Safety of hot water extract of fruits and peduncles of Hovenia dulcis as a novel food pursuant to Regulation 1(EU) 2015/2283
2020; Wiley; Volume: 18; Issue: 8 Linguagem: Inglês
10.2903/j.efsa.2020.6196
ISSN1831-4732
AutoresDominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen Ildico Hirsch‐Ernst, John Kearney, 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, Josef Schlatter, Henk Van Loveren, Wolfgang Gelbmann, Helle Katrine Knutsen,
Tópico(s)Agricultural safety and regulations
ResumoEFSA JournalVolume 18, Issue 8 e06196 Scientific OpinionOpen Access Safety of hot water extract of fruits and peduncles of Hovenia dulcis as a novel food pursuant to Regulation 1(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 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 authorJohn Kearney, John KearneySearch 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 Cubadda, Francesco CubaddaSearch 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 authorJosef Rudolf Schlatter, Josef Rudolf SchlatterSearch for more papers by this authorHenk van Loveren, Henk van LoverenSearch for more papers by this authorWolfgang Gelbmann, Wolfgang GelbmannSearch 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 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 authorJohn Kearney, John KearneySearch 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 Cubadda, Francesco CubaddaSearch 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 authorJosef Rudolf Schlatter, Josef Rudolf SchlatterSearch for more papers by this authorHenk van Loveren, Henk van LoverenSearch for more papers by this authorWolfgang Gelbmann, Wolfgang GelbmannSearch for more papers by this authorHelle Katrine Knutsen, Helle Katrine KnutsenSearch for more papers by this author First published: 28 August 2020 https://doi.org/10.2903/j.efsa.2020.6196 Requestor: European Commission following an application by Hovenia Dulcis AB Question number: EFSA-Q-2018-00279 Panel members: Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, John Kearney, 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. Acknowledgements: The Panel wishes to thank for the preparatory work on this scientific opinion: Qingqing Sun. Adopted: 30 June 2020 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 onFacebookTwitterLinkedInRedditWechat 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 the safety of 'Hovenia dulcis fruit extract' as a novel food (NF) for its use in food supplements. The NF concerns a hot water extract of sliced and dried fruits and peduncles of Hovenia dulcis Thun. The production process is described in sufficient detail but contains contradictory information regarding the mixing with another ingredient of the NF. The NF is comprised of mostly carbohydrates (about 90%), about 2% proteins, 5% moisture, less than 1% fat and about 2% ash. In addition, the NF contains small amounts of flavonoids such as dihydromyricetin, myricetin and quercetin. The Panel notes limitations of the data provided from the batch testing regarding proximate analyses and plant secondary metabolites. Given these limitations, the Panel considers that the data provided by the applicant do not demonstrate that different batches produced with the described production process meet the proposed specifications. The target population is the general adult population excluding pregnant and lactating women and people with a chronic disease, such as liver malfunction. Limited information was provided on a history of consumption of Hovenia dulcis fruits and on an extract approved in South Korea. A number of toxicological studies were performed. However, the study reports did not allow to verify that the test item was representative of the NF. The same applied to a human study provided by the applicant. The Panel concludes that the safety of the NF has not been established. 1 Introduction 1.1 Background and Terms of Reference as provided by the European Commission On 28 of April 2014, the company Hovenia dulcis AB submitted a request in accordance with Article 4 of the Novel Food Regulation (EU) 258/19971 to place on the market the dried fruit and peduncle extract of Hovenia dulcis Thunberg (HDFPE), as a novel food (NF) to be used in food supplements. On 20 July 2017, the competent authority of Germany forwarded to the Commission its initial assessment report, which came to the conclusion that the NF did not meet the criteria for acceptance of a NF defined in Article (3)1 of Regulation (EU) 258/1997. On 14 December 2017, the Commission forwarded the initial assessment report to the other Member States (MSs). The concerns of a scientific nature raised in the initial assessment and by other MSs can be summarised as follows: The NF was inadequately characterised. Regarding the previous human exposure, the documents did not include any data on actual quantities consumed. The dose proposed and the intake of the NF had not been justified. Regarding the toxicological information, none of the reports contained precise information on the test material. In the study of subchronic toxicity, the applicant did not provide sufficient information to show that the test material used was representative of the NF. The potential allergenicity of the NF had not been well explored. No assessment of the botanical relationship between Hovenia dulcis fruits and other fruits known to cause allergic reactions in the European population had been undertaken which would have been a valuable indicator for potential cross reactivity to the food by allergic consumers. According to Article 35 (1) of Regulation (EU) 2015/22832, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EU) 258/1997 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application under this Regulation. In accordance with Article 10 (3) of Regulation (EU) 2015/2283, EFSA shall give its opinion as to whether the update of the Union List referred to in Article 10 (1) is liable to have an effect on human health. 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 two EFSA requests for supplementary information. 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) 2017/24693. A common and structured format on the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of a NF application.4 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 to supporting the safety of the proposed NF. 2.2 Methodologies The assessment follows the methodology set out in the EFSA guidance on NF applications 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. This assessment concerns only risk that might be associated with consumption of the NF under the proposed conditions of use, and is not an assessment of the efficacy of HDFPE with regard to any claimed benefit. 3 Assessment 3.1 Introduction The NF is a hot water extract of dried fruits and peduncles of Hovenia dulcis Thunberg (family: Rhamnaceae), which is commonly named as Japanese raisin tree, Japanese cherry tree and Chinese raisin tree. Hovenia dulcis trees originate from China, Korea, Himalaya region and Japan and are cultivated in China, South America and Tanzania (Hyun et al., 2010). The NF is intended to be used as an ingredient for food supplements. The applicant indicated that according to Regulation (EU) 2015/2283 this NF falls under the following categories: (iv) 'foods and food ingredients consisting of or isolated from plants, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe use'. 3.2 Identity of the NF The NF is a hot water extract obtained from the dried fruits and peduncles of Hovenia dulcis Thunberg. 3.3 Production process The fruits and peduncles are harvested manually in the wild in China in September and October. Once the fruits and peduncles are mature, they fall off the tree and the workers collect them by hand. After collection and sorting, the fruits and peduncles are packed in nylon bags of 25 kg and transported by ship to South Korea where they are screened for pesticide residues and other impurities. Then they are stored frozen until they are sliced and dried in the dark, followed by an addition of water at a ratio of 1:10 (w/v). According to the applicant, the mixture of the dried slices and water is kept at a temperature of 110–150°C, preferably 120–125°C, and under a pressure ranging from 1 to 3 atm, optimally 1.5 atm, for 15 min to 48 h. In response to EFSA questioning, this wide range for the duration of the extraction, the applicant explained that the normal production schedule is between 15 min and 12 h and that due to weekends and holidays the schedule has to be adjusted and the extraction procedure will be different. After the extraction, the mixture is cooled, filtered and concentrated by evaporation at room temperature at –1.5 atm to a solid content of 40%. In response to an EFSA question, the applicant informed that subsequently dextrin or maltodextrin is added at a ratio of 10:6 [extract:(malto)dextrin] to avoid clotting of the pure dried extract, before the mixture is spray-dried. The Panel notes discrepant information received from the applicant (i.e. file 'Reply on EFSA Risk Assessment 1' on the production process 4/5/2020 provides a Korean and an English package label which indicates 'Dextrin 37.5%', but the same file included also a copy of a certificate of analysis on a 'maltodextrin' product). After addition of the dextrin/maltodextrin, the NF is delivered to Sweden in airtight polyethylene bags for encapsulation and packaging. The initial assessment raised concerns by a Member State regarding the use of ethanol in the production process, however, the applicant clarified that no ethanol is used. The applicant provided GMP certificates issued by the South Korean Ministry for Food and Drug Safety and the Korean Food and Drug Agency (KFDA) for the production of the ingredient and by Läkemedelsverket (Swedish Medical Products Agency) for the filling of capsules and packaging. The Panel notes that no analytical data were provided on whether and to which degree the wide range of the extraction time (i.e. 15 min to 48 h) may impact the composition of the NF. It is also unclear whether the HDFPE is mixed with dextrin or maltodextrin. The Panel considers that the production process of the NF is not sufficiently described. 3.4 Compositional data According to the application, the NF consists of a spray-dried mixture of 62.5% HDFPE and 37.5% dextrin or maltodextrin. The NF is comprised of mostly carbohydrates (about 90%), about 2% proteins, 5% moisture, less than 1% fat and about 2% ash; in addition, the NF contains small amounts (< 100 ppm) of flavonoids. The applicant provided compositional information on Hovenia dulcis from the literature: Park et al. (2015) studied the content of four flavonoids in four batches of an extract obtained from the manufacturer of the NF with a high-performance liquid chromatographic (HPLC) method. That extract was produced of dried fruit powder extracted with hot water (100°C for 3 h) at a ratio at 1:40 (w/v). In addition to the differences of the processing of the raw material (i.e. powder) and the extraction conditions, also the further processing of the extract (centrifugation to remove insoluble particles) and the drying method (freeze-drying) differed from the production process of the NF. There is also no note on an addition of (malto)dextrin in this publication by Park et al. (2015). The results of this batch testing are provided in Table 1. Dihydromyricetin and taxifolin were the most abundant flavonoids in that extract. Table 1. Contents of flavonoids in four batches of a Hovenia dulcis extract (mg/g) produced differently to the NF, published by Park et al. (2015) and measured by HPLC Flavonoids (mg/g) Batch No. 703 701 0807-5 0807-6 Dihydromyricetin 0.88 ± 0.05 1.19 ± 0.03 1.17 ± 0.03 0.33 ± 0.07 Taxifolin 0.86 ± 0.05 0.15 ± 0.01 0.93 ± 0.02 1.64 ± 0.01 Myricetin 0.17 ± 0.01 0.24 ± 0.01 0.06 ± 0.01 0.04 ± 0.01 Quercetin 0.13 ± 0.01 0.03 ± 0.00 0.04 ± 0.01 0.05 ± 0.01 HPLC: high-performance liquid chromatography. Park et al. (2015) referred also to, but did not quantify, other components in the seeds or fruits of Hovenia dulcis, such as hovenodulinol, hovenitins I, II and III, (+)-3,3′,5′,5,7-pentahydroflavanone, laricitrin, myricetin, (+)-gallocatechin, dihydrokaempferol, saponin C2, β-daucosterol, hovenidulciosides A1, A2, B1 and B2, hodulosides I and III and hovenidulcigenin reported by Ding et al. (1997), ShuZhen et al. (2009), Yoshikawa et al. (1995, 1996, 1997) and Xu et al. (2003). In a letter to the applicant, EFSA noted scientific literature (Yoshikawa et al., 1996; Murakami et al., 1997) about other phenolic compounds and saponins present in the seeds and fruits of Hovenia dulcis, some of which may raise safety concerns at certain concentrations (Heim et al., 2002; Hobbs et al., 2013; Engen et al., 2015). The applicant did not address these concerns. The applicant also provided information on other batches produced by the manufacturer of the NF in 2011 and 2013 and on batches produced in 2019. The certificates of analyses issued by the manufacturer of the NF for four different batches produced in 2011 and 2013 provided only information on moisture (ranging from 4.3% to 4.7%), quercetin (5.9–8.9 μg/g) and on some microbiological and chemical contaminants (Table 2). Table 2. Results from testing of batches produced in 2011 and 2013 provided by the applicant Parameter Batch number* LT111048P LT113028P LT113027P LT113026P 14 November 2011 1 October 2013 30 September 2013 3 September 2013 Moisture (%) 4.7 4.3 4.5 4.7 Quercetin (μg/g) 8.3 8.0 7.5 7.3 Total Aerobic Count (CFU/g) 5 25 5 5 Yeast and mould (CFU/g) 5 5 5 5 Coliforms (CFU/g) Negative Negative Negative Negative Lead (ppm) 0.10 0.1 0.1 0.1 Mercury (ppm) 0.003 n.d. n.d. n.d. Arsenic (ppm) 0.07 0.1 0.1 0.1 Cadmium (ppm) 0.01 n.d. n.d. n.d. CFU: colony forming unit. * The date below the batch number is the production date; n.d. not detected. Consequently, EFSA asked the applicant to provide more qualitative and quantitative data on the main constituents/proximate analyses of the NF (i.e. ash, moisture, protein, fat, and carbohydrates, flavonoids) and batch-to-batch analyses in order to show that these parameters meet the limits of the proposed specifications of the NF. In response to this request, the applicant provided certificates of analyses from the manufacturer of the NF on five batches produced in 2019. The results are provided in Table 3. Table 3. Results of batches produced in 2019 and certified by the manufacturer of the NF Parameter Batch number* LT119027P LT119037P LT119043P LT119044P LT119046P 31 July 2019 23 October 2019 28 November 2019 3 December 2019 26 December 2019 Moisture (%) 5.20 5.20 5.20 5.20 5.20 Protein (%) 2.34 2.34 2.34 2.34 2.34 Fat (%) 0.09 0.09 0.09 0.09 0.09 Carbohydrates (%) 91.40 91.40 91.40 91.40 91.40 Polysaccharides (mg/g) 185.17 185.17 185.17 185.17 185.17 Ash (%) 1.4 1.4 1.4 1.4 1.4 Sodium (mg/100 g) 20.97 20.97 20.97 20.97 20.97 Quercetin (μg/g) 8.49 7.94 7.94 7.99 8.74 Microbiology Aerobic counts (CFU) < 1,000/g < 1,000/g < 1,000/g < 1,000/g < 1,000/g E. coli (per 50 g) n.d. n.d. n.d. n.d. n.d. Coliforms (CFU/g) n.d. n.d. n.d. n.d. n.d. Yeast and moulds (CFU/g) n.d. n.d. n.d. n.d. n.d. Heavy metals** (ppm) Lead 0.111 0.111 0.111 0.111 0.111 Mercury 0.001 0.001 0.001 0.001 0.001 Cadmium 0.001 0.001 0.001 0.001 0.001 Arsenic 0.080 0.080 0.080 0.080 0.080 NF: novel food; CFU: colony forming units. * The date below the batch number is the production date. ** Not a specification parameter. The Panel notes that the results of all tested parameters, except for quercetin (ranging from 7.94 to 8.74 μg/g), are identical for all five presented batches produced at different time points in 2019, which is considered unrealistic. These five batches produced in 2019 and a sixth batch (LT119045P, production date not specified) were analysed by an external laboratory for their flavonoid content (Table 4). Table 4. Flavonoid content of six batches produced by the manufacturer of the NF and certified by an external laboratory Flavonoids (μg/g) Batch no. LT119027P 31 July 2019 LT119037P 23 October 2019 LT119043P 28 November 2019 LT119044P 3 December 2019 LT119045P no date LT119046P 26 December 2019 Dihydromyricetin n.d. 91.37 67.30 66.02 73.20 42.83 Taxifolin n.d. n.d. n.d. n.d. n.d. n.d. Myricetin 12.08 36.69 27.96 28.05 30.04 27.35 Quercetin 5.18 3.39 4.64 5.13 4.47 4.46 n.d. not detected; NF: novel food. The Panel notes that taxifolin could not be detected in these six batches and that the results for the contents of the other three flavonoids in these batches are up to more than 10-fold lower (for dihydromyricetin) than the results (presented in Table 1) obtained on an extract produced differently to the NF and which have been proposed by the applicant for setting specifications for dihydromyricetin, taxifolin and myricetin. The information from this external laboratory indicated that the analysed substance was a mixture consisting of 62.5% Hovenia dulcis extract and 32.5% dextrin vs. '37.5%' as indicated in the production process description in the application and as indicated on a product labelling provided by the applicant. Thus, it appears that the batches produced and tested in 2019 are not identical to the NF. Another sample of a 'Hovenia dulcis extract powder' (as stated by the applicant) and two samples of food supplements provided by the manufacturer of the NF (without further information on the tested material) were analysed by the external laboratories Eurofins and the Korean Health Supplements Institute. The proximate analyses (moisture, protein, fat, carbohydrates, ash) of these samples were within the proposed specification limits. Flavonoids were not analysed by these laboratories. The Panel notes the concerns described above for the proximate analyses provided by the certificates of the manufacturer of the NF (i.e. identical figures) and regarding the identity of the analysed batches produced in 2019. Furthermore, the Panel considers that the NF is not sufficiently characterised regarding secondary plant metabolites. 3.4.1 Stability No data regarding the stability of the NF were provided by the applicant. 3.5 Specifications The specifications of the NF proposed by the applicant are presented in Table 5. They include the parameters for proximate analyses, flavonoids, heavy metals and microbiological specifications. Table 5. Specifications of the NF proposed by the applicant Parameter Specification Analytical method Typical proximate analyses Moisture (%) 4–6 * Protein (%) 1–3 * Fat (%) < 1 * Carbohydrates (%) 89–94 * Sugars (%) 18–21 * Ash (%) 1.0–2.5 * Sodium (mg/100 g) ≤ 70 * Flavonoids Quercetin (μg/g) 5.9–8.9 HPLC Dihydromyricetin (mg/g) 0.33–1.19 HPLC Taxifolin (mg/g) 0.15–1.64 HPLC Myricetin (mg/g) 0.04–0.24 HPLC Microbiological parameters Total aerobic count (CFU/g) < 5 × 103 * Yeast and mould (CFU/g) < 30 * Coliforms (CFU/g) < 10 * E. coli (CFU/g) < 10 * Coagulase-positive Staphylococcus (CFU/g) < 10 * S. aureus (CFU/g) < 10 * Salmonella (CFU/g) ND/25g * Heavy metals Lead (ppm) < 1 * Mercury (ppm) < 0.1 * Arsenic (ppm) < 1 * Cadmium (ppm) < 1 * * No methods were proposed in section 'Specifications' by the applicant, CFU: colony forming unit, ND: not detected; HPLC: high-performance liquid chromatography; NF: novel food. Given the limitations of the batch testing described in Section 3.4, the Panel considers that the data provided by the applicant do not demonstrate that different batches produced with the described production process meet the proposed specifications. It is also noted that the testing of batches produced in 2019 showed significantly lower contents of dihydromyricetin, taxifolin and myricetin (Table 4) as compared to the proposed specification limits for these flavonoids (Table 5) which were based on analyses of an extract, which was produced differently from the NF. 3.6 History of use of the NF and/or of its source According to the applicant, literature (Bampi et al., 2010; Chau and Wu, 2006; Dieu, 1853; Eleotério et al., 2012; Lim, 2013; Martin-Garcia and Diez, 2012) demonstrates that Hovenia dulcis fruits are a commonly used food in Taiwan, Japan, China and Brazil. Bampi et al. (2010), who studied the composition of Hovenia dulcis fruits and extracts and flour made of the fruits, noted that Hovenia dulcis is widely distributed in southern Brazil, but that there were no literature reports of its use in food products. According to two other references from Brazil, noted by the applicant, Hovenia dulcis is widespread in south Brazil but not well documented (Eleotério et al., 2012) and is considered as an invasive species (Martin-Garcia and Diez, 2012). The applicant has provided a reference for recipes with Hovenia dulcis fruits published in a Brazilian Blog (Sexta-Feira, 2008). According to Chau and Wu (2006), fruits and seeds of Hovenia dulcis can be used as a food ingredient in Taiwan, but not in China. Dieu (1853) noted in his medical and therapeutic compendium that fruits from Hovenia dulcis were tasting like pears when they are ripe, and that local Japanese called the tree 'Siku'. According to a compendium by Lim (2013) on edible medicinal and non-medicinal plants, the ripe fruits and fruit peduncles are edible raw or cooked and can be used to make candies and substitutes for honey and wine; it also has been used as a traditional Chinese medicine for more than 1,000 years to treat alcohol abuse in China. The applicant also provided an inventory handbook from the US Department of Agriculture on 'Perennial Edible Fruits of the Tropics' which indicates the peduncle of Hovenia dulcis as edible parts under the list of 'minor fruits' of Southeast Asia (USDA, 1987). 'Minor fruits' were defined as '[citation] usually not widely distributed. They are often small. They may only grow wild and have little or no potential for cultivation and marketing. Most probably merit neglect, but some may have the potential to be improved and developed into a major fruit'. The dossier contains a scientific article on dietary supplement use by South Korean adults based on data from the National Complementary and Alternative Medicine Use Survey in 2006 (Ock et al., 2010). According to this article, 5.2% of South Korean adults had consumed food supplements with 'Hovenia dulcis' in 2006. There was no information, however, in this article about the dose or duration of the intake or any other specific information on the consumption pattern or on the consumed supplements. According to the applicant, Hovenia dulcis has been permitted for food use by the KFDA. The applicant also stated that Hovenia dulcis fruits and peduncles are consumed also as a fresh or dried fruit in Korea at an estimated quantity of 200,000 kg/year (no reference provided). The dossier also contains a table presenting 11 food products (eight beverages and three food supplements) from different companies with 'Hovenia dulcis extracts' on the market in South Korea (Table 6). According to the applicant, a product similar to the NF is already on the market in South Korea. Table 6. Hovenia dulcis extract products on the market in South Korea in 2013 Type of Product Country Daily Dose Yearly Total Consumption USD Volume in Units Beverage Korea 140 mL (2,460 mg) 80,000,000 40,000,000 bottles Beverage Korea 100 mL (2,460 mg) 2,400,000 600,000 bottles Tablet Korea 2,460 mg/Tablet 60,000,000 600,000 boxes Capsule Korea 2,460 mg/Capsule 250,000 5,000 boxes Tablet Korea 2,460 mg/Tablet 360,000 6,000 boxes Beverage Korea 100 mL (1,000 mg) 24,000,000 6,000,000 bottles Beverage Korea 100 mL 75,000,000 18,750,000 bottles Beverage (Tea Drinks) Korea 350 mL or 500 mL 40,000,000 20,000,000 bottles Beverage (Tea Drinks) Korea 350 mL or 500 mL 25,000,000 16,600,000 bottles Beverage (Tea Drinks) Korea 500 mL 7,000,000 3,880,000 bottles Beverage (Tea Drinks) Korea 500 mL 5,000,000 2,500,000 bottles 3.7 Proposed uses and use levels and anticipated intake 3.7.1 Target population The applicant intends to target the general adult population. 3.7.2 Proposed uses and use levels The applicant intends to use the NF as an ingredient in food supplements in capsule or tablet form taken up to 6 times a day and with a maximum daily intake of 2.5 g. 3.7.3 Precautions and restrictions of use According to the applicant, the NF is not recommended for children, pregnant women and individuals with chronic diseases such as liver malfunction. Following a request by EFSA to provide the rationale for these restrictions of use, the applicant indicated that no studies have been performed on pregnant women and children and that recommendations of the Swedish Food Administration regarding food supplements were followed. 3.8 Absorption, distribu
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