EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

EFSA Publication; Inge Tetens

doi:10.2903/j.efsa.2014.3758

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

EFSA Publication, Inge Tetens

1 Citation (Scopus)

Abstract

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.

Original language	English

Publisher	Europen Food Safety Authority
DOIs	https://doi.org/10.2903/j.efsa.2014.3758
Publication status	Published - 2014
Externally published	Yes

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10.2903/j.efsa.2014.3758

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@book{e0c773da3c114c7984112151f021056b,

title = "EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Statement on the safety of {\textquoteleft}Cetyl Myristoleate Complex{\textquoteright} as an ingredient in food supplements",

abstract = "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 {\textquoteleft}Cetyl Myristoleate Complex{\textquoteright} (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 {\textquoteleft}Cetyl Myristoleate Complex{\textquoteright} has not been established.",

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year = "2014",

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N2 - 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.

AB - 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.

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BT - EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

PB - Europen Food Safety Authority

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