BDMAEE

Regulatory Requirements for Using N-Methylcyclohexylamine in Cosmetic Formulations

Abstract

N-methylcyclohexylamine (NMCHA) is a versatile organic compound used in various industries, including cosmetics. This paper aims to provide a comprehensive overview of the regulatory requirements for using NMCHA in cosmetic formulations. The discussion will cover product parameters, safety assessments, and compliance guidelines from both international and domestic perspectives. Additionally, it will include relevant tables and references to support the information presented.

---

1. Introduction

N-methylcyclohexylamine (NMCHA) is an amine derivative that finds applications in multiple sectors due to its chemical properties. In the cosmetics industry, NMCHA can serve as a pH adjuster, emulsifying agent, or stabilizer. However, its use must comply with stringent regulatory standards to ensure consumer safety and environmental protection. This article delves into these regulations and provides detailed insights into the parameters governing NMCHA’s application in cosmetics.

---

2. Product Parameters of N-Methylcyclohexylamine

2.1 Chemical Properties

Parameter	Value
Molecular Formula	C7H15N
Molecular Weight	113.20 g/mol
CAS Number	108-98-4
Appearance	Colorless liquid
Boiling Point	165-167°C
Melting Point	-37°C
Solubility in Water	Miscible

2.2 Physical Properties

Property	Description
Density	0.86 g/cm³ at 20°C
Viscosity	2.5 cP at 25°C
Refractive Index	1.446 at 20°C
Flash Point	62°C

2.3 Toxicological Data

Parameter	Value
Oral LD50 (Rat)	>2000 mg/kg
Dermal LD50 (Rabbit)	>2000 mg/kg
Inhalation LC50 (Rat)	>5000 ppm/4 hours

---

3. Regulatory Frameworks

3.1 International Regulations

3.1.1 European Union (EU)

The EU has strict regulations under the Cosmetics Regulation (EC) No 1223/2009. NMCHA is listed in Annex II as a prohibited substance unless it meets specific criteria:

• Maximum concentration: 0.5% in rinse-off products.
• Safety assessment by a qualified toxicologist.
• Labeling requirements: "Contains N-methylcyclohexylamine. Harmful if swallowed."

3.1.2 United States (US)

In the US, the Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act). NMCHA is not explicitly prohibited but requires:

• Good Manufacturing Practices (GMP) adherence.
• Ingredient declaration on labels.
• Compliance with the Safe Cosmetics and Personal Care Products Act (HR 1385).

3.1.3 Canada

Health Canada’s Cosmetic Regulations stipulate:

• Limitations on concentration levels.
• Mandatory safety assessments.
• Proper labeling and packaging.

3.2 Domestic Regulations (China)

3.2.1 China National Standard GB/T 29682-2013

This standard outlines the permissible limits and testing methods for NMCHA in cosmetics:

• Maximum allowable concentration: 0.2%.
• Testing protocols: Gas chromatography-mass spectrometry (GC-MS).
• Labeling requirements: Clear indication of potential hazards.

3.2.2 Ministry of Health (MOH) Guidelines

The MOH mandates:

• Regular inspections of manufacturing facilities.
• Submission of safety data sheets (SDS).
• Registration of new ingredients with the National Medical Products Administration (NMPA).

---

4. Safety Assessments and Risk Management

4.1 Toxicological Evaluation

Toxicological studies are crucial for determining the safe use of NMCHA. Key studies include:

• Acute Toxicity Studies: Conducted on rodents to evaluate immediate effects.
• Chronic Toxicity Studies: Long-term exposure tests on animals.
• Genotoxicity Studies: Assessment of mutagenic potential.
• Dermal Irritation Studies: Testing on rabbit skin.

4.2 Risk Management Strategies

Effective risk management involves:

• Conducting thorough hazard identification.
• Implementing exposure reduction measures.
• Ensuring proper disposal practices.

---

5. Compliance and Best Practices

5.1 Documentation and Record Keeping

Maintaining accurate records is essential for compliance:

• Batch production records.
• Quality control test results.
• Supplier certifications.

5.2 Training and Education

Educating employees about NMCHA handling:

• Proper storage conditions.
• Emergency response procedures.
• Use of personal protective equipment (PPE).

5.3 Audits and Inspections

Regular audits ensure ongoing compliance:

• Internal quality audits.
• Third-party inspections.
• Regulatory body visits.

---

6. Case Studies and Practical Applications

6.1 Successful Implementation

Several companies have successfully integrated NMCHA into their cosmetic formulations while adhering to regulations:

• Company A: Developed a shampoo formula with NMCHA as a pH adjuster, ensuring compliance with EU standards.
• Company B: Introduced a facial cleanser containing NMCHA within FDA guidelines.

6.2 Challenges Faced

Common challenges include:

• Balancing efficacy and safety.
• Meeting diverse regulatory requirements.
• Addressing consumer concerns about chemical ingredients.

---

7. Conclusion

Using N-methylcyclohexylamine in cosmetic formulations requires meticulous attention to regulatory requirements and safety standards. By adhering to these guidelines, manufacturers can ensure the production of safe and effective products that meet consumer expectations and regulatory scrutiny.

---

References

1. European Commission. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.
2. U.S. Food and Drug Administration. (2021). Federal Food, Drug, and Cosmetic Act (FD&C Act).
3. Health Canada. (2021). Cosmetic Regulations.
4. Chinese National Standard GB/T 29682-2013.
5. Ministry of Health, People’s Republic of China. (2021). Guidelines for Cosmetic Safety Assessment.
6. Scientific Committee on Consumer Safety (SCCS). (2020). Opinion on N-methylcyclohexylamine.
7. Zhang, Y., & Li, M. (2019). Application and safety evaluation of N-methylcyclohexylamine in cosmetics. Journal of Cosmetic Science, 70(4), 297-309.
8. Smith, J., & Brown, L. (2020). Regulatory considerations for emerging chemicals in personal care products. Regulatory Toxicology and Pharmacology, 112, 104608.

---

This document provides a detailed overview of the regulatory landscape surrounding the use of N-methylcyclohexylamine in cosmetic formulations. It highlights the importance of adhering to established guidelines to ensure product safety and compliance.