Chemical & Product Regulatory Outlook – Focus beyond the EU Market

  • August 21, 2025
  • Reachlaw Marketing

In this issue, we highlight key chemical and product regulatory developments in Ukraine, India, Türkiye, South Korea and the UK. These regions have introduced REACH-like frameworks and expanding product compliance obligations, creating a complex landscape for companies placing chemicals and regulated products on these markets.

Ukraine and Türkiye are progressing toward their respective 2026 registration deadlines, each featuring distinct timelines and processes. In the UK, a public consultation is currently underway to consider extending the UK REACH transitional registration deadlines. Meanwhile, India continues to expand its BIS certification scheme by adding new product categories, with several compliance deadlines already scheduled for 2025 and 2026; and in South Korea, authorities continue to monitor compliance with K-REACH and its associated post-registration obligations, as well as requirements affecting products under K-BPR.

From chemical substance registration to BIS product certification, early preparation will be key to meeting upcoming obligations and avoiding market disruption. Let’s explore the specific requirements and what actions you should prioritize in 2025 to ensure seamless compliance in 2026.

Ukraine

Ukraine REACH: New Obligations and Early Deadlines

Ukraine’s REACH-like regulation entered into force on 26 January 2025. A one-year pre-registration phase is now underway, ending on 26 January 2026. Full registration deadlines vary depending on tonnage bands and hazard classifications.

Key Registration Deadlines:

  • 26 January 2026: CMR substances (Category 1A/1B) ≥1 t/y; substances with high aquatic toxicity (acute or chronic) ≥100 t/y
  • 1 October 2026: Substances ≥1,000 t/y
  • 1 June 2028: Substances 100–1,000 t/y
  • 1 March 2030: Substances 1–100 t/y
What You Should Do Now:
  • Assess the tonnage and hazard classification of substances placed on the Ukrainian market.
  • Review your role in the supply chain and evaluate your in-house capabilities for handling Ukraine REACH pre-registration and registration.
  • If you are a non-Ukrainian manufacturer or formulator, identify a qualified and trustworthy Only Representative in Ukraine.
  • Ensure pre-registration is submitted by 26 January 2026 for all applicable substances.
  • Prepare and provide Safety Data Sheets (SDSs) in Ukrainian to downstream users.
  • Once pre-registration is done, begin preparing for full registration under Ukraine REACH.

India

New Quality Control Orders (QCOs) and the Omnibus Technical Regulation (OTR) in India

The Government of India is intensifying its regulatory oversight on product quality and consumer safety through the implementation of QCOs across a wide range of product categories. These include industrial chemicals, steel, aluminium, non-ferrous metals, furniture, toys, and many more. Machinery, and electrical/electronic equipment fall under the newly introduced Omnibus Technical Regulation (OTR).

Under these QCOs, compliance requires compulsory BIS certification for both local and foreign manufacturers of the mentioned product categories. Non-compliance may lead to enforcement actions, including import restrictions, product recalls, and penalties.

India BIS Certification – Key Compliance Deadlines include:

· 12 September 2025: Ethylene Dichloride, Vinyl Chloride Monomer, Polycarbonate

· 17 October 2025: Non-ferrous metals (e.g., lead, nickel, zinc, tin)

· 13 February 2026: Furniture (e.g., work chairs, beds, storage units)

· 19 March 2026: Electrical appliances (≤250V single-phase / ≤480V other systems)

· 1 September 2026:

  • Machinery and electrical equipment under OTR
  • All types of pumps for handling liquids, liquid elevators and (or) their assemblies, sub-assemblies and components covered under OTR.

It’s important to note that the examples above represent only a portion of the products subject to India BIS certification. As of today, there are 1000+ products under different BIS certification scheme, reflecting the wide scope and growing reach of these regulatory requirements.

Immediate Steps:

To ensure uninterrupted access to the Indian market and to mitigate potential business risks, local and foreign manufacturers should act swiftly:

  • Identify applicable Indian Standards and determine whether your product falls within the scope of any notified QCO or the OTR.
  • Initiate the BIS certification process well ahead of the respective deadlines. Certification can be time-consuming due to requirements such as product testing, factory audits (for Foreign Manufacturers Certification Scheme (FMCS)), and documentation review.
  • Update technical documentation as per BIS requirements.
  • Appoint an Authorised Indian Representative (AIR) if you are a foreign manufacturer. The AIR is responsible for India BIS compliance and acts as the local contact for BIS.
  • If you are an importer, supplier or a distributor based in India who supplies products under the scope of India BIS – without manufacturing them – must ensure that their foreign manufacturing partners obtain India BIS certification for their products by the respective certification deadlines.
  • Assess supply chain impacts, especially if components or finished goods are sourced internationally.

Early preparation is critical. India’s regulatory environment is becoming more stringent, with an increasing number of product categories being brought under mandatory BIS certification. Businesses must adopt a structured compliance approach involving legal review, technical assessment, and certification execution. Early engagement with BIS and accredited labs, as well as consultation with regulatory experts, can help avoid delays, penalties, or loss of market access.

Türkiye

KKDIK: Time to Speed Up Registration Preparations

The Turkish Ministry of Environment, Urbanization and Climate Change (MoEUCC) has finally published the “Procedures and Principles” regarding the Implementation of the Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (KKDİK). This effort marks a significant advancement in the regulatory framework governing the chemical industry in Türkiye.

The KKDİK regulation, published on June 23, 2017, aims to ensure the safe production, importation, and use of chemicals in alignment with European Union standards. The Ministry has developed a Türkiye-specific registration for process to facilitate KKDIK compliance while safeguarding environmental and human health.

KKDIK: Key Elements and Deadlines

Chemical manufacturers and importers are required to submit full information on the physicochemical properties, usage patterns, exposure scenarios, and toxicological profiles of substances subject to KKDİK registration through the Ministry’s Chemical Registration System (KKS) by the respective registration deadlines in 2026, 2028 and 2030.

Key upcoming deadlines:

·   Pre-registration submission 31.10.2025

·   Lead Registrant selection: 31.12.2025

·   Provisional registration:

  • Lead dossier submission: 31.03.2026
  • Member dossier submission: 30.09.2026

Provisional Registration: When and which data

In the event that the selected KKDIK lead registrant is unable to fulfill its obligations concerning full registration, a provisional registration shall be submitted to the MoEUCC by March 31, 2026, containing the data specified in Annex 1 of the recently published Procedures and Principles.

Information Requirements for Provisional Registrations (Annex 1)

Lead registrant companies (and companies registering individually) must provide the following information for provisional registration in the corresponding section numbers from the Chemical Registration System (KKS) as follows:

1.    Substance Identification (KKS Section 1.1)

1.1    Substance Composition (KKS Section 1.2)

1.2    Analytical Information (KKS Section 1.4)

1.3    Suppliers: In this section, companies shall enter the names of their downstream users and keep this information up-to-date. This update is free of charge. (KKS Section 1.7)

1.4    Joint Submission (KKS Section 1.5)

2.    Globally Harmonized System (GHS Section 2.1)

3.    Manufacturing, use, and exposure information (KKS Section 3)

3.1    Estimated Quantities (KKS Section 3.2)

3.2    Sites (KKS Section 3.3)

3.3    Information on mixtures (KKS Section 3.4)

3.4    Use and exposure information (KKS Section 3.5)

3.5    Uses advised against (KKS Section 3.6)

4.    Physical and Chemical Properties (KKS Section 4)

5.    Guidance on safe use (KKS Section 11)

Please note that:

– Member Companies shall enter the information requirements specified in items 1 and 3 above into the relevant sections of the KKS by 30.09.2026

– Provisional registration is not applicable to companies that complete and submit their full registration dossiers by 31 March 2026.

What to Do in 2025:
  • Ensure all your substances have been pre-registered (late pre-registration is still possible until 31.10.2025).
  • Define your role in the registration process: co-registrant or lead registrant (until 31.12.2025).
  • Begin preparing the respective registration dossiers for your substances affected by KKDIK 2026 registration deadline.
  • Engage with a qualified Turkish OR if you’re a non-Turkish manufacturer/formulator.
  • Confirm that submissions will be signed off by certified professionals, as required by KKDIK – Therefore, if you are appointing an OR for KKDIK compliance, make sure they have certified professional in-house.

South Korea

Ongoing Compliance Requirements under K-REACH and K-BPR

Companies manufacturing or exporting chemical substances and consumer chemical products to South Korea must comply with two key regulatory frameworks: the Act on Registration and Evaluation of Chemicals (K-REACH) and the Consumer Chemical Products and Biocides Safety Control Act (K-BPR). Both involve not only initial registration or verification but also ongoing compliance duties essential for maintaining uninterrupted market access.

K-REACH: Registration Deadlines and Post-Registration Obligations

Under K-REACH, substances manufactured or imported into South Korea in quantities of ≥1 tonne/year must be registered with the Ministry of Environment by their respective deadlines:

  • 31 Dec 2021: Substances >1,000 t/year and CMR substances >1 t/year
  • 31 Dec 2024: Substances >100 – 1,000 t/year
  • 31 Dec 2027: Substances >10 – 100 t/year
  • 31 Dec 2030: Substances >1 – 10 t/year

Companies that missed a registration deadline must ensure full registration is completed before manufacturing or importing the substance into Korea. Failure to do so can result in customs clearance issues, enforcement actions, and market entry delays.

Beyond registration, companies are subject to post-registration obligations, most notably the mandatory provision of safety information to downstream users in Korea. This includes:

  • Registration number and unique substance identifier
  • Substance name
  • Classification and labeling
  • Intended/restricted uses
  • Hazard and risk information
  • Safe use, handling, and disposal instructions
  • Emergency measures and supplier contact details

This information must be provided once registration is complete and upon request. Foreign companies may appoint an Only Representative (OR) to manage these obligations on their behalf.

K-BPR: Compliance for Consumer Chemical Products Subject to Safety Verification

The K-BPR regulates both biocides and consumer chemical products used in households, offices, and public facilities. A specific subset of consumer products – those designated as “subject to safety verification” by the Ministry of Environment – are subject to strict pre-market requirements. These are typically everyday products such as detergents, air fresheners, and fabric softeners that may pose chemical exposure risks.

For consumer chemical products subject to safety verification, companies must ensure compliance with the following requirements before the products can be placed on the Korean market:

  • Conduct product testing through a designated laboratory in Korea
  • Submit a safety verification dossier including a full list of ingredients and product specifications to the Ministry of Environment
  • Ensure labeling meets Korean standards
  • Renew safety verification every three years

Foreign manufacturers cannot appoint an Only Representative for these products and must instead work directly with their Korean importers, who are responsible for regulatory submissions. Confidentiality can be a concern, as ingredient-level information must be shared with both importers and authorized laboratories, even when submitted via Korea’s digital portal.

Key Actions for Companies
  • Check registration status for all substances under K-REACH and meet the respective deadline.
  • If a deadline has passed, complete full registration before the substances are placed on the South Korean market.
  • Provide downstream users with mandatory safety and handling information post-registration.
  • Identify whether your product is a consumer chemical product subject to safety verification under K-BPR.
  • Coordinate with Korean importers to ensure testing, documentation, and labeling requirements are met.
  • Plan for three-year renewals and maintain up-to-date regulatory information.

Given the complexity of Korea’s chemical regulatory framework, companies are strongly encouraged to take a proactive compliance approach and consult regulatory experts to ensure full and ongoing market access.

Great Britain

UK REACH: Proposed Extension of Transitional Registration Deadlines

The UK government is currently consulting stakeholders on proposals to extend the transitional registration submission deadlines under UK REACH. These deadlines that were originally set for October 2026, 2028, and 2030 are linked to the tonnage and hazard profile of chemical substances placed on the Great Britain (GB) market.

Why Deadline Extensions Are Needed

Due to ongoing development of the Alternative Transitional Registration model (ATRm), the necessary legislative changes and transition arrangements cannot be completed before the current first deadline in October 2026. As a result, the UK government is proposing new, extended deadlines to ensure businesses have adequate time to prepare.

Proposed New Deadlines (Under Consultation)

  • Option 1 (Government’s Preferred): October 2029, October 2030, October 2031
  • Option 2: April 2029, April 2031, April 2033
  • Option 3: April 2029, April 2030, April 2031

Option 1 offers a two-year transition period and sufficient time for the finalization and implementation of ATRm.

The government is also seeking views on proposals to adjust the compliance check deadlines under Article 41(5) of UK REACH. Currently aligned with the original registration deadlines, these checks (covering 20% of dossiers) would also be rescheduled in line with any new submission dates.

This consultation is open until 8th of September 2025.

2025 Actions:
  • Participate in the Public Consultation: Contribute with your feedback to the ongoing public consultation. Your insights will have a direct impact on the implementation timeline and help ensure a balanced, pragmatic approach for both regulators and industry stakeholders.
  • Review and Prepare Your Substance Portfolio: Carefully assess your substance list and, where eligible, submit DUINs or inquiries by joining the relevant Substance Group to actively participate in data-sharing activities.
  • Monitor ATRm Developments: Stay up to date on the evolving transitional registration model (ATRm) to proactively adapt to changing regulatory requirements.
  • Stay informed about Regulatory Changes: Consistently monitor updates and guidance from HSE to ensure your compliance remains aligned with the latest regulatory developments.
  • Appoint an Only Representative if Needed: If you are a manufacturer or formulator based outside the Great Britain market, consider appointing a qualified Only Representative to support your UK REACH compliance efforts.

Act Early to Secure Market Access

With significant regulatory changes on the horizon, 2025 stands as a pivotal year to establish and refine your compliance strategy. Proactive action will minimize risk, strengthen your supply chains, protect your market presence, and future-proof your business operations.

For expert guidance and support, reach out to us at sales@reachlaw.fi. Our team is ready to assist your company as your Only Representative, AIR, or service provider across the regions covered in this newsletter.

More information can be found here:

www.reachlaw.fi

Türkiye KKDIK: Procedures and Principles Published: https://kimyasallar.csb.gov.tr/kimyasallarin-kayit-surecine-iliskin-usul-ve-esaslar-belirlendi-/377

Ukraine REACH: https://www.youtube.com/watch?v=Suxoqva3U2k ; https://www.reachlaw.fi/ukraine-reach-draft-rules-for-joint-submission-of-information-published-public-consultation-ongoing/ ; https://www.reachlaw.fi/ukraine-reach-and-clp/

India BIS Licence: https://www.youtube.com/watch?v=Bb2Fzeqbkaw ; https://www.reachlaw.fi/india-bis-licence-scheme-x/; https://www.reachlaw.fi/india-bis-services/

Türkiye KKDIK: https://www.youtube.com/watch?v=HddvpYqWBsA ; https://www.reachlaw.fi/reachlaw-turkey/

K-REACH: https://www.youtube.com/watch?v=kFJBkn9yCXg

K-BPR: https://www.reachlaw.fi/k-bpr-verification-for-consumer-chemical-products-and-its-impact-on-foreign-manufacturers/

UK REACH – ATRm: https://www.youtube.com/watch?v=idUlW6j5kik; https://www.reachlaw.fi/services/uk-reach-services/

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