Gmp+ Ba1 Product Standards 1y5r6j

BA Module: Feed Safety Assurance

GMP+ BA1 GMP BA1 Product standards Version: June 2014

1

EN

© GMP+ International B.V. All rights reserved. The information in this publication may be consulted on the screen, ed and printed as long as this is done for your own, non-commercial use. For other desired uses, prior written permission should be obtained from the GMP+ International B.V.

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

1 / 109 © GMP+ International B.V.

History of the document Revision nr./ Date of approval 0.0 / 01-01-2010 0.1 / 17-03-2010 0.2 / 29-09-2010 0.3 / 14-11-2011 0.4 / 01-10-2012 0.4 / 11-2012 05 / 03-2014

Amendment Previous versions canvan be found in History van Overgang de documenten

Final implementation date 01-01-2010 17-03-2010 25-11-2010 20-12-2011 01-11-2012 01-03-2013

Changes in feed legislation: - maximum levels for melamine in canned pet food - special conditions on the imports of guar gum originating in or consigned from India - maximum levels for arsenic, cium, lead, nitrites, volatile mustard oil and harmful botanical impurities - maximum levels for radioactivity

Part A, par. 3

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

Part A, par. 3

New limit for Moulds and yeast

Part A, par. 3

Summary of residue standards for coccidiostats and histomonostats: minor corrections


Concers

Part B, par. 3.1


INDEX 1

INTRODUCTION

5

1.1

GENERAL

5

1.2

STRUCTURE OF THE GMP+ FEED CERTIFICATION SCHEME

5

PART A: PRODUCT STANDARDS

7

1

INTRODUCTION TO THE PRODUCT STANDARDS

7

2

CONDITIONS

7

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

8

4

RESIDUE LEVELS OF PESTICIDES IN FEEDS

83

4.1

INTRODUCTION

83

4.2

THE ESTABLISHMENT OF AND MRL 4.2.1 General 4.2.2 Questionnaire for basic products 4.2.3 Questionnaire for by-products 4.2.4 Questionnaire for compound feeds 4.2.5 Fumigators

4.3

83 83 85 86 86 86

SPECIAL REQUIREMENTS

89

PART B: RESIDUE STANDARDS

90

1

INTRODUCTION

90

2

ADDITIONAL PROVISIONS

91

2.1

GENERAL

91

2.2

COMPOUND FEED 2.2.1 Installation Carry-over level 2.2.2. The coefficient 2.2.3. Carry-over and flush batches 2.2.4 Items for attention and other remarks

2.3

PREMIX 2.3.1 General 2.3.2 Direct contamination 2.3.3 Indirect contamination

3

92 92 92 93 93 94 94 94 94

RESIDUE STANDARDS FOR COCCIDIOSTATS AND HISTOMONOSTATS 3.1 SUMMARY OF RESIDUE STANDARDS 3.2 ADDITIONAL INFORMATION FOR SOME COCCIDIOSTATS AND HISTOMONOSTATS *


95 95 100


4

RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL PRODUCTS 4.1

101

SUMMARY OF RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL PRODUCTS

101

4.2

OVERVIEW OF ISSIBLE MEDICATED PREMIXES

102

4.3

Product standards GMP+ BCN-NL1 Antibiotics free feed

108



1 Introduction 1.1

General

The GMP+ Feed Certification scheme was initiated and developed in 1992 by the Dutch feed industry in response to various more or less serious incidents involving contamination in feed materials. Although it started as a national scheme, it has developed to become an international scheme that is managed by GMP+ International in collaboration with various international stakeholders. Even though the GMP+ Feed Certification scheme originated from a feed safety perspective, in 2013 the first feed responsibility standard has been published. For this purpose, two modules are created: GMP+ Feed Safety Assurance (focussed on feed safety) and GMP+ Feed Responsibility Assurance (focussed on responsible feed). GMP+ Feed Safety Assurance is a complete module with standards 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 module can facilitate this excellently. Based on needs in practice, multiple components have been integrated into the GMP+ FSA standards, such as requirements for a feed safety management system, for application of HAC principles, to traceability, monitoring, prerequisites programmes, chain approach and the Early Warning System. With the development of the GMP+ Feed Responsibility Assurance module, GMP+ International is responding to requests from GMP+ participants. The animal feed sector is confronted with requests to operate more responsible. This includes, for example, the sourcing of soy and fishmeal which are produced and traded with respect for humans, animals and the environment. In order to demonstrate responsible production and trade, a company can get certified for the GMP+ Feed Responsibility Assurance. GMP+ International facilitates via independent certification the demands from the market. Together with the GMP+ partners, GMP+ International transparently lays down clear requirements in the Feed Certification scheme. Certification bodies are able to carry out GMP+ certification independently. GMP+ International s the GMP+ participants with useful and practical information by way of a number of guidance documents, databases, newsletters, Q&A lists and seminars. 1.2

Structure of the GMP+ Feed Certification scheme

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



GMP+ Feed Certification scheme A – documents General requirements for participation in the GMP+ FC scheme

B – documents Normative documents, appendices and country notes Feed Safety Assurance

Feed Responsibility Assurance

C – documents Certification requirements of the GMP+ FC scheme D – documents Guidelines to help companies with the implementation of the GMP+ requirements

All these documents are available via the website of GMP+ International (www.gmpplus.org). This document is referred to as GMP+ BA1 Product standards and is part of the GMP+ FSA module.



PART A: PRODUCT STANDARDS Introduction to the product standards There are references in the various GMP+ standards to the product standards. This part of this appendix contains the legal and a number of additional GMP+ product standards with respect to contaminants. The product standards included in this appendix are: a. the product standards as laid down in the European Union feed legislation, or b. a number of product standards, as determined within the framework of the GMP+ FSA scheme in consultation with the subsequent links in the animal production chain. DISCLAIMER: The GMP+ International has adopted this list in order to inform interested parties with respect to the standards in the legislation (European Union and additional GMP+ standards). The list will be regularly updated. The GMP+ International is not liable for any errors in this list.

2 Conditions In arriving at the product standards a distinction has been made between action and rejection limits. The action limits for undesirable contaminants is appreciably lower than the rejection limit. Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. Where the action limit is exceeded an investigation must be carried out into the source of the contamination and measures must be taken to remove or limit the source of the contamination. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If the rejection limit is exceeded then the product is not suitable for use as a feed material or animal feed. In the various GMP+ standards it is stated that the participant must ensure that deviations (in the product or process) from the requirements in this standard are recorded and controlled in order to prevent unintentional use or delivery of the product. Product standards for mixes of feed materials (semi-manufactured product) which are marketed as such The product standards for the maximum level of undesirable substances is calculated proportionately from the product standard for the individual components. This calculation principle is also applied for the calculation of the product standard for pesticides for compound feeds (see section 4.2.4 question no.5).



SUMMARY OF GMP+ PRODUCT STANDARDS FOR THE ANIMAL FEED SECTOR Contaminant

Product

Action limit(1)

Rejection limit(1)

Source

Supplementary requirements

Analysis method7

-

< 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

Microbiological: Other undesirable substances and products

M1

Antibacterial inhibition

- Feed materials

- 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)




Rejection limit(1)

Source


Analysis method7

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


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

From animal by-products derived canned petfood

-


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

Product

Action limit(1)

Microbiological

M3

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) [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.




Product

Action limit(1)

Rejection limit(1)

Source

Analysis method7


Microbiological: Microbiological contamination

M4a

Salmonella

Consumption chick feed: end products and feed materials for:

GMP+

- Top breeding consumption chicks

-

- Breeding increase consumption chicks

-

- Increase consumption chicks

-

OZM Part 2; M-2a to M2e

0+% 20(approaching 0%)



- Consumption chicks

-


Laying poultry feed: end products and feed materials for: - Top breeding laying poultry

GMP+ -


- Raising increase laying poultry

-


- Increase laying poultry

-

- Laying-hens and breeding hens

1%


0+% 20(approaching 0%) for S. enteritidus and S. typhimurium

Turkey feed: end products and feed materials for: - Raising increase turkeys

GMP+ -


0+% 20(approaching

- Increase turkeys

-

- Consumption turkeys

-

Other animal feeds, feed materials and wet mixes intended for cattle farms (except for poultry feeds). From animal by-products derived products with the exception of canned petfood

-

Absent in 25 gr

GMP+

-

Absent in 25 gr


0%)



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


Contaminant

M4b

Salmonella preservation determined through pH

Rejection limit(1)

Source

From animal by-products derived canned petfood

-

- Feed materials for delivery to cattle farms, and

Maximum pH for guarantee:

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

Product

Action limit(1)

Supplementary requirements Canned petfood which has been subjected to heat treatment with a Fc value of at least 3 If preservation can be achieved at a higher pH then this should be ed with data.

Analysis method7

OZM Part 2; M-5

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

- Spontaneous lactic acid fermentation

-

4.5

- Add organic acids

4

- Add inorganic acids

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.




Product

Action limit(1)

Rejection limit(1)

Source


-

10,000 kve/gram

GMP+


Suggestion for analysis method

Microbiological: Microbiological contamination

M5a

Moulds

OZM Part 2; M-4

- Wet mixes for delivery to livestock farmers with an Aw value > 0.75 (if this is not known then a moisture content > 13%) Feed materials

M5b

Yeast

6

10 CFU/g

6

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

10 CFU/g

Feed materials ≥ 12% moisture content or awvalue ≥ 0.95

-

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

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





Product

Action limit(1)

Rejection limit(1)

Source

Feed materials intended for (direct) delivery to dairy farmers

-

0.005 mg/kg

GMP+

Feed materials

-

0.02 mg/kg

Complementary and complete feed with the exception of:

-

0.01 mg/kg

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

- 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


Analysis method7

Chemical: Mycotoxin

C1

Aflatoxin B1

OZM Part 2; OSP1a to 1e





Product

Action limit(1)

Rejection limit(1)

Source


Analysis method7

-

0.01 mg/kg


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

OZM Part 2; OSP11

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

C2

Aldrin

Feed materials and compound feed, with the exception of:

Dieldrin (Singly or combined expressed as dieldrin)

- fats and oils,

0,1 mg/kg

- compound feed for fish

0.2 mg/kg





Action limit(1)

Rejection limit(1)

-

2 mg/kg

- 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, - seaweed meal and feed materials derived from seaweed

-

25 mg/kg15

-

40 mg/kg15

Iron particles used as tracer

-

50 mg/kg

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

-

30 mg/kg

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

-

50 mg/kg

- zinc oxide, manganous oxide and cupric oxide

-

100 mg/kg

Complete feed, with the exception of:

-

2 mg/kg

- complete feed for fish and fur animals.

-

10 mg/kg15

- complete feed for pet animals containing fish, other aquatic animals and products derived thereof and/or seaweed meal and feed materials derived from seaweed. Complementary feed, with the exception of:

-

10 mg/kg15

-

4 mg/kg

- mineral feed

-

12 mg/kg

Product

Source


Analysis method7

Chemical: Heavy metals

C3

Arsenic16


Feed materials, with the exception of:

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

OZM Part 2; OSP26


Contaminant

Product

Action limit(1)

Rejection limit(1)

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

10 mg/kg 15

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

30 mg/kg

Source


Analysis method7

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [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)




Action limit(1)

Rejection limit(1)

Source


-

50 mg/kg

- linseed

-

250 mg/kg

- linseed cakes - manioc products and almond cake.

-

350 mg/kg 100 mg/kg



-

50 mg/kg

- complete feed for young chickens (< 6 weeks)

-

10 mg/kg

Product


Analysis method7

Chemical: Other undesirable substances and products

C4

Hydrocyanic acid

OZM Part 2; OSP-9





Product

Action limit(1)

Rejection limit(1)

Source


Analysis method7

-

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; OSP23


C5

Biogenic amines*

- Animal feeds> 30% crude protein





Product

Action limit(1)

Rejection limit(1)

Source

Feed materials of vegetable origin

-

1 mg/kg

Feed materials of animal origin

-

2 mg/kg

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


Analysis method7


C6

Cium

Feed materials of mineral origin, with the exception of:

2 mg/kg

- phosphates

-

10 mg/kg

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

-

10 mg/kg

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

-

30 mg/kg

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

-

2 mg/kg

Premixtureses

-

15 mg/kg2

Complementary feed with the exception of:

-

0,5 mg/kg

-

5 mg/kg

-

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

Complementary feed for pet animals

-

2 mg/kg

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

-

15 mg/kg

-

0,5 mg/kg

OZM Part 2; OSP27

Mineral feed - containing < 7% phosphorus 8 - containing> 7% phosphorus

8

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


1 mg/kg


Contaminant

Product

Action limit(1)

Rejection limit(1)

- complete feed for pet animals

-

2 mg/kg

Source


Analysis method7

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [2]The maximum level established for premixtures takes into the additives with the highest level of lead and cium and not the sensitivity of the different animal species to lead and cium. 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 %.




Product

Action limit(1)

- Feed materials for delivery to livestock farms, and

10 g/kg (dry matter)

Rejection limit(1)

Source


Analysis method7

GMP+

If the action limit is exceeded then a warning or processing advice must be demonstrably communicated to the customer.

OZM deel 2; OSP22

Chemical: Salts

C7

Chloride

- Wet mixes for delivery to livestock farmers

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





Action limit(1)

Rejection limit(1)

Source

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

-

0.02 mg/kg

- fish oi

-

0.2 mg/kg


Complete feed for fish

-

0.05 mg/kg

Product


Analysis method7


C8

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

OZM Part 2; OSP11

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, 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.




Action limit(1)

Rejection limit(1)

Source

Feed materials and compound feed with the exception of:

-

0.02 mg/kg

- fats and oils

-

0.05 mg/kg


Product


Analysis method7


C9

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

OZM Part 2; OSP11





Product

Action limit(1)

Rejection limit(1)

Source

Feed materials and compound feed

-

100 mg/kg



Analysis method

Chemical: Botanical impurities C10

Crotalaria spp.

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.




Action limit(1)

Rejection limit(1)

Source


-

0.05 mg/kg

- fats en oils

-

0.5 mg/kg


Product


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)

OZM Part 2; OSP11





Product

Action limit(1)

Rejection limit(1)

Source

-

0

Regulation 999/2001, art. 7 and Appendix IV


Analysis method7


C12

Prohibited Animal proteins (Restricted animal proteins)

Animal feeds for productive livestock

See GMP+ BA 3: Negative list

OZM Part 2; OSP12





Action limit(1)

Rejection limit(1)(4)

Source


Analysis method7

0,5 ng WHOPCDD/FTEQ/kg

0,75 ng WHOPCDD/F-TEQ/kg

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

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

OZM Part 2; OSP18

0,5 ng WHOPCDD/FTEQ/kg 0,5 ng WHOPCDD/FTEQ/kg


Animal fat including milk fat and egg fat



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



Fish oil



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



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



Product

(4)

Chemical: Toxic substances

C13a

Feed materials of plant origin with the exception of Dioxin 18 vegetable oils and their by-products (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHOTEFs (toxic equivalency factors, Vegetable oils and their by-products 2005)) Feed materials of mineral origin


Feed materials of animal origin:


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


Contaminant

Product

Action limit(1)

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


(4)

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

C13b

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




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



Premixes



Compound feeds with the exception of:



- compound feed for pet animals and fish



- compound feed for fur animals

-

-

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

1.25 ng WHOPCDD/F-PCBTEQ/kg

Vegetable oils and their by-products

1.5 ng WHOPCDD/F-PCB-

Source


Analysis method7



OZM Part 2; OSP18


Contaminant

Product

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

Action limit(1) (4)


Source


Analysis method7

TEQ/kg Feed materials of mineral origin

1,0 ng WHOPCDD/F-PCBTEQ/kg

Feed materials of animal origin: - Animal fat including milk fat and egg fat


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


- Fish oil

20,0 ng WHOPCDD/F-PCBTEQ/kg 4,0 ng WHOPCDD/F-PCBTEQ/kg

- Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20% fat6 - Fish protein hydrolysates containing more than 20% fat The feed additives kaolinitic clay, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin, belonging to the functional groups of binders and anti-caking agents Feed additives belonging to the functional group of compound of trace elements.


Premixtures

1.5 ng WHOPCDD/F-PCBTEQ/kg 1.5 ng WHOPCDD/F-PCBTEQ/kg

Compound feed with the exception of:


9,0 ng WHOPCDD/F-PCBTEQ/kg 1.5 ng WHOPCDD/F-PCBTEQ/kg

- Compound feed for pet animals and fish


- Compound feed for fur animals

-


C13c

Contaminant

Product

Action limit(1)

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

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

0.35 ng WHOPCB-TEQ/kg

Vegetable oils and their by-products


Feed materials of mineral origin


(4)


Source


Analysis method7


OZM Part 2; OSP18

Feed materials of animal origin: - Animal fat including milk fat and egg fat




- Fish oil

11,0 ng WHOPCB-TEQ/kg

- Fish, other aquatic animals and products derived 2,0 ng WHOthereof with the exception of fish oil and fish PCB-TEQ/kg protein, hydrolysed, containing more than 20% fat 6


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


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


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


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


Contaminant

C13d

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

Product

Action limit(1)

Premixtures




- Compound feed for pet animals and fish,


- Compound feed for fur animals

-

(4)


Source


Analysis method7


Feed materials of plant origin

10 μg/kg (ppb)

Feed materials of mineral origin

10 μg/kg (ppb)

Feed materials of animal origin:

10 μg/kg (ppb)

- Animal fat, including milk fat and egg fat

10 μg/kg (ppb)


10 μg/kg (ppb)

- Fish oil

175 μg/kg (ppb)

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

30 μg/kg (ppb)

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

50 μg/kg (ppb)

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

10 μg/kg (ppb)

5



Contaminant

Action limit(1)

Product

(4)


Source


Analysis method7

the functional groups of binders and anti-caking agents Feed additives belonging to the functional group of compounds of trace elements

10 μg/kg (ppb)

Premixture

10 μg/kg (ppb)


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-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification. [5] Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 75 μg/kg product are applicable to fresh fish and 200 μg/kg product are applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food. [6] Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 3,5 ng WHO-PCDD/FTEQ/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) [18] Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs: WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin- like Compounds. Toxicological Sciences 93(2), 223–241 (2006))

Congener

TEF value

Dibenzo-p-dioxins (PCDDs)

Congener

TEF value

Dioxin-like PCBs:

2,3,7,8-TCDD

1

1,2,3,7,8-PeCDD

1

Non-ortho-PCBs

1,2,3,4,7,8-HxCDD

0.1

PCB 77

0,0001

1,2,3,6,7,8-HxCDD

0.1

PCB 81

0,0003

1,2,3,7,8, 9-HxCDD

0.1

PCB 126

0,1

0.01

PCB 169

0,03

1,2,3,4,6,7,8-HpCDD OCDD

0,0003 Mono-ortho-PCBs



Dibenzofuranes (PCDFs)

PCB 105

0,00003

2,3,7,8-TCDF

0.1

PCB 114

0,00003

1,2,3,7,8-PeCDF

0,03

PCB 118

0,00003

2,3,4,7,8-PeCDF

0,3

PCB 123

0,00003

1,2,3,4,7,8-HxCDF

0.1

PCB 156

0,00003

1,2,3,6,7,8-HxCDF

0.1

PCB 157

0,00003

1,2,3,7,8,9-HxCDF

0.1

PCB 167

0,00003

2,3,4,6,7,8-HxCDF

0.1

PCB 189

0,00003

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

0.01

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

0.01

OCDF

0,0003

Abbreviations used: T= tetra;

Pe= penta;


Hx=hexa;

Hp= hepta;

O= octa;

CDD= chlorodibenzodioxin;

CDF= chlorodibenzofuran;

CB= chlorobiphenyl



Product

Action limit(1)

Rejection limit(1)

Source


Analysis method7

GMP+

(*) The supplier provides information to the livestock farmer in the event of infringement of the action limit for the level of the undesirable substance and provides advice on processing the product in the days ration

OZM Part 2; OSP19 ELISA, Lateral flow analysis

Chemical: Mycotoxin

C15

DON

Animal feed on full ration basis for:

(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

- 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

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

The European Commission has published “Recommendation 2006/576/EC” regarding the guidance values for this mycotoxin. GMP+ International has established other values to comply.





Product

Action limit(1)

Rejection limit(1)

Source


Analysis method7


C16

Endosulfan (sum of alfa and bètaisomers and of endosulfan sulphate, expressed as endosulfan)


0,1 mg/kg

- maize and maize products derived from the processing thereof

-

0,2 mg/kg

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

-

0,5 mg/kg

- crude vegetable oil,

-

1,0 mg/kg

- complete feed for fish except for Salmonids,

-

0,005 mg/kg

- complete feed for Salmonids

-

0,05 mg/kg

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

OZM Part 2; OSP11





Action limit(1)

Rejection limit(1)

Source


-

0.01 mg/kg

- fats and oils

-

0.05 mg/kg


Product


Analysis method7


C17

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

OZM Part 2; OSP11





Product

Action limit(1)

Rejection limit(1)

Source


-

150 mg/kg

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

-

500 mg/kg


- marine crustaceans such as marine krill

-

3 000 mg/kg

- phosphates

-

2 000 mg/kg


-

350 mg/kg

- magnesium oxide

-

600 mg/kg

- calcareous marine algae

-

1,000 mg/kg

Vermiculite (E 561)

-

3 000 mg/kg

- containing < 4% phosphorus 8

-

500 mg/kg

- containing > 4% phosphorus 8

-


-

125 mg/kg per 1% phosphorus 8 150 mg/kg

- 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


Analysis method7

Chemical: Salts

C19

Fluorine 3

OZM Part 2; OSP-6

Complementary feed

- complete feed for cattle, sheep and goats



[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)




Action limit(1)

Rejection limit(1)

Source


-

0.01 mg/kg

- fats and oils

-

0.2 mg/kg


Product


Analysis method7


C20

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

OZM Part 2; OSP11





Action limit(1)

Rejection limit(1)

Source


-

0.01 mg/kg

- fats and oils

-

0.2 mg/kg


Product


Analysis method7


C21

Hexachlorobenzene (HCB)

OZM Part 2; OSP11





Product

Action limit(1)

Rejection limit(1)

Source



Analysis method7


C22a

Hexachlorocyclohexane (HCH):

- Alfa-isomer


-

0.02 mg/kg

- fats and oils

-

0.2 mg/kg

OZM Part 2; OSP11





Product

Action limit(1)

Rejection limit(1)

Source



Analysis method7


C22b


- Beta-isomer

-

Compound feeds with the exception of:

-

0.01 mg/kg

- compound feed for dairy cattle

-

0.005 mg/kg


-

0.01 mg/kg

- fats and oils

-

0.1 mg/kg

OZM Part 2; OSP11





Product

Action limit(1)

Rejection limit(1)

Source



Analysis method7


C22c


- Gamma-isomer (lindane)

-


-

0.2 mg/kg

- fats and oils

-

2.0 mg/kg

OZM Part 2; OSP11





Product

Action limit(1)


60 g/kg (dry matter)

Rejection limit(1)

Source


Analysis method7

GMP+


OZM deel 3; WM08

Chemical: Salts

C23

Potassium

- Wet mixes for delivery to cattle farmers






Product

Action limit(1)

Rejection limit(1)

Source

Animal fat, with the exception of:

-

400 mg/kg (on product basic)

GMP+

- crude fish oil

-

3,000 mg/kg (on product basic)

Vegetable oil (with the exception of sunflower oil)

-


Sunflower oil and sunflower fatty acids

-


Vegetable fatty acids incl. Mixes of fatty acids (with the exception of sunflower fatty acids)

-


Palm oil

-

25 mg/kg calculated as diesel oil

Analysis method7



C24

Hydrocarbons (C10-C40)

Hydrocarbons (mineral paraffin/oil) : saturated hydrocarbons in the range C10C56 from external sources minus the alkanes C27, C29 and C31

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


Commission Regulation (EC) 1151/2009 of 27 November 2009

OZM Part 2; OSP15a

This norm applies if the hydrocarbons (calculated as diesel oil) are determined via the GCMS method. If use is made of the GC-FID method, then the norm for vegetable oil applies

OZM Part 2; OSP15b

The batch must be accompanied by a report of analysis and a Health certificate

The sampling has to be performed in accordance with Commission Regulation (EC) No 333/2007 and the standard ISO5555:2003 and the analysis by a laboratory accredited according to EN ISO/IEC 17025

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently.



Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods)




Product (complete feedingstuff)

Action limit(1)

Rejection limit(1)

Source


Analysis method7


C25

Copper (E4)

Pigs: - Piglets up to 12 weeks

-

170 mg/kg total

- Other pigs

-

25 mg/kg total

- 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

Bovine: 1. Bovine before the start of rumination:

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

OZM Part 1; TVMI-2





Product

Action limit(1)

Rejection limit(1)


-

0.1 mg/kg

- 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

Source


Analysis method7


C26

Mercury 16


OZM Part 2; OSP-5

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [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)




Product

Action limit(1)

Rejection limit(1)


-

10 mg/kg

-

30 mg/kg

- phosphates and calcareous marine algae

-

15 mg/kg


-

20 mg/kg

- yeast

-

Source


Analysis method7


C27

Lead *

- forage

9

5 mg/kg

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

100 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


OZM Part 2; OSP28


400 mg/kg

Complementary feed, with the exception of:

-

10 mg/kg

- mineral feed

-

15 mg/kg

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

-

60 mg/kg

-

5 mg/kg

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a 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 the additives with the highest level of lead and cium and not the sensitivity of the different animal species to lead and cium. As provided



in Article 16 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJL 268, 18.10.2003, p. 29), in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feed. [11] Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials. * for the determination of lead in kaolinitic clay and in feed containing kaolinitic clay, the maximum level refers to an analytical determination of lead, whereby extraction is performed in nitric acid (5 % w/w) for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.




Product

Action limit(1)

Rejection limit(1)

Source

Feed materials and compound feed containing unground cereals

-

1,000 mg/kg



Analysis method7

Chemical: Mycotoxin

C28

Rye ergot (Claviceps purpurea)

OZM Part 2; OSP32





Product

Action limit(1)


8 g/kg (dry matter)

Rejection limit(1)

Source


Analysis method7

GMP+


OZM deel 3; WM09

Chemical: Salts

C29

Sodium

- Wet mixes for delivery to cattle farmers






Product

Action limit(1)

Rejection limit(1)

Feed fats

20 mg / kg (on a fat basis)

50 mg / kg (on a fat GMP+ basis)

Source


Analysis method7


C30

Nickel

OZM Part 2; OSP29

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a mo isture content of 12% unless mentioned differently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Ma ximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods)




Action limit(1)

Rejection limit(1)

Source


-

15 mg/kg (expressed in sodium nitrite)

- Fish meal

-

30 mg/kg (expressed in sodium nitrite) -

- Products and by-products from sugar beet and sugarcane and from starch production and alcoholic drink production. Complete feed, with the exception of:

-

-


-

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

-

15 mg/kg (expressed in sodium nitrite) -

Product


Analysis method7


C31

Nitrites

- silage

OZM Part 2; OSP-7





Product

Action limit(1)

Rejection limit(1)

Source

Feed material and compound feed

-

3,000 mg/kg



Analysis method

Chemical: Botanical impurities C32

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






Product

Action limit(1)

Rejection limit(1)

Source

-

1,000 mg/kg



Analysis method

Chemical: Botanical impurities C32a

- Datura sp.

Feed material and compound feed





Product

Action limit(1)

Rejection limit(1)

Source

-

0,15%

Commission Regulation (EU) 142/2011, Annex X, Chapter II, Section 3


Analysis method7


C33

Insoluble impurities

Rendered fats from ruminants

OZM Part 2; OSP16





Product

Action limit(1)

Rejection limit(1)

Source


Analysis method7

GMP+


OZM Part 2; OSP19 HPLC, ELISA, Lateral flow analysis

Chemical: Mycotoxin

C34

Ochratoxin A

Animal feed on full ration basis for: - sows and consumption pigs and piglets

0.04 mg/kg

0.05 mg/kg

- poultry

0.16 mg/kg

0.2 mg/kg


- Sows and pigs and piglets

0.05 mg/kg

0.15 mg/kg

- Poultry

0.2 mg/kg

0.6 mg/kg

The European Commission has published recommendation 2006/576/EC regarding the guidance values for this mycotoxin. GMP+ International has established other values to comply.





Product

Action limit(1)

Rejection limit(1)

Source


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

160 μg/kg (on fat basis)


GMP+

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



(PAH4=sum of benzo(a)pyrene, benzo(a)anthracene, benzo(b)fluoranthene and chrysene See the GMP+ D documents: - GMP+ D4.14 - GMP+ D415

Analysis method


C35a

Polycyclic Aromatic Hydrocarbons (PAH4)

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

http://www.gmpplus.org/nl/gmp+_fsa/Ddocumenten.php

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed.




Product

Action limit(1)

Rejection limit(1)

Source

Feed materials and compound feed.

-

10 mg/kg 23



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


[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.




Product

Action limit(1)


8 g/kg (dry matter)

Rejection limit(1)

Source

Analysis method7


Chemical: Salts

C39

Sulphate

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

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; OSP24





Product

Action limit(1)

Rejection limit(1)

Source


-

300 mg/kg

- complete feed for pigs

-

200 mg/kg

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

-

50 mg/kg



Analysis method7

Chemical: Antinutritional factors: Alkaloids C40

Theobromine

OZM Part 2; OSP-8





Product

Action limit(1)

Rejection limit(1)

Source

Complete feed for poultry with the exception of:

-

1,000 mg/kg

- complete feed for laying hens

-

500 mg/kg



Analysis method7


Vinyl thiooxazolidone (5vinyloxazolidine-2-thione)

OZM Part 2; OSP31





Product

Action limit(1)

Rejection limit(1)

Source


-

100 mg/kg (calculated as allylisothiocyanate)

- rapeseed cakes - Camelina seed and products derived thereof (*), products derived from mustard seed (*), rape seed and products derived thereof. Complete feed, with the exception of:

-

4,000 mg/kg (calculated as allylisothiocyanate)

-



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

-

1,000 mg/kg (calculated as allylisothiocyanate)

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

-



Analysis method7


Volatile mustard oil

OZM Part 2; OSP20

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




Product

Action limit(1)

Rejection limit(1)

Source


-

20 mg/kg

- cotton seed

-

5,000 mg/kg

- cotton seed cake and cotton seed meal

-

1,200 mg/kg



-

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


Analysis method

Chemical: Antinutritional factors: Other C43

Free gossypol

OZM Part 2; OSP21





Product

Action limit(1)

Rejection limit(1)

Source


Analysis method7

GMP+


OZM Part 2; OSP19 HPLC, ELISA, Lateral flow analysis

Chemical: Mycotoxin

C44

Zearalenon

Animal feed on full ration basis for: - sows and consumption pigs

0.2 mg/kg

0.25 mg/kg

- young pigs

0.08 mg/kg

0.1 mg/kg

- young cattle and dairy cattle

0.4 mg/kg

0.5 mg/kg


- sows and pigs

0.25 mg/kg

0.75mg/kg

- young pigs

0.1 mg/kg

0.3 mg/kg

- young cattle and dairy cattle

0.2 mg/kg

1.5 mg/kg

The European Commission has published “Recommendation 2006/576/EC” regarding the guidance values for this mycotoxin. GMP+ International has established other values to comply.





Product

Action limit(1)

Rejection limit(1)

Source

Pets13

-

250 mg/kg total

Fish 13

-

200 mg/kg total

-

200 mg/kg total

-

150 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


Analysis method7


C45

Zinc (E6)

13

Milk replacer

13

Other animals

OZM Part 1; TVMI-4

[1 ] Action limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should be taken to remove or control that cause. Maximum levels in m g/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently. Rejection limit: A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, deri ved to a moisture content of 12% unless mentioned differently. [7] The research methods (OZM) can be found via the PDV website (www.pdv.nl ; quality; research methods) [13] If the GMP norm for this product and the animal type in question is lower than the norm specified here, then the GMP no rm applies. In complete animal feed




Rejection limit(1)

Source


Feed, with the exception of

2,5 mg/kg

- canned pet food

2,5 mg/kg *


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

Product

Action limit(1)

Analysis method


C46

Melamine 24

- the following feed additives: - 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. *: The maximum level is applicable to canned pet food as sold.




Product

Action limit(1)

Rejection limit(1)

Source


Analysis method

GMP+ (Commission Recommendation No 2006/576/EC)

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

HPLC, Lateral flow analysis

Chemical: Mycotoxin

C109

Fumonisin B1 + B2

Feed materials

- maize and maize products *

60 mg/kg

Complementary and complete feedingstuffs for: - pigs, horses (Equidae), rabbits and pet animals

5 mg/kg

- fish

10 mg/kg

- poultry, calves (< 4 months), lambs and kids

20 mg/kg

- adult ruminants (> 4 months) and mink

50 mg/kg

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




Product

Action limit

Rejection limit

Source


Analysis method


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

HPLC, ELISA, Lateral flow analysis

Chemical: Mycotoxin

C113

T-2 and HT-2 toxin, Sum of

Unprocessed cereals:

- barley (including malting barley) and maize

200 μg/kg (on product basis) *

- oats (with husk)

1000 μg/kg(on product basis) *

- wheat, rye and other cereals

100 μg/kg(on product basis) *

Cereal products for feed and compound feed - oat milling products (husks)

2000 μg/kg *1

- other cereal products

500 μg/kg *1

- compound feed, with the exception of feed for cats

250 μg/kg *1

Compound feed for cats

0,05 mg/kg *1


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




Product

Action limit(1)

Rejection limit(1)

Source


Analysis method7


-

1.5 g/kg (dry matter basis)

GMP+

Via manual separation and weighing

Microscopic determination in accordance with the instructions of the laboratory.

Fysical: Bodies foreign to the product

F1

Plastics

See GMP+ BA 3: Negative list - Wet mixes for delivery to livestock farmers

This norm was included subject to the outcome of the discussion taking place in the European Commission.





Product

Action limit(1)

Rejection limit(1)

Source


Analysis method7


0.25 g/kg (on fat basis)

0.5 g/kg (on fat basis)

GMP+

See GMP+ BA 3: Negative list.

OZM Part 2; OSP13

Fysical: Bodies foreign to the product

F2

Polyethylene

- Wet mix for delivery to livestock farmers





Product

Action limit(1)

Rejection limit(1)

Source


-

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



Analysis method

Fysical: Botanical impurities F5

Unhusked beech mast - Fagus siylvatica L.




SUMMARY OF GMP+ PRODUCT STANDARDSNORMS FOR THE ANIMAL FEED SECTOR Contaminant

Product

Action limit(1)

Rejection limit(1)

Source


-




Analysis method


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





Product

Action limit(1)

Rejection limit(1)

Source


Analysis method


Ethiopian mustard – Brassica carinata A. Braun


-







Product

Action limit(1)

Rejection limit(1)

Source


Analysis method


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


-







Product

Action limit(1)

Rejection limit(1)

Source

-




Analysis method


Purghera - Jatropha curcas L.






Product

Action limit(1)

Rejection limit(1)

Source


-




Analysis method

Fyscial: Botanical impurities F12

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





Product

Action limit(1)

Rejection limit(1)

Source

Feed materials 12 , with the exception of:

-

50 mg/kg



Analysis method


Seeds from Ambrosia spp.

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

200 mg/kg

-

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.




Product

Action limit(1)

Rejection limit(1)

Source

-




Analysis method


Black mustard – Brassica nigra (L.) Koch






Product

Action limit(1)

Rejection limit(1)

Source


Analysis method

Commission Implementing Regulation (EU) No 961/2011 Commission Implementing Regulation (EU) No 996/2012 repealing Commission Implementing Regulation (EU) No 961/2011 and 284/2012

Special conditions governing the import of feed originating in or consigned from Japan following the accident at the Fukushima nuclear power station.

Fysical: Other undesirable substances and products F26

Radioactivity

Sum of Cs-134 and Cs-137

Feedingstuffs

-

500 (Bq/kg)

Sum of Isotopes of iodine, notably I-131

Feedingstuffs

-

2 000 (Bq/kg)

Sum of Cs-134 and Cs-137

Feed intended for:

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

- cattle and horses

100 (Bq/kg)

- pig

80 (Bq/kg)

- poultry

160 (Bq/kg)

- fish (*)

40 (Bq/kg)

In order to ensure consistency with action levels currently applied in Japan, this value replaces on a provisional basis the value laid down in Commission Regulation (Euratom) No 770/90. This value is laid down on a provisional basis and taken to be the same as for foodstuffs, pending an assessment of transfer factors of iodine from feedingstuffs to food products.) See Commission Implementing Regulation (EU) No 996/2012 Annex III for additional requirements.

[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. * With the exemption of feed for ornamental fish.



4

4.1

Residue levels of pesticides in feeds

Introduction

A start was made in April 2005 in the EU on the revision of the community legislation with respect to the permitted maximum levels of residues of pesticides by way of Regulation (EG) No. 396/2005. This regulation includes the maximum residue levels (MRL) for simple products of vegetable and animal origin intended for human consumption and for feeds. In as much as the MRLs apply to feeds they are applicable to both feeds for food-producing animals and for non-food-producing animals. The layout of the standard is such that in many cases it is not possible immediately to indicate a standard for a certain combination of feed / pesticide. This chapter indicates: a. How the correct standard for a simple, untreated/unprocessed product can be out-of-date; b. How the correct standard for a derived product can be determined; c. How the correct standard for a compound feed can be determined; d. Which special requirements apply. 4.2

The establishment of and MRL

4.2.1 General The MRLs (maximum residue levels) are established for simple products. Many of these MRLs are to be found on “Pesticides Web”, a database which was created by the EC. (http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=substance.selection &ch=1) This is almost always the untreated form of a product. This means that a number of calculations must be carried out both for the determination of the MRL in a derived product (for example, sunflower oil, maize gluten meal) and for the determination in compound products (compound feeds, supplementary feeds). The correct standard can be determined using the enclosed questionnaires. The basic principle of the questionnaires is that there is a known pesticide and that the associated residue standard must be found for a particular feed. The questionnaires have been drawn up so that you always are led to a result. The following questionnaires are available. a. Questionnaire for basic products. This questionnaire helps you determine the MRL for basic products. b. Questionnaire for by-products. This questionnaire helps you determine the MRL for auxiliary products. c. Questionnaire for compound feeds. This questionnaire helps you determine the MRL for compound feeds. It is of great importance to note here that Regulation (EC) No. 396/2005 only applies to products of vegetable or animal origin! If this is not the case then any standards in Directive 2002/32/EG still apply.



To make this chapter easier to read the questionnaire makes use of the definitions in the following table. Table 1: Definitions and questionnaires

Product group

Definition

Questionnaire

Basic product

Simple, unprocessed product of vegetable or animal origin (wheat,

4.2.2.

barley, linseed, sunflower seeds, soya bean, peas, shrimps) Auxiliary products

Simple, treated/processed or derived product, originating from an

4.2.3

basic product. (flour, semolina pellets, potato press fibres, soya flakes, linseed oil, peapod meal, fish meal) Compound feed

Compound product consisting of at least two components being basic

4.2.4.

products, by-products and/or feed additives. (complete feed, supplementary feed, petfood, grain mixes, premixes)

NOTE: These definitions have only been drawn up to improve the readability of Chapter 4 and have no value or legitimacy outside this chapter. The questionnaires help you to determine the standard. You are not always immediately 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) Palm hearts

Fish, fish products, crustaceans and shellfish and other products from salt and fresh water creatures* Only for crops used for feed* Loquats Cherimoya’s Guavas

Kohl-rabi foliage

Bread fruits

Leaves and sprouts of Brassica spp. Purslain Vine leaves Herbs (sage, rosemary, thym, basi, laurel, tarragon) Lentils (fresh) Bamboo shoots

Durians Soursops (durian blanda) Arrowroot

Nut shells Sprouts stems

Palm kernels

Garden cress

Fungi

Palm fruits

Winter cress Rucola Red amsoi

Seaweed Lupines (dried) Shells, seeds and possibly skins of oil-retaining seeds and fruits (such as soya hulls) Borage

Kapok Millet Sorghum

Pumpkin seed Hemp seed Camelina

Herbal tea Cacao bean Carob

Safflower seed Olives (oil recovery)

Spices Sugar crops

Coffee beans

* : The standards of Reg. 396/2005 apply neither to feeds nor to foodstuffs for (parts of) products in these groups.

For all other products of vegetable or animal origin, Regulation (EC) No. 396/2005 applies.



4.2.2 Questionnaire for basic products 1.

Is your basic product in Table 2 and does it have the exclusive destination animal feed? Yes This new regulation does not yet apply to your basic product. Check if Directive 2002/32/EG contains a standard for your basic product / pesticide combination (end). No Go to question 2.

2.

Is your basic product included in Appendix I of Reg. 396/2005, either as an Individual product (column 3, 4 and 5) or as a group of products (column 2)? Yes Go to question 3. No Your basic product is probably not a simple untreated / Unprocessed product of vegetable or animal origin. Check your product using 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 Pesticides 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 current 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 Pesticides 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 products to which your basic product belongs and the pesticide for which you want the MRL. Click on the button “Search current MRL”. You have found the standard. Place the mouse cursor on the MRL or click on the pesticide for additional information (end).



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 byproduct (column 2 in combination with 3, 4 or 5) or as a group of products (column 2) or in the form of the original product? Yes Go to question 3. No Your by-product is probably not a product of vegetable or animal origin. Check your product using the definitions in Table 1. Consult your supplier.

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 byproduct/pesticide combination (end). You have established that the standards from this regulation apply to your by-product. You then use the questionnaire for basic products (4.2.2.) question 3 and further, to determine the standard for your individually-specified by-product, the original product or the relevant product group. Now proceed with question 4 in this questionnaire.

4.

Is the by-product for which the standard is established equal to the byproduct for which you are looking for a standard? Yes The standard you have found is the standard for this by-product / pesticide combination. (end) No Go to question 5.

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.



NOTE: At the time of the first publication of this document Appendix VI was not yet completed 6.

Is the treatment / processing for this by-product based on the separation of a fat and water fraction? Yes Go to question 7. No The processing / treatment has no effect on the residue level, the standard which you have found is the final standard for this byproduct/pesticide combination. (end)

Your by-product has been created as a result of the separation of a fat-oil fraction and a fat-oil free fraction (pressing, extraction). In the rest of this questionnaire you determine if there is an accumulation of residues in the fat fraction or in the fat-free fraction 7.

Does the name of the pesticide in Pesticiden Web have the suffix (F)? Yes The pesticide is soluble in fat. Determine, using the fat percentage in the original product and in your by-product, the dilution or concentration factor see website MVO: http://www.mvo.nl/voedselveiligheid/codes/MVO-reportingrequirements-on-pesticides) and divide or multiply this by the standard found for the original product(group) in order to determine the final standard.(end) 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? Yes The pesticide is soluble in fat. Determine, using the fat percentage in the original product and in your by-product, the dilution or concentration factor and divide or multiply this by the standard found for the original product(group) in order to determine the final standard(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 byproduct. (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 dilution or concentration factor and divide or multiply this by the standard you found for the original product or product group in order to determine the final standard.(end). Note: In this case, where there is a pesticide which is soluble in water, there is dilution of the fat fraction and concentration of the fatfree fraction!



NOTE: the method described in this section for the determination of maximum residue limits (MRL) in fats and oils also applies to fatty acids.

4.2.4 Questionnaire for compound feeds 1.

Specify the individual components of your compound feed. In Reg. 396/2005, Appendix VI, has a concentration or dilution factor has been established for your compound feed, A certain fraction of your compound feed. A byproduct that is part of your compound feed? Yes Use this factor or factors to determine the final standard for this specific part of your compound feed and to determine the pesticide in question. Go to question 2 . No Go to question 2.

NOTE: At the time of the first publication of this document Appendix VI was not yet completed 2.

Does your compound feed contain basic products among other things? Yes For each of these components go through the questionnaire in par. 4.2.2. In order to determine the standards for these components. Go to question 3 No Go to question 3.

3.

Your compound feed contains (among other things) by-products. For each of these components go through the questionnaire in par. 4.2.3. In order to determine the standards for these components. Go to question 4.

4.

Have you determined a standard for all the components for which a standard has been set and have you taken 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 component / 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 pesticide specified in Appendix II or III of Reg. 396/2005. This relates to an excess as a



result of treatment of feeds with gaseous pesticides (gas generation, fumigation) after harvesting. The pesticides for which this permission applies and also the products involved are specified in Appendix VII of Reg. 396/2005.

4.3

Special requirements

In addition to the standards for undesirable substances which have a broad validity within the feed chain, some specific measures are announced with some regularity for precisely-defined products or product groups. These are often temporary measures as a result of very specific contamination. The following measures are currently in force. Decision 2008/352/EG of 29/04/08 adopting special requirements for guar flour originating or sent from India due to the risks of contamination of this product with pentachlorophenol and dioxins. Commission Regulation EU) No 258/2010 of 25 March 2010 imposing special conditions on the imports of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins, and repealing Decision 2008/352/EC.



PART B: RESIDUE STANDARDS

1

INTRODUCTION

In addition to compliance with the adopted standards in appendix 1, part A, the participant must also comply with the (residue) levels of additives and veterinary medical products. Please refer to the definition of feed safety as laid down in the list of definitions for the GMP+ Feed Safety Assurance scheme. The participant must ensure that a. the correct additives and veterinary medical products get into the right feed in the right dosage (GMP+ B1, section 6.7.1.2). b. (residues of) additives and veterinary medical products are not present or are under set maximum limits (the so-called residue standards) in feeds in which they should not be present (GMP+ B1, section 6.7.1.5). In order to be able to control the residue levels the participant should, among other things, measure carry-over in the installations (see GMP+ BA4) and establish production sequences. In chapter 2 of part B of this appendix there are further instructions for this. Chapter 3 of part B of this appendix states the maximum residue standards for coccidiostats, histomonostats and critical veterinary medical products. These standards apply to compound feeds, semi-manufactured products, feed materials and premixtures and are applicable to producers of these products.



2

Additional provisions

2.1

General

The control of residue levels using the production sequence is shown in diagram form in the following table. Wall adhesion factor measurement instruction

Relative wall adhesion factor measurement

Installation internal carry-over

Coefficient factor (GMP+ BA1, Part B, Chapter 3)

Carried out by TNO-Nutrition

Carry-over measurement instruction (GMP+ BA 4)

Coefficient (=carry-over x factor)

Carry-over percentage

Max. residue norm (GMP+ BA1, Part B, Chapter 3)

Calculation

Production sequence / flush batches



2.2

Compound feed

2.2.1

Installation Carry-over level:

The installation’s own carry-over is the carry-over measured using an inspection procedure as laid down in GMP+BA4 Minimum Requirements for Sampling and Analysis. The frequency at which the carry-over must be measured is determined as follows: a. If the participant processes or transports (animal feed containing) feed additives for which a residue standard has been determined in the table in Chapter 3 or veterinary medical products then the degree of carry-over must be known for the lines on which these products are processed. b. If the participant has relevant 1 lines then he must measure carry-over at least once per two years. c. The minimum frequency for the measurement of carry-over may be lowered to once per four year on condition that: 1. the carry over measured is less than 10% and 2. as soon as the last measurement is over two years old, the participant must assume the degree of carry over of the line in question is 15%. The carry-over must be re-established in the event of major changes to the installation.

2.2.2. The coefficient The coefficient is intended to take of an extra carry-over in addition to the installation carry-over, as a consequence of the processing properties of the additive or veterinary medicine. A factor of 1 means that the product contains no processing properties other than those of a standard measurement substance. The actual carry-over of the product therefore corresponds to the installation carry-over. If the factor is greater than 1, this means that the product has anomalous processing properties, such that the actual carry-over will be higher than the installation carry-over. The coefficient is determined on the basis of a so-called relative wall adhesion factor using a method specially developed for this purpose. Refer to TNO report I-9631006 Carry-over of a number of critical substances in cattle feed and the relationship to their characteristic properties.

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 determined residue norm are produced and/or transported.



The relationship between the relative wall adhesion factor and the co-efficient is shown in the following table. Relative wall adhesive factor according to the established method. <1 > 1 and < 2 > 2 and < 3 unknown, > 3

Coefficient 1 2 2,5 3

2.2.3. Carry-over and flush batches The actual carry-over of additives and carry-over or veterinary medical products must be calculated in order to establish the number of flushes. This carry-over can be calculated by multiplying the installation carry-over by the coefficient. This coefficient can be used to calculate how many flush batches are minimally required to remain under the established residue standards. A sample calculation follows. Example: Broiler feed with nicarbazine Company’s own carry-over in installation: Coefficient Maximum residue standard for broiler feed for the last five days:

: 80 ppm : 5% : "1" : 0.5 ppm

Calculation of actual carry-over = 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 operations in the installation. It is also necessary for the participant to establish company requirements and procedures in order to comply with the residue standards for: a. transport (sequence) and storage (sequence) b. intake of premixes, additives and veterinary medical products. The participant must check that the prescribed residue standards are not exceeded. If an infringement of these residue standards is detected, the instructions for use and procedures must be modified. The coefficients and the minimum carry-over levels calculated from them may be deviated from provided that the carry-over is measured using the relevant product itself.



2.3 Premix 2.3.1

General

The objective of these supplementary instructions is that compound feed producers must be able to use premixes from GMP+-certified manufacturers in producing compound feeds, without exceeding the maximum carry-over levels. Carry-over of critical additives and veterinary medicines also occurs in the preparation of premixes. In order to prevent GMP+-certified compound feed mixers from exceeding the standards for coccidiostats, histomonostats and critical veterinary medical products because of excessive levels in premixes, a general rule of thumb is that no more than 50% of the residue standard as stated for compound feed may be used up as a result of the premixes used. The maximum level in the premix must be derived from the dosage of the premix in the compound feed. Carry-over of coccidiostats, histomonostats and critical veterinary medical products may take place via direct and indirect contamination.

2.3.2

Direct contamination

Direct contamination is possible through use of a premix destined for an animal feed for which a maximum residual level has been established. The premix producer is to ensure through his GMP+ feed safety system that no more than 50% of the residue standard as stated for that compound feed is used up via the premix. For any flush batches required, the relevant coefficient as established for that product should be adopted.

2.3.3

Indirect contamination

In order to achieve extremely low residue standards in premixes, producers of premixes will have to first produce a number of batches for a non-critical use following the production of premixes with coccidiostats, histomonostats and critical veterinary medicines. A premix which is produced subsequent to one prepared with a coccidiostats or histomonostats (a so-called flush batch) may still contain such high levels of coccidiostats or histomonostats that this can cause problems for the compound feed producer. Compound feed manufacturers use these premixes mainly in animal feeds which are also used to flush an installation clean. In certain cases the level of critical additives is so high that, together with the company’s own carry-over levels, the residue standards in compound feeds are exceeded.



3

Residue standards for coccidiostats en histomonostats

3.1

Summary of residue standards for coccidiostats and histomonostats according to Commission Regulation (EU) No. 574/2011 of 16 June 2011 and No. 744/2012 of 16 August 2012 amending Annex I to Directive 2002/32/EC 2

Additives

Products intended for animal feed ( )

Lasalocid A sodium

Feed materials Compound feed for: - dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 16 weeks) and chickens reared for laying (> 16 weeks)

Narasin

Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 %

1,25

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 prohibited (withdrawal feed)

1,25

- pheasants, guinea fowl, quails and partridges (except laying birds) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed), - other animal species

1,25

Premixtures for use in feed in which the use of lasalocid A sodium is not authorised

()

Feed materials

0,7

3,75 3

Compound feed for: - turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks)

0,7

- other animal species

2,1

Premixtures for use in feed in which the use

()

3

2

Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. 3 The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50 % of the maximum levels established in the feed when the instructions for use of the premixture are followed.



Additives

2



of narasin is not authorised. Salinomycin sodium

Monensin 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


2,1

Premixtures for use in feed in which the use of salinomycin sodium is not authorised.

()

Feed materials

3

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 (withdrawal feed)

1,25


3.75

Premixtures for use in feed in which the use of monensin sodium is not authorised. Semduramicin sodium

Feed materials

3

()

0.25

Compound feed for:


- laying birds and chickens reared for laying (> 16 weeks)

0,25

- chickens for fattening for the period before

0,25


Additives

2



slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed) - other animal species Premixtures for use in feed in which the use of semduramicin sodium is not authorised. Maduramicin ammonium alpha

Feed materials

Compound feed for: - equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks) - chickens for fattening and turkeys (< 16 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed) - other animal species

Robenidine hydrochloride

Decoquinate

3

()

0,05

0,05

0,05

0,15 3

Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised.

()

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 before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed)

0,7


2,1

Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised.

()

Feed materials

0,4

Compound feed for: - laying birds and chickens reared for laying (> 16 weeks) - chickens for fattening for the period before


0,75

3

0,4 0,4


Additives

2



slaughter in which the use of decoquinate is prohibited (withdrawal feed)

Halofuginone hydrobromide


1,2

Premixtures for use in feed in which the use of decoquinate is not authorised

()

Feed materials

3

0,03

Compound feed for:

Nicarbazin

- 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) Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised Feed materials

0,09 3

()

1.25

Compound feed for:

Diclazuril

- equine species, laying birds and chickens reared for laying (> 16 weeks)

1.25


3.75

Premixtures for use in feed in which the use of nicarbazin (in combination with narasin) is not authorised Feed materials

3

()

0,01

Compound feed for: - laying birds, chickens reared for laying (> 16 weeks) - rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed).


0,01 0,01


Additives

Feed additives not ed in the EU which are intended for use in feeds for export outside the EU.


2



- other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening, guinea fowl and turkeys for fattening.

0,03

Premixtures for use in feed in which the use of diclazuril is not authorised.

()

All feeds intended for marketing within the EU.

1

3


3.2 Additional information for some coccidiostats and histomonostats * Trade name

Manufacturer

Compound of narasin and nicarbazine (E 772) Maxiban G 160 premix Eli Lilly

Importer

Concentration

Coefficient Pigs

Other

Eli Lilly Nederland BV

80 g/kg narasin 80 g/kg nicarbazine

5

1

Roche

Alpharma

15g/100g Lasalocide-sodium

1

1

Roche

Alpharma

66g/kg Robenidinehydrochloride

1

1

Eli Lilly Huvepharma

Eli Lilly Nederland BV Huvepharma NV

200g/kg monensin sodium 200g/kg monensin natrium

1 1

1 1

Eli Lilly

Eli Lilly Nederland BV

100g/kg narasin

1

1

Huvepharma

Huvepharma NV

6 g/kg halofuginone hydrobromide

1

1

Janssen Pharmaceutica nv

Janssen Pharmaceutica nv

0.5g/100g diclazuril

2

2

Salinomycin-sodium (E 766) Sacox 120 microGranulate Kokcisan 12%

Huvepharma KRKA

120g/kg salinomycine 120g/kg salinomycine

1 1

1 1

Other

Other

Huvepharma NV Lansdowne Chemicals Europe BV Other

N/a

3

3

Lasalocid sodium (E 763) Avatec 15% CC Robenidine-hydrochloride (E758) Cycostat 66G Monensin-sodium (E757) Elancoban G200 premix Coxidin (5 1 701) Narasin (E765) Monteban G100 premix Halofuginone-hydrobromine (764) Stenorol Diclazuril (E 771) Clinacox 0,5 % Premix

*: This list can be extended at new available data of relative wall adhesion test



4 Residue standards for critical veterinary medical products 4.1

Summary of residue standards for critical veterinary medical products

Veterinary medical product

Established maximum residue standards 4 in animal feeds in ppm

7

laying 5 hens

slaughter 6 chickens fattening 6 turkeys

pigs

dairy 8 cattle

Sulfadiazine sodium

5

8

1

1

Sulfamethoxazol

5

8

1

1

Doxycycline

8

8

10

-

Oxytetracycline

1

10

10

-

0.1

0.1

0.1

-

Tiamuline

1

8

10

-

Tilmicosine

1

4

10

-

Ivermectine

Established precautionary measure for dairy cattle

9

1 batch

10

9

1 batch

10

9

1 batch

10

9

1 charge

9

1 charge

10 10

Trimethoprim

Linked to Sulfadiazine and therefore sufficiently guaranteed

For other products

1

4

5 6 7 8 9

10

1

1

1

The max. residue norms for premixes amount to maximum. 50% of the indicated residue norms for animal feeds calculated on an animal feed basis feed given to laying animals feed given from 5 days before slaughter feed given from 28 days before slaughter feed given to milk-producing cows, goats and sheep At this moment there is insufficient knowledge available in order to be able to establish a carryover norm for this additive for these categories. Dairy cow feed may not immediately be produced on a production line which has just produced feed with these additives.



4.2 Overview of issible medicated premixes Trade name

Registration holder

Registration nummer

Concentration

Coefficient Pigs

Amoxicilline Suramox 5% premix Virbac Nederland B.V. Amproliumhydrochloride Amprolium Concentrate 25% Dopharma Research B.V. Doxycyclinehyclaat/broomhexinehydrochloride Feedmix Doxy-B Dopharma Research B.V. Pulmodox 5% Premix Virbac Laboratories Doxyprex Industrial Veterinaria S. A.

Max. dosing for complete feeds Other 1

REG NL 8543

50g/kg

3

3

400 ppm (8kg/ton)

REG NL 2051

250g/kg

-

3

500 ppm (2kg/ton)

REG NL 2588 REG NL 9826 REG NL 10393

20g/kg 50g/kg 100g/kg

2,5 2,5 2,5

2,5 2,5 2,5

300 ppm (15kg/t) 4 250 ppm (5kg/t) 5 250 ppm (2,5kg/t)

Intervet Nederland B.V.

REG NL 10473

40g/kg

3

3

200 ppm (5kg/t)

Dopharma Research B.V.

REG NL 9674

6g/kg

3

3

Flubenol 0.6%

Janssen Pharmaceutica N.V.

REG NL 5335

6g/kg

3

3

Flubenol 5%


REG NL 3106

50g/kg

3

3

Flubenol 5% Poultry


REG NL 9556

50g/kg

-

3

Flubenol 50%


REG NL 3160

500g/kg

3

3

30 ppm (5kg/t) (pigs, chickens) 60 ppm (10kg/t) pheasants) 30 ppm (5kg/t) (pigs, chickens) 60 ppm (10kg/t) (pheasants) 30 ppm (0,6kg/t) (pigs, 7 chickens) 60 ppm (1,2kg/t) 7 (pheasants) 30 ppm (0,6kg/t) 7 (chickens) 60 ppm (1,2kg/t) 7 (pheasants) 30 ppm (0,06kg/t) 8 (pigs, chickens) 60 ppm (0,12kg/t)

Florfenicol Nuflor 40mg/g medicated premix for pigs Flubendazol Feedmix Flubendazole


2

3

6


Trade name

Registration holder

Registration nummer

Concentration

Coefficient Pigs


(pheasants) 30 ppm (0,4kg/t) (pigs, 9 chickens) 60 ppm (0,8kg/t) 9 (pheasants) 30 ppm (5kg/t) (pigs, chickens) 60 ppm (10kg/t) (pheasants) 30 ppm (0,4kg/t) (pigs, 9 chickens) 60 ppm (0,8kg/t) 9 (pheasants) 30 ppm (0,6kg/t) (pigs, 7 chickens) 60 ppm (1,2kg/t) 7 (pheasants) 30 ppm (0,6kg/t) (pigs, 7 chickens) 60 ppm (1,2kg/t) 7 (pheasants)

Flubenol 7.5%


REG NL 5261

75g/kg

3

3

Flutelmium 0.6%


REG NL 6082

6g/kg

3

3

Flutelmium 7,5%


REG NL 6010

75g/kg

3

3

Flubenol 5%

Wirtz Farma B.V.

REG NL 10380/3106

50 g/kg

3

3

Flubendazol 5% concentrate


REG NL 101512

50g/kg

3

3

Ivermectine Ivomec Premix

Merial B.V.

REG NL 8731

6g/kg

3

3

2,4 ppm (0,4kg/t)

Noromectin Premix 0,6% G/G for pigs Ecomectin 6mg/g premix

Norbrook Laboratories Ltd (Station Works) ECO Animal Health LTD.

REG NL 10465 REG NL 10529

6g/kg

3

3

2,4 ppm (0,4kg/t)

6g/kg

3

3

2,4 ppm (0,4kg/t)

110g/kg Linco 44g/kg Linco.

3 3

3 3

220 ppm (2,0kg/t) 220 ppm (5kg/t)

6,6g/kg Linco. 6,6g/kg Spec

3

3

33 ppm (5kg/t)

Lincomycine(-hydrochloride)/Spectinomycine(-sulfaat) Lincomix 110 Pfizer Animal Health B.V. Lincomix 220 premix Pfizer Animal Health B.V. Vualin Plus-33 V11


Eurovet Animal Health B.V.

REG NL 7957 REG NL 10076 REG NL 2295

10

10

10

11


Trade name

Registration holder

Registration nummer

Concentration

Linco-spectin Premix

Pfizer Animal Health B.V.

REG NL 9708

22g/kg Linco. 22g/kg Spec

Dopharma Research B.V. Dopharma Research B.V. Framelco B.V. Eurovet Animal Health B.V. Univet Ltd.

REG NL 2158 REG NL 2004 REG NL 7254 REG NL 7277 REG NL 106877

80g/kg 100g/kg 80g/kg 80g/kg 150g/kg

Laboratoires Sogeval

REG NL 10278

Coefficient Pigs 3


12

44 ppm (2kg/t)

Oxytetracycline(-hydrochloride) Feedmix V4 Feedmix Oxy 10% OTC-400 OXY-400 V4 Chloromed 150mg/g premix for pigs Paracetamol Pracetam 10%

Sulfadiazinenatrium/Trimethoprim Feedmix Trim/sul 80/420 Aesculaap BV

REG NL 1808

Trimethosulf premix


REG NL 7589

Feedmix sulfatrim


REG NL 8541

Sulfamethoxazol/Trimethoprim Feedmix TS Dopharma Research B.V.

REG NL 8674

Tiamulinwaterstoffumaraat Tiamutin 10% premix Denagard 2% premix Tialin 10% premix

Novartis Consumer Health B.V. Novartis Consumer Health B.V. Eurovet Animal Health B.V.

Tialin 2% premix


Vetmulin 2% premix

Huvepharma N.V.

Vetmulin 10% premix for medicated feeds

Huvepharma N.V.


REG NL 8015 REG NL 8016 REG NL 10178 REG NL 10177 REG NL 100731 REG NL 101337

3 3 3 3 3

3 3 3 3 3

800 ppm (10kg/t) 700 ppm ( 7kg/t) 400 ppm (5kg/t) 1000 ppm (12,5kg/t) 19 400 ppm (2,66 kg/t)

3

3

800 ppm (8kg/t)

77,1g/kg Sulfa 16g/kg Trim 62,5g/kg Sulfa 12,5g/kg Trim 60g/kg Sulfa 12g/kg Trim

5

3

5

2

5

3

385 ppm Sulfa en 80 ppm Trim (5kg/t) 625 ppm Sulfa en 125 ppm Trim (10kg/t) 600 ppm Sulfa en 120 ppm Trim (10kg/t)

50g/kg Sulfa 10g/kg Trim

5

3

500 ppm Sulfa en 100 ppm Trim (10kg/t)

100g/kg 20g/kg 100g/kg

3 3 3

3 3 3

40 ppm (0,4 kg/t) 14 40 ppm (2,4 kg/t) 13 40 ppm (0,4 kg/t)

20g/kg

3

3

40 ppm (2,4 kg/t)

20g/kg

3

3

176 ppm (8,8 kg/t)

100g/kg

31

31

180 ppm (1,8 kg/t)

100g/kg

13

14


Trade name

Registration holder

Registration nummer

Concentration

Coefficient Pigs

Tilmicosinefosfaat Pulmotil G40 PREMIX

Max. dosing for complete feeds Other

Eli Lilly Nederland B.V /Elanco Animal Health

REG NL 9166

40g/kg

3

3

Pulmotil G100 PREMIX


REG NL 9167

100g/kg

3

3

Pulmotil G200 PREMIX


REG NL 9168

200g/kg

3

3

Pneumotil G40 PREMIX

Eli Lilly Nederland B.V /Elanco Animal Health Huvepharma N.V.

REG 10368 REG NL 103646

40g/kg

3

3

400 ppm (10 kg/t) (pigs) 200 ppm (5 kg/t) (rabbits) 400 ppm (4 kg/t) (pigs) 200 ppm (2 kg/t) (rabbits) 400 ppm (2 kg/t) (pigs) 200 ppm (1 kg/t) (rabbits) 400 ppm (10 kg/t)

100g/kg

1

1

400 ppm (4 kg/t)

40g/kg 200g/kg

1 1

1 1

400 ppm (10 kg/t) 400 ppm (2 kg/t)

200 ppm (2 kg/t) (pigs) 1100 ppm (11 kg/t) (, chickens reared for laying) 200 ppm (10 kg/t) (pigs) 1100 ppm (55 kg/t) (slaughter chickens, chickens reared for laying) 15 200 ppm (0.8 kg/t) (pigs) 15 1100 ppm (4,4 kg/t) (slaughter chickens,

Tilmovet 10%, premix for medicated feed for pigs Tilmovet 4% Tilmovet 20%, premix for medicated feeds for pigs Tylosinefosfaat Tylan 100 Premix 10%

Huvepharma N.V. Huvepharma N.V.

NL

REG NL 100742


REG NL 3917

100g/kg

3

3

Tylan 20 premix 2%


REG NL 9976

20g/kg

3

3

Tylan G250 Premix 25%


REG NL 9982

250g/kg

3

3



Trade name

Registration holder

Registration nummer

Concentration

Coefficient Pigs

Max. dosing for complete feeds Other chickens reared for laying)

Pharmasin 20 mg/g premix Pharmasin 100mg/g premix for medicated feeds for pigs, slaughter chickens and chickens reared for laying

Huvepharma N.V. Huvepharma N.V.

REG 101024

NL

20g/kg 100g/kg

1 1

1 1

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

Huvepharma N.V.

REG 101027

NL

250g/kg

1

1

ECO Animal Health Limited

REG 10266

NL

42,5g/kg

3

3

REG 10430

NL

13

200 ppm (2 kg/t) (pigs) 1100 ppm (11 kg/t) (slaughter chickens, chickens reared for laying) 15 200 ppm (0.8 kg/t) (pigs, chickens) 15 1100 ppm (4,4 kg/t) (slaughter chickens, chickens reared for laying)

Tylvalosine Aivlosin 42,5 mg/g Aivlosin 8,5 mg/g

ECO Animal Health Limited

85 ppm (2 kg/t) (pigs) 16

8,5g/kg

3

3

85 ppm (10 kg/t) (pigs) 16

Valnemulin Econor 1%

Novartis Animal Health Austria GmbH

REG NL 9792


REG NL 9794

Econor 50%


REG NL 9795

For other products

-

-

Econor 10%


10g/kg

3

3

75 ppm (7,5 kg/t) (pigs) 17

100g/kg

3

3

200 ppm (2 kg/t) (pigs) 18

500g/kg

3

....

3

3

3

200 ppm (0,4 kg/t) 18 (pigs) ….


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. : 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 3



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 Antibiotics - B lactam AmoxiciIllin Ampicillin Penicillin G Cloxacillin Dicloxacillin Nafcillin Oxacillin Cefalexin Cefapirin Cefazolin Cefoperazone Cefquinome Ceftiofur Antibiotics - Quinolones Danofloxacin Difloxacin Cirprofloxacin Enrofloxacin Flumequine Marbofloxacin Oxolinic acid Sarafloxacin Norfloxacin Cinoxacin Antibiotics – Macrolides Erythromycin Spiramycin Tilmicosin Tylosin Tylvalosin Antibiotics - Phenicoles Thiamphenicol Florfenicol Chloramphenicol Antibiotics – Tetracyclines Chlortetracycline Doxycycline Oxytetracycline Tetracycline Antibiotics – Pleuromutilines Tiamulin Valnemuline Antibiotics - Lincosamides


Maximum level in μg/kg 200 100 100 20 4 200 10 100 100 100 50 200 10 40 2 50 4 2 30 2 20 20 4 2 2 0,2 4 4 5 1 1,5 20 1 4 20 1 2


Lincomycin Antibiotics - Sulfonamides Sulfadimethoxine Sulfapyrimidine = sulfadiazine Sulfamethoxazole Sulfathiazole Sulfamerazine Sulfamethazine = sulfadimidine Sulfadoxine Antibiotics – other Trimethoprim


2 2 2 2 2 2 2 2 2


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