India: Chemical Safety of Fish, Draft Rules


Posted By: Selerant RSA

The FSSAI has proposed amendments related to pharmacologically active substances prohibited in fish and fishery products, mainly pesticides and veterinary drugs residues, including antibiotics. The amendments relate to Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.

The most important changes in the regulation will relate to how insecticide MRLs are set and the rules for defining veterinary drugs MRLs (certain MRLs will directly mirror Codex standards).

Here are the details:

Insecticides (draft sections 2.3.1 and 2.3.2)

In the current regulation, Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, under section 2.3.1 sub-regulation- 1, no insecticide is allowed for direct use on food other than the fumigants that have been registered and approved for specific use by the Registration Committee, under the Insecticides Act, 1968 (46 of 1968).

The draft regulation proposes the following changes:

-        If MRL’s have been fixed for crops as per the Insecticide Act, 1968 (46 of 1968), then they shall be retained unless there is any concern or new data becomes available for considering modification of the MRL’s;

-        For MRL’s that are not fixed, Codex shall be referred as the source for information;

-        For MRL’s recommended by Codex, if the MRL is at limit of quantification (LOQ), then it shall be adopted as such;

-        For MRL’s recommended by Codex that are above the LOQ, a risk assessment shall be carried our considering the Codex value;

-        For insecticides that are not registered under Insecticides Act, 1968 (46 of 1968), a default tolerance limit value of 0.01 mg./kg  shall apply;

-        For insecticides banned under Insecticides Act, 1968 (46 of 1968), data recorded shall be taken into consideration on the basis of criteria of whether the residues were measured at LOQ or above the LOQ.

-        For values measured at LOQ, an extraneous MRL (EMRL) as 0.01 mg/kg at LOQ shall be adopted.  For values measured above LOQ, the EMRL shall be fixed using OECD calculator and reviewed after every 5 years and amendments made accordingly until a LOQ is arrived at.

In the draft regulation, a detailed table with names of insecticides that are allowed, the name of the related food commodities and MRLs (mg/kg) are listed (draft section 2.3.2).

Drugs, Pesticides and Antimicrobials (draft sections 2.3.3 and 2.3.4)

1. For drugs, pesticides and antimicrobials including antibiotics for veterinary use registered under Drugs and Cosmetics Act, 1940 (23 of 1940):

-    For antimicrobials used in both humans and animals, the MRL shall be fixed at LOQ;

-    For antimicrobials used exclusively in animals, the MRLs limits fixed by Codex shall be adopted;

-    For antimicrobials used exclusively in animals, where Codex MRLs are not fixed, the MRL shall be fixed at LOQ/minimum required performance limit (MRPL) until risk assessment data becomes available to FSSAI for revision of MRLs, after due risk assessment;
-   For all other veterinary drugs, Codex MRLs may be adopted wherever available

-   For veterinary drugs for which Codex MRLs are not available, MRL to be fixed at LOQ/MRPL until the latest data is made available to FSSAI for revision of MRLs after due risk assessment;
-   For pesticides used for topical application, Codex MRLs may be adopted wherever available.

2 For drugs, pesticides and antimicrobials including antibiotics for veterinary use not registered under Drugs and Cosmetics Act, 1940 (23 of 1940):

- For drugs that are not registered under the Act for use in India, 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.

3.  Wherever the MRLs are fixed without availability of data, the status shall be assigned as “temporary or T”.

Antibiotics MRLs (draft section 2.3.4), used in humans and animals, as well as MRLs for other veterinary drugs are given presented in a table.

Use RegData®, our global food legislation library, to get the latest MRLs for different contaminants and residues.

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