Brexit: Transition period
The UK has now left the EU. Your health and safety responsibilities have not changed in the transition period.
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 [email protected].
- 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 EU BPR (Regulation 528/2012) as "A substance or micro-organism that has an action on or against harmful organisms”
- Additional data set
- EU BPR (Regulation 528/2012) sets out the data to be included in dossiers for active substances to be included in the Union list of approved active substances or for the authorisation 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).
- An 'advertisement' is defined by the EU BPR (Regulation 528/2012) as “a means of promoting the sale or use of biocidal products by printed, electronic or other media”.
- 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.
- An official change or modification to the conditions of a COPR product approval or an EU BPR (Regulation 528/2012) product authorisation (such as a change to the formulation, product name, packaging etc) either at the request of the approval holder or imposed by the regulator.
- Annex I of Regulation 528/2012
- List of active substances that meet the eligibility criteria for the simplified authorisation procedure. Please Note this is NOT equivalent to the older Biocidal Products Directive Annex I.
- A person or company submitting a dossier to a Competent Authority in order to gain either inclusion of a new active substance on the Union list of approved active substances or authorisation of a biocidal product under the EU BPR (Regulation 528/2012), or the company applying for a product approval for a pesticide under the Control of Pesticides Regulations.
- Approval (COPR)
- A company wishing to advertise, sell, supply, store and/or use a non-agricultural pesticide which is still regulated under the Control of Pesticides Regulations in the UK must apply to HSE for an approval under the COPR. 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. The product cannot be advertised, sold, supplied, stored and/or used until the approval has been granted, and any conditions of the approval have to be met.
- Approval holder (COPR)
- The applicant (company or individual) that is granted the product approval under the Control of Pesticides Regulations.
- See National authorisation, Simplified authorisation, Union authorisation.
- Back to back application
- An application (under COPR) for an 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.
- see active substance or biocidal product
- Biocidal active substance
- see active substance
- Biocidal product
Defined by the EU BPR (Regulation 528/2012) 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 Committee
A Committee set up within ECHA responsible for preparing the opinion of ECHA:
- applications for approval and renewal of approval of active substances;
- review of approval of active substances;
- applications for inclusion in Annex I of active substances meeting the conditions laid down in Article 28 of Regulation 528/2012 and review of the inclusion of such active substances in Annex I;
- identification of active substances which are candidates for substitution;
- applications for Union authorisation of biocidal products and for renewal, cancellation and amendments of Union authorisations, except where the applications are for administrative changes;
- scientific and technical matters concerning mutual recognition in accordance with Article 38 of Regulation 528/2012;
- at the request of the Commission or of Member States’ competent authorities, any other questions that arise from the operation of this Regulation relating to technical guidance or risks to human health, animal health or the environment.
- 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 BPD set up a European Community product authorisation scheme for biocidal products, such as non-agricultural pesticides, disinfectants and preservatives. The BPD was replaced by the EU BPR (Regulation 528/2012) which applied from 1 September 2013.
- Biocidal Products Regulation 528/2012 (EU BPR)
- Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. Applying from 1 September 2013 this directly acting Regulation replaces the Biocidal Products Directive.
- Biocidal Product Family
- A group of biocidal products having similar uses, the same active substances, similar compositions with specified variations, and similar levels of risk and efficacy.
- CAS number
- Chemical Abstract Service index number. It is a unique numeric identifier designating only one substance.
- 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.
- Certificate 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.
- Certificate 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.
- Certificate 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.
- Certificate 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
- Certificate 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.
- The Chemicals (Hazard Information and Packaging for Supply) Regulations 2009. All biocidal products authorised under EU BPR (Regulation 528/21012) or approved under COPR have to be classified, packaged and labelled in accordance with CHIP or with the CLP Regulations that replace CHIP from 1 June 2015; however there are also some additional labelling requirements under EU BPR/COPR.
- The Communication and Information Resource Centre for Administrations, Businesses and Citizens is a European Commission information portal used to create collaborative workspaces where communities of users can work together over the web and share information and resources. There are several biocides related interest groups such as Competent Authority Meetings, and documents for discussion at meetings, and those finalised are published on CIRCABC.
- Common core data set
- Regulation 528/2012 sets out the data to be included in dossiers for active substances to be included on the Union list of approved active substances or authorisation of biocidal products. The common core data sets define the data which must be provided for all active substances and biocidal products.
- European Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures. These will replace the UK CHIP regulations and biocidal products will have to be in accordance with CLP from 1 June 2015.
- Presently under the Control of Pesticides Regulations the consents (for example the permission to advertise, sell, supply, store and use a product) form the basis of a product approval. These may be restricted (e.g. for the purposes of disposal only).
- 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 EU BPR (Regulation 528/2012) once the active ingredients contained in them have been reviewed and included on the Union list of approved active substances.
- COPR Data protection
- See "Data protection" below
- 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 inclusion on the Union list of approved active substances or product authorisation under Regulation 528/2012, 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.
- The Department for the Environment, Food and Rural Affairs. DEFRA website .
- Departmental / Departmental 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.
- EC Classification
- The Chemicals (Hazard Information and Packaging for Supply) (CHIP) Regulations and The Dangerous Preparations Directive (99/45/EC) stipulate how a product should be classified – these are being replaced by European Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (CLP). 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.
- An EINECS number is the numerical identifier assigned to chemical substances on the European Inventory of Existing Commercial Substances (EINECS). This is a list of the chemical substances available in the European Community market between 01 January 1971 and 18 September 1981. The European Chemicals Agency (ECHA) maintains a database of chemicals and the identifier numbers, classification details and other information.
- Emergency authorisation
- The term ‘Emergency authorisation’ is not used in Regulation 528/2012. However, Article 55 allows for a derogation from the requirements of authorisation requirements laid out in Articles 17 and 19 for a period not exceeding 180 days for a limited and controlled use under the supervision of the competent authority, if such measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.
- EU BPR (Regulation 528/2102)
- See Biocidal Products Regulation
- European Chemicals Agency (ECHA)
- The European Chemicals Agency based in Helsinki, Finland was set up under Regulation (EC) No 1907/2006 (the ‘REACH’ Regulation) and was assigned specific duties in relation to the evaluation of active substances and authorisation of biocidal products under the EU Biocidal Products Regulations (528/2012).
- 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.
- Under the EU BPR (Regulation 528/2012) this is the process undertaken by the Competent Authority once it has completed the validation process. Evaluation involves a detailed assessment of the information submitted by the applicant to determine if the active substance or biocidal product pose unacceptable risks to people, animals or environment.
- 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 had been placed on the UK market at the date of inclusion of the active substance on the Union list of approved active substances
- Expiry dates
- Product 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 be valid and it becomes illegal to advertise, sell, supply, store or use 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.
- Food and feed
- The EU BPR (Regulation 528/2012) defines food and feed as “food as defined in Article 2 of Regulation (EC) No 178/2002 and feed as defined in Article 3(4) of that Regulation”.
- 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 the Union list of approved active substances 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.
- Harmful organism
- Defined by Regulation 528/2012 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"
- Hazard warning symbol
- Products carrying an EC classification as determined by CHIP or CLP criteria may be required to display the appropriate hazard warning symbol/pictogram on the product label.
- 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.
- 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 EU BPR (Regulation 528/2012).
- 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.
- Letter of Access
- A document, signed by the owner or owners of relevant data protected under the provisions of COPR or Regulation 528/2012, which states that these data may be used by the Competent Authority for the purpose of granting an authorisation under EU BPR (Regulation 528/2012) or an approval under COPR.
- 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.
- 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.
- Main group
- The EU BPR (Regulation 528/2012) applies to 22 classes of biocidal product. These Product Types have been categorised into 4 Main Groups; Disinfectants, Preservatives, Pest Control, and Other Biocidal Products.
- Making available on the market
- Making available on the market is defined as any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge.
- Marketing company
- The company which will market a COPR approved product, i.e. the company whose name will appear on the product label. This company may also be the COPR approval holder.
- Member States (MS)
- The member countries of the European Union.
- Mutual recognition
- When a biocidal product is authorised in one Member State under EU BPR (Regulation 528/2012), authorisation may be granted in other Member States without having to repeat the full authorisation process - known as mutual recognition. Companies can apply for this at the same time they make their initial application for authorisation of the product (mutual recognition in parallel) or alternatively, at any point after the initial authorisation has been granted (mutual recognition in sequence).
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 1-100nm.
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 nanmaterial, '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
- An administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof.
- 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 substance which was not on the European market as an active substance of a 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
- 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. 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.
- A person, company or task force supporting an active substance in the EU BPR (Regulation 528/2012) review programme.
- 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.
- A pesticide is defined in the Control of Pesticides Regulations as a substance, preparation or organism used to control or destroy any pest.
- Placing on the market
- The EU BPR (Regulation 528/2012) defines placing on the market as the first making available on the market of a biocidal product or of a treated article.
- 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 EU BPR (Regulation 528/2012), but under the Plant Protection Products Regulations (Regulation 1107/2009) – unless the product is intended to have both plant protection and biocidal uses, in which case it may need to be regulated under both sets of legislation.
- Process Orientated Research and Development (PORD)
- Under EU BPR (Regulation 528/2012), 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 National authorisation
- Product Family
- See ‘Biocidal Product Family’.
- Product Type
- The definition of a biocidal product generally sets out which products fall within the scope of EU BPR (Regulation 528/2012). This is further refined by the definition of 22 classes of product to which the Regulation applies, known as Product Types. These Product Types have been categorised into 4 Main Groups.
- Provisional authorisation/registration
- Provisional authorisation may be granted for products containing active substances which have not yet been included on the Union list of approved active substances, but for which the evaluating competent authority has evaluated an application and recommended inclusion on the Union list of approved active substances.
- Register for Biocidal Products (R4BP)
- ECHA’s dedicated IT system used for submitting all biocides applications, including those for active substance approval or product authorisation, recording decisions and the exchange of information between Member States and the applicant.
- Under EU BPR (Regulation 528/2012) both product authorisations and approvals of active substances are time-limited, and applications to renew an authorisation or approval must be made at least 550 days before the relevant expiry date.
- 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 and the use of the product is limited to the use shown. An example of such a phrase is ‘For use only as an insecticide.’
- Review Programme
- The programme under EU BPR (Regulation 528/2012) to review existing biocidal active substances to assess their potential effects for users, bystanders and the wider environment. The review leads to a decision on whether the active substance can be included on the Union list of Approved Active Substances and therefore whether products contain that substance can be Authorised to be made available and used on the EU market.
- The COPR approval for a product can be revoked, and the product has to be removed from the market and can no longer be used in-line with the dates given in revocation notice.
- 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.
- SANCO is the Health and Consumer Protection Directorate General (DG SANCO) of the EU Commission and is responsible for ensuring the health of European citizens
- 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.
- The official COPR document referred to in a Notice of Approval which lists specific conditions of the approval. The Schedule includes details of the product, its formulation, the source of the active ingredients, the product’s intended uses and users, any specific risk mitigation measures or labelling requirements, details of its packaging and any other relevant information
- 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.
- Simplified authorisation procedure
- A simplified authorisation process, open to biocidal products which contain only active ingredients included on Annex I of EU BPR (Regulation 528/2012) and which meet the eligibility criteria as laid out in Article 25 of the Regulation.
- 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 ECHA Biocidal Products Committee on the Approval of active substances and votes on whether those substances should be included on the Union list of approved active substances.
- Stopping the clock
- HSE, as a Competent Authority, is required to meet deadlines for various tasks it carries out under EU BPR (Regulation 528/2012). 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.
- Chemical elements and their 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
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 Directive 67/548/EEC, and that is present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC; or
- a substance classified as hazardous or that meets the criteria for classification as hazardous according to Regulation (EC) No 1272/2008, and that is present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation; or
- a substance which meets the criteria for being a persistent organic pollutant (POP) under Regulation (EC) No 850/2004, 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 to Regulation (EC) No 1907/2006
- 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
- Transitional period
- Until existing biocidal active substances have been reviewed for possible inclusion the Union list of approved active substances etc, a transitional period will apply. During this period, the existing national controls (e.g. the Control of Pesticides Regulations) will apply to products containing existing active substances in the product types that have been supported for review, until the review have been completed and a decision has been made whether to include the active substance on the Union list of approved active substances.
- Treated article
- Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.
- Union authorisation
- An administrative act by which the Commission authorises the making available on the market and the use of a biocidal product or a biocidal product family in the territory of the Union or in a part thereof
- Union list of approved active substances
- List of active substances that have been assessed under the EU BPR (Regulation 528/2012) and it has been agreed at the EU-level that they are acceptable to be used in certain biocidal product types. The ‘Union list’ is the replacement for Annex I of BPD.
- Validation (EU BPR)
- The process undertaken by the Competent Authorities or ECHA entailing an initial check to ensure that the applicant has submitted the required information.
- Withdrawal (COPR)
- The instruction or act to remove a previously approved product from the market.