Autorisation of Feed Additives - the Risk

Transcription

1 Autorisation of Feed Additives - the Risk Managers perspective New Challenges in Food Safety Review in Japan & the EU the Example of Food & Feed Additives Tokyo - 2 July 2013 James Moynagh Head of Unit Animal Nutrition European Commission

2 What are feed additives in the EU Risk management structure (legal and decision making) Approval criteria Ongoing work Examples of Risk Management issues and problems International co-operation

3 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 of the functions. (a) favourably affect the characteristics of feed, (b) favourably affect the characteristics of animal products, (c) favourably affect the colour of ornamental fish and birds, (d) satisfy the nutritional needs of animals, (e) favourably affect the environmental consequences of animal production, (f) favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs, or (g) have a coccidiostatic or histomonostatic effect.

4 Additive Groups Technological l Preservatives Antioxidents Emulsifiers Stabilisers Thickeners Gelling agents Binders Reduce Radionucleide contamination Anticaking Acidity regulators Silage additives Denaturants Reduce mycotoxins Sensory Colourants (feed, food, animal) Flavourings Nutritional Vitamins Trace elements Amino oacds acids Urea Zootechnical Digestibility enhancer Gut flora stabilisers Environmental effects others

5 Feed Additives - Actors in Europe The Applicant European Commission 28 Countries One Law Member States European Food Safety Authority

6 Legal Structure t for Feed Additives Regulation 1831/2003 Additives used in Animal Nutrition Regulation 429/2008 Implementing Rules for above

7 Decison Making Commission assesses Report of European Food Safety Authority After internal consultation; makes proposal to Member States Standing Committee of the Food Chain and Animal Health All Member States on committee (28) Draft discussed, amendments possible Voted Qualified Majority needed

8 Time Limits it Set in legislation 6 Months for EFSA Risk Assessment (clock stopped for additional data/questions) 3 Months for Risk Manager to present proposal to Member States (extended if exceptionally complex)

9 All Decisions published in Official Journal Online Register of Additives Additive description, composition, analytical method, species/type of animal, max dose, other provisions (compatibility, post market monitoring, worker safety) Usually enters into force 21 days after Transition periods if necessary eg products already on market, labels etc

10 Feed Additive Evaluation and Re-evaluation Exercise Midway through re-evaluation of all additives which began in 2010 Plus new applications per annum

11 Additives under review Category Oi Originali Under review Technological Sensory Nutritional Zootechnical* Coccidiostats* 23 5 Total

12 Risk assessment Safety target species, user, consumer Efficacy eg zootechnical additives No adverse effect on animal health, human health and the environment May not mislead the user May not harm or mislead the consumer

13 Risk management Authorisation or not? Maximum doses? Species? Compatibilities? Post market monitoring? User safety Depends on the application, and risk assessment and management of risk

14 Recent problematic cases Safety Antibiotic resistance (transferable) Some microbiological additives Genotoxicity Some sensory additives Efficacy Small studies, non significant results

15 International ti International Feed Regulators CODEX FAO Bilateral Co-operation

16 Useful Web sites EU Commission Animal Nutrition Register of Additives Eurlex europa eu/en/index htm EFSA opinions on Feed additive applications Better Training for safer Food

17 Thank you for your attention