Re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives

SCIENTIFIC OPINION ADOPTED: 30 January 2018 doi: 10.2903/j.efsa.2018.5180 Re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Maged Younes, Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Metka Filipic, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus, Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Polly Boon, Dimitrios Chrysafidis, Rainer G urtler, Pasquale Mosesso, Dominique Parent-Massin, Paul Tobback, Claudia Cascio, Ana Maria Rincon and Claude Lambre Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) when used as food additives. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) not specified for the fatty acids (myristic-, stearic-, palmitic- and oleic acid) and their salts. The sodium, potassium, calcium and magnesium salts of fatty acids are expected to dissociate in the gastrointestinal tract to fatty acid carboxylates and their corresponding cations. There were no data on subchronic toxicity, chronic toxicity, reproductive and developmental toxicity of the salts of fatty acids. There was no concern for mutagenicity of calcium caprylate, potassium oleate and magnesium stearate. From a carcinogenicity study with sodium oleate, a no observed adverse effect level (NOAEL) could not be identified but the substance was considered not to present a carcinogenic potential. Palmitic- and stearic acid which are the main fatty acids in E 470a and E 470b were already considered of no safety concern in the re-evaluation of the food additive E 570. The fatty acid moieties of E 470a and E 470b contributed maximally for 5% to the overall intake of saturated fatty acids from all dietary sources. Overall, the Panel concluded that there was no need for a numerical ADI and that the food additives sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) were of no safety concern at the reported uses and use levels. 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: sodium salts of fatty acids, potassium salts of fatty acids, calcium salts of fatty acids, E 470a, magnesium salts of fatty acids, E 470b, food additives Requestor: European Commission Question number: EFSA-Q-2011-00555; EFSA-Q-2011-00556 Correspondence: fip@efsa.europa.eu www.efsa.europa.eu/efsajournal EFSA Journal 2018;16(3):5180

Panel members: Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Metka Filipic, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle, Claude Lambre, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus, Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. Acknowledgements: The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output and Davide Arcella and Zsuzsanna Horvath. Suggested citation: EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), Younes M, Aggett P, Aguilar F, Crebelli R, Dusemund B, Filipic M, Frutos MJ, Galtier P, Gott D, Gundert-Remy U, Kuhnle GG, Leblanc J-C, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Waalkens-Berendsen I, Woutersen RA, Wright M, Boon P, Chrysafidis D, G urtler R, Mosesso P, Parent-Massin D, Tobback P, Cascio C, Rincon AM and Lambre C, 2018. Scientific Opinion on the re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives. EFSA Journal 2018;16(3):5180, 34 pp. https://doi.org/ 10.2903/j.efsa.2018.5180 ISSN: 1831-4732 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. www.efsa.europa.eu/efsajournal 2 EFSA Journal 2018;16(3):5180

Summary Sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) are authorised as food additives according to Regulation (EC) No 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/2012. The Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) not specified for the fatty acids (myristic-, stearic-, palmitic- and oleic acid) and their salts in 1991. In 1974, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) considered that myristic, palmitic and stearic acid and their salts were normal products of the metabolism of fats and that their metabolic fate was well established. JECFA further considered that, provided the contribution of the cations did not add excessively to the normal body load, there was no need to consider the use of these substances in any different light to that of dietary fatty acids and established an ADI not limited. The Panel considered that it is unclear, whether, according to the definition in the Commission Regulation 231/2012, the fatty acids or the salts thereof are occurring in food fats and oils. However, according to the literature, salts of fatty acids are not expected to occur in significant amounts in food fats and oils (low Na, K, Ca or Mg content and acidic conditions due to free fatty acids). Hence, this evaluation has been performed assuming that only the fatty acids (either free or bound) not the salts of fatty acids occur in food fats and oils. According to information from industry, the fatty acids used for the production of sodium, potassium, calcium and magnesium salts of fatty acids are obtained either from edible (i.e. vegetable or animal) fats and oils or from distilled food fatty acids. In the Regulation, no indication is given as regards the chemical nature of the fatty acids or the level at which an individual fatty acid may be present. According to information provided by interested parties, salts of fatty acids consist for 95 99% (by weight) of salts, of which 4 5% account for the cation. In commercial products, the fatty acid fraction consists at least of 90% stearic- and palmitic acid with a minimum of 40% stearic acid. The Panel noted that sodium, potassium, calcium and magnesium salts of fatty acids are expected to dissociate in the gastrointestinal tract into fatty acid carboxylates and their corresponding cations. The resulting low amounts of sodium, potassium, calcium and magnesium ions will enter normal physiological processes. Therefore, the properties of the corresponding cations are not discussed further in the opinion and the Panel considered that a read-across approach could be applied for the evaluation of the sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) using the previous assessment of the food additive fatty acids (E 570). The Panel (EFSA ANS Panel, 2017) evaluated the absorption, distribution,. metabolism, excretion (ADME) of the fatty acids caprylic-, capric-, oleic-, lauric-, palmitic-, myristic- or stearic acid and considered that they, like other fatty acids, were readily and extensively absorbed from the gastrointestinal tract and metabolised via the b-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide and excreted. The Panel noted that the number of toxicological studies on the salts of fatty acids was very limited. The Panel considered that: As regards genotoxicity, only the mutagenicity studies on calcium caprylate, potassium oleate and magnesium stearate were available and negative results were obtained. In addition, the Panel noted that available genotoxicity data for caprylic-, capric-, lauric-, myristic-, palmitic-, stearic- or oleic acid used as a food additive (E 570) do not raise a concern for genotoxicity. As regards carcinogenicity, the Panel noted that in a study in rats, the pancreatic tumours reported were adenomas not carcinomas; therefore, the Panel considered that sodium oleate did not present a carcinogenic potential. However, it was not possible to identify a no observed adverse effect level (NOAEL) from this study. No data were available as regards subchronic toxicity, chronic toxicity, reproductive and developmental toxicity. However, the EFSA ANS Panel evaluated the safety of the linear free fatty acids caprylic- (C8), capric- (C10), lauric- (C12), myristic- (C14), palmitic- (C16), stearic- (C18) and oleic acid (C18:1) when used as a food additive (E 570) and concluded that the use of these acids are of no safety concern at the reported use and use levels (EFSA ANS Panel, 2017). For the exposure assessment of E 470a,b, reported uses were available for 24 out of 69 food categories in which E 470a and E 470b are authorised but only 12 food categories were considered in the refined exposure scenarios. The Panel noted that the information from the Mintel s Global New www.efsa.europa.eu/efsajournal 3 EFSA Journal 2018;16(3):5180

Products Database (GNPD) supported the observation that sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) are apparently not used in all food categories in which the food additives are authorised. Based on information from the Mintel s GNPD, the Panel considered that E 470a and E 470b are not likely to be used in combination in the same food product and, therefore, the exposure assessment of E 470a and E 470b was performed considering the maximum reported use level (of the maximum and typical) for either E 470a or E 470b per food category. As salts of fatty acids are not expected to occur in significant amounts in foods, the Panel only considered the dietary intake of saturated fatty acids as such to assess the contribution of the food additives (E 470a and E 470b) to the intake of saturated fatty acids via all dietary sources. Considering that: sodium, potassium, calcium and magnesium salts of fatty acids are expected to dissociate in the gastrointestinal tract to fatty acid carboxylates and their corresponding cations, according to information from industry, palmitic acid and stearic acid are the main fatty acids present in E 470a and E 470b, palmitic acid and stearic acid are fatty acids included in the food additive E 570 already evaluated by the Panel and for which it was concluded that its use was of no safety concern, the fatty acid moieties of sodium, potassium, calcium and magnesium salts of fatty acids (E 470a, E 470b) contributed at the mean maximally 5% to the overall dietary exposure to saturated fatty acids, the Panel concluded that there was no need for a numerical ADI and that the food additives sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) were of no safety concern at the reported uses and use levels. The Panel recommended that: the European Commission considers lowering the current limits for toxic elements (arsenic, lead, mercury and cadmium) in the European Union specifications for sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) in order to ensure that the food additive will not be a significant source of exposure to these toxic elements in food. the European Commission considers revising the EU specifications for sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) including maximum limits for trans-fatty acids because sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) can be manufactured by glycerolysis of hydrogenated fats and/or oils, which contain significant amounts of trans fatty acids. the European Commission considers revising the EU specifications for sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) including maximum limits for erucic acid because as erucic acid can be present among the fatty acids in edible oils, which can be used for manufacturing of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b). the European Commission considers revising the EU specifications for sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) by rephrasing the definition in order to clarify that the fatty acids used as source materials be obtained only from edible fats and oils. in the event that practices reported in this opinion change (e.g. sources of starting material, uses and use levels), revision of this evaluation would be needed. www.efsa.europa.eu/efsajournal 4 EFSA Journal 2018;16(3):5180

Table of contents Abstract... 1 Summary... 3 1. Introduction... 6 1.1. Background and Terms of Reference as provided by the European Commission... 6 1.1.1. Background... 6 1.1.2. Terms of Reference... 6 1.2. Information on existing authorisations and evaluations... 6 2. Data and methodologies... 7 2.1. Data... 7 2.2. Methodologies... 7 3. Assessment... 8 3.1. Technical data... 8 3.1.1. Identity of the substance... 8 3.1.2. Specifications... 9 3.1.3. Manufacturing process... 13 3.1.4. Methods of analysis in food... 14 3.1.5. Reaction and fate in food... 14 3.2. Authorised uses and use levels... 14 3.3. Exposure assessment... 17 3.3.1. Reported use levels of E 470a and E 470b... 17 3.3.2. Summarised data extracted from the Mintel s Global New Products Database... 18 3.3.3. Food consumption data used for exposure assessment... 19 3.4. Exposure estimate... 21 3.4.1. Exposure to sodium, potassium, calcium and magnesium salts of fatty acids (E 470a, E 470b) from their use as food additives... 21 3.4.2. Exposure via the regular diet... 25 3.5. Biological and toxicological data... 25 3.5.1. Absorption, distribution, metabolism and excretion... 25 3.5.2. Acute oral toxicity... 25 3.5.3. Short-term and subchronic toxicity... 25 3.5.4. Genotoxicity... 25 3.5.5. Chronic toxicity and carcinogenicity... 26 3.5.6. Reproductive and developmental toxicity... 26 3.5.7. Other studies... 27 3.5.8. Studies with other emulsifiers... 27 3.6. Discussion... 27 4. Conclusions... 29 5. Recommendations... 29 Documentation provided to EFSA... 29 References... 30 Abbreviations... 33 Appendix A Summary of reported use levels of E 470a and E 470b provided by industry (mg/kg)... 34 Appendix B Number and Percentage of food products labelled with E470a and E470b as present on the Mintel GNPD per food subcategory between 2012 and 2017... 34 Appendix C Concentration levels of E 470a,b used in the MPL and in the refined exposure scenarios (mg/kg or ml/kg as appropriate)... 34 Appendix D Summary of total estimated exposure of E 470a,b from their use as food additives for the maximum level exposure scenario and the refined exposure assessment scenarios per population group and survey: mean and 95th percentile (mg/kg bw per day)... 34 Appendix E Summary of total estimated exposure of E 470a,b from their use as food additives for the food supplement consumer only scenario per population group and survey: mean and 95th percentile (mg/kg bw per day)... 34 Appendix F Main food categories contributing to exposure to E 470a,b using the maximum level exposure scenario and the refined exposure assessment scenarios (> 5% to the total mean exposure)... 34 www.efsa.europa.eu/efsajournal 5 EFSA Journal 2018;16(3):5180

1. Introduction The present opinion deals with the re-evaluation of the safety of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) when used as food additives. 1.1. Background and Terms of Reference as provided by the European Commission 1.1.1. Background Regulation (EC) No 1333/2008 1 of the European Parliament and of the Council on food additives requires that food additives are subject to a safety evaluation by the European Food Safety Authority (EFSA) before they are permitted for use in the European Union. In addition, it is foreseen that food additives must be kept under continuous observation and must be re-evaluated by EFSA. For this purpose, a programme for the re-evaluation of food additives that were already permitted in the European Union before 20 January 2009 has been set up under the Regulation (EU) No 257/2010 2. This Regulation also foresees that food additives are re-evaluated whenever necessary in light of changing conditions of use and new scientific information. For efficiency and practical purposes, the reevaluation should, as far as possible, be conducted by group of food additives according to the main functional class to which they belong. The order of priorities for the re-evaluation of the currently approved food additives should be set on the basis of the following criteria: the time since the last evaluation of a food additive by the Scientific Committee on Food (SCF) or by EFSA, the availability of new scientific evidence, the extent of use of a food additive in food and the human exposure to the food additive taking also into account the outcome of the Report from the Commission on Dietary Food Additive Intake in the EU of 2001. The report Food additives in Europe 2000 submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re-evaluation. As colours were among the first additives to be evaluated, these food additives should be re-evaluated with a highest priority. In 2003, the Commission already requested EFSA to start a systematic re-evaluation of authorised food additives. However, as a result of adoption of Regulation (EU) 257/2010 the 2003 Terms of References are replaced by those below. 1.1.2. Terms of Reference The Commission asks the EFSA to re-evaluate the safety of food additives already permitted in the Union before 2009 and to issue scientific opinions on these additives, taking especially into account the priorities, procedures and deadlines that are enshrined in the Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with the Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. 1.2. Information on existing authorisations and evaluations Sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) are authorised as food additives according to Regulation (EC) No 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/2012 3 for them. The SCF established a group acceptable daily intake (ADI) not specified for the fatty acids (myristic-, stearic-, palmitic- and oleic acid) and their salts (SCF, 1991). The Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated the salts of different fatty acids in the period 1973 2001 (JECFA, 1974, 1984, 1986, 1989, 2001a,b,c). JECFA considered that myristic, palmitic and stearic acid and their salts were normal products of the metabolism of fats and that their metabolic fate was well established. JECFA further considered that, provided the 1 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. OJ L 354, 31.12.2008, p. 16 33. 2 Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. OJ L 80, 26.3.2010, p. 19 27. 3 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) no 1333/2008 of the European Parliament and of the Council. OJ L 83, 22.3.2012, p. 1 295. www.efsa.europa.eu/efsajournal 6 EFSA Journal 2018;16(3):5180

contribution of the cations did not add excessively to the normal body load, there was no need to consider the use of these substances in any different light to that of dietary fatty acids and established an ADI not limited (JECFA, 1974). Fatty acids and their sodium, potassium, calcium and magnesium salts were also reviewed by the Nordic Council of Ministers (TemaNord, 2002). The Committee stated that no exhaustive systematic toxicological studies seemed to have been carried out. However, there was no reason to expect any health problems when these food additives would be used according to good manufacturing practise. The EFSA ANS Panel evaluated the safety of the linear free fatty acids caprylic- (C8), capric- (C10), lauric- (C12), myristic- (C14), palmitic- (C16), stearic- (C18) and oleic acid (C18:1) when used as a food additive E 570 and concluded that the use of these acids was of no safety concern (EFSA ANS Panel, 2017). 2. Data and methodologies 2.1. Data The Panel on Food Additives and Nutrient Sources added to Food (ANS) was not provided with a newly submitted dossier. EFSA launched public calls for data. 4,5 The Panel based its assessment on information submitted to EFSA following the public calls for data, information from previous evaluations and additional available literature up to January 2018. Attempts were made at retrieving relevant original study reports on which previous evaluations or reviews were based however these were not always available to the Panel. Food consumption data used to estimate the dietary exposure to sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) were derived from the EFSA Comprehensive European Food Consumption Database (Comprehensive Database. 6 ) The Mintel s Global New Products Database (GNPD) was used to verify the use of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) in food products. The Mintel s GNPD is an online database that contains the compulsory ingredient information present on the label of numerous food products. 2.2. Methodologies This opinion was formulated following the principles described in the EFSA Guidance on transparency with regard to scientific aspects of risk assessment (EFSA Scientific Committee, 2009) and following the relevant existing guidance documents from the EFSA Scientific Committee. The ANS Panel assessed the safety of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b), in line with the principles laid down in Regulation (EU) 257/2010 and in the relevant guidance documents: Guidance on submission for food additive evaluations by the SCF (2001). When the test substance was administered in the feed or in the drinking water, but doses were not explicitly reported by the authors as mg/kg bw per day based on actual feed or water consumption, the daily intake was calculated by the Panel using the relevant default values as indicated in the EFSA Scientific Committee Guidance document (EFSA Scientific Committee, 2012) for studies in rodents or, in the case of other animal species, by JECFA (2000). In these cases, the daily intake is expressed as equivalent. Dietary exposure to sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) from their use as food additives was estimated by combining the food consumption data available within the EFSA Comprehensive Database with the maximum permitted levels and/or reported use levels submitted to EFSA following a call for data. The exposure was estimated according to different scenarios (see Section 3.4). Uncertainties in the exposure assessment were identified and discussed. 4 Call for scientific data on food additives permitted in the EU and belonging to the functional classes of emulsifiers, stabilisers and gelling agents. Published: 22 November 2009. Available from: http://www.efsa.europa.eu/en/dataclosed/call/ans091123 5 Call for food additives usage level and/or concentration data in food and beverages intended for human consumption Published 12 October 2015. Available online: http://www.efsa.europa.eu/en/data/call/151012 6 Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm www.efsa.europa.eu/efsajournal 7 EFSA Journal 2018;16(3):5180

3. Assessment 3.1. Technical data 3.1.1. Identity of the substance According to Commission Regulation (EU) No 231/2012, (E 470a) and (E 470b) are sodium, potassium, calcium and magnesium salts of fatty acids occurring in food oils and fats, salts being obtained either from edible fats and oils or from distilled food fatty acids. According to information provided by industry (APAG, 2016 (Documentation provided to EFSA n. 2)), there are four different origins of the fatty acids used for the production of the additives E 470a and E 470b: (i) three are derived from vegetable oils, differing in their palmitate/stearate ratio (i.e. high, medium and low), and (ii) one is derived from animal fat with a high content in stearic acid. It is further stated that current commercially available salts of fatty acids consist for 95 99% (by weight) of salts, of which 4 5% account for the metal cation. The fatty acid fraction consists at least of 90% stearic- and palmitic acid with a minimum of 40% stearic acid. It is stated that other fatty acids such as lauric acid, myristic acid, pentadecanoic acid, heptanoic acid, oleic acid and arachidic acid may be present in minor amounts (see Table 1). The composition and the nature of the fatty acid moieties depend on the source material (vegetable or animal) used for the production of the food additive and on the selection of the fatty acid fraction of the distillation, to which the hydrolysed source material was subjected (EFSA ANS Panel, 2017). Industry provided analytical data, summarising the composition of 36 commercially available salts of fatty acids (APAG, 2016 (Documentation provided to EFSA n. 2)). These data are shown in Table 1. The Panel noted that in the information provided by the individual producers regarding the nature of most commercially available substances, these substances are described as salts (i.e. Mg-, Ca-, Naor K-salts) of stearic acid, whereas, based on the gas liquid chromatography (GLC) data provided by APAG, 2016 (Documentation provided to EFSA n. 2), all substances consist of a mixture of salts of mainly stearic- and palmitic acid (Table 1). Table 1: Fatty acids composition of the commercially available salts of fatty acids as provided by industry (APAG, 2016 (Documentation provided to EFSA n. 2)) Fatty acids Proportion of fatty acid (%) Type Vegetable based (low palmitate) Vegetable based (medium palmitate) Vegetable based (high palmitate) Animal based Lauric acid (C12) 0.0 0.1 0.0 0.6 0.0 1.1 Myristic acid (C14) 0.0 0.3 0.2 0.5 0.0 1.4 1.1 2.3 Pentadecanoic acid 0.0 0.1 00 1.2 0.2 0.3 (C15) Palmitic acid (C16) 30.2 34.2 44.9 45.9 53.5 56.9 28 31 Margaric acid (C17) 0.1 0.2 0.1 0.2 0.2 0.3 0.9 1.0 Stearic acid (C18) 65.1 69.5 52.4 53.7 41.1 44.8 64.2 67.0 Oleic acid (C18:1) 0.0 0.0 0.0 0.1 0.0 0.1 0.0 0.2 Arachidic acid (C20) 0.0 0.7 0.5 0.9 0.4 05 1.3 1.5 Palmitic + stearic acid (C16 + C18) 98.8 99.5 98.1 99.1 97.1 99.4 92.1 95.2 APAG (2016 (Documentation provided to EFSA n. 2)) informed that in one batch of animal-based fatty acids the following acids also were present: 0.1% ketostearic acid (substance not further specified), 0.1% palmitoleic acid (9-cis-hexadecenoic acid; C 16 H 30 O 2 ) and 0.2% nonadecanoic acid (C 19 H 38 O 2 ). In the batches analysed, the amount of total fatty acids other than palmitic or stearic acid ranged from 0.5% to 8% in the batches analysed. The chemical identity of the fatty acids present in the commercially available salts of fatty acids E 470a and E 470b is given in Table 2. www.efsa.europa.eu/efsajournal 8 EFSA Journal 2018;16(3):5180

Table 2: Identity of the fatty acids present in commercially available E 470a and E 470b as listed in Table 1 Fatty acid (common name) Lauric acid (C12) Myristic acid (C14) Pentadecylic acid (C15) Palmitic acid (C16) Margaric acid (C17) Stearic acid (C18) Oleic acid (C18:1) Arachidic acid (C20) Fatty acid (systematic name) The Panel noted that natural fats and oils are always a mixture of fatty acids with a discrete carbon chain length. Nevertheless, in the analytical data on the composition of the commercially available salts of fatty acids provided by industry (APAG, 2016 (Documentation provided to EFSA n. 2)), low amounts of two odd-numbered fatty acids (C15 and C17 compounds) have been reported. According to Commission Regulation (EU) No 231/2012, sodium and potassium salts of fatty acids are soluble in water, while calcium and magnesium salts are insoluble in aqueous media. The Panel noted that, due to their amphipathic (amphiphilic) nature, when dispersed in water, fatty acid salts partially or totally dissolve (depending on their solubility and concentration) and tend to form micelles (Alberts et al., 2002). 3.1.2. Specifications Structural formula of fatty acid anion CAS registry number acid/ EINECS number Salt cation CAS registry number EINECS (EC number) 143-07-7/205-582-1 Na + 629-25-4 211-082-4 544-63-8/208-875-2 Na + 822-12-8 212-487-9 Dodecanoic acid CH 3 (CH 2 ) 10 COO K + 10124-65-9 233-344-7 1/2 Ca 2+ 4696-56-4 225-166-3 1/2 Mg 2+ 4040-48-6 223-727-7 Tetradecanoic acid CH 3 (CH 2 ) 12 COO K + 13429-27-1 236-550-5 1/2 Ca 2+ 15284-51-2 239-328-6 1/2 Mg 2+ 4086-70-8 223-817-6 Pentadecanoic acid CH 3 (CH 2 ) 13 1002-84-2/213-693- COO 1 Na + 4268-63-7 224-255-4 K + 17378-35-7 241-415-9 1/2 Ca 2+ 4499-92-7 224-802-7 57-10-3/200-312-9 Na + 408-35-5 206-988-1 506-12-7/208-027-1 Na + 1002-82-0 213-692-6 57-11-4/200-313-4 Na + 822-16-2 212-490-5 1/2 Mg 2+ 93966-75-7 301-028-9 Hexadecanoic acid CH 3 (CH 2 ) 14 COO K + 2624-31-9 220-088-6 1/2 Ca 2+ 542-42-7 208-811-3 1/2 Mg 2+ 2601-98-1 220-010-0 Heptadecanoic acid CH 3 (CH 2 ) 15 COO K + 17378-36-8 241-416-4 1/2 Ca 2+ 4499-95-0 224-804-8 1/2 Mg 2+ 94266-34-9 304-441-2 Octadecanoic acid CH 3 (CH 2 ) 16 COO K + 593-29-3 209-786-1 1/2 Ca 2+ 1592-23-0 216-472-8 1/2 Mg 2+ 557-04-0 209-150-3 cis-9-octadecenoic 112-80-1/204-007-1 Na + 143-19-1 205-591-0 acid CH 3 (CH 2 ) 7 CH=CH (CH 2 ) 7 COO n-eicosanoic acid CH 3 (CH 2 ) 18 506-30-9//208-031- COO 3 CAS: Chemical Abstracts Service; EINECS: European Inventory of Existing Chemical Substances. K + 143-18-0 205-590-5 1/2 Ca 2+ 142-17-6 205-525-0 1/2 Mg 2+ 1555-53-9 216-303-8 Na + 13257-34-6 236-248-3 K + 18080-76-7 241-990-6 1/2 Ca 2+ 22302-43-8 244-900-3 1/2 Mg 2+ 57593-01-8 260-840-0 Specifications for the sodium, potassium and calcium salts of fatty acids (E 470a) and for the magnesium salts (E 470b) are defined in Commission Regulation (EU) No 231/1012. According to www.efsa.europa.eu/efsajournal 9 EFSA Journal 2018;16(3):5180

JECFA, specifications for sodium, potassium and calcium salts of fatty acids (INS No 470) and for magnesium distearate (INS No 470(iii)) are available (Table 3). Table 3: Specifications for sodium, potassium and calcium salts of fatty acids (E 470a) according to Commission Regulation (EU) No 231/2012 and JECFA (2006), and for magnesium salts of fatty acids (E 470b) according to Commission Regulation (EU) No 231/2012 and magnesium distearate (JECFA, 2015) Definition Assay Description Identification Solubility Sodium, potassium and calcium salts of fatty acids (E 470a) Commission Regulation (EU) No 231/2012 Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids Content on the anhydrous basis not less than 95% (105 C till a constant weight) White or creamy white light powders, flakes or semi-solids Sodium and potassium salts: soluble in water and ethanol Calcium salts: insoluble in water, ethanol and ether Magnesium salts of fatty acids (E 470b) Commission Regulation (EU) No 231/2012 Magnesium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids Content on the anhydrous basis not less than 95% (105 C till a constant weight) White or creamy white light powders, flakes or semi-solids Insoluble in water, partially soluble in ethanol and ether Salts of fatty acids (INS No 470) Magnesium distearate, dibasic magnesium stearate, INS No 470(iii) JECFA (2006) JECFA (2015) These products consist of calcium, potassium or sodium salts of commercial myristic, oleic, palmitic, stearic, acids or mixtures of these acids from edible fats and oils. The article of commerce can be further specified by: saponification value, solidification point for the fatty acids obtained from the salts, iodine value, residue on ignition including assay of the cation, and moisture content Not less than 95% total fatty acid salts, dry weight basis Hard, white or faintly yellowish, somewhat glossy and crystalline solids or semi-solids or white or yellowishwhite powder Potassium and sodium salts are soluble in water and ethanol; calcium salts are insoluble in water, ethanol and ether Magnesium stearate is a mixture of magnesium salts of fatty acids obtained from edible fats and oils. The product consists mainly of magnesium stearate and palmitate in varying proportions. It is manufactured by one of the two following processes: (a) direct process wherein fatty acids are directly reacted with a magnesium source, such as magnesium oxide to form magnesium salts of the fatty acids; (b) indirect process where a sodium soap is produced by the reaction of fatty acids with sodium hydroxide in water and the product is precipitated by adding magnesium salts to the soap Practically insoluble in water www.efsa.europa.eu/efsajournal 10 EFSA Journal 2018;16(3):5180

Sodium, potassium and calcium salts of fatty acids (E 470a) Magnesium salts of fatty acids (E 470b) Salts of fatty acids (INS No 470) Test for cations Passes test Heat 1 g of the sample with a mixture of 25 ml of water and 5 ml of hydrochloric acid. Fatty acids are liberated, floating as a solid or oil layer on the surface which is soluble in hexane. After cooling, aqueous layer is decanted and evaporated to dryness. Dissolve the residue in water and test for the appropriate cation Test for magnesium Test for fatty acids Purity Sodium Magnesium distearate, dibasic magnesium stearate, INS No 470(iii) Passes test Using the Method of Assay, identify presence of magnesium in the sample Passes test Passes test Using the Method of Assay, identify the individual fatty sample. The fatty acid(s) in primary abundance should conform to those declared on the label of the product Not less than 9% and not more than 14% expressed as Na 2 O Potassium Not less than 13% and not more than 21.5% expressed as K 2 O Calcium Not less than 8.5% and not more than 13% expressed as CaO Magnesium Not less than 6.5% and not more than 11% expressed as MgO Unsaponifiable Not more than 2% matter Free fatty acids Not more than 3% estimated as oleic acid Not more than 2% Not more than 3% estimated as oleic acid Not less than 4.0% and not more than 5.0%, on dried basis Not more than 2% Not more than 2% Not more than 3% Measure free fatty acids as directed in the method Free Fatty Acids. Compute free fatty acid content using an equivalence factor (e) equal to 1/10th the molecular weight of the salt Not less than 40.0% stearic acid in the fatty acid fraction; and not less than 90.0% as the sum of stearic acid and palmitic acid in the fatty acid fraction www.efsa.europa.eu/efsajournal 11 EFSA Journal 2018;16(3):5180

Arsenic Lead Mercury Cadmium Nickel Free alkali Matter insoluble in alcohol Sodium, potassium and calcium salts of fatty acids (E 470a) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 0.1% expressed as NaOH Not more than 0.2% (sodium and potassium salts only) Magnesium salts of fatty acids (E 470b) Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 0.1% expressed as MgO Salts of fatty acids (INS No 470) Not more than 2 mg/kg Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4, Instrumental Methods Magnesium distearate, dibasic magnesium stearate, INS No 470(iii) Not more than 2 mg/kg Not more than 1 mg/kg Not more than 3 mg/kg The Panel considered that it is unclear, whether, according to the definition in the Regulation 231/2012, the fatty acids or the salts thereof are occurring in food fats and oils. However, according to the literature, salts of fatty acids are not expected to occur in significant amounts in food fats and oils (low Na, K, Ca or Mg content and acidic conditions due to free fatty acids). Therefore, this evaluation has been performed assuming that only the fatty acids (either free or bound) not the salts of fatty acids occur in food fats and oils. The Panel noted that in Commission Regulation (EU) No 231/2012, the term distilled food fatty acids is used. In the view of the Panel this term should be more clearly described. Indeed, without any further specification of this term, fatty acids that are identical to those present in foods, but that are produced by distillation from non-food sources, could also be used as source material for the production of the food additives E 470a and E 470b. The Panel considered that the safety of use of salts of fatty acids produced using fatty acids, obtained via distillation from non-food sources cannot be assessed. Therefore, the use of these sources should be avoided. The Panel noted that, according to the EU specifications for E 470a and E 470b, impurities of the toxic elements arsenic, cadmium, lead and mercury are accepted up to concentrations of 3, 2, 1 and 1 mg/kg, respectively. Contamination at these levels could have a significant impact on the exposure to these toxic elements, which are already close to the health-based guidance values or benchmark doses (lower confidence limits) established by EFSA (EFSA CONTAM Panel, 2009a,b, 2010, 2012a,b,c, 2014). According to information provided by industry (APAG, 2016 (Documentation provided to EFSA n. 2)), nickel present in the starting material could be a potential impurity in the final product. The Panel noted that no maximum limit for nickel is included in the EU specifications for E 470a and E 470b, although it is included in JECFA specifications for magnesium distearate. According to EU specifications, E 470a and E 470b can be manufactured by using food oils and fats. Beside natural oils and fats, also hydrogenated fats and or oils can be used for manufacturing of E 470a and E 470b. According to EFSA (EFSA NDA Panel, 2004), industrial hydrogenation (used to produce semi-solid and solid fats that can be used for the production of foods such as margarines, shortenings, and www.efsa.europa.eu/efsajournal 12 EFSA Journal 2018;16(3):5180

biscuits) and deodorisation (a necessary step in refining) of unsaturated vegetable oils high in polyunsaturated fatty acids is one of the three main pathways for the formation of trans fatty acids in food. According to EFSA (EFSA NDA Panel, 2010), higher intakes of trans-fatty acids have consistently been found to be associated with an increased risk of coronary heart disease and it was recommended that trans fatty acids intake should be as low as possible within the context of a nutritionally adequate diet. The Panel noted that there is no limit for trans fatty acids in the specifications for E 470a and E 470b. According to the EU specifications for E 470a and E 470b, rapeseed oil, which contains erucic acid, could be used for the manufacturing E 470a and E 470b according to their EU specifications. Maximum levels for erucic acid have been established in EU according to Commission Regulation (EU) No 696/2014 7 in edible oils and fats as well as in food containing fats and oils. A tolerable daily intake (TDI) of 7 mg/kg body weight (bw) per day for erucic acid has been established by the EFSA CONTAM Panel based on a no observed adverse effect level (NOAEL) of 700 mg/kg bw per day for myocardial lipidosis observed in a 7-day feeding study in young (5 7 weeks) rats and in a 2-week feeding study in newborn piglets (EFSA CONTAM Panel, 2016). The Panel noted that there are no limits for erucic acid in the current EU specifications E 470a and E 470b. The Panel noted that there is a maximum limit set for sum of dioxins in Regulation (EC) 1881/2006 (Section 5) for marine oils (5.7), fat of bovine animals and sheep, poultry and pigs (5.10), mixed animal fat (5.11) and vegetable oils and fats (5.12). 3.1.3. Manufacturing process According to information provided by industry (APAG, 2016 (Documentation provided to EFSA n. 2)), the sodium, potassium, calcium and magnesium salts of fatty acids (E 470a, E 470b) are commonly manufactured by one of two of the following processes: a direct process or a precipitation process. Direct process In this process, fatty acids are neutralised to yield a specific salt of fatty acids. As cation sources, oxides (magnesium or calcium oxide) or hydroxides (sodium-, potassium-, magnesium- or calcium hydroxide) may be used. General reaction equation: fatty acid þ metal oxide/hydroxide! metal fatty acid salt þ water Precipitation process This process consists of two consecutive steps. In a first step, a sodium soap is produced by the reaction of the fatty acids with sodium hydroxide in water. In the second step, the salts of fatty acids are precipitated by adding the required metal cation salt. General reaction equations: Step 1: fatty acid þ NaOH! Fatty acid sodium salt þ water Step 2: fatty acid sodium salt þ X 2þ! X(fatty acid) 2 þ 2Na þ X 2+ : being Ca 2+ or Mg 2+ Nature of raw materials used in the manufacturing processes In Commission Regulation (EU) No 231/2012, it is stated that the salts of fatty acids are obtained either from edible fats and oils or from distilled food fatty acids. According to information provided by industry (APAG, 2016 (Documentation provided to EFSA n. 2)), the fatty acids used for the manufacturing of all four salts are derived from edible fats and oils. They are obtained from either vegetable sources (e.g. palm oil) or animal sources such as food grade lard and tallows (e.g. lard, suet or bone fat from beef and pigskin fat). It is stated that the fatty acids derived from edible fats and oils consist mainly of stearic or palmitic acid. 7 Commission Regulation (EU) No 694/2014 of 24 June 2014 amending Regulation (EC) No 1881/2006 as regards maximum levels of erucic acid in vegetable oils and fats and foods containing vegetable oils and fats. OJ L 184, 25.6.2014, p. 1 2. www.efsa.europa.eu/efsajournal 13 EFSA Journal 2018;16(3):5180

3.1.4. Methods of analysis in food For the method of analysis, interested parties (APAG, 2016 (Documentation provided to EFSA n. 2)) referred to the procedure described in the JECFA method (JECFA, 2006). The method involves esterification by methanol of the fatty acids in the presence of boron trifluoride and alkaline conditions. The fatty acid methyl esters are subsequently analysed by GLC and the percentage area of the fatty acids in the chromatogram is calculated. The Panel presented an overview of methods for the analysis of individual fatty acids in food in the re-evaluation of fatty acids (E 570) as a food additive (EFSA ANS Panel, 2017). 3.1.5. Reaction and fate in food Metal salts of saturated fatty acids are stable products for which no decomposition products are expected under normal storage conditions (Rustan and Drevon, 2005). Auto-oxidation products can typically be present in unsaturated fatty acids (Belitz et al., 2008) and are not expected to be found in saturated fatty acids such as stearic acid and palmitic acid. According to APAG (2016 (Documentation provided to EFSA n. 2)), a moisture uptake during longer storage (> 12 months) may take place. 3.2. Authorised uses and use levels Maximum levels of sodium, potassium, calcium and magnesium salts of fatty acids (E 470a, E 470b) have been defined in Annex II to Regulation (EC) No 1333/2008 8 on food additives, as amended. In this opinion, these levels are named maximum permitted levels (MPLs). Currently, sodium, potassium, calcium and magnesium salts of fatty acids (E 470a, E 470b) are authorised as Group I food additive in 67 food categories and have a specific authorised use in only two food categories (of which one has only an authorisation for E 470a). E 470a and E 470b are authorised at (QS) in all food categories. Table 4 summarises foods that are permitted to contain E 470a or E 470b as set by Annex II to Regulation (EC) No 1333/2008. Table 4: MPLs of E 470a and E 470b in foods according to Annex II to Regulation (EC) No 1333/2008 Food category Food category name number 1.3 Unflavoured fermented milk products, heat-treated after fermentation E-number/ group Group I Restrictions/ exception MPL (mg/l or mg/kg as appropriate) 1.4 Flavoured fermented milk products Group I including heat-treated products 01.6.3 Other creams Group I 01.7.1 Unripened cheese excluding Group I Except mozzarella products falling in category 16 01.7.5 Processed cheese Group I 01.7.6 Cheese products (excluding Group I products falling in category 16) 1.8 Dairy analogues, including Group I beverage whiteners 02.2.2 Other fat and oil emulsions Group I including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions 2.3 Vegetable oil pan spray Group I 3 Edible ices Group I 04.2.1 Dried fruit and vegetables Group I 04.2.2 Fruit and vegetables in vinegar, oil, or brine Group I 8 Commission Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. OJ L 354, 31.12.2008, p. 16. www.efsa.europa.eu/efsajournal 14 EFSA Journal 2018;16(3):5180

Food category number Food category name E-number/ group Restrictions/ exception MPL (mg/l or mg/kg as appropriate) 04.2.4.1 Fruit and vegetables preparations Group I excluding compote 04.2.5.4 Nut butters and nut spreads Group I 04.2.6 Processed potato products Group I 5.1 Cocoa and Chocolate products as covered by Directive 2000/36/EC Group I Only energy-reduced or with no added sugar 5.2 Other confectionery including Group I breath freshening microsweets 5.3 Chewing gum Group I 5.4 Decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4 Group I 6.2.2 Starches Group I 6.3 Breakfast cereals Group I 6.4.2 Dry pasta Group I Only gluten free and/ or pasta intended for hypoproteic diets in accordance with Directive 2009/39/EC 6.4.4 Potato gnocchi Group I Except fresh refrigerated potato gnocchi 6.4.5 Fillings of stuffed pasta (ravioli and Group I similar) 6.5 Noodles Group I 6.6 Batters Group I 6.7 Pre-cooked or processed cereals Group I 7.1 Bread and rolls Group I Except products in 7.1.1 and 7.1.2 7.2 Fine bakery wares Group I 8.3.1 Non-heat-treated meat products Group I 8.3.2 Heat- treated meat products Group I Except foie gras, foie gras entier, blocs de foie gras, libamaj, libamaj egeszben, libamaj t ombben 8.3.3 Casings and coatings and decorations for meat 9.2 Processed fish and fishery products including molluscs and crustaceans Group I Group I 9.3 Fish roe Group I Only processed fish roe 10.2 Processed eggs and egg products Group I 11.2 Other sugars and syrups Group I 11.4.3 Table-top sweeteners in tablets E 470a E 470b 12.1.2 Salt substitutes Group I 12.2.1 Herbs and Spices E 470a Only when dried 12.2.2 Seasonings and condiments Group I 12.3 Vinegars Group I www.efsa.europa.eu/efsajournal 15 EFSA Journal 2018;16(3):5180

Food category number Food category name E-number/ group Restrictions/ exception MPL (mg/l or mg/kg as appropriate) 12.4 Mustard Group I 12.5 Soups and broths Group I 12.6 Sauces Group I 12.7 Salads and savoury-based Group I sandwich spreads 12.8 Yeast and yeast products Group I 12.9 Protein products, excluding Group I products covered in category 1.8 13.2 Dietary foods for special medical Group I purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) 13.3 Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet) Group I 13.4 Foods suitable for people Group I Including dry pasta intolerant to gluten as defined by Regulation (EC) No 41/2009 14.1.2 Fruit juices as defined by Directive 2001/112/EC and vegetable juices Group I Only vegetable juices 14.1.3 Fruit nectars as defined by Group I Only vegetable nectars Directive 2001/112/EC and vegetable nectars and similar products 14.1.4 Flavoured drinks Group I 14.1.5.2 Other Group I Excluding unflavoured leaf tea; including flavoured instant coffee 14.2.3 Cider and perry Group I 14.2.4 Fruit wine and made wine Group I 14.2.5 Mead Group I 14.2.6 Spirit drinks as defined in Regulation (EC) No 110/2008 Group I Except whisky or whiskey 14.2.7.1 Aromatised wines Group I 14.2.7.2 Aromatised wine-based drinks Group I 14.2.7.3 Aromatised wine-product cocktails Group I 14.2.8 Other alcoholic drinks including Group I mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15% of alcohol 15.1 Potato-, cereal-, flour- or starchbased Group I snacks 15.2 Processed nuts Group I 16 Desserts excluding products Group I covered in category 1, 3 and 4 17.1 (a) Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms Group I www.efsa.europa.eu/efsajournal 16 EFSA Journal 2018;16(3):5180