Laboratory management in the chemical and pharmaceutical industries is closely intertwined with legislation. Below is a summary of regulations directly relevant to a company operating and exporting from Türkiye.
1. Chemical legislation
Arrangement
Scope
Meaning from a laboratory/system perspective
UN GHS
The global framework for classification and labeling is revised every two years; the current version is the 11th revised edition.
The classification rule set must be versionable; affected products can be identified when transitioning to a new revision.
AB CLP
GHS stands for Classification, Labelling and Packaging Rules in the European Union.
Mandatory for exports to the EU; monitoring of harmonized classifications.
SEA Regulation
The Turkish equivalent of CLP is; Classification, Labelling and Packaging of Substances and Mixtures.
The primary reference point for supplying the domestic market.
KKDİK
Registration, evaluation, authorization and restriction of chemicals; the Turkish equivalent of REACH.
Monitoring the registration status of the substance, ensuring the consistency of the safety data sheet content with the registration data.
Safety data sheet rules
16-point standard structure and preparatory competence
The document must be prepared by a certified Chemical Assessment Expert, and the expert's knowledge must be included in section 16.
Transportation legislation
Transportation of hazardous materials by land, sea and air.
The UN number, class, and packaging group must be included in the product registration.
Poison control notification
The composition information of hazardous mixtures must be reported to the competent authority, along with a unique formula identifier.
Generating notification data from the prescription and transferring the identifier to the label.
Upcoming calendar: new hazard classes for mixtures.
The new hazard classes added to the CLP by the European Union — endocrine disruptors, persistent-bioaccumulative-toxic (PBT/vPvB) and persistent-mobile-toxic (PMT/vPvM) — came into effect on 1 May 2025; for mixtures, this date became effective on 1 May 2026. From this date onwards, mixtures placed on the market for the first time must also be assessed according to these classes. Transition periods have been granted for mixtures previously placed on the market.
Practical impact: especially in product groups such as industrial auxiliary chemicals, cleaning products, coatings and additives, a review of sections 2 (classification and labeling elements), 3 (composition) and 11 and 12 (toxicological and ecotoxicological information) is required. While businesses with a prescription-based classification infrastructure can perform this assessment collectively for the entire portfolio, those managing manually have to proceed product by product.
2. Pharmaceuticals and regulated industries
Good Manufacturing Practices (GMP): The laboratory is audited as an integral part of the production quality system; batch release decisions are based on laboratory findings.
Computerized systems: The most comprehensive revision of Annex 11 of the European Union Good Manufacturing Practices since 2011 was published as a draft on July 7, 2025; the five-page text was expanded into a document of approximately nineteen pages comprising seventeen chapters. The consultation period closed on October 7, 2025, and the final text is expected to be published in mid-2026. Along with the same package , a new annex and documentation section revision relating to AI-based systems was also introduced. The draft covers risk-based verification, supplier oversight, identity and access management, and for the first time, cybersecurity as a core requirement .
Electronic records and signatures: The regulations governing the validity of electronic records and signatures, as defined by their counterparts in the United States.
Data integrity guidelines: ALCOA+ principles, audit trail review obligation, and risks of hybrid (paper + electronic) systems.
Good Laboratory Practices (GLP): A quality system for planning and reporting safety assessment studies.
3. Accreditation and food
ISO/IEC 17025: Competence of testing and calibration laboratories; the basis of accreditation.
ISO 15189: Quality and competency requirements for medical laboratories.
Sustainability regulations: Requesting machine-readable information on material composition, restricted substances, and end-of-life data under a digital product passport — a new use for laboratory and product safety data.