TY - JOUR
T1 - Calcium l‐methylfolate as a source of folate added for nutritional purposes to infant and follow‐on formula, baby food and processed cereal‐based food
AU - Turck, Dominique
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Hirsch‐Ernst, Karen Ildico
AU - Kearney, John
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McArdle, Harry J
AU - Naska, Androniki
AU - Pelaez, Carmen
AU - Pentieva, K.
AU - Siani, Alfonso
AU - Thies, Frank
AU - Tsabouri , Sophia
AU - Vinceti, Marco
AU - Cubadda, Francesco
AU - Engel, Karl-Heinz
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Marchelli, Rosangela
AU - Neuhauser-Berthold, Monika
AU - Poulsen, Morten
AU - Sanz, Yolanda
AU - Schlatter, Josef Rudolf
AU - van Loveren, Henk
AU - Bernasconi, Giovanni
AU - Germini, Andrea
AU - Knutsen, Helle Katrine
PY - 2020/1/17
Y1 - 2020/1/17
N2 - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the extension of use of calcium l‐methylfolate to be used as a source of folate added for nutritional purposes to infant and follow‐on formula, baby food and processed cereal‐based food pursuant to Regulation (EU) 609/2013. In 2004, EFSA assessed the use of calcium l‐methylfolate as a source of folate in foods for particular nutritional uses, food supplements and foods intended for the general population. The new alternative synthetic step proposed to produce the nutrient source, using platinum as a catalyst, did not raise any safety concern and the production process was found to consistently yield a product in line with the proposed specifications. Based on the studies assessed in the previous evaluation, it was concluded that calcium l‐methylfolate is non‐genotoxic and that subchronic and embryotoxicity/teratogenicity studies in rats did not reveal any adverse effects up to the highest doses tested. The Panel considered that no additional toxicological studies are required on the nutrient source. The intervention study in healthy infants provided by the applicant did not indicate differences in growth and tolerance parameters in infants who consumed either an infant formula supplemented with calcium l‐methylfolate or with folic acid, and did not raise concerns regarding safety or tolerability of the infant formula with the proposed nutrient source. The study also provided further supporting evidence for the bioavailability of calcium l‐methylfolate. The Panel considers that calcium l‐methylfolate is a source from which folate is bioavailable and concludes that calcium l‐methylfolate is safe under the proposed uses and use levels for infants and young children.
AB - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the extension of use of calcium l‐methylfolate to be used as a source of folate added for nutritional purposes to infant and follow‐on formula, baby food and processed cereal‐based food pursuant to Regulation (EU) 609/2013. In 2004, EFSA assessed the use of calcium l‐methylfolate as a source of folate in foods for particular nutritional uses, food supplements and foods intended for the general population. The new alternative synthetic step proposed to produce the nutrient source, using platinum as a catalyst, did not raise any safety concern and the production process was found to consistently yield a product in line with the proposed specifications. Based on the studies assessed in the previous evaluation, it was concluded that calcium l‐methylfolate is non‐genotoxic and that subchronic and embryotoxicity/teratogenicity studies in rats did not reveal any adverse effects up to the highest doses tested. The Panel considered that no additional toxicological studies are required on the nutrient source. The intervention study in healthy infants provided by the applicant did not indicate differences in growth and tolerance parameters in infants who consumed either an infant formula supplemented with calcium l‐methylfolate or with folic acid, and did not raise concerns regarding safety or tolerability of the infant formula with the proposed nutrient source. The study also provided further supporting evidence for the bioavailability of calcium l‐methylfolate. The Panel considers that calcium l‐methylfolate is a source from which folate is bioavailable and concludes that calcium l‐methylfolate is safe under the proposed uses and use levels for infants and young children.
KW - bioavailability
KW - calcium l-methylfolate
KW - extension of use
KW - folate
KW - folic acid
KW - infants
KW - nutrient source
KW - safety
KW - young children
UR - http://www.scopus.com/inward/record.url?scp=85079135037&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2020.5947
DO - 10.2903/j.efsa.2020.5947
M3 - Article
C2 - 32626499
SN - 1831-4732
VL - 18
SP - 5947
JO - EFSA Journal
JF - EFSA Journal
IS - 1
M1 - e05947
ER -