Setting Up a Cosmetic Manufacturing Site: Notification, Premises and Personnel Requirements

In Turkey, cosmetic products are governed by Cosmetics Act No. 5324. Since the Act came into force on 30 March 2005, no separate production or import permit has been issued for cosmetic products or manufacturing sites; the competent authority is responsible for market surveillance and inspection. Nevertheless, cosmetic products must be notified to the Ministry before being placed on the market.

"No permit" does not mean "no restrictions." Quite the opposite: because there is no upfront filter, responsibility falls entirely on you. From the moment a product reaches the shelf, your file, your facility and your personnel must all be in order. When an inspector arrives unannounced, the phrase "I was still getting ready" has no legal standing.

In cosmetics, the notification system — not a prior-permit system — applies; registering and notifying products to the system is the fundamental requirement. Notifications are submitted via the ÜTS (Product Tracking System), and the product must be registered before it is placed on the market; sales, distribution and market placement are not possible without registration.

In summary, the correct sequence is: premises and licence first, then quality system, then personnel, and finally notification. Most people do this in reverse order — and that is where the most expensive mistakes originate.

Cosmetic manufacturing falls under the municipal classification of sanitary nuisance establishments (GSM); "production facilities for all types of cosmetic products" appear as a separate line item on the list of sanitary nuisance establishments. The class assigned to your facility is not a matter of free interpretation: classification for sanitary nuisance establishments is determined by taking the facility's capacity report into account.

Class matters because it determines the relationship with residential properties. A second-class GSM is defined as an establishment that does not necessarily need to be kept away from dwellings but is assessed in terms of the wellbeing of those nearby; a third-class GSM is one for which sanitary supervision is considered sufficient to allow it to operate adjacent to dwellings. In other words, the idea of "a small perfume workshop in an apartment basement" is, in most cases, blocked at the very first legal hurdle. Describe your capacity and activity scope clearly to the municipality and let them state the class.

What does a GMP-compliant premises mean?

The quality framework in cosmetics is called Good Manufacturing Practice (GMP), and the reference standard is ISO 22716, published in 2007 and designed specifically for cosmetic products; in Turkey it has been adopted by TSE as TS EN ISO 22716. The standard is not a "hygiene recommendation" — it covers all of the following: personnel training and hygiene, hygienic design of facilities, equipment cleaning and calibration, raw material and packaging controls, manufacturing process and in-process controls, finished product and dispatch, the quality control laboratory, and waste management. The design, layout, lighting and ventilation of the facility are defined, and production areas must be organised to minimise the risk of contamination.

In practice, this means unidirectional flow: raw materials arrive, wait in quarantine, are weighed, manufactured, rested, filled, labelled, and leave. Every point where a dirty path intersects a clean path is a risk item.

One more caution: if you plan to process food flavourings and cosmetic fragrance oils in the same facility, set these up as separate lines from the outset. Cosmetic and perfume fragrance oils are not food products; they are not edible or drinkable. The term "food grade" refers to a packaging or raw material classification — it does not mean the product can be ingested. Build your label, storage and container distinctions around that statement.

The responsible person is the head of the chain. Cosmetic products may only be placed on the market if a natural or legal person established within the country is designated as the responsible person. For products manufactured domestically, if the manufacturer is established in-country, the manufacturer is the responsible person. In other words, if you are producing in your own workshop, you are the responsible person.

The responsible technical expert (RTE) is the technical conscience. The responsible person employs a responsible technical expert; the RTE is responsible for verifying that the product to be placed on the market complies with cosmetics legislation, good manufacturing practices and other relevant regulations. The wording of the Act is clear on this: these establishments cannot be operated without employing a responsible technical expert and personnel of the quality required by the service.

Who can be an RTE? Chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists and pharmacists may be designated as responsible technical personnel; if the responsible person meets these requirements, they may assume the role themselves. A previous regulation imposed an additional experience requirement: a pharmacist, or a chemist, biochemist, chemical engineer, biologist or microbiologist who could document two years of active work in the cosmetics field, could be appointed. Verify the current diploma and experience requirements directly from the applicable regulation and RTE guidance before making any appointment.

The third role is most often overlooked: the safety assessor. The cosmetic product safety assessment must be carried out by a person holding a diploma or equivalent qualification demonstrating completion of theoretical and practical university training in pharmacy, toxicology, medicine or a similar discipline. This person need not be the same as the RTE; in most small businesses, they are not.

1. Legal entity and activity definition

   Establish your company and add cosmetic manufacturing along with the relevant NACE code to the objects clause in your articles of association. If your registered address and production address differ, declare both correctly.

2. Premises, capacity report and business operating licence

   Before signing a lease, ask about zoning status, certificate of occupancy and the likelihood of a fire-safety report. The capacity report is the basis for GSM class assignment; declare your capacity realistically. Do not order equipment before the licence is granted.

3. Quality system and GMP infrastructure

   Write up the flow diagram, room separation plan and cleaning schedule. The quality manual, standard operating procedures (SOPs), formulas, specifications, cleaning instructions, batch record forms and training records are all created at this stage. Documentation is born alongside the system, not added afterwards.

4. Appointment of the responsible technical expert

   Draw up the contract and put the job description in writing. Every step taken without an RTE in place will need to be redone later.

5. EBS and ÜTS company registration

   The company and its authorised representatives must be registered on ÜTS and EBS, login credentials obtained, and the responsible technical expert registered via ÜTS. The product notification screen will not open to you until the company registration is approved.

6. Formulation and raw material file

   Collect the SDS, technical data sheet, allergen declaration and, where applicable, IFRA compliance declaration for every raw material. Write formulas on a gram (g) basis; account for density when converting to ml. Citrus oils are around ~0.84 g/ml, while heavy resins and some synthetics can exceed 1.10 g/ml — the same 100 g occupies a very different volume in the bottle.

7. Stability, compatibility and microbiological tests

   Plan for shelf-life studies, packaging–content compatibility and, where required, preservative efficacy testing. Include a clarity check here: test on a small scale with your sample, and identify your own formula's haze threshold.

8. Safety assessment (CPSR)

   A qualified assessor prepares the report using exposure and toxicological data. Without this report the file is incomplete; every subsequent change to the formula also triggers a new report.

9. PIF (Product Information File)

   Formula, manufacturing method, GMP declaration, label, packaging, test reports and CPSR are brought together in a single file. Where more than one address is specified, the address at which the responsible person holds the product information file must be stated on the label.

10. Label design and ingredient declaration

    Responsible person details, ingredient list, batch number, net quantity, warnings and instructions for use. Do not include a permit/notification number on the label; do not make any treatment or health claims.

11. Barcode and ÜTS product notification

    Following company and RTE registration, cosmetic product notifications are submitted for the products to be placed on the market. Completing the electronic data entry alone does not mean notification is finalised — always check the status shown on screen and any additional steps required.

12. First batch, records and retain sample

    Open a batch card, retain the weighing slips and set aside a retain sample from every batch. Where there is no traceability, complaints cannot be defended.

13. Change notification

    After registration, any changes that occur to the product or the manufacturer must also be notified. Do not let changes to the address, formula, packaging or responsible person accumulate.

Budget: the hidden line items

Most entrepreneurs' budget tables include machinery and rent — but not documentation costs. Yet those are precisely the items that most often determine cash flow in the first year.

Three classic mistakes first

One: buying equipment before the licence arrives. Two: printing labels before the formula is finalised. Three: mistaking concentration for performance. This last one is technically the most widespread error: longevity and sillage do not depend solely on the fragrance oil percentage. The true determinant is the volatility of the raw materials. A citrus-heavy 25% extrait may dissipate rapidly, while a 10% product rich in amber, oud or musk can last far longer on skin. The percentage alone does not determine performance; the structure of the formula does.

A fourth mistake also appears frequently: labelling materials such as MPG (monopropylene glycol) and IPM (isopropyl myristate) as "fixatives." These are not true fixatives — they are carrier solvents / emollients; they do regulate volatility to a minor degree, producing a slight effect, and nothing more. When speaking of true fixatives, the discussion turns to macrocyclic musks, glucose ethers (e.g. Glucam P-20) and heavy balsams/resins. Using MPG at high levels (2% and above) leaves a tacky feel on skin.

Setting up a workshop is not a list of machinery — it is an architecture of responsibility. Once the walls, the shelves and the signatures are in the right place, all that remains is the formula. The rest is your signature.