Articles on regulation and quality

Standards, regulatory file, product safety and quality control in cosmetics and dermocosmetics.

Regulation and quality govern every cosmetic product, from the written formula to the delivered batch. This category is for quality managers, pharmacists, importers and brand founders who want to place their products on the market with a solid file. The articles cite their sources, starting with official texts such as Regulation (EC) No 1223/2009 for the European Union.

They cover the product information file (PIF), CPNP notification for the European Union, safety assessment, labelling, claims and production checks. For the local market, start with the regulation of cosmetic products in Tunisia, which separates what is established from what needs to be confirmed with the authorities.

On the production floor, our laboratory manufactures according to GMP ISO 22716 and retrieves the complete history of a batch within 24 hours. We also prepare the PIFs and CPNP notifications of our clients. The cosmetic batch production page shows how these requirements apply to our manufacturing.

Reference article

Cosmetic products regulation in Tunisia: the essentials, with evidence

Regulation and quality · 1 November 2026 · 13 min

In Tunisia, the requirements applying to a cosmetic product must be confirmed in writing with the competent authority and INNORPI, as public sources describe few specific rules. Some cosmetics also bear a consumption duty on top of VAT. To sell in the European Union, Regulation (EC) No 1223/2009 applies in full: a Responsible Person established in the EU, a PIF (Product Information File), CPNP notification and compliant labelling.

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Regulation and quality · 1 November 2026 · 8 min

Cosmetic GMP and ISO 22716: why they are essential

Yes, cosmetic GMP are mandatory to place a product on the European Union market: Article 8 of Regulation (EC) No 1223/2009 requires them, and ISO 22716 makes it possible to demonstrate compliance. Certification remains voluntary, but partners often ask for it. This article provides a checklist to vet a laboratory and a Tunisia and export perspective.

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Regulation and quality · 1 November 2026 · 9 min

Cosmetic claims: what you can say (and what to avoid)

A cosmetic claim is permitted when it meets the common criteria of Commission Regulation (EU) No 655/2013 and is backed by evidence in the PIF (Product Information File). Promises to treat or cure, and mentions of approval by an authority, should be avoided. To export to the EU, link each wording to a document in the file and validate it with the Responsible Person.

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Regulation and quality · 1 November 2026 · 9 min

Cosmetic product information file (PIF): contents, retention period and the manufacturer’s role

The cosmetic product information file (PIF) is the file the Responsible Person keeps for every product placed on the EU market, under Article 11 of Regulation (EC) No 1223/2009. It includes the product description and the safety report, and is kept for ten years after the last batch. The laboratory supplies the manufacturing elements; the Responsible Person established in the EU, whether the brand or a designated third party, remains responsible for the complete file. Informative article.

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