ISO 22716 Certificate: When Is It Required, the Process and Costs

ISO 22716 is the Good Manufacturing Practices (GMP) guideline written specifically for cosmetic products. The standard was first published in 2007 and has been listed as a harmonised standard in the EU Official Journal since 2013. In Turkey it has been adopted by TSE under the designation TS EN ISO 22716.

The logic on the European side is as follows: Article 8 of the EU Cosmetics Regulation requires that cosmetic products be manufactured in accordance with good manufacturing practices; the European Commission references ISO 22716 directly for this purpose, and a manufacturer who complies with the standard benefits from a "presumption of conformity" — the competent authority presumes that the GMP requirement has been met. In other words, the law does not tell you to "obtain a certificate"; it says "manufacture in accordance with GMP and prove it when required." ISO 22716 certification is the shortest route to that proof, not the only one.

The picture is similar in Turkey. The regulation issued by TİTCK for cosmetics manufacturers requires manufacturers to act in accordance with the Good Manufacturing Practices Guide and stipulates that procedures relating to analytical quality must comply with the requirements of TS EN ISO 17025 and TS EN ISO 22716. Nevertheless, the certificate itself is not a legally mandated document; for companies exporting to the EU, however, it is in practice indispensable.

One further note: ISO 22716 audits the manufacturing and quality system. It does not declare that the product itself is safe. That is the domain of the CPSR (Cosmetic Product Safety Report) and the PIF (Product Information File). None of the three replaces the others; together, the three form a single documentation architecture.

As you read the table, notice this: the certificate protects you not against the authorities but against your customer. When a brand decides to work with you on a contract basis, it wants to rest its own legal risk on your documentation. ISO 22716 at that moment becomes a "risk transfer" document.

A second distinction: accreditation. There is a price difference between certificates issued under TÜRKAK accreditation and those issued under IAF-recognised foreign accreditation — and there is also a difference in acceptance on the buyer's side. A client company's quality department will sometimes ask directly: "Which accreditation body?" A document obtained from a body with no accreditation — one that simply "prints certificates" — will be discarded at the first serious supplier audit.

For facilities producing alcohol-based perfumes and room fragrances, there is an additional dimension: flammable material management. High-proof ethanol and room fragrance solvents such as DPM and MMB have low flash points — meaning they are highly flammable. A GMP auditor will read this through the lens of occupational safety as much as product safety: earthing/grounding against static electricity, explosion-proof equipment, effective ventilation, and use of personal protective equipment (gloves, eye protection). If this section is weak, the audit report is compromised on the very first day.

1. Define the scope

   What are you certifying? Filling only, or does it include blend preparation and warehousing as well? The scope of ISO 22716 is not limited solely to manufacturing activities; it also covers control, storage and dispatch operations. Keeping the scope narrow reduces cost, but when your customer asks "is filling included in the scope?" your answer will be weak.

2. Conduct a gap analysis

   Identifying the gaps between your existing system and the standard typically takes 1–2 weeks; writing the documentation tailored to your business takes a further 2–4 weeks. The most common mistake is skipping this step and purchasing a ready-made document set: the paper describes someone else's factory, not yours.

3. Correct the layout and flow

   Raw material intake, quarantine, production, packaging, finished goods and dispatch areas must be separated physically or procedurally. Storage of volatile raw materials such as fragrance oils and alcohol is assessed separately. If the risk of cross-contamination cannot be shown on a floor plan, the auditor cannot see it either.

4. Collect raw material specifications

   For every fragrance oil, solvent and packaging material, the technical data sheet, safety data sheet (SDS), allergen declaration and IFRA certificate of conformity must be in the file. The critical point here: IFRA limits are set not on the basis of the total fragrance oil percentage but on individual substances within the fragrance oil and the product category (leave-on / rinse-off). A generalisation such as "any fragrance oil is safe up to 20%" will undermine your file; read the fragrance oil's own certificate.

5. Write the incoming inspection criteria

   On what basis do you accept an incoming batch? Odour check (comparison against reference sample), visual clarity, density measurement, batch number and expiry date. Acceptance criteria cannot be "it smelled fine"; they must be measurable.

6. Fix the process parameters

   Many mistakes are made here. Maceration (maturation) is a chemical process: alcohol–fragrance interaction and esterification slow down as temperature falls. For this reason, maceration is carried out at room temperature (approximately 15–20 °C) and in the dark — not in a refrigerator. Chilling (approximately 0–4 °C, typically for one day) is a separate step that comes after maceration; its purpose is to precipitate insoluble waxy structures, which are then removed by cold filtration. If you write both steps into the same instruction, your product will throw sediment and your records will become inconsistent.

7. Establish weighing and filling controls

   Write formulas on a gram (g) basis, but build the density difference into the procedure. Citrus-dominant fragrance oils are typically in the ~0.84 g/ml range, while heavy resins and some synthetics can exceed 1.10 g/ml. If you do not account for density when converting grams to millilitres, you will experience overfilling or underfilling in volumetric bottling. The fill quantity must be verified and recorded in both grams and millilitres.

8. Make cleaning verifiable

   In cosmetic GMP, "evidence-based cleaning" is fundamental: measurable cleanliness is expected, not an eye-check (e.g. ATP testing, pH, microbial swab). If the method, duration and verification record for tank and line cleaning are missing, a non-conformity will be raised regardless of how clean your product actually is.

9. Train staff and record it

   Delivering training and bringing the system into operation typically takes 1–3 weeks. Training records must be signed; the auditor will ask an operator on the floor directly: "What does this instruction say?" An audit is not a document review — it is an audit of implementation and hygiene culture.

10. Run an internal audit and corrective action cycle

    The functioning of the established system is checked through internal audits; gaps are identified and resolved. Do not enter an external audit without at least one complete internal audit cycle and one management review meeting.

11. Undergo the certification audit

    The on-site assessment by the accredited body and the issue of the certificate is typically a 2–5 day on-site exercise. The certificate is generally valid for three years and is maintained through annual surveillance audits.

This is why the price varies from company to company: headcount, number of locations, sector risk, chosen standard and consultancy requirements all differ for every business; the number of person-days is determined by accreditation rules. A quote that gives you a single figure without seeing your facility is either narrowing the scope or working under weak accreditation.

On the timeline side there is a similar range: the certification process is typically completed within 1 to 3 months, depending on the organisation's state of readiness. If you are building a facility from scratch, plan for a longer period — because the time needed to actually run the system is additional.

Do not overlook the regulatory fees either. Every cosmetic product placed on the market in Turkey is subject to a notification obligation through the ÜTS (Product Tracking System); notifications are submitted via ÜTS, and administrative fines and other sanctions are prescribed by law for products placed on the market without notification. Official fees/charges apply for company registration and product notification — do not build your budget on the assumption that it is "free." These fees are updated by TİTCK annually in line with the revaluation rate, so always verify the current tariff directly from the schedule published by the authority.

Finally, do not confuse responsibility with procedure. Notification is a procedure — who enters what data, where. Liability is a separate matter: the obligation of the responsible person/manufacturer for the product's regulatory compliance does not end simply because the notification has been filed. In an inspection the two are examined separately.

A certificate is not a destination — it is a threshold. What you gain when you cross it is not a framed piece of paper but a production line where every batch is traceable and every scent is repeatable. The rest is your signature.