Written by the Oppenheimer Lab team — Reviewed by Mohamed Arbi Jallali, Partner, Head of Production and Formulator
Published on
8 min read
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 is the harmonised standard used to demonstrate compliance. According to DNV, this requirement has been mandatory since 11 July 2013. Certification is not formally mandatory, but many partners ask for it.
This article explains what this changes for a brand that entrusts its manufacturing to a laboratory, notably in cosmetic contract manufacturing in Tunisia. You will find the difference between the requirement and certification, a checklist for vetting a laboratory and a Tunisia and export perspective. It is for information only: consult the official texts.
What are cosmetic GMP and the ISO 22716 standard?
GMP (Good Manufacturing Practice) are the rules governing control of cosmetic manufacturing. ISO 22716 is the standard that details them for production, control, storage and shipment. It was published in November 2007. It targets manufacturers, contract manufacturers, fillers and control laboratories.
What the standard covers
ISO 22716 is a good manufacturing practice standard specific to the cosmetics sector. According to DNV, it provides guidelines for the production, control, storage and shipment of cosmetic products. These guidelines do not apply to research and development, or to the distribution of finished products.
According to Management Qualité, the standard was harmonised for the European Union in 2008. It also covers the following topics, from personnel to raw materials:
- personnel, premises and equipment;
- raw materials and packaging components;
- production and finished products;
- the quality control laboratory and the handling of non-conforming products;
- deviations, complaints and recalls;
- internal audit and documentation.
In practice, in a workshop, these topics translate into verifiable actions. As a general illustration, here is what you should be able to observe at a manufacturer:
- on receipt, raw materials are identified and quarantined until they are released;
- weighing is recorded and checked before each manufacturing run;
- tanks and equipment are cleaned according to a written procedure, with a record of each cleaning;
- finished products are checked before release;
- a non-conformity is isolated, recorded and dealt with, never set aside without a trace;
- the batch record is archived and makes it possible to trace the manufacturing.
Who it is for
According to Management Qualité, the standard is aimed at manufacturers, including subcontractors. It also concerns contract manufacturers, fillers and cosmetic quality control laboratories.
For a brand that entrusts its manufacturing to a laboratory, the question is therefore simple: does the site that produces your formulas apply these rules, and can it prove it? We detail the points to check below.
Are GMP mandatory to sell cosmetics in Europe?
Yes: Article 8 of Regulation (EC) No 1223/2009 requires cosmetic products to be manufactured in line with GMP, an obligation in force since 11 July 2013. The harmonised standard ISO 22716 makes it possible to demonstrate compliance. The Responsible Person established in the EU (Article 4 of Regulation (EC) No 1223/2009) must ensure this compliance, including for a product made outside the EU.
What Article 8 of Regulation (EC) No 1223/2009 says
Article 8 of Regulation (EC) No 1223/2009 deals with good manufacturing practice. According to Intertek France, compliance with GMP according to ISO 22716 has been a requirement of this article since 11 July 2013.
“Since 11 July 2013, compliance with the requirements of these GMP has become mandatory.” (DNV)
According to Management Qualité, ISO 22716 is the GMP reference standard recognised by this regulation. The regulation is a European Union text that governs cosmetic products. This article is for information only: refer to the official text on EUR-Lex.
Who must ensure it
According to Intertek France, all products placed on the European market must be manufactured in line with these GMP. The same source specifies that responsible importers and distributors must ensure this compliance.
Our advice: manufacturing in Tunisia does not exempt you from the requirements of the destination market. For the European Union, you notably need a Responsible Person established in the EU, a PIF (Product Information File) with a safety assessment, and a notification on the CPNP portal before marketing. This notification is neither an authorisation nor a quality certification.
Complying with GMP or being ISO 22716 certified: what is the difference?
Complying with GMP is a legal requirement for any cosmetic product placed on the European market. ISO 22716 certification is a voluntary step, often requested by brand owners and distributors; the authorities, for their part, check compliance with GMP, certified or not. It is proven by an audit, surveillance checks and recertification.
An ISO 22716 certificate is an attestation issued after an audit, confirming that a site applies the standard. According to Management Qualité, it is not formally mandatory but it is widely required by brand owners and distributors. A laboratory can therefore comply with GMP without being certified, but it must then demonstrate it through other evidence.
The table below compares the three notions that are most often confused.
| Notion | Nature | What it covers |
|---|---|---|
| Compliance with GMP | Legal requirement (Article 8 of Regulation (EC) No 1223/2009) | Manufacturing of cosmetic products placed on the EU market |
| ISO 22716 certification | Voluntary step, often required by partners | Attestation by audit that the site applies the standard |
| ISO 9001 | Management standard, voluntary | Quality management in general |
According to Management Qualité, ISO 9001 covers quality management in general, while ISO 22716 specifically targets cosmetic GMP. Many manufacturers combine the two.
According to Intertek France, the certification process includes defining the scope, the audit, the decision of the certification committee, then surveillance audits. The same source indicates recertification after a period of three years.
How can you check that a laboratory really complies with GMP?
Ask for evidence, not promises: quality documentation, batch traceability, management of deviations and complaints, the possibility of auditing the site. A serious laboratory answers each of these points precisely. This check protects your brand before any manufacturing or packaging order.
A supplier audit is a visit or a document review by which a brand checks the practices of its subcontractor. It does not replace legal obligations, but it gives you concrete evidence. According to Management Qualité, the standard notably covers subcontracting, deviations, complaints and recalls. These topics therefore structure your questions.
Checklist before signing
Here are the points worth checking before signing. These are general tips, valid for any laboratory.
- Documents: ask your laboratory for its quality documentation and, where applicable, its GMP certificate or declaration of conformity.
- Traceability: check that it can trace the history of a batch, from raw materials through to shipment.
- Deviations: ask how it records and handles deviations and non-conforming products.
- Complaints and recalls: have the procedure described in the event of a problem found on the market.
- Subcontracting: ask who works outside the site and how these parties are controlled.
- Audit: check that you can visit the site or conduct a supplier audit.
- Regulatory files: ask who prepares the PIF (Product Information File) and the CPNP notification.
A laboratory can comply with GMP without being certified, but it must then demonstrate it with verifiable evidence. Refuse any vague answer.
At Oppenheimer Lab, manufacturing follows cosmetic Good Manufacturing Practice (ISO 22716 / GMP) at our Ben Arous site. A batch’s full history is available within 24 hours, and we prepare the PIF and CPNP notifications. To find out more, see our cosmetic manufacturing under GMP.
What does ISO 22716 change for Tunisia and export?
Producing in Tunisia does not exempt you from the requirements of the target market: for the European Union, GMP apply to products placed on the market. ISO 22716 certification can make export easier, and GIZ Tunisia has offered support to Tunisian companies in the sector.
An export certification is a document that some countries ask for before authorising imports. According to DNV, some countries require an ISO 22716 certification among the criteria to be met to authorise imports. This document can therefore weigh in the choice of a laboratory when you target several markets.
Our advice: define your sales countries from the brief. Each market has its own documents and packaging, and manufacturing in Tunisia replaces none of them. For the local context, see our guide to cosmetic contract manufacturing in Tunisia.
Take a typical example: a young French brand wants to launch a short range of skincare and is considering producing in Tunisia. Its decision criteria are concrete: talking directly in French with the technical team, geographical proximity and an offer suited to its starting volumes. It then compares sample quality, available documentation, delivered cost and the reliability of the schedule. GMP evidence is added to this list.
Support in Tunisia
According to Managers.tn (7 February 2025), GIZ Tunisia offers Tunisian cosmetics and personal care companies technical support to obtain ISO 22716 certification. The initiative is part of the “Croissance Qualitative pour l’Emploi” project.
According to Managers.tn (23 October 2023), a comparable scheme, carried out with the ministère de l’Industrie, des Mines et de l’Énergie, also aimed to strengthen companies’ export capacity. These calls for applications are time-limited: check their current availability with the bodies concerned.
How do you move from GMP to your brand project?
Define your sales countries from the brief, then ask for quality evidence before launching manufacturing and packaging. Each market has its own requirements, and the quote must specify what is included. This order avoids redoing packaging or files mid-project.
A brief is the document that sets the objective of your project: target, product, quantity, budget and target markets. We recommend listing the sales countries from the outset, so that the corresponding documents and packaging can be prepared.
Next, go back to the checklist in the previous section. Ask for the GMP evidence, the documentation and the audit arrangements, then compare them across several laboratories. A validated sample and clear documentation are worth more than a verbal promise.
At Oppenheimer Lab, small batches possible: from 200 units, or even 100 depending on the project, subject to assessment, and quote requests receive a reply within 48 working hours. To start the conversation, you can request a quote from Oppenheimer Lab, stating your target markets and your quality requirements.
Sources
- ISO 22716 – Industrie de la Cosmétique – Bonnes Pratiques de Fabrication (BPF) (in French), DNV, undated
- Certification ISO 22716 – BPF Cosmétiques (in French), Intertek France, undated
- ISO 22716 : guide complet, articles et ressources (in French), Management Qualité, undated
- Appel à candidatures pour obtenir la certification ISO 22716 : ces secteurs sont concernés (in French), Managers.tn, 7 February 2025
- ISO 22716 : la GIZ appuie l’industrie cosmétique tunisienne (in French), Managers.tn, 23 October 2023
Frequently asked questions
Are cosmetic GMP mandatory?
Yes, for any cosmetic product placed on the European Union market. Article 8 of Regulation (EC) No 1223/2009 requires manufacturing in line with good practice, and ISO 22716 is the harmonised standard used to demonstrate it. The Responsible Person established in the EU must ensure compliance, including for a product made outside the EU. See the official text on EUR-Lex for details.
Is ISO 22716 certification mandatory?
No, certification is not formally mandatory, unlike compliance with GMP. It remains a voluntary step, often requested by brand owners and distributors, while the authorities check actual compliance with GMP. A non-certified laboratory can comply with GMP, provided it proves it with verifiable evidence.
What is the difference between ISO 22716 and ISO 9001?
ISO 9001 covers quality management in general, while ISO 22716 targets good manufacturing practice for cosmetics. The first applies to all sectors, the second is specific to cosmetics. Many manufacturers combine the two standards, which complement each other.
How can you check that a laboratory complies with GMP?
Ask for concrete evidence rather than promises. Request the quality documentation, a GMP certificate or declaration of conformity where applicable, batch traceability, and the handling of deviations and complaints. Also check that you can visit the site or carry out a supplier audit before signing.
Is there support for ISO 22716 in Tunisia?
Yes, GIZ Tunisia has offered technical support to Tunisian cosmetics companies, notably in February 2025, as part of the “Croissance Qualitative pour l’Emploi” project. These calls for applications are time-limited: check their current availability with the bodies concerned.
