GMP Ba1 20-12-2011 7436

GMP+ Feed Safety Assurance scheme
Product standards
BA
GMP+ BA1
Version: December 20th, 2011
EN
GMP+ International B.V. All rights reserved. The information in this publication may be consulted on the screen, downloaded and printed as long as this is done for your own, non-commercial use. For other desired uses, prior written permission should be obtained from the GMP+ International B.V.
Product Standards Version: 16-04-2012 13:34
1 / 110 GMP+ International B.V.
History of the document

Revision no. / Amendment Date of approval 0.0 / 01-01-2010 Transfer of the document from PDV to GMP+ International Change in feed legislation Concerns Final implementatio n date 01-01-2010
Entire document
0.1 / 17-03-2010
Part A, 3 Part B, 4.2 Part B, 3.2 Part B, 4.2 Part A, 3 Part B, 3.1 Part B, 4.1 Part B, 4.2 Part B, 4.3
17-03-2010
0.2 / 29-09-2010
0.3 / 14-11-2011
Specification of Kokcisan Update of approved medicated premixes - Change in feed legislation - Residue standards for critical veterinary medical products: product group For other products is added. - Overview of admissible medicated premixes is updated. - Product standards GMP+ BCN-NL1 Anti-bicsfree feed
25-11-2010
20-12-2011
INDEX
1
1.1 1.2
INTRODUCTION
GENERAL STRUCTURE OF THE GMP+ FEED SAFETY ASSURANCE SCHEME
5
5 5
PART A: PRODUCT STANDARDS 1 2 INTRODUCTION TO THE PRODUCT STANDARDS CONDITIONS
7 7 7 9 84
84 84 84 86 87 89 90 90
3 SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR 4

4.1
RESIDUE LEVELS OF PESTICIDES IN FEEDS

INTRODUCTION 4.2 THE ESTABLISHMENT OF AND MRL 4.2.1 General 4.2.2 Questionnaire for basic products 4.2.3 Questionnaire for by-products 4.2.4 Questionnaire for compound feeds 4.2.5 Fumigators 4.3 SPECIAL REQUIREMENTS
PART B: RESIDUE STANDARDS 1 2

2.1
91 91 93
93 93 93 93 94 94 95 95 95 95
INTRODUCTION ADDITIONAL PROVISIONS

GENERAL 2.2 COMPOUND FEED 2.2.1 Installation Carry-over level 2.2.2. The coefficient 2.2.3. Carry-over and flush batches 2.2.4 Items for attention and other remarks 2.3 PREMIX 2.3.1 General 2.3.2 Direct contamination 2.3.3 Indirect contamination
3 RESIDUE STANDARDS FOR COCCIDIOSTATS AND HISTOMONOSTATS

3.1
96
SUMMARY OF RESIDUE STANDARDS FOR COCCIDIOSTATS AND HISTOMONOSTATS ACCORDING TO COMMISSION REGULATION (EU) NO 574/2011 OF 16 JUNE 2011 DIRECTIVE 2002/32/EC AMENDING ANNEX I TO DIRECTIVE 2002/32/EC 96
3.2
ADDITIONAL INFORMATION FOR SOME COCCIDIOSTATS AND HISTOMONOSTATS *
101
4 RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL PRODUCTS 102

4.1 4.2 4.3 SUMMARY OF RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL 102 103 109 OVERVIEW OF ADMISSIBLE MEDICATED PREMIXES Product standards GMP+ BCN-NL1 Antibioticsfree feed
PRODUCTS
Introduction
1.1
General
The GMP+ Feed Safety Assurance Scheme (GMP+ FSA 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. The GMP+ FSA scheme is a complete scheme for the assurance 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 scheme can facilitate this excellently. The basic principle of the GMP+ FSA scheme is that the feed chain is part of the food production chain. Proper quality assurance of feed safety throughout the feed chain has a high priority. It is important that companies take their responsibilities in this respect by responding in a proper and convincing way to the need for safe feed materials in the food production chain. Based on needs in practice, multiple components have been integrated into the GMP+ FSA scheme, such as requirements for the quality management system (ISO 9001), HACCP, product standards, traceability, monitoring, prerequisites programmes, chain approach and the Early Warning System. Together with the GMP+ partners, GMP+ International transparently sets clear requirements so that feed safety is guaranteed and certification bodies are able to carry out GMP+ certification independently. GMP+ International supports the GMP+ participants with useful and practical information by way of its various databases, newsletters, Q&A lists and seminars.
1.2
Structure of the GMP+ Feed Safety Assurance scheme
The documents within the GMP+ FSA scheme are subdivided into a number of series. The next page shows a schematic representation of the contents of the GMP+ FSA scheme:
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 scheme.
PART A: PRODUCT STANDARDS
1 Introduction to the product standards

There are references in the various GMP+ standards to the product standards. This part of this appendix contains the 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 production chain. The following standards apply in addition to those in the tables: the residue standards in part B of this appendix.
DISCLAIMER: The GMP+ International has adopted this list in order to inform interested parties with respect to the standards in the legislation (European Union and additional GMP+ standards). The list will be regularly updated. The GMP+ International is not liable for any errors in this list.
2 Conditions
In arriving at the 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: a. source of the contamination and measures must be taken to b. remove or limit the source of the contamination. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If the rejection limit is exceeded then the product is not suitable for use as a feed material or animal feed. In the various GMP+ standards it is stated that the participant must ensure that deviations (in the product or process) from the requirements in this standard are recorded and controlled in order to prevent unintentional use or delivery of the product. Product standard for mixes of feed materials (semi-manufactured product) which are marketed as such
Product Standards Version: 16-04-2012 13:34 7 / 110 GMP+ International B.V.
The product standard for the maximum level of undesirable substances is calculated 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 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. Analysis method7
Microbiological: Other undesirable substances and products
M1
Antibacterial inhibition
- Feed materials
< 15 mm
GMP+
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 diifferently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods)

Contaminant
Microbiological
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary requirements
Analysis method7
M3
Enterobacteriaceae
Feed for pets and dog bones
300 kve/gram
Reg. 1774/2002/EC n = 5, c = 2, m = 10, M = 300 in 1 gram , 14 Tinned feed for pets which has been subjected to heat treatment with a Fc value of at least 3 does not necessarily have to be sampled and tested for Salmonella and Enterobacteriaceae.
OZM Part 2; M-3
From animal by-products derived products, with the exception of canned petfood and raw petfood
300 kve/g
Commission Regulation (EU) 142/2011, annex X, chapter 1
n = 5, c = 2, m = 10, M = 300 14 However, the microbiological standards set out in this Chapter shall not apply to rendered fats and fish oil from the processing of animal byproducts, when the processed animal protein, which is obtained during the same processing, is subject to sampling to ensure compliance with those standards. For more information about this exception see Regulation (EC) No 853/2004 (consideration 25) n = 5, c = 0, m = 0, M =5.000 14
From animal by-products derived raw petfood
5.000 kve/g
Commission Regulation (EU) 142/2011, annex XIII, chapter 2 Commission Regulation (EU) 142/2011, annex XIII, chapter 2
From animal by-products derived canned petfood
Canned petfood which has been subjected to heat treatment with a Fc value of at least 3
[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) [14] n = number of samples to be tested; m = threshold value for the number of bacteria; the results will be considered to be satisfactory if the number of bacteria in none of the samples is greater than m, M = maximum value for the number of bacteria in one or more samples is equal to or greater than M, c = number of samples for which the bacteria count gives a result between m and M and where the sample is still considered acceptable if the result of the bacteria for the other samples is not higher than m.

Contaminant
Microbiological: Microbiological contamination
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
M4a
Salmonella
Consumption chick feed: end products and feed materials for: - Top breeding consumption chicks - Breeding increase consumption chicks - Increase consumption chicks - Consumption chicks Laying poultry feed: end products and feed materials for: - Top breeding laying poultry - Raising increase laying poultry - Increase laying poultry - Laying-hens and breeding hens 1% 0+% 20(approaching
0%)
GMP+ 0+% 20(approaching

0%)
OZM Part 2; M-2a to M2e
0+% 20(approaching
0%)
0+% 20(approaching
0%)
0+% 20(approaching
0%)
GMP+
0+% 20(approaching
0%)
0+% 20(approaching
0%)
0+% 20(approaching
0%) for S. enteritidus and S. typhimurium
Turkey feed: end products and feed materials for: - Raising increase turkeys - Increase turkeys - Consumption turkeys Other animal feeds, feed materials and wet mixes intended for cattle farms (except for poultry feeds). Feed for pets and dog bones From animal by-products derived products with the exception of canned petfood 0+% 20(approaching
0%)
GMP+
0+% 20(approaching
0%)
0+% 20(approaching
0%)
Absent in 25 gr Absent in 25 gr
GMP+ Reg. 1774/2002 Commission Regulation (EU) 142/2011, annex X, chapter 1 n = 5, c = 0, m = 0, M = 0

14
However, the microbiological standards set out in this Chapter shall not apply to rendered fats and fish oil from the processing of animal byproducts, when the
Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary Analysis method7 requirements processed animal protein, which is obtained during the same processing, is subject to sampling to ensure compliance with those standards. For more information about this exception see Regulation (EC) No 853/2004 (consideration 25) Canned petfood which has been subjected to heat treatment with a Fc value of at least 3 If preservation can be achieved at a higher pH then this should be supported with data.
From animal by-products derived canned petfood
M4b
Salmonella preservation determined through pH
- Feed materials for delivery to cattle farms, and
Maximum pH for guarantee:
Commission Regulation (EU) 142/2011, annex XIII, chapter 2 GMP+
OZM Part 2; M-5
- Wet mixes for delivery to livestock farmers on the basis of:
- Spontaneous lactic acid fermentation - Add organic acids - Add anorganic acids
4.5 4 3,5
These norms do not apply if the products are supplied at a temperature of at least 60C 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,
[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) [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+).

Contaminant
Microbiological: Microbiological contamination
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
M5
Moulds
- Feed materials for delivery to cattle farms, and - Wet mixes for delivery to livestock cattle farmers with an Aw value > 0.75 (if this is not known then a moisture content > 13%)
10,000 kve/gram
GMP+
OZM Part 2; M-4
[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)

Contaminant
Chemical: Mycotoxin
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C1
Aflatoxin B1
Feed materials intended for (direct) delivery to dairy farmers All Feed materials Complementary and complete animal feeds for cattle, sheep and goats with the exception of:
0.005 mg/kg
GMP+
OZM Part 2; OSP1a to 1e
0.02 mg/kg 0.01 0.02 mg/kg
- dairy cattle compound feed for dairy cattle and calves, dairy sheep and lambs, dairy goats and kids, piglets and young poultry animals, - calves and lambs 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). Complete animal feeds for pigs and poultry (with the exception of young animals) Other complete animal feeds Supplementary animal feeds for cattle, sheep and goats (with the exception of supplementary animal feeds for dairy cattle, calves, lambs)
0.005 mg/kg
Directive 2003/100/EEC amending Directive 2002/32/EEC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
0,02 0.01 mg/kg
0.02 mg/kg
0.01 mg/kg 0.02 mg/kg
Supplementary animal feeds for pigs and poultry (with the exception of young animals)
0.02 mg/kg
Other supplementary animal feeds
0.005 mg/kg
[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)

Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements Maximum level for aldrin and dieldrin, singly or combined, expressed as dieldrin. Analysis method7
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 all animal feeds, with the exception of:
0.01 mg/kg
OZM Part 2; OSP11
- fats and oils, - compound feed for fish fish feed
0,1 mg/kg 0.2 mg/kg

Contaminant
Chemical: Heavy metals
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C3
Arsenic16, , 2
Feed materials, with the exception of:
2 mg/kg 4 mg/kg
- ground grass meal, alfalfa meal and clover meal and also molassed and unmolassed dried sugar beet pulp meal made from grass, from dried lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp - Palm kernel flakes expeller, -
Directive 2009/141/EC amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP26
4 mg/kg15
- phosphates and calcareous marine algaelimestone - calcium carbonate - magnesium oxide and magnesium carbonate
10 mg/kg 15 mg/kg 20 mg/kg
- animal feeds obtained by processing fish or other sea creatures, including fish fish, other aquatic animals and products derived thereof, - ground dried seaweed and feed materials derived from on the basis of seaweed Iron particles used as tracer Feed additives belonging to the functional group of compounds of trace elements except: - cupric copper sulphate pentahydrate and cupric copper carbonate - zinc oxide, manganese oxide and cupric copper oxide Complete animal feeds, with the exception of: - complete feed for fish and complete animal feed for fur-bearing animals. Complementary animal feeds, with the exception of:
25 mg/kg15
40 mg/kg15 50 mg/kg 30 mg/kg 50 mg/kg 100 mg/kg 2 mg/kg 10 mg/kg15 4 mg/kg
Contaminant
Product - mineral feed mixes
Action limit(1) -
Rejection limit(1) 12 mg/kg
Source
Analysis method7
[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. [2] The maximum levels refer to an analytical determination of arsenic/ cadmium / mercury where the extraction is done for 30 minutes a boiling temperature in Nitric acid (5% m/m). Equivalent extraction procedures may be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [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

Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7
Chemical: Other undesirable substances and products
C4
Hydrocyanic acid
Feed materials, with the exception of: - linseed - linseed cakes - manioc cassava products and almond cake. Complete animal feeds, with the exception of:
50 mg/kg 250 mg/kg 350 mg/kg 100 mg/kg 50 mg/kg
Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-9
- complete animal feeds for young chickens (< 6 weeks)
10 mg/kg

Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements * 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 Analysis method7
C5
Biogenic amines*
- Animal feeds> 30% crude protein
4,000 mg/kg. protein
GMP+
OZM Part 2; OSP23

Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C6
Cadmium 2
Feed materials of vegetable origin Feed materials of animal origin Feed materials of mineral origin, with the exception of: - phosphates Feed additives, belonging to the functional group "Compounds of trace elements", with the exception of: - cupric copper oxide, manganous manganese (II)oxide, zinc oxide and manganous manganese (II) sulphate-monohydrate Feed additives belonging to the functional group "Bindersing and anti-caking agents and thinners"
1 mg/kg 2 mg/kg 2 mg/kg
10 mg/kg 10 mg/kg
OZM Part 2; OSP27
30 mg/kg8
2 mg/kg
Premixes Complementary feed with the exception of: Mineral feed mixes - containing < 7% phosphorus 8 - containing> 7% phosphorus
8
15 mg/kg8 2 0,5 mg/kg
5 mg/kg 0.75 mg/kg per 1% phosphorus 8, with a maximum of 7.5 mg/kg 2 mg/kg
Complementary Additional animal feeds for pets animals Other supplementary animal feeds Complete feed with the exception of: - complete animal feeds for cattle (except calves), sheep (except lambs) and goats (except kids) and fish feed with the exception of: - complete feed for pet animalspet feeds
0.5 mg/kg 0,5 mg/kg 1 mg/kg
2 mg/kg
Contaminant
Product - complete animal feeds for calves, lambs and goat lambs and other complete animal feeds
Action limit(1) -
Rejection limit(1) 0.5 mg/kg
Source
Analysis method7
[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. [2] The maximum levels refer to an analytical determination of arsenic/ cadmium / mercury where the extraction is done for 30 minutes a boiling temperature in Nitric acid (5% m/m). Equivalent extraction procedures may be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency 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. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [8] The levels will be reviewed before 31 December 2008 with a view to lowering the maximum levels The % of phosphorus is relative to a feed with a moisture content of 12 %.

Contaminant
Chemical: Salts
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary requirements 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
Analysis method7
C7
Chloride
- Feed materials for delivery to livestock farms, and
10 g/kg (dry matter)
10x the action limit (dry matter) 21
GMP+
OZM deel 2; OSP22
- Wet mixes for delivery to livestock farmers
[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) [21]The rejection limits do not apply to feeds such as salt or mineral licks which are deliberately supplied with high mineral levels.

C8
Camphechlor (toxaphene) sum of the indicators CHB 26, 50 and 62 22
Fish, other aquatic sea animals creatures and (by)products thereof with the exception of fish oil - fish oi
0.02 mg/kg
0.2 mg/kg
OZM Part 2; OSP11
Complete feed for fish food
0.05 mg/kg
[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 me asures 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 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. 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) [22] The levels will be reviewed before 31 December 2007 with a view to lowering the maximum levels [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 in as chlordane)
Feed materials and compound feed all animal feeds, with the exception of:
0.02 mg/kg
- fats and oils
0.05 mg/kg
OZM Part 2; OSP11
[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 t his 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)

Contaminant Chemical: Botanical impurities C10 Crotalaria spp. Feed materials and compound feed All animal feeds 100 mg/kg Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Microscopic determination in accordance with the instructions of the manufacturer laboratory Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Chemical: Crop protection agents and biocides (permitted in the EU)
C11
DDT (sum of DDT -, DDD- (or TDE-) and DDE-isomers, expressed as in DDT)
Feed materials and compound feed all animal feeds, with the exception of: - fats en oils
0.05 mg/kg
0.5 mg/kg
OZM Part 2; OSP11
[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 c ause 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)

Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements See GMP+ BA 3: Negative list Analysis method7
C12
Animal proteins
Animal feeds for productive livestock
Regulation 999/2001, art. 7 and Appendix IV
OZM Part 2; OSP12

Contaminant
Chemical: Toxic substances
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary requirements In the event of exceeding the action limit: Determination of the source of the contamination. Once the source of the contamination has been established take, if possible, suitable measures to reduce or eliminate this Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.
Analysis method7
C13a
Dioxin 11 + 18
Feed materials of vegetable origin with the exception of vegetable oils and their by-products
0.5 ng WHOPCDD/FTEQ/kg 4 + 17
0.75 ng WHO4+ PCDD/F-TEQ/kg

5
Directive 2006/13/EC to amend Directive 2002/32/EEC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP18
Vegetable oils and their by-products
Feed materials of mineral origin
0.5 ng WHOPCDD/FTEQ/kg 4 + 17 0.5 ng WHOPCDD/F4 + 17 TEQ/kg
0.75 ng WHO4 PCDD/F-TEQ/kg

5
1.0 ng WHOPCDD/F-TEQ/kg 4 +
5
Animal fat including milk fat and egg fat
2,0 ng WHOPCDD/F-TEQ/kg 4 +
5
Products from other than land animals including milk, milk products, eggs and products from eggs Other land animal products including milk and milk products and eggs and egg products.
0,5 ng WHOPCDD/FTEQ/kg 4 + 17
5
Fish oil
6.0 ng WHO4+ PCDD/F-TEQ/kg

5
In the event of exceeding the action limit: In many cases it may perhaps not be necessary to carry out an investigation into the source of the contamination as the background level in some areas is close or above the action level.
Contaminant
Product Fish, other aquatic animals and products derived thereof sea creatures and their (subsidiary) products , with the exception of fish oil and fish protein hydrolysates which containing more than 20% fat 6 Fish protein hydrolysates containing more than 20% fat 6
Action limit(1) 1.0 ng WHOPCDD/FTEQ/kg 4 + 17
Rejection limit(1) 1.25 ng WHO4+ PCDD/F-TEQ/kg

5
Source
1.75 ng WHOPCDD/FTEQ/kg 4 + 17 1.75 ng WHOPCDD/FTEQ/kg 4 + 17 0.5 ng WHOPCDD/FTEQ/kg 4 + 17
5
Fish food Feeds for pets Feed additives belonging to the functional groups of binders and anti-caking agents "Binding agents and thinners" The feed additives kaolinitic clay, calcium sulphate dihydrate, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin, belonging to the functional groups of binders and anti-caking agents "Binding agents and thinners"
5
Supplementary requirements If the action limit is really exceeded then all the details such as the sampling period, geographical origin, fish species, etc., should be recorded with a view to future measures for the presence of dioxins and dioxin-like compounds in these animal feeds.
Analysis method7
5
Feed additives belonging to the functional group of compounds of trace elements compounds"
5
Premixes
5
Compound feeds with the exception of: feeds for fur-bearing animals and pets and of fishfeed
0.5 ng WHOPCDD/F4 + 17 TEQ/kg 1.75 ng WHOPCDD/FTEQ/kg 4 + 17
5
- compound feed for pet animals and fish
5
In the event of exceeding the action limit: Determination of the source of the contamination. Once the source of the contamination has been established take, if possible, suitable measures to reduce or eliminate this Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination. In the event of exceeding the action limit: In many cases it may perhaps not be necessary to carry out an investigation into the source of the contamination as the background level in some areas is close or above
Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary requirements the action level. If the action limit is really exceeded then all the details such as the sampling period, geographical origin, fish species, etc., should be recorded with a view to future measures for the presence of dioxins and dioxin-like compounds in these animal feeds
Analysis method7
- compound feed for fur animals
C13b
Sum of dioxins and dioxin-like 12 +18 PCBs
Feed materials of vegetable origin with the exception of vegetable oils and their by-products
1.25 ng WHOPCDD/F-PCBTEQ/kg 4
OZM Part 2; OSP18
Vegetable oils and their by-products
1.5 ng WHOPCDD/F-PCB4 TEQ/kg 1.5 ng WHOPCDD/F-PCBTEQ/kg 4 3.0 ng WHOPCDD/F-PCBTEQ/kg 4 1.25 ng WHOPCDD/F-PCBTEQ/kg 4
Products from other than land animals including milk, milk products, eggs and products from eggs Other land animal products including milk and milk products and eggs and egg products Fish oil
Fish, other aquatic animalssea creatures and their (subsidiary) products derived thereof , with the exception of fish oil and fish protein hydrolysates which containing more than 20% fat6
24.0 ng WHOPCDD/F-PCBTEQ/kg 4 4.5 ng WHOPCDD/F-PCBTEQ/kg 4
Fish protein hydrolysates which containing more than 20% fat
11 ng WHOPCDD/F-PCBTEQ/kg 4
Contaminant
Product The feed additives kaolinitic clay, calcium sulphate dihydrate, 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 "Binding agents and thinners" Feed additives belonging to the functional group of compound of "Trace elements compounds"
Action limit(1)
Rejection limit(1) 1.5 ng WHOPCDD/F-PCBTEQ/kg 4
Source
Analysis method7
1.5 ng WHOPCDD/F-PCBTEQ/kg 4 1.5 ng WHOPCDD/F-PCBTEQ/kg 4 1.5 ng WHOPCDD/F-PCB4 TEQ/kg 7.0 ng WHOPCDD/F-PCB4 TEQ/kg -
Premixtures
Compound feed with the exception of: feeds for fur-bearing animals and pets and of fishfeed
Fish food Feeds for pets - Compound feed for pet animals and fish - Compound feed for fur animals
C13c
Dioxin-like PCBs19 +18
Feed materials of vegetable origi n with the exception of vegetable oils and their by-products Vegetable oils and their by-products
0.35 ng WHOPCB-TEQ/kg 4
+ 17
+ 17
+ 17
0.75 ng WHO4 PCB-TEQ/kg

+ 17
Products from other than land animals including milk, milk products, eggs and products from eggs Other land animal products including milk and milk products and eggs and egg products

+ 17
In the event of exceeding the action limit: Determination of the source of the contamination. Once the source of the contamination has been established take, if possible, suitable measures to reduce or eliminate this Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.
OZM Part 2; OSP18
Contaminant
Product Fish oil
Action limit(1) 14.0 ng WHO4 PCB-TEQ/kg

+ 17
Rejection limit(1)
Source
Fish, other aquatic animals sea creatures and their (subsidiary) products derived thereof, with the exception of fish oil and fish protein hydrolysates which containing more than 20% fat Fish protein hydrolysates which containing more than 20% fat
+ 17
+ 17
Fish food Feeds for pets Feed additives belonging to the functional groups of binders and anti-caking agents "Binding agents and thinners" Feed additives belonging to the functional group of compounds of trace elements "Trace elements compounds"

+ 17
Supplementary requirements In the event of exceeding the action limit: In many cases it may perhaps not be necessary to carry out an investigation into the source of the contamination as the background level in some areas is close or above the action level. If the action limit is really exceeded then all the details such as the sampling period, geogrpahical origin, fish species, etc., should be recorded with a view to future measures for the presence of dioxins and dioxin-like compounds in these animal feeds In the event of exceeding the action limit: Determination of the source of the contamination. Once the source of the contamination has been established take, if possible, suitable measures to reduce or eliminate this Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination. In the event of exceeding the action limit: In many cases it may perhaps not be necessary to carry out an investigation into the source of the contamination as the background level in some areas is close or above the action level. If the action limit is really exceeded then all the
Analysis method7

+ 17
+ 17
Premixtures
+ 17
Compound feed with the exception of: eeds for furbearing animals and pets and of fishfeed
+ 17
- Compound feed for pet animals and fish,

+ 17
Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary requirements details such as the sampling period, geographical origin, fish species, etc., should be recorded with a view to future measures for the presence of dioxins and dioxin-like compounds in these animal feeds
Analysis method7
- Compound feed for fur animals
[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If t his 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 mo isture content of 12% unless mentioned diifferently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [4] Upper limit concentrations; in the calculation of upper limit concentrations it must be assumed that values lying under the detection limits for the various congenors are equal to the detection limit. [5] The individual maximum level for dioxins (PCDD/Fs) remains temporarily applicable. The values specified in item C13a for products intended for feeding to animals must correspond in this period to the maximum levels for dioxins and the maximum levels for the sum of dioxins and dioxin -like PCBs. 6] Fresh fish which is supplied directly without any further processing and used for the production of feeds for fur-bearing animals gebruikt, is exempted from the maximum level, and for fresh fish which is used for the direct feeding of pets, zoo animals and circus animals there is a maximum level of 4.0 ng WHO -PCDD/F-TEQ/kg product and 8.0 ng WHO-PCDD/F-TEQ/kg product. The products, processed animal proteins from these animals (fur-bearing animals, pets, zoo animals and circus animals), may not get into the feed chain and the feeding of them to productive livestock which are kept for the production foodstuffs, are being fattened up or bred, is forbidden. Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed f or fur animals are not subject to the maximum levels, while maximum levels of 4,0 ng WHO-PCDD/F-TEQ/kg product and 8,0 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 25,0 ng WHO-PCDD/F-PCB-TEQ/kg product 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 p rocessed 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. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [11] (sum of the polychlorinated dibenzo-para dioxins (PCDDs) and the polychlorinated dibenzofurans (PCDFs) expressed in toxicity equivalent s established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997) [12] (sum of the polychlorinated dibenzo-para dioxins (PCDDs) and the polychlorinated dibenzofurans (PCDFs) and the polychlo rinated biphenyls (PCBs) expressed in toxicity equivalents established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997) [17] The Commission will evaluate these action limits at the same time as the maximum levels for the sum of dioxins and dioxin-like PCBs before 31 December 2008. [18] TEF's from the WHO for the asse ssment of the risks to humans based on the conclusions of the meeting of the World Healt h Organisation in Stockholm, Sweden, 15-18 June 1997 (van den Berg et al., (1998) Toxic Equivalence Factors (TEF's) for PCB's, PCDD's, PCFD' s for Humans and for Wildlife Environmental Health Perspectives, 106(12), 775). Congenor Dibenzo-p-dioxins (PCDDs) 2,3,7,8-TCDD 1,2,3,7,8-PeCDD 1,2,3,4,7,8-HxCDD 1 1 0.1 TEF Value Congenor Dioxin-like PCBs Non-ortho-PCBs + mono-ortho-PCBs Non-ortho-PCB' PCB 77 0,0001 TEF Value
1,2,3,6,7,8-HxCDD 1,2,3,,7,8, 9-HxCDD 1,2,3,4,6,7,8-HpCDD OCDD
0.1 0.1 0.01 0.0001
PCB 81 PCB 126 PCB 169
0,0001 0,1 0,01
Mono-ortho-PCBs Dibenzofuranes (PCDFs) 2,3,7,8-TCDF 1,2,3,7,8-PeCDF 2,3,4,7,8-PeCDF 1,2,3,4,7,8-HxCDF 1,2,3,6,7,8-HxCDF 1,2,3,7,8,9-HxCDF 2,3,4,7,8-HxCDF 1,2,3,4,6,7,8-HpCDF 1,2,3,4,7,8,9-HpCDF OCDF Key to abbreviations: T= tetra; Pe= penta; Hx=hexa; Hp= hepta; O= octa; 0.1 0.05 0.5 0.1 0.1 0.1 0.1 0.01 0.01 0.0001 CDD= chlordibenzodioxin; CDF= chlordibenzofuran; CB= chlorbiphenyl PCB 105 PCB 114 PCB 118 PCB 123 PCB 156 PCB 157 PCB 167 PCB 189 0,0001 0,0005 0,0001 0,0001 0,0005 0,0005 0,00001 0,0001
[19] (sum of the polychlorinated biphenyls (PCBs) expressed in toxicity equivalents established by the World Health Organisa tion (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997)

Contaminant
Chemical: Mycotoxin
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C15
DON (Deoxynivalenol)
Animal feed on full ration basis for: - Pigs - Cattle - Calves up to 4 months - Dairy cattle - Poultry Feed material (supplied to the livestock cattle farmer for immediate feeding) for - Pigs - Cattle - Calves up to 4 months - Dairy cattle - Poultry 1 mg/kg 5 mg/kg 2 mg/kg 3 mg/kg 4 mg/kg 5 mg/kg 15 mg/kg 6 mg/kg 9 mg/kg 12 mg/kg 0.8 mg/kg 4 mg/kg 1.6 mg/kg 2.4 mg/kg 3.2 mg/kg 1 mg/kg 5 mg/kg 2 mg/kg 3 mg/kg 4 mg/kg
GMP+
OZM Part 2; OSP19
The supplier provides information to the livestock cattle 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

C16
Endosulfan (sum of alfa and btaisomers and of endosulfan sulphate, expressed in endosulfan)
Feed materials and compound feedall animal feeds, with the exception of: - maize and maize products derived from the processing thereofproducts - oil-bearing seeds and products derived from the processing thereofproducts with the exception of crude vegetable oil, - crude vegetable oil,
0.1 mg/kg 0.2 mg/kg 0.5 mg/kg
1,0 mg/kg
Directive 2003/100/EEC amending Directive 2002/32/EEC Directive 2006/77/EEC amending Directive 2002/32/EEC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP11
- complete feed for fish food
0.005 mg/kg
[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 t hen 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)

C17
Endrin (sum of endrin and deltaketo-endrin, expressed asin endrin)
Feed materials and compound feedAll animal feeds, with the exception of: - fats and oils
0.01 mg/kg 0.05 mg/kg
2002/32/EC Directive 2006/77/EEC amending Directive 2002/32/EEC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP11
[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 level s 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 th e 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)

Contaminant
Chemical: Heavy metals Salts
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C19
Fluorine
Feed materials, with the exception of: - Feed materials animal feeds of animal origin with the exception marine crustaceansof sea water shellfish such as marine krill - marine crustaceans seawater shellfish such as marine krill - phosphates - calcium carbonate - magnesium oxide
150 mg/kg 500 mg/kg
Directive 2005/87/EEC amending Directive 2002/32/EEC Directive 2008/76/EEC amending Annex I to Directive 2002/32/EEC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-6
3,000 mg/kg 2,000 mg/kg 350 mg/kg 600 mg/kg
- calcareous marine algae
1,000 mg/kg
Vermiculite (E 561)
3,000 mg/kg 8
Complementary Supplementary animal feeds - containing < 4% phosphorus 8 - containing > 4% phosphorus 8 Complete animal feeds, with the exception of: - complete animal feeds for cattle, sheep and goats - which suck in lactation - others - complete animal feeds for pigs - complete animal feeds for poultry (except chicks) and fish - complete animal feeds for chicks 30 mg/kg 50 mg/kg 100 mg/kg 350 mg/kg 250 mg/kg 500 mg/kg 125 mg/kg per 1% phosphorus 8 150 mg/kg
[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 co ntent 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. [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 [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [8] The levels will be reviewed before 31 December 2008 with a view to lowering the maximum levels The % of phosphorus is relative to a feed with a moisture content of 12 %.

C20
Heptachlor (sum of heptachlor and All animal feeds Feed materials and compound heptachlor epoxyd, expressed in feed, with the exception of: as heptachlor) - fats and oils
0.01 mg/kg 0.2 mg/kg
OZM Part 2; OSP11

C21
Hexachlorobenzene (HCB)
All animal feeds Feed materials and compound feed, with the exception of: - fats and oils
OZM Part 2; OSP11

C22a
Hexachlorocyclohexane (HCH):
- Alfa-isomer
OZM Part 2; OSP11
[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, deri ved 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)

C22b
- Beta-isomer
Compound feeds with the exception of: - feeds compound feedingstuffs for dairy cattle Feed materials, with the exception of: - fats and oils
0.01 mg/kg 0.005 mg/kg 0.01 mg/kg 0.1 mg/kg
Directive 2002/32/EC Directive 2006/77/EEC amending Directive 2002/32/EEC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP11
[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 m g/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 produ ct 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)

C22c
- Gamma-isomer (lindane)
0.2 mg/kg 2.0 mg/kg
Directive 2002/32/EC Directive 2006/77/EEC amending Directive 2002/32/EEC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP11
[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 m g/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. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods)

Contaminant
Chemical: Salts
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C23
Potassium
- Feed materials for delivery to cattle farms, and - Wet mixes for delivery to cattle farmers
60 g/kg (dry matter)
GMP+
OZM deel 3; WM08

Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C24
Hydrocarbons (C10-C40)
Animal fat, with the exception of: - crude fish oil Vegetable oil (with the exception of sunflower oil)
400 mg/kg (on product basic) 3,000 mg/kg (on product basic) 400 mg/kg (on product basic) 1,000 mg/kg (on product basic) 3,000 mg/kg (on product basic)
GMP+
OZM Part 2; OSP15a
Sunflower oil and sunflower fatty acids
Vegetable fatty acids incl. Mixes of fatty acids (with the exception of sunflower fatty acids)
Palm oil
25 mg/kg calculated as diesel oil
This norm applies if the hydrocarbons (calculated as diesel oil) are determined via the GCMS method. If use is made of the GC-FID method, then the norm for vegetable oil applies Commission Regulation (EC) 1151/2009 of 27 November 2009 The batch must be accompanied by a report of analysis and a Health certificate
OZM Part 2; OSP15b
Hydrocarbons (mineral paraffin/oil) : saturated hydrocarbons in the range C10C56 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)
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. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods)

Contaminant
Product (complete feedingstuff)
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C25
Copper (E4)
Pigs: - Piglets up to 12 weeks - Other pigs Bovine: 1. Bovine before the start of rumination: - Milk replace - Other complete feeingstuffs 2. Other bovine Ovine Fish Crustaceans Other species 15 mg/kg total 15 mg/kg total 35 mg/kg total 15 mg/kg Total 25 mg/kg total 50 mg/kg total 25 mg/kg total 170 mg/kg total 25 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; TVMI-2

Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C26
Mercury2, 16
0.1 mg/kg 0.5 mg/kg
- fish, other aquatic animals and products derived thereof,animal feeds obtained by processing fish or other aquatic animals - calcium carbonate Compound (complementary and complete) animal feeds, with the exception of: - mineral feed - compound feedingstuffs for fish - compound feedingstuffs for dogs, cats and fur animals - supplementary animal feeds for dogs and cats Compound (complementary and complete) animal feeds, with the exception of: -
0.3 mg/kg 0.1 mg/kg 0.2 mg/kg 0,2 mg/kg 0,3 mg/kg 0.1 mg/kg
Directive 2010/6/EC amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-5
[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. [2] The maximum levels refer to an analytical determination of arsenic/ cadmium / mercury where the extraction is done for 30 minutes a boiling temperature in Nitric acid (5% m/m). Equivalent extraction procedures may be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [16] The maximum levels refer to the total level of arsenic / mercury respectively.

Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C27
Lead 10
Feed materials, with the exception of: - forage green fodder 9
10 mg/kg 30 mg/kg 8
OZM Part 2; OSP28
- phosphates and calcareous marine algaelimestone - calcium carbonate - yeast Feed additives belonging to the functional group of compounds of trace elements, with the exception of: - zinc oxide - manganousese (II)oxide, ferrous carbonate, cupricopper carbonate Feed additives belonging to the functional group of binders and anti-cakingBinding agents and thinners", with the exception of: - clinoptilolite of vulcanic origin Premixtures 2 Complementaryte animal feeds, with the exception of: - mineral feedmixes Complete animal feeds
15 mg/kg 20 mg/kg 5 mg/kg 100 mg/kg 400 mg/kg 8 200 mg/kg 8 30 mg/kg 8
60 mg/kg 8 200 mg/kg 8 10 mg/kg 15 mg/kg 5 mg/kg
[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 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 f or use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moistu re content of 12% unless mentioned differently. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [8] The levels will be reviewed before 31 December 2008 with a view to lowering the maximum levels
[9] Green fodder includes products which are intended for feeding to animals such as hay, silage, fresh grass, etc. [10] The maximum levels refer to an analytical determination of leadwhere the extraction is done for 30 minutes a boiling temperature in Nitric acid (5% m/m). Equivalent extraction procedures may be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency

Contaminant
Chemical: Mycotoxin
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C28
Rye ergotErgot of rye (Claviceps purpurea)
All animal feeds which contain unground grain Feed materials and compound feed containing unground cereals
1,000 mg/kg
Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP32

Contaminant
Chemical: Salts
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C29
Sodium
8 g/kg (dry matter)
GMP+
OZM deel 3; WM09
- Wet mixes for delivery to cattle farmers

Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C30
Nickel
Feed fats
20 mg / kg (on a fat basis)
50 mg / kg (on a fat GMP+ basis)
OZM Part 2; OSP29
[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 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. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods)

C31
Nitrites
15 mg/kg (expressed in sodium nitrite) 30 mg/kg (expressed in sodium nitrite) 15 mg/kg (expressed in sodium nitrite) -
- Fish meal
- products and by-products from sugar beet and sugarcane and from starch production. Complete animal feeds, with the exception of:
Directive 2010/6/EU amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-7
- complete feedingstuffs for dogs and cats with a moisture content exceeding 20 %.

Contaminant Chemical: Botanical impurities C32 Weed seeds and unground or pulverised fruits which contain alkaloids, glucosides or other poisonous substances separately or jointly Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including All animal feeds Feed material and compound feed 3,000 mg/kg Directive 2009/141/EC amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Microscopic determination in accordance with the instructions of the manufacturerlaboratory Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Contaminant Chemical: Botanical impurities C32a - Datura sp. Feed material and compound feed 1,000 mg/kg Directive 2009/141/EC amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method

C33
Insoluble impurities
Melted Rendered fats from ruminants
0,15%
Regulation 1774/2002/EC Commission Regulation (EU) 142/2011, Annex X, Chapter II, Section 3
OZM Part 2; OSP16

Contaminant
Chemical: Mycotoxin
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C34
Ochratoxin A
Animal feed on full ration basis for:
GMP+
OZM Part 2; OSP19
- sows and consumption pigs and piglets - poultry
0.04 mg/kg 0.16 mg/kg
Feed material (supplied to the livestock cattle farmer for immediate feeding) for
- Sows and pigs and piglets - Poultry

Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary requirements BaPEQ = Benzo(a)pyrene equivalent
Analysis method7
C35
Polycyclic Aromatic Hydrocarbons Feed fats (PAHs)
15 g/kg BaPEQ (on fat basis)
50 g/kg BaPEQ (on fat basis)
GMP+
OZM Part 2; OSP33
[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded t hen 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 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. 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)

Contaminant 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 All animal feeds Feed materials and compound feed. 10 mg/kg (expressed in ricinus husks) 23 Directive 2009/141/EC amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Microscopic determination in accordance with the instructions of the manufacturer laboratory Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7
[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) [23] Includes also seed husk fragments.

Contaminant
Chemical: Salts
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C39
Sulphate
8 g/kg (dry matter)
GMP+
- Wet mixes for delivery to cattle farmers which are preserved with sulphuric acid and not for products which by nature are rich in sulphur
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; OSP24

Contaminant Chemical: Antinutritional factors: Alkaloids C40 Theobromine Complete animal feeds, with the exception of: - complete animal feeds for pigs - complete animal feeds for dogs, rabbits, horses and fur animals 300 mg/kg 200 mg/kg 50 mg/kg Directive 2009/141/EC amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC OZM Part 2; OSP-8 Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Contaminant Chemical: Antinutritional factors: Glucosides C41 Vinylthiooxazolidon (Vinyloxazolidine thion) Vinyl thiooxazolidone (5vinyloxazolidine-2-thione) Complete animal feeds for poultry with the exception of: 1,000 mg/kg Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC OZM Part 2; OSP31 Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7
- complete animal feeds for laying henspoultry
500 mg/kg

Contaminant Chemical: Antinutritional factors: Glucosides C42 Volatile mustard oil Feed materials, with the exception of: 100 mg/kg (calculated as allylisothiocyanate) 4,000 mg/kg (calculated as allylisothiocyanate) 150 mg/kg (calculated as allylisothiocyanate) 1,000 mg/kg (calculated as allylisothiocyanate) 500 mg/kg (calculated as allylisothiocyanate) Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC OZM Part 2; OSP20 Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7
- colza rapeseed cakes
Complete animal feeds, with the exception of:
- Complete animal feeds for cattle (except calves), sheep (except lambs) and goats (except kids)with the exception of young animals) - Complete animal feeds for pigs (with the exception of piglets) and poultry

Contaminant Chemical: Antinutritional factors: Other C43 Free gossypol Feed materials, with the exception of: - cotton seed - cotton seed cake and cotton seed meal Complete animal feeds, with the exception of: - complete feed for adult cattle (except calves) 20 mg/kg 5,000 mg/kg 1,200 mg/kg 20 mg/kg 500 mg/kg 2010/6/EU amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC OZM Part 2; OSP21 Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method
- complete feed for sheep (except lambs) and goats (except kids), - complete feed for poultry (except laying hens) and calves - complete animal feeds for rabbits, lambs, kids and pigs (except piglets)
300 mg/kg
100 mg/kg
60 mg/kg

Contaminant
Chemical: Mycotoxin
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C44
Zearalenon
Animal feed on full ration basis for: - sows and consumption pigs - young pigs - young cattle and dairy cattle Feed material (supplied to the livestock cattle farmer for immediate feeding) for 0.2 mg/kg 0.08 mg/kg 0.4 mg/kg 0.25 mg/kg 0.1 mg/kg 0.5 mg/kg
GMP+
OZM Part 2; OSP19
- sows and pigs - young pigs - young cattle and dairy cattle
0.25 mg/kg 0.1 mg/kg 0.2 mg/kg
0.75mg/kg 0.3 mg/kg 1.5 mg/kg

Contaminant
Product
Action limit(1)
Rejection limit(1)
Source
Analysis method7
C45
Zinc (E6)
Pets13 Fish 13 Milk replacer

13
250 mg/kg total
200 mg/kg total 200 mg/kg total 150 mg/kg total
Other animals
13
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; TVMI-4
[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 m g/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. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [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

Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements Identity and physical checks, including sampling and analysis to control the presence of melamine, shall be carried out on approximately 20 % of such consignments. Identity and physical checks, including sampling and analysis to control the presence of melamine, shall be carried out on approximately 20 % of such consignments. Random checks be carried out to control the presence of melamine EFSA recommendation: LC-MS/MS (liquid chromatography coupled to mass spectrometry Analysis method7
C46
Melamine 24
- All feeds which contain milk and milk products, soya or soya products originating from or sent from China.
2,5 mg/kg
- Ammonium bicarbonate intended for use in feeds originating from or sent from China.
2,5 mg/kg
Commission Regulation (EC) No 1135/2009 of 25 November 2009 Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
- All other feeds originating in China which have a high protein content.
2,5 mg/kg
Feed, with the exception of the feed additives - guanidino acetic acid (GAA), - urea - biuret
2,5 mg/kg -
[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned diifferently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [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.

Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements 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. Analysis method
Microbiological: Other undesirable substances and products
M1
Antibacterial inhibition
- Feed materials
< 15 mm
GMP+
OZM Part 1; O-1
- Wet mixes

Contaminant
Fysical: Bodies foreign to the product
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary requirements Via manual separation and weighing See GMP+ BA 3: Negative list
Analysis method7
F1
Plastics
1.5 g/kg (dry matter basis)
GMP+
Microscopic determination in accordance with the instructions of the manufacturer laboratory.
- Wet mixes for delivery to livestock cattle farmers
This norm was included subject to the outcome of the discussion taking place in the European Commission.
[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is e xceeded 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 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. 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)

Contaminant
Fysical: Bodies foreign to the product
Product
Action limit(1)
Rejection limit(1)
Source
Supplementary requirements See GMP+ BA 3: Negative list.
Analysis method7
F2
Polyethylene
0.25 g/kg (on fat basis)
0.5 g/kg (on fat basis)
GMP+
OZM Part 2; OSP13
- Wet mix for delivery to livestock cattle farmers
[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 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. 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)

Contaminant Fysical: Botanical impurities F5 Unhusked beech mast, unpeeled seeds - Fagus silvatica (L.) Feed materials and compound feed Seeds and fruits of the adjacent plant types and the byproducts obtained from processing may not appear in animal feeds unless as traces which can not be quantitatively determined the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7
SUMMARY OF GMP+ PRODUCT STANDARDSNORMS FOR THE ANIMAL FEED SECTOR

Contaminant Fysical: Botanical impurities F6 Chinese mustard Brassica juncea (L.) Czern. and Coss. ssp. juncea var. lutea Batalin All animal feeds Feed materials and compound feed Seeds and fruits of the adjacent plant types and the byproducts obtained from processing may not appear in animal feeds unless as traces which can not be quantitatively determined the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Contaminant Fysical: Botanical impurities F7 Ethiopian mustard Brassica carinata A. Braun Feed materials and compound feed Seeds and fruits of the adjacent plant types and the byproducts obtained from processing may not appear in animal feeds unless as traces which can not be quantitatively determined the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Contaminant Fysical: Botanical impurities F8 Indian brown mustard - Brassica juncea (L.) Czern. and Coss. ssp. integrifolia (West.) Thell. Feed materials and compound feed Seeds and fruits of the adjacent plant types and the byproducts obtained from processing may not appear in animal feeds unless as traces which can not be quantitatively determined the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Contaminant Fysical: Botanical impurities F10 Purghera Physic nut - Jatropha curcas L. Feed materials and compound feed Seeds and fruits of the adjacent plant types and the byproducts obtained from processing may not appear in animal feeds unless as traces which can not be quantitatively determined the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Contaminant Fyscial: Botanical impurities F12 Sarepta mustard - Brassica juncea (L.) Czern. and Coss. ssp. juncea Feed materials and compound feed Seeds and fruits of the adjacent plant types and the byproducts obtained from processing may not appear in animal feeds unless as traces which can not be quantitatively determined the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Contaminant Fysical: Botanical impurities F13 Seeds from Ambrosia spp. Feed materials, with the exception of: 50 mg/kg Commission The provisions as regards Regulation (EU) No Ambrosia spp. shall apply 574/2011 amending from 1 January 2012. Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7
Compound feed containing unground grains and seeds
50 mg/kg

Contaminant Fysical: Botanical impurities F14 Black mustard Brassica nigra (L.) Koch Feed materials and compound feed Seeds and fruits of the adjacent plant types and the byproducts obtained from processing may not appear in animal feeds unless as traces which can not be quantitatively determined the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable Directive 2002/32/EC Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis method7

Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements 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.) Analysis method
Fysical: Other undesirable substances and products F26 Radioactivity Commission Implementing Regulation (EU) No 961/2011
Sum of Cs-134 and Cs-137
Feedingstuffs
500 (Bq/kg)
Sum of Isotopes of iodine, notably I-131
Feedingstuffs
2 000 (Bq/kg)
[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 correct ive 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.
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 legislation 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 applicable 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 determination 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 applies 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
Basic product Auxiliary products
Definition
Simple, unprocessed product of vegetable or animal origin (wheat, barley, linseed, sunflower seeds, soya bean, peas, shrimps) 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)
Questionnaire
4.2.2. 4.2.3
Compound feed
Compound product consisting of at least two components being basic products, by-products and/or feed additives. (complete feed, supplementary 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 imm ediately 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 Fish, fish products, crustaceans and shellfish and other products from salt and fresh water creatures* Only for crops used for feed* Loquats Cherimoyas Guavas Kohl-rabi foliage Product (groups) Palm hearts Palm kernels
Garden cress Winter cress Rucola Red amsoi
Fungi Seaw eed Lupines (dried) Shells, seeds and possibly skins of oil-retaining seeds and fruits (such as soya hulls) Borage Pumpkin seed Hemp seed Camelina
Palm fruits Kapok Millet Sorghum
Bread fruits Durians Soursops (durian blanda) Arrowroot
Nut shells Sprouts stems
Leaves and sprouts of Brassica spp. Purslain Vine leaves Herbs (sage, rosemary, thym, basi, laurel, tarragon) Lentils (fresh) Bamboo shoots
Coffee beans Herbal tea Cacao bean Carob
Safflower seed Olives (oil recovery)
Spices Sugar crops
*:
The standards of Reg. 396/2005 apply neither to f eeds nor to f oodstuffs f or (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. 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 / Unprocessed product of vegetable or animal origin. Check your product using the definitions in Table 1. Consult your supplier. Is your basic product individually included in Appendix I of Reg. 396/2005, (column 3, 4 and 5) Yes Go to question 4. No Go to question 7. Is the pesticide for which you are looking for a standard included in Pesticides Web , the online EU pesticides database? Yes Go to question 5. No Go to question 6. 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 current MRL. You have found the standard. Place the mouse cursor on the MRL or click on the pesticide for additional information (end). 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 Is the pesticide for which you are looking for a standard included in Pesticides Web , the online EU pesticides database? Yes Go to question 8. No Go to question 9. On Pesticides Web select the language you want, the (sub) group of products 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).
2.
3.
4.
5.
6.
7.
8.
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). No Go to question 2. Is your by-product included in Appendix I of Reg. 396/2005, either as a byproduct (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. 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 byproduct/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.) question 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 byproduct for which you are looking for a standard? Yes The standard you have found is the standard for this by-product / pesticide combination. (end) No Go to question 5. 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) No Go to question 6.
2.
3.
5.
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 byproduct/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 concentration factor (see table 3) and divide or multiply this by the standard found for the original product(group) in order to determine the final standard.(end)
Table 3: Concentration factors for many vegetable oils which are used Oil-retaining basic product Palm fruit Sheanut Coconut Palm kernel Sesame seed Peanut Rapeseed Linseed Sunflower seeds Kardi / Safflower seed Cotton seed Soya bean Grape seed Avg. oil level 50 50 50 49 49 48 40 45 32 31 20 19 15 Concentration factor in oil 2 2 2 2 2 2 2 2 3 3 5 5 6
Source: Product Board f or Margarine, Fats and Oils (MVO), Memora ndum Crude Oils MRLs, Sept. 2003
No 8.
Go to question 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 concentration factor and divide or multiply this by the standard found for the original product(group) in order to determine the final orm.(end)
No 9.
Go to question 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 byproduct. (end) No Go to question 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 dilution or concentration factor and divide or multiply this by the the standard you found for the original product or product group in order to determine the final standard.(end). Note: In this case, where there is a pesticide which is soluble in water, there is dilution of the fat fraction and concentration of the fat-free fraction!
10.
NOTE: the method described in this section for the determination of maximum residue limits (MRL) in fats and oils also applies to fatty acids. 4.2.4 Questionaire for compound feeds 1. Specify the individual components of your compound feed. In Reg. 396/2005, Appendix VI, has a concentration or dilution factor has been established for your compound feed, A certain fraction of your compound feed. A byproduct that is part of your copound feed? Yes Use this factor or factors to determine the final standard for this specific part of your compound feed and to determine the pesticide in question. Go to question 2 . No Go to question 2.
NOTE: At the time of the first publication of this document Appendix VI was not yet completed 2. Does your compound feed contain basic products among other things? Yes For each of these components go through the questionnaire in par. 4.2.2. In order to determine the standards for these components. Go to question 3 No Go to question 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. Have you determined a standard for all the components for which a standard has been set and have you taken account of the factors laid down in question 1? Yes Go to question 5. No Go through this questionnaire again starting at question 1
3.
4.
5.
Now determine the MRL for the specific pesticide in the compound feed in the following way MRLx = {(Nx C1 * C1) + (Nx C2 * C2) . + (Nx Cn * Cn)}/ C1:Cn Where: MRLx : Is the maximum residue standard for pesticide X in the compound feed Nx Cn : The standard found for the component / group of components C (1 to n) Cn : The percentage in the compound feed for component / group of components C (1 to n) C1: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 pesticide 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.
PART B: RESIDUE STANDARDS
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.
Additional provisions
2.1
General
The control of residue levels using the production sequence is shown in diagram form in the following table.
Carry-over measurement instruction (GMP+ BA 4) Wall adhesion factor measurement instruction
Carried out by TNO-Nutrition
Relative wall adhesion factor measurement
Installation internal carry-over
Coefficient factor (GMP+ BA1, Part B, Chapter 3)
Coefficient (=carry-over x factor)
Carry-over percentage
Max. residue norm (GMP+ BA1, Part B, Chapter 3)
Calculation
Production sequence / flush batches
2.2 2.2.1
Compound feed Installation Carry-over level:
The installations 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 additives 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 installation. 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 additive or veterinary medicine. A factor of 1 means that the product contains no processing 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 processing properties, such that the actual carry-over will be higher than the installation carryover. The coefficient is determined on the basis of a so-called relative wall adhesion factor using a method specially developed for this purpose. Refer to TNO report I-9631006 Carry-over of a number of critical substances in cattle feed and the relationship to their characteristic properties.
Relevant lines are lines on which (products with) feed additives for which a residue norm has b een determined in the table in Chapter 3 or veterinary medical products and also products with a d etermined 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 establi shed method. <1 > 1 and < 2 > 2 and < 3 unknown, > 3 Coefficient 1 2 2,5 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 Companys own carry-over in installation: Coefficient Maximum residue standard for broiler feed for the last five days: : 80 ppm : 5% : "1" : 0.5 ppm
Calculation of actual carry-over = companys 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 operations 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 exceeded. 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 preparation 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 veterinary 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 producer 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 product should be adopted. 2.3.3 Indirect contamination
In order to achieve extremely low residue standards in premixes, producers of premixes 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 coccidiostats 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 additives is so high that, together with the companys own carry-over levels, the residue standards in compound feeds are exceeded.
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 Directive 2002/32/EC amending Annex I to Directive 2002/32/EC
Products intended for animal feed (2) Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 %
Additives
Lasalocid sodium
Feed materials Compound feed for: - dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 16 12 weeks) and chickens reared for laying (> 16 weeks) - chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (<16 12 weeks) for the period before slaughter in which the us e of las alocid sodium is prohi bited (withdrawal feed) - other animal species Premixtures for use in feed in which the use of lasalocid sodium is not authorised
1,25
1,25
1,25
3,75 ()
3
Narasin
Feed materials Compound feed for: - turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks) - chickens for fattening for the period before slaughter in which the use of narasin is prohibited (withdrawal feed) - other animal species
0,7
0,7
0,7
2,1
Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutr ition. 3 The maximum level of the sub stance in the premixture is the concentration which shall not result in a level of the sub stance higher than 50 % of the maximum levels established in the feed when the instructions for use of the premixture are followed.
Additives
Products intended for animal feed (2)
Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 %
Premixtures for use in feed in which the use of narasin is not authorised. Salinomycin sodium Feed materials Compound feed for: - equine species, turkeys, laying birds and chickens reared for laying (> 12 weeks) - chickens for fattening, chickens reared for laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed) - other animal species Premixtures for use in feed in which the use of salinomycin sodium is not authorised. Monensin sodium Feed materials Compound feed for: - equine species, dogs, small ruminants (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turk eys (> 16 weeks) - chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (withdrawal feed) - other animal species Premixtures for use in feed in which the use of monensin sodium is not authorised. Semduramicin sodium Feed materials Compound feed for: - laying birds and chickens reared for laying (> 16 weeks)
()
0,7
0,7
0,7
2,1 ()
3
1,25
1,25
1,25
3.75 ()
3
0.25
0,25
Additives
- chickens for fattening for the period before slaughter in which the use of semduramicin sodium is prohibited (wit hdrawal feed) - other animal species Premixtures for use in feed in which the use of semduramicin sodium is not authorised. Maduramicin ammonium alpha Feed materials
0,25
0,75 ()
3
0,05
Compound feed for: - equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks) - chickens for fattening and turk eys (< 16 weeks) for the period before slaughter in which the us e of maduramicin ammonium alpha is prohibited (withdrawal feed) - other animal species Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised. Robenidine hydrochloride Feed materials Compound feed for: - laying birds and chickens reared for laying (> 16 weeks) - chickens for fattening, rabbits for fattening and breeding and turkeys for the period before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed) - other animal species Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised. Decoquinate Feed materials Compound feed for: - laying birds and chickens reared for laying
0,05
0,05
0,15 ()
3
0,7
0,7
0,7
2,1 ()
3
0,4
0,4
Additives
(> 16 weeks) - chickens for fattening for the period before slaughter in which the use of decoquinate is prohibited (withdrawal feed) - other animal species Premixtures for use in feed in which the use of decoquinat e is not authorised Halofuginone hydrobromide Feed materials 0,4
1,2 ()
3
0,03
Compound feed for: - laying birds, chickens reared for laying (> 16 weeks) and turk eys (> 12 weeks) - chickens for fattening and turk eys (< 12 weeks) for the period before slaughter in which the us e of halofuginone hydrobromide is prohibit ed (withdrawal feed) - other animal species other than chickens reared for laying (< 16 weeks) Premixtures for use in feed in which the use of halofuginone hydrobromide is not autho rised Feed materials Compound feed for: - equine species, laying birds and chickens reared for laying (> 16 weeks) - chickens for fattening for the period before slaughter in which the use of nicarbazin (in combination with narasin) is prohibited (withdrawal feed) - other animal species Premixtures for use in feed in which the use of nicarbazin (in combination with narasin) is not authorised Feed materials 1.25 0,5 0,03
0,03
0,09
()
Nicarbazin
1.25 0,5
1.25 0,5
3.75 1,5 ()
3
Diclazuril
0,01
Additives
Compound feed for: - laying birds, chickens reared for laying (> 16 weeks) and turk eys for fattening (> 12 weeks) - rabbits for fattening and breeding for the period before slaughter in which the us e of diclazuril is prohibited (withdrawal feed). - other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening and turk eys for fattening (< 12 weeks) Premixtures for use in feed in which the use of diclazuril is not authorised. Feed additives not registered in the EU which are intended for use in feeds for export outside the EU. All feeds intended for marketing within the EU. 0,01
0,01
0,03
()
3.2 Additional information for some coccidiostats and histomonostats *

Trade name Manufacturer Importer Concentration Coefficient Pigs Compound of narasin and nicarbazine (E 772) Maxiban G 160 premix Eli Lilly Lasalocid sodium (E 763) Avatec 15% CC Robenidine-hydrochloride (E758) Cycostat 66G Monensin-sodium (E757) Elancoban G200 premix Coxidin (5 1 701) Narasin (E765) Monteban G100 premix Halofuginone-hydrobromine (764) Stenorol Diclazuril (E 771) Clinacox 0,5 % Premix Salinomycin-sodium (E 766) Sacox 120 microGranulate Kokcisan 12% Other Eli Lilly Nederland BV 80 g/kg narasin 80 g/kg nicarbazine 15g/100g Lasalocide-sodium 66g/kg Robenidinehydrochloride 200g/kg monensin sodium 200g/kg monensin natrium 100g/kg narasin 6 g/kg halofuginone hydrobromide 0.5g/100g diclazuril 5 Other 1
Roche Roche
Alpharma Alpharma
1 1
1 1
Eli Lilly Huvepharma Eli Lilly Huvepharma
Eli Lilly Nederland BV Huvepharma NV Eli Lilly Nederland BV Huvepharma NV
1 1 1 1
1 1 1 1
Janssen Pharmaceutica nv Huvepharma KRKA Other
Janssen Pharmaceutica nv Huvepharma NV Lansdowne Chemicals Europe BV Other
120g/kg salinomycine 120g/kg salinomycine N/a
1 1 3
1 1 3
*: This list can be extended at new available data of relative wall adhesion test
4 Residue standards for critical veterinary medical products

4.1 Summary of residue standards for critical veterinary medical products
Established maximum residue standards 4 in animal feeds in ppm Established precautionary measure for dairy cattle
Veterinary medical product
laying 5 hens
slaughter 6 chickens fattening 6 turkeys 8 8 8 10 0.1 8 4 1
pigs
dairy 8 cattle
Sulfadiazine sodium Sulfamethoxazol Doxycycline Oxytetracycline Ivermectine Tiamuline Tilmicosine Trimethoprim For other products for export (not in NL for animal feed registered materials) and for any new registrations in the Netherlands
5 5 8 1 0.1 1 1 1
1 1 10 10 0.1 10 10 1
1 1 9
1 batch 1 batch
10
9 9 9 9
10 10 10 10
1 batch
1 charge 1 charge
Linked to Sulfadiazine and therefore sufficiently guaranteed 1
5 6 7 8 9
The max. residue norms for premixes amount to maximum. 50% of the indicated residue norms for animal feeds calculated on an animal feed b asis feed given to laying animals feed given from 5 days b efore slaughter feed given from 28 days b efore slaughter feed given to milk -producing cows, goats and sheep At this moment there is insufficient knowledge availab le in order to be ab le to estab lish a carryover norm for this additive for these categories. Dairy cow feed may not immediately b e produced on a production line which has just produced feed with these additives.
10
4.2 Overview of admissible medicated premixes

Trade name Registration holder Registration nummer Concentration Coefficient Pigs Amoxicilline Suramox 5% premix Virbac Nederland B.V. Amproliumhydrochloride Amprolium Concentrate 25% Dopharma Research B.V. Doxycyclinehyclaat/broomhexinehydrochloride Feedmix Doxy-B Dopharma Research B.V. Pulmodox 5% Premix Virbac Laboratories Doxyprex Industrial Veterinaria S. A. Florfenicol Nuflor 40mg/g medicated premix for pigs Flubendazol Feedmix Flubendazole REG NL 8543 REG NL 2051 REG NL 2588 REG NL 9826 REG NL 10393 REG NL 10473 REG NL 9674 50g/kg 250g/kg 20g/kg 50g/kg 100g/kg 3 2,5 2,5 2,5 Other 3 3 2,5 2,5 2,5 400 ppm (8kg/ton) 500 ppm (2kg/ton)
3 1
Max. dosing for complete feeds
300 ppm (15kg/t) 4 250 ppm (5kg/t) 5 250 ppm (2,5kg/t)

6
Intervet Nederland B.V.
40g/kg
200 ppm (5kg/t)
Dopharma Research B.V.
6g/kg
Flubenol 0.6%
Janssen Pharmaceutica N.V.
REG NL 5335
6g/kg
Flubenol 5%
REG NL 3106
50g/kg
Flubenol 5% Poultry
REG NL 9556
50g/kg
Flubenol 50%
REG NL 3160
500g/kg
30 ppm (5kg/t) (pigs, chickens) 60 ppm (10kg/t) pheasants) 30 ppm (5kg/t) (pigs, chickens) 60 ppm (10kg/t) (pheasants) 30 ppm (0,6kg/t) (pigs, 7 chickens) 60 ppm (1,2kg/t) 7 (pheasants) 30 ppm (0,6kg/t) 7 (chickens) 60 ppm (1,2kg/t) 7 (pheasants) 30 ppm (0,06kg/t) 8 (pigs, chickens) 60 ppm (0,12kg/t)
Trade name
Registration holder
Registration nummer
Concentration
Coefficient Pigs Other 3
Max. dosing for complete feeds (pheasants) 30 ppm (0,4kg/t) (pigs, 9 chickens) 60 ppm (0,8kg/t) 9 (pheasants) 30 ppm (5kg/t) (pigs, chickens) 60 ppm (10kg/t) (pheasants) 30 ppm (0,4kg/t) (pigs, 9 chickens) 60 ppm (0,8kg/t) 9 (pheasants) 30 ppm (0,6kg/t) (pigs, 7 chickens) 60 ppm (1,2kg/t) 7 (pheasants) 30 ppm (0,6kg/t) (pigs, 7 chickens) 60 ppm (1,2kg/t) 7 (pheasants) 30 ppm (0,6kg/t) (pigs, 7 chickens) 60 ppm (1,2kg/t) 7 (pheasants) 2,4 ppm (0,4kg/t)
10 8
Flubenol 7.5%
REG NL 5261
75g/kg
Flutelmium 0.6%
REG NL 6082
6g/kg
Flutelmium 7,5%
REG NL 6010
75g/kg
Flubenol 5%
Wirtz Farma B.V.
REG NL 10380/3106
50 g/kg
Flubenol 5%
Schippers Bladel B.V.
REG NL 10451/3106
50 g/kg
Flubendazol 5% concentrate
Dopharma Research B.V.
REG NL 101512
50g/kg
Ivermectine Ivomec Premix Noromectin Premix 0,6% G/G for pigs Ecomectin 6mg/g premix
Merial B.V. Norbrook Laboratories Ltd (Station Works) ECO Animal Health LTD.
REG NL 8731 REG NL 10465 REG NL 10529 REG NL 7957
6g/kg 6g/kg 6g/kg
3 3 3
3 3 3
2,4 ppm (0,4kg/t) 2,4 ppm (0,4kg/t)
10
10
Lincomycine(-hydrochloride)/Spectinomycine(-sulfaat) Lincomix 110 Pfizer Animal Health B.V.
110g/kg Linco
220 ppm (2,0kg/t)
11
Trade name
Registration holder
Registration nummer REG NL 10076 REG NL 2295 REG NL 5068 REG NL 9708
Concentration 44g/kg Linco. 6,6g/kg Linco. 6,6g/kg Spec 6,6g/kg Linco. 6,6g/kg Spec 22g/kg Linco. 22g/kg Spec 80g/kg 100g/kg 80g/kg 80g/kg 150g/kg
Coefficient Pigs 3 3 3 3 Other 3 3 3 3
Max. dosing for complete feeds 220 ppm (5kg/t) 33 ppm (5kg/t) 33 ppm (5kg/t) 44 ppm (2kg/t)
12
Lincomix 220 premix Vualin Plus-33 V11 Feedmix V11 Linco-spectin Premix
Pfizer Animal Health B.V. Eurovet Animal Health B.V. Dopharma Research B.V. Pfizer Animal Health B.V.
Oxytetracycline(-hydrochloride) Feedmix V4 Feedmix Oxy 10% OTC-400 OXY-400 V4 Chloromed 150mg/g premix for pigs Paracetamol Pracetam 10% Dopharma Research B.V. Dopharma Research B.V. Framelco B.V. Eurovet Animal Health B.V. Univet Ltd. REG NL 2158 REG NL 2004 REG NL 7254 REG NL 7277 REG NL 106877 REG NL 10278 REG NL 1808 REG NL 7589 REG NL 8541 3 3 3 3 3 3 3 3 3 3 800 ppm (10kg/t) 700 ppm ( 7kg/t) 400 ppm (5kg/t) 1000 ppm (12,5kg/t) 19 400 ppm (2,66 kg/t)
Laboratoires Sogeval
100g/kg
800 ppm (8kg/t)
Sulfadiazinenatrium/Trimethoprim Feedmix Trim/sul 80/420 Aesculaap BV Trimethosulf premix Feedmix sulfatrim Eurovet Animal Health B.V. Dopharma Research B.V.
77,1g/kg Sulfa 16g/kg Trim 62,5g/kg Sulfa 12,5g/kg Trim 60g/kg Sulfa 12g/kg Trim 50g/kg Sulfa 10g/kg Trim 100g/kg 20g/kg 100g/kg
5 5 5
3 2 3
385 ppm Sulfa en 80 ppm Trim (5kg/t) 625 ppm Sulfa en 125 ppm Trim (10kg/t) 600 ppm Sulfa en 120 ppm Trim (10kg/t) 500 ppm Sulfa en 100 ppm Trim (10kg/t) 40 ppm (0,4 kg/t) 14 40 ppm (2,4 kg/t) 13 40 ppm (0,4 kg/t)
13
Sulfamethoxazol/Trimethoprim Feedmix TS Dopharma Research B.V. Tiamulinwaterstoffumaraat Tiamutin 10% premix Denagard 2% premix Tialin 10% premix
REG NL 8674
Novartis Consumer Health B.V. Novartis Consumer Health B.V. Eurovet Animal Health B.V.
REG NL 8015 REG NL 8016 REG NL 10178
3 3 3
3 3 3
Trade name
Registration holder
Registration nummer REG 10177 REG 100731 REG NL 101337 NL NL
Concentration 20g/kg 20g/kg 100g/kg
Coefficient Pigs 3 3 31 Other 3 3 31
Max. dosing for complete feeds 40 ppm (2,4 kg/t)

14
Tialin 2% premix Vetmulin 2% premix Vetmulin 10% premix for medicated feeds Tilmicosinefosfaat Pulmotil G40 PREMIX
Eurovet Animal Health B.V. Huvepharma N.V. Huvepharma N.V.
176 ppm (8,8 kg/t) 180 ppm (1,8 kg/t)
Eli Lilly Nederland B.V /Elanco Animal Health
REG NL 9166
40g/kg
Pulmotil G100 PREMIX
Eli Lilly Nederland B.V /Elanco Animal Health Eli Lilly Nederland B.V /Elanco Animal Health Eli Lilly Nederland B.V /Elanco Animal Health Huvepharma N.V.
REG NL 9167
100g/kg
Pulmotil G200 PREMIX
REG NL 9168
200g/kg
Pneumotil G40 PREMIX Tilmovet 10%, premix for medicated feed for pigs Tilmovet 4% Tilmovet 20%, premix for medicated feeds for pigs Tylosinefosfaat Tylan 100 Premix 10%
Huvepharma N.V. Huvepharma N.V.
REG 10368 REG NL 100528 103646 REG NL 100739 REG NL 100742
NL
40g/kg 100g/kg
3 31
3 31
400 ppm (pigs) 200 ppm (rabbits) 400 ppm 200 ppm (rabbits) 400 ppm 200 ppm (rabbits) 400 ppm
(10 kg/t) (5 kg/t) (4 kg/t) (pigs) (2 kg/t) (2 kg/t) (pigs) (1 kg/t) (10 kg/t)
400 ppm (4 kg/t)
40g/kg 200g/kg
31 31
31 31
400 ppm (10 kg/t) 400 ppm (2 kg/t)
REG NL 3917
100g/kg
Tylan 20 premix 2%
REG NL 9976
20g/kg
200 ppm (2 kg/t) (pigs) 1100 ppm (11 kg/t) (, chickens reared for laying) 200 ppm (10 kg/t) (pigs)
Trade name
Registration holder
Registration nummer
Concentration
Coefficient Pigs Other
Max. dosing for complete feeds 1100 ppm (55 kg/t) (slaughter chickens, chickens reared for laying) 15 200 ppm (0.8 kg/t) (pigs) 15 1100 ppm (4,4 kg/t) (slaughter chickens, chickens reared for laying) 200 ppm (2 kg/t) (pigs) 1100 ppm (11 kg/t) (slaughter chickens, chickens reared for laying) 15 200 ppm (0.8 kg/t) (pigs, chickens) 15 1100 ppm (4,4 kg/t) (slaughter chickens, chickens reared for laying) 85 ppm (2 kg/t) (pigs)
16 13
Tylan G250 Premix 25%
REG NL 9982
250g/kg
Pharmasin 20 mg/g premix Pharmasin 100mg/g premix for medicated feeds for pigs, slaughter chickens and chickens reared for laying
Huvepharma N.V. Huvepharma N.V.
REG 101024
NL
20g/kg 100g/kg
1 31
1 31
Pharmasin 250mg/g premix for medicated feeds pigs, slaughter chickens and chickens reared for laying
Huvepharma N.V.
REG 101027
NL
250g/kg
31
31
Tylvalosine Aivlosin 42,5 mg/g Aivlosin 8,5 mg/g Valnemulin Econor 1% Econor 10% Novartis Animal Health Austria GmbH Novartis Animal Health Austria REG NL 9792 REG NL 9794 10g/kg 100g/kg 3 3 3 3 75 ppm (7,5 kg/t) (pigs)
17
ECO Animal Health Limited ECO Animal Health Limited
REG 10266 REG 10430
NL NL
42,5g/kg 8,5g/kg
3 3
3 3
85 ppm (10 kg/t) (pigs)

16
200 ppm (2 kg/t) (pigs)
Trade name
Registration holder
Registration nummer
Concentration
Coefficient Pigs Other
Max. dosing for complete feeds

18
GmbH Econor 50% Novartis Animal Health Austria GmbH REG NL 9795 500g/kg 3 3
200 ppm (0,4 kg/t) 18 (pigs) .
For other products for export (not in NL for animal feed registered materials) and for any new registrations in the Netherlands
1
2
....
: Dosage for weaned piglets, calculated on the b asis of a 15 mg dose of amoxicillin per kg of b ody weight per day. : The product is made up b y mixing 2 kg of premix (concentration 250 g / kg) to 5 kg premix. 3 : The dose was calculated on the b asis of a 10 mg dose of doxycycline and 1 mg dose of b romine hexine per kg of b ody weight p er day.
4 5
: The dose was calculated on the b asis of a 12.5 mg dose of doxycycline per kg of body weight per day. : The dose was calculated on the b asis of a 10 mg dose of doxycycline per kg of body weight per day. 6 : The dose was calculated on the b asis of a 10 mg dose of florfenicol per kg of b ody weight per day.
7: 8
The product is made up b y mixing XX kg of premix (concentration 50 g/ kg) to 5 kg premix. : The product is made up b y mixing XX kg of premix (concentration 500 g / kg) to 5 kg premix. 9 : The product is made up b y mixing XX kg of premix (concentration 75 g / kg) to 5 kg premix.
10 11
: The dose was calculated on the b asis of a 0,1 mg dose of ivermectine per kg of body weight per day. : The product is made up b y mixing XX kg of premix (concentration 110 g / kg) to 5 kg premix. 12 : The product is made up b y mixing XX kg of premix (concentration 22 g / kg) to 5 kg premix.
13 14
: The product is made up b y mixing XX kg of premix (concentration 100 g / kg) to 5 kg premix. : The product is made up b y mixing XX kg of premix (concentration 20 g / kg) to 5 kg premix. 15 : The product is made up b y mixing XX kg of premix (concentration 250 g / kg) to 5 kg premix.
16 17
: Dose was calculated on the b asis of a dose of 4,25 mg tylvalosine per kg of b ody weight per day. : Dose was calculated on the b asis of a dose of 3-4 mg valnemulin per kg of b ody weight per day. 18 : Dose was calculated on the b asis of a dose of 10-12 mg valnemulin per kg of body weight per day.
19
: Dose was calculated on the b asis of a dose of 10-12 mg Oxytetracycline per kg of b ody wei
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 Antibioti cs - B lactam AmoxiciIllin Ampicillin Penicillin G Cloxacillin Dicloxacillin Nafcillin Oxacillin Cefalexin Cefapirin Cefazolin Cefoperazone Cefquinome Ceftiofur Antibioti cs - Quinolone s Danofloxacin Difloxacin Cirprofloxacin Enrofloxacin Flumequine Marbofloxacin Oxolinic acid Sarafloxacin Norfloxacin Cinox acin Antibioti cs Macrolides Erythromycin Spiramycin Tilmicosin Tylosin Tylvalosin Antibioti cs - Phenicoles Thiamphenicol Florfenicol Chloramphenicol Antibioti cs Tetracyclines Chlortetracycline Doxycycline Oxytetracycline Tetracycline Antibioti cs Pleuromutilines Tiamulin Valnemuline Antibioti cs - Lincosamide s Maximum level in g/kg 200 100 100 20 4 200 10 100 100 100 50 200 10 40 2 50 4 2 30 2 20 20 4 2 2 0,2 4 4 5 1 1,5 20 1 4 20 1 2
Lincomycin Antibioti cs - Sulfonamides Sulfadimethoxine Sulfapyrimidine = sulfadiazine Sulfamethox azole Sulfat hiazole Sulfamerazine Sulfamethazine = sulfadimidine Sulfadoxine Antibioti cs other Trimethoprim
2 2 2 2 2 2 2 2 2

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GMP+ Feed Safety Assurance scheme

Product Standards Version: 16-04-2012 13:34

1 / 110 GMP+ International B.V.

History of the document

Product Standards Version: 16-04-2012 13:34

2 / 110 GMP+ International B.V.

PART A: PRODUCT STANDARDS 1 2 INTRODUCTION TO THE PRODUCT STANDARDS CONDITIONS

3 SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR 4

RESIDUE LEVELS OF PESTICIDES IN FEEDS

PART B: RESIDUE STANDARDS 1 2

INTRODUCTION ADDITIONAL PROVISIONS

3 RESIDUE STANDARDS FOR COCCIDIOSTATS AND HISTOMONOSTATS

Product Standards Version: 16-04-2012 13:34

3 / 110 GMP+ International B.V.

ADDITIONAL INFORMATION FOR SOME COCCIDIOSTATS AND HISTOMONOSTATS *

4 RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL PRODUCTS 102

Product Standards Version: 16-04-2012 13:34

4 / 110 GMP+ International B.V.

Structure of the GMP+ Feed Safety Assurance scheme

Product Standards Version: 16-04-2012 13:34

5 / 110 GMP+ International B.V.

Product Standards Version: 16-04-2012 13:34

6 / 110 GMP+ International B.V.

PART A: PRODUCT STANDARDS

1 Introduction to the product standards

Product Standards Version: 16-04-2012 13:34

8 / 110 GMP+ International B.V.

SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR

Microbiological: Other undesirable substances and products

OZM Part 1; O-1

Product Standards Version: 16-04-2012 13:34

9 / 110 GMP+ International B.V.

SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR

Feed for pets and dog bones

OZM Part 2; M-3

Commission Regulation (EU) 142/2011, annex X, chapter 1

From animal by-products derived raw petfood

From animal by-products derived canned petfood

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10 / 110 GMP+ International B.V.

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11 / 110 GMP+ International B.V.

SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR

GMP+ 0+% 20(approaching

OZM Part 2; M-2a to M2e

GMP+ Reg. 1774/2002 Commission Regulation (EU) 142/2011, annex X, chapter 1 n = 5, c = 0, m = 0, M = 0

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12 / 110 GMP+ International B.V.

From animal by-products derived canned petfood

Salmonella preservation determined through pH

- Feed materials for delivery to cattle farms, and

Maximum pH for guarantee:

Commission Regulation (EU) 142/2011, annex XIII, chapter 2 GMP+

OZM Part 2; M-5

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

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SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR

OZM Part 2; M-4

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SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR