Post on 01-Jan-2016
description
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“European Union Risk Evaluation Process on Safety of Chemical Additives used in Animal Nutrition”
PROFESSOR – EU Risk ExpertSulhattin Yasar : sulhattinyasar@sdu.edu.tr
Süleyman Demirel University Isparta Turkey 2005-2010 Formerly worked for EC JRC
IRRM Geel Bellgium
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ContentContent EUROPEAN UNION – LAW, SAFETY RISKS
FOOD AND FEED SAFETY REGULATIONS
Feed Additives (FA)
◦ Regulations, Directives, Guidelines – authorisation
◦ Safety Evaluation
◦ Who does what?
◦ Summary – Opinion & Authorisation
◦ Method of analysis - Official control of FADs
Chemical Residues
Conclusion
GENERAL FOOD LAW
Regulation (EC)178/2002 ◦laying down the General Principles and requirements
of Food Law covering all stages of food/feed production and distribution..
◦The aim to provide a framework to ensure a coherent approach in the development of food legislation.
◦At the same time, provides the general framework for those areas not covered by specific harmonised rules but where the functioning of the Internal Market is ensured by mutual recognition.
Community Reference Laboratories
ECGeneral
directorate for
health&consumer
EUROPEAN FOODSAFETY
AUTHORITY
EUROPEAN MECIDINES
AGENCY
COMMUNITY PLANT VARIETY OFFICE
EXECUTIVE AGENCYFOR
HEALTH&CONSUMER
Risk EVALUATION
Risk management Policy maker
National Reference Laboratories
Risk management
Elements of Food and Feed Safety
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!!!!!!!!!! Not be marketed - without Not be marketed - without authorisationauthorisation !!!!!!!!
A scientific evaluation needed:
• SHOWING no harmful effects, on human, animal and environment.
FEED ADDITIVE
The General Food Law Regulation (EC) 178/2002
Feed Hygiene Reg. (EC) 183/2005
Feed Additives
Reg. (EC) 1831/2003
Feed materialsReg. (EC) 767/2009
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FEED ADDITIVES
feed and animal products
colour of ornamental fish and birds
nutritional needs of animals
environmental consequences of animal production
animal production, performance or welfare, enhance digestibility, improve gut flora
coccidiostatic or histomonostatic effectArticle 5(3) of 1831/2003
substances, m.o. or prep., other than feed material and premixtures, intentionally added to feed or water
Article 2(a) of 1831/2003
WHAT is FA ?
Legally classified by Cat/Func groups
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FADs? Cont.,FADs? Cont.,(A
nn
ex I
of
1831
/200
3)
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Safety EvalutionSafety Evalution
Risk assessment: Stability -Safety -Efficacy
Risk management: Authorisation
Member States’official laboratory
Application
Technical Dossiers
Method of analysis: Safety
OPINION
Producer
Samples + Fee
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Two types of authorisations
• Regulation 1831/2003, article 6: Categories of feed additives:
a) technological additives: any substance added to feed for a technological purpose;
b) 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;
c) nutritional additives;
d) zootechnical additives: any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment;
e) coccidiostats and histomonostats
• Authorisation is granted for an additive without mentioning a producer
• Authorisation is granted for a specific additive produced by the holder of the authorisation, placing a specific product on the market: Holder specific authorisation
Specification in the authorisation regulation
Who does what?Who does what? COM- COM- DG SANCODG SANCO
Applications submitted following the procedures specified in Reg. 1831/2003 and Reg. 429/2008.
Once the application is electronically submitted, send a copy to the functional mailbox SANCO-APPLICATIONS-1831@ec.europa.eu.
◦ Application form in accordance with Annex I of Regulation (EC) No 429/2008 ◦ Public summary; ◦ List of the confidential parts of the dossier
These particulars and documents to be submitted to the Commission are in addition to the information to be submitted to EFSA and the CRL-FA
http://ec.europa.eu/food/food/animalnutrition/feedadditives/guidelines_en.htm
Who does what?Who does what? EFSA EFSA
The FEEDAP Panel, independent scientific board: advising on safety and/or efficacy of FADs
The 21 members expertise covering :
◦ animal physiology, biochemistry, pharmacology,
◦ toxicology, microbiology, (animal) nutrition (including fish),
◦ veterinary sciences,
◦ feed materials and technology,
◦ husbandry, product quality,
◦ ecotoxicology.
http://www.efsa.europa.eu/EFSA/ScientificPanels/efsa_locale-1178620753812_FEEDAP.htm
EFSA is assisted by a Community Reference Laboratory for additives for use in animal nutrition (CRL for Feed Additives).
Regulation (EC) No 1831/2003 on additives for use in animal nutrition nominates the Joint Research Centre (JRC) as the CRL for Feed Additives and its Institute for Reference Materials and Measurements (IRMM) has taken up the task.
Regulation (EC) No 378/2005, as last amended by Regulation (EC) No 885/2009, details the rules for the implementation of Regulation (EC) No 1831/2003 and provides the practical conditions for the duties and tasks of the CRL.
Additional tasks are assigned to the CRL 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 competent authorities in each Member State.
http://irmm.jrc.ec.europa.eu/html/CRLs/crl_feed_additives/index.htm
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EvaluationEvaluation
• 300 Reports from CRL-FA
•450 – 1000 Applications to COMMISSION
•250 Opinions adopted by EFSA
•50 Opinions in progress at EFSA
CURRENT WORK since 2004- summary
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FINAL AUTHORISATIONFINAL AUTHORISATION
http://ec.europa.eu/food/food/animalnutrition/feedadditives/registeradditives_en.htm
Example …..Community RegisterExample …..Community Register
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Example…..Registry Entry
Focus is on the concentration of the active substance in feed, premixtures, feed additive per se, and ITS RESIDUES/metabolites in animal food and tissues.
Feed additives are authorised via a European regulation specifying the conditions of use (register entry)
Target concentrations of the active substance as defined in the register entry are legal limits
The CRL together with the NRLs evaluate methods that are suitable to enforce the legal limit in the frame of the official control purposes
The analytical methods are applied in the frame of official controlImportance of Community/CEN method
OFFICAL CONTROL OF FA
Why we need Why we need analytical methods?analytical methods?
• Official feed laboratories are enabled to enforce conditions of use of the authorised product regarding the content of the active substance in feedingstuffs.
Why we need analytical methods? cont.
• Official feed laboratories are enabled to enforce conditions of use of the authorised product regarding
• …(1) the identification of the additive – if approproate .
• …(2) the determination of impurities – if approproate
• …(3) Maximum Residue Limits (MRLs) - if appropriate.
Undesirable substances/impuritiesUndesirable substances/impurities
• Impurities in additives:
• Limits for lead, cadmium and dioxins are established in Directive 2002/32
Other CRLs have been established for these elements
Undesirable substances: Undesirable substances: ExamplesExamples
Directive 2002/32: Setting legal limits for undesirable substances in feed additives
Legal limits for impurities set in the authorisation regulation of the feed additive
Food and feed control regulation 882/2004
Community methodsCEN methodsRing trial validated methodsSingle laboratory methods
This principle is applied whatever the applicant proposes !!
Not evaluate applicants’ methods, if there is a standard method available
The standard should cover all “analyte/matrix/concentration”-combination
The cascade approach
Examples of Commission and CEN methods
ANALYTE SOURCE STATUS
Vitamin A Regulation 152-2009 Official Methods in force
Amino Acids Regulation 152-2009 Official Methods in force
Trace Element EN 15510 approved
Probiotics CEN standards approved
Not in all cases the active substance and the target analyte are identical
Feed additive, active substance and analyte to measure
Additive Active Substance Legal limits in feed Sel-Plex® 2000, selenized yeast
selenomethionine and other selenocompounds
Total selenium
Mintrex Zn, Cu, Mn
Trace elements chelates of the hydroxy analogue of methionine
Zn or Cu or Mn
The analytical method does not measure the active substance, but an important
“component” – here the elements
The concentration of the target element is influenced by the background level
The legal limit applies, regardless of whether the target element has been introduced via the feed additive or not (specificity)
Active substance – legal limits and target analyte:
EXAMPLEEXAMPLE
The identification of the feed additive when present in feed
Identification important holder specific authorisations (e.g. coccidiostats, ‘zootechnical additives’)
Non-holder authorisations may subject of the specific restrictions
In most cases no analytical methods to show the active substance is added via a feed additive
Identification may be possible when working on the product itself.
Identification of the additive in feed is possible in the case of probiotics
Limitations of the use of analytical methods
Identification
EXAMPLEEXAMPLE
The conditions of use contain:
◦ Limits for residues/metabolities in animal products, food, tissues.
◦ Officially controlled by the official methods
◦ EFSA proposes to set MRLs for the sum of various residues, if no legal limits are proposed/established.
Residues in food
ExampleExample• Maximum Residue Limits (MRLs) - if appropriate.
Residues of Veterinary Medicinal Products
Animals (cattle, pigs, poultry, fish) treated with medicines
Their residues could remain in tissues and foods (meat, milk, egg)
No hazards to be guaranteed by toxicologic evaluation
If necessary they are banned when the established MRLs are exceeded
Regulation (EC) No 470/2009 by DG-ENTERPRISE
EMA-european mecidines agency
Opinions and reports on MRLs
the Committee for Medicinal Products for Veterinary Use (CVMP) The European public MRL assessment report provides an overview
of the assessment carried out by the CVMP on an application submitted for the establishment of MRLs.
EU Legislation – Eudralex
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union".
Volume 1 - EU pharmaceutical legislation for medicinal products for human use
Volume 5 - EU pharmaceutical legislation for medicinal products for veterinary use
Pre-authorisations -guidelines
Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use
Volume 3 - Scientific guidelines for medicinal products for human use
Volume 4 - Guidelines for good manufacturing practices for medicinal products for human and veterinary use
Volume 6 - Notice to applicants and regulatory guidelines for medicinal products for veterinary use
Volume 7 - Scientific guidelines for medicinal products for veterinary use Volume 8 - Maximum residue limits
Volume 9 - Guidelines for pharmacovigilance for medicinal products for human and veterinary use
Volume 10 - Guidelines for clinical trial
Medicinal products for paediatric use, orphan, herbal medicinal products and advanced therapies are governed by specific rules.
Post-authorisation
Aim of EMA is to support the work of Health Authorities outside the European Union.
The legal bases are Art. 127 of Directive 2001/83/EC (medicinal product for human use) and Art. 93 of Directive 2001/82/EC (veterinary medicinal products).
As foreseen by the legislation, the Agency's certification scheme is based on World Health Organisation recommendations .
Certificates are issued by the Agency, on behalf of the EC, to confirm the Marketing Authorisation status of products either authorised by the EC through the centralised procedure or products for which a centralised application has been submitted to the Agency, and products pursuant to Art. 58 of Regulation 726/2004/EC.
The certificates also confirm the Good Manufacturing Practice (GMP) compliance status.
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Official controlOfficial control
•Council Directive 96/23/EC
•measures to monitor certain substances and residues thereof in live animals and animal products
•establishes that Member States should draft a national residue monitoring plan for the groups of substances detailed in Annex I.
•These plans must comply with the sampling rules in Annex IV to the Directive Directive 96/23/EC
European Union Reference Laboratories The EU's network of laboratories for the control of residues
includes: EU Reference Laboratories (EU-RLs) designated by the
Commission; National Reference Laboratories (NRLs) designated by each
EU-countries; Official control laboratories under the responsibility of EU-
countries. EU and national reference laboratories contribute to high
quality and uniformity of analytical results. Functions Provide analytical and reference methods to NRLs; Coordinate the application by NRLs of the methods Conduct training for NRL staff Provide the Commission with scientific and technical
assistance Collaborate with laboratories that analyse feed and food in
non-EU countries.
MRL – established - example
Active agent: Benzylpenicillin
Marker residue: Benzylpenicillin
Animal Species: All food producing species MRLs – target tissues: 50 μg/kg -muscle 50 μg/kg - Fat 50 μg/kg - Liver 50 μg/kg - Kidney 4 μg/kg -Milk
Other provisions: MRLs for fat, liverand kidney do not apply to fin fish. For porcine and poultry species the fat MRL relates to ‘skin and fat in
naturalproportions’. Not for use in animals from which eggs are produced for human consumption.
Classification: Anti-infectiousagents/Antibiotics
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ConclusionConclusion- Chemical Additives must be safe before placing on the market: farm to fork.
- Risks managed by EC and assessed by respective Agencies and CRLs
- Safety Evaluation - Human, animal, health, welfare, consumer, environment, end-user benefits (Efficacy)
- Official controls of significant importance to monitor the practical aspects of consumer concerned safety.
Recommended linksRecommended links• EU-Lex:
http://eur-lex.europa.eu/en/index.htm• CRL web site:
http://irmm.jrc.ec.europa.eu/html/CRLs/crl_feed_additives/index.htm
• EFSA Web site: http://www.efsa.europa.eu • DGSANCO Web site:
http://ec.europa.eu/food/food/animalnutrition/feedadditives/index_en.htm
• Feed additive register:http://ec.europa.eu/food/food/animalnutrition/feedadditives/registeradditives_en.htm