BIOCIDES
assessments ; and in the costs and efforts associated with the approval process .
Review participants have exclusive access to accurate information on the status of the dossiers , potential risks and risk mitigation measures . They defend and advocate the use of the active substance and support customers for their product authorisations on the market . In addition , they are always up to date with current regulatory developments and new requirements .
Article 95-listed companies are those that have applied under Article 95 ( 1 ) of the BPR and whose application has been found to be compliant by ECHA . The list includes participants in the review programme , supporters of new active substances who have submitted a dossier under Article 11 of Directive 98 / 8 / EC or Article 7 of the BPR , and suppliers who have access to or refer to a full active substance dossier .
Article 95 ensures that all companies placing active substances on the market are treated equally . This applies to both active substance suppliers and product suppliers . To be included in the Article 95 list , companies must meet the data requirements to operate on the market .
Case study
In recent years increasing regulatory pressure has led to a situation where important biocidal actives , which are used in major industries , have been restricted or banned and related biocidal products containing them are phased out . A current example of this is the pressure on the active ingredient di-bromo-nitrilopropionamide ( DBNPA ), for which Lanxess has been leading advocacy under the BPR .
The company has made significant investments , including stakeholder activation and position papers . However , the approval process for DBNPA is still ongoing , with public consultations and member state surveys currently underway . The outcome remains unclear .
Companies must anticipate substance phase-outs and seek alternative solutions , which are scarce or unavailable for specific uses . The non-approval of DBNPA will impact the entire production process of water-based substances , covering areas such as process hygiene and raw material sanitation . This could significantly affect end products like industrial water-based goods or paper produced by paper mills .
Generally speaking , review participants need to secure adequate financial returns through sufficient volumes to justify both the effort and investment in substance defence . This case study shows that the future of preservation systems depends greatly on collaboration between the industry and the review participants .
There are several steps for companies to follow in order to navigate the regulatory landscape . End users need to communicate with the review participants to get reliable and updated information about the status of the substances , the potential risks and the mitigation measures . They also need to support the review participants in defending and advocating for their specific use of the substances .
Ensuring high quality products
The aforementioned regulatory challenges threatens to reduce the number and use of active substances , making it harder for the end-use customer to properly preserve largescale industrial products , including paints and coatings , adhesives , detergents , polymer emulsions and construction materials .
The majority of remaining biocidal active substances have technical disadvantages , such as lower temperature and pH stability , a limited spectrum of activity or lower efficacy compared to state-of-the-art biocides . The occurrence of contaminated or defective products will further increase so that producers need to
defend existing systems and look for alternative solutions to maintain the high quality in their industrial products .
It is evident that the solution to this problem demands a holistic approach , one that moves beyond mere preservation . Emphasis must be placed on raw material control , monitoring and stringent hygiene within the production facilities .
This comprehensive strategy is the only viable path to sustainably overcome future challenges within preservation . Intensive collaboration between producers and biocide manufacturers can not only defend and thereby save existing active substances but can also explore all other possibilities for a safe and clean production .
Conclusion
The future of biocidal substances is uncertain due to increasing regulatory pressure . However , by actively participating in the review and approval processes , collaborating with review participants , and advocating the use of active substances , companies can navigate these challenges and ensure the sustainability of their preservation systems . ● J j
Monika Lamoratta
GLOBAL TECHNICAL MANAGER
LANXESS monika . lamarotta @ lanxess . com www . lanxess . com
34 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981