integrifolia (West.) Thell.











F10 Purghera - Jatropha curcas L. Feed materials and compound feed - Seeds and fruits of the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable









Fyscial: Botanical impurities

F12 Sareptia Sareptian mustard - Brassica juncea (L.) Czern. and Coss. ssp. juncea











F13 Seeds from Ambrosia spp. Feed materials 12 , with the exception of: - 50 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 1275/2013 amending Annex I to Directive 2002/32/EC

- Millet (grains of Panicum miliaceum L.) and sorghum (grains of Sorghum bicolor (L) Moench s.l.) not directly fed to animals 12

200 mg/kg

Compound feed containing unground grains and

seeds - 50 mg/kg



[12] In case unequivocal evidence is provided that the grains and seeds are intended for milling or crushing, there is no need to perform a cleaning of the grains and seeds containing non-compliant levels of seeds of Ambrosia spp. before milling or crushing. Prevention measures shall be taken to avoid dissemination of Ambrosia spp. seeds into the environment during transport, storage or processing of these seeds and grains.







F14 Black mustard – Brassica nigra (L.) Koch










Fysical: Other undesirable substances and products

F26 Radioactivity

Commission Implementing Regulation (EU) No 961/2011 Commission Implementing Regulation (EU) No 996/2012 repealing Commission Implementing Regulation (EU) No 961/2011 and 284/2012 (Commission Implementing Regulation (EU) No 996/2012 is amended by Commission Implementing Regulation (EU) No 495/2013. The new regulation does not concern adoption of new standards)

Special conditions governing the import of feed originating in or consigned from Japan following the accident at the Fukushima nuclear power station. In order to ensure consistency with action levels currently applied in Japan, this value replaces on a provisional basis the value laid down in Commission Regulation (Euratom) No 770/90. This value is laid down on a provisional basis and taken to be the same as for foodstuffs, pending an assessment of transfer factors of iodine from feedingstuffs to food products.) See Commission Implementing Regulation (EU) No 996/2012 - Annex III for additional requirements.

Sum of Cs-134 and Cs-137 Feedingstuffs - 500 (Bq/kg)

Sum of Isotopes of iodine, notably I-131

Feedingstuffs - 2 000 (Bq/kg)

Sum of Cs-134 and Cs-137 Feed intended for:

- cattle and horses 100 (Bq/kg)

- pig 80 (Bq/kg)

- poultry 160 (Bq/kg)

- fish (*) 40 (Bq/kg)





* With the exemption of feed for ornamental fish.



4 Residue levels of pesticides in feeds

4.1 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.

4.2 The establishment of and MRL

4.2.1 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.

(http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=substance.selection

&ch=1) 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

standards in Directive 2002/32/EG still apply.



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)

4.2.2.

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)

4.2.3

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)

4.2.4.

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 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-taceans and shellfish and other products from salt and fresh water creatures*

Kohl-rabi foliage Palm hearts Palm kernels

Only for crops used for feed*

Garden cress Fungi Palm fruits

Loquats Winter cress Seaweed Kapok Cherimoya’s Rucola Lupines (dried) Millet Guavas Red amsoi Shells, seeds and possi-

bly skins of oil-retaining seeds and fruits (such as soya hulls)

Sorghum

Bread fruits Leaves and sprouts of Brassica spp.

Borage Coffee beans

Durians Purslain Pumpkin seed Herbal tea Soursops (durian blanda) Vine leaves Hemp seed Cacao bean Arrowroot Herbs (sage, rosemary,

thym, basi, laurel, tarra-gon)

Camelina Carob

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.



4.2.2 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 / Unpro-

cessed product of vegetable or animal origin. Check your product us-

ing the definitions in Table 1. Consult your supplier.

3. Is your basic product individually included in Appendix I of Reg. 396/2005,

(column 3, 4 and 5) Yes Go to question 4.


4. Is the pesticide for which you are looking for a standard included in Pesti-

cides Web , the online EU pesticides database?



5. On Pesticides Web select the language 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 specified. The standard amounts to 0.01 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 Pesti-

cides Web , the online EU pesticides database?



8. On Pesticides Web select the language 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).



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 specified. The standard amounts to 0.01 mg/kg

for basic products. (end)

NOTE: At the time of the first publication of this document Appendix V was not yet

completed

4.2.3 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).


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 Table 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 (4.2.2.) ques-

tion 3 and further, to determine the standard for your individually-specified

by-product, the original 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)


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)




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 accumulation 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 percentage

in the original product and in your by-product, the dilution or concen-

tration factor see website MVO:

http://www.mvo.nl/voedselveiligheid/codes/MVO-reporting-

requirements-on-pesticides) and divide or multiply this by the stand-

ard found for the original product(group) in order to determine the fi-nal standard.(end)


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?

Yes The pesticide is soluble in fat. Determine, using the fat percentage in

the original product and in your by-product, the dilution or concentra-

tion factor and divide or multiply this by the standard found for the

original product(group) in order to determine the final standard(end)


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 subjected. The standard

which you found in the Pesticides Web also applies to your by-product. (end)


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 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 solu-

ble 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.

4.2.4 Questionnaire 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 compound feed?

Yes Use this factor or factors to determine the final standard for this spe-

cific part of your compound feed and to determine the pesticide in

question. 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.

4.2.2. In order to determine the standards for these components. 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. 4.2.3. In order to

determine the standards for these components. Go to question 4.

4. Have you determined a standard for all the components for which a stand-

ard has been set and have you taken account of the factors laid down in

question 1?


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

4.2.5 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.

4.3 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

measures as a result of very specific contamination. The following measures are

currently 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. Commission Regulation EU) No 258/2010 of 25 March 2010 imposing spe-cial conditions on the imports of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins, and re-pealing Decision 2008/352/EC.



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 6.7.1.2). 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 6.7.1.5).

In order to be able to control the residue levels the participant should, among other

things, measure carry-over in the installations (see GMP+ BA4) 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.



2 Additional provisions

2.1 General

The control of residue levels using the production sequence is shown in diagram

form in the following table.

Carried out by TNO-Nutrition

Carry-over

measurement

instruction

(GMP+ BA 4)

Installation internal

carry-over

Wall adhesion factor

measurement

instruction

Relative wall adhesion

factor measurement

Carry-over

percentage

Coefficient

(=carry-over

x factor)

Max. residue norm

(GMP+ BA1, Part

B, Chapter 3)Calculation

Coefficient factor

(GMP+ BA1, Part B,

Chapter 3)

Production

sequence / flush

batches



2.2 Compound feed

2.2.1 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 addi-

tives 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 relevant 1 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 lowered to once per four 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.

2.2.2. 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 pro-

cessing properties other than those of a standard measurement substance. The

actual 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 pro-

cessing properties, such that the actual carry-over will be higher than the installa-

tion 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.



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

established method.

Coefficient

< 1 1

> 1 and < 2 2

> 2 and < 3 2,5

unknown, > 3 3

2.2.3. 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: : 0.5 ppm

Calculation of actual carry-over = company’s own carry-over x coefficient

= 0.05 (5%) x 1 = 0.05

Calculation: calculated level of nicarbazine

- batch a broiler feed 80 ppm

- batch a+1 follow-on feed 4 ppm (= 0.05 x 80)

- batch a+2 follow-on feed 0.2 ppm (= 0.05 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.

2.2.4 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 exceed-

ed. 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.



2.3 Premix

2.3.1 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.

2.3.2 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 produc-

er 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.

2.3.3 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 coccidi-

ostats or histomonostats (a so-called flush batch) may still contain such high levels

of coccidiostats or histomonostats that this can cause problems for the compound

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.



3 Residue standards for coccidiostats en histomonostats

3.1 Summary of residue standards for coccidiostats and histomonostats

according to Commission Regulation (EU) No. 574/2011 of 16 June 2011

and No. 744/2012 of 16 August 2012 amending Annex I to Directive

2002/32/EC

Additives Products intended for animal feed (2) Maximum content in

mg/kg (ppm) relative to a

feedingstuff with a

moisture content of 12 %

Lasalocid A

sodium

Feed materials 1,25

Compound feed for:

- dogs, calves, rabbits, equine species, dairy

animals, laying birds, turkeys (> 16 weeks)

and chickens reared for laying (> 16 weeks)

1,25

- chickens for fattening, chickens reared for

laying (< 16 weeks) and turkeys (<16

weeks) for the period before slaughter in

which the use of lasalocid A sodium is prohib-

ited (withdrawal feed)

1,25

- pheasants, guinea fowl, quails and par-

tridges (except laying birds) for the period

before slaughter in which the use of lasalocid

A sodium is prohibited (withdrawal feed),

1,25

- other animal species

3,75

Premixtures for use in feed in which the use

of lasalocid A sodium is not authorised

(3)

Narasin Feed materials

0,7

Compound feed for:

- turkeys, rabbits, equine species, laying birds

and chickens reared for laying (> 16 weeks)

0,7


2,1

Premixtures for use in feed in which the use (3)

2 Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the Eu-

ropean Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. 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.





feedingstuff with a


of narasin is not authorised.

Salinomycin

sodium

Feed materials

0,7

Compound feed for:

- equine species, turkeys, laying birds and

chickens reared for laying (> 12 weeks)

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)

0,7


2,1


of salinomycin sodium is not authorised.

(3)

Monensin

sodium

Feed materials

1,25

Compound feed for:

- equine species, dogs, small ruminants

(sheep and goat), ducks, bovine, dairy cattle,

laying birds, chickens reared for laying (> 16

weeks) and turkeys (> 16 weeks)

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)

1,25


3.75


of monensin sodium is not authorised.

(3)

Semdurami-

cin sodium

Feed materials

0.25

Compound feed for:

- laying birds and chickens reared for laying

(> 16 weeks)

0,25

- chickens for fattening for the period before 0,25





feedingstuff with a


slaughter in which the use of semduramicin

sodium is prohibited (withdrawal feed)


0,75


of semduramicin sodium is not authorised.

(3)

Maduramicin

ammonium

alpha

Feed materials

0,05

Compound feed for:

- equine species, rabbits, turkeys (> 16

weeks), laying birds and chickens reared for

laying (> 16 weeks)

0,05

- chickens for fattening and turkeys (< 16


which the use of maduramicin ammonium

alpha is prohibited (withdrawal feed)

0,05


0,15


of maduramicin ammonium alpha is not au-

thorised.

(3)

Robenidine

hydro-

chloride

Feed materials

0,7

Compound feed for:


(> 16 weeks)

0,7

- chickens for fattening, rabbits for fattening

and breeding and turkeys for the period be-

fore slaughter in which the use of robenidine

hydrochloride is prohibited (withdrawal feed)

0,7


2,1


of robenidine hydrochloride is not authorised.

(3)

Decoquinate Feed materials

0,4

Compound feed for:


(> 16 weeks)

0,4

- chickens for fattening for the period before 0,4





feedingstuff with a


slaughter in which the use of decoquinate is

prohibited (withdrawal feed)


1,2


of decoquinate is not authorised

(3)

Halofuginone

hydro-

bromide

Feed materials

0,03

Compound feed for:

- laying birds, chickens reared for laying (> 16

weeks) and turkeys (> 12 weeks)

0,03

- chickens for fattening and turkeys (< 12


which the use of halofuginone hydrobromide

is prohibited (withdrawal feed)

0,03

- other animal species other than chickens

reared for laying (< 16 weeks) 0,09


of halofuginone hydrobromide is not author-

ised

(3)

Nicarbazin Feed materials

1.25

Compound feed for:

- equine species, laying birds and chickens

reared for laying (> 16 weeks)

1.25


3.75


of nicarbazin (in combination with narasin) is

not authorised

(3)

Diclazuril Feed materials

0,01

Compound feed for:

- laying birds, chickens reared for laying (> 16

weeks)

0,01

- rabbits for fattening and breeding for the

period before slaughter in which the use of

diclazuril is prohibited (withdrawal feed).

0,01





feedingstuff with a


- other animal species other than chickens

reared for laying (< 16 weeks), chickens for

fattening, guinea fowl and turkeys for fatten-

ing.

0,03


of diclazuril is not authorised.

(3)

Feed

additives not

registered in

the EU which

are intended

for use in

feeds for

export out-

side the EU.

All feeds intended for marketing within the EU. 1



3.2 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

80 g/kg nicarbazine

5 1

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-

hydrochloride

1 1

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

hydrobromide

1 1

Diclazuril (E 771)

Clinacox 0,5 % Premix Janssen

Pharmaceutica nv

Janssen

Pharmaceutica nv

0.5g/100g diclazuril 2 2

Salinomycin-sodium (E 766)

Sacox 120 microGranulate Huvepharma Huvepharma NV 120g/kg salinomycine 1 1

Kokcisan 12% KRKA Lansdowne Chemicals

Europe BV

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



4 Residue standards for critical veterinary medical pro-ducts

4.1 Summary of residue standards for critical veterinary medical products

Veterinary medical

product

Established maximum residue standards

in animal feeds4 in ppm

Established

precautionary

measure for

dairy cattle

laying

hens5

slaughter

chickens6

fattening

turkeys6

pigs7

dairy

cattle8

Sulfadiazine sodium 5 8 1 1

Sulfamethoxazol 5 8 1

1

Doxycycline 8 8 10 -9 1 batch

10

Oxytetracycline 1 10 10 -9 1 batch

10

Ivermectine 0.1 0.1 0.1 -9 1 batch

10

Tiamuline 1 8 10 -9 1 charge

10

Tilmicosine 1 4 10 -9 1 charge

10

Trimethoprim Linked to Sulfadiazine and therefore sufficiently guaranteed

For other products

1 1 1 1

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.



4.2 Overview of admissible medicated premixes

Trade name Registration holder Registration

nummer Concentra-tion

Coefficient Max. dosing for complete feeds

Pigs Other

Amoxicilline

Suramox 5% premix Virbac Nederland B.V. REG NL 8543 50g/kg 3 3 400 ppm (8kg/ton)1

Amproliumhydrochloride

Amprolium Concentrate 25% Dopharma Research B.V. REG NL 2051 250g/kg - 3 500 ppm (2kg/ton)2

Doxycyclinehyclaat/broomhexinehydrochloride

Feedmix Doxy-B Dopharma Research B.V. REG NL 2588 20g/kg 2,5 2,5 300 ppm (15kg/t)3

Pulmodox 5% Premix Virbac Laboratories REG NL 9826 50g/kg 2,5 2,5 250 ppm (5kg/t)4

Doxyprex Industrial Veterinaria S. A. REG NL 10393

100g/kg 2,5 2,5 250 ppm (2,5kg/t)5

Florfenicol

Nuflor 40mg/g medicated premix for pigs

Intervet Nederland B.V. REG NL 10473

40g/kg 3 3 200 ppm (5kg/t)6

Flubendazol

Feedmix Flubendazole Dopharma Research B.V. REG NL 9674 6g/kg 3 3 30 ppm (5kg/t) (pigs, chickens)

60 ppm (10kg/t) pheasants)

Flubenol 0.6% Janssen Pharmaceutica N.V. REG NL 5335 6g/kg 3 3 30 ppm (5kg/t) (pigs, chickens)

60 ppm (10kg/t) (pheasants)

Flubenol 5% Janssen Pharmaceutica N.V. REG NL 3106 50g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)

7

60 ppm (1,2kg/t) (pheasants)

7

Flubenol 5% Poultry Janssen Pharmaceutica N.V. REG NL 9556 50g/kg - 3 30 ppm (0,6kg/t) (chickens)

7


7

Flubenol 50% Janssen Pharmaceutica N.V. REG NL 3160 500g/kg 3 3 30 ppm (0,06kg/t) (pigs, chickens)

8

60 ppm (0,12kg/t)



Trade name Registration holder Registration nummer

Concentra-tion


Pigs Other

(pheasants)8

Flubenol 7.5% Janssen Pharmaceutica N.V. REG NL 5261 75g/kg 3 3 30 ppm (0,4kg/t) (pigs, chickens)

9


9

Flutelmium 0.6% Janssen Pharmaceutica N.V. REG NL 6082 6g/kg 3 3 30 ppm (5kg/t) (pigs, chickens)

60 ppm (10kg/t) (pheasants)

Flutelmium 7,5% Janssen Pharmaceutica N.V. REG NL 6010 75g/kg 3 3 30 ppm (0,4kg/t) (pigs, chickens)

9


9

Flubenol 5% Wirtz Farma B.V. REG NL 10380/3106

50 g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)

7


7

Flubendazol 5% concentrate

Dopharma Research B.V. REG NL 101512

50g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)

7


7

Ivermectine

Ivomec Premix Merial B.V. REG NL 8731 6g/kg 3 3 2,4 ppm (0,4kg/t)10

Noromectin Premix 0,6% G/G for pigs

Norbrook Laboratories Ltd (Station Works)

REG NL 10465

6g/kg 3 3 2,4 ppm (0,4kg/t)10

Ecomectin 6mg/g premix ECO Animal Health LTD. REG NL 10529

6g/kg 3 3 2,4 ppm (0,4kg/t)10

Lincomycine(-hydrochloride)/Spectinomycine(-sulfaat)

Lincomix 110 Pfizer Animal Health B.V. REG NL 7957 110g/kg Linco 3 3 220 ppm (2,0kg/t)11

Lincomix 220 premix Pfizer Animal Health B.V. REG NL 10076

44g/kg Linco. 3 3 220 ppm (5kg/t)

Vualin Plus-33 V11 Eurovet Animal Health B.V. REG NL 2295 6,6g/kg Linco. 6,6g/kg Spec

3 3 33 ppm (5kg/t)




Concentra-tion


Pigs Other

Linco-spectin Premix Pfizer Animal Health B.V. REG NL 9708 22g/kg Linco. 22g/kg Spec

3 3 44 ppm (2kg/t)12

Oxytetracycline(-hydrochloride)

Feedmix V4 Dopharma Research B.V. REG NL 2158 80g/kg 3 3 800 ppm (10kg/t)

Feedmix Oxy 10% Dopharma Research B.V. REG NL 2004 100g/kg 3 3 700 ppm ( 7kg/t)

OTC-400 Framelco B.V. REG NL 7254 80g/kg 3 3 400 ppm (5kg/t)

OXY-400 V4 Eurovet Animal Health B.V. REG NL 7277 80g/kg 3 3 1000 ppm (12,5kg/t)

Chloromed 150mg/g premix

for pigs

Univet Ltd. REG NL

106877

150g/kg 3 3 400 ppm (2,66 kg/t)19

Paracetamol

Pracetam 10% Laboratoires Sogeval REG NL 10278

100g/kg 3 3 800 ppm (8kg/t)

Sulfadiazinenatrium/Trimethoprim

Feedmix Trim/sul 80/420 Aesculaap BV REG NL 1808 77,1g/kg Sulfa 16g/kg Trim

5 3 385 ppm Sulfa en 80 ppm Trim (5kg/t)

Trimethosulf premix Eurovet Animal Health B.V. REG NL 7589 62,5g/kg Sulfa 12,5g/kg Trim

5

2 625 ppm Sulfa en 125 ppm Trim (10kg/t)

Feedmix sulfatrim Dopharma Research B.V. REG NL 8541 60g/kg Sulfa 12g/kg Trim


Sulfamethoxazol/Trimethoprim

Feedmix TS Dopharma Research B.V. REG NL 8674 50g/kg Sulfa 10g/kg Trim


Tiamulinwaterstoffumaraat

Tiamutin 10% premix Novartis Consumer Health B.V. REG NL 8015 100g/kg 3 3 40 ppm (0,4 kg/t)13

Denagard 2% premix Novartis Consumer Health B.V. REG NL 8016 20g/kg 3 3 40 ppm (2,4 kg/t)14

Tialin 10% premix Eurovet Animal Health B.V. REG NL 10178

100g/kg 3 3 40 ppm (0,4 kg/t)13

Tialin 2% premix Eurovet Animal Health B.V. REG NL 10177

20g/kg 3 3 40 ppm (2,4 kg/t)14

Vetmulin 2% premix Huvepharma N.V. REG NL 100731

20g/kg 3 3 176 ppm (8,8 kg/t)

Vetmulin 10% premix for medicated feeds

Huvepharma N.V. REG NL 101337

100g/kg 3 1 3 1 180 ppm (1,8 kg/t)




Concentra-tion


Pigs Other

Tilmicosinefosfaat

Pulmotil G40 PREMIX Eli Lilly Nederland B.V /Elanco Animal Health

REG NL 9166 40g/kg 3 3 400 ppm (10 kg/t) (pigs) 200 ppm (5 kg/t) (rabbits)


REG NL 9167 100g/kg 3 3 400 ppm (4 kg/t) (pigs)

200 ppm (2 kg/t) (rabbits)



200 ppm (1 kg/t) (rabbits)

Pneumotil G40 PREMIX Eli Lilly Nederland B.V /Elanco Animal Health

REG NL 10368

40g/kg 3 3 400 ppm (10 kg/t)

Tilmovet 10%, premix for medicated feed for pigs

Huvepharma N.V. REG NL

103646

100g/kg 1 1 400 ppm (4 kg/t)

Tilmovet 4% Huvepharma N.V. 40g/kg 1 1 400 ppm (10 kg/t)

Tilmovet 20%, premix for medicated feeds for pigs

Huvepharma N.V. REG NL

100742

200g/kg 1 1 400 ppm (2 kg/t)

Tylosinefosfaat

Tylan 100 Premix 10% Eli Lilly Nederland B.V /Elanco Animal Health

REG NL 3917 100g/kg 3 3 200 ppm (2 kg/t) (pigs) 1100 ppm (11 kg/t) (, chickens reared for laying)

Tylan 20 premix 2% Eli Lilly Nederland B.V /Elanco Animal Health

REG NL 9976 20g/kg 3 3 200 ppm (10 kg/t) (pigs) 1100 ppm (55 kg/t) (slaughter chickens, chickens reared for laying)

Tylan G250 Premix 25% Eli Lilly Nederland B.V /Elanco Animal Health

REG NL 9982 250g/kg 3 3 200 ppm (0.8 kg/t)15

(pigs) 1100 ppm (4,4 kg/t)

15

(slaughter chickens,




Concentra-tion


Pigs Other

chickens reared for laying)

Pharmasin 20 mg/g premix Huvepharma N.V. 20g/kg 1 1

Pharmasin 100mg/g premix for medicated feeds for pigs, slaughter chickens and chickens reared for laying


100g/kg 1 1 200 ppm (2 kg/t) 13

(pigs) 1100 ppm (11 kg/t) (slaughter chickens, chickens reared for laying)

Pharmasin 250mg/g premix for medicated feeds pigs, slaughter chickens and chickens reared for laying


250g/kg 1 1 200 ppm (0.8 kg/t)15

(pigs, chickens) 1100 ppm (4,4 kg/t)

15

(slaughter chickens, chickens reared for laying)

Tylvalosine

Aivlosin 42,5 mg/g ECO Animal Health Limited REG NL

10266

42,5g/kg 3 3 85 ppm (2 kg/t) (pigs)

16

Aivlosin 8,5 mg/g ECO Animal Health Limited REG NL

10430

8,5g/kg 3 3 85 ppm (10 kg/t) (pigs)

16

Valnemulin

Econor 1% Novartis Animal Health Austria

GmbH

REG NL 9792 10g/kg 3 3 75 ppm (7,5 kg/t) (pigs)

17


GmbH


18


GmbH

REG NL 9795 500g/kg 3 3 200 ppm (0,4 kg/t)

(pigs) 18

For other products

- - .... 3 3 ….



1: Dosage for weaned piglets, calculated on the basis of a 15 mg dose of amoxicillin per kg of body weight per day. 2: The product is made up by mixing 2 kg of premix (concentration 250 g / kg) to 5 kg premix.

3: The dose was calculated on the basis of a 10 mg dose of doxycycline and 1 mg dose of bromine hexine per kg of body weight per day.

4: The dose was calculated on the basis of a 12.5 mg dose of doxycycline per kg of body weight per day.

5: The dose was calculated on the basis of a 10 mg dose of doxycycline per kg of body weight per day.

6: The dose was calculated on the basis of a 10 mg dose of florfenicol per kg of body weight per day.

7: The product is made up by mixing XX kg of premix (concentration 50 g/ kg) to 5 kg premix.

8: The product is made up by mixing XX kg of premix (concentration 500 g / kg) to 5 kg premix.


10: The dose was calculated on the basis of a 0,1 mg dose of ivermectine per kg of body weight per day.






16: Dose was calculated on the basis of a dose of 4,25 mg tylvalosine per kg of body weight per day.

17: Dose was calculated on the basis of a dose of 3-4 mg valnemulin per kg of body weight per day.

18: Dose was calculated on the basis of a dose of 10-12 mg valnemulin per kg of body weight per day.

19: Dose was calculated on the basis of a dose of 10-12 mg Oxytetracycline per kg of body weight per day



4.3 Product standards GMP+ BCN-NL1 Antibiotics-free feed

In the table below the product standards are stated that are applicable for the

Country Note GMP+ BCN-NL1 Antibiotics-free feed.

Antibiotic Maximum level in

μg/kg

Antibiotics - B lactam

AmoxiciIllin 200

Ampicillin 100

Penicillin G 100

Cloxacillin 20

Dicloxacillin 4

Nafcillin 200

Oxacillin 10

Cefalexin 100

Cefapirin 100

Cefazolin 100

Cefoperazone 50

Cefquinome 200

Ceftiofur 10

Antibiotics - Quinolones

Danofloxacin 40

Difloxacin 2

Cirprofloxacin 50

Enrofloxacin 4

Flumequine 2

Marbofloxacin 30

Oxolinic acid 2

Sarafloxacin 20

Norfloxacin 20

Cinoxacin 4

Antibiotics – Macrolides

Erythromycin 2

Spiramycin 2

Tilmicosin 0,2

Tylosin 4

Tylvalosin 4

Antibiotics - Phenicoles

Thiamphenicol 5

Florfenicol 1

Chloramphenicol 1,5

Antibiotics – Tetracyclines

Chlortetracycline 20

Doxycycline 1

Oxytetracycline 4

Tetracycline 20

Antibiotics – Pleuromutilines

Tiamulin 1

Valnemuline 2

Antibiotics - Lincosamides



Lincomycin 2

Antibiotics - Sulfonamides

Sulfadimethoxine 2

Sulfapyrimidine = sulfadiazine 2

Sulfamethoxazole 2

Sulfathiazole 2

Sulfamerazine 2

Sulfamethazine = sulfadimidine 2

Sulfadoxine 2

Antibiotics – other

Trimethoprim 2



GMP+ BA1 Product Standards

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