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International Food Risk Analysis Journal Food Risk Analysis Communication Issued By Health Canada’s Food Directorate Proposed Approach to Setting Maximum Levels for Vitamins, Mineral Nutrients, and Amino Acids in Beverages, Beverage Mixes and Concentrates, Powders, Bars and Confectionaries Eligible for a Temporary Marketing Authorization in Canada Chantal Martineau1, Jennifer Barber1, Jesse Bertinato1, Steve Brooks1, Eunice Chao1, Janice Daoust1, Nora Lee1, Lindsay Lukeman1, Robin J. Marles1 and Natasha Hinkson1 1 Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch, Health Canada Health Canada’s Food Directorate is making available this paper, following an internal peer review by Food Directorate scientific and regulatory experts, to seek comments from peer scientists, regulators and stakeholders prior to finalization. This paper is open for comment commencing June 2, 2014 and closing on August 2, 2014 (60 calendar days). Only comments of a scientific nature will be considered in developing the final version of this document. Authors will strive to document how the various comments received, when deemed relevant, were considered in amending this document and in shaping the final version that will be published. Comments may be submitted in writing by regular mail or electronically at the address indicated below. If you are submitting your comments electronically, please use the phrase “Setting of Vitamin, Mineral Nutrients and Amino Acids Maximum Levels” in the subject box of your email. Submission Management and Information Unit 251 Sir Frederick Banting Driveway Tunney’s Pasture, PL: 2202E Ottawa, Ontario K1A 0L2 E-mail: [email protected] © 2014 Health Canada. Licensee InTech. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 1. Introduction In recent years, a number of food products containing added vitamins, mineral nutrients and amino acids not in compliance with the Food and Drug Regulations (FDR) were introduced into the Canadian marketplace as natural health products (NHPs) through the early implementation of the Natural Health Products Regulations. These were mainly beverages and a small number of other food formats. Health Canada has determined, based on public perception, history of use, product representation to consumers and product format, in accordance with the classification guidance outlined on its website (Health Canada, 2013) that many of these products fit the definition of a food and are therefore more appropriately regulated under the food regulatory framework. In contrast, Natural Health Products encompass products more commonly sold in dosage forms such as pills, capsules and tinctures. Int Food RiskDaoust, Anal J, 2014, 4:3 Chantal Martineau, Jennifer Barber, Jesse Bertinato, Steve Brooks, Eunice Chao, Janice Nora Lee, Lindsay Lukeman, Robin J. Marles and Natasha Hinkson: Food Risk Analysis Communication 1 As a result, these products were transitioned from the natural health products regulatory framework to the food regulatory framework in 2012. The nature of these food products challenges the traditional premise of food regulations, which has been based on a model of food consumption generally without conditions (ad libitum). While there appear to be no immediate safety concerns with these products, there remain a number of outstanding data and information gaps in order to inform potential regulatory requirements under the FDR for these products and to appropriately manage any potential health risk associated with their consumption. Examples of data gaps include, but are not limited to, consumption patterns in the dietary context as food and the effectiveness of labelling as a risk mitigation tool. As a result, Temporary Marketing Authorizations (TMAs), a food regulatory tool in Canada (The Minister of Justice, 2014), have been issued to allow market access to safe products for the purpose of gathering in-market data to inform appropriate regulatory amendments. These products are subject to all of the requirements applicable to food products, including the provisions of the Food and Drugs Act and its Regulations and the Consumer Packaging and Labelling Act and its Regulations, except for those requirements of the Food and Drug Regulations which have been exempted as set out in a Temporary Marketing Authorization Letter. product’s label. Setting maximum levels for the purpose of issuing TMAs will also improve predictability of access to the Canadian market, during the TMA eligibility period. It is important to note that these proposed maximum levels may be subject to change once data gathered during the TMA period is analyzed. Therefore, the proposed levels should not be construed as final regulatory requirements for these products. 2. Proposed Approach to Setting Maximum Levels for Vitamins, Mineral Nutrients, and Amino Acids Health Canada’s Food Directorate used a risk-based approach to set the proposed maximum levels of addition supporting the issuance of TMAs. The levels are not related to nutritional requirements and they are not intended as recommended levels for addition. It is important to note that the nutrients listed and their maximum levels are subject to change based on future review as new evidence becomes available. The proposed approach was followed for nutrients that are in products for which manufacturers are seeking access to the Canadian market or that are already available. The addition of other nutrients will be subject to case-by-case analysis in order to set such maximum levels. 3. Determining Maximum Levels per Serving Health Canada is developing additional requirements for these types of products to alert the consumer to their uniqueness and to help reduce the potential risks associated with their inappropriate consumption. These include compositional and labelling requirements. With regards to compositional requirements, Health Canada is proposing to set maximum levels for the addition of vitamins, mineral nutrients and amino acids. This report describes the scientific and risk analysis approach followed by scientists and standard setters in Heath Canada’s Food Directorate for setting maximum levels for the addition of vitamins, mineral nutrients and amino acids in beverages, beverage mixes and concentrates, bars and confectionaries that will be permitted for the purposes of issuing TMAs for eligible products. TMAs will be valid for a number of years to enable Heath Canada to collect data to estimate actual consumption of these products and better determine nutrient exposure. The research conducted through the TMA period is expected to help estimate the usual and upper levels of intake of these products in order to understand their impact on intakes of vitamins, mineral nutrients and amino acids by the Canadian population, as well as the effectiveness of cautionary statements on the 2 Int Food Risk Anal J, 2014, 4:3 The main goal of the proposed approach to establishing maximum levels for vitamins, mineral nutrients and amino acids is to help ensure that their addition to the foods receiving TMAs does not contribute to excessive intakes. A general approach was developed for vitamins and mineral 1 nutrients with a Tolerable Upper Intake Level (UL) established by the Institute of Medicine (IOM). For the general approach, maximum levels were determined by adding the 95th percentile of daily dietary intake from Canadian Community Health Survey (Health Canada et al., 2009), unless otherwise noted, to the estimated intake from 2 supplements , and subtracting this total from the UL. This provided a maximum daily intake that could be permitted for these foods for each nutrient. This was then divided by 1 A Tolerable Upper Intake Level (UL) is the highest level of continuing daily nutrient intake that is likely to pose no risk of adverse health effects in almost all individuals in the life-stage group for which it has been designed (IOM, 2006). 2 An assumed value for Canadian supplement intake has been estimated by determining the highest level of each nutrient found in the top 5 selling multivitamin/mineral supplements for children and adults currently marketed in Canada, based on an AC Nielsen market survey (Nielsen Market Track, 2012). five to allow for the possibility that consumers might have up to 5 servings of these food products in a day. The 95th percentile of dietary intake was selected as a reference value in order to address potential health risks from overconsumption in agreement with the approach for the safe addition of vitamins and minerals to foods recommended by Flynn et al. (2003) and Rasmussen et al. (2006). To ensure safe intakes from added nutrients, it is necessary to take into account individuals who already consume high levels of nutrients from foods. Thus, the 95th percentile represents individuals who have intakes considerably above the population mean, i.e., those in the top 5% of consumption for each nutrient (Flynn et al., 2003). In the case of a few nutrients (folic acid, nicotinic acid, iodine and iron) with a UL, the general approach described above was not used because an overriding issue was identified to justify the decision not to permit their addition to foods eligible for TMAs. Elevated physiological status in certain segments of the Canadian population was used to justify the decision for folic acid and iodine. In the case of nicotinic acid, because of the potential for flushing associated with this form of the nutrient, it is recommended that the niacinamide form be used as a source of niacin. It is also proposed that iron not be permitted for TMA products as it can be a hazard for those with undiagnosed hemochromatosis. Where there was no UL or other information was determined more appropriate (niacinamide and vitamin E), different approaches were adopted depending on the nutrient. The maximum levels per serving are meant to apply to the declared nutrient amount and include both naturally occurring and added amounts. 4. Setting Maximum Levels by Target Population and Risk Categories In the case of many nutrients, the proposed approach described below differentiates between foods intended for the general population (i.e., including children) and those intended for adults only. In particular, for certain nutrients with a UL1, more than one maximum level has been set to account for this difference as ULs for children are generally lower than ULs for adults. It is proposed that a food permitted to use levels above those for the general population but below the maximum levels specified for adults only be clearly labelled with the cautionary statement “For adults only”. Vitamins and mineral nutrients are not all equal with respect to the human body’s ability to metabolize and eliminate excess intake. Some are so efficiently handled that no adverse effects have been associated with excess intake from food or supplements, although this does not mean that there is no potential for adverse effects resulting from high intakes. In some cases the majority of Canadian consumers already consume as much as or more than the UL, so additional food sources of intake are not advisable. Other vitamins and mineral nutrients have well known toxicity in excess, either to all consumers or to particular at-risk subpopulations. Since maximum levels thus cannot be set for vitamin and mineral nutrients as a single group, nutrients have been classified into five categories based on risk and intended target population. The five tables below provide information on: 1) Vitamins or Mineral Nutrients not Acceptable for Addition 2) Vitamins or Mineral Nutrients only Permitted to be Added to Products Targeted to Adults 3) Vitamins or Mineral Nutrients with a Different Maximum Level for Products Targeted to Adults and to the General Population 4) Vitamins or Mineral Nutrients with Only One Maximum Level Set for All Populations 5) Vitamins for which No Maximum Level has been Set at this Time. 4.1 Vitamins or Mineral Nutrients not Acceptable for Addition Certain nutrients have the potential for considerable risk for the general population, for children or for a specific vulnerable population. Table 1 includes nutrients not permitted to be added to TMA products and the rationale for the proposed approach. 4.2 Vitamins or Mineral Nutrients only Permitted to be added to Products Targeted to Adults It is recommended that nutrients listed in Table 2 be permitted to be added to products targeted to adults only because of the risk of exceeding the UL for these nutrients in children. These nutrients are therefore not permitted to be added to products targeted to the general population. Under the proposed approach, products containing these nutrients will be required to have an indication “For adults only” on their label. Vitamin A (retinol) It is recommended that Vitamin A in the form of retinol and its derivatives (e.g., retinyl acetate, retinyl palmitate) not be permitted for addition to products targeted to the general population because, based on nutrient intake data (Health Canada et al., 2009), the 95th percentile of food intake is above the UL for children 4-8 years of age. The adverse effect associated with exceeding the UL is liver toxicity (IOM, 2001). Chantal Martineau, Jennifer Barber, Jesse Bertinato, Steve Brooks, Eunice Chao, Janice Daoust, Nora Lee, Lindsay Lukeman, Robin J. Marles and Natasha Hinkson: Food Risk Analysis Communication 3 Nutrient Folic acid1 Reason A large proportion (53-73%) of the Canadian population has blood values associated with intakes above the UL (MacFarlane et al., 2011). Adverse effects associated with exceeding the UL is masking and potentially delaying diagnosis of vitamin B12 deficiency. Nicotinic acid1 Has known side effect and niacinamide can be used more safely in foods. Adverse effects associated with exceeding the UL is flushing of the skin. Calcium The 95th percentile of combined food and supplement intake exceeds the UL for females 51-70 years of age (Health Canada et al., 2009). Adverse effects associated with exceeding the UL is kidney stones. Manganese2 The 95th percentile of combined food and supplement intake exceeds the UL for children 4-8 years of age and for adults. Adverse effects associated with exceeding the UL is neurotoxicity. Vitamin K Hazard for those on blood thinning medications. Iodine1 The 95th percentile of estimated intake3 exceeds the UL for children 4-8 years of age and for adults. Adverse effects associated with exceeding the UL is thyroid dysfunction. Iron1 Hazard for those with undiagnosed hemochromatosis. Hereditary hemochromatosis is an inherited disorder of iron metabolism which affects 1 in every 200–300 individuals of Northern European descent (Lyon, 2001). 1The general approach to determine maximum level for nutrients with a UL was not used in the case of this nutrient due to an overriding issue as stated in the 2nd column. 2 Canadian intake data not available; therefore, U.S. intake data from the Total Diet Study was used to calculate maximum level (IOM, 2001). 3 Daily iodine intake was estimated using urinary iodine concentrations from Canadian Health Measures Survey: Cycle 1 Data Tables (Statistics Canada, 2013). Table 1. Vitamins or Mineral Nutrients not Acceptable for Addition Nutrient Vitamin A [retinol and its derivatives (e.g., retinyl acetate, retinyl palmitate] Zinc Maximum Level (per serving) 125 µg 0.4 mg Table 2. Vitamins or Mineral Nutrients only Permitted to be Added to Products Targeted to Adults Zinc It is recommended that zinc not be permitted to be added to products targeted to the general population because, based on nutrient intake data (Health Canada et al., 2009), the 95th percentile of food intake is above the UL for children 4-8 years of age. The adverse effect associated with exceeding the UL is reduction of copper status (IOM, 2001). 4.3 Vitamin or Mineral Nutrients with a Different Maximum Level for Products Targeted to Adults and to the General Population For the group of nutrients with a UL listed in Table 3, different maximum levels have been recommended for products intended for the general population (i.e., including children) and those intended for adults only. To set the maximum level for products targeted to the general population, the UL for the most vulnerable population was used, which was 4-8 year olds in the majority of cases. The maximum level for adults was set using the UL for the most vulnerable adult group. For products to be permitted to contain the maximum levels that are specified for adults only, they must have an indication “For adults only” on their label. 4 Int Food Risk Anal J, 2014, 4:3 Nutrient Population1 Maximum Level (per serving) Choline2 General Population 54 mg Adults Only 492 mg Niacinamide3 General Population 34 mg Adults Only 158 mg Vitamin B6 General Population 7 mg Adults Only 18 mg Vitamin C General Population 66 mg Adults Only 305 mg Vitamin D General Population 11 µg Adults Only 13 µg Copper4 General Population 342 µg Adults Only 1070 µg Magnesium General Population 12 mg Adults Only 57 mg Molybdenum5 General Population 80 µg Adults Only 351 µg Selenium6 General Population 6 µg Adults Only 23 µg 1 For products to be permitted to use the maximum levels that are specified for adults only they must have an indication “For adults only” on their label. 2 Canadian intake data not available; therefore, intake estimated from the Dietary Reference Intake Report (IOM, 1998). 3 The maximum level was calculated using the UL from the European Commission Scientific Committee on Food as opposed to the IOM UL. 4 Canadian intake data not available; therefore, U.S. intake data from National Health and Nutrition Examination Survey III (NHANES III) was used to calculate the maximum level (IOM, 2001). 5Canadian intake data not available; therefore, intake was estimated from the Dietary Reference Intake Report (IOM, 2001). 6Canadian intake data not available; therefore, U.S. intake data from NHANES III was used to calculate the maximum level (IOM, 2000). Table 3. Vitamin or Mineral Nutrients with a Different Maximum Level for Products Targeted to Adults and to the General Population 4.4 Vitamins or Mineral Nutrients with One Maximum Level Set for All Populations For the nutrients in this group, only one maximum level was set for each nutrient for all population groups. In all cases except for phosphorus, a value other than the IOM UL was used to set the level, because in some cases the IOM has not set a UL or even where there was such a UL, new information relative to toxicity has emerged since the publication of the IOM report. • • Nutrient Beta-carotene Maximum Level (per serving) 1040 µg • Vitamin E 5 mg Chromium(III)1 30 µg • Phosphorous 185 mg Potassium 300 mg Chromium (VI) is a form of chromium that is not permitted for addition to foods. It is found in the environment as a chemical by-product and has been shown to be carcinogenic when inhaled (IOM, 2001). 1 Table 4. Vitamins or Mineral Nutrients with One Maximum Level Set for All Products Details on setting maximum levels for nutrients listed in Table 4 Beta-Carotene The IOM did not set a UL for beta-carotene due to insufficient data (IOM, 2000). The maximum level was derived using the United Kingdom Expert Group on Vitamins and Minerals Safe Upper Level for daily consumption of supplemental beta-carotene over a lifetime (7000 µg/d) (Expert Group on Vitamins and Minerals, 2003) and subtracting the estimated consumption from supplements (1800 µg/d) to derive a value of 5200 µg/d. This value was then divided by five to arrive at a maximum level of 1040 µg/serving. Vitamin E The IOM set the adult UL at 1000 mg alpha-tocopherol (AT) (which applies to supplements, fortified foods, or a combination of the two) based on the potential for haemorrhagic effects (IOM, 2000). However, since the publication of that report, a number of other studies have cast doubt on the safety of vitamin E in certain vulnerable subpopulations at intakes below the UL. Health Canada Food Directorate’s proposed approach to set a maximum level for Vitamin E followed the rationale described below. • A Lowest Observed Adverse Effect Level (LOAEL) of 180 mg AT/d (400 IU “synthetic” or 268 IU “natural” vitamin E) (PEN, 2013) was determined based on two clinical trials which found that supplemental vitamin E may increase the risk of prostate cancer and second primary cancer in healthy older (≥ 50 years of age) men and patients undergoing radiation therapy, respectively (Klein et al., 2011); (Bairati et al., 2005). An uncertainty factor of 3 was applied for the extrapolation of the LOAEL of 180 mg AT to reach a No Observed Adverse Effect Level (NOAEL) (Expert Group on Vitamins and Minerals, 2003) equalling 60 mg; The safe upper level for daily consumption of vitamin E added to foods is therefore taken to be 60 mg AT/d; The Canadian consumption from supplements was estimated to be equal to 34 mg AT/d; The estimated Canadian consumption from supplements (34 mg AT/d) was subtracted from the safe upper level for daily consumption in foods (60 mg AT/d) to derive a value of 26 mg AT/d. This value was divided by five to arrive at a maximum level of 5 mg/serving (after rounding). It is important to note that dietary vitamin E was not subtracted from the safe upper level as it has not been linked to adverse outcomes. Current fortification levels in the general food supply are limited. A separate maximum level was not set for children since the maximum was based on adverse effects in adult subpopulations. Chromium The IOM did not set a UL for chromium (IOM, 2001). The European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food concluded that the safety of chromium(III) as a nutrient added to foods for particular nutritional uses and foods intended for the general population (including food supplements) is not of concern, provided that the intake of chromium(III) from these sources does not exceed 250 µg/d, the value established by the World Health Organization for supplemental intake of chromium(III) that should not be exceeded (EFSA, 2010; World Health Organization, 1996). The highest level of chromium(III) found in the top 5 selling multivitamin/mineral supplements for adults currently marketed in Canada (100 µg/d) was subtracted from the maximum level for chromium(III) (250 µg/d) established by the WHO and EFSA. This maximum value per day (150 µg) was divided by five to arrive at a maximum level of 30 µg/serving. Phosphorus The IOM UL was used to set the maximum level (IOM, 1997) but given that the most vulnerable group was adult males older than 70 years of age, only one level was set. The same method was used as other nutrients with a UL by adding the 95th percentile of daily dietary intake to the estimated intake from supplements, and subtracting this total from the UL and dividing by 5. Chantal Martineau, Jennifer Barber, Jesse Bertinato, Steve Brooks, Eunice Chao, Janice Daoust, Nora Lee, Lindsay Lukeman, Robin J. Marles and Natasha Hinkson: Food Risk Analysis Communication 5 Potassium Certain medications and medical conditions can decrease renal excretion of potassium and predispose individuals to hyperkalemia (Bakris et al., 2013). Although the IOM has not determined a UL for potassium (IOM, 2006), the maximum level for potassium was established to protect vulnerable individuals from hyperkalemia. Intake above 1500 mg from these products was deemed inappropriate because vulnerable individuals on a low potassium diet are often instructed to consume no more than 1500–2700 mg potassium/d (Bakris et al., 2013). Also, vulnerable individuals on a low potassium diet may not be counselled currently to avoid potassium-fortified foods. Limiting the amount of potassium that can be added to these products to 300 mg per serving (1500 mg/d ÷ 5 servings) provides a measure of protection in the event that these individuals choose to consume these products, unaware of the added level of potassium. 4.5 Vitamins for which No Maximum Level will be Set at this Time Table 5 includes nutrients with no UL for which no maximum levels have been proposed. The absence of a UL for these nutrients means that there is either no adverse effects that have been associated with high intakes or data on adverse effects were not considered sufficient for derivation of a threshold (IOM, 2006). Even if no maximum levels are being proposed for these nutrients, the acceptability of any levels above those found in currently marketed products will be assessed by Health Canada. • • • The 5th percentile of dietary intake was selected as a reference value because for amino acids, the greatest risk appears to be from a negative effect on protein quality among those consumers who have a low dietary intake of protein, rather than a risk from overconsumption associated with toxicity as is the case for vitamins and minerals. The concern is that adding individual amino acids to these products may cause a decrease in protein quality of the diets, particularly for individuals with an already low intake of protein or intake of poor quality protein. Amino Acid Maximum Level (per serving) Alanine 67 mg Arginine 78 mg Aspartic Acid + Asparagine1 115 mg Cysteine + Cystine1 16 mg Glutamic Acid + Glutamine1 340 mg 58 mg Nutrient Population Glycine Thiamine General Population Histidine 46 mg Riboflavin General Population Isoleucine 71 mg Vitamin B12 General Population Pantothenic Acid General Population Leucine 124 mg Biotin General Population Lysine 105 mg Methionine 36 mg Phenylalanine 72 mg Proline 122 mg Table 5. Vitamins for which No Maximum Levels will be Set at this Time 5. Proposed Maximum Levels for Amino Acids The IOM has not established ULs for amino acids (IOM, 2006) and neither has any other food safety or nutrition authoritative body. Therefore a conservative approach was developed based on potential adverse effects on dietary protein quality in vulnerable populations that may result from consuming high amounts of single amino acids rather than whole proteins. The proposed approach to establish maximum levels for amino acids (Table 6) followed the rationale described below: 6 A daily maximum level of each amino acid was determined such that intake from these products would not exceed 20% of the total daily intake of each amino acid for individuals at the 5th percentile of dietary intake (Health Canada et al., 2009). Each daily maximum level was divided by five assuming people might consume up to 5 servings of these products in a day. For all amino acids only one level was proposed, which applies to the general population given that the most vulnerable group was adult females >70 years of age. Int Food Risk Anal J, 2014, 4:3 Serine Taurine 71 mg 2 Threonine 600 mg 56 mg Tryptophan 17 mg Tyrosine 58 mg Valine 79 mg The maximum level applies to both forms of the amino acid combined 2Taurine is often considered an amino acid but it is actually a 2aminoethanesulfonic acid 1 Table 6. Maximum Levels of Addition for Amino Acids for the General Population In addition, the risks associated with some amino acids as separate food ingredients are not the same as for amino acids that are components of protein because the human body regulates the breakdown of proteins into their constituent amino acids in a manner that helps to ensure there will not be an excess of any individual amino acid in the bloodstream. Taurine There is insufficient information to establish a UL for taurine. Based on published clinical trials and supported by animal studies, a Highest Observed Intake approach established an Observed Safe Level of 3 g/d of taurine as a daily maximum level of supplemental intake (Shao, 2008). This amount was divided by five, based on the assumption that people might consume up to 5 servings of these products in a day, which resulted in a maximum level for taurine of 600 mg per serving, applicable to the general population. 6. Conclusion This paper attempts to present a risk-based approach to set maximum levels for the addition of vitamins, mineral nutrients and amino acids to foods that are intended to be consumed as a vehicle of nutrient supplementation. The approach proposed is limited by data gaps related to the consumption patterns of these foods with added nutrients by different subsets of the population. The approach was also challenged by the uncertainty related to the way these products would be represented to consumers and therefore the consumers’ ability to distinguish them from their equivalent that are not intended as a vehicle for nutrient supplementation. Where risks were clearly identified or uncertainties deemed important, a conservative approach was followed to set proposed maximum levels for addition of these nutrients. The proposed levels will be thoroughly re-examined upon collection of additional data characterizing Canadians’ consumption of foods and beverages intended to be used as a vehicle for supplementation or “supplemented foods”. Information and data related to the effectiveness of labelling as a measure to alert consumers to the exceptional nature of these products and their differentiation from their “non-supplemented” equivalent will also support the evaluation of the proposed risk management approach. This may in turn impact the proposed composition requirements for nutrients discussed in this paper. The temporary marketing authorization of selected products, satisfying to provisional formulation and labelling requirements, with a data collection obligation to fill some of the knowledge gaps on consumption information and consumers’ reaction will be an avenue used by Health Canada’s Food Directorate to support the re-evaluation of the current proposed approach. 7. 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