The topic is short and compact
Whether the formulation may be taken with you is governed by the contract: with white label it remains with the manufacturer, with private label the contractual rights arrangement determines the outcome.
In addition to the quantitative formulation, the new manufacturer needs raw material qualities, manufacturing instructions, specifications with measurement methods, test data, and retention samples.
The Product Information File requires a new description of the manufacturing method and GMP declaration; the CPNP notification changes primarily in the case of a new responsible person or formulation.
The previous manufacturer should deliver until the first batch is approved at the new manufacturer; the safety stock covers this overlap.
The schedule is determined by stability testing on batches from the new production facility in the original packaging, often accelerated over one to three months.
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
When does it make sense to switch manufacturers?
A switch makes sense when problems occur as a pattern rather than an isolated case. A single delayed delivery or a batch with deviating viscosity does not justify a switch. However, if several of the following signs occur simultaneously across multiple batches, a planned transition is generally more cost-effective than waiting any longer:
Recurring quality discrepancies: Color discrepancies between batches of a foundation line, fluctuating payoff in lipsticks, phase separation, or changes in odor in creams.
Declining on-time delivery: Postponements without a comprehensible reason, for example because your orders are scheduled behind larger customers.
Incomplete documentation: Certificates of analysis, stability data, or manufacturing method details arrive late upon request or not at all.
Lack of development depth: formulation adjustments, new shades, or packaging material changes are not possible or only with long waiting times.
What do brands risk by waiting too long?
Those who switch only when the current manufacturer fails lose the most critical safeguard: parallel operation. Retention samples and reference batches for comparison are then missing, inventories run empty, and retail shortages and delistings threaten. Added to this is a regulatory risk: the responsible person must keep the product information file readily accessible to the authorities at the address stated on the label (Art. 11 Para. 3 Regulation (EC) No 1223/2009). If parts of it are only held by the previous manufacturer and are no longer accessible, every authority inquiry becomes a problem.
Who owns the formulation, and what can be taken along?
Whether you are allowed to take the formulation with you is determined by your contract, not by the desire to switch. With white label, the brand adopts a finished, tested formulation from the manufacturer and adapts it; the formulation remains with the manufacturer. In this case, switching almost always means that a comparable formulation must be developed with the new manufacturer. With private label, the formulation is newly developed according to the brand's requirements; whether the rights transfer to you and whether you can demand the release of the quantitative formulation is governed by the contract. Check these clauses before terminating; information on formulation ownership and confidentiality can be found in the article Confidentiality with the contract manufacturer: NDA and formulation ownership.
Why the INCI list is not enough for a replication
If the formulation is not available, replicating the existing product as a benchmark remains the only option. The list of ingredients on the packaging is of limited help here: it lists the ingredients in descending order of their weight at the time of addition, but gives no concentrations, and groups fragrances together under "Parfum" (Art. 19 (1) (g) Regulation (EC) No 1223/2009). In addition, the same INCI designation may conceal raw materials from different suppliers with different particle sizes, purities, or viscosities. A replication is therefore laboratory work involving several rounds of sampling, during which texture, sensory profile, and, in the case of make-up, the shade are matched against the original. A 1:1 result is not guaranteed; what is realistic is a product that falls within agreed tolerances for the defined test characteristics.
Which documents must the previous manufacturer hand over?
The more complete the handover, the shorter the transition phase. Request the documents early and in writing, ideally before giving notice of termination. For a technical transfer, the new manufacturer needs:
Quantitative formulation with trade names, suppliers, and qualities of all raw materials, not just the INCI names.
Raw material documentation: Specifications, safety data sheets, and certificates of analysis for the raw materials used. They originate from the raw material supplier and can usually also be requested directly from them if the trade name is known.
Manufacturing instructions: Phase breakdown, order of addition, temperatures, homogenization and stirring times, cooling profile, and, for hot-pour sticks, the pouring temperature.
Bulk and finished product specifications with limit values and measurement methods, such as pH range, viscosity including spindle and rotational speed, density, color standard per shade.
Test data: Stability studies, results of the preservative challenge test, microbiological specifications, and packaging compatibility data.
Packaging documentation: Specifications and suppliers for jars, tubes, airless dispensers, or mascara wipers.
Retention samples of recent batches as physical references for sensory profile and color comparison.
If manufacturing instructions or raw material qualities are missing, the new manufacturer may weigh out the formulation, but the result might still deviate: for emulsions, homogenization time and cooling rate determine droplet size and viscosity; for pigment dispersions, they determine color strength.
What changes regarding the Product Information File and CPNP notification?
In the case of manufacturing in the EU, the production site itself is not stated in the CPNP notification; however, the product information file, which contains a description of the manufacturing method, is affected. Which documents need to be adapted depends on who the responsible person is and whether the formulation changes.
Who is the responsible person?
Within the meaning of the Regulation, the manufacturer is whoever places a product on the market under their own name or trademark (Art. 2(1)(d) Regulation (EC) No 1223/2009), which means the brand in the case of contract manufacturing. It is the responsible person and can transfer this role by written mandate to another person in the EU (Art. 4(3) Regulation (EC) No 1223/2009). If the previous contract manufacturer was the responsible person by mandate, this mandate usually ends when cooperation ceases; the brand then either assumes the role itself or designates the new manufacturer by mandate. In both cases, the name and address on the label change (Art. 19(1)(a)) as well as the CPNP details, which the responsible person must update without delay pursuant to Art. 13(7) Regulation (EC) No 1223/2009. The same applies if the notified frame formulation or the details on nanomaterials change as a result of replication.
What is newly created in the product information file
The product information file contains a description of the manufacturing method and a declaration on good manufacturing practice (Art. 11(2)(c)). Both must be recreated for the new manufacturer. Manufacturing in accordance with the harmonised standard EN ISO 22716 merely establishes the presumption that good manufacturing practice has been complied with (Art. 8(2) Regulation (EC) No 1223/2009). An ISO 22716 certificate is neither mandatory nor proof; therefore, have the new manufacturer provide you with the manufacturing description and the GMP declaration for your specific product.
The safety assessor also checks whether the existing data still covers the product from the new production. The Guidelines on Annex I (Implementing Decision 2013/674/EU) require proof that the composition of the product from the stability test corresponds to the product actually placed on the market, and explicitly mention the manufacturing process as a possible source of traces. If a raw material supplier or packaging material also changes along with the manufacturer, the old stability data is generally no longer sufficient. An overview of the mandatory documents is provided in the article EU Cosmetics Regulation in practice: CPNP notification, product information file, and safety report.
Which tests does the first batch require with the new manufacturer?
The first batches at the new manufacturer are tested against the existing specification and against retain samples from the previous manufacturer before they enter the market. Laboratory batches alone are usually not sufficient for this: The Cosmetics Europe Stability Guideline considers it necessary, as development progresses, to test samples from batches produced on representative production equipment, because equipment type, process, and batch size influence stability. These are precisely the factors that change when switching manufacturers.
Which tests determine the timeline
Accelerated stability testing: According to the same guideline, frequently at 37 °C, 40 °C, or 45 °C over one, two, or three months, depending on the product type. Tested parameters include color, odor, appearance, pH, viscosity, and weight changes.
Testing in original packaging: The packaging must consist of the exact same materials as the sales packaging; in the case of multiple sizes, the guideline recommends testing the smallest container.
Preservation challenge test according to ISO 11930: recommended as soon as raw materials, manufacturing process, or packaging change; the Guidelines on Annex I mention preservation efficacy results, such as a challenge test, where appropriate as part of the stability data in the safety report.
Sensory and color comparison: Texture, spreadability, skin feel, and for make-up, shade and payoff in direct comparison with the retain sample.
For color ranges, the guideline recommends a representative selection of shades that reflects the product's stability extremes, in practice for example very light and very dark shades or shades with critical pigments; for fragrance variants, it may make sense to test each variant, because fragrances are more likely to interact with the product than color shades. Which tests must be completed before a launch is described in the article Stability and Safety Testing for Cosmetics.
How will delivery capability be maintained during the transition?
Delivery capability remains ensured if the previous manufacturer continues to supply until the first batch at the new manufacturer is released. A hard cut without overlap leaves no leeway if a test batch needs to be reworked.
Calculate safety stock: The range of coverage should at least cover the duration of handover, stability testing, packaging procurement, and initial production. Take into account the remaining shelf life until the best-before date so that stock does not expire during the transition phase.
Coordinate termination and final order: The final order with the previous manufacturer is only placed once the schedule with the new manufacturer is established. Clarify what happens to remaining stocks of raw materials and printed packaging materials.
Assign batches clearly: Every batch requires a batch number or identification mark on the container (Art. 19(1)(e)). Determine how the number ranges of both manufacturers will remain distinguishable so that complaints can be allocated to the correct production run.
Monitor after the handover: Closely track complaints, batch consistency, and retention samples of the first production batches. In addition, Cosmetics Europe recommends real-time monitoring of production goods in the final packaging.
Also consider the documentation of old batches: The product information file must be kept for ten years after the last batch has been placed on the market (Art. 11(1)). Therefore, secure the documents of the batches manufactured by the previous manufacturer before the collaboration ends. How repeat productions can be planned over years is shown in the article Planning cosmetic repeat production.
Labtree is a B2B cosmetics developer and cosmetics manufacturer with its own laboratory and production capacities in Germany. When switching manufacturers, Labtree covers formulation development, in-house laboratory work, sampling, manufacturability testing, and cosmetics production: A provided formulation is tested for manufacturability and transferred to in-house manufacturing; if it is not available, the existing product is technically replicated in the laboratory as a benchmark. Sample quantities are created in the in-house laboratory so that sensory profile and nuance are aligned early on using physical samples. Safety assessment, filling, and batch release are part of the process.
Regarding the timeframe: If the product is based on an adapted white-label formulation from Labtree, it is usually ready for delivery in 2 to 3 months with standard packaging. A new private-label development typically takes 3 to 6 months to reach market readiness. The minimum order quantity is generally 1,500 units per product, depending on the product type, fill size, and packaging. The process from conceptualization to production is described on the page Having cosmetics developed.
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FAQ
How long does it take to change cosmetics manufacturers?
This depends primarily on whether the formulation is provided or needs to be recreated, how complete the documentation is, and how long the stability testing in the original packaging takes. Accelerated stability tests typically run for one to three months. Packaging materials with long delivery times will further extend the timeline.
Can the previous manufacturer refuse to release the formulation?
With white label, the formulation remains with the manufacturer, and there is generally no entitlement to its release. With private label, the contract determines whether the rights and quantitative formulation are transferred to the brand. Learn more in the Labtree magazine article "Confidentiality with the contract manufacturer: NDA and formulation ownership".
Does a product need to be re-notified in the CPNP after a change of manufacturer?
For manufacturing within the EU, the production site is not part of the CPNP notification. However, if the responsible person, the frame formulation, or other notified details change, the responsible person must promptly update the notification pursuant to Article 13(7) of Regulation (EC) No 1223/2009. In any case, the product information file must be updated to include the description of the new manufacturing method and the GMP statement.
Can a cosmetic product be replicated based on the INCI list alone?
Not exactly. The INCI list specifies neither concentrations nor raw material suppliers or process parameters, and fragrances are merely listed as “Parfum”. A recreation requires laboratory work and several rounds of sampling until texture, sensory profile, and nuance are within agreed tolerances.
Where does the new manufacturer get the safety data sheets for the raw materials?
Safety data sheets, specifications, and certificates of analysis originate from the raw material supplier. If trade names and suppliers are known from the formulation, the new manufacturer can request them directly from there. If this information is missing, the raw materials must be re-selected and qualified.
Who remains responsible for batches that were still produced by the former manufacturer?
The responsible person under whom the batches were placed on the market remains responsible, typically the brand. Complaints and regulatory inquiries regarding these batches will therefore continue to end up with you, even if the previous manufacturer no longer supplies. For this reason, agree before the end of the contract that batch records, certificates of analysis, and retained samples of these batches are handed over to you or kept available.
What questions should brands ask the new manufacturer before making the switch?
Important factors include in-house laboratory capacity for replication and adaptation, experience with comparable product formats, minimum order quantities, packaging procurement, and the question of who prepares the safety report and product information file. A structured checklist is provided in the Labtree magazine article "Ten questions to ask a cosmetics contract manufacturer before you sign".
