The topic is short and compact
The brand is the manufacturer and the responsible person, even when a contract manufacturer produces the product (Art. 2, Art. 4 of Regulation (EC) No 1223/2009).
Stability must be tested on the market-ready product in its intended container; a new pack component generally requires new testing (Guidelines 2013/674/EU).
The PIF contains the manufacturing method and the GMP statement and must be kept for 10 years after the last batch (Art. 11).
Labtree produces according to its own formulation, usually starting from 1,500 units per product, depending on product type, filling volume, and packaging.
ISO 22716 merely establishes a presumption of good manufacturing practice; it is neither mandatory nor proof of compliance (Art. 8(2)).
So läuft die Entwicklung bei Labtree
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Konzeptionierung
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Bemusterung – Standardmuster in 24 h
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Individualisierung
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Prototyping
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Produktion
White Label 2–3 Monate · Private Label 3–6 Monate · Produktion ab 1.000 Stück
What does production to your own formula actually mean?
You can only have a finished formula manufactured once its dossier is in place: the complete formula, raw material specifications, test data and manufacturing instructions, plus clarity on who carries regulatory responsibility. The manufacturer can only produce your formula once these documents are available and responsibility has been clarified under Regulation (EC) No 1223/2009. The Regulation has applied since 11 July 2013; the responsible person maintains a Product Information File for every cosmetic product they place on the market.
This must be distinguished from a finished manufacturer formula under White Label: there, the brand takes on a tested formula from the manufacturer and adapts it, and the formula remains with the manufacturer. If you bring your own formula, it remains your intellectual property, and you also carry the regulatory responsibility for it. The following sections cover the documents in detail.
The handover dossier: formula, specifications, test data, manufacturing instructions
Stability data and the question of whether laboratory results hold up in the market pack component
Raw material changes at the manufacturer and their effect on specification and safety assessment
Responsible person and Product Information File in contract manufacturing
The path from laboratory sample to series production with batch release
Which documents does a manufacturer need for your formula?
The manufacturer does not review your formula out of curiosity, but because they must later manufacture and document it under good manufacturing practice. The safety report under Annex I Part A of the Regulation requires information on the quantitative and qualitative composition, stability, microbiological quality, impurities and packaging material. Under Article 11(2)(c), the Product Information File also contains a description of the manufacturing method and a statement of compliance with good manufacturing practice. What you compile therefore follows precisely these requirements.
Complete formula: every ingredient with function and quantity in mass percent, avoiding concentration ranges where possible
Raw material specifications: identity (INCI, CAS), purity, test methods, supplier information for each raw material
Test data from your laboratory work: stability, microbiological quality, preservative challenge test, impurity profile
Pack component details: material, sealing, intended interactions with the formula
Manufacturing instructions: order of phases, temperatures, stirring and homogenisation conditions, where available
If any of this information is missing, the manufacturer will request it, and every follow-up request delays the production start. The Guidelines to Annex I do allow parts of the data to come from suppliers, from specialist literature or from experience with comparable formulas, but the responsibility for the dossier being complete remains with you.
Are stability data from your own laboratory sufficient?
That depends on the container in which the data were collected. The Guidelines 2013/674/EU require that physical stability testing be carried out both in inert containers and in the containers intended for marketing. Stability testing in a laboratory beaker or a standard wide-neck jar therefore only holds as long as the market pack component is identical or at least comparable.
Data in the intended market pack component: generally sufficient for production release
Data in a laboratory vessel, market pack component identically constructed: often transferable, to be confirmed case by case
Different market pack component, for example an airless dispenser instead of an open jar: usually requires new testing, because suction behaviour, sealing and material contact differ
If the data for the market pack component are missing, a concrete cost driver arises: the stability test runs over weeks to months, requires sample quantities in the final container and ties the production start to its completion. Describe this effort in your planning rather than underestimating it. The Guidelines also require proof that the composition of the stability sample matches the product actually placed on the market, so a later formula change renders old data worthless.
What changes when the manufacturer uses different raw materials?
The manufacturer usually sources raw materials through its own suppliers and purchasing terms. That is normal and no cause for concern, as long as the specifications are reconciled. The Guidelines 2013/674/EU require information on the purity of substances and mixtures as well as the identification of toxicologically relevant unintended substances. If the impurity profile of a substitute raw material differs, this can affect the safety assessment and require new test data.
Specification check per raw material: identity, purity, test methods, manufacturing process of the raw material
Compare the impurity profile: deviations feed into the safety assessment and can trigger retesting
Practical example pigment change: a different milling or surface treatment shifts the shade and coverage, so shade matching has to be repeated
Practical example preservative change: a different preservative system or different raw material microbiology affects the preservative challenge test
Agree with the manufacturer that every raw material change is reported before use. An unannounced supplier change that only surfaces in the finished batch costs you the batch release and, in the worst case, the quantity already produced.
Who is the responsible person and who keeps the PIF?
In contract manufacturing the allocation of roles is clearly defined. The manufacturer within the meaning of the Regulation is whoever manufactures a cosmetic product or has it manufactured and places it on the market under their own name or brand. That is your brand, not the contract manufacturer. The responsible person is therefore the manufacturer established in the Community, i.e. you; the role can only be transferred to another person established in the Community by a written mandate that this person accepts in writing.
Role | Who that is | Core obligation |
|---|---|---|
Manufacturer within the meaning of the Regulation | Your brand, which places the product on the market under its own name | Ensure compliance with the Regulation |
Responsible person | The manufacturer established in the EU, i.e. the brand; transfer only by written mandate | Keep the PIF, safety assessment, authority access |
Contract manufacturer | Manufactures on commission, without its own brand on the product | Manufacture according to good manufacturing practice, documentation |
The responsible person keeps the PIF and retains it for ten years after the last batch was placed on the market. In practice this means: clarify before the production start who actually maintains the file and who makes it easily accessible to the competent authority at the address stated on the label. Many brands have the contract manufacturer contribute the technical documentation, but responsibility for completeness and currency remains with them. Our magazine article on the EU Cosmetics Regulation covers the details of the PIF, CPNP notification and safety report.
How does your laboratory formula get into series production?
A formula that works in the laboratory kettle is not yet a production-ready formula. Viscosity, homogenisation and filling behaviour in the large kettle differ from the laboratory scale, which is why the manufacturer first validates the formula at production scale. Our article on development and production from the same manufacturer describes why the separation of development and manufacturing creates problems here; the article on scaling cosmetic production covers the individual steps from pilot batch to series.
Validation of the formula at production scale: process control, viscosity and filling behaviour are verified on the real kettle
Manufacture according to good manufacturing practice: compliance is presumed under Article 8(2) when production follows the harmonised standards whose references are published in the Official Journal of the EU; this includes DIN EN ISO 22716 (reference 2011/C 123/04). The standard is neither mandatory nor the sole proof; it only establishes the presumption
Testing per batch: specifications of the finished product, such as pH value and viscosity, are checked before release
Batch release: only after passing the tests does the batch leave the plant
The PIF must also continue to contain the description of this manufacturing method and the GMP declaration, so record the parameters under which series production actually runs.
Labtree is a B2B cosmetics developer and cosmetics manufacturer with its own laboratory in Hamburg and handles manufacturing, filling and packaging with its own production capacities in Germany, from the first batch to reproduction, with batch release. Because laboratory work and manufacturing are under one roof, the manufacturability of your formula is checked before it goes into the production vessel, not afterward. The minimum order quantity is usually 1,500 units per product, depending on product type, fill size and packaging.
If you have your own formula with a complete dossier or a partial step of it, the Labtree laboratory reviews the documents, clarifies the responsible person and responsibility for the PIF, and transfers the approved formula into production: manufacturing, filling, packaging and batch release at Labtree. There you will also find the process steps from conception through sampling to production and the current framework conditions for your quantity.
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FAQ
Who owns the formula when I hand it over to a manufacturer?
In genuine contract manufacturing, the formula remains the property of the brand. Unlike White Label, where a finished manufacturer's formula is only adapted and stays with the manufacturer, you bring your own formula. Exclusivity and formula rights can be regulated contractually within the scope of the project.
Do I have to disclose my complete formula to the manufacturer?
For the safety report and the Product Information File, the manufacturer needs the complete composition with function and quantity of each ingredient, because Annex I of Regulation (EC) No 1223/2009 requires information on composition, stability, microbiology and impurities. Without these data, no safety assessment can be prepared.
Are my stability data from our own laboratory sufficient?
Only if the later market pack component matches the test vessel. Guidelines 2013/674/EU require the stability test to be carried out on the market product in its intended container. If the packaging material differs, for example with airless dispensers or tubes instead of laboratory glassware, new testing is generally required.
Who is the responsible person when a contract manufacturer produces?
The manufacturer within the meaning of the Regulation is whoever places the product on the market under their own name or brand (Art. 2(1)(d)), i.e. the brand. The brand is therefore the responsible person (Art. 4(3)) and can only transfer this role to the contract manufacturer by written mandate.
Must the manufacturer be certified to ISO 22716?
No, certification to ISO 22716 is not mandatory. Under Art. 8(2) of Regulation (EC) No 1223/2009, it is only presumed that good manufacturing practice is observed if production follows the harmonised standard. The standard establishes this presumption; it is neither proof nor a legal requirement.
How long must the Product Information File be retained?
The responsible person keeps the Product Information File and, under Art. 11(1) of Regulation (EC) No 1223/2009, retains it for ten years after the date on which the last batch of the cosmetic product was placed on the market.
From what quantity can a custom formulation be produced?
At Labtree, the minimum order quantity is generally 1,500 units per product. The exact quantity depends on the product type, fill size, and packaging, as filling lines and packaging processes require certain batch sizes to achieve cost-effective unit costs.
