Last fall marked a turning point in the European Unions regulation of formaldehyde-releasing biocides used in metalworking fluids. As of September 1, 2013, the European Chemicals Agencys 1998 directive on the use of biocides became a regulation, known as the Biocidal Product Regulation. However, the law – which mandates that all active substances in biocide products must be approved before they are authorized for the marketplace – will roll out in increments over the next few years.
All manufacturers, suppliers, producers and importers of biocides will need to send a dossier or letter of authorization for each product or product family with data on all active substances, along with fees starting at 40,000 per product or product type. The dossier or LoA must be submitted to an ECHA member state of choice by September 1, 2015. After that, the sale of products with substances that have not been included on the approved list will no longer be permitted. But even though sales of products with non-approved substances wont be allowed, manufacturers will still be able to legally use those products for an additional year. Non-approved products are not fully banned until September 1, 2016.
This three-year rollout period presents some issues, Lubrizols Dr. Uwe Falk told the 2013 UEIL Congress in Brussels, Belgium, in October 2013. Falk, the global commercial manager of biocides at Lubrizol, presented an update on the changes to the ECHA regulations.
First, he noted that effective April 2015, the ECHAs Committee for Risk Assessment mandates a reclassification of formaldehyde to both Category 1B Carcinogen and Mutagen Category 2. This means that formaldehyde is presumed to have carcinogenic potential for humans, based primarily on animal evidence, and that they are suspected to cause cancer in high exposure scenarios. Falk stressed that until late 2016, biocides containing carcinogenic substances such as formaldehyde and formaldehyde-releasers may still be present in the metalworking workplace, even if they fall under these newly mandated categories.
Furthermore, those who comply with the regulation early face a competitive disadvantage. There is really no obligation to pay any fee to continue sales [of non-approved biocides products] until September 1, 2015, Falk said. And its very costly, he continued, pointing to a list of regulatory costs that include registration fees, product fees, fees for changes, annual fees and varying individual country fees.
However, having products approved ahead of time can also be a selling point to customers, an industry expert told LubesnGreases, adding that meanwhile, its up to the industry to continue to provide safe products, with or without regulations.