Requirements of Test Reports

Understand the requirements of test reports for CPM.

Parameters to be Tested and Their Limits

Tests must be conducted on finished products. Tests done on intermediate products or raw materials would not be accepted.

Toxic heavy metal limits

Toxic heavy metal limits

Your product must not exceed the following heavy metal limits:

Heavy metal Permissible limits
Arsenic 5 parts per million (ppm)
Cadmium 0.3ppm
Lead 10ppm
Mercury 0.5ppm

Dealers may wish to take note of the following suggestions in controlling the heavy metal contents of their products:

  • Identify starting materials (e.g. certain herbs, minerals) that may contribute to higher heavy metal content in their product;
  • Source for starting materials which have been tested to contain heavy metals below stipulated limits;
  • Ensure that herbal materials are free from soil particles before use (e.g. by washing thoroughly, if applicable); and
  • Incorporate relevant extraction processes in the manufacturing workflow to remove heavy metals in the product, if necessary.

Microbial limits

Microbial limits

CPM must be tested to comply with the following microbial count:

Oral CPM

Microbe Microbial limits 

Total aerobic microbial count

Not more than 105 CFU per g or ml 

Yeast and mould count

Not more than 5 x 102 CFU per g or ml

Escherichia coli, Salmonellae and Staphylococcus aureus

Absent in 1g or ml

Topical CPM

Microbe Microbial limits 
Total aerobic microbial count Not more than 104 CFU per g or ml
Yeast and mould count Not more than 5 x 102 CFU per g or ml
Pseudomonas aeruginosa and Staphyloccocus aureus Absent in 1g or ml

Other substances as may be required by HSA

Other substances as may be required by HSA

Test reports for CPM containing herbs with specific naturally occurring substances listed under the Poisons Act of Singapore have to be tested at laboratories with accredited testing methods, and the test results must be quantified in the test reports to be within the stipulated limits:

Substances Acceptable limits or conditions
Aconite and its alkaloids

Dosing of no more than 60 mcg per day
Boric acid, sodium borate Not more than 5% boric acid or 5% sodium borate or 5% of a combination of both
Ephedra and its alkaloids   Less than 1%
Lobelia and its alkaloids
  Less than 0.1%
Lovastatin  Less than 1%
Tetrahydropalmatine  Dosing of no more than 19 mg per day

 

Every batch for CPM containing herbs with naturally occurring substances (as described above), as well as those considered as high-risk (e.g. those with slimming claims) has to be tested at laboratories with accredited testing methods for the contents of toxic heavy metals and microbial contamination.

Requirements on Test Reports

  1. The product's batch number must be stated on the test report, and it must be in accordance with the batch numbering system declared in the online application form. A written explanation should be submitted for any deviation from the declared batch numbering system. The same batch should be tested and reflected on both test reports if the tests on toxic heavy metals and microbial limits were done separately.
  2. The product's full product name must be stated on the test report:
    Type of CPM Acceptable product name on test report 
    Imported products Either the product name in the country of origin or the one intended for local sale
    Locally manufactured products Product name stated in online application form
    Locally assembled products (Primary assembly) Product name of CPM after assembly
    Locally assembled products (Secondary assembly) Either the product name of CPM before or after assembly
  3. The date of analysis stated on the test report must be within 2 years from the date of evaluation on the CPM product listing.
  4. If the test result is "not detected/ND", the limit of detection must be stated on the test report.
  5. The test result cannot be stated as "less than legal limit" (e.g. "Arsenic < 5 ppm"). A product with a test result that is too close to the legal limit is likely to fail re-testing conducted by different laboratories or using different equipment.

 

Sample of Test Report

Sample of Test Report

Testing Methodology

Toxic heavy metals and microbial contamination tests should be conducted using methods that are in accordance with the latest edition of one of the following pharmacopoeias: British Pharmacopoeia, Chinese Pharmacopoeia, European Pharmacopoeia, United States Pharmacopoeia, etc.

Accredited Laboratories

The requirement for testing of CPM to be conducted at laboratories with accredited testing methods has commenced in stages and CPM dealers are encouraged to send their products for testing at such laboratories.

Dealers with specific products that require testing at the laboratories accredited for testing of CPM have been informed by HSA accordingly. For new CPM product applications, the applicant will be informed prior to product approval whether the CPM requires testing at such laboratories. 

HSA has compiled a list of laboratories accredited for testing of CPM in Singapore as well as a list of overseas laboratories for dealers' easy reference. Test reports from overseas laboratories accredited for testing of CPM would be acceptable for the following tests:
a) Toxic heavy metals
b) Microbial contamination
c) Other substances as may be required by HSA

List of laboratories accredited for testing of CPM in Singapore58 KB

List of overseas laboratories accredited for testing of CPM in Singapore182 KB

Please be reminded that the lists serve as a reference and may not necessarily be valid. In view that the types of tests and test methods that the laboratories are accredited to conduct may vary from time to time, dealers are advised to verify the accreditation status of the laboratories’ test methods when intending to engage their services. The onus of responsibility remains with the dealers to ensure that the laboratory they have engaged holds the necessary valid accreditation for the relevant test methods.

For the detailed description of the laboratories’ scope of accreditation, please visit the websites stated in the User Guide214 KB which HSA has prepared to help dealers navigate the websites.

Share