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Article 95 list under the Biocidal Products Regulation: Stay on the market with your biocidal product after 1 September 2015

Posted Date: 
Wednesday, December 10, 2014

This news update regarding the Article 95 list under the Biocidal Products Regulation is brought to you by ECHA

From 1 September 2015, a biocidal product consisting of, containing, or generating a relevant substance, cannot be placed on the EU market if the substance supplier or product supplier is not included in the Article 95 list for the product type(s) to which the product belongs. An updated guidance is now available. 

ECHA reminds all companies producing or marketing biocidal products to make sure that their substance or product suppliers are added to the Article 95 list under the Biocidal Products Regulation.
From 1 September 2015 onwards, a biocidal product consisting of, containing, or generating a relevant substance, cannot be placed on the EU market unless the substance supplier or product supplier is included in the list for the product type(s) to which the product belongs.

To make sure that the product stays legally on the market, companies need to:

  • Ensure within their supply chain that the first EU company in the supply chain applies to be on the Article 95 list.
  • Start their preparations in time, especially for data-sharing negotiations.
  • Submit the application in time to allow ECHA to assess it by 1 September 2015.
  • Allow sufficient time to cover the need to provide additional data if the ECHA draft decision is negative.

The guidance on active substances and suppliers has also been updated. It explains the obligations for companies in light of the revisions to Article 95 which came into force on 25 April 2014.

For more information regarding Article 95 list under the Biocidal Products Regulation please visit the ECHA link above. Please contact Nexreg for Regulatory Services

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International Lubricants, Inc. has been very pleased with the international regulatory compliance services that Nexreg Compliance Inc. provides to us. These services range from the generation of OSHA/WHMIS MSDS to CCCR compliance label reviews. We can rely upon the accuracy of their information and their attention to detail. In addition, their project turnaround times are excellent.
Wayne Everett, Ph.D., International Lubricants, Inc.