Safety of dried coffee husk (cascara) from Coffea arabica L. as a Novel food pursuant to Regulation (EU) 2015/2283
2022; Wiley; Volume: 20; Issue: 2 Linguagem: Inglês
10.2903/j.efsa.2022.7085
ISSN1831-4732
AutoresDominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Peláez, Kristina Pentieva, Alfonso Siani, Frank Thiès, Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhäuser‐Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Schlatter, Henk Van Loveren, Ermolaos Ververis, Helle Katrine Knutsen,
Tópico(s)Coffee research and impacts
ResumoEFSA JournalVolume 20, Issue 2 e07085 Scientific OpinionOpen Access 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), Corresponding Author EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) nda@efsa.europa.eu Correspondence:nda@efsa.europa.euSearch for more papers by this authorDominique Turck, Dominique TurckSearch for more papers by this authorTorsten Bohn, Torsten BohnSearch for more papers by this authorJacqueline Castenmiller, Jacqueline CastenmillerSearch for more papers by this authorStefaan De Henauw, Stefaan De HenauwSearch for more papers by this authorKaren Ildico Hirsch-Ernst, Karen Ildico Hirsch-ErnstSearch for more papers by this authorAlexandre Maciuk, Alexandre MaciukSearch for more papers by this authorInge Mangelsdorf, Inge MangelsdorfSearch for more papers by this authorHarry J McArdle, Harry J McArdleSearch for more papers by this authorAndroniki Naska, Androniki NaskaSearch for more papers by this authorCarmen Pelaez, Carmen PelaezSearch for more papers by this authorKristina Pentieva, Kristina PentievaSearch for more papers by this authorAlfonso Siani, Alfonso SianiSearch for more papers by this authorFrank Thies, Frank ThiesSearch for more papers by this authorSophia Tsabouri, Sophia TsabouriSearch for more papers by this authorMarco Vinceti, Marco VincetiSearch for more papers by this authorFrancesco Cubbada, Francesco CubbadaSearch for more papers by this authorThomas Frenzel, Thomas FrenzelSearch for more papers by this authorMarina Heinonen, Marina HeinonenSearch for more papers by this authorRosangela Marchelli, Rosangela MarchelliSearch for more papers by this authorMonika Neuhäuser-Berthold, Monika Neuhäuser-BertholdSearch for more papers by this authorMorten Poulsen, Morten PoulsenSearch for more papers by this authorMiguel Prieto Maradona, Miguel Prieto MaradonaSearch for more papers by this authorJosef Schlatter, Josef SchlatterSearch for more papers by this authorHenk van Loveren, Henk van LoverenSearch for more papers by this authorErmolaos Ververis, Ermolaos VerverisSearch for more papers by this authorHelle Katrine Knutsen, Helle Katrine KnutsenSearch for more papers by this author EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Corresponding Author EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) nda@efsa.europa.eu Correspondence:nda@efsa.europa.euSearch for more papers by this authorDominique Turck, Dominique TurckSearch for more papers by this authorTorsten Bohn, Torsten BohnSearch for more papers by this authorJacqueline Castenmiller, Jacqueline CastenmillerSearch for more papers by this authorStefaan De Henauw, Stefaan De HenauwSearch for more papers by this authorKaren Ildico Hirsch-Ernst, Karen Ildico Hirsch-ErnstSearch for more papers by this authorAlexandre Maciuk, Alexandre MaciukSearch for more papers by this authorInge Mangelsdorf, Inge MangelsdorfSearch for more papers by this authorHarry J McArdle, Harry J McArdleSearch for more papers by this authorAndroniki Naska, Androniki NaskaSearch for more papers by this authorCarmen Pelaez, Carmen PelaezSearch for more papers by this authorKristina Pentieva, Kristina PentievaSearch for more papers by this authorAlfonso Siani, Alfonso SianiSearch for more papers by this authorFrank Thies, Frank ThiesSearch for more papers by this authorSophia Tsabouri, Sophia TsabouriSearch for more papers by this authorMarco Vinceti, Marco VincetiSearch for more papers by this authorFrancesco Cubbada, Francesco CubbadaSearch for more papers by this authorThomas Frenzel, Thomas FrenzelSearch for more papers by this authorMarina Heinonen, Marina HeinonenSearch for more papers by this authorRosangela Marchelli, Rosangela MarchelliSearch for more papers by this authorMonika Neuhäuser-Berthold, Monika Neuhäuser-BertholdSearch for more papers by this authorMorten Poulsen, Morten PoulsenSearch for more papers by this authorMiguel Prieto Maradona, Miguel Prieto MaradonaSearch for more papers by this authorJosef Schlatter, Josef SchlatterSearch for more papers by this authorHenk van Loveren, Henk van LoverenSearch for more papers by this authorErmolaos Ververis, Ermolaos VerverisSearch for more papers by this authorHelle Katrine Knutsen, Helle Katrine KnutsenSearch for more papers by this author First published: 25 February 2022 https://doi.org/10.2903/j.efsa.2022.7085 Requestor: European Commission Question number: EFSA-Q-2020-00229 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 and Marco Vinceti. Declarations of interest: The declarations of interest of all scientific 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 scientific output. Adopted: 16 December 2021 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat 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 skin of 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 complies with the proposed specification 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 specification limit set for caffeine and the proposed use levels, the maximum concentration of caffeine in infusions produced using the NF could be up to 600 mg/L of drink, a concentration comparable to those in coffee beverages. The Panel notes that consumption of beverages produced using the NF will add significantly 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 if the 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 concludes that the NF, dried husk of the fruit of Coffea arabica L., is safe under the proposed conditions of use. 1 Introduction 1.1 Background and Terms of Reference as provided by the requestor On 6 February 2020, the company Panama Varietals GmbH11 During the evaluation, the applicant's company name changed from 'Panama Varietals GmbH' to 'Goldkind GmbH' and 'Caskai GmbH'. submitted a request to the European Commission in accordance with Article 10 of Regulation (EU) No 2015/228322 Regulation (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 the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. OJ L 327, 11.12.2015, p. 1–22. to 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 scientific 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 specified 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 this EFSA evaluation. On that basis, the Commission amended the title to 'Request for a scientific 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 258/9733 Regulation (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. to 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 a novel food ingredient defined 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 the MS submitted comments or raised objections. The concerns of a scientific 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 food application under Regulation (EU) 2015/2283. On 5 June 2020, the Federal Food Safety and Veterinary Office 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 notification 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 notification 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 notifications, EFSA considered that the available data on composition and history of use do not raise safety concerns. 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 the assessment, the Panel identified additional data which were not included in the application. Administrative and scientific 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). As indicated in this guidance, it is the duty of the applicant to provide all of the available (proprietary, confidential and published) scientific 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 the EFSA Scientific 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 UCT Prague et al. (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 efficacy of the NF with regard to any claimed benefit. 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 is consisting 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 significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable 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,44 https://powo.science.kew.org/ another identified scientific 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 'dried coffee fruit pulp' are some of the common names identified for the NF. The NF comprises the skin (exocarp), pulp (mesocarp), mucilage (pectin), parchment (endocarp) and a portion of the silver skin 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 propagation of 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. The propagation (through seeding) and cultivation of the coffee plants take place in Central America (hills of 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, phosphate and potassium), as well as pesticides (fungicides, acaricides and insecticides) are used. The applicant provided 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 process before drying (sun/air drying at ambient temperature). The drying process takes place on raised drying beds 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 to prevent 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 if needed, to achieve the intended moisture level. The whole dried coffee fruits undergo a resting period of 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 handling involves packaging, storage and transport of the NF. The Panel considers that the production process is sufficiently described. 3.4 Compositional data In order to confirm that the manufacturing process is reproducible and adequate to produce on a commercial scale a product with certain characteristics, the applicant provided analytical information for several representative, independently produced batches of the NF originating from different farms and geographical locations. Certificates of accreditation for the laboratories that conducted the analyses were provided by the applicant. The NF is a 'whole food' as defined by EFSA Scientific Committee (EFSA Scientific Committee, 2011), meaning that all its constituents cannot be fully identified 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 '3.9 Nutritional information'. Table 1. Batch-to-batch proximate analysis of the NF Parameter (unit) Analytical method Batch number #1 #3 #6 #7 #9 #10 Total carbohydrates (g/100 g of NF) Calculationaa 100 – (crude protein + fat + ash + moisture). 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 × 6.25) (ŠPP INO.M.077) 6.2 7.5 7.6 6.6 6.9 7.7 Ash (g/100 g of NF) Gravimetric method (ŠPP 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 (ŠPP 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) Calculationcc 100 – dry matter. 12.1 16.1 16.5 13.7 12.4 13.4 Water activity (aw) 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. 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 of compositional values is acceptable.55 Figures rounded as per (EFSA Scientific Committee, 2012). The applicant provided microbiological data on five independently produced batches of the NF at various time points after production (Table 2). 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 4833-2 1,600 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. 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 of heavy metals reported for the NF are below maximum levels set for other foodstuffs or food supplements as set in Commission Regulation (EC) No 1881/200666 Commission 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. and food supplements as set in Regulation (EU) No 488/201477 Commission 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.. Table 3. Concentrations of contaminants in the NF Parameter Analytical method Batch 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 (μg/kg) Ochratoxin A HPLC-FLD (EN 16007, EN 14132, EN 15829, EN 15835) / < 0.050 < 0.050 < 0.050 0.250 ± 0.10 < 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 aflatoxins / < 0.02 < 0.02 < 0.02 < 0.02 < 0.02 Polycyclic Aromatic Hydrocarbons (μg/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. Analytical data on the concentrations of aflatoxins 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 to sorting, 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 quantified in one and two batches, respectively. Upon EFSA's request, the applicant provided further analytical data (three additional batches of the NF, other than those described 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 μg/kg (LOQ), and the highest levels of benzo[a]anthracene and chrysene were 0.653 and 0.561 μg/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 to the 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 of beverages 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 below the LOD of the analytical method used. Azoxystrobin, carbendazim, cypermethrin, cyproconazole, deltamethrin, epoxiconazole, flutriafol, imidacloprid, propamocarb, propiconazole, tebuconazole, triadimenol and trifloxystrobin have been quantified 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 quantified at concentrations higher than the MRL set for coffee bean in EU. The quantified 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 1146/201488 Commission 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, benfluralin, 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.. The Panel considers that the information provided on the composition is sufficient for characterising the NF. 3.4.1 Stability The applicant provided data on the microbiological profile of eight independently produced batches of the NF analysed at various time points after the dehulling, i.e. the last step of the production process 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. Table 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 / / < 10 / / / / / / E. coli (cfu/g) < 10 < 10 < 10 < 10 / / < 10 < 10 < 10 < 10 / / / Yeasts (cfu/g) < 100 < 100 < 100 200 / / < 100 < 10 < 10 < 10 / / / Moulds (cfu/g) < 100 < 100 < 100 < 100 / / < 100 < 10 < 10 < 10 / / / Coagulase-positive staphylococci (cfu/g) < 10 < 10 < 10 < 10 / / < 10 / / / / / / B. cereus (cfu/g) < 100 < 100 < 100 100 / / < 100 / / / / / / Salmonella sp. in 25g nd nd nd nd / / nd / / / / / / Clostridium perfringens (cfu/g) < 10 < 10 < 10 < 10 / / < 10 / / / / / / Water activity (aw) / / /
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