Statement on the use of feed additives authorised/applied for use in feed when supplied via water 1

Transcription

1 SCIENTIFIC OPINION Statement on the use of feed additives authorised/applied for use in feed when supplied via water 1 This Statement replaces the previous version published on 16 December EFSA Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP) 3,4 European Food Safety Authority (EFSA), Parma, Italy SUMMARY The European Food Safety Authority (EFSA) asked the Panel on Additives and Products or Substances Used in Animal Feed to produce a statement on the assessment of safety and efficacy of feed additives when used in water. In the view of the FEEDAP Panel, there is no need to separately assess safety and efficacy of an additive administered via water when an application for its use in feed is submitted or an authorisation exists, provided that the exposure of the animals is essentially the same. The FEEDAP Panel considers that additives which exert their effect directly in feedingstuffs and those intended for fish or other aquatic species should not be authorised for use in water for drinking. The FEEDAP Panel applied the principles contained in this Statement to the feed additives for which an application for the use of the additive in feed and in water has been submitted. A list has been drawn containing the additives for which the FEEDAP Panel considers that the use in water for drinking does not represent an additional risk to their use in feed. Where applicable, this recommendation is made without prejudice to the outcome of the re-evaluation of these additives according to Article 10(2) of Regulation (EC) No 1831/2003. KEY WORDS Feed additives, additives used in water. 1 On request from EFSA, Question No EFSA-Q , adopted on 07 December Revised on 1 February Revision 1: a more detailed recommendation list and an annex have been introduced. 3 Panel members : Gabriele Aquilina, Georges Bories, Paul Brantom, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Reinhard Kroker, Lubomir Leng, Anne- Katrine Lundebye Haldorsen, Alberto Mantovani, Miklós Mézes, Derek Renshaw and Maria Saarela Correspondence: FEEDAP@efsa.europa.eu 4 Acknowledgement: The Panel wishes to thank the members of the Working Group on Guidance for the preparatory work on this scientific opinion. Suggested citation: EFSA Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP); Scientific Opinion on the use of feed additives authorised/applied for use in feed when supplied via water. EFSA Journal 2010;8(12):1956. [9 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2011

2 TABLE OF CONTENTS Summary... 1 Table of contents... 2 Background as provided by EFSA... 3 Terms of reference as provided by EFSA... 3 Statement Introduction Additive administration via feed and water... 4 Conclusions... 4 Recommendations

3 BACKGROUND AS PROVIDED BY EFSA Feed additives supplied via water Regulation (EC) No 1831/ establishes the rules governing the Community authorisation of additives for use in animal nutrition. Moreover, Regulation (EC) No 429/ provides 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. Regulation (EC) No 1831/2003 foresees that, for the first time, feed additives can be used in water. However, no specific provisions have been included in Regulation (EC) 429/2008 for the assessment of safety and efficacy of additive when used in water. TERMS OF REFERENCE AS PROVIDED BY EFSA The FEEDAP Panel is requested to produce a statement on the assessment of safety and efficacy of feed additives when used in water. 5 OJ L 268, , p OJ L 133, , p. 1. 3

4 STATEMENT 1. Introduction Regulation (EC) No 1831/2003, Article 2, 2(a) defines feed additives as substances, microorganisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Article 5(3). In addition, Regulation (EC) No 429/2008, Annex II, 2.5, outlines under proposed use in animal nutrition that the applicant shall define the proposed use of the additive in feed or water: Details of the proposed method of administration and level of inclusion must be provided for [ ] water for drinking. Regarding the nature of applications for the re-evaluation of additives, EFSA has received an increasing number of applications for use of additives in feed and/or water. In most applications, the concentration in water is derived from that in feed. However, there are applications proposing a dosing regime in water for drinking which would lead to an animals exposure different from that resulting from feed. The terms use in water, use via water and use through water are considered synonymous. 2. Additive administration via feed and water Additives for use in water for drinking should be water soluble/miscible or at least able to form stable suspensions in water with a demonstrated homogeneity of distribution and stability of the active substance for a minimum of 24h. With respect to the physiological background of intestinal absorption, distribution, metabolism and excretion, oral administration routes of additives via feed or water are considered, in principle, as bioequivalent. In consequence, for an additive for which a minimum effective dose is already established in feed, the corresponding concentration in water can be derived from feed intake. For additives without a minimum effective dose, the water concentration should be derived from practical use level in feed, usually that recommended by an applicant. For poultry, pigs and rabbits the water intake would be 2 3 times higher than feed intake and the concentration of the additive in water reduced accordingly. In ruminants (and horses), the concentrations of an additive cannot be consistently extrapolated from feed to water using a fixed ratio of feed to water intake. However, concentrations in feed for ruminants can be also quantified in terms of a daily dose, which can then be equally administered via feed or water. The conversion of feed concentration to water concentration should be made on the basis of the daily ration (amount of the additive per head and day). Administration of an additive via water for drinking is not applicable to fish and other aquatic species. CONCLUSIONS In the view of the FEEDAP Panel, there is no need to separately assess safety and efficacy of an additive administered via water when an application for its use in feed is submitted or an authorisation exists, provided that the exposure of the animals is essentially the same. 4

5 The FEEDAP Panel considers water as water for drinking, and consequently does not view the in-feed application of an additive which is delivered in a liquid form as an application in water. RECOMMENDATIONS If an application concerns the use in water of an additive for which the use in feed has been applied for or is authorised, then the applicant should state either that (i) the daily exposure of the animal to the additive from feed or water is essentially the same or (ii) the daily exposure of the animal to the additive from feed or water is different. In the first case, no further assessment is necessary. In the second case, an assessment of the consequences resulting from the proposed change of exposure may be required. The FEEDAP Panel considers that the following groups of additives should generally not be used in water for drinking: Additives for which a maximum content in feed is set by authorisation, because of the difficulty of respecting the maximum daily exposure under practical conditions, irrespective of the safety concerns which resulted in the setting of a maximum content: Sensory additives Functional group: (a) colourants: (ii) substances which, when fed to animals, add colours to food of animal origin Nutritional additives Functional groups: (a) vitamins, pro-vitamins and chemically well-defined substances having similar effect Vitamin A and D (b) compounds of trace elements All compounds containing Fe, Zn, Mn, Co, Cu, I, Se and Mo Additives for which safety concerns for the target animals would arise from use in water: Nutritional additives Functional groups: (c) amino acids, their salts and analogues, because of the risk of imbalances and for hygienic reasons (d) urea and its derivatives Urea due to its toxicity to ruminants when administered via water Additives intended for fish and other aquatic species To the current knowledge of the FEEDAP Panel there are no reasons that would support the use of the following additives in water for drinking: Additives which exert their effects directly on feed: Technological additives Functional groups: b) antioxidants; (c) emulsifiers; (d) stabilisers; (e) thickeners; (f) gelling agents; (g) binders; (i) anticaking agents; (j) acidity regulators; (k) silage additives and (l) denaturants 5

6 Sensory additives Feed additives supplied via water Functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs The principles contained in this statement have been applied to the list of feed additives 7 for which an application for the use of the additive in feed and in water has been submitted. The Annex lists the additives for which the FEEDAP Panel considers that the use in water for drinking does not represent an additional risk to their use in feed. Where applicable, this recommendation is made without prejudice to the outcome of the re-evaluation of these additives according to Article 10(2) of Regulation (EC) No 1831/ Not subject to a holder of the authorisation. 6

7 ANNEX Specific additives for which the FEEDAP Panel considers that the use in water for drinking does not represent an additional risk to use in feed - Ammonium formate, sodium formate, calcium formate - Betaine in the form of betaine anhydrous and betaine hydrochloride - Biotin - Botanically defined flavourings BDG1 - Lamiales - Botanically defined flavourings BDG2 - Apiales/Austrobaileyales - Botanically defined flavourings BDG3 - Asparagales - Botanically defined flavourings BDG4 - Asterales - Botanically defined flavourings BDG5 - Fabales - Botanically defined flavourings BDG6 - Laurales/ Magnoliales/ Piperales - Botanically defined flavourings BDG7 - Myrtales/ Poales/ Geraniales - Botanically defined flavourings BDG8 - Sapindales - Botanically defined flavourings BDG9 - Zingiberales - Botanically defined flavourings BDG10 - Dipsacales - Botanically defined flavourings BDG11 - Ericales - Botanically defined flavourings BDG12 - Gentianales - Botanically defined flavourings BDG13 - Malpighiales - Botanically defined flavourings BDG14 - Malvales - Botanically defined flavourings BDG15 - Ranunculales - Botanically defined flavourings BDG16 - Rosales - Botanically defined flavourings BDG17 - miscellaneous angiosperms (Brassicales, Cucurbitales, Fagales, Saxifragales, Solanales, Vitales) - Botanically defined flavourings BDG18 - Gymnosperms (Coniferales, Ginkgoales) - Botanically defined flavourings BDG19 - Lower plants/fungi (Equisetales, Fucales) - Botanically defined flavourings BDG20 for cats and dogs only - Chemically defined flavouring Disodium guanosine 5--monophosphate - Chemically defined flavouring Naringin - Chemically defined flavouring Tannic acid - Chemically defined flavouring Thaumatin - Chemically defined flavourings Group CDG 01 - Straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols and acetals containing saturated aldehydes - Chemically defined flavourings Group CDG 02 - Branched-chain primary aliphatic alcohols/aldehydes/acids, acetal and esters - Chemically defined flavourings Group CDG 03 α, β-unsaturated (alkene or alkyne) straight-chain and branched-chain aliphatic primary alcohols/aldehydes/acids, acetals and esters - Chemically defined flavourings Group CDG 04 - Non-conjugated and accumulated unsaturated straight-chain and branched-chain aliphatic primary alcohols/aldehydes/acids, acetals and esters with esters containing unsaturated alcohols and acetal - Chemically defined flavourings Group CDG 05 - Saturated and unsaturated aliphatic secondary alcohols-ketones-ketals-esters with esters containing secondary alcohols. No aromatic or heteroaromatic moiety as a component of an ester or ketal - Chemically defined flavourings Group CDG 06 - Aliphatic alcohols - Chemically defined flavourings Group CDG 08 - Sec Alicyclic Sat & Unsat Alcohols-Ketones-Ketals- Esters 7

8 - Chemically defined flavourings Group CDG 09 - Primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones - Chemically defined flavourings Group CDG 10 - Secondary aliphatic saturated alcohols - Chemically defined flavourings Group CDG 11 - Alicyclic and aromatic lactones - Chemically defined flavourings Group CDG 12 - Maltol derivatives and ketodioxane derivatives - Chemically defined flavourings Group CDG 13 - Furanones and tetrahydrofurfuryl derivatives - Chemically defined flavourings Group CDG 14 - Furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms - Chemically defined flavourings Group CDG 15 - Phenyl ethyl alcohols, phenylacetic acids, related esters, phenoxyacetic acids and related esters - Chemically defined flavourings Group CDG 16 - Aliphatic and alicyclic ethers - Chemically defined flavourings Group CDG 17 - Propenylhydroxybenzenes - Chemically defined flavourings Group CDG 18 - Allylhydroxybenzenes - Chemically defined flavourings group CDG 20- Aliphatic and aromatic mono- and di- thiols and mono-, di-, tri, and polysulfides with or without additional oxygenated functional groups - Chemically defined flavourings Group CDG 21 - Aromatic ketones, secondary alcohols and related esters - Chemically defined flavourings Group CDG 22 - Aryl-substituted primary alcohol/aldehyde/acid/ester/acetal derivatives, including unsaturated ones - Chemically defined flavourings Group CDG 23 - Benzyl alcohols/aldehydes/acids/esters/acetals - Chemically defined flavourings Group CDG 24 - Pyrazine derivatives - Chemically defined flavourings Group CDG 26 - Aromatic ethers including anisole derivatives - Chemically defined flavourings Group CDG 27 - Anthranilate derivatives - Chemically defined flavourings Group CDG 28 - Pyridine, pyrrole, and quinoline derivatives - Chemically defined flavourings Group CDG 29 - Thiazoles, thiophene, thiazoline and thienyl derivatives - Chemically defined flavourings Group CDG 31 - Aliphatic and aromatic hydrocarbons - Chemically defined flavourings Group CDG 33 - Aliphatic and aromatic amines - Chemically defined flavourings Group CDG 34 - Amino acids - Choline chloride - Citric acid - Folic acid - Glycyrrhizic acid, ammoniated - Inositol - L-Carnitine and L-Carnitine L-tartrate - Macleaya cordata extract - Melissa officinalis dry extract - Neohesperidine dihydrochalcone - Niacin (Nicotinic acid) and Niacinamide (Nicotinamide) - Origanum heracleoticum L. (oil) - Pantothenic acid (Calcium-d-pantothenate and d-panthenol) - Pantothenic acid in the form of Calcium D-pantothenate and D-Panthenol - Potassium sorbate - Propionic acid, sodium propionate, calcium propionate, ammonium propionate - Sorbic Acid - Taurine - Vitamin B1 in form of Thiamine hydrochloride and Thiamine mononitrate - Vitamin B12 in the form of Cyanocobalamin 8

9 - Vitamin B2 - Riboflavin / Vitamin B2 - Riboflavin 5--phosphate ester monosodium salt - Vitamin B6 - Pyridoxine Hydrochloride - Vitamin C in the form of L-Ascorbic acid and Ascorbyl monophosphate Calcium sodium salt - Vitamin K3 in the form of Menadione Sodium Bisulphite and Menadione Nicotinamide Bisulphite 9