Safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97
2017; Wiley; Volume: 15; Issue: 5 Linguagem: Inglês
10.2903/j.efsa.2017.4777
ISSN1831-4732
AutoresDominique Turck, Jean‐Louis Bresson, Barbara Burlingame, Tara Dean, Susan J. Fairweather‐Tait, Marina Heinonen, Karen Ildico Hirsch‐Ernst, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Monika Neuhäuser‐Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Marco Vinceti, Peter Willatts, Karl‐Heinz Engel, Rosangela Marchelli, Annette Pöting, Morten Poulsen, Josef Schlatter, Wolfgang Gelbmann, Henk Van Loveren,
Tópico(s)Pharmacology and Obesity Treatment
ResumoEFSA JournalVolume 15, Issue 5 e04777 Scientific OpinionOpen Access Safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)Search for more papers by this authorDominique Turck, Dominique TurckSearch for more papers by this authorJean-Louis Bresson, Jean-Louis BressonSearch for more papers by this authorBarbara Burlingame, Barbara BurlingameSearch for more papers by this authorTara Dean, Tara DeanSearch for more papers by this authorSusan Fairweather-Tait, Susan Fairweather-TaitSearch for more papers by this authorMarina Heinonen, Marina HeinonenSearch for more papers by this authorKaren Ildico Hirsch-Ernst, Karen Ildico Hirsch-ErnstSearch 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 authorMonika Neuhäuser-Berthold, Monika Neuhäuser-BertholdSearch for more papers by this authorGrażyna Nowicka, Grażyna NowickaSearch for more papers by this authorKristina Pentieva, Kristina PentievaSearch for more papers by this authorYolanda Sanz, Yolanda SanzSearch for more papers by this authorAlfonso Siani, Alfonso SianiSearch for more papers by this authorAnders Sjödin, Anders SjödinSearch for more papers by this authorMartin Stern, Martin SternSearch for more papers by this authorDaniel Tomé, Daniel ToméSearch for more papers by this authorMarco Vinceti, Marco VincetiSearch for more papers by this authorPeter Willatts, Peter WillattsSearch for more papers by this authorKarl-Heinz Engel, Karl-Heinz EngelSearch for more papers by this authorRosangela Marchelli, Rosangela MarchelliSearch for more papers by this authorAnnette Pöting, Annette PötingSearch for more papers by this authorMorten Poulsen, Morten PoulsenSearch for more papers by this authorJosef Schlatter, Josef SchlatterSearch for more papers by this authorWolfgang Gelbmann, Wolfgang GelbmannSearch for more papers by this authorHenk Van Loveren, Henk Van LoverenSearch for more papers by this author EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)Search for more papers by this authorDominique Turck, Dominique TurckSearch for more papers by this authorJean-Louis Bresson, Jean-Louis BressonSearch for more papers by this authorBarbara Burlingame, Barbara BurlingameSearch for more papers by this authorTara Dean, Tara DeanSearch for more papers by this authorSusan Fairweather-Tait, Susan Fairweather-TaitSearch for more papers by this authorMarina Heinonen, Marina HeinonenSearch for more papers by this authorKaren Ildico Hirsch-Ernst, Karen Ildico Hirsch-ErnstSearch 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 authorMonika Neuhäuser-Berthold, Monika Neuhäuser-BertholdSearch for more papers by this authorGrażyna Nowicka, Grażyna NowickaSearch for more papers by this authorKristina Pentieva, Kristina PentievaSearch for more papers by this authorYolanda Sanz, Yolanda SanzSearch for more papers by this authorAlfonso Siani, Alfonso SianiSearch for more papers by this authorAnders Sjödin, Anders SjödinSearch for more papers by this authorMartin Stern, Martin SternSearch for more papers by this authorDaniel Tomé, Daniel ToméSearch for more papers by this authorMarco Vinceti, Marco VincetiSearch for more papers by this authorPeter Willatts, Peter WillattsSearch for more papers by this authorKarl-Heinz Engel, Karl-Heinz EngelSearch for more papers by this authorRosangela Marchelli, Rosangela MarchelliSearch for more papers by this authorAnnette Pöting, Annette PötingSearch for more papers by this authorMorten Poulsen, Morten PoulsenSearch for more papers by this authorJosef Schlatter, Josef SchlatterSearch for more papers by this authorWolfgang Gelbmann, Wolfgang GelbmannSearch for more papers by this authorHenk Van Loveren, Henk Van LoverenSearch for more papers by this author First published: 12 May 2017 https://doi.org/10.2903/j.efsa.2017.4777Citations: 6 Correspondence: nda@efsa.europa.eu Requestor: European Commission following an application by Ocean Spray Cranberries, Inc. Question number: EFSA-Q-2016-00325 Panel members: Jean-Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts. Adopted: 4 April 2017 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 Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 'cranberry extract powder' as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. The NF contains about 55–60% proanthocyanidins (PACs). The Panel considers that the information provided on the composition, the specifications, batch-to-batch variability and stability of the NF is sufficient and does not raise safety concerns. Cranberry extract powder is produced from cranberry juice concentrate through an ethanolic extraction using an adsorptive resin column to retain the phenolic components. The Panel considers that the production process is sufficiently described and does not raise concerns about the safety of the novel food. The NF is intended to be added to beverages and yogurts to provide 80 mg PACs per serving. The target population is the adult general population. The mean and 95th percentile estimates for the all-user intakes from all proposed food-uses are 68 and 192 mg/day, respectively, for female adults, and 74 mg/day and 219 mg/day, respectively, for male adults. Taking into account the composition of the novel food and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. While no animal toxicological studies have been conducted on the NF, a number of human clinical studies have been conducted with cranberry products. Considering the composition, manufacturing process, intake, history of consumption of the source and human data, the Panel considers that the data provided do not give reasons for safety concerns. The Panel concludes that the cranberry extract powder is safe as a food ingredient at the proposed uses and use levels. Summary Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 'cranberry extract powder' as a novel food (NF) ingredient submitted pursuant to Regulation (EC) No 258/971 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The assessment, which follows the methodology set in Commission Recommendation 97/618/EC is based on the data supplied in the original application, the initial assessment by the competent authority of France, the concerns and objections of the other Member States and the responses of the applicant. The NF is prepared from the juice concentrate of sound, mature berries of the cranberry cultivar (Vaccinium macrocarpon). According to the specification, the NF contains 55–60% proanthocyanidins (PACs) as measured by OSC-DMAC (colorimetric analysis using dimethylaminocinnamaldehyde (DMAC) with isolated cranberry PACs as a standard compound). Other main constituents of the NF are anthocyanins, other phenolic compounds such as flavonols, sugars and organic acids. The Panel considers that the information provided on the composition, the specifications, batch-to-batch variability and stability of the NF is sufficient and does not raise safety concerns. Cranberry extract powder is produced from cranberry juice concentrate through an ethanolic extraction using an adsorptive resin column to remove sugars and organic acids and to retain the phenolic components which are eluted, concentrated and spray-dried to yield the powder. Silicon dioxide is added as a flow agent and maltodextrin as a carrier. The manufacturing process is performed according to good manufacturing practice (GMP). About 66 mL of pure (7.5 Brix) cranberry juice is needed to produce 145 mg of cranberry extract containing 33–36 mg PACs (about 80 mg measured by OSC-DMAC) and this amount approximately corresponds to a 240 mL serving of Ocean Spray's 27% 'cranberry juice classic' currently on the market. The Panel considers that the production process is sufficiently described and does not raise concerns about the safety of the novel food. The NF is intended to be added to fruit-flavoured drinks (regular and low calorie), isotonic drinks (including electrolyte types), tea drinks (ready-to-drink, iced), vitamin enhanced waters, yogurts and yogurt drinks with the intention to provide 80 mg PACs per serving (based on OSC-DMAC method). According to the applicant, the target population is the adult general population and the NF is not intended to be marketed to children. When assuming that 240 mL of 27% cranberry juice contains on the average 156 mg PACs, the mean and 95th percentile of an adult female consumer is about 200 and 1,200 mL, respectively, cranberry juice per day. The corresponding mean and 95th percentile intakes of PACs from cranberry juice would be about 130 and 780 mg PACs per day for adult females, and 108 and 246 mg for adult males. For female adults, the mean and 95th percentile estimates for the all-user intakes of PACs from all proposed food-uses of the NF were 68 mg/day and 192 mg/day, respectively. The mean and 95th percentile estimates for the all-user intakes for male adults of PACs from all proposed food-uses also were 74 and 219 mg/day, respectively. Taking into account the composition of the novel food and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. While no animal toxicological studies have been conducted on the NF, a number of human clinical studies have been conducted with cranberry products other than the NF. None of these studies have indicated adverse effects caused by cranberry consumption. In addition, three clinical studies have been conducted with the NF. The Panel notes that the PACs dose of these clinical studies is high as compared to the conditions of use of the NF. The Panel considers these studies do not raise safety concerns of the NF. Based on the data provided, and considering the composition, manufacturing process, anticipated intake, history of consumption of the source and human studies, the Panel considers that the consumption of the cranberry extract powder under the proposed conditions of use does not raise safety concerns. The Panel concludes that the cranberry extract powder is safe as a food ingredient at the proposed uses and use levels. 1 Introduction 1.1 Background and Terms of Reference as provided by the European Commission On 20 September 2011, the company Ocean Spray Cranberries Inc. submitted a request in accordance with Article 4 of the Novel Food Regulation (EC) No 258/97 to place on the market cranberry extract powder as a novel food (NF) ingredient. On 11 December 2014, the competent authority of France forwarded to the Commission its initial assessment report, which came to the conclusion that cranberry extract powder meets the criteria for acceptance of a NF defined in Article (3) 1 of Regulation (EC) No 258/97. On 16 January 2015, the Commission forwarded the initial assessment report to the other Member States. Several Member States submitted comments or raised objections. The concerns of a scientific nature raised by the Member States can be summarised as follows: The specification of the product is incomplete. In particular, the application and the documents submitted subsequently contain discrepancies in the information on the concentration of proanthocyanidins (PACs) and intake amounts. There are no studies in children on the safety and tolerance of PACs intake at the 95th percentile of the anticipated intake. The cumulative intake of polyphenols from the NF for children between 1 and 3 years of age together with other sources of polyphenols in a child's diet would bring total exposure to polyphenols to a level 2–7 times higher than that of adults. Given that there are known adverse effects related to the overconsumption of polyphenols, reassurance is required that daily levels of total polyphenols exposure inclusive of the intakes from the NF would be safe for children. Possible side effects can be observed from long-term elevated polyphenol intake, for example inhibition of iron and folic acid absorption, interaction with other food components in the stomach, such as inhibiting triglyceride absorption by restricting pancreatic lipase (Sugiyama et al., 2007), interaction with carrier proteins (Faria et al., 2006), potential interaction with warfarin (Pham and Pham, 2007). Information on the protein content is needed to confirm that an allergy risk is unlikely. In accordance with Article 29(1)(a) of Regulation (EC) No 178/2002, the European Commission asks the European Food Safety Authority (EFSA) to provide a scientific opinion by carrying out the additional assessment for cranberry extract powder as a novel food ingredient in the context of Regulation (EC) No 258/97. 2 Data and methodologies 2.1 Data The assessment of the safety of this novel food ingredient (NFI) is based on data supplied in the original application, the initial assessment by the competent authority of France, the concerns and objections of the other Member States and the responses of the applicant. The data are required to comply with the information required for novel foods of Subclass 2.1: 'the source of the novel food has a history of food use in the Community', i.e. structured schemes I, II, III, IX, X, XI, XII and XIII of Commission Recommendation 97/618/EC. In the current opinion, these structured schemes are listed in Sections 3.1–3.9. The intention of the applicant is to add 'cranberry extract powder' to beverages, milk and other dairy products. The target population is the general population. This assessment concerns only risk that might be associated with consumption under the proposed conditions of use, and is not an assessment of the efficacy of the NF with regard to any claimed benefit. 2.2 Methodologies The assessment follows the methodology set out in Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council. 3 Assessment 3.1 Specification of the Novel Food (NF) The NF is prepared from the juice concentrate of sound, mature berries of the cranberry cultivar (Vaccinium macrocarpon). The NF is a fine, free-flowing deep red powder obtained from spray drying of chromatographically isolated Cranberry Extract Liquid – Type R, standardised to the PACs content with maltodextrin as a carrier and silicon dioxide as a flow agent (Table 1). Table 1. Specifications proposed by the applicant Parameters Range Method of Measurement Moisture (% w/w) ≤ 4 Gravimetric, loss of drying (CEM microwave oven or equivalent) PACs (% DWB) OSC-DMAC methoda, c BL-DMAC methodb, c 55.0–60.0 15.0–18.0 OSC-DMAC (25 EtOH wash) using cranberry extract response factor. BL-DMAC using procyanidin A2 standard Total phenolics (GAE, % DWB)c > 46.2 Folin–Ciocalteau using gallic acid standard Solubility 100%, with no visible insoluble particles Powder should dissolve completely in 2 min with agitation Ethanol content (mg/kg) ≤ 100 AOCS Official method Ca 3b-87, hexane residues in fats and oils, or equivalent Screen analysis 100% through 30-mesh screen Rotap with hammer, 5 min Appearance & aroma; as powder Free-flowing, deep red colour. Earthy aroma with no burnt character Sensory Heavy metals Arsenic (ppm) < 3 EPA 200.8 Lead (ppm) < 2 EPA 200.8 Cadmium (ppm) < 10 EPA 200.8 Mercury (ppm) < 1 EPA 200.8 Microbiology Yeast < 100 cfu/g Microbiological methods as described by AOACd, APHAe or BAMf (FDA) Mould < 100 cfu/g Aerobic plate count < 1,000 cfu/g Coliforms < 3 mpn/g or < 10 cfu/g Escherichia coli < 3 mpn/g or < 10 cfu/g Salmonella Absent in 375 g composite sample PAC: proanthocyanidin; DWB: dry weight basis; GAE: gallic acid equivalent; cfu: colony forming unit; mpn: most probably number. a OSC-DMAC method (J. Agric. Food Chem. 1998). b BL-DMAC method (J. Agric. Food Chem. 2010). c The different values for these three parameters are due to the different methods used. d AOAC (Association of Official Analytical Chemists or Association of Analytical Communities). e APHA American Public Health Association). f BAM (Bacteriological Analytical Manual, FDA). Regarding heavy metals, the applicant provided information on the testing of three batches which gave the following ranges: arsenic 71.9–95 ppb, cadmium < 10 ppb, mercury < 10 ppb and lead 42.3–110 ppb. The applicant notes that the NF must comply with regulatory limits for pesticides, herbicides, heavy metals, growth regulators and mycotoxins. In this regard, the applicant points out that the berry juice concentrate used for the manufacture of the product in question complies with the maximum levels of contaminants laid down in Regulation (EC) No 1881/2006. Tests were carried out on at least three different production batches for PACs and the total phenolic content as well as for the content of residual heavy metals (including As, Cd, Hg and Pb) and ethanol, and the content of the flow agent SiO2. According to the specification, the NF contains 55–60% PACs as measured by OSC-DMAC (colorimetric analysis using dimethylaminocinnamaldehyde (DMAC) with isolated cranberry PACs as a standard compound). The PACs content was also analysed using the BL-DMAC method (colorimetric analysis using DMAC with the procyanidin dimer A2 as a standard compound) with a content of 15–18%. Analytical data on the distribution of the PACs monomers, dimers, trimers and larger polymers in the NF was provided. Additional information provided by the applicant indicates that the NF also contains 3.2% anthocyanins, 4.8% sugars and 6.0% organic acids. The residual protein content of the NF is 1.16% as measured by the Dumas method with a limit of quantitation of 1 g/kg. The Panel considers that the information provided on the composition, the specifications and the batch-to-batch variability of the NF is sufficient and does not raise safety concerns. 3.1.1 Stability of the NF Based on the analysis of the PAC content, of anthocyanins and total phenolics, the results of stability tests demonstrate that the cranberry extract powder is stable for 30 months when stored in dry conditions at 25°C. The applicant also provided results (PACs and total phenolic analyses) indicating that cranberry extract powder is stable as incorporated at a level of 45 mg PAC per portion (240 mL) into diet- or water-type beverages for up to 22 weeks at room temperature. Additional stability testing of water-type beverages containing 70 mg PACs (measured by OSC-DMAC) per portion (240 mL) stored at 32°C showed no appreciable change in PACs content during a 12-week period. The Panel considers that the data provided sufficient information with respect to the stability of the NF. 3.2 Effect of the production process applied to the NF Typically, cranberry juice contains sugars, organic acids and phenolic compounds (including flavonols, flavan-3-ols, anthocyanins and PACs). Of the solid material in cranberry juice, 90% are organic acids and sugars (Ocean Spray Cranberries internal compositional cranberry juice database). These phenolic compounds are selectively isolated from the other components of cranberry juice to yield cranberry extract. The applicant provided a detailed description of the production process including a flowchart. Cranberry extract powder is produced from cranberry juice concentrate through an ethanolic extraction using an adsorptive resin column to remove sugars and organic acids, and to retain the phenolic components which are eluted, concentrated and spray-dried to yield the powder. Silicon dioxide is added as a flow agent and maltodextrin as a carrier. The material is packaged in two polyethylene bags, each with a twist tie, and placed in a standard fibre drum. The outer bag contains one desiccant sachet. A second desiccant sachet is placed at the top of the drum, outside the outer bag. Each drum contains about 22.7 kg powder net. The manufacturing process is performed according to good manufacturing practice (GMP). The material shall be processed under sanitary conditions in accordance with GMP regulations FDA 21 CFR Part 110. Additionally, a HACCP plan shall be documented, reviewed, and implemented. In response to an EFSA request to provide information on the production yield (i.e. how much cranberry juice is needed to produce a defined amount of the NF), the applicant informed that 66 mL of pure (7.5 Brix) cranberry juice is needed to produce 145 mg of cranberry extract containing 33–36 mg PACs (about 80 mg measured by OSC-DMAC) and that this amount approximately corresponded to a 240 mL serving of Ocean Spray's 27% 'cranberry juice classic' currently on the market. The Panel considers that the production process is sufficiently described and does not raise concerns about the safety of the novel food. 3.3 History of the organism used as a source of the NF The source of the NF is cranberry (Vaccinium macrocarpon) juice. According to ANSES (2013), cranberry juice has a history of food use in European Union (EU). According to the applicant, cranberry juice products are sold globally and are marketed without limitations on their consumption. The provided consumption data concern exclusively for the US. According to the US Agricultural Marketing Resource Center, the annual consumption of cranberries per person is about 1 kg cranberries, almost entirely in the form of juice or juice blends (AGMRC, 2016). The estimated mean per-user daily intake of cranberries by male and female adults in the US is 23.6 and 42.1 g, respectively, and the estimated 90th percentile per-user daily intake of cranberries is 69.3 and 103.9 g/day, respectively (CDC, 2006). These intake estimates are based on food consumption data included in the National Center for Health Statistics' (NCHS), National Health and Nutrition Examination Surveys (NHANES) (survey data from years 2003–2004, 2005–2006). According to the NHANES of 2005–2008, the mean per-user daily intake consumption of cranberry juice (100% cranberry juice, cranberry juice cocktail, low-calorie cranberry juice cocktail and blended cranberry drinks) was 221 mL. Duffey and Sutherland (2013) considered that the amount of cranberry juice in products to be around 27% due to the astringency of cranberry juice. The applicant concurs with the assumption that 'cranberry juice' consumption as recorded by NHANES represents beverages with about 27% cranberry juice and not the pure juice. In response to a request by EFSA, the applicant provided data on the adults' consumption of cranberry beverage in the US NHANES (2013–2014), presented in Table 2 (per consumer only) and Table 3 (per kg body weight (bw), consumer only). Following a request from EFSA regarding data on cranberry juice consumption by children and regarding the target population, the applicant provided intake estimates also for children, but confirmed that children are not the target group. Table 2. Estimated daily intake of cranberry beverage in the US by adults Population group Age group (years) Consumer-only Intake (mL/day) %a n Mean 90th percentile 95th percentile 97.5th percentile Female Adults ≥ 20 2.1 60 203 310 1,201 1,201 Male Adults ≥ 20 1.5 30 166 314 379 521 a Percentage of consumers among survey population. Source: 2013–2014 NHANES Data. Table 3. Estimated daily per kilogram body weight intake of cranberry beverage in the US by adults Population group Age group (years) Consumer-only Intake (mL/kg bw per day) %a n Mean 90th percentile 95th percentile 97.5th percentile Female adults ≥ 20 2.1 60 2.2 5.0 7.4 7.4 Male adults ≥ 20 1.5 30 1.9 2.8 6.4 7.2 Bw: body weight. a Percentage of consumers among survey population. The applicant proposed to establish the safety of the NF on the basis of the history of consumption of its source (cranberry juice), along with the provided compositional data on the source and on the NF. Table 4 presents a comparison between the composition of pure (100%, 7.5 brix) and 27% cranberry juice, cranberry juice cocktail and the contents of cranberry extract powder constituents at the intended use level of the NF in beverages. According to the applicant, 8 oz (≈ 240 mL) of 100% unsweetened cranberry juice contain 576 mg PACs, 736 mg phenolics and 53 mg anthocyanins (Table 4). These values present the mean of 64 samples over several years. A mean PACs content of 156 mg/240 mL has been calculated by EFSA for 27% cranberry juice (27/100 of 576 mg PACs). To confirm this figure, the applicant referred to analyses over the shelf-life of cranberry juice cocktail samples have resulted to a range of PACs content from 70 to 140 mg/240 mL.. Table 4. Constituents of existing cranberry juice products and of beverages based on proposed use levels of cranberry extract powder and naturally occurring constituents provided by the applicant Constituents (mg/240 mLa) Cranberry beverage products Proposed uses in beverages 100% cranberry juice (unsweetened) 27% cranberry juicec Cranberry juice Cocktail Cranberry extract powder 0 0 0 144d Proanthocyanidins 576b (481–916) 156 90 (70–140) 76.8d Phenolics 736 199 211 61 Anthocyanins 53 14 12 12 Quinic acid 2,304 623 648 0.1 Malic acid 1,872 506 504 0.4 Citric acid 2,520 681 672 0.4 Quercetin – – 3 0.4 Galacturonic acid – – 288 – Dextrose 7,512 2,030 16,372 0 Fructose 1,824 493 12,408 0 Sucrose 120 32 1,512 0 Ascorbic acid Not provided – 69.6 – Water (mL) 222 – 207 – a 240 mL ≈ 8 oz which is the amount considered as one portion size by the applicant. b Mean and range on the basis of 64 samples over several years. c These values are calculated on the basis of the provided figures for pure (100%) cranberry juice and does not consider any addition other than water, noting that existing 27% cranberry juices on the market may contain higher amounts of some of these constituents deriving from other fruit/vegetable juice used for blending. d Calculated on the basis of a level equivalent to 150 mg cranberry extract powder and 80 mg PACs (by OSC-DMAC) per 250 mL beverage. When assuming that 240 mL of 27% cranberry juice contains on average 156 mg PACs (0.65 mg/mL) (Table 4, measured by the OSC-DMAC method), and that the mean and 95th percentile of an adult female consumer is about 200 and 1,200 mL, respectively, cranberry juice per day (according to Table 2), then the resulting estimated mean and 95th percentile PACs intake from cranberry juice products would be about 130 and 780 mg PACs per day. The mean and 95th percentile daily PACs per kg bw for adult females were 2.2 and 7.4 mL (Table 3) which would correspond to a PACs intake of 1.43 and 4.81 mg/kg bw per day, respectively. For male adults, the mean and 95th percentile intakes of PACs from cranberry juice would be 108 (1.24 mg/kg bw) and 246 mg (4.16 mg/kg bw) per day, respectively. 3.4 Anticipated intake/extent of use of the NF 3.4.1 Uses and use levels Cranberry extract powder is intended to be added to fruit-flavoured drinks (regular and low calorie), isotonic drinks (including electrolyte types), tea drinks (ready-to-drink, iced), vitamin-enhanced waters, yogurts and yogurt drinks with the intention to provide 80 mg PACs per serving (based on OSC-DMAC method). In order to achieve this level, the proposed
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