Glossary

The glossary of terms is being updated on a regular basis - but if you cannot find what you are looking for, please try the 'Search' facility. The glossary of terms is constantly developing - and we welcome your feedback. Please contact us at biocides e-mail account

• A
• B
• C
• D
• E
• F
• G
• H
• I
• J
• K
• L
• M
• N
• O
• P
• Q
• R
• S
• T
• U
• V
• W
• X
• Y
• Z

A

Active ingredient

The active component or mix in a formulation that confers the efficacy of a product. Initially a COPR term, but is now often used as a synonym to '‘active substance'.

Active substance

Defined by the Biocidal Products Directive as "a substance or micro-organism having a general or specific action on or against harmful organisms"

Additional data set

The Biocidal Products Directive sets out the data to be included in dossiers for active substances to be included on Annex I or IA or authorisation/registration of biocidal products. This comprises a set of data which must be provided for all active substances and products (the common core data set), together with additional data required for certain active substances and uses (additional data sets). The additional data sets are specified in Annexes IIIA and IIIB of the Biocidal Products Directive.

Advertisement

An 'advertisement' is not defined by either the BPD or the BPR, so the common understanding of the term is presently adopted for purposes of regulatory activity (e.g. enforcement). As such an advertisement is a notice or display drawing attention to goods. Therefore, information distributed by way of magazine inserts, leaflets posted to customers, brochures, websites or other marketing material would seem to fall into this category, but safety data sheets about specific products given out with purchases of that product might not.

Advisory Committee on Pesticides (ACP)

The independent statutory body which advises UK Government Ministers on all matters relating to the control of pests under the Control of Pesticides Regulations or the Plant Protection Products Regulations. Further information can be found on the ACP webpage.

Amendment

An official change or modification to the conditions of a marketing approval (such as a change to the formulation, product name, packaging etc) of a product either at the request of the approval holder or imposed by the regulator.

Annex I, IA, IB of the Biocidal Products Directive

Annexes I, IA and IB are the lists of active substances that have been assessed as having hazards that can be sufficiently controlled to allow their effective use in certain biocidal product types.

• Annex I
  Is the main list of active substances permitted for inclusion in biocidal products. Biocidal products containing active substances listed on Annex I require authorisation at Member State level.
• Annex IA
  Is a set of active substances that have been agreed at the European level for inclusion in 'low risk biocidal products'.  These active substances cannot be classified as carcinogenic, mutagenic, toxic for reproduction or sensitising, cannot be bioaccumulative and must readily biodegrade.  Biocidal products that contain only active substances included in Annex IA and which contain no substance of concern are subject to a simplified procedure of registration.
• Annex IB
  Is the list of Basic Substances. These are active substances whose main use is non-pesticidal, but that have a minor use as a biocide either directly or in a simple diluent (and the diluent must not be an active substance or a substance of concern).  Basic substances cannot be marketed for their biocidal use.

Annex V of Council Directive 67/548/EEC

Annex V of Council Directive 67/548/EEC, as amended (the first directive on classification, packaging and labelling of dangerous substances). Annex V relates to test methods for the detection of physico-chemical properties, toxicity and ecotoxicity.

Applicant

A person or company submitting a dossier to a Competent Authority in order to gain either inclusion of a new active substance on Annex I or IA or authorisation/registration of a biocidal product under the Biocidal Products Directive/Regulations, or the company applying for a product approval for a pesticide under the Control of Pesticides Regulations.

Approval

A company wishing to advertise, sell, supply, store and/or use a non-agricultural pesticide in the UK must apply to HSE for an approval under the Control of Pesticides Regulations. An approval will only be given when all the required evidence and information on the safety, efficacy, and where relevant, the humaneness, of the pesticide has been submitted and evaluated. The final decision on approvals rests with Ministers.

Approval holder

The applicant (company or individual) that is granted the marketing approval by a regulatory body.

Approved Supply List

The Approved Supply List ‘Information approved for the classification and labelling of substances and preparations dangerous for supply’ is a publication containing detailed information to assist manufacturers, importers and suppliers in the classification and labelling of preparations in accordance to CHIP. It is based on the Dangerous Substances Directive (67/548/EEC) and the 8th edition incorporates up to the 29th Adaptation to Technical Progress.

Asterisked "non-statutory" precautionary phrases

Directives 67/548/EEC and 1999/45/EC require that safety phrases appear on each label and safety data sheet for hazardous chemicals and preparations. The safety phrases consist of the letter S followed by a number and are often referred to as S-phrases. Part V of the Approved Supply List (eighth edition) which incorporates the 29th Adaptations to Technical Progress lists the safety phrases in numerical order. These are recommended (non-statutory) safety precautions. The S-phrases denote the appropriate safety precautions or personal protective equipment to minimize these risks. Additional advice may also appear.

Authorisation

The administrative act by which the Competent Authority of a Member State authorises the placing on the market of a biocidal product in its territory or in a part thereof, following an application submitted by an applicant.

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B

Back to back application

An application (under COPR) for a marketing approval for a new product that is based on a data-set previously considered and approved for another product. The applicant does not have to be the data-owner or manufacturer of the active substance provided the data owner gives its consent to the applicant in the form of a Letter of Access and the supplier issues a Letter of Intent to Supply the active ingredient.

Basic substance

A substance which is listed in Annex IB of the Biocidal Products Directive, whose major use is non-pesticidal but which has some minor use as a biocide.

Biocide

see active substance or biocidal product

Biocidal active substance

see active substance

Biocidal product

Defined by the BPD as "active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of or otherwise exert a controlling effect on any harmful organism by chemical or biological means."

Biocidal Products Directive (BPD)

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. The Biocidal Products Directive sets up a European Community product authorisation scheme for biocidal products, such as non-agricultural pesticides, disinfectants and preservatives. The Directive has the central objectives of harmonising the European market for biocidal products and their active substances, and providing a high level of protection for humans, animals and the environment.

Biocidal Products Regulations (BPR)

The Biocidal Products Regulations 2001 (SI No. 2001/880) (as amended) implement the requirements of the Biocidal Products Directive into British law, including the requirement for a regulatory scheme.

Biocides Consultative Committee (BCC)

The purpose of the BCC is to provide independent advice to HSE (as the UK Competent Authority) on the work it does under the Biocidal Products Regulations. The Committee comprises an independent chair, independent expert members and lay members.

Biocide Technical Meetings

These are 3-5 day meetings held 3-5 times a year in Brussels. They are chaired by the European Chemicals Bureau (ECB) with a member of the COM present. Regular attendees are the representatives from all EU Member States’ CAs for biocides and Industry. Individual Applicants are invited to attend for discussion of their own active substance only. The meetings focus on substance-based and technical issues, with the outcomes being presented to the CAs for endorsement/ratification. Issues that are political can be referred upwards to the CA for a decision. The meetings are minuted. Although the full minutes of these meetings are only available to Member States via CIRCA, a summary is available to Industry and the public in ECB newsletters.

Biological means

A substance controlling harmful organisms is considered as an active substance acting by biological means when the control action directly involves living micro-organisms (biological means).

Borderline cases

During the implementation of the Biocidal Products Directive, it emerged that there were many cases where it was not clear whether the substances under consideration were biocides or not. These ‘borderline cases’ were discussed within an expert group of all Member States and the Commission. The cases have been collected in the Manual of Decisions and specific borderline documents available on the DG Environment website. In cases of uncertainty the Member States or the European Commission should be consulted.

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C

CAS number

Chemical Abstract Service index number. The number (up to 9 digits) is separated into 3 groups by hyphens and takes the form XXXXXX-XX-X. It is a unique numeric identifier designating only one substance.

CEFIC

CEFIC is the umbrella organisation of the European Chemical industry (Confédération Européenne des Fédérations de l'Industrie Chimique). As the European Chemical Industry Council (CEFIC) based in Brussels it is the organisation that represents National Chemical Industry Federations and Chemical Companies of Europe.

CHIP

The Chemicals (Hazard Information and Packaging for Supply) Regulations 2002. All biocidal products authorised under Biocidal Products Regulations have to be classified, packaged and labelled in accordance with CHIP, however there are also some additional labelling requirements under BPR.

CIRCA

The Communication and Information Resource Centre Administrator is the information portal developed under a European Commission programme for public administrations needs. It enables a community (e.g. committee, working group, project group etc.) geographically spread across Europe (and beyond) to maintain a private space or ‘Interest Group’ (IG) on the internet where they can share information, documents, participate in discussions and benefit from various other functionalities. Access and navigation in this virtual space is done via any internet browser (Netscape, Internet Explorer), but requires a user-ID and password to enter the site. For each IG one member plays the role of chairman or moderator which in CIRCA is termed the ‘leader’.

Commission of European Communities

Now the European Commission (COM).

Common core data set

The Biocidal Products Directive sets out the data to be included in dossiers for active substances to be included on Annex I or IA or authorisation/registration of biocidal products. The common core data sets define the data which must be provided for all active substances and biocidal products. Annexes IIA and IIB of the Biocidal Products Directive list the common core data sets.

Competent Authority (CA)

An organisation authorised to carry out the work under the BPD. Each European Union Member State is responsible for establishing their own CA. In the UK, the Health and Safety Executive (HSE) was authorised to act as the CA on behalf of Ministers.

Competent Authorities Meetings

These are usually 2-day meetings with simultaneous translation, held about 3-5 times a year in Brussels. They are chaired by the COM. Regular attendees are the representatives from all EU Member States’ CAs for biocides and Industry. They focus on political issues, and endorse technical issues referred to them by the Technical Meetings (TM). The Competent Authorities Meeting will also review and endorse Rapporteur Member State (RMS) evaluations that have been agreed at the technical meeting, prior to any vote on Annex I inclusion. The meetings are minuted, but the full minutes of these meetings are only available via the restricted part of CIRCA. Industry may have access to the minutes via CEFIC whilst members of the public would need to contact the COM for further information

Chemical means

A substance controlling harmful organisms is regarded as an active substance acting by chemical means when the control is linked to the interference of that substance in biological/physiological processes through direct chemical interaction (inside or outside the target organisms) or indirect modifications because of the physical/chemical properties of the substance (chemical means).

Completeness check

When a Competent Authority receives a dossier under BPD on an active substance, together with the initial fees, it is checked to make sure that it contains all of the required data. The CA has 90 days (3 months) to make a decision and inform the COM. If the dossier is incomplete, the applicant will be contacted and asked to send in the required information. The applicant has 30 days to respond and a subsequent 3 months to provide the information.  A request for further information will delay the process of accepting the dossier.

Consents

Presently under the Control of Pesticides Regulations the consents (for example the permission to advertise, sell, supply, store and use) form the basis of a marketing approval. These may be restricted (e.g. for the purposes of disposal only). The consents under BPD will probably be similar, but as yet none have been issued as no products have yet progressed this far.

Contents statement

The contents statement must appear on the product label for products approved under the Control of Pesticides Regulations and should state the concentration of the active component(s) and any dangerous substances in the product as it is supplied.

Control of Pesticides Regulations (COPR)

The Control of Pesticides Regulations 1986 (SI No: 1986 No 1510), as amended, are the basis for the current legal controls over non-agricultural pesticides within Great Britain. Products currently approved via HSE under COPR will be regulated under the Biocidal Products Regulations once the active ingredients contained in them have been reviewed for inclusion on Annex I etc.

COPR Data protection

See "Data protection" below

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D

Data protection

The principle under which a producer or manufacturer of an active substance or biocidal/pesticidal product may control access to any data they have generated in support of their application for Annex I etc inclusion or product authorisation/registration under the Biocidal Products Directive, or product approval under the Control of Pesticides Regulations. During a period of data protection, third parties may not use that data in support of their own applications without the permission of the data owner.  This is to allow the producer/manufacturer to recoup some of the costs of generating the data in the first place. Data are only protected for defined periods of time after they are submitted.

Data requirements

Those details deemed necessary by a regulatory body in order for it to fully assess or evaluate the safety and efficacy of a substance or product. These can be additional to the common core data set and may be unique to a given application.

Data rich

'Data rich' means that there are extensive data or information available on endpoints or the issue(s) under consideration.

DEFRA

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

Departmental (the evaluation)

In the context of the Control of Pesticides Regulations in the UK this term refers to an application for approval which is outside existing precedents where the new risks the product presents will need to be assessed. For example, an increase in active ingredient concentration above that previously used or if a product previously used indoors is now to be used outdoors. Additional data may need to be submitted for evaluation, and where necessary other government departments/bodies (such as the Department of Health, Natural England, Department for Environment, Food and Rural Affairs (DEFRA), Scottish Executive, National Assembly for Wales) and the Advisory Committee on Pesticides may need to be consulted.

Dossier

An application dossier is a package of information prepared by the applicant, which contains all of the data required by the EU Commission and Member States in order to evaluate an application for inclusion of an active substance on Annex I etc or authorisation/registration of a biocidal product. The dossier is made up of 4 documents termed Document I, II, III and IV plus several appendices which cover claims for confidentiality, references, literature searches etc. Documents II, III and IV are further split into ‘A’ and ‘B’ categories for the active substance and associated product(s) respectively.

• Document I – is the application form with appendices (lists of end points, standard terms and abbreviations, completeness check forms, safety data sheets, overall summary and conclusions, proposal for decision)
• Document II – risk assessment.
• Document III – study summaries.
• Document IV – the original and study reports.

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E

EC Classification

The Chemicals (Hazard Information and Packaging for Supply) (CHIP 3) Regulations and The Dangerous Preparations Directive (99/45/EC) stipulate how a product should be classified. Examples of EC classifications can range from ‘not classified’ to carcinogen, corrosive, explosive, flammable, harmful, etc. Some of these have accompanying hazard symbols that must also be displayed on product labels. Please consult the regulations for a complete list of the classifications and hazard symbols.

EINECS

EINECS (European Inventory of Existing Commercial Chemical Substances) is an inventory containing over 100,200 substances. Chemical substances listed on the EINECS are by definition considered to be ‘existing’ chemical substances by the EU. The term ‘existing’ in this case is used in the context of the general meaning of word (i.e. to be) rather than the more technical term used under BPD (see ‘Existing Active Substance’).

Emergency authorisation

Emergency authorisation is a process whereby a non-authorised biocidal product may be quickly considered for use if unforeseen circumstances arise that cannot be controlled by any other means, e.g. an outbreak of foot and mouth disease where no authorised disinfectant product is efficacious against the organism that causes the disease-causing organism.  Emergency authorisations can be for up to 120 days, although the Standing Committee on Biocidal Products may extend this.

Environmental Exposure Scenario Documents (ESD)

These are guidance documents produced by the Commission. Environmental Exposure Scenario Documents are publicly available – but where these are not available, the Applicant should rely on the known use patterns with knowledge of the ESD approaches taken for similar product types.

European Commission (COM)

The European Commission is the executive body of the European Union. It acts as the guardian of the EU treaties to ensure that EU legislation is applied correctly, prepares policy initiatives and presents legislation suggestions, and serves as an authority in certain fields. Alongside the European Parliament and the Council of the European Union, it is one of the three main institutions governing the Union. However, its exclusive power of initiative is unique to it that sets it apart from the other EU bodies.

The Commission presently consists of 27 Commissioners, one from each member state of the EU supported by an administrative body of over 20,000 European civil servants divided into departments called Directorate-General (DG). The DG Environment has a main role in the BPD including participation in Technical Meetings and chairing of CA meetings and the Standing Committee on Biocidal Products. The term "the Commission" is generally used to refer both to the administrative body in its entirety, and to the team of Commissioners who lead it.

The EU Commission website provides a homepage with information on the BPD, related guidance documents, biocidal product types, the Review of Existing Substances (including its current status and non-confidential versions of Rapporteur Member States’ evaluations that can also be seen on CIRCA), substances on Annex I/IA and CA & MS contact details.

Existing active substance

A biocidal active substance which was on the European market for use in biocidal products before 14 May 2000, and is included in the lists in the Second Review Regulation. Active substances which were on the market before that date but which were not identified will be treated as new active substances.

Existing Biocidal Product

A products that has been placed on the UK market at the date of inclusion of the active substance on to Annex I/IA of the BPD.

Experimental authorisation

Experimental authorisations allow unauthorised biocidal products or active substances which are not on Annex I etc. for a product type to be placed on the market, in order to allow an applicant to undertake research and development where there is a release into the environment, prior to an application being made for inclusion on Annex I etc.

Expiry dates

Marketing approvals under COPR are granted for a fixed period of time. The last date for which the approval is valid is the expiry date. The granted consents cease to apply and it becomes illegal to market (advertise, sell, store, use or supply) the product after this date.

Experimental Permit

Under the Control of Pesticides Regulations, an approval granted to allow a company to use a substance, preparation or organism for the purpose of research/development or in an experimental trial.

Exposure Scenario

An exposure scenario is a set of assumptions concerning how humans and/or the environment may be exposed to the substances of concern contained within a biocidal product. These assumptions are then used in the process of determining or estimating the magnitude, frequency or duration of exposure to such substances.

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F

First Review Regulation

Commission Regulation (EC) No. 1896/2000 of 7 September 2000, which describes the framework for reviewing existing active substances. The processes of declaring the links between the manufacturers, suppliers and sellers and identifying and notifying active substances is stated as are the consequences upon those, hitherto, existing active substances that are not supported.

Fourth Review Regulation

Commission Regulation (EC) No 1849/2006 of 14 December 2006 amending Regulation (EC) No 2032/2003 concerning the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. It:

• amends the lists of active substances on Annexes II, III, V and VII of the second Review Regulation;
• requires the Rapporteur Member State to produce an ‘assessment report’, based on their competent authority report for a reviewed substance, and that the Commission will make this assessment report publicly available;
• requires that when a decision is taken not to include a substance in the Directive’s Annexes, Member States ensure products containing that substance are no longer on the market with effect from 12 months after the date of the decision coming into effect.

Fifth Review Regulation

Commission Regulation (EC) No. 1451/2007/EC came into effect on the 24 December 2007. It updates and replaces the Second Review regulation (2032/2003/EC and its amendments (1048/2005/EC and 1849/2006/EC (the Third and Fourth review regulations))).

Frame formulation

Specifications for a group of biocidal products having the same use and user type. This group of products must contain the same active substance, and must only have differences in composition from a previously authorised product which do not affect the level of risk or efficacy associated with the product. They are subject to a streamlined authorisation process.

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G

General Industry Charge

An annual charge levied on the biocides industry to recover ongoing costs incurred by the UK authorities in operating the regulatory system. The GIC is separate to the fees charged for the processing of applications for product authorisation/registration or inclusion of active substances on Annex I etc., and covers those costs which cannot be attributed to specific applications.

Good Laboratory Practice (GLP)

Defines a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. The GLP principles were developed to promote the quality and validity of data generated in the testing of chemicals in order to facilitate their recognition for purposes of assessment and other uses relating to the protection of human health and the environment.

Government Departments

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H

Harmful organism

Defined by the BPR as "an organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or the environment"

Hazard warning symbol

Products carrying an EC classification as determined by CHIP3 criteria are required to display the appropriate hazard warning symbol on the product label. Part V of the Approved Supply List (8th edition) lists the complete

HSE number

Pesticides approved under COPR are issued a unique product-specific HSE number when they are first approved under COPR. This number must be displayed on product labels.

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I

Identification

Identification was the process whereby the producer of an active substance or a product formulator provided information to the European Chemicals Bureau on which active substances they wished to continue to supply but did not necessarily intend to support at review (substances that were intended to be supported needed to be Notified). Products containing active substances which were identified only were withdrawn from the EU market from 1st September 2006 (as set in the Second Review Regulation).

Interdepartmental Committee on Biocides (ICB)

The purpose of the ICB is to provide Departmental scientific and policy input into the work HSE carries out as the UK competent authority for biocides. This committee is made up of representatives from HSE and other Government Departments and Agencies who have an interest in biocidal products. 

International Uniform Chemical Information Database (IUCLID)

A database developed as a tool for data collection and evaluation for the European Risk Assessment Programme on Existing Substances, and which has been subsequently adopted for use under the Biocidal Products Directive.

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J

Joint Research Centre-Institute for Health and Consumer Protection (JRC-IHCP)

The JRC-IHCP is the European focal point for data and for the assessment procedure on dangerous chemicals and biocides. It provides scientific and technical support to Member States and the Commission on biocides including chairing the Biocides Technical Meetings (TM) and updating the CA meeting on TM activities. The JRC-IHCP websie provides access to guidance documents (ESDs, TNGs and TGDs).

Justification for non-submission

A justification is a reasoned (scientifically robust) case for the non-submission of data. A justification of non-submission of data can be based upon ‘the nature of the biocidal product or of its proposed uses’ or ‘where it is not scientifically necessary or technically possible’. A justification will not be sufficient if it only states that information for a particular endpoint is not required or not relevant. While the justification should be concise and to the point, it should also be long and detailed enough for the reader to be able to decide the case for themselves.

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K

Key studies

A key study, which must be summarised in Document III-A/B and have a reliability indicator of 1 or 2, provides a critical endpoint and is regarded as adequate for use in the risk assessment.

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L

Letter of Access

A document, signed by the owner or owners of relevant data protected under the provisions of COPR or BPD, which states that these data may be used by the CA for the purpose of granting an authorisation or a registration of a biocidal product under COPR or BPD.

Letter of intent to supply

A document signed by the supplier of an active substance which declares that it supplies the active substance to the recipient. The letter can be specific for a single product or general for all the recipient’s relevant products.

Levy

For the Control of Pesticides Regulations, under section 18 of the Food and Environment Act 1985, as amended by the Pesticides (Fees and Enforcement) Act 1989, Ministers are empowered to recover costs of running the COPR pesticides scheme and for operating monitoring systems. The levy collection exercise commences each year in September with a request to Approval Holders to declare their sales turnover for a given 12 month period. Invoices are subsequently sent out the following January. All Approval Holders are charged an annual Pesticide Levy on HSE approved pesticide products. The declaration figures are needed to enable the levy rate to be set, which varied from year to year depending on the total turnover for all HSE approved products. For 2007/2008 the levy was 0.6% of gross turnover.

Low risk biocidal products

Low risk biocidal products are those which, under the conditions of use, pose only a low risk to humans, animals and the environment. These products must contain only active substances which are listed in Annex IA, and must not contain any substance(s) of concern. They are subject to a simplified procedure of registration.

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M

Main group

The Biocidal Products Directive applies to 23 classes of biocidal product. These Product Types have been categorised into 4 Main Groups; Disinfectants and General Biocidal Products, Preservatives, Pest Control, and Other Biocidal Products.

Major metabolite

A major metabolite or degradation product is considered relevant for additional data requirements if it appears at a level of ≥ 10 % of the applied parent compound in any media.

Manual of Decisions

A log of the decisions made by the Commission on matters of scope and product type designations. The up to date version is available for viewing online

Marketing company

The company that places an approved product on the market in its final presentation with full packaging for sale.

Member States (MS)

The 27 member countries of the European Union.

Mutual recognition

When a biocidal product has been authorised or registered in one Member State under BPD, then authorisation/registration may subsequently be granted in other Member States without having to go through the full authorisation/registration process. This is known as mutual recognition. Mutual recognition cannot be applied to biocidal products that only have provisional authorisation.

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N

National Poisons Information Service (NPIS)

The NPIS is an organisation supported by the Department of Health, which is responsible for providing a year-round service for health care staff on the diagnosis, treatment and management of patients who may have been poisoned. The Birmingham Centre is responsible for receiving and disseminating product safety information for pesticides, agrochemicals, biocides and veterinary products marketed in the UK.

New active substance

A biocidal active substance which was not on the European market for use in biocidal products before 14 May 2000.

Non-agricultural pesticides

Non-agricultural pesticides are regulated by the Health and Safety Executive under the Control of Pesticides Regulations current national regulatory scheme. Non-agricultural pesticides include products such as insecticides for public hygiene use, insect repellents for application to animals, rodenticides, wood preservatives, surface biocides and antifouling products.

Notification

Notification was the process whereby the producer of an active substance or a product formulator provided information to the COM on which active substances they intended to continue to supply and support at review. Where an active substance was only notified in specific product types, those product types which were not notified were automatically considered to have been identified and products containing such substances had to be withdrawn from the EC market by 1st September 2006 (set in the Second Review Regulation). Substances which have a Notification accepted will be included in the review programme.

Notice of Approval

The official document issued under the Control of Pesticides Regulations that is sent to an applicant (the new Approval Holder) informing them that an approval has been granted. 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.

Notice of Approval (Amendment)

The official document under COPR that is issued to an Approval Holder informing it of the changes made to the conditions of its marketing approval granted previously. The original document is kept on file by HSE and a copy is issued to the approval holder. At present it is unclear how such processes will be administered under BPD.

Notice of Approval (Amendment) Voluntary Withdrawn Product

The official document that is issued to an Approval Holder who has voluntarily withdrawn its product previously submitted or approved under COPR. The original document is kept on file by HSE and a copy is issued to the approval holder. At present it is unclear how this process will be administered under BPD.

Notice to Revoke Approval

The official document that is issued to an Approval Holder informing it of an imposed withdrawal of its product under COPR. The original document is kept on file by HSE and a copy is issued to the approval holder. At present it is unclear how this process will be administered under BPD.

Notice of Approval (Automatic Experimental Permit)

The official document that is issued to an Applicant consenting to its use in an experimental setting for the purposes of generating data that are required to support its approval under COPR. The original document is kept on file by HSE and a copy is issued to the approval holder.

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O

Organisation for Economic Co-operation and Development (OECD)

The OECD groups 30 member countries sharing a commitment to democratic government and the market economy. Best known for its publications and its statistics, its work covers economic and social issues from macroeconomics, to trade, education, development and science and innovation. The OECD Biocide Programme has two main objectives:

• to increase the efficiency in the registration of biocides; and
• to help countries to reduce risks associated with biocides use.

Biocides dossiers sometimes make use of OECD’s experimental protocols to address end-points.

Official Journal of the European Union (OJEU)

Previously the Official Journal of the European Communities (OJEC). The Official Journal (OJ) is a periodical published by the European Union every working day. It consists of two related series (L for legislation and C for information and notices) and a supplement (S for public tenders), and is published in all 11 official languages. It is the authoritative source of EU law.

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P

Participant

A person or company who is supporting an active substance in the BPD review programme, following acceptance of a Notification.

Personal protective equipment (PPE)

Equipment used to decrease or eliminate the exposure to a chemical, biological or other substance (e.g. radiation, noise etc.) Examples of PPE can include gloves, goggles, masks etc.

Pesticide

A pesticide is defined as a substance, preparation or organism used to control or destroy any pest.

Pesticides Safety Directorate (PSD) (Now part of the Chemicals Regulation Directorate)

An agency of HSE tasked with regulating agricultural products.

Placing on the market

BPD defines this as any supply, whether in return for payment or free of charge, or subsequent storage other than storage followed by consignment from the customs territory of the Community or disposal. Importation of a biocidal product into the customs territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive.

Plant protection product

Plant protection products are pesticides intended to protect plants or plant products against harmful organisms, preserve plant products, or to destroy undesired plants or parts of plants. They are not regulated under the Biocidal Products Directive, but under the Plant Protection Products Directive (as implemented by the Plant Protection Products Regulations). The Pesticides Safety Directorate (an agency of the Health and Safety Executive) is responsible for the regulation of plant protection products.

Precautionary (Statutory) phrases

The Dangerous Substances Directives (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC) require that risk phrases appear on each label and safety data sheet for hazardous chemicals and preparations. The safety phrases consist of the letter R followed by a number and are often referred to as R-phrases. Part V of the Approved Supply List (eighth edition) which incorporates the 29th Adaptations to Technical Progress lists the safety phrases in numerical order. These are the special risks associated with the substance or preparation under consideration and the R-phrases denote the appropriate safety precautions or personal protective equipment to minimise these risks.

Process Orientated Research and Development (PORD)

Under the Biocidal Products Regulations, PORD relates to development activities for a substance or product, in the course of which pilot plant or production trials are used to test the fields of application. It applies to situations such as transfer from bench-top to a pilot plant or a full-scale production facility.

Product Authorisation

See authorisation

Product Registration

See registration

Product Type

The definition of a biocidal product generally sets out which products fall within the scope of the Biocidal Products Directive.  This is further refined by the definition of 23 classes of product to which the Directive applies. These have been categorised into 4 Main Groups.

Prolongation Regulation

Regulation number 1687/2002, gave an additional period until 31 January 2003, during which producers, formulators and associations could Notify existing active substances that had previously only been Identified and/or to Notify previously Notified active substances in further product types.

Provisional authorisation/registration

Provisional authorisations/registrations may be granted for products containing active substances which are not yet to be included on Annex I etc., but for which the evaluating competent authority has evaluated an application and recommended Annex I etc. inclusion.

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Q

Qualified Majority Voting (QMV)

Each member state has a specified number of votes, allocated broadly according to their population size. 255 votes are needed for a qualified majority out of a total of 345 votes to carry a decision. In addition, the 255 votes in favour of a proposal have to be cast by a majority (or in some cases a two-thirds majority) of Member States, and at least 62% of the Union’s population. The UK has 29 votes.

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R

Rapporteur Member State (RMS)

A Member State of the EU with responsibility for the evaluation of one or more BPD dossiers.

Reasonable worst-case assumptions

any assumptions made for the prediction of exposure (environmental or human) should be precautionary but realistic. For example, to assume that every house in the UK will use the same insecticide product at the same time would not be reasonable, but to assume a 5 % market share would be reasonable as once approved for use the sales cannot be controlled by the regulator and the risk assessment needs to consider the maximum potential risk using the available data.

Registration

The administrative act by which the competent authority of a Member State allows the placing on the market of a low-risk biocidal product in its territory or in a part thereof, following an application submitted by an applicant. Registration is a simplified form of the authorisation process, and may only take place after verification that the dossier meets the relevant requirements of the Directive.

Reliability Indicators

Reliability indicators are given as part of the study summary format as a check of the inherent quality of the test methodology and study documentation

Residues

One or more of the substances present in a biocidal product which remains as a result of its use, including the metabolites of such substances and products resulting from their degradation or reaction.

Restriction of use

The limitation of use phrase that is stated on a product’s approval Schedule issued under COPR. The phrase must be shown on the product label. An example of such a phrase is ‘For use only as an insecticide.’

Review Regulations

The Review Programme for active substances covered by BPD is controlled by a series of Commission Regulations which set out the procedures and timescales for the programme. These are the Review Regulations.

• 1st Review Regulation – Commission Regulation (EC) No 1896/2000 of
  7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products. It describes the notification procedure of existing active substances.
• Prolongation Regulation – Commission Regulation (EC) No 1687/2002 of
  25 September 2002 on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Regulation (EC) No 1896/2000.
• 2nd Review Regulation – Commission Regulation (EC) No 2032/2003 of
  4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000. The 2nd Review Regulation gives the outcomes of the notification and identification procedures as lists of substances and the product types in which they have been nominated.
• 3rd Review Regulation – Commission Regulation (EC) No 1048/2005 of 13 June 2005 amending Regulation (EC) No 2032/2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. This Regulation
  • amends the Second Review Regulation (EC) No 2032/2003
  • gives the third (Part C) and fourth (Part D) priority lists and the associated Rapporteur Member States
  • gave the opportunity for an active, which was only identified, or one that had been notified but not for use in the particular product type you are interested in, to be upgraded to the 'notified' status by submitting a full dossier for review on the active substance and a representative product containing it, to a Member State Competent Authority by 1 March 2006. (This method of entering the review process is set out in article 4b of the Third Review Regulation)
• 4th Review Regulation – Commission Regulation (EC) No 1849/2006 of 14 December 2006 amending Regulation (EC) No 2032/2003 concerning the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. It
  • amends the lists of active substances on Annexes II, III, V and VII of the second Review Regulation
  • requires the Rapporteur Member State to produce an ‘assessment report’, based on their competent authority report for a reviewed substance, and that the Commission will make this assessment report publicly available
  • requires that when a decision is taken not to include a substance in the Directive’s Annexes, Member States ensure products containing that substance are no longer on the market with effect from 12 months after the date of the decision coming into effect.
• 5th Review Regulation – Commission Regulation (EC) No. 1451/2007/EC came into effect on the 24 December 2007. It updates and replaces the Second Review regulation (2032/2003/EC and its amendments (1048/2005/EC and 1849/2006/EC (the Third and Fourth review regulations. The main changes this regulation makes are:
  • It allows for the removal from consideration of Animal and Human foodstuffs marketed as Attractants or Repellents (product type (PT) 19, i.e. honey, jam) until the end of the end of the review period, at present 14th May 2010. 
  • When a non-inclusion decision has been published for a substance in a particular product type, then from the date of publication there is a 12 month phase out from sale period. (See Article 4 (2)).
  • Also when support has been withdrawn for a substance in the review programme, it states that it can be taken over by another participant. This must happen within the 3 month period as outlined by the Commission. This change of support can only happen on one occasion. (See Article 12).  So if you have an interest in taking over support of a substance, you must do it within this 3 month period otherwise it will be withdrawn from the review process and would then have to be treated as a new active.
  • Where a substance is supported through the review, others apart from the original Applicant may submit dossiers to support the active. However, they will have to work to the same timescale as the original submission. (See Articles (7) and (8)).
  • Also the regulation provides updated and simplified Annexes for existing chemicals, the Member States responsible for evaluation and the product types that support has been registered under. The 5th review regulation should now be used to check substance notification under the review programme as it replaces previous review regulations.

Review Programme

The 10-year programme to review all existing biocidal active substances, in order to bring existing biocides under the control of the BPD. Once an active substance has been reviewed for use in a product type, that substance and products containing it will be controlled under the BPD rather than under national legislation.

Revocation

The withdrawal from the market of a COPR approved product and its marketing consents.

Risk Assessment

Risk assessment (of biocides) refers to the quantitative and qualitative evaluation of the risk posed to human health and/or the environment by the actual or potential presence of and exposure to particular biocidal chemicals/active substances.

Risk phrases

See ‘Asterisked “non-statutory” precautionary phrases’ and ‘Precautionary (Statutory) phrases’.

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S

SANCO

SANCO is the Health and Consumer Protection Directorate General (DG SANCO) and is responsible for ensuring the health of European citizens. See ‘European Commission’ for the role of DG’s within the EC setup.

Scientific research and development

Scientific experimentation, analysis or chemical research carried out under controlled conditions. It includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development;

Schedule

The official COPR document listing the particulars of a product application to which a Notice of Approval applies. The Schedule includes details of the product, its formulation, the source of the active ingredients, the product’s intended uses and users, its efficacy claims, classification, the user specific risk and safety phrases, details of its packaging and any other relevant comments.

Second Review Regulation

Also known as ‘COMMISSION REGULATION (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000.’ The second review regulation published in the Official Journal of the European Communities (OJ) and its Annexes the

• lists of Identified active substances (Annex I). [Note that this is NOT the so-called positive list]
• list of Notified active substances (and the product types for which they have been Notified) or for which a Member State has expressed an interest (Annex II).
• list of Identified active substances that have had neither an accepted Notification or an expression of interest from a Member State (Annex III), for which set the priority order for evaluating the different product types under BPD.
• the requirements for the complete dossier and the summary dossier (Annex IV).
• specified the dossier submission deadlines for all 23 product types and provided further details on how active substances should be regarded with respect to these dates and their placement on the market and Annex I (the so-called positive list).
• listed the allocated Rapporteur Member State to receive the dossiers (Annex V).
• listed the details of the known 16 CA’s at the time of publication.

Secretariat

An application for approval of a product under the Control of Pesticides Regulations where the formulation and use profile are similar to previously approved products. As the application is within existing precedents it can be evaluated ‘in-house’, without the need for consultation with other Government departments or the Advisory Committee on Pesticides. A ‘Secretariat’ is also a term for a civil service body responsible for servicing a given Committee and ensuring its smooth operation. The secretariat makes arrangements for meetings, compiles and prepares reports and co-ordinates with other relevant bodies.

Series change

An amendment to the conditions of a COPR approval made at the request of the Approval Holder or imposed by the regulator that is of a general nature and impacts on all similar products. For example there is a single approval holder which is changed for another or a single marketing company is changed for another or both.

Standing Committee on Biocidal Products (SCBP)

The SCBP is a committee created to assist the European Commission.  It is composed of representatives of the Member States and chaired by a representative of the Commission. It considers recommendations made by the Commission and provides comments on the assessment report (agreed changes are subsequently incorporated in the report by the Rapporteur Member State). The SCBP decides by Qualified Majority Voting (QMV) whether to accept the draft decision relying on the EU Technical Note for Guidance on Annex I Inclusion to help reach a decision.

Statutory Box

An obligatory framed (boxed) area on a COPR product label that includes A statutory box should be found on the draft label. Within the statutory box the following should be included:

• An initial statement “STATUTORY CONDITIONS RELATING TO USE”
• The restriction of use phrase as detailed on the draft schedule.
• The application rate as detailed on the draft Schedule.
• The precautionary phrases without asterisks (R-phrases) as they appear on the draft Schedule. Those with asterisks should appear elsewhere on the label.
• A final statement” READ ALL PRECAUTIONS BEFORE USE. HSE XXXX”

"Stopping the clock"

HSE, as a Competent Authority, is required to meet deadlines for various tasks it carries out under BPD. Under certain circumstances, such as waiting for the submission of additional data, the evaluation can be suspended. The time remaining to the deadline will also be suspended. This suspension period (also known as "stopping the clock"), which runs from the date the applicant\participant is contacted until the extra information is received. The time taken to respond will not be counted against the deadline. 

Study Summary

Study summaries provide the general basis for the further evaluation by the CA and should present comprehensive summaries of test and key studies and any other information required according to the BPD

Substances

Chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products 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

Any substance, other than the active substance, which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in sufficient concentration to create such an effect.

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T

Task force

A task force is formed when 2 or more companies, with an interest in the same active substance, come to a commercial agreement to share data on that substance. The reasons for this include reducing animal testing and to reduce costs.

Technical Guidance Documents (TGD)

Documents produced by the Commission to provide guidance on a number of areas: Technical Guidance Document on Risk Assessment for NONS, ESR and Biocides

Technical Meeting (TM)

Technical Notes for Guidance (TNsG)

Documents produced by the Commission to provide guidance on a number of areas, in particular the implementation of the authorisation procedures, the entry of active substances in the appropriate Annexes, the Annexes relating to data requirements and the Annex dealing with the common principles.

• TNsG on Dossier Preparations
• TNsG on Data Requirements

Third Review Regulation

Commission Regulation (EC) No 1048/2005 of 13 June 2005 amending regulation (EC) No 2032/2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. This Regulation

• amends the Second Review Regulation (EC) No 2032/2003
• gives the third (Part C) and fourth (Part D) priority lists and the associated Rapporteur Member States
• gave the opportunity for an active, which was only identified, or one that had been notified but not for use in the particular product type you are interested in, to be upgraded to the 'notified' status by submitting a full dossier for review on the active substance and a representative product containing it, to a Member State Competent Authority by 1 March 2006. (This method of entering the review process is set out in article 4b of the Third Review Regulation).

Transitional period

Until all existing biocidal active substances have been reviewed for possible inclusion on Annex I etc., the Biocidal Products Regulations are in a transitional period. During this period, the existing national controls (e.g. the Control of Pesticides Regulations) will apply to existing active substances until they have been reviewed and a decision has been made whether to include them on Annex I etc. of BPD.

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U

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V

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W

Withdrawal

The instruction or act to remove a previously approved product (revoke) from the market.

Withdrawal lists

In accordance with Articles 8 (3) and 9(5) of Regulation (EC) No 2032/2003, the Commission must give public notice where all participants for a given active substance or product type combination withdraw from the review program or where no dossier is received within the time period specified in Annexes V and VIII to that Regulation. This information is contained in the withdrawal lists. Within three months of this publication, producers, formulators, associations or other persons wishing to take over the role of participants for the active substance or product type combination concerned must inform the Commission accordingly.

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X

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Y

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Z

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