Feed Additive Approval An Industry View. Dr Heidi Burrows Regulatory manager

Transcription

1 Feed Additive Approval An Industry View Dr Heidi Burrows Regulatory manager

2 Classification of substances and products used in Animal Nutrition Processing Aid (EC No 1831/2003) Veterinary Substance / Products (Dir 2001/82) Feed additive (1831/2003) Feed material (96/25, 82/471, 183/2005) Premixture (1831/2003) Compound Feed (79/373) Complete Feed (79-373) Complementary Feed (79/373) Diatetic Feed (79/3737) Medicated Feed (79/373)

3 Feed Additive vs Feed Material Grey zone products glycerol / calcium carbonate Marketing and Use of Feed (767/2009) indicated that the Commission would adopt guidelines to clarify the distinction between feed materials and feed additives Commission Recommendation (2011/25/EU) Feed material principal purpose to meet animals nutritional needs Supply energy, nutrients, minerals or dietary fibre Maintain the function of the intestinal tract Feed additive substance other than feed material or premixtures which perform a specific function Sets criteria based on production and processing method, safety and mode of use, and functionality

4 ID-Feed a tool to help classify your product FEFANA Decision Tree for Classification of Substances and Products in Animal Nutrition ID Feed Your tool to regulatory definition of feed products!

5 Feed Material Product of vegetable or animal origin, whose principal purpose is to meet animals nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives which are intended for use in oral animal feeding whether directly as such, or after processing, or in the preparation of compound feed, or as carrier of premixtures (Art 3(2)(g) Reg EC No 767/2009) Catalogue of feed materials common EU system for description and labelling of feed non-exhaustive and voluntary (19/03/2010 Reg (EU) 242/2010) Register of feed materials (767/2009,Art 24(6)) the person who, for the first time, places on the market a feed material that is not listed in the Catalogue shall immediately notify it s use to the representatives of the European feed business sectors shall publish a Register of such notifications

6 Feed Additive Substances, micro-organisms, coccidiostats, histomonostats or preparations, but not a feed material or premixture which are intentionally added to feed (or water) in order to favourably affect the feed, animal products, environment, animal production, nutrition or welfare Only additives that have been through an authorisation procedure may be placed on the market (Reg (EC) No 1831/2003) Authorisations are granted for specific species, specific conditions of use and for 10 year periods Approved additives are listed on the European Union Register of Feed Additives er_feed_additives_ pdf

7 Classification of Feed Additives Technological additives preservatives / antioxidants / emulsifiers / stabilisers / thickeners / binders / silage additives Sensory additives Colourants / flavouring compounds Nutritional additives Vitamins / trace elements / amino acids / urea Zootechnical additives Digestibility enhancers / gut flora stabilisers / substances that favourably affect the environment Coccidiostats and histomonostats

8 How to register a feed additive Dossier must enable an assessment to be made based on the current state of knowledge and permit verification of the compliance of the additives with the fundamental principles of authorisation (reg 1831/2003) European Food Safety Authority (EFSA) evaluates the data and issues an opinion. The Commission (Standing Committee on the Food Chain and Animal Health Animal Butrition) then prepare a draft regulation and this is voted on by Member States Guidance on EFSA website FEEDAP panel Documents need to be sent to - EFSA, European Commission and CRL 6 weeks prior to sending dossier to EFSA and Commission you need to have applied to CRL and fees must be paid before you can submit information to the Commission

9 Timeline 3 samples of feed and fee to CRL, dossier to EFSA, application to Commission EFSA have 15 days to acknowledge receipt of dossier EFSA have 15 days to acknowledge application request from Commission. EFSA have 30 days for completeness check. Once considered valid the scientific assessment starts - 6 months EFSA will prepare an opinion, adopt it at a meeting and send it to the Commission. Commission discuss and vote on the opinion. Entry into Official Journal

10 Dossier requirements II Characterisation Qualitative and quantitative compositions Purity QC Full description of origin of product Manufacturing process Stability shelf life, in-feed Homogeneity Directions for use Assay

11 Dossier requirements III Safety Target animal safety tolerance tests Worker safety skin and eye irritation, skin sensitisation, inhalation studies, Human (consumer) safety metabolic residue studies, sub-chronic toxicity, genotoxicity Environmental safety QPS system qualified presumption of safety no need for studies concerning safety of use for target animals, consumers or for the environment for micro-organisms (or enzymes produced by them)

12 Dossier requirements IV Efficacy 3 significant trials (P<0.05) for each species claimed at minimum dose Species, age of animals and length of trial defined in EFSA guidance Categories for swine, poultry, bovines, sheep, goat, fish, rabbits, horses, pets Chickens for fattening from hatch to 35 days ( kg) (35 day trials) Laying hens from weeks old 13 (18) months, (112 day trials) Piglets (weaned) days old 120 days (42 day trials) Lambs for rearing from birth to 3 months (56 day trials) Kids for fattening from birth to six months (56 day trials)

13 EURL Process Institute of Reference Materials and Measurements (IRMM) of the Joint Research Centre (JRC) nominated as the EURL for feed additives Regulation (EC) No 885/2009 details rules, duties and tasks for EURL Pre-validation phase Declaration send 6 weeks before application to Commission Application when fee has been paid send reference samples to CRL and application to Commission Fees have 2 components To support EURL admin costs EUR 2000 To support costs of rapporteur laboratory EUR 4000

14 EURL Process Samples validation phase Very specific labelling and packaging requirements If not valid they are disposed off Reference samples of pure active agents Supply new samples when shelf life expires Evaluation phase Section 2.6 methods of analysis is made available to NRLs and one is appointed as Rapporteur laboratory Can request supplementary information Rapporteur sends initial report to the EURL, compiles comments from other NRLS and sends final report to EFSA Takes 3 4 months

15 EURL Requirements Assay The methods of analysis should be either Known assay ISO / CEN / AOAC In house assay requires validation and verification Product assay, in-feed assay, in-premix assay, in water, in target tissue or animal products Assay method provided as an Operating Procedure (OP) using format in ISO 78-2 Foreword Reagents and Materials Title and Scope Sampling Definitions Procedure Introduction Calculation and Precision Warnings Quality Assurance and control Normative references Special cases Principle Test report Reactions Annexes and bibliography

16 EURL Requirements Validation If not using a known method then need to validate the assay In-house validation applies recommendation of international standards or guidance documents IUPAC harmonised protocol, ISO standard Accuracy Applicability Limit of Detection Limit of Determination / Quantification Precision Repeatability Reproducibility (intermediate precision) Recovery Selectivity Sensitivity (and interferences) Linearity Measurement Uncertainty

17 EURL requirements Verification Independent Expert laboratory to run it not easy to find expensive. Blank, known and blind samples sent and tested over 2 days Modifications suggested and implemented Results on samples compared between the in-house lab and the independent lab

18 Controls Tolerances for analytical constituents and feed additives in labelled feed materials and compound feeds Commission Regulation (EU) No 939/2010 amending Annex IV to Regulation 767/2009 Tolerances of feed additives apply to the total amount labelled as the guaranteed quantity at the end of storage life Technical tolerance only not analytical If below the declared content the following apply 10% of declared content if 1000 units or more 100 units if less than 1000 units but not less than 500 units 20% if less than 500 units but not less than 1 unit 0.2 units if less than 1 unit but not less than 0.5 units 40% if less than 0.5 units Where 1 unit = 1 mg, 1000 IU, 1*10 9 CFU or 100 enzyme activity units per kg feed

19 Thank you! Any questions