Perhitungan Margin of Safety (MoS)

dalam Safety Assesment Kosmetik

Konsultasi Layanan dan Bimbingan

Dokumen Informasi Produk dan Notifikasi Kosmetik
- KOLABORASI –
Surabaya, November 2024
• Definisi Kosmetik
• Kosmetik adalah bahan atau sediaan yang dimaksudkan
untuk digunakan pada bagian luar tubuh manusia seperti
epidermis, rambut, kuku, bibir dan organ genital bagian luar,
atau gigi dan membran mukosa mulut terutama untuk
membersihkan, mewangikan, mengubah penampilan dan/atau
memperbaiki bau badan atau melindungi atau memelihara
tubuh pada kondisi baik (Permenkes RI No.
1176/MENKES/PER/VIII/2010 tentang Notifikasi Kosmetika)
 Peraturan BPOM terkait keamanan kosmetik
1. Peraturan Menteri Kesehatan No. 1176/MENKES/PER/VIII/2010 tentang
Notifikasi Kosmetik
2. Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2022
tentang Perubahan Atas Peraturan Badan Pengawas Obat dan Makanan
No.23 Tahun 2019 tentang Persyaratan Teknis Bahan Kosmetika
3. Peraturan Badan Pengawas Obat dan Makanan Nomor 21 Tahun 2022
tentang Tata Cara Pengajuan Notifikasi Kosmetika
4. Keputusan Kepala Badan POM Nomor 479 Tahun 2023 Tentang Perubahan
Bahan Yang Diizinkan Dalam Kosmetik
5. Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2023
tentang Pedoman Dokumen Informasi Produk Kosmetik
Introduction
• PerBPOM No 17 tahun 2023 tentang Pedoman
Dokumen Informasi Produk Kosmetik, Lampiran BAB
II
• Bagian IV DIP memuat Laporan penilaian keamanan Kosmetik
berdasarkan bahan Kosmetik, struktur kimia dan tingkatan
paparan, yang ditandatangani oleh penanggung jawab teknis atau
penilai keamanan (safety assessor). Penilai keamanan (safety
assessor) tersebut merupakan seseorang dengan kualifikasi dan
pengalaman tertentu yang bertanggungjawab untuk melakukan
penilaian keamanan Kosmetik baik sebelum maupun selama
Kosmetik diedarkan
Laporan penilaian keamanan produk kosmetik disusun secara lengkap

Pengujian
keamanan produk
jadi
(user test)
Struktur
kimia
Bahan
kosmetik Tingkatan
paparan. Review data
keamanan Laporan
Perhitungan nilai
keamanan margin
masing-masing penilaian of safety (MoS)
bahan dalam keamanan bahan dalam
formula formula
Laporan kosmetika

penilaian
keamanan
kosmetik
Lengkap
Referensi Format
Lengkap

Cosmetic Europe
Guidelines for the safety
assessment of a cosmetic
product

ASEAN Guidelines for the

safety assessment of a
cosmetic product

The SCCS notes of

guidance for the testing
of cosmetic ingredient
and their safety
evaluation 12th revision
Contoh Format Penilaian Keamanan Produk Kosmetik secara lengkap
 Data keamanan diambil dari data keamanan di bagian II
DIP. Jika versi lengkap, maka dapat mencantumkan nilai
MoS masing-masing bahan baku penyusun formula,
namun tidak diwajibkan.

Pada penutup laporan keamanan

terdapat kalimat yang menyatakan
bahwa produk kosmetik tersebut
dinilai aman.
 THE SCCS NOTES OF GUIDANCE
FOR THE TESTING OF
UPDATE OF SAFETY
COSMETIC INGREDIENTS AND
ASSESSMENT THEIR SAFETY EVALUATION
12TH REVISION
Safety Assessment*

*Safety Assessment of Cosmetics in EU, Vera Rogiers, VBU.

Exposure Assessment*

*Safety Assessment of Cosmetics in EU, Vera Rogiers, VBU.

Safety Assessment*

*Safety Assessment of Cosmetics in EU, Vera Rogiers, VBU.

Safety Assessment*

*Safety Assessment of Cosmetics in EU, Vera Rogiers, VBU.

 Calculation of
Margin of Safety
(MoS)
Calculation of MoS

PoDsys : Point of Departure (Systemic)

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION
Calculation of MoS

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION
Calculation of MoS
Calculation Of The Systemic Exposure Dose (SED)

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION
Calculation of MoS
Calculation Of The Systemic Exposure Dose (SED)
1) When Dermal absorption of test substance reported in μg/cm²

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION
 SSA
fappl

Calculation of MoS
Calculation Of The Systemic Exposure Dose (SED)

1) When Dermal absorption of test substance reported in μg/cm²

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION
Calculation of MoS
Calculation Of The Systemic Exposure Dose (SED)
2) When Dermal absorption reported as a percentage of the amount of substance applied

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION
 Calculation of MoS
Calculation Of The Systemic
Exposure Dose (SED)
2) When Dermal absorption reported as a
percentage of the amount of substance applied

Eproduct

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY
EVALUATION 12TH REVISION
Calculation of MoS
Calculation Of The Systemic Exposure Dose (SED)
2) When Dermal absorption reported as a percentage of the amount of substance applied

Estimated daily exposure to a cosmetic product per kg body weight, based upon the
amount applied and the frequency of application (for calculated relative daily exposure
levels for different cosmetic product types,

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION
 Calculation of MoS
Calculation Of The Systemic
Exposure Dose (SED)
2) When Dermal absorption reported as a
percentage of the amount of substance applied

Eproduct

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY
EVALUATION 12TH REVISION
Calculation of MoS
It is advised to perform dermal absorption studies in the risk assessment process. In
the absence of experimentally determined dermal absorption, a 50% default
value is used. This conservative value may also be used in cases where only
inadequate dermal absorption data are available.

*THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION
Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers
Calculation of MoS

Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers
Calculation of MoS

Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers
Calculation of MoS

Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers
Calculation of MoS

Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers
EXAMPLE for MoS Calculation
 Calculation of MoS – Example 1
Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers

• Substance A: 2% in body lotion

• Toxicology profile :
• LD50 – oral – rat >2000 mg/kg
• Not irritating to skin and eyes
• Not sensitizing
• Not Mutagenic, caricongenic, teratogenic or reproduction
toxic
Which NOAEL to use ➔
• Dermal absorption : 1.5%
❑ Most sensitive spesies?
• NOAEL (rat, oral, 90d) : 20 mg/kg bw/day ❑ Study after 1981, op to
• NOAEL (dog,oral, 6m) : 50 mg/kg bw/day date study?
• Oral toxicokinetic data shows a very high bioavailability ❑ Quality study according
(100%) to OECD Protocol?
❑ Chronic study >90-day
study>28-day study?
Calculation
of MoS
Example 1

Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers
 Calculation of MoS – Example 1
• Daily exposure to a body lotion (Eproduct) : 123,20 mg/kg bw/day
• Concentration ingredient in finished product (C) : 2,0%
• Dermal absorption (DAp) : 1.5%
• NOAEL (rat, oral, 90d) : 20 mg/kg bw/day

• No extra default value necessary because of very high oral biovaolability

taken as 100%

Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers

11/7/2024 34
 Calculation of MoS – Example 2
Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers

• Substance X: 15% in face cream

• Toxicology profile :
• LD50 – oral – rat >2000 mg/kg
• Not irritating to skin and eyes
• Not sensitizing
• Not Mutagenic, caricongenic, teratogenic or reproduction
toxic For Consideration
• Dermal and oral absorption not known
• NOAEL (rat, oral, 90d) : 400 mg/kg bw/day
Calculation
of MoS
Example 2

Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers
 Calculation of MoS – Example 2
• Daily exposure to a face cream (Eproduct) : 24,14 mg/kg bw/day
• Concentration ingredient in finished product (C) : 15,0%
• Dermal absorption (DAp) : 50%
• NOAEL (rat, oral, 90d) : 400 mg/kg bw/day

• MoS = 400 = 220 ➔ oral absorption not known →50% → MoS = 220 x 50% =110
1.81
Safe
Safety assessment of cosmetic course, 2024 vrije Universiteit brussel, Vera Rogiers

11/7/2024 37
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