Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of Urtica urens L. (dwarf nettle 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 leaves of Urtica urens L. (dwarf nettle 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 0.50%–0.80% (w/w) and to contain 0.9–1.8 mg/L p‐coumaric acid. The product contains on average 0.0076% (w/w) total polyphenols. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that dwarf nettle tincture is safe up to the maximum proposed use levels of 600 mg/kg complete feed for horses and 50 mg/kg complete feed for the other animal species. 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. No safety concern would arise for the consumer and the environment from the use of dwarf nettle tincture up to the maximum proposed use levels in 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. There is no evidence that dwarf nettle tincture would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the tincture.

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 7 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, hop tincture, apple concentrate, tormentil tincture, rose tincture, blackberry 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. ³ These additives were deleted from the register of feed additives. ⁴ 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: dwarf nettle tincture from Urtica urens L. ⁵ for use in all animal species.

The remaining four additives belonging to the 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 dwarf nettle tincture from the leaves of U. urens, when used under the proposed conditions of use (see Section 3.3.3 ).

1.2. Additional information

Dwarf nettle tincture from Urtica urens L. 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.

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 ⁶ in support of the authorisation request for the use of dwarf nettle tincture from U. urens 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‐2026‐00417. ⁷

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. ⁸ 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 ⁹ of the original report. The additive under assessment is included in the amendment. In particular, for dwarf nettle 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 p‐coumaric acid in the additive and (iii) high‐performance thin layer chromatography (HPTLC) for the fingerprint of dwarf nettle tincture.

2.2. Methodologies

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of dwarf nettle tincture from U. urens is in line with the principles laid down in Regulation (EC) No 429/2008 ¹⁰ 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, ¹¹ 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, 2019), Statement on the genotoxicity assessment of chemical mixtures (EFSA Scientific Committee, 2019) and Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Scientific Committee, 2019).

3. ASSESSMENT

The additive under assessment, dwarf nettle tincture, is obtained from the dried leaves of Urtica urens L. 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.

3.1. Origin and extraction

Urtica urens L., commonly referred to as the dwarf or small nettle or sometimes the burning nettle, is an annual herbaceous plant belonging to the family Urticaceae. It is native to most temperate areas of Eurasia and North Africa but is now found throughout the world. It shares its widespread geographical distribution with the common or stinging nettle (Urtica dioica L.). The two species are similar in appearance and both have stinging hairs on the surface of the leaves and stems. The dwarf nettle, as the name implies, is smaller in height (0.5 m) compared to the common nettle (1–2 m), has smaller leaves, is monoecious and is propagated only by seed production. In contrast, U. dioica is a dioecious perennial plant and spreads predominantly by means of underground rhizomes. The leaves of both species are considered edible.

The tincture is produced from the leaves 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 U. urens preparation when used to provide flavour in food, according to Regulation (EC) No 1334/2008 ¹² 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’.

Nettle leaf (Urticae folium) from Urtica dioica L. and Urtica urens L. is described in monographs of the European Pharmacopoeia 12.2 (PhEur, 2026a) and of the European Medicines Agency (EMA, 2025a, 2025b) for medicinal uses. The EMA assessment report does not recognise a well‐established pharmacological use of Urtica dioica and Urtica urens, folium and their preparations (EMA, 2025a).

3.3. Characterisation

The Chemical Abstract Service (CAS) number 90131‐83‐2 and the European Community (EC) number 290‐397‐9 refer to extractives and their derivatives obtained from U. urens. The EC number 939‐829‐6 is associated with U. urens tincture. ¹³ The Council of Europe (CoE) number 468 covers any preparation of U. urens.

3.3.1. Characterisation of dwarf nettle tincture

Dwarf nettle tincture is a brown liquid, with a characteristic herbal odour. It has an average density of ■■■■■ kg/m³ (■■■■■ kg/m³) and a pH of 8.23 (8.17–8.30). ¹⁴

The additive is a water/ethanol ■■■■■ tincture, specified to have a dry matter (DM) content of 0.50%–0.80% (w/w) and to contain 0.9–1.8 mg/L p‐coumaric acid. Analysis of five batches of the additive showed compliance with the specifications (see Tables 1 and 2).

TABLE 1.

Proximate analysis of dwarf nettle tincture, based on the analysis of five batches.

Constituent	Mean	Range
	% (w/w)	% (w/w)
Dry matter	0.65	0.63–0.67
Ash	0.31	0.30–0.33
Organic fraction	0.33	0.32–0.35
Proteins	< 0.08	< 0.08
Lipids	0.016	0.010–0.022
‘Carbohydrates+ fibres’ 1	0.24	0.23–0.26
Solvent	99.35	99.33–99.38

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

TABLE 2.

Concentrations of secondary metabolites in dwarf nettle 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	72	69–77
p‐Coumaric acid	501‐98‐4	HPLC‐DAD	1.28	1.10–1.47

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 dwarf nettle tincture expressed as % of the tincture (w/w). ¹⁵ The DM consists of inorganic material measured as ash (48.5% DM) and a plant‐derived organic fraction of 51.5% DM, which includes lipids (2.2% DM) and ‘carbohydrates + fibres’ (36.8% 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 total polyphenols (up to 77 μg/mL or 0.0081%, w/w) determined by spectrophotometry (at 760 nm) and expressed as gallic acid equivalents (GAE). ¹⁶ The FEEDAP Panel notes that, while the Folin–Ciocalteu method is a widely used method for the determination of total content of phenolic compounds in plant extracts, it does not give true concentrations for individual polyphenol types. This may lead to an overestimation of their concentrations in comparison to results obtained by 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 five unidentified peaks that the applicant assigned to caffeic acid derivatives (two peaks), phenolic acids (two peaks) and chlorophylls (one peak). ¹⁷ No bands corresponding to flavonoids were identified in the tincture. p‐Coumaric acid (1.28 μg/mL on average, corresponding to 0.000135% w/w), indicated by the applicant as marker substance, was quantified by HPLC with diode array detection (HPLC‐DAD). ¹⁸

According to existing monographs (EMA, 2025a; PhEur Commentary, 2022), nettle leaves, which are originating mainly from U. dioica, are known to contain: (i) 0.5%–0.6% flavonoids (overestimated in older literature); (ii) caffeic acid esters (> 0.3% for the total of caffeoylmalic acid and chlorogenic acid); the total of all caffeic acid esters amounts to 75% of the phenolic substances occurring in nettle leaves (PhEur, 2026a) (15 different hydroxycinnamic acid derivatives are described in the literature); (iii) silicates (1%–4% SiO₂), partly as water‐soluble silicates; (iv) chlorophyll (approximately 2.7%). Other constituents include scopoletin (a phenolic coumarin), sitosterol and its 3‐O‐βD‐glucoside, proteins, fats, carbohydrates, traces of nicotine, and in the stinging hairs, low concentrations of acetylcholine, serotonin, formic acid and leukotrienes. The Panel notes that the compositional data described by EMA (2025a) and the PhEur Commentary (2022) refer to leaves from U. dioica; however, because of the close botanical relationship of the two species, a similar composition can be expected for U. urens.

The EFSA Compendium of botanicals ¹⁹ reports as substances of potential concern for human and animal health the occurrence of antinutrients such as phytic acid (4730 mmol/kg dry matter) in the leaves of U. urens (Afolayan & Jimoh, 2009).

The applicant performed a literature search on the chemical composition of U. urens and its botanical preparations, and the possible presence of substances of concern, ²⁰ the results of which (e.g. Carvalho et al., 2017) confirmed the information in the existing monographs (EMA, 2025a; PhEur Commentary, 2022) and the EFSA Compendium.

In the absence of analytical data on the characterisation of the phenolic fraction in the additive under assessment and considering the information reported in the existing monographs (EMA, 2025a; PhEur Commentary, 2022), it is assumed that the fraction of total polyphenols determined by the Folin–Ciocalteu method mainly consists of caffeic acid esters.

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, fluoride, pesticides, dioxins and polychlorinated biphenyls (PCBs) and microbial contamination. ²¹ 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. ²² 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 dwarf nettle 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.

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

Among the secondary plant metabolites, only p‐coumaric acid was individually identified and quantified. Although polyphenols were not individually identified, it is assumed that 75% of the phenolic fraction consists of caffeic acid derivatives (see Section 3.3.1). Hydroxycinnamic acid derivatives such as p‐coumaric acid are ubiquitous in food and feeds of plant origin. They will be readily metabolised and excreted and are not expected to accumulate in animal tissues and products. These compounds are not of concern at concentrations resulting from the use of the additive at the maximum proposed use level in feed. Therefore, p‐coumaric acid is not further considered in the assessment. According to the information from monographs (see Section 3.3.1), nettle leaves may contain scopoletin, a coumarin which is widely distributed in plants. If present in the additive, scopoletin would be at very low concentrations and is not further addressed.

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, 2019).

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 ²³ ).

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 mostly contain caffeic acid derivatives, polyphenols were allocated to Cramer Class I.

As the result of the hazard characterisation, a reference point of 3 mg/kg bw per day was identified from the fifth percentile of the distribution of the no observed adverse effect levels (NOAELs) for Cramer Class I compounds (Munro et al., 1996).

For the assessment group total polyphenols, 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 concentration in the additive and the default values for body weight (bw) 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 the assessment group total polyphenols as the ratio between the reference point and the exposure. A MOE ≥ 100 allowed for interspecies differences and intra‐individual variability.

The approach to the safety assessment of dwarf nettle tincture for the target species is shown in Table 3. The calculations shown in Table 3 were made for chickens for fattening, which is the species with the highest ratio of feed intake/body weight ²⁴ at the proposed use level of 50 mg dwarf nettle tincture/kg complete feed.

TABLE 3.

Compositional data, intake values (calculated for chickens for fattening at 50 mg/kg complete feed), reference points, margin of exposure (MOE) for the assessment group total polyphenols in dwarf nettle tincture.

Tincture composition		Exposure		Hazard characterisation		Risk characterisation
	Highest concentration in the tincture	Highest concentration in feed	Daily intake 1	Cramer class	NOAEL 2	MOE 3
Constituent	%	mg/kg	mg/kg bw per day	–	mg/kg bw per day	–
Total polyphenols 4	0.0080	0.0040	0.00036	I	3	8389

Abbreviations: MOE, margin of exposure; NOAEL, no observed adverse effect level.

¹ Rounded intake values.

² Values in italics are the 5th percentile of the distribution of NOAELs of the corresponding Cramer Class.

³ 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).

⁴ Polyphenols (after subtraction of p‐coumaric acid) are assumed to consist mainly of caffeic acid derivatives.

As shown in Table 3, for the assessment group polyphenols, the MOE calculated for chickens for fattening at the use level of the additive of 50 mg/kg complete feed was ≥ 100. The MOE for polyphenols, calculated at 600 mg/kg complete feed for horses and at 50 mg/kg complete feed for the other target species, is summarised in Table 4.

TABLE 4.

Margin of exposure (MOE) for the assessment group total polyphenols (after subtraction of p‐coumaric acid) calculated for the different target animal categories at the proposed use levels in feed.

Animal category	Daily feed intake (g DM/kg bw)	Use level (mg/kg complete feed) 1	MOE polyphenols 2
Chickens for fattening	79	50	8389
Laying hens	53	50	12,504
Turkeys for fattening	59	50	11,296
Piglets	44	50	15,062
Pigs for fattening	37	50	18,074
Sows lactating	30	50	21,965
Veal calves (milk replacer)	19	50	37,654
Cattle for fattening	20	50	33,135
Dairy cows	31	50	21,538
Sheep/goats	20	50	33,135
Horses	20	600	2761
Rabbits	50	50	13,254
Salmonids	18	50	37,869
Dogs	17	50	39,763
Cats	20	50	33,135
Ornamental fish	5	50	147,269

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 dwarf nettle 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 in the additive after subtraction of p‐coumaric acid (0.0080%, w/w).

At the maximum proposed use levels in complete feed, the MOE exceeds the value of 100 for all animal species (Table 4). The maximum proposed use level of 600 mg/kg complete feed is safe for horses and the level of 50 mg/kg complete feed is safe for all the other species listed in Table 4. These levels are extrapolated to physiologically related minor species. For the other species not considered, the proposed maximum level of 50 mg additive/kg complete feed is safe.

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 concludes that dwarf nettle tincture is safe at the maximum proposed use levels of 600 mg/kg complete feed for horses and 50 mg/kg complete feed for the other animal species.

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

No data on residues in products of animal origin were made available for any of the constituents of the tincture. When considering the absorption, distribution, metabolism and excretion (ADME), phenolic compounds such as hydroxycinnamic acids 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 dwarf nettle 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 ²⁵ concerning the presence of ethanol in the tincture. ²⁶

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.

3.4.4. Safety for the environment

U. urens is a species native to Europe where it grows wild.

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

3.5. Efficacy

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

No evidence was provided by the applicant showing that dwarf nettle tincture would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the tincture.

4. CONCLUSIONS

The additive is safe at the maximum proposed use levels of 600 mg/kg complete feed for horses and 50 mg/kg complete feed for the other animal species. 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 dwarf nettle 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 an irritant to skin and eyes and as a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk.

In the absence of evidence that dwarf nettle tincture would impart flavour to a food or feed matrix, the FEEDAP Panel cannot conclude on the efficacy of the tincture.

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: dwarf nettle 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‐2026‐00417 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 dwarf nettle tincture (EFSA‐Q‐2026‐00417). 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)

GAE

gallic acid equivalent

HACCP

Hazard Analysis and Critical Control Points

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

NOAEL

no observed adverse effect level

PCBs

polychlorinated biphenyls

PhEur

European Pharmacopoeia

SB

solvent‐based

TTC

threshold of toxicological concern

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‐2026‐00417

COPYRIGHT FOR NON‐EFSA CONTENT

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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 leaves of Urtica urens L. (dwarf nettle tincture) for use in all animal species (FEFANA asbl). EFSA Journal, 24(10), e10345. 10.2903/j.efsa.2026.10345