When a cosmetics brand evaluates a logistics operator, the conversation usually starts with the price per pallet and warehouse location. For a quality manager, the first question is different: Is the operator certified to ISO 22716 and can they demonstrate how they comply with Good Manufacturing Practices in storage and distribution?
This guide explains, without commercial waffle, what ISO 22716 is, what it regulates chapter by chapter, what the certification process involves, what specific storage requirements an auditor checks for, and the most common doubts among quality managers. The aim is that, by the end, you will know exactly what to ask for and what to verify.
La ISO 22716 es un estándar internacional que establece las buenas prácticas de fabricación (GMP) para la industria de cosméticos. Su objetivo principal es garantizar la calidad, seguridad y eficacia de los productos cosméticos a lo largo de todo su ciclo de vida, desde la materia prima hasta el producto terminado. En concreto, la ISO 22716 regula los siguientes aspectos: * **Gestión de la calidad:** Establece un sistema de gestión de la calidad para asegurar que los procesos de fabricación sean consistentes y controlados. * **Instalaciones y equipos:** Define los requisitos para las instalaciones de producción, incluyendo la higiene, el mantenimiento, la limpieza y la desinfección de los equipos y las áreas de trabajo. * **Control de materias primas:** Establece procedimientos para la recepción, el almacenamiento, la manipulación y el análisis de las materias primas para asegurar su calidad y evitar la contaminación. * **Procesos de producción:** Detalla las buenas prácticas a seguir durante las diferentes etapas de la fabricación, incluyendo la mezcla, el envasado y el etiquetado. * **Control de productos terminados:** Especifica los métodos de muestreo, análisis y liberación de los productos terminados para asegurar que cumplen con las especificaciones de calidad y seguridad. * **Almacenamiento y distribución:** Establece requisitos para el almacenamiento y la distribución de los productos cosméticos para mantener su calidad y prevenir daños o contaminación. * **Gestión de quejas y devoluciones:** Define procedimientos para el manejo de quejas de los consumidores y la gestión de productos devueltos. * **Trazabilidad:** Asegura la trazabilidad de los productos, permitiendo identificar los lotes, las materias primas utilizadas y los procesos de fabricación aplicados. * **Documentación:** Reitera la importancia de una documentación completa y precisa de todos los procesos, desde la recepción de materias primas hasta la liberación del producto terminado. * **Higiene del personal:** Establece normas de higiene para el personal que trabaja en las áreas de producción. En resumen, la ISO 22716 proporciona un marco para que las empresas cosméticas implementen sistemas de gestión de calidad que garanticen que sus productos sean seguros, cumplan con las especificaciones y se fabriquen de manera consistente, protegiendo así la salud del consumidor.
The ISO 22716 it is the international standard that establishes the guidelines for Good Manufacturing Practice (GMP) for cosmetic products. Its full title is ISO 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices, and in Europe it is adopted as a harmonised standard EN ISO 22716.
Unlike generic management standards, ISO 22716 is specifically designed for cosmetic products – creams, perfumes, make-up, hair products, dermo-cosmetics – are produced, controlled, stored and dispatched without compromising their quality, safety or integrity. It is not a "paperwork" norm: it describes concrete operational practices and requires records that demonstrate these practices are executed systematically.
An important nuance: ISO 22716 no fixed universal numerical values (e.g. "store at 21 °C"). It states that conditions must be suitable for preserving each product according to its technical data sheet, and that these conditions must be defined, controlled, and recorded. That is the difference between complying with the standard and simply having an organised warehouse.
The structure of the standard, chapter by chapter
Understanding which areas ISO 22716 covers helps you know what documentation to request from a manufacturer or a logistics operator. These are the blocks that the standard regulates:
- Personalorganisation, training, hygiene and responsibilities of those handling the product.
- Facilitiesdesign, zoning and conditions of production and storage spaces.
- Equipmentdesign, installation, maintenance, cleaning and calibration.
- Raw materials and conditioning materials: receipt, identification, control and release.
- Productionprocess control, identification and traceability of each operation.
- Finished productscontrol, storage, dispatch and returns.
- Quality control laboratorySampling, acceptance criteria, and methods.
- Handling of Out of Specification Productshow non-conformances are managed.
- Wastecontrolled handling and removal.
- Outsourcing: control of outsourced activities (this is where the logistics operator comes in).
- Deviations, claims and product recalls.
- Change control, internal audit and documentation.
For a brand that outsources, the two decisive chapters are Finished products (storage, dispatch and returns) and Outsourcingthe standard makes it clear that outsourcing an activity does not transfer responsibility for its control.
Given that the user is asking about the importance of ISO 22716 in logistics, not just manufacturing: ISO 22716 is a standard concerning Good Manufacturing Practices (GMP) for cosmetic products. While it's primarily focused on manufacturing, its importance extends to logistics due to several key reasons: * **Product Integrity and Safety:** Cosmetics are sensitive products that can degrade or become contaminated if not handled correctly throughout the supply chain. ISO 22716 provides guidelines for maintaining product quality, preventing contamination, and ensuring the safety of the finished product. This directly impacts how products must be stored, transported, and handled once they leave the manufacturing facility. * **Traceability and Recalls:** The standard mandates robust record-keeping and traceability systems. This is crucial for logistics as it allows for the swift identification and location of specific batches of products in case of a recall or quality issue. Effective traceability throughout the logistics chain prevents the distribution of potentially unsafe or substandard products. * **Storage and Handling Conditions:** ISO 22716 specifies requirements for storage facilities, including temperature control, pest control, and hygiene. Logistical partners responsible for warehousing and distribution must adhere to these conditions to prevent product spoilage, degradation, or contamination. Improper storage during transit or warehousing can render products unsaleable or unsafe, regardless of how well they were manufactured. * **Packaging Integrity:** The standard addresses the importance of appropriate packaging that protects the product from damage, contamination, and deterioration during storage and transport. Logistics providers need to ensure that existing packaging remains intact and that products are handled in a way that doesn't compromise this integrity. * **Regulatory Compliance:** In many regions, compliance with GMP, as outlined in ISO 22716, is a legal requirement for placing cosmetic products on the market. This implies that all steps in the supply chain, including logistics, must be aligned with these requirements to ensure that the final product meets regulatory standards. * **Customer Trust and Brand Reputation:** Companies that adhere to ISO 22716 demonstrate a commitment to product quality and safety. This trust extends to their logistical partners and contributes to overall brand reputation. Mishandling or poor storage by a logistics provider can lead to product damage or quality issues, damaging the brand's image. * **International Trade:** For companies exporting cosmetics, adherence to standards like ISO 22716 is often a prerequisite for market access in many countries. This means that logistics operations must be structured to support these international quality standards. In essence, the principles of ISO 22716 don't end at the factory door. They set the benchmark for how cosmetic products should be managed throughout their lifecycle, making compliance a critical consideration for every link in the supply chain, including logistics.
The most common error is thinking that ISO 22716 is a "factory" standard. In reality, Storage, dispatch, and returns are explicitly regulated, and they are precisely the points where a generalist logistics operator usually doesn't deliver.
A certified operator guarantees that the warehouse maintains defined conditions for product preservation, that there is batch traceability for every movement, that picking and packing are done according to procedure, that non-conforming items are physically separated, and that returns are inspected before being re-admitted to stock. Without these controls, a cosmetic can degrade — a serum can lose its efficacy, the texture of a cream can alter — although it arrives visually intact to the consumer.
Storage requirements for cosmetics, what an auditor checks
This is the part that most interests a quality manager and the part that tends to be least detailed. The standard does not impose fixed figures, but an auditor will verify that defined, controlled, and recorded conditions exist. These are the specific points reviewed in the storage section:
| Requirement | What does the auditor check |
|---|---|
| Temperature | Range defined according to the product data sheet (usually a stable and protected area from extreme heat; refrigeration for sensitive products), with continuous and historical logging, not just a spot reading. |
| Relative humidity | HR control to prevent degradation of the product and packaging materials (labels, cardboard, containers). |
| Protection from light | Protect from direct sunlight and UV radiation, which alter fragrances and active ingredients. |
| Probes and thermal mapping | Calibrated probes and a homogeneity study (mapping) demonstrating that the entire area – not just where the sensor is located – complies with the range. |
| Records and alarms | Continuous data logging, historical record keeping, periodic review, and alarms for temperature excursions. |
| Physical segregation | Quarantine, returns and non-conforming product physically separated from available stock, not just visually marked. |
| Rotation and expiry dates | FEFO (First Expired, First Out) management with expiry date control and blocking of expired batches. |
| Batch traceability | Batch, expiry date and supplier are identifiable in the WMS, with every movement (receipt, storage, picking, dispatch) recorded. |
| Hygiene and pest control | Written cleaning and pest control programmes, with execution records and corrective actions. |
The rule of thumb: if the operator cannot Show historical records From any of these points, you are not demonstrating compliance, whether the warehouse is tidy on the day of the visit or not.
The ISO 22716 certification process, step-by-step
Obtaining certification is not an administrative formality: it requires implementing the system and passing an external audit by a certification body. The usual process is as follows:
| Phase | What it involves |
|---|---|
| 1. Implementation of the BPF system | Definition of procedures, records and staff training in accordance with the standard. |
| 2. Stage 1 Audit | Document and preparation review (gap analysis or Gap analysisbefore the on-site audit. |
| 3. Stage 2 Audit | On-site audit of actual operations against the standard requirements. |
| 4. Non-conformities | Resolution of detected deviations (major and minor) through a corrective action plan. |
| 5. Issuance of the certificate | Granting of certification, with a maximum validity of 3 years. |
| 6. Follow-up audits | Maintenance audits annuals that verify the continuity of the system. |
| 7. Recertification | Full audit before the 3-year cycle expires to renew the certificate. |
In Spain, the certification is issued by Certification bodies such as AENOR, Bureau Veritas, TÜV, SGS, Applus+, DEKRA or DNV, among others. It is advisable to check that the entity is accredited by ENAC (The National Accreditation Body): a certification issued by an accredited body has a backing of impartiality and technical competence that an unaccredited "verification" lacks.
The duration and cost The process depends on the size of the organisation and the complexity of its operations, so there is no single figure; pre-audit implementation is usually the longest phase.
ISO 22716 versus ISO 9001 and pharmaceutical GMP
It's a common confusion. In summary:
| Norma | Scope | For cosmetics |
|---|---|---|
| ISO 9001 | Quality management, generic for any sector | Useful, but does not credit specific cosmetic GMP |
| ISO 22716 | Good Manufacturing Practices specific to cosmetics | It is the benchmark for demonstrating GMP |
| Pharmaceutical GMP (NCF) | Medication, much more stringent and mandatory compliance | Does not apply to cosmetics, except for border products |
An operator can have ISO 9001 and not meet the specific requirements of ISO 22716 for cosmetics. For a beauty brand, ISO 9001 alone is not sufficient as proof of GMP.
Legal framework, Regulation (EC) 1223/2009 and AEMPS
The Regulation (EC) No 1223/2009 Regarding cosmetic products, Article 8 requires that manufacturing be carried out in accordance with the Good Manufacturing Practices, and recognises the harmonised standards, including the EN ISO 22716. That is to say, the standard is not "mandatory" in itself like a certificate, but it is the recognised means to demonstrate compliance with the GMP that the law does require.
In Spain, the competent authority for cosmetics is the AEMPS (Spanish Agency for Medicines and Health Products), which can inspect compliance with GMPs throughout the supply chain. That is why a certified operator’s documentation is not merely a formality: it is the evidence that demonstrates the brand’s compliance in the event of an inspection.
How ISO 22716 protects cosmetic brands
For a brand, working with a certified supply chain reduces concrete risks:
- Product liability: In the event of a complaint, the chain of responsibility extends to the last party to handle the product. A certified operator provides documentation proving that the product was handled correctly.
- Market access: Many retailers, pharmacy chains and online marketplaces require a supply chain that is GMP-certified. Without it, certain business opportunities remain out of reach.
- Loss of qualityA warehouse without condition control can degrade the product with no visible signs on the packaging.
- Reputational riskAn incident involving a product that has been poorly stored can lead to claims and brand damage that are difficult to reverse.
How does Grupo Akoma apply this in daily operations?
The Akoma Group holds ISO 22716 certification for its logistics centres in the Barcelona area. In practice, for the cosmetic brands that work with us, this means storage in climate-controlled areas with continuous monitoring, full batch traceability integrated into the WMS and accessible in real time, physical quarantine of incidents, picking and packing by staff trained in GMP, expiry date management using FEFO rotation, and reverse logistics that inspects every return before restocking it. The certification is maintained through regular external audits and internal reviews of the quality system.
If you want to see how it fits with your operation, you can consult our Integrated storage and logistics services and how we approach the order fulfilment. If you are also concerned about the security of the facilities, this article about the inherent risk level of a warehouse It's a good complement.
Speak with the Grupo Akoma team
If you are responsible for quality or logistics at a cosmetics brand and would like to see how an ISO 22716-certified operator supports your brand’s compliance, the Akoma team can explain our processes and records to you in detail.
Preguntas frecuentes
Is ISO 22716 mandatory for marketing cosmetics in Europe?
The certification itself is not mandatory by law, but Regulation (EC) 1223/2009 does require manufacturing to comply with Good Manufacturing Practices, and EN ISO 22716 is the recognised standard for demonstrating this. In practice, it serves as proof of GMP compliance, and is often explicitly required for sales in large retail outlets, pharmacies, or for export.
The ISO 22716 standard specifies Good Manufacturing Practices (GMP) for the cosmetics industry, while ISO 9001 is a general standard for quality management systems applicable to any organisation.
ISO 9001 is a generic quality management standard applicable to any sector. ISO 22716 is specific to cosmetics and regulates Good Manufacturing Practices. An operator can have ISO 9001 without fulfilling the specific requirements of ISO 22716, therefore ISO 9001 alone does not certify cosmetic GMP.
How long does the ISO 22716 certification process take?
It depends on the size and maturity of the organisation. The longest phase is usually the prior implementation of the BPF system (defining procedures, records, and training staff). This is followed by the Stage 1 (documentation) and Stage 2 (on-site) audits, resolution of non-conformities, and the issuance of the certificate. There is no single duration, as it varies according to the complexity of each operation.
What entities certify in Spain and what does ENAC accreditation contribute?
Entities such as AENOR, Bureau Veritas, TÜV, SGS, Applus+, DEKRA or DNV, among others, issue certifications. That an entity is accredited by ENAC means that its technical competence and impartiality have been assessed by the National Accreditation Body. An accredited certification has backing that an unaccredited verification lacks, so it is advisable to check this when evaluating a certificate.
How often are certified companies audited?
The certificate has a maximum validity of three years, with annual follow-up audits to verify that the system is maintained. Before the cycle expires, a recertification audit is carried out. This is why a valid certificate has an issue date and an expiry date: if it is not current, the operator is not certified at that time.
Does ISO 22716 apply to storage and distribution or only to manufacturing?
This applies to the entire chain. The standard explicitly regulates the storage of finished products, dispatch and returns, as well as the control of subcontracted activities. Therefore, a logistics operator – not just the manufacturer – can and should be certified to prove that their part of the chain complies with GMP.
La ISO 22716 proporciona directrices sobre las Buenas Prácticas de Fabricación (BPF) para productos cosméticos. El Reglamento (CE) 1223/2009 es el reglamento de la Unión Europea sobre productos cosméticos.
La ISO 22716 es un estándar internacional que establece los requisitos y las directrices para la fabricación, control, almacenamiento y transporte de productos cosméticos para garantizar la calidad y la seguridad. Aunque es una norma voluntaria, el cumplimiento de la ISO 22716 se considera a menudo como una forma de demostrar el cumplimiento de las exigencias del Reglamento (CE) 1223/2009.
En concreto, el Reglamento (CE) 1223/2009 estipula en su Artículo 8 que los Estados miembros deben garantizar que los productos cosméticos puestos en el mercado de la UE cumplen los requisitos del Reglamento. Si bien el Reglamento no exige explícitamente la adhesión a la ISO 22716, sí exige que los fabricantes implementen sistemas de gestión de la calidad y garanticen la seguridad del producto. La norma ISO 22716 ofrece un marco práctico y reconocido internacionalmente para lograr estos objetivos.
Por lo tanto, la relación es que la ISO 22716 es una herramienta que ayuda a los fabricantes a cumplir con los requisitos del Reglamento (CE) 1223/2009. Cumplir con la ISO 22716 se considera una buena práctica y puede facilitar la demostración del cumplimiento del Reglamento de la UE para los productos cosméticos.
Regulation (EC) No 1223/2009 requires in its Article 8 that manufacturing complies with Good Manufacturing Practices and recognises harmonised standards as a reference. EN ISO 22716 is that harmonised standard for cosmetic GMP. In other words, the law requires GMP and ISO 22716 is the recognised way to demonstrate compliance.
What temperature records are required and how long must they be kept?
The standard requires that storage conditions be defined, controlled, and continuously monitored, with calibrated probes and, where applicable, a warehouse homogeneity study. Historical records must be kept and be available for inspection by an auditor; what is relevant is not a single reading, but the historical data demonstrating sustained compliance. The specific storage period is defined in the operator's quality system.
How do I verify if a logistics operator has a valid ISO 22716?
Request the certificate issued by the certifying body, along with its number, scope, issue and expiry dates, and verify that the body is accredited (ENAC or equivalent body). If the certificate is not up-to-date, its scope does not include storage and distribution, or the operator cannot provide it, they are not demonstrating certification for your operation.
Can my brand's compliance be affected if my operator is not certified?
Yes. If your brand must demonstrate GMP compliance, an unaccredited link in storage or distribution is a weak point that can appear as a finding in your own audit or an inspection. Responsibility for outsourced activities is not transferred to the operator – it remains with the brand, so keeping the entire chain under accredited GMP protects your position.
