New review program
Since its entry into force in September of Regulation No. 58/2012 on biocides, several changes have been made, including a new amendment which repeals the review programme of active substances (Delegated Regulation No. 1062/2014). The introduction of a new review programme is now leading to new processes and procedures detailed in the PDF file below (P.2). Let us recall the main aspects:
Notification
The notification is framed by ECHA (European Chemicals Agency). The three cases where you are obliged to submit a notification described in the publication below on pages 2 and 3. The notification is a submission made to ECHA. It incurs costs (10,000 euros), which will be refunded after submission of the application file of the active substance. You can appeal against decisions if necessary. In some cases, you can apply for inclusion in the review program. This is particularly the case when a biocidal product placed on the market consists of an existing active substance which is neither approved nor included in Annex I to Regulation nor included in the review programme for the type of product. For more information, see our PDF on page 3.
Computer tools
Current versions of the software tools are R4BP IUCLID 3.1.2 and 5.6. Visit our publication for information on these software and functionality.
Treated articles
The restrictions will be maintained for the use of an active substance in an article if the substance presents an identified hazard. There are also special rules for specific labeling and complex items. You can find answers in our PDF pages 5 and 6.
Questions ?
Any questions regarding the biocides regulation and the changes to come? Do not hesitate to consult EcoMundo services for Biocides regulations or directly contact our experts who will answer your questions! contact@ecomundo.eu
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New review program
Since its entry into force in September of Regulation No. 58/2012 on biocides, several changes have been made, including a new amendment which repeals the review programme of active substances (Delegated Regulation No. 1062/2014). The introduction of a new review programme is now leading to new processes and procedures detailed in the PDF file below (P.2). Let us recall the main aspects:
Notification
The notification is framed by ECHA (European Chemicals Agency). The three cases where you are obliged to submit a notification described in the publication below on pages 2 and 3. The notification is a submission made to ECHA. It incurs costs (10,000 euros), which will be refunded after submission of the application file of the active substance. You can appeal against decisions if necessary. In some cases, you can apply for inclusion in the review program. This is particularly the case when a biocidal product placed on the market consists of an existing active substance which is neither approved nor included in Annex I to Regulation nor included in the review programme for the type of product. For more information, see our PDF on page 3.
Computer tools
Current versions of the software tools are R4BP IUCLID 3.1.2 and 5.6. Visit our publication for information on these software and functionality.
Treated articles
The restrictions will be maintained for the use of an active substance in an article if the substance presents an identified hazard. There are also special rules for specific labeling and complex items. You can find answers in our PDF pages 5 and 6.
Questions ?
Any questions regarding the biocides regulation and the changes to come? Do not hesitate to consult EcoMundo services for Biocides regulations or directly contact our experts who will answer your questions! contact@ecomundo.eu
