Regulatory Support - Sanitizers

Registration of sanitizers without regulatory complications

Complete technical-scientific support: from risk assessment and DL50 calculation to registration, amendment and revalidation with ANVISA.

Stricter regulations for sanitizers

With the publication of RDC 989/2025 replacing RDC 59/2010, the requirements for registering sanitizers have been updated. Companies that fail to adapt face rejections and delays in marketing.

Risk classification (Risk 1 vs. Risk 2) requires technical mastery of DL50, pH, corrosivity and microbiological criteria. An error in classification can result in irregular marketing or unnecessary registration requirements.

Poorly-founded technical-scientific opinions generate cycles of requirements with ANVISA, delaying for months what could have been resolved in the first submission.

How SmartTox solves

We offer complete technical support for sanitizers, from formulation evaluation to publication of the registration in the DOU. Our analyses are conducted based on experimental data, predictive models and WHO methodologies, ensuring scientific rigor and regulatory compliance.

Detailed services

Risk assessment:

Technical-scientific human health risk assessment studies and estimates of toxicological parameters in accordance with ANVISA's RDC 989/2025 and RDC 682/2022.

Theoretical calculation of LD50:

Theoretical calculation of the Lethal Dose 50 by oral route according to the methodology recommended by the WHO, determining the risk classification of the product (Risk 1 or Risk 2) with precision.

Laboratory Studies:

Evaluation of toxicological, physico-chemical and microbiological studies to support the registration dossier with solid data accepted by ANVISA.

Registration, Amendment and Revalidation:

Complete handling of the product registration process, post-registration changes and revalidation with ANVISA, including company registration and formulation assessment.

Technical-Scientific Opinion:

Preparation of robust opinions that anticipate ANVISA's questions and reduce cycles of requirements, speeding up the approval of your product.

Why SmartTox

Mastery of RDC 989/2025 (new) and RDC 682/2022.

WHO methodology for theoretical calculation of LD50.

End-to-end support: registration, alteration and revalidation.

25+ years of expertise in regulatory toxicology.