Technology
& Regulation

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

The United States Toxic Substances Control Act (TSCA) provides authority to the United States Environmental Protection Agency (U.S.EPA) to regulate new chemicals. Under TSCA Section 5, manufacturer or importer of a new chemical must submit a Pre-Manufacturing Notification (PMN) to U.S.EPA for review before manufacturing or importing. On the other hand, if a new chemical is manufactured or imported at 10,000 kg/year or less, a Low Volume Exemption (LVE) can be submitted to U.S.EPA in lieu of a PMN. After the U.S.EPA approves the LVE, usually under certain conditions, the manufacturer or import can legally manufacture or import the new chemical in the U.S.

TSCA Section 8(e) requires that U.S.EPA be immediately notified when substances or mixtures present a substantial risk of injury to health or the environment. U.S.EPA considers TSCA Section 8(e) to be a critically important information gathering tool that serves as an "early warning" mechanism for keeping the Agency and others apprised of new-found serious chemical hazards and/or exposures.

REACH is the European Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which entered into force on June 1st 2007.
REACH regulations require every manufacturer/importer who produces/import more than one ton of a substance per year into the European Union to register the substance with the European Chemicals Agency. As part of the registration process, the importer/manufacturer is obligated to provide a registration dossier containing information about the substance's properties, its uses, key risks, and precautionary measures to be taken for each substance. Additionally, for the sake of transparency, it is required that specific information (which is not confidential) be available and flow along the supply chain to the end user.
Marketing approval under the Toxic Substances Control Act (TSCA) - The purpose of this law is to prevent unreasonable risks from new and existing chemicals to human health and the environment. In order to market its products in the USA, BioPHarms requires approval under this law.

Risk assessment by GAB: In this document the hazard of the final application of OxiLast with added NaDCC and subsequently its safety for use in hospitals was assessed. Extensive toxicological data for NaDCC is available and shows that it is safe for the use in hospitals and only has local effects. Due to the low concentration in the product this is of no concern. Dermal, oral and inhalation exposure was assessed semi-quantitatively for the available chlorine in the product OxiLast and it was shown that no risk for the professional user applying the product, nor the general public (staff and patients present in the hospital) is foreseen. In conclusion, the application of OxiLast containing NaDCC as active substance is considered safe for use in hospital.