BIOCIDES
The evaluation process is vital for maintaining public safety , but it also puts significant strain on manufacturers of biocidal actives and products . This pressure could result in the removal of essential active ingredients from the market , due to the lack of suitable alternatives . Without these , the quality of the final products will decline .
This situation has become even more severe recently due to discussions on endocrine-disrupting properties and related requests to provide additional data to prove that biocidal active substances are not endocrine-disrupting . The tightening of regulations in this area of testing poses significant challenges .
New data must be provided to assess the potential impact of active substances on the endocrine system of humans and on the environment . This stringent process ensures that only biocidal active substances meeting the highest safety standards are approved for use in the EU , but it also increases compliance costs and the risk of losing market access for substances with endocrine-disrupting properties or other properties ( e . g . carcinogenic , mutagenic and reprotoxic ( CMR ) classification ) meeting the exclusion criteria of the BPR as outlined in Article 5 ( 1 ).
The companies supporting the approval of the active substance cover most of these risks and costs . They are referred to as review participants and are actively participating in the evaluation processes to support active substances and biocidal products . Substance dossier preparation is the basis for active substance approval and product authorisation , and is a key activity for review participants . By submitting a dossier , review participants show their commitment to the active and its safe and effective use in biocidal products in many aspects . They are directly involved in discussions with authorities on substance properties and exposure
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