The topic is short and compact
The safety report in accordance with Art. 10 of Regulation (EC) No 1223/2009 assesses the final composition; a formulation change after the start of testing therefore often results in a new round of testing.
Stability should be tested in the final sales packaging made from identical material; changing the packaging material after testing is completed therefore significantly impacts the schedule.
Color ranges and fragrance variations expand the test plan; shade architecture and perfume oils must be determined before testing begins, including allergen data pursuant to Regulation (EU) 2023/1545.
The CPNP notification itself has no waiting period; lead time is required for the safety report, labeling, and, in the case of nanomaterials, the six-month deadline.
According to Regulation (EU) No. 655/2013, advertising claims determine the scope of evidence required and must be defined prior to study planning, not just at the artwork stage.
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Where do delays occur during a cosmetics launch?
Most delays do not occur during filling, but before testing: decisions made too late postpone steps that cannot themselves be accelerated. A cosmetic launch follows a critical path, i.e., a chain of interdependent steps, and key links in this chain are stipulated by EU law.
Pursuant to Art. 10 of Regulation (EC) No 1223/2009, the responsible person must ensure prior to placing on the market that the product has undergone a safety assessment and that a safety report in accordance with Annex I is available; this takes into account the exposure through the ingredients in the final composition. The safety report is based, among other things, on stability, microbiological quality, and the characteristics of the packaging material. This results in the following sequence:
Formulation and primary packaging are final: Only then do stability and skin compatibility tests provide data that apply to the product being sold.
The test results are available: Only then can the safety report and Product Information File pursuant to Art. 11 be finalized.
Shelf life is evaluated: Only then is it determined whether a best-before date or a period after opening belongs on the label.
The label and packaging are printed: Pursuant to Art. 13(2), notification upon placing on the market also includes the original labeling and a photograph of the packaging.
If any of these specifications lies on the critical path, every week of delay generally postpones the final launch by at least that week. Typical triggers include a briefing without a target price and efficacy claims, an unresolved packaging issue, an increasing number of variants, and advertising claims that are only developed during artwork design. How these factors determine the overall timeline is examined in the article Realistic timelines in cosmetics development.
Why does a late packaging decision cost so much time?
Because formulation and packaging material are tested as a system. The Cosmetics Europe stability testing guidelines recommend testing in packaging materials that consist of exactly the same materials and are as similar as possible to the sales container. If a product is offered in several types of packaging, each type of packaging should be tested; if there are several sizes, preferably the smallest container.
What this involves is described by the Commission in its Guidelines on Annex I to the Cosmetics Regulation (Implementing Decision 2013/674/EU): interactions between the product and packaging material, the barrier properties of the material, and the migration of substances from or into the packaging material. Physical stability tests are therefore run with inert containers and with the containers intended to be used for marketing. For materials from the food sector, data on stability and migration are often already available; for new or novel packaging, additional assessments may be necessary.
This results in an asymmetry for the schedule: if the packaging material changes after the tests are completed, for example from a glass jar to a plastic airless dispenser or to a tube containing recycled material, the existing results do not cover the new container. A change shortly before the end of testing then costs not just the days needed for the changeover, but an entire new round of testing.
What helps in practice
Definitively specify primary packaging before starting stability testing, including material, pump, wiper, or applicator.
Use test samples in the supplier's production series material, not prototypes made of different material.
If there are two realistic candidates, store both in parallel: this increases testing effort, but saves a second round of testing.
Clarify delivery times and minimum order quantities with packaging suppliers before design, because custom colors, decorations, or proprietary tooling have their own lead times.
Which exams cannot be shortened?
Stability testing cannot be condensed arbitrarily, only started earlier. According to Cosmetics Europe, accelerated tests are frequently conducted at 37, 40, or 45 °C over one, two, three, or more months; temperature and duration depend on the product type. From these data and experience with similar products, the shelf life under market conditions is derived, supplemented by the observation of retain samples after launch.
The result directly impacts packaging design. According to Commission guidelines, stability data serve to determine the minimum durability and the period of use after opening. Art. 19(1)(c) of the Cosmetics Regulation requires a date of minimum durability; if the minimum durability exceeds 30 months, it is not mandatory, and instead an indication of how long the product can be used after opening is provided. As long as it remains undecided which indication applies, the artwork is not ready for print.
Further steps with their own timelines
Preservation challenge test: The Commission guidelines mention the results of a study on preservation efficacy, such as a challenge test, as part of the stability information. It can run in parallel with stability storage, but requires the final preservation system. For products with low microbiological risk, such as those with more than 20% alcohol, it can be omitted with scientific justification.
Scale-up: Cosmetics Europe recommends testing samples from batches produced on pilot-scale or production-like equipment during development, because equipment type, process, and batch size influence stability. Anyone who tests manufacturability only after laboratory release risks a second round of testing.
Skin compatibility and efficacy studies: Their scope arises from the marketing claims and can only be planned once these claims are established.
The specific scope of testing is described in the article Stability and safety testing for cosmetics.
How do color ranges and scent variants affect the schedule?
Each variant can expand the testing plan. Cosmetics Europe recommends testing a representative selection of color shades and fragrance variants that reflect the stability extremes of the product, and including further shades if these extremes show conspicuous results. According to the same guideline, fragrances are more likely to react with the product than color shades, which is why it may make sense to test all fragrance variants.
For a makeup line with a foundation, concealer, or blush range, this means: The shade architecture must be defined before testing begins. Light and dark shades usually differ significantly in their proportion of titanium dioxide and iron oxides, which can affect viscosity and settling behavior. If shades outside the tested extremes are added after testing begins, additional data is required. How a range can be structured systematically is shown in the article Shade Development for Makeup.
Fragrance allergens after July 31, 2026
For fragranced products, labeling is an additional factor. Regulation (EU) 2023/1545 expands the list of allergenic fragrances that must be listed individually in the ingredients list as soon as they exceed 0.001% in leave-on products and 0.01% in rinse-off products. Products that do not meet these requirements could only be placed on the market for the first time until July 31, 2026, and may still be made available on the market until July 31, 2028.
Therefore, for every launch: The perfume oil supplier's allergen information must be available before the INCI list and artwork are approved. Changing the perfume oil after approval changes the list of ingredients and thus usually also the print.
When do advertising claims need to be finalized?
Before test planning, not just at the artwork stage. According to Art. 2 of Regulation (EU) No 655/2013, the responsible person shall ensure that claims comply with the common criteria and are consistent with the documentation proving the effect in the product information file. The criterion of evidential support requires adequate and verifiable evidence; studies must be relevant to the product and the claimed benefit and be based on valid, reliable, and reproducible methods.
Each claim therefore defines part of the testing scope. A moisturization claim over a specific period is usually substantiated with an instrumental application study on the finished product, while a claim regarding skin compatibility on sensitive skin requires dermatological testing on an appropriate subject panel. Raw material supplier data is not automatically sufficient: Anyone transferring properties of an ingredient to the end product requires their own evidence in accordance with the Annex to the Regulation, such as on the effective concentration in the product.
Define claims together with the briefing and identify the required evidence for each claim.
Plan studies on samples that correspond to the final formulation in the final packaging.
Eliminate claims lacking realistic substantiation early on, rather than removing them shortly before printing.
Which wordings are permissible is discussed in the article Cosmetic Advertising Claims in the EU.
Which regulatory deadlines belong in the schedule?
There is no regulatory approval with a waiting period for cosmetic products in the EU. Prior to placing the product on the market, the responsible person notifies the product electronically in accordance with Art. 13 of the Cosmetics Regulation, including the category, name, address for the product information file, and frame formulation. The Commission describes the Cosmetic Products Notification Portal (CPNP) as a free online notification system. The time required therefore lies not in the notification itself, but in the documentation preceding it: the safety report, product information file, and final label.
Nevertheless, three points prolong the lead time:
Nanomaterials: Art. 16(3) additionally requires a notification six months prior to placing on the market for products containing nanomaterials. Exceptions include nanomaterials regulated as colorants, UV filters, or preservatives under Art. 14, and those complying with the requirements of Annex III. Determining whether a raw material falls under this belongs in the raw material review at the start of the project, not in the final weeks.
Responsible Person: Who maintains the product information file and submits the notification must be clarified before the launch. In contract manufacturing, this is generally the brand, which can delegate this role under Art. 4 by written mandate.
Regulatory changes during development: The annexes to the Regulation are updated regularly. For instance, Regulation (EU) 2025/877, applicable from September 1, 2025, added further substances classified as CMR to the list of prohibited substances, including Trimethylbenzoyl Diphenylphosphine Oxide, which was previously permitted under Annex III for professional use in artificial nail systems. Checking raw materials against foreseeable changes avoids a reformulation with a new testing cycle.
A resilient schedule identifies the critical path, names decision points with dates and responsibilities, and specifies what a delayed decision costs in weeks. A mere list of phases cannot achieve this. Multiple workstreams can run in parallel once their prerequisite conditions are known:
Workstream | Can start once | Blocks as long as pending |
|---|---|---|
Packaging selection and procurement | Product category, fill volume, and target price are defined | Stability and skin compatibility testing |
Raw material testing (Annexes II to VI, nanomaterials, fragrance allergens) | the formulation direction is defined | Safety report and notification |
Marketing claims and study planning | Briefing and target audience are defined | Efficacy proof and artwork |
Artwork and printing | Packaging, INCI list, and shelf life specification are defined | Assembly and notification |
Production planning | manufacturability has been tested on a pilot batch | Filling and batch release |
Some risks remain outside of any planning: bottlenecks for individual raw materials, extended lead times for specific containers, or changed requirements on the brand side. A buffer should therefore be placed behind steps with third-party delivery times, not blanketly at the end of the project. When choosing a manufacturer, it pays to ask precisely about this: Does the schedule show the critical path, when is manufacturability tested, and what happens to timeline and costs if a test fails? A schedule that confirms every requested timeline is a declaration of intent, not a plan.
What Labtree covers in this process
Labtree is a B2B cosmetics developer and cosmetics manufacturer from Hamburg with its own laboratory and production capacities in Germany. Formulation development, in-house laboratory work, sampling, manufacturability testing, and cosmetics production are under a single responsibility, and manufacturability is tested already during development, not only upon transfer to production scale. The starting point is over 1,000 proprietary formulations; samples of pre-qualified formulations are typically dispatched within 24 hours from the sample warehouse, and standard sample shipping is free of charge. The process follows the steps of conceptualization, sampling, customization, prototyping, and production.
The minimum order quantity is generally 1,500 units per product, depending on product type, fill size, and packaging. How this works in a project is shown in the overview Having cosmetics developed.
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FAQ
How long does it take to develop a cosmetic product until its launch?
This primarily depends on whether a tested formulation is being adapted or a new one is being developed, as well as how early packaging, variants, and claims are finalized. At Labtree, white-label products with standard packaging are generally ready for delivery in 2 to 3 months, while a new private-label development typically takes 3 to 6 months. The individual timeline stages are explained in our magazine article "Cosmetic Development: Realistic Timelines and the Factors That Determine Them".
Does a cosmetic product require official approval in the EU?
No. Cosmetic products are notified via the CPNP before being placed on the market; there is no approval process with a waiting period. However, before doing so, the responsible person must ensure that a safety assessment has been carried out and a safety report has been drawn up. For products containing certain nanomaterials, an additional notification must be submitted six months prior to placing them on the market.
What applies to the labeling of fragrance allergens from August 2026?
After July 31, 2026, only products that comply with the extended allergen labeling requirements under Regulation (EU) 2023/1545 may be newly placed on the market. Products that have already been placed on the market with the old labeling may still remain available on the market until July 31, 2028. For new launches and relaunches, the fragrance oil allergen data must therefore be available prior to artwork approval.
Does the stability test need to be repeated for new packaging materials?
Generally yes, if the material or design of the packaging that comes into contact with the product changes, as stability testing must be carried out in the commercial packaging made of the exact same materials. If only an additional size made of the same material is added, Cosmetics Europe recommends testing the smallest container as a priority. The safety assessor determines whether existing data is sufficient.
Can production begin before all checks are completed?
Preparations such as ordering packaging materials, procuring raw materials, and tentatively reserving production capacity can run in parallel. However, the product may only be placed on the market once the safety report for the final formulation is available. Committing to large-scale production prior to this point carries the risk that a failed test could require reformulation.
Who owns the formulation, and does that change the schedule?
With white label, the brand adopts a ready-made, tested formulation from the manufacturer and customizes it; the formulation remains with the manufacturer. With private label, the formulation is newly developed according to the brand's requirements, with rights and exclusivity agreed upon contractually. White label is usually faster because it builds on existing formulation data, whereas private label offers exclusivity.
What happens if an ingredient is banned during development?
Then the formulation must be adapted, and the stability and safety data must apply to the new composition. An example is Regulation (EU) 2025/877, under which additional CMR substances have been prohibited since September 1, 2025. Checking raw materials against foreseeable classifications at the start of a project reduces this risk.
