Antibacterial Claims & Biocidal Authorisation: When Do You Need a Licence?

In Turkey, the logic of the distinction is clear: a cosmetic product cleans, beautifies, or imparts a scent; a biocidal product destroys, repels, renders harmless, or exerts a controlling effect on a harmful organism. The definition of a biocidal product covers substances or mixtures containing one or more active substances, used to destroy, repel, render harmless, or prevent the action of any harmful organism by means other than purely physical or mechanical action.

The critical word here is "purpose". And what determines purpose is not the molecule inside the product, but your claim. The label, the brochure, the product name, advertising copy — even a social media post. A public notice issued by the Ministry of Health years ago establishes this principle explicitly: products such as soap, hand-washing liquid, and hand-sanitising gel fall within the scope of cosmetics, but if the word "antibacterial" appears on their packaging, in their advertising, or in their promotional materials, they are treated as biocidal products.

In other words, there are not two separate worlds; there is a single threshold. What crosses that threshold is not the formula — it is the sentence.

A division has also been established on the institutional side. Biocidal products that come into direct contact with the human body (Product Type 1 and Product Type 19) have been placed under the authority, jurisdiction, and responsibility of the Turkish Medicines and Medical Devices Agency (TİTCK). For other product types, the competent authority handling the process is the Ministry of Health's General Directorate of Public Health. Accordingly, even the answer to the question "which door do I knock on?" depends on the sentence you have written.

This article explains the cost of that sentence. And how to describe your product without incurring that cost.

Biocidal products are divided into four main groups and twenty-two product types according to their area of use and purpose. The section relevant to fragrance oil and cosmetic manufacturers is almost entirely the first main group: within the disinfectants main group, Product Type 1 covers biocidal products for human hygiene; Product Type 2 covers disinfectants for personal and public areas; Product Type 3 covers veterinary hygiene; and Product Type 4 covers disinfectants used in food and feed areas.

The table below matches the scenarios most frequently confused in practice. Read it not by asking "what is my product?" but by asking "what does the label say?"

Note: do not read the table as "room sprays are cosmetics". Room fragrances are not applied to the human body, so in most cases they do not fall within the cosmetic definition either — they are neither cosmetic nor biocidal and are subject to general product safety legislation. However, the moment the phrase "kills germs" is added, the product shifts directly into the disinfectant category.

For hand products, the dividing line is sharpened by rinse-off behaviour. In a hygienic liquid soap that is rinsed off and removes dirt, the cleansing function is primary; marketing a leave-on hand gel as "antiseptic", "disinfectant", or a product that destroys specific microorganisms points to a biocidal purpose. TİTCK's borderline product guidance presses the same point: for leave-on products marketed as antiseptic or antibacterial, biocidal claims framed as a secondary function must be regulated with both sets of legislation taken into account.

First, let us clear up a misconception: once you have obtained biocidal authorisation, you still cannot "write whatever you like". The rule introduced by the regulatory amendment is unambiguous: all information on the label specimen approved by the Ministry must appear on the label of the finished product, and no claims or statements outside the scope of the Regulation may be included in the approved label specimen. Placement of a QR code on the label for traceability purposes has also been mandated. The advertising side is equally restricted: no verbal, written, or visual publication may be made for the purpose of promoting a biocidal product that contradicts the information on its approved label or that could cause misinterpretation or misuse.

Then there is the numbers issue. The sentence "kills 99.9% of germs" is not a marketing embellishment — it is a measurable efficacy claim and must be backed by laboratory data. Efficacy is the ability of a product to produce the claimed effect on target organisms when actually used under the conditions of use declared on its label specimens; efficacy tests are the tests that an applicant must submit to demonstrate this.

So what do the tests actually look like? The most widely referenced method for bactericidal efficacy is TS EN 1276. The TS EN 1276 method is generally applied in antibacterial efficacy testing and tests take approximately 10–15 days. The threshold is demanding: products are expected to demonstrate a reduction of at least 5 log₁₀ (i.e., a kill rate of 99.999%) against all four test organisms within the specified contact time. For hand hygiene, the conditions are defined in the TİTCK guideline by product and area of use; for example, bactericidal efficacy for a hygienic hand-wash disinfectant is assessed using TS EN 1276 at 20 °C with a 60-second contact time against strains of S. aureus, P. aeruginosa, E. coli, and E. hirae.

The rationale behind the 99.9% figure commonly seen in the market for rinse-off products is the same: products that are found to be at least 99.9% effective against bacteria in tests may include expressions such as "destroys 99.9% of bacteria" on their packaging. In short, the number comes from the report, not from the marketing department. No report, no number.

There is also the production line itself to consider. Alcohol-based hand antiseptics and room fragrance solvents (DPM, MMB, and similar glycol ethers) are highly flammable; their flash points are low. When working with high-grade ethanol, avoid plastic containers and clothing that accumulate static electricity, take earthing and ventilation seriously, and wear gloves and eye protection. Storage capacity, fire classification, and licensed manufacturing site conditions are issues that must be resolved before the biocidal dossier.

On the raw materials side, two parallel tracks also apply: chemical registration/notification obligations under KKDİK, and IFRA compliance declarations for fragrance oils. Bear in mind that IFRA limits are determined not by the overall fragrance oil percentage but by individual substances within the fragrance oil and by the product category (rinse-off/leave-on) — the generalisation that "any fragrance oil is safe up to a certain percentage" is incorrect. Request an IFRA certificate, a Safety Data Sheet (SDS), and an allergen list from your supplier.

Final word: Biocidal legislation is a living text; regulatory annexes, label formats, and analysis guides are updated throughout the year. This article provides a framework — it does not make decisions. Before placing your product on the market, verify the current legislation and application requirements from the official sources of TİTCK and the Ministry of Health's General Directorate of Public Health; if in doubt, request a classification opinion from the authority. You design the formula; legislation draws the boundary. The rest is your signature.