gmp_ba1_-_uk_20121018_7436
DESCRIPTION
GMP+TRANSCRIPT
BA
1
EN
GMP+ Feed Safety Assurance scheme
Product standards
GMP+ BA1 Version: October 2012
© GMP+ International B.V.
All rights reserved. The information in this publica-
tion may be consulted on the screen, downloaded
and printed as long as this is done for your own,
non-commercial use. For other desired uses, prior
written permission should be obtained from the
GMP+ International B.V.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.1 / 108
History of the document Revision no. / Date of approval
Amendment Concerns Final im-plementatio
n date
0.0 / 01-01-2010 Transfer of the document from PDV to GMP+ International
Entire document 01-01-2010
0.1 / 17-03-2010 Change in feed legislation Part A, § 3
Part B, §4.2
17-03-2010
0.2 / 29-09-2010 Specification of Kokcisan Part B, § 3.2 25-11-2010
Update of approved medicated pre-mixes
Part B, § 4.2
0.3 / 14-11-2011 - Change in feed legislation - Residue standards for critical veteri-nary medical products: product group ‘For other products’ is added. - Overview of admissible medicated premixes is updated. - Product standards GMP+ BCN-NL1 Anti-bicsfree feed
Part A, § 3
Part B, § 3.1
Part B, § 4.1 Part B, § 4.2 Part B, § 4.3
20-12-2011
0.4 / 01-10-2012 - Change in feed legislation (maximum levels for arsenic, fluorine, lead, mercury, endosulfan, dioxins, Ambrosia spp., diclazuril and lasalocid A sodium and action thresholds for dioxins) GMP+ standards: Animal protein (name); PAH’s - Pesticides (concentration factors)
Part A, § 3 and Part B,
§ 3.1
Part A, § 4
The new standards
are already in use
01-11-2012
01-11-2012
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.2 / 108
INDEX
1 INTRODUCTION 5
1.1 GENERAL 5
1.2 STRUCTURE OF THE GMP+ FEED SAFETY ASSURANCE SCHEME 5
PART A: PRODUCT STANDARDS 7
1 INTRODUCTION TO THE PRODUCT STANDARDS 7
2 CONDITIONS 7
3 SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR 9
4 RESIDUE LEVELS OF PESTICIDES IN FEEDS 82
4.1 INTRODUCTION 82
4.2 THE ESTABLISHMENT OF AND MRL 82 4.2.1 General 82 4.2.2 Questionnaire for basic products 84 4.2.3 Questionnaire for by-products 85 4.2.4 Questionnaire for compound feeds 87 4.2.5 Fumigators 88
4.3 SPECIAL REQUIREMENTS 88
PART B: RESIDUE STANDARDS 89
1 INTRODUCTION 89
2 ADDITIONAL PROVISIONS 90
2.1 GENERAL 90
2.2 COMPOUND FEED 91 2.2.1 Installation Carry-over level 91 2.2.2. The coefficient 91 2.2.3. Carry-over and flush batches 92 2.2.4 Items for attention and other remarks 92
2.3 PREMIX 93 2.3.1 General 93 2.3.2 Direct contamination 93 2.3.3 Indirect contamination 93
3 RESIDUE STANDARDS FOR COCCIDIOSTATS AND HISTOMONOSTATS 94
3.1 SUMMARY OF RESIDUE STANDARDS FOR COCCIDIOSTATS AND
HISTOMONOSTATS ACCORDING TO COMMISSION REGULATION (EU) NO 574/2011 OF
16 JUNE 2011 AND NO. 744/2012 OF 16 AUGUST 2012 AMENDING ANNEX I TO
DIRECTIVE 2002/32/EC 94
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.3 / 108
3.2 ADDITIONAL INFORMATION FOR SOME COCCIDIOSTATS AND
HISTOMONOSTATS * 99
4 RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL PRODUCTS 100
4.1 SUMMARY OF RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL
PRODUCTS 100
4.2 OVERVIEW OF ADMISSIBLE MEDICATED PREMIXES 101
4.3 Product standards GMP+ BCN-NL1 Antibioticsfree feed 107
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.4 / 108
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 stake-
holders.
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 pro-
grammes, chain approach and the Early Warning System.
Together with the GMP+ partners, GMP+ International transparently sets clear re-quirements 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 infor-
mation 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:
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.5 / 108
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.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.6 / 108
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.
DISCLAIMER: The GMP+ International has adopted this list in order to inform in-
terested parties with respect to the standards in the legislation (European Union
and additional GMP+ standards). The list will be regularly updated. The GMP+ In-
ternational is not liable for any errors in this list.
2 Conditions
In arriving at the product standards a distinction has been made between action and rejection limits. The action limits for undesirable contaminants is appreciably lower than the rejection limit. Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. Where the action limit is exceeded an investigation must be carried out into the: 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 mate-rial 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
The product standard for the maximum level of undesirable substances is calcu-
lated proportionately from the product standard for the individual components. This
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.7 / 108
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).
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.8 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Microbiological: Other undesirable substances and products
M1 Antibacterial inhibition - Feed materials - < 15 mm GMP+ According to the 5-plate test MB003, derived from EG-4-plate test, product basis (RIVM report no. 206; Archiv fur Lebensmittelhygiene 31 (1981) page 97-140.
OZM Part 1; O-1
- Wet mixes
[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently.
Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently.
[7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.9 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Microbiological
M3 Enterobacteriaceae From animal by-products derived products, with the exception of canned petfood and raw petfood
300 kve/g Commission Regulation (EU) 142/2011, annex XIII, chapter 2
n = 5, c = 2, m = 10, M = 300 14
OZM Part 2; M-3
From animal by-products derived raw petfood 5.000 kve/g Commission Regulation (EU) 142/2011, annex XIII, chapter 2
n = 5, c = 0, m = 0, M =5.000 14
From animal by-products derived canned petfood - Commission Regulation (EU) 142/2011, annex XIII, chapter 2
Canned petfood which has been subjected to heat treatment with a Fc value of at least 3
[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; the result shall be considered unsatisfactory if the number of bacteria in one or more samples is M or more; c = number of samples for which the bacteria count gives a result between m and M and where the sample is still considered acceptable if the result of the bacteria for the other samples is not higher than m.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.10 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Microbiological: Microbiological contamination
M4a Salmonella Consumption chick feed: end products and feed materials for:
GMP+ OZM Part 2; M-2a to M2e
- Top breeding consumption chicks - 0+% 20(approaching
0%)
- Breeding increase consumption chicks - 0+% 20(approaching
0%)
- Increase consumption chicks - 0+% 20(approaching
0%)
- Consumption chicks - 0+% 20(approaching
0%)
Laying poultry feed: end products and feed materials for:
GMP+
- Top breeding laying poultry - 0+% 20(approaching
0%)
- Raising increase laying poultry - 0+% 20(approaching
0%)
- Increase laying poultry - 0+% 20(approaching
0%)
- Laying-hens and breeding hens 1% 0+% 20(approaching
0%) for S. enteritidus and S. typhimurium
Turkey feed: end products and feed materials for: GMP+
- Raising increase turkeys - 0+% 20(approaching
0%)
- Increase turkeys - 0+% 20(approaching
0%)
- Consumption turkeys - 0+% 20(approaching
0%)
Other animal feeds, feed materials and wet mixes intended for cattle farms (except for poultry feeds).
- Absent in 25 gr GMP+
From animal by-products derived products with the exception of canned petfood
- Absent in 25 gr Commission Regulation (EU) 142/2011, annex XIII, chapter 2
n = 5, c = 0, m = 0, M = 0 14
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.11 / 108
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements
Analysis method7
From animal by-products derived canned petfood - Commission Regulation (EU) 142/2011, annex XIII, chapter 2
Canned petfood which has been subjected to heat treatment with a Fc value of at least 3
M4b Salmonella preservation determined through pH
- Feed materials for delivery to cattle farms, and Maximum pH for guarantee:
GMP+ If preservation can be achieved at a higher pH then this should be supported with data.
OZM Part 2; M-5
- Wet mixes for delivery to livestock farmers on the basis of:
- Spontaneous lactic acid fermentation - Add organic acids - Add inorganic acids
- 4.5 4 3,5
These norms do not apply if the products are supplied at a temperature of at least 60°C and the supplier is demonstrably informed of the storage conditions. The absence of Salmonella can also be shown in heat-treated wet mixes and feed materials (<13% moisture) through compliance with the norms for Enterobacteriaceae.
[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+).
[14] n = number of samples to be tested; m = threshold value for the number of bacteria; the results will be considered to be satisfactory if the number of bacteria in none of the samples is greater than m, M = maximum value for the number of bacteria; the result shall be considered unsatisfactory if the number of bacteria in one or more samples is M or more; c = number of samples for which the bacteria count gives a result between m and M and where the sample is still considered acceptable if the result of the bacteria for the other samples is not higher than m.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.12 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Microbiological: Microbiological contamination
M5 Moulds - Feed materials for delivery to cattle farms, and - 10,000 kve/gram GMP+ OZM Part 2; M-4
- Wet mixes for delivery to livestock farmers
with an Aw value > 0.75 (if this is not known then a moisture content > 13%)
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.13 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Mycotoxin
C1 Aflatoxin B1 Feed materials intended for (direct) delivery to dairy farmers
- 0.005 mg/kg GMP+ OZM Part 2; OSP1a to 1e
Feed materials - 0.02 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Complementary and complete feed with the exception of:
- 0.01 mg/kg
- compound feed for dairy cattle and calves, dairy sheep and lambs, dairy goats and kids, piglets and young poultry animals.
- 0.005 mg/kg
- compound feed for cattle (except dairy cattle and calves), sheep (except dairy sheep and lambs), goats (except dairy goats and kids), pigs (except piglets) and poultry (except young animals).
- 0,02 mg/kg
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.14 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements 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, with the exception of:
- 0.01 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Maximum level for aldrin and dieldrin, singly or combined, expressed as dieldrin.
OZM Part 2; OSP-11
- fats and oils, 0,1 mg/kg
- compound feed for fish 0.2 mg/kg
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.15 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Heavy metals
C3 Arsenic16 Feed materials, with the exception of:
- 2 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC
OZM Part 2; OSP-26
- meal made from grass, from dried lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp,
- 4 mg/kg
- palm kernel expeller, - 4 mg/kg15
- phosphates and calcareous marine algae - 10 mg/kg
- calcium carbonate; calcium and magnesium carbonate 11
- 15 mg/kg
- magnesium oxide and magnesium carbonate
- 20 mg/kg
- fish, other aquatic animals and products derived thereof,
- 25 mg/kg15
- ground dried seaweed meal and feed materials derived from seaweed
- 40 mg/kg15
Iron particles used as tracer - 50 mg/kg
Feed additives belonging to the functional group of compounds of trace elements except:
- 30 mg/kg
- cupric sulphate pentahydrate; cupric carbonate; di copper chloride trihydroxide,
- 50 mg/kg
- zinc oxide, manganousese oxide and cupric oxide - 100 mg/kg
Complete feed, with the exception of: - 2 mg/kg
- complete feed for fish and fur animals. - 10 mg/kg15
- complete feed for pet animals containing fish, other aquatic animals and products derived thereof and/or seaweed meal and feed materials derived from seaweed.
- 10 mg/kg15
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.16 / 108
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements
Analysis method7
Complementary feed, with the exception of: - 4 mg/kg
- mineral feed - 12 mg/kg
- complementary feed for pet animals containing fish, other aquatic animals and products derived thereof and/or seaweed meal and feed materials derived from seaweed.
10 mg/kg 15
[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)
[15] At the request of the competent authorities the responsible operator must carry out an analysis to show that the level of anorganic arsenic is lower than 2 ppm. This analysis is especially important for the Hizikia fusiforme seaweed
[16] The maximum levels refer to the total level of arsenic / mercury respectively
[11] Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.17 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
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: - 50 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-9
- linseed - 250 mg/kg
- linseed cakes - 350 mg/kg - manioc products and almond cake. - 100 mg/kg
Complete feed, with the exception of: - 50 mg/kg
- complete feed for young chickens (< 6 weeks) - 10 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.18 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Other undesirable substances and products
C5 Biogenic amines* - Animal feeds> 30% crude protein - 4,000 mg/kg protein
GMP+ * In as far as these are created by decay due to protein decay and are not the consequence of the normal processing of the product
OZM Part 2; OSP-23
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.19 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Heavy metals
C6 Cadmium Feed materials of vegetable origin - 1 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-27
Feed materials of animal origin - 2 mg/kg
Feed materials of mineral origin, with the exception of:
2 mg/kg
- phosphates - 10 mg/kg
Feed additives, belonging to the functional group "Compounds of trace elements", with the exception of:
- 10 mg/kg
- cupric oxide, manganous oxide, zinc oxide and manganous sulphate-monohydrate
- 30 mg/kg
Feed additives belonging to the functional group "Binders and anti-caking
- 2 mg/kg
Premixes - 15 mg/kg 2
Complementary feed with the exception of: - 0,5 mg/kg
Mineral feed
- containing < 7% phosphorus 8 - 5 mg/kg
- containing> 7% phosphorus 8 - 0.75 mg/kg per 1% phosphorus 8, with a maximum of 7.5 mg/kg
Complementary feed for pet animals - 2 mg/kg
Complete feed with the exception of: - complete feed for cattle (except calves), sheep (except lambs) goats (except kids) and fish feed
- 0,5 mg/kg 1 mg/kg
- complete feed for pet animals - 2 mg/kg
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.20 / 108
[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 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 % of phosphorus is relative to a feed with a moisture content of 12 %.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.21 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Salts
C7 Chloride - Feed materials for delivery to livestock farms, and
10 g/kg (dry matter)
GMP+ If the action limit is exceeded then a warning or processing advice must be demonstrably communicated to the customer. Supply of additional water to the animals is also important to avoid health problems. More recommendations in the event of excess of the action limit can be found in GMP+ D4.13 Salts in rations with wet feeds for fattening pigs and sows
OZM deel 2; OSP-22
- Wet mixes for delivery to livestock farmers
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.22 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents (Pesticides which are not permitted in the EU)
C8 Camphechlor (toxaphene) – sum of the indicators CHB 26, 50 and 6222
Fish, other aquatic animals and products thereof with the exception of fish oil
- 0.02 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- fish oi - 0.2 mg/kg
Complete feed for fish - 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 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)
[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.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.23 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents (Pesticides which are not permitted in the EU)
C9 Chlordane (sum of cis- en transisomers and of oxychlordane expressed chlordane)
Feed materials and compound feed with the exception of:
- 0.02 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- fats and oils - 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 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.24 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Botanical impurities
C10 Crotalaria spp. Feed materials and compound feed - 100 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Microscopic determination in accordance with the instructions of the laboratory
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.25 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant 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 DDT)
Feed materials and compound feed with the exception of:
- 0.05 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- fats en oils - 0.5 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 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.26 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Other undesirable substances and products
C12 Animal proteins Prohibited Animal proteins (Restricted animal proteins)
Animal feeds for productive livestock - 0 Regulation 999/2001, art. 7 and Appendix IV
See GMP+ BA 3: Negative list
OZM Part 2; OSP-12
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.27 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1)
(4)
Rejection limit(1)(4) Source Supplementary requirements Analysis method7
Chemical: Toxic substances
C13a Dioxin 11 + 18
(sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005))
Feed materials of vegetableplant origin with the exception of vegetable oils and their by-products
0,5 ng WHO-PCDD/F-TEQ/kg4 + 17
0,75 ng WHO-PCDD/F-TEQ/kg4 +
5
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 277/2012 and 744/2012 amending Annex I and II to Directive 2002/32/EC
In the event of exceeding the action limit: Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.
OZM Part 2; OSP-18
Vegetable oils and their by-products 0,5 ng WHO-PCDD/F-TEQ/kg4 + 17
0,75 ng WHO-PCDD/F-TEQ/kg4 +
5
Feed materials of mineral origin 0,5 ng WHO-PCDD/F-TEQ/kg4 + 17
1,0 0,75 ng WHO-PCDD/F-TEQ/kg4 +
5
Feed materials of animal origin:
Animal fat including milk fat and egg fat 0,75 1.0 ng WHO-PCDD/F-TEQ/kg4 + 17
2,0 1,50 ng WHO-PCDD/F-TEQ/kg4 +
5
Other land animal products including milk and milk products and eggs and egg products.
0,5 ng WHO-PCDD/F-TEQ/kg4 + 17
0,75 ng WHO-PCDD/F-TEQ/kg4 +
5
Fish oil 5,0 4,0 ng WHO-PCDD/F-TEQ/kg4 + 17
6.0 5,0 ng WHO-PCDD/F-TEQ/kg4 +
5
In the event of exceeding the action limit: In many cases it mightmay perhaps not be necessary to performcarry out an investigation into the source of the contamination as the background level in some areas is close or above the action level. However, in cases where If the action levellimit is really exceeded, then all information the details, such as the sampling period, geographical origin, fish species, etc., should shall be recorded with a view to future measures to manage for the presence of dioxins and dioxin-like compounds in these materials for animal nutrition. feeds.
Fish, other aquatic animals and products derived thereof, with the exception of fish oil and hydrolysed fish protein hydrolysates containing more than 20% fat6 and crustacean meal.
0,75 1,0 ng WHO-PCDD/F-TEQ/kg4 + 17
1,25 ng WHO-PCDD/F-TEQ/kg4 +
5
Hydrolysed fish protein hydrolysates containing more than 20% fat ; crustacean meal.
1,75 1,25 ng WHO-PCDD/F-TEQ/kg4 + 17
2.25 1,75 ng WHO-PCDD/F-TEQ/kg4 +
5
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.28 / 108
Contaminant Product Action limit(1)
(4)
Rejection limit(1)(4) Source Supplementary requirements Analysis method7
Feed additives belonging to the functional groups of binders and anti-caking agents
0,5 ng WHO-PCDD/F-TEQ/kg4 + 17
In the event of exceeding the action limit: Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.
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
0,75 ng WHO-PCDD/F-TEQ/kg4 +
5
Feed additives belonging to the functional group of compounds of trace elements.
0,5 ng WHO-PCDD/F-TEQ/kg4 + 17
1,0 ng WHO-PCDD/F-TEQ/kg4 +
5
Premixes 0,5 ng WHO-PCDD/F-TEQ/kg4 + 17
1,0 ng WHO-PCDD/F-TEQ/kg4 +
5
Compound feeds with the exception of: 0,5 ng WHO-PCDD/F-TEQ/kg4 + 17
0,75 ng WHO-PCDD/F-TEQ/kg4 +
5
- compound feed for pet animals and fish 1,75 1,25 ng WHO-PCDD/F-TEQ/kg4 + 17
2,25 1,75 ng WHO-PCDD/F-TEQ/kg4 +
5
In the event of exceeding the action limit: In many cases it mightmay perhaps not be necessary to performcarry out an investigation into the source of the contamination as the background level in some areas is close or above the action level. However, in cases where If the action levellimit is really exceeded, then all information the details, such as the sampling period, geographical origin, fish species, etc., should shall be recorded with a view to future measures to manage for the presence of dioxins and dioxin-like compounds in these materials for animal nutrition. feeds.
- compound feed for fur animals - -
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.29 / 108
Contaminant Product Action limit(1)
(4)
Rejection limit(1)(4) Source Supplementary requirements Analysis method7
C13b Sum of dioxins and dioxin-like PCBs12 +18 (sum of polychlorinated dibenzo- para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005))
Feed materials of vegetable plant origin with the exception of vegetable oils and their by-products
1.25 ng WHO-PCDD/F-PCB-TEQ/kg 4
OZM Part 2; OSP-18
Vegetable oils and their by-products 1.5 ng WHO-PCDD/F-PCB-TEQ/kg 4
Feed materials of mineral origin 1.5 1,0 ng WHO-PCDD/F-PCB-TEQ/kg 4
Feed materials of animal origin:
- Animal fat including milk fat and egg fat 3.0 2,0 ng WHO-PCDD/F-PCB-TEQ/kg 4
- Other land animal products including milk and milk products and eggs and egg products
1.25 ng WHO-PCDD/F-PCB-TEQ/kg 4
- Fish oil 24.0 20,0 ng WHO-PCDD/F-PCB-TEQ/kg 4
- Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20% fat6
4.5 4,0 ng WHO-PCDD/F-PCB-TEQ/kg 4
- Fish protein hydrolysates containing more than 20% fat
11 9,0 ng WHO-PCDD/F-PCB-TEQ/kg 4
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
1.5 ng WHO-PCDD/F-PCB-TEQ/kg 4
Feed additives belonging to the functional group of compound of trace elements.
1.5 ng WHO-PCDD/F-PCB-TEQ/kg 4
Premixtures 1.5 ng WHO-PCDD/F-PCB-TEQ/kg 4
Compound feed with the exception of: 1.5 ng WHO-PCDD/F-PCB-TEQ/kg 4
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.30 / 108
Contaminant Product Action limit(1)
(4)
Rejection limit(1)(4) Source Supplementary requirements Analysis method7
- Compound feed for pet animals and fish 7.0 5,0 ng WHO-PCDD/F-PCB-TEQ/kg 4
- Compound feed for fur animals -
C13c Dioxin-like PCBs19 +18 (sum of polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO- TEFs (toxic equivalency factors, 2005)
Feed materials of vegetableplant origin with the exception of vegetable oils and their by-products
0.35 ng WHO-PCB-TEQ/kg 4
+ 17
In the event of exceeding the action limit: Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.
OZM Part 2; OSP-18
Vegetable oils and their by-products 0.5 ng WHO-PCB-TEQ/kg 4
+ 17
Feed materials of mineral origin 0.35 ng WHO-PCB-TEQ/kg 4
+ 17
Feed materials of animal origin:
- Animal fat including milk fat and egg fat 0.75 ng WHO-PCB-TEQ/kg 4
+ 17
- Other land animal products including milk and milk products and eggs and egg products
0.35 ng WHO-PCB-TEQ/kg 4
+ 17
- Fish oil 14 11,0 ng WHO-PCB-TEQ/kg 4 + 17
In the event of exceeding the action limit: In many cases it mightmay perhaps not be necessary to performcarry out an investigation into the source of the contamination as the background level in some areas is close or above the action level. However, in cases where If the action levellimit is really exceeded, then all information the details, such
- Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20% fat 6
2.5 2,0 ng WHO-PCB-TEQ/kg 4 + 17
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.31 / 108
Contaminant Product Action limit(1)
(4)
Rejection limit(1)(4) Source Supplementary requirements Analysis method7
- Fish protein, hydrolysed, containing more than 20% fat
7.0 5,0 ng WHO-PCB-TEQ/kg 4 + 17
as the sampling period, geographical origin, fish species, etc., should shall be recorded with a view to future measures to manage for the presence of dioxins and dioxin-like compounds in these materials for animal nutrition. feeds.
Feed additives belonging to the functional groups of binders and anti-caking
0.5 ng WHO-PCB-TEQ/kg 4
+ 17
In the event of exceeding the action limit: Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.
Feed additives belonging to the functional group of compounds of trace elements
0.35 ng WHO-PCB-TEQ/kg 4
+ 17
Premixtures 0.35 ng WHO-PCB-TEQ/kg 4
+ 17
Compound feed with the exception of: 0.5 ng WHO-PCB-TEQ/kg 4
+ 17
- Compound feed for pet animals and fish, 3.5 2,5 ng WHO-PCB-TEQ/kg 4 + 17
In the event of exceeding the action limit: In many cases it mightmay perhaps not be necessary to performcarry out an investigation into the source of the contamination as the background level in some areas is close or above the action level. However, in cases where If the action levellimit is really exceeded, then all information the details, such as the sampling period, geographical origin, fish species, etc., should shall be recorded with a view to future measures to manage for the presence of dioxins and dioxin-like compounds in these materials for animal nutrition. feeds.
- Compound feed for fur animals -
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.32 / 108
Contaminant Product Action limit(1)
(4)
Rejection limit(1)(4) Source Supplementary requirements Analysis method7
C13d Non-dioxin-like PCBs (sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (ICES – 6))
Feed materials of plant origin 10 μg/kg (ppb)
Feed materials of mineral origin 10 μg/kg (ppb)
Feed materials of animal origin: 10 μg/kg (ppb)
- Animal fat, including milk fat and egg fat 10 μg/kg (ppb)
- Other land animal products including milk and milk products and eggs and egg products
10 μg/kg (ppb)
- Fish oil 175 μg/kg (ppb)
- Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat 5
30 μg/kg (ppb)
- Fish protein, hydrolysed, containing more than 20 % fat
50 μg/kg (ppb)
The feed additives kaolinitic clay, vermiculite, natrolite- phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents
10 μg/kg (ppb)
Feed additives belonging to the functional group of compounds of trace elements
10 μg/kg (ppb)
Premixture 10 μg/kg (ppb)
Compound feed with the exception of: 10 μg/kg (ppb)
- compound feed for pet animals and fish 40 μg/kg (ppb)
- compound feed for fur animals -
[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.
[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. Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.33 / 108
[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. Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 75 μg/kg product are applicable to fresh fish and 200 μg/kg product are applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.
[6] Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 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 processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food. Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 3,5 ng WHO-PCDD/F-TEQ/kg product and 6,5 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20,0 ng WHO-PCDD/F-PCB-TEQ/kg product is applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.
[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 equivalents established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997)
[12] (sum of the polychlorinated dibenzo-para dioxins (PCDDs) and the polychlorinated dibenzofurans (PCDFs) and the polychlorinated biphenyls (PCBs) expressed in toxicity equivalents established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997)
[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
[18] TEF's from the WHO for the assessment of the risks to humans based on the conclusions of the meeting of the World Health Organisation in Stockholm, Sweden, 15-18 June 1997 (van den Berg et al., (1998) Toxic Equivalence Factors (TEF's) for PCB's, PCDD's, PCFD's for Humans and for Wildlife Environmental Health Perspectives, 106(12), 775). Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs: WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin- like Compounds. Toxicological Sciences 93(2), 223–241 (2006))
Congener TEF value Congener TEF value
Dibenzo-p-dioxins (PCDDs) Dioxin-like PCBs:
2,3,7,8-TCDD 1
1,2,3,7,8-PeCDD 1 Non-ortho-PCBs
1,2,3,4,7,8-HxCDD 0.1 PCB 77 0,0001
1,2,3,6,7,8-HxCDD 0.1 PCB 81 0,0001 0,0003
1,2,3,7,8, 9-HxCDD 0.1 PCB 126 0,1
1,2,3,4,6,7,8-HpCDD 0.01 PCB 169 0,01 0,03
OCDD 0.0001 0,0003
Mono-ortho-PCBs
Dibenzofuranes (PCDFs) PCB 105 0,0001 0,00003
2,3,7,8-TCDF 0.1 PCB 114 0,0005 0,00003
1,2,3,7,8-PeCDF 0.05 0,03 PCB 118 0,0001 0,00003
2,3,4,7,8-PeCDF 0.5 0,3 PCB 123 0,0001 0,00003
1,2,3,4,7,8-HxCDF 0.1 PCB 156 0,0005 0,00003
1,2,3,6,7,8-HxCDF 0.1 PCB 157 0,0005 0,00003
1,2,3,7,8,9-HxCDF 0.1 PCB 167 0,00001 0,00003
2,3,4,7,8-HxCDF 0.1 PCB 189 0,0001 0,00003
1,2,3,4,6,7,8-HpCDF 0.01
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.34 / 108
1,2,3,4,7,8,9-HpCDF 0.01
OCDF 0.0001 0,0003
Abbreviations used: T= tetra; Pe= penta; Hx=hexa; Hp= hepta; O= octa; CDD= chlorodibenzodioxin; CDF= chlorodibenzofuran; CB= chlorobiphenyl
[19] (sum of the polychlorinated biphenyls (PCBs) expressed in toxicity equivalents established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.35 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Mycotoxin
C15 DON Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-19
(Deoxynivalenol) - Pigs 0.8 mg/kg 1 mg/kg
- Cattle 4 mg/kg 5 mg/kg
- Calves up to 4 months 1.6 mg/kg 2 mg/kg
- Dairy cattle 2.4 mg/kg 3 mg/kg
- Poultry 3.2 mg/kg 4 mg/kg
Feed material (supplied to the livestock farmer for immediate feeding) for
The supplier provides information to the livestock farmer in the event of infringement of the action limit for the level of the undesirable substance and provides advice on processing the product in the days ration
- Pigs 1 mg/kg 5 mg/kg
- Cattle 5 mg/kg 15 mg/kg
- Calves up to 4 months 2 mg/kg 6 mg/kg
- Dairy cattle 3 mg/kg 9 mg/kg
- Poultry 4 mg/kg 12 mg/kg
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.36 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents and biocides (permitted in the EU)
C16 Endosulfan (sum of alfa and bèta-isomers and of endosulfan sulphate, expressed as endosulfan)
Feed materials and compound feed with the exception of:
0,1 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC
OZM Part 2; OSP-11
- maize and maize products derived from the processing thereof
- 0,2 mg/kg
- oilseeds and products derived from the processing thereof, with the exception of crude vegetable oil,
- 0,5 mg/kg
- crude vegetable oil, - 1,0 mg/kg
- complete feed for fish except for Salmonids, - 0,005 mg/kg
- complete feed for Salmonids - 0,05 mg/kg
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.37 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents and biocides (permitted in the EU)
C17 Endrin (sum of endrin and deltaketo-endrin, expressed as endrin)
Feed materials and compound feed with the exception of:
- 0.01 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- fats and oils - 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 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.38 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Salts
C19 Fluorine 3 Feed materials, with the exception of: - 150 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC
OZM Part 2; OSP-6
- Feed materials of animal origin except marine crustaceans such as marine krill
- 500 mg/kg
- marine crustaceans such as marine krill
- 3 000 mg/kg
- phosphates
- 2 000 mg/kg
- calcium carbonate; calcium and magnesium carbonate 11
- 350 mg/kg
- magnesium oxide - 600 mg/kg
- calcareous marine algae - 1,000 mg/kg
Vermiculite (E 561) - 3 000 mg/kg
Complementary feed
- containing < 4% phosphorus 8 - 500 mg/kg
- containing > 4% phosphorus 8 - 125 mg/kg per 1% phosphorus 8
Complete feed, with the exception of: - 150 mg/kg
- complete feed for cattle, sheep and goats
- in lactation - 30 mg/kg
- others - 50 mg/kg
- complete feed for pigs - 100 mg/kg
- complete feed for poultry (except chicks) and fish - 350 mg/kg
- complete feed for chicks - 250 mg/kg
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.39 / 108
[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.
[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 % of phosphorus is relative to a feed with a moisture content of 12 %.
[11] Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.40 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents (Pesticides which are not permitted in the EU)
C20 Heptachlor (sum of heptachlor and heptachlor epoxyd, expressed as heptachlor)
Feed materials and compound feed, with the exception of:
- 0.01 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- fats and oils - 0.2 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.41 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents and biocides (permitted in the EU)
C21 Hexachlorobenzene (HCB) Feed materials and compound feed, with the exception of:
- 0.01 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- fats and oils - 0.2 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.42 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents and biocides (permitted in the EU)
C22a Hexachlorocyclohexane (HCH): Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- Alfa-isomer Feed materials and compound feed, with the exception of:
- 0.02 mg/kg
- fats and oils - 0.2 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.43 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents and biocides (permitted in the EU)
C22b Hexachlorocyclohexane (HCH): - Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- Beta-isomer Compound feeds with the exception of: - 0.01 mg/kg
- compound feed for dairy cattle - 0.005 mg/kg
Feed materials, with the exception of: - 0.01 mg/kg
- fats and oils - 0.1 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.44 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Crop protection agents and biocides (permitted in the EU)
C22c Hexachlorocyclohexane (HCH): - Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-11
- Gamma-isomer (lindane) Feed materials and compound feed, with the exception of:
- 0.2 mg/kg
- fats and oils - 2.0 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.45 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Salts
C23 Potassium - Feed materials for delivery to cattle farms, and 60 g/kg (dry matter)
GMP+ If the action limit is exceeded then a warning or processing advice must be demonstrably communicated to the customer. Supply of additional water to the animals is also important to avoid health problems. More recommendations in the event of excess of the action limit can be found in GMP+ D4.13 Salts in rations with wet feeds for fattening pigs and sows
OZM deel 3; WM-08
- Wet mixes for delivery to 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 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.46 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit
(1) Rejection limit
(1) Source Supplementary
requirements
Analysis method7
Chemical: Toxic substances
C24 Hydrocarbons (C10-C40) Animal fat, with the exception of: - 400 mg/kg (on product basic)
GMP+ OZM Part 2; OSP-15a
- crude fish oil - 3,000 mg/kg (on product basic)
Vegetable oil (with the exception of sunflower oil) - 400 mg/kg (on product basic)
Sunflower oil and sunflower fatty acids - 1,000 mg/kg (on
product basic)
Vegetable fatty acids incl. Mixes of fatty acids (with
the exception of sunflower fatty acids)
- 3,000 mg/kg (on
product basic)
Palm oil - 25 mg/kg
calculated as diesel oil
This norm applies if the
hydrocarbons (calculated as diesel oil) are
determined via the GC-MS method. If use is
made of the GC-FID method, then the norm for
vegetable oil applies
OZM Part 2; OSP-
15b
Hydrocarbons (mineral paraffin/oil) : saturated
hydrocarbons in the range C10-C56 from external sources minus
the alkanes C27, C29 and C31
Sunflower oil (falling within CN code 15121191 or TARIC Code 1512199010) originating in or
consigned from Ukraine
50 mg/kg (on product basic)
Commission Regulation (EC)
1151/2009 of 27 November 2009
The batch must be accompanied by a report
of analysis and a Health certificate
The sampling has to be performed in
accordance with Commission
Regulation (EC) No 333/2007 and the
standard ISO5555:2003 and
the analysis by a laboratory
accredited according to EN
ISO/IEC 17025
[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be
taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.47 / 108
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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.48 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product (complete feedingstuff) Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Heavy metals
C25 Copper (E4) Pigs: Commission Regulation (EC) No 1334/2003 amending the conditions for authorisation of a number of additives in feedingstuffs belonging to the group of trace elements
OZM Part 1; TVM-I-2
- Piglets up to 12 weeks - 170 mg/kg total
- Other pigs - 25 mg/kg total
Bovine:
1. Bovine before the start of rumination:
- Milk replace - 15 mg/kg total
- Other complete feeingstuffs - 15 mg/kg total
2. Other bovine - 35 mg/kg total
Ovine - 15 mg/kg Total
Fish - 25 mg/kg total
Crustaceans - 50 mg/kg total
Other species - 25 mg/kg total
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.49 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Heavy metals
C26 Mercury 16 Feed materials, with the exception of: - 0.1 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC
OZM Part 2; OSP-5
- fish, other aquatic animals and products derived thereof,
- 0.5 mg/kg
- calcium carbonate; ; calcium and magnesium carbonate 11
- 0.3 mg/kg
Compound feed, with the exception of: - 0.1 mg/kg
- mineral feed - 0.2 mg/kg
- compound feed for fish - 0,2 mg/kg
- compound feed for dogs, cats and fur animals - 0,3 mg/kg
[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)
[16] The maximum levels refer to the total level of arsenic / mercury respectively.
[11] Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.50 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Heavy metals
C27 Lead Feed materials, with the exception of: - 10 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC
OZM Part 2; OSP-28
- forage 9 - 30 mg/kg
- phosphates and calcareous marine algae - 15 mg/kg
- calcium carbonate; calcium and magnesium carbonate 11
- 20 mg/kg
- yeast - 5 mg/kg
Feed additives belonging to the functional group of compounds of trace elements, with the exception of:
100 mg/kg
- zinc oxide 400 mg/kg
- manganous oxide, ferrous carbonate, cupric carbonate
200 mg/kg
Feed additives belonging to the functional group of binders and anti-caking agents, with the exception of:
30 mg/kg
- clinoptilolite of vulcanic origin; natrolite-phonolite 60 mg/kg
Premixtures 2 200 mg/kg
Complementary feed, with the exception of: - 10 mg/kg
- mineral feed - 15 mg/kg
Complete feed - 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 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)
[9] Green fodder includes products which are intended for feeding to animals such as hay, silage, fresh grass, etc.
[2]The maximum level established for premixtures takes into account the additives with the highest level of lead and cadmium and not the sensitivity of the different animal species to lead and cadmium. As provided in Article 16 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (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.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.51 / 108
[11] Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.52 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Mycotoxin
C28 Rye ergot (Claviceps purpurea) Feed materials and compound feed containing unground cereals
- 1,000 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-32
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.53 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Salts
C29 Sodium - Feed materials for delivery to cattle farms, and 8 g/kg (dry matter)
GMP+ If the action limit is exceeded then a warning or processing advice must be demonstrably communicated to the customer. Supply of additional water to the animals is also important to avoid health problems. More recommendations in the event of excess of the action limit can be found in GMP+ D4.13 Salts in rations with wet feeds for fattening pigs and sows
OZM deel 3; WM-09
- Wet mixes for delivery to 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 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.54 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit
(1) Rejection limit
(1) Source Supplementary
requirements
Analysis method7
Chemical: Heavy metals
C30 Nickel Feed fats 20 mg / kg (on
a fat basis)
50 mg / kg (on a fat
basis)
GMP+ OZM Part 2; OSP-
29
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.55 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Other undesirable substances and products
C31 Nitrites Feed materials, with the exception of: - 15 mg/kg (expressed in sodium nitrite)
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-7
- Fish meal - 30 mg/kg (expressed in sodium nitrite)
- Products and by-products from sugar beet and sugarcane and from starch production.
- -
Complete feed, with the exception of: - 15 mg/kg (expressed in sodium nitrite)
- complete feed for dogs and cats with a moisture content exceeding 20 %.
- -
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.56 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Botanical impurities
C32 Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including
Feed material and compound feed - 3,000 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Microscopic determination in accordance with the instructions of the laboratory
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.57 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Botanical impurities
C32a - Datura sp. Feed material and compound feed - 1,000 mg/kg
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.58 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Other undesirable substances and products
C33 Insoluble impurities Rendered fats from ruminants - 0,15% Commission Regulation (EU) 142/2011, Annex X, Chapter II, Section 3
OZM Part 2; OSP-16
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.59 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Mycotoxin
C34 Ochratoxin A Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-19
- sows and consumption pigs and piglets 0.04 mg/kg 0.05 mg/kg
- poultry 0.16 mg/kg 0.2 mg/kg
Feed material (supplied to the livestock farmer for immediate feeding) for
The supplier provides information to the livestock farmer in the event of infringement of the action limit for the level of the undesirable substance and provides advice on processing the product in the days ration
- Sows and pigs and piglets 0.05 mg/kg 0.15 mg/kg
- Poultry 0.2 mg/kg 0.6 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.60 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary requirements Analysis
method7
Chemical: Toxic substances
C35 Polycyclic Aromatic Hydrocarbons (PAHs) (PAH4)
Feed fats 15 μg/kg BaPEQ (on fat basis)
50 μg/kg BaPEQ (on fat basis)
GMP+ BaPEQ = Benzo(a)pyrene equivalent (PAH4=sum of benzo(a)pyrene, benzo(a)anthracene, benzo(b)fluoranthene and chrysene
OZM Part 2; OSP-33
See the GMP+ D documents: - GMP+ D4.14 - GMP+ D415 http://www.gmpplus.org/nl/gmp+_fsa/D-documenten.php
See the GMP+ D documents: - GMP+ D4.14 - GMP+ D415
Oils and fats (excluding palm(kernel)-, coconutoil and products derived thereof)
160 μg/kg (on fat basis)
200 μg/kg (on fat basis)
Palm(kernel)-, coconutoil and and products derived thereof)
320 μg/kg (on fat basis)
400 μg/kg (on fat basis)
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.61 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Antinutritional factors: Glucosides
C38 Seeds and husks from Ricinus communis L., Croton tiglium L. and Abrus precatorius L. as well as their processed derivatives (in so far determinable by analytical microscopy), separately or in combination
Feed materials and compound feed. - 10 mg/kg 23 Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Microscopic determination in accordance with the instructions of the laboratory
[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.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.62 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Salts
C39 Sulphate - Feed materials for delivery to cattle farms, and 8 g/kg (dry matter)
GMP+ If the action limit is exceeded then a warning or processing advice must be demonstrably communicated to the customer. Supply of additional water to the animals is also important to avoid health problems. More recommendations in the event of excess of the action limit can be found in GMP+ D4.13 Salts in rations with wet feeds for fattening pigs and sows
OZM deel 2; OSP-24
- Wet mixes for delivery to cattle farmers which are preserved with sulphuric acid and not for products which by nature are rich in sulphur
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.63 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Antinutritional factors: Alkaloids
C40 Theobromine Complete feed, with the exception of: - 300 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-8
- complete feed for pigs - 200 mg/kg
- complete feed for dogs, rabbits, horses and fur animals
- 50 mg/kg
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.64 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Antinutritional factors: Glucosides
C41 Vinyl thiooxazolidone (5-vinyloxazolidine-2-thione)
Complete feed for poultry with the exception of:
- 1,000 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-31
- complete feed for laying hens - 500 mg/kg
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.65 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Antinutritional factors: Glucosides
C42 Volatile mustard oil Feed materials, with the exception of: - 100 mg/kg (calculated as allylisothiocyanate)
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-20
- rapeseed cakes - 4,000 mg/kg (calculated as allylisothiocyanate)
Complete feed, with the exception of: - 150 mg/kg (calculated as allylisothiocyanate)
- Complete feeds for cattle (except calves), sheep (except lambs) and goats (except kids)
- 1,000 mg/kg (calculated as allylisothiocyanate)
- Complete feeds for pigs (with the exception of piglets) and poultry
- 500 mg/kg (calculated as allylisothiocyanate)
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.66 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method
Chemical: Antinutritional factors: Other
C43 Free gossypol Feed materials, with the exception of: - 20 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
OZM Part 2; OSP-21
- cotton seed - 5,000 mg/kg
- cotton seed cake and cotton seed meal - 1,200 mg/kg
Complete feed, with the exception of: - 20 mg/kg
- complete feed for cattle (except calves) - 500 mg/kg
- complete feed for sheep (except lambs) and goats (except kids),
- 300 mg/kg
- complete feed for poultry (except laying hens) and calves
- 100 mg/kg
- complete feed for rabbits, lambs, kids and pigs (except piglets)
- 60 mg/kg
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.67 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Chemical: Mycotoxin
C44 Zearalenon Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-19
- sows and consumption pigs 0.2 mg/kg 0.25 mg/kg
- young pigs 0.08 mg/kg 0.1 mg/kg
- young cattle and dairy cattle 0.4 mg/kg 0.5 mg/kg
Feed material (supplied to the livestock farmer for immediate feeding) for
The supplier provides information to the livestock farmer in the event of infringement of the action limit for the level of the undesirable substance and provides advice on processing the product in the days ration
- sows and pigs 0.25 mg/kg 0.75mg/kg
- young pigs 0.1 mg/kg 0.3 mg/kg
- young cattle and dairy cattle 0.2 mg/kg 1.5 mg/kg
[1 ] 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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.68 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit
(1) Rejection limit
(1) Source Supplementary
requirements
Analysis method7
Chemical: Heavy metals
C45 Zinc (E6) Pets13
- 250 mg/kg total Commission
Regulation (EC) No 1334/2003
amending the conditions for
authorisation of a number of additives
in feedingstuffs belonging to the
group of trace elements
OZM Part 1; TVM-
I-4
Fish13
- 200 mg/kg total
Milk replacer13
- 200 mg/kg total
Other animals13
- 150 mg/kg total
[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)
[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
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.69 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method
Chemical: Other undesirable substances and products
C46 Melamine 24 Feed, with the exception of the feed additives 2,5 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
EFSA recommendation: LC-MS/MS (liquid chromatography coupled to mass spectrometry
- guanidino acetic acid (GAA), -
- urea -
- biuret -
[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.
[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.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.70 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Fysical: Bodies foreign to the product
F1 Plastics - Feed materials for delivery to cattle farms, and - 1.5 g/kg (dry matter basis)
GMP+ Via manual separation and weighing See GMP+ BA 3: Negative list
Microscopic determination in accordance with the instructions of the laboratory.
- Wet mixes for delivery to livestock farmers This norm was included subject to the outcome of the discussion taking place in the European Commission.
[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.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.71 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Fysical: Bodies foreign to the product
F2 Polyethylene - Feed materials for delivery to cattle farms, and 0.25 g/kg (on fat basis)
0.5 g/kg (on fat basis)
GMP+ See GMP+ BA 3: Negative list.
OZM Part 2; OSP-13
- Wet mix for delivery to livestock farmers
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.72 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Fysical: Botanical impurities
F5 Unhusked beech mast - Fagus silvatica (L.)
Feed materials and compound feed - Seeds and fruits of the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.73 / 108
SUMMARY OF GMP+ PRODUCT STANDARDSNORMS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Fysical: Botanical impurities
F6 Chinese mustard – Brassica juncea (L.) Czern. and Coss. ssp. juncea var. lutea Batalin
Feed materials and compound feed - Seeds and fruits of the plant species listed opposite as w ell as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.74 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Fysical: Botanical impurities
F7 Ethiopian mustard – Brassica carinata A. Braun
Feed materials and compound feed - Seeds and fruits of the plant species listed opposite as w ell as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.75 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
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 plant species listed opposite as w ell as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.76 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Fysical: Botanical impurities
F10 Purghera - Jatropha curcas L. Feed materials and compound feed - Seeds and fruits of the plant species listed opposite as w ell as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.77 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Fyscial: Botanical impurities
F12 Sarepta mustard - Brassica juncea (L.) Czern. and Coss. ssp. juncea
Feed materials and compound feed - Seeds and fruits of the plant species listed opposite as w ell as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.78 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method
Fysical: Botanical impurities
F13 Seeds from Ambrosia spp. Feed materials 12 , with the exception of: - 50 mg/kg Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
Commission Regulation (EU) No 744/2012 amending Annex I and II to Directive 2002/32/EC
The provisions as regards Ambrosia spp. shall apply from 1 January 2012.
- Millet (grains of Panicum miliaceum L.) and sorghum (grains of Sorghum bicolor (L) Moench s.l.) not directly fed to animals 12
200 mg/kg
Compound feed containing unground grains and
seeds - 50 mg/kg
[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.
[12] In case unequivocal evidence is provided that the grains and seeds are intended for milling or crushing, there is no need to perform a cleaning of the grains and seeds containing non-compliant levels of seeds of Ambrosia spp. before milling or crushing. Prevention measures shall be taken to avoid dissemination of Ambrosia spp. seeds into the environment during transport, storage or processing of these seeds and grains.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.79 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method7
Fysical: Botanical impurities
F14 Black mustard – Brassica nigra (L.) Koch
Feed materials and compound feed - Seeds and fruits of the plant species listed opposite as w ell as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable
Commission Regulation (EU) No 574/2011 amending Annex I to Directive 2002/32/EC
[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)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.80 / 108
SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary
requirements Analysis method
Fysical: Other undesirable substances and products
F26 Radioactivity
Commission Implementing Regulation (EU) No 961/2011
Special conditions governing the import of feed originating in or consigned from Japan following the accident at the Fukushima nuclear power station.
Sum of Cs-134 and Cs-137 Feedingstuffs - 500 (Bq/kg) In order to ensure consistency w ith action levels currently applied in Japan, this value replaces on a provisional basis the value laid dow n in Commission Regulation (Euratom) No 770/90.
Sum of Isotopes of iodine, notably I-131
Feedingstuffs - 2 000 (Bq/kg) 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.)
[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.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.81 / 108
4 Residue levels of pesticides in feeds
4.1 Introduction
A start was made in April 2005 in the EU on the revision of the community legisla-
tion with respect to the permitted maximum levels of residues of pesticides by way
of Regulation (EG) No. 396/2005. This regulation includes the maximum residue
levels (MRL) for simple products of vegetable and animal origin intended for human
consumption and for feeds. In as much as the MRLs apply to feeds they are appli-
cable to both feeds for food-producing animals and for non-food-producing animals.
The layout of the standard is such that in many cases it is not possible immediately
to indicate a standard for a certain combination of feed / pesticide. This chapter
indicates: a. How the correct standard for a simple, untreated/unprocessed product can be
out-of-date; b. How the correct standard for a derived product can be determined; c. How the correct standard for a compound feed can be determined; d. Which special requirements apply.
4.2 The establishment of and MRL
4.2.1 General
The MRLs (maximum residue levels) are established for simple products. Many of
these MRLs are to be found on “Pesticides Web”, a database which was created by
the EC.
(http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=substance.selection
&ch=1) This is almost always the untreated form of a product. This means that a
number of calculations must be carried out both for the determination of the MRL in
a derived product (for example, sunflower oil, maize gluten meal) and for the de-
termination in compound products (compound feeds, supplementary feeds).
The correct standard can be determined using the enclosed questionnaires. The
basic principle of the questionnaires is that there is a known pesticide and that the
associated residue standard must be found for a particular feed.
The questionnaires have been drawn up so that you always are led to a result. The
following questionnaires are available. a. Questionnaire for basic products.
This questionnaire helps you determine the MRL for basic products. b. Questionnaire for by-products.
This questionnaire helps you determine the MRL for auxiliary products. c. Questionnaire for compound feeds.
This questionnaire helps you determine the MRL for compound feeds.
It is of great importance to note here that Regulation (EC) No. 396/2005 only ap-
plies to products of vegetable or animal origin! If this is not the case then any stan-
dards in Directive 2002/32/EG still apply.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.82 / 108
To make this chapter easier to read the questionnaire makes use of the definitions
in the following table.
Table 1: Definitions and questionnaires
Product group Definition Questionnaire
Basic product Simple, unprocessed product of vegetable or animal origin (wheat,
barley, linseed, sunflower seeds, soya bean, peas, shrimps)
4.2.2.
Auxiliary products Simple, treated/processed or derived product, originating from an
basic product. (flour, semolina pellets, potato press fibres, soya
flakes, linseed oil, peapod meal, fish meal)
4.2.3
Compound feed Compound product consisting of at least two components being basic
products, by-products and/or feed additives. (complete feed, supple-
mentary feed, petfood, grain mixes, premixes)
4.2.4.
NOTE: These definitions have only been drawn up to improve the readability of
Chapter 4 and have no value or legitimacy outside this chapter.
The questionnaires help you to determine the standard. You are not always imme-
diately led to a number or value. It could be that you are referred to another point in
a table or to another table. It may also be possible that you have to carry out a few
calculations.
For a limited number of products (table 2) the MRL in Regulation (EC) No.
396/2005 may not (yet) apply for parts of these products are given the exclusive
destination animal feed. For these products the MRLs for pesticides therefore still
apply as specified in the Directive 2002/32/EG.
Table 2: Product (groups) of which parts with the exclusive destination animal feed are not (yet) covered under
Reg. 396/2005
Product (groups) Fish, fish products, crus-taceans and shellfish and other products from salt and fresh water creatures*
Kohl-rabi foliage Palm hearts Palm kernels
Only for crops used for feed*
Garden cress Fungi Palm fruits
Loquats Winter cress Seaweed Kapok Cherimoya’s Rucola Lupines (dried) Millet Guavas Red amsoi Shells, seeds and possi-
bly skins of oil-retaining seeds and fruits (such as soya hulls)
Sorghum
Bread fruits Leaves and sprouts of Brassica spp.
Borage Coffee beans
Durians Purslain Pumpkin seed Herbal tea Soursops (durian blanda) Vine leaves Hemp seed Cacao bean Arrowroot Herbs (sage, rosemary,
thym, basi, laurel, tarra-gon)
Camelina Carob
Nut shells Lentils (fresh) Safflower seed Spices Sprouts stems Bamboo shoots Olives (oil recovery) Sugar crops
* : The standards of Reg. 396/2005 apply neither to feeds nor to foodstuffs for (parts of) products in these groups.
For all other products of vegetable or animal origin, Regulation (EC) No. 396/2005
applies.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.83 / 108
4.2.2 Questionnaire for basic products
1. Is your basic product in Table 2 and does it have the exclusive destination
animal feed? Yes This new regulation does not yet apply to your basic product.
Check if Directive 2002/32/EG contains a standard for your basic
product / pesticide combination (end).
No Go to question 2.
2. Is your basic product included in Appendix I of Reg. 396/2005, either as an
Individual product (column 3, 4 and 5) or as a group of products (column 2)?
Yes Go to question 3.
No Your basic product is probably not a simple untreated / Unproc-
essed product of vegetable or animal origin. Check your product us-
ing the definitions in Table 1. Consult your supplier.
3. Is your basic product individually included in Appendix I of Reg. 396/2005,
(column 3, 4 and 5) Yes Go to question 4.
No Go to question 7.
4. Is the pesticide for which you are looking for a standard included in Pesti-
cides Web , the online EU pesticides database?
Yes Go to question 5.
No Go to question 6.
5. On Pesticides Web select the language you want, your basic product and
the pesticide for which you want the MRL. Click on the button “Search cur-
rent MRL”. You have found the standard. Place the mouse cursor on the
MRL or click on the pesticide for additional information (end).
6. Is the pesticide included in Appendix V of Reg. 396/2005?
Yes You have found the standard for the pesticide. Carefully read any
footnotes which apply to the standard (end).
No The pesticide is not specified. The standard amounts to 0.01 mg/kg
for basic products. (end)
Note: At the time of the first publication of this document Appendix V was
not yet completed
7. Is the pesticide for which you are looking for a standard included in Pesti-
cides Web , the online EU pesticides database?
Yes Go to question 8.
No Go to question 9.
8. On Pesticides Web select the language you want, the (sub) group of prod-
ucts to which your basic product belongs and the pesticide for which you
want the MRL. Click on the button “Search current MRL”. You have found
the standard. Place the mouse cursor on the MRL or click on the pesticide for additional information (end).
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.84 / 108
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.
2. Is your by-product included in Appendix I of Reg. 396/2005, either as a by-
product (column 2 in combination with 3, 4 or 5) or as a group of products
(column 2) or in the form of the original product? Yes Go to question 3.
No Your by-product is probably not a product of vegetable or animal ori-
gin. Check your product using the definitions in Table 1. Consult your
supplier.
3. Is your by-product from that part of the (derived) product or the product
group for which the MRL applies (Reg. 396/2005, Appendix I, column 6)? Yes The standards in this regulation apply to your by-product. Go to
question 4. No This new regulation does not yet apply to your by-product. Check if
Directive 2002/32/EG contains a standard for your by-
product/pesticide combination (end).
You have established that the standards from this regulation apply to your
by-product. You then use the questionnaire for basic products (4.2.2.) ques-
tion 3 and further, to determine the standard for your individually-specified
by-product, the original product or the relevant product group. Now proceed
with question 4 in this questionnaire.
4. Is the by-product for which the standard is established equal to the by-
product for which you are looking for a standard? Yes The standard you have found is the standard for this by-product /
pesticide combination. (end)
No Go to question 5.
5. In Reg. 396/2005, Appendix VI, is there a concentration or dilution factor
established for your by-product or for the treatment / processing which is the
basis for your by-product? Yes Use this factor to determine the final standard for this by-product /
pesticide combination. (end)
No Go to question 6.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.85 / 108
NOTE: At the time of the first publication of this document Appendix VI was not yet
completed
6. Is the treatment / processing for this by-product based on the separation of
a fat and water fraction? Yes Go to question 7.
No The processing / treatment has no effect on the residue level, the
standard which you have found is the final standard for this by-product/pesticide combination. (end)
Your by-product has been created as a result of the separation of a fat-oil fraction
and a fat-oil free fraction (pressing, extraction). In the rest of this questionnaire you
determine if there is an accumulation of residues in the fat fraction or in the fat-free
fraction
7. Does the name of the pesticide in Pesticiden Web have the suffix (F)? Yes The pesticide is soluble in fat. Determine, using the fat percentage
in the original product and in your by-product, the dilution or concen-
tration factor (see table 3 see website MVO:
http://www.mvo.nl/Kernactiviteiten/KwaliteitenVoedselveiligheid/MVO
statementsencodes/Reportingrequirements/tabid/3135/language/en-
US/Default.aspx) and divide or multiply this by the standard found
for the original product(group) in order to determine the final stan-dard.(end)
Table 3: Concentration factors for many vegetable oils which are used
Oil-retaining basic product Avg. oil level Concentration
factor in oil
Palm fruit 50 2
Sheanut 50 2
Coconut 50 2
Palm kernel 49 2
Sesame seed 49 2
Peanut 48 2
Rapeseed 40 2
Linseed 45 2
Sunflower seeds 32 3
Kardi / Safflower seed 31 3
Cotton seed 20 5
Soya bean 19 5
Grape seed 15 6
Source: Product Board for Margarine, Fats and Oils (MVO), Memorandum Crude Oils MRLs, Sept. 2003
No Go to question 8.
8. Search on International Chemical Safety Cards (ICSCs) for the pesticide in
question and note the “Octanol/water partition coefficient” (log Pow) which
you will find in the chapter “Physical properties”. The log Pow is a measure
of the solubility in water or fat of the pesticide. Is the log Pow greater than
4?
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.86 / 108
Yes The pesticide is soluble in fat. Determine, using the fat percentage in
the original product and in your by-product, the dilution or concentra-
tion factor and divide or multiply this by the standard found for the original product(group) in order to determine the final orm.(end)
No Go to question 9.
9. Is the log Pow between 3 and 4?
Yes The pesticide is not specifically soluble in water or fat. There is no
Dilution or concentration of the pesticide residue as a Result of the
treatment to which the original product was subjected. The standard
which you found in the Pesticides Web also applies to your by-product. (end)
No Go to question 10.
10. The log Pow is less than 3. The pesticide is soluble in water. Use the fat
percentage in the original product and your by-product to determine the dilu-
tion or concentration factor and divide or multiply this by the the standard
you found for the original product or product group in order to determine the final standard.(end). Note: In this case, where there is a pesticide which is
soluble in water, there is dilution of the fat fraction and concentration of the
fat-free fraction!
NOTE: the method described in this section for the determination of maximum resi-
due limits (MRL) in fats and oils also applies to fatty acids.
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 es-
tablished for
your compound feed, A certain fraction of your compound feed. A by-
product that is part of your copound feed?
Yes Use this factor or factors to determine the final standard for this spe-
cific 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.
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.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.87 / 108
4. Have you determined a standard for all the components for which a stan-
dard has been set and have you taken account of the factors laid down in
question 1? Yes Go to question 5.
No Go through this questionnaire again starting at question 1
5. Now determine the MRL for the specific pesticide in the compound feed in
the following way
MRLx = {(NxC1 * C1) + (NxC2 * C2) …. + (NxCn * Cn)}/ ΣC1:Cn
Where: MRLx : Is the maximum residue standard for pesticide X in
the compound feed
NxCn : The standard found for the component / group of
components C (1 to n)
Cn : The percentage in the compound feed for compo-
nent / group of components C (1 to n)
ΣC1:Cn: The sum of the percentages of components for which
an MRL for pesticide X actually applies
4.2.5 Fumigators
It is permitted to trade feeds which at the moment of sale exceed an MRL for a pes-
ticide specified in Appendix II or III of Reg. 396/2005. This relates to an excess as a
result of treatment of feeds with gaseous pesticides (gas generation, fumigation)
after harvesting. The pesticides for which this permission applies and also the
products involved are specified in Appendix VII of Reg. 396/2005.
4.3 Special requirements
In addition to the standards for undesirable substances which have a broad validity
within the feed chain, some specific measures are announced with some regularity
for precisely-defined products or product groups. These are often temporary meas-
ures as a result of very specific contamination. The following measures are cur-
rently in force.
Decision 2008/352/EG of 29/04/08 adopting special requirements for guar flour originating or sent from India due to the risks of contamination of this product with pentachlorophenol and dioxins.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.88 / 108
PART B: RESIDUE STANDARDS
1 INTRODUCTION
In addition to compliance with the adopted standards in appendix 1, part A, the
participant must also comply with the (residue) levels of additives and veterinary
medical products. Please refer to the definition of feed safety as laid down in the list
of definitions for the GMP+ Feed Safety Assurance scheme.
The participant must ensure that a. the correct additives and veterinary medical products get into the right feed in the
right dosage (GMP+ B1, section 6.7.1.2). b. (residues of) additives and veterinary medical products are not present or are
under set maximum limits (the so-called residue standards) in feeds in which they should not be present (GMP+ B1, section 6.7.1.5).
In order to be able to control the residue levels the participant should, among other
things, measure carry-over in the installations (see GMP+ BA4) and establish
production sequences. In chapter 2 of part B of this appendix there are further
instructions for this.
Chapter 3 of part B of this appendix states the maximum residue standards for
coccidiostats, histomonostats and critical veterinary medical products. These
standards apply to compound feeds, semi-manufactured products, feed materials
and premixtures and are applicable to producers of these products.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.89 / 108
2 Additional provisions
2.1 General
The control of residue levels using the production sequence is shown in diagram
form in the following table.
Carried out by TNO-Nutrition
Carry-over
measurement
instruction
(GMP+ BA 4)
Installation internal
carry-over
Wall adhesion factor
measurement
instruction
Relative wall adhesion
factor measurement
Carry-over
percentage
Coefficient
(=carry-over
x factor)
Max. residue norm
(GMP+ BA1, Part
B, Chapter 3)Calculation
Coefficient factor
(GMP+ BA1, Part B,
Chapter 3)
Production
sequence / flush
batches
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.90 / 108
2.2 Compound feed
2.2.1 Installation Carry-over level:
The installation’s own carry-over is the carry-over measured using an inspection
procedure as laid down in GMP+BA4 Minimum Requirements for Sampling and
Analysis.
The frequency at which the carry-over must be measured is determined as follows: a. If the participant processes or transports (animal feed containing) feed addi-
tives for which a residue standard has been determined in the table in Chapter 3 or veterinary medical products then the degree of carry-over must be known for the lines on which these products are processed.
b. If the participant has relevant 1 lines then he must measure carry-over at least once per two years.
c. The minimum frequency for the measurement of carry-over may be lowered to once per four year on condition that: 1. the carry over measured is less than 10% and 2. as soon as the last measurement is over two years old, the participant
must assume the degree of carry over of the line in question is 15%.
The carry-over must be re-established in the event of major changes to the installa-
tion.
2.2.2. The coefficient
The coefficient is intended to take account of an extra carry-over in addition to the
installation carry-over, as a consequence of the processing properties of the addi-
tive or veterinary medicine. A factor of 1 means that the product contains no proc-
essing properties other than those of a standard measurement substance. The ac-
tual carry-over of the product therefore corresponds to the installation carry-over. If
the factor is greater than 1, this means that the product has anomalous processing
properties, such that the actual carry-over will be higher than the installation carry-
over.
The coefficient is determined on the basis of a so-called relative wall adhesion fac-
tor using a method specially developed for this purpose. Refer to TNO report I-96-
31006 Carry-over of a number of critical substances in cattle feed and the relation-
ship to their characteristic properties.
1 Relevant lines are lines on which (products with) feed additives for which a residue norm has been
determined in the table in Chapter 3 or veterinary medical products and also products with a de-termined residue norm are produced and/or transported.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.91 / 108
The relationship between the relative wall adhesion factor and the co-efficient is
shown in the following table.
Relative wall adhesive factor according to the
established method.
Coefficient
< 1 1
> 1 and < 2 2
> 2 and < 3 2,5
unknown, > 3 3
2.2.3. Carry-over and flush batches
The actual carry-over of additives and carry-over or veterinary medical products
must be calculated in order to establish the number of flushes. This carry-over can
be calculated by multiplying the installation carry-over by the coefficient.
This coefficient can be used to calculate how many flush batches are minimally
required to remain under the established residue standards. A sample calculation
follows.
Example: Broiler feed with nicarbazine : 80 ppm
Company’s own carry-over in installation: : 5 %
Coefficient : "1"
Maximum residue standard for broiler feed
for the last five days: : 0.5 ppm
Calculation of actual carry-over = company’s own carry-over x coefficient
= 0.05 (5%) x 1 = 0.05
Calculation: calculated level of nicarbazine
- batch a broiler feed 80 ppm
- batch a+1 follow-on feed 4 ppm (= 0.05 x 80)
- batch a+2 follow-on feed 0.2 ppm (= 0.05 x 4)
The second batch complies with the residue standard for broiler feed in the final fattening
phase. Therefore a first flush batch must be produced with a non-critical feed.
2.2.4 Items for attention and other remarks
The supplementary instructions for use relate to the sequence of production opera-
tions in the installation. It is also necessary for the participant to establish company
requirements and procedures in order to comply with the residue standards for: a. transport (sequence) and storage (sequence) b. intake of premixes, additives and veterinary medical products.
The participant must check that the prescribed residue standards are not ex-
ceeded. If an infringement of these residue standards is detected, the instructions
for use and procedures must be modified.
The coefficients and the minimum carry-over levels calculated from them may be
deviated from provided that the carry-over is measured using the relevant product
itself.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.92 / 108
2.3 Premix
2.3.1 General
The objective of these supplementary instructions is that compound feed producers
must be able to use premixes from GMP+-certified manufacturers in producing
compound feeds, without exceeding the maximum carry-over levels.
Carry-over of critical additives and veterinary medicines also occurs in the prepara-
tion of premixes. In order to prevent GMP+-certified compound feed mixers from
exceeding the standards for coccidiostats, histomonostats and critical veterinary
medical products because of excessive levels in premixes, a general rule of thumb
is that no more than 50% of the residue standard as stated for compound feed may
be used up as a result of the premixes used.
The maximum level in the premix must be derived from the dosage of the premix in
the compound feed. Carry-over of coccidiostats, histomonostats and critical veteri-
nary medical products may take place via direct and indirect contamination.
2.3.2 Direct contamination
Direct contamination is possible through use of a premix destined for an animal
feed for which a maximum residual level has been established. The premix pro-
ducer is to ensure through his GMP+ feed safety system that no more than 50% of
the residue standard as stated for that compound feed is used up via the premix.
For any flush batches required, the relevant coefficient as established for that prod-
uct should be adopted.
2.3.3 Indirect contamination
In order to achieve extremely low residue standards in premixes, producers of pre-
mixes will have to first produce a number of batches for a non-critical use following
the production of premixes with coccidiostats, histomonostats and critical veterinary
medicines. A premix which is produced subsequent to one prepared with a coc-
cidiostats or histomonostats (a so-called flush batch) may still contain such high
levels of coccidiostats or histomonostats that this can cause problems for the com-
pound feed producer.
Compound feed manufacturers use these premixes mainly in animal feeds which
are also used to flush an installation clean. In certain cases the level of critical addi-
tives is so high that, together with the company’s own carry-over levels, the residue
standards in compound feeds are exceeded.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.93 / 108
3 Residue standards for coccidiostats en histomonostats
3.1 Summary of residue standards for coccidiostats and histomonostats
according to Commission Regulation (EU) No. 574/2011 of 16 June 2011
and No. 744/2012 of 16 August 2012 amending Annex I to Directive
2002/32/EC
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
Lasalocid A
sodium
Feed materials 1,25
Compound feed for:
- dogs, calves, rabbits, equine species, dairy
animals, laying birds, turkeys (> 16 weeks)
and chickens reared for laying (> 16 weeks)
1,25
- chickens for fattening, chickens reared for
laying (< 16 weeks) and turkeys (<16
weeks) for the period before slaughter in
which the use of lasalocid A sodium is prohib-
ited (withdrawal feed)
1,25
- pheasants, guinea fowl, quails and par-
tridges (except laying birds) for the period
before slaughter in which the use of lasalocid
A sodium is prohibited (withdrawal feed),
1,25
- other animal species
3,75
Premixtures for use in feed in which the use
of lasalocid A sodium is not authorised
(3)
Narasin Feed materials
0,7
Compound feed for:
- turkeys, rabbits, equine species, laying birds
and chickens reared for laying (> 16 weeks)
0,7
- other animal species
2,1
2 Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September 2003 on additives for use in animal nutri-
tion. 3 The maximum level of the substance in the premixture is the concentration which shall not result in a
level of the substance higher than 50 % of the maximum levels established in the feed when the
instructions for use of the premixture are followed.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.94 / 108
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.
(3)
Salinomycin
sodium
Feed materials
0,7
Compound feed for:
- equine species, turkeys, laying birds and
chickens reared for laying (> 12 weeks)
0,7
- 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)
0,7
- other animal species
2,1
Premixtures for use in feed in which the use
of salinomycin sodium is not authorised.
(3)
Monensin
sodium
Feed materials
1,25
Compound feed for:
- equine species, dogs, small ruminants
(sheep and goat), ducks, bovine, dairy cattle,
laying birds, chickens reared for laying (> 16
weeks) and turkeys (> 16 weeks)
1,25
- 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 (with-
drawal feed)
1,25
- other animal species
3.75
Premixtures for use in feed in which the use
of monensin sodium is not authorised.
(3)
Semdurami-
cin sodium
Feed materials
0.25
Compound feed for:
- laying birds and chickens reared for laying
(> 16 weeks)
0,25
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.95 / 108
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
- chickens for fattening for the period before
slaughter in which the use of semduramicin
sodium is prohibited (withdrawal feed)
0,25
- other animal species
0,75
Premixtures for use in feed in which the use
of semduramicin sodium is not authorised.
(3)
Maduramicin
ammonium
alpha
Feed materials
0,05
Compound feed for:
- equine species, rabbits, turkeys (> 16
weeks), laying birds and chickens reared for
laying (> 16 weeks)
0,05
- chickens for fattening and turkeys (< 16
weeks) for the period before slaughter in
which the use of maduramicin ammonium
alpha is prohibited (withdrawal feed)
0,05
- other animal species
0,15
Premixtures for use in feed in which the use
of maduramicin ammonium alpha is not
authorised.
(3)
Robenidine
hydro-
chloride
Feed materials
0,7
Compound feed for:
- laying birds and chickens reared for laying
(> 16 weeks)
0,7
- chickens for fattening, rabbits for fattening
and breeding and turkeys for the period be-
fore slaughter in which the use of robenidine
hydrochloride is prohibited (withdrawal feed)
0,7
- other animal species
2,1
Premixtures for use in feed in which the use
of robenidine hydrochloride is not authorised.
(3)
Decoquinate Feed materials
0,4
Compound feed for:
- laying birds and chickens reared for laying 0,4
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.96 / 108
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
(> 16 weeks)
- chickens for fattening for the period before
slaughter in which the use of decoquinate is
prohibited (withdrawal feed)
0,4
- other animal species
1,2
Premixtures for use in feed in which the use
of decoquinate is not authorised
(3)
Halofuginone
hydro-
bromide
Feed materials
0,03
Compound feed for:
- laying birds, chickens reared for laying (> 16
weeks) and turkeys (> 12 weeks)
0,03
- chickens for fattening and turkeys (< 12
weeks) for the period before slaughter in
which the use of halofuginone hydrobromide
is prohibited (withdrawal feed)
0,03
- other animal species other than chickens
reared for laying (< 16 weeks)
0,09
Premixtures for use in feed in which the use
of halofuginone hydrobromide is not author-
ised
(3)
Nicarbazin Feed materials
1.25
Compound feed for:
- equine species, laying birds and chickens
reared for laying (> 16 weeks)
1.25
- chickens for fattening for the period before
slaughter in which the use of nicarbazin (in
combination with narasin) is prohibited (with-
drawal feed)
1.25
- other animal species
3.75
Premixtures for use in feed in which the use
of nicarbazin (in combination with narasin) is
not authorised
(3)
Diclazuril Feed materials 0,01
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.97 / 108
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
Compound feed for:
- laying birds, chickens reared for laying (> 16
weeks) and turkeys for fattening (> 12 weeks)
0,01
- rabbits for fattening and breeding for the
period before slaughter in which the use of
diclazuril is prohibited (withdrawal feed).
0,01
- other animal species other than chickens
reared for laying (< 16 weeks), chickens for
fattening, guinea fowl and turkeys for fatten-
ing (< 12 weeks)
0,03
Premixtures for use in feed in which the use
of diclazuril is not authorised.
(3)
Feed
additives not
registered in
the EU which
are intended
for use in
feeds for
export out-
side the EU.
All feeds intended for marketing within the EU. 1
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.98 / 108
3.2 Additional information for some coccidiostats and histomonostats *
Trade name Manufacturer Importer Concentration Coefficient
Pigs Other
Compound of narasin and nicarbazine (E 772)
Maxiban G 160 premix Eli Lilly Eli Lilly Nederland BV 80 g/kg narasin
80 g/kg nicarbazine
5 1
Lasalocid sodium (E 763)
Avatec 15% CC Roche Alpharma 15g/100g Lasalocide-sodium 1 1
Robenidine-hydrochloride (E758)
Cycostat 66G Roche Alpharma 66g/kg Robenidine-
hydrochloride
1 1
Monensin-sodium (E757)
Elancoban G200 premix Eli Lilly Eli Lilly Nederland BV 200g/kg monensin sodium 1 1
Coxidin (5 1 701) Huvepharma Huvepharma NV 200g/kg monensin natrium 1 1
Narasin (E765)
Monteban G100 premix Eli Lilly Eli Lilly Nederland BV 100g/kg narasin 1 1
Halofuginone-hydrobromine (764)
Stenorol Huvepharma Huvepharma NV 6 g/kg halofuginone
hydrobromide
1 1
Diclazuril (E 771)
Clinacox 0,5 % Premix Janssen
Pharmaceutica nv
Janssen
Pharmaceutica nv
0.5g/100g diclazuril 2 2
Salinomycin-sodium (E 766)
Sacox 120 microGranulate Huvepharma Huvepharma NV 120g/kg salinomycine 1 1
Kokcisan 12% KRKA Lansdowne Chemicals
Europe BV
120g/kg salinomycine 1 1
Other Other Other N/a 3 3
*: This list can be extended at new available data of relative wall adhesion test
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.99 / 108
4 Residue standards for critical veterinary medical pro-ducts
4.1 Summary of residue standards for critical veterinary medical products
Veterinary medical
product
Established maximum residue standards
in animal feeds4 in ppm
Established
precautionary
measure for
dairy cattle
laying
hens5
slaughter
chickens6
fattening
turkeys6
pigs7
dairy
cattle8
Sulfadiazine sodium 5 8 1 1
Sulfamethoxazol 5 8 1
1
Doxycycline 8 8 10 -9 1 batch
10
Oxytetracycline 1 10 10 -9 1 batch
10
Ivermectine 0.1 0.1 0.1 -9 1 batch
10
Tiamuline 1 8 10 -9 1 charge
10
Tilmicosine 1 4 10 -9 1 charge
10
Trimethoprim Linked to Sulfadiazine and therefore sufficiently guaranteed
For other products
1 1 1 1
4 The max. residue norms for premixes amount to maximum. 50% of the indicated residue norms for
animal feeds calculated on an animal feed basis 5 feed given to laying animals
6 feed given from 5 days before slaughter
7 feed given from 28 days before slaughter
8 feed given to milk-producing cows, goats and sheep
9 At this moment there is insufficient knowledge available in order to be able to establish a carry-
over norm for this additive for these categories. 10
Dairy cow feed may not immediately be produced on a production line which has just produced
feed with these additives.
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.100 / 108
4.2 Overview of admissible medicated premixes
Trade name Registration holder Registration
nummer Concentra-tion
Coefficient Max. dosing for complete feeds
Pigs Other
Amoxicilline
Suramox 5% premix Virbac Nederland B.V. REG NL 8543 50g/kg 3 3 400 ppm (8kg/ton)1
Amproliumhydrochloride
Amprolium Concentrate 25% Dopharma Research B.V. REG NL 2051 250g/kg - 3 500 ppm (2kg/ton)2
Doxycyclinehyclaat/broomhexinehydrochloride
Feedmix Doxy-B Dopharma Research B.V. REG NL 2588 20g/kg 2,5 2,5 300 ppm (15kg/t)3
Pulmodox 5% Premix Virbac Laboratories REG NL 9826 50g/kg 2,5 2,5 250 ppm (5kg/t)4
Doxyprex Industrial Veterinaria S. A. REG NL 10393
100g/kg 2,5 2,5 250 ppm (2,5kg/t)5
Florfenicol
Nuflor 40mg/g medicated premix for pigs
Intervet Nederland B.V. REG NL 10473
40g/kg 3 3 200 ppm (5kg/t)6
Flubendazol
Feedmix Flubendazole Dopharma Research B.V. REG NL 9674 6g/kg 3 3 30 ppm (5kg/t) (pigs, chickens)
60 ppm (10kg/t) pheasants)
Flubenol 0.6% Janssen Pharmaceutica N.V. REG NL 5335 6g/kg 3 3 30 ppm (5kg/t) (pigs, chickens)
60 ppm (10kg/t) (pheasants)
Flubenol 5% Janssen Pharmaceutica N.V. REG NL 3106 50g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
Flubenol 5% Poultry Janssen Pharmaceutica N.V. REG NL 9556 50g/kg - 3 30 ppm (0,6kg/t) (chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
Flubenol 50% Janssen Pharmaceutica N.V. REG NL 3160 500g/kg 3 3 30 ppm (0,06kg/t) (pigs, chickens)
8
60 ppm (0,12kg/t)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.101 / 108
Trade name Registration holder Registration nummer
Concentra-tion
Coefficient Max. dosing for complete feeds
Pigs Other
(pheasants)8
Flubenol 7.5% Janssen Pharmaceutica N.V. REG NL 5261 75g/kg 3 3 30 ppm (0,4kg/t) (pigs, chickens)
9
60 ppm (0,8kg/t) (pheasants)
9
Flutelmium 0.6% Janssen Pharmaceutica N.V. REG NL 6082 6g/kg 3 3 30 ppm (5kg/t) (pigs, chickens)
60 ppm (10kg/t) (pheasants)
Flutelmium 7,5% Janssen Pharmaceutica N.V. REG NL 6010 75g/kg 3 3 30 ppm (0,4kg/t) (pigs, chickens)
9
60 ppm (0,8kg/t) (pheasants)
9
Flubenol 5% Wirtz Farma B.V. REG NL 10380/3106
50 g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
Flubendazol 5% concentrate
Dopharma Research B.V. REG NL 101512
50g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
Ivermectine
Ivomec Premix Merial B.V. REG NL 8731 6g/kg 3 3 2,4 ppm (0,4kg/t)10
Noromectin Premix 0,6% G/G for pigs
Norbrook Laboratories Ltd (Station Works)
REG NL 10465
6g/kg 3 3 2,4 ppm (0,4kg/t)10
Ecomectin 6mg/g premix ECO Animal Health LTD. REG NL 10529
6g/kg 3 3 2,4 ppm (0,4kg/t)10
Lincomycine(-hydrochloride)/Spectinomycine(-sulfaat)
Lincomix 110 Pfizer Animal Health B.V. REG NL 7957 110g/kg Linco 3 3 220 ppm (2,0kg/t)11
Lincomix 220 premix Pfizer Animal Health B.V. REG NL 10076
44g/kg Linco. 3 3 220 ppm (5kg/t)
Vualin Plus-33 V11 Eurovet Animal Health B.V. REG NL 2295 6,6g/kg Linco. 6,6g/kg Spec
3 3 33 ppm (5kg/t)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.102 / 108
Trade name Registration holder Registration nummer
Concentra-tion
Coefficient Max. dosing for complete feeds
Pigs Other
Linco-spectin Premix Pfizer Animal Health B.V. REG NL 9708 22g/kg Linco. 22g/kg Spec
3 3 44 ppm (2kg/t)12
Oxytetracycline(-hydrochloride)
Feedmix V4 Dopharma Research B.V. REG NL 2158 80g/kg 3 3 800 ppm (10kg/t)
Feedmix Oxy 10% Dopharma Research B.V. REG NL 2004 100g/kg 3 3 700 ppm ( 7kg/t)
OTC-400 Framelco B.V. REG NL 7254 80g/kg 3 3 400 ppm (5kg/t)
OXY-400 V4 Eurovet Animal Health B.V. REG NL 7277 80g/kg 3 3 1000 ppm (12,5kg/t)
Chloromed 150mg/g premix
for pigs
Univet Ltd. REG NL
106877
150g/kg 3 3 400 ppm (2,66 kg/t)19
Paracetamol
Pracetam 10% Laboratoires Sogeval REG NL 10278
100g/kg 3 3 800 ppm (8kg/t)
Sulfadiazinenatrium/Trimethoprim
Feedmix Trim/sul 80/420 Aesculaap BV REG NL 1808 77,1g/kg Sulfa 16g/kg Trim
5 3 385 ppm Sulfa en 80 ppm Trim (5kg/t)
Trimethosulf premix Eurovet Animal Health B.V. REG NL 7589 62,5g/kg Sulfa 12,5g/kg Trim
5
2 625 ppm Sulfa en 125 ppm Trim (10kg/t)
Feedmix sulfatrim Dopharma Research B.V. REG NL 8541 60g/kg Sulfa 12g/kg Trim
5 3 600 ppm Sulfa en 120 ppm Trim (10kg/t)
Sulfamethoxazol/Trimethoprim
Feedmix TS Dopharma Research B.V. REG NL 8674 50g/kg Sulfa 10g/kg Trim
5 3 500 ppm Sulfa en 100 ppm Trim (10kg/t)
Tiamulinwaterstoffumaraat
Tiamutin 10% premix Novartis Consumer Health B.V. REG NL 8015 100g/kg 3 3 40 ppm (0,4 kg/t)13
Denagard 2% premix Novartis Consumer Health B.V. REG NL 8016 20g/kg 3 3 40 ppm (2,4 kg/t)14
Tialin 10% premix Eurovet Animal Health B.V. REG NL 10178
100g/kg 3 3 40 ppm (0,4 kg/t)13
Tialin 2% premix Eurovet Animal Health B.V. REG NL 10177
20g/kg 3 3 40 ppm (2,4 kg/t)14
Vetmulin 2% premix Huvepharma N.V. REG NL 100731
20g/kg 3 3 176 ppm (8,8 kg/t)
Vetmulin 10% premix for medicated feeds
Huvepharma N.V. REG NL 101337
100g/kg 3 1 3 1 180 ppm (1,8 kg/t)
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.103 / 108
Trade name Registration holder Registration nummer
Concentra-tion
Coefficient Max. dosing for complete feeds
Pigs Other
Tilmicosinefosfaat
Pulmotil G40 PREMIX Eli Lilly Nederland B.V /Elanco Animal Health
REG NL 9166 40g/kg 3 3 400 ppm (10 kg/t) (pigs) 200 ppm (5 kg/t) (rabbits)
Pulmotil G100 PREMIX Eli Lilly Nederland B.V /Elanco Animal Health
REG NL 9167 100g/kg 3 3 400 ppm (4 kg/t) (pigs)
200 ppm (2 kg/t) (rabbits)
Pulmotil G200 PREMIX Eli Lilly Nederland B.V /Elanco Animal Health
REG NL 9168 200g/kg 3 3 400 ppm (2 kg/t) (pigs)
200 ppm (1 kg/t) (rabbits)
Pneumotil G40 PREMIX Eli Lilly Nederland B.V /Elanco Animal Health
REG NL 10368
40g/kg 3 3 400 ppm (10 kg/t)
Tilmovet 10%, premix for medicated feed for pigs
Huvepharma N.V. REG NL
103646
100g/kg 1 1 400 ppm (4 kg/t)
Tilmovet 4% Huvepharma N.V. 40g/kg 1 1 400 ppm (10 kg/t)
Tilmovet 20%, premix for medicated feeds for pigs
Huvepharma N.V. REG NL
100742
200g/kg 1 1 400 ppm (2 kg/t)
Tylosinefosfaat
Tylan 100 Premix 10% Eli Lilly Nederland B.V /Elanco Animal Health
REG NL 3917 100g/kg 3 3 200 ppm (2 kg/t) (pigs) 1100 ppm (11 kg/t) (, chickens reared for laying)
Tylan 20 premix 2% Eli Lilly Nederland B.V /Elanco Animal Health
REG NL 9976 20g/kg 3 3 200 ppm (10 kg/t) (pigs) 1100 ppm (55 kg/t) (slaughter chickens, chickens reared for laying)
Tylan G250 Premix 25% Eli Lilly Nederland B.V /Elanco Animal Health
REG NL 9982 250g/kg 3 3 200 ppm (0.8 kg/t)15
(pigs) 1100 ppm (4,4 kg/t)
15
(slaughter chickens,
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.104 / 108
Trade name Registration holder Registration nummer
Concentra-tion
Coefficient Max. dosing for complete feeds
Pigs Other
chickens reared for laying)
Pharmasin 20 mg/g premix Huvepharma N.V. 20g/kg 1 1
Pharmasin 100mg/g premix for medicated feeds for pigs, slaughter chickens and chickens reared for laying
Huvepharma N.V. REG NL 101024
100g/kg 1 1 200 ppm (2 kg/t) 13
(pigs) 1100 ppm (11 kg/t) (slaughter chickens, chickens reared for laying)
Pharmasin 250mg/g premix for medicated feeds pigs, slaughter chickens and chickens reared for laying
Huvepharma N.V. REG NL 101027
250g/kg 1 1 200 ppm (0.8 kg/t)15
(pigs, chickens) 1100 ppm (4,4 kg/t)
15
(slaughter chickens, chickens reared for laying)
Tylvalosine
Aivlosin 42,5 mg/g ECO Animal Health Limited REG NL
10266
42,5g/kg 3 3 85 ppm (2 kg/t) (pigs)
16
Aivlosin 8,5 mg/g ECO Animal Health Limited REG NL
10430
8,5g/kg 3 3 85 ppm (10 kg/t) (pigs)
16
Valnemulin
Econor 1% Novartis Animal Health Austria
GmbH
REG NL 9792 10g/kg 3 3 75 ppm (7,5 kg/t) (pigs)
17
Econor 10% Novartis Animal Health Austria
GmbH
REG NL 9794 100g/kg 3 3 200 ppm (2 kg/t) (pigs)
18
Econor 50% Novartis Animal Health Austria
GmbH
REG NL 9795 500g/kg 3 3 200 ppm (0,4 kg/t)
(pigs) 18
For other products
- - .... 3 3 ….
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.105 / 108
1: Dosage for weaned piglets, calculated on the basis of a 15 mg dose of amoxicillin per kg of body weight per day. 2: The product is made up by mixing 2 kg of premix (concentration 250 g / kg) to 5 kg premix.
3: The dose was calculated on the basis of a 10 mg dose of doxycycline and 1 mg dose of bromine hexine per kg of body weight per day.
4: The dose was calculated on the basis of a 12.5 mg dose of doxycycline per kg of body weight per day.
5: The dose was calculated on the basis of a 10 mg dose of doxycycline per kg of body weight per day.
6: The dose was calculated on the basis of a 10 mg dose of florfenicol per kg of body weight per day.
7: The product is made up by mixing XX kg of premix (concentration 50 g/ kg) to 5 kg premix.
8: The product is made up by mixing XX kg of premix (concentration 500 g / kg) to 5 kg premix.
9: The product is made up by mixing XX kg of premix (concentration 75 g / kg) to 5 kg premix.
10: The dose was calculated on the basis of a 0,1 mg dose of ivermectine per kg of body weight per day.
11: The product is made up by mixing XX kg of premix (concentration 110 g / kg) to 5 kg premix.
12: The product is made up by mixing XX kg of premix (concentration 22 g / kg) to 5 kg premix.
13: The product is made up by mixing XX kg of premix (concentration 100 g / kg) to 5 kg premix.
14: The product is made up by mixing XX kg of premix (concentration 20 g / kg) to 5 kg premix.
15: The product is made up by mixing XX kg of premix (concentration 250 g / kg) to 5 kg premix.
16: Dose was calculated on the basis of a dose of 4,25 mg tylvalosine per kg of body weight per day.
17: Dose was calculated on the basis of a dose of 3-4 mg valnemulin per kg of body weight per day.
18: Dose was calculated on the basis of a dose of 10-12 mg valnemulin per kg of body weight per day.
19: Dose was calculated on the basis of a dose of 10-12 mg Oxytetracycline per kg of body weight per day
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.106 / 108
4.3 Product standards GMP+ BCN-NL1 Antibiotics-free feed
In the table below the product standards are stated that are applicable for the
Country Note GMP+ BCN-NL1 Antibiotics-free feed.
Antibiotic Maximum level in
μg/kg
Antibiotics - B lactam
AmoxiciIllin 200
Ampicillin 100
Penicillin G 100
Cloxacillin 20
Dicloxacillin 4
Nafcillin 200
Oxacillin 10
Cefalexin 100
Cefapirin 100
Cefazolin 100
Cefoperazone 50
Cefquinome 200
Ceftiofur 10
Antibiotics - Quinolones
Danofloxacin 40
Difloxacin 2
Cirprofloxacin 50
Enrofloxacin 4
Flumequine 2
Marbofloxacin 30
Oxolinic acid 2
Sarafloxacin 20
Norfloxacin 20
Cinoxacin 4
Antibiotics – Macrolides
Erythromycin 2
Spiramycin 2
Tilmicosin 0,2
Tylosin 4
Tylvalosin 4
Antibiotics - Phenicoles
Thiamphenicol 5
Florfenicol 1
Chloramphenicol 1,5
Antibiotics – Tetracyclines
Chlortetracycline 20
Doxycycline 1
Oxytetracycline 4
Tetracycline 20
Antibiotics – Pleuromutilines
Tiamulin 1
Valnemuline 2
Antibiotics - Lincosamides
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.107 / 108
Lincomycin 2
Antibiotics - Sulfonamides
Sulfadimethoxine 2
Sulfapyrimidine = sulfadiazine 2
Sulfamethoxazole 2
Sulfathiazole 2
Sulfamerazine 2
Sulfamethazine = sulfadimidine 2
Sulfadoxine 2
Antibiotics – other
Trimethoprim 2
Version: 18-10-2012 13:16Product Standards
© GMP+ International B.V.108 / 108