Through a recent notice, FSSA has called for claims, suggestions, views, comments etc. from stakeholders on the draft amendment related to Pharmacologically active substance prohibited for fish and fishery products; Harmonization of Pesticides, Antibiotics, and Veterinary Drugs Residues; Fixation of MRLs for 17 pesticides.
In the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011, in regulation 2.3 relating to ‘Residues’ changes have been proposed and the following has been added
Insecticide Residues on Agricultural Commodities and Resultant Processed Food
According to this proposed addition, maximum residue limits (MRL) of insecticides on recommended crops will be accepted if they are
- Registered under Insecticides Act, 1968 (46 of 1968) and in the FSSAI regulations. If new information is available then the MRL will be modified.
- If Codex MRL is available and if it is at LOQ it will be adopted otherwise risk assessment will be carried out and if risk exposure is within acceptable range it will be adopted.
- If in the Codex MRL exposure is not within recommended range then refinement of risk will be carried out and if the value is within range it will be adopted
- If the value is not within range then Central Insecticides Board and Registration Committee (CIB&RC) shall be requested to delete appropriate label claims.
- In case there is no Codex MRL then it could be checked according to availability of relevant data and MRL calculated on the basis of OECD calculator followed by risk assessment, refinement may be undertaken of exposure is not within acceptable range and if ADI does not exceed by 100 % then MRL could be fixed on recalculated value. If no monitoring data is available then CIB&RC shall be requested to delete label claim on specific commodities.
- In cases where insecticides which are not registered under the Insecticides Act, 1968 (46 of 1968), a default tolerance limit value of 0.01 mg/kg will apply.
In cases where the insecticides are banned under Insecticides Act, 1968 (46 of 1968), the identification will be carried out to see if monitoring data indicates residues at LOQ or higher than that. In case the value is at LOQ, the extraneous maximum residue limit (EMRL) as 0.01 mg/kg at LOQ will be adopted. In case the value is above LOQ, an EMRL based on monitoring data shall be fixed using OECD calculator. It shall be reviewed after every 5 years and amendment shall be made accordingly till the figure comes to LOQ.
The table for this amendment contains the names of the insecticides and the crops and foods against which a particular insecticide is used and the MRL for each food type. In the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011 the number of insecticides named was 149. In the proposed draft there is an increase of almost 50 more insecticides as the number has increased to 198 for which MRL has been mentioned.
The draft amendments also make a mention of the insecticides that are banned per the Insecticides Act, 1968 (46 of 1968). The insecticides are named in a table form against the specified foods. Banned insecticides were not mentioned in the earlier regulations
The comprehensive list of the insecticides includes herbicides, fungicides, pesticides etc. as per the Insecticides Act, 1968 (46 of 1968) and the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011;
The second change has been made to the Drugs, Pesticides and Antimicrobials Including Antibiotics for Veterinary Use
The Drugs, Pesticides, and Antimicrobials mentioned include Antibiotics for Veterinary Use, registered under the Drugs and Cosmetic Act, 1940 (23 of 1940). There are separate tables for
Antimicrobials Including Antibiotics;
(i) Used in both humans and animals for which the MRL/ tolerance limit shall be fixed at LOQ for this category.
(ii) Exclusively used in animals or Other Veterinary Drugs then codex MRLs/ tolerance limit may be adopted wherever available. If codex MRL is not available MRL will be fixed at LOQ/minimum required performance limit (MRPL) until the fresh data are made available to FSSAI for revision of MRLs, after due risk assessment. In such cases, MRL will be valid for a period of 5 years. The manufacturer is required to submit the data for revision or otherwise the same shall continue.
For all pesticides used for topical application those mentioned in regulations or codex and their MRLs/tolerance limit will be adopted wherever available.
If no regulations/codex MRLs/tolerance limits are available, risk assessment based on the metabolism data and withdrawal period shall be carried out which will be considered together with its MRL/tolerance limit, if any, as a pesticide. This will help to determine residues left in the tissues/ milk/ eggs as well as the crops in which it is allowed to be used. Thereafter, appropriate MRLs/ tolerance limits may be fixed. Wherever the MRL/tolerance limits are fixed without any data, it should be prefixed with “T” (Temporary).
Drugs, Pesticides, and Antimicrobials including Antibiotics for Veterinary Use, not registered under the Drugs and Cosmetics Act, 1940(23 of 1940) will have a default tolerance limit of 0.001 mg/kg. Since this category includes import tolerances, in case of any objection from the exporting country, the relevant data shall be asked from the exporting country for review and, if appropriate, necessary upward revision of the tolerance limit can be made.
Antibiotic and other Pharmacologically Active Substances
- The tables indicate the names of antibiotics and the seafood including shrimps, prawns or any other variety of fish and fishery products and the tolerance limit prescribed. The antibiotics and other Pharmacologically Active Substances that are prohibited in these products are also mentioned.
- The limit of antibiotics mentioned in honey on the basis of Limit of Quantification and the tolerance limit prescribed when determined by the LC-MS/MS method are given in a separate level
- The limit of antibiotics for the animal tissues are mentioned in a separate table along with the tolerance limit prescribed for
- Antibiotics (Used Both in Humans & Animals)
- Antibiotics (Exclusive use in Animals)
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