Joint Research Centre Futtermittelzusatzstoffe das EURL im Bereich der Zulassung Christoph von Holst 4.-5. November 2015: Vergleichbarkeit von Messergebnissen Analytik im Spannungsfeld globaler Warenströme www.jrc.ec.europa.eu Serving society Stimulating innovation Supporting legislation
Content Legal aspects of feed additive authorisation How does the EURL work? Examples Outlook 6 November 2015 2
Operation of EURLs and legal basis: Two legal branches: Official food and feed regulation 882/2004 Examples Authorisation regulations Examples Mycotoxins Dioxins Animal proteins Two types of EURLs Compliance with European Legislation: Control by Member States official laboratories GMOs (Regulation 1829/2003) Feed additives (Regulation 1831/2003)
EURL Feed Additives Authorisation Feed Additives Categories REG(EC) No 1831/2003 1. Technological - Preservatives - Antioxidants - Emulsifiers - Stabilisers - Silage additives - Mycotoxins binders 2. Sensory - Colourants - Flavouring compounds 3. Nutritional - Vitamins - Trace elements - Amino acids - Urea & derivatives 4. Zootechnical - Digestibility enhancers - Gut flora stabilisers - Sustances which favourably effect the environment 5. Coccidiostats More than 1000 individual products
The authorisation procedure Application Form Declaration Form, Samples Technical Dossier
Authorisation regulation: Example 6
Overview: The EURL, Regulation (EC) No 1831/2003 and related Regulations This Regulation establishes the EURL at the JRC For each feed additives applicants have to prepare a dossier including methods of analysis for the submitted feed additive Regulation No 429/2008 specifies that the analytical methods have to comply with the criteria for official control (link to Regulation EC (No) 882/2004) Main tasks of the EURL Evaluation of the submitted method against their suitability for official control Maintenance of the feed additive sample bank
EURL Operation and legal documents I Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives Chapter 2.6. of Section II of the dossier containing the analytical methods Proposed register entry specifying the frame of the authorisation Identification of feed additive Target levels in in feed MRLs for residues
EURL Operation and legal documents II COMMISSION REGULATION (EC) No 378/2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives, lastly amended by Commission implementing regulation (EU) 2015/1761.various guidelines and guidance documents of the web-site of DG SANTE, EFSA and EURL
Evaluation of dossiers from applicants Scientific evaluation of analytical methods provided with each application Support by a network of National Reference Laboratories (NRL) Also a NRL can be a rapporteur Peer review of initial report by all NRLs Consultation with other EURLs (e.g BVL) The EURL can ask additional experiments to be performed by the applicant EURL delivers evaluation report 6 November 2015 10
The cascade approach I: Priority of methods 1. Community methods Regulation EC (No) 882/2004 2. CEN/ISO methods /National methods 3. Single laboratory methods, validated against IUPAC protocol 4. Applies to the applicant and the EURL
The cascade approach II Examples for Community/CEN/ISO methods Analyte Source Status Vitamin A REGULATION (EC) No 152/2009 Community method Amino acids REGULATION (EC) No 152/2009 Community method Lasalocid REGULATION (EC) No 152/2009 Community method Monensin, Narasin, Salinomycin ISO 14183: 2005 Official ISO standard Trace elements EN 15510 (2007) Official CEN standard Semduramicin EN 16158 Official CEN standard Phytase CEN/ISO 30024 Official CEN/ISO standard Preference of these methods also in dossier evaluation
Single laboratory validated methods Details are specified in Commission Regulation (EC) No 429/2008, Annex II, chapter 2.6 Method protocol written according to ISO 78-2 standard Scope of the method Clear and detailed description of the method protocol Method performance profile Report on single-laboratory validation Report on verification of second lab
Single laboratory validated methods fit for official control? First: single laboratory validation But the method needs to work also in an official laboratory? Check for transferability Prior to submitting the dossier, the method need to be tested in a second lab? Is the protocol clearly written? Results of verification experiments need to be comparable with those from the validation study! Transferability is an important prerequisite for fitness for purpose 14
Often occurring problems requiring interaction with the applicant Validation/verification reports are not available for all analyte/matrix combinations Method protocol utilises matrix matched standards for calibration: Most often not applicable in official control Not sufficient sensitivity of the methods Options for EURL Extension of deadline for report (3 to 4 months) Asking EFSA to stop the clock for submitting additional information regarding analytical methods
Target of evaluation: Active subtance in feed 16
Target of evaluation: Also characterisation of product Feed additives reducing the mycotoxin content in feed Feed additive Regulation authorising the feed additive Criteria included in the Regulation specifying the conditions of use Method of analysis included in the Regulation to enforce the conditions of use of the authorisation Micro-organism strain DSM 11798 of the Coriobacteriaceae family Regulation (EU) No 1016/2013 Minimum content: 1,7 10 8 CFU/kg of complete feedingstuff Enumeration of microorganism strain DSM 11798 of the Coriobacteriaceae family: pour plate method. Identification of microorganism strain : Pulsed Field Gel Electrophoresis (PFGE). Bentonite Regulation (EU) No 1060/2013 Maximum content: 20 000 mg/kg feedingstuff with a moisture content of 12 % AfB 1 -binding capacity (BC AfB 1 ) above 90 % For the determination of bentonite in feed additive: X- ray diffraction (XRD) For the determination of BC AfB 1 of the additive: adsorption test carried out Fumonisin esterase EC 3.1.1.87 Regulation (EU) No 1115/2014 Preparation of fumonisin esterase. Minimum content: 15 U/kg of complete feedingstuff For the determination of fumonisin esterase activity: (HPLC-MS/MS) quantification of the tricarballylic acid 17
Spectroscopic Data bank: 720 FA in the Sample Bank Confirming identity of samples Check for authorised products FT-NIRM MIR/FT-Raman Cocciidiostats: Maxiban, Nicarbazin, Narasin & vegetable carrier and NIRM spectra FT- Raman Microscope
Identification of feed additives with infrared microscopy Spectroscopy supported by multivariate statistics Omar Jone, Boix A., von Holst C. Differentiation of coccidiostats-containing feed additives by mid and near infrared microscopy. Food Additives & Contaminants: Part A, (2015) Vol. 32, No. 9, 1464 1474 19
Informations I: DG SANTE Feed additive register: List of all feed additives including link to Regulation authorising the product http://ec.europa.eu/food/food/animalnutrition/f eedadditives/registeradditives_en.htm 20
Informations II: EURL web site https://ec.europa.eu/jrc/en/eurl/feed-additives List of all EURL reports, Guidelines for applicants. Methods from authorised products are available from EURL on request 21
Upcoming challenges Feed additives and nanomaterials Feed additives produced by GMOs Do the characteristics of the additive found on the market correspond to those previously evaluated by EFSA and authorised? Identification of feed materials and additives are getting more important. New functional group: Marker? 22
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