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    4.0 Safety Parameters
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    4.0 Safety Parameters

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    Infant, Follow-up, Young Child Formula
    Malaysia


    This section provides the safety parameters (microbiological, contaminants, heavy metals, pesticides, veterinary residues, and food contact materials).

    4.1 Microbiological Standards

     

    Provision, Limits, Testing Methods 

    Infant Formula [1]

    Maximum limits for microorganisms:

    - Total plate count at 37deg Celcius for 48hours: 10^4 cfu per g

    - Coliform count at 37deg Celcius for 48hours: 10 cfu per g

    - Escherichia coli: comply with GMP

     

    Maximum limits for mycotoxins

    Aflatoxin M1: 0.025 ppb (reconstituted, ready to drink)

    Follow-up Formula [1]

    Same as IF

    Young Child Formula [1]

    Maximum limits for microorganisms:

    - Total plate count at 37deg Celcius for 48 hours: 10^5 cfu per g or per ml

    - Coliform count at 37deg Celcius for 48 hours: 5 x 10 cfu per g or per ml

    - Escherichia coli: comply with GMP 

     

    Maximum limits for mycotoxins

    Aflatoxin M1: 0.5 ppb (limit of milk)

    In addition, refer to Section 4.1 in “4.0 Safety Parameters" of the "General Foods" guidebook for Malaysia. 

    4.2 Contaminants and Heavy Metals

     

    Provision, Limits, Testing Methods 

    Infant Formula [2]

    Maximum limits for heavy metals

    Arsenic: 0.1 ppm

    Lead: 0.02 ppm (reconstituted, ready to drink)

    Mercury: 0.05 ppm

    Tin: 50 ppm

    Cadmium: 1 ppm

    Antimony: 1 ppm

     

    Maximum limits for other contaminants

    Melamine: 1 ppm (powder)

    *3-MCPD: 0.02 ppm (for liquid foods), 0.05 ppm (for solid foods)

     

    Notes:

    *Only relevant if containing acid-hydrolyzed vegetable protein

    Follow-up Formula [2]

    Same as IF

    Young Child Formula [2]

    Maximum limits for heavy metals

    Arsenic: 0.1 ppm

    Lead: 0.2 ppm 

    Mercury: 0.05 ppm

    Tin: 50 ppm

    Cadmium: 1 ppm

    Antimony: 1 ppm

     

    Maximum limits for other contaminants

    Melamine: 1 ppm (powder)

    *3-MCPD: 0.02 ppm (for liquid foods), 0.05 ppm (for solid foods)

     

    Notes:

    *Only relevant if containing acid-hydrolyzed vegetable protein 

    In addition, refer to Section 4.2 in “4.0 Safety Parameters" of the "General Foods" guidebook for Malaysia.

    4.3 Pesticides

     

    Provision, Limits, Testing Methods 

    All Products

    There are no pesticide limits specific to “Infant, Follow-up and Young Child Formula”.

    MRLs of pesticides are specified for agricultural products. Manufacturers are advised to rely on ingredient-specific requirements to determine appropriate MRLs such as for dairy and dairy products.

    Refer to Section 4.3 in “4.0 Safety Parameters" of the "General Foods" guidebook for Malaysia.

    4.4 Veterinary Standards

     

    Provision, Limits, Testing Methods 

    All Products

    There are no veterinary drug residue limits specific to “Infant, Follow-up and Young Child Formula”.

    Manufacturers are advised to rely on ingredient-specific requirements to determine appropriate MRLs such as for dairy and dairy products.

    Refer to Section 4.4 in “4.0 Safety Parameters" of the "General Foods" guidebook for Malaysia.

    4.5 Food Contact Materials

    4.6 References

    1. Regulation 39, Fifteenth Schedule Malaysia Food Regulations  

    http://fsq.moh.gov.my/v6/xs/page.php?id=72


    2. Regulation 38, 38A, Fourteenth Schedule, Fourteenth A Schedule, Malaysia Food Regulations  

    http://fsq.moh.gov.my/v6/xs/page.php?id=72


    3. Regulation 41, Sixteenth Schedule Malaysia Food Regulations  

    http://fsq.moh.gov.my/v6/xs/page.php?id=72


    4. Regulation 40, Fifteenth A Schedule Malaysia Food Regulations  

    http://fsq.moh.gov.my/v6/xs/page.php?id=72


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