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October 31, 2023
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June 20, 2024
Published
October 25, 2024
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Abstract

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.

Keywords

1.4-Dioxane Cosmetic Pre-market Surveillance Laboratory Network Indonesian FDA 1.4-Dioksan Kosmetik Pengawasan pre-market Jejaring laboratorium BPOM

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How to Cite
Arpan, S. G., Sri Purwaningsih, Hasti Kusuma, Lusianti, E., & Yustina, Y. (2024). Strengthening the Surveillance of 1,4-Dioxane Contaminants in Cosmetics through Harmonization of Analysis Methods and Networking of Cosmetics Laboratories in Indonesia. Eruditio : Indonesia Journal of Food and Drug Safety, 4(2), 88–104. https://doi.org/10.54384/eruditio.v4i2.187
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References

  1. Agency for Toxic Substances and Disease Registry. 2012. Public Health Statement for 1,4 Dioxane. https://www.atsdr.cdc.gov/tp187–c1-b
  2. ASEAN. 2019. ASEAN Guidelines on Limits of Contaminants for Cosmetics Version 3.0.
  3. Castor K, Fernando S, Taylor A. 2021. Quantifying 1,4-dioxane in personal care, cosmetic, and cleaning products. Chemical and engineering news webinar. Virtual: American Chemical Society.
  4. Commission, E. (n.d.). Public Health. Retrieved from Scientific Committees: https://health.ec.europa.eu/scientific-committees_en#:~:text=Scientific%20Committee%20on%20Consumer%20Safety,tattooing%2C%20artificial%20sun%20tanning. Diakses tanggal 28 Oktober 2023.
  5. Dutch Expert Committee on Occupational Safety, Health Council of the Netherlands. 78 pp, 2011. https://www.healthcouncil.nl/documents/advisory-reports/2011/06/24/1-4-dioxane-health-based-recommended-occupational-exposure-limit.
  6. Health Canada. 2010. https://www.canada.ca/en/health-canada/services/chemical-substances/challenge/batch-7/1-4-dioxane.html. Diakses pada tanggal 27 Oktober 2023.
  7. Hayes, D. G., Williams, M., Pechacek, N., Hebert, B., & Stanton, K. 2022. Precise measurement of 1,4-dioxane concentration in cleaning products: A review of the current state-of-the-art. Journal of Surfactants and Detergents, 25(6), 729-741. https://doi.org/10.1002/jsde.12633
  8. Indonesian FDA. 2008. Peraturan Kepala Badan Pengawas Obat Dan Makanan Republik Indonesia No. HK.00.05.42.1018 Tentang Bahan Kosmetik tahun 2008 tentang Bahan Kosmetik
  9. Indonesian FDA. 2015. Peraturan Kepala Badan POM No. 8 Tahun 2015 tentang Persyaratan Teknis Bahan Kosmetika.
  10. Indonesian FDA. 2019. Peraturan Badan Pengawas Obat Dan Makanan No. 23 Tahun 2019 tentang Persyaratan Teknis Bahan Kosmetika.
  11. Indonesian FDA. 2019. Peraturan Badan Pengawas Obat Dan Makanan Nomor 12 Tahun 2019 tentang Cemaran Dalam Kosmetika.
  12. Indonesian FDA. 2022. Peraturan Badan Pengawas Obat Dan Makanan No. 17 Tahun 2022 tentang Perubahan Atas Peraturan Badan Pengawas Obat Dan Makanan Nomor 23 Tahun 2019 Tentang Persyaratan Teknis Bahan Kosmetika.
  13. Indonesian FDA. 2022. Peraturan Badan Pengawas Obat dan Makanan No. 21 tahun 2022 tentang Tata Cara Pengajuan Notifikasi Kosmetika.
  14. Indonesian FDA. 2022. Regionalisasi Laboratorium BPOM. Majalah POM Edisi XII/2022.
  15. Indonesian FDA, ____. Harmonisasi ASEAN di Bidang Kosmetik. https://www.pom.go.id/berita/harmonisasi-asean-di-bidang-kosmetik. Diakses pada tanggal 27 Oktober 2023.
  16. Indonesian FDA Provincial Office at Surabaya. 2022. Laporan Tahunan Balai Besar POM di Surabaya Tahun 2022. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Surabaya.pdf. Diakses pada tanggal 27 Oktober 2023.
  17. Indonesian FDA Provincial Office at Aceh. 2022. Laporan Tahunan 2022 BBPOM di Banda Aceh. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Banda%20Aceh.pdf. Diakses pada tanggal 27 Oktober 2023.
  18. Indonesian FDA Provincial Office at Jakarta. 2022. Laporan Tahunan 2022 Balai Besar POM di Jakarta. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Jakarta.pdf. Diakses pada tanggal 27 Oktober 2023.
  19. Indonesian FDA Provincial Office at Banjarmasin. 2022. Laptah 2022 Balai Besar POM di Banjarmasin. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Banjarmasin.pdf. Diakses pada tanggal 27 Oktober 2023.
  20. Indonesian FDA Provincial Office at Jayapura. 2022. Laporan Tahunan Balai Besar POM di Jayapura 2022. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Jayapura.pdf. Diakses pada tanggal 27 Oktober 2023.
  21. Indonesian FDA Provincial Office at Medan. 2022. Laporan Tahunan 2022 BBPOM di Medan. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Medan.pdf. Diakses pada tanggal 27 Oktober 2023.
  22. Indonesian FDA Provincial Office at Padang. 2022. Laporan Tahunan 2022 BBPOM di Padang. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Padang.pdf. Diakses pada tanggal 27 Oktober 2023.
  23. Indonesian FDA Provincial Office at Mataram. 2022. Laporan Tahunan 2022 BBPOM di Mataram. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Mataram.pdf. Diakses pada tanggal 27 Oktober 2023.
  24. Indonesian FDA Provincial Office at Palembang. 2022. Laporan Tahunan 2022 BBPOM di Palembang. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Palembang.pdf. Diakses pada tanggal 27 Oktober 2023.
  25. Indonesian FDA Provincial Office at Pontianak. 2022. Laporan Tahunan 2022 BBPOM di Pontianak. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Pontianak.pdf. Diakses pada tanggal 27 Oktober 2023.
  26. Indonesian FDA Provincial Office at Samarinda. 2022. Laporan Tahunan 2022 BBPOM di Samarinda. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20BBPOM%20Samarinda.pdf. Diakses pada tanggal 27 Oktober 2023.
  27. Indonesian FDA Provincial Office at Kendari. 2022. Laporan Tahunan 2022 BPOM di Kendari. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20Balai%20POM%20Kendari.pdf. Diakses pada tanggal 27 Oktober 2023.
  28. Indonesian FDA Provincial Office at Kupang. 2022. Laporan Tahunan 2022 BPOM di Kendari. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20Balai%20POM%20Kupang.pdf. Diakses pada tanggal 27 Oktober 2023.
  29. Indonesian FDA Provincial Office at Gorontalo. 2022. Laporan Tahunan 2022 BPOM di Gorontalo. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20Balai%20POM%20Gorontalo.pdf. Diakses pada tanggal 27 Oktober 2023.
  30. Indonesian FDA Provincial Office at Bengkulu. 2022. Laporan Tahunan 2022 BPOM di Bengkulu. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20Balai%20POM%20Bengkulu.pdf. Diakses pada tanggal 27 Oktober 2023.
  31. Indonesian FDA Provincial Office at Pangkalpinang. 2022. Laporan Tahunan 2022 BPOM di Pangkalpinang. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20Balai%20POM%20Pangkalpinang.pdf. Diakses pada tanggal 27 Oktober 2023.
  32. Indonesian FDA Provincial Office at di Palu. 2022. Laporan Tahunan 2022 Balai POM di Palu. https://www.pom.go.id/storage/sakip/Laporan%20Tahunan%202022%20Balai%20POM%20Palu.pdf. Diakses pada tanggal 27 Oktober 2023.
  33. International Agency for Research on Cancer, 1,4-Dioxane, pages 593 and 599. http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-25.pdf
  34. Pubchem. ____. Compound Summary Dioxane. https://pubchem.ncbi.nlm.nih.gov/compound/Dioxane. Diakses pada tanggal 29 Oktober 2023.
  35. Ramos, P. R. (n.d.). Dioxane in consumer products: Is the guidance changing? https://www.rssl.com/insights/food-consumer-goods/dioxane-in-consumer-products-is-the-guidancechanging/#:~:text=This%20law%20limits%20the%20dioxane,by%2031st%20December%202023. Diakses tanggal 28 Oktober 2023.
  36. Ron Honnold, Fernando, S., Haddad-Carroll, A., Honnold, R., Jones, S., Coleman, S., Hendrick, J., & Conjelko, T. (2021). Application Note Consumer Products. https://doi.org/10.13140/RG.2.2.27600.23042
  37. Scientific Committee on Consumer Safety (SCCS). 2015. Scientific Opinion on The Report of the ICCR Working Group: Considerations on Acceptable Trace Level of 1,4-Dioxane in Cosmetic Products.
  38. Sujan Fernando, S, Haddad-Carroll, A, Honnold, R, Jones, S, Coleman, S, Hendrick, J, dan Conjelko, T. ____. Application Note : Analysis of 1,4-Dioxane in Consumer Products by Headspace-Gas Chromatography/Mass Spectrometry.
  39. Taiwan FDA. 2018. Cosmetic Hygiene and Safety Act and Relevant Laws. https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f638108611765076453. Diakses pada tanggal 27 Oktober 2023.
  40. U.S. Food and Drug Administration (FDA). 2022. https://www.fda.gov/cosmetics/potential-contaminants-cosmetics/14-dioxane-cosmetics-manufacturing-byproduct#:~:text=In%20an%20independent%20risk%20assessment,levels%20of%20%E2%89%A410%20ppm. Diakses pada tanggal 27 Oktober 2023.
  41. U.S. Environmental Protection Agency (U.S. EPA) http://clu-in.org/contaminantfocus/default.focus/sec/14-dioxane/cat/policy_and_guidance/.Diakses pada tanggal 27 Oktober 2023.
  42. Wilbur S, Jones D, Risher JF, et al. 2012. Toxicological Profile for 1,4-Dioxane. Atlanta (GA): Agency for Toxic Substances and Disease Registry (US); Apr. 7, Analytical Methods.
  43. Zhou, W. 2019. The determination of 1,4-dioxane in cosmetic products by gas chromatography with tandem mass spectrometry. Journal of Chromatography A, 1607, 460400. https://doi.org/10.1016/j.chroma.2019.460400