KKDIK (Turkish REACH): SDS Rules and Registration Deadlines
KKDIK (Türkiye REACH) compliance is tightening: the 2025 procedures require accurate submissions through the Ministry’s chemical systems, updated SDS formats (Annex 2), and joint registration (“One Substance–One Registration”), with staged registration deadlines running to 2030. This briefing also covers India’s machinery safety order, withdrawn in January 2026, and the EU’s New Legislative Framework revision, now folded into the proposed European Product Act.
Table of Contents
Chemical rules, product framework reform and one withdrawn safety mandate are reshaping regulatory strategy across key markets. Here’s what’s changed — and what it means for your file.
🇮🇳 India Machinery & Electrical Equipment Safety Order: Withdrawn January 2026
The "Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024" required that the manufacture, import and sale of machinery and electrical equipment meet national and international safety standards. It has since been withdrawn.
It defines machinery categories, applicable technical standards, and conformity assessment processes. The regulation emphasizes essential safety principles from IS 16819:2018 and ISO 12100:2010, as well as additional Type B and Type C standards. Initially issued in 2024 and amended in 2025, the mandatory implementation date is set for September 1, 2026.
Status: Withdrawn. BIS Scheme X certification for the machinery categories once covered by the Order — compressors, centrifuges and filtering machines, cranes, construction and mining machinery, electrical machinery, switchgear, motor starters and converters, textile machinery, metal cutting and processing machines and machine tools, industrial packaging and plastic processing equipment — is now voluntary rather than a condition of market entry.
📌 What This Means for Manufacturers
- Keep the safety file you built for Scheme X — IS 16819:2018 and ISO 12100:2010 alignment still carries weight for multi-market SKUs, and voluntary certification remains available.
- Re-check your bill of materials: withdrawing the Order does not touch other mandatory BIS Quality Control Orders, so components and electrical equipment may still need ISI marking or CRS registration.
- Treat machinery safety certification in India as a commercial and liability decision now, not a border requirement — buyers and insurers may still ask for it.
🇹🇷 KKDIK (Turkish REACH): SDS Upload and Joint Registration Rules
The procedures and principles (usul ve esaslar) under the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK, or Turkish REACH) were published on 5 August 2025. The underlying regulation itself dates from 23 June 2017.
These rules set out how registration, evaluation, authorisation and restriction work for chemical substances and mixtures in Türkiye. Any substance manufactured in or imported into Türkiye at 1 tonne or more per year must be registered under the "One Substance–One Registration" principle, through a joint registration group led by a lead registrant.
Registration is staged by tonnage and hazard. Substances at 1,000 tonnes/year or more, substances at 100 tonnes/year or more classified for acute or chronic aquatic hazard (H400/H410), and CMR Category 1A/1B substances at 1 tonne/year or more must be fully registered by 31 December 2026. Substances at 100 tonnes/year or more follow by 31 December 2028, and everything else at 1 tonne/year or more by 31 December 2030. The interim registration window for member companies closed on 30 September 2026, so a substance that missed it needs a full registration dossier to stay on the market.
Safety data sheets must be prepared under the Annex 2 (EK-2) headings and uploaded to the Ministry of Environment, Urbanisation and Climate Change through its dedicated SDS software, reached via the Integrated Environmental Information System (e-ÇBS). Section 16 must carry the name, contact details and certificate number of the certified Chemical Assessment Expert (Kimyasal Değerlendirme Uzmanı, KDU) who prepared the sheet.
Status: In force. KKDIK applies to any company placing substances, mixtures or substances in articles on the Turkish market at or above the registration threshold — EU REACH registration does not cover it.
📌 What This Means for Manufacturers
- Appoint a Turkish legal entity — an importer or an Only Representative — to hold the registration; a non-Turkish manufacturer cannot register directly.
- Confirm your position in the joint registration group for each substance, and check that the lead registrant's dossier actually covers your tonnage band and uses.
- Have your SDSs reissued in the Annex 2 format by a certified KDU — a sheet that only meets the EU CLP format will not be accepted.
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🇪🇺 EU New Legislative Framework (NLF) Revision: Digital CE + DPP + Surveillance
The NLF is the legal foundation for harmonised product legislation in the EU. It sets out essential requirements, conformity assessment procedures, CE marking rules and the basis for market surveillance.
The framework rests on Regulation (EC) No 765/2008 and Decision No 768/2008/EC. The Commission is revising both as part of the proposed European Product Act, a package that also reopens the Market Surveillance Regulation (EU) 2019/1020 and the Standardisation Regulation (EU) No 1025/2012. The announced direction is digital by default: a wider digital product passport regime, digital CE marking, and provisions on remanufacturing and high-quality recycling.
Stronger compliance and market surveillance across the whole product lifecycle are also emphasised, with e-commerce oversight a stated priority.
Status: Proposal pending. Regulation (EC) No 765/2008 and Decision No 768/2008/EC continue to apply unchanged; the European Product Act has not yet been published by the Commission, and nothing in it is enforceable until it is adopted and in force.
📌 What This Means for Manufacturers
- Start building digital product passport capability against the sectoral rules that already mandate it — the Batteries Regulation and the revised Toy Safety Regulation — rather than waiting for the horizontal framework.
- Re-evaluate remanufactured product strategies in light of stricter traceability and CE marking expectations.
- Monitor updates to EU harmonised standards — market access could be affected if surveillance flags non-conformities.
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