Anvisa, through a Technical Note (NT), disclosed the positioning of the agency on the regularization of repellents applied to objects and fabrics. In the document decided that clothing, accessories for personal use, repellent or insecticide objects and fabrics, and repellent products or insecticides for application in these articles, should be regularized as sanitizers.
Repellents can be framed as sanitist or cosmetic (depending on the type of use). For a repellent to be registered as cosmetics, the company must submit a complete safety and efficacy dossier of the asset and the finished product.
Thus, the agency comes with the objective of standardizing the requirements of products with similar risk profile, namely, clothing, fabrics, accessories for personal use and repellent or insecticide objects, both repellent products or insecticides for application in these objects, as well as the impregnated objects themselves, will be framed as sanitizing products.
The guidelines of the Technical Note are intended for companies that manufacturer of such products that must meet the criteria for registration of sanitantes. The agency allowed to extend the application of cosmetic insect repellents, which are applied to the skin, for use in clothing and accessories, since it has proven that the product has effectiveness.
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The insect repellent has substances that are applied to the skin to ward off the approach of insects. ANVISA classifies the repellentas cosmetic, but in the case of registration of repellent clothing it should be classified as sanitante, until they have scientific evidence that affirm the efficiency of the same.
To start the process of how to register repellent in Anvisa it’s necessary to perform an analysis of its composition and classify the product according to it’s constitution.
Before we know how to register repellent clothing in ANVISA, the company that’ll manufacture the repellent needs to be regularized with the competent body.
For your company to be regularized with ANVISA, it’ll need to obtain the Operating License. It’s concession is made from a survey carried out in the establishment by the Local Sanitary Surveillance (VISA).
After the approval of the operating license is that the company has technical and operational conditions for the manufacture and storage of the repellent.
The Business Operating Authorization is a mandatory authorization for you to register repellent clothing with ANVISA. After the petition is sent to the National Health Surveillance Agency, and after it’s approval, the authorization will be published in the Official Gazette.
AFE means that the company is regularized with ANVISA and operates in accordance with Brazilian legislation, and without AFE it isn’t possible to register repellent clothing in ANVISA.
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