Risk assessment of refills for hand disinfectant dispensers and their use

Hand disinfectants are sold in ready-to-use containers, but are also offered as refills for dispensers or smaller bottles (pump applicators or otherwise). Therefore, for dispensing and refilling, the risks must also be assessed. For hand disinfectants that are assessed under the Biocidal Products Regulation (BPR), during the March 2022 CA meeting the following agreements were made:

  1. A separate risk assessment should be conducted for dispensing and refilling (in dispensers or smaller bottles – pump applicators or otherwise). This use should be specified in the summary of product characteristics (SPC). The available packaging, intended for refills, and the corresponding dispensing system should also be specified in the SPC.
  2. The dispenser or container that has been refilled must have at least the following labelling information:
    a. The authorisation number
    b. The trade name of the biocidal product
    c. The identity and concentration of each active substance
    d. The instructions for use, including the exposure time required for the biocidal effect
    e. The information according to CLP (if applicable)
  3. In those cases where refilling is not part of the assessment, it was agreed to include the the following sentence in the SPC: ‘Use only the original packaging. Not for refilling or transferring into other containers/devices.’

Where relevant, the Ctgb will consider these agreements when assessing applications. When submitting an application, an applicant must indicate whether the product will also be used for refills, including information on the packaging to be used for this purpose and the specifications of the dispensing system. In addition, the applicant should include information on the dispensers/containers for refilling with the hand disinfectant.

See the full document CA-March22-Doc.4.4 Hand disinfectants (PT 1) to be used with dispensers and refilled containers (clarification on risk assessment, SPC and labelling/information on dispensers and refilled containers)