ISO 24442
ISO 24442:2022 is the latest international standard that specifies the in-vivo testing method for determining the sun protection factor (SPF) of sunscreen products applied to human skin. It plays a vital role in protecting consumers by ensuring the effectiveness and safety of sun protection products. Quality Asia Certification offers ISO 24442:2022 certification services to cosmetic and skincare product manufacturers, enabling them to demonstrate the efficacy and reliability of their UV protection formulations.
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What is ISO 24442?
ISO 24442:2022 is titled: "Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF)".
This standard outlines a detailed protocol for conducting in-vivo SPF testing on human volunteers. The method measures the level of protection a sunscreen product offers against erythema (sunburn) caused by ultraviolet B (UVB) radiation. The test ensures scientific accuracy, ethical compliance, and product reliability, helping companies meet regulatory and market requirements.
The 2022 version replaces previous editions and includes updated technical parameters, ethical considerations, and safety standards for human testing. This version aligns with international regulatory expectations and market trends focused on consumer safety and transparency.
Why is ISO 24442 important?
With increasing global awareness about skin cancer, premature aging, and the harmful effects of UV radiation, consumers demand scientifically validated sun protection. ISO 24442:2022 enables skincare brands to:
- Gain customer trust by providing transparent SPF claims
- Meet regulatory requirements in markets like the EU, US, Japan, and India
- Differentiate their product in a crowded and competitive cosmetics market
- Avoid false or misleading SPF labelling claims, reducing legal risks
This certification acts as third-party validation for sunscreen effectiveness, making it crucial for brands aiming for credibility and market acceptance.
What are the benefits of ISO 24442?
- Validated Testing Method: Uses scientifically proven in-vivo testing protocols under controlled lab conditions
- Standardized SPF Claims: Ensures SPF ratings are consistent and reproducible across different markets
- Regulatory Compliance: Helps meet local and global product safety standards, including FDA and EU cosmetic regulations
- Consumer Safety: Supports ethical testing and provides assurance that the product genuinely protects against harmful UVB rays
- Updated Best Practices: Includes latest testing techniques, exposure conditions, and volunteer safety requirements
What kind of businesses can benefit from ISO 24442?
Implementing ISO 24442:2022 certification delivers both commercial and compliance-related advantages. Key business benefits include:
✅ Enhanced Brand Reputation – Demonstrate your commitment to consumer safety and scientific credibility
✅ Global Market Access – Align with international regulations for sunscreen products, enabling easier exports
✅ Competitive Differentiation – Gain trust over competitors lacking validated SPF testing
✅ Risk Reduction – Avoid consumer lawsuits or penalties related to misleading SPF claims
✅ Faster Product Approvals – Accelerate acceptance in regulatory and retail environments
✅ Marketing Leverage – Use ISO certification as a unique selling proposition (USP) in promotional materials
✅ Customer Confidence – Build trust with dermatologists, regulatory bodies, and end-users
Top Tips on making ISO 9001 effective for you.
#1
Top management commitment while practicing and accomplishing the standard is the key to success.
#2
Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.
#3
Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.
#4
Review systems, policies, processes, and procedures for a smooth working of QMS.
#5
Speaking to customers & suppliers while getting feedback & working on improvements.
#6
Training staff carrying out the internal audits with the opportunity for improvement.
#7
Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.
#8
Ensure continuous improvement by regularly reviewing and updating your quality management practices.
#9
Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.
Why QualityAsia?
QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:
Initial Certification – Stage 1 (Preparatory Phase)
- Thorough documented information review.
- Exchange of information with staff through online or onsite presence.
- Identification of key performances, processes & objectives as per the standard requisites.
- Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.
Initial Certification – Stage 2 (On-site Audit)
- Measurement, reporting & reviewing the performances against key performances objectives.
- Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
- Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
- Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.
Surveillance & Certification Renewal
Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.
