Main Article Content
Abstract
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.
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References
- Ahern, D. (2019). “Regulators Nurturing Fintech Innovation: Global Evolution of the Regulatory Sandbox as Opportunity-Based Regulation.” Indian Journal of Law and Technology, 15(2). https://doi.org/10.55496/snpi2967
- Alaassar, A., Mention, A. L., & Aas, T. H. (2020). Exploring how social interactions influence regulators and innovators: The case of regulatory sandboxes. Technological Forecasting and Social Change, 160. https://doi.org/10.1016/j.techfore.2020.120257
- Allen, H. J., Awrey, D., Ford, C., Gevurtz, F., Oei, S.-Y., & Pollman, E. (2019). Regulatory Sandboxes (Vol. 87, Issue 3).
- Amarawardani, N., Qolbi, L., Ramadhan, H. R., & Saputra, I. K. (2023). Analisis Kadar Lemak Menggunakan Uji Fat Gerber pada Biskuit Varian Makanan Tambahan (MT) Ibu Hamil di PT Satoria Agro Industri. Proceedings of Life and Applied Sciences.
- Brown, E., & Piroska, D. (2022). Governing Fintech and Fintech as Governance: The Regulatory Sandbox, Riskwashing, and Disruptive Social Classification. New Political Economy, 27(1), 19–32.
- Buocz, T., Pfotenhauer, S., & Eisenberger, I. (2023). Regulatory sandboxes in the AI Act: Reconciling innovation and safety? Law, Innovation and Technology, 15(2), 357–389. https://doi.org/10.1080/17579961.2023.2245678
- Burd, J. T. J. (2021). Regulatory Sandboxes for Safety Assurance of Autonomous Vehicles. In UNIVERSITY of PENNSYLVANIA JOURNAL of LAW & PUBLIC AFFAIRS (Vol. 7, Issue 1). https://www.
- Devaera, Y., Syaharutsa, D. M., Jatmiko, H. K., & Sjarif, D. R. (2018). Comparing Compliance and Efficacy of Isocaloric Oral Nutritional Supplementation Using 1.5 kcal/mL or 1 kcal/mL Sip Feeds in Mildly to Moderately Malnourished Indonesian Children: A Randomized Controlled Trial. Pediatric Gastroenterology, Hepatology and Nutrition, 21(4), 315–320. https://doi.org/10.5223/pghn.2018.21.4.315
- Direktorat Cegah Tangkal BPOM RI. (2023). Data Kerawanan Kejahatan Obat dan Makanan Tahun 2023 .
- Direktorat Registrasi Pangan Olahan BPOM RI. (2024). Registration Officer Pangan Olahan.
- Eggers, W. D., & Turley, M. (2018). The future of regulation Principles for regulating emerging technologies.
- Eichler, H. G., Oye, K., Baird, L. G., Abadie, E., Brown, J., L Drum, C., Ferguson, J., Garner, S., Honig, P., Hukkelhoven, M., Lim, J. C. W., Lim, R., Lumpkin, M. M., Neil, G., O’Rourke, B., Pezalla, E., Shoda, D., Seyfert-Margolis, V., Sigal, E. V., … Hirsch, G. (2012). Adaptive licensing: Taking the next step in the evolution of drug approval. Clinical Pharmacology and Therapeutics, 91(3), 426–437. https://doi.org/10.1038/clpt.2011.345
- Feng, Y., Liu, L., & Li, W. (2021). Research on the Construction of Regulatory Sandbox for Safety Supervision on Intelligent Connected Products. E3S Web of Conferences, 235. https://doi.org/10.1051/e3sconf/202123503043
- Frazier, G., & Walter, N. (2020). Regulatory Sandboxes: How Federal Agencies Can Take Part in Cooperative Federalism and Catalyze Innovation and Economic Growth by Exercising Their Exemptive Authority. https://www.mercatus.org/system/files/Baugus-Sunset-Legislation.pdf
- Fuad, A., Tiara, A., Kusumasari, R. A., Rimawati, R., & Murhandarwati, E. E. H. (2023). Introducing a Regulatory Sandbox Into the Indonesian Health System Using e-Malaria as a Use Case: Participatory Action Study. Journal of Medical Internet Research, 25, e47706. https://doi.org/10.2196/47706
- Gromova, E., & Ivanc, T. (2020). Regulatory sandboxes (Experimental legal regimes) for digital innovations in brics. BRICS Law Journal, 7(2), 10–36. https://doi.org/10.21684/2412-2343-2020-7-2-10-36
- Heymann, F., Schmid, J., Vazquez, M., & Galus, M. (2021). Regulatory Sandboxes in The Energy Sector - Review and Learnings for The Case of Switzerland. IET Conference Proceedings, 2021(6), 3229–3233. https://doi.org/10.1049/icp.2021.1730
- Holle, M. (2018). Pre-Market Approval and Its Impact on Food Innovation: The Novel Foods Example. In Regulating and Managing Food Safety in the EU (pp. 291–330). Springer International Publishing. https://doi.org/10.1007/978-3-319-77045-1_14
- Leckenby, E., Dawoud, D., Bouvy, J., & Jónsson, P. (2021). The Sandbox Approach and its Potential for Use in Health Technology Assessment: A Literature Review. In Applied Health Economics and Health Policy (Vol. 19, Issue 6, pp. 857–869). Adis. https://doi.org/10.1007/s40258-021-00665-1
- Maci, J., & Marešová, P. (2022). Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry. Risk Management and Healthcare Policy, Volume 15, 71–91. https://doi.org/10.2147/RMHP.S346928
- Malaria Working Group. (2021). Panduan Uji Coba Regulatory Sandbox untuk e-Malaria Edisi Kedua Malaria Working Group.
- Peraturan Pemerintah (PP) Nomor 32 Tahun 2017 Tentang Jenis Dan Tarif Atas Jenis Penerimaan Negara Bukan Pajak Yang Berlaku Pada Badan Pengawas Obat Dan Makanan (2017).
- Peraturan Presiden RI. (2021). Peraturan Presiden Nomor 72 Tahun 2021 tentang Percepatan Penurunan Stunting.
- Ranchordas, S. (2021). Experimental Regulations for AI: Sandboxes for Morals and Mores. Morals & Machines, 1(1), 86–100. https://doi.org/10.5771/2747-5174-2021-1-86
- Sherkow, J. S. (2022). Regulatory Sandboxes and The Public Health. University of Illinois Law Review, 2022(1), 357–410. https://perma.cc/7DMQ-JN38].
- Tan, S. Y., & Taeihagh, A. (2021). Adaptive governance of autonomous vehicles: Accelerating the adoption of disruptive technologies in Singapore. Government Information Quarterly, 38(2), 101546. https://doi.org/10.1016/j.giq.2020.101546
- Tsai, C., Lin, C.-F., & Liu, H.-W. (2019). The Diffusion of the Sandbox Approach to Disruptive Innovation and Its Limitations. SSRN Electronic Journal. https://doi.org/10.2139/ssrn.3487175
- Undang-Undang Republik Indonesia. (2023). Undang-Undang Republik Indonesia Nomor 6 Tahun 2023 tentang Penetapan Peraturan Pemerintah Pengganti Undang-Undang Nomor 2 Tahun 2022 tentang Cipta Kerja menjadi Undang-Undang.
- Wallach, J. D., Ross, J. S., & Naci, H. (2018). The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements. Clinical Trials, 15(3), 219–229. https://doi.org/10.1177/1740774518770648
- Zhu, Y., Chu, M., Wen, X., & Wang, Y. (2021). Food Safety Risk Communication between the Food Regulator and Consumer in China: An Evolutionary Game Perspective. Complexity, 2021(1). https://doi.org/10.1155/2021/9933796.
References
Ahern, D. (2019). “Regulators Nurturing Fintech Innovation: Global Evolution of the Regulatory Sandbox as Opportunity-Based Regulation.” Indian Journal of Law and Technology, 15(2). https://doi.org/10.55496/snpi2967
Alaassar, A., Mention, A. L., & Aas, T. H. (2020). Exploring how social interactions influence regulators and innovators: The case of regulatory sandboxes. Technological Forecasting and Social Change, 160. https://doi.org/10.1016/j.techfore.2020.120257
Allen, H. J., Awrey, D., Ford, C., Gevurtz, F., Oei, S.-Y., & Pollman, E. (2019). Regulatory Sandboxes (Vol. 87, Issue 3).
Amarawardani, N., Qolbi, L., Ramadhan, H. R., & Saputra, I. K. (2023). Analisis Kadar Lemak Menggunakan Uji Fat Gerber pada Biskuit Varian Makanan Tambahan (MT) Ibu Hamil di PT Satoria Agro Industri. Proceedings of Life and Applied Sciences.
Brown, E., & Piroska, D. (2022). Governing Fintech and Fintech as Governance: The Regulatory Sandbox, Riskwashing, and Disruptive Social Classification. New Political Economy, 27(1), 19–32.
Buocz, T., Pfotenhauer, S., & Eisenberger, I. (2023). Regulatory sandboxes in the AI Act: Reconciling innovation and safety? Law, Innovation and Technology, 15(2), 357–389. https://doi.org/10.1080/17579961.2023.2245678
Burd, J. T. J. (2021). Regulatory Sandboxes for Safety Assurance of Autonomous Vehicles. In UNIVERSITY of PENNSYLVANIA JOURNAL of LAW & PUBLIC AFFAIRS (Vol. 7, Issue 1). https://www.
Devaera, Y., Syaharutsa, D. M., Jatmiko, H. K., & Sjarif, D. R. (2018). Comparing Compliance and Efficacy of Isocaloric Oral Nutritional Supplementation Using 1.5 kcal/mL or 1 kcal/mL Sip Feeds in Mildly to Moderately Malnourished Indonesian Children: A Randomized Controlled Trial. Pediatric Gastroenterology, Hepatology and Nutrition, 21(4), 315–320. https://doi.org/10.5223/pghn.2018.21.4.315
Direktorat Cegah Tangkal BPOM RI. (2023). Data Kerawanan Kejahatan Obat dan Makanan Tahun 2023 .
Direktorat Registrasi Pangan Olahan BPOM RI. (2024). Registration Officer Pangan Olahan.
Eggers, W. D., & Turley, M. (2018). The future of regulation Principles for regulating emerging technologies.
Eichler, H. G., Oye, K., Baird, L. G., Abadie, E., Brown, J., L Drum, C., Ferguson, J., Garner, S., Honig, P., Hukkelhoven, M., Lim, J. C. W., Lim, R., Lumpkin, M. M., Neil, G., O’Rourke, B., Pezalla, E., Shoda, D., Seyfert-Margolis, V., Sigal, E. V., … Hirsch, G. (2012). Adaptive licensing: Taking the next step in the evolution of drug approval. Clinical Pharmacology and Therapeutics, 91(3), 426–437. https://doi.org/10.1038/clpt.2011.345
Feng, Y., Liu, L., & Li, W. (2021). Research on the Construction of Regulatory Sandbox for Safety Supervision on Intelligent Connected Products. E3S Web of Conferences, 235. https://doi.org/10.1051/e3sconf/202123503043
Frazier, G., & Walter, N. (2020). Regulatory Sandboxes: How Federal Agencies Can Take Part in Cooperative Federalism and Catalyze Innovation and Economic Growth by Exercising Their Exemptive Authority. https://www.mercatus.org/system/files/Baugus-Sunset-Legislation.pdf
Fuad, A., Tiara, A., Kusumasari, R. A., Rimawati, R., & Murhandarwati, E. E. H. (2023). Introducing a Regulatory Sandbox Into the Indonesian Health System Using e-Malaria as a Use Case: Participatory Action Study. Journal of Medical Internet Research, 25, e47706. https://doi.org/10.2196/47706
Gromova, E., & Ivanc, T. (2020). Regulatory sandboxes (Experimental legal regimes) for digital innovations in brics. BRICS Law Journal, 7(2), 10–36. https://doi.org/10.21684/2412-2343-2020-7-2-10-36
Heymann, F., Schmid, J., Vazquez, M., & Galus, M. (2021). Regulatory Sandboxes in The Energy Sector - Review and Learnings for The Case of Switzerland. IET Conference Proceedings, 2021(6), 3229–3233. https://doi.org/10.1049/icp.2021.1730
Holle, M. (2018). Pre-Market Approval and Its Impact on Food Innovation: The Novel Foods Example. In Regulating and Managing Food Safety in the EU (pp. 291–330). Springer International Publishing. https://doi.org/10.1007/978-3-319-77045-1_14
Leckenby, E., Dawoud, D., Bouvy, J., & Jónsson, P. (2021). The Sandbox Approach and its Potential for Use in Health Technology Assessment: A Literature Review. In Applied Health Economics and Health Policy (Vol. 19, Issue 6, pp. 857–869). Adis. https://doi.org/10.1007/s40258-021-00665-1
Maci, J., & Marešová, P. (2022). Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry. Risk Management and Healthcare Policy, Volume 15, 71–91. https://doi.org/10.2147/RMHP.S346928
Malaria Working Group. (2021). Panduan Uji Coba Regulatory Sandbox untuk e-Malaria Edisi Kedua Malaria Working Group.
Peraturan Pemerintah (PP) Nomor 32 Tahun 2017 Tentang Jenis Dan Tarif Atas Jenis Penerimaan Negara Bukan Pajak Yang Berlaku Pada Badan Pengawas Obat Dan Makanan (2017).
Peraturan Presiden RI. (2021). Peraturan Presiden Nomor 72 Tahun 2021 tentang Percepatan Penurunan Stunting.
Ranchordas, S. (2021). Experimental Regulations for AI: Sandboxes for Morals and Mores. Morals & Machines, 1(1), 86–100. https://doi.org/10.5771/2747-5174-2021-1-86
Sherkow, J. S. (2022). Regulatory Sandboxes and The Public Health. University of Illinois Law Review, 2022(1), 357–410. https://perma.cc/7DMQ-JN38].
Tan, S. Y., & Taeihagh, A. (2021). Adaptive governance of autonomous vehicles: Accelerating the adoption of disruptive technologies in Singapore. Government Information Quarterly, 38(2), 101546. https://doi.org/10.1016/j.giq.2020.101546
Tsai, C., Lin, C.-F., & Liu, H.-W. (2019). The Diffusion of the Sandbox Approach to Disruptive Innovation and Its Limitations. SSRN Electronic Journal. https://doi.org/10.2139/ssrn.3487175
Undang-Undang Republik Indonesia. (2023). Undang-Undang Republik Indonesia Nomor 6 Tahun 2023 tentang Penetapan Peraturan Pemerintah Pengganti Undang-Undang Nomor 2 Tahun 2022 tentang Cipta Kerja menjadi Undang-Undang.
Wallach, J. D., Ross, J. S., & Naci, H. (2018). The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements. Clinical Trials, 15(3), 219–229. https://doi.org/10.1177/1740774518770648
Zhu, Y., Chu, M., Wen, X., & Wang, Y. (2021). Food Safety Risk Communication between the Food Regulator and Consumer in China: An Evolutionary Game Perspective. Complexity, 2021(1). https://doi.org/10.1155/2021/9933796.