EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 2H: known to contain methyleugenol in unspecified quantities Acacia senegal (L.) Willd. 2H: unspecified parts Acanthea virilis Pharm. ex Wehmer 2D: unspecified parts Achillea abrotanoides Vis. 2H: unspecified parts 2H: known to contain methyleugenol in unspecified quantities Achillea fragrantissima Sch.Bip. 2E: unspecified parts 2E: known to contain estragole in unspecified quantities Achillea millefolium L. 2D: unspecified parts 1H herb, flowers 1G: herb, flower 1H- Plant used as a source of food flavourings and subject to assessment. Category 4, with restrictions for camphor, eucalyptol, thujone (alpha and beta thujone 0.5 ppm under Leg. Decree 107/92 Annex V) (herb, flowers); Achyrantes bidentata Blume 2D: unspecified parts Acorus calamus L. 2N: leaves, rhizome; 2D: unspecified parts 2E: unspecified parts 2H: rhizome 1B: oil, rhizome 1C: roots 1D: unspecified parts The food additive Acacia gum ( E414) is obtained from the dried exudation obtained from the stems and branches of Acacia senegal or closely related species. 2D: only the use of the root is authorised 2N: known to contain asarone in unspecified quantities; (diploide no cis isoasaron; tetraploide up to 80% in essential oil) 2E: known to contain estragole in unspecified quantities 2H: methyleugenol content 1.0% , 1.025 ppm (rhizome) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 1 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Acorus calamus L. var. calamus 2N: leaves, rhizome 2N: known to contain asarone: 50-65% (leaves), 9-19% (rhizome), 0.3% (dried rhizome); triploid herb Acorus calamus L. var.angustatus Bess 2N: leaves, rhizome 2N: known to contain asarone: 85-95% (rhizome), 4.4-8.3% (dried rhizome); tetraploid herb Acorus gramineus Sol. 2N: unspecified parts 2N: known to contain asarone in unspecified quantities 2G: unspecified parts 1G: leaves (classified as unacceptable) 2G: plant from which active pharmaceutical ingredients are extracted (vasicine =? peganine); quinazoline alkaloids Adhatoda vasica Nees. Justicia adhatoda L. Adiantum capillusveneris L. 2D: folium Aesculus hippocastanum L. 2D: unspecified parts 2G: unspecified parts 1B: seeds 1G:entire plant 2D: food containing the seeds must have the warning not to ingest quantities of escin >75mg/day 2G: active ingredient: escin 2A and 2C: dry ripe seed, containing not less than 3% triterpene glycosides, expressed as anhydrous escin. Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 2 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Aframomum angustifolium (Sonn.) K.Schum. Synonyms Amomum angustifolium Sonn. Aframomum Amomum melegueta melegueta K.Schum. Rosc. Agastache foeniculum (Pursh) Kuntze Lophantus anisatus (Nutt.) Benth., Agastache anethiodora Britton Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 2D: unspecified parts spice (seeds) 2D: fructus, semen 1H: seeds 1G: seed 1 G: seed classified as unacceptable 1H: Category 5 2E: plant, essential oil 2H: unspecified parts 2E: estragole content: 555-12.160ppm (plant); 43.7% (essential oil) 2H: known to contain methyleugenol in unspecified quantities Agastache nepetoides (L.) Kuntze 2H: unspecified parts Agastache rugosa Kuntze 2E: essential oil 2H: unspecified parts 2E: estragole content: 90% (essential oil) 2H: known to contain methyleugenol in unspecified quantities Agathosma cerefolium Bartl. & Wendl. 2E: unspecified parts 2E: known to contain estragole in unspecified quantities Agrimonia eupatoria L. 2D: unspecified parts 1G: entire plant Agropyron repens (L.) Beauv. Elymus repens (L.) Gould 2D: rhizoma 1G: rhizome 1H: rhizome 2H: known to contain methyleugenol in unspecified quantities 1H: plant used as a source of food flavourings and subject to assessment. Category 5, with restrictions for carvacrol. CEFS of the Council of Europe, maximum allowed limits 5 ppm for food, 2 ppm for beverages (TDI 2.5 mg/kg bw/day) Ajuga reptans L. Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 3 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Akebia quinata (Houtt.) Decne Akebia trifoliata (Thunb.) Koidz. 2L: caulis Alaria esculenta (L.) Grev. 2D: thallus Albizia julibrissin Durazz. 2D: bark Alchemilla alpina L. 2D: herba Alchemilla vulgaris L. 2D: herba Alchemilla xanthochlora Rothm. 2D: herba Alisma orientale (Sam.) Juz. 2D: rhizoma 1G: rhizome 1H: rhizome Alliaria petiolata (M.Bieb.) Cavara & Grande 2D: herba Allium cepa L. 2A: fresh or dried bulb 2D: unspecified parts 2O: bulb 2D: only bark authorised in food, with the warning that it is prohibited from use by pregnant women 2D: only the use of the rhizome is authorised in food Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 4 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Allium sativum L. 2A: fresh, cut and dried bulb 2C: fresh, cut and dried bulb 2D: bulb 2O: bulb Alnus glutinosa (L.) Gaertn. 2D: cortex, folium Aloe barbadensis Mill. Alpinia galanga (L.) Willd. 2A and 2C: fresh bulb, cut and dried at a temperature not higher than 65°C or dried and powdered, containing not less than 0.45% aglycine, calculated in reference to dried drug 1G: latex (reference to the limits for aloin in the regulation on flavourings), 2A: dried essence from the leaves containing not less than 18% hydroxyanthracenes, expressed as babaloin and gel Aloe vera (L.) Burm.f. calculated in reference to dried drug 1H: leaves 1H: Category 5, with restrictions for aloin (0.1 ppm), aloe-emodine 2A: leaves, dried leaves 2D: unspecified parts 2A: leaves 2C: leaves 2D: folium, gel, latex (juice) 2A and 2C: Aloe ferox M. and its hybrids, A. africana M. and A. spicata B.: dried essence from the leaves containing 1G: latex (reference to the limits for not less than 18% hydroxyanthracenes, expressed as babaloin and calculated in reference to dried drug aloin in the regulation on flavourings), gel Aloe ferox Mill. Aloe vera (L. ) Burm.f. Items of information discussed in the source documents or provided by WG Experts See Aloe barbadensis Mill. 2D: folium, gel, latex (juice) 2D: rhizoma 2H: unspecified parts 2O: rhizome used as food (spice) 2H: known to contain methyleugenol in unspecified quantities Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 5 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Alpinia officinarum Hance 2D: 1H: 1G: 2O: Alpinia katsumadae Hayata A. katsumadai Hayata 2D: fructus, semen, rhizoma Alpinia oxyphylla Miq. Althaeae officinalis L. rhizoma rhizome rhizome rhizome rarely used as food 2D: fructus Malva officinalis Schimp. & Spenn. Items of information discussed in the source documents or provided by WG Experts 2D: only seeds authorised for use in foodstuffs 2D: only the fruit is authorised for use in foodstuffs 2A: peeled or whole dried root 2D: folium, radix; flos 1G: Root Ammi visnaga Lam. 2D: fructus 2F: fruit 2G: unspecified parts 1B: fruit, herbaceous plant with fruit, essence from the leaves 1I: fruit 2G: plant from which active pharmaceutical ingredients are extracted (khellin) Amorphophallus konjac K.Koch 2D: Tube The food additive konjac gum E 425 is obtained by aqueous extraction of Konjac flour, which is the unpurified raw product from the ground roots of Amorphophallus konjac. So products made from these plant may be regulated as a food additive Anabasis aphylla L. 2G: unspecified parts 2G: plant from which active pharmaceutical ingredients are extracted (anabasine) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet ; khelline) Pagina 6 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Ananas comosus (L.) Merrill 2D: fructus, caulis 2G: unspecified parts 2O: fruit 2G: plant from which active pharmaceutical ingredients are extracted (bromelin) Anemarrhena asphodeloides Bunge 2D: rhizoma 1H: rhizome 2D: only use of the rhizomes is authorised Anethum graveolens L. 2E: unspecified parts 2F: fruit 2D: fructus, aetherolum fruit + herb, seeds (EHIA list) 2O: leaf, fruit (schizocarp), infrutescence (immature) 2E: known to contain estragole in unspecified quantities Angelica archangelica L. ssp. archangelica 2D: folium, fructus, rhizoma, radix 1A: fruit, herb 1H: leaves, fruit, roots 2O: leaf, petiole, stem 1A: Presence of phototoxic furanocoumarins for certain parts and preparations 1H: Plant used as a source of food flavourings and subject to assessment. Category 4, with restrictions for coumarin (2 ppm) and furocoumarin Angelica dahurica (Fisch.) Benth.& Hook.f. ex Franch. & Sav. 2D: unspecified parts 2D: only the use of the root is authorised Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 7 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Angelica pubescens Maxim. 2D: radix, rhizoma, folium 2D: only the use of the root is authorised Angelica sinensis (Oliv.) Diels 2A: dried root 2D: radix 1L: root 1L: Known to contain isosafrole carcinogenic on mice and rats (IARC, 1987; IECEA, 1981) Angelica sylvestris L. 1H: fruit, roots, relevant essential oils 1H: Plant used as a source of food flavourings and subject to assessment. Category 5, with restrictions for + herb (EHIA list) furocoumarin Antennaria dioica (L.) Gaertn. 2D: Capitulum ,herba Arbutus unedo L. 1F: unspecified parts 2O: fruit Arctium lappa L. Lappa major Gaertn. Arctium minus (Hill) Lappa minor Hill Bernh. 2D: Radix, herba, fructus 1G: root 2D: radix, semen, folium, caulis Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 8 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms 2A: dried leaves 2C: dried leaves 2D: folium Arctostaphylos uvaursi (L.) Spreng. Artemisia abrotanum L. Artemisia absinthium L. Artemisia vulgaris L. Documented sources and parts of plants subject to restrictions 1F: unspecified parts 1H: herb Absinthium officinale Brot., Artemisia vulgare Lam. 1B: oil 1F: unspecified parts 1H: herb 1L: herb 2D: folium, flos, caulis 1H: herb, flowers 1L: herb Items of information discussed in the source documents or provided by WG Experts 2A and 2C: dried leaves containing not less than 8% hydroquinonic derivatives expressed as arbutin anhydride and calculated in reference to dried drug 1H: Herb and essential oil: Category 4, with restrictions for eucalyptol, methyleugenol, thujone (alpha and beta thujone 0.5 ppm under Leg. Decree 107/92 Annex V) 1L: it may contain up to 3.7% eucalyptol in essential oil and 1.3% of thujone 1L: it may contain up to 26.8% eucalyptol in essential oil 1H: Plant used as a source of food flavourings and subject to assessment. Herb and preparations: Category 4, with restrictions for camphor, eucalyptol, polyecetylenic compounds, thujone (alpha and beta thujone 0.5 ppm under Leg. Decree 107/92 Annex V) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 9 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Ascophyllum nodosum (L.) Le Jolis Synonyms Fucus nodosus L. Documented sources and parts of plants subject to restrictions 2D: thallus 1G: entire "plant" (reference to a footnote) Asparagus officinalis L. 2D: rhizoma, radix, sprout 2O: Stem (shoot) Astragalus membranaceus Bunge 2A: dried root 2D: unspecified parts Astragalus mongholicus Bunge 2A: dried root 2D: unspecified parts Avena sativa L. 2D: semen 1G: shoot/sprout 2O: fruit Ballota nigra L. 2D: herba Barosma betulina (Bergius) Bartl & H.L.Wendl. Agathosma betulina (Bergius) Pillans Betula alba L. 1G footnote: the total amount of iodine from Ascophyllum nodosum, Fucus vesicolosus and Macrocystis pyrifera must not exceed 250 µg per daily dose 1G: leaf 2G: 1A: 1C: 1D: 1F: Berberis vulgaris L. Items of information discussed in the source documents or provided by WG Experts unspecified parts bark, root bark, root bark, root bark, root bark, root unspecified parts 2G: active ingredients: berberine 1A: Presence of toxic substances (berberine alkaloid) 2O: As a source for flavouring (Council of Europe 1981) - restriction on the content of berberine in foods (EU law on flavourings). The fruit is specified as a food but with the remark it is rarely used See B. pubescens Ehrh. Betula pendula Roth B. verrucosa Ehrh. 1G: bark, leaves Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 10 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Items of information discussed in the source documents or provided by WG Experts 1G: bark, leaves 2C: leaves 2D: folium, cortex, gemma, juice 2C: dried whole or parts of birch leaf, containing not less than 1.5% flavonoids, calculated in hyperoxide form in reference to the dried active ingredient - Category B (can contain pyrrolizidine alkaloids??)(dried leaves); Borago officinalis L. 1A: herb, flowers 1B: flowers, leaves, herbaceous plant with flowers 1E: unspecified parts 1G: herb, fatty oil from the seed 1A: Presence of pyrrolizidine alkaloids with genotoxic, carcinogenic and hepatotoxic properties 1G: The herb is not acceptable due to the content of pyrrolizidine alkaloids. The fatty oil: restrictions on the content of pyrrolizidine alkaloids 2D: only oil pyrrolizidine alkaloid free accepted Boswellia serrata Roxb. 2E: unspecified parts; 2D: gummiresina 2E: known to contain estragole in unspecified quantities Brassica nigra (L.) W.D.J.Koch. 2G: unspecified parts 1E: unspecified parts (1E 2) 2G: active ingredients: allyl isothiocyanate 1E: 1E2 (with the exception of the seeds) 2O: the seed is a food Bupleurum chinense DC. 2D: radix, folium, sprouts Bupleurum falcatum L. 2A: dried root Bupleurum scorzonerifolium Willd. 2A: dried root Betula pubescens Ehrh. Betula alba L., B. tomentosa Retz. & Abel Documented sources and parts of plants subject to restrictions 2D: only the use of the roots is authorised in food Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 11 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms 2A: 2B: 2C: 1G: Calendula officinalis L. Calamintha nepeta (L.) Savi C. officinalis Moench Calluna vulgaris (L.) Hull Camellia sinensis (L.) Kuntze Capsicum annuum L. var. annuum Items of information discussed in the source documents or provided by WG Experts flowers flowers flowers flowers, herb 2D: unspecified parts 2D: unspecified parts Thea sinensis L. Capsella bursapastoris (L.) Medik. Capsicum annuum L. var. minimum (Mill.) Heiser Documented sources and parts of plants subject to restrictions 2D: folium 2G: active ingredients: caffeine, theophylline 2O: leaf for tea - Category B (possible presence of saponin) (leaves, seeds) 2D: unspecified parts 1G: herb C. annuum L. var. glabriusculum (Dunal) Heiser & Pickersgill 2I: dried fruit 2I: known to contain capsaicin 1H: Fruit and preparations: Category 5, with restrictions for capsaicin (0.05 ppm (TDI 0.2 mg/kg bw/day) CEFS of the Council of Europe)). Category B (presence of capsaicin and other capsaicinoids with mutagenic activity and suspected carcinogenic activity) 1H: fruit 2O: fruit 1H: Fruit and relevant preparations: Category 5, with restrictions for capsaicin (0.05 ppm (TDI 0.2 mg/kg bw/day) CEFS of the Council of Europe), solanine and solanidine glycoalkaloids. Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 12 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Capsicum frutescens L. 2I: unspecified parts 1H: fruit 2O: fruit Carex arenaria L. 2D: unspecified parts Carica papaya L. 2D: unspecified parts 2G: unspecified parts fruit, leaves (EHIA list) 2O: fruit Carlina acaulis L. 2D: radix Carum carvi L. 2C: fruit 2D: unspecified parts dried ripe fruit + seeds (EHIA list) 2O: fruit Caryophyllus aromaticus L. See Syzygium aromaticum (L.) Merr. & L.M.Perry Items of information discussed in the source documents or provided by WG Experts 2I: known to contain capsaicin 2G: active ingredients: chymopapain, papain 2C: dried ripe fruit, containing not less than 3% v/m essential oil 2F: unspecified parts Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 13 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Cassia acutifolia Delile Cassia angustifolia Vahl Cassia fistula L. Synonyms C. senna L., Senna alexandrina Mill. Senna angustifolia (Vahl) Batka Documented sources and parts of plants subject to restrictions 2A: 2C: 2D: 2G: 1G: 2A: 2C: 2D: 2G: 1G: Items of information discussed in the source documents or provided by WG Experts fruit, leaves fruit, leaves pods, leaves unspecified parts leaves, fruit 2A and 2C: dried ripe fruit, containing not less than 3.4% hydroxyanthracenic glucosides, calculated as sennoside B in reference to dried drug; dried new leaves containing not less than 2.5% hydroxyanthracenic glucosides, calculated as sennoside B in reference to raw drug 2D: food containing the pods and/or the leaves must have the warning not to ingest quantities of hydroxyanthracene (calculated as sennoside B) > 18 mg/day and "not to be given to children under 12 years of age; consult a physician if pregnant or breastfeeding; for prolonged use consult a specialist” 2G: active ingredients: sennosides A and B 1G: with a max. level and a footnote saying that if more anthraquione containg plants are found in the same product the max. dose for each plant part has to be reduced accordingly The antraquinone containing plants mentioned are: Cassia acutifolia and C. angustifolia , Rhamnus carthartica , R. frangula and R. purshiana and Rheum officinale and R. palmatum) fruit, leaves fruit, leaves pods, leaves unspecified parts leaves, fruit 2A and 2C: dried ripe fruit containing not less than 2.2% hydroxyanthracenic glucosides, calculated as sennoside B in reference to dried drug; dried leaves containing not less than 2.5% hydroxyanthracenic glucosides, calculated as sennoside B in reference to raw drug 2D: food containing the pods and/or the leaves must have the warning not to ingest quantities of hydroxyanthracene (calculated as sennoside B) > 18 mg/day and "not to be given to children under 12 years of age; consult a physician if pregnant or breastfeeding; for prolonged use consult a specialist” 2G: active ingredients: sennosides A and B 1G: with a max. level and a footnote saying that if more anthraquione containg plants are found in the same product the max. dose for each plant part has to be reduced accordingly The antraquinone containing plants mentioned are: Cassia acutifolia and C. angustifolia, Rhamnus carthartica, R. frangula and R. purshiana and Rheum officinale and R. palmatum) 2D: pods, leaves fruit (EHIA list) 2D: food containing the pods and the leaves must have the warning not to ingest quantities of hydroxyanthracene (calculated as sennoside B) > 18 mg/day and “not to be given to children under 12 years of age; consult a physician if pregnant or breastfeeding; for prolonged use consult a specialist” Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 14 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions C. tora L. var. obtusifolia (L.) Cassia obtusifolia L. Haines, Senna obtusifolia (L.) H.S.Irwin & Barneby 2D: unspecified parts Cassia occidentalis L 1B: seeds Castanea sativa Mill. C. vesca Gaertn., C. vulgaris L. Items of information discussed in the source documents or provided by WG Experts 2D: only seeds authorised for use in foodstuffs 2F: flowers Centaurea centaurium L. Centaurea cyanus L. 2D: flos Centaurium erythraea Rafn. C. minus Moench, C.umbellatum Gilib., Erythraea centaurium (L.) Borkh. 2C: whole or cut, dried aerial flowering parts 2D: herba 1H: flowering tops 1H: Flowering tops: Category 4, with restrictions for xanthones Centella asiatica (L.) Urb. Hydrocotyle asiatica L. 2A: dried aerial parts of the entire plant 2D: herba 2G: active ingredients: asiaticoside Cetraria islandica (L.) Ach. Chamaemelum nobile (L.) All. 2C: dried thallus 2D: unspecified parts Anthemis nobilis L. 2D: flos 2O: Inflorescence, flower 2O: inflorescence, flower for tea Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 15 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Chondrus crispus Stack. Synonyms Fucus crispus L. Documented sources and parts of plants subject to restrictions 2D: thallus Chrysanthellum americanum Vatke 2D: unspecified parts Cichorium intybus L. 2D: unspecified parts herb, root (EHIA list) 2O: root from C. intybus L. ssp. intybus Sativum group Cimicifuga racemosa (L.) Nutt. Cimicifuga serpentaria Pursh, Actaea racemosa L. Cinchona ledgeriana C. officinalis L., C. (Howard) calisaya Wedd.., Bern.Moens 2A: dried root and rhizome 2D: rhizoma, radix 1G: entire plant 1I: unspecified parts 2G: unspecified parts 1H: bark from the branches C. succirubra Pav.ex Cinchona pubescens Klotzsch, C. cordifolia 1H: bark from the branches Vahl Mutis ex Humb. Cinnamomum camphora (L.) J.Presl. Items of information discussed in the source documents or provided by WG Experts 2D: food containing the rhizome must have the warning not to ingest more than 3.0 mg/day of triterpene glycosides (calculated as 27-deoxyactein)) >3.0 mg/day 1G: the use in food supplements are not acceptable 2G: active ingredients: quinidine, quinine 1H: Bark: Category 4, with restrictions for quinine. CEFS of the Council of Europe, maximum allowed limits for quinine: 0.0 ppm per foodstuff, 100 ppm for beverages 1H: Category 4, with restrictions for quinine. CEFS of the Council of Europe, maximum allowed limits for quinine: 0.0 ppm per foodstuff, 100 ppm for beverages 2G: active ingredients: camphor 2G: unspecified parts Used in cosmetics and subject to assessment; essential oil: Category C (presence of allergenic substances such as cinnamic aldehyde) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 16 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Cinnamomum cassia Cinnamomum (Nees) Blume aromaticum Nees 2A: bark from the trunk without cork 2D: unspecified parts 2E: unspecified parts - bark from the trunk without cork (4 old list of sources) 2O: bark 2E: known to contain estragole in unspecified quantities Cinnamomum platyphyllum (Diels) C.K. Allen 2H: unspecified parts 2H: known to contain methyleugenol in unspecified quantities Cinnamomum rigidissimum H.T.Chang 2H: unspecified parts 2H: known to contain methyleugenol in unspecified quantities Cinnamomum septentrione Hand.Mazz. 2H: unspecified parts 2H: known to contain methyleugenol in unspecified quantities Cinnamomum verum J.Presl. 2A: internal dried bark of sprouts grown on cut graft stems 2E: unspecified parts 2H: unspecified parts 2O: bark 2E: known to contain estragole in unspecified quantities to contain methyleugenol in unspecified quantities Cinnamomum zeylanicum Blume Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet The bark used for food, spice 2H: known Pagina 17 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Citrus aurantium L. C. aurantium L. ssp. amara Engl., C. aurantium L. ssp. sinensis L., C. aurantium L. ssp. aurantium L, C. aurantium var. dulcis Citrus aurantifolia (Christm. & Panz.) Swingle Documented sources and parts of plants subject to restrictions 2D: folium, flos, cortex, 1D: entire plant 1G: extracts that concentrate synephrine are not acceptable 1H: bark, flowers, leaves, twigs 1D: the assessment (not suitable as a food) only applies to the extracts with high content of synephyrine 2D:food supplements max. synephrine content of 20 mg/daily dose 1H: Rind infusion and essential oil: Category 3, with restrictions for furocoumarin. 1H: fruit, pulp, bark, leaves, small branches 2O: fruit 1H: Distilled oil or pressed lime oil: Category 3, with restrictions for eucalyptol, furocoumarin 1B: essence Citrus aurantium L. C. bergamia (Risso) 1H: bark , leaves, fruit, twigs, rind ssp. bergamia (Risso) Risso & Poit. and relevant essential oil Engl. 2O: fruit 1B: resin Citrus limon (L.) C. limonum Risso 1H: bark , leaves, fruit, pulp, twigs Burm.f 2O: fruit Citrus medica L. Items of information discussed in the source documents or provided by WG Experts 2D:fructus, semen 2O: fruit 1H: Rind and relevant essential oil: Category 3, with restrictions for furocoumarin 1H: Essential oil from the rind: Category 4, with restrictions for furocoumarin 2D: only the fruit is authorised for use in foodstuffs Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 18 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Citrus x paradisi Macfad. Synonyms C. grandis (L. ) Osbeck var. racemosa (Roem.) B.C.Stone Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 1H: bark , leaves, fruit, pulp 2O: fruit 1H: Essential oil from the leaves and naringin extract: Category 5 Citrus reticulata Blanco 1G: extracts that concentrate synephrine are not acceptable 2D: unspecified parts 2O: fruit 2D: food supplements max. synephrine content of 20 mg/daily dose Cnicus benedictus L. 2D: unspecified parts Cochlearia officinalis L. 2D: unspecified parts 2O: leaf Coffea arabica L. 1H: seeds 2O: fruit, seed Coffea canephora Pierre ex Froehner Cola acuminata (P.Beauv.) Schott & Endl. 2D: semen 1H: seeds Cola ballayi Cornu ex Heckel 2D: unspecified parts 1H: Kola and Kola nut extract: Category 4 with restrictions for caffeine Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 19 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Cola nitida (Vent.) Schott et Endl. C. vera K.Schum. 2D: semen 1H: seeds 1G: seed with restriction on caffeine (max. 100 mg/dose max. 300 mg/day) 2O: seed Coleus forskohlii (Willd.) Briq. Plectranthus barbatus Andr. 2D: herba 1C: aerial parts 1D: entire plant Combretum micranthum G.Don. Commiphora molmol Engl. Items of information discussed in the source documents or provided by WG Experts 1H: Kola and Kola nut extract: Category 4 with restrictions for caffeine raw material for forskoline extraction 2D: unspecified parts C. myrrha (Nees) Engl. 2C: gum resin 2D: unspecified parts Commiphora mukul Engl. 2D: gummiresina 2E: unspecified parts Coptis chinensis Franch. 2A: dried rhizome 2C: gum-resin obtained by incision or produced by spontaneous exudation from stem and branches 2E: known to contain estragole in unspecified quantities 2A: contain berberine Coptis deltoides C.Y.Cheng & P.K.Hsiao Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 20 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Coriandrum sativum L. 2D: unspecified parts leaves, seeds (EHIA list) 1L: herb essential oil 2O: fruit, leaf 1L: it contain also camphor Crataegus laevigata (Poir.) DC. 2A: 2C: 2D: 1G: 2D: food containing the flowering tops must have the warning not to ingest quantities of flavonoids > 2.6 mg/day and > 22.5 mg/day of the procyanidin oligomers Crataegus monogyna Jacq. 2A: unspecified parts 2C: unspecified parts 2D: unspecified parts 2D: food containing the flowering tops must have the warning not to ingest quantities of flavonoids > 2.6 mg/day and > 22.5 mg/day of the procyanidin oligomers Crocus sativus L. 2F: unspecified parts 2D: unspecified parts 2O: style 1H Plant used as a source of food flavourings and subject to assessment. Saffron: Category 3, with restrictions for eucalyptol. Saffron extract: Category 4 with restrictions for eucalyptol (stigma); 1F- Belgian regulations, list 3 Cucurbita pepo L. 2D: semen 2O: fruit unspecified parts unspecified parts fructus, folium, flos flower, leaf Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 21 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Cuminum cyminum L. 2E: fruit 2D: unspecified parts 1H: fruit (seeds) 2O: fruit Cupressus sempervirens L. 2D: unspecified parts Curcuma longa L. Curcuma kwangsiensis S.G.Lee & C.F. Liang C. domestica Valeton, Amomum curcuma Jacq. 2A: dried rhizome 2D: rhizoma 2G: unspecified parts 1H: rhizome 2O: rhizome Items of information discussed in the source documents or provided by WG Experts 2E: estragole content: 30ppm (fruit) 1H: Seeds and relevant preparations: Category 5, with restrictions for eucalyptol 2D: only powder from the plant is authorised 2G: active ingredients: turmeric 1H: Essential oil and rhizome: Category 3, with restrictions for eucalyptol T 2A: dried rhizome, dried rhizome Curcuma phaeocaulis Valeton Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 22 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Curcuma wenyujin Y.H.Chen & C.Ling Curcuma xanthorrhiza Roxb. 2D: rhizoma Cyamopsis tetragonolobus (L.) Taub. 2D: semen, gum Cydonia oblonga P.Mill. 2D: fructus, semen 2O: fruit Cymbopogon Andropogon citratus citratus (DC.) Stapf. DC. 2H: 1G: 1H: 2O: Cynara cardunculus L. 2C: dried leaves 2D: follium leaves (EHIA list) 2G: unspecified parts 1G: leaf 2O: inflorescence 2G: active ingredients: cynarin 2D: unspecified parts 2D: only the use of the rhizome is permitted in food products Dioscorea hypoglauca Palib. Cynara scolymus L. unspecified parts herb herb, leaves leaf 2H: known to contain methyleugenol in unspecified quantities 1H: Herb: Category 3, with restrictions for eucalyptol, thujone (alpha and beta thujone 0.5 ppm under Leg. Decree 107/92 Annex V) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 23 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Dioscorea opposita Thunb. 2D: rhizoma tuberosum Dioscorea villosa L. 2D: rhizoma tuberosum Drosera rotundifolia L. 2D: unspecified parts 1G: herb Echinacea angustifolia DC. 2A: 2D: 1D: 1G: Echinacea pallida (Nutt.) Nutt. 2A: fresh or dried root 2C: fresh or dried root 2D: radix, rhizoma fresh or dried root radix, rhizoma, herba entire plant root, herb Items of information discussed in the source documents or provided by WG Experts 2D: only the use of the rhizome is permitted in food products 2A: Echinacea angustifolia DC.var. angustifolia or stringosae 2D: food containing the E. angustifolia D.C. root must have the warning not to ingest an amount of product > 2.4 g/day of the dried root. 1D: E. angustifolia D.C. is an ingredient in authorised herbal medicinal products 2D: food containing the E. angustifolia D.C. root must have the warning not to ingest an amount of product > 720 mg/day of dried root Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 24 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Echinacea purpurea (L.) Moench Synonyms Rudbeckia purpurea L. Elettaria cardamomum (L.) Maton. Eleutherococcus senticosus (Rupr. & Maxim.) Maxim. Acanthopanax senticosus (Rupr. & Maxim.) Harms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 2A: fresh or dried aerial parts collected in full bloom, fresh or dried roots 2C: fresh or dried aerial parts collected in full bloom, fresh or dried roots 2D: radix, rhizoma, herba 1D: entire plant 1G: root 2D: food containing the herbaceous parts must have the warning not to ingest quantities of product > 2 g/day of the dry herb 1D: the plant is an ingredient in authorised herbal medicinal products 2D: fructus, semen 2H: oil fruit, husk (EHIA list) 1L: seed 2O: fruit 2H: methyleugenol content: 0.1% 1L: it may contain eucalyptol (up to 51.3%) in essential oil. 2A: dried rhizome and roots 2D: radix 1G: root Epilobium angustifolium L. 2D: herba Equisetum arvense L. 2D: herba 1G: herb Erica cinerea L. 2D: Flos, sumitatus con floribus Epilobium spec. on EHIA list Erica tetralix L. Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 25 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Eriobotrya japonica (Thunb.) Lindl. 2D: unspecified parts 2O: fruit 2D: only the leaf is authorised for use in foodstuffs Eriodictyon californicum (Hook. & Arn.) Torr. 2D: follium 1H: herb 1H: Herb and preparations: Category 5 Eryngium campestre L. 2D: radix, folium, sprouts Eschscholzia californica Cham. 2D: herba Eucalyptus globulus Labill. 2A: essential oil from fresh leaves and branch tips, dried leaves 1L and 2A and 2C: essential oil from fresh leaves and branch tips containing not less than 70% 1,8-cineole 2C: essential oil from fresh leaves and (eucalyptol) branch tips, dried leaves 1H: Leaves, flowers and relevant preparations: Category 4, with restrictions for eucalyptol 2D: folium 1G: leaf 1L: leaves Euphorbia hirta L. Chamaesyce hirta (L.) Millsp. 1B: herbaceous plant Euphrasia officinalis L. 2D: herba, folium Ficus carica L. 2D: fructus (receptaculum), folium, caulis (latex) 2O: fruit Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 26 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Filipendula ulmaria (L.) Maxim. 2F: herb 2D: unspecified parts herb + flowers (EHIA list) 1G: herb, flower Foeniculum vulgare Mill. 2D: fructus, herba 2E: fruit, essential oil 2D: food containing the fruit must have the warning for children under the age of 12 not to ingest quantities of estragole > 0.05 mg/kg bw/day 2E - estragole content: fruit (70-4.018 ppm), essential oil (0.8->80%) Foeniculum vulgare Mill. ssp. vulgare var. vulgare 2C: whole dried cremocarp and pericarp - whole dried cremocarp and pericarp containing dried oil 1L: fruit essential oil 2C: whole dried cremocarp and pericarp containing not less than 4% v/m dessicated oil, calculated in reference to anhydrous drug; oil contains not less than 60% anethol and not less than 15% phencone Use as cosmetic: hydroalcoholic extract, glycolic extract: Category C 1L: 3.5-12% estragole in essential oil Foeniculum vulgare Mill. ssp. vulgare var. dulce (Mill.) Batt. & Trab. 2C: whole dried cremocarp and pericarp - whole dried cremocarp and pericarp containing dried oil 1L: fruit essential oil 2O: Fruit, leaf, shoot 2C: whole dried cremocarp and pericarp containing not less than 2% v/m essential oil, calculated in reference to anhydrous drug; oil contains not less than 80% anethol use as cosmetic: hydroalcoholic extract, glycolic extract: Category C 1L: 1.5-5.0% estragole in essential oil Forsythia suspensa (Thunb.) Vahl 2D fructus, folium, radix 2D: only unripened fruit is authorised Fragaria vesca L. 2D: folium, fructus fruit, leaves (EHIA list) 1G:leaf 2O: fruit Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 27 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Fraxinus excelsior L. 2D: cortex, folium, semen Fraxinus ornus L. 2D: unspecified parts Fucus serratus L. 1F: unspecified parts 2D: thallus Fucus vesiculosus L. 2D: thallus 1G: entire "plant" (reference to a footnote) Fumaria officinalis L. 2D: herba 1I: herb Items of information discussed in the source documents or provided by WG Experts 1G footnote: the total amount of iodine from Ascophyllum nodosum, Fucus vesicolosus and Macrocystis pyrifera must not exceed 250 µg per daily dose Galeopsis segetum Neck. Galeopsis ochroleuca Lam. 2D: herba Galium odoratum (L.) Scop. Asperula odorata L. 2D: Herba, folium 1G: herb 1H: herb 1G: (footnote) If more than one of the plants: Galium odoratum, Medicago sativa, Melilotus officinalis and Melilotus albus are used in the same preparation, the total intake of coumarin from the preparation must not exceed 0,4 mg. 1H: Herb: Category 4, with restrictions for coumarin (2ppm) Garcinia cambogia Desr. Cambogia gutta L. 2D: unspecified parts 1D: entire plant 1G: fruit 1D, 1G: unsuitable or not acceptable in food including food supplements Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 28 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Gastrodia elata Blume 2D: radix, rhizoma 2D: only the use of the rhizome is permitted in food products Gaultheria procumbens L. 2G: unspecified parts 1B: oil 1F: unspecified parts 2G: active ingredients: methyl salicilate Gentiana lutea L. 2C: dried and fragmented rhizomes subterraneous parts 2D: radix, rhizoma 1H: roots (biennial plant), herb 1G: root 1L: dried root essential oil Geranium robertianum L. 2D: Herba, folium Geum urbanum L. 2D: herba, radix Ginkgo biloba L. 2A: whole dried leaves 2D: folium, semen testa 1D: entire plant Glechoma hederacea L. 1B: herbaceous plant with flowers 1F: unspecified parts 1G: herb Glycine max. (L.) Merr. 2D: semen 2O: seed 2H: known to contain methyleugenol in unspecified quantities 1L: it contain also elimicin 1H: Roots, herb and relevant preparations: Category 4, with restrictions for xanthones - Plant used as a source of food flavourings and subject to assessment. Roots, herb: Category 4, with restrictions for xanthones 2D: food containing the leaves must have the warning not to ingest more than 21.6 mg/day of flavonol glycosides and 5.4 mg/day of terpene lactones and to consult a physician if anticoagulants are taken 1D: The entire plant is an ingredient in authorised herbal medicinal products 2D: (foodstuffs containing the fruit must have the warning not to ingest more than 40 mg of isoflavones per day (expressed as glycosides of the main ingredient)) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 29 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Glycyrrhiza glabra L. 2A: dried rhizome and roots 2D: radix, rhizoma 2E: unspecified parts unspecified parts 2O: root Glycyrrhiza uralensis Fisch. ex DC. 2A: dried rhizome and roots Gossypium barbadense L. 1B: root bark, seeds 2O: seed oil Gracilaria gracilis (Stackhouse) Steentoft Grindelia camporum Greene Gracilaria verrucosa (Huds.) Papenfuss Items of information discussed in the source documents or provided by WG Experts 2D: food containing the rhizome must have the warning not to ingest more than 100 mg/day of glycyrrhetinic acid and to “not use for more than 6 weeks without medical consultation” 2E: known to 2G: contain estragole in unspecified quantities 2G: active ingredients: glycyrrhizin (glycyrrhetinic acid) contains gossypol 2D: unspecified parts 2D: unspecified parts Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 30 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Grindelia robusta Nutt. 2D: unspecified parts Grindelia squarrosa (Pursh) Dunal 2D: herba Guajacum officinale L. Guaiacum officinale L. 2D: unspecified parts 1G: gum/resin Guajacum sanctum L. Guaiacum sanctum L. 2D: unspecified parts 1G: gum/resin Gymnema sylvestre (Retz.) R.Br. 2D: folium 1G: leaves Haematoxilum campechianum L. 2D: unspecified parts Items of information discussed in the source documents or provided by WG Experts 1G: not acceptable Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 31 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Hamamelis virginiana L. 2A: dried bark, fresh or dried leaves 2C: dried bark, fresh or dried leaves 2D: unspecified parts 2F: twigs 2H: unspecified parts 1H: leaves 2A and 2C: dried fresh leaf containing not less than 7% tannins, calculated in reference to dried drug 2F: clear, colourless distillate of freshly cut and dried twigs 2H: known to contain methyleugenol in unspecified quantities 1H: Leaves and preparations: Category 5, with restrictions for safrole (1 ppm under Leg. Decree 107/92 Annex V), carvacrol. CEFS of the Council of Europe, maximum allowed limits for carvacrol: 5 ppm for food, 2 ppm for beverages (TDI 2.5 mg/kg bw/day) Harpagophytum procumbens (Burch.) DC. 2B: root in accordance with European Pharmacopoeia 2C: dried secondary root tuber 2D: radix (secondary tuber) 1G: root 2C: cut and dried secondary root tuber containing not less than 2.2% iridoid glucosides, calculated as harpagosides, or less than 1% harpagoside 2D: food containing the secondary roots must have the warning not to ingest more than 40 mg/day of total iridoids (calculated as harpagoside) Harpagophytum zeyheri Decne. 2D: radix (secondary tuber) 2D: food containing the secondary roots must have the warning not to ingest more than 40 mg/day of total iridoids (calculated as harpagoside) Hedera helix L. 2F: leaves 2D: unspecified parts 1B: bark, wood, seeds 1C: leaves, fruit, resin 2D: only the leaf is authorised for use in foodstuffs Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 32 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Helianthus annuus L. 2D: unspecified parts flowers, seeds (EHIA list) Helianthus tuberosus L. 2D: folium, flos, semen, gemma 2O: root (tuber) Helichrysum arenarium (L.) Moench. 2D: flos 2N: unspecified parts flowers (EHIA list) 1G: flower 2N: known to contain beta-asarone in unspecified quantities Herniaria glabra L. 2D: herba Herniaria hirsuta on EHIA list Hibiscus sabdariffa L. var. sabdariffa 1G: herb, flower (calyx) calyx of Hibiscus sabdariffa L. var. sabdariffa (2O) Hieracium pilosella L. Hippophae rhamnoides L. fruit of H. annuus L. ssp. annuus var. annuus (2O) Pilosella officinarum 2D: unspecified parts F.W.Schultz & Sch.Bip 2D: fructus fruit (EHIA list) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 33 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Humulus lupulus L. Hypericum perforatum L. Synonyms Documented sources and parts of plants subject to restrictions 2B: inflorescence in accordance with European Pharmacopoeia 2D: strobulus 1G: flower 2O: inflorescence Items of information discussed in the source documents or provided by WG Experts 2D: food containing the plant must have the warning not to ingest more than the equivalent of 400 micrograms per day of 8-prenylnaringenin 2A and 2C: dried flowering tips or aerial parts, harvested during or immediately after blooming, containing not less 2A: flowering top or aerial part than 0.04% naphthol-diantrones of the hypericin group (or total hypericin), calculated as hypericin 2C:flowering top or aerial part 2D: food containing the herbaceous parts must have the warning not to ingest more than the equivalent of 700 2D: herba micrograms of hypericin per day and to “consult a physician if medicinal products are taken" 1H: leaves, caulis, flowering top, herb 1H: Herb: Category 5, with restrictions for hypericin (0.1 ppm), xanthones. CEFS of the Council of Europe, 1G: flower (fresh), herb maximum allowed limits for hypericin: 0.0 ppm for food, 0.4 ppm for beverages (TDI 0.0003 mg/kg bw/day) 1I: herb 1G: The intake of herb should equivalete max. 0.1 mg totalhypericin per daily dose. Warning of photosensitivity Hyssopus officinalis L. 2E: bud 2D: unspecified parts 2H: oil extract of aerial parts, plant 2O: leaf, (young) shoot Ilex paraguariensis A. St.-Hil. 2D: unspecified parts leaves (EHIA list) 1G: leaves with restriction on caffeine 1G:( footnote) Total amount of caffeine from preparations with Cola nitida, Ilex paraguiensis and Paullinia cupana (max. 100 mg/dose max. 300 to be controled. mg/day) - see footnote 2O: leaf (for tea) 2E: estragole content: 1-260 ppm (bud) 2H: methyleugenol content: 43.9%; 0.54% (oil extract of aerial parts); 100ppm (plant) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 34 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Illicium verum Hook.f. 2E: fruit, essential oil 2D: fructus 1H: seeds 2O: fruit Inula helenium L. 2D: radix, rhizoma 2L: root 1B: roots 1G: root Iris florentina L. 1H: rhizome, roots (peeled after two years of aging) 1H: Rhizome, roots and preparations: Category 5, with restrictions for xanthone Iris germanica L. 1H: rhizome, roots (peeled after two years of aging) 1H: Rhizome, roots and preparations: Category 5 Juniperus communis L. 2C: dried ripe fruit 2D: fructus, radix, lignum, resina 2O: fleshy cone Krameria triandra Ruiz & Pav. 2D: radix Lamium album L. 2D: Flos, Folium, herba, sumitatus con floribus flowers, herb (EHIA list) Laurus nobilis L. 2D: folium, fructus 2H: leaves 1H: berries, leaves 2E: estragole content: 280-6500 ppm (fruit), 0.6-6% (essential oil) 1H: Anise and its oil: Category 3, with restrictions for estragole, safrole (1 ppm under Leg. Decree 107/92, Annex V) 2H: methyleugenol content: 213-2.608ppm 1H: Leaves and leaf essential oil and extract: Category 3, with restrictions for eucalyptol and methyleugenol presence of alkaloids Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 35 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Lavandula angustifolia Mill. L.officinalis Chaix., L.vera DC. 1G: flowers 2D: flowers (flos) 2F: flowers Lavandula latifolia Medik. Lavandula spica auct., non L. 1L: herb essential oil it contains also camphor Ledum palustre L. 2D: flowers 1A: herb, entire plant 1C: entire plant 1E: unspecified parts (1E 2) 1A: Contains an essential oil that is an irritant to the gastro-intestinal system, kidneys and urinary tract Leonurus cardica L. 1G: herb Lippia triphylla (L'Hér.) Kuntze Aloysia triphylla (L'Hér.) Britton, Verbena triphylla L'Her., Lippia citriodora (Lam) H.B.K. 2D: folium, herba 1H: herb, leaves 1G: leaves 1H: Herb, leaves and preparations: Category 5, with restrictions for eucalyptol Linum usitatissimum L. 2B: dried ripe seed in accordance with European Pharmacopoeia 2C: dried 1L: known to contain linamarin corresponding to a maximum of 500 mg HCN/kg seed ripe seed seed of L. usitatissimum L. ssp. usitatissimum (2O) 2D: semen 1L: seed Lithothamnium calcareum 2D: unspecified parts Lotus corniculatus L. 2D: folium, radix Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 36 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Lycopodium clavatum L. 2D: herba, spores 1G: entire plant Lycopodium saururus Lam. 1B: herb Lycopodium serratum Thunb. 2D: caulis, flos, folium Lycopus europaeus L. 2D: herba 1E: unspecified parts (1E 2) Lythrum salicaria L. 2D: sumitatus con floribus Magnolia officinalis Rehder & Wilson 2D: cortex, flos 1C: entire plant 1F: unspecified parts Malva sylvestris L. 2D: folium, flos 1H: leaves, flowering tops 1G: flower Marrubium vulgare L. 2D: herba 1H: herb, leaves 1G: herb Items of information discussed in the source documents or provided by WG Experts 1G: entire plant is classified as unacceptable 1H: Extract and preparations: Category 5 1H: Herb, leaves and relevant preparations: Category 5 some chemotypes may contain hepatotoxic diterpenes Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 37 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Marsdenia cundurango Rchb.f. Matricaria recutita L. Chamomilla recutita (L.) Rauscert, M. chamomilla L. Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 2D: cortex (dry) 1H: tree bark 1G: bark 1H: Bark and preparations: Category 4, with restrictions for curarine 2A: 2C: 2D: 1G: 2D: foodstuff containing the flowers must have the warning not to ingest more than the equivalent of 1.9 mg/day of alpha-bisabolol and 5.6 mg/day of apigenin-7-glucoside flowers flowers flos flower Medicago sativa L. 2D: folium - aerial parts (7-11) 1G: herb (referral to footnote) 1G: (footnote) If more than one of the plants: Galium odoratum, Medicago sativa, Melilotus officinalis and Melilotus albus are used in the same preparation, the total intake of coumarin from the preparation must not exceed 0,4 mg. Melaleuca alternifolia (Maiden & Betche) Cheel 2A: 1C: 1D: 1G: 2A: essential oil obtained by steam flow distillation of leaves and branch tips 1D: The assessment relates to the oil obtained from the leaves; the leaf oil is an ingredient in authorised herbal medicinal plants for external use 1G: classified as not acceptable leaves, branch tips leaves unspecified parts essential oil from leaf Melaleuca 2H: methyleugenol - oil M. leucadendra (L.) L. leucadendron (L.) L. 1H: leaves 2H: methyleugenol content: 99% 1H: Leaves and preparations: Category 5 Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 38 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Melilotus officinalis (L.) Pall. Melissa officinalis L. Synonyms M. officinalis Lam. Documented sources and parts of plants subject to restrictions 2C: dried flowering tops 2D: flos, (herba) 2E: unspecified parts 1G: herb (referral to footnote) 2A: dried leaves 2B: leaf in compliance with the European Pharmacopoeia 2C: dried leaves 2D: follium 2H: unspecified parts 2O: leaf 1H: herb, flowering tops, flowers 1L: leaf Items of information discussed in the source documents or provided by WG Experts 2E: known to contain estragole in unspecified quantities Dried flowering tops used for cosmetics- Category C (presence of coumarin with hepatic carcinogenic activity in rodents and mutagenic activity in vitro, and the presence of quercetin and rutin with less clear toxicity evidence) 1G: (footnote) If more than one of the plants: Galium odoratum, Medicago sativa, Melilotus officinalis and Melilotus albus are used in the same preparation, the total intake of coumarin from the preparation must not exceed 0,4 mg. 2H: known to contain methyleugenol in unspecified quantities 1L: known to contain eucalyptol (up to 18%) in essential oil 1H: Flowers and preparations: Category 5; flowering tops and preparations: Category 4, with restriction for methyleugenol Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 39 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Mentha x piperita L. 2A: fresh epigaeal parts, dried leaves 2B: essential oil in compliance with the European Pharmacopoeia, whole, cut or dried leaves 2C: fresh epigaeal parts, dried leaves 2D: follium 2G: unspecified parts 2M: oil 1G: herb, leaf 2O: leaf 1L: herb 2A and 2C: essential oil obtained by steam flow distillation of the fresh epigaeal parts, containing menthol (3035%), mentone (14-32%), isomentone (1.5-10%), menthyl acetate (2.8-10%), menthofurane (1-9%), cineole (3.514%), limonene (1-5%) and not more than 4% pulegone and 1% carvone; dried leaf containing not less than 1,2%v/m essential oil 2G: active ingredients: menthol 2M: known to contain pulegone and menthofurane 1L: Known to contain eucalyptol (up to 18%) in essential oil Menyantes trifoliata L. 2D: folium, sumitatus cum floribus, rhizoma, radix 1H: leaves collected during the flowering season 1G: leaf 1I: leaves 1H: Leaves and preparations: Category 5 with restrictions for curarine (leaves collected during the flowering season); Momordica charantia L. 1G: leaf, stem (not acceptable) 2O: fruit Morinda officinalis F.C.How 2D: radix Botanical name Synonyms 2D: only the use of the roots is permitted in food products Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 40 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Myristica fragrans Houtt. Synonyms M. moscata Thunb., M. officinalis L. Documented sources and parts of plants subject to restrictions 2D: semen 1L: seed essential oil 2P: seed, aril Myroxylon balsamum (L.) Harms 2D: cortex (balsam) Myrtus communis L. 2D: fructus, folium, gemma 2E: plant 2H: leaf oil Nardostachys grandiflora DC. N. jatamansi DC. 2D: unspecified parts Nasturtium officinale R.Br. Rorippia nasturtiumaquatica (L.) Hayek 2D: herba, semen, folium 2O: leaf Ocimum basilicum L. 2D: unspecified parts 2E: plant, essential oil 2H: plant 2O: leaf 1A: essential oil 1L: essential oil of leaves or herb Items of information discussed in the source documents or provided by WG Experts Seeds (nutmeg) and aril (mace) ssed in cosmetics and subject to assessment; Category C (presence of: elimicin positive in the UDS test in which the 1-hydroxy-metabolite is carcinogenic; eucalyptol or 1,8-cineole or p-cineole with a NOEL of 300 mg/kg bw; methyleugenol along with its 1-hydroxy-metabolite is mutagenic in many systems and able to induce DNA adducts and liver tumours in mice; myristicin, present in the oleoresin and having mutagenic activities and capable of inducing the formation of DNA adducts and its metabolite (1-hydroxymyristicin) is considered carcinogenic; safrole, a weak carcinogen in rats and mice, transplacental carginogen in mice and mutagenic in a variety of assays 1L: seed essential oil contains elimicin and myristicin (13000 mg/kg in nutmeg and 27000 mg/kg in man) Seed and aril are foods (2O), spice 2E: estragole content: 58-88 ppm 2H: methyleugenol content: 0.2%-6%; 2.3% (leaf oil) 2E: estragole content: 238-8.780 ppm (plant), 5-85% (essential oil) 2H: methyleugenol content: 13-1400ppm 2O: also with a note of plants used as natural sources for flavourings 1A: Presence of high amounts of estragole, genotoxic and carcinogenic in rodents 1L: it contain also camphor estragole (0.4% in the herb) and eucalyptol (8% in the essential oil) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 41 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Oenothera biennis L. 2A: stabilised oil extracted from the seeds 2D: semen, semini oleum 1G: seed oil Olea europea L. var. Olea sativa europaea Hoffmanns.& Link. 1H: leaves, fruit 2D: folium, fructus, cortex 2O: fruit Ononis arvensis L. 2D: unspecified parts Opuntia ficus-indica (L.) Mill. 2D: fructus, flos, radix, semen fruit, cladode of O. ficus-indica ( L.) Mill. var. ficus-indica (2O) Origanum majorana L. 2D: herba 2E: plant fruits, herb (EHIA list) 1L: herb essential oil 2O: leaf 2E: estragole content: 96-550 ppm 1L: it contain also camphor Origanum vulgare L. 2D: herba leaf of O. vulgare L. ssp. vulgare (2O) 2C: leaves, dried stem tips 2D: folium 2D: food containing the leaves must have the warning not to ingest an amount of extract that is greater than the equivalent of 5.5 g of dried leaves Orthosiphon stamineus Benth. O. aristatus (Blume) Miq. 1H: Leaves: Category 5 Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 42 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Oryza sativa L. 2D: unspecified parts seeds (EHIA list) 2O: fruit Paeonia lactiflora Pall. 2A: dried roots 2D: flos, radix Paeonia officinalis L. 1C: flowers P. arborea Donn ex Paeonia suffruticosa K.Koch, P. moutan Andrews Sims Panax ginseng C.A.Mey. Panax schin-seng T.Nees Items of information discussed in the source documents or provided by WG Experts 2D: radix 2A: dried roots 2D: radixs 1G: root Papaver rhoeas L. 2D: petales, semen flowers (EHIA list) Parietaria officinalis L. 2D: unspecified parts Passiflora incarnata L. 2B: 2C: 2D: 1G: herb dried aerial parts herba flower 1G: with a maximum daily dose described 2C: dried aerial part containing not less than 0,3-0,4% flavonoids, calculated in hyperoxide, or not less than 0,8% total flavonoids, calculated in vitexin Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 43 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Paullinia cupana Kunth 2D: 1G: 1H: 2O: Pelargonium sidoides DC. 2E: unspecified parts leaf oil Persea americana Mill. 2D: unspecified parts 2O: fruit Persea americana Mill var. drymifolia ( Schltdl. & Cham.) S.F.Blake Persea drymifolia Schltdl. & Cham. semen seed seeds, guarana (dried seed pulp) seed Items of information discussed in the source documents or provided by WG Experts 1G:( footnote) Total amount of caffeine to be controlled 1H: Guarana (pulp) and other preparations: Category 3, with restrictions for caffeine, carvacrol, estragole. CEFS of the Council of Europe, maximum allowed limits for carvacrol: 5 ppm for food, 2 ppm for beverages (TDI 2.5 mg/kg bw/day) 2H: 2E: known to contain estragole in unspecified quantities 2H: methyleugenol content: 4.3% 2E: essential oil (leaf) 2E: estragole content: essential oil (leaves) (3-85%) Petroselinum crispum (Mill.) A.W.Hill 2D: herba, fructus, semen, radix 1A: fruit 1B: oil 1C: fruit 1H: fruit, seeds, herb (leaves and flowering tops), roots 1L: seed and herb essential oil 2O: leaf, root (depending on convar. of species) 1A: Contains significant quantities of essential oil with toxic apiole. Apiole (fruit) is used to induce abortion. 1L: it contain elimicin and myristicin (727 mg/kg plant) 1H: Herb and essential oil: Category 3, with restrictions for furocoumarin, myristicin, apiol, elimicin. Essential seed oil, seed gum resin, root infusion and decoction: Category 5, with restrictions for furocoumarin, myristicin, apiol, elimicin Peumus boldus Molina 2C: dried leaves 2D: folium 2H: leaves 2C: dried leaves containing not less than 2% v/m essential oil and not less than 0.2% m/m total alkaloids, calculated as boldine 2H: methyleugenol content: 100-125 ppm Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 44 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Phaseolus vulgaris L. 2D: fructus (immature) pods, seeds (EHIA list) 1L: seed use only after cooking : lectin Phellodendron amurense Rupr. 2D: unspecified parts 2D: only the bark is permitted in food products with the warning that it is prohibited from use by pregnant women Physalis alkekengi L. 1C: fruit, roots The fruit is on the 2O list with the comment: Use of the plant may give rise to health concern, questionable if any use as food 2D: folium, fructus 2E: leaves 2H: leaves 2O: fruit (immature) 2E: estragole content: 3 ppm (leaves) 2H: methyleugenol content: 190 ppm (leaves) Pimenta racemosa (Mill.) J.W.Moore 2D: unspecified parts 2E: leaves 2H: leaves 2E: estragole content: 30- 10.745 ppm (leaves) content: 4.31-14.65 ppm (leaves) Pimpinella anisum L. 2C: seed 2D: fructus 1L, 2E: fruit 1H: fruit (seeds) Pimpinella major (L.) Huds. 2D: radix, folium 1G: root Pimenta dioica (L.) Merr. P. officinalis Lindl. 1L: Known to contain linamarin corresponding to 20 mg HCN/kg of seed 2H: methyleugenol 2C: seed containing not less than 2% v/v essential oil 1L, 2E: estragole content: 400-1050 ppm 2O: Fruit is a food and used as natural sources for flavourings Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 45 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Pimpinella saxifraga L. Documented sources and parts of plants subject to restrictions 2D: radix, folium, semen, (sprouts) 1G: root Pinus pinaster Ait. Pinus maritima Lam. 2D: cortex, gemma Piper cubeba L. Cubeba officinalis Raf. 2D: unspecified parts 1H: fruit Pistacia lentiscus L. 2D: resina 2H: unspecified parts Plantago asiatica L. 2A: dried mature seeds 2C: dried mature seeds Plantago indica L 2H: known to contain methyleugenol in unspecified quantities P. arenaria Waldst. & 2A: dried mature seeds Kit. 2C: dried mature seeds Plantago lanceolata L. 2C: leaves, herb 1G: leaf, herb Plantago major L. 1G: leaf Plantago ovata Forssk. Items of information discussed in the source documents or provided by WG Experts Plantago ispaghula Roxb. 2B: husks and seeds in compliance with the European Pharmacopoeia 2C: husks 2C: dried leaves containing not less than 1.5% total derivatives of ortho-dihydrocinna, micro-expressed as acteoside and calculated in reference to dried active ingredient 2C: hispagula husk, consisting of the epidermis and the adjacent layers removed from the dried seed Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 46 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Plantago psyllium L. Plantago afra L. 2A: dried mature seeds 2B: dried mature seeds in compliance with the European Pharmacopoeia 2C: dried mature seeds Pluchea sagittalis (Lam.) Cabrera 2H: unspecified parts 2H: known to contain methyleugenol in unspecified quantities Polygala senega L. 2A: 2C: 2D: 1B: 1G: roots, roots, radix, roots, root 2A and 2C: dried and, generally, crushed root and root crown 1G: with a restriction on max. daily dose Polygala tenuifolia Willd. 2A: 2C: 2D: 1B: roots, root crown roots, root crown unspecified parts roots Polygonum aviculare L. 1G: herb Polygonum bistorta L. Populus nigra L. dried root crown dried root crown rhizoma rhizome 2A and 2C: dried and, generally, crushed root and root crown 2D: only the use of the roots is permitted in food products 2D: radix, rhizoma P. pannonica Kit. ex Bess. 1H: leaf bud, bark 1H: Leaf bud, bark : Category 5 Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 47 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Potentilla anserina L. 1I: herb Potentilla erecta (L.) Raeusch. 2D: radix, rhizoma 1H: roots 1G: root Primula veris L. P. officinalis (L.) Hill. Prunella vulgaris L. Prunus africana (Hook.f.) Kalkman Items of information discussed in the source documents or provided by WG Experts 1H: Root and preparation: Category 5 2C: dried roots and rhizome 2D: radix, flos 1G: flower 2D: herba, folium Pygeum africanum Hook.f 2C: dried trunk bark 2D: cortex 1B: bark Pulmonaria officinalis L. 2D: unspecified parts Punica granatum L. 2D: fructus, folium, semen, flos 1B: tree bark, root bark 1G: root (unacceptable) 2O: fruit Quercus alba L. 1H: wood, bark Quercus robur L. 1G: bark 1H: Bark and extract: Category 5 Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 48 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Rhamnus cathartica L. Rhamnus catharticus L. Rhamnus frangula L. Frangula alnus Mill. Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 2D: cortex 1C: entire plant 1G: fruit presence of anthracene laxative derivatives. 1G: with a max. level and a footnote saying that if more anthraquione containg plants are found in the same product the max. dose for each plant part has to be reduced accordingly. The antraquinone containing plants mentioned are: Cassia acutifolia and C. angustifolia, Rhamnus carthartica, frangula and purshiana and Rheum officinale and R. palmatum 2A: dried bark from the stem and branches 2C: dried bark from the stem and branches 2D: cortex 1G: bark 2A and 2C: dried bark from the stem and branches containing at least 7% gluco-frangulins, expressed as glucofrangulin A and calculated in reference to dried drug 1G:with a max. level and a footnote saying that if more anthraquione containg plants are found in the same product the max. dose for each plant part has to be reduced accordingly. The antraquinone containing plants mentioned are: Cassia acutifolia and C. angustifolia, Rhamnus carthartica, frangula and purshiana and Rheum officinale and R. palmatum Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 49 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Rhamnus purshianus DC. Frangula purshiana (DC.) J.C.Cooper, R. purshiana DC. 2A: dried bark 2C:dried bark 2D:cortex 1C: entire plant 1G: bark 2A and 2C: dried bark containing not less than 8% hydroxyanthracenic glucosides of which at least 60% consisting of cascaroside, better known as cascaroside A, calculated in reference to dried drug 1G: with a max. level and a footnote saying that if more anthraquione containg plants are found in the same product the max. dose for each plant part has to be reduced accordingly. The antraquinone containing plants mentioned are: Cassia acutifolia and C. angustifolia, Rhamnus carthartica, frangula and purshiana and Rheum officinale and R. palmatum Rhaponticum carthamoides (Willd.) Iljin Delete 2D: unspecified parts 1B: unspecified parts 1B: Plant not allowed by the Dietetics Committee 2A: roots, rhizome 2C: roots, rhizome 2D:radix, rhizoma 1G: root 2D: food containing the rhizome must have the warning not to ingest more than the equivalent of 25 mg/day of anthraquinones (calculated as rhein) and “not to give to children of less than 12 years of age; consult a physician if pregnant or nursing; consult a specialist for prolonged use” 1G: with a max. level and a footnote saying that if more anthraquione containg plants are found in the same product the max. dose for each plant part has to be reduced accordingly. The antraquinone containing plants mentioned are: Cassia acutifolia and C. angustifolia, Rhamnus carthartica, frangula and purshiana and Rheum officinale and R. palmatum Rheum officinale Baill. Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 50 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms 2A: 2C: 2D: 1G: Rheum palmatum L. Rhodiola rosea L. Documented sources and parts of plants subject to restrictions Sedum roseum (L.) Scop. roots, rhizome roots, rhizome radix, rhizoma root Items of information discussed in the source documents or provided by WG Experts 2D: food containing the rhizome must have the warning not to ingest more than the equivalent of 25 mg/day of anthraquinones (calculated as rhein) and “not to give to children of less than 12 years of age; consult a physician if pregnant or nursing; consult a specialist for prolonged use”) 1G: with a max. level and a footnote saying that if more anthraquione containg plants are found in the same product the max. dose for each plant part has to be reduced accordingly. The antraquinone containing plants mentioned are: Cassia acutifolia and C. angustifolia, Rhamnus carthartica, frangula and purshiana and Rheum officinale and R. palmatum 2D: herba, radix 2D: only the roots and the herbaceous part are authorised for use in foodstuffs Ribes nigrum L. 2B: leaves 2C: leaves 2D: folium, fructus, semen 1G: leaf 2O: fruit 2B and 2C: dried leaf containing not less than 1,5% flavonoids, calculated as rutin Robinia pseudoacacia L. 2D: flos, semen 1B: leaves, seeds Rosmarinus officinalis L. 2C: flowering tops 2D: folium, flowering tops 2H: unspecified parts 1L: leaves 2O: leaf Rubus fructicosus L. s.l . 2D:folium, fructus fruit, leaves (EHIA list) 1G: leaf 2O: fruit 2C: dried flowering tops containing not less than 1.5% v/m volatile oil 2H: known to contain methyleugenol in unspecified quantities 1L: it contain also camphor and eucalyptol (up to 47%) in essential oil from leaves Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 51 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Items of information discussed in the source documents or provided by WG Experts 1G: leaf 2O: fruit Rubus idaeus L. Rumex rugosa Campd. Documented sources and parts of plants subject to restrictions Rumex acetosa L. 1G: herb 2O: leaf Ruscus aculeatus L. 2C: partial or whole dried portion 2D: rhizoma, herba 2C: partial or whole dried portion containing not less than 1% total sapogenins, expressed as ruscogenin Salix alba L. 2G: unspecified parts 2G: active ingredients: salicin Salix purpurea L. bark of young branches dried bark of young branches, containing not less than 1% total salicin calculated as salicin Salvia lavendulifolia Vahl 1H: herb 1H: Herb and preparations: Category 5, with restrictions for eucalyptol and camphor Salvia miltiorrhiza Bunge 2D: roots 2D: only the use of the roots is permitted in food products Salvia officinalis L. 2C: dried leaves 2D: herba 2O: leaf 2C: dried leaves containing not less than 1.5% v/m essential oil calculated in reference to anhydrous drug Salvia sclarea L. 1H: herb, flowers 1H: Herb, flowers and preparations: Category 5, with restrictions for estragole, 1,8-cineole, and camphor Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 52 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Sambucus nigra L. Synonyms Sambucus vulgaris Neck. Documented sources and parts of plants subject to restrictions 2A: dried flowers 2D: flos, fructus, folium 1H: flowering heads, flowers, fruit, leaves 2O: fruit, inflorescence Items of information discussed in the source documents or provided by WG Experts 1H: Fruit: Category 3, with restrictions for hydrocyanic acid; Leaves and extract: Category 5, with restrictions for hydrocyanic acid (1 ppm). CEFS of the Council of Europe, maximum allowed limits: 0.5 ppm for food, 0.05 ppm for beverages (TDI 0.02 mg CN per kg bw/day); 7 Category B (presence of quercetin and rutin) Sanguisorba officinalis L. 2D: radix, folium Sanicula europaea L. 2D: unspecified parts 1G: root Santolina chamaecyparissus L. 2D: sumitatus cum floribus, folium 1B: capitolum, herbaceous plant with flowers Saponaria officinalis L. 1C: entire plant 1F: unspecified parts 1G: root Satureja montana L. 2H: plant 2H: methyleugenol content: 25-415 ppm Schinus molle L. 1H: leaves, fruit 1F: unspecified parts 1H: Fruit: Category 4, with restrictions for carvacrol. CEFS of the Council of Europe, maximum allowed limits for carvacrol: 5 ppm for food, 2 ppm for beverages (TDI 2.5 mg/kg bw/day) Schisandra chinensis (Turcz.) Baill. 2D: unspecified parts fruit (EHIA list) 1G: fruit Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 53 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 2D: only the use of the root is permitted in food products Scutellaria baicalensis Georgi 2D: radix 1F: unspecified parts Sedum acre L. 2D: herba only dried allowed 2A: dried ripe fruit 2D: fructus 1G: entire plant 2D: food containing the fruit must have the warning not to ingest more than the equivalent of 256 mg/day of lipidic constituents from the fruit and to “consult a physician and/or chemist” 1G: not acceptable in food supplement Sigesbeckia orientalis L. 2D: unspecified parts 2D: only the herbaceous part is authorised for use in foodstuffs Silybum marianum (L.) Gaertn. 2A: ripe fruit dried after removal of the pappus 2D: semen, herba 2G: unspecified parts 1H: flowering tops, seeds 1G: fruit 2G: active ingredients: silymarin 1H : Flowering tops, seeds and preparations: Category 5 Serenoa repens (Bartram) Small Sisymbrium officinale ( L.) Scop. Smilax officinalis Kunth Sabal serrulata Roem. et Schult. Erysimum officinale L. 2D: herba 2D: radix, rhizoma 1G:root Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 54 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Solidago odora Ait. 2E: essential oil Solidago virgaurea L. 2C: dried aerial parts collected while flowering 2D: unspecified parts 1G: herb 1I: herb Sophora japonica L. 2D: flos, sumitatus cum floribus, folium, caulis, semen 1B: flowers 1G: flowerbuds Sorbus aucuparia L. 2D: unspecified parts 2O: fruit Spirulina maxima ( Setchell & Gardner) Geitler 1G: entire algae Styrax benzoides Craib 1G: balm Items of information discussed in the source documents or provided by WG Experts 2E: estragole content: 75% (essential oil) industrial source of rutin 1G: with a max. daily dose Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 55 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Styrax tonkinensis (Pierre) Craib ex Hartwich 1G: balm Swertia chirata Ophelia chirata Buch.-Ham. ex Wall. Griseb. 1H: entire plant with small part of the 1H: Category 4 with restrictions for xanthones root 2A: dried flower bud 2E: unspecified parts 2F: unspecified parts 2H: flowers 2D: flos (buds) 2O: flower bud (immature) 2E: known to contain estragole in unspecified quantities 2H: methyleugenol content: 310-340 ppm 2H (about Eugenia caryophyllata: known to contain methyleugenol in unspecified quantities Tabebuia impetiginosa (Mart. ex. DC.) Standl. 1G: bark 1G: restricted with a max. daily dose Tamarindus indica L. 2D: fructus fruit (EHIA list) 2O: fruit Syzygium aromaticum (L.) Merr. & L.M.Perry Caryophyllus aromaticus L., Eugenia caryophyllata Thunb. (nom. illeg.) Mansfeld Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 56 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 2A:leaves, dried aerial parts 2D: herba 1I: herb 1L: herb essential oil parthenolide 2A: leaves or dried aerial parts containing not less than 2% parthenolide 1L: it contain also camphor Taraxacum officinale (L.) Weber 2C: dried root and rhizome, dried leaves collected before flowering 2D: folium, radix herb (EHIA list) 1G: leaf, root leaf of Taraxacum officinale F.H.Wiggs s.l. (2O) Terminalia chebula (Gaertn.) Retz. 2D: fructus Theobroma cacao L. 2D: unspecified parts 2G: unspecified parts husk (EHIA list) 2O: seed Thymus serpyllum L. 2D: herba 2O: leaf Tanacetum parthenium (L.) Sch.Bip. Chrysanthemum parthenium (L.) Bernh. 2G: plant from which active pharmaceutical ingredients are extracted (theobromine) Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 57 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Thymus vulgaris L. 2A: 2B: 2C: 2D: whole leaves, flowering tops herb whole leaves, flowering tops herba, aetheroleum Thymus zygis L. 2B: herbaceous plant Tilia cordata Mill. 1G: flower, wood 2O: flower (tea) Tilia europaea L. 1G: flower, wood Tilia platyphyllos Scop. 1G: flower, wood 2O: flower (tea) Trigonella foenumgraecum L. 2A: dried seeds 2D: semen 2O: seed Tropaeolum majus L. 2D: folium, flos, fructus, semen 2O: leaf, flower Turnera diffusa Willd. 2D: folium, caulis 1G: leaf Uncaria gambier Roxb. 2D: unspecified parts 1H: leaves, young branches Uncaria tomentosa (Willd.) DC. 2D: cortex radii, cortex cauli, radix Items of information discussed in the source documents or provided by WG Experts 2A and 2C: dried whole leaves and flowering top containing not less than 1.2%(v/m) essential oil and not less than 0.5% volatile phenols, expressed as thymol, both calculated in reference to anhydrous drug 2B: see Deutsches Arzneibuch 2D: food containing the herbaceous parts must have the warning not to ingest more than 4 g/day of the dry herb 2G: active ingredients: thymol 2O: leaf is a food 2B: see Deutsches Arzneibuch 1H : Leaves, young branches: Category 5 Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 58 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Urtica dioica L. 2A: dried leaves, herb, dried, cut or powdered root and rhizome 2B: dried leaves, root 2C: dried leaves, herb, dried, cut or powdered root and rhizome 2D: folium, herba, radix, fructus 1G: herb, leaf 2O: leaf 2A and 2C: dried leaves and dried aerial parts collected during the flowering season 2B: dried leaves: see Deutsches Arzneibuch and European Pharmacopoeia; root: see Deutsches Arzneibuch 2002 2D: food containing the rhizome must have the following warnings: avoid ingesting a daily amount exceeding the equivalent of 3.2 g of dried rhizome; the amount of ethanol extract (60%) must not exceed 192 mg/day; and “consult a physician and/or chemist” Usnea barbata L. 2D: unspecified parts usnic acid used in cosmetics, extract: Category B (usnic acid is a relatively strong antibiotic); Vaccinium myrtillus L. 2D: folium, fructus 1H: leaves, fruit 2O: fruit 1H: Leaves: Category 5 Valeriana officinalis L. 2A: all dried underground parts including the roots, rhizome, stolon 2B: root 2C: all dried underground parts including the roots, rhizome, stolon 2G: unspecified parts 1G: root 2A and 2C: all dried underground parts including the rhizome, roots and stolon dried at temperatures lower than 40°C, containing not less than 0.5% essential oil calculated in reference to whole drug and not less than 0.3% v/m essential oil calculated in reference to cut drug, in reference to anhydrous drug 2B: root in compliance with the European Pharmacopoeia 2G: plant from which active pharmaceutical ingredients are extracted (valepotriates) Valeriana wallichii DC. 2D: radix, rhizoma - thallus Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 59 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Verbascum densiflorum Bertol. Synonyms Verbascum thapsiforme Schrad. Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts 1G: flower Verbascum phlomoides L. 1G: flower Verbena officinalis L. 1G: herb Viburnum lantana L. 2D: unspecified parts 1B: fruit Viburnum prunifolium L. 1B: tree bark and root bark 1F: unspecified parts 1I: bark Viola odorata L. 1H: flowers, leaves 1H: Leaves: Category 5 Viola tricolor L. 2D: herba 1G: herb, 1H: herb, flowers 1H: Flowers, herb: Category 5 Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 60 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Items of information discussed in the source documents or provided by WG Experts Vitex agnus-castus L. whole dried fruit 2D: fructus 1I fruit : whole dried fruit containing not less than 0.08% casticin expressed as anhydrous 2D: food containing the fruit must have the warning not to ingest more than 96 mg/day of the dried fruit Vitis vinifera L. 2D: folium, fructus, semen fruit of Vitis vinifera L. ssp. vinefera (2O) Zea mays L. 2D: stigma, semen 1H: corn husk (stigma, inflorescence from female plant) 2O: fruit 1H: Corn husk and relevant oil: Category 4, with restrictions for carvacrol. CEFS of the Council of Europe, maximum allowed limits: 5 ppm for food, 2 ppm for beverages (TDI 2.5 mg/kg bw/day); Zingiber officinale Roscoe 2D: unspecified parts 2H: unspecified parts 2O: rhizome 2D: food containing the rhizome must have the warning not to ingest more than the equivalent of 190 mg/day of the dried rhizome 2H: known to contain methyleugenol in unspecified quantities Ziziphus jujuba Mill. 2D: unspecified parts 2O: fruit Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Pagina 61 di 62 EFSA/SC/BOTAN/446rev3 DRAFT COMPENDIUM OF BOTANICALS AND BOTANICAL PREPARATIONS THAT HAVE BEEN CONSIDERED FOR FOOD AND/OR FOOD SUPPLEMENT USE AND HAVE BEEN REPORTED TO HAVE ALSO A MEDICINAL USE This compendium lists in alphabetical order botanicals without any judgment on whether these are safe or not safe for food / feed applications. This compendium is part of a preliminary work undertaken by EFSA to harmonise the methodology across its panels for assessing the safety of botanicals and botanical preparations used in food and feed. Such compendium has no legal status and may not be used as support or evidence in any disagreement or dispute pertaining to the legal classification of products or substances. This compendium is still under development and open for additional contributions and comments. Botanical name Synonyms Documented sources and parts of plants subject to restrictions Codes used to refer to the source of information considered (e.g. 2A) are explained in the "sources of information" sheet Items of information discussed in the source documents or provided by WG Experts Pagina 62 di 62
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