Only 1 year left for Chrysanthemum cinerariafolium approval as biocidal active substance as insecticide (PT18) according to BPR.
The European Commission published on July 7th 2023 the approval date for Chrysanthemum cinerariafolium as an insecticide active substance in PT18.
Both Chrysanthemum cinerariafolium obtained with supercritical carbon dioxide and with hydrocarbon solvents will be approved as active substances according to BPR. The CAS and EC numbers of the substance Chrysanthemum cinerariafolium in its two chemical variants are the same: CAS 89997-63-7 and EC 289-699-3.
The substance is obtained from the extract of open and mature flowers of Tanacetum cinerariifolium (pyrethrum or Dalmatian pyrethrum) for use in insecticides. The substance (pyrethrin) is not only used as an insecticide, but companies also use it in the formulation of topical repellents to repel insects (PT19).
The approval date for Chrysanthemum cinerariafolium in PT18 is 1 February 2025.
Companies that formulate biocides with these two active substances, without incorporating other active substances that are still under review, must prepare a BPR authorisation application. Some of these insecticidal products also typically contain:
- PBO (Piperonyl butoxide): already approved for use as PT18
- Geraniol: still under review for use as PT18
- Permethrin: already approved for use as PT18
- Deltamethrin: already approved for use as PT18
- (1R)-trans-Phenothrin: already approved for use as PT18
- Cypermetrhin: already approved for use as PT18
MSCBS from Spain was the Competent Authority for the assessment of the biocidal active substance.
Spain was designated rapporteur Member State, and its competent authority for assessment submitted the evaluation report to the Commission. Following the submission of the evaluation report, the ECHA held several technical meetings (Biocides Committee) to decide on its approval as an active substance.
What do companies that market products with pyrethrins (Chrysanthemum cinerariafolium ext.) need to do now?
- Have a letter of access to the active substance Chrysanthemum cinerariafolium ext., obtained either with hydrocarbon solvents or with supercritical carbon dioxide. The letter of access must be provided by a licensed active substance supplier (art. 95 BPR).
- Understand the BPR requirements for the specific uses of your biocidal products.
- Define a current and future commercial strategy (5 or 6 years ahead) in the EU. This will be essential for marketing in other markets and completing the notification/registration procedures in those countries under their transitional laws (pre-BPR). The procedures must be completed before the approval of the active substance in BPR, as it will then be impossible to notify or register the product and it will not be able to be marketed until the authorities resolve the BPR application.
- Prepare a BPR application (which Nordiik can prepare) for the formulated biocidal products.
- Determine the applicable fees according to the marketing countries.
- Have the BPR application ready and submit it to the competent authorities before the approval date.
Do you need help registering your biocidal products? Nordiik is an expert in the EU Biocidal Products Regulation and can help you, contact us!
Source: European Commission
Download the approval documents for the active substances here:
- Chrysanthemum cinerariaefolium obtained with supercritical carbon dioxide: CELEX_32023R1429_EN_TXT
- Chrysanthemum cinerariafolium obtained with hydrocarbon solvents: CELEX_32023R1530_EN_TXT
