The work of the European Union Reference Laboratory for Food Additives (EURL) and its support for the authorisation process of feed additives in the European Union: a review

Figures & data

Figure 1. (colour online) Overview of the authorisation procedure for feed additives as outlined by Regulation (EC) No. 1831/2003, showing the interactions between the applicants and the European Union Reference Laboratory (EURL), the European Food Safety Authority (EFSA) and the European Commission. The main deliverables of the organisations involved are the EURL evaluation report of the analytical method, the scientific opinion of EFSA, and the regulation issued by the European Commission to grant or deny authorisation of the feed additive.

Table 1. Example for the authorisation of the feed additive ‘Deccox’ containing the coccidiostat decoquinate as active substance.

Regulation	Commission Implementing Regulation (EU) No. 291/2014 of 21 March 2014 amending Regulation (EC) No. 1289/2004 as regards the withdrawal time and maximum residues limits (MRLs) of the feed additive decoquinate
Feed additive	Decoquinate (Deccox)
Active substance	Decoquinate
Reference to EFSA opinion	EFSA (2013)
Reference to EURL report in EFSA opinion	FAD 2013–009
Target levels of active substance in feed matrices	Feed additive: 60.6 g kg^–1 Compound feed: 20 to 40 mg kg^–1
Other components of the feed additive	Refined deodorised soya oil: 28.5 g kg^–1, wheat middling: quantum satis 1 kg
Target levels of active substance in food matrices	1000 μg of decoquinate kg^–1 of wet liver and wet skin + fat; 800 μg of decoquinate kg^–1 of wet kidney; 500 μg of decoquinate kg^–1 wet muscle
Short description of the method in feed matrices as evaluated by the EURL	Reversed-phase high-performance liquid chromatography with fluorescence detection (RP-HPLC-FL) – EN 16162
Short description of the method in food matrices as evaluated by the EURL	RP-HPLC coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS)

Note: Shown is the example for the authorisation of the feed additive ‘Deccox’ containing the coccidiostat decoquinate as active substance, submitted under article 13 (3) of Regulation (EC) No. 1831/2003. The feed additive was previously authorised by Regulation (EC) No. 1289/2004 and via the recent Regulation (EU) No. 291/2014 the conditions of the authorised product as proposed by the applicant are modified. Some key information provided in the regulation is given. The regulation also contains a link to the EURL website to have access to the EURL report.

Table 2. EURL evaluation reports on analytical methods in the period 2005–14: number of feed additives covered by these reports and distribution across categories and functional groups.

	Category		Functional group	Total
1	Technological	A	Preservatives	14
		B	Antioxidants	9
		C	Emulsifiers	13
		D	Stabilisers	11
		E	Thickeners	11
		F	Gelling agents	10
		G	Binders	7
		H	Substances for control of radionuclide contamination	1
		I	Anti-caking agents	6
		J	Acidity regulators	6
		K	Silage additives	19
		L	Denaturants	–
		M	Reduction of the contamination of feed by mycotoxins	8
2	Sensory	A	Colorants	22
		B	Flavouring compounds	43
3	Nutritional	A	Vitamins, pro-vitamins	28
		B	Compounds of trace elements	27
		C	Amino acids	25
		D	Urea and its derivatives	1
4	Zootechnical	A	Digestability enhancers	65
		B	Gut flora stabilisers: microorganisms	57
		C	Substances which favourably affect the environment	14
		D	Other zootechnical additives	37
5	Coccidiostats and histomonostats			30
			Total	464

Figure 2. (colour online) Evaluation reports issued by the EURL-FA and their impact expressed in terms of number of EFSA opinions and European Commission regulations delivered per year and total number across all years.

Table 3. Authorisation of 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
Microorganism strain DSM 11798 of the Coriobacteriaceae family	European Commission implementing Regulation (EU) No. 1016/2013	Minimum content: 1.7 × 10^8 CFU kg^–1 of complete feedingstuff with a moisture content of 12% and specific strain	Enumeration of microorganism strain DSM 11798 of the Coriobacteriaceae: pour plate method using agar supplemented with oxyrase. Identification of microorganism strain DSM 11798 of the Coriobacteriaceae: pulsed-field gel electrophoresis (PFGE)
Bentonite	European Commission implementing Regulation (EU) No. 1060/2013	Maximum content: 20 000 mg kg^–1 feedingstuff with a moisture content of 12% Characterisation of active substance bentonite: ≥ 70% smectite (dioctahedral montmorillonite) < 10% opal and feldspar < 4% quartz and calcite AFB1-binding capacity (BC AFB1) > 90%	For the determination of bentonite in feed additive: X-ray diffraction (XRD) For the determination of BC AFB1 of the additive: adsorption test carried out in a buffer solution at pH 5.0 with a concentration of 4 mg l^–1 for AFB1 and 0.02% (w/v) for the feed additive
Fumonisin esterase EC 3.1.1.87	European Commission implementing Regulation (EU) No. 1115/2014	Preparation of fumonisin esterase produced by Komagataella pastoris DSM 26643 containing a minimum of 3000 U g^–1 Minimum content: 15 U kg^–1 of complete feedingstuff with a moisture content of 12%	For the determination of fumonisin esterase activity: HPLC-MS/MS method based on the quantification of the tricarballylic acid released from the action of the enzyme on fumonisin B1 at pH 8.0 and 30°C

Conditions of use and analytical methods are as specified in the corresponding European Union regulations authorising these feed additives. CFU, colony-forming unit; U, 1 U is the enzymatic activity that releases 1 μmol of tricarballylic acid per minute from 100 μΜ fumonisin B1 in 20 mM Tris-Cl buffer pH 8.0 with 0.1 mg ml^–1 bovine serum albumin at 30°C. The purpose of the methods of analyses is to enforce the conditions of use. However, to enforce the maximum content of bentonite, no method of analysis suitable for official control could be identified.

EFSA. 2013. Scientific opinion on the modification of authorisation of Deccox® (decoquinate) as feed additive for chickens for fattening. EFSA J. 11:3370:1–12.

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