Simplified active substances

To encourage the use of products with a more favourable environmental or human or animal health profile, the GB Biocidal Products Regulation (GB BPR) establishes a list of active substances that are eligible for simplified product authorisation in Great Britain (GB).

The GB Simplified Active Substance List is intended to include substances identified as presenting a "low risk" and currently includes substances in the following categories:

category A – equivalent to categories 1-5 of Annex I of the EU Biocidal Products Regulation (EU BPR) – includes substances such as food additives, weak acids and pheromones
category B – equivalent to category 6 of Annex I of EU BPR – includes substances for which an active substance dossier has been validated in accordance with Article 7 (3) of GB BPR
category C – equivalent to category 7 of Annex I of EU BPR – includes substances other than those in categories A and B

Applications can be made to HSE to include an active substance in category A or B of the GB Simplified Active Substance List. Products using simplified active substances may be eligible for the simplified authorisation procedure.

Active substances that may meet the criteria to be included on the GB Simplified Active Substance List (and that were not supported in the GB Review Programme) cannot be used in biocidal products / biocidal product families made available on the GB market until the active substance is formally included on the List and the biocidal product / biocidal product family is authorised.

Making available on the market means any supply of a biocidal product, whether in return for payment or free of charge, at all stages of the supply chain. Some examples of this could include:;

manufacturer to distributor
distributor to retail store
retail store to user

Enforcement action may be taken where a simplified biocidal active substance that is not yet included on the List is made available on the GB market in a biocidal product / biocidal product family.

Check the criteria

Before considering supporting a simplified active substance for inclusion on the List in GB, you should check if it meets the criteria. To be considered for inclusion on the GB Simplified Active Substance List, there must be evidence that the substance does not give rise to concern.

An active substance is considered to give rise to concern where:

it meets the criteria for classification according to GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulation as
- explosive / highly flammable
- an organic peroxide
- acutely toxic (category 1, 2 or 3)
- corrosive (category 1A, 1B or 1C)
- respiratory sensitising
- skin sensitising
- germ cell mutagenic (category 1 or 2)
- carcinogenic (category 1 or 2)
- toxic for reproduction (category 1 or 2 or with effects on or via lactation)
- toxic for specific target organs (single or repeated exposure)
- toxic to aquatic life (acute category 1)
it fulfils any of the substitution criteria set out in Article 10 (1) of GB BPR:
- it meets the criteria for classification according to GB CLP as:
  - carcinogenic (category 1A or B)
  - mutagenic (category 1A or B)
  - toxic for reproduction (category 1A or B)
- it meets the criteria to be considered to have endocrine disrupting properties
- it meets the criteria for being Persistent, Bio-accumulative and Toxic (PBT) or very Persistent and very Bio-accumulative (vPvB) according to UK REACH
- it meets the criteria for classification according to GB CLP as respiratory sensitising
- the acceptable daily intake / acute reference dose / acceptable operator exposure level is significantly lower that the majority of approved active substances for the same product type and use
- it meets two of the criteria for being PBT according to UK REACH
- there are concerns linked to the nature of the critical effects even with very restrictive risk mitigation measures
- it contains a significant proportion of non-active isomers or impurities
it has neurotoxic or immunotoxic properties
a level of concern equivalent to that described in points 1 to 3 can be reasonably demonstrated based on reliable information

How to Apply

The prospective applicant or company acting on their behalf must submit, in English, a completed application form to [email protected] – companies may wish to mark emails as appropriate eg confidential. Please note that your application form may be returned if it is incomplete.

Only the application form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, including:

For category A of the GB Simplified Active Substance List
- evidence to show that the substance fits within the relevant category
- evidence of a robust consensus of expert opinion or data to show that the substance does not give rise to concern against the criteria in Article 28 (2) of GB BPR
- Safety Data Sheet (SDS) where applicable
- any pre-submission correspondence with HSE
For category B of the GB Simplified Active Substance List
- a dossier, in IUCLID format, that satisfies the requirements of Annex II of GB BPR - this dossier will include information about the active substance's:
  - physical, chemical, technical and, where appropriate, biological properties
  - physical hazards and respective characteristics
  - methods of detection and identification
  - effectiveness against target organisms
  - intended uses and exposure
  - toxicological profile for humans and animals, including metabolism
  - ecotoxicology
  - fate and behaviour in the environment
  - risk mitigation measures
  - classification, labelling and packaging
- a dossier, in IUCLID format, that satisfies the requirements of Annex III of GB BPR for a representative biocidal product containing the active substance, including:
  - formulation details
  - physical, chemical, technical and, where appropriate, biological properties
  - effectiveness against target organisms
  - intended uses and exposure
  - toxicological profile for humans and animals
  - ecotoxicology
  - fate and behaviour in the environment
  - risk mitigation measures
  - classification, labelling and packaging
- a draft Risk Assessment Report (RAR)for the active substance and representative product
- Safety Data Sheet (SDS)
- reference list of studies
- any pre-submission correspondence with HSE

Using the HSE Secure File Sharing Service

Once we have received and processed your application form, you will be sent a link to upload the files associated with the relevant application – please do not use the link to upload files related to other applications.
Links will be sent out Monday – Friday and are valid for 5 working days – if the link expires before you are able to upload your files, please email [email protected] to request a new link.
Please ensure you comply with the terms and conditions of using the HSE Secure File Sharing Service – these will be included in the email alongside the link.
Please check the spam settings on your email account to ensure our emails are not going to your junk folder.

Dossier guidance

Dossiers should be submitted in one of two formats:
- IUCLID (International Uniform Chemical Information Database)
- structured file system consisting of word, excel and PDF documents etc – it is expected that this kind of submission will only be applicable to applicants who already have a dossier in this format and do not have a current IUCLID version

Paper dossiers (or partial paper dossiers) must not be submitted.
Dossiers should consist of three main sections:
- data in the form of study reports
- summaries of those data – either in IUCLID or word documents
- assessments of the hazard, exposures, risks and efficacy of the active substance in a representative product, including an overall summary – using this Risk Assessment Report (RAR) template
All documents / attachments should be included within your IUCLID dossier
Guidance on information requirements for active substances and biocidal products – applicants should use this document when preparing dossiers for active substance approval
Biocides Submission Manual (BSM) series - describes how to build IUCLID dossiers with detailed and illustrative technical assistance
Guidance and training on IUCLID is also available – please note that HSE is unable to provide support on IUCLID

Things to note

HSE encourages pre-submission meetings with applicants to discuss:
- the simplified active substance dossier structure
- potential issues
- the basis of data waiving arguments – to reduce potential problems later in the process
- the proposed timescale for submission – to allow better work scheduling
- fees and likely timelines

What HSE will do

Applications for category A

After receiving your application HSE will:

conduct a brief initial check of the information to confirm that it meets the requirements for the application type
estimate how much it may cost ("initial estimated fee") to process the application based on the information provided
issue an invoice to the applicant which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in your application being rejected
evaluate the application (once the initial estimated fee has been paid) to assess whether there is evidence that the substance does not give rise to concern – this will take approximately 180 days from the payment of the fees
make a recommendation to the Secretary of State and Devolved Authorities as to whether the active substance can be included on the GB Simplified Active Substance List
issue an invoice for a "top up" fee if the cost of evaluating the application has gone beyond the initial estimated fee, which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in the substance's inclusion in the List being withheld

You may be asked to provide further information at various stages of the process. When such requests are made, the indicative timeframes given above will be suspended. Please note if the information you provide is not satisfactory, or you fail to provide the information within the specified deadline, your application may be rejected.

Applications for category B

After receiving your application HSE will:

conduct a brief initial check of the information to confirm that it meets the requirements for the application type
issue an invoice to the applicant for the validation fee which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in your application being rejected
conduct an initial assessment (validation) of the submitted information – this will take approximately 30 days from receiving the application and includes:
- determining if there are any significant data gaps – additional information may be requested
- estimating how much it may cost ("initial estimated fee") to evaluate the full application based on the information provided
issue an invoice to the applicant for the initial estimated fee once the application has been validated
evaluate the application to assess whether there is evidence that the substance does not give rise to concern – this will take approximately 365 days from validating the application
make a recommendation to the Secretary of State and Devolved Authorities as to whether the active substance can be included on the GB Simplified Active Substance List
issue an invoice for a "top up" fee if the cost of evaluating the application has gone beyond the initial estimated fee, which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in the substance's inclusion in the List being withheld

Active substance inclusion / non-inclusion decision

When the evaluation of an application is completed, a decision will be made as to whether the active substance can be included on the GB Simplified Active Substance List. HSE will recommend that the active substance is not included on the List where:

it cannot be suitably demonstrated that the substance does not give rise to concern (ie it cannot be shown that the substance does not meet the criteria for concern given in Article 28 (2) of GB BPR)

Inclusion recommended

HSE will:

send the applicant a copy of the draft conditions HSE intends to set for the active substance – these are set out in a draft Competent Authority Report (CAR)
take into account the applicant's comments, where relevant
recommend to the Secretary of State and Devolved Authorities that the active substance be included on the GB Simplified Active Substance List
publish the Secretary of State's decision
add the active substance onto the GB Simplified Active Substance List

You should:

examine the draft Competent Authority Report (CAR) and return it to HSE (with comments if necessary) to indicate your agreement with the conditions
wait until the inclusion decision has been published, and the active substance is included on the GB Simplified Active Substance List, and ensure you apply for and gain Product authorisation overview before making any products available on the market in GB
ensure you comply with any deadlines associated with the inclusion, such as for any post inclusion data requirements or the substance may be removed from the List
ensure you comply with general chemical and product safety law which continues to operate such as:
- GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulation

Inclusion not recommended

HSE will:

send the applicant a copy of HSE's assessment and conclusions – these are set out in a draft Competent Authority Report (CAR)
take into account the applicant's comments, where relevant
recommend to the Secretary of State and Devolved Authorities that the active substance is not included on the GB Simplified Active Substance List
publish the Secretary of State's non-inclusion decision

You should:

examine the draft Competent Authority Report (CAR) and return it to HSE with comments if necessary
ensure that you do not use or supply biocidal products containing the active substance in GB

Rejecting applications

An application can be rejected at any stage if the relevant fees or requested information / data are not submitted or are unacceptable.