Why Biocides Testing Matters in a Regulated Antimicrobial Market

Testing before market placement

Disinfectants, antiseptics and sanitizers are essential tools for controlling harmful microorganisms across healthcare, industrial, and consumer environments. Yet for products designed to eliminate bacteria, fungi, or viruses, effectiveness cannot simply be assumed. Their antimicrobial performance must be scientifically demonstrated through regulatory compliant testing before they can be placed on the market.

At the same time, regulatory expectations in Europe continue to evolve. Under the EU Biocidal Products Regulation (BPR), manufacturers must demonstrate the safety, efficacy, and environmental responsibility of biocidal products before they can be authorised. With approval processes becoming increasingly complex and data-driven, robust testing strategies have become essential for companies seeking reliable market access.

As demand for antimicrobial solutions continues to grow across industries—including healthcare, professional hygiene, and sectors connected to consumer products such as cosmetics—biocides testing plays a critical role in ensuring that disinfectant formulations perform as intended.

Demonstrating antimicrobial efficacy

The primary objective of biocidal products is the effective control of microorganisms. To validate this function, antimicrobial efficacy testing is applied to determine whether disinfectant formulations achieve the required level of microbial reduction against specific target organisms.

Testing is performed in accordance with validated European Normatives, such as EN 14885, which defines the legislative framework under ECHA for evaluating antimicrobial activity in Europe. These standards include a range of laboratory methods—from suspension tests to surface tests—designed to assess disinfectant performance under controlled conditions that simulate practical use. Through the generation of scientifically robust data, antimicrobial efficacy testing substantiates performance claims and demonstrates that disinfectant products deliver reliable and consistent protection.

Beyond laboratory evaluation, simulated industrial disinfectant efficacy testing provides a more realistic assessment of disinfectant performance. By incorporating the actual microflora present within a production facility, this approach reflects true operating conditions, enabling the identification of potential gaps and supporting the optimization of hygiene protocols. Such studies are also aligned with GMP expectations, particularly within pharmaceutical manufacturing environments.

Holding Time Disinfection Studies further extend this evaluation by determining the duration of disinfectant effectiveness before recontamination occurs. This enables the definition of scientifically justified re-disinfection intervals, supporting both product safety and operational efficiency.

For industries such as food production, cosmetics, and pharmaceuticals, these testing approaches support:
• Validation of disinfectant performance under real-use conditions
• Strengthening of compliance and audit readiness
• Optimization of cleaning and disinfection schedules
• Reduction of risk to consumers and brand reputation

Ensuring product stability and long-term performance

Beyond initial efficacy, disinfectant products must also maintain their performance throughout their shelf life. Changes in storage conditions, temperature, or formulation characteristics can influence the stability of active substances and potentially affect antimicrobial activity.

Stability studies for biocides evaluate the physicochemical properties of products over time, using approaches such as accelerated stability testing, long-term storage studies, and low-temperature evaluations. These studies help determine product shelf life and confirm that antimicrobial performance remains consistent under different conditions.

For manufacturers, stability testing provides essential data supporting product reliability and quality assurance. In highly regulated sectors, this information is also a key component of regulatory submissions and product documentation.

Navigating an evolving regulatory landscape

The European regulatory framework governing biocidal products continues to develop as authorities seek to strengthen protection for both human health and the environment. The EU Biocidal Products Regulation (BPR) requires manufacturers to demonstrate comprehensive safety and efficacy data, while ongoing regulatory reviews are examining how the framework can further support innovation and environmental responsibility.

To meet these requirements, manufacturers often rely on regulatory compliance support, covering key elements such as marketing authorisation, safety data sheets (SDS), poison centres notification (PCN/UFI), and product labelling. Effective regulatory preparation helps ensure that products meet European and national obligations while facilitating smoother entry to the market.

With more than 20 years of experience, QACS Lab provides comprehensive biocides testing services, including antimicrobial efficacy testing, stability studies, and regulatory compliance support. Operating under GMP compliance and ISO 17025 accreditation, the laboratory helps manufacturers generate the scientific data required to demonstrate safety, efficacy, and compliance.

In an antimicrobial market increasingly defined by scientific validation, regulatory scrutiny, and transparent performance claims, robust biocides testing remains fundamental. By proving that disinfectant products work as intended, manufacturers can deliver solutions that protect environments, support regulatory approval, and ultimately safeguard public health.

For all your Testing needs, get in touch with QACS at info@qacslab.com

In Vitro Testing Services for Cosmetics: Safety Evaluation and Claims Substantiation

The Role of In Vitro Testing in Modern Cosmetic Development

Ensuring the safety and performance of cosmetic products is a critical requirement for manufacturers operating in today’s regulated and competitive market. Cosmetic formulations must be carefully evaluated to demonstrate that ingredients and finished products are safe for human use and supported by reliable scientific evidence. In this context, in vitro testing services have become a fundamental tool for cosmetic safety assessment and product development.

By using human-relevant biological models under controlled laboratory conditions, in vitro testing services allow manufacturers to evaluate the toxicological profile of ingredients and finished cosmetic formulations. These studies generate data on key safety endpoints such as skin irritation, eye irritation, corrosion potential, cytotoxicity, genotoxicity, and phototoxicity, enabling potential risks to be identified early in the product development process. Early safety evaluation helps cosmetic companies optimize formulations, avoid costly reformulation cycles, and ensure compliance with regulatory requirements.

In addition to improving safety evaluation, in vitro testing services also provide scientific data that supports product dossiers, safety assessments, and regulatory documentation required for placing cosmetic products on the market.

OECD Test Guidelines and Regulatory Acceptance

International regulatory authorities increasingly rely on standardized scientific protocols to ensure the reliability and reproducibility of laboratory results. Many in vitro testing services used in cosmetic safety assessment are therefore performed according to OECD Test Guidelines, which provide validated and internationally recognized testing methods.

Common OECD methods used in cosmetic in vitro testing include:

• OECD 492 – In Vitro Eye Irritation Test using reconstructed human corneal epithelium models
• OECD 492B: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification
• OECD 439 – In Vitro Skin Irritation Test using reconstructed human epidermis
• OECD 431 – In Vitro Skin Corrosion Test
• OECD 432 – 3T3 NRU Phototoxicity Test
• OECD 471 – Ames Test for mutagenicity assessment

These OECD test guidelines ensure that in vitro testing services generate scientifically robust and internationally accepted results. Data obtained from these methods support classification and safety evaluation under regulatory frameworks such as GLP quality system, and are widely used in safety documentation for cosmetic ingredients and formulations.

In Vitro Testing Services at QACS Lab

For cosmetic manufacturers, the value of in vitro testing services lies in their ability to deliver rapid, reproducible, and human-relevant results. At QACS Lab, these evaluations are performed using reconstructed human epidermis and corneal epithelium tissue models, cultured mammalian cells, and specialized biochemical assays designed to replicate biological responses under controlled laboratory conditions.

This approach allows QACS Lab to generate accurate toxicological data on cosmetic ingredients and finished formulations, providing safety information that is directly relevant to human exposure scenarios. The laboratory’s experimental unit operates under GLP certification and follows the OECD Principles of Good Laboratory Practice, ensuring reliability, traceability, and regulatory acceptance of the results.

Beyond cosmetics, the same in vitro testing services are also widely applied for safety evaluation of medical devices, chemical substances, disinfectants, and biocidal products, where similar toxicological assessment principles apply.

Supporting Cosmetic Claims Through In Vitro Testing

In addition to safety evaluation, in vitro testing services play an important role in supporting cosmetic product claims and scientific substantiation. In a market where consumers expect transparency and scientifically supported claims, manufacturers must provide reliable data demonstrating the performance of their formulations.

Advanced in vitro models allow laboratories to measure biological responses such as free radical neutralization, antioxidant capacity, and protection of skin cells from oxidative stress, which are commonly associated with anti-aging and skin-protection claims. Assays such as DPPH, ORAC, and Cellular Antioxidant Activity (CAA) generate quantitative results that help substantiate antioxidant-related claims in cosmetic formulations.

Similarly, phototoxicity testing and UV-related cellular studies provide valuable information for sunscreen products and cosmetic formulations designed to protect skin from UV-induced damage. By generating measurable and scientifically robust data, in vitro testing services allow cosmetic manufacturers to support product claims while maintaining regulatory compliance and scientific credibility.

In Vitro Testing as a Key Resource for Cosmetic Manufacturers

As cosmetic formulations become more complex and regulatory expectations continue to evolve, in vitro testing services are increasingly recognized as a critical component of modern cosmetic safety assessment. By combining validated OECD testing methods, human-relevant biological models, and advanced laboratory technologies, these services provide cosmetic manufacturers with reliable data that supports both product safety and product claims.

For cosmetic brands seeking to ensure regulatory compliance, substantiate performance claims, and maintain consumer trust, collaboration with specialized laboratories offering advanced in vitro testing services has become an essential part of the product development process.

For In Vitro Testing for Cosmetics, get in touch with QACS at info@qacslab.com

In Vitro 3T3 NRU Phototoxicity Test – OECD 432

Assessing the safety of substances that may interact with light is a critical component of modern product development. Our laboratory offers the In Vitro 3T3 Neutral Red Uptake (NRU) Phototoxicity Test, performed in full compliance with OECD Test Guideline 432, providing reliable data to support regulatory safety assessments across multiple industries.

A phototoxicity test predicts whether a toxic response may arise from skin exposure of a substance followed by subsequent exposure to light. Phototoxic reactions typically occur when compounds absorb energy in the UV or visible spectrum, triggering cellular damage after irradiation. Identifying this potential early is essential for ensuring product safety and regulatory compliance.

The 3T3 NRU Phototoxicity Test is a validated in vitro assay used to evaluate phototoxic potential by measuring the reduction in cell viability through Neutral Red uptake. The assay compares the cytotoxic effects of a test substance in the presence (+UVA) and absence (–UVA) of light exposure, allowing the identification of substances that may induce phototoxic responses.

As part of our In Vitro Toxicology Testing Services, this method represents a scientifically robust and regulatory-accepted non-animal alternative method (NAM) aligned with the 3R principle – Replacement, Reduction and Refinement of animal experiments. Such New Approach Methodologies (NAMs) are increasingly adopted worldwide to support safer, ethical, and more efficient product safety assessments.

Our testing services support regulatory safety evaluation of:

• Cosmetic products and raw materials – including UV filters, sunscreens, leave-on formulations for daily use, and ingredients intended for topical application
• Pharmaceutical substances – active compounds and excipients, particularly those administered dermally with potential exposure to light
• Medical device formulations – especially products containing photo-reactive or UV-absorbing components, such as dermal or ophthalmic applications
• Chemical substances – compounds demonstrating absorption in the UV/visible spectrum that may require phototoxicity evaluation under OECD test guidelines

In addition to phototoxicity testing, our laboratory also offers photostability studies, supporting the evaluation of how substances and formulations behave when exposed to light during storage or use.

Our quality control laboratories operate according to the highest standards, ensuring the reliability and regulatory acceptance of generated data. All studies are conducted in GLP-compliant laboratories guaranteeing rigorous quality systems and scientific integrity throughout the testing process.

With extensive expertise in in vitro toxicology, advanced in vitro assays, and internationally recognized OECD test guidelines, our team supports companies in developing safe and compliant products using state-of-the-art non-animal testing approaches.

By partnering with our laboratory, clients benefit from high-quality In Vitro Toxicology Testing Services, expert scientific guidance, and reliable data to support regulatory submissions and product safety evaluations.

Ethanol in Biocides: Regulatory Developments Following ECHA BPC Opinion

On 24 February 2026 the European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) adopted the opinions supporting the approval of Ethanol as active substance in the following biocidal product-types:

• Product-type 1: Human hygiene products, such as hand disinfectants;
• Product-type 2: Disinfectants and algaecides not intended for direct contact with humans or animals; and
• Product-type 4: Products used in food and feed areas.

Following the BPC adoption, the European Commission will prepare a draft Implementing Regulation proposing either approval or non-approval of the substance. If supported by the EU Member States in the Standing Committee on Biocidal Products, the Commission will formally adopt the decision and it becomes legally binding.

If ethanol is approved as active substance for the above-mentioned product types:

According to EOF Circular No. 39102/10-5-2016, applications may be submitted to the National Organization for Medicines (EOF) for the authorisation of biocidal products containing ethanol as active substance, up to one year before the approval date that will be specified in the relevant Implementing Regulation. For variations that do not require evaluation, as well as for renewals, applications will be accepted up to six months before the specified approval date. Following the approval date, the provisions of the EU Regulation 528/2012 will apply and marketing authorisation holders will be required to take one of the following actions:

I) Submit an application for parallel mutual recognition of the biocidal product for the Greek market in accordance with Article 34 of Regulation (EU) No 528/2012.

II) Apply for Union authorisation of the biocidal product to the European Chemicals Agency (ECHA), in accordance with Articles 41 to 43 of Regulation (EU) No 528/2012.

III) Apply for a national authorisation of the biocidal product in Greece, in accordance with Article 29 of Regulation (EU) No 528/2012.

If ethanol is not approved as active substance for the above-mentioned product types:

Products containing the substance must be withdrawn from the EU market within the applicable transition periods.

Packaging Microbial Barrier Testing (ASTM F1608-21)

Ensuring Sterile Integrity Through Validated Microbial Barrier Performance

Packaging Microbial Barrier Test is a critical component in the validation and quality assurance of sterile medical device packaging systems. At QACS Laboratory, we provide Packaging Microbial Barrier Testing in accordance with ASTM F1608-21 to evaluate the effectiveness of porous packaging materials in preventing microbial ingress while allowing sterilant penetration. This testing supports manufacturers of medical devices, pharmaceutical products, and sterile healthcare packaging in demonstrating compliance with regulatory and industry expectations for sterile barrier systems.

What Is Packaging Microbial Barrier Testing?

Packaging Microbial Barrier Testing, also referred to as ASTM F1608-21 testing, is a laboratory method used to determine the microbial barrier properties of porous packaging materials. The test assesses whether packaging materials effectively block microorganisms under controlled exposure conditions, helping ensure product sterility throughout shelf life and distribution. Maintaining sterility is essential for patient safety and regulatory compliance. Even small breaches in packaging integrity can lead to microbial contamination, product recalls, or regulatory findings. This method is particularly applicable to porous sterile barrier systems, such as:

• Medical device packaging
• Sterilization wraps
• Pouches and lids
• Porous packaging materials designed for terminal sterilization

ASTM F1608-21 Standard Overview

ASTM F1608-21 – Standard Guide for Selection of Materials for Packaging Based on Microbial Barrier Properties provides guidance on evaluating packaging materials intended to function as microbial barriers. While ASTM F1608-21 does not define a single pass/fail test method, it outlines principles and testing approaches used to assess microbial barrier performance. Testing under this standard is often used as supporting validation evidence for:

• ISO 11607 compliance
• Sterile barrier system validation
• Packaging material selection and qualification
• Regulatory submissions and technical documentation

QACS Laboratory performs testing aligned with ASTM F1608-21 principles to generate reliable, defensible data for your packaging validation program.

Microbial Barrier Testing helps manufacturers:

• Demonstrate packaging effectiveness against microbial penetration
• Support sterile barrier system validation
• Reduce contamination and sterility failure risks
• Meet regulatory and customer requirements
• Select appropriate packaging materials early in development

For medical device manufacturers, microbial barrier performance is a key element of risk management and design validation.

When Is ASTM F1608-21 Testing Required?

Packaging Microbial Barrier Testing is commonly performed during:

• New packaging material selection
• Packaging design validation
• Supplier qualification
• Packaging changes or material substitutions
• Risk assessments related to sterility maintenance
• Regulatory audits or submissions

Although ASTM F1608-21 testing is not always explicitly required, it is widely recognized as best practice for demonstrating microbial barrier performance of porous materials.

Our Packaging Microbial Barrier Testing Services

At QACS Laboratory, we offer professional, controlled microbial barrier testing tailored to your packaging system and validation needs. Our capabilities include:

• Testing aligned with ASTM F1608-21 guidance
• Controlled microbial exposure conditions
• Evaluation of porous packaging materials
• Detailed technical reporting suitable for regulatory use
• Support for ISO 11607 sterile packaging validation

Our experienced microbiology team works closely with clients to ensure test conditions, documentation, and reporting align with industry expectations.

Benefits of Testing with QACS Laboratory

Choosing QACS Lab for Packaging Microbial Barrier Test provides several advantages, including access to experienced microbiology and packaging specialists, regulatory-focused test documentation, and support for FDA, ISO, and international compliance requirements. Our testing delivers reliable, defensible data to support packaging validation and risk management activities, while our team maintains clear communication and provides practical technical guidance throughout the testing process. We understand the importance of accurate, reproducible results when it comes to maintaining the integrity of sterile barrier systems.

Industries We Support

Our ASTM F1608-21 Packaging Microbial Barrier Testing services support a wide range of industries, including:

• Medical device manufacturing
• Pharmaceutical packaging
• Healthcare and hospital supplies
• Contract sterilization providers
• Packaging material manufacturers

Whether you are validating a new sterile packaging system or supporting an existing product line, our testing services help ensure confidence in microbial barrier performance. If you require Packaging Microbial Barrier Testing or need support with ASTM F1608-21 compliance, QACS Laboratory is here to help. Contact our team to discuss your packaging materials, validation requirements, and testing timelines. We are committed to providing accurate, timely, and regulatory-ready microbiological testing services.

Metagenomic Mapping Service (MMS): Turning Environmental Microbiomes into Actionable Intelligence

From Detection to Understanding

Environmental monitoring has long been a cornerstone of quality assurance and safety programs. However, traditional culture-based methods and targeted molecular tests provide only a partial and often delayed picture of microbial risks. In today’s complex production environments, manufacturers need more than detection — they need understanding.

QACS’ Metagenomic Mapping Service (MMS) represents a next-generation approach to environmental monitoring. By combining deep microbiological expertise with Next-Generation Sequencing (NGS) and advanced bioinformatics, MMS delivers a comprehensive, data-driven view of microbial ecosystems within production facilities. This enables proactive risk management, faster root-cause analysis, and smarter hygiene strategies.

What Is Metagenomic Mapping?

Metagenomic Mapping is the study of all genetic material recovered directly from environmental samples. Unlike classical microbiology or targeted PCR methods, metagenomics does not rely on culturing or predefined targets. Instead, it captures the entire microbiome, including:

• Cultivable and non-cultivable microorganisms
• Background flora and spoilage organisms
• Pathogens and indicator organisms
• Persistent strains and biofilm-associated microbes

The result is a high-resolution microbial map that reflects the true biological reality of your production environment.

Why Traditional Environmental Monitoring Falls Short

Conventional swabbing and plating approaches typically:

• Detect only a small fraction of existing microorganisms
• Miss stressed, VBNC (viable but non-culturable), or slow-growing organisms
• Provide fragmented data that is difficult to interpret holistically
• React to contamination events instead of preventing them

MMS overcomes these limitations by offering full-depth microbial insight, transforming environmental monitoring from a reactive compliance activity into a strategic quality tool.

The QACS MMS Approach: From Sample to Strategy

QACS’ Metagenomic Mapping Service follows a structured, end-to-end workflow designed for real-world manufacturing environments:

1. Strategic Sampling Design

Samples are collected from all critical control and risk-relevant areas, including:

• Food contact and non-food contact surfaces
• Drains, air, water, and difficult-to-clean niches
• Equipment, transfer points, and traffic zones

Sampling strategies are customized based on process flow, product risk, and historical QA data.

2. High-Resolution NGS Analysis

Total DNA is extracted from each sample and sequenced using Next-Generation Sequencing technologies. This reveals the complete microbial composition at each location — not just what grows on a plate.

3. Microbiome Mapping & Data Integration

By combining results from all samples, QACS generates a facility-wide microbiome map that highlights:

• Microbial hotspots and reservoirs
• Routes of contamination and cross-contamination
• Biofilm-associated communities
• Persistent or recurring microbial populations

4. Advanced Data Interpretation

Raw data alone has limited value. QACS transforms sequencing results into actionable insight using:

• Metadata correlation (zone, time, process step)
• Heatmaps and trend analysis
• Comparative and retrospective analysis
• Expert microbiological interpretation

5. Actionable Reporting & Corrective Guidance

Clients receive a clear, decision-oriented report that includes:

• Interpreted results, not just taxonomic lists
• Identified risks and contamination pathways
• Practical recommendations for sanitation, zoning, and process improvements
• Support for root-cause analysis in case of QC failures

Key Benefits of MMS for Manufacturers

Metagenomic Mapping Service empowers QA/QC and food safety teams to:

• Gain full visibility of microbial populations before they impact products
• Identify hidden risks missed by routine monitoring n- Track contamination sources proactively
• Validate and optimize sanitation and hygiene programs
• Strengthen preventive controls and environmental monitoring plans
• Reduce recall risk and improve overall quality confidence

MMS vs. Classical Molecular Mapping

While molecular mapping approaches focus on selected organisms or genetic markers, MMS delivers:

• Unbiased, full-microbiome coverage
• Higher sensitivity and resolution
• Detection of emerging or unexpected risks
• Deeper insight into microbial ecology and persistence

This makes MMS a powerful evolution of environmental monitoring rather than just an incremental improvement.

Conclusion: From Data to Confidence

In an era of heightened regulatory scrutiny and brand vulnerability, understanding your production environment is no longer optional. QACS’ Metagenomic Mapping Service transforms complex microbial data into practical intelligence — helping manufacturers move from reactive problem-solving to proactive quality control.

By revealing what traditional methods cannot see, MMS enables smarter decisions, stronger preventive strategies, and greater confidence in product safety and quality