Regulatory

Information on the BPR

What does the BPR say?

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the making available 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.

What does the BPR 528/2012 mean for marketing companies?

Companies making available biocidal products on the market place will need authorisations for their biocidal products. They will have to invest in data specific to their formulations showing that these are safe and sufficiently efficacious. Approvals granted by the authorities of the different members states will allow the authorisation holders to sell their authorised products for 10 years in general before they must be reregistered.  

Fulltec´s role as Notifier

By defending Biocidal Active Substances, Fulltec is building the foundation for any biocidal product reaching the market addressing to the targets and uses. Fulltec takes responsibilty for the listing of the Active Substances on EU-level and it coordinates further action around product Task Forces helping the keep the cost for dossier set-up and regulatory fees on an acceptable level. Fulltec also helps to make sure that modern, safe and efficient biocidal products can be offered at a competitive price.


Timeline

Fullagreen® MPC High

Eucalyptus citriodora oil hydrated, cyclized (EC Oil (H/C)

* All biocidal products not yet notified at the National Poison Center of the country the product is marketed in, must be notified via PCN by January 01, 2021 (PC notification mandatory).
** Biocidal Consumer Products already successfully notified via a national body need to be compliant with the new system by January 01, 2025.

IMPORTANT: Biocidal consumer Products undergoing evaluation for authorisation in the period between January 01, 2021 and January 01, 2025 are recommended to be authorized according to the new PCN system as changes during the dossier evaluation will cost extra and endanger the success of the product authorisation processes. Explanation PCN: Poison Center Notification

Notice: Above timeline is the currently best possible approximation to when upcoming regulatory steps in the evaluation processes will take place.


Fullagreen® IGC

Geraniol Concentrate

* All biocidal products not yet notified at the National Poison Center of the country the product is marketed in, must be notified via PCN by January 01, 2021 (PC notification mandatory).
** Biocidal Consumer Products already successfully notified via a national body need to be compliant with the new system by January 01, 2025.

IMPORTANT: Biocidal consumer Products undergoing evaluation for authorisation in the period between January 01, 2021 and January 01, 2025 are recommended to be authorized according to the new PCN system as changes during the dossier evaluation will cost extra and endanger the success of the product authorisation processes. Explanation PCN: Poison Center Notification

Notice: Above timeline is the currently best possible approximation to when upcoming regulatory steps in the evaluation process will take place (one additional extended study has been requested by the eCA France, this may have an impact on the timing). If the AS-evaluation will be postponed to the study submission deadline of Nov 26, 2021, then the overall timing and each regulatory time step will be pushed back by 1 year. It is however possible that FRCA will make a note in the decision for AS-inclusion to deliver the end-points of the study and progress with the evaluation instead of waiting for the study outcome.

The moment the monitor will be aware of changes in the AS evaluation process, an updated version of the given timeline will be created and published.