Eruditio : Indonesia Journal of Food and Drug Safety

Strengthening the Surveillance of 1,4-Dioxane Contaminants in Cosmetics through Harmonization of Analysis Methods and Networking of Cosmetics Laboratories in Indonesia

Susan Gracia Arpan — 2024-10-25

Laboratories play a strategic role in protecting public health by ensuring the quality and safety of drugs, food, and cosmetics. The Centre of National Quality Laboratory of Drugs and Food (CNQLDF), as the central laboratory of the Indonesian Food and Drug Authority (Indonesian FDA), continuously develops reliable, selective, sensitive, and accurate analytical methods (AM) for cosmetic testing in line with advancements in cosmetic formulation technology. However, both the Indonesian FDA and external cosmetic laboratories need more human resources and infrastructure, hindering the development of analytical method and the testing of cosmetic products. Strengthening these laboratories through stakeholder networks is essential. Indonesia actively participates in the ASEAN Cosmetic Testing Laboratories Committee (ACTLC) and the Indonesian Cosmetic Laboratory Network (ICLN). One of the main tasks of CNQLDF is to develop a new ASEAN Cosmetic Method (ACM) for 1,4-Dioxane contaminants in cosmetics. Currently, CNQLDF, along with the Indonesia National Standard Body (INSB), Ministries and External Laboratories, in which together became members of ICLN, harmonized the analytical method of 1,4-Dioxane at the national level, leading to the issuance of the Indonesian National Standard (INS). Both the INS and ACM have main purpose to standardize analytical methods across laboratories, ensure the safety and quality of cosmetic products and enhance national product competitiveness. This study examines method to strengthen pre-market cosmetic surveillance through harmonizing the analytical method of 1,4-Dioxane at the national and ASEAN regional levels, using a qualitative approach based on the Indonesian FDA's internal data and stakeholder information on 1,4-Dioxane testing capabilities.

Performance Characteristics of the Quantitative Method for Staphylococcus aureus in Food Products corresponds to ISO 16140-3: 2021

Fannisa Putri — 2024-10-25

Good food sanitation is one of the main pillars for achieving food security goals. High levels of Staphylococcus aureus in food can indicate poor hygiene and handling practices during food production, processing, or storage. Before testing, the laboratory needs to verify the quantitative method for Staphylococcus aureus to produce valid data to ensure food safety and quality. The Centre of National Quality Laboratory of Drugs and Food, Indonesian Food and Drug Authority (FDA) has never verified the Staphylococcus aureus quantification method based on the latest ISO 16140-3:2021. Following the guidelines established in ISO 16140-3:2021, method verification is accomplished by calculating the Interlaboratory Reproducibility Standard Deviation (S_IR) for implementation validation and the eBias value for verifying the method's suitability for assessing specific food items. This research was conducted to confirm the ISO 6888-1:2021 as the designated reference method for quantifying Staphylococcus aureus in food products. The cheese was utilized as the test food item to verify the implementation of the method. At the same time, several products, including condensed milk, margarine, baby porridge, cassava chips, and ready-to-eat sausage, were examined as challenging food types. Every chosen food item was artificially contaminated with Staphylococcus aureus WDCM 00034. The S_IR value obtained was 0.04 ≤ 2× 0.11 (the lowest mean of SR value from ISO 6888-1:2021), which indicated that the Centre of National Quality Laboratory of Drugs and Food Indonesian FDA was able to implement the method very well. In addition, the eBias value for all types of food tested was below 0.5log10, which showed that the quantitative method for coagulase-positive Staphylococci (Staphylococcus aureus and other types) could be applied in the Centre of National Quality Laboratory of Drugs and Food laboratory for the extensive scope of food.

Optimization and Validation of Analytical Method for Detection of Shigella sp. in Oral Preparations of Quasi-Drugs in the Form of Lozenges

Desty Herawati — 2024-10-25

Lozenges, a quasi-drug used to relieve sore throats, must meet the safety and quality requirements according to Indonesian FDA Regulation No. 7 of 2023 concerning the criteria and procedures for quasi-drug registration, which stipulates that oral preparations of quasi-drugs must be free from Shigella spp—microbial contamination. Contamination by Shigella bacteria can cause diseases such as shigellosis, characterized by symptoms such as diarrhoea, vomiting, and fever. This study aims to validate the Shigella spp—detection method in quasi-drug lozenges using the WHO (Quality Control Methods for Herbal Materials) reference method. Validation was carried out to ensure that this method can be used for routine analysis in the Indonesian FDA laboratory. The guidelines used to validate the microbiological method are the Singapore Accreditation Council (SAC) Guidance Notes C&B AND ENV 002 of 2019 and refer to pharmacopoeias. The study results showed that the WHO (Quality Control Methods for Herbal Materials) method in detecting Shigella sp. has a sensitivity and specificity of 100%, with false positive and false negative rates of 0% each. The detection limit obtained was 3 cfu/g, which meets the requirements (below 10 cfu/g). The method suitability test (optimization) showed that the initial solvent used for sample homogenization in Shigella detection was sufficient using Tryptone Soya Broth (1:10) without additional neutralization or modification procedures at the sample homogenization stage. Based on these results, the Shigella spp. The WHO reference (Quality Control Methods for Herbal Materials) detection method is accurate. It can be applied for routine microbial contamination testing analysis in the Food and Drug Supervisory Agency laboratories.

Development and Validation of a Method for Detecting and Quantifying Mitragynine in Kratom Samples Using HPLC-PDA

Neni Isnaeni — 2024-10-25

Kratom (Mitragyna speciosa Korth) has been identified as a New Psychoactive Substance (NPS) by the United Nations Office on Drugs and Crime (UNODC) and included in the list of prohibited ingredients in food supplements and traditional medicine by Indonesian FDA. Therefore, a rapid, easy, and reliable analytical method is necessary to detect and quantify this plant and its products. This study developed a method for the detection and quantification of kratom products based on a unique compound, mitragynine, as a biomarker. A previous survey of determining mitragynine in Kratom using GC-MS, LC-MS/MS, UPLC, and HPLC-PDA. Previously, the HPLC-PDA method used a C8 column. Yet, for efficiency, it is also necessary to develop a test method using a C18 column. Analysis was performed using an HPLC - PDA system with Waters Atlantis T3-C18 (250 x 4.6 mm, 5 µm) column. The mobile phase comprises acetonitrile and formic acid 0.05%, pH 5.0 (75:25 v/v), delivered at a 1.0 mL/min flow rate. Detection was carried out at a wavelength of 225 nm. The analytical method was validated with test parameters of selectivity, system suitability, accuracy, precision, linearity, detection limit, and quantification limit. The validation study demonstrated an excellent linear concentration range of 1.96 - 6.01 µg/mL with a correlation coefficient of 0.9996; the detection limit is 0.14 µg/mL, while the limit of quantification is 0.45 µg/mL—accuracy method of 98.88 - 101.44% and a bias of 0.27%. The percent relative standard deviation for six independent assay determinations was 0.67%, and the intermediate precision was 1.56% on two days. The mitragynine amounts in these materials ranged from 6.01 to 6.31 mg/g of dried leaf material. Based on the research results, it can be concluded that the method developed provides quick, simple, reliable, accurate, and valid, and has an advantage over existing methods in terms of simplicity of sample preparation, short analysis time, and cost-effectiveness compared to GCMS and LCMS/MS and can be applied for future analysis in Kratom samples.

Analysis of the Effectiveness of Food Safety of School Snacks Program in Changing Knowledge, Attitude, and Behavior of School Children in Southeast Sulawesi

Dewi Amni Idrus — 2024-10-25

Snacks are trendy foods with school-age children to fulfil their energy and nutrition needs in the school environment and must be ensured to be safe from biological, chemical, and physical contamination. However, food safety of school snacks program (PJAS) in Indonesia is still a reasonably concerning problem. One of the efforts made by the government to protect school-age children from unsafe PJAS is by increasing the knowledge, behavior, and attitudes of school children in choosing, buying, and consuming food through the Safe PJAS Program. This study aimed to examine the effect of the Safe PJAS program on the knowledge, attitudes, and behavior of school children in Southeast Sulawesi and the effectiveness of the Safe PJAS program in terms of the Knowledge, Attitudes, and Behavior of school children. The research methodology used was the quantitative analysis with Wilcoxon Test and Oneway Anova Test and literature review. The research results showed it was found that the Safe PJAS program carried out in Southeast Sulawesi in 2023 in Wakatobi and Central Buton Regencies had an impact and was influential in increasing the knowledge, attitudes, and behavior of school children in choosing and consuming snack foods. The author's recommendation for the Safe PJAS Program is that the Indonesian FDA can improve coordination and communication with the Ministry of Education and Culture to include food safety material in the independent learning curriculum and increase advocacy to obtain support from the Regional Government in allocating a budget for improving canteen facilities and infrastructure and to replicate the Safe PJAS program.

Public Engagement on the Instagram Social Media Account Format of Indonesian Food and Drug Authority Regional Office in Ambon in 2023

Mohammad Viva Agusta — 2024-10-25

Public awareness regarding the importance of safe drugs and food is crucial. However, products still have the potential to be unsafe, so the community needs to be equipped with knowledge through Information, Education, and Communication (IEC). Due to advances in information technology and the increasing number of internet users, IEC can be conducted through electronic and social media to reach a wider audience. Instagram is one of the platforms used by the Indonesian Food and Drug Authority (Indonesian FDA) Regional Office in Ambon for IEC. It has the potential to serve as a medium for communicating, disseminating information, and educating the public about safe drugs and food. However, an analysis of Instagram user engagement with the content created is needed. This study aims to determine Instagram user engagement with content formats on the Indonesian FDA Regional Office in Ambon. Instagram account using quantitative research methods with a descriptive approach. The research-dependent variable is the content format (video, photo, infographic), and the independent variable is engagement (like, comment, save, share). Engagement analysis was conducted on 509 posts during 2023, consisting of 51 (10.02%) video content, 174 (34.19%) photos, and 284 (55.80%) infographics. The results of the analysis show that photo content formats have higher engagement than videos and infographics, with an average number of likes (25.03), saves (0.29), and shares (0.69). Meanwhile, video content formats have a higher average number of comments (0.14) compared to photos and infographics. This study concludes that photo and video content have higher engagement, so it can be chosen as priority content to increase follower engagement on the Indonesian FDA Regional Office in Ambon Instagram account.

Analysis of ZnPtO in Anti-dandruff Shampoo by High-Performance Liquid Chromatography - Photo Diode Array

Zahara Zahara — 2024-10-25

ZnPtO is widely used as an active substance in anti-dandruff shampoo. Instead of describing its benefits, many articles have reported that ZnPtO can harm the environment and human health. Through the Food and Drugs Administration, Indonesia has been regulated to have a maximum limit of 2.0% for rinse-off hair products. The research aims to develop an accurate and reliable method to determine product ZnPtO level. ZnPtO was analyzed using High-Performance Liquid Chromatography (HPLC) with Photo Diode Array (PDA) at a wavelength of 257.9 nm. This research used a C18 column with dimensions of 250 x 4.6 nm and five μm in particle size. The mobile phase consisted of acetonitrile and a mixture of potassium dihydrogen phosphate solution and disodium EDTA at pH 4.0 (30:70). Column temperature was maintained at 40oC at a 1.0 ml/min flow rate. The results showed that ZnPtO was detected at a retention time of 7 minutes. The method's correlation coefficient and residual deviation were 0.999% and 0.65%, respectively. Method precision at 20, 100, and 160 μg/ml was 0.6694, 0.4511, and 0.4728%, respectively. Method accuracy at those levels was 98.3 to 100.9%. All validation parameters have fulfilled the qualification. ZnPtO levels contained in anti-dandruff shampoos were 0.0081%, 0.0040%, and 0.016%, respectively. The developed method has proven selective, accurate, and reliable. It can control the quality and safety of anti-dandruff shampoo due to pre-market and post-market surveillance.