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Potensi Peredaran Kosmetik Dalam Bentuk Mainan (Mainan Kosmetik) Tidak Memiliki Izin Edar Sende, Iin Febrianti; Kembaren, Anita; Yunianto , Edi Priyo; Barus , David Julianto; Arrahman , Yovia Rizki
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 1 (2023): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i1.176

Cosmetics in the form of children's toys/cosmetic toys such as eyeshadow, lipstick/lip gloss, blush on, nail polish, and others are popular among children. Cosmetic toys distributed offline in toy shops/online in the marketplace. Cosmetic toys have the potential to contain harmful ingredients such as mercury, formaldehyde, etc. These ingredients have the potential to cause health problems, especially in children who have immature skin protective functions and immune systems. Nowadays, there is still a dualism in the distribution license of cosmetic toys: as cosmetics that must have a notification number from Indonesian FDA or as toys which must have SNI standards and be produced by toys manufacturers. The research aims to determine trends in the circulation of cosmetic toys and the potential impact of license dualism to ensure the safety of cosmetic toys in circulation. The research was conducted by collecting data on cosmetic toys in 48 toy shops in Jakarta, Bogor, Depok, Tangerang, Bekasi, Denpasar, and Surabaya areas in period of April – June 2023. The results of the research showed that all cosmetic toys are decorative cosmetics, and most often as toys with SNI marking. Most of the cosmetic toys in circulation are import products from China. Besides that, in circulation it was also found there are cosmetic toys do not have a distribution permit (illegal) and/or also have a double category as toys and cosmetics. This could be a loophole for business actors who produce or sell illegal cosmetic toys that have the potential to contain dangerous ingredients and could cause losses for business actors who register their products in both categories. BPOM needs to coordinate with related sectors to review regulations on cosmetic toy products to determine the boundaries between toys and cosmetics.

Validasi Metode Analisis Penetapan Kadar Bahan Baku Lapatinib Ditosylate secara KCKT-DAD Nopi, Nely Suryani; Isnaeni, Neni
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 1 (2023): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i1.178

The validation analytical method of the Lapatinib ditosylate assay is crucial to increase testing capability and capacity in strengthening the supervision of post-marketing drugs in Indonesia. A fast, precise, accurate, valid, and efficient test method is needed to carry out the test. A previous study on determining Lapatinib ditosylate assay generally used a C18 column, yet for efficiency, it is also necessary to develop a test method that can use existing resources in the laboratory, where the research used a C8 column. In this study, an analytical method to determine the assay of Lapatinib ditosylate developed using a High-Performance-Liquid Chromatography-Diode Array Detector (HPLC-DAD) system equipped with an autosampler and XBridge ® C8 column (Waters); 250 x 4.6 mm i.d. 5 μm. The mobile phase consisted of pentane-1-sulfonic acid sodium salt 10 mM - acetonitrile (65:35) eluted isocratically at a 0.6 mL/min flow rate. Detection was carried out at a wavelength of 222 nm. The analytical method was validated with test parameters of selectivity, system suitability, accuracy, precision, linearity, detection limit and quantification limit. Results from the validation study demonstrated a retention time of 4.63 minutes, good linear in the concentration range of 0.06 – 0.18 mg/mL with a correlation coefficient and Vx0 of 1.00000 and 0.1%. Test accuracy (% bias) obtained a value of 0.77% with precision (system, method and intermediate) less than 2.0%. The detection and quantification limits were 0.67 µg/mL and 2.02 µg/mL. Based on the research results, it can be concluded that the method developed provides fast, accurate and valid performance. Validation of the Analytical Method for Determining Lapatinib Ditosylate Raw Material Contents using HPLC-DAD.

Analisis Keterlibatan Publik dalam Pemanfaatan Instagram Untuk Komunikasi, Informasi, dan Edukasi Pengembangan Vaksin COVID-19 oleh BPOM Dharma, Alexander Arie Sanata
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 1 (2023): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i1.179

The COVID-19 pandemic has become a complicated problem faced by the world. The absence of specific antiviral drugs or vaccines at the beginning of the outbreak made the public health approach the primary strategy for preventing the spread of COVID-19. The lack of transparency at the start of the COVID-19 outbreak also led to public misinformation. WHO called it an infodemic, an excess of information, whether true or not, making it difficult for people to determine valid references. In Indonesia, misinformation on health matters is not a new difficulty and is in the top rank along with socio-political. The government utilizes social media to provide information to the citizens. Social media itself has a vital role in the infodemic as a medium for disseminating information, whether credible or not. The Indonesian FDA plays an essential role in conducting education through social media. This study aims to map the elements forming citizens' engagement in Indonesian FDA social media use, especially in disseminating information about the COVID-19 vaccine. This study uses a regression method with citizens' engagement (calculated from the number of likes and comments) as the dependent variable. Three independent variables form citizen engagement elements: media richness, content production, and content type defined by the government. The sentiment toward government Instagram posts was measured by analyzing citizens' comments using the dataset from InSet Semantic Lexicon. Based on negative binomial regression results, data obtained that the framework developed in this research was statistically significant in observing the phenomenon. Media richness and content production significantly affect citizens' engagement. On the other hand, original and informative content encourages more citizen engagement. Generally, public sentiment on Indonesian FDA Instagram content, both head office and regional offices, tends to be more positive than negative.

Pengujian Senyawa Marker Sebagai Kontrol Kualitas Produk Fitofarmaka: Studi Kasus Pada Produk Fitofarmaka Kelas Terapi Kardiovaskular Kurniawati, Farida; Risma Uli, Aan; Bodrorini, Nany
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 1 (2023): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i1.185

Quality control of phytopharmaceutical products becomes a priority because they are included in the National Health Insurance. Quality control is carried out through active compound determination in the product. Currently, testing methods for active compounds are in herbs or plant extracts, but none for products. Phytopharmaceutical products for cardiovascular system therapy class contain Apii graveolentis herba and Orthosiphomis staminei folium extracts. The research aims to develop analytical methods that are selective, accurate and reliable to assay the active compounds of sinensetin in product contains Apii graveolentis herba extract by TLC and apigenin in product contains Orthosiphomis staminei folium extract by LC-MS/MS. From the results, it is proven that both methods are valid and reliable with linearity, precision and accuracy values that meet the requirements. The linearity of sinensetin and apigenin has correlation coefficient values of 0.9972 and 0.9995, with residual deviation values (Vx0) of 4.0% and 1.7%. Good repeatability is represented by the low number of precision values. Sinensetin precision at a concentration of 91.83; 310.33; and 586.68 µg/g were 1.11; 0.61; and 1.50%, while the apigenin precision at a concentration of 5; 15; and 25 µg/g were 5.82; 4.36; and 2.32% respectively. Accuracy of sinensetin at a concentration of 100.24; 300.72; and 601.44 µg/g were 90.8 - 92.7%; 102.5 - 103.7%; and 96.5 - 99.2%, while the accuracy of apigenin at a concentration of 5; 15; and 25 µg/g were 81.58 - 91.57%; 86.71 - 93.76%; and 89.12 - 93.31 % respectively. The developed methods were sensitive with the limit of quantitation (LoQ) values for sinensetin and apigenin were 3.34 ng/g and 6.67 µg/g. The validated methods can be applied to determine sinensetin and apigenin in cardiovascular system therapy class phytopharmaceutical products.

Penerapan ISO 16140-3:2021 untuk Pencacahan Enterobacteriaceae pada Produk Pangan Nagur, Kemala S.; Surati, Sri; Marusaha Sitorus , Aditya Anugerah; Cahyaningsih, Eni; Putri, Fannisa; Wilasti, Yulin
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 1 (2023): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i1.195

Method verification is one of the steps required to ensure that all methods used meet the standards required for data reliability and accuracy in a laboratory that implements Good Laboratory Practices (GLP). In accordance with ISO 16140-3:2021, the method verification for microbiology testing implemented by calculating the Intralaboratory Reproducibility Standard Deviation (SIR) for implementation verification and eBias value for food item verification. Method verification for enumeration of Enterobacteriaceae in food products using ISO 16140-3 has never been carried out at the Indonesian Food and Drug Authority (FDA) laboratories. Therefore, verification of this method needs to be performed. This study aimed to verify the ISO 21528-2:2017 as reference method for enumeration of Enterobacteriaceae in food products by colony count technique. The selected food item for implementation verification was pasteurized milk while for food item verification, the selected food items were yogurt, traditional preserved egg (telur pindang), sweet and hard candy, seasoning dry powder, worcester sauce and cassava chips. All of selected foods were artificially contaminated with Escherichia coli WDCM 00012. The SIR value obtained was 0.12 ≤ 2× 0,18 (lowest mean value of SR from ISO 21528-2:2017), indicating that the acceptability limit for the implementation verification was met. While the eBias value for all selected food item were less than 0,5 log10, thus the verification study in the National Quality Contol Laboratory of Drug and Food (NQCLDF), Indonesian FDA, meets the acceptance criteria defined in the standard ISO 16140-3:2021.

Studi Kandungan Residu Antibiotik Kloramfenikol pada Produk Pangan Olahan Madu, Udang, dan Ikan di Sulawesi dan Maluku Ebtasari, Ma'rifah; Aini , Alifah Nur
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.157

Antibiotic residues in food products can cause significant public health problems. Using antibiotics in livestock farming can potentially cause antibiotic residues in animal-based foods. We conducted this study to determine the results of chloramphenicol residue testing in processed honey, shrimp, and fish food products in the Sulawesi and Maluku regions. This study can determine the distribution of test results based on business type. This study is expected to produce recommendations to stakeholders to minimize the use of chloramphenicol, which is not covered by the provisions. The research samples came from processed honey, shrimp, and fish food products distributed in the Central Sulawesi, Ambon, Sofifi, Mamuju, Morotai, and Tanimbar regions in 2021-2022. Testing was carried out at the laboratory of the Indonesian Food and Drug Authority Regional Office in Palu according to the analysis method of PPPOMN 071/PA/17 concerning the Determination of Chloramphenicol Residue Levels in Shrimp by ELISA and MA PPPOMN 11/PA/09 concerning the Determination of Chloramphenicol Residue Levels in Honey by ELISA. Based on the test results, processed honey, shrimp, and fish food products were found to contain chloramphenicol residues. Of the total 92 samples tested, there were 15 honey products, four processed shrimp food products, and seven processed fish food products that did not meet the requirements (TMS). Chloramphenicol residue levels ranged from 0.01 to 0.09 ppb. The number of TMS samples in honey and fish food products with PIRT distribution permits was more significant in percentage when compared to products with MD/ML distribution permits. The rate of TMS in honey and processed fish food products with PIRT distribution permits was 53% and 21%, respectively. Further research on the source of chloramphenicol residues and the origin of honey, shrimp, and fish-producing areas needs to be conducted by relevant institutions or academics. In addition, it is necessary to conduct socialization and education among the public regarding the use of chloramphenicol antibiotics according to the provisions for both the treatment of diseases and livestock practices to minimize the presence of chloramphenicol residues in processed food products.

Implementasi Regulatory Sandbox dalam Konteks Pengawasan Pangan Olahan di Indonesia Handoko, Yulian Dwi Anggraeni Puspa; Wibowo, Andi; Arrahman, Yovia Rizki; Fauziah, Pepi; Yuliani
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.172

The enhancement of innovation in processed food products in Indonesia faces regulatory challenges that often limit the speed and flexibility of development, particularly for high-risk products. The recent implementation of the Omnibus Law has brought significant changes to the food oversight framework, including the exemption of criminal sanctions for low to medium-risk business activities and the transition of distribution permits into business licenses. However, these regulations have not fully addressed the barriers to innovation in processed food development. The concept of a regulatory sandbox has been identified as a promising prospective approach to overcoming these challenges, providing a controlled testing environment for businesses to develop innovative products within a more adaptive ecosystem. This article explores the potential of a regulatory sandbox as a creative tool for overseeing high-risk processed food products through a qualitative literature review method. The study indicates that the success of implementing a sandbox depends on several key factors: collecting robust experimental data to assess product safety and efficacy, developing adaptive procedures responsive to industry feedback, and granting limited yet flexible authorization for testing new technologies. Other factors, such as limitations on the duration, scope, and use of the sandbox, must be established to avoid consumer safety risks. As a recommendation, The Indonesian Food and Drug Authority (BPOM) may consider adopting a regulatory sandbox as a strategic framework to support the oversight of processed food products with a dynamic approach, accelerating innovation while maintaining a balance between consumer safety and industry growth.

Analisis Zink Pirition dalam Sampo Anti Ketombe secara Kromatografi Cair Kinerja Tinggi untuk Mendukung Pengawasan Pre-Market dan Post-Market Zahara, Zahara; Kurniawati, Farida; Lusianti, Erita
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.175

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.

Harmonisasi Metode Analisis Pengujian Cemaran 1,4-Dioksan dalam Kosmetik sebagai Upaya Memperkuat Pengawasan Pre-Market Melalui Jejaring Laboratorium Kosmetik di Indonesia Arpan, Susan Gracia; Sri Purwaningsih; Hasti Kusuma; Lusianti, Erita; Yustina, Yustina
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.187

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.

Deteksi Salmonella spp pada pakan hewan laboratorium berbentuk pelet menggunakan Real Time Polymerase Chain Reaction (qPCR) dan Loop Mediated Isothermal Amplification (LAMP) P, Fitra Yovita Delviona; Puspita Dewi Fortuna; Nur Aini
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.194

Salmonella spp. contamination in animal feed is challenging for the commercial feed industry and laboratory animal facilities. Salmonellosis is a term used for Salmonella infection. Salmonellosis is a zoonosis directly transmitted to humans through contaminated feed, food, water, or infected animals. Nevertheless, infection in animals is mainly caused by contaminated feed. Since it provokes a significantly high economic loss due to its high mortality, accurate and rapid Salmonella detection methods are necessary for monitoring the quality of animal feed. The standard method for Salmonella detection in animal feed, which refers to ISO 6579, is based on the culture method, which takes about 5-7 days. Thus, an alternative method is required to give valid results faster. This study aims to develop alternative methods for Salmonella spp. detection in animal feed using Loop isothermal Amplification (LAMP) and Real-time Polymerase Chain Reaction (PCR) methods. Salmonella detection has been carried out on animal feed pellets artificially inoculated with Salmonella Typhimurium ATCC 14028 at three concentration levels, namely 1, 3, and 9 cfu per test portion (25-gram samples). e-LOD range values between the LAMP method and Real PCR are compared with the culture method and analyzed descriptively. Salmonella detection method using LAMP and Real-Time PCR showed the value e-LOD50 at 0.62 cfu/portion in mouse feed and e-LOD50 at 0.37 cfu/portion in rabbit feed. Compared to the LOD of the culture method, the e-LOD of LAMP and PCR showed similarity. This e-LOD value is the same as the e-LOD culture method. Related laboratories can utilize the results of this study to monitor the quality of animal feed.

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Listia Ningsih

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+6281395105898

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eruditi@pom.go.id

Editorial Address
Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location
Kota adm. jakarta pusat,

Dki jakarta

INDONESIA

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Home Page

OAI Link

Editorial Team

Contact

Reviewer

Google Scholar

Contact Name Listia Ningsih

Contact Email listia.n@pom.go.id

Phone +6281395105898

Journal Mail Official eruditi@pom.go.id

Editorial Address Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location Kota adm. jakarta pusat, Dki jakarta INDONESIA

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Contact Name
Listia Ningsih

Contact Email
listia.n@pom.go.id

Phone
+6281395105898

Journal Mail Official
eruditi@pom.go.id

Editorial Address
Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location
Kota adm. jakarta pusat,

Dki jakarta

INDONESIA