The obligations of a party producing or importing a chemical begin before the question of whether that substance is hazardous. In the European Union the framework governing this field is REACH, and in Türkiye the KKDİK regulation, which follows the same logic. Both names come from the initials of the four areas they cover: registration, evaluation, authorisation and restriction.
Two frameworks, one shared logic
REACH came into force with Regulation (EC) No 1907/2006 and replaced the scattered rules that preceded it. Its basic approach is to shift the responsibility for generating information from the public authorities to industry. The burden of showing under which conditions a substance can be used safely rests with whoever places it on the market. This approach is often summed up in a single phrase: no data, no market.
KKDİK is the regulation covering the same four areas in Türkiye. Its structure parallels REACH; the content of the registration dossier, the format of the safety data sheet and the transfer of information along the supply chain rest on similar principles. For an exporting producer this similarity is a practical convenience: the same technical dossier forms a largely valid basis on both sides. Registration procedures are nevertheless carried out separately; a registration made in one does not automatically hold good in the other.
| Topic | What does it mean? |
|---|---|
| Records | Preparing a technical dossier for a substance produced or imported above a given quantity and submitting it to the competent authority |
| Assessment | Examination of the submitted dossier, and where necessary of the substance itself, by the competent authority |
| Authorisation | Allowing substances of very high concern to be used only under an authorisation |
| Restriction | Limiting certain uses or banning them altogether |
Who carries the registration duty?
The duty rests with the party that produces the substance or brings it into the country. A laboratory or industrial organisation buying from abroad may become an importer under its own country's rules; in that case the responsibility lies with the buyer rather than the supplier. Most misunderstandings in B2B supply arise at exactly this point, so which party makes which registration is clarified before an order is placed.
Whether the duty arises depends on quantity. Where annual production or import stays below a certain threshold, a registration dossier may not be required; once the threshold is passed, the scope of the information required widens along with the quantity. Separate provisions exist for limited quantities used for research and development. Because thresholds, deadlines and exemptions are updated over time, the current position has to be confirmed with the competent authority.
The content of the registration dossier also changes with quantity. At the lower tiers the identity of the substance, its physical and chemical properties and basic safety information are required, while a broader data set is expected as the quantity rises. Above a certain threshold, carrying out a chemical safety assessment and defining exposure scenarios come into play as well. Preparing the dossier is often months of work, which is why the regulatory side is factored into shipping plans from the outset.
Exemptions are defined for some groups of substances. Whether a material falls within their scope is assessed substance by substance, on the basis of its composition and intended use rather than its name. Having that assessment made with an expert competent in this field guards against mistakes that are hard to correct later.
Classification and the flow of information
The registration regime does not work on its own; alongside it stands the classification and labelling regime. In Europe this function is served by the CLP Regulation, and in Türkiye by the regulation on the classification, labelling and packaging of substances and mixtures. Both are based on the globally harmonized system; how pictograms and hazard statements are read is explained in the article on GHS06.
The most visible everyday output of these frameworks is the safety data sheet. The sheet is the instrument that lets information flow downstream along the supply chain; the order of its sections is covered in the article on safety data sheets. It should be added that information does not travel downstream alone: if the buyer intends to use the substance in an unforeseen way, it is obliged to tell the supplier. A breakdown of the buyer's obligations is given in the article on buyer obligations.
Where do biologically sourced materials sit?
A material of living origin such as scorpion venom does not automatically occupy a separate place in this system. What is decisive is not that the source is biological but whether the material is placed on the market as a substance or a mixture. In practice the assessment is made according to how far the composition can be defined and what the intended use is.
For materials of complex composition, the hardest point is how the substance is to be defined. For a chemical consisting of a single molecule, the identity information is clear-cut; for a multi-component mixture, the definition is built as far as the analytical methods applied can show. Analytical data are therefore both an annex to the regulatory dossier and the ground it stands on.
For this reason, the route we follow is to document the material in as well-defined a state as possible. The safety data sheet prepared for our product is drawn up with reference to REACH, ISO 11014-1, (EU) 2020/878 and the KKDİK framework; the person who prepared it is a chemical assessment expert certified under TÜRKAK accreditation. The details of our documents are listed on the documents page.
Another practical point is not to confuse these rules with transport rules. Chemical legislation governs the substance itself and its placing on the market, whereas the rules applied during shipment come from a separate framework and are covered in the article on transport regulations. The two fields feed one another but do not take one another's place.
Regulatory texts are documents that get updated. What is described here is meant to introduce the general framework; before a shipping or registration decision is made, the texts in force and the current announcements of the competent authority must be taken as the basis.
