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PROFESSOR – EU Risk Expert Sulhattin Yasar : sulhattinyasar@sdu.tr

“European Union Risk Evaluation Process on Safety of Chemical Additives used in Animal Nutrition”. PROFESSOR – EU Risk Expert Sulhattin Yasar : sulhattinyasar@sdu.edu.tr Süleyman Demirel University Isparta Turkey 2005-2010 Formerly worked for EC JRC IRRM Geel Bellgium. Content.

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PROFESSOR – EU Risk Expert Sulhattin Yasar : sulhattinyasar@sdu.tr

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  1. “European Union Risk Evaluation Process on Safety of Chemical Additives used in Animal Nutrition” PROFESSOR – EU Risk Expert Sulhattin Yasar : sulhattinyasar@sdu.edu.tr • Süleyman Demirel University Isparta Turkey • 2005-2010 Formerly worked for EC JRC IRRM Geel Bellgium

  2. Content • 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

  3. GENERAL FOOD LAW • Regulation (EC)178/2002 • laying down the General Principles and requirements of Food Lawcovering 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.

  4. Community Reference Laboratories Risk management National Reference Laboratories

  5. Elements of Food and Feed Safety

  6. !!!!!Not be marketed - without authorisation!!!! FEED ADDITIVE The General Food Law Regulation (EC) 178/2002 Feed Hygiene Reg. (EC) 183/2005 Feed materials Reg. (EC) 767/2009 Feed Additives Reg. (EC) 1831/2003 • A scientific evaluation needed: • SHOWING no harmful effects, on human, animal and environment.

  7. WHAT is FA? colour of ornamental fish and birds FEED ADDITIVES feed and animal products nutritional needs of animals substances, m.o. or prep., other than feed material and premixtures, intentionally added to feed or water Legally classified by Cat/Func groups animal production, performance or welfare, enhance digestibility, improve gut flora environmental consequences of animal production Article 2(a) of 1831/2003 coccidiostatic or histomonostatic effect Article 5(3) of 1831/2003

  8. FADs? Cont., (Annex I of 1831/2003)

  9. Regulations and Directives

  10. Safety Evalution Risk management: Authorisation Producer Application OPINION Risk assessment: Stability -Safety-Efficacy Technical Dossiers Samples + Fee Method of analysis: Safety Member States’official laboratory

  11. Two types of authorisations • Regulation 1831/2003, article 6: Categories of feed additives: • 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

  12. Specification in the authorisation regulation

  13. Who does what? COM- DG 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

  14. Who does what? 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

  15. 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

  16. Evaluation CURRENT WORK since 2004- summary • 450 – 1000 Applications to COMMISSION • 50 Opinions in progress at EFSA • 250 Opinions adopted by EFSA • 300 Reports from CRL-FA

  17. FINAL AUTHORISATION http://ec.europa.eu/food/food/animalnutrition/feedadditives/registeradditives_en.htm

  18. Example …..Community Register

  19. Example…..Registry Entry Authorised by (EC) No 379/2009

  20. OFFICAL CONTROL OF FA 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 control Importance of Community/CEN method

  21. 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?

  22. …(1) the identification of the additive – if approproate . • …(2) the determination of impurities – if approproate • …(3) Maximum Residue Limits (MRLs) - if appropriate. Why we need analytical methods? cont. • Official feed laboratories are enabled to enforce conditions of use of the authorised product regarding

  23. 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/impurities

  24. 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 Undesirable substances: Examples

  25. The cascade approach Food and feed control regulation 882/2004 Community methods CEN methods Ring trial validated methods Single 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

  26. Not in all cases the active substance and the target analyte are identical Active substance – legal limits and target analyte: 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)

  27. EXAMPLE

  28. Identification • 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

  29. EXAMPLE

  30. The conditions of use contain: • Limits for residues/metabolities in animal products, food, tissues. • Officiallycontrolled 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

  31. Maximum Residue Limits (MRLs) - if appropriate. Example

  32.   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

  33. 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

  34. 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.

  35. 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.

  36. Official 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 38

  37. 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.

  38. 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

  39. Conclusion - Chemical Additives must be safe before placing on the market: farm to fork. - Risks managed by EC andassessed by respective Agencies and CRLs • SafetyEvaluation - Human, animal, health, welfare, consumer, environment, end-user benefits (Efficacy) • Official controls of significant importance to monitor the practical aspects of consumer concerned safety.

  40. 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 Recommended links

  41. thank you for your attention

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