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Material Issue 2-2
Ensuring Customer Safety/Cosmetics

Ensuring Customer Safety/Cosmetics


Ⅰ. Corporate Governance

Decision-Making Structure

Hanmi Science operates a cosmetic safety management system with the CEO as the highest decision-maker to systematically manage the safety and quality of cosmetics. The CEO has final approval authority for strategies to ensure customer safety in the cosmetics sector. The Head of Consumer Health Division, who oversees cosmetic customer safety, manages and approves cosmetic safety objectives, annual action plans, major policies, and directions. The QA manager of the Cosmetics Group verifies product safety and compliance with laws and regulations, and ensures consistent application of domestic and international regulations. Through this, from raw material selection to advertising and labeling, potential risks throughout the entire process are pre-inspected and prevented, thereby striving to provide safe and reliable cosmetics to consumers. Through this decision-making structure, Hanmi Science systematically manages all processes related to cosmetic safety and promotes continuous improvement activities with customer safety as its top priority.


Roles and Responsibilities

Category

Key Roles and Responsibilities

CEO

ㆍFinal approval of customer safety assurance strategies

Head of Consumer Health Division

ㆍDecision-making on food and cosmetic safety-related matters
ㆍApproval of goals and action plans related to food and cosmetic safety

Cosmetics Group QA Manager

ㆍVerification of product safety and regulatory compliance


Mandatory Professional Training

Target Audience

Frequency

Training Content

Cosmetics Group QA Manager

Once a year

Training for Cosmetic Responsible Sales Managers (Ensuring product safety, quality control, cosmetic labeling and advertising regulations, document management, industry status, etc.)



Ⅱ. Strategy_Risk and Opportunity Identification

Hanmi Science identifies key risks and opportunities that can significantly impact stakeholders and sustainability related to ensuring customer safety, based on the results of IRO analysis, and continuously strives to establish effective response measures based on this.

RISK


Potential for consumer misunderstanding caused by misleading advertising and labeling as pharmaceutical products

Characteristics of Impact

Potential Impact

Affected Stakeholders

Customers, Government, and Related Institutions

Severity of Impact on
Society and Environment

Scale ■■■□□ Scope ■■■■□ Recoverability ■■■□□

Expected Financial Impact

Likelihood ■■■□□ Impact ■■■■□

Impact on the Company

ㆍIncreased risk of customer safety incidents such as product use errors, misuse, and side effects
ㆍPotential for administrative sanctions due to violations of advertising and labeling regulations

Company's Response

ㆍSystem for drafting product advertising and labeling phrases based on domestic and international regulatory standards
ㆍSystem for managing product advertising and labeling phrases to provide accurate and reliable information

OPPORTUNITY


Proactive global regulatory compliance and stringent quality management system

Characteristics of Impact

Actual Impact

Affected Stakeholders

Customers, Government, and Related Institutions

Severity of Impact on
Society and Environment

Impact ■■■■□ Scope ■■■□□

Expected Financial Impact

Likelihood ■■■□□ Impact ■■■■□

Impact on the Company

ㆍEnhanced product reliability and global competitiveness
ㆍReduced operating costs by proactively preventing regulatory agency sanctions and fines, product recalls, and compensation
for damages

Company's Response

ㆍSelection of raw materials conforming to international standards
ㆍThorough quality verification through full ingredient safety assessment and skin compatibility clinical trials



Ⅱ. Strategy_Risk and Opportunity Response Plan

System for drafting product advertising and labeling phrases based on domestic and international regulatory standards

Hanmi Science adheres to the following 4P principles, based on its cosmetic advertising and labeling phrase drafting process established in compliance with domestic and international cosmetic laws. Furthermore, for advertisements or expressions that could mislead consumers, a ‘Zero Tolerance’ policy is applied. If a violation is confirmed, immediate corrective action will be taken, along with concurrent education and system improvements to prevent recurrence.

Basic Principles (4P Principles)

System for managing product advertising and labeling phrases to provide accurate and reliable information

Hanmi Science manages product advertising and labeling phrases across all stages — proactive prevention, monitoring, and incident response — to provide consumers with accurate and reliable information. Given the nature of the cosmetics industry, where products are applied directly to consumers' skin, proactive management, real-time monitoring, and immediate response in the event of an incident are crucial to minimize consumer misunderstandings and adverse effects from misuse.

Proactive
Prevention

Advertisement Phrase
Pre-screening System

ㆍOperation of an advertisement phrase pre-screening system to provide accurate information to
consumers

Joint Review Process
with Partners

ㆍOperation of a review process with partners' RA teams in accordance with relevant laws
(Cosmetics Act, Act on Fair Labeling and Advertising, etc.)

Monitoring

Real-time Monitoring

ㆍReal-time monitoring of consumer inquiries and complaints received through various channels
such as call centers, official malls, and social media

Immediate VOC sharing

ㆍImmediately share all received issues with quality control personnel
ㆍThoroughly review product ingredients, manufacturing processes, and distribution stages to identify
abnormal signs

VOC data analysis
and reflection

ㆍIdentify recurring complaint types
ㆍIncorporate feedback into quality improvement and new product development stages

Incident
Response

Activation of 3-step
response process

ㆍActivate a 3-step response process: ‘Immediate suspension – Cause identification – Consumer
notification’
ㆍImmediately suspend the relevant advertisement and temporarily halt sales and promotion of
related products upon problem discovery

Cause Identification
and Notification

ㆍIdentify the cause through internal investigation and verification, then provide public notification to
consumers

Selection of Raw Materials Conforming to International Standards

Hanmi Science thoroughly complies with cosmetic safety regulations in major countries such as the United States and Europe, providing products that global consumers can use with confidence. To achieve this, from the new product planning stage, we review the list of prohibited and restricted ingredients (Negative List) in each country and use internationally verified safe ingredients. This process is part of our efforts to establish a proactive safety management system at a global level, going beyond mere legal compliance.

Global Regulatory Compliance Status

Category

Key Details

Applicable Regions

Remarks

MoCRA
(Modernization of Cosmetics Regulation Act)

Certification

ㆍRaw material safety, manufacturing process,
adverse reaction reporting obligations

United States

Certification Completed

EU Cosmetics Regulation

Regulations

ㆍLabeling compliance
ㆍCosmetic safety assessment
ㆍCMR substance restrictions
ㆍAllergen labeling requirements
ㆍDesignation of Responsible Person
ㆍGMP compliance

EU

Certification in Progress

EU CPNP
(Cosmetic Products Notification Portal)

Certification

UK Cosmetics Regulation

Regulations

United Kingdom

Certification in Progress

UK SCPN
(Submit Cosmetic Product Notifications)

Certification

ASEAN Cosmetic Directive

Regulations

ㆍCompliance with integrated standard
ingredient list

Indonesia,
Mongolia

Regulatory compliance
completed

Global Market Expansion Status

Currently, having completed US MoCRA certification, we have fully entered the US market, and by utilizing ingredients compliant with the ASEAN Cosmetic Directive, we are stably supplying products to emerging markets such as Mongolia, Taiwan, and Indonesia. Additionally, we are in the process of obtaining EU CPNP and UK SCPN certifications for entry into the UK and European (EU) markets.

Thorough quality verification through full ingredient safety assessment and skin compatibility clinical trials

All cosmetic products sold by Hanmi Science, to ensure consumer safety and skin compatibility, undergo both full ingredient verification and human application tests from the product development stage.

Skin Hypoallergenic Test

Content

ㆍConducting human application tests (24–48h patch test / HRIPT)

Purpose and Effects

ㆍVerification of skin irritation response
ㆍSecuring grounds for skin irritation assessment by patch application
ㆍSecuring grounds for labeling hypoallergenic products

Cosmetic Efficacy
Clinical Trials

Content

ㆍInstrumental measurement and statistical verification of product-specific functions such as
moisturizing, elasticity, and sebum control

Purpose and Effects

ㆍSecuring grounds for advertising and labeling claims
ㆍDemonstrating consumer perceived effects

Compilation of Safety
Data for Infants and
Toddlers

Content

ㆍSkin irritation test (no age restriction)
ㆍAnalysis of 10 types of ingredients according to cosmetic safety management standards
ㆍPreparation of documents such as manufacturing records and product standards

Purpose and Effects

ㆍEnsuring safety for infant, toddler, and children's cosmetics

Paraben 7 types and
Phenoxyethanol-free
test

Content

ㆍVerification of preservative residue detection using instrumental analysis equipment
(7 types of parabens: Methylparaben, Ethylparaben, Isopropylparaben, Propylparaben,
Isobutylparaben, Butylparaben, p-Hydrox ybenzoic acid)

Purpose and Effects

ㆍSecuring substantiated data for cosmetic labeling and advertising
ㆍEnhancing consumer trust

Content Stability Test

Content

ㆍEvaluation of whether the contents degrade due to the passage of time or environmental
changes (temperature, light, humidity, etc.)

Purpose and Effects

ㆍEnsuring consistent quality
ㆍSecuring scientific evidence for product claims (e.g., spoilage)



III. Risk Management

Risk and Opportunity Monitoring

Period

Target

Method

Oversight

Operating a proactive prevention-monitoring-incident
response process

Ongoing

All products

ㆍMonitoring consumer inquiries and complaints received through various channels such as call centers, official malls, and SNS
in real-time
ㆍReceived issues are immediately transferred to the product quality control manager for response and resolution


Cosmetics Group



Ⅳ. Indicators and Goals

Key Indicators

2025 Target

2025 Performance

Achievement

Strengthening customer
safety through
thorough quality control

Achieved 0 product recalls through pre-verification and quality control

Achieved 0 product recalls

Achieved

100% safety testing performed on all products

100% safety assessment and skin compatibility testing performed on all products

Achieved

Achieved 100% U.S. FDA MoCRA registration

100% MoCRA registration completed for items subject to export to the U.S.

Achieved

Minimizing legal risks and
potential for consumer
misunderstanding due to
misleading advertising and
labeling as pharmaceuticals

Maintained 0 violations of labeling and advertising regulations

Maintained 0 violations of relevant regulations

Achieved

Key Indicators

2026 Target

Mid-to-Long-Term Plan (2030)

Strengthening customer
safety through
thorough quality control

Safety assessment of all ingredients and skin compatibility tests for new and renewed products
100% performed

Advanced product safety verification system and data-driven quality management system in compliance with global standards

Establishment of a global certification-based product safety management system and expansion into global markets
by enhancing compliance with major global market regulations such as the EU and UK

Enhancing product safety management system and strengthening global brand trustworthiness based on experience in responding to regulations in major global markets

Minimizing legal risks and
potential for consumer
misunderstanding due to
misleading advertising and
labeling as pharmaceuticals

Through the advancement of the pre-review process for advertising and labeling copy, strengthening the system to pre-emptively block expressions that could mislead about pharmaceuticals and maintaining 0 product recalls.

By continuously advancing advertising and labeling management guidelines that reflect global regulatory standards, we establish a management system that minimizes the potential for consumer misunderstanding.

Through enhanced pre-screening and internal education regarding advertising and marketing content, maintaining 0 violations of laws and regulations related to labeling and advertising.

Operating a continuous content management system that responds to global regulatory changes and strengthening internal education.