The topic is short and compact
In contract manufacturing, the brand is considered the manufacturer under the Cosmetics Regulation and is therefore the responsible person, unless this role is transferred via a written mandate.
Minimum order quantity per variant, lead time per component, and the manufacturer's development capacity determine whether a supplier relationship scales with the product range.
Only the manufacturer can provide the manufacturing method and GMP declaration for the product information file; their handover must be included as an obligation in the contract.
As of August 1, 2026, only products with allergen labeling compliant with Regulation (EU) 2023/1545 may be placed on the market.
A larger batch size or a new system is a change requiring testing: system type, process, and batch size belong in the stability program.
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 contract manufacturer management mean in cosmetics?
Legally, management begins with the division of roles. According to Art. 2(1)(d) of Regulation (EC) No 1223/2009, a manufacturer is considered to be any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark. In contract manufacturing, this is the brand. It is therefore the responsible person under Art. 4 and can transfer this role by written mandate to a person established within the EU, such as the contract manufacturer, who accepts the mandate in writing.
From this follows the core of the task: the responsible person is accountable for the safety assessment, product information file, CPNP notification, and labeling, even if the manufacturer does the work. Contract manufacturer management ensures that each of these obligations is assigned to one party, that the documents reach the responsible person in full, and that volume and scheduling align with sales.
Roles: who the responsible person is and who prepares and maintains which documents.
Performance: quantities, deadlines, batch quality, and response times in the event of deviations.
Development: whether the manufacturer can develop the next formulation itself or the brand requires an additional partner for it.
Which three variables must grow with the brand?
A manufacturer relationship becomes a bottleneck for growth if it was tailored to the initial situation and cannot scale alongside it. Three variables determine this, and they can be vetted before signing rather than under delivery pressure.
Variable | Typical bottleneck | What you should clarify in advance |
|---|---|---|
Minimum order quantity | Too high for initial sales or inflexible when variants are added | Minimum quantity per product and per variant, dependence on batch size and packaging materials |
Lead time | Reorders wait for available production slots, packaging materials, or raw materials | Lead time per component, forecasting rhythm, handling of rush orders |
Development capacity | The manufacturer produces but does not develop; expanding the product line starts from scratch with another partner | In-house laboratory, sampling, feasibility testing of new formulations |
Minimum order quantities result from the smallest feasible vessel batch size, cleaning cycles between batches, and the minimum order quantities of packaging suppliers, not from sales policy. In make-up, there is the added factor that each shade in a color line is produced as a separate variant: a concealer line with twelve shades multiplies batches, cleaning effort, and testing scope. Where these values come from in detail is explained in MOQ in cosmetics.
The third variable is the most frequently overlooked. A facility that only mixes and fills according to specifications forces the brand to involve an additional partner for every formulation adjustment. This creates the exact interfaces where information gets lost and timelines slip.
Which obligations and documents belong in the contract?
What the regulation requires from the responsible person should reappear in the contract with the contract manufacturer as a delivery or cooperation obligation. Otherwise, documents may be missing precisely when an authority requests them.
Good Manufacturing Practice: According to Art. 8, manufacturing is carried out in accordance with good manufacturing practice; compliance is presumed when manufacturing conforms to the relevant harmonized standards. The European Commission lists EN ISO 22716:2007 as a harmonized standard for the Cosmetics Regulation. A certificate is therefore neither mandatory nor proof, but rather a reliable audit item in the supplier audit.
Documentation and Traceability: The Federal Office of Consumer Protection and Food Safety highlights comprehensive documentation of the manufacturing process to ensure traceability. Agree on which batch records, test certificates, and retention samples the manufacturer must retain and for how long.
Product Information File: According to Art. 11(2)(c), it contains a description of the manufacturing method and a statement on compliance with good manufacturing practice. Both can only be provided by the manufacturer.
CPNP Notification: The notification pursuant to Art. 13 is submitted by the responsible person via the European Commission's notification portal. The contract governs who supplies the composition details required for this.
Serious Undesirable Effects: Art. 23 obliges the responsible person and distributors to report to the competent authority. Complaints received by the manufacturer must therefore go directly to the responsible person without detour.
A second contractual section concerns the formulation. Who owns it depends on the service model: In white label, the tested formulation remains with the manufacturer; in private label, rights and exclusivity are governed by contract. Under Section 2 No. 1 GeschGehG, a formulation is protected as a trade secret only if it is subject to reasonable steps to keep it secret. A non-disclosure agreement with the manufacturer and regulated access to formulation data are among these measures.
How do you measure quality and on-time delivery?
Whether a manufacturer relationship is viable becomes apparent in a few key figures, which are recorded per batch and discussed together at a regular rhythm. No regulation prescribes target values; it is advisable to define them in the contract and align them with sales planning.
On-time delivery: confirmed versus actual delivery date, separated by initial batch and subsequent production runs.
Quantity reliability: delivered versus ordered quantity; recurring underdeliveries indicate filling losses or packaging bottlenecks.
Batch consistency: deviations in pH value, viscosity, color, and odor compared to the approved specification; for makeup, additionally the deviation from the reference shade.
Deviations and complaints: number, cause, and time until resolution.
Development response time: duration from request to laboratory sample of a formulation adjustment.
For planning purposes, the forecast also matters. A rolling demand forecast, updated by the brand at a regular rhythm, allows the manufacturer to order raw materials and packaging in good time and reserve production slots. If it is missing, every reorder becomes a rush order. How to safeguard delivery capability across many reorders is described in Planning cosmetic reorders.
What changes when the batch size increases?
Growing sales mean larger batch sizes, and a formulation does not automatically behave in a larger vessel the same way it does in the laboratory. With different equipment, shear forces, heating and cooling rates, and mixing times change. In emulsions, this can alter viscosity and stability; in hot-filled sticks, it can affect solidification behavior and thus breaking strength and surface appearance.
The stability guideline from Colipa (now Cosmetics Europe) and CTFA therefore considers it potentially necessary, as development progresses, to test samples from batches produced on equipment representative of subsequent production. Equipment type and configuration, process, batch size, and product type belong in the stability program. According to the guideline, accelerated storage often runs at 37, 40, or 45 °C over one, two, three, or more months, depending on the product type; in addition, it recommends real-time monitoring of production goods in the final container.
For management, this means: A larger batch size or a change in the production line is a change that requires testing, not merely a matter of quantity. Clarify with the manufacturer in advance at what batch size a pilot batch is necessary and which tests must be completed before the initial series release. The procedure is described in Scaling cosmetic production.
How do you manage changes to formulation, packaging, and regulatory requirements?
With growth, the number of changes increases: new shades and fragrance variants, different packaging for retail, a raw material from a new supplier, a changed legal situation. Every change requires a defined path from the request through evaluation to approval, and both sides must know who initiates it.
Packaging and Variants
According to the stability guideline, the test packaging should consist of the exact same material as the sales container. If there are multiple packaging types, testing each type is recommended; for multiple sizes, testing the smallest container is recommended. For color ranges, it recommends a representative selection of shades that reflects the stability extremes, and additional shades if one of these extremes is noticeable; in some cases, testing all fragrance variants is recommended because fragrances are more likely to interact with the product than color shades.
Documentation
If reported information changes, the responsible person ensures the update of the CPNP notification pursuant to Art. 13(7). New variants must be covered by a safety assessment pursuant to Art. 10 and documented in the product information file.
Regulatory Affairs
A current example is Regulation (EU) 2023/1545 on the labeling of fragrance allergens. Allergens must be listed individually if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. Products that do not meet the extended requirements could only be placed on the market until July 31, 2026, and may be made available on the market until July 31, 2028. Every batch placed on the market since then must meet the extended requirements. If the formulation contains affected fragrances above the thresholds, it requires an adapted ingredients list; this affects the manufacturer's recipe data just as much as the brand's artwork and packaging inventory.
Not every bottleneck justifies a switch, because the switch itself takes time: formulation transfer, test batches, stability testing in the final packaging, as well as updating the product information file, label, and CPNP notification. Renegotiating is worthwhile if the bottleneck can be resolved contractually, for example via forecast agreements, reserved production slots, or stockpiling packaging materials.
A switch becomes realistic when the problem is structural: repeated deviations between batches without a clarified cause, lack of GMP documentation, no access to documents for the product information file, or a manufacturer that does not technically cover the next product category, such as the hot-filling of sticks or filling mascara with a wiper. Timing is crucial: the transition should be planned in parallel with the ongoing supply, not after the first delivery failure. Formulation rights, handover of documentation, and testing at the new manufacturer are covered in Switching cosmetics manufacturers.
Labtree is a B2B cosmetics developer and cosmetics manufacturer from Hamburg with its own laboratory and production facilities in Germany. Formulation development, in-house laboratory work, sampling, manufacturability testing, and cosmetics production are all under one roof: Manufacturability is checked during development rather than during scale-up to production, and approved formulations go directly into production. Product line extensions also remain under single-source responsibility, right up to the finished cosmetic product.
White Label: market-ready, tested Labtree formulations, customized for the brand; usually deliverable within 2 to 3 months with standard packaging.
Private Label: new development according to the brand's requirements, typically 3 to 6 months to market readiness; formulation rights or exclusivity can be contractually transferred.
sampling: Samples of pre-qualified formulations are usually dispatched from the sample warehouse within 24 hours; shipping of standard samples is free of charge.
Mindestbestellmenge: usually 1,500 units per product, depending on product type, filling size, and packaging.
You can view the process and timeline on the page Have cosmetics developed.
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FAQ
Who is the responsible person in contract manufacturing?
Under Regulation (EC) No 1223/2009, the manufacturer is whoever places the product on the market under their own name or trademark—meaning, in the case of contract manufacturing, the brand owner. This entity is the responsible person pursuant to Article 4. By written mandate, they may designate a person established within the EU, such as the contract manufacturer, who accepts the mandate in writing.
Who owns the formulation if the contract manufacturer develops it?
This is governed by the contract and depends on the service model. With white label, the tested formulation remains with the manufacturer; with private label, rights and exclusivity can be transferred to the brand. How confidentiality and ownership of formulations are safeguarded is explored in depth in the magazine article "Confidentiality with the contract manufacturer: NDAs and Formulation Ownership".
What belongs in a quality assurance agreement with the contract manufacturer?
At a minimum, the allocation of responsibilities under the Cosmetics Regulation, the finished product specification, rules for batch release, retention samples and retention periods, as well as the reporting procedure for complaints and deviations. In addition, there is a change procedure that defines which changes to raw materials, processes or packaging materials must be agreed in advance.
Does a larger batch need to be retested for stability?
Not every change in quantity necessitates a new testing program, but according to the Colipa and CTFA stability guideline, equipment type, process, and batch size must be considered in the evaluation. When switching to larger equipment, a pilot batch with testing in the final packaging is recommended before series release.
What does the new allergen labelling change for existing products?
According to Regulation (EU) 2023/1545, products that do not comply with the extended labeling rules for fragrance allergens may no longer be newly placed on the market after July 31, 2026. Goods already placed on the market may continue to be made available on the market until July 31, 2028. Therefore, if a formulation contains affected fragrances above the thresholds, the list of ingredients, label, and packaging material inventory must be adapted for subsequent production runs.
How often should a brand audit its contract manufacturer?
The Cosmetics Regulation does not prescribe a frequency. We recommend conducting an audit before initial production, followed by a risk-based schedule determined by complaints, deviations, and changes to the facility or site. Manufacturing in accordance with ISO 22716 merely establishes a presumption of good manufacturing practice and is no substitute for reviewing the specific batch documentation.
When is it worth changing the contract manufacturer?
If bottlenecks are structural—such as repeated batch deviations without a clarified cause, missing GMP documentation, or a product category that the manufacturer cannot technically cover. If the problem can be resolved through forecasting, slots, or packaging stockpiling, renegotiating is usually faster. The process is described in the magazine article "Changing cosmetics manufacturers: How a structured transition works".
