Guidelines for Registering Hair Straightening Cosmetic Products with ANVISA.

ANVISA (National Health Surveillance Agency) determines the risk classification of hair straighteners by assessing the ingredients in their formulation and evaluating potential risks associated with product use. Given that certain chemicals in hair straighteners may present health risks, ANVISA categorizes these products into distinct risk classes.

The risk classification is generally divided into three categories:

Risk I (Low Risk): Products with minimal potential for causing health harm when used as directed. Generally, such products incorporate ingredients deemed safe within suitable concentrations.

Risk II (Medium Risk): Products that carry a potential health risk if not used appropriately. Typically, these products feature ingredients that may trigger adverse reactions if not applied in accordance with instructions or in cases of prolonged skin contact.

Risk III (High Risk): Products with an elevated potential to inflict health damage, particularly if utilized incorrectly. Typically, these products consist of ingredients that can present substantial health risks.

Prohibited or Restricted Products:

Certain ingredients or formulations may be deemed so hazardous that the product is either prohibited or subject to restrictions on use.

The precise classification of a hair straightener hinges on factors such as the product's formulation, concentrations of ingredients, and other safety considerations. It's crucial to be aware that ANVISA may revise its regulations and classifications. Therefore, staying informed by checking the latest information or reaching out directly to Stone Okamont for specific details on the updated risk classification for hair straighteners is always advisable.

The registration process for hair straighteners at ANVISA encompasses a series of essential steps to ensure adherence to regulations. Here is a general guide on how this process unfolds:

Complete Documentation:

Compilation of thorough documentation, encompassing details about the product's formulation, manufacturing methods, stability studies, safety and efficacy data, among other pertinent information.

Categorization:
Categorization of the product into the relevant category, taking into account the nature of the hair straightener and ensuring adherence to specific regulations governing this product type.

Labeling According to Regulations:

Creation of labels that adhere to ANVISA regulations, incorporating mandatory details about ingredients, usage instructions, precautions, and manufacturer contact information.

Good Manufacturing Practices (GMP):

Embracing and showcasing adherence to Good Manufacturing Practices, guaranteeing that the manufacturing process aligns with rigorous quality and safety standards.

Testing for Safety and Efficacy:

Performing laboratory tests to substantiate the safety and efficacy of the product, thereby verifying its alignment with the manufacturer's claims.

Require help with the registration process for your hair straightening product and feeling uncertain about where to begin? Rely on Stone Okamont; we specialize in streamlining the bureaucratic aspects of product registration, ensuring a more efficient experience for you. Reach out to us for assistance.