Dow Biocides Submits Initial Dossiers for European Biocidal Product Directive

As part of its continued investment, Dow Biocides (a business unit of The Dow Chemical Company (Dow)) has recently submitted completed dossiers to the European Union (EU) authorities as part of the requirements of the Biocidal Products Directive (BPD), meeting the July 31, 2007 deadline. Each dossier contains 15-20 binders full of toxicology, environmental, risk assessment, efficacy data and technical and safety information on our key biocidal actives that relate to in-can preservatives; metalworking preservatives; and the disinfectant product group which covers human hygiene, private area & public health area disinfectants; veterinary hygiene; food & feed area disinfectants and drinking water disinfectants.

“Registration in the BPD is a fundamental part of our continued business strategy for the long term sustainability of the biocides industry,” said Welmoed Clous, Dow Biocides product stewardship and regulatory leader. “The BPD represents one of the highest levels of regulatory approvals needed in the world. We remain committed to our biocide products through the registration process, and believe that the financial and people resources necessary to achieve BPD registration will help sustain our products in the long term.”

“After 2010 when the BPD comes into full effect, our customers will need to rely on their biocide suppliers to have met all applicable regulations for their region,” said Nanette Hermsen, global marketing manager for Dow Biocides. “Backed by regulatory, toxicological research and environmental research expertise along with Dow’s product stewardship leadership, Dow Biocides is well positioned to support the products that our customers have found most effective for their individual applications. Combining our extensive product portfolio with best-in-class application expertise, we will continue to guide our customers into identifying and using the best biocide for their application well after full implementation of the BPD.”

Prior to 1998, biocide regulations for use in Europe were country-dependent and varied from having no specific regulations to heavy regulatory approval requirements like that of the United States Environmental Protection Agency (EPA).

In 1998 however, the BPD was created to harmonize regulatory requirements for biocides within the member states, and provide mutual recognition of product authorization. The BDP has two main objectives:

Establish a high level of protection for humans and for the environment
Eliminate barriers to trade by harmonizing processes for using/selling biocidal products within the EU

All active substances that were already on the market before May 2000 are subject to a transitional period of 10 years (until 2010) until the provisions of the BPD are implemented in full. Current national approval requirements will continue to exist through 2010.

The BPD describes biocides as preparations containing one or more active substances that are intended to control harmful organisms by either chemical or biological means. Its classification is broken down into 23 product types, or application categories, with several of those including different subgroups.

Under the BPD, the approval system requires two regulatory submissions for a biocidal product to continue to be marketed: the first, which has just been completed, focuses on active substances. The second level will look at each formulated biocidal products and will be submitted in 2009/2010.

For each individual dossier, Dow Biocides is required to submit data and information related to:

Biocidal efficacy
Use and application
Toxicology
Ecotoxicological properties
Risk Assessments

The dossiers will now be reviewed by the appointed Rapporteur Member State. At the end of the evaluation process, which is expected during late 2008/2009, if no major comments or restrictions in use are applied, the active substance will be listed on Annex I of the BPD, meaning the active is approved for use in biocidal products. Formulated products will still need to be authorized after that date.

While the current dossiers are under evaluation, work has not slowed down for Dow Biocides regulatory and EH&S teams. BPD biocidal active dossiers for additional product groups are due in October 2008.

For a more detailed overview of the European Biocidal Products Directive, please visit the European Commission website : http://ec.europa.eu/environment/biocides/index.htm

®™^* Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow


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Each dossier contains 15-20 binders full of toxicology, environmental, risk assessment, efficacy data and technical and safety information on our key biocidal actives that relate to in-can preservatives; metalworking preservatives; and the disinfectant product group which covers human hygiene, private area & public health area disinfectants; veterinary hygiene; food & feed area disinfectants and drinking water disinfectants. “Registration in the BPD is a fundamental part of our continued business strategy for the long term sustainability of the biocides industry,” said Welmoed Clous, Dow Biocides product stewardship and regulatory leader. “The BPD represents one of the highest levels of regulatory approvals needed in the world. We remain committed to our biocide products through the registration process, and believe that the financial and people resources necessary to achieve BPD registration will help sustain our products in the long term.” “After 2010 when the BPD comes into full effect, our customers will need to rely on their biocide suppliers to have met all applicable regulations for their region,” said Nanette Hermsen, global marketing manager for Dow Biocides. “Backed by regulatory, toxicological research and environmental research expertise along with Dow’s product stewardship leadership, Dow Biocides is well positioned to support the products that our customers have found most effective for their individual applications. Combining our extensive product portfolio with best-in-class application expertise, we will continue to guide our customers into identifying and using the best biocide for their application well after full implementation of the BPD.” Prior to 1998, biocide regulations for use in Europe were country-dependent and varied from having no specific regulations to heavy regulatory approval requirements like that of the United States Environmental Protection Agency (EPA). In 1998 however, the BPD was created to harmonize regulatory requirements for biocides within the member states, and provide mutual recognition of product authorization. The BDP has two main objectives: Establish a high level of protection for humans and for the environment Eliminate barriers to trade by harmonizing processes for using/selling biocidal products within the EU All active substances that were already on the market before May 2000 are subject to a transitional period of 10 years (until 2010) until the provisions of the BPD are implemented in full. Current national approval requirements will continue to exist through 2010. The BPD describes biocides as preparations containing one or more active substances that are intended to control harmful organisms by either chemical or biological means. Its classification is broken down into 23 product types, or application categories, with several of those including different subgroups. Under the BPD, the approval system requires two regulatory submissions for a biocidal product to continue to be marketed: the first, which has just been completed, focuses on active substances. The second level will look at each formulated biocidal products and will be submitted in 2009/2010. For each individual dossier, Dow Biocides is required to submit data and information related to: Biocidal efficacy Use and application Toxicology Ecotoxicological properties Risk Assessments The dossiers will now be reviewed by the appointed Rapporteur Member State. At the end of the evaluation process, which is expected during late 2008/2009, if no major comments or restrictions in use are applied, the active substance will be listed on Annex I of the BPD, meaning the active is approved for use in biocidal products. Formulated products will still need to be authorized after that date. While the current dossiers are under evaluation, work has not slowed down for Dow Biocides regulatory and EH&S teams. BPD biocidal active dossiers for additional product groups are due in October 2008. For a more detailed overview of the European Biocidal Products Directive, please visit the European Commission website : http://ec.europa.eu/environment/biocides/index.htm ®™^* Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow
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