Geosil50 Achieves GB BPR Authorisation

Geosil50 Now GB BPR Authorised!

GEOSIL50 achieves Product Authorised Certificate UK-2020-1225 under EU Biocidal Products Regulation (EU BPR).

On the 16th June 2020, Zebec Systems Ltd was awarded a Certificate of Authorisation for Geosil50, for Product Types PT 2 and PT 4. Full information on ECHA Product Types can be found here.

Geosil50 is the first, and to date, only silver stabilised hydrogen peroxide to be awarded this Authorisation anywhere in the EU or the UK.

Martin Gorevan, founder and managing director of Zebec Systems Ltd, realised in 2016 that the Biocides Directive would have increasing importance in the light of EU efforts to improve human health & environmental protections against hazardous and potentially toxic chemicals.

He and Zebec were well prepared and organised to submit a comprehensive dossier to support the Geosil50 application, when the deadline of January 2017 arrived.

As Martin says, “In order to stay ahead in the chemical manufacturing & distribution market, it’s necessary to fully appreciate the importance and ongoing impact of government regulations. Here in Zebec we have that appreciation.”

The UK’s Health & Safety Executive determined that the conditions detailed in Article 19 of Regulation (EU) No. 528/2012 were fully met.

It is important to note that Geosil50 Authorisation will be automatically grand-fathered into GB BPR.

The UK HSE Geosil50 Certificate can be downloaded from here.

Other Silver Stabilised Hydrogen Peroxide products

It is also important to note that other biocidal products described by their vendors as “Compliant”, “Registered”, “Certified”, “Participating Under”, “Ratified By” or “HSE-recognised” does NOT mean that they have been Authorised for use in the UK under GB BPR.

Also implying that any stabilised hydrogen peroxide biocide is Authorised, because Hydrogen Peroxide is an Approved Active Substance is both misleading and inaccurate.

Background to the GB BPR Application

Biocidal Product Regulations (BPR, Regulation (EU) 528/2012 regulation), was adopted to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

BPR places the burden of proof on suppliers of these chemicals, so to comply with the regulation companies must identify and manage the risks associated with the substances they manufacture and market across the EU.

The existing EU Biocidal Products Regulation (EU BPR) has been copied into GB law and amended to enable it to operate effectively in GB. The GB Biocidal Products Regulation (GB BPR) came into force at 11pm on 31 December 2020. Health & Safety Executive will now be solely responsible for the regulation of Biocides in the UK.

Registration

The EU regulation on EU BPR was created in 2006, and manufacturers and suppliers of chemicals which fell within its scope were given until the 31st January 2017 to submit a comprehensive dossier on the hazardous properties of all substances manufactured or imported into the EU. No applications for existing substances were accepted after that date.

The dossier had to include risk assessment and controls measures for using the substance safely to downstream users.

Evaluation

In the UK, this is carried out by the Health & Safety Executive. There are two types of evaluation: Dossier Evaluation and Substance Evaluation:

Dossier Evaluation

Dossier evaluation is conducted by authorities to examine proposals for testing to ensure that unnecessary animal tests and costs are avoided, and to check the compliance of the registration dossier with the registration requirements.

It is interesting to note that chemical companies failed to provide “important safety information” in nearly three quarters of cases checked by authorities, according to the European Chemical Agency’s 2018 annual progress report. Happily, Geosil was in the 24% of companies who supplied comprehensive and accurate information to HSE.

Substance Evaluation

Substance evaluation is performed by the HSE when there is a reason to suspect that a substance presents a risk to human health or the environment. Therefore, all registration dossiers submitted for a substance are examined together and any other available information is taken into account.

The Dossier is also required to contain detailed information on the efficacy against target organisms (in this case legionella), to establish the benefit arising from the use of the active substances in the biocide and must be balanced against the risks their use poses to man and the environment.

Authorisation

At the end of the Registration and Evaluation process, products which meet the high standards required are granted an Authorisation Certificate.

In addition to health and safety considerations, Zebec Systems Ltd detailed instructions for use, supported by a UKAS Accredited laboratory were also supplied.

In summary, Geosil is Authorised by the UK HSE, under Product Types PT 2 and PT 4

For more information click here