Safety and efficacy of a feed additive consisting of a tincture derived from the aerial parts of Filipendula ulmaria (L.) Maxim. (meadowsweet tincture) for use in all animal species (FEFANA asbl)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the aerial parts of Filipendula ulmaria (L.) Maxim. (meadowsweet tincture) when used as a sensory additive in feed and/or in water for drinking for all animal species. The additive under assessment is a water/ethanol ■■■■■ tincture specified to have a dry matter content of 1.00%–1.60% (w/w) and to contain 70–120 mg/L ellagic acid and 30–80 mg/L rutin. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that meadowsweet tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for ornamental fish. For the other species, the resulting maximum safe levels in complete feed are 6 mg/kg for chickens for fattening; 9 mg/kg for laying hens and turkeys for fattening; 11 mg/kg for piglets; 14 mg/kg for pigs for fattening; 17 mg/kg for sows; 28 mg/kg for veal calves (milk replacer); 25 mg/kg for cattle for fattening, sheep/goats and horses; 16 mg/kg for dairy cows; 10 mg/kg for rabbits; 29 mg/kg for salmonids; 30 mg/kg for dogs; and 25 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 6 mg/kg complete feed. No safety concern would arise for the consumer and the environment from the use of the additive in animal feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk. Since the aerial parts of F. ulmaria and their preparations are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

1. INTRODUCTION

1.1. Background and Terms of Reference

Regulation (EC) No 1831/2003 ¹ establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any person seeking authorisation for a feed additive or for a new use of a feed additive shall submit an application in accordance with Article 7. In addition, Article 10(2) of that Regulation specifies that for existing products within the meaning of Article 10(1), an application shall be submitted in accordance with Article 7, within a maximum of seven years after the entry into force of this Regulation.

The European Commission received a request from Feed Flavourings Authorisation Consortium European Economic Interest Grouping (FFAC EEIG) ² for authorisation/re‐evaluation of 10 additives (hawthorne tincture, dropwort tincture (meadowsweet tincture), ³ hop tincture, apple concentrate, tormentil tincture, rose tincture, black berry tincture, common nettle extract (solvent‐based, sb), common nettle extract (water‐based, wb) and dwarf nettle tincture) belonging to botanically defined group (BDG) 16 – Rosales, when used as a feed additive for all animal species (category: sensory additives; functional group: flavouring compounds). During the assessment, the applicant withdrew the applications for five additives. ⁴ These additives were deleted from the register of feed additives. ⁵ In addition, during the course of the assessment, the application was split and the present opinion covers only one out of the remaining five additives under application: meadowsweet tincture from Filipendula ulmaria (L.) Maxim. ⁶ for use in all animal species.

The remaining four additives belonging to botanically defined group (BDG) 16 – Rosales, under application are assessed in separate opinions.

According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 4(1) (authorisation of a feed additive or new use of a feed additive) and under Article 10(2) (re‐evaluation of an authorised feed additive). The dossier was received on 02 March 2011 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2011‐00188. The particulars and documents in support of the application were considered valid by EFSA as of 9 March 2021.

According to Article 8 of Regulation (EC) No 1831/2003, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the feed additive consisting of meadowsweet tincture from the aerial parts of F. ulmaria, when used under the proposed conditions of use (see Section 3.3.3).

1.2. Additional information

Dropwort tincture from Filipendula ulmaria (L.) Maxim. is currently authorised as a feed additive according to the entry in the European Union Register of Feed Additives pursuant to Regulation (EC) No 1831/2003 (2b natural products – botanically defined). It has not been assessed as a feed additive in the EU. The FEEDAP Panel and the applicant noted that the common name dropwort has been wrongly associated with F. ulmaria, as it refers to F. vulgaris. Since the English vernacular name of Filipendula ulmaria (L.) Maxim. is meadowsweet, the additive is called meadowsweet tincture.

2. DATA AND METHODOLOGIES

2.1. Data

The present assessment is based on data submitted by the applicant in the form of a technical dossier ⁷ in support of the authorisation request for the use of meadowsweet tincture from F. ulmaria as a feed additive. The dossier was received on 17 July 2026 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2026‐00415. ⁸

The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, peer‐reviewed scientific papers, other scientific reports and experts' knowledge, to deliver the present output.

EFSA has verified the European Union Reference Laboratory (EURL) report as it relates to the methods used for the control of the phytochemical markers in the additive. ⁹ The evaluation report is related to the methods of analysis for each feed additive included in BDG 16 – Rosales. During the assessment, upon request of EFSA, the EURL issued an amendment ¹⁰ of the original report. The additive under assessment is included in the amendment. In particular, for meadowsweet tincture, the EURL recommended methods based on (i) spectrophotometry for the determination of total polyphenols, (ii) high‐performance liquid chromatography with diode array detection (HPLC‐DAD) for the quantification of ellagic acid and rutin and (iii) high‐performance thin layer chromatography (HPTLC) for the fingerprint of meadowsweet tincture.

2.2. Methodologies

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of meadowsweet tincture from F. ulmaria is in line with the principles laid down in Regulation (EC) No 429/2008 ¹¹ and the relevant guidance documents: Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements (EFSA Scientific Committee, 2009), Compendium of botanicals, ¹² Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017a), Guidance on the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017b), Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017c), Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019), Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2024), Guidance on the assessment of the safety of feed additives for the users (EFSA FEEDAP Panel, 2023), Guidance document on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals (EFSA Scientific Committee, 2019a), Statement on the genotoxicity assessment of chemical mixtures (EFSA Scientific Committee, 2019b) and Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Scientific Committee 2019c).

3. ASSESSMENT

The additive under assessment, hereinafter referred to as meadowsweet tincture, is obtained from the dried aerial parts of Filipendula ulmaria (L.) Maxim. and is intended for use as a sensory additive (functional group: flavouring compounds) in feed and/or in water for drinking for all animal species and categories.

3.1. Origin and extraction

Filipendula ulmaria (L.) Maxim. is a common perennial herbaceous plant belonging to the family Rosaceae. It is native to the damp temperate regions of Eurasia and Iran. It is still rarely found outside its native range, although it has become naturalised in the eastern parts of the USA. Two intraspecific forms are accepted: Filipendula ulmaria subsp. ulmaria with a distribution which mirrors that of the species as a whole and Filipendula ulmaria subsp. picbaueri (Podp.) Smejikal with a distribution largely restricted to Russia. The plant characteristically produces an erect stem of 1–2 m topped in season by a mass of small cream/white flowers in large flowerheads (cymes). F. ulmaria has many common names but is usually referred to as meadowsweet or mead wort, both names reflecting the traditional addition of the flowerheads to mead and other beverages as a flavour.

The tincture is produced from the aerial parts of the plant by extended extraction for ■■■■■ under ambient conditions with a water/ethanol ■■■■■ solvent mixture and a plant: solvent ratio of ■■■■■. The tincture is recovered by pressing to separate solid and liquid phases, and the solution obtained is then clarified by filtration.

3.2. Uses other than feed flavourings

While there is no specific EU authorisation for any F. ulmaria preparation when used to provide flavour in food, according to Regulation (EC) No 1334/2008 ¹³ flavouring preparations produced from food may be used without an evaluation and approval as long as ‘they do not, on the basis of the scientific evidence available, pose a safety risk to the health of the consumer, and their use does not mislead the consumer’.

Meadowsweet (Filipendulae ulmariae herba), the whole or cut, dried flowering tops of Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria L.) are described in monographs of the European Pharmacopoeia 12.2 (PhEur, 2026a) and of the European Medicines Agency (EMA, 2011a, 2011b, 2020a) for medicinal uses. In addition to the assessment of Filipendulae ulmariae herba, the EMA has also evaluated Filipendulae ulmariae flos (meadowsweet flower) (EMA 2011a, 2011c, 2020b). The EMA assessment report and monographs do not recognise a well‐established pharmacological use of Filipendula ulmaria herba and flos and their preparations (EMA, 2011a).

3.3. Characterisation

The Chemical Abstract Service (CAS) number 84775‐57‐5 and European Community (EC) number 283‐886‐3 refer to extractives and their derivatives obtained from F. ulmaria. ¹⁴ The EC number 940‐941‐2 is associated with F. ulmaria hydro‐alcoholic extract. The Council of Europe (CoE) number 199 covers any preparation of F. ulmaria.

3.3.1. Characterisation of meadowsweet tincture

Meadowsweet tincture is a brown liquid, with a characteristic odour of salicylate derivatives. It has an average density of ■■■■■ kg/m³ (■■■■■ kg/m³) and a pH of 5.19 (5.16–5.22). ¹⁵

The additive is a water/ethanol ■■■■■ tincture, specified to have a dry matter (DM) content of 1.00%–1.60% (w/w) and to contain 30–80 mg/L rutin and 70–120 mg/L ellagic acid. Analysis of five batches of the additive showed compliance with the specifications (see Tables 1 and 2).

TABLE 1.

Proximate analysis of meadowsweet tincture, based on the analysis of five batches.

Constituent	Mean	Range
	% (w/w)	% (w/w)
Dry matter	1.33	1.22–1.42
Ash	0.24	0.23–0.26
Organic fraction	1.09	1.00–1.16
Proteins	0.09	0.09–0.10
Lipids	0.004	< 0.001–0.005
‘Carbohydrates + fibres’ 1	1.03	0.91–1.26
Solvent	98.67	98.59–98.78

¹ ‘Carbohydrates + fibres’ (by difference) include secondary plant metabolites, such as phenolic compounds.

TABLE 2.

Concentrations of secondary metabolites in meadowsweet tincture, based on the analysis of five batches (mean and range).

Constituent	CAS no	Method	Mean	Range
			μg/mL	μg/mL
Total polyphenols 1	–	Folin–Ciocalteu 2	2576	2352–2722
Ellagic acid	476‐66‐4	HPLC‐DAD	96.5	88.5–104.1
Rutin	153‐18‐4	HPLC‐DAD	56.5	38.1–68.7
Salicylaldehyde	90‐02‐8	HPTLC	4.83	2.80–6.94
Ethyl salicylate	118‐61‐1	HPLC‐DAD	3.96	2.93–5.28

Abbreviations: CAS no, Chemical Abstracts Service number; HPLC‐DAD, high‐performance liquid chromatography with diode array detection.

¹ Expressed as gallic acid equivalents (GAE).

² Determined by an internal method based on European Pharmacopoeia (PhEur, 2026b): Chapter 2.8.14, Tannins in herbal drugs.

Table 1 summarises the results of the proximate analysis of five batches of meadowsweet tincture expressed as % of the tincture (w/w). ¹⁶ The DM consists of inorganic material measured as ash (18.3% DM) and a plant‐derived organic fraction of 81.7% DM, which includes protein (7.1% DM), lipids (0.3% DM ¹⁷ ) and ‘carbohydrates + fibres’ (77.3% DM). The latter fraction is obtained after subtracting the values for proteins and lipids from the organic fraction and contains a variety of plant‐derived compounds including phenolic compounds, in addition to any carbohydrate present.

The fraction of secondary metabolites was characterised in the same batches of the tincture and the results are summarised in Table 2. The tincture was shown to contain polyphenols (up to 2722 μg/mL or 0.281%, w/w) determined by spectrophotometry (at 760 nm) and expressed as gallic acid equivalents (GAE). ¹⁸ The FEEDAP Panel notes that the polyphenols were determined by the Folin–Ciocalteu method, which is a widely used method for the determination of total content of polyphenols in plant extracts, but which does not give the true concentrations of polyphenols of different types. This may lead to an overestimation of their concentrations in comparison to results obtained by high‐performance liquid chromatography (HPLC) depending on the substances of interest and the standard used (Everette et al., 2010; Samara et al., 2022).

High‐performance thin‐layer chromatography (HPTLC) showed nine unidentified peaks that the applicant assigned to caffeic acid derivatives (three peaks), other phenolic acids (five peaks), flavonones (one peak) and flavones and flavonols (one peak). ¹⁹ The concentration of free ellagic acid (up to 0.011%, w/w) and rutin (up to 0.007%, w/w) indicated by the applicant as marker substances were quantified by HPLC with diode array detection (HPLC‐DAD). ²⁰ In the same five batches of the tincture, ethyl salicylate (up to 0.0005%, w/w) and methyl salicylate (below the limit of quantification, 0.94 mg/L, corresponding to 0.000097%, w/w) were also analysed by HPLC‐DAD, whereas salicylaldehyde (up to 0.0007%, w/w) was quantified by HPTLC. ²¹

According to the existing monographs (PhEur Commentary, 2023; EMA, 2011a), the main groups of components described for the herb (including flowers) of F. ulmaria are (i) 0.3%–0.5% ‘simple phenolic glycosides’, cleaved by drying under heat in sugars and steam‐volatile phenols (salicylaldehyde, methyl salicylate); (ii) 1%–6% flavonoids (mainly glycosides of quercetin); (iii) 5%–10% ellagitannins; (iv) monoterpenes (linalool, alpha‐terpineol, geraniol); (v) anisaldehyde and (vi) beta‐ionone. The PhEur monograph (PhEur, 2026a) requires that the herb contains ≥ 1 mL/kg ‘essential oil’. The term ‘essential oil’ here means ‘steam‐volatiles’ and includes mainly salicylaldehyde and methyl salicylate, apart from monoterpenes (linalool, alpha‐terpineol, geraniol), anisaldehyde and beta‐ionone which are genuine occurring.

The substances of potential concern for human and animal health reported in the EFSA Compendium of botanicals ²² and considered relevant for the current assessment are methyl salicylate and salicylaldehyde in the essential oil (steam‐volatiles) from the aerial parts, leaves or flowers of F. ulmaria; salicylic acid (0.039%–0.063%) in aqueous and methanolic/ammonium formate extracts of the aerial parts of the plant; tannins (12.5%–56.8%) in aqueous extracts and saponins (0.6%–30.7%) in chloroform extracts from flowers and leaves.

The applicant performed a literature search on the chemical composition of F. ulmaria and its botanical preparations and the possible presence of substances of concern, ²³ the results of which confirmed the information in the existing monographs (PhEur Commentary, 2023; EMA, 2011a) and the EFSA Compendium.

In the absence of analytical data on the presence of flavonoids and ellagitannins in the additive under assessment and considering the information reported in the existing monographs (PhEur Commentary, 2023; EMA, 2011a), it is assumed that total polyphenols determined by the Folin–Ciocalteu method include flavonoids and ellagitannins.

3.3.1.1. Impurities

The applicant controls contamination at the level of the raw material, including knowledge of the cultivation conditions and pesticides applied. Specifications are set with suppliers covering cadmium, mercury, lead and arsenic, mycotoxins, pesticides, fluoride, dioxins and polychlorinated biphenyls (PCBs) and microbial contamination. ²⁴ An example of a quality control certificate of the raw material was provided.

The applicant stated that analysis of impurities in the tincture is made on an irregular basis. However, no data were provided on the presence of these impurities.

3.3.2. Shelf‐life

The shelf life of the tincture is declared by the applicant to be at least 36 months when stored in tightly closed containers under standard conditions. ²⁵ No evidence was provided to support this claim.

3.3.3. Conditions of use

The additive is intended for use in feed or in water for drinking for all animal species and categories. The applicant proposes a maximum concentration of 50 mg meadowsweet tincture/kg complete feed or 50 mg/L water for drinking for all animal species except for horses, for which the proposed use is 600 mg/kg complete feed or 600 mg/L water for drinking.

3.4. Safety

No studies to support the safety for target animals, consumers or users were performed with the additive under assessment.

Meadowsweet tincture contains plant‐derived proteins, lipids and carbohydrates, which are not of concern, and are not further considered.

Among the secondary plant metabolites, total polyphenols were quantified, but only free ellagic acid and rutin were individually identified and quantified. These compounds are readily metabolised and excreted and are not expected to accumulate in animal tissues and products.

A few individual components identified in the tincture have been already assessed as chemically defined flavourings for use in feed by the FEEDAP Panel. The flavouring compounds currently authorised for food ²⁶ and/or feed ²⁷ use, together with the EU Flavour Information System (FLAVIS) number, the chemical group as defined in Commission Regulation (EC) No 1565/2000, ²⁸ and the corresponding FEEDAP opinion are listed in Table 3.

TABLE 3.

Flavouring compounds identified among the components of meadowsweet tincture already assessed by EFSA as chemically defined flavourings, grouped according to the chemical group (CG) as defined in Commission Regulation (EC) No 1565/2000, with indication of the EU Flavour Information System (FLAVIS) number and the corresponding EFSA opinion.

CG	Chemical group	Product (EU register name)	FLAVIS no.	FEEDAP opinion, year
23	Benzyl alcohols, aldehydes, acids, esters and acetals	Salicylaldehyde	05.055	2012
		Ethyl salicylate	09.748
		Methyl salicylate	09.749

Abbreviations: CG, chemical group; FEEDAP, EFSA Panel on Additives and Products or Substances used in Animal Feed; FLAVIS no, EU Flavour Information System number.

3.4.1. Safety for the target species

Tolerance studies with the target species and/or toxicological studies in laboratory animals with the tincture under application were not submitted. In the absence of these data, the approach to the safety assessment of the mixture is based on the safety assessment of its individual components (when individually identified and quantified) or groups of components (assessment groups). The combined toxicity can be predicted using the dose addition assumption within an assessment group (EFSA Scientific Committee, 2019a).

For hazard characterisation, each component (or group of components) was first assigned to the structural class according to Cramer classification using Toxtree (version 3.1.0, May 2018 ²⁹ ).

For salicylaldehyde [05.005], a no observed adverse effect level (NOAEL) of 10 mg/kg bw per day was identified from a 49‐day study in rats, where effects on liver histopathology were observed starting at 40 mg/kg bw per day (EFSA FEEDAP Panel, 2012). An additional uncertainty factor (UF) of 2 was applied to the NOAEL of 10 mg/kg bw per day because of the short duration of the study.

The NOAEL of 50 mg/kg bw per day ³⁰ identified from a 2‐year study with methyl salicylate in rats has been applied to ethyl salicylate [09.748] by read‐across (EFSA FEEDAP Panel, 2012).

For rutin, the FEEDAP Panel identified a NOAEL of 677 mg/kg bw per day from a chronic study in rat carried out with enzymatically decomposed rutin ³¹ (consisting of 95% isoquercitrin, quercetin 3‐O‐glucopyranoside) (EFSA FEEDAP Panel, 2026).

For ellagic acid, a NOAEL of 3011 mg/kg bw per day (the highest dose tested) was identified from a 90‐day oral toxicity study in rats (Tasaki et al., 2008).

For the group assessment of total polyphenols, in the absence of data, the threshold of toxicological concern (TTC) was applied (EFSA FEEDAP Panel, 2017b). Since the group is assumed to contain unidentified flavonoids and ellagitannins, polyphenols were allocated to Cramer Class III.

As the result of the hazard characterisation, a reference point was identified for each component or group of components in the assessment group from the fifth percentile of the distribution of the NOAELs of the corresponding Cramer Class (i.e. 0.15 mg/kg bw per day, for Cramer Class III compounds; Munro et al., 1996). Reference points selected for each compound are shown in Table 4.

TABLE 4.

Compositional data, intake values (calculated for chickens for fattening at 50 mg meadowsweet tincture/kg complete feed), reference points, margin of exposure (MOE) for the individual components of meadowsweet tincture classified according to assessment groups and combined margin of exposure (MOET) for each assessment group.

Tincture composition		Exposure		Hazard characterisation		Risk characterisation
	Highest concentration in the tincture	Highest concentration in feed	Daily intake 1	Cramer Class 2	NOAEL 3	MOE 4	MOET 5
Constituent	%	mg/kg	mg/kg bw/day	–	mg/kg bw/day	–
Assessment group
Salicylates
Salicylaldehyde	0.0007	0.0004	0.00003	(I)	5 6	155,853
Ethyl salicylate	0.0005	0.0003	0.00002	(I)	50	2,046,414
MOET salicylates							144,823
Polyphenols
Ellagic acid	0.0124 7	0.0062	0.00056	(III)	3011	5,424,577
Rutin	0.0082 7	0.0041	0.00037	(III)	677	1,829,511
Polyphenols subtracted 8	0.2632	0.1316	0.01181	III	0.15	13

Abbreviations: MOE, margin of exposure; MOET, combined (total) MOE; NOAEL, no observed adverse effect level.

¹ Rounded intake values.

² When a NOAEL value is available or read‐across is applied, the allocation to the Cramer Class is put into parentheses.

³ Values in italics are the fifth percentile of the distribution of NOAELs of the corresponding Cramer Class, other values (plain text) are NOAELs extrapolated by using read‐across.

⁴ The MOE for each component is calculated as the ratio of the reference point (no observed adverse effect level, NOAEL) to the intake (non‐rounded values are used in the calculations).

⁵ The combined margin of exposure (MOET) is calculated for each assessment group as the reciprocal of the sum of the reciprocals of the MOE of the individual substances. MOET values are reported in bold.

⁶ An additional uncertainty factor (UF) of 2 was applied to the NOAEL of 10 mg/kg bw per day because of the short duration of the study.

⁷ According to maximum specified concentration.

⁸ Polyphenols other than ellagic acid and rutin, including unidentified flavonoids and ellagitannins.

For each component in the assessment group, exposure in target animals (expressed as mg/kg bw per day) was estimated considering the maximum proposed use level, the percentage of the component in the tincture, the highest analysed or specified concentration in the additive and the default values for body weight and feed intake according to the guidance on the safety of feed additives for target species (EFSA FEEDAP Panel, 2017b).

For risk characterisation, the margin of exposure (MOE) was calculated for each component as the ratio between the reference point and the exposure. An MOE ≥ 100 allowed for interspecies differences and intra‐individual variability.

The approach to the safety assessment of meadowsweet tincture for the target species is shown in Table 4. The calculations shown in Table 4 were made for chickens for fattening, which is the species with the highest ratio of feed intake/body weight ³² at the proposed use level of 50 mg meadowsweet tincture/kg complete feed.

As shown in Table 4, for all assessment groups except polyphenols after subtraction of ellagic acid and rutin, the MOE calculated for chickens for fattening at the use level of the additive of 50 mg/kg complete feed was ≥ 100. The MOEs for polyphenols after subtraction of ellagic acid and rutin was calculated for the other target species considering the respective daily feed intake/kg bw and the proposed use levels in feed. The results are summarised in Table 5.

TABLE 5.

Margin of exposure (MOE) for the assessment group polyphenols (after subtraction of ellagic acid and rutin) calculated for the different target animal categories at the proposed use levels in feed and maximum safe use levels in feed calculated to ensure an MOE ≥ 100.

Animal species/categories	Daily feed intake (g DM/kg bw)	Use level (mg/kg complete feed) 1	Lowest MOE polyphenols 2	Maximum safe concentration (mg/kg complete feed) 1
Chickens for fattening	79	50	13	6
Laying hens	53	50	19	9
Turkeys for fattening	59	50	17	9
Piglets	44	50	23	11
Pigs for fattening	37	50	27	14
Sows lactating	30	50	33	17
Veal calves (milk replacer)	19	50	57	28
Cattle for fattening	20	50	50	25
Dairy cows	31	50	33	16
Sheep/goats	20	50	50	25
Horses	20	600	4	25
Rabbits	50	50	20	10
Salmonids	18	50	57	29
Dogs	17	50	60	30
Cats	20	50	50	25
Ornamental fish	5	50	223	– 3

Abbreviations: DM, dry matter; MOE, margin of exposure.

¹ Complete feed containing 88% DM, milk replacer 94.5% DM.

² Calculated at the proposed use level of meadowsweet tincture in complete feed (600 mg/kg complete feed for horses and 50 mg/kg for the other animal species) and considering the highest analysed value of polyphenols (after subtraction of ellagic acid and rutin) in the additive (0.263%, w/w).

³ The proposed use level of 50 mg/kg complete feed is considered safe.

At the proposed use levels in complete feed, the MOE exceeds the value of 100 for ornamental fish. For the other species, the maximum safe use levels in feed were calculated to ensure an MOE ≥ 100. The maximum proposed use level of 50 mg/kg is safe for ornamental fish. For the other species, the resulting maximum safe levels in feed are shown in Table 5. These levels are extrapolated to physiologically related minor species. For the other species not considered, the lowest level of 6 mg additive/kg complete feed is applied.

Use in water for drinking

The FEEDAP Panel considers that the use of the tincture in water for drinking alone or in combination with its use in feed is safe provided that the daily amount resulting from the exposure via feed alone at the maximum use level is not exceeded.

3.4.1.1. Conclusions on safety for the target species

The FEEDAP Panel considers that the levels of meadowsweet tincture summarised in Table 6 are safe for the respective target species.

TABLE 6.

Safe concentrations of meadowsweet tincture in complete feed (mg/kg) for all animal species and categories.

Animal species/categories	Safe concentration (mg/kg complete feed) 1
Turkeys for fattening	9
Chickens for fattening, other poultry for fattening or reared for laying/reproduction and ornamental birds	6
Laying hens and other laying/reproductive birds	9
Piglets and other porcine species for meat production or reared for reproduction	11
Pigs for fattening	14
Sows and other porcine species for reproduction	17
Veal calves (milk replacer)	28
Sheep/goats	25
Cattle for fattening, other ruminants for fattening or reared for milk production/reproduction and camelids at the same physiological stage	25
Dairy cows and other ruminants and camelids for milk production or reproduction	16
Horses and other equids	25
Rabbits and other leporids	10
Salmonids and minor fin fish	29
Dogs	30
Cats	25
Ornamental fish	50
Other species	6

¹ Complete feed containing 88% dry matter (DM), milk replacer 94.5% DM.

The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered safe when consumed via feed alone.

3.4.2. Safety for the consumer

Extracts from meadowsweet herb are used in the food industry to modify flavour (PhEur Commentary, 2023).

No data on residues in products of animal origin were made available for any of the constituents of meadowsweet tincture. When considering the absorption, distribution, metabolism and excretion (ADME) of salicylates and polyphenols including flavonoids and ellagitannins, they will be readily metabolised and excreted and are not expected to accumulate in animal tissues and products.

No safety concern would be expected for the consumer from the use of meadowsweet tincture up to the highest proposed use level in feed for the target animals.

3.4.3. Safety for the user

No specific experimental data were provided by the applicant regarding the safety of the additive for users.

The applicant provided information according to Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008 ³³ concerning the presence of ethanol in the tincture. ³⁴

The additive under assessment meadowsweet tincture should be considered as irritant to skin and eyes and as a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk.

3.4.4. Safety for the environment

F. ulmaria is a species native to Europe where it grows wild.

The use of meadowsweet tincture in animal feed under the proposed conditions of use is not expected to pose a risk to the environment.

3.5. Efficacy

F. ulmaria or its extracts are not listed in Fenaroli's Handbook of Flavour Ingredients (Burdock, 2009) or by the Flavour and Extract Manufactures Association (FEMA).

However, the applicant provided evidence from monographs (EMA, 2011a) and literature, ³⁵ which showed that meadowsweet has been used historically as a flavouring in alcoholic beverages like mead, wine and beer, and also in some culinary applications like stewed fruits, jams, and desserts. Furthermore, the Commentary to the PhEur (2023) mentions extracts from meadowsweet herb being used as a flavour modifier in food.

Since the aerial parts of F. ulmaria and their preparations are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

4. CONCLUSIONS

The FEEDAP Panel considers that the levels of meadowsweet tincture summarised in Table 6 are safe for the respective target species:

Animal species/categories	Safe concentration (mg/kg complete feed) 1
Turkeys for fattening	9
Chickens for fattening, other poultry for fattening or reared for laying/reproduction and ornamental birds	6
Laying hens and other laying/reproductive birds	9
Piglets and other porcine species for meat production or reared for reproduction	11
Pigs for fattening	14
Sows and other porcine species for reproduction	17
Veal calves (milk replacer)	28
Sheep/goats	25
Cattle for fattening, other ruminants for fattening or reared for milk production/reproduction and camelids at the same physiological stage	25
Dairy cows and other ruminants and camelids for milk production or reproduction	16
Horses and other equids	25
Rabbits and other leporids	10
Salmonids and minor fin fish	29
Dogs	30
Cats	25
Ornamental fish	50
Other species	6

¹ Complete feed containing 88% DM, milk replacer 94.5% DM.

The FEEDAP Panel considers that the use of the tincture in water for drinking alone or in combination with its use in feed is safe provided that the daily amount resulting from the exposure via feed alone at the maximum use level is not exceeded.

The use of meadowsweet tincture in animal feed under the proposed conditions of use is safe for the consumers and the environment.

The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk.

Since the aerial parts of F. ulmaria and their preparations are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

5. DOCUMENTATION PROVIDED TO EFSA/CHRONOLOGY

Date	Event
05/11/2010	Dossier received by EFSA. Botanically defined flavourings from Botanical Group 16 – Rosales for all animal species and categories. Submitted by Feed Flavourings Authorisation Consortium European Economic Interest Grouping (FFAC EEIG)
02/03/2011	Reception mandate from the European Commission
26/02/2013	EFSA informed the applicant (EFSA ref. 7150727) that, in view of the workload, the evaluation of applications on feed flavourings would be re‐organised by giving priority to the assessment of the chemically defined feed flavourings, as agreed with the European Commission
24/06/2015	Technical hearing during risk assessment with the applicant according to the “EFSA's Catalogue of support initiatives during the life‐cycle of applications for regulated products”: data requirement for the risk assessment of botanicals
27/02/2019	Partial withdrawal of application for the following additive: apple concentrate
09/03/2021	Application validated by EFSA – Start of the scientific assessment
24/03/2021	Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: characterisation, safety for target species, safety for the consumer, safety for the user and environment
10/06/2021	Comments received from Member States
20/10/2021	Reception of the Evaluation report of the European Union Reference Laboratory for Feed Additives
08/07/2024	Partial withdrawal of the application for the following additives: tormentil tincture, black berry tincture
28/11/2024	Reception of supplementary information from the applicant (partial dataset: dropwort tincture) – Scientific assessment remains suspended
23/04/2026	Partial withdrawal of the application for the following additives: Hawthorne tincture, hop tincture
17/07/2026	The application was split and a new EFSA‐Q‐2026‐00415 was assigned to the additive included in the present assessment – Scientific assessment re‐started for the additive included in the present assessment
21/08/2026	Reception of an amendment of the Evaluation report of the European Union Reference Laboratory for Feed Additives related to dwarf nettle tincture, meadowsweet tincture, rosehip shell tincture and rosehip tincture
10/09/2026	Opinion adopted by the FEEDAP Panel on meadowsweet tincture (EFSA‐Q‐2026‐00415). End of the Scientific assessment for the additive included in the present assessment. The assessment of other additives in BDG 16 is still ongoing

ABBREVIATIONS

ADME

absorption, distribution, metabolism and excretion

BDG

botanically defined group

BW

body weight

CAS

Chemical Abstracts Service

CLP

Classification, Labelling and Packaging

CoE

Council of Europe

DM

dry matter

EEIG

European Economic Interest Grouping

EMA

European Medicines Agency

EURL

European Union Reference Laboratory

FEEDAP

EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed

FEMA

Flavour and Extract Manufactures Association

FFAC

Feed Flavourings Authorisation Consortium of FEFANA (EU Association of Specialty Feed Ingredients and their Mixtures)

FLAVIS

The EU Flavour Information System

GAE

gallic acid equivalent

HPLC

high‐performance liquid chromatography

HPLC‐DAD

high‐performance liquid chromatography with diode array detection

HPTLC

high‐performance thin layer chromatography

MOE

margin of exposure

MOET

combined (total) margin of exposure

NOAEL

no observed adverse effect level

PhEur

European Pharmacopoiea

SB

solvent‐based

TTC

threshold of toxicological concern

UF

uncertainty factor

WB

water‐based

AUTHOR CONTRIBUTIONS

Under Regulation 178/2002, the Scientific Panel is the author of the scientific output. Contributions include: Working Groups who provide the draft assessment which is reviewed and adopted by the Panel; EFSA staff members who provide scientific support including inter alia data collection and analysis and literature searching; and other contributors such as staff of national food safety agencies, EFSA trainees and interim staff members who have contributed meaningfully to the work.

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2026‐00415

COPYRIGHT FOR NON‐EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.

PANEL MEMBERS

Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Giovanna Martelli, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona and Katerina Theodoridou.

LEGAL NOTICE

Relevant information or parts of this scientific output have been blackened in accordance with the European Commission decision on the confidentiality requests formulated by the applicant. The full output has been shared with the European Commission, EU Member States and the applicant.

EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Villa, R. E. , Azimonti, G. , Bonos, E. , Christensen, H. , Durjava, M. , Dusemund, B. , Gehring, R. , Glandorf, B. , Kouba, M. , López‐Alonso, M. , Marcon, F. , Martelli, G. , Nebbia, C. , Pechová, A. , Prieto‐Maradona, M. , Theodoridou, K. , Bastos, M. L. , Benfenati, E. , … Manini, P. (2026). Safety and efficacy of a feed additive consisting of a tincture derived from the aerial parts of Filipendula ulmaria (L.) Maxim. (meadowsweet tincture) for use in all animal species (FEFANA asbl). EFSA Journal, 24(10), e10344. 10.2903/j.efsa.2026.10344