The topic is short and compact
Subsequent batches are only reproducible if the formulation, raw material specifications, packaging materials, and manufacturing instructions are frozen prior to the initial batch.
Batch documentation includes raw material batches, phase temperatures, homogenization, cooling profile, pH and viscosity under specified measurement conditions, as well as the packaging material batch.
The product information file must be kept for ten years after the last batch is placed on the market; each subsequent production extends this period.
New ingredient rules, such as Regulation (EU) 2026/909, apply after transitional periods that should be scheduled as the deadline for the last unchanged batch.
A change of raw material, fragrance supplier, or packaging is a modification that requires a stability comparison and a review of the safety report, not merely a purchasing decision.
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What makes cosmetic reorders predictable?
A repeat production is only as reproducible as the documentation of the initial batch. The Federal Office of Consumer Protection and Food Safety (BVL) describes the objective of good manufacturing practice in precisely this way: to manufacture cosmetic products reproducibly in the desired quality. According to the BVL, this includes exact manufacturing instructions, described testing of raw materials and finished products, and documentation of the manufacturing process that ensures traceability.
From a legal perspective, Regulation (EC) No. 1223/2009 requires manufacturing in accordance with good manufacturing practice in Article 8(1). If manufacturing is carried out according to the harmonized standard ISO 22716, compliance is presumed under Article 8(2); the standard is a guideline, not proof in its own right.
What should be frozen prior to the initial batch
formulation with version number, quantities used in percent and kg per batch size
Raw material specifications per ingredient: trade name, supplier, inspection criteria upon goods receipt
Packaging material specification: material, supplier, tooling or article number, artwork/decoration
Manufacturing instructions with process steps and tolerances
Release specification for bulk and finished product with reference sample
If any of these points changes later, it is no longer a repeat production, but a change that must be evaluated.
Which batch parameters should you document?
Batch documentation records what actually happened in a specific batch, not just what the manufacturing instructions specify. For emulsions, serums, and poured makeup formats, these values are critical:
Parameter | Why it matters for the subsequent batch |
|---|---|
Raw material batches and weighed quantities | Traceability in the event of deviations; proof of which delivery was processed |
Addition sequence and phase temperatures | Emulsification behavior and droplet size depend on when which phase comes together at what temperature |
Homogenization speed, mixing time, vacuum | Control viscosity, air entrapment, and texture |
Cooling profile, pouring temperature for hot-pour formats | Determines crystallization of waxes, breaking strength, and surface appearance of sticks |
pH, viscosity with measurement temperature and spindle | Values are only comparable between batches under identical measurement conditions |
Color measurement against standard | The basis for batch consistency in complexion products and shade ranges |
Hold time of the bulk product, filling temperature, filling volume | Long hold times before filling can alter viscosity and microbiology |
Packaging material batch and label version | Links finished product, labeling, and packaging material delivery |
Keeping identification and labeling repeatable
According to Art. 19(1)(e), every batch requires a batch number or a reference enabling identification. For a date of minimum durability of up to 30 months, letter (c) also requires the date of minimum durability, which changes with each batch. To ensure labeling remains repeatable, it is recommended to define the label version, coding format, and print position in the manufacturing instructions rather than re-coordinating them for each batch.
According to Art. 11(1), the product information file must be kept for ten years after the last batch was placed on the market and, pursuant to Art. 11(2)(c), must contain a description of the method of manufacturing. Every repeat production extends this period.
Why does a subsequent batch deviate despite having the same formulation?
The most common cause is raw materials that are formally the same, but technically not identical. Natural substances are particularly susceptible: A review in iScience on plant-derived ingredients in cosmetics describes variations in composition due to environmental and cultivation conditions, as well as sometimes low stability in color and activity. Standardizing to a marker substance can keep the content of an active ingredient constant, but does not eliminate every variation in odor, color, or viscosity contribution.
Overview of Typical Causes
Vegetable oils and butters: differing fatty acid profile alters melting behavior and skin feel
Pigments: a new batch of an iron oxide can shift the shade of a foundation range; correction via pigment proportions must be documented
Thickeners and polymers: delivery batches with different viscosity yields can shift the final viscosity
Fragrances: reformulations by the perfume manufacturer can alter the scent and allergen profile
Batch size and equipment: a different vessel with different shear performance can produce a different texture, even if the formulation is identical
Therefore, the release of a subsequent batch should not only be based on numerical values, but additionally against a reference sample of the initial batch stored under defined conditions.
How do you secure the supply of raw materials?
Ability to deliver primarily depends on raw materials with a single source of supply. During formulation development, check for each component whether there is a second supplier or a technically equivalent substitute, and qualify them before the primary supplier fails.
What raw material substitution requires
Comparison of specifications and impurities of the substitute
Laboratory batch and stability comparison against the existing formulation
Verification of whether the safety report and product information file need to be adapted
Check whether the INCI list and therefore the labeling changes
The safety report according to Annex I of the Cosmetics Regulation covers the purity of substances and mixtures (Part A No. 4) and, for fragrance and aromatic substances, the name, code number, and information on the supplier's identity (Part A No. 1). A change of perfume supplier is therefore never just a purchasing decision.
For critical active ingredients and packaging materials with long delivery times, a defined safety stock is worthwhile. Its level is determined by replenishment time, consumption per batch, and shelf life of the raw material, not by a rule of thumb.
What stability data is required for a follow-up production?
According to Annex I Part A No. 2 of the Regulation, the stability of the cosmetic product under reasonably foreseeable storage conditions belongs in the safety report. For subsequent production, this means: the data must match the formulation actually produced in the packaging actually used.
Short-term stress tests reveal weaknesses early on. In a stability study on a cosmetic multiple emulsion, samples were stored for 30 days at 8 °C, 25 °C, 40 °C, and 40 °C with 75% relative humidity and tested for pH, conductivity, phase separation, and viscosity; at 40 °C and 75% humidity, the viscosity dropped from 26.86 to 11.66 cP. Such values indicate where a formulation is sensitive. However, they do not replace long-term data over the claimed shelf life.
What has proven successful for subsequent batches
Continue real-time storage of the initial batch beyond the planned shelf life, do not stop after launch
Retain reference samples of each batch in the sales packaging
Start a new comparison against the baseline formulation if raw materials or packaging materials change
For a minimum shelf life of more than 30 months, reconcile the period of use after opening (Art. 19(1)(c)) with the data
The article on stability and safety testing describes which tests must be completed prior to the initial launch.
What applies if packaging or ingredient regulations change?
In practice, two changes most frequently force a revision: a delisted packaging material and a new rule for an ingredient.
Packaging materials
The safety report must contain the relevant characteristics of the packaging material, in particular purity and stability (Annex I Part A point 4). A new jar, a different airless dispenser, or a tube made of a different material therefore requires a new skin compatibility test with the formulation. Added to this are filling technology and format parts: a different neck diameter or a different pump can mean retooling the filling line.
Regulatory changes
The annexes to the Regulation are continuously updated. With Regulation (EU) 2026/909, the European Commission prohibited triphenyl phosphate in cosmetic products in May 2026, among other things, and established maximum concentrations for benzyl salicylate; the rules apply after a transitional period. For ongoing follow-up production, this means: regularly check formulations against new amending regulations and schedule the transitional period as the deadline for the last unchanged batch.
If an adaptation changes any of the notified information, such as the frame formulation, the responsible person must promptly update the CPNP notification pursuant to Article 13(7). The relationship between the CPNP notification, product information file, and safety report is explained in the article EU Cosmetics Regulation in practice.
Reordering without supply gaps requires that the brand and manufacturer share the same numbers. The brand provides a rolling sales forecast, announced retail promotions, and seasonal peaks; the manufacturer knows replenishment times for raw materials and packaging materials, available production slots, and the duration of release testing.
What determines the lead time
Lead time of the raw material or packaging material with the longest replenishment time
Available capacity for manufacturing and filling
Release testing of the bulk and finished product, including microbiological testing
Printing of new labels or folding boxes if information has changed
Define a minimum stock level at which reordering is triggered, and calculate it backward from the longest lead time and sales rate. Response times and reserved capacities belong in the supply agreement.
How Labtree prepares repeat production
Labtree is a B2B cosmetics developer and cosmetics manufacturer with its own laboratory and production facilities in Germany. formulation development, in-house laboratory work, sampling, manufacturability testing, and cosmetics production are under one roof, ensuring that manufacturability is evaluated during development rather than when scaling up to production. Production includes manufacturing, filling, packaging, and repeat production; the minimum order quantity is generally 1,500 units per product, depending on the product type, filling size, and packaging.
How minimum quantities are calculated is explained in MOQ in cosmetics; the transition from laboratory batch to series production is described in Scaling cosmetics production.
More useful links
FAQ
How long must the documentation of a batch be retained?
According to Article 11(1) of Regulation (EC) No 1223/2009, the product information file is kept for ten years after the last batch is placed on the market. Since it describes the manufacturing method, it is recommended to keep the associated batch documentation available for at least the same period.
Does the CPNP notification need to be updated when changing raw material suppliers?
Only if notified information changes, such as the frame formulation or details regarding nanomaterials; in that case, Art. 13 (7) applies. Regardless of this, it should be checked whether the cosmetic product safety report and the product information file need to be updated, for example, due to different impurities.
Does every reproduction require new stability tests?
Not if formulation, raw materials, packaging materials, and manufacturing processes remain unchanged and ongoing long-term data support the stated shelf life. If raw materials or packaging materials are changed, a new comparison against the original formulation is recommended.
Who owns the formulation and manufacturing instructions if I want to change manufacturers?
That depends on the service model. With white label, the formulation remains with the manufacturer; with private label, the formulation is newly developed for the brand, and rights as well as exclusivity are contractually agreed upon. The magazine article "Changing Cosmetics Manufacturers: How a Structured Transition Works" describes how a switch is carried out in a structured manner.
Can a reorder be smaller than the initial batch?
This depends on the minimum economically viable batch size, the minimum order quantities of the packaging materials, and the filling effort. At Labtree, the minimum order quantity is typically 1,500 units per product, depending on the product type, fill size, and packaging. The cost drivers are detailed in the magazine article “MOQ in Cosmetics Explained: What Really Determines Minimum Order Quantities”.
What does Regulation (EU) 2026/909 mean for current products?
Among other things, it bans triphenyl phosphate in cosmetic products and limits the concentration of benzyl salicylate; other substances are subject to revised conditions of use. The rules apply after a transition period during which affected formulations should be adapted and reassessed.
What happens if a subsequent batch does not meet the specification?
The batch is not released and is not filled or delivered. Based on the batch documentation, it is checked whether a raw material batch, a process deviation, or a measurement error is the cause; only then is a decision made as to whether rework is permitted or the batch is discarded.
