ISO 11930

ISO 11930:2019 outlines the evaluation methods for the antimicrobial protection of cosmetic products, ensuring safety and regulatory compliance before market release. Issued by the International Organization for Standardization (ISO), this standard is crucial for cosmetic manufacturers, testing laboratories, and quality assurance teams to assess the preservative efficacy and microbiological safety of products. Quality Asia Certification helps you achieve compliance with ISO 11930 through a structured certification process, aligned with global regulatory expectations.

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What is ISO 11930?

ISO 11930:2019 – Cosmetics — Microbiology — Evaluation of the Antimicrobial Protection of a Cosmetic Product is a globally accepted standard that prescribes a testing framework to ensure cosmetic products do not support the growth of harmful microorganisms. The certification involves challenge testing (also known as preservative efficacy testing), which measures the effectiveness of the product’s preservation system over time against defined microorganisms.

This standard is especially relevant for:

  1. Creams, lotions, and emulsions
  2. Shampoos, conditioners, and body washes
  3. Cosmetics stored in jars, bottles, and tubes

The latest version of this standard is ISO 11930:2019, which replaces older editions and incorporates updated microbial challenge criteria, test strains, and evaluation metrics.

Why is ISO 11930 important?

With increasing regulatory scrutiny and consumer awareness, ensuring microbiological safety has become a critical requirement in the cosmetic industry. ISO 11930:2019 certification provides scientific validation of your product's antimicrobial efficacy, helping you:

  1. Comply with EU Cosmetic Regulation (EC) No. 1223/2009
  2. Meet FDA expectations in the US
  3. Gain acceptance in Middle Eastern, Asian, and global markets

Choosing ISO 11930:2019 also allows your organization to avoid product recalls, build consumer trust, and maintain brand reputation.

What are the benefits of ISO 11930?

ISO 11930:2019 certification from Quality Asia Certification offers the following technical advantages:

  1. Ensures Product Safety: Confirms the product resists microbial contamination during storage and use.
  2. Standardized Testing Methodology: Utilizes validated procedures for challenge testing as per international norms.
  3. Global Market Access: Complies with EU, ASEAN, and FDA guidelines, facilitating product registration and exports.
  4. Supports R&D Optimization: Helps evaluate the performance of preservatives during product formulation.
  5. Risk Reduction: Minimizes the risk of microbial spoilage, consumer infections, and regulatory non-compliance.
  6. Consumer Confidence: Demonstrates your commitment to high product quality and safety.


What kind of businesses can benefit from ISO 11930?

ISO 11930:2019 certification delivers measurable business outcomes that directly impact your brand, compliance status, and profitability:

Regulatory Compliance

Meet international regulatory standards for microbiological safety and preservative efficacy.

Product Differentiation

Stand out in the marketplace by showcasing ISO-certified cosmetic products.

Reduced Product Recalls

Prevent contamination-related complaints, thereby reducing customer returns and losses.

Improved Brand Reputation

Gain consumer trust by validating your commitment to safety and quality.

Faster Market Approvals

Speed up product registration with national and international regulatory bodies.

Supply Chain Trust

Demonstrate quality assurance to distributors, retailers, and end-users, improving B2B relationships.


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.

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