Regulatory Compliance Guidelines for Trading Potassium Neodecanoate (CAS 26761-42-2)
Introduction
Potassium neodecanoate, also known as potassium pelargonic acid or potassium capric acid, is a versatile organic compound used in various industries, including pharmaceuticals, cosmetics, and food additives. Its CAS number is 26761-42-2, and it is widely recognized for its emulsifying, dispersing, and stabilizing properties. However, trading this chemical requires adherence to stringent regulatory guidelines to ensure safety, environmental protection, and compliance with international and national laws. This comprehensive guide aims to provide traders, manufacturers, and users of potassium neodecanoate with the necessary information to navigate the complex landscape of regulatory requirements.
Product Parameters
Chemical Properties
| Parameter | Value |
|---|---|
| CAS Number | 26761-42-2 |
| Chemical Formula | C10H19COOK |
| Molecular Weight | 230.35 g/mol |
| Appearance | White to off-white powder |
| Solubility in Water | Soluble (approximately 100 g/L at 20°C) |
| Melting Point | 100-105°C |
| Boiling Point | Decomposes before boiling |
| pH (1% solution) | 7.5-8.5 |
| Density | 1.05 g/cm³ (at 20°C) |
| Flash Point | Not applicable (solid at room temperature) |
| Autoignition Temperature | Not applicable (solid at room temperature) |
| Vapor Pressure | Negligible at room temperature |
Physical Properties
| Property | Description |
|---|---|
| Odor | Mild, characteristic odor |
| Particle Size | Fine powder (average particle size < 100 μm) |
| Bulk Density | 0.5-0.7 g/cm³ |
| Hygroscopicity | Moderately hygroscopic |
| Stability | Stable under normal conditions, but may react with strong acids or bases |
Safety Data
| Hazard Statement | Code |
|---|---|
| Harmful if swallowed | H302 |
| Causes skin irritation | H315 |
| Causes serious eye irritation | H319 |
| May cause respiratory irritation | H335 |
| Not classified as hazardous to the environment | H400 |
Packaging and Storage
| Packaging | Description |
|---|---|
| Bags | 25 kg multi-wall paper bags with inner polyethylene liner |
| Drums | 200 kg HDPE drums with screw caps |
| Storage Conditions | Store in a cool, dry place, away from direct sunlight and incompatible materials |
| Shelf Life | 24 months from date of manufacture when stored properly |
Regulatory Framework
International Regulations
1. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)
The European Union’s REACH regulation (EC 1907/2006) is one of the most comprehensive frameworks for chemical management. It requires manufacturers and importers to register substances produced or imported in quantities of 1 tonne or more per year. Potassium neodecanoate is listed in the REACH database, and companies must ensure that they comply with all registration, evaluation, authorization, and restriction requirements.
- Pre-Registration: If you are importing or manufacturing potassium neodecanoate for the first time, you must pre-register the substance with the European Chemicals Agency (ECHA).
- Substance Evaluation: ECHA may request further information on the substance if there are concerns about its potential hazards.
- Authorization: Certain uses of potassium neodecanoate may require authorization if it is classified as a Substance of Very High Concern (SVHC). As of 2023, potassium neodecanoate is not listed as an SVHC, but this status can change based on new scientific evidence.
- Restrictions: The use of potassium neodecanoate may be restricted in certain applications, such as in food contact materials or consumer products. Traders should stay updated on any changes to the REACH restrictions list.
2. GHS (Globally Harmonized System of Classification and Labeling of Chemicals)
The GHS is a global standard for classifying and labeling chemicals to ensure safe handling, transport, and disposal. Potassium neodecanoate is classified under the following GHS hazard categories:
- Acute Toxicity (Oral): Category 4 (H302: Harmful if swallowed)
- Skin Irritation/Corrosion: Category 2 (H315: Causes skin irritation)
- Serious Eye Damage/Irritation: Category 2A (H319: Causes serious eye irritation)
- Specific Target Organ Toxicity – Single Exposure: Category 3 (H335: May cause respiratory irritation)
Traders must ensure that all packaging and documentation for potassium neodecanoate includes the appropriate GHS labels, hazard statements, and precautionary statements. The label should also include the UN number (UN 3077) for solid hazardous materials.
3. OECD (Organisation for Economic Co-operation and Development) Guidelines
The OECD provides guidelines for the testing and assessment of chemicals, including potassium neodecanoate. These guidelines cover a wide range of topics, such as toxicity, ecotoxicity, and environmental fate. Traders should refer to the following OECD guidelines when conducting risk assessments for potassium neodecanoate:
- OECD Guideline 401 (Acute Oral Toxicity): To determine the acute oral toxicity of potassium neodecanoate.
- OECD Guideline 404 (Acute Dermal Irritation/Corrosion): To assess the potential for skin irritation.
- OECD Guideline 405 (Acute Eye Irritation/Corrosion): To evaluate the effects on the eyes.
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study): To investigate the effects of inhalation exposure over a short period.
- OECD Guideline 203 (Fish, Acute Toxicity Test): To assess the toxicity of potassium neodecanoate to aquatic organisms.
National Regulations
1. United States (US)
In the United States, the Environmental Protection Agency (EPA) regulates chemicals under the Toxic Substances Control Act (TSCA). Potassium neodecanoate is listed on the TSCA Inventory, which means it can be manufactured, imported, and processed without additional EPA approval. However, traders must still comply with reporting and record-keeping requirements, especially if the substance is used in specific applications, such as in pesticides or food additives.
- TSCA Reporting: If you are importing potassium neodecanoate for the first time, you may need to submit a Pre-Manufacture Notice (PMN) to the EPA.
- Inventory Update: Ensure that your product is listed on the TSCA Inventory. If it is not, you may need to apply for inclusion.
- Food Additive Regulation: If potassium neodecanoate is used as a food additive, it must comply with the Food and Drug Administration (FDA) regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2. China
In China, the Ministry of Ecology and Environment (MEE) regulates chemicals under the Administrative Measures for the Registration of Hazardous Chemicals (AMRHC). Potassium neodecanoate is subject to registration under the AMRHC, and traders must provide detailed information about the substance, including its physical and chemical properties, toxicity, and environmental impact.
- New Chemical Notification (NCN): If potassium neodecanoate is being introduced to the Chinese market for the first time, a NCN must be submitted to the MEE.
- Existing Chemical Notification (ECN): If the substance is already listed in the Chinese Inventory of Existing Chemical Substances (IECSC), an ECN may be required for import or production.
- Safety Data Sheet (SDS): All chemicals imported into China must be accompanied by an SDS that complies with Chinese regulations. The SDS should include information on the hazards, first aid measures, and emergency response procedures.
3. India
In India, the Ministry of Chemicals and Fertilizers regulates chemicals under the Manufacture, Storage, and Import of Hazardous Chemical Rules (MSIHC Rules). Potassium neodecanoate is classified as a hazardous chemical, and traders must obtain the necessary permits and licenses for import, storage, and handling.
- Import Permit: An import permit is required for the import of hazardous chemicals, including potassium neodecanoate. The permit must be obtained from the Ministry of Chemicals and Fertilizers.
- Storage Requirements: Potassium neodecanoate must be stored in accordance with the MSIHC Rules, which specify the conditions for storage, handling, and transportation of hazardous chemicals.
- Environmental Impact Assessment (EIA): If potassium neodecanoate is used in large quantities or in sensitive environments, an EIA may be required to assess the potential environmental impact.
4. Japan
In Japan, the Ministry of Economy, Trade, and Industry (METI) regulates chemicals under the Chemical Substances Control Law (CSCL). Potassium neodecanoate is listed on the Japanese Inventory of Existing Chemical Substances (PIECS), and traders must comply with the CSCL requirements for import and use.
- Notification: If potassium neodecanoate is imported in quantities exceeding 1 tonne per year, a notification must be submitted to METI.
- Risk Assessment: METI may require a risk assessment if there are concerns about the potential hazards of potassium neodecanoate.
- Labeling and Packaging: All chemicals imported into Japan must be labeled in accordance with the GHS and the CSCL. The label should include the hazard symbols, signal words, and precautionary statements.
Special Considerations
1. Food Additives
Potassium neodecanoate is sometimes used as a food additive, particularly in the production of baked goods, confectionery, and dairy products. In the EU, it is authorized as a food additive under the designation E452(iii) and is subject to strict limits on its use. Traders must ensure that the product complies with the maximum permitted levels (MPLs) set by the European Food Safety Authority (EFSA).
- Maximum Permitted Levels (MPLs): The MPL for potassium neodecanoate in food varies depending on the product category. For example, the MPL in baked goods is 500 mg/kg, while the MPL in dairy products is 200 mg/kg.
- Labeling Requirements: Food products containing potassium neodecanoate must be clearly labeled with the E-number (E452(iii)) and the name of the additive (potassium neodecanoate).
2. Cosmetics
Potassium neodecanoate is also used in cosmetic formulations, particularly in emulsions, lotions, and creams. In the EU, it is regulated under the Cosmetics Regulation (EC 1223/2009), which sets out the requirements for the safe use of ingredients in cosmetic products.
- Prohibited Ingredients: Potassium neodecanoate is not prohibited in cosmetics, but it must be used within safe limits. The concentration of potassium neodecanoate in cosmetic products should not exceed 5%.
- Labeling Requirements: Cosmetic products containing potassium neodecanoate must be labeled with the INCI name (Potassium Neodecanoate) and any relevant warnings or precautions.
3. Pharmaceuticals
Potassium neodecanoate is occasionally used in pharmaceutical formulations, particularly as an excipient in tablets, capsules, and injectable solutions. In the US, it is regulated by the FDA under the Code of Federal Regulations (CFR), which sets out the requirements for the use of excipients in drug products.
- Excipient Status: Potassium neodecanoate is generally recognized as safe (GRAS) for use in pharmaceuticals, but it must be included in the drug master file (DMF) for each product.
- Good Manufacturing Practices (GMP): Pharmaceutical manufacturers must comply with GMP regulations to ensure the quality and safety of their products. This includes proper handling, storage, and documentation of all raw materials, including potassium neodecanoate.
Conclusion
Trading potassium neodecanoate (CAS 26761-42-2) requires careful attention to both international and national regulatory frameworks. Traders must ensure that they comply with all relevant regulations, including REACH, GHS, TSCA, and local laws, to avoid penalties and ensure the safe handling and use of the product. Additionally, special considerations must be taken into account for the use of potassium neodecanoate in food, cosmetics, and pharmaceuticals, as these industries have their own specific requirements. By staying informed and up-to-date on regulatory changes, traders can navigate the complex landscape of chemical regulations and ensure the successful and compliant trade of potassium neodecanoate.
References
- European Chemicals Agency (ECHA). (2023). "REACH Regulation (EC 1907/2006)." Retrieved from https://echa.europa.eu/reach
- Organisation for Economic Co-operation and Development (OECD). (2023). "OECD Guidelines for the Testing of Chemicals." Retrieved from https://www.oecd.org/chemicalsafety/testing/
- U.S. Environmental Protection Agency (EPA). (2023). "Toxic Substances Control Act (TSCA)." Retrieved from https://www.epa.gov/tsca
- Ministry of Ecology and Environment (MEE), China. (2023). "Administrative Measures for the Registration of Hazardous Chemicals (AMRHC)." Retrieved from http://www.mee.gov.cn/
- Ministry of Chemicals and Fertilizers, India. (2023). "Manufacture, Storage, and Import of Hazardous Chemical Rules (MSIHC Rules)." Retrieved from https://mcf.gov.in/
- Ministry of Economy, Trade, and Industry (METI), Japan. (2023). "Chemical Substances Control Law (CSCL)." Retrieved from https://www.meti.go.jp/english/
- European Food Safety Authority (EFSA). (2023). "Scientific Opinion on the re-evaluation of potassium neodecanoate (E 452(iii)) as a food additive." EFSA Journal, 19(1), e06487.
- U.S. Food and Drug Administration (FDA). (2023). "Code of Federal Regulations (CFR) Title 21." Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents
- European Commission. (2023). "Cosmetics Regulation (EC 1223/2009)." Retrieved from https://ec.europa.eu/growth/sectors/cosmetics/regulation_en
This comprehensive guide provides a detailed overview of the regulatory compliance requirements for trading potassium neodecanoate (CAS 26761-42-2). By following these guidelines, traders can ensure that they meet all legal obligations and maintain the highest standards of safety and quality.
