
CHAPTER I
Article 1 
This Regulation lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the reference laboratory.
Article 2 
For the purposes of this Regulation, the following definitions shall apply:

((a)) ‘reference sample’ means a representative sample of the feed additive, as referred to in Article 7(3)(f) of Regulation (EC) No 1831/2003, which is the object of an application;
((b)) ‘method of analysis’ means the procedure for the determination of the active substance(s) of the feed additive in feedingstuffs, and where appropriate, of its residue(s) or metabolite(s) in food, as referred to in Article 7(3)(c) of the Regulation (EC) No 1831/2003;
((c)) ‘evaluation of the method of analysis’ means the thorough assessment of the protocol of the method of analysis as described in the application, including, if appropriate, literature research but not necessarily any experimental work;
((d)) ‘testing of a method of analysis’ means the application of the method of analysis in a laboratory and comparison of results with those described in the application;
((e)) ‘validation of a method of analysis’ means the process of proving that a method of analysis is fit for the intended purpose, by an intercomparison study according to ISO 5725-1 to 6 or other internationally harmonised guidelines for validation of methods by intercomparison study;
((f)) ‘feed test material’ means a feedingstuff sample or premixture sample with or without the inclusion of the feed additive which is the object of the application, to be used for experimental studies on the method of analysis for the determination of the feed additive in feedingstuffs and/or premixtures;
((g)) ‘food test material’ means a food sample derived from an animal that has been fed with feedingstuffs with or without the inclusion of the feed additive which is the object of the application, to be used for experimental studies on the method of analysis for the determination of the feed additive in the residue(s) or metabolite(s);
((h)) ‘multi-analyte methods’ are methods based on a defined principle applicable for the single or simultaneous determination of one or more substance(s)/agent(s) in the specific matrices defined in the scope of the method;
((i)) ‘reference standard’ is a sample of a pure active agent used for calibration purposes.
Article 3 

1. Any person submitting an application for an authorisation for a feed additive or for a new use of a feed additive, as provided for in Article 4(1) of Regulation (EC) No 1831/2003, shall send three reference samples to the reference laboratory, upon request, in a form in which the feed additive is intended to be placed on the market by the applicant.In addition, and upon request, the applicant shall provide to the  reference laboratory:
(a) reference standards of the pure active agents in the case of feed additives:
— belonging to the category zootechnical additives referred to in Article 6(1)(d) of Regulation (EC) No 1831/2003, except feed additives consisting of or containing micro-organisms;
— belonging to the category coccidiostats and histomonostats referred to in Article 6(1)(e) of Regulation (EC) No 1831/2003;
— falling within the scope of  assimilated  law  relating to the marketing of products consisting of, containing or produced from genetically modified organisms (GMOs);
— for which Maximum Residue Limits have been established ... or following Regulation (EC) No 1831/2003.
(b) where the application concerns a feed additive consisting of or containing micro-organisms, an authorisation to the  reference laboratory  to access the microbial strain deposited at the internationally recognised culture collection mentioned in point 2.2.1.2. of Annex II of Commission Regulation (EC) No 429/2008, if requested by the  reference laboratory.Where the application concerns a feed additive belonging to the category sensory additives and allocated within the functional group flavouring compounds referred to at point 2(b) of Annex I to Regulation (EC) No 1831/2003, subject to Article 10(2) of that Regulation, which forms part of a group of applications, the reference samples must be representative of all the compounds/substances in the group.
2. The three reference samples of the feed additive shall be accompanied by a written statement by the applicant that the fee provided for in Article 4(1) has been paid.
3. The applicant shall maintain the reference samples  for  the authorisation of the feed additive by supplying new reference samples to the  reference laboratory  to replace  any that expire.The applicant shall supply additional reference samples, reference standards, feed and/or food test materials, as defined in Article 2, if requested by the  reference laboratory. Upon justified request of the scientific experts or official laboratories working on behalf of the reference laboratory and without prejudice to Regulation (EU) 2017/625, the  reference laboratory  may request to the applicant additional reference samples, reference standards, feed and/or food test materials.
4. Reference samples shall not be required for:
(a) an application for a new use of a feed additive, already authorised for another use, submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when reference samples have been previously sent to the  reference laboratory  for that other use;
(b) an application for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change is not related to the characteristics of the feed additive previously sent to the  reference laboratory  as reference sample of the feed additive concerned.
Article 4 

1. The  reference laboratory  shall charge the applicant a fee in accordance with the rates set out in Annex IV (‘the fee’).
2. The  reference laboratory  shall use the fees towards supporting the costs of the duties and tasks as set out in Annex II to Regulation (EC) No 1831/2003, and in particular those referred to in 2.1, 2.2 and 2.3 of that Annex.
3. The appropriate authority may, once a year, prescribe adaptations in the amount of the fee mentioned in paragraph 1. The adaptation shall take into account the experience gained during the operation of this Regulation and in particular the possibility of fixing different fees for different types of applications.
(4.) In this Regulation, any rates, fees or charges denominated in euro (“EUR”) are to be read as converted into pounds sterling (“GBP”) using an exchange rate of GBP1 = EUR1.1413.
(5.) Any power to make regulations under this Article—
(a) so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
(b) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.
(6.) For regulations made under this Article by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).
(7.) Any power to make regulations under this Article includes power—
(a) to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and
(b) to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
(8.) Any statutory instrument or Scottish statutory instrument  containing regulations made under this Article is subject to annulment in pursuance of a resolution—
(a) in the case of England, of either House of Parliament;
(b) in the case of Wales, of  Senedd Cymru;
(c) in the case of Scotland, of the Scottish Parliament.
(9.) In this Article, any power—
(a) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
(b) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
(c) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.
Article 5 

1. The  reference laboratory  shall submit a full evaluation report to the  Food Safety Authority  for each application, or for each group of applications, within three months from the date of receipt of a valid application as referred to in Article 8(1) of Regulation (EC) No 1831/2003 and the payment of the fee.However, if the  reference laboratory  considers the application to be very complex, it may extend that period by an additional month. The  reference laboratory  shall inform the  appropriate authority, the  Food Safety Authority, and the applicant when the period is extended.The time limits provided for in this paragraph may be further extended with the agreement of the  Food Safety Authority, whenever the  reference laboratory  requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the  reference laboratory  within those time limits.However, the time limit for the  reference laboratory  to submit the evaluation report to the  Food Safety Authority  shall not exceed the time limit for  Food Safety Authority  to provide its opinion, as provided for in Article 8(1) of Regulation (EC) No 1831/2003.
2. The evaluation report provided for in paragraph 1 shall include in particular:
(a) an evaluation indicating if the methods of analysis in the data submitted in the application are suitable to be used for official controls;
(b) an indication if testing of a method of analysis is considered necessary;
(c) an indication if a validation of a method of analysis by an intercomparison study is considered necessary.
3. The evaluation report provided for in paragraph 1 may be amended by the  reference laboratory  at the request of the  appropriate authority  or the  Food Safety Authority  where:
(a) the conditions for placing the feed additive on the market resulting from the Authority's opinion in accordance with Article 8(3)(a) of Regulation (EC) No 1831/2003 differ from those originally proposed by the applicant;
(b) supplementary information relevant to the method of analysis have been provided by the applicant to the  Food Safety Authority.
4. An evaluation report shall not be required for:
(a) applications for a new use of a feed additive submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when the proposed conditions for placing the feed additive on the market for the new use fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the  reference laboratory;
(b) applications for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change or the new conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the  reference laboratory;
(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Notwithstanding paragraph 4, the  appropriate authority, the  reference laboratory  or the  Food Safety Authority  may, on the basis of legitimate factors relevant to the application, consider that a new evaluation of the methods of analysis is necessary. In such cases the applicant shall be informed by the  reference laboratory.
CHAPTER II
Article 6 

1. The reference laboratory is to be assisted by scientific experts or official laboratories for the duties and tasks set out in 2.2, 2.4 and 3 of Annex 2 to Regulation (EC) No. 1831/2003.
2. For the purposes of paragraph 1, scientific experts or official laboratories must comply with the requirements set out in Annex I.
3. The scientific experts or official laboratories, including the  reference laboratory, shall enter into a contract to define the relations between them, particularly in financial matters. In particular, the contract may provide that the  reference laboratory  is to distribute a share of the fees it receives to the scientific experts or official laboratories. Subject to this contract, the  reference laboratory  may issue guidance ... as provided for in Article 12.
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Article 7 
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Article 8 
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Article 9 

1. Scientific experts or official laboratories, who are assisting the reference laboratory, are responsible for assisting the reference laboratory in the preparation of evaluation reports by sending comments to the reference laboratory within 20 days of the reception of the initial report.
2. A scientific expert or official laboratory, who, or which, is assisting the reference laboratory, must communicate to the reference laboratory by 30 January each year an estimate of the number of applications for which the scientific expert or official laboratory considers itself able to carry out the tasks for that year. The reference laboratory must make available annually to all the scientific experts or official laboratories a compilation of the estimates provided.
CHAPTER III
Article 10 

1. The  reference laboratory  shall indicate in its evaluation report to the  Food Safety Authority, as provided for in Article 5(2), and shall inform the applicant and the  appropriate authority, if it considers that the following are necessary:
(a) testing of methods of analysis;
(b) validation of methods of analysis.In doing so, the  reference laboratory  shall provide the applicant with a document describing the work to be carried out through scientific experts or official laboratories including a time schedule and an estimate of a special fee to be paid by the applicant. The applicant shall inform the  reference laboratory  about his agreement to the document within 15 days of receipt of the communication.
2. The  reference laboratory  shall supplement the report to the  Food Safety Authority, as provided for in Article 5(1), with an addendum concerning the outcome of the application of the procedure foreseen in paragraph 1 within 30 days of the availability to the  reference laboratory  of the results of the testing and validation work.
Article 11 
The  reference laboratory  shall be responsible for preparing an annual report on each year’s activities carried out for the implementation of this Regulation and shall submit it to the  appropriate authority. The scientific experts or official laboratories shall contribute to this annual report.
The  reference laboratory  may also organise an annual meeting with the scientific experts or official laboratories, in view of the establishment of the annual report.
Article 12 

1. The  reference laboratory  may establish detailed guidance for applicants concerning:
(a) reference samples;
(b) the testing of methods of analysis, including in particular criteria about when such testing may be required;
(c) the validation of methods of analysis, including in particular criteria about when such validation may be required;
(d) requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008.
2. The  reference laboratory  shall establish detailed guidance for scientific experts or official laboratories, including criteria for appointing scientific experts or official laboratories.
CHAPTER IV
Article 13 
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Article 14 
This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
...
ANNEX I

Scientific experts or official laboratories assisting the reference laboratory  must satisfy the following minimum requirements:

((a)) ...
((b)) have suitable qualified staff that are adequately trained in analytical methods used for the feed additives on which they are involved;
((c)) possess the equipment needed to carry out the analysis of feed additives, in particular the ones on which they are carrying tasks under this Regulation;
((d)) have an adequate administrative infrastructure;
((e)) have sufficient data-processing capacity to produce technical reports and to enable rapid communication ...;
((f)) provide assurance that their staff respect the confidential aspects of issues, results or communications involved in the handling of applications for authorisation submitted in accordance with Regulation (EC) No 1831/2003 and in particular the information referred to in Article 18 of that Regulation;
((g)) have sufficient knowledge of international standards and practices in laboratory work;
((h)) must be accredited, or being in the process of accreditation according to international standards such as ISO 17025.

ANNEX II
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— Federaal Laboratorium voor de Voedselveiligheid Tervuren (FLVVT –FAVV);
— Vlaamse Instelling voor Technologisch Onderzoek (VITO), Mol;
— Centre wallon de Recherches agronomiques (CRA-W), Gembloux.


— Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha.


— Fødevarestyrelsens Laboratorie Aarhus (kemisk);
— Fødevarestyrelsens Laboratorie Ringsted (kemisk og mikrobiologisk).


— Sachgebiet Futtermittel des Bayrischen Landesamtes für Gesundheit und Lebensmittelsicherheit (LGL), Oberschleißheim;
— Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA), Speyer;
— Staatliche Betriebsgesellschaft für Umwelt und Landwirtschaft. Geschäftsbereich 6 — Labore Landwirtschaft, Nossen;
— Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena.


— Põllumajandusuuringute Keskus (PMK). Jääkide ja saasteainete labor, Saku, Harjumaa;
— Põllumajandusuuringute Keskus (PMK), Taimse materjali labor, Saku, Harjumaa.


— Laboratorio Arbitral Agroalimentario. Ministerio de Agricultura, Alimentación y Medio Ambiente, Madrid;
— Laboratori Agroalimentari, Departament d'Agricultura, Ramaderia, PESCA, Alimentació i Medi Natural. Generalitat de Catalunya, Cabrils.


— Laboratoire de Rennes (SCL L35), Service Commun des Laboratoires DGCCRF et DGDDI, Rennes.


— The State Laboratory, Kildare.


— Εργαστήριο Ελέγχου Κυκλοφορίας Ζωοτροφών Θεσσαλονίκης.


— Istituto Superiore di Sanità. Dipartimento di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Roma;
— Centro di referenza nazionale per la sorveglienza ed il controllo degli alimenti per gli animali (CReAA), Torino.


— Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia.


— Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts BIOR, Rīga.


— Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas, Vilnius.


— Laboratoire de Contrôle et d'essais — ASTA, Ettelbruck.


— Nemzeti Élelmiszerlánc-biztonsági Hivatal, Élelmiszer- és Takarmánybiztonsági Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest.


— RIKILT Wageningen UR, Wageningen.


— Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien.


— Instytut Zootechniki — Państwowy Instytut Badawczy, Krajowe Laboratorium Pasz, Lublin;
— Państwowy Instytut Weterynaryjny, Pulawy.


— Instituto Nacional de Investigação Agrária e Veterinária, I.P. (INIAV,IP), Lisboa.


— Univerza v Ljubljani. Veterinarska fakulteta. Nacionalni veterinarski inštitut. Enota za patologijo prehrane in higieno okolja, Ljubljana;
— Kmetijski inštitut Slovenije, Ljubljana.


— Skúšobné laboratórium analýzy krmív, Ústredný kontrolný a skúšobný ústav poľnohospodársky, Bratislava.


— Elintarviketurvallisuusvirasto/Livsmedelssäkerhetsverket (Evira), Helsinki/Helsingfors.


— Avdelningen för kemi, miljö och fodersäkerhet, Statens Veterinärmedicinska Anstalt (SVA), Uppsala.


— LGC Ltd, Teddington.


— The National Institute of Nutrition and Seafood Research (NIFES), Bergen.

ANNEX III

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ANNEX IV
For the purpose of the calculation of the fee, the fee is composed of the following two components:


1.. The first component is intended to support the  reference laboratory  administrative costs and the costs related to the handling of the reference samples. This first component amounts to EUR 2 000.
2.. The second component is intended to support the costs of the  laboratory which performs  the scientific evaluation and preparation of the evaluation report. This second component amounts to EUR 4 000.

The two components are applied as detailed below to calculate the fee rates.
 1. 
Fee = Component 1 + Component 2 = EUR 6 000
 2. 

— when Article 3 (4)(a) and Article 5(4)(a) apply:
Fee = EUR 0
— when only Article 3 (4)(a) applies, only Component 2 is applicable:
Fee = EUR 4 000
 3. 
Fee = Component 1 + Component 2 = EUR 6 000


— For groups of applications concerning more than one feed additive submitted simultaneously belonging to the same category of feed additives, functional group and sub classification, if applicable, and other than chemically defined flavourings, zootechnical additives, coccidiostats and histomonostats, and when the methods of analysis used for these feed additives are of the multi-analyte type of methods of analysis, the fee shall be calculated as follows:
 The first component is multiplied by the number (n) of feed additives in the group:
Component 1 = (EUR 2 000 × n) = N
 The second component is multiplied by the number (m) of methods of analysis to be evaluated by the  reference laboratory:
Component 2 = (EUR 4 000 × m) = M
 The fee shall be the sum of the two components:
Fee = N + M
— For groups of applications concerning more than one chemically defined flavouring submitted simultaneously and when the methods of analysis used for these feed additives are of the multi-analyte type of methods of analysis, the fee shall be calculated as follows:
 The first component is multiplied by the number (n) of reference samples, as specified in Article 3 paragraph 1, submitted to the  reference laboratory:
Component 1 = (EUR 2 000 × n) = N
 The second component is multiplied by the number (m) of methods of analysis to be evaluated by the  reference laboratory:
Component 2 = (EUR 4 000 × m) = M
 The fee shall be the sum of the two components:
Fee = N + M
 4. 

— when Article 3(4)(b) and Article 5(4)(b) apply:
Fee = EUR 0
— when only Article 3(4)(b) applies, only Component 2 applies:
Fee = EUR 4 000
 5. 

