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

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
Health and
Consumers
Outline
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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
Health and
Consumers
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)
Health and
Consumers
Categories of feed (legal base)
FEED (178/2002)
Feed Materials
Feed Additives and
(767/2009)
Premixtures (1831/2003)
Medicated
Feed (90/167)
Compound Feed (767/2009)
Complete Feed
Complementary Feed
Dietetic Feed "ParNuts" (767/2009)
Health and
Consumers
767/2009
Regulation (EC) N° 767/2009 on the placing on the market and use of feed
Scope: 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 materials
Chapter 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
Health and
Consumers
767/2009
 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)
Health and
Consumers
767/2009
Additive labelling in feed materials and compound feed
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
Health and
Consumers
767/2009
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)"
Health and
Consumers
1831/2003
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
Health and
Consumers
1831/2003
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:
Health and
Consumers
1831/2003
1. Technological additives
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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
Health and
Consumers
1831/2003
• 2. Sensory additives
 Colourants
 Flavouring compounds
• 3. Nutritional additives 
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Health and
Consumers
Vitamins and vitamin-like
Trace elements
Amino acids
Urea and derivatives
1831/2003
4. Zootechnical
additives
 Digestibility enhancers
 Gut flora stabilisers
 Substances which
favourably affect the
environment
 Other zootechnical
additives
5. Coccidiostats and
histomonostats
• Substances intended
to kill or inhibit
protozoa
Health and
Consumers
The different roles by the different
actors
Health and
Consumers
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
Health and
Consumers
• 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
Health and
Consumers
Guidelines for the application for
authorisation of feed additives:
COM Regulation 429/2008
Health and
Consumers
Health and
Consumers
1831/2003
After EFSA:
European
Commission
=>
& Member States
Standing Committee on the Food Chain
Health and
Consumers
1831/2003
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
probably the best systems in terms of safety and efficacy evaluation,
transparency, predictability and quickness compared to the in other
parts of the world
Health and
Consumers
1829/2003
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 zerotolerance policy on non-authorised GM-material in feed
- Sets a technical zero at a level of 0.1 %
Health and
Consumers
1829/2003
http://ec.europa.eu/food/dyna/gm_register/index_en.cfm
Maize
(Bt11)
SYN-BT
Ø11-1
Foods and food ingredients
containing, consisting of, or
the cryIA (b) gene inserted to confer produced from SYN-BTØ11insect-resistance
1xMON-ØØØ21-9
Genetically modified maize that
contains:
[
the pat gene inserted to confer
Syngen tolerance to the herbicide glufosinateta ]
ammonium
Feed containing, consisting
of, or produced from SYNBTØ11-1xMON-ØØØ21-9
Products other than food
and feed containing or
consisting of SYN-BTØ111xMON-ØØØ21-9
Health and
Consumers
27/07/
2020
183/2005
Feed Hygiene 183/2005
 Covers all feed business operations except retail of pet food
 Regulates manufacturing standards for FBOs,
 Introduces HACCP for Annex-II-FBOs i.e. apart from primary
production
 Foresees approval or registration of FBOs depending on
activity
 Encourages "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!
Health and
Consumers
183/2005
 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
Health and
Consumers
1069/2009
Regulation 1069/2009 on animal by-products not intended for
human consumption => animal and public health protection
 Categorisation of ABPs: 1 – 2 – 3
 Processing standards
 Channelling for the different products
 Catering waste prohibition in feed
 Prohibition intra-species recycling
 Feed ban laid down in Annex IV of TSE-Regulation 999/2001
(recently revised by Reg. 56/2013)
Health and
Consumers
882/2004
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 controls
 To 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”
Health and
Consumers
882/2004
 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%
Health and
Consumers
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!)
Health and
Consumers
Questions ?
Health and
Consumers