Through a notification dated 19 January 2021 the FSSAI has issued Directions regarding import of speciality foods for Inborn Errors of Metabolism (IEM) and hypoallergenic conditions.
In the notification the FSSAI has drawn attention to its directions dated 2 November 2016, regarding import and manufacturing of foods required for management of Inborn Errors of Metabolism (IEM) and Hypoallergenic conditions and the FSSIA had permitted the import of such foods for a period of two years or till their standards are developed and notified, whichever is earlier. This compliance was further extended till 05 May 2021.
The FSSAI notification states that the standards for Foods for Infants and IEM and Hypoallergenic infant milk substitutes are now notified under the Food Safety and Standards (foods for Infant Nutrition) Regulations 2020 which shall come into force on their publication in the Official Gazette and Food Business Operators shall comply with the provisions of these regulations by 1 July 2021.
Since the Standards for IEM were notified on 4 December 2020, under the Food Safety and Standards (foods for Infant Nutrition) Regulations 2020 and earlier direction is superseded by this notification, it has been decided to allow import of food products for IEM conditions, as listed in the Annexure-1 till 30 June 2021, under the following conditions.
- The importing firm shall submit to the FSSAI, well in advance, all the necessary documents related to the composition, label and claims for the product they intend to import. FSSAI after due examination, would allow the import of such foods on a case to case basis. Once a particular composition, label and claim is permitted by FSSAI for import, future consignments, strictly adhereing to the requirements, can be imported on the basis of this onetime permission.
- The labels on these foods shall clearly mention the medical conditions for which they have to be used.
- The importer, manufacturer of such foods shall ensure that they are consumed only under supervision of health care professionals.
The above conditions shall also apply to the domestically produced speciality food products for which FSSAI shall grant permission after due examination.
Inborn Errors of Metabolism IEM Conditions
Description of food products for IEM conditions
Maple syrup urine disease
Isoleucine, Leucine and Valine free diet powder
Glutaric Acidemia Type I
Lysine and Tryptophan free diet powder
Methionine free diet powder
3-Methylcrotonyl – CoA
Leucine free diet powder
Methylmalonic Acidemias, Propionic Acidemia
Isoleucine, Methionine, Threonine and Valine free diet powder
Amino Acid metabolic disorders
Protein and amino acid free diet powder (with and without fat)
Phenylalanine free diet powder
Urea cycle disorders
Argininosuccinic Aciduria Carbamoylphosphate
Synthetase Deficiency 1
Non-essential amino acid free diet powder
Phenylalanine and Tyrosine free diet powder
Galactose free formula
3-Hydroxy Long Chain Acyl-CoA Dehydrogenase Deficiency
Defects in the intraluminal hydrolysis of fat; defective mucosal fat absorption; defective lymphatic transport of fat
Milk protein based powder with medium chain triglycerides (MCT) for children and adults
Disorders of carbohydrate metabolism
Sucrase/isomaltase deficiency Fructose intolerance
Protein hydrolysate formula base powder with iron for use with added carbohydrate
Non-ketotic Hyperglycinemia, Lysinuric protein intolerance
Protein free formula
Glucose transport defect (Glut1 Def) Pyruvate dehydrogenase
Low carbohydrate, sucrose, fructose sugar free formula
Source : FSSAI