How to regulate sanitizers?

A sanitizing product is any substance or preparation intended to sanitize, disinfect, pest control, clean, purify, or deodorize environments, objects, utensils, or water. In other words, these are products used for cleaning and disinfecting various places, surfaces, and materials.

These products are regulated and must meet safety and efficacy criteria established by the competent authorities in each country. It is important to follow the manufacturer's instructions for use and storage to ensure effectiveness and prevent health risks.

Registration of sanitizers is required in various situations, especially when it comes to products that pose a higher risk to human health and the environment. Some examples of these risks include:

Sanitizers posing health risks:

Products classified as high-risk to human health, such as sanitizers used in healthcare settings (hospitals, clinics, offices), sanitizers used in food services, sanitizers used in water treatment systems for air conditioning, and sanitizers used in pools.

Sanitizers posing environmental risks:

Products that pose significant risks to the environment, such as sanitizers used in water treatment systems for human consumption and sanitizers used in air conditioning systems.

Highly effective sanitizers:

Products with claims of high efficacy, such as hospital disinfectants, sanitizers for eliminating specific pathogenic microorganisms, and products with long-lasting antimicrobial action.

In addition to these specific cases, ANVISA may require the registration of sanitizers in other situations if any health or environmental risks are identified.

These are products used for personal hygiene, household cleaning, or in communal environments. Some examples include:

• General-purpose detergents and cleaners;
• Bleaches, laundry detergents, and fabric softeners;
• General-use disinfectants;
• Dishwashing detergents;
• Air fresheners, odor neutralizers, and others.

It is worth noting that, although these categories of sanitizers are exempt from registration, they must still comply with quality, labeling, and packaging requirements established by ANVISA. Additionally, the registration exemption does not apply to sanitizers that fall into other categories or pose a higher risk to health or the environment.

Yes, in Brazil, an Operating Authorization for Companies (AFE) is required for companies wishing to manufacture, import, store, distribute, or engage in other activities related to sanitizers.

AFE is issued by the National Health Surveillance Agency (ANVISA) and aims to ensure that companies comply with good manufacturing and handling practices, ensuring the quality and safety of products.

To obtain an AFE for sanitizers, the company must meet the requirements established by ANVISA, which may include:

• Appropriate facilities;
• Technical documentation;
• Quality system;
• Qualified personnel, among others.

Once these requirements are met, the Operating Authorization for the Company can be requested, and a review of the process will be conducted. If approved, ANVISA will issue the AFE, which will have a specified validity period and must be renewed periodically.

Stone Okamont has experience in regulatory processes with the Brazilian Health Regulatory Agency (ANVISA). With personalized service, we understand the needs of each process and offer extraordinary solutions for registering sanitizers with ANVISA.

Contact us, request a quote, and obtain sanitizer registration.