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Article 8 of the European Regulation 1223/2009 legally prescribes compliance with Good Manufacturing Practice, which is demonstrated via ISO 22716.
The COSMOS ORGANIC certification requires at least 20 percent organic ingredients in the finished formulation.
ISO 22716 describes 17 operational areas to prevent contamination and keep raw materials traceable during production.
For cosmetics brands, compliance with Good Manufacturing Practice (GMP) is not a quality seal for premium providers, but rather the legal basis for market access. In the European Union, Article 8 of Regulation (EC) No. 1223/2009 stipulates that all cosmetic products placed on the market must be manufactured in accordance with GMP guidelines. In the United States too, the Modernization of Cosmetics Regulation Act of 2022 has turned GMP from a recommendation into an enforceable legal requirement. This development makes a structured manufacturer audit indispensable for brands before a development project starts.
GMP is not a simple checklist, but a comprehensive quality management system designed to eliminate human errors, equipment failures, and environmental contamination. It closes the crucial gap between early sample formulation in the controlled laboratory and industrial production. When a formulation moves from a small beaker into a large production vessel, every physical and chemical variable must be monitored so that the final texture corresponds to the approved laboratory sample.
Systematic controls in cosmetics production. The following areas form the backbone of any GMP-compliant manufacturing:
Raw material control: Testing the identity, purity, and safety of each raw material before it enters the formulation.
Microbiological protection: Cleanroom conditions to rule out contamination risks in water-based serums or emulsions.
Full batch traceability: Seamless production logs from raw material delivery to the finished packaged product.
Process validation: Standardization of mixing speeds, temperature curves, and filling logs so that production reproduces the approved laboratory sample.
Ultimately, GMP is about reproducibility. A cosmetics manufacturer must prove that a formulation developed in the laboratory behaves in a 1,000-kilogram batch exactly as it does in a 500-gram beaker. For brands planning this transition, a structured guide to cosmetics manufacturing and a specialized development partner are key to scalable, marketable results.
The regulatory basis: Why GMP for cosmetics is not optional
For cosmetics brands, compliance with Good Manufacturing Practice (GMP) is not a quality seal for premium providers, but rather the legal basis for market access. In the European Union, Article 8 of Regulation (EC) No. 1223/2009 stipulates that all cosmetic products placed on the market must be manufactured in accordance with GMP guidelines. In the United States too, the Modernization of Cosmetics Regulation Act of 2022 has turned GMP from a recommendation into an enforceable legal requirement. This development makes a structured manufacturer audit indispensable for brands before a development project starts.
GMP is not a simple checklist, but a comprehensive quality management system designed to eliminate human errors, equipment failures, and environmental contamination. It closes the crucial gap between early sample formulation in the controlled laboratory and industrial production. When a formulation moves from a small beaker into a large production vessel, every physical and chemical variable must be monitored so that the final texture corresponds to the approved laboratory sample.
Systematic controls in cosmetics production. The following areas form the backbone of any GMP-compliant manufacturing:
Raw material control: Testing the identity, purity, and safety of each raw material before it enters the formulation.
Microbiological protection: Cleanroom conditions to rule out contamination risks in water-based serums or emulsions.
Full batch traceability: Seamless production logs from raw material delivery to the finished packaged product.
Process validation: Standardization of mixing speeds, temperature curves, and filling logs so that production reproduces the approved laboratory sample.
Ultimately, GMP is about reproducibility. A cosmetics manufacturer must prove that a formulation developed in the laboratory behaves in a 1,000-kilogram batch exactly as it does in a 500-gram beaker. For brands planning this transition, a structured guide to cosmetics manufacturing and a specialized development partner are key to scalable, marketable results.
ISO 22716 Decoded: The International Standard for Cosmetics GMP
ISO 22716 is the harmonized international framework for Good Manufacturing Practices in the cosmetics sector. In major global markets, including the European Union under Regulation (EC) 1223/2009, proof of GMP compliance is a legal prerequisite for the sale of cosmetic products. An ISO 22716 certificate is considered the primary, globally recognized proof of this compliance. It demonstrates that a manufacturer operates a strict quality management system that spans from raw material procurement to the shipment of the finished product.
The standard is divided into 17 sections that systematically manage quality and safety risks. These chapters define specific requirements for personnel, premises, equipment, raw materials, packaging, production, finished products, and quality control laboratories. For brands developing complex products like complexion makeup or functional skincare, this structure ensures that every batch maintains exact stability and sensory profile without deviations.
Personnel and Premises: Trained staff, strict hygiene requirements, and sanitized facility layouts prevent cross-contamination during production.
Raw Materials and Packaging: Rigorous testing processes for incoming materials ensure that pigments for shade development and packaging components are technically flawless.
Production and Quality Control: Defined production processes, validated cleaning procedures, and systematic laboratory testing of finished products.
As a B2B cosmetics developer and manufacturer, Labtree integrates these GMP standards into every stage of product development. During formulation development and in-house laboratory work, Labtree translates concepts into physical laboratory samples, manufacturable formulations, and production-ready formulas before serial production begins. By assessing manufacturability early on through the lens of ISO 22716, Labtree ensures a smooth transition to compliant finished products.
COSMOS Organic vs. COSMOS Natural: What this means for brands
For beauty brands looking to tap into the natural cosmetics market, distinguishing between the two COSMOS signatures is an important starting point. Both standards guarantee strict criteria for raw material sourcing, packaging sustainability, and ecological processing, but set different thresholds for the organic content. COSMOS NATURAL does not require a minimum share of organic ingredients, however, at least 95 percent of the formulation must be of natural origin. COSMOS ORGANIC is significantly more demanding and is therefore a key point in early formulation development.
Minimum thresholds for COSMOS ORGANIC: At least 95 percent of the physically processed agricultural raw materials must be certified organic.
Organic share of the total formulation: At least 20 percent of the total product must be organic for leave-on products such as creams or serums.
Exceptions for rinse-off: For rinse-off products, non-emulsified aqueous products, and mineral-rich formulations, the minimum requirement drops to 10 percent.
Achieving these standards requires precise laboratory work and early planning. At Labtree, we focus on translating organic concepts into manufacturable formulations within our own laboratory work. In make-up development, for example, replacing synthetic silicones with esters of natural origin while maintaining texture, color payoff, and stability is a typical challenge. Through consistent sampling, we ensure that natural emulsifiers and preservation systems remain stable before the formulation goes into production.
In addition, manufacturing certified organic cosmetics requires a fully audited manufacturing partner. The B2B operation must undergo regular physical audits by authorized certification bodies that confirm the complete separation of organic and conventional lines, validated cleaning protocols, and seamless batch traceability. When evaluating cosmetics manufacturers, brands must ensure that the facility is pre-qualified for COSMOS-compliant raw materials.
Formulations under natural standards: Technical feasibility and performance
COSMOS certification places strict limits on the selection of raw materials. Synthetic polymers, petrochemical solvents, and classic silicones such as dimethicone are not permitted, meaning formulators must find natural alternatives. This is a significant hurdle in both color cosmetics and skincare. For example, it is notoriously difficult to replicate the light skin feel, volatile evaporation, and smooth application of silicones in skin tints or complexion products without sacrificing wear time. Replacing synthetic film formers and thickeners frequently leads to stability issues, phase separation, or undesirable textures.
To solve these challenges, Labtree conducts structured work on private-label cosmetics and custom formulation development in its own laboratory. By creating physical samples early on, the team directly evaluates how raw materials of natural origin behave under stress. This hands-on laboratory work is essential to verify texture, color payoff, and emulsion stability before investing in raw materials.
Rheology and Texture: Replacing carbomers with natural gums like xanthan or sclerotium requires precise calibration to avoid a sticky skin feel.
Emulsion Stability: Replacing ethoxylated emulsifiers with alternatives of natural origin for a stable phase distribution without separation.
Sensory profile: Replicating the volatility and light spreading of cyclic silicones using biodegradable plant-based esters approved under organic standards.
Ultimately, the scalability of a product can only be proven through early evaluation of these factors. Converting a natural cosmetics concept into a production-ready formulation requires proof of manufacturability under real conditions. This early diligence ensures that the product retains its sensory profile, chemical stability, and certification during the transition to series production without late-stage redevelopment.
Vegan Cosmetics: Certification Standards and Raw Material Sourcing
Building a vegan cosmetics brand means more than just leaving out animal ingredients. The demand for certified vegan make-up and skincare has evolved from a niche trend into a commercial baseline requirement. When developing new formulations, brands must distinguish between vegan formulation, cruelty-free, and natural certification, as these standards are governed by completely different regulatory frameworks. To obtain a recognized vegan seal like the Vegan Society Trademark, the entire supply chain must be audited.
No animal ingredients: Neither animal products, by-products nor derivatives may be used in raw materials, active ingredients, additives, or processing aids.
No animal testing: Neither the manufacturer nor its raw material suppliers may conduct or commission animal testing on ingredients, components, or the finished product.
Avoidance of cross-contamination: Production equipment must be thoroughly cleaned and rinsed before a vegan batch to keep cross-contamination below 100 ppm.
GMO restrictions: If genetically modified organisms are used in the production of ingredients, no animal genes or substances may be involved.
Compliance for products such as vegan mascara, complexion products, or serums requires extensive work at the raw material level. A competent partner must trace every ingredient back to its source and obtain declarations of conformity from the supplier network. During formulation development, any change of a raw material supplier can jeopardize the certification status if trace contamination cannot be ruled out. If these checks are integrated directly into early sampling and feasibility testing, formulations remain ready for production and brands can implement cosmetic trends without downstream delays.
The pitfalls of cruelty-free and vegan: Regulatory reality
In professional cosmetics development, the terms cruelty-free and vegan are often conflated, which creates regulatory and logistical confusion. Animal testing for finished cosmetic products has been banned in the European Union since 2004, and the ban on ingredients has been fully applicable since 2013 under Regulation (EC) No. 1223/2009. Advertising a product in the EU as cruelty-free can therefore be legally problematic if it suggests a specific product benefit instead of a legal obligation. Vegan claims, on the other hand, relate strictly to the ingredients and require a formulation without any animal raw materials.
The development of a certified vegan formulation requires consistent raw material screening and precise verifiability of claims. Classic color cosmetics and make-up development often rely on animal substances, such as carmine for red pigments in blushes or beeswax for the texture of sticks. Replacing these raw materials with synthetic or plant-based alternatives requires careful development work in one's own laboratory so that texture, color payoff, and stability are maintained.
Procurement of supplier documents confirming the absence of animal processing aids.
Clear traceability of raw materials to rule out cross-contamination during production.
Avoidance of substances such as lanolin, carmine, keratin, and beeswax in the formulation.
Microbiological testing and stability tests to validate alternative natural preservation and binding systems.
To manage this complexity without delay, brands need a technical partner to guide the path from concept to compliant sample. By addressing documentation requirements early in the sampling process, we ensure that production runs on tested, certifiable formulations.
When entering cosmetics production, compliance with standards such as GMP (ISO 22716), COSMOS or vegan requirements is not just a regulatory hurdle, but an important commercial asset. Launching a new product line requires alignment between formulation decisions and the manufacturing plant's certifications. A partner who works in accordance with GMP guidelines from the very beginning prevents expensive redevelopment at a later stage. Working within pre-certified frameworks also accelerates the creation of the Cosmetic Product Safety Report (CPSR) and thus shortens the time-to-market.
Verification of raw material compliance with COSMOS or vegan criteria already in the concept phase.
Implementation of Good Manufacturing Practice according to ISO 22716 to ensure quality, safety and traceability.
Conducting compatibility and stability tests in accordance with strict regulatory requirements.
In order to navigate these certification paths efficiently, Labtree integrates regulatory logic directly into the development cycle. Instead of treating compliance as a downstream check, our product development begins in our own laboratory. We transfer cosmetic concepts into physical laboratory samples at an early stage and ensure that vegan raw materials or COSMOS-compliant ingredients function optimally from the very start. This early sampling and careful formulation development allow for manufacturability testing long before mass production begins. The result is a production-ready formulation that meets strict certification standards without sacrificing performance, texture or stability.
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FAQ
Is Good Manufacturing Practice (GMP) for cosmetics required by law?
Yes. In the European Union, Article 8 of Regulation 1223/2009 stipulates that all cosmetic products must be manufactured according to Good Manufacturing Practice. Under MoCRA in the United States, GMP compliance is also crucial for safety. Manufacturers use the international standard ISO 22716 to demonstrate and document this compliance.
What is the relationship between ISO 22716 and GMP?
ISO 22716 is the harmonized international standard providing practical guidelines for Good Manufacturing Practices in cosmetics. It regulates 17 operational areas of a production facility, including staff training, hygiene, raw material storage, and equipment calibration. An ISO 22716 audit certificate is the most important proof of GMP compliance for a B2B cosmetics manufacturer.
What is the difference between COSMOS Natural and COSMOS Organic?
Both standards require ingredients of natural origin and prohibit petrochemical raw materials, but COSMOS ORGANIC sets fixed percentage thresholds. At least 95 percent of the physically processed plant raw materials must be organic, and at least 20 percent of the finished formulation (10 percent for rinse-off products). COSMOS NATURAL does not require a minimum proportion of organic raw materials.
What does a Vegan Society certification guarantee?
The Vegan Society Trademark guarantees that a product does not contain any animal ingredients, by-products, or genetically modified organisms with animal genes at any stage. Crucially, the standard also prohibits animal testing by or on behalf of the manufacturer, thereby ensuring a clean supply chain.
Does a cosmetics manufacturer need a separate certificate for vegan makeup?
Yes. GMP or ISO 22716 certification does not automatically qualify a facility for certified vegan products. The manufacturer must undergo a thorough audit of its raw material supply chain and its protocols for preventing cross-contamination.
How do certification standards influence individual formulation development?
Formulations under natural standards such as COSMOS require the replacement of synthetic ingredients such as silicones or parabens with natural alternatives. This affects texture, performance, and stability. Developers like Labtree carry out formulation development in their own laboratory, create samples, and test stability early on so that the formulation is completely ready for production and compliant.
