Lime flower – Tiliae flos (Tilia cordata Miller, Tila platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures)
|Latin name of the genus:||Tiliae flos|
|Latin name of herbal substance:||Tilia cordata miller|
|Botanical name of plant:||Tilia x vulgaris heyne or their mixtures|
|English common name of herbal substance:||Tila platyphyllos scop.|
Latin name of the genus: Tiliae flos
Botanical name of plant: Tilia cordata Miller, Tila platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures
English common name of herbal substance: Lime flower
1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof
Tilia flos (lime flower) consists of the whole dried inflorescence of Tilia cordata Miller, of Tilia platyphyllos Scop., of Tilia x vulgaris Heyne or a mixture of these (European Pharmacopoeia 2008).
Lime tree (Linden) is a tall deciduous tree native throughout Europe as far north as 65o in latitude, which can grow to heights approaching to 30 metres. It is found in the wild and purposely planted in gardens. It is also cultivated in Europe and North America while the material of commerce originates mainly from Balkan countries such as Bulgaria, Romania, former Yugoslavia, Turkey and in part from China. Lime tree bark is smooth and grey and its leaves are
Tilia has a faint aromatic odour and a faint sweet and mucilaginous taste (European Pharmacopoeia 2008).
Lime flower’s inflorescence is
Lime flower comprises of the dried inflorescence of Tilia cordata Miller, of Tilia platyphyllos Scop., of Tilia x vulgaris Heyne (fam. Tiliaceae), or a mixture of these and is used in herbal medicine.
(VIth Hungarian Pharmacopoeia 1970; British Herbal Pharmacopoeia (BHP) 1976; Bradley 1992; Blaschek et al. 2010; PDR for Herbal Medicines 2007).
Common names: European Lime, basswood, Linden tree.
Tilia cordata Miller = Tilia officinarum Crantz, Tilia officinarum Crantz subsp. officinarum pro parte, Tilia ulmifolia Scop., Tilia parvifolia Ehrh. ex Hoffm.,
Tilia platyphyllos Scop. = Tilia officinarum Crantz, Tilia officinarum Crantz subsp. officinarum pro parte,
Tilia x vulgaris Heyne, a hybrid of the above = Tilia x europaea auct. non L.
Chemical constituents according to existing references (BHP 1976; Bradley 1992; Barnes et al. 2007; Duke 1985; Review of Natural Products 2005; WHO 2010):
−Acids – Caffeic acid, chlorogenic acid and
−Amino acids – Alanine, cysteine, cystine, isoleucine, leucine, phenylalanine and serine
−Carbohydrates – Mucilage polysaccharides (3%). Five fractions identified yielding arabinose, galactose, rhamnose, with lesser amounts of glucose, mannose, and xylose; galacturonic and glucuronic acids (Kram & Franz 1985; Yakovlev 1985)
−Flavonoids – Kaempferol, quercetin, myricetin and their glycosides (mainly
−Volatile oil – (0.02% to 0.1%) Many components including alkanes, phenolic alcohols and esters, and terpenes including citral, citronellal, citronellol, eugenol, limonene, nerol,
−Other constituents – Saponin (unspecified), tannin (condensed) and tocopherol (phytosterol).
The ratio of tannins to mucilage appears to be important in determining the flavour of teas prepared from lime flowers. Those teas with a high (2% or greater) tannin level and low mucilage content produce the more flavourful teas. Flowers from Tilia cordata and Tilia platyphyllos contain relatively more tannin than mucilage (Blumenthal et al. 2000). More than 2 dozen additional minor compounds have been identified in the wood, flowers and fruits of lime. The fragrant components of the flowers degrade rapidly under conditions of high moisture (Blaschek et al. 2010; PDR for Herbal Medicines 2007; Review of Natural Products 2005).
The herbal substance should contain not less than 15%
Macroscopic and microscopic tests are used for detecting common adulterations with other species (mainly Tilia tomentosa = Tilia argentea). According to the European Pharmacopoeia (2008), a maximum of 2% of foreign matter can be determined on 30 g. There are no inflorescences with a bract bearing at the abaxial face stellate, five to
a)Comminuted herbal substance
b)Liquid extract (DER 1:1), extraction solvent ethanol 25% V/V
c)Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 45% V/V
•Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of traditional combination herbal medicinal products assessed, where applicable.
There are several combinations registered in the European Union (EU):
–herbal tea containing Plantaginis folium(25%), Althaeae radix (20%), Cynosbati fructus sine semine (20%), Liquiritiae radix (15%), Serpylli herba (15%), Tiliae flos (5%) (Czech Republic)
–herbal tea containing Foeniculi dulcis fructus (15%), Sambuci nigrae flos (25%), Tiliae flos (25%), Plantaginis folium (20%), Liquiritiae radix (15%) (Czech Republic)
–herbal tea containing Tiliae flos & Salicis cortex (Germany)
–herbal tea containing Tiliae flos, Thymi herba & Anisi fructus, Thymi herba, Foeniculi amari fructus, Lichen islandicus (Germany)
–herbal tea containing Tiliae flos, Farfarae folium and Melissae folium (Poland) (Muszyński 1954)
This assessment report refers only to Tiliae flos.
1.2. Information about products on the market in the Member States
Other information on relevant combination products:
1.Herbal tea containing Plantaginis folium(25%), Althaeae radix (20%), Cynosbati fructus sine semine (20%), Liquiritiae radix (15%), Serpylli herba (15%), Tiliae flos (5%) – on the market since 1995 – for oral use, adjuvant for treatment of catarrhs of upper respiratory tract associated with dry cough
2.Herbal tea containing Foeniculi dulcis fructus (15%), Sambuci nigrae flos (25%), Tiliae flos (25%), Plantaginis folium (20%), Liquiritiae radix (15%) – on the market since 1997 – for oral use – indications: for treatment of common cold associated with elevated temperature; inflammations of oral cavity and upper respiratory tract; diaphoretic effect
9 Herbal teas since 1976
for oral use in adults and adolescents over 12 years
1 – 2 times daily a cup of fresh prepared infusion (2 – 4 g herbal substance) or
1 – 2 cups very hot as “sweat infusion” before going to bed.
Indications: Used as a diaphoretic in feverish colds 2 authorised combination products
1.herbal tea containing Tiliae flos & Salicis cortex
2.herbal tea containing Tiliae flos, Thymi herba & Anisi fructus, Thymi herba, Foeniculi amari fructus, Lichen islandicus
single active ingredient: 9 herbal teas combination products: 11 herbal teas
Regulatory status overview
MA: Marketing Authorisation TRAD: Traditional Use Registration
Other TRAD: Other national Traditional systems of registration Other: If known, it should be specified or otherwise add ’Not Known’
This regulatory overview is not legally binding and does not necessarily reflect the legal status of the products in the MSs concerned.
1.3. Search and assessment methodology
Search terms: Tilia cordata Miller, Tilia platyphyllos Scop. Tilia x vulgaris Heyne, flowers, Tiliae flos.
Tilia sp., tiliroside,
Databases: Pubmed, Medline, HealLink, scopus.
Libraries: University of Athens, Laboratory of Pharmacognosy and Chemistry of Natural Products of the University of Athens.
2. Historical data on medicinal use
2.1. Information on period of medicinal use in the Community
Since the middle ages, the lime flowers have been used as a diaphoretic to promote perspiration. In addition, the flowers have been used traditionally as tranquiliser and to treat headaches, indigestion and diarrhoea. Infusions of the flowers make a
The lime flowers are referred in the VIth Hungarian Pharmacopoeia (1967; English version 1970) with the following posology: usual single dose: 0.5 – 1 g and usual daily dose: 2.5 – 5 g. In the Hungarian book by Augustin et al. 1948, it is mentioned that the lime flowers are used in the form of infusion for promoting sweating in the case of common cold, chronic coughing and catarrh and they are even used for preparing candies to relieve cough.
Tiliae flos can be found also in the first edition of the Czechoslovak Pharmacopoeia (Československý lékopis) published in 1947, as well as in the current version of Czech Pharmacopoeia (Český lékopis 2009, suppl. 2010).
Moreover the monograph of Tiliae flos has been defined in details in the Polish Pharmacopoeia of 1970 (Farmakopea Polska 1970), while, also in Poland, Inflorescentia Tiliae (Ożarowski et al. 1978) has been known to stimulate secretory and excretory functions – diuretic, gastric fluid, bile flow, transpiration and skin perspiration. It was for oral use as an infusion, as a supportive mean in fever states with sore throat and bronchitis. These infusions have been used also in nervousness, states of nervous tension and even in hysteria or hypochondria.
In Germany, lime flower is approved in the Commission E monographs (Blumenthal et al. 1998), and the tea form is official in the German Standard Licence monographs, and it was also official in the pharmacopoeia of the former German Democratic Republic (Blumenthal et al. 1998). It is used as a component of common cold and antitussive preparations and also as an urological and sedative drug.
In German paediatric medicine, it is used as a diaphoretic component of an influenza tea for children comprised of lime flower, willow bark, meadowsweet flower, chamomile flower and bitter orange peel. It is also a primary component of “Schweisstreibender Tee” (diaphoretic tea) composed of lime flower, peppermint leaf, meadowsweet flower and bitter orange. In Switzerland, a comparable diaphoretic tea is known, composed of lime flower, elder flower, mint leaves and jaborandi leaf (Blumenthal et al. 1998). There is a strong experience available, particularly in the German market, on the use of lime flower preparations, especially the herbal tea, in children of almost all age groups (Peter 1963; Kooperation Phytopharmaka 2002; Bühring et al. 2008; Schilcher 1992; Schilcher & Dorsch 2006).
The Commission E approved lime flower for colds and
Bradley (1992) indicates its use for upper respiratory catarrh, common colds, irritable coughs, hypertension and restlessness.
The German Standard Licence indicates lime flowers infusion for alleviation of cough irritation due to catarrh of the respiratory tract and for feverish colds for which a sweat treatment is desired.
Tilia cordata has been used in other sedative effects therapies include relief of sinus headache and migraines, insomnia, stress and panic disorders. It has been used also to treat nervous palpitations and has been also reported to lower high blood pressure caused by stress and nervous tension (Blumenthal et al. 1998).
Lime flower is listed by the Council of Europe as a natural source of food flavouring (category N2). This category indicates that lime flower can be added to foodstuffs in small quantities, with a possible limitation of an active principle (as yet unspecified) in the final product. Previously, lime flower has been listed as GRAS (Generally Recognised As Safe) (Barnes et al. 2007).
For Tilia flos a period of at least 30 years of medicinal use as requested by Directive 2004/24/EC for qualification as a traditional herbal medicinal product is easily fulfilled. The evidence on traditional medicinal use is confirmed by a large number of publications providing consistent information.
2.2. Information on traditional/current indications and specified substances/preparations
According to the overview of the European market, the herbal preparation (a) fulfils the criteria for at least 30 years of medicinal use in the EU, while the herbal preparations (b) and (c) were found in literature references, and the period of their use is longer than 30 years (BHP 1976).
From information on the use in Germany since 1976, in Hungary since 1948 (Augustin et al. 1948), in Czechoslovakia/Czech Republic since 1947:
a) Comminuted herbal substance for herbal tea preparation
From the literature (BHP 1976; Augustin et al. 1948; Bradley 1992; Blumenthal et al. 1998; Barnes et al. 2007; PDR 2007):
b)Liquid extract (DER 1 : 1) extraction solvent ethanol 25% (V/V)
c)Tincture (ratio of herbal substance to extraction solvent: 1 : 5), extraction solvent ethanol 45% V/V)
Indications approved in the Member states:
Herbal medicinal product used as a diaphoretic in feverish colds (Germany, Poland).
Traditionally is used as an adjuvant for treatment of catarrhs of the upper respiratory tract and cold associated with dry, irritating cough (Czech Republic).
The traditional indication is: for the relief of early symptoms of common cold (Austria).
Traditionally used to promote sweating in the case of common cold, chronic coughing and catarrh and to relieve coughing (Hungary).
Traditional herbal medicinal product used as expectorant in dry cough associated with cold and to promote perspiration in case of fever (Lithuania).
Traditional herbal medicinal product used in states of nervous tension (Poland) (Ożarowski et al. 1978).
The following indications are proposed for the Community herbal monograph:
1.Traditional herbal medicinal product used for the relief of symptoms of common cold.
2.Traditional herbal medicinal product for the relief of mild symptoms of mental stress.
2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications
The following posologies have been recorded for lime flower: a) Comminuted herbal substance
Single dose: 1.5 g, daily dose 3 – 6 g (Český lékopis 2009, supp. 2010) 1.5 g in 150 ml of boiled water 2 – 4 times daily (Blumenthal et al. 1998)
single dose: 0.5 – 1 g, usual daily dose: 2.5 – 5 g (Hungarian Pharmacopoeia 1970)
b)Liquid extract (1 : 1 in 25% alcohol) 2 – 4 ml daily (BHP 1976)
c)Tincture (1 : 5 in 45% alcohol) 1 – 2 ml daily (BHP 1976)
Based on literature data and information from the Member States, the following posology and duration of use are proposed for the Community herbal monograph:
Adolescents, adults and elderly
Indication 1) and indication 2)
a)Comminuted herbal substance
Herbal tea: 1.5 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion 2 – 4 times daily
Daily dose: 3 – 6 g
Single dose: 2 ml, 1 – 2 times daily Daily dose: 2 – 4 ml
Single dose: 1 ml, 1 – 2 times daily Daily dose: 1 – 2 ml
Children between 4 and 12 years of age
a)Comminuted herbal substance
Herbal tea: 1 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion 2 – 4 times daily
Daily dose: 2 – 4 g
Duration of use
The therapy should start at first signs of common cold. If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof
In vitro and animal studies
Differential cell growth effects on lymphocytes
The antiproliferative action of aqueous, dichloromethane and ethanol extracts obtained from Tilia cordata Miller, flowers on tumoral (BW 5147 lymphoma) and normal lymphocytes was described. All extracts showed a selective action on tumoral cells, inducing apoptosis. In the case of normal T cells these extracts suppressed
Anxiolytic and sedative activity
The aqueous extract of Tilia cordata flowers showed in vitro stimulatory effects on lymphocyte proliferation (maximum stimulatory concentration: 20 μg/ml). This effect was mimicked by Ro
Lime flower’s sedative effects have been reported as significant upon inhalation of Tilia sp. oil in mice (Blumenthal et al. 1998).
Antispasmodic – spasmogenic activity
In vitro, lime’s seeds water extracts of Tilia platyphylla and Tilia vulgaris have been reported to exhibit antispasmodic activity followed by a spasmogenic effect on rat duodenum (Lanza & Steinmetz 1986).
The activity of selected constituents of lime flower (flavonoids and phenolic acids) was inhibited by atropine and papaverine, and reinforced by acetylcholine. The diaphoretic and antispasmodic properties claimed for lime flower have been attributed to
The effects of the ethanol extract of Tilia cordata Miller were studied in vitro using intestinal smooth muscle cells of guinea pigs dispersed by collagenase. The extract induced a
Antimicrobial and antifungal activity
Pancreatic lipase inhibition
Lipids are important components in human nutrition; however, their increased intake contributes to the development of obesity and can lead to multiple
Bioactivities of secondary metabolites from lime flower
The diaphoretic activity of the flowers of lime is suggested to be caused by quercetin, kaempherol and
A recent study on traditionally used medicinal plants, herbs and spices in Latin America included Tilia platyphyllos flowers. These were investigated to determine their phenolic profiles, antioxidant activity and in vitro inhibitory potential against key enzymes relevant for hyperglycaemia and hypertension.
Lime flowers inhibited strongly both the
Diuretic, sedative and antispasmodic effects
Tilia species are traditional medicinal plants widely used as sedatives and tranquilisers (Zhang 2004). For this purpose, the infusion of their inflorescences is used to prepare a tea.
In the study by Viola et al., extracts of inflorescences from Tilia tomentosa Moench, one of the species found in the market, were purified using a benzodiazepine (BZD) binding assay to detect BZD receptor ligands in the different fractions. One of the ligands was identified as kaempferol, but it had low affinity (K(i) = 93 μM) for this receptor, and did not produce sedative or anxiolytic effects in mice. On the other hand, a complex fraction, containing yet unidentified constituents, but probably of a flavonoid nature, when administered intraperitoneally in mice, had a clear anxiolytic effect in both the elevated
In addition, a number of actions have been associated with volatile oils including diuretic, sedative and antispasmodic effects in mice, which may also account for some of the reputed uses of lime flower (Tilia cordata) (Taddei et al. 1988; Barnes et al. 2007). Volatile oils are not thought to possess any true diuretic activity, but to act as a result of certain terpenoid components having an irritant action on the kidneys during renal excretion.
All these observations of such bioactivities help to account for some of the existing medical effects.
3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof
No data on lime flower extracts have been found or reported.
3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof
No data have been found.
Among six herbal infusions used worldwide (Matricaria chamomilla, Tilia cordata, Mentha piperita,
Mentha pulegium, Uncaria tomentosa and Valeriana officinalis) were assayed for
using the Somatic Mutation And Recombination Test (SMART) in Drosophila melanogaster. All these infusions are traditionally used for various medical purposes. Hydrogen peroxide was used as an oxidative genotoxicant to test the
No adequate genotoxicity studies carried out on lime flower in the scientific literature.
No carcinogenicity studies carried out on lime flower in the scientific literature.
Reproductive and developmental toxicity studies
No reproductive and developmental toxicity studies carried out on lime flower are reported in the scientific literature.
The safety of lime flower during pregnancy and lactation has not been established. In accordance with general medical practice, the herbal medicinal products (herbal teas, other finished products) should not be used during pregnancy and lactation without medical advice.
3.4. Overall conclusions on
Lime flower has officially been recognised since 1947 in the first edition of the Czechoslovak Pharmacopoeia (Československý lékopis) till the current version of Czech Pharmacopoeia (Český lékopis 2009, suppl. 2010). Also it has been proposed since 1948 (Augustin et al. 1948) and then introduced in the VIth edition of the Hungarian Pharmacopoeia in 1970 as an herbal remedy traditionally used in for the relief of symptoms in common cold (diaphoretic in feverish cold). Lime flower is in the Polish Pharmacopoeia (Farmakopea Polska 1970). Also according to Ożarowski et al. (1978), Inflorescentia Tiliae has been known in Poland to stimulate secretory and excretory functions (diuretic, gastric fluid, bile flow, transpiration, skin perspiration), as supportive treatment in fever states with sore throat and bronchitis, and in states of nervous tension. It has been also referred in the BHP (1976).
Based on the
The published data referring to the indications and preparations is limited, but on the basis of existing data the pharmacological activities (BHP 1976; Madaus 1979; Bradley 1992) support the traditional use of Tilia cordata, Tilia platyphyllos and Tilia x vulgaris and preparations thereof in the proposed indications:
1.Traditional herbal medicinal product for the relief of symptoms of common cold
2.Traditional herbal medicinal product used to relieve mild symptoms of mental stress
The efficacy of traditional herbal medicinal products is only plausible but not proven by clinical data.
Although no adequate toxicity data are available, lime flower and lime flower preparations can be regarded as safe based on the fact that lime flower is listed by the Council of Europe as a natural source of food flavouring (category N2). Lime flower is listed as Generally Recognised as Safe (GRAS) by the FDA.
Nevertheless, the lack of genotoxicity, carcinogenicity as well as reproductive and developmental toxicity studies does not allow the establishment of a Community list entry.
4. Clinical Data
4.1. Clinical Pharmacology
4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents
No data available.
4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents
No data available.
4.2. Clinical Efficacy
4.2.1. Dose response studies
No data available.
4.2.2. Clinical studies (case studies and clinical trials)
(10.4%), Salvia officinalis (3.1%) and Tilia cordata (1%). The side effects for all the assayed herbs were reported by 36.5% of the patients and included headache, nausea, dizziness, itching, palpitation and sweating. Among the patients, 72.9% used the herbs as adjunctive therapy along with their antidiabetic drugs and 80.2% of the patients informed their physicians about their use. A 79.2% of the sample confirmed their intention to
The diaphoretic action of Tiliae flos was investigated in an open controlled clinical trial in patients with uncomplicated catarrhal disease. Fifteen patients with catarrhal disease inhaled water vapour from a preparation made with two sachets of Tiliae flos in 500 ml of water. Inhalation was maintained for 10 minutes at
improvement was observed only for the first 120 minutes, and after addition of other symptomatic treatment. It was suggested that the inhalation of a preparation of Tiliae flos had a kind of diaphoretic effect. As there was no statistical analysis of the data, an objective assessment of this investigation is not possible (WHO 2010).
There is a lack of clinical research, except the
4.2.3. Clinical studies in special populations (e.g. elderly and children)
4.3. Overall conclusions on clinical pharmacology and efficacy
Due to the lack of the data, no conclusion can be drawn.
5. Clinical Safety/Pharmacovigilance
5.1. Overview of toxicological/safety data from clinical trials in humans
There is a lack of clinical and
5.2. Patient exposure
No data available.
5.3. Adverse events and serious adverse events and deaths
Observations of suspected allergy to lime flower pollen (Tilia cordata) have been published several times and aeroallergen sensitisation due to Tilia cordata is believed to be among the most common (Loureiro et al. 2005; Krakowiak et al. 2004; Mur et al. 2001).
It has been advised that lime flower should be avoided by individuals with an existing cardiac disorder (Duke 1985), as excessive use may result in cardiac toxicity; however, the scientific basis for this statement, if any, is not known (Barnes et al. 2007).
5.4. Laboratory findings
No data available.
5.5. Safety in special populations and situations
Special patient population
Available evidence and experience on the use of lime flower preparations, especially the herbal tea, in children of different age groups can be found in several textbooks e.g. Kooperation Phytopharmaka 2002 or Bühring et al. 2008, where the preparation of a herbal tea from lime flower as well as of two combination teas for the specific paediatric use is described. Similar recommendations for combination teas are given by Schilcher (1992) and Schilcher & Dorsch (2006), e.g. a “species diaphoreticae” with reference to a clinical study of Traisman and Hardy who treated various groups of children suffering from respiratory infections with different medications and
The use for the relief of symptoms of common cold in children under 4 years of age has not been established due to lack of adequate data.
The use for the relief of mild symptoms of mental stress in children under 12 years of age has not been established due to lack of adequate data.
Fertility, pregnancy and lactation
No data are available. In the absence of sufficient data and in accordance with general medical practice, it is recommended not to use herbal medicinal products containing lime flower during pregnancy and lactation.
No fertility data available.
No cases of overdose have been recovered in the scientific literature.
No information retrieved from the literature search.
Effects on ability to drive or operate machinery or impairment of mental ability
No data retrieved from the literature search.
Potential for interactions
5.6. Overall conclusions on clinical safety
Tiliae flos is intended for use in adolescents, adults and elderly. Tiliae flos can also be used for the relief of symptoms of common cold in children between 4 and 12 years of age, however the use in children under 4 years of age for this indication has not been established due to lack of adequate data.
In the absence of sufficient data and in accordance with general medical practice, it is recommended not to use herbal medicinal products containing Tiliae flos (lime flower) during pregnancy and lactation.
Some cases of allergic reactions have been reported, however the frequency is not known.
No other adverse effects have been reported, showing sufficient safety for the proposed traditional use of Tiliae flos preparations.
The establishment of a Community list entry is not possible, as there are no available data on genotoxicity, carcinogenicity, reproductive and developmental toxicity of lime flower extracts.
6. Overall conclusions
The positive effects of lime flower on the relief of symptoms of common cold as well as its activity to relieve the symptoms of mild nervous tension have been recognised empirically. The traditional use is recognised as plausible, based on the existing in vitro and in vivo pharmacological data. There is a lack of controlled clinical studies with preparations containing lime flower.
In conclusion, Tiliae flos and its preparations can be regarded as traditional herbal medicinal products in the following indications:
−Traditional herbal medicinal product used for the relief of symptoms of common cold
−Traditional herbal medicinal product for the relief of mild symptoms of mental stress.
Based on information from the Member States and on literature data, Tiliae flos can be recommended for use in adolescents, adults and elderly and can be recommended for use in children between 4 and 12 years of age for the relief of symptoms of common cold.
In the absence of sufficient data and in accordance with general medical practice, it is recommended not to use herbal medicinal products containing lime flowers during pregnancy and lactation.
Safety data reported above support a safe use at the recommended posology in the proposed traditional uses, for traditional herbal medicinal products containing Tiliae flos preparations.
As there are no data available on the genotoxicity, carcinogenicity, reproductive and developmental toxicity of lime flowers and preparations thereof, the establishment of a Community list entry is not possible due to safety concerns.