FSSAI drafts notification related to tolerance limit of antibiotics and pharmacology active substances

Through a notification uploaded on 12 May 2017 the FSSAI has invited comments, suggestions and views from stake holders which are related to the tolerance limit of antibiotics and pharmacology active substances as mentioned in the draft notification. The FSSAI has proposed some changes in the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011, in regulation relating to “Residues”, in the category ANTIBIOTIC AND OTHER PHARMA-COLOGICALLY ACTIVE SUBSTANCES (2.3.2). The comments and suggestions must reach the FSSAI office within 60 days of the above mentioned date.

In the sub-regulation ‘Antibiotics and other pharmacologically active substances’ the FSSAI has made some changes. It has removed the names of some antibiotics and other pharmacologically active substances and added some new ones to the list of those which are prohibited for use in any unit processing sea foods including shrimps, prawns or any other variety of fish and fishery products. The prohibited antibiotics and substances proposed in the draft notification are as follows:

• Nitrofurans including-

(i) Furaltadone;

(ii) Furazolidone;

(iii) Nitrofurnatoin;

(iv) Nitrofurazone.

• Chloramphenicol
• Sulphamethoxazole
• Aristolochia spp and preparations thereof.
• Chloroform
• Chloropromazine
• Colchicine
• Dapsone
• Dimetridazole
• Metronidazole
• Ronidazole
• Ipronidazole and other nitromidazoles.
• Clenbuterol
• Diethylstibestrol (DES).
• Glycopeptides
• Stilbenes and other steroids.
• Crystal Violet.
• Malachite Green

FSSAI has proposed the tolerance level of antibiotics in other animal foods in tabular form. In table number one FSSAI has also provided the names of the antibiotic used in human beings as well as animals and the tolerance limits of these antibiotics per mg/kg in various foods derived from animals like meat, fats and milk. For most antibiotics like ampicillin, Cloxacillin, etc.( table has a list of 21 antibiotics) the tolerance level for all edible animal tissue, fats derived from animal tissues and milk has been limited to 0.01mg per kg of food.

Similarly the FSSAI has drafted a list of antibiotics that are exclusively used only on animals and has also proposed the tolerance level of these antibiotics which in this table varies as per type of animal and the organ from which the food is derived; like edible animal tissues, animal fats and milk and includes the fat, muscle, kidney and liver of cattle, pigs, sheep, goat, rabbit, chicken, quail and turkey. The antibiotics listed in this category number 21 in the table.

Table 3 is composed of the list of other veterinary drugs and their maximum residual limit that can be found in animal derived foods and includes, muscle, liver, kidney, fat and milk. Here too the MRL varies according to the type of antibiotic used and the part of the body the food is derived from, for example the tolerance limit of the same drug Doramectone will vary in the muscle, kidney, liver, fat and milk; though the MRL will be measured as mg/per kg of food. The tolerance limit of the same antibiotic in foods derived from different animals will also be varied. For instance the MRL for cattle will be different from that of pig or sheep. Table 3 has the longest list of veterinary drugs and contains 77 names.