Cosmetic products regulation in Tunisia: the essentials, with evidence

In Tunisia, the regulation applying to a cosmetic product has to be checked case by case with the authorities, in particular to know which INNORPI standards concern your product. Taxation is better documented: since 2018, certain cosmetic products, including perfumes, skincare and make-up, have borne a 25% consumption duty, on top of 19% VAT, according to La Presse. To sell in the European Union, Regulation (EC) No 1223/2009 applies in full, whatever the country of manufacture.

This informative article separates what can be verified from unsourced claims (“mandatory authorisation”, a “strict” framework): regulatory findings, key players, taxation, steps to confirm, ISO 22716, export to the EU, labelling and a checklist. It refers to the official texts. To go further, see the guides in the Regulation and quality category.

Is there a specific cosmetics regulation in Tunisia?

According to the CONECT’s cosmetics manufacturers’ group, cited by La Presse in December 2025, no regulatory framework organises the sector. For local manufacturing, the standards recommended by INNORPI serve as technical benchmarks. Imported cosmetics subject to technical import control fall under the ANMPS, which issues a consumption authorisation (AMC). The group is calling for a body of legislation inspired by European and American standards.

What the industry reports

The CONECT is a confederation within which cosmetics manufacturers have grouped together to call for a legal framework. The sector carries real weight in the national economy, with more than 10 thousand jobs and 600 companies according to La Presse. A recommended standard is a technical reference whose application is not imposed by law.

For manufacturers, this lack of rules weighs on the market. They consider that this legal vacuum has encouraged unfair competition, made worse by the rise of the informal sector.

“Cosmetics manufacturing is not a luxury industry. Besides perfumery products, it includes everyday personal hygiene products, such as toothpastes, soap, shampoos…” Aslan Berjeb, president of the CONECT (La Presse de Tunisie).

Why online guides claim the opposite

Several online guides describe a “strict” Tunisian framework, with a mandatory authorisation, without citing any text. These claims are not supported by the public sources consulted for this article. They do not prove, however, that no administrative requirement exists.

The absence of a specific framework remains the position reported by the industry, not a definitive legal analysis. Before any launch, ask the competent authority, for example the Ministry of Health or the Ministry of Trade, which requirements apply to your product. To follow developments on these topics, see our Regulation and quality articles.

Which public and professional players should you know?

Several players are involved around cosmetics in Tunisia. INNORPI publishes the recommended standards and the CONECT represents manufacturers. The Ministries of Health and Trade handle health and commercial matters. The ANMPS controls imported products. Public sources remain thinly detailed: confirm directly with these players their exact role in your project.

A professional group is an association of companies from the same sector that carries their collective requests to the public authorities. The other players below are administrations and public bodies. This list shows whom to ask, without describing a procedure.

• INNORPI: reference point for recommended technical standards. Ask it which standards concern your product category.
• CONECT: it hosts the cosmetics manufacturers’ group, according to La Presse.
• Ministry of Health, ANMPS and DPM: contacts on the health status of your product and on any documents requested.
• Ministry of Trade: to be asked about putting products on sale and about importing finished products.
• Ministry of Industry and APII: reference points for a project to set up or invest in industry.
• CEPEX: body to approach for your export promotion steps.

Technical import control (CTI) is the framework in which the ANMPS controls certain imported products, including cosmetics. It is described in its procedure P-OP2-001-FR of 5 June 2025. Among its references, this procedure cites Law No 94-41 of 7 March 1994 on foreign trade. It also cites Decree No 94-1744 of 29 August 1994.

The AMC is the consumption authorisation issued by the ANMPS. According to the procedure, cosmetic products are usually subject to an annual analysis, then a technical opinion. Those that obtained an AMC after analysis during the previous two years can obtain, under conditions, an “administrative” AMC.

The ANMPS guide T-OP2-004-FR (June 2025) details the technical file required. It notably requires the qualitative and quantitative composition of the product. It also asks for a GMP compliance certificate, which may be an ISO 22716 certificate, as well as the analysis report of the finished product. The labelling or leaflet must be written in Arabic, French or both languages.

These two documents form part of technical import control, and the guide applies to cosmetic products controlled by the ANMPS. They describe neither local manufacturing nor all cosmetics sold in Tunisia. To know whether they apply to your product (scope, documents to provide, competent department), contact the Directorate of Pharmacy and Medicines (DPM) directly.

When you consult these documents or other official DPM pages, check these five points:

1. the publication or last update date, to rule out an outdated procedure;
2. explicit mention of cosmetic products in the scope, and not only medicines;
3. the list of documents requested and who submits them (importer, manufacturer or agent);
4. the department to contact and the means of obtaining a written reply;
5. any involvement of the Ministry of Trade for imported finished products.

Before committing a budget, ask the competent authority which documents apply to your product. Keep its written replies in your file, with the date you consulted the pages.

What taxation applies to cosmetic products in Tunisia?

Since 2018, certain cosmetic products sold in Tunisia, such as perfumes, skincare and make-up, have borne a 25% consumption duty, on top of 19% VAT, according to La Presse. This tax affects imported and local products alike. Yet the importer pays it on its purchase price, and the local manufacturer on its selling price.

Consumption duty and VAT

Consumption duty is a tax added to the price of certain product categories, on top of VAT. For cosmetics, it was meant to be temporary, according to La Presse. It was planned for two years, but was still in force in 2025.

Imported or locally made: the calculation gap

The basis of calculation changes everything. The importer applies the tax to its acquisition cost. The newspaper illustrates this gap with the same moisturising cream, imported or made in Tunisia.

For the industry, this burden weighs on the competitiveness of local manufacturers. According to La Presse (December 2025), their market share fell from 24% to 15% between 2015 and 2020. Over the same period, the weight of the informal sector rose from 23% to 35%.

These figures describe the situation reported by the press at a given date. Taxation can change from one year to the next: check the rates and bases of calculation in the finance law currently in force, then have your cost price validated by your tax adviser.

Putting a cosmetic on the Tunisian market: which steps should you anticipate?

In the absence of a specific cosmetics text described in the public sources consulted, the best approach is to prepare a complete file before any launch: formula, safety, labelling, traceability and taxation. Have the competent authorities confirm the documents required for your product, especially if it is imported or intended for pharmacies and parapharmacies.

A product file is the set of documents that describe a formula, its safety, its manufacture and its labelling. Prepared in advance, it lets you respond quickly to a buyer, a distributor or an authority. It does not replace written confirmation of the requirements applying to your case.

Before committing a budget, put these questions to the competent authority and to your laboratory:

• Product status: does your product really count as a cosmetic, or does it fall under another category, such as food supplements?
• Import: which documents are requested at entry, for a finished product as well as for raw materials?
• Labelling: which statements and which languages are expected for sale in Tunisia?
• Taxation: what treatment applies to your product category, and on what basis of calculation?
• Sales channel: do pharmacies and parapharmacies ask for additional documents?

On the manufacturing side, Oppenheimer Lab prepares PIFs (Product Information Files) and CPNP notifications. The PIF is the product information file required for every cosmetic sold in the European Union, by Article 11 of Regulation (EC) No 1223/2009. The complete history of a batch is available within 24 hours, an asset if an authority or a distributor questions you.

If you start from already documented ready-to-launch formulas, ask your laboratory which documents already exist and which remain to be produced. You will save time on your file, without prejudging the requirements specific to your product.

Is the ISO 22716 standard mandatory?

ISO 22716 is the international standard for good cosmetics manufacturing practice. In Tunisia, no public source consulted establishes that it is mandatory, and the question should be confirmed with INNORPI and the competent authority. In the European Union, production compliant with the EN ISO 22716:2007 standard gives a presumption of compliance with the GMP required by Article 8 of Regulation (EC) No 1223/2009.

In Tunisia

Good manufacturing practice (GMP) is a set of organisation, hygiene, control and traceability rules that govern production. For your product category, ask INNORPI about the relevant standards and the competent authority about the applicable requirements. Also ask your distributors whether they require proof of compliance.

Oppenheimer Lab manufactures according to cosmetic Good Manufacturing Practice (ISO 22716 / GMP). To understand how these rules apply on the shop floor, see our page on cosmetic manufacturing according to GMP.

In the European Union

Article 8 of Regulation (EC) No 1223/2009 requires good manufacturing practice for every cosmetic placed on the European market. The PIF (Product Information File) must also contain a declaration of compliance with these GMP, according to the FPS Public Health (Belgium).

ISO 22716 is therefore not the requirement itself, but the recognised means of demonstrating it. If you are aiming for export, ask your laboratory which documents attest to its GMP compliance, then build them into your file from the start.

What is needed to sell a cosmetic made in Tunisia in the European Union?

Manufacturing in Tunisia does not exempt you from European requirements. Every cosmetic sold in the EU requires a Responsible Person established in the Union, a PIF (Product Information File) with a safety assessment, a compliant composition and labelling, then a notification on the CPNP portal before marketing, according to Regulation (EC) No 1223/2009.

We are often asked this question: “If my product is made in Tunisia, can I sell it directly in France?” Our answer: manufacturing in Tunisia does not exempt you from the requirements of the destination market. Oppenheimer Lab, which exports to more than 30 countries, prepares PIFs and CPNP notifications for its clients.

The Responsible Person established in the EU

The Responsible Person is the natural or legal person who is answerable for the compliance of a cosmetic in the Union, within the meaning of Article 4 of Regulation (EC) No 1223/2009. The FPS Public Health (Belgium) points out that it is mandatory for every product. For a product made outside the Union, the importer takes on this role, unless it designates another person established in the EU by written mandate: a Tunisian manufacturer therefore cannot itself be the Responsible Person. A distributor also becomes the Responsible Person when it is the only one to put its name on the label.

The PIF and the safety assessment

Provided for by Article 11 of Regulation (EC) No 1223/2009, the PIF (Product Information File) contains in particular the following items, according to the FPS Public Health:

• a description of the product;
• the production method and the declaration of GMP compliance;
• a positive safety report;
• proof of efficacy, unless it is obvious;
• information on any animal testing.

The CPSR is the cosmetic product safety report that concludes the assessment required by Article 10. This assessment is entrusted to a qualified assessor. The Responsible Person then keeps this file available.

CPNP notification before placing on the market

The CPNP is the European cosmetic products notification portal, provided for by Article 13 of Regulation (EC) No 1223/2009. According to the FPS Public Health, notification comes before any sale. It is neither an authorisation nor a quality certification.

Our advice: define your countries of sale from the brief, so as to prepare the corresponding supporting documents and packaging. To explore each market in depth, see our guides on cosmetics export.

Which labelling statements should you plan for from the design stage?

For the European Union, the label of a cosmetic states in particular the name and address of the Responsible Person in the EU, the nominal content, the date of minimum durability or the period after opening, the batch number, the function, the directions for use and the list of ingredients in INCI names. Planning these statements from the packaging stage avoids a reprint.

Article 19 of Regulation (EC) No 1223/2009 sets the labelling rules for cosmetics sold in the Union. INCI is the international nomenclature of cosmetic ingredients. The FPS Public Health (Belgium) points out that the Responsible Person must comply with strict rules, including for labelling. Here are the points to build into your artwork:

• Responsible Person and origin: their name and address in the Union, as well as the country of origin, mandatory for a product made in Tunisia and imported into the EU.
• Date of minimum durability: it is required for products whose shelf life is under 30 months.
• Period after opening: it replaces the date for more stable products.
• Ingredients: the complete list in INCI names.
• Allergens: they appear on the label, including those in the fragrance.

Language also depends on the country of sale. In Belgium, for example, the function and directions for use follow the language of each region, that is French and Dutch in Brussels. Each Member State may thus impose its own languages.

Claims also matter: they must be substantiated. Refer to Article 20 of Regulation (EC) No 1223/2009 and to Commission Regulation (EU) No 655/2013. For sale in Tunisia, have the competent authority confirm the statements and languages expected.

Checklist: your compliance roadmap

A realistic roadmap comes down to a few steps: define the countries of sale from the brief, document the formula and its safety, check the taxation and documents requested in Tunisia, designate a Responsible Person for the EU, build the PIF, notify on the CPNP and validate the labelling. This checklist serves as a basis for discussion with your laboratory.

The brief is the starting document that sets the target, the product, the markets aimed at and the project’s constraints. Our advice: define your countries of sale at this stage, so as to prepare the corresponding supporting documents and packaging. The two lists below take up, in order, the points developed above.

For the Tunisian market

1. Product status: confirm that it really counts as a cosmetic and specify your sales channels.
2. Administrative documents: ask the competent authority in writing for the documents required, in particular for an imported product.
3. Taxation: check the consumption duty, VAT and their basis of calculation in the finance law currently in force.
4. Labelling: have the statements and languages expected validated before printing.
5. Traceability: require a batch number on every product. At Oppenheimer Lab, the complete history of a batch is available within 24 hours.

For export to the European Union

1. Responsible Person: designate them in the Union before any placing on the market.
2. PIF (Product Information File): gather the description, the GMP declaration, the safety report and the proof of efficacy.
3. Labelling and claims: check them against Articles 19 and 20 of Regulation (EC) No 1223/2009.
4. CPNP notification: carry it out before the first sale.
5. Updates: the FPS Public Health (Belgium) recommends keeping this file permanently up to date.

Oppenheimer Lab, based in Tunisia, manufactures according to ISO 22716 / GMP and prepares PIFs and CPNP notifications. COSMOS, Ecocert, Vegan and Halal certifications are available on request. To frame your timeline, you can request a quote for your cosmetic project: we reply within 48 working hours.

This article is informative and does not replace legal advice. Refer to the official text of Regulation (EC) No 1223/2009 and have the Tunisian requirements confirmed by the competent authorities.

Sources

• Industrie des cosmétiques : La Conect appelle à une mise à niveau du secteur (in French), La Presse de Tunisia, 5 December 2025
• Cosmétiques en Tunisie : une fiscalité inéquitable qui pénalise l’industrie locale (in French), La Presse de Tunisia, 7 February 2025
• Cosmétiques : mise sur le marché, importation ou distribution (in French), SPF Santé publique, Sécurité de la chaîne alimentaire et Environnement (Belgium), February 2026
• Contrôle des dispositifs médicaux, des compléments alimentaires, des produits cosmétiques et des objets de puériculture dans le cadre du contrôle technique à l’importation (procédure P-OP2-001-FR) (in French), Agence nationale du médicament et des produits de santé (ANMPS), 5 June 2025
• Guide d’élaboration d’un dossier technique des produits cosmétiques (T-OP2-004-FR) (in French), Agence nationale du médicament et des produits de santé (ANMPS), June 2025