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Health andConsumers

TEC feed seminar (7 march 2013, Bangkok)

Regulatory framework for Feed in the European Union (EU):

Marketing of feed materials, compound feed and feed additives - Feed Hygiene - Feed Control

Dr. Wolfgang Trunk

EUROPEAN COMMISSION DG SANCO - Animal Nutrition

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Outline

Legislative structure Feed marketing (Reg 767/2009) Feed additives (Reg 1831/2003) GM-Feed (Reg 1829/2003) Feed Hygiene (Reg 183/2005) Animal By-Products (Reg 1069/2009) Feed Control (Reg 882/2004) Resume

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Legislative structure (1)

Basic Legislation on EU feed law is set in Directives or Regulations of the European Parliament and the Council (27 Member States) adoption based on Commission proposal.

COM-Regulations to implement basic acts Trend to Regulations as directly applicable (no

transposition in national law)

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Categories of feed (legal base)

FEED (178/2002)

Medicated Feed (90/167)

Feed Materials(767/2009)

Feed Additives and Premixtures (1831/2003)

Compound Feed (767/2009)Complete Feed Complementary Feed

Dietetic Feed "ParNuts" (767/2009)

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Regulation (EC) N° 767/2009 on the placing on the market and use of feedScope: feed materials & compound feed (including pet food)No pre-market authorisation procedure for feed material: Feed business operator is in the first hand responsible for their safety “Bio-proteins” became ordinary feed materialsChapter on dietetic feed ("ParNuts")List of materials prohibited/restricted for feed use ("negative list")Feed materials not listed in the EU-Catalogue must be contained in feed material register

767/2009

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Labelling rules for additives in feed materials & compound feed (ex!) Tolerances for analytical constituents AND feed additives Feed additive functions can be claimed for FM and compound feed

(scientific substantiation in the moment of marketing; The MS-authority … may submit the issue of doubtful claims to the

Commission who may adopt a decision. Pilot discussion at EU level on a pre-biotic (MOS)

767/2009

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The name of the additive, identification number and the added amount; example for Zinc*:

Compounds of trace elements, mg/kg (in brackets trace element)

Zinc chelate of hydroxy analogue of methionine, 3b6.10: 250 (50); Zinc chelate of amino acids hydrate, E6: 300 (50); Zinc sulphate, monohydrate, E6: 150 (50); all Zinc compounds:150)

* Voluntary labelling in blue

Additive labelling in feed materials and compound feed

767/2009

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Authorisation of feed for particular nutritional purposes = dietetic feed

Parnuts = special claim - borderline with vet medicine

“Exclusivity” of parnut with respect to essential nutritional characteristics and animal species? Example:

Parnut: "Support of renal function in case of chronic renal insufficiency"

Essential nutritional characteristics:

"- Low level of phosphorus and restricted level of protein but of high quality (dogs and cats) or- Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate (adult cats)"

767/2009

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Feed Additive Regulation (EC) No 1831/2003

• Ban on antimicrobial growth promoters as additives• pre-marketing authorisation => Principle of a positive list:

only what is in the list can be placed on the market and can be used as additive in feed under conditions clearly established (type of feed, level of addition, animals intended to consume the feed, etc…)

• Current Register with almost 2500 additives• Labelling of additives and premixtures

1831/2003

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Definition of feed additives

• 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 specific functions.

• 5 Categories are currently established for the different functions:

1831/2003

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Preservatives Antioxidants Emulsifiers, Stabilisers, Thickeners, Gelling agents, Binders Substances for control of radionucleides Anticaking agents Acidity regulators Silage additives Denaturants Mycotoxin contamination reducers

1831/2003

1. Technological additives

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• 2. Sensory additives

• 3. Nutritional additives

Colourants Flavouring compounds

Vitamins and vitamin-like Trace elements Amino acids Urea and derivatives

1831/2003

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4. Zootechnical additives

5. Coccidiostats and histomonostats

Digestibility enhancers Gut flora stabilisers Substances which

favourably affect the environment

Other zootechnical additives

• Substances intended to kill or inhibit protozoa

1831/2003

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The different roles by the different actors

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General aspects of applications for authorisation

Application to the Commission Technical dossier to EFSA Reference samples and the part of the technical

dossier with the methods of analysis to the EURL

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• EURL for Feed Additives COM Regulation 378/2005 details the rules for the implementation of

Regulation 1831/2003 and provides the practical conditions for the duties and tasks of the EURL

Additional tasks are assigned to the EURL by Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. In accordance with this regulation, sampling and analysis in the context of official controls are carried out by official laboratories designated by CAs in each MS

Guidance documents available on website Specific presentation on EURL tasks and activities by Mr De Jong

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Guidelines for the application for authorisation of feed additives:

COM Regulation 429/2008

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Regulation 429

/2008

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After EFSA:

& Member StatesStanding Committee on the Food Chain

European Commission

=>

1831/2003

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Register of EU-authorised feed additives:http://ec.europa.eu/food/food/animalnutrition/feedadditives/comm_register_feed_additives_1831-03.pdf

=> Although the EU authorisation regime may look complex, it is => Although the EU authorisation regime may look complex, it is probably the best systems in terms of safety and efficacy evaluation, probably the best systems in terms of safety and efficacy evaluation, transparency, predictability and quickness compared to the in other transparency, predictability and quickness compared to the in other parts of the worldparts of the world

1831/2003

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Reg (EC) No 1829/2003 on GM food and feed

• Authorisation procedure for GMOs (=> Register)• State of play "new approach" on freedom for Member States to deny on

their territory cultivation of authorised GM-crops on "grounds other than those based on a scientific assessment of health and environmental risks"

• NO labelling for the adventitious or technically unavoidable presence of authorised GM food and feed in a proportion that is no higher than 0.9 %.

• Regulation EC 619/2011 harmonising the implementation of the zero-tolerance policy on non-authorised GM-material in feed- Sets a technical zero at a level of 0.1 %

1829/2003

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http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

Maize (Bt11)

SYN-BT Ø11-1

[ Syngenta ]

Genetically modified maize that contains:

the cryIA (b) gene inserted to confer insect-resistance

the pat gene inserted to confer tolerance to the herbicide glufosinate-ammonium

Foods and food ingredients containing, consisting of, or produced from SYN-BTØ11-1xMON-ØØØ21-9

27/07/2020

Feed containing, consisting of, or produced from SYN-BTØ11-1xMON-ØØØ21-9Products other than food and feed containing or consisting of SYN-BTØ11-1xMON-ØØØ21-9

1829/2003

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Feed Hygiene 183/2005 Covers all feed business operations except retail of pet foodRegulates manufacturing standards for FBOs, Introduces HACCP for Annex-II-FBOs i.e. apart from primary productionForesees approval or registration of FBOs depending on activityEncourages "Guides for good manufacturing practice"Self-regulation – Industry scheme – NO safety insurance=> the adherence to a certain scheme like FAMI-QS might improve the manufacturing in the additive factory but does not imply for the control authorities in the EU an assumed safety of the products or even safety certification!

183/2005

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Import rules for feed containing animal products including pet food => ABP-Reg 1069/2009: harmonised import rules – certificates Marketing rules acc 767/2009

Import rules for feed of non-animal origin including additives:NO Third Country lists nor establishments lists of the TC=> importer as responsible FBO must be on MS list

Revision of annex II by Reg 225/2012 ("dioxin package"): approval of establishments placing on the market, for feed use, products derived from vegetable oils and blended fats and as regards the specific requirements for production, storage, transport and dioxin testing

183/2005

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Regulation 1069/2009 on animal by-products not intended for human consumption => animal and public health protectionCategorisation of ABPs: 1 – 2 – 3Processing standardsChannelling for the different productsCatering waste prohibition in feedProhibition intra-species recyclingFeed ban laid down in Annex IV of TSE-Regulation 999/2001 (recently revised by Reg. 56/2013)

1069/2009

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Regulation 882/2004 on official controls on feed and food To ensure they are done on a risk basis = with appropriate frequency To establish EU framework for greater harmonisation and the integration of controls across the entire food and feed chain (“farm to fork”) EU list with high risk products of non-animal origin (Art 15 V) => increased and harmonised import controlsTo establish a community and national reference laboratories network; Requirement for CAs to prepare of a single integrated multi-annual national control plan for effective implementation of the Regulation; To organise and develop a Community food safety training strategy “Better Training for Safer Food”

882/2004

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Reg 669/2009 on increased level of official controls on imports of certain feed and food of non-animal:

Import procedure: DPE, Common Entry Doc (CED), List: intended use - CN code - Country of origin – Hazard - Frequency

physical + id-checks Thailand only listed with food Ex: Groundnuts (peanuts), in shell (Feed and food) - 1202 41 00 - India (IN) –

Aflatoxins – 20% Ex: Feed additives and premixtures - ex 2309 - India (IN) - Cadmium and lead

- 10%

882/2004

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Resume

1. EU food safety system has been completely reformed since 2000

2. Establishment of the "farm to fork" principle includes in particular feed safety, in concrete by the

provisions on feed hygiene marketing rules for feed integration in system for official controls

3. Reg 1831/2003 made EU system with centralised authorisation procedure based on an

independent risk assessment world class EU a pioneer on reduction of AGPs (AMR!)

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Questions ?