SCIENTIFIC OPINION
ADOPTED: 16 December 2021
doi: 10.2903/j.efsa.2022.7085
Safety of dried coffee husk (cascara) from Coffea arabica
L. as a Novel food pursuant to Regulation (EU) 2015/2283
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA),
Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw,
Karen Ildico Hirsch-Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle,
Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies,
Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen,
Rosangela Marchelli, Monika Neuh €auser-Berthold, Morten Poulsen, Miguel Prieto Maradona,
Josef Schlatter, Henk van Loveren, Ermolaos Ververis and Helle Katrine Knutsen
Abstract
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and
Food Allergens (NDA) was asked to deliver an opinion on dried coffee husk (cascara) from Coffea
arabica L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF comprises the skin
(exocarp), pulp (mesocarp), mucilage (pectin), parchment (endocarp) and a portion of the silver skinof the coffee fruit, and consists mainly of digestible carbohydrates, dietary ﬁbre and water. The
Panel considers that there are no safety concerns regarding the stability of the NF if the NF complieswith the proposed speci ﬁcation limits during its entire shelf-life. The NF as such will not be consumed,
instead, beverages produced with the infusion of the NF in water will be available to consumers.
Considering an 100% extraction of caffeine from the NF to the beverage, the speci ﬁcation limit set for
caffeine and the proposed use levels, the maximum concentration of caffeine in infusions producedusing the NF could be up to 600 mg/L of drink, a concentration comparable to those in coffeebeverages. The Panel notes that consumption of beverages produced using the NF will addsigni ﬁcantly to the total dietary intake of caffeine of the general population. The consumption of
beverages containing caffeine is not recommended for children, pregnant or breast-feeding women ifthe caffeine content exceeds 150 mg/L. Taking into account the nature of the NF , the history of use of
the NF as food and the proposed uses and use levels, the Panel considers that no toxicological studies
are required on the NF. The risk of allergic reactions to the NF is considered low. The Panel concludesthat the NF , dried husk of the fruit of Coffea arabica L., is safe under the proposed conditions of use.
©2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
Keywords: Novel Foods, food safety, Coffea arabica L. coffee husk, cascara, caffeine
Requestor: European Commission
Question number: EFSA-Q-2020-00229
Correspondence: nda@efsa.europa.eu
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Panel members: Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen
Ildico Hirsch-Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle,Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri andMarco Vinceti.
Declarations of interest: The declarations of interest of all scienti ﬁc experts active in EFSA ’s work
are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch .
Acknowledgements: The Panel wishes to thank Panagiota Zakidou and Gabriela Precup who, as
trainees, provided support to the preparation of this scienti ﬁc output.
Suggested citation: EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens),
Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ,
Naska A, Pelaez C, Pentieva K, Siani A, Thies F , Tsabouri S, Vinceti M, Cubadda F , Frenzel T, HeinonenM, Marchelli R, Neuh €auser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter J, van Loveren H,
Ververis E and Knutsen HK, 2022. Scienti ﬁc Opinion on the safety of dried coffee husk (cascara) from
Coffea arabica L. as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2022;20(2):7085,
16 pp. https://doi.org/10.2903/j.efsa.2022.7085
ISSN: 1831-4732
©2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License,
which permits use and distribution in any medium, provided the original work is properly cited and nomodi ﬁcations or adaptations are made.
The EFSA Journal is a publication of the European Food Safety
Authority, a European agency funded by the European Union.
Safety of dried coffee husk (cascara) from Coffea arabica L.
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Table of contents
Abstract ............................................................................................................................... .................... 1
1. Introduction ............................................................................................................................... .. 4
1.1. Background and Terms of Reference as provided by the requestor ................................................... 4
1.2. Additional information ................................................................................................................... 4
2. Data and methodologies ............................................................................................................... 5
2.1. Data ............................................................................................................................... ............. 5
2.2. Methodologies .............................................................................................................................. 5
3. Assessment ............................................................................................................................... ... 5
3.1. Introduction ............................................................................................................................... .. 5
3.2. Identity of the NF ......................................................................................................................... 5
3.3. Production process ....................................................................................................................... 6
3.4. Compositional data ....................................................................................................................... 6
3.4.1. Stability ............................................................................................................................... ........ 9
3.5. Speci ﬁcations ............................................................................................................................... 10
3.6. History of use of the NF and/or of its source .................................................................................. 11
3.6.1. History of use of the source .......................................................................................................... 11
3.6.2. History of use of the NF ................................................................................................................ 11
3.7. Proposed uses and use levels and anticipated intake ....................................................................... 11
3.7.1. Target population ......................................................................................................................... 11
3.7.2. Proposed uses and use levels ........................................................................................................ 11
3.7.3. Anticipated intake of the NF .......................................................................................................... 12
3.7.4. Precautions and restrictions of use ................................................................................................ 12
3.8. Absorption, distribution, metabolism, and excretion (ADME) ............................................................ 12
3.9. Nutritional information .................................................................................................................. 12
3.10. Toxicological information ............................................................................................................... 13
3.10.1. Human data ............................................................................................................................... .. 13
3.11. Allergenicity ............................................................................................................................... .. 13
4. Discussion ............................................................................................................................... .... 14
5. Conclusions ............................................................................................................................... ... 14
6. Steps taken by EFSA .................................................................................................................... 14
References ............................................................................................................................... ................ 15
Abbreviations ............................................................................................................................... ............ 16Safety of dried coffee husk (cascara) from Coffea arabica L.
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1. Introduction
1.1. Background and Terms of Reference as provided by the requestor
On 6 February 2020, the company Panama Varietals GmbH1submitted a request to the European
Commission in accordance with Article 10 of Regulation (EU) No 2015/22832to place on the EU
market coffee husk (cascara) as a novel food (NF).
The NF is intended to be used in non-alcoholic, water based, infusions and drinks.The applicant has requested data protection according to the provisions of Article 26 of Regulation
(EU) 2015/2283.
On 7 September 2020 and in accordance with Article 10(3) of Regulation (EU) 2015/2283, the
European Commission asked the European Food Safety Authority to provide a scienti ﬁc opinion on
coffee husk (cascara).
In the process of the evaluation of this novel food, it became apparent that the Commission should
amend the title of the mandate. The term ‘dried ’is added to coffee husk, and the coffee plant species
Coffea arabica L. is speci ﬁed so that the novel food subject to this application is more accurately
described. As the changes are editorial, they should not affect the timing of the completion of thisEFSA evaluation. On that basis, the Commission amended the title to ‘Request for a scienti ﬁc opinion
on the safety of dried coffee husk (cascara) from Coffea arabica L . as a novel food ’.
1.2. Additional information
On 21 June 2017, the company Panama Varietals GmbH submitted a request under Article 4 of the
Novel Food Regulation (EC) No 258/973to place on the market dried coffee husk (cascara) as an NF .
On 31 August 2017, the competent authority of Austria forwarded to the Commission its initial
assessment report, which came to the conclusion that the NF meets the criteria for acceptance of anovel food ingredient de ﬁned in Article (3)1 of Regulation (EC) No 258/97. On 29 September 2017, the
Commission forwarded the initial assessment report to the other Member States (MS). Several of theMS submitted comments or raised objections. The concerns of a scienti ﬁc nature raised by the MS can
be summarised as follows:
–Limited compositional characterisation
–Limited information on the food safety management system
–Pesticide residues (fungicides) exceeding maximum residue levels (MRL) for similar foods
(azoxystrobin, propamocarb, cyproconazole and tebuconazole)
–Representativeness of testing item in the cited toxicological studies
The application was submitted under Regulation (EC) No 258/97 and since there was not a ﬁnal
decision taken before 1 January 2018, the application was resubmitted and treated as a novel foodapplication under Regulation (EU) 2015/2283.
On 5 June 2020, the Federal Food Safety and Veterinary Of ﬁce of Switzerland decided to authorise
the placing on the Swiss market of dried peels and pulp of the coffee cherry ( Coffea arabica L.)
originating from Yemen, Ethiopia and Brazil, only for use as infusion.
On 29 April 2021, EFSA approved a technical report on the noti ﬁcation of cherry pulp from Coffea
arabica L. and Coffea canephora Pierre ex A. Froehner as a traditional food from a third country
pursuant to Article 14 of Regulation (EU) 2015/2283 (EFSA, 2021a).
On 20 July 2021, EFSA approved a technical report on the noti ﬁcation of dried cherry pulp from
Coffea arabica L. and Coffea canephora Pierre ex A. Froehner as a traditional food from a third country
pursuant to Article 14 of Regulation (EU) 2015/2283 (EFSA, 2021b). For both noti ﬁcations, EFSA
considered that the available data on composition and history of use do not raise safety concerns.
1During the evaluation, the applicant ’s company name changed from ‘Panama Varietals GmbH ’to ‘Goldkind GmbH ’and ‘Caskai
GmbH ’.
2Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending
Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of theEuropean Parliament and of the Council and Commission Regulation (EC) No 1852/2001. OJ L 327, 11.12.2015, p. 1 –22.
3Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and
novel food ingredients. OJ L 43, 14.2.1997, p. 1 –6.Safety of dried coffee husk (cascara) from Coffea arabica L.
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2. Data and methodologies
2.1. Data
The safety assessment of this NF is based on data supplied in the application and information
submitted by the applicant following an EFSA request for supplementary information. During theassessment, the Panel identi ﬁed additional data which were not included in the application.
Administrative and scienti ﬁc requirements for NF applications referred to in Article 10 of Regulation
(EU) 2015/2283 are listed in the Commission Implementing Regulation (EU) 2017/2469.
A common and structured format on the presentation of NF applications is described in the EFSA
guidance on the preparation and presentation of an NF application (EFSA NDA Panel, 2016). Asindicated in this guidance, it is the duty of the applicant to provide all of the available (proprietary,conﬁdential and published) scienti ﬁc data (including both data in favour and not in favour) that are
pertinent to the safety of the NF .
This NF application includes a request for protection of proprietary data in accordance with Article
26 of Regulation (EU) 2015/2283. The data requested by the applicant to be protected comprise
analytical data on the composition of the NF , stability studies and allergenicity information.
2.2. Methodologies
The assessment follows the methodology set out in the EFSA guidance on NF applications (EFSA
NDA Panel, 2016) and the principles described in the relevant existing guidance documents from theEFSA Scienti ﬁc Committee. The legal provisions for the assessment are laid down in Article 11 of
Regulation (EU) 2015/2283 and in Article 7 of the Commission Implementing Regulation (EU) 2017/2469.
Additional information which was not included in the application was retrieved by literature search
following a search strategy and standard operating procedure as described by Dibusz and Vejvodova
(2020).
This assessment concerns only the risks that might be associated with consumption of the NF
under the proposed conditions of use and is not an assessment of the ef ﬁcacy of the NF with regard
to any claimed bene ﬁt.
3. Assessment
3.1. Introduction
The NF subject of the application is the dried husk of the coffee fruit ( Coffea arabica L .), known
also as ‘cascara ’. The NF falls under the category ‘food consisting of, isolated from or produced from
plants or their parts, except when the food has a history of safe food use within the Union and isconsisting of, isolated from or produced from a plant or a variety of the same species obtained by:
–traditional propagating practices which have been used for food production within the Union
before 15 May 1997; or
–non-traditional propagating practices which have not been used for food production within the
Union before 15 May 1997, where those practices do not give rise to signi ﬁcant changes in
the composition or structure of the food affecting its nutritional value, metabolism or level ofundesirable substances ’, as described in Article 3(2)(iv) of Regulation (EU) 2015/2283.
The NF is produced by mechanical dehulling of dried coffee fruits and consists mainly of digestible
carbohydrates, ﬁbre and water. The NF is proposed to be used as an ingredient in non-alcoholic,
water-based infusions and drinks. Products with the NF can be consumed by the general population.
3.2. Identity of the NF
The NF is the dried husk of the fruit of Coffea arabica L. (Rubiaceae ). According to the Plants of
the World Online,4another identi ﬁed scienti ﬁc synonym for Coffea arabica L. is Coffea vulgaris. Coffea
arabica L. originates from Ethiopia and is widely cultivated in Brazil, Colombia and Ethiopia. ’Cascara ’,
‘dried husk of the coffee cherry ’,‘dried husk of the coffee fruit ’,‘dried coffee pulp ’,‘husk cascara ’and
4https://powo.science.kew.org/Safety of dried coffee husk (cascara) from Coffea arabica L.
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‘dried coffee fruit pulp ’are some of the common names identi ﬁed for the NF . The NF comprises the
skin (exocarp), pulp (mesocarp), mucilage (pectin), parchment (endocarp) and a portion of the silverskin of the coffee fruit. It has an irregular shape, between 1 and 6 mm, with colour ranging from‘honey to light brown to dark brown with reddish overtones ’, and consists mainly of digestible
carbohydrates, dietary ﬁbre and water.
3.3. Production process
According to the information provided, the NF is produced following conventional agricultural
practices and Hazard Analysis Critical Control Points (HACCP) principles. The seeds for the propagationof the NF source were obtained from Coffea arabica L. cultivars in Panama, Nicaragua and Colombia.
The NF is obtained from coffee trees propagated, grown and harvested under the same conditions
used to obtain green coffee beans used for coffee production. Six different varieties of arabica coffee(Geisha, Caturra, Typica, Catuai, Pacamara and Maragogype) are used in the NF production. Thepropagation (through seeding) and cultivation of the coffee plants take place in Central America (hillsof former volcanic mountain ranges of Nicaragua and Panama), on various coffee farms or plantations.During cultivation, organic (e.g. compost) and inorganic fertilisers (containing e.g. nitrogen, phosphateand potassium), as well as pesticides (fungicides, acaricides and insecticides) are used. The applicantprovided a detailed plan on the identity of the pesticides used, as well as information on the identity of
these products.
Harvesting of the ripe coffee fruits is performed manually (multi-pass method) and occurs between
December and April, 3 –5 years after the propagation of coffee trees. The ripe coffee fruits are
gathered in dedicated containers (e.g. woven baskets) and may undergo an initial rinsing processbefore drying (sun/air drying at ambient temperature). The drying process takes place on raised dryingbeds or concrete patios for approximately 15 –24 days until reaching a moisture level of approximately
12%. The drying beds allow air circulation and are covered with a translucent material as roof toprevent potential contamination and moisture exposure from rainfall. The coffee fruits are manually
rotated at varying intervals, to ensure even drying and to prevent mould formation. Under- and over-
ripe, damaged or moulded cherry fruits are manually removed by visual inspection during this step.Commercial air dryers (at ambient temperature) can be used at the end of the primary drying step ifneeded, to achieve the intended moisture level. The whole dried coffee fruits undergo a resting periodof 90 –100 days in woven bags (green coffee ﬂavour development). Subsequently, the dried coffee
fruits are mechanically dehulled, separating the seed from the coffee husk. Post-processing handlinginvolves packaging, storage and transport of the NF .
The Panel considers that the production process is suf ﬁciently described.
3.4. Compositional data
In order to con ﬁrm that the manufacturing process is reproducible and adequate to produce on a
commercial scale a product with certain characteristics, the applicant provided analytical informationfor several representative, independently produced batches of the NF originating from different farmsand geographical locations. Certi ﬁcates of accreditation for the laboratories that conducted the
analyses were provided by the applicant.
The NF is a ‘whole food ’as de ﬁned by EFSA Scienti ﬁc Committee (EFSA Scienti ﬁc Committee,
2011), meaning that all its constituents cannot be fully identi ﬁed and/or characterised (EFSA NDA
Panel, 2016).
The NF consists mainly of digestible carbohydrates, dietary ﬁbre and water. The results of
proximate analysis are presented in Table 1. The amino acid, fatty acid, vitamin and mineral
compositions are reported in section ‘3.9Nutritional information ’.Safety of dried coffee husk (cascara) from Coffea arabica L.
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Given the possible variations in cultivation practices (e.g. propagation, harvesting, time of harvest
in relation to both season and stage of the plant growth), the Panel considers that the variation ofcompositional values is acceptable.
The applicant provided microbiological data on ﬁve independently produced batches of the NF at
various time points after production (Table 2).
Concentrations of heavy metals (Pb, Cd, Hg, As) are reported in Table 3. There are no maximum
limits applicable for similar products in the EU Legislation. The Panel notes that the concentrations ofheavy metals reported for the NF are below maximum levels set for other foodstuffs or foodTable 1: Batch-to-batch proximate analysis of the NF
Parameter (unit) Analytical methodBatch number
#1 #3 #6 #7 #9 #10
Total carbohydrates
(g/100 g of NF)Calculation(a)74.9 69.9 69.7 74.6 74.0 72.7
Digestible carbohydrates
(g/100 g of NF)Calculation(b)39.9 37.3 36.5 40.1 39.8 35.6
Dietary ﬁbre (g/100 g of NF) Enzymatic –gravimetry (STN
56 0031)35.0 32.6 33.2 34.5 34.2 37.1
Total sugars (g/100 g of NF) HPLC/RID (SPP ORG.M.040;
STN EN 12630; ASU L
48.01-3)35.6 24.7 27.2 31.0 34.2 38.1
Crude protein (g/100 g of NF) Kjeldahl method (N 96.25)
(/C20SPP INO.M.077)6.2 7.5 7.6 6.6 6.9 7.7
Ash (g/100 g of NF) Gravimetric method (/C20SPP
INO.M.036; ASU L 06.00-4)5.9 6.1 5.7 4.4 6.2 5.9
Fat (g/100 g of NF) Gravimetric method (ASU L
06.00-6)0.9 0.4 0.5 0.7 0.5 0.3
Dry matter (g/100 g of NF) Gravimetric method (/C20SPP
INO.M.035; ASU L 06.00-3)87.9 83.9 83.5 86.3 87.6 86.6
Moisture (g/100 g of NF) Calculation(c)12.1 16.1 16.5 13.7 12.4 13.4
Water activity (a w) Hygrometry 0.483 0.498 0.546 / 0.476 0.531
HPLC/RID: High-Performance Liquid Chromatography with Refractive Index Detector.
/: not provided.
(a): 100 –(crude protein +fat+ash+moisture).
(b): total carbohydrates –dietary ﬁbre.
(c): 100 –dry matter .
Table 2: Batch-to-batch microbiological analysis of the NF
Microbiological parameters (unit) Analytical method #2 #3 #4 #5 #6
Total aerobic count (cfu/g) EN ISO 4833-1
EN ISO 4833-21,600 5,200 7,900 9,600 1,600
Enterobacteriaceae (cfu/g) EN ISO 21258-2 <10 <10 <10 <10 <10
Escherichia coli (cfu/g) ISO 16649 <10 <10 <10 <10 <10
Yeasts (cfu/g) ISO 21527 <100 <100 <100 200 <100
Moulds (cfu/g) ISO 21527 <100 <100 <100 <100 <100
Coagulase-positive staphylococci (cfu/g) EN ISO 6888-2 <10 <10 <10 <10 <10
Bacillus cereus (cfu/g) EN ISO 7932 <100 <100 <100 100 <100
Salmonella spp. in 25g EN ISO 6579 ND ND ND ND ND
Clostridium perfringens (cfu/g) EN ISO 7937 <10 <10 <10 <10 <10
cfu: colony forming units; ISO: International Organization for Standardization.
5Figures rounded as per (EFSA Scienti ﬁc Committee, 2012).Safety of dried coffee husk (cascara) from Coffea arabica L.
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supplements as set in Commission Regulation (EC) No 1881/20066and food supplements as set in
Regulation (EU) No 488/20147.
Analytical data on the concentrations of a ﬂatoxins B1, B2, G1, G2 and ochratoxin A were provided
(Table 3). Values were lower than the maximum levels set for other foodstuffs in Regulation (EC) No
1881/2006 (e.g. roasted coffee beans and ground roasted coffee, or dried fruit to be subjected tosorting, or other physical treatment before human consumption/use as ingredient in foodstuffs).
Polycyclic aromatic hydrocarbons (PAHs) were initially analysed in two batches of the NF . Chrysene
and benzo[ a]anthracene were quanti ﬁed in one and two batches, respectively. Upon EFSA ’s request,
the applicant provided further analytical data (three additional batches of the NF , other than thosedescribed in Table 3) on benzo[ a]anthracene, benzo[ a]pyrene, benzo[ b]ﬂuoranthene and chrysene.
Among these samples, benzo[ a]pyrene and benzo[ b]ﬂuoranthene were found to be below 0.05 lg/kg
(LOQ), and the highest levels of benzo[ a]anthracene and chrysene were 0.653 and 0.561 lg/kg,
respectively. The applicant argued that the NF may be contaminated with such compounds through air,soil and water, as well as due to the burning of material (e.g. wood, fossil fuels) in the regions close tothe farms. The Panel notes that the reported levels for benzo[ a]pyrene and sum of PAH4 in the NF are
below the respective maximum levels set e.g. for powders of food of plant origin for the preparation ofbeverages in Commission Regulation (EC) No 1881/2006.
Moreover, the applicant investigated by LC-GC-FID the levels of mineral oil hydrocarbons (MOSH,
POSH, MOAH) in two batches of the NF, and the reported results were below the LOD (0.6 mg/kg for
MOSH/POSH and <0.15 mg/kg for MOAH).
Analytical data of the pesticide levels for ﬁve independently produced batches of the NF have been
provided. The results showed that most of the analysed pesticide residue levels in the NF are belowTable 3: Concentrations of contaminants in the NF
Parameter Analytical methodBatch number
#1 #2 #3 #4 #5 #6
Heavy metals (mg/kg)
Pb ICP-MS; ICP-OES (DIN EN
15763:2010 or EN ISO
11885)0.06 <0.01 0.072 0.03 <0.05 0.03
Cd <0.01 0.02 <0.005 <0.009 <0.005 0.009
Hg <0.01 <0.005 0.005 <0.005 <0.005 <0.005
As 0.06 0.020 0.011 <0.005 0.01 <0.005
Mycotoxins (lg/kg)
Ochratoxin A HPLC-FLD (EN 16007,
EN 14132, EN 15829,
EN 15835)/ <0.050 <0.050 <0.050 0.250 /C60.10 <0.05
Aﬂatoxin B1 HPLC-FLD; (EN 14123 and
EN 12955)/ <0.02 <0.02 <0.02 <0.02 <0.02
Aﬂatoxin B2 / <0.02 <0.02 <0.02 <0.02 <0.02
Aﬂatoxin G1 / <0.02 <0.02 <0.02 <0.02 <0.02
Aﬂatoxin G2 / <0.02 <0.02 <0.02 <0.02 <0.02
Sum of a ﬂatoxins / <0.02 <0.02 <0.02 <0.02 <0.02
Polycyclic Aromatic Hydrocarbons (lg/kg)
Benzo[ a]anthracene HS-GC/MS / / 0.8 / / <0.05
Benzo[ a]pyrene / / <0.05 / / <0.05
Benzo[ b]ﬂuoranthene / / <0.05 / / <0.05
Chrysene / / 1.2 / / 0.9
Sum PAH4 / / 2.00 / / 0.9
ICP-MS: Inductively Coupled Plasma Mass Spectrometry; ICP-OES: Inductively Coupled Plasma - Optical Emission Spectroscopy;
HPLC-FLD: High-Performance Liquid Chromatography with Fluorescence Detection; HS-GC/MS: Headspace-Gas Chromatography/
Mass Spectrometry; PAH: Polycyclic Aromatic Hydrocarbons; PAH4: Sum of benzo[ a]pyrene, benz[ a]anthracene, benzo[ b]
ﬂuoranthene and chrysene; /: not provided.
6Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in
foodstuffs (Text with EEA relevance). OJ L 364, 20.12.2006, p. 5 –24.
7Commission Regulation (EU) No 488/2014 of 12 May 2014 amending Regulation (EC) No 1881/2006 as regards maximum
levels of cadmium in foodstuffs. OJ L 138, 13.5.2014, p. 75 –79.Safety of dried coffee husk (cascara) from Coffea arabica L.
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the LOD of the analytical method used. Azoxystrobin, carbendazim, cypermethrin, cyproconazole,
deltamethrin, epoxiconazole, ﬂutriafol, imidacloprid, propamocarb, propiconazole, tebuconazole,
triadimenol and tri ﬂoxystrobin have been quanti ﬁed in some of the analysed NF batches. The
Panel notes that ﬁve of these active substances, i.e. azoxystrobin, cyproconazole, epoxiconazole,
tebuconazole and triadimenol, have been quanti ﬁed at concentrations higher than the MRL set for
coffee bean in EU. The quanti ﬁed levels of these ﬁve substances are lower than the MRL set for other
foodstuffs by EU Regulations.
Additionally, the applicant investigated the concentration of anthraquinone in the NF (in-house
HPLC/MS method, LOQ =0.05 mg/kg and LOD =0.01 mg/kg). The Panel notes that the reported
values, which were below the LOD, are below the MRL (0.02 mg/kg) for anthraquinone in tea, coffee,herbal infusions and cocoa, set in Commission Regulation (EU) No 1146/2014
8.
The Panel considers that the information provided on the composition is suf ﬁcient for characterising
the NF .
3.4.1. Stability
The applicant provided data on the microbiological pro ﬁle of eight independently produced batches
of the NF analysed at various time points after the dehulling, i.e. the last step of the productionprocess before packaging, took place (Table 4). The Panel notes that the NF batches analysed at the
various time points are not always the same ones, and that the NF has not been analysed at time =0.
The proposed shelf-life by the applicant is 3.5 years (after dehulling).
The applicant declared that the intended storage conditions of the NF are 15 –20°C and 50 –65%
relative humidity (after transportation from the farms to the applicant ’s facilities), in hermetically closed
packaging.
Stability in the intended for use matrices
Since the NF is going to be used as an ingredient for the manufacturing of other foods, the
applicant investigated its stability when used as an ingredient in the intended-for-use matrices (seeTable 4: Microbiological status of the NF during storage
Parameter
(unit)Batch number
#2 #3 #4 #5 #6 #13 #6 #2 #3 #6 #7 #3 #6
Time after
dehulling (days)180 465 480 520 1,000 1,560 1,740 2,220
Total aerobic
counts (cfu/g)1,600 5,200 7,900 9,600 3,960 4,240 1,600 5,200 4,700 3,100 2,380 2,480 3,420
Enterobacteriaceae
(cfu/g)<10<10<10 <10 / / <1 0 / / ////
E. coli (cfu/g) <10<10<10 <10 / / <10 <10 <10 <1 0 ///
Yeasts (cfu/g) <100<100<100 200 / / <100 <10 <10 <1 0 ///
Moulds (cfu/g) <100<100<100 <100 / / <100 <10 <10 <1 0 ///
Coagulase-positive
staphylococci(cfu/g)<10<10<10 <10 / / <1 0 / / ////
B. cereus (cfu/g) <100<100<100 100 / / <100 / / / / / /
Salmonella sp .i n
25gnd nd nd nd / / nd / / / / / /
Clostridium
perfringens (cfu/g) <10<10<10 <10 / / <1 0 / / ////
Water activity (aw) / / / / 0.491 0.495 0.483 / / / 0.460 0.461 0.546
cfu: colony forming units.
/: not provided.
8Commission Regulation (EU) No 1146/2014 of 23 October 2014 amending Annexes II, III, IV and V to Regulation (EC) No
396/2005 of the European Parliament and of the Council as regards maximum residue levels for anthraquinone, ben ﬂuralin,
bentazone, bromoxynil, chlorothalonil, famoxadone, imazamox, methyl bromide, propanil and sulfuric acid in or on certain
products. OJ L 308, 29.10.2014, p. 3 –60.Safety of dried coffee husk (cascara) from Coffea arabica L.
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Section 3.7.2 Proposed uses and use levels). The applicant described how the NF is going to be used
(via infusion) for the production of beverages and provided data on the total aerobic counts ofbeverages produced using the NF . The Panel notes that the food items containing the NF have tocomply with any applicable existing legislative limits.
Provided that the speci ﬁcations are met also at the end of shelf-life and that products containing
the NF are compliant with respective legislative limits, the stability data do not raise safety concerns.
3.5. Speci ﬁcations
The speci ﬁcations of the NF are indicated in Table 5.
The Panel amended the speci ﬁcation limits for heavy metals and microbiological parameters
considering the analytical data presented by the applicant in the batch-to-batch analysis.
The Panel considers that the information provided on the speci ﬁcations of the NF is suf ﬁcient and
does not raise safety concerns.Table 5: Speci ﬁcations of the NF
Description: dried coffee husk (cascara) from Coffea arabica L.
Parameter Unit Speci ﬁcation
Moisture g/100 g <17
Crude protein (N 96.25) g/100 g 6 –8
Fat g/100 g <1%
Ash g/100 g 4 –7
Digestible carbohydrates g/100 g 35 –41
Sugars g/100 g 24 –40
Total dietary ﬁbre g/100 g 32 –38
Caffeine mg/100 g 100 –1,000
Heavy metals
Lead mg/kg <0.1
Cadmium mg/kg <0.1
Mercury mg/kg <0.1
Arsenic mg/kg <0.1
Mycotoxins
Aﬂatoxin B1 lg/kg <2.0
Aﬂatoxin B1 +B2+G1+G2 lg/kg <4.0
Ochratoxin A lg/kg <5.0
Polycyclic Aromatic Hydrocarbons
Benzo[ a]pyrene lg/kg <10.0
Sum of benzo[ a]pyrene, benz[ a]anthracene, benzo[ a]ﬂuoranthene, chrysene lg/kg <50.0
Microbiological parameters
Total aerobic colony count cfu/g <104
Bacillus cereus cfu/g <100
Yeasts and moulds cfu/g <100
Salmonella spp. In 25 g Not detected
Escherichia coli cfu/g <50
water activity (a w) Not applicable <0.60
cfu: colony forming units.Safety of dried coffee husk (cascara) from Coffea arabica L.
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3.6. History of use of the NF and/or of its source
3.6.1. History of use of the source
The source of the NF is the fruit of Coffea arabica L. The whole coffee fruit, or portions thereof, has
a long history of consumption in Yemen, Ethiopia, Uganda and more recently in Bolivia and Brazil
(Weinberg and Bealer, 2004; Wild, 2005; Soux, 2016; Alves et al., 2017).
3.6.2. History of use of the NF
The coffee husk is traditionally consumed in the Middle East, Africa and South America in the form
of infusion or as an ingredient in various dishes (Hestler and Spilling, 2010; Thurston et al., 2013;
Hattox, 2014). The Oromo ethnic group from Ethiopia was reported as the ﬁrst consumers of coffee
fruits during different cultural or religious rituals, as slightly roasted and melted in butter in a dishcalled ‘bunaqalaa ’or coffee husks mixed with milk ( ‘hoja ’) (Hussen et al., 2008; Wayessa, 2011; Bacha
et al., 2018). Infusions of coffee husks have been also consumed in Yemen (named ‘qishr ’or ‘al Kahwa
al Kishria ’, i.e. husk coffee, ﬂavoured with spices) since the 16th century (Thesiger, 1947; Hestler and
Spilling, 2010; Hattox, 2014; Alves et al., 2017; Keiko, 2018).
3.7. Proposed uses and use levels and anticipated intake
3.7.1. Target population
As the NF is intended to be used as an ingredient in standard food categories, the NF may be
consumed by any groups of the population. Therefore, the safety data and the exposure assessmentshall cover all population groups (Commission implementing Regulation (EU) 2017/2469, article 5(6)
9).
The Panel notes that the consumption of beverages containing caffeine is not recommended to
children, pregnant or breast-feeding women if the caffeine content exceeds 150 mg/L, as stipulated by
Regulation (EU) No 1169/201110.
3.7.2. Proposed uses and use levels
The NF is proposed to be used as an ingredient for the preparation of non-alcoholic drinks and
infusions. The food categories de ﬁned using the FoodEx2 hierarchy (EFSA, 2015), and the maximum
use levels are reported in Table 6.
Upon EFSA ’s request, the applicant clari ﬁed that the NF as such will not be consumed, beverages
produced with the infusion of the NF in water will be available to consumers.
Additionally, the applicant proposed food categories de ﬁned according to the guidance document
describing the food categories for Food Additives11and the respective maximum use levels, i.e.
‘Flavoured drinks with sugar ’(6 g NF/100 mL), ‘Flavoured drinks with sweetener ’(6 g NF/100 mL) and
‘Coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions, and chicory extracts;
tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of theseTable 6: Food categories and maximum use levels intended by the applicant
FoodEx2 level FoodEx2 code Food category Max use level (g NF/100 mL)
A03LG 3 Herbal and other non-tea infusions 4
A03GA 4 Energy drinks 6
A03DZ 3 Soft drinks 2
9Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scienti ﬁc
requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the
Council on novel foods. OJ L 351, 30.12.2017, p. 64 –71.
10Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food
information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and
of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/
EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/ECand Commission Regulation (EC) No 608/2004. OJ L 304, 22.11.2011, p. 18 –63.
11Guidance document describing the food categories in Part E of Annex II to Regulation (EC) No 1333/2008 on Food Additives
(https://ec.europa.eu/food/sites/food/ ﬁles/safety/docs/fs_food-improvement-agents_guidance_1333-2008_annex-2.pdf ).Safety of dried coffee husk (cascara) from Coffea arabica L.
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products ’(4 g NF/100 mL). The Panel notes that the food categories for Food Additives have been
used also in the context of EFSA ’s technical report on coffee cherry pulp (EFSA, 2021a).
3.7.3. Anticipated intake of the NF
The Panel concluded that, considering the compositional information on the Novel Food, the
speci ﬁcation limits and the proposed uses, a calculation of the anticipated intake of the NF and an
exposure assessment for the NF do not provide meaningful information for this assessment. Aspectsregarding the intake of caffeine due to consumption of beverages produced using the NF is discussedin section ‘3.9 Nutritional information ’.
3.7.4. Precautions and restrictions of use
Considering the maximum caffeine concentrations in drinks/infusions produced using the NF
(Section 3.9Nutritional information), the Panel notes that labelling provisions in Regulation (EU) No
1169/2011 apply if caffeine exceeds 150 mg/L in the products containing the NF .
3.8. Absorption, distribution, metabolism and excretion (ADME)
No ADME data have been provided for the NF .
3.9. Nutritional information
The applicant provided a nutritional analysis of the NF which consists mainly of digestible
carbohydrates, dietary ﬁbre, water and ash (described in Section 3.4Compositional data). Analytical
data on the amino acid composition, the fatty acids content, vitamins and minerals have been provided
for three to six batches of the NF.
The applicant provided information on the NF vitamin and mineral content. Considering the
reported concentrations in the NF and the fact that beverages produced using the NF (via infusion) areconsumed and not the NF as such, the Panel is of the view that the contribution to the overall dietaryintake is not of relevance.
Given the possible variations in cultivation practices, the Panel considers that the variation
regarding the content of vitamins and minerals among the NF batches is acceptable.
The applicant quanti ﬁed the amino acids in three batches of the NF , and the fatty acids in ﬁve
batches of the NF . Erucic acid has been detected in three out of the tested ﬁve batches of the NF in
levels varying from 0.3% to 2.62% of total fatty acids. The Panel notes that, considering the low levelof total fat (0.5 /C60.2% w/w) in the NF, and the proposed uses, the concentration of erucic acid does
not raise any safety concern.
It has been reported that coffee husk may contain antinutritional factors (Augur et al., 2006;
Akande et al., 2010; Didanna, 2014) such as tannins (Clifford and Ramirez-Martinez, 1991; DeColmenares et al., 1994; Ramirez-Coronel et al., 2004) and chlorogenic acid (Mullen et al., 2013). Theapplicant determined the concentrations of total polyphenols, tannins, chlorogenic acid, caffeine, oxalic
acid and catechol in the NF (Table 7). The reported values in the NF are lower or comparable to the
occurrence levels of these compounds in other foodstuffs (Charrier et al., 2002; He /C20cimovi /C19c et al., 2011;
Kopjar et al., 2015; Kr /C19ol et al., 2019).
Table 7: Batch-to-batch analysis of antinutritional factors in the NF
Parameter UnitsAnalytical
methodBatches
#3 #5 #6 #7 #9 #10 #11
Total polyphenol
contentmg GAE/
100 gUV/VIS 1,194.1 / 1,362.8 / 1,650 1,280 1,330
Tannins (total) g/100 g UV/VIS 3.06 / / 4.25 3.57 4.09 3.54
Tannins
(condensed)g/100 g UV/VIS 2.36 / / 3.39 2.86 4.09 2.83
Tannins
(hydrolysable)g/100 g UV/VIS 0.702 / / 0.858 0.706 0.661 0.708
Oxalic acid g/100 g HPLC/UV 0.0412 / / 0.0509 0.0636 0.0283 0.0782
Catechol (free) g/100 g HPLC/UV <0.01 / / <0.01 <0.01 <0.01 <0.01Safety of dried coffee husk (cascara) from Coffea arabica L.
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The safety of caffeine has been previously assessed by EFSA (EFSA NDA Panel, 2015) and it was
concluded that the estimated habitual intake of caffeine from all sources, i.e. 400 mg/day for adultsother than pregnant and lactating women, did not raise safety concerns. Regarding pregnant andlactating women, a 200 mg/day intake of caffeine was considered not to raise safety concerns. Withregard to children and adolescents, the available body of evidence was not suf ﬁcient to derive a safe
level of caffeine intake, and the level of no safety concern derived for single doses of caffeine foradults (i.e. 3 mg/kg body weight (bw) per day) for habitual caffeine consumption by children andadolescents was considered as safe (EFSA NDA Panel, 2015).
The applicant quanti ﬁed the caffeine levels in the NF (Table 8) and investigated the caffeine
extraction rate (i.e. caffeine in the NF/caffeine in the infusion) in hot infusions, and the extraction ratesforﬁve individual batches of the NF (3 g of NF in 100 mL distilled water at 95 °C for 5 min) ranged
from 78.2% to 100%.
Considering the proposed uses and use levels (Section 3.7Proposed uses and use levels and
anticipated intake), a maximum concentration of caffeine at 1000 mg/100 g (Section 3.5
Speci ﬁcations) and assuming an 100% extraction of caffeine from the NF to the infusion, the
Panel notes that the concentration of caffeine among the proposed food categories may result into acaffeine concentration of 200 mg/L in soft drinks, 400 mg/L in herbal and other non-tea infusions and600 mg/L in energy drinks. Based on literature data, the highest estimated caffeine concentration inthe NF ’s infusions was compared with those in commonly consumed caffeine-containing beverages.
Caffeine content in coffees ranges from 270 to 1,340 mg/L, in teas from 150 to 220 mg/L and in
energy drinks ~320 mg/L (EFSA NDA Panel, 2015).
The Panel notes that the consumption of beverages produced using the NF may lead to coverage
or exceedance of the habitual intake of caffeine previously considered as safe for adults other thanpregnant and lactating women (i.e. 400 mg/day), pregnant and lactating women (i.e. 200 mg/day)and children (i.e. 3 mg/kg bw per day). The Panel also notes that parts of the population alreadyexceed the habitual intake of caffeine from other sources than the NF (EFSA NDA Panel, 2015).
The Panel notes that consumption of beverages produced using the NF will signi ﬁcantly add to the
total dietary intake of caffeine of the general population. The consumption of beverages containing
caffeine is not recommended to children, pregnant or breast-feeding women if the caffeine content
exceeds 150 mg/L and the labelling provisions of Regulation (EU) No 1169/2011 would apply.
3.10. Toxicological information
The Panel notes that no toxicological studies with the NF were provided. Taking into account the
nature of the NF , the history of use of the NF as food and the proposed uses and use levels, thePanel considers that no toxicological studies are required on the NF.
3.10.1. Human data
No human studies with the NF were submitted by the applicant, apart from the skin-prick test.
3.11. Allergenicity
In order to investigate the allergenic potential of the NF , the applicant commissioned a skin-prick
test study. The NF (in the form of powder) was suspended in water and was tested on 40 individualsParameter UnitsAnalytical
methodBatches
#3 #5 #6 #7 #9 #10 #11
Chlorogenic acid mg/100 g HPLC/UV 73.4 51.3 / / 52.6 41.9 61.9
Table 8: Batch-to-batch analysis of caffeine concentration in the NF
Parameter Units Analytical methodBatches
#1 #2 #3 #4 #5 #6 #7
Caffeine mg/100 g HPLC/UV with external
standardisation; DIN 10811-2202 460 533 652 350 639 135Safety of dried coffee husk (cascara) from Coffea arabica L.
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(with previously diagnosed reactions to other allergens), alongside a series of established allergens, as
well as positive and negative controls. None of the individuals had an allergic reaction to the aqueoussuspension of the NF .
The NF contains detectable amounts of protein (7.1 /C60.6% w/w); thus, allergic reactions are
possible. However, the Panel considers the allergenic risk to be low.
4. Discussion
The NF which is the subject of the application is the dried husk of the fruit of Coffea arabica L. The
production process is suf ﬁciently described and does not raise safety concerns. The Panel considers
that the NF is suf ﬁciently characterised. The NF consists mainly of carbohydrates (both digestible
carbohydrates and dietary ﬁbre) and water. The concentration of contaminants (e.g. heavy metals,
pesticide residues, organic contaminants) depends mainly on the production process (cultivation). ThePanel notes that there are no safety concerns regarding stability, if the NF complies with the proposedspeci ﬁcation limits during its entire shelf-life.
The applicant intends to market the NF as an ingredient in beverages. The consumers will not have
access to the actual NF but will consume the ﬁnal products, i.e. beverages, produced using the NF (via
infusion). The target population is the general population.
Caffeine concentration in the NF was analysed. Considering an 100% extraction of caffeine from
the NF to the beverage, the speci ﬁcation limit set for caffeine and the proposed use levels, the
maximum concentration of caffeine in infusions of the NF could be up to 600 mg/L of drink, aconcentration comparable to those in coffee beverages. The Panel notes that consumption ofbeverages produced using the NF will signi ﬁcantly add to the total dietary intake of caffeine of the
general population. The consumption of beverages containing caffeine is not recommended tochildren, pregnant or breast-feeding women if the caffeine content exceeds 150 mg/L and the labellingprovisions of Regulation (EU) No 1169/2011 would apply.
Considering the nature of the NF , the thorough compositional characterisation, the long history of
use of the NF as food and the proposed uses and use levels, the Panel did not deem further
toxicological studies with the NF as testing material necessary.
The risk of allergic reactions to the NF is considered low.
5. Conclusions
The Panel concludes that the NF , dried husk of the fruit of Coffea arabica L ., is safe under the
proposed conditions of use.
The Panel could not have reached the conclusion on the safety of the NF under the proposed
conditions of use without the data claimed as proprietary by the applicant (detailed description of the
production process, analytical data on the composition of the NF and stability data).
6. Steps taken by EFSA
1) On 07 September 2020 EFSA received a letter from the European Commission with the
request for a scienti ﬁc opinion on the safety of coffee husk (Cascara) as a novel food [Ref.
Ares (2020)4646086-07/09/2020].
2) On 07 September 2020, a valid application on coffee husk (Cascara), which was submitted
by Panama Varietals GmbH, was made available to EFSA by the European Commissionthrough the Commission e-submission portal (NF 2018/0192) and the scienti ﬁc evaluation
procedure was initiated.
3) On 12 February 2021, EFSA requested the applicant to provide additional information to
accompany the application and the scienti ﬁc evaluation was suspended.
4) On 07 December 2021, EFSA received a letter from the European Commission with the
request for a scienti ﬁc opinion on the safety of dried coffee husk (cascara) from Coffea
arabica L . as a novel food [Ref. Ares (2021)7536867-07/12/2021].
5) On 08 December 2021, additional information was provided by the applicant through the
Commission e-submission portal and the scienti ﬁc evaluation was restarted.
6) During its meeting on 16 December 2021, the NDA Panel, having evaluated the data,
adopted a scienti ﬁc opinion on the safety of dried coffee husk (cascara) from Coffea arabica
L. as a NF pursuant to Regulation (EU) 2015/2283.Safety of dried coffee husk (cascara) from Coffea arabica L.
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References
Akande KE, Doma UD, Agu HO and Adamu HM, 2010. Major antinutrients found in plant protein sources: their
effect on nutrition. Pakistan Journal of Nutrition, 9, 827 –832.
Alves RC, Rodrigues F , Nunes MA, Vinha AF and Oliveira MBP , 2017. State of the Art in Coffee Processing By-
Products, Elsevier, Handbook of coffee processing by-products. pp. 1 –26.
Augur C, Gutierrez-Sanchez G, Ramirez-Coronel A, Contreras-Dominguez M, Perraud-Gaime I and Roussos S,
2006. Analysis of antiphysiological components of coffee pulp. Current Topics in Bioprocesses in Food
Industries, 1, 391 –402.
Bacha A, Kuto L, Fufa D and Kamil M, 2018. Buna Qalaa Ritual of the Boorana Oromo. €Universitepark B €ulten, 7, 26.
Charrier MJ, Savage GP and Vanhanen L, 2002. Oxalate content and calcium binding capacity of tea and herbal
teas. Asia Paci ﬁc Journal of Clinical Nutrition, 11, 298 –301.
Clifford MN and Ramirez-Martinez JR, 1991. Tannins in wet-processed coffee beans and coffee pulp. Food
Chemistry, 40, 191 –200.
De Colmenares NG, Ram /C19ırez-Mart /C19ınez JR, Aldana JO and Clifford MN, 1994. Analysis of proanthocyanidins in coffee
pulp. Journal of the Science of Food and Agriculture, 65, 157 –162.
Dibusz K and Vejvodova P , 2020. Systematic literature search to assist EFSA in the preparatory work for the safety
assessment of novel food applications and traditional food noti ﬁcations. EFSA supporting publication 2020:EN-
1774, 72 pp. https://doi.org/10.2903/sp.efsa.2019.EN-1774
Didanna HL, 2014. A critical review on feed value of coffee waste for livestock feeding. World Journal of Biological
Science, 2, 72 –086.
EFSA (European Food Safety Authority), 2015. The food classi ﬁcation and description system FoodEx 2 (revision 2).
EFSA Supporting Publication 2015;EN-804, 90 pp. https://doi.org/10.2903/sp.efsa.2015.EN-804
EFSA (European Food Safety Authority), 2021a. Technical Report on the noti ﬁcation of cherry pulp from Coffea
arabica L. and Coffea canephora Pierre ex A. Froehner as a traditional food from a third country following
Article 14 of Regulation (EU) 2015/2283. EFSA supporting publication 2021;18(5):EN-6657, 17 pp. https://doi.
org/10.2903/sp.efsa.2021.EN-6657
EFSA (European Food Safety Authority), 2021b. Technical Report on the noti ﬁcation of dried cherry pulp from
Coffea arabica L. and Coffea canephora Pierre ex A. Froehner as a traditional food from a third country
pursuant to Article 14 of Regulation (EU) 2015/2283. EFSA supporting publication 2021;18(9):EN-6808, 13 pp.https://doi.org/10.2903/sp.efsa.2021.EN-6808
EFSA NDA Panel (EFSA Panel on Dietetic Products), 2015. Scienti ﬁc Opinion on the safety of caffeine. EFSA
Journal 2015;13(5):4102, 120 pp. https://doi.org/10.2903/j.efsa.2015.4102
EFSA NDA Panel (EFSA Panel on Dietetic Products), Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S,
Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle H, Naska A, Neuh €auser-Berthold M, Nowicka G, Pentieva K,
Sanz Y, Siani A, Sj €odin A, Stern M, Tom /C19e D, Vinceti M, Willatts P , Engel K-H, Marchelli R, P €oting A, Poulsen M,
Salminen S, Schlatter J, Arcella D, Gelbmann W, de Sesmaisons-Lecarre A, Verhagen H and van Loveren H 2016.Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of
Regulation (EU) 2015/2283. EFSA Journal 2016;19(3):6555, 27 pp. https://doi.org/10.2903/j.efsa.2021.6555
EFSA Scienti ﬁc Committee, 2011. Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on
whole food/feed. EFSA Journal 2011;9(12):2438, 21 pp. https://doi.org/10.2903/j.efsa.2011.2438
EFSA Scienti ﬁc Committee, 2012. Guidance on selected default values to be used by the EFSA Scienti ﬁc
Committee, Scienti ﬁc Panels and Units in the absence of actual measured data. EFSA Journal 2012;10(3):2579,
60 pp. https://doi.org/10.2903/j.efsa.2012.2579
Hattox RS, 2014. Coffee and Coffeehouses: The Origins of A Social Beverage in the Medieval Near East. University
of Washington Press.
He/C20cimovi /C19c I, Bel /C20s/C20cak-Cvitanovi /C19c A, Hor /C20zi/C19c D and Komes D, 2011. Comparative study of polyphenols and caffeine in
different coffee varieties affected by the degree of roasting. Food Chemistry, 129, 991 –1000.
Hestler A and Spilling J-A, 2010. Yemen, Marshall Cavendish.
Hussen K, Tegegne A, Kurtu MY and Gebremedhin B, 2008. Traditional Cow An Camel Milk Production and
Marketing in Agro-Pastoral and Mixed Crop-Livestock Systems: The Case of Mieso District, Oromia Regional
State, Ethiopia, ILRI (aka ILCA and ILRAD).
Keiko, O 2018. Coffee as a global beverage before 1700. Journal of International Economic Studies, 32, 43 –55.
Kopjar M, Tadi /C19c M and Pili /C20zota V, 2015. Phenol content and antioxidant activity of green, yellow and black tea
leaves. Chemical and Biological Technologies in Agriculture, 2, 1 –6.
Kr/C19ol K, Gantner M, Tatarak A and Hallmann E, 2019. The content of polyphenols in coffee beans as roasting, origin
and storage effect. European Food Research and Technology, 246, 33 –39.
Mullen W, Nemzer B, Stalmach A, Ali S and Combet E, 2013. Polyphenolic and hydroxycinnamate contents of
whole coffee fruits from China, India, and Mexico. Journal of Agricultural and Food Chemistry, 61, 5298 –5309.
Ramirez-Coronel MA, Marnet N, Kolli VK, Roussos S, Guyot S and Augur C, 2004. Characterization and estimation
of proanthocyanidins and other phenolics in coffee pulp ( Coffea arabica ) by thiolysis /C0high-performance liquid
chromatography. Journal of Agricultural and Food Chemistry, 52, 1344 –1349.Safety of dried coffee husk (cascara) from Coffea arabica L.
www.efsa.europa.eu/efsajournal 15 EFSA Journal 2022;20(2):7085
 18314732, 2022, 2, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2022.7085 by Cochrane Saudi Arabia, Wiley Online Library on [26/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Soux ML, 2016. Apuntes para una historia del caf /C19e en los Yungas pace ~nos. Historia, 27, 43 –74.
Thesiger W, 1947. A Journey Through the Tihama, the ’Asir, and the Hijaz Mountains. The Geographical Journal,
110, 188 –200.
Thurston RW, Morris J and Steiman S, 2013. Coffee: A comprehensive guide to the bean, the beverage, and the
industry, Rowman & Little ﬁeld Publishers.
Wayessa BS, 2011. Buna Qalaa: a quest for traditional uses of coffee among Oromo people with special emphasis
on Wallaga, Ethiopia. African Diaspora Archaeology Newsletter, 14, 3.
Weinberg BA and Bealer BK, 2004. The world of caffeine: the science and culture of the world ’s most popular
drug, Routledge.
Wild A, 2005. Coffee: A dark history, WW Norton & Company.
Abbreviations
ADME Absorption, Distribution, Metabolism and Excretion
bw Body Weight
FAIM Food Additive Intake ModelGMP Good Manufacturing PracticeHACCP Hazard Analysis Critical Control PointsHPLC/MS High Performance Liquid Chromatography Mass SpectrometerHPLC/UV High-Pressure Liquid Chromatography with Ultraviolet DetectorISO International Organization for StandardizationLC-GC-FID Coupled Liquid Chromatography-Gas Chromatography with Flame Ionisation Detection
LOD Limit of Detection
LOQ Limit of Quanti ﬁcation
MOAH Mineral Oil Aromatic HydrocarbonsMOSH Mineral Oil Saturated HydrocarbonsMRL Maximum Residue LevelNDA EFSA Panel on Nutrition, Novel Foods and Food AllergensNF Novel FoodPAH Polycyclic aromatic hydrocarbons
PAH4 Sum of benzo [a]pyrene, benz [a]anthracene, benzo [b]ﬂuoranthene and chrysene
POSH Polyole ﬁn Oligomeric Saturated Hydrocarbons
UV/VIS Ultraviolet-Visible SpectroscopySafety of dried coffee husk (cascara) from Coffea arabica L.
www.efsa.europa.eu/efsajournal 16 EFSA Journal 2022;20(2):7085
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