Quality & regulatory
Driven by expertise, our Quality & Regulatory team guarantees materials that excel in performance, compliance, and sustainability. We don’t just meet standards — we set them. With us, reliability and innovation go hand in hand. Our commitment: chemistry you can rely on, today and for the future.
Axcentive takes total responsibility for protecting the regulatory status of our products. With ongoing changes in the field, such as NADA in the US, BPR and REACH in Europe ,we maximize the synergy of close cooperation with partners, where experts on safety, health, environment and regulatory affairs are -already for decades- familiar with our products.
We are unique in the fact that we have a substantial package of toxicology data available for our products which makes us optimally positioned to support our products for regulations such as BPR and REACH.
You can rest assured that we will continue to comply with all relevant regulations.
Regulatory service
AXCENTIVE takes full responsibility for protecting the regulatory status of its products. This includes ensuring that our substances and products are appropriately registered, supported, and listed in relevant regulatory inventories worldwide. In a constantly evolving regulatory landscape, including U.S. FDA requirements, BPR, REACH, UK-REACH, and Pharmacopeias’ standards, we monitor regulatory changes. We maximize the synergies of close cooperation with experienced partners and regulatory experts in safety, health, environmental, and regulatory affairs, who have been familiar with our products for decades.
AXCENTIVE is uniquely positioned through its extensive and robust toxicological data packages supporting its product portfolio. This strong scientific foundation enables efficient and reliable compliance with international regulatory frameworks, while supporting long-term regulatory sustainability.
Please note that the use of AXCENTIVE products may be subject to local regulations, and additional registrations or authorisations may be required depending on the country of use. We therefore encourage customers and partners to consult their local authorities or contact AXCENTIVE directly for further information on the regulatory and registration status applicable in their country.
The Science behind Sol-Gel
Understanding the molecular mechanisms that enable ultra-thin functional coatings.
European Regulatory Compliance and Stewardship
It is our policy to comply with the most stringent regulations, and we therefore carefully follow the developments at ECHA (European Chemical Agency) to stay in line with the requirements the REACH regulation imposes on us.
Among the various products we offer, we are Lead Registrant for 4 products: PTSC, PTSA, OTSA and Ketjenflex®9S.
In Europe, our Halamid® complies with the Directive 98/8/EC and the Biocidal Product Regulation (EU/528/2012) for the product types 2, 3, 4 and 5. This makes Halamid® a Europe-wide registered disinfectant for virtually all relevant disinfectant applications. Until finalization of the BPD/BPR program, the national registrations apply. Axcentive is listed on the Article 95 as a substance and product supplier.
Quality system
AXCENTIVE’s Quality Management System (QMS) is designed to ensure the highest standards of reliability, compliance, and continuous improvement across all our activities. Built on structured processes, risk-based thinking, and data-driven decision-making, our QMS governs how we develop, manufacture, and deliver our products while meeting applicable regulatory and customer requirements. Through robust documentation, regular performance monitoring, and a continuous improvement-oriented attitude, AXCENTIVE is committed to product excellence, operational efficiency, and long-term customer satisfaction.
Contact us
Speak to our sales team
Please do not hesitate to contact our team if you have any questions.
Our teams are always ready to help and support you.