This document discusses the roles and responsibilities of various stakeholders involved in the authorisation and control of feed additives in the European Union. It outlines the networks established between the Directorate-General for Health and Consumers (DG SANCO), the European Food Safety Authority (EFSA), the European Union Reference Laboratory for Feed Additives (EURL-FA), and National Reference Laboratories (NRLs). It describes the duties of the EURL-FA in coordinating the NRL network, maintaining sample banks, evaluating analytical methods, and supporting legislation. It also provides examples of workflows, checklists, and reporting procedures used in the authorisation and control process.

1. European Union
Reference
Laboratory
Feed Additive
Authorisation
(& Control)
Piotr Robouch
1

2. Stakeholders
SANCO
The Stakeholders
Dossier Responsible
Applicant EURL-FA

NRL
EFSA
Rapporteur
2

3. DG SANCO networks
• DG SANCO
n
• European
io
Control
at
Union
is
or
th
• National
Au
The Network The Roles
3

4. Duties EURL-FA Authorisation
• Coordinate NRL Network
• Maintain Sample-Bank of Submitted Feed Additives
• Evaluate analytical methods for Official Control
• Develop relevant guidance documents
 Workshop
 Setup Expert Groups
 Training – dissemination of competence
• Support COM in drafting legislation
• Close collaboration with SANCO & EFSA
4

5. 2010 Expectations
done 2010 Experties
1A 47 9
1B 1 12 7
1C 15 1
1D 15 1
1E 15 0
1F 15 0
1G 22 3
1H 1
1I 1
1J 33 5
1K 308 2
1L 0
2A 2 32 8
2B 1792 4
3A 41 20
3B 6 48 25
3C 4 15 15
3D 4 12
4A 16 59 3
4B 24 27 10
4C 0
4D 4 6
5 5 22 24
total 62 2522 157
5

6. EURL in 2010
120% 50
cumulativ Number of samples per week
Declaration
100% 40
Forms
80%
30
60%
Payment 20
40%
10
20%
week
0% 0
0 4 8 12 16 20 24 28 32 36 40 44 48 52 0 4 8 12 16 20 24 28 32 36 40 44 48 52
Total = 374 DF Total = 567 Samples
6

7. October 2011
7

8. Workflow
Applicant Request DF
filled the (Letter to Appl.; No DF filled
Declaration CC: COM, EFSA) by the Applicant
Form
Request correct DF
(Letter to Appl.) DF - OK? DECLARATION Send scanned
No Yes FORM - OK
(cf. decision tree) DF to MSU
&
Valid – VSAR NFA
(letter to Applicant) SAMPLE - OK (letter to Appl.;
CC: COM + EFSA)
Yes Fee = 0 €?
Yes &
No
Invalid - ISAR
Sample PAYMENT - OK Debit Note - DN
( letter to Applicant) No
OK ? (From MSU to Appl)
&
Applicant
TECHNICAL FAR
sent
DOSSIER - OK (letter to Appl.;
samples Applicant paid
CC: COM + EFSA)
Sample e-mail EFSA
Procedure notification:
Dossier Valid Payment
Procedure
Dossier Evaluation
Procedure
8

9. Fee
9

10. The Declaration Form
• Common mistakes
• Not dated, Not Signed
• Did not provide “Company Letter”
with proper Logo & Address
• “Fee to pay” – Choose wisely
10

11. FAQ - Samples
• Dispatch & Storage temperature v.s. Shelf-Life
• Tamper Proof dilemma – send a picture for advice
• Sample Quantity – call in case of volumes > 1 L
• Solvents; Acid; Base – use proper containers
• Non-holder specific products (?)
• Reference Samples & Standards (cocci, zootech)
11

12. Sample Validity Check List
12

13. Documents List
Scope
Replaceme Reference
Type of the document New sample
nt Sample standard
Certificate of analysis
Material Safety Data Sheet (MSDS)
Samples Validity checklist (F-0????)
Proper labels
Letter of access to culture collection (µ-org)
Copy of the Application Form sent to DG SANCO
(signed and/or submission number on it)
Public summary of the technical dossier
Scientific summary of the technical dossier
13

14. Label Check List
Labelling Reference
Reference standards
samples
Name of the additive (a)/active agent (b) (a) (b)
Name of the applicant (c)/producer (d) (c) (d)
Address of the applicant (e)/producer (f) (e) (f)
Specific name of active components
Physical state
Category/Functional group
Target Species
Net weight-volume/container
Directions/Conditions for use
Safety recommendations, if any
Specific requirements, if any
Identification number, if any
Batch reference number
Manufacturing date
Expiry date
Concentration or activity (enzyme) or c.f.u. (µ-org)
Units
I.U.B. identification number (enzyme)
Specific name of the enzyme
Strain identification number (µ-org)
Incorporation in premixtures (flavour)
14

15. new VSAR
Subject: Valid Samples Acknowledgment of Receipt (VSAR)
Reference: CRL/xxxx
Dear «Contact_person»,
The EURL-FA hereby acknowledges receipt of your samples of <<Sample_name>>. The
samples are considered VALID and have been registered with the following EURL Sample
Number <<Sample_Number>>.
You are requested to:
1. keep this document for future reference;
2. retain the EURL Sample Number (required for future applications related to the same
feed additive) and
3. monitor the Expiry Date in order to supply replacement samples on time, in accordance
with Article 3 (3) of Regulation (EC) No. 378/2005. as last amended by Regulation (EC)
No 885/2009.
Please provide the missing documentation (selected below) at your earliest convenience:
Copy of the Application form sent to DG SANCO
Letter of access to culture collection (for micro-organisms)
Public summary of the technical dossier
Scientific summary of the technical dossier Sample labels
Thank you for your collaboration.
Yours Sincerely,
15

16. Remember… (EC) 429/2008
Section I – summary of the dossier
Section II
2.1 Identity of the additive
2.1.1 name of additive
2.1.2 proposal of classification
2.1.3 qualitative and quantitative composition
2.1.4 purity
2.2 Characterisation of the active substance(s)/agent(s)
2.3 manufacturing process
2.4 Physico-chemical and technological properties
2.5 Conditions of use
2.6 Method of analysis
Section III – safety
Section IV – efficacy
16

17. Normal cycle
ISO 78:2
Application
SOP
(EC) 1831/2003 – Art. 7
IUPAC (EC) 429/2008 - Annex II – 2.6
Valid- Method of
ation Analysis
(EC) 882/2004 – Annex III Authorisation
(EC) 378/2008 – Art. 5
Verifi- (EC) 882/2004 – Art. 11
cation
Evaluation
CRL guide, 2008
17

18. “validation” check list
 Selectivity / interferences
 Working range
 Linearity / sensitivity
 LOD; LOQ
 Repeatability
 Intermediate precision or Reproducibility
 Recovery (*)
 Robustness
 Uncertainty
 Traceability
18

19. (EC) 429/2008 Section II
2.6 Method of analysis
2.6.1.1. These methods shall meet the same requirements as those for methods of
analysis used for official control purpose laid down in Article 11 of Regulation (EC)
882/2004. In particular they shall meet at least one of the following requirements:
— comply with relevant Community rules (e.g. Community methods of analysis)
where they exist;  (EC) 152/2009
— comply with internationally recognised rules or protocols, for example those that
the European Committee for Standardisation (CEN) has accepted, or those agreed in
national legislation (e.g. CEN Standard methods);
— are fit for the intended purpose, developed in accordance with scientific protocols
and validated in a ring test in accordance with an internationally recognised protocol
on collaborative trials (e.g. ISO 5725 or IUPAC); or
— are validated in-house according to international harmonised guidelines for the
single laboratory validation of methods of analysis (9) with respect to the
characterising parameters mentioned in 2.6.1.2.
 IUPAC Harmonised Protocol
2.6.1.2. The detailed characterisation of the method(s) shall include the appropriate
characteristics set out in Annex III of Regulation (EC) 882/2004.
19

20. The cascade Approach
other National
methods
& VERIFICATION
20

21. Methods?
http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/method_database/
21

22. Planning example
draft report
from EFSA
comment
revise
to EFSA
CRL finalisation & SANCO
& Applicant
22

23. FAD reports
100
80
60
40
20
0
2005 2006 2007 2008 2009 2010 2011 2012
13 Apr. 2012
23

24. Reporting
• made systematic
• developed “pre-filled” reports for outsourcing to NRLs
• Finalised report sent to SANCO, EFSA and Applicant
• Web updated @ end of each month
24

25. FAD reports on the web
Updated Monthly
ives/
ed_ addit spx
RL_fe ex.a
EUR Ls/EU Pages/ind
eu/ s/
ropa. eport
rc. ec.eu luation_r
rmm.j /eva
htt p://i orisation
auth
25

26. Remarks Report/Methods
• (1,n) analyte(s)/active substance(s)
• FA, PM, FS, water, Tissues
• methods NOT provided for ALL relevant matrices
(& all FA: i.e. Metal amino chelates)
• verification AND validation (when single-lab
validation)
• determination of TOTAL vs. ADDED
(efficacy vs. official control)
• non-confidential analytical methods
26

27. Ch. von Holst
• M. De Smet
• A. Gorcsi
• D. Mitić
• C.M. Pinto
• S. Bellorini
• Z. Ezerskis
• P. Robouch
27

28. • Thank you for your invitation
• Thank you for your attention
• Looking forward to our future collaboration
Piotr Robouch, PhD
EURL-FA Authorisation, Project Leader
EC-JRC-IRMM
Retieseweg, 111
BE - 2440 Geel
 +3214571980
piotr.robouch@ec.europa.eu
irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/
28