Comprehensive Support in the Compliance of Your Biocidal Products
Overcome biocide compliance challenges with expertise: simplify regulations, master deadlines, and ensure a smooth transition through transitional measures and permanent authorizations.
Navigate Regulatory Challenges Related to Transitional Measures and Market Authorization
Mastering the Implementation of Transitional Measures in the European Market
Regulation (EU) No 528/2012, replacing Directive 98/8/EC, concerns any business involved in the manufacture, import, use, or marketing of biocidal products or treated articles. This regulation establishes rules for the list of approved active substances, the authorization of biocidal products at the national or Union level, and the marketing of treated articles.
During the evaluation of biocidal active substances, the re-examination program, initiated under Directive 98/8/EC and framed by Delegated Regulation (EU) No 1062/2014, has established transitional measures. This program is expected to conclude by 2030. During this period, national provisions specific to each Member State continue to apply to biocidal products.
Response and evaluation times by authorities can be considerably long during this transitional period, adding a time factor to regulatory complexity.
Market Authorization, the Key to Avoid Sales Disruptions of Your Biocidal Products
A key substance in your products is about to be approved at the European level? Once this approval is in place, you could face the inability to continue marketing your products. To avoid withdrawing your products from the market and ensure the continuity of your sales, it is essential to submit a Market Authorization (MA) dossier before the approval of this active substance, or be covered by such a dossier.
An expert in biocidal product compliance in Europe, EcoMundo accompanies you in creating and filing Market Authorization (MA) dossiers, whether for a single product or a family of biocidal products.
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