Through a notification dated 2 November 2016, the FSSAI has given directions regarding the import of speciality foods for IEM disorders. Inborn Errors of Metabolism (IEM) and Hypoallergenic conditions require speciality foods which are not available in India. A number of hospitals require these speciality foods for the management of infants and children suffering from these medical conditions.
Unfortunately, since there are no standards for these speciality foods in our country as yet, importing these speciality foods from other countries also becomes a problem. Since these foods are globally available, the FSSAI has been receiving a number of representations from various organisations to allow the import of these speciality foods.
The Scientific Panel of FSSAI on Functional Foods, Nutraceuticals, Dietic Products and other Speciality products has initiated work for setting standards for these products. Since this category of foods is complex the FSSAI feels that it could take time to finalise the standards. Seeing the urgency in the requirement for import of speciality foods for the management of IEM and Hypoallergenic conditions; the Scientific Panel has recommended that the FSSAI permit the import of these products for a period of two years or till their standards are developed and notified, whichever is earlier.
After careful consideration, the Scientific Panel has recommended allowing the import of foods for fifteen types of IEMs and two types of Hypoallergenic conditions which FSSAI has outlined in an Annexure. However, the FSSAI has permitted the import of these foods with some conditions, which are as follows:
- The importing firm must submit all the necessary documents related to the composition, label and claims of these foods well in time
- FSSAI would allow import of these speciality foods on a case by case basis for a period of two years from 2 November 2016 or till standards are developed and notified
- Once the FSSAI has permitted a particular composition, label and claims the importer can also import future consignments on the basis of this one time permission provided that they adhere strictly to the requirements.
- The labels on the food packaging will clearly mention the medical conditions for which they are to be used
- The importer/ manufacturer of such foods will need to ensure that the foods are consumed only under strict supervision of health care professionals.
- The above mentioned conditions will also apply to any speciality foods that are domestically produced for which FSSAI shall grant permission after due examination.
FSSAI has permitted import of speciality foods for the following Inborn Errors or Metabolism (IEM) and Hypoallergenic conditions
|S. No||Medical Condition||Description|
|A : IEM conditions|
|1.||Maple syrup urine disease||Isoleucine, Leucine and Valine free diet powder|
|2.||Glutaric Acidemia Type I||Lysine and Tryptophan free diet powder|
|3.||Homocystinuria||Methionine free diet powder|
3-Methylcrotonyl – CoA
|Leucine free diet powder|
|Isoleucine, Methionine, Threonine and Valine free diet powder|
|6.||Amino Acid metabolic disorders||Protein and amino acid free diet powder (with and without fat)|
|7.||Phenylketonuria (PKU)||Phenylalanine free diet powder|
|8.||Urea cycle disorders|
Argininosuccinic Aciduria Carbamoylphosphate
Synthetase Deficiency 1
|Non-essential amino acid free diet powder|
|9.||Tyrosinemia||Phenylalanine and Tyrosine free diet powder|
|10.||Galactosemia||Galactose free formula|
|11.||3-Hydroxy Long Chain Acyl-CoA Dehydrogenase Deficiency||LCHAD Deficiency|
|12.||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
|Protein hydrolysate formula base powder with iron for use with added carbohydrate|
|14.||Non-ketotic Hyperglycinemia, Lysinuric protein intolerance||Protein free formula|
|15.||Glucose transport defect (Glut1 Def) Pyruvate dehydrogenase||Low carbohydrate, sucrose, fructose sugar free formula|
|B. Hypoallergenic Conditions|
|1.||Severe allergy due to multiple food protein intolerance that cannot be effectively managed by extensively hydrolysed formula||Amino acid based Hypoallergenic formula|
|2.||Severe allergy due to intact milk protein and soya protein||For Cow’s milk allergy hypoallergenic formula|