2-Ethylhexanoic acid (CAS 149-57-5) is on the SVHC Candidate List under REACH Article 57(c) - reproductive toxicant Category 1B or 2. The SVHC listing triggers several immediate obligations for downstream users and importers regardless of whether the substance appears on Annex XIV.

• Article 33: Suppliers of articles containing >0.1% w/w 2-EHA must provide SVHC information to customers and consumers on request
• Article 7(2): Producers/importers of articles containing >0.1% 2-EHA must notify ECHA if production/import exceeds 1 tonne/year
• SCIP database: EU companies placing articles on the market must submit SVHC information to the SCIP database (Waste Framework Directive requirement since January 2021)

The REACH authorisation process (Annex XIV) requires companies to obtain authorisation from ECHA for continued use of SVHC substances in specified applications after a sunset date. As of early 2025, 2-EHA is on the SVHC Candidate List but has not yet been added to Annex XIV. However, the authorisation process is active for several reproductive toxicants, and the regulatory trajectory points toward potential Annex XIV listing for 2-EHA.

• Monitor ECHA's priority substance recommendations annually
• If added to Annex XIV, users would need to apply for authorisation or transition to INA / alternatives before the sunset date
• This regulatory uncertainty is one of the key drivers for proactive IOA → INA substitution in EU formulations

Under 19 CFR 12.118–12.127, all importers of chemical substances subject to TSCA must certify at US Customs entry. For IOA, the Positive TSCA Certification applies:

• Include on commercial invoice or as a separate letter filed with CBP Form 7501
• IOA is on the Active TSCA Inventory - positive certification is straightforward
• No additional EPA approval or permit needed for commercial import

US importers of Chinese-origin IOA face potential Section 301 tariffs in addition to MFN duties. Carboxylic acids and derivatives under HS Chapter 29.15 have been subject to Section 301 actions in various tranches. The current tariff rate applicable to IOA from China (HS 2915.90) may include additional Section 301 duty of 7.5–25%. US buyers must:

• Confirm the exact 10-digit HTS classification for IOA with their customs broker
• Check current USTR Section 301 list and any applicable exclusions
• Factor Section 301 tariff into total landed cost comparison vs US domestic or non-China origin supply

The reproductive toxicity classification (H361 equivalent) that applies in the EU is also recognised under Japan's JIS GHS classification system - SDS for Japan must include this hazard.

Korea applies K-REACH CMR obligations more strictly than TSCA - the reproductive toxicity classification triggers enhanced worker protection requirements for companies handling >1 tonne/year in Korea.

Q1: Is 2-ethylhexanoic acid on the EU REACH SVHC Candidate List?

Yes - 2-ethylhexanoic acid (CAS 149-57-5, EC 205-743-6) was added to the REACH SVHC Candidate List under Article 57(c) on the basis of its reproductive toxicity classification (Repr. Cat. 2, H361). The Candidate List is a dynamic list maintained by ECHA; substances can be added or removed as new scientific evidence and regulatory decisions are made. To verify the current status, always check the ECHA SVHC Candidate List at echa.europa.eu/candidate-list-table - do not rely on any article (including this one) as the definitive current status. As of early 2025, 2-EHA remains on the Candidate List, triggering Article 33 downstream notification obligations and SCIP database requirements for companies placing articles containing >0.1% 2-EHA on the EU market.

Q2: What documents should an EU buyer request from a Chinese IOA supplier for REACH compliance?

For REACH compliance when importing IOA from China, request these documents: (1) REACH Only Representative (OR) letter - naming the EU OR company, the ECHA registration number for 2-EHA (CAS 149-57-5) and/or CAS 25637-84-7, and confirming EU importers purchasing from this manufacturer are covered by the registration; (2) Extended Safety Data Sheet (eSDS) - 16 sections plus attached exposure scenarios (ES) in your language, compliant with REACH Annex II (Regulation 2020/878), including DNEL values for reproductive systemic effects (inhalation and dermal); (3) SVHC declaration - confirming that 2-EHA is on the Candidate List and that Article 33 notifications may be required for your downstream products if IOA content exceeds 0.1% w/w in articles; (4) Certificate of Analysis - per batch (acid value, colour, water, RI); (5) Certificate of Origin - for import duty purposes. Sinolook Chemical provides all five documents for every EU IOA shipment.

Q3: Does the H361 classification apply to formulated products containing IOA (driers, stabilisers) as well as to the pure acid?

Yes - the H361 classification applies to mixtures (formulated products) containing IOA above the applicable classification threshold. Under EU CLP (and GHS generally), the cut-off/concentration limit for H361 in mixtures is 0.3% w/w for reproductive toxicant Category 2 substances: any mixture containing ≥0.3% of a Repr. Cat. 2 ingredient must carry the H361 classification on its own SDS and label. Cobalt isooctanoate drier solutions in mineral spirits typically contain 50–60% of cobalt isooctanoate by weight, which in turn is ~80% isooctanoate ligand - so the final drier solution contains substantial 2-EHA content and must carry H361. Similarly, liquid Ca/Zn one-pack stabilisers containing Ca/Zn isooctanoates will exceed the 0.3% threshold for the isooctanoate component and must declare H361 in their SDS. This cascade of H361 through the supply chain - from pure IOA to the derived metal soap products - is one of the key regulatory drivers for the industry to consider INA-based alternative products.

Q4: How does the SCIP database requirement affect companies using IOA?

The SCIP (Substances of Concern In articles as such or in complex objects/Products) database was established under the EU Waste Framework Directive (2008/98/EC, amended by 2018/851). Since 5 January 2021, EU companies that place articles containing SVHC at >0.1% w/w on the market must submit information to ECHA's SCIP database. For IOA, this applies to: end products (e.g., coating products formulated as articles) if the 2-EHA content in the article is >0.1%; intermediate products (e.g., drier solutions in metal containers) if the container with contents is treated as a complex article and 2-EHA content is >0.1%. The SCIP database requirement does not apply to plain chemical substances or mixtures (SDS/supply chain communication covers these). In practice, most drier and stabiliser manufacturers who formulate with IOA and sell to industrial chemical users (not direct consumer articles) are primarily affected by the Article 33 customer notification obligation rather than SCIP directly - but this depends on how their products are characterised under EU waste law. Consult your legal counsel on the SCIP applicability for your specific product portfolio.

Q5: Is IOA restricted under China's Hazardous Chemicals Catalogue and what does this mean in practice?

Yes - isooctanoic acid is listed in China's Hazardous Chemicals Catalogue (危险化学品目录, 2022 edition), which triggers a specific set of operational requirements for Chinese companies producing, storing, or trading IOA. In practice, this means: Chinese IOA manufacturers must hold a Hazardous Chemical Production Licence (危险化学品生产许可证) from the relevant provincial safety authority; storage facilities must comply with the Regulations on Safe Management of Hazardous Chemicals and pass safety inspection; all personnel handling IOA must complete formal hazardous chemical safety training; chemical accident emergency response plans must be prepared and filed with local authorities; Chinese-language safety data sheets (Chinese SDS format per GB/T 16483) must be provided to domestic customers. For international buyers, the practical implication is that legitimate Chinese IOA suppliers should be able to produce their hazardous chemical production licence upon request - this is a basic qualification check that distinguishes a properly licensed manufacturer from informal traders. Sinolook Chemical holds all required Chinese hazardous chemical licences and can provide copies upon request.

Q6: If I switch from IOA to INA to avoid H361, do I need to re-register under REACH?

If you are a downstream user (DU) of IOA who switches to purchasing INA from your supplier (rather than IOA), you do not need to file a new REACH registration yourself - registration is the obligation of manufacturers and importers, not downstream users. What you need to do: (1) Update your SDS - the new SDS for INA will not include H361, GHS08, or SVHC notifications; distribute updated SDS to your customers; (2) Update Article 33 / SCIP notifications - once you have switched to INA, your products no longer contain an SVHC (if INA is the only isooctanoic acid-type component); Article 33 and SCIP obligations cease to apply; (3) Update chemical inventory - change the CAS number in your chemical management system from 149-57-5/25637-84-7 to 26896-18-4; (4) Verify INA's REACH registration - confirm with your INA supplier that they have an EU OR and that INA is registered under REACH (CAS 26896-18-4); (5) Inform your OR - if you have been listed as using IOA under a specific OR's registration dossier, notify the OR that you have changed raw material; the OR can update the identified use records. The substitution is administratively manageable for most downstream users; the main effort is updating SDS, informing customers, and verifying the INA registration chain.