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Proposals to Amend the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards 2008

7 Proposal to set an MRL for Lincomycin

It is proposed that an MRL is set for lincomycin when used as a veterinary medicine for cattle. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to include the following; this will be the resulting entry for lincomycin in Schedule One of the NZ (MRL) Food Standards 2008:

Compound

CAS#

Residue definition

Food

Maximum Residue Limit (mg/kg)

Lincomycin

154-21-2

Lincomycin

Cattle milk

0.15

Amendment Rationale

The proposed MRL represents the setting of a New Zealand MRL for lincomycin in cattle milk that will be harmonised with MRLs set internationally by the European Union and by the Codex Alimentarius Commission.

It is intended that the increase in the MRL will allow the milking withholding period to be decreased allowing a greater flexibility in the use of lincomycin in the treatment of mastitis

Chemical Information

Common name of compound

Lincomycin

Use of compound

Antibiotic

Chemical Abstract Services (CAS) Registry number

154-21-2

Type of compound

Lincosamide

Administration method

Intramammary

Good Agricultural Practice

Lincomycin is currently approved in New Zealand as an antibiotic treatment for mastitis in cattle by way of intramammary, with a withholding period of 3 days for milk and 30 days for meat.

Residues Information

The proposed MRL has been determined by Codex to represent a suitable international standard for residues.

Dietary Risk Assessment

Acceptable Daily Intake (ADI)

0.03mg/kg bw/day

The potential daily exposure via food (PDE(food))is used for dietary intake calculation where a value has been set. An appropriate acceptable daily intake (ADI) is used in the absence of a PDE(food).

The chronic dietary exposure to lincomycin is estimated by the National Estimated Dietary Intake (NEDI) calculation encompassing all registered uses of the chemical and food consumption data based upon the 1997 National Nutritional Survey for adults and the 1995 National Nutrition Survey of Australia, for children. The NEDI calculation is made in accordance with Guidelines for predicting dietary intake of pesticide residues (revised) [World Health Organisation, 1997].

The NEDI for lincomycin is equivalent to 3% of the ADI. It is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.

Toxicological / Public Health Assessment

Promulgation of the proposed MRL for lincomycin as an antibiotic treatment for mastitis in cattle is very unlikely to pose any health risks from consumption of the milk from treated cattle.

Other International MRLs

Compound

Food

Maximum Residue Limit (mg/kg)

Codex

   

Lincomycin

Cattle Milk

0.15

European Union

   

Lincomycin

Milk

0.15

Japan

   

Lincomycin

Milk

0.15 (Provisional)

To meet New Zealand’s obligations under the Agreement on the Application of Sanitary and Phytosanitary Measures the proposed MRL will be notified to the World Trade Organization. Any country may choose to comment if they believe the proposed MRL represents a barrier to their trade.

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