Glossary

A

Active substance

Defined by the GB Biocidal Products Regulation (GB BPR) as:
A substance or micro-organism that has an action on or against harmful organisms.

Administrative change

Defined by the GB Biocidal Products Regulation (GB BPR) as:
An amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family.
Administrative changes may be carried out at the request of the approval holder or imposed by HSE.

Advertisement

Defined by the GB Biocidal Products Regulation (GB BPR) as:
A means of promoting the sale or use of biocidal products by printed, electronic or other media.

Amendment (COPR)

A change or modification to an existing COPR product approval, such as a change to the formulation, product name, packaging etc. Amendments may be carried out at the request of the approval holder or imposed by HSE.

Annual Charge (COPR)

A charge to approval holders under the Control of Pesticides Regulations (COPR). The annual charge is allowed by the Food and Environment Protection Act 1985, and the Plant Production Products (Fees and Charges) Regulations 2011 (as amended), so that HSE can recover the costs of running the COPR approval scheme and its related monitoring systems.
The annual charge rate varies from year to year depending on the total annual turnover of all products approved under COPR. In order to calculate this, every year in September, approval holders are asked to declare their sales turnover for COPR approved products for a set 12-month period.

Applicant

A person or company submitting a dossier to HSE in order to gain active substance approval or biocidal product authorisation under the GB Biocidal Products Regulation (GB BPR), or the company applying for a product approval under the Control of Pesticides Regulations (COPR).

Application withdrawn

On the GB List of Active Substances this status means that the application for a new active substance for the listed product types was withdrawn by the applicant. It also means that active substance cannot be used in biocidal products in Great Britain (GB) for that product type(s).

Approval (COPR)

A legal requirement for the advertisement, sale, supply, storage and/or use of all biocidal products (non-agricultural pesticides) in the scope of the Control of Pesticides Regulations (COPR) which cannot yet be authorised under the GB Biocidal Products Regulation (GB BPR). Approval is granted by HSE on behalf of the Ministers.

Approval (GB BPR)

A legal requirement for active substances used in biocidal products that are made available on the market in Great Britain (GB). Depending on their nature, active substances can either receive approval for specific product types or be included on the GB Simplified Active Substance List.

Approval date (GB BPR)

The approval date of an active substance acts as the deadline by which, for existing products, applications for product authorisation under the GB Biocidal Products Regulation (GB BPR) must be made to allow the product be able to stay on the market while the GB BPR application is being evaluated.

Approval holder (COPR)

The applicant (person or company) that is granted approval for a product under the Control of Pesticides Regulations (COPR).

Approved (GB BPR)

An active substance is approved for use in biocidal products for the relevant product types under the GB Biocidal Products Regulation (GB BPR). This includes active substances on the GB Simplified Active Substance List

Approved - under renewal (GB BPR)

An active substance is approved for use in biocidal products for the relevant product types and is currently undergoing assessment for renewal of the approval under the GB Biocidal Products Regulation (GB BPR).

Article 3(3) decision

A published decision made by the Secretary of State (working with the Scottish and Welsh administrations) on whether:

• a substance should be classed as a 'nanomaterial'
• a product, or group of products, is a 'biocidal product', a 'treated article' or neither

Article 93 active substance

An active substance that is supported under the transitional measures of Article 93 of the GB Biocidal Products Regulation (GB BPR).

Article 93 transitional measures

Article 93 of the GB Biocidal Products Regulation (GB BPR) provides a derogation for biocidal products that were not in scope of previous biocides legislation (the Biocidal Products Directive) to allow them to remain on the GB market as long as the active substance was supported by the relevant deadline. The transition period for a biocidal product ends on the date of approval (or non-approval) of the active substance it contains.

Article 93 submission

The submission of a compliant application to support an active substance under the transitional measures of Article 93 of the GB Biocidal Products Regulation (GB BPR).

Article 95 submission

The submission of a compliant application under Article 95(1) of the GB Biocidal Products Regulation (GB BPR).

Assessment

The detailed evaluation of the information submitted by an applicant in support of an active substance or biocidal product and carried out by HSE. The purpose of an assessment is to determine if the active substance or biocidal product presents unacceptable risks to people, animals or the environment.
May also be referred to as evaluation.

Assessment Report (AR)

A non-confidential version of the report produced by HSE for an active substance assessment. Assessment Reports are publicly available.

Authorisation

A legal requirement for the making available on the market of a biocidal product in Great Britain (GB). See also National authorisation, Simplified authorisation, same biocidal product authorisation and essential use authorisation.

Authorisation holder

Defined by the GB Biocidal Products Regulation (GB BPR) as:
The person established in the United Kingdom (UK) who is responsible for the placing on the market of a biocidal product in Great Britain (GB) and specified in the authorisation.
An authorisation holder may be a person or company that is a legal entity in the UK.
Authorisation holders are legally responsible for their authorisation and ensuring that all relevant legislation is complied with. Therefore, they cannot be nominated in name only.

Authorisation number

An authorisation number is a unique identifier issued to a biocidal product or product family when it is first authorised under the GB Biocidal Products Regulation (GB BPR).
Authorisation numbers take the format UK-YYYY-XXXX / GB-YYYY-XXXX, where YYYY is the year and XXXX is a unique number.
Where a product authorisation contains multiple trade names each trade name is assigned a suffix ZZZZ, giving the authorisation number the format UK-YYYY-XXXX-ZZZZ / GB-YYYY-XXXX-ZZZZ.
Products that are authorised as part of a biocidal product family have an extra component, M, which is the meta SPC identifier, giving the authorisation number the format UK-YYYY-XXXX-M-ZZZZ / GB-YYYY-XXXX-M-ZZZZ.
Full authorisation numbers must be displayed on product labels.

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B

Back to back (COPR)

An application for approval of an identical product to one that is already approved under the Control of Pesticides Regulations (COPR), with the following differences allowed:

• product name
• approval holder
• marketing company

If the applicant is not the approval holder of the already approved product, the approval holder will need to give their consent via a Letter of Access.

Biocide

Biocides are used to protect people and animals from 'germs', to preserve manufactured goods, to protect industrial processes and to stop pests like rats or cockroaches. See also active substance and biocidal product.

Biocidal product

Defined by the GB Biocidal Products Regulation (GB BPR) as:
Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
Any substance or mixture generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical means.
A treated article that has a primary biocidal function shall be considered a biocidal product.

Biocidal product family

Defined by the GB Biocidal Products Regulation (GB BPR) as:
A group of biocidal products having similar uses, the same active substances, similar compositions with specified variations, and similar levels of risk and efficacy.

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C

Candidate for substitution

An active substance is considered a candidate for substitution if it meets the substitution criteria outlined in Article 10 (1) of the GB Biocidal Products Regulation (GB BPR).
Biocidal products containing active substances that are considered to be candidates for substitution must undergo a comparative assessment as part of the evaluation of an application for authorisation.

CAS number

Chemical Abstract Service index number. A unique numeric identifier designating only one substance.

CEFIC

CEFIC is the umbrella organisation of the European Chemical Industry Council (Confederation Europeenne des Federations de l'Industrie Chimique). Based in Brussels, it is the organisation that represents national chemical industry federations and chemical companies of Europe.

Certificate of Approval (COPR)

The official document issued under the Control of Pesticides Regulations (COPR) for a product approval. The Certificate includes an Approval Notice and Schedule. Details of the product with its new HSE number, the approval holder, marketing company, consents and expiry dates are stated. The original document is kept on file by HSE and a copy is issued to the approval holder.

Certificate of Approval (Amendment) (COPR)

The official document issued under the Control of Pesticides Regulations (COPR) for changes made to the conditions of an existing product approval. The Certificate usually includes an Approval Amendment Notice and Schedule but, if the amendment has not changed any of the details on the Schedule, a revised Schedule may not be issued. The original document is kept on file by HSE and a copy is issued to the approval holder.

Certificate of Approval (Amendment) Voluntary Withdrawn Product (COPR)

The official document issued under the Control of Pesticides Regulations (COPR) when an approval holder voluntarily withdraws an existing product approval. The Certificate includes a Revocation Notice. The original document is kept on file by HSE and a copy is issued to the approval holder.

Certificate to Revoke Approval (COPR)

The official document issued under the Control of Pesticides Regulations (COPR) when an existing product approval is withdrawn by HSE. The Certificate includes a Revocation Notice. The original document is kept on file by HSE and a copy is issued to the approval holder.

Certificate of Approval (Automatic Experimental Permit) (COPR)

The official document issued under the Control of Pesticides Regulations (COPR) for experimental testing for the purposes of research and development into non-approved biocidal products and active substances, where the testing complies with strict conditions. The certificate includes an Approval Notice. The original document is kept on file by HSE and a copy is issued to the permit holder.

Certificate of Approval (Experimental Permit) (COPR)

The official document issued under the Control of Pesticides Regulations (COPR) for experimental testing for the purposes of research and development into non-approved biocidal products and active substances, where the testing cannot comply with the strict conditions for an Automatic Experimental Permit. The Certificate includes an Approval Notice and Schedule. The original document is kept on file by HSE and a copy is issued to the permit holder.

Certificate of Authorisation (CoA)

The official document issued under the GB Biocidal Products Regulation (GB BPR) for a product authorisation. The Certificate of Authorisation sets out the terms and conditions of the authorisation and includes a Summary of Biocidal Product Characteristics (SPC).

Certificate of Free Sale (CFS)

An official document confirming that a product or active substance complies with the relevant laws on biocides and may be freely sold across GB. Certificates of Free Sale are usually requested when the country the product is being exported to does not have its own regulatory regime.

Comparative assessment

An assessment of the risks and benefits of a biocidal product when compared with other biocidal products authorised under the GB Biocidal Products Regulation (GB BPR), non-chemical means of control and prevention methods. Comparative assessments contribute to the decision to authorise or not authorise a biocidal product and must be carried out when a biocidal product contains an active substance that is a candidate for substitution.

Competent Authority Report (CAR)

The full confidential report produced by HSE for an active substance assessment.
A non-confidential version, the Assessment Report (AR), is made publicly available.

Complex article

Articles that are made up of several parts (other articles) eg a sofa is made up of a frame, cushions, fabric cover etc

Consent requirement

Some functions of the GB Biocidal Products Regulation (GB BPR) concern issues that the Devolved Authorities (DAs) in Great Britain (GB) have the power to make independent decisions on. Where this is the case, the function may only be applied if the relevant DAs have given their consent.

Consents (COPR)

Under the Control of Pesticides Regulations (COPR) the permissions to advertise, sell, supply, store and use a product are collectively known as consents. When an approval is granted or amended, the consents may be restricted (eg for the purposes of storage and disposal only).

Consortium

A group of two or more companies jointly supporting an active substance for approval under the GB Biocidal Products Regulation (GB BPR). As the data are usually agreed to be shared between the members, this reduces animal testing and the members' individual costs.
A consortium may also be known as a task force.

Contents statement (COPR)

Under the Control of Pesticides Regulations (COPR), the contents statement gives the amount of pure active substance in the biocidal product. It is calculated based on the minimum purity of the active substance and the technical amount of active substance put into the product. The contents statement must appear on the product label for all products approved under COPR and can be found in section 3/1 h of the Schedule.

Control of Pesticides Regulations (COPR)

In Great Britain (GB), COPR is the law that regulates some types of biocides (sometimes called non-agricultural pesticides) before they can be authorised under the GB Biocidal Products Regulation (GB BPR). Products currently approved under COPR in GB will need to be authorised under GB BPR once the active substances they contain have been approved under GB BPR to remain on the GB market.
In Northern Ireland (NI), COPR(NI) is the law that regulates some types of biocides (sometimes called non-agricultural pesticides) before they can be authorised under the EU Biocidal Products Regulation (EU BPR). Products currently approved under COPR(NI) in NI will need to be authorised under EU BPR once the active substances they contain have been approved under EU BPR to remain on the NI market.

Critical situation permit

Allows for the temporary and controlled use of a biocidal product under the GB Biocidal Products Regulation (GB BPR), that does not meet the conditions for national or simplified authorisation, in the case of a danger to:

• public health
• animal health
• the environment

It must be shown that the situation cannot be contained by any other means.

Cultural heritage authorisation

Allows for the authorisation of a biocidal product under the GB Biocidal Products Regulation (GB BPR) containing a non-approved active substance if it shown to be essential for the protection of cultural heritage and no appropriate alternatives are available.
The protection of cultural heritage includes items or structures that are considered to:

• have cultural significance
• be national treasures
• have artistic value
• have historic value
• have archaeological value

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D

Data protection

When data are submitted to HSE for the first time in support of an application for active substance approval or product authorisation under the GB Biocidal Products Regulation (GB BPR), or product approval under the Control of Pesticides Regulations (COPR), they benefit from a protection which means that third parties cannot use those data in support of their own applications without the permission of the data owner. This is to allow the data owner to recover some of the costs of generating the data in the first place. Data are only protected for defined periods of time starting from the date they are submitted.

Data requirements

Data requirements describe the information needed for HSE to fully evaluate the safety and efficacy of an active substance or biocidal product. The data requirements under the GB Biocidal Products Regulation (GB BPR) are set out in Annexes II and III of the law.

Declaration of interest

The first step in adding an active substance / product type combination into the GB Review Programme. Declarations of interest can only be submitted where certain criteria can be met.

DEFRA

The Department for the Environment, Food and Rural Affairs. DEFRA website.

Departmental (COPR)

An application for approval of a product under the Control of Pesticides Regulations (COPR) which is outside the existing precedents and the new risks presented by the product will need to be assessed. For example:

• the proposed amount of active substance is above that previously assessed in similar products
• the proposed use areas for the product include outdoor use where the previous assessments for similar products only include indoor use

Devolved Authority (DA)

The Devolved Authorities (DAs) of Great Britain (GB) are:

• the Scottish Ministers for Scotland
• the Welsh Ministers for Wales

Dossier

A collection of data and other documentation submitted as part of an application for active substance approval or product authorisation under the GB Biocidal Products Regulation (GB BPR).
Active substance and biocidal product dossiers must meet the requirements of Annex II and Annex III of GB BPR respectively.

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E

EC number

European Community number. A unique seven-digit identifier assigned to substances on the market within the European Union.

Essential use authorisation

Allows for the authorisation of a biocidal product under the GB Biocidal Products Regulation (GB BPR) where the active substance has received an essential use derogation.

Essential use derogation

Where an active substance in the GB Review Programme is given a non-approval decision, it may be granted an essential use derogation if either:

• evidence shows that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment
• not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment

Established in the UK

Normally interpreted as a person or company having a physical presence, such as a registered office, central headquarters or permanent business establishment, in the UK.
'A physical presence' is considered to be the permanent location where the necessary human and technical resources needed to carry out, either in whole or in part, the business operations of the person or company are based.
The person or company should be a legal entity in the UK – branch offices are the same legal entity as the overseas parent company and therefore would not meet this definition.

EU Biocidal Products Regulation (EU BPR)

The law that regulates biocides in the European Union (EU), the EEA, Switzerland and Northern Ireland (NI).

European Chemicals Agency (ECHA)

An agency of the European Union (EU) that oversees the implementation of the EU Biocidal Products Regulation (EU BPR) across the EU, and is based in Helsinki, Finland.

Evaluation

The detailed assessment of the information submitted by an applicant in support of an active substance or biocidal product and carried out by HSE. The purpose of an evaluation is to determine if the active substance or biocidal product presents unacceptable risks to people, animals or the environment.
May also be referred to as assessment.

Exclusion criteria

A set of criteria, outlined in Article 5(1) of the GB Biocidal Products Regulation (GB BPR), which if met means an active substance will not normally be approved.
Active substances meeting the exclusion criteria may only be approved if suitable justification can be provided against the criteria outlined in Article 5(2) of GB BPR.

Existing active substance

A substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product or process-orientated research and development.

Existing biocidal product

A product that was legally on the GB market (eg regulated under other national law such as the Control of Pesticides Regulations (COPR)) on the date of approval of the active substance it contains under the GB Biocidal Products Regulation (GB BPR).

Expert Committee on Pesticides (ECP)

The DEFRA body which provides independent scientific advice to UK Government Ministers on all matters relating to the control of pests under the Control of Pesticides Regulations (COPR) and the Plant Protection Products Regulations (PPPR). Further information can be found on the ECP website.

Expired

Active substance approvals and product authorisations under the GB Biocidal Products Regulation (GB BPR) will expire if no application for renewal is submitted.
Expired active substances cannot be used in biocidal products in Great Britain (GB) after the expiry date.
Expired product authorisations may receive phase out periods for making available on the GB market and use.

Expiry date

The last date for which an active substance approval or product authorisation under the GB Biocidal Products Regulation (GB BPR). After this date it becomes illegal to advertise, sell, supply, store or use the product (make available on the market) in Great Britain (GB).
The last date for which a product approval under the Control of Pesticides Regulations (COPR) is valid. After this date it becomes illegal to advertise, sell, supply, store or use the product (make available on the market) in GB and/or Northern Ireland (NI).

Export statement

An official document issued in place of a Certificate of Free Sale (CFS) if a product or active substance does not comply with the relevant laws on biocides but is solely intended for export from Great Britain (GB) (so is not made available on the GB market).

Exposure scenarios

Descriptions of how people, animals and the environment may be exposed to the active substances and other substances of concern in a biocidal product. Exposure scenarios are used in the evaluation to determine the worst-case amount, frequency and duration of exposure to such substances.

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F

Food and feed

The GB Biocidal Products Regulation (GB BPR) adopts the definitions given in the EC General Food Law Regulation:
'Food' (or 'foodstuff') means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.
'Feed' (or 'feedingstuff') means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals.

Former Review Programme participant

A company that has withdrawn support for the active substance under the GB Review Programme. Phase out periods will apply where a subsequent non-approval decision is published.

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G

GB Article 95 List

A list of the suppliers for active substance/product type combinations that can be used in biocidal products in Great Britain (GB).

GB Biocidal Products Regulation (GB BPR)

The law that regulates biocides in Great Britain (GB).

GB Classification, Labelling and Packaging Regulations (GB CLP)

The law that regulates the classification, labelling and packaging of chemical substances and mixtures in Great Britain (GB).

GB List of Active Substances

A list detailing the status of active substance/product type combinations under the GB Biocidal Products Regulation (GB BPR).

GB List of Authorised Biocidal Products

A list detailing the biocidal products that are currently, or were previously, authorised under the GB Biocidal Products Regulation (GB BPR). Includes the GB Simplified Active Substance List.

GB Review Programme

The system of evaluating existing biocidal active substances under the GB Biocidal Products Regulation (GB BPR) in Great Britain (GB).

GB Review Regulation

The law that provides the rules and procedures for the GB Review Programme.

GB Simplified Active Substance List

The list of active substances that can be used in products eligible for simplified authorisation under the GB Biocidal Products Regulation (GB BPR). The GB Simplified Active Substance List is a sub-list of the GB List of Active Substances.

General public user

A member of the public who is using biocides in their own home/for personal use.

Good Laboratory Practice (GLP)

A set of rules and criteria for planning, performing, monitoring, recording, archiving and reporting non-clinical health and environmental safety studies. The purpose of GLP is to ensure the validity, quality, consistency, reliability and reproducibility of data generated by research laboratories and organisations in the testing of chemicals.

Great Britain (GB)

Great Britain refers to England, Scotland and Wales. Includes islands that are part of England, Scotland or Wales, such as the Isle of Wight, Anglesey, the Isles of Scilly, the Hebrides, Orkney and Shetland. Does not include Northern Ireland (NI).

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H

Harmful organism

Defined by the GB Biocidal Products Regulation (GB BPR) as:
An organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment.

HSE number (COPR)

An HSE number is a unique identifier issued to a product when it is first approved under the Control of Pesticides Regulations (COPR). HSE numbers take the format HSE XXXXX and must be displayed on product labels.

HSE Secure File Sharing Service

A secure file sharing service used as a tool for submitting dossiers and other documentation to HSE eg as part of an active substance or biocidal product application under the GB Biocidal Products Regulation (GB BPR).

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I

In situ biocidal products

In situ biocidal products may:

• be supplied to the user to generate one or more active substances
• be generated from substances or mixtures that do not meet the definition of a biocidal product themselves

In situ generated active substances

Active substances that are generated at the place of use from one or more precursors.

In situ generation

The reaction of one or more precursors to generate an active substance at the place of use and for direct application without isolation, purification, storage or transport.

Industrial user

A person who is using biocides in an industrial/manufacturing setting and has received appropriate information, instruction and training in their use.

Initial estimated fee

The initial fee charged by HSE for an application under the GB Biocidal Products Regulation (GB BPR). It is an estimate of how much it may cost to process the application based on the information provided.

International Uniform Chemical Information Database (IUCLID)

A tool for recording, storing, submitting, and exchanging data on chemical substances that is the preferred format for submitting active substance and biocidal product dossiers to HSE under the GB Biocidal Products Regulation (GB BPR).

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J

Justification

A reasoned and scientifically robust case which may be needed in support of such things as:

• the non-submission of data in an active substance or biocidal product application
• the selected parameters for a study
• the applicability of a study
• the acceptability of study results
• claims of confidentiality
• vertebrate testing as a 'last resort'

A justification will not be acceptable if it only makes basic statements eg that particular information is not required or that releasing particular information would harm a company's commercial interests. Justifications should be concise and to the point, but they must give reasons why for example the basic statements above are true and provide enough information for the reader to be able to decide the case for themselves.

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L

Letter of Access (LoA)

A document signed by a data owner that gives permission for HSE to use data that is protected under the GB Biocidal Products Regulation (GB BPR) or the Control of Pesticides Regulations (COPR), in their evaluation of a named application for active substance approval or product authorisation under GB BPR, or product approval under COPR.

Letter of intent to supply

A document signed by an active substance supplier stating that it supplies the active substance to a named applicant. The letter can be for a specific named product or general, for all of the applicant's relevant products.

Levy (COPR)

An annual charge on approval holders under the Control of Pesticides Regulations (COPR). The levy is allowed by the Food and Environment Protection Act 1985, as amended by the Pesticides (Fees and Enforcement) Act 1989, so that HSE can recover the costs of running the COPR approval scheme and its related monitoring systems.
The levy rate varies from year to year depending on the total annual turnover of all products approved under COPR. In order to calculate this, every year in September, approval holders are asked to declare their sales turnover for COPR approved products for a set 12-month period.

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M

Main group

The GB Biocidal Products Regulation (GB BPR) groups biocidal products into 22 product types that are split up into 4 main groups:

• disinfectants
• preservatives
• pest control
• other biocidal products.

Major change

Defined by the GB Biocidal Products Regulation (GB BPR) as:
An amendment of an existing authorisation which is neither an administrative change nor a minor change.
An example of a major change would be a change in the amount of active substance in the formulation.

Making available on the market

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

Marketing company

The company which will market a COPR approved product, ie the company whose name will appear on the product label. This company may also be the COPR approval holder.

Meta Summary of Biocidal Product Characteristics (meta-SPC)

A section of the Summary of Biocidal Product Family Characteristics (SPfC) under the GB Biocidal Products Regulation that describes a sub-group of a biocidal product family. Products of a family are grouped into different meta-Summary of Product Characteristics (meta-SPCs) depending on their properties and use patterns. Every product within a meta-SPC must have the same classification. Biocidal product families can contain multiple meta-SPCs.

Micro-organism

Defined by the GB Biocidal Products Regulation (GB BPR) as:
Any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths.

Minor change

Defined by the GB Biocidal Products Regulation (GB BPR) as:
An amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family.
An example of a minor change would be a change in shelf life.

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N

Nanomaterial

Defined by the GB Biocidal Products Regulation (GB BPR) as:
A natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm.
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.
For the purposes of the definition of nanomaterial, 'particle', 'agglomerate' and 'aggregate' are defined as follows:

• 'particle' means a minute piece of matter with defined physical boundaries
• 'agglomerate' means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components
• 'aggregate' means a particle comprising strongly bound or fused particles

National Authorisation

Defined by the GB Biocidal Products Regulation (GB BPR) as:
An administrative act by which the competent authority authorises the making available on the market and the use of a biocidal product or a biocidal product family.
A national authorisation allows biocidal products / biocidal product families that are not eligible for simplified authorisation to be made available on the market in Great Britain (GB).

National Poisons Information Service (NPIS)

The National Poisons Information Service (NPIS) is an organisation, supported by the Department of Health and Social Care (DHSC) and Public Health England (PHE), that provides expert advice to healthcare professionals on the diagnosis, treatment and management of patients who may have been poisoned either accidentally or intentionally.

New active substance

A substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development.

New active substance submission

The submission of an application for a new active substance under the GB Biocidal Products Regulation (GB BPR).

No longer supported

An active substance is no longer supported in Great Britain (GB) Review Programme for the relevant product types, usually following participant withdrawal or redefinition, where no successful notification or dossier was submitted by the relevant deadline. An active substance that is no longer supported will subsequently be given a non-approval decision.

Non-agricultural pesticides

Biocides are sometimes described as non-agricultural pesticides, typically under the Control of Pesticides Regulations (COPR).

Non-Review Programme existing active substance

An active substance that was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development and is being / was assessed outside of the GB Review Programme.

Not approved (GB BPR)

An active substance is not approved for use in biocidal products for the relevant product types in Great Britain (GB) following a non-approval decision. Phase out periods may apply.

Notified

An active substance has been successfully notified for support for the relevant product types in the GB Review Programme, usually following participant withdrawal or redefinition. Active substances that have been notified may be able to continue to be used in biocidal products of the relevant product type in Great Britain (GB) but GB Article 95 will temporarily not apply (as the full dossier has not yet been submitted).

Notification

A step in supporting an active substance/product type combination in Great Britain (GB) Review Programme. Notification can happen in two situations:

• as the first step in supporting an active substance / product type combination following participant withdrawal or redefinition - notifications of this type can only be submitted for active substance/product type combinations with a published open invitation
• as the second step in supporting an active substance / product type combination with a valid declaration of interest - notifications of this type must be submitted within 6 months of the validation of the declaration of interest

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O

Open invitation

An invitation is open for companies to take over the role of participant for an active substance / product type combination in the GB Review Programme following participant withdrawal or redefinition. Active substances with an open invitation can continue to be used in biocidal products of the relevant product type in Great Britain but GB Article 95 will temporarily not apply (as the full dossier has not yet been submitted).

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P

Participant

A person, company or task force / consortium supporting an active substance through the GB Review Programme under the GB Biocidal Products Regulation (GB BPR).

Personal Protective Equipment (PPE)

Equipment used or worn to protect users from the hazards associated with things such as chemicals, biological agents, radiation, heat, noise etc. Examples of PPE most commonly related to the use of biocides include protective coveralls, gloves, eye protection, and respiratory protective equipment (RPE).

Pesticide

Defined by the Control of Pesticides Regulations (COPR) as a substance, preparation or organism used to control or destroy any pest.
The term pesticide is often used broadly to describe some biocides and plant protection products.

Phase out periods

Allow for existing stocks of biocidal products to be gradually removed from the market over set periods of time. Phase out periods are usually granted, eg when a change is made to a product, so that the stock labelled with the old conditions can gradually be replaced with stock labelled with the new conditions, without having to recall old stock and have it relabelled.

Placing on the market

Placing on the market means the first making available on the market of a biocidal product or treated article. This means the first act of supply of a biocidal product or treated article, whether in return for payment or free of charge. Some examples of this could include:

• manufacturer to distributor, retail store or end user
• importer to distributor, retailer or end user

Plant protection product

Defined by the GB Plant Protection Products Regulation (GB PPPR) as:
Products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:

• protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products
• influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient
• preserving plant products, in so far as such substances or products are not subject to EU retained law provisions on preservatives
• destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants
• checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants.

Plant protection products are regulated under GB PPPR but if a product is intended to have both plant protection and biocidal uses it may need to be authorised under both GB PPPR and the GB Biocidal Products Regulation (GB BPR).

Post-approval data requirement

A condition placed on an active substance approval under the GB Biocidal Products Regulation (GB BPR) that additional data must be provided. Post-approval data requirements are usually set when the data gap is not significant enough to delay the approval however, if the data is not submitted by the deadline set as part of the approval then the approval may be cancelled.

Post-authorisation data requirement

A condition placed on a product authorisation under the GB Biocidal Products Regulation (GB BPR) that additional data must be provided. Post-authorisation data requirements are usually set when the data gap is not significant enough to delay the authorisation however, if the data is not submitted by the deadline set as part of the authorisation then the authorisation will be cancelled.

Primary biocidal function

As a general principle, the biocidal function of an article is considered primary if the biocidal function cannot be removed without fundamentally altering the purpose or intended use of the article.

Process Orientated Research and Development (PORD)

The GB Biocidal Products Regulation (GB BPR) adopts the definitions given by the UK Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (UK REACH):
Any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and / or to test the fields of application of the substance.
Examples of such development activities include transfer from bench-top to a pilot plant or full-scale production facility.

Product Assessment Report (PAR)

The report produced by HSE under the GB Biocidal Products Regulation (GB BPR) for a biocidal product/biocidal product family assessment. A non-confidential version is made publicly available.

Product supplier

A company that manufactures or makes available on the market in Great Britain (GB) a biocidal product consisting of, containing or generating an active substance.

Product Type

The GB Biocidal Products Regulation (GB BPR) groups biocidal products into 22 product types:

• Product type 1 (PT1) - human hygiene
• Product type 2 (PT2) - disinfectants and algaecides not intended for direct application to humans or animals
• Product type 3 (PT3) - veterinary hygiene
• Product type 4 (PT4) - food and feed area
• Product type 5 (PT5) - drinking water
• Product type 6 (PT6) - preservatives for products during storage
• Product type 7 (PT7) - film preservatives
• Product type 8 (PT8) - wood preservatives
• Product type 9 (PT9) - fibre, leather, rubber and polymerised materials preservatives
• Product type 10 (PT10) - construction material preservatives
• Product type 11 (PT11) - preservatives for liquid-cooling and processing systems
• Product type 12 (PT12) - slimicides
• Product type 13 (PT13) - working or cutting fluid preservatives
• Product type 14 (PT14) - rodenticides
• Product type 15 (PT15) - avicides
• Product type 16 (PT16) - molluscicides, vermicides and products to control other invertebrates
• Product type 17 (PT17) - piscicides
• Product type 18 (PT18) - insecticides, acaricides and products to control other arthropods
• Product type 19 (PT19) - repellents and attractants
• Product type 20 (PT20) - control of other vertebrates
• Product type 21 (PT21) - antifouling products
• Product type 22 (PT22) - embalming and taxidermist fluids

Professional user

A person who is using biocides as part of their job/in their business and has received appropriate information, instruction and training in their use.

Professional user with demonstrated competence

A person who is using biocides as part of their job / in their business who has received the appropriate information, instruction and training in their use, and in addition, holds specific certification relating to that use. Products authorised for these users cannot be sold to anyone who is unable to demonstrate that they have the right certification.

Provisional authorisation

Allows for the authorisation under the GB Biocidal Products Regulation (GB BPR) of a biocidal product/biocidal product family containing a new active substance before that active substance has been formally approved. This authorisation type is only available once HSE has completed its assessment of the active substance and allows the product to be made available on the market in Great Britain (GB) whilst the active substance goes through the formal approval decision-making process

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R

Redefinition

The establishment of a new identity for an active substance in the GB Review Programme.
Active substances may be redefined if, during the evaluation, it becomes clear that the identity of the substance being evaluated does not entirely match the identity of the substance that was initially supported. It may not be appropriate to apply the conclusions of such an evaluation to the substance as it was initially identified, and the active substance may therefore be redefined.

Regulatory process

The route by which an active substance has been supported for approval under the GB Biocidal Products Regulation (GB BPR) eg as part of the GB Review Programme or as a new active substance.

Renewal

Product authorisations and active substance approvals granted under the GB Biocidal Products Regulation (GB BPR) are time-limited and must therefore be renewed for the products to stay on the market. Applications to renew an authorisation or approval must be submitted to HSE at least 550 days before the relevant expiry date.

Representative biocidal product

A biocidal product that is considered representative of the use of the active substance that it contains. A dossier on a representative biocidal product forms part of an application for active substance approval under the GB Biocidal Products Regulation (GB BPR).

Research and Development (R&D) notice

Allows research and development into biocidal products that are not yet authorised under the GB Biocidal Products Regulation (GB BPR) or into active substances that are not yet approved.

Residue

Defined by the GB Biocidal Products Regulation (GB BPR) as:
A substance present in or on products of plant or animal origin, water resources, drinking water, food, feed or elsewhere in the environment and resulting from the use of a biocidal product, including such a substance's metabolites, breakdown or reaction products.

Restriction of use (COPR)

A phrase given on the Schedule for a product approval issued under the Control of Pesticides Regulations (COPR) that states what the product can be used for eg 'For use only as an insecticide.' Restriction of use phrases must appear on the product label.

Review Programme for existing active substances

On the GB List of Active Substances this regulatory process means an active substance that was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development and is being/was assessed under the GB Review Programme.

Review Programme participant

A company that supported an active substance under the GB Review Programme.

Revocation

When the approval for a product under the Control of Pesticides Regulations (COPR) is withdrawn by either the approval holder or HSE, the official term is that the approval is revoked. Products that have had their approval revoked must be removed from the market and can no longer be used after the dates stated on the Revocation Notice.

Risk assessment

A quantitative and qualitative determination of the potential and actual risk presented by specific actives substances and other substances of concern to people and/or the environment. Risk assessments are a part of the overall evaluation of an active substance or biocidal product.

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S

Same biocidal product authorisation

Allows for the authorisation of a biocidal product / biocidal product family under the GB Biocidal Products Regulation (GB BPR) which is identical to another biocidal product/biocidal product family/part of a biocidal product family which is already authorised under GB BPR.

Scientific research and development

The GB Biocidal Products Regulation (GB BPR) adopts the definitions given by the UK Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (UK REACH):
Any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year.
It includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development.

Schedule (COPR)

The official document issued under the Control of Pesticides Regulations (COPR) for a product approval. The Schedule lists specific conditions of the approval, including details of the product, its formulation, the source of the active substances, the product's intended uses and users, any specific risk mitigation measures or labelling requirements, details of its packaging and any other relevant information. The Schedule forms part of the Certificate of Approval.

Scope

Whether something should, or should not, be regulated under the GB Biocidal Products Regulation (GB BPR) and/or the Control of Pesticides Regulations (COPR).

Secondary biocidal function

As a general principle, the biocidal function of an article is secondary if the biocidal function can be removed and the article can still be used for the non-biocidal purpose and by the same intended user.

Secretariat (COPR)

An application for approval of a product under the Control of Pesticides Regulations (COPR) which is within the existing precedents ie:

• the amount of each active substance in the product is no greater than for any product that is already approved for similar uses
• the intended use areas of the product are not greater than for any product that is already authorised with the same active substance for a similar purpose - eg a product for outdoor use cannot be approved by the secretariat route if all similar products are only approved for indoor use

Secretary of State (SoS)

The Cabinet Minister in charge of the Department for Work and Pensions, the parent government department for HSE.

Series change (COPR)

A change or modification to an existing COPR product approval, usually administrative, that can be applied to a number of similar products at the same time. Series changes typically involve changing a single approval holder or marketing company for a group of products. Series changes may be carried out at the request of the approval holder or imposed by HSE.

Single biocidal product

Defined by the GB Biocidal Products Regulation (GB BPR) as:
A biocidal product with no intended variations as to the percentage of the active or non-active substances it contains
Single biocidal products have a fixed formulation but may be authorised with multiple trade names.

Simplified active substance

An active substance that does not give rise to concern in accordance with Article 28(2) of the GB Biocidal Products Regulation (GB BPR) and is included in the GB Simplified Active Substance List. Simplified active substances can be used in products eligible for simplified authorisation as they may be considered to have a more favourable environmental or human or animal health profile.

Simplified authorisation

A type of product authorisation under the GB Biocidal Products Regulation (GB BPR) that is only available to biocidal products containing only active substances that are on the GB Simplified Active Substances List and also meet certain other criteria.
Simplified product authorisation is intended to encourage the use of products with a more favourable environmental or human or animal health profile.

Stopping the clock

The suspension of the evaluation period defined in the law for an application for active substance approval or product authorisation under the GB Biocidal Products Regulation (GB BPR) when HSE asks the applicant to provide additional information.
Depending on the information that is requested, the clock may be stopped for a period not normally more than 180 days in total over a 365-day evaluation period. Therefore, the purpose of stopping the clock is to allow HSE full use of the legal timeframes given by GB BPR for completing its evaluation.

Substance

The GB Biocidal Products Regulation (GB BPR) adopts the definitions given by the UK Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (UK REACH):
A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

Substance of concern

Defined by the GB Biocidal Products Regulation (GB BPR) as:
Any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect.
Such a substance would, unless there are other grounds for concern, normally be:

• a substance classified as dangerous or that meets the criteria to be classified as dangerous according to the GB Classification, Labelling and Packaging Regulations (GB CLP), and that is present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of that regulation
• a substance which meets the criteria for being a persistent organic pollutant (POP) under the GB Persistent Organic Pollutant Regulations (GB POP), or which meets the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII of the UK Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (UK REACH).

Substance supplier

A company that manufactures or imports to Great Britain (GB), an active substance on its own or in biocidal products.

Substitution criteria

A set of criteria, outlined in Article 10(1) of the GB Biocidal Products Regulation, against which active substances will be considered candidates for substitution.

Summary of Biocidal Product Characteristics (SPC)

Part of the Certificate of Authorisation (CoA) issued for a single product authorisation under the GB Biocidal Products Regulation (GB BPR). The Summary of Biocidal Product Characteristics (SPC) gives the important details of the product, such as trade names, application rate and instructions for use.

Summary of Biocidal Product Family Characteristics (SPfC)

Part of the Certificate of Authorisation (CoA) issued for a product family authorisation under the GB Biocidal Products Regulation (GB BPR). The Summary of Biocidal Product Family Characteristics (SPfC) gives the important details of the product family, such as trade names, application rates and instructions for use, set out in the meta-Summary of Biocidal Product Characteristics (meta-SPCs).

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T

Task force

A group of two or more companies jointly supporting an active substance for approval under the GB Biocidal Products Regulation (GB BPR). As the data are usually agreed to be shared between the members, this reduces animal testing and the members' individual costs.
A task force may also be known as a consortium.

Technical equivalence

The active substances used in biocidal products authorised under the GB Biocidal Products Regulation (GB BPR) may be sourced from multiple GB Article 95 suppliers; but only if each source has been determined by HSE to be technically equivalent to the specific source(s) that the active substance approval was based on (the 'reference source').
An active substance source may be granted technical equivalence if it has a similar chemical composition (this may include impurities) and hazard profile.

Technical sift

The first stage of the evaluation of an application for national authorisation under the GB Biocidal Products Regulation (GB BPR). The technical sift is conducted by HSE's specialist assessors is designed to identify any obvious data gaps or other issues upfront. The technical sift is a more in-depth check of an application than validation, but less in-depth than a full evaluation.

Top-up fee

A fee that may be charged by HSE in addition to the initial estimated fee for applications under the GB Biocidal Products Regulation (GB BPR). HSE operates on a cost recovery basis which means that the actual cost for evaluating an application is based on the total time spent on it by the assessment manager, specialist assessors and the business support team. Sometimes this actual cost is more than the initial estimated fee, so the extra cost has to be recovered by charging a top-up fee.

Transitional measures

Article 89 of the GB Biocidal Products Regulation (GB BPR) lets biocidal products, which are currently allowed to be made available on the market under other national law in Great Britain (GB), transition to authorisation under GB BPR. Such products will contain existing active substances that are under review for the relevant product type as part of the GB Review Programme. The transition period for a biocidal product ends on the date of approval (or non-approval) of the active substance it contains.

Treated article

Defined by the GB Biocidal Products Regulation (GB BPR) as:
Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.
The law also states:
A treated article that has a primary biocidal function shall be considered a biocidal product.

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U

UK Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations (UK REACH)

The law that regulates chemical substances in Great Britain (GB).

UK representative

A company that is established in the UK and acts on the behalf of another company based outside the UK. For example, this could be for the purposes of GB Article 95 under the GB Biocidal Products Regulation (GB BPR).

Under assessment

An active substance that is currently under assessment for the relevant product types by HSE under the GB Biocidal Products Regulation (GB BPR), but not as part of the GB Review Programme. An active substance that is under assessment may be able to be used in biocidal products in Great Britain (GB) before its approval date depending on the regulatory process it is supported under.

Under review

An active substance that is currently under review for the relevant product types by HSE as part of the GB Review Programme. An active substance that is under review may be able to be used in biocidal products in Great Britain (GB) before its approval date.

United Kingdom (UK)

The United Kingdom (UK) of Great Britain (GB) and Northern Ireland (NI). Refers to England, Scotland, Wales and Northern Ireland. Also includes islands that are part of England, Scotland, Wales or Northern Ireland, such as the Isle of Wight, Anglesey, the Isles of Scilly, the Hebrides, Orkney and Shetland.

Use

Defined by the GB Biocidal Products Regulation (GB BPR) as:
All operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside Great Britain (GB).

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V

Validation

An initial check on an application made to HSE under the GB Biocidal Products Regulation (GB BPR) to check for significant information gaps.

Vulnerable groups

Defined by the GB Biocidal Products Regulation (GB BPR) as:
Persons needing specific consideration when assessing the acute and chronic health effects of biocidal products. These include pregnant and nursing women, the unborn, infants and children, the elderly and, when subject to high exposure to biocidal products over the long term, workers and residents.

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W

Withdrawal (COPR)

An approval holder under the Control of Pesticides Regulations (COPR) can inform HSE that they intend to remove a product from the market in Great Britain (GB) and/or Northern Ireland (NI) that already has an existing approval. HSE will then act to revoke the approval.

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