Reformulation Pitfalls: How to safely qualify alternative cosmetic ingredients?
Introducing an alternative ingredient into a formulation should not be treated solely as a response to supply shortages or rising component costs. Today, it is an integral part of strategic formulation management, supply chain resilience and production continuity.
The same INCI name, a similar function or a lower price is not enough to consider an ingredient a true substitute. What matters most is understanding the role the ingredient performs within a specific formulation, how it may affect stability, sensory properties, microbiological quality, product claims and the manufacturing process, and what data must be collected to ensure that the decision can still be properly justified at a later stage.
A thoroughly documented reformulation history makes it possible to reconstruct the decision-making process during a regulatory inspection, a retail customer audit or a subsequent product review.
Identical INCI name and a lower price do not guarantee product stability
Diversifying the ingredient base should always begin with mapping the technological function of the ingredient currently in use. A controlled implementation of an alternative requires a thorough review of the TDS, SDS and CoA documentation, followed by an assessment of the ingredient’s performance in the specific formulation. Comprehensive archiving of physicochemical, sensory and microbiological parameters helps reduce the risk of product separation and, in the broader perspective, supports the protection of the product against loss of quality, consistency and market position.
Maintaining records of stability test results, for example after 30 and 60 days, is also an important element in substantiating a reformulation decision during retail chain audits or sanitary inspections.
Production continuity instead of firefighting – formulation modification as a standard operating practice
Modifying a cosmetic formulation is an ongoing part of product management, not merely a response to a sudden shortage of an ingredient. It may be driven by cost pressure, extended lead times, raw material shortages, as well as regulatory changes, retailer requirements and the growing importance of ESG criteria.
Efficient implementation of alternative ingredients supports production continuity and reduces the risk of downtime, which particularly affects SMEs. High minimum order quantities (MOQs), sudden price increases or the unavailability of a single specialised ingredient can delay new product launches, disrupt production schedules or force the rapid reformulation of an existing product.
Why do companies look for alternative ingredients?
The objective of the search directly determines the ingredient qualification pathway and the scope of the required assessment. An ingredient intended to serve as a backup source of supply under a second-sourcing strategy will be evaluated differently from one introduced to reduce costs, improve sensory properties or refresh brand positioning.
Diversification of the ingredient base is most often driven by specific operational and market factors, including:
limited availability of a component from existing distributors,
budget pressure and the need to optimise production costs,
the need to secure a second source of supply to reduce the risk of production downtime,
the withdrawal of an ingredient from a supplier’s portfolio or regulatory changes,
new retailer guidelines, export requirements or stringent certification criteria,
the need to align the formulation with an ESG strategy, including the sourcing of upcycled, biodegradable or vegan ingredients.
The same INCI name does not mean identical technological functionality
An INCI name is only a starting point, not a technical specification. Two ingredients with the same INCI name may differ significantly in their physicochemical properties, purity grade or manufacturing process. These differences can directly affect how the ingredient performs in a specific formulation base, how it interacts with other components, the stability of the system, sensory properties and the consistency of the finished product.
Technological differences most commonly relate to properties such as:
active substance content and the distribution of individual fractions,
pH, viscosity, solubility and melting point,
impurity profile, moisture content, and odour and colour stability,
botanical origin, carrier type and preservation system,
completeness of quality documentation and certificates.
Hidden differences in key parameters
In formulation practice, the same INCI name may be associated with very different technological challenges depending on the ingredient grade, origin, quality parameters and manufacturing process. The examples below do not cover every possible difference between ingredients, but they demonstrate why an identical INCI name should be treated as a starting point for further assessment rather than as confirmation of full technological equivalence.
alkyl polyglucosides (APGs) and amino acid-based surfactants – may differ in active matter content, pH, foam profile, compatibility with other surfactants and their effect on the final viscosity of the product,
urea – technical-grade urea differs from pharmaceutical-grade urea in terms of purity, moisture content, solubility, impurity profile and batch-to-batch consistency,
cetearyl alcohol – grades from different manufacturers may have different fraction profiles and melting points, which can affect emulsion structure, hardness, slip and the final sensory properties of the product,
conditioning polymers – despite having a similar declared function, they may differ in their level of deposition on the hair, their effect on slip and solution clarity, foam profile and the risk of weighing down the formulation.
Five key risk areas when changing an ingredient
Replacing a component requires an assessment of how the alternative ingredient may affect the product’s physicochemical, microbiological, sensory and processing characteristics. Failure to properly control the substitute can lead directly to technological defects, production downtime, financial losses and batch rejection by the QA department.
A controlled implementation of an alternative source requires risk assessment across five key areas:
physical stability – helps assess the risk of changes in viscosity, emulsion separation, sediment formation in toners, loss of gel clarity, and changes in colour or odour,
chemical stability – includes the assessment of potential pH fluctuations, degradation of active substances, susceptibility to oxidation and interactions between ingredients,
microbiological stability – requires verification that the alternative ingredient does not adversely affect the preservation system, particularly where the substitute introduces water, carriers, extracts or other components that may alter the microbiological profile of the formulation,
sensory and performance properties – helps evaluate characteristics that influence the consumer experience, such as slip, foam structure, skin feel, ease of rinsing and the risk of weighing down the hair,
manufacturing process – makes it possible to assess the ingredient’s behaviour at industrial scale, including its impact on processing temperature, homogenisation time, order of addition, foaming during mixing, filtration, filling and product behaviour in the final packaging.
A four-stage qualification matrix for alternative ingredients
A systematic approach to reformulation requires a multi-level assessment of the substitute. The qualification process for a new ingredient should be structured around four areas, each of which helps identify different technological, quality, documentation or implementation risks.
Assessment level | Parameters to be verified |
1. Ingredient function and identity | TDS specification, active substance content, purity, impurity profile, preservatives, botanical origin, quality certificates and supplier availability |
2. Physicochemical parameters and behaviour in the formulation base | Impact on formulation pH and viscosity, stability, compatibility with other ingredients, foam profile, melting point, sensory properties and behaviour under manufacturing conditions |
3. Area of application and scope of the required assessment | Type of cosmetic product (leave-on/rinse-off), frequency of use, area of application, characteristics of the target group (e.g. children or sensitive skin), and any need for additional assessment by the regulatory department or safety assessor |
4. Documentation implications, claims and market requirements | Impact of the change on labelling and marketing claims, updates to the CPSR and PIF, documentation required by retailers, certification requirements, ESG criteria, export requirements and the documented history of the reformulation decision |
Compiling documentation at each assessment level shortens implementation time, reduces the risk of overlooking important data and facilitates the subsequent reconstruction of the decision-making process. Archiving stability test results together with TDS, SDS and CoA documentation does not replace laboratory or regulatory assessment, but it is an important part of the evidence supporting a reformulation decision during an audit, sanitary inspection or subsequent product review.
Reformulation documentation – a decision-making process that can be reconstructed over time
A controlled reformulation process requires the complete documentation of the decision-making pathway. A positive laboratory result does not mark the end of the procedure. Internal records should contain a comprehensive history of the change, clearly setting out:
the business rationale for seeking an alternative,
a comparison of the ingredients assessed, together with the evaluation criteria applied,
the scope of the tests and analyses performed, as well as a list of the documents updated,
the individuals or departments involved in approving the change,
a record of any tests that were not performed, together with the technological rationale for omitting them.
The collected data do not replace laboratory or regulatory assessment, nor the decision of the responsible person, but they help reconstruct the rationale behind the reformulation and substantiate the actions taken during a sanitary inspection, retail customer audit, complaint investigation or subsequent product review. The rationale for modifying the formulation should remain fully understandable and traceable, even several years after the project has been completed.
Cross-functional purchasing committee – five departments, different performance indicators
Selecting an alternative ingredient requires close cross-departmental cooperation. Each department assesses the change from a different perspective: cost, technology, quality, regulatory compliance or marketing. The qualification process should therefore be based on a single set of technical and commercial data, making it easier to compare available options and reducing the risk of late-stage objections during implementation.
Responsibilities and assessment criteria may be divided as follows:
procurement – analyses the unit cost of the ingredient, minimum order quantities (MOQs), price stability, payment terms and lead time,
research and development (R&D) – assesses compatibility with the formulation, physicochemical parameters, purity and the ingredient’s impact on product structure, stability and sensory properties,
quality assurance (QA) – verifies compliance with technical specifications, completeness of certificates, storage conditions and batch-to-batch consistency,
regulatory affairs – works with the safety assessor to evaluate the impact of the change on product documentation, the PIF, CPSR, labelling, claims and applicable legal requirements,
marketing – assesses whether the ingredient is consistent with the brand positioning, product claims, consumer communication and trends such as upcycling, vegan formulations and biodegradability.
A precise request for quotation (RFQ) can accelerate the selection of an alternative ingredient
General enquiries to a distributor about the availability of a “substitute” are often insufficient to identify the right alternative quickly. The more clearly the ingredient’s function in the formulation, quality requirements, technological constraints and commercial expectations are defined, the easier it is to narrow down the list of viable options and avoid inconsistent proposals.
A complete request for quotation (RFQ) sent to a commercial partner should precisely define both the technical and business requirements:
mapping the technological function – defining the role of the ingredient in the formulation, such as emulsion stabilisation, viscosity building, mild cleansing, conditioning or sensory enhancement,
physicochemical requirements – specifying the expected ranges for parameters such as pH, viscosity and solubility, as well as sensory stability and compatibility with the formulation base,
purity and origin criteria – defining acceptable impurity limits, the required ingredient grade and origin, together with any applicable ESG requirements,
documentation scope – specifying which documents should be provided with the quotation or sample, including the TDS, SDS, CoA and certificates such as COSMOS, RSPO or vegan certification, as well as any other documents relevant to the product,
format of the commercial information – requiring details of the unit price, Incoterms, precise lead time, MOQ and a price validity guarantee for a period of three to six months.
The most common mistakes in qualifying alternative ingredients that can generate additional costs
A lack of a systematic approach to ingredient changes increases the risk of technological problems, production delays, additional costs and objections from the quality department. A superficial assessment of an alternative ingredient at an early stage may complicate subsequent batch approval, prolong the implementation process or require additional testing and updates to the product documentation.
In practice, the most common mistakes made when qualifying an alternative ingredient include:
Treating the INCI name as a complete description of the ingredient – overlooking the fact that the same INCI name from a different manufacturer may refer to a different purity grade, preservation system, quality profile or active substance concentration.
Focusing solely on the price per kilogram – disregarding the total cost of ownership (TCO) within the formulation. A cheaper but less effective ingredient may require a higher dosage, longer homogenisation time, additional pH adjustment, greater energy consumption or higher minimum order quantities (MOQs).
Approving an alternative based only on a laboratory trial – without assessing the product’s behaviour over time, compatibility with the final packaging, short- and long-term stability and, where necessary, its performance during larger-scale production trials.
Overlooking the impact of the change on marketing claims – an alternative ingredient may affect the ability to maintain claims such as “vegan”, “suitable for sensitive skin” or “upcycled”, potentially resulting in costly label reprinting and undermining the brand narrative.
Involving QA and regulatory affairs too late in the process – situations may arise in which the formulator approves the ingredient, but QA blocks its implementation due to missing certificates, the absence of REACH registration or delays in providing the TDS and SDS documentation.
Failing to formally document the rationale for the change – disorganised documentation makes it difficult to reconstruct the reasons for the reformulation at a later date or explain the decision during a complaint investigation, retail customer audit, sanitary inspection, supplier change or subsequent product reformulation.
Using a precise RFQ format helps reduce the risk of hidden implementation costs. A well-prepared enquiry to the supplier should combine the R&D team’s quality requirements, the procurement department’s commercial expectations, QA requirements and the documentation and regulatory requirements applicable to the specific product.
Alternative ingredient qualification pathway – the MEDICOS model
The checklist below provides a practical framework for structuring the qualification process for an alternative ingredient and reducing technological, quality and documentation risks during product reformulation:
step 1 – define the reason for seeking an alternative, such as cost optimisation, supply continuity, source diversification, regulatory changes, sensory modification or implementation of an ESG strategy,
step 2 – precisely define the ingredient’s function in the formulation, such as viscosity building, emulsion stabilisation, foam generation, moisturising, conditioning or a purely marketing-related role,
step 3 – establish the comparison criteria, identifying which parameters should remain as similar as possible and defining acceptable technical deviations in terms of active matter content, pH, viscosity, purity, origin, odour, colour and documentation,
step 4 – narrow down the list of ingredients and review the documentation – at this stage, MEDICOS supports its partners in selecting suitable alternatives and reviewing TDS, SDS and CoA documentation, as well as quality declarations,
step 5 – conduct laboratory trials and a sensory assessment, including the evaluation of viscosity, emulsion stability, foam profile, sensory properties, compatibility with the formulation base and product behaviour over time,
step 6 – assess the need for additional testing, which may include stability and microbiological testing, packaging compatibility studies, an evaluation of the impact on claims or consultation with the regulatory department and safety assessor,
step 7 – formally document the decision by preparing a description of the change, a comparison of the ingredients assessed, the rationale for the final selection, an archive of test results and a list of product documents that may require updating, such as the PIF, CPSR and product label.
A well-managed reformulation process is not about finding “anything similar” as a temporary solution, but about selecting an alternative that is technologically, qualitatively, commercially and documentarily justified. The same INCI name, a more favourable price or a shorter lead time may provide a starting point for discussion, but they should not replace an assessment of the ingredient’s function in the specific formulation or its impact on stability, sensory properties, the manufacturing process, product claims and documentation.
MEDICOS supports customers in narrowing down the available options, comparing technical and quality documentation and structuring enquiries to suppliers. As a result, the decision to change an ingredient does not have to be a reactive response to limited availability or rising prices, but can become part of a deliberate approach to formulation management, supply chain resilience and production continuity
