Bureau Circular No. 16 s. 2004

On what date was Bureau Circular No. 16 s. 2004 issued?

October 26, 2004

Which international standard serves as the reference for Bureau Circular No. 16 s. 2004?

WHO-FAO "Guidelines for the Evaluation of Probiotics in Food" (2002)

Guidelines on Probiotics

Bureau Circular No. 16 s. 2004

How is a "Probiotic" defined under Bureau Circular No. 16 s. 2004 (citing Gaarner and Scharfema, 1998)?

A dietary supplement based on living microorganisms which, when administered in sufficient quantity, has a beneficial effect on the host organism by improving the equilibrium of the intestinal microflora.

Process of identifying the specific genetic variant of the bacteria using phenotypic and genotypic methods.

Strain Identification

Tests to determine if the probiotic performs the intended function (in vitro and animal studies).

Functional Characterization

List the five specific bacterial strains/types explicitly approved for use as probiotics under Bureau Circular No. 16 s. 2004.

• Lactobacilli

• Bifidobacteria

• Nonpathogenic strains of Streptococcus

• Saccharomyces boulardii

• Bacillus clausii

According to Bureau Circular No. 16 s. 2004, what are the two requirements for using bacterial strains not found on the approved list?

• Demonstration of evidence of safe use as a food supplement.

• Analysis of the bacterial species found in the formulation.

For a probiotic to be considered effective, it must demonstrate the following properties:

1. Beneficial effect on the host organism.

2. Ability to survive in the digestive tract.

3. Ability to adhere to the mucosal epithelial cells.

4. Exhibit enhancement and protection of the intestinal ecology.

5. Remain viable during periods of storage and use.

What four key documents or assessments must be submitted to demonstrate the safety of a probiotic strain under Bureau Circular No. 16 s. 2004?

1. Determination of antibiotic resistance patterns.

2. Assessment of metabolic activities (e.g., D-lactate production, bile salt deconjugation).

3. Assessment of side-effects during human studies.

4. Epidemiological surveillance of adverse incidents (post-market).

What four key documents or assessments must be submitted to demonstrate the safety of a probiotic strain under Bureau Circular No. 16 s. 2004?

1. Determination of antibiotic resistance patterns.

2. Assessment of metabolic activities (e.g., D-lactate production, bile salt deconjugation).

3. Assessment of side-effects during human studies.

4. Epidemiological surveillance of adverse incidents (post-market).

According to Bureau Circular No. 16 s. 2004, when is toxin production testing required?

It is required if the strain belongs to a species that is a known mammalian toxin producer.

Which specific scheme does Bureau Circular No. 16 s. 2004 recommend for toxin production testing?

The EU Scientific Committee on Animal Nutrition (SCAN) 2000 scheme.

According to Bureau Circular No. 16 s. 2004, what are the three required elements of Strain Identification in the evaluation process?

• Use of Phenotypic and Genotypic methods (Genus, species, strain).

• Deposition of the strain in an international culture collection.

What two types of studies are required for Functional Characterization under Bureau Circular No. 16 s. 2004?

In vitro tests and Animal studies

According to Bureau Circular No. 16 s. 2004, what constitutes the Safety Assessment phase?

In vitro/animal tests and a Phase 1 human study

Under Bureau Circular No. 16 s. 2004, what is the specific requirement for Efficacy Trials for products classified as Drugs?

Double-blind, randomized, placebo-controlled (DBPC) Phase 2 trials, followed by Phase 3 effectiveness trials

How do the requirements for Efficacy Trials differ for Food products under Bureau Circular No. 16 s. 2004?

For Food, functional characterization and safety assessment are generally sufficient (extensive clinical trials like those for drugs are not explicitly demanded).

According to Bureau Circular No. 16 s. 2004, what three details regarding the "Contents" must appear on a probiotic product label?

• genus

• species

• strain designation

How must the bacterial count be expressed on the label according to Bureau Circular No. 16 s. 2004?

It must state the minimum numbers of viable bacteria at the end of shelf life.

Besides contents and count, what other two pieces of information are mandatory on the label under Bureau Circular No. 16 s. 2004?

• Proper storage conditions.

• Corporate contact details for consumer information.

According to Bureau Circular No. 16 s. 2004, what are the four specific claims BFAD (FDA) recognizes/approves for probiotic food supplements?

1. Enhancement of intestinal ecology.

2. Helping improve lactose malabsorption.

3. Improving digestion.

4. Aid to the enhancement of natural resistance to intestinal infections.

Under Bureau Circular No. 16 s. 2004, where are these approved food supplement claims permitted to appear?

labels, ads, and promotions

According to Bureau Circular No. 16 s. 2004, if a probiotic product makes claims such as "Altering disease" or "Immunomodulator," how is it classified?

drug

What constitutes a "Drug" claim under Bureau Circular No. 16 s. 2004, and what does it denote?

Claims that denote a therapeutic advantage (specifically "altering disease" or "immunomodulator")

What level of scientific evidence is required for a probiotic to be classified as a drug under Bureau Circular No. 16 s. 2004?

It must be supported by sound scientific evidence based on studies on human subjects (specifically Phase 2 and Phase 3 trials).