Written by the Oppenheimer Lab team — Reviewed by Mohamed Arbi Jallali, Partner, Head of Production and Formulator
Published on
14 min read
The stages of custom cosmetic formulation lead to the development of an exclusive formula, based on your specification. R&D carries it out in stages, from the brief to the choice of ingredients, then from prototypes to stability and compatibility tests, through to industrial scale-up and the regulatory file. At each stage, it balances performance, stability, industrial feasibility, cost and compliance.
This guide shows that real work and how these choices prepare the PIF, the Responsible Person and the CPNP notification required for export, drawing on the errors identified by the DGCCRF. For a specific project, discover our custom formulation service. This informative article refers to Regulation (EC) No 1223/2009 for the obligations.
What is custom cosmetic formulation, and when should you prefer it to an existing formula?
Custom cosmetic formulation is the creation of an exclusive formula from a brand’s specification. It is justified when no existing formula meets the intended benefit, texture or positioning. It takes more time than private label. At Oppenheimer Lab, allow 6 to 12 months, compared with 45 to 90 days.
Custom, private label, custom private label: three levels of commitment
Private label is an existing formula, already developed by the laboratory, that you sell under your name with your packaging. Custom private label is a formula adapted from an existing base, with adjustments to texture, fragrance or actives according to your positioning. Custom formulation starts from a blank page: R&D designs an exclusive formula specific to your project.
These three levels involve neither the same timeline nor the same investment. At Oppenheimer Lab, private label takes 45 to 90 days, custom private label 3 to 6 months and custom formulation 6 to 12 months. Small batches are possible subject to assessment, from 200 units, or even 100 depending on the project. To compare these options in detail, see our articles on private label and custom private label.
The signs that justify an exclusive development
Before starting a development, check that no existing formula is suitable. Oppenheimer Lab offers more than 500 available formulas, a faster alternative if one of them meets your brief. Custom formulation becomes relevant in the following situations:
- An uncovered benefit: the intended result does not exist in any formula in the catalogue.
- A specific texture: the sensory feel sought requires a new formula architecture.
- A signature ingredient: your brand is built on an identity-defining active, such as prickly pear seed oil, nigella or rosemary.
- A certification constraint: the formula must meet a specific standard. At Oppenheimer Lab, COSMOS, Ecocert, Vegan and Halal certifications are available on request.
The following sections detail each stage of this development, and the satellite articles of the Formulation cluster explore each of them in greater depth.
How do you write a brief that R&D can actually use?
A usable brief sets the target, the benefit sought, the selling price, the quantity and the overall budget, including marketing, from the outset. Without these five benchmarks, R&D cannot balance performance, cost and feasibility. A brief that changes along the way lengthens the development and increases the risk of the project failing.
The five elements to set before any development
The cosmetic specification is the document that translates your project into precise requirements for the formulator. Before developing, we set five elements with you:
- The target: who the product is for, with which type of skin or hair.
- The benefit sought: the result the product must deliver.
- The selling price: it caps the cost of the formula and the packaging.
- The quantity: the volume of the first batch guides industrial choices.
- The overall budget: development, manufacturing and marketing included.
Other information makes the brief stronger: the desired texture, the planned packaging, the intended claims and the certifications sought. We also recommend defining the countries of sale in the brief, in order to prepare the corresponding supporting documents and packaging.
Why an unstable brief makes the project drift
What most often makes a project fail is the mismatch between ambition, budget and timeline. An exclusive formula, custom packaging and several references, with a limited starting budget and a launch date that is too close, make for an equation that is hard to satisfy. A brief that keeps changing makes the problem worse, because each change restarts part of the work.
The commercial calendar also weighs on the brief. Our clients’ requests follow the seasons: in summer, mainly sun care products; in winter, moisturising care and solutions for oily skin. Our advice: anticipate these peaks by several months in your development and manufacturing schedule. To place the brief within your overall project, browse the steps to launch your cosmetic brand.
How does R&D choose the ingredients of a formula?
R&D chooses each ingredient according to its function, its compatibility with the rest of the formula, its regulatory status, its availability and its cost. The intended claims also guide this choice: every benefit claimed must be substantiated, in accordance with Article 20 of Regulation (EC) No 1223/2009 and Commission Regulation (EU) No 655/2013.
Performance, stability, cost, compliance: the trade-offs
Each ingredient fulfils a precise role: active, emulsifier, texturiser, preservative or fragrance. The formulator checks that a high-performing active does not destabilise the emulsion and that its cost remains compatible with the selling price set in the brief. A signature ingredient, such as argan oil or shea butter, must also be available in a consistent quality for future batches.
The INCI list is the international nomenclature of cosmetic ingredients, used to declare the composition on the label. According to the DGCCRF, ingredients appear there in a specific order. Each choice made by R&D can therefore be read directly on your packaging.
Claims are prepared as soon as the actives are chosen
A claim is a statement, written or visual, that attributes a benefit or a characteristic to the product. According to the DGCCRF, a significant share of the claims inspected were not compliant. Among the most frequent anomalies is a lack of evidence. The authority also notes ingredients highlighted but absent or underdosed.
“[…] the presence of claims tending to give the products the status of a medicinal product […]” (DGCCRF)
To avoid these pitfalls, list your claims from the brief stage. Then ask your laboratory how each chosen active justifies them: dosage, supplier data or planned tests. A benefit that cannot be proven must be reworded before development, not at the labelling stage.
What happens between the first prototype and the validated formula?
The prototype is a first version of the formula, made in a small quantity at the laboratory. R&D adjusts it through successive iterations (texture, fragrance, colour, pH, sensory feel) until a sample matching the brief is obtained. The brand then validates this sample. Stability and compatibility tests follow, then industrial scale-up.
Laboratory iterations
An iteration is a new version of the prototype, modified based on the brand’s feedback or the formulator’s observations. Each adjustment addresses a specific parameter: a texture that is too rich, a fragrance that is too strong, an unstable colour or a finish that does not match the positioning. To pinpoint the sensory feel you are aiming for, browse the overview of cosmetic textures.
Document every change to the formula, even minor ones. According to the DGCCRF, some safety assessments inspected had not kept up with changes to the product. So ask your laboratory for a version history, with the date and nature of each change.
The criteria for validating a sample
A validated sample meets the brief on the essentials. Before giving your approval, check several points:
- Appearance and smell: they match the experience promised to the consumer.
- Behaviour on application: absorption, finish and feel after use comply with the brief.
- The estimated cost: it remains compatible with the selling price set at the outset.
- Industrial feasibility: the formula can be reproduced at production scale.
This validation marks the end of the exploratory work. Any later change restarts part of the tests: it is therefore better to decide at this stage rather than after industrial scale-up.
Which stability and container-content compatibility tests should you plan?
The stability test checks that the formula keeps its appearance, smell, texture and properties over time and under different storage conditions. The container-content compatibility test checks that the packaging protects the formula without altering it, and vice versa. These results, together with microbiological control, feed into the safety assessment and the Product Information File.
The stability test: checking that the formula holds over time
The stability test is a series of observations carried out on the validated formula, stored under controlled conditions, to detect any drift. It makes it possible to check that the product sold still matches the approved sample. The parameters monitored include:
- Appearance: homogeneity, shine, absence of sediment.
- Smell and colour: no change perceptible by the consumer.
- pH: it stays within the range planned for the formula.
- Viscosity: the texture neither thickens nor becomes runny.
- Separation: the emulsion does not split and the oils do not rise to the surface.
These results also guide the durability statement shown on the packaging. According to the DGCCRF, the date of minimum durability provides information on the safety of the product over time. The PAO (period after opening) is the length of time a product can be used after being opened, shown by the open jar symbol.
Article 19 of Regulation (EC) No 1223/2009 sets the rule: the date of minimum durability is mandatory for products whose durability does not exceed the threshold defined by the text. Beyond that threshold, the PAO replaces it. Check the rule in the official text with your laboratory before finalising the label.
Microbiological control and preservative efficacy
Microbiological control is the analysis that checks that a product does not contain micro-organisms beyond acceptable limits. The challenge test, or preservative efficacy test, is a trial that deliberately contaminates the formula to check that its preservative system limits the growth of germs. It applies primarily to water-rich formulas, which are more exposed to contamination during use.
The dosage of the preservative remains regulated. During its inspections of cosmetics for babies and children, the DGCCRF found one non-compliant product on this point. Ask your laboratory for the results of these two analyses: they feed into the safety assessment.
The formula-container pair: a test not to skip
Container-content compatibility is the absence of any undesirable interaction between the formula and its packaging. A container must protect the product, dispense its texture properly and withstand transport. Advice we often repeat: never order your bottles before you have validated their compatibility with the formula.
An airless bottle may be relevant for certain formulas, but it is not automatically the best choice. We recommend testing the formula-container pair before placing the whole order. This test must also appear in the file: during its inspections, the DGCCRF found gaps in PIFs. To explore these requirements further, see our regulation and quality guides.
How does a formula go from the laboratory to the industrial batch?
Industrial scale-up consists of reproducing on a large scale a formula developed in the laboratory, with the same result. The equipment, the order of incorporation of the ingredients and the mixing times change. Manufacturing must follow cosmetic Good Manufacturing Practice (ISO 22716), required by Article 8 of Regulation (EC) No 1223/2009.
Industrial scale-up: changing scale without changing the product
A formula that works in a beaker does not always behave the same way in a production vessel. The stirring speed, the temperature rise and the cooling alter the texture or stability. R&D therefore adjusts the process, without touching the validated composition, to recover the approved sample.
This process must be described precisely in the file. During its inspections, the DGCCRF noted a frequent shortcoming. Ask your laboratory for a written manufacturing method, linked to the final version of the formula. To learn about manufacturing capacity, see our page cosmetic production and manufacturing.
GMP and batch traceability
GMP are the set of organisational, hygiene and control rules that ensure consistent and controlled manufacturing. Before launching your first batch, ask your laboratory which standard its manufacturing is based on, for example ISO 22716, and what minimum quantity it sets per reference.
A batch is a quantity of product made in a single operation, identified by a unique number. Traceability is the ability to retrieve the history of that batch: raw materials, stages, controls. At Oppenheimer Lab, the full history of a batch is available within 24 hours.
Also require a signed GMP compliance declaration. According to the DGCCRF, this document is sometimes missing from the files inspected. In France, the DGCCRF issues a GMP certificate to establishments that export outside the EU. This procedure applies only to sites located in France.
Which regulatory files does R&D prepare for export?
To sell in the European Union, a cosmetic must have a Responsible Person established in the EU and a Product Information File (PIF) including the safety assessment (CPSR). It also needs compliant labelling and a CPNP notification before being placed on the market. R&D provides most of the technical data for this file: formula, manufacturing method and test results.
Responsible Person, PIF, safety assessment and CPNP
The Responsible Person is the party who guarantees the compliance of the product placed on the market, within the meaning of Article 4 of Regulation (EC) No 1223/2009. According to the DGCCRF, this role does not always fall to the same party. The PIF is the technical file provided for in Article 11. It brings together the formula, the manufacturing method and the CPSR, the cosmetic product safety report required by Article 10.
The CPNP notification is the declaration of the product on the European portal, provided for in Article 13. The DGCCRF specifies that it takes place before marketing. Labelling, governed by Article 19, then reuses the data from the file. Oppenheimer Lab prepares Product Information Files (PIF) and CPNP notifications.
One question comes up often: can a product made in Tunisia be sold directly in France? Our answer: manufacturing in Tunisia does not exempt you from the requirements of the destination market. The notification is neither an authorisation nor a quality certification.
The errors most often found during inspections
According to the DGCCRF, labelling and the file top the list of failings. The authority also observes poorly regulated subcontracting arrangements.
“Thus, the Responsible Person sometimes does not hold the PIF, which constitutes an infringement of the Cosmetics Regulation.” (DGCCRF)
To avoid this risk, ask your laboratory for a written contract. It must specify who compiles the PIF, who carries out the safety assessment and who holds the final file. To prepare each market, see our articles on cosmetics export. This content is informative: only the official text of Regulation (EC) No 1223/2009 is authoritative.
How long does a custom development last, stage by stage?
At Oppenheimer Lab, a custom cosmetic formulation takes 6 to 12 months, compared with 3 to 6 months for custom private label and 45 to 90 days for private label. The duration depends mainly on the stability of the brief, the number of iterations, the tests, the availability of the packaging and the preparation of the regulatory file.
Summary table of the stages
The development timeline is the sequence of stages leading from the brief to the first marketable batch. Each stage produces a deliverable that conditions the next. The table below summarises the six stages of this guide.
| Stage | Role of R&D | Main trade-off | Deliverable |
|---|---|---|---|
| Brief | Translate the project into technical requirements | Ambition, budget and timeline | Validated specification |
| Choice of ingredients | Select actives, texturisers and preservatives | Performance, cost and compliance | Starting composition |
| Prototypes | Adjust the formula through iterations | Sensory feel and fidelity to the brief | Approved sample |
| Stability and compatibility | Observe the formula and its container over time | Choice of packaging | Test results, PAO |
| Industrial scale-up | Adapt the process to production scale | Industrial feasibility | Written manufacturing method |
| Regulatory file | Provide the technical data | Destination markets | PIF, CPSR, CPNP notification |
What lengthens or shortens the timeline
The first factor is the stability of the brief. Every change of target, benefit or budget restarts part of the work. Setting the five benchmarks of the brief from the outset therefore remains the best way to meet deadlines.
Packaging also weighs on the schedule. We recommend testing the formula-container pair before placing the whole order of bottles. A container ordered too early, then judged incompatible, delays the entire project.
Finally, take the seasons into account. Sun care products are mainly in demand in summer, moisturising care and solutions for oily skin in winter. Our advice: start development several months before the targeted peak.
To estimate the timeline of your project, you can request a quote for your formula. Oppenheimer Lab replies to quote requests within 48 working hours.
Why develop your formula in Tunisia?
Tunisia has an established, export-oriented cosmetics sector, close to Europe and the Gulf, with local ingredients such as olive oil or rosemary. The choice of a laboratory nonetheless rests on verifiable elements: quality of samples, ISO 22716 compliance, regulatory documentation, delivered cost and reliability of the schedule.
A structured, export-oriented sector
According to La Presse (March 2025), the Tunisian sector has about 774 companies and nearly 7,600 jobs. The same outlet puts exports at about 225 million dinars at the end of 2024. According to L’Économiste Maghrébin (March 2025), the sector accounts for 1.35% of GDP. Its products go notably to France, Germany and Spain.
According to WMC (January 2026), the sector comprises 60 companies and exports about 270 MD. The gap between 774 and 60 companies shows that these two counts do not rest on the same scope: keep an order of magnitude in mind. The Ministry of Industry also wishes to promote local plants.
Oppenheimer Lab is based in Tunisia, where it offers 48-hour delivery. The laboratory has supported more than 50 brands and exports to more than 30 countries.
What to check at your laboratory
The delivered cost is the price of the product delivered to destination, transport and formalities included. Before committing, check the following points:
- Samples: they comply with the brief and are reproducible.
- ISO 22716 compliance: the GMP declaration is provided and signed.
- Regulatory documentation: the contract specifies who prepares the PIF and the CPNP notification.
- The delivered cost: it includes transport and export formalities.
- The schedule: each stage has a dated deliverable.
To explore each stage further, browse all our articles on cosmetic formulation.
Sources
- Contrôle des produits cosmétiques (in French), DGCCRF (ministère de l’Économie, France), October 2024
- Produits cosmétiques : la DGCCRF assure désormais seule le contrôle des produits et établissements (in French), DGCCRF (ministère de l’Économie, France), October 2025
- Le secteur des cosmétiques en Tunisie appelle à un allègement fiscal (in French), La Presse de Tunisia, 7 March 2025
- Le ministère de l’Industrie renforce son soutien à l’industrie cosmétique (in French), L’Économiste Maghrébin, 7 March 2025
- Parapharmaceutique : 270 MD d’exportations pour les parfums et cosmétiques tunisiens (in French), WMC (webmanagercenter), 23 January 2026
Frequently asked questions
How long does it take to develop a custom cosmetic formula?
At Oppenheimer Lab, a custom cosmetic formulation takes 6 to 12 months. This period covers the brief, prototype iterations, stability and compatibility tests, industrial scale-up and the regulatory file. It grows mainly when the brief changes along the way or when the packaging arrives late. By comparison, private label takes 45 to 90 days.
What is the difference between a custom formula and a private label formula?
A custom formula is created exclusively for your project, whereas private label uses an existing formula already developed by the laboratory. The first meets a benefit, a texture or a signature ingredient that cannot be found in a catalogue; the second allows a faster launch. At Oppenheimer Lab, allow 45 to 90 days for private label, compared with 6 to 12 months for custom.
What should the specification of a cosmetic product contain?
The specification must set at least the target, the benefit sought, the selling price, the quantity and the overall budget, including marketing. Complete it with the desired texture, the planned packaging, the intended claims, the certifications sought and the countries of sale. These benchmarks allow the formulator to balance performance, cost and compliance without restarting the work at each stage.
What is a PIF and who must compile it?
The PIF is the Product Information File provided for in Article 11 of Regulation (EC) No 1223/2009, and the Responsible Person must hold it. It brings together, among other things, the formula, the manufacturing method and the safety report (CPSR). Its compilation can be entrusted to the laboratory: a written contract must then specify who prepares it and who holds the final version. Oppenheimer Lab prepares PIFs.
Can a cosmetic formulated and manufactured in Tunisia be sold in Europe?
Yes, provided European Union requirements are met, from which manufacturing in Tunisia does not exempt you. You need a Responsible Person established in the EU, a PIF with a safety assessment, a compliant composition and labelling, then a CPNP notification before placing on the market. This notification is neither an authorisation nor a quality certification.
