Written by the Oppenheimer Lab team — Reviewed by Mohamed Arbi Jallali, Partner, Head of Production and Formulator
Published on
8 min read
Yes, a parapharmacy, like any retailer of health, beauty and wellness products, can launch its own private label range without a pharmacist’s degree: it chooses an existing formula, made by a laboratory, and sells it under its own name. In France, opening a parapharmacy does not require a pharmacist’s degree, according to Orange Pro and Les Echos Publishing. It then becomes the Responsible Person if it has the product made and places it on the EU market under its name alone, with the obligations that follow; this person must be established in the EU.
This article details the launch steps, the timeline, the indicative budget and the Tunisia/EU export context. It also explains who bears which obligations, from ready-to-launch formulas to the shelf. It is informative: consult the official texts for your case.
What is private label for a health and wellness retailer?
Private label is a model in which a retailer of health, beauty and wellness products sells under its own name an existing formula made by a laboratory. It chooses the formula, the packaging and the name of its range, without developing a formula. This model differs from custom private label, which relies on a formula of its own, and from custom formulation.
Three approaches coexist, and the choice depends on your budget, your timeline and the degree of exclusivity you want:
- Private label: you start from an existing formula. Ready-to-launch private label formulas at Oppenheimer Lab draw on a catalogue of more than 500 formulas, with lead times of 45 to 90 days.
- Custom private label: the formula is your own, with lead times of three to six months. The term “MDD” (retailer’s own brand) in practice refers to this same principle, applied to the retail chain that sells the range.
- Custom formulation: the formula is entirely developed for your project, with lead times of six to twelve months.
For a first launch, private label therefore limits development time. Custom private label and custom formulation suit a range that needs to stand out through its composition.
Who becomes the Responsible Person when a retailer has its range made?
In the European Union, whoever has a cosmetic made in order to place it on the market is automatically the Responsible Person. A retailer that puts its name alone on the label therefore bears these obligations. For an imported product, the Responsible Person is the importer or a representative appointed in writing.
The Responsible Person is the party established in the EU that guarantees the compliance of a cosmetic and answers to the authorities. Regulation (EC) No 1223/2009 provides for it in Article 4.
Manufacturer, importer or distributor: who is who?
According to the FPS Public Health (Belgium), whoever produces a cosmetic, imports it or has it made in order to place it on the European Union market is automatically the Responsible Person.
The distributor, for its part, sells products that it has neither produced nor imported. It must check the label and report serious undesirable effects, but it is not responsible for the composition or safety of the product.
The pitfall concerns private label: the same body specifies that distributor status disappears in one specific case.
if you are the only one to put your name on the label, or if you sell the products in smaller packs, you are automatically considered the Responsible Person, with the same obligations as manufacturers and importers. (FPS Public Health, Belgium)
A retailer that launches its range under its name alone must therefore prepare for the obligations of a Responsible Person, the Belgian page cited applying common European law (Article 4 of Regulation (EC) No 1223/2009). This notably involves keeping the product’s technical file and making it available to the authorities.
The case of a product made in Tunisia
According to Cosreglo, for an imported product, the Responsible Person is the importer or a representative appointed in writing.
Our advice: manufacturing in Tunisia does not exempt you from the requirements of the destination market. For the European Union, you need a Responsible Person established in the EU. We recommend defining your sales countries in the brief, so that the corresponding supporting documents and packaging can be prepared.
What regulatory obligations apply before selling your private label?
Before any marketing in the European Union, four elements are needed: a Responsible Person established in the EU, a Product Information File with safety report, a notification on the CPNP portal and compliant labelling. The reference text is Regulation (EC) No 1223/2009. This article is informative; consult the official texts.
The PIF (Product Information File) is the technical file that the Responsible Person keeps available for the authorities. The table below places each obligation within Regulation (EC) No 1223/2009, whose text is available on EUR-Lex.
| Obligation | Article | Subject |
|---|---|---|
| Appoint a Responsible Person | Article 4 | Responsible Person |
| Have safety assessed | Article 10 | Safety assessment |
| Compile the file | Article 11 | Product Information File (PIF) |
| Notify the product | Article 13 | Notification (CPNP) |
| Label correctly | Article 19 | Labelling |
| Substantiate claims | Article 20 | Claims regarding the product |
According to Cosreglo, the Product Information File is kept for 10 years after the last batch is placed on the market. The same publisher indicates that, in France, the DGCCRF can require this file at any time.
On the label side, the FPS Public Health (Belgium) notably requires the name and address of the Responsible Person in the European Union, as well as the manufacturing batch number. The ingredient list must use INCI names, the international nomenclature of cosmetic ingredients.
CPNP notification is neither an authorisation nor a quality certification: it registers the product before it is marketed. A retailer launching its range also makes sure its products comply with European standards, as Orange Pro and Les Echos Publishing point out.
Oppenheimer Lab prepares PIFs and CPNP notifications, and ensures manufacturing carried out according to GMP (ISO 22716). Ask any laboratory to provide you with these documents before ordering.
What are the steps to launch your range, from brief to shelf?
A private label launch follows five steps: the brief (target, benefit, price, quantity, budget), the choice of formula, the testing of the formula-container pairing, the validations with the regulatory file, then manufacturing. For private label, lead times range from 45 to 90 days.
Define the target, price and a short range
The brief is the document that sets the project’s constraints before any development. Our advice: set five elements before developing, namely the target, the desired benefit, the selling price, the quantity and the overall budget, marketing included. A brief that keeps changing widens the gaps between ambition, budget and timeline.
The most common mistake is wanting to launch a range of ten products without having defined the customer base, the price and the distribution channel. We recommend starting with one or two well-positioned products, keeping budget to market them, then expanding the range based on customer feedback.
Choose the formula, the packaging and validate samples
- Formula: choose an existing formula from the catalogue, suited to your target and your price.
- Packaging: test the formula-container pairing before placing the order.
- Samples: validate them, then finalise the regulatory file.
- Manufacturing: launch the batch once the validations are obtained.
Our advice: never order your bottles before checking their compatibility with the formula. A container must protect the product, dispense its texture properly and withstand transport. An airless bottle may suit certain formulas, but it is not automatically the best choice. For filling and packaging, test before ordering.
A realistic timeline
Take a typical example: a Tunisian entrepreneur launches her first skincare brand sold online. She starts with a single product, a 50 ml moisturising face cream with a light texture and an accessible positioning, based on an existing, already validated formula. For 1,000 units, a timeline of about 12 weeks is realistic, if the packaging is available, if validations are quick and if the checks are satisfactory.
A fully custom formulation would require a different schedule. Requests also follow the seasons: sun care in summer, moisturising care and solutions for oily skin in winter. We advise anticipating these peaks by several months in the development and manufacturing schedule.
What budget and minimum order should you plan for?
At Oppenheimer Lab, small batches are possible: from 200 units, or even 100 depending on the project, subject to assessment. The price depends on the product, the actives and the packaging. The free quote arrives within 48 hours and specifies what is included: packaging, label and filling and packaging.
The minimum order quantity (MOQ) is the lowest quantity a laboratory agrees to produce for a product. This quantity directly affects your starting cash flow, because it determines the stock to finance before the first sales.
The starting price varies mainly according to the actives used in the formula. A simple cream and a formula enriched with actives therefore do not cost the same, even with identical packaging. Always compare quotes drawn up on the same scope: same quantities, same containers, same included items.
The quote also mentions any fees, which are added to the unit price:
- specific development, if you request an adaptation of the formula;
- additional tests;
- the carton, if your product has one;
- transport;
- export formalities, if you sell outside Tunisia.
It is useful to include in your overall budget the marketing of the range, and not just manufacturing. A first batch, even reduced to 100 or 200 units depending on the project, sells more comfortably when part of the budget remains available for promotion and distribution.
As for response times, Oppenheimer Lab replies to quote requests within 48 working hours, and delivery within Tunisia takes 48 hours. To obtain a costing adapted to your project, you can request a quote specifying the target formula, the packaging and your sales countries.
Can you launch your private label in Tunisia and sell in Europe?
Yes, a brand can be manufactured in Tunisia, but selling in the European Union requires a Responsible Person established in the EU, a Product Information File and a notification on the CPNP portal. Define your sales countries in the brief, because they determine the supporting documents and packaging to prepare.
Our advice: manufacturing in Tunisia does not exempt you from the requirements of the destination market. CPNP notification is neither an authorisation nor a quality certification. The CPNP is the European portal for the notification of cosmetic products, to be completed before any marketing.
Take a typical example: a young French brand wants to launch a short range of skincare. Its criteria for producing in Tunisia are direct exchange in French with the technical team, geographical proximity and an offer suited to its starting volumes. Its decision then rests on concrete elements: the quality of the samples, the documentation available, the delivered cost and the reliability of the schedule.
Oppenheimer Lab, based in Tunisia, exports to more than 30 countries. Checks remain possible after the product is on the market: according to Cosreglo, in France, the DGCCRF can require the Product Information File at any time.
This article is informative: consult Regulation (EC) No 1223/2009 on EUR-Lex and, if needed, a regulatory professional for your market.
Sources
- Cosm\u00e9tiques : mise sur le march\u00e9, importation ou distribution (in French), SPF Sant\u00e9 publique (Belgium), February 2026
- Comment ouvrir une parapharmacie : dipl\u00f4me, budget, \u00e9tapes ? (in French), Orange Pro et Les Echos Publishing, undated
- R\u00e8glement cosm\u00e9tique (CE) n\u00b0 1223/2009 : le guide complet 2026 (in French), Cosreglo, August 2026
Frequently asked questions
What is private label for a health and wellness retailer?
Private label is a model where a retailer sells under its own name an existing formula made by a laboratory. It chooses the formula, the packaging and the name of the range, without developing a formula. At Oppenheimer Lab, more than 500 formulas are available, with lead times of 45 to 90 days.
What is the difference between private label and custom private label?
Private label relies on an existing formula, custom private label on a formula that is your own. Lead times also differ: 45 to 90 days for private label, 3 to 6 months for custom private label. The term MDD (retailer’s own brand) refers to the same principle applied to the retail chain that distributes the range.
Who is the Responsible Person when you have a cosmetic made?
In the European Union, it is the party that produces, imports or has the cosmetic made in order to place it on the market. A retailer that is the only one to put its name on the label is therefore considered the Responsible Person. For an imported product, it is the importer or a representative appointed in writing.
Does the product have to be notified on the CPNP portal?
Yes, notification on the CPNP portal is required before any marketing in the European Union. It is neither an authorisation nor a quality certification: it registers the product. Oppenheimer Lab prepares PIFs and CPNP notifications; always confirm your obligations against the official texts.
What is the minimum order for private label cosmetics?
At Oppenheimer Lab, small batches are possible: from 200 units, or even 100 depending on the project, subject to assessment. The price depends on the product, the actives and the packaging: free quote, reply within 48 hours. This minimum varies between laboratories: ask for it in writing, with what the quote includes (packaging, label, filling and packaging).

