Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

Products, Efsa Panel on Dietetic

doi:10.2903/j.efsa.2013.3261

Cited by 4 publications

(6 citation statements)

References 2 publications

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“…The Panel notes the low rate of hydrolysis of the two esters found in a newly provided in vitro hydrolysis study and therefore reiterates the need for adequate safety information on the unhydrolysed esters contained in CMC as expressed in its opinions of and 2013(EFSA NDA Panel, 2010, 2013.…”

Section: Discussionmentioning

confidence: 99%

“…In 2012, the Commission requested EFSA to review and update its opinion by taking into account a report of a new subchronic 90-day oral toxicity study conducted with -Cetylated Fatty Acid Esters Powder 50 %‖ (Cetyl Myristoleate Complex, CMC) in mice (CMC Study Report, 2012). In 2013, the NDA Panel noted that the new 90-day study and its report have many shortcomings, and considered that this study cannot serve as a reliable source of information supporting the absence of adverse effects of CMC (EFSA, 2013). The Panel also noted that apart from information on the safety of the hydrolysis moieties, and in the absence of sufficient data with respect to kinetics of hydrolysis, adequate safety information on the parent compounds of CMC remains relevant.…”

Section: Discussionmentioning

confidence: 99%

“…In 2013, the NDA Panel noted that the new 90-day study and its report have many shortcomings, and considered that this study cannot serve as a reliable source of information supporting the absence of adverse effects of CMC (EFSA, 2013). The Panel also noted that apart from information on the safety of the hydrolysis moieties, and in the absence of sufficient data with respect to kinetics of hydrolysis, adequate safety information on the parent compounds of CMC remains relevant.…”

Section: © European Foodmentioning

confidence: 99%

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Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

Products¹

2014

EFSA Journal

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Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of ‗Cetyl Myristoleate Complex' (CMC) as a novel food ingredient in the light of additional information submitted by the applicant. In its previous opinion of 2010, the Panel concluded that the safety of CMC as an ingredient in food supplements at an intake of 3.3 g per day has not been established. This conclusion was based on the considerations that in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data were insufficient. In 2012, the Commission requested EFSA to review and update its opinion by taking into account a new subchronic 90-day oral toxicity study conducted with -Cetylated Fatty Acid Esters Powder 50 %‖ in mice. In its opinion of 2013, the Panel considered that a new 90-day study cannot serve as a reliable source of information supporting the absence of adverse effects of CMC. The dossier of this new mandate contains three new references which were not submitted and hence not considered in the previous assessments. The Panel notes that two references do not address the concerns expressed by the Panel in its previous assessments. The third reference provided is a report on an in vitro hydrolysis study demonstrating a low rate of hydrolysis of cetyl myristoleate and cetyl myristate. The Panel notes the low rate of hydrolysis of the two esters found in this in vitro hydrolysis study and therefore reiterates the need for adequate safety information on the unhydrolysed esters contained in CMC as expressed in its opinions of 2010 and 2013. The Panel concludes that, even after considering the newly submitted information, the safety of ‗Cetyl Myristoleate Complex' has not been established. Panel, 2010). This conclusion was based on the considerations that, in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data were insufficient. © European FoodIn 2012, the Commission requested EFSA to review and update its opinion by taking into account a report of a new subchronic 90-day oral toxicity study conducted with -Cetylated Fatty Acid Esters Powder 50 %‖ (Cetyl Myristoleate Complex, CMC) in mice (CMC Study Report, 2012). In 2013, the NDA Panel noted that the new 90-day study and its report have many shortcomings, and considered that this study cannot serve as a reliable source of information supporting the absence of adverse effects of CMC (EFSA, 2013). The Panel also noted that apart from information on the safety of the hydrolysis moieties, and in the absence of sufficient data with respect to kinetics of hydrolysis, adequate safety information on the parent compounds of CMC remains relevant. The Panel reiterated its previous conclusion from 2010 that the safety of ‗Cetyl Myristoleate Complex' has not been established.Following a request from the European Commission, the NDA Panel was asked in 2014 to update its opinion on...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: © European Foodmentioning

confidence: 99%

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Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

Products¹

2014

EFSA Journal

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“…No ADME studies were provided for the NF or with other cetylated fatty acids. The applicant referred to the ADME on triglycerides, fatty acids and the EFSA Opinions on another, similar NF application ('CMC') (EFSA NDA Panel, 2010, 2013.…”

Section: Absorption Distribution Metabolism and Excretion (Adme)mentioning

confidence: 99%

Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283

Nutrition¹,

Turck²,

Castenmiller³

et al. 2021

EFS2

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Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on an application for cetylated fatty acids as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns primarily a mixture of cetylated myristic acid and cetylated oleic acid synthesised from cetyl alcohol, myristic acid and oleic acid, and to a lesser degree, other cetylated fatty acids and other compounds from olive oil. The NF is intended for use in food supplements for the general adult population. The highest dose tested in a subchronic toxicity study in rats, i.e. 4,500 mg/kg per day, was considered to be the no-observedadverse effect level. By applying the default uncertainty factor of 200 as suggested by the EFSA Scientific Committee (2012), and considering a default body weight of 70 kg for the adult target population, this would result in an intake of 1.6 g per day, which is lower than the maximum intake proposed by the applicant (i.e. 2.1 g per day). The Panel concludes that the NF, cetylated fatty acids, is safe at an intake of 1.6 g per day for the intended target population, i.e. adults.

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“…In terms of use in foods, the safety of cetyl myristoleate complex, a specific CFA formulation comprising 50% CFAs, 48% corn starch, and 2% silicon dioxide, for use as a novel food has been previously reviewed by the European Food Safety Authority (EFSA, 2010(EFSA, , 2013(EFSA, , 2014. During the course of these risk assessments, EFSA concluded that the data presented were insufficient to support the safety in foods.…”

mentioning

confidence: 99%

Genotoxicity and subchronic toxicity studies of Lipocet®, a novel mixture of cetylated fatty acids

Brilli

Tarantino²

2020

J of Applied Toxicology

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Cetylated fatty acids (CFAs) are a group of fats that contain a single ester group within a hydrocarbon chain, which are reported to have beneficial biological effects. A novel mixture of CFAs produced by combining fatty acids derived from refined olive oil with cetyl esters (Lipocet®) is proposed for use as a food ingredient and was therefore subjected to a nonclinical safety assessment. The safety of Lipocet® was evaluated in a bacterial reverse mutation test and an in vitro mammalian cell micronucleus test, followed by a 90‐day oral (gavage) toxicity study. In the 90‐day study, Sprague–Dawley rats were administered with the vehicle (corn oil) or Lipocet® at 1,500, 3,000, or 4,500 mg/kg body weight/day for 90 days. A comparator reference control group received noncetylated fatty acids derived from olive oil at 4,500 mg/kg body weight/day to identify any effects that may be expected following consumption of high doses of fat. Lipocet® was nongenotoxic in vitro. In the 90‐day study, changes observed in hematological and clinical biochemistry parameters were minor in nature and/or showed poor dose dependency. Histopathology findings in the gastrointestinal tract and lungs were noted but were not associated with a clear dose response and were likely incidental. Moreover, Lipocet® was just as well tolerated as the reference control. Therefore, 4,500 mg/kg body weight/day (the highest dose tested) was considered the no‐observed‐adverse‐effect‐level. These results support the safety of Lipocet® for use as a food ingredient.

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Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

Cited by 4 publications

References 2 publications

Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283

Genotoxicity and subchronic toxicity studies of Lipocet®, a novel mixture of cetylated fatty acids

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