EFe

uropeed Improc

ean vmpor

cedur

versurt legres C

us Chislati

Comp

hineson aared

dr

se nd

ir. F.Ars. T. den H

A.J. Gort Hollander

2

European versus Chinese Feed Import legislation and procedures Compared June 2013 ir. F.A.J. Gort drs. T. den Hollander

Zoetermeer: Product Board Animal Feed, The Netherlands Copyright by Product Board Animal Feed, The Netherlands 2013 Information and text provided in this publication may be quoted only if their source is specified. Disclaimer In spite of the care and attention paid by the Product Board Animal Feed to the composition of this publication, it is possible that the information which is published here is incomplete or incorrect. The Product Board Animal Feed cannot guarantee that the information in this publication is suitable for the purpose for which you consulted it. All information, products and services are offered on an as-is basis and without any guarantee, implicit or otherwise, with respect to their soundness or suitability for a particular purpose or otherwise. The Product Board Animal Feed excludes all liability for any form of direct or indirect damage of any nature whatsoever arising from or related in any way to the use of this publication. The Product Board Animal Feed is also not liable for direct or indirect damage which is the result of making use of information which was obtained through this publication.

3

Content Introduction 5 EU Animal Feed Legislation .. 7

Introduction; on regulations and directives .. 7 The General Food Law (GFL) 8 Feed Hygiene Law (reg. 183/2005) (FHL) ... 10 Registration, approval & licensing of operators in feed, besides the FHL. 15 Registration and authorization of feed .. 18 Undesirable substances in feed . 25 Official control in feed ... 28

Import of Feed in the EU .. 32

Exporting feed to / importing feed into EU 32 EU legal acts related to feed .. 35

Structure Chinese Government . 39

Structure . 39 Registration crucial points . 39 Product registration at MOA . 39 Product registration at AQSIQ . 41

Chinese Legislation 43

MOA import feed registration legislation . 43 AQSIQ import feed regulations . 43

Comparison .. 45

Definitions Feed, Feed material and feed additive 45 Food Safety Law of the peoples republic of China (no.9) 48 HACCP . 49 Registration .. 50 Regulation on the management of feed and feed additives (no.609) .. 51 Administrative measures for the registration of imported feed and feed additives (no.38) .. 55 Catalogue of Feed additive 56 Measures for administration of inspection, quarantine and supervision on import and export feed and feed additives (no.118) . 57

Annex 1 58 Annex 2 107

4

5

Introduction China is since 1990 the world leading country in the production of pork. Pork is one of the most important food sources for urban and rural residents in China, and next to rice traditionally the basic industry to guarantee food security for Chinese residents. The Chinese government expects that in relation to pork the future demand will grow. Next to this it is stated that China wants to become self-sufficient regarding protein production, meaning that China needs to expand their domestic pork production to meet supply with demand. As land is scarce in China, consequently the central focus of the government is that China will be more and more relying on feed imports.

To ensure health of the pigs and safety of pork, there is a growing need for specific quality ingredients and high-grade by-products to produce high quality feed for pig(let)s. With these feeds, feed efficiency at animal level will be enhanced and use of raw materials in feed formulation will be reduced. Dutch feed (ingredient) companies have the products and the know-how to do so and to lead China to a more sustainable feed and pork chain.

The past years the Dutch feed and feed ingredients producing industry faced several trade barriers, which disturbs the possibility to be successful in the Chinese market. The import of specific quality ingredients and high-grade by-products to produce high quality feed for amongst others piglets is hardly/not possible.

In China 8 categories of feed and feed ingredients are defined. For each category an apart protocol have to be agreed bilaterally between China and The Netherlands. Also several registrations of the product and its producer needs to be arranged in China. Also the other way around comparable problems appear for the export from China to Europe. The main reasons can be found in the fact that procedures are unclear, the language barrier and legislation and definitions differ. This publication is meant to give an overview of the legislation of both sides and assists in giving backgrounds for the several registration procedures. Of course this document will not be the solution to make the bilateral trade possible, it is meant to assist in finding the solution to create the market access and fulfil the official procedures.

The document is developed by first making an inventory, as complete as possible, of all relevant Chinese import legislation for the import of Feed and Feed additives. After the inventory, the Chinese text is translated into English. We point out that the text in Chinese is always leading. After the translation the legislation is compared to the European and Dutch legislation and combined together, with the purpose to show in what way guarantees could be given in fulfilling the Chinese legislation. For this comparison the Product Board of Animal Feed in The Netherlands worked closely together with the Chinese Ministry of Agriculture and the Chinese General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ).

This document would not have come to this result without the hard work of Frank Gort, Mr. Luo Jun and Mr. Shu Anxin. Their time invested in inventorying, comparing and discussing all parts of the Chinese, European and Dutch legislation was without doubt enormous.

6

Finally a vote of thanks to all other parties involved in collection of the information, translating, writing and comparing this elements of Chinese and European Feed Legislation. Especially thanks to the Embassy of the Kingdom of the Netherlands in Beijing, The Feed Division of AQSIQ, The Feed Division of the Chinese Ministry of Agriculture, The Dutch Meat & Feed Centre (DMFC)/Orange Pig, NL EVD International and the Ministry of Economic Affairs in The Netherlands for their contribution to this project.

7

EU Animal Feed Legislation INTRODUCTION; ON REGULATIONS AND DIRECTIVES

Before turning towards the content of European Animal Feed Legislation, it is important to identify the various legal tools the EU uses in the act of law-making. The EU has 4 elements of law it can use to exercise the Unions competences, as it states in the Treaty on the functioning of the European Union. These four are

Regulations: A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States.

Directives: A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods.

Decisions: A decision shall be binding in its entirety upon those to whom it is addressed.

Recommendations: Recommendations shall have no binding force. Most important for animal feed legislation are the regulations and directives. It is important to note the difference between a regulation: applicable, completely and at a specific date, in all EU member states, with no possibility to change the content or date of application, and a directive with national space for implementation. So regulations have no national influence and results in harmonization. As directives have the possibility for national influence, this can cause disharmony between the EU member states.

8

THE GENERAL FOOD LAW(GFL)

The basis of EU food and feed safety legislation, is laid down in the General Food Law, officially entitled

REGULATION (EC) No 178/2002, of 28 January 2002 laying down the general principles and requirements of food law, establishing the European

Food Safety Authority and laying down procedures in matters of food safety Any other item of food or feed safety legislation, is based up on the principles laid down in this fundamental piece of legislation. Some of these principles, as far as they are relevant to this brochure, are mentioned below.

It applies to all stages of production, processing and distribution of food and feed. Feed shall not be placed on the market or fed to any foodproducing animal if it is

unsafe Feed shall be deemed to be unsafe for its intended use if it is considered to:

o have an adverse effect on human or animal health; o make the food derived from food-producing animals unsafe for human

consumption. The traceability of food, feed, food-producing animals, and any other substance

intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution

To achieve the general objective of a high level of protection of human health and life, food law shall be based on risk analysis;

Risk assessment shall be based on the available scientific evidence and undertaken in an independent , objective and transparent manner;

Food an feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods and feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met;

EU Member States shall enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution;

Food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognized by the Community to be at least equivalent thereto or, where a specific agreement exists between the Community and the exporting country, with requirements contained therein;

Food and feed exported or re-exported from the Community for placing on the market of a third country shall comply with the relevant requirements of food law, unless otherwise requested by the authorities of the importing country or established by the laws, regulations, standards, codes of practice and other legal and administrative procedures as may be in force in the importing country

It shall be no surprise that the principles mentioned above are only a small extract of the GFL. The GFL also regulates the basis for control by the member states, the role the

9

European Food Safety Authority (EFSA) etc. Nevertheless, this short extract does make clear that:

The food law also covers feed; Defines unsafe feed Covers all stages of production, processing and distribution; Feed and food safety is the responsibility of the operator (the government controls) Food and feed law is based on risk analysis; Imported and exported food and feed must meet the same standards as food and

feed produced within the EU; Traceability is a major element of a food and feed safety system.

Although other elements of the GFL will be dealt with at the specific chapters of this brochure, it is important to mention various feed related definitions here, as they are often referred to in other elements of law regarding feed.:

feed (or feedingstuff) means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals

feed business means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on his own holding;

feed business operator means the natural or legal persons responsible for ensuring that the requirements of food law are met within the feed business under their control;

placing on the market means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves;

stages of production, processing and distribution means any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production,manufacture, storage, transport, distribution, sale and supply of feed;

Regarding these definitions, however clear and straightforward they are, can do with some notes. First of all, it is of great importance that feed is something for oral feeding; intravenous therapy, even it being a simple buffer solution or parenteral nutrition, are not feed according to this law. Second, it is not relevant if the feed is sold on a market or give away for free (f.e. a sample for a new feed); these are both expressions of placing on the market as the GFL defines. Finally, it is important to realize that feed additives, although subject to various other regulations too, are also feed / feedingstuff.

10

FEED HYGIENE LAW (REG. 183/2005) (FHL)

INTRODUCTION In the previous chapter the basics of European food and feed safety, as regulated in the General Food Law (GFL, Reg. EC No. 178/2002) has been briefly indicated. This chapter will focus on the main legal element covering feed safety, the Feed Hygiene law (FHL). Feed Hygiene Law is the commonly used name for the regulation that officially is known as:

REGULATION (EC) No 183/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 January 2005 laying down requirements for feed hygiene

To understand the importance and impact of this regulation, that covers the following subjects:

general rules on feed hygiene; conditions and arrangements ensuring traceability of feed; conditions and arrangements for registration and approval of establishments

Besides these three subjects the FHL covers, it is necessary to clarify the scope of the FHL and to introduce the most relevant definitions. SCOPE The scope of any legal element is important to understand the impact of it. The regulation states that it applies to:

the activities of feed business operators at all stages, from and including primary production of feed, up to and including, the placing of feed on the market;

the feeding of food-producing animals; imports and exports of feed from and to third countries.

Almost equally important as the issue as that are in the scope of law, are in general also those that a law does not apply to. For the FHL these are the following;

the private domestic production of feed: o for food-producing animals kept for private domestic consumption; and o for animals not kept for food production;

the feeding of food-producing animals kept for private domestic consumption.); the feeding of animals not kept for food production; the direct supply of small quantities of primary production of feed at local level by the

producer to local farms for use on those farms; the retailing of pet food.

From the exclusions from the scope of the FHL it is clear that every company involved in feed must apply, except those retailing pet food. The exclusion are merely for private production and consumption. DEFINITIONS Before even mentioning relevant definitions in the FHL, it is good to bear in mind that in legal terms, definitions are only valid in the legal element where they are listed. This small remark can sometimes be the key to understand differences in interpretation of law, when apparently similar subjects are dealt with differently.

11

In the context of this report, the following definitions in the FHL are important:

feed hygiene means the measures and conditions necessary to control hazards and to ensure fitness for animal consumption of a feed, taking into account its intended use;

feed business operator means the natural or legal person responsible for ensuring that the requirements of the present Regulation are met within the feed business under their control;

feed additives means substances or micro-organisms authorized under Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition;

establishment means any unit of a feed business; competent authority means the authority of a Member State or of a third country

designated to carry out official controls; primary production of feed means the production of agricultural products, including

in particular growing, harvesting, milking, rearing of animals (prior to their slaughter) or fishing resulting exclusively in products which do not undergo any other operation following their harvest, collection or capture, apart from simple physical treatment.

GENERAL RULES FOR FEED HYGIENE AND CONDITIONS AND ARRANGEMENTS ENSURING TRACEABILITY AND RECALL OF FEED After some important but preliminary issues in the FHL the focus is directed to the three subjects of the FHL, feed hygiene rules, ensuring traceability and registration and approval of establishments. Feed Business Operators (see definition in GFL, further referrd to as operators)) have to ensure that they work in accordance to the FHL. Although the FHL also includes farmers and the feeding of farm animals, the focus in this document is on feed business. The basic requirements they have to full fill are listed in Annex II of the FHL. The annex, not explained in detail here, holds requirements for

Facilities & Equipment Personnel Production Quality Control Storage & Transport Record-keeping Complaints & Product Recall

Alongside these requirements, operators are required to put in place, implement and maintain HACCP (Hazard Analysis and Critical Control Points) based written procedures. Documents related to the operators HACCP system, are the subject of inspection by the competent authority. The competent authority, whilst inspecting the HACCP system, will take into account, the size and complexity of the operators business NOTE: An explanation of HACCP is no part of this document.

12

These general rules are clear and fairly short. It is important to note that feed safety is built upon the HACCP principles and that feed safety is the responsibility of the operator; the competent authority only inspects. Traceability is a major concern in EU food and feed law and is mainly dealt with in the GFL. For feed this results in roughly three areas of interest:

1. The traceability of feed and any other substance intended to be, or expected to be, incorporated into a feed shall be established at all stages of production, processing and distribution. So an operator should know where the feed comes from. This is applicable for all relevant parties; collectors, trucks, ships, warehouses, traders, producers, farmers

2. Operators shall be able to identify any person from whom they have been supplied with a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a feed. To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand. So operators should identify and register the suppliers.

3. Operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand. So operators should also identify and register the clients. Any moment anyone in feed chain should be able to tell within 4 hrs

The central question can be formulated a:

When has how much of what product been supplied to which client and who supplied the product or the raw materials for that product

Feed which is placed on the market or is likely to be placed on the market shall be adequately labeled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions. Batch numbers are imperative to determine affected product in case of contamination and recall A batch should not exceed a days production Although recall is mentioned in annex II of the FHL, it is judged of such relevance that it is highlighted here, alongside traceability, as they are closely related subjects. Recall is defined as a number of actions to prevent the further distribution of unfit/unsafe feed and to minimize food/feed safety, environmental and economic effects of the concerned feed already on the market

The key to a successful recall is:

o Quick action o Good traceability o Complete and open communication o Annual recall training (fake recall)

13

CONDITIONS AND ARRANGEMENTS FOR REGISTRATION AND APPROVAL OF ESTABLISHMENTS Registration and approval of operators is an important tool in the whole of feed (and food) safety legislation. For competent authorities to be able to execute their tasks in relation to feed (as it is described in various European and national laws), they need to identify operators active in feed business. For operators in feed, clear identification of other companies in feed,

improves traceability of feedingstuffs they buy or sell; gives a certain guarantee on the level of quality assurance of their counterparts in the

feed business Operators and farmers are by law, forced to only source and use feed from registered and approved operators. As list of registered and approved operators are freely accessible (at least they should be in the EU and they are in The Netherlands) for the public, consumers can always check whos responsible for marketing the product they are feeding their animals. In NL, the NVWA (Netherlands Food and Consumer Product Safety Authority) is the competent authority. Approved and registered operators can be found on their website. The FHL sets the rules for approval & registration of operators in the animal feed sector. In general terms, all operators in feed need to register and for some activities in feed registration does not suffice. Operators active in those need an approval. Activities requiring approval are of an intrinsic higher risk level than those only requiring registration

LOW RISK >>> REGISTRATION HIGH RISK >>> APPROVAL

Regulation EC No. 183/2005 states the above as follows:

Feed business operators and farmers shall only source and use feed from establishments which are registered and/or approved in accordance with this Regulation

Feed business operators shall notify the appropriate competent authority of any establishments under their control, active in any of the stages of production, processing, storage, transport or distribution of feed with a view to registration.

The competent authority shall maintain a register of establishments

All operators in the feed chain must register (unless their activity requires approval) at the NVWA, but generally registration is done through the different Product Boards. So operators in feed, primary producers excluded, register at the Product Board Animal Feed. PDV forwards data to NVWA. Approval is requested with the NVWA. Approval is required if an operator in feed is:

manufacturing and/or placing on the market feed additives covered by Reg (EC) No 1831/2003 and referred to in Chapter 1 of Annex IV to the FHL;

manufacturing and/or placing on the market premixtures prepared using feed additives referred to in Chapter 2 of Annex IV to the FHL;

14

manufacturing for placing on the market, or producing for the exclusive requirements of their holdings, compound feedingstuffs using feed additives or premixtures containing feed additives and referred to in Chapter 3 of Annex IV to the FHL;

manufacturing and placing on the market, for feed use, products derived from vegetable oils and blended fats.

FINAL REMARKS Registration and approval according to Reg.EC No. 183/2005 the FHL is the most important and comprehensive registration & approval requirement in EU feed law, however there are other regulations in feed and feed related subjects, that require registration or approval of the operator. They will be dealt with in the next chapter. Another chapter will focus on the requirements of feedingstuffs to be registered or approved.

15

REGISTRATION, APPROVAL & LICENSING OF OPERATORS IN FEED, BESIDES THE FHL INTRODUCTION In the previous chapter registration and approval of operators, based up on the FHL (Reg. EC No. 183/2005) has been discussed. In this chapter other legal elements that require approval, registration or licensing of operators in feed are discussed. These legal elements have to do with animal-based feedingstuffs and the manufacturing and distribution of medicated feed. REGULATION EC NO. 999/200, TSE REGULATION Although this regulation covers many subjects that have little to do with animal feed, it holds important sections on the (restricted) use of various animal-based feedingstuffs. The TSE regulation, as it is commonly knows, is officially entitled:

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001

laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

Article 7 and Annex IV of the TSE Regulation regulate, under strict rules, the use of some (processed) animal byproducts in feed. Where some products can be used freely (f.e. milk and egg products), other products can only be used in feed for specified animal categories (like fur animals, fish or non-ruminants). It is this limited use in feed that is closely linked to a approval procedure. Approval is granted by the competent authority of a EU member state, in the case of The Netherlands, the NVWA. The operators active in the following fields need approval.

Manufacturers of feed using fish meal, tri- or dicalciumphosphate, blood meal and blood products;

Operators transporting the above mentioned products, need to have their cleaning procedures approved.

An application for approval is to be submitted to the NVWA through its website. REGULATION EC NO. 1069/2009 & REGULATION EC NO. 142/2011, THE ABP REGULATIONS Reg. EC No. 1069/2009 (Animal By-product Regulation) regulates animal by-products (ABP) and derived products which are excluded for human consumption by law, or which, by decision of an operator are destined for purposes other than human consumption. The regulation is officially entitled:

REGULATION (EC) No 1069/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No

1774/2002 As Reg. EC No. 1069/2009 holds merely the framework of ABP legislation, it is always used and referred to, together with its implementing regulation EC No. 142/2011;

16

COMMISSION REGULATION (EU) No 142/2011 of 25 February 2011 implementing

Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human

consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive

These two regulations cover all aspects of non-food ABP, like Rules for sourcing, processing and hygienic thresholds for all types of products

containing or originating from ABP Classification of unprocessed ABP in categories 1, 2 or 3 (high risk >> low risk) The (im)possibilities for use of (un)processed ABP of various categories, like:

o Raw material for pet food or feed, o Live bait o Veterinary diagnostics o Fuel (incineration) o Fertilizers o Game trophies o Raw material for oleochemical industry o Raw material for cosmetics o Etc.

The application of HACCP principles Product identification and traceability Rules and health certificates for export to the EU Approval/registration of operators in ABP

Many of the activities related to animal byproducts are subject to registration (art. 23) or approval (art. 24) by the NVWA. The following operators need registration;

Any stage of the generation, transport, handling, processing, storage, placing on the market, distribution, use or disposal of animal by-products and derived products; (Excluded are: ABP originating at food-approved companies, ABP generated at farms or other premises where animals are kept, bred or taken care of).

Approval is needed for following (feed-related) activities:

processing of animal by-products by pressure sterilisation, by processing methods referred to in point (b) of the first subparagraph of Article 15(1) or by alternative methods authorised in accordance with Article 20;

manufacturing of pet food; handling of animal by-products after their collection, by way of operations such as

sorting, cutting, chilling, freezing, salting, removal of hides and skins or of specified risk material;

storage of animal by-products; storage of derived products intended to be used as feed, excluding establishments or

plants approved or registered in accordance with Regulation (EC) No 183/2005; The two regulation constitute a very elaborate and complex set of rules, and a thorough discussion or assessment of these regulations, is beyond the scope of this document. Some

17

elements however will be dealt with in various parts of this document, like issues covering approval and registration of operators (see above) and export to / import in the EU. COUNCIL DIRECTIVE 90/167/EEC, THE MEDICATED FEED DIRECTIVE This old directive, although under revision, is still valid. It covers medicated feed in the EU. It is officially entitled: COUNCIL DIRECTIVE 90/167/EEC, of 26 march 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the community

This directive sets, as it states clearly in its title, the preparation and marketing of medicated feed. It is a short and fairly straightforward piece of legislation. It is included separately here, as it is the final legal element in European feed law that requires operators to be approved by the competent authority. The directive states in article 4, sub 1 (a) that Member states shall take all necessary measures to ensure that medicated feedingstuffs are manufactured only under the conditions set out below the manufacturer shall have premises which have previously been approved by the competent national authority The competent authority in The Netherlands has appointed the Product Board Animal Feed the coordinate the approval procedures (assessment of operators and licensing of the approved operators) The directive covers various issues on medicated feed, most of them are not of major concern to this document. It is however interesting to indicate the format of the certificate of free sales for medicated feed (annex B), which is used for the trade of medicated feed between member states. This certificate is necessary because up until now EU member states have their own procedures for the approval of medicated premixes so medicated premixes from different member states may differ in dosage and target animal. To overcome the problems this might give rise to, the free sales certificate medicated feed is introduced. As stated earlier in this section, EU legislation on medicated feed is under revision, both for reasons of improving harmonization as for the discussion on the use of veterinary medicine and its role in antibiotic resistance. (MRSA, ESBL).

18

REGISTRATION AND AUTHORISATION OF FEED INTRODUCTION In the previous chapters the most relevant elements of law have been discussed. As these are closely linked to issues of approval and registration of operators in feed, the document continued with other elements of law that require registration or approval of operators. Once again it must be stated that within the scope of this document, it is not possible to thoroughly discuss all subject covered in these various regulations and directives. The focus of document so far has been on the operators. In chapter the focus will be on the various feed / feedingstuffs and the legal demands for registration and authorization. TYPES OF FEED Before discussing the legal demands for registration and authorization of feed, is necessary to give an overview of various types of feed / feedingstuff that are distinguished within the EU legal framework First, there is the definition of feed / feedingstuff itself, as it is mentioned in the GFL: Feed / feedingstuff means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals (Reg. EC No. 178/2002, art. 3) Then there are the various types of feed, as defined in various legal acts Feed additives means substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the following functions (Reg. EC No. 1831/2003, art 2) .

favourably affect the characteristics of feed, favourably affect the characteristics of animal products, favourably affect the color of ornamental fish and birds, satisfy the nutritional needs of animals, favourably affect the environmental consequences of animal production, favourably affect animal production, performance or welfare, particularly by affecting

the gastro-intestinal flora or digestibility of feedingstuffs, or have a coccidiostatic or histomonostatic effect.

Feed additives are divided into five categories

Technological additives: any substance added to feed for a technological purpose. This includes the following functional groups

o preservatives: substances or, when applicable, micro-organisms which protect feed against deterioration caused by micro-organisms or their metabolites;

o antioxidants: substances prolonging the storage life of feedingstuffs and feed materials by protecting them against deterioration caused by oxidation;

o emulsifiers: substances that make it possible to form or maintain a homogeneous mixture of two or more immiscible phases in feedingstuffs;

19

o stabilisers: substances which make it possible to maintain the physico- chemical state of feedingstuffs;

o thickeners: substances which increase the viscosity of feedingstuffs; o gelling agents: substances which give a feedingstuff texture through the

formation of a gel; o binders: substances which increase the tendency of particles of feedingstuffs

to adhere; o substances for control of radionucleide contamination: substances that

suppress absorption of radionucleides or promote their excretion; o anticaking agents: substances that reduce the tendency of individual particles

of a feedingstuff to adhere; o acidity regulators: substances which adjust the pH of feedingstuffs; o silage additives: substances, including enzymes or micro-organisms, intended

to be incorporated into feed to improve the production of silage; o denaturants: substances which, when used for the manufacture of processed

feedingstuffs, allow the identification of the origin of specific food or feed materials;

o substances for reduction of the contamination of feed by mycotoxins: substances that can suppress or reduce the absorption, promote the excretion of mycotoxins or modify their mode of action.

Sensory additives: any substance, the addition of which to feed improves or changes the organoleptic properties of the feed, or the visual characteristics of the food derived from animals. This includes the following functional groups:

o colourants: substances that add or restore colour in feedingstuffs; substances which, when fed to animals, add colours to food of animal

origin; substances which favourably affect the colour of ornamental fish or

birds; o flavouring compounds: substances the inclusion of which in feedingstuffs

increases feed smell or palatability Nutritional additives; These include the following functional groups.

o vitamins, pro-vitamins and chemically well-defined substances having similar effect;

o compounds of trace elements; o amino acids, their salts and analogues; o urea and its derivatives

Zootechnical additives: any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment. These include the following functional groups:

o digestibility enhancers: substances which, when fed to animals, increase the digestibility of the diet, through action on target feed materials;

o gut flora stabilisers: micro-organisms or other chemically defined substances, which, when fed to animals, have a positive effect on the gut flora;

o substances which favourably affect the environment; o other zootechnical additives

20

Coccidiostats and histomonostats One group of products used in the feed industry are often mistaken for being feed additives, when in fact hey are not feed at all. These are the processing aids. They are defined in feed law (Reg. EC No. 1831/2003, art 2) to clearly distinguish them from feed Processing aids means any substance not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed; From this long definition two elements are of great importance to understand the processing aid issue. That the intentional use in the feed of the processing aid. Second, the fact that it may not have any technological effect on the finished feed. Especially this second characteristic distinguishes a processing aid from a feed additive. With this final remark on processing aids, which are no feed, the section on feed additives is closed. There are of course other types of feed / feedingstuff. Feed materials means products of vegetable or animal origin, whose principal purpose is to meet animals nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier of premixtures (Reg. EC No. 767/2009, art. 3) Premixtures means mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, not intended for direct feeding to animals (Reg. EC No. 1831/2003, art 2) Carrier means a substance used to dissolve, dilute, disperse or otherwise physically modify a feed additive in order to facilitate its handling, application or use without altering its technological function and without exerting any technological effect itself (Reg. EC No. 767/2009, art. 3) Compound feed means a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete or complementary feed (Reg. EC No. 767/2009, art. 3). Various types of compound feed are defined:

complete feed means compound feed which, by reason of its composition, is sufficient for a daily ration;

complementary feed means compound feed which has a high content of certain substances but which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed;

mineral feed means complementary feed containing at least 40 % crude ash;

21

milk replacer means compound feed administered in dry form or after dilution in a given quantity of liquid for feeding young animals as a complement to, or substitute for, post-colostral milk or for feeding young animals such as calves, lambs or kids intended for slaughter

All products orally fed to animals belong to one of the above mentioned types of feed. REGISTRATION AND AUTHORIZATION This section must start with some general remarks on registration and authorization of feed (feed and feedingstuff or two identical legal entities in EU feed law, for reasons of readability the term feed will be used in the rest of this document). Any product can be used as a feed material, as long as it meets the animals nutritional needs and it is not on the forbidden list. There is no list of allowed feed materials. Feed additives have to be authorized before they may enter the EU market. Except for national approval of medicated premixes, premixes do not need registration or authorization. Compound feed of any type does not need authorization or registration. The cases for feed materials and feed additives will be discussed in more detail Feed materials Feed materials do not need legal authorization before manufacturing or placing on the market. Feed materials placed on the EU market for the first time must be registered by operator placing them on the market. This register is kept the EU Feed Industry and has no legal value as such. The register is accessible to the public http://www.feedmaterialsregister.eu/ Effectively very few products are listed as forbidden feed materials. The forbidden feed materials are listed below (Reg. EC No. 767/2009, annex III)

Faeces, urine and separated digestive tract content resulting from the emptying or removal of digestive tract, irrespective of any form of treatment or admixture.

Hide treated with tanning substances, including its waste. Seeds and other plant-propagating materials which, after harvest, have undergone

specific treatment with plant-protection products for their intended use (propagation), and any by-products derived therefrom.

Wood, including sawdust or other materials derived from wood, which has been treated with wood preservatives as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market

All waste obtained from the various phases of the treatment of the urban, domestic and industrial waste water, as defined in Article 2 of Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment, irrespective of any further processing of that waste and irrespective of the origin of the waste waters

Solid urban waste, such as household waste. Packaging from the use of products from the agri-food industry, and parts thereof. Protein products obtained from yeasts of the Candida variety cultivated on n-alkanes

22

There are of course numerous product (f.e. (un)processed animal byproducts) that have only limited use in feed and that are the subject of various restrictions. For any other product marketed as feed, the operator is fully responsible for its safe use in animal feed . Verification of the suitability of product to be used as feed is an essential part of the inspection and control of the NVWA of registered and approved feed operators The above mentioned on feed materials leads to the simple conclusion that there is no positive list of feed materials in EU feed law. The EU does have a Catalogue of Feed Materials (Reg. EU No. 68/2013) but list only serves as an tool / aid for labeling practices. It must be appointed here that although the EU does not a positive list of feed materials based up on a legal basis, many European (and thus Dutch) operators have to obey positive lists of feed materials that are obligatory in various quality assurance schemes they are certified for, like GMP Internationals Feed Safety Assurance Scheme (Dutch), GMP OVOCOM (Belgium) en Qualitt & Sicherheit (Quality & Security, German). All these QA scheme have lists of approved feed materials certified companies must comply with. The list of approved feed materials of GMP+ FSA can be found via https://www.gmpplus.org/pagina/4/products-list.aspx Feed additives Contrary to other feed, feed additives require EU authorization before manufacturing or placing on the market. Feed additives are described in the Feed Additive Regulation (Reg. 1831/2003) (FAR), officially entitled:

REGULATION (EC) No 1831/2003 OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL of 22 September 2003 on additives for use in animal nutrition and the Feed Additive Approval Regulation (Reg. 429/2008) (FAPR), officially entitled:

COMMISSION REGULATION (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the

Council as regards the preparation and the presentation of applications and the assessment and the authorization of feed additives

These regulations stipulate that authorization of feed additives is required before they can be placed on the market; no person shall place on the market, process or use a feed additive unless it is covered by an authorization granted in accordance with this Regulation. Authorization of feed additives are separate from approval of food additives. As a result of this, authorized food additives are not automatically allowed in feed. The authorization is based upon an assessment where safety (human, animal), environment, misleading of users and efficacy are major elements. Not only new feed additives must apply for authorization, also a new use (new target animals) of an already authorized feed additive requires an application for an (adapted) authorization. Although this process of authorization is a EU legal issue, the application process is also open for operators in 3rd countries. The EC however requires a contact point inside the EU, The applicant for an authorization or his representative shall be established in the

23

Community. So this means that also Chinese manufacturers can apply for a new feed additive to be authorized in the EU. However they do need an EU-based representative to do so. The application procedure is a complex, time and money consuming process. Which is treated in detail in Reg. EC No. 429/2008. Although the application process is not within the scope of this document, some highlights will be mentioned below

There are two types of authorizations: o Authorizations issued to the holder of authorization. Those authorizations are

granted for the additives belonging to the categories "Zootechnical additives" and "Coccidiostats and histomonostats" as well as the additives consisting of, containing or produced from genetically modified organisms (GMOs). These authorizations effectively give the right to market the authorized additive to the holder (manufacturer etc.)

o Authorizations not issued to the holder of authorization for substances belonging to the other categories of additives "technological additives", "sensory additives" and "nutritional additives. These authorization give the right for every operator to use this feed additive according to the prescription in the authorization.

There is a fee of 6000,= for each application to be paid to the European Union Reference Laboratory (EURL)

Application form (annex I of EC No. 429/2008) must be sent both digital and on paper (duly signed) to the EC.

Documents to be sent to the EC include o Application form in accordance with Annex I of Regulation (EC) No 429/2008 o Public summary of the dossier; o Detailed summary of the dossier; o List of the parts of the dossier requested to be treated as confidential and a

copy of the respective concerned parts of the dossier In accordance with Article 2 " .The applicant shall send to the Commission a copy of the parts of the dossier requested to be treated as confidential and of the accompanying justification.".

The analytical methods to determine the presence of an additive in feed and its possible residues in foods are evaluated by the European Union Reference Laboratory for feed additives authorisation.

There are special (simplified) application forms, annex III for specific application types o feed additives already used in food, o additives used only for "minor species" (minor species means food-producing

animals other than bovines (dairy and meat animals, including calves), sheep (meat animals), pigs, chickens (including laying hens), turkeys and fish belonging to the Salmonidae),

o additives only used in pet food (pets and other non-food producing animals means animals belonging to species normally nourished, bred or kept, but not consumed by humans, except horses)

o modifications

24

A lot of practical information (like electronic versions of the annexes, various guidelines) can be found on the website of the EU, http://ec.europa.eu/food/food/animalnutrition/feedadditives/guidelines_en.htm Once an authorization is published, in the form of a regulation, the additive is added to the Community Register of Feed Additives. This register is open to the public and can be reached via the EU website, http://ec.europa.eu/food/food/animalnutrition/feedadditives/registeradditives_en.htm As mentioned earlier, the application process to obtain an authorization, especially for a new feed additive is time and money consuming. It will often take up to a year to get an approval (authorization).. Besides the fee for the EURL, considerable sums of money are needed to perform the necessary tests on efficacy at various dosages with the intended target animals. Also a safety assessment is required:

Safety for animals at the highest inclusion rate (plus safety margin, like twice or triple the highest dosage)

Safety for consumers eating the animal-based food (eggs, meat, milk) Safety for persons handling the feed additive in premix or compound feed mills Safety for the environment, both as a result of spilling the feed additive, or excreted

feed additives (ant their metabolites). If the feed additive is already known in other regions (outside the EU) or for other animals, or it is a food additive, a substantial part of the information will be available from scientific journals or EFSA / WHO studies etc. When a completely new product is applied for, the costs for this safety assessment can rise considerably.

25

UNDESIRABLE SUBSTANCES IN FEED

In the previous chapters issues on operator and feed were discussed, mainly in relation to approval, registration and authorization procedures. All these procedures aim to get safe un misleading feed on the EU market and to have optimal traceability by identifying operators active in feed.

In the next chapter the focus will be on the official control in feed. This official control has of course min targets. As far as feed is concerned, a major part of those inspections is to verify if all those requirements for approval and registration are met by the operator. But part of these inspections are also to check the quality of feed. Quality in this particular sentence refers to the presence (or rather absence) of undesirable substances.

This chapter will focus on the legislation on undesirable substances in feed. Two major and one minor laws cover undesirable substances in feed.

However clear this might seem, operators must be aware that also in other feed laws, like the ABP regulations, there will be legal limits for undesirable substances. In the case of the ABP regulations these are microbiological thresholds, like Salmonella, Enterobacteriaceae and Clostridia.

Furthermore the EC has published some recommendation on mycotoxins (other than aflatoxin and ergot) that operators must take into account when manufacturing feed. That fact that these undesirable substances are not in a regulation or directive does not release the operator of dealing with these mycotoxins in an appropriate way. Hence , the latter is the case for any undesirable substance, for which no legal maximum content has been set. The operator is always responsible for placing safe feed up on the market, and must do what is necessary to reduce the levels of contaminants, regardless of a legal limit. The best possible principle for the operator would be to work according to the best practice and follow the ALARA principle :levels should be As Low As Reasonably Achievable

The most important law on undesirable substances in feed is Directive No. 2002/32/EC, officially entitled: DIRECTIVE 2002/32/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7

May 2002 on undesirable substances in animal feed This directive, which frequently updated, with new undesirtable substances and adapted maximum levels, holds the legal maximum limits for undesirable substances like:

Inorganics (heavy metals, nitrite, melamine) Mycotoxines (aflatoxine, ergot) Plant toxines (gossypol, theobromine etc.) Dioxins and PCBs and other organochlorines Harmful botanical impurities (Datura, Brassica, Jatropha, Ambrosia)

The levels indicated are applicable for every type of feed and type of animal (also wild animals) unless indicated differently.

26

Except these straightforward threshold values, some other elements are worthwhile mentioning here;

Dilution; Products intended for animal feed containing levels of an undesirable substance that exceed the maximum level fixed in the annex may not be mixed for dilution purposes with the same, or other, products intended for animal feed;

Import into EU: Products intended for animal feed may enter for use in the Community from 3rd countries, be put into circulation and/or used in the Community only if they are sound, genuine and of merchantable quality and therefore when correctly used do not represent any danger to human health, animal health or to the environment or could adversely affect livestock production. In particular, products intended for animal feed shall be deemed not to be in conformity with the above mentioned if the level of undesirable substances they contain does not comply with the maximum levels laid down in Annex I.

How logical these two elements might seem, they are of great importance, both for operators inside or outside the EU Directive 2002/32/EC is especially for feed, but does not cover all undesirable substances. One large group of contaminants are residues of pesticides and insecticides, is hardly covered by Directive 2002/32/EC. Due to the numerous and always of crop protecting agents, and its importance for both food and feed, maximum residue level for these contaminants are covered, for both food and feed, in Regulation EC No. 396/2005, officially entitled:

REGULATION (EC) No 396/2005 OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

The regulation covers the origin and setting of maximum residue levels (MRL), both in products of plant or animal origin. It is a large regulation and the setting of MRL is an ongoing process. There also some expansion needed as far as the covered product are concerned. So far, no MRL for fishery products have been set, nor are product only used for feed determined.. This of course does not mean that are no MRL for these product groups, but that for these products operators must refer to the old national MRL. For all there is to say on this regulation, one item must be highlighted. The MRL are usually set for the primary product (f.e. soya bean). To determine the MRL for soya bean expellers or soya bean oil, the operator must determine whether the pesticide accumulates in one of the fractions. For example, fat-soluble pesticides would accumulate in soya bean oil. This accumulation factor may be taken into account. In this particular example the concentration factor from soya bean to soya bean oil is 5 >> for a fat-soluble pesticide the MRL in soya bean oil is 5 x MRL in soya beans. This is of course the other way round for soya bean expeller. It can be difficult to find MRL for individual feed materials, as it is to find the MRL of one specific pesticide for all feed materials. To make these data easily accessible, The EC has introduced a public database, Pesticide Web, http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=homepage&CFID=9446817&CFTOKEN=10512262&jsessionid=08047dd69c5d17ae2749TR

27

Both active substances as MRLs can be accessed easily. The search for an MRLs can be initiated from the feed material or from the pesticide. To conclude this chapter, a final, third regulation is introduced, this specifically covers radioactive components as an undesirable substance. This regulation, EC No. 777/90 is officially entitled:

Commission Regulation (Euratom) No 770/90 of 29 March 1990 laying down maximum permitted levels of radioactive contamination of feedingstuffs following a nuclear accident or

any other case of radiological emergency

This is a general regulation. Specific incidents, like the Tsjernobyl or the Fukushima nucleair incidents, might evoke special (temporary) legislation. Not all contaminations above the maximum allowed level, make a feed permanently unfit for feed. Both in the control regulation Regulation EC No. 884/2004 and in the Regulation EC No. 767/2009 on the placing on the market of feed, there are some option other than destroying. According to Reg. EC No. 884/2004, art. 19, non-compliant imported products can also be re-exported. If the non-compliancy is linked to an undesirable substance in Directive 2002/32/EC, the feed (EU or non EU origin) can also be subjected to special treatment to make it comply with EU regulations or given another destination inside or outside the feed chain. Reg. EC No. 767/2009, art. 20, and Annex VIII holds the specific provisions for these non-complaint products.

28

OFFICIAL CONTROL IN FEED

Inspection and control in feed in The Netherlands based on the Control Regulation, CR, (Reg. EC No. 882/2004), officially entitled:

REGULATION (EC) No 882/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on official controls performed to ensure the verification of

compliance with feed and food law, animal health and animal welfare rule

It covers both feed and food produced market, imported and exported to the EU. The Dutch competent authority is NVWA. Key element in the CR is the fact that inspection and control are risk-based. The CR states it as follows

Member States shall ensure that official controls are carried out regularly, on a risk basis and with appropriate frequency, so as to achieve the objectives of this Regulation taking account of:

Identified risks associated with animals, feed or food, feed or food businesses, the use of feed or food or any process, material, substance, activity or operation that may influence feed or food safety, animal health or animal welfare;

feed or food business operators' past record as regards compliance with feed or food law or with animal health and animal welfare rules;

the reliability of any own checks that have already been carried out; and any information that might indicate non-compliance.

Inspection includes al long list of activities from the competent authority oir designated control bodies:

Official controls on feed and food shall include, inter alia, the following activities:

examination of any control systems that feed and food business operators have put in place and the results obtained;

inspection of: o primary producers' installations, feed and food businesses, including their

surroundings, premises, offices, equipment, installations and machinery, transport, as well as of feed and food;

o raw materials, ingredients, processing aids and other products used for the preparation and production of feed and food;

o semi-finished products; o materials and articles intended to come into contact with food; o cleaning and maintenance products and processes, and pesticides; o labelling, presentation and advertising;

checks on the hygiene conditions in feed and food businesses; assessment of procedures on good manufacturing practices (GMP), good hygiene

practices (GHP), good farming practices and HACCP, taking into account the use of guides established in accordance with Community legislation;

examination of written material and other records which may be relevant to the assessment of compliance with feed or food law;

interviews with feed and food business operators and with their staff; the reading of values recorded by feed or food business measuring instruments;

29

controls carried out with the competent authority's own instruments to verify measurements taken by feed and food business operators;

any other activity required to ensure that the objectives of this Regulation are met As mentioned controls and inspection according to the CR, include all areas in food and feed (primary producers, import, intermediate product, compound feed mills, feed additives, finished products, pet food, organic farming, feeding food-producing animals, export, animal by-products, web-based sales).

As all operators in the feed chain are either registered or approved (see chapter on FHL and on approval and registration of operators in feed), all operators are inspected at regular intervals, depending on the risk-based assessment of the NVWA. Besides these standard inspections, operators in specific areas can be subjected to specific ad hoc controls, f.e. as result on an incident or specific control operation. NVWA has delegated some inspection task to other control bodies (CR, art. 5.1). So, the product Board Animal Feed (PDV) has delegated responsibility for inspection and administration in medicated feed and the COKZ (Netherlands Controlling Authority for Milk and Milk products) for the inspections of diary plants and dairy farmers. Both these bodies and other bodies (in feed and food) must report on a regular basis to the competent authority, the NVWA The European Commission (EC) needs to be informed on the inspections and controls of the member states. As a result, EU member states are obliged to inspect according to so called multi-annual control plans (MAP) (CR, art. 41). These plans must be submitted to the EC. The annual inspection & control plan for is an integral part of the MAP. This Annual Feed Plan consists of a number of dedicated plans, for various parts of the animal feed chain. An example of one of these plans is the National Plan Undesirable substances in feed. In this plan the number of samples to be taken and the analysis of these samples for various undesirable substances is laid down. These samples are taken during regular inspection visits. The 2011 plan included samples & analysis) approximately 4000 samples, amongst which

750 on forbidden animal protein (harbours, farmers, compound feed mills) 350 on heavy metals (premix manufacturers and compound feed mills) 300 on pesticides (compound feed mills and importers of palm and soya oil) 550 on dioxins & PCBs (premix manufacturers and compound feed mills) 250 on Cupper and Zink (compound feed mills producing feed for pigs and

sheep) 450 on mycotoxins (harbours, compound feed mills and dairy farms) 450 on illegal antibiotics (trade in feed materials, compound feed mills)

Of course, many more samples are taken during regular inspections visits, target-based inspections or incident based inspections. All sampling and analysis is to performed according international standards. Laboratories have to accredited according to EN ISO/IEC 17025. As a result of the risk-based character of inspection and controls, the frequency of visits / assessments can vary largely between companies / plants, varying from monthly regular inspections up to once every 2 years.

30

The CR does not stand alone. Of course operators in feed ( and food) have the right to be aware, moreover, must be aware of the demands and requirements they must meet. The General Food law states that feed, placed on the market, (produced or through import) in the EU, and exported from the EU, must be safe (in the broadest sense). For operators in feed, Feed Hygiene Law holds the basic requirements:

for operators in feed (annex II),; for primary producers (farmers) (annex I) and for for feeding food-producing animals (annex III).

These requirements are target-driven and build around the HACCP approach. In case of non-compliance the competent authority (NVWA) has a variety of tools to enforce compliance. These tools include warnings, re-inspection, fines, confiscating products, withdrawal of registration or approval, closing down factories, order destruction or re-export of products. As the authorities in member states inspect operators and product imported on their territory (from outside the EU), so does the EC inspect the member states. The Commission, in its role as guardian of the European Community Treaties, is responsible for ensuring that Community legislation on feed safety (amongst others) is properly implemented and enforced. As a Commission service, the Food and Veterinary Office (FVO) plays an important role in fulfilling this task. The mission of the Food and Veterinary Office is, through its audits, inspections and related activities, to:

check on compliance with the requirements of EU feed safety and quality, within the European Union and on compliance with EU import requirements in third countries exporting to the EU,

contribute to the development of European Community policy in the feed safety sectors,

contribute to the development and implementation of effective control systems in the feed safety sectors, and

to inform stakeholders of the outcome of its audits and inspections The FVO works to assure effective control systems and to evaluate compliance with EU standards within the EU, and in third countries in relation to their exports to the EU. The FVO does this mainly by carrying out inspections in Member States and in 3rd countries exporting to the EU. Each year the FVO develops an inspection program, identifying priority areas and countries for inspection. In order to ensure that the program remains up to date and relevant, it is reviewed regularly. These programs are published on the website of DG SANCO. The findings of each inspection carried out under the program are set out in an inspection report, together with conclusions and recommendations. The competent authority of the country visited is given the opportunity to comment on the reports at draft stage. The inspection reports and the comments of the countries visited are freely accessible to the public on the DG SANCO website.

31

The FVO makes recommendations to the countrys competent authority to deal with any shortcomings revealed during the inspections. The competent authority is requested to present an action plan to the FVO on how it intends to address any shortcomings. Together with other Commission services, the FVO evaluates this action plan and monitors its implementation through a number of follow-up activities. In so-called country profiles, the last five audit reports in a member state are published on the internet. For The Netherlands, these can be found here, http://ec.europa.eu/food/fvo/last5_en.cfm?co_id=NL .

32

Import of Feed in the EU EXPORTING FEED TO / IMPORTING FEED INTO EU

The basic principle for bringing feed to the EU is that any product imported in / exported from EU, should be so safe that it could be marketed in EU and thus must comply with all relevant EU standards. Inspection and control on imported feed is divided between the control of feed of non-animal origin under Reg. EC No. 882/2004 and the control of feed of animal origin under Reg. EC No. 1069/2009 and Reg. EC No. 142/2011. As European and Dutch authorities have only legal powers within the EU / The Netherlands, the party thats held responsible for the feed safety of the product is the importer or the first receiver of the product.

FEED CONTAINING PRODUCTS FROM ANIMAL ORIGIN For these types of feed, the rules set in the ABP regulations 1069/2009 and especially the implementing regulation 142/2001 are leading. They can be described as a set of specific import conditions, of which the CR, 882/2004 states some basic procedural information in articles 46 to 49. On ABP implementing regulation 1042/2011. However complex and overwhelming the ABP regulation might seem (over 250 pages), the parts that are of importance with regard to the export to the EU are listed clearly in annex XIV. This annex contains

listing of product types that can be imported; A reference to lists of approved 3rd countries for the different product; instructions and required veterinary health certificate

The 3rd country where the ABP or derived product is originating from, should be listed. These lists represent the 3rd countries approved for supplying food of animal origin to the EU (Reg. EC No. 1069/2009 art. 41.3).

The establishments and plant in those 3rd countries, must also be on a list thats regularly updated by the 3rd country in question (Reg. EC No. 1069/2009 art. 41.3).

EC publishes lists of approved ABP plants within the EU, http://ec.europa.eu/food/food/biosafety/establishments/list_abp_en.htm

And the EC publishes lists of approved ABP plants in 3rd countries, http://ec.europa.eu/food/food/biosafety/establishments/third_country/index_en.htm including China For proper use of annex XIV it is important to distinguish between the two chapters. Chapter I covers the specific of category 3 material and derived products for uses in the feed chain other than for petfood or for feed to fur animals >> farm animals. Chapter II covers the specific requirements of animal by-products and derived products for uses outside the feed chain for farmed animals other than fur animals

33

A long list of various veterinary health certificates in annex XV, make up a large part of regulation 142/2011. A small but significant note on export from EU. Although the GFL is clear on this subject, as all product exported must comply with EU legal requirements (so they are free to place on the market in the EU), it is of course the receiving country that can additional requirements. This is where the role of the EU stops. Export from EU Member States to 3rd countries is between that Member State and the 3rd country. In general this type of export is based upon individual agreements between EU MS and 3rd countries. Currently agreements between PRC and NL on export to China from feed with animal-based products include:

animal feed with dairy products, petfood with animal-based products, fat for feed, petfood with plant-based products

FEED NOT CONTAINING PRODUCTS FROM ANIMAL ORIGIN There is no specific set of rules (as in ABP) for these feed materials without animal origin products. They are mainly covered by common trade rules (these are not in scope of feed law, like WTO treaties). Of course, the general rules on control and inspection of feed imported into the EU stated in the Control regulation article 46 to 49, as mentioned previously, are applicable. On this subject there are some other, more detailed issues to indicate here and that are within the scope and aim of this document. As feed produced within the EU is subject to inspection and control, so are products from 3rd countries imported to the EU. The products are inspected at customs at the so called First Points of Entry in EU (legal basis: Reg. 882/2004).These inspections include

Document check, product verification, product check Possibly need for phyt-osanitairy certificates (risk for import of unwanted organisms

(plant- or animal pests), unallowed GMO) The EU distinguishes critical and non-critical non-animal feed. For non-critical non-animal products, controls are randomly at the border by Customs (document control) and physical control is at the premises of operators in feed during regular inspection visits. The operator buying feed from any origin (EU or non-EU) remains responsible for the quality and feed safety of the products he buys, regardless of any governmental control, and is obliged to inform the authorities in any case of unsafe feed that comes to his knowledge. The control of critical feed (and food) of non-animal origin is regulated in Reg. EC No. 669/2009, officially entitled:

Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of

official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC

Importers have to use a Common Entry Document CED to inform the competent authority (in The Netherlands the NVWA) of the expected amount and date of arrival of a consignment (standard format of CED in annex II of Reg. 669/2009 )

34

Inspections on imports of the critical non-animal origin feed include the following types of control

Document checks (100% of consignments): Are the documents all right) Identity checks (100% of consignments): Do the goods comply with the

documents? Physical checks (including sampling and analysis acc. to annex I of Reg.

669/2009)

Currently there are no feed products from Chinese origin listed as critical non-animal feed in this Annex I.

35

EU LEGAL ACTS RELATED TO FEED

REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT ND OF THE COUNCIL of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Current consolidated version from 07-08-2009, Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2002R0178:20090807:EN:PDF REGULATION (EC) No 183/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 January 2005 laying down requirements for feed hygiene Current consolidated version from 20-04-2009 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2005R0183:20090420:EN:PDF REGULATION (EC) No 882/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rule Current consolidated version from 01-01-2012 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2004R0882:20120101:EN:PDF COMMISSION REGULATION (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC Current consolidated version form 18-02-2013 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:02009R0669-20130218:EN:NOT REGULATION (EC) No 1831/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003 on additives for use in animal nutrition Current consolidated version from 01-09-2010 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2003R1831:20100901:EN:PDF COMMISSION REGULATION (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives Current consolidated version from 22-05-2008 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:133:0001:0065:EN:PDF REGULATION (EC) No 767/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive

36

80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC Current consolidated version from 01-09-2010 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2009R0767:20100901:EN:PDF REGULATION (EC) No 1069/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) Current consolidated version from 09-11-2010 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2009R1069:20101109:EN:PDF COMMISSION REGULATION (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive Current consolidated version from 15-03-2013 Link http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2011R0142:20130315:EN:HTML COMMISSION REGULATION (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials Current consolidated version from 30-01-2013 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:029:0001:0064:EN:PDF Community Register of Approved Feed Additives Current edition no. 161 from 03-06-2013 Link: http://ec.europa.eu/food/food/animalnutrition/feedadditives/comm_register_feed_additives_1831-03.pdf NOTE: continuously revised and updated DIRECTIVE 2002/32/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 May 2002 on undesirable substances in animal feed Current consolidated version from 26-02-2013 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2002L0032:20130226:EN:PDF REGULATION (EC) No 396/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC Current consolidated version from 26-10-2012

37

http://eur-lex.europa.eu/Result.do?T1=V1&T2=2005&T3=396&RechType=RECH_consolidated&Submit=Search Pesticide Web

Current status, update active substances 12-06-2013, MRLs 06-06-2013. Link: http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=homepage&CFID=9446817&CFTOKEN=10512262&jsessionid=08047dd69c5d17ae2749TR

REGULATION (EC) No 1829/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003 on genetically modified food and feed Current consolidated version from 10-04-2008 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2003R1829:20080410:EN:PDF REGULATION (EC) No 1830/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC Current consolidated version from 11-12-2008 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2003R1830:20081211:EN:PDF COMMISSION REGULATION (EU) No 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired Current consolidated version from 25-06-2011 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:166:0009:0015:EN:PDF NOTE: This regulation settles some of the problems with the import of feed with traces of non-EU authorized GMP-events COUNCIL DIRECTIVE 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC Current consolidated version from 18-12-2008 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1996L0022:20081218:EN:PDF NOTE: This directive includes the withdrawal / repeal of the approval for all B-agonist drugs (like ractopamine). The EU applies to meat produced in the EU and imported from 3rd countries

38

RELEVANT EU WEBSITES AND LINKS EUR-Lex, the place to find EU legislation Link to search page: http://eur-lex.europa.eu/RECH_menu.do?ihmlang=en Lists of approved feed establishments in the EU Link: http://ec.europa.eu/food/food/biosafety/establishments/feed_list_en.htm Lists of approved establishment for animal byproducts inside and outside EU Link: http://ec.europa.eu/food/food/biosafety/establishments/animal_byproducts_en.htm Guidelines for the application for new feed additives Link: http://ec.europa.eu/food/food/animalnutrition/feedadditives/guidelines_en.htm Register of EU-approved GMO event and events of which the approval has been withdrawn Link: http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

StruSTRU

Within Cused in productmarket official s

REGIS

Feed anregistracertificaresult ofadditiveinto the laboratoThe EUmust be

PROD

China feMoA ca

Ag

ucturCTURE

China two mthe Chines

ts to be useaccess for

supervision

STRATION

nd feed addtion certifica

ate needs tof EU testing

es) is needeChinese m

ory. Non-EU approved b

e evaluated

DUCT REG

eed and feean be used f

Mingricul

TheNationa*Checkinga*Approvala*Issueanreg

NewfeedEv*Evaluationapplications

ChinaNation*Feedexam*4institutesGuangdonga

re Ch

ministries ase market. Ted for a certr the produability and

N CRUC

ditives cannate by MoA

o be reneweg (necessared when the

market ,the feU approved but non-Chby the Chin

GISTRAT

ed additivesfor feeding t

nistryoture(Mlfeedofficepplicationdocumpplication

gistrationcertific

valuationExpertCfortheevaluatio

nalFeedQualityplestestingandeslocatedinBeijinandShandongpro

hines

are involvedThe Ministrytain purpos

ucts. MoA ithe enterpr

CIAL POI

ot be sold aA. The registed 6 monthsry for the ape productioneed divisionfeed additivina approvena feed divi

TION AT M

s are alloweto certain a

ofMoA)

ment

cate

Committee

on/newfeedprod

ControlCenterexaminingng,Liaoning,ovince

e Go

d in allowingy of Agricule. The Mins for the prise & the pr

INTS

and used intration certifs before exppproval of van is registeren of MOA hves cannoted feed addision before

MOA

ed based onnimals. The

duct

overn

g feed mateture (MoA) istry of AQS

production qroduction ris

China withficate is valpiry date. It arious proded. After theas plan to cbe exporte

ditives can ee registration

n a positive e procedure

A

DepartmMarketafeedprod

Departme

Audit(coInspection

ment

erials and feis responsi

SIQ is respquality, andsk.

hout obtaininid for 5 yeashould be nucts (espece productiocheck the prd into the C

enter into Cn.

list. Only pre for allowan

AQSIQ

entofVeterinaryccessregistrationducts)

entofVeterinaryomplywithHACCnandsupervision

t

eed additivible for allowonsible for

d AQSIQ is

ng an imporars. The regnoted that tcially feed n has beenroducts with

Chinese marhina, but pr

roducts allonce is as fo

Q

yandPhytosanitn(onlyforanim

yandPhytosanitP)

n

39

es to be wing the granting

s for the

rt istration the

located h local rket. roducts

wed by llows:

tarymalorigin

ary

The ste

CaRaw

Ex

NRe

ps to follow

Raw

atalogueofwMaterials(2012)

xcludeSFC

NONEEDegistrationbyMoA

Examples

w for registra

Materials

CatalogRawMa

(201

Catalo(64

Regis(no

proce

Submit

Applic

Exam

testing(acc

Dispute

Issuean

ation are:

ImportFe

gueofaterials12)

ogue4)

strationormaledure)

thecomplet

cationAccept

plesrecheck

ordingtothew

eontherete

importregis

MOA

edregistratio

Premixs,Compoundfeed,Concentratfeed

complemenfeed

Registrat(norma

procedu

tedrequired

tancewithin

kingbyMoA

estatestandwithin3mont

estresultwit

strationcerti

on

Fee

dte

nt

tionalre)

Fee

Cat

A

Reg(

pro

ddocuments

n10working

appointedin

dardorChinaths

thin15work

ficate,withi

edproducts

dAdditivetalogueofFeed

Additives

gistrationnormalocedure)

toMoA

gdays

nstitute

aindustrials

kingdays

n10days

Evaluatfeed

materiaFeed/Feadditiv

MostDifficult

Registra

standard),

40

iond

als,eedves

tt!!!

ation

41

PRODUCT REGISTRATION AT AQSIQ

Besides the registration of the Ministry of Agriculture, in China feed and feed additives to be imported into the country need a registration of AQSIQ. This registration for import consists two parts:

Country registration Producer registration

China has defined eight types of feed:

Aquatic animal protein and grease (For example :fish meal, fish oil, fish grease, shrimp meal, sleeve-fish liver meal, sleeve-fish meal, cuttlefish grease, cuttlefish meal, refined fish meal, refined scallop meal, etc.)

Pet food (similar to EU) Hay (For example : Alfalfa, timothy grass, straw, etc.) Processed plant protein (For example : wheat bran, bran coat, soybean cake/meal,

peanut cake / meal, rapeseed cake / meal, cottonseed cake / meal, sunflower cake / meal, safflower seed cake / meal, linseed cake / meal, coconut cake / meal, palm cake / meal, distillers dried grains with soluble from maize, distillers dried grains with soluble from cassava, sugar beet pulp, etc.)

Processed terrestrial animal protein and grease (For example : powdered meat (livestock and poultry), meat and bone meal(livestock and poultry), blood meal, blood plasma meal, hematocyte meal, blood corpuscle meal, blood serum meal, fermented blood meal, animal leftovers meal, feather meal, hydrolyzed feather meal, leather protein meal, hoof meal, horn meal, chicken giblets meal, goldbeaters skin protein meal, gluten, whey meal, dry milk, egg powder, dry silkworm pupa and powder, bone meal, bone ash, bone charcoal, bone di-calcium phosphate, shrimp shell meal, eggshell meal, bone glue, animal oil residue, anima