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Actors in the supply chain
means all manufacturers and/or importers and/or downstream users in a supply chain

Alloy
means a metallic material, homogeneous an a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures under CLP

Article
means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition

BauA
Federal Institute for Occupational Safety and Health

BfR
Federal Institute for Risk Assessment

Biocidal product

  • any substance or mixture, in 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, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other 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 action

A treated article thas has a primary biocidal function shall be considered a biocidal product

Biocidal product family
means a group of biocidal products having similar uses, the active substances of which habe the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products

Caracal
Advisory Committee for CLP and REACH

CAS
short name for the "Registry Number (RN)" of the "Chemical Abstracts Service" of the "American Chemical Society (ASC)"

CMR
Carcinogenic, Mutagenic or Toxic for Reproduction Chemicals

Concentration Limit
means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture that may trigger classification of the substance or the mixture, respectively

Cosmetic product
means any substances or mixtures intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours

CSR
Chemical Safety Report

Cut-off value
means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture, above which threshold these shall be taken into account for determinig if the substance or the mixture, respectively, shall be classified

Distributor
means any natural or legal person established whitin the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture for third parties

DMEL
Dervided Maximum Exposure Level

DNEL
Dervided No-Effect Level - The DNEL-value is calculated from the lowest value in combination with certain safety factors. It is used for oral and dermal exposure in mg per day per person or body weight mg per day

Downstream user
means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either in its own or in a mixture, in the course of his industrial or professional activities. A distributor or a pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006 shall be regarded as a downstream user

EchA
European Chemical Agency

EINECS
European Inventory of Existing Chemical Substances

ELINCS
European List of Notified Chemical Substances

EmS
Emergency prevention measures for ships carrying dangerous goods

End user
means either a consumer or professional using the cosmetic product

eSDS
Safety Data Sheet extended by annexed exposure scenario

ESIS
European Chemical Substance Information System

Exposure scenario
means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importeur controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate

GHS
Globally Harmonised System of Classification and Labelling

GLP
Good Laboratory Paractice (GLP) is 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

Hazard category
means the division of criteria wihtin each hazard class, specifying hazard severity

Hazard class
means the nature of the physical, health or environmental hazard

Hazard pictorgramm
means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned

Hazard statement
means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard

Identified use
means a use of a substance on its or in a mixture or a use of a mixture, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user

Import
means the physical introduction into the customs territory of the Community

Importer
means any natural or legal person established within the Community who is responsible for import

In vitro-testing
Studies done with cell or tissue cultures - In vitro literally stands for "in glass", or "in test tube", taking place outside the body of an organism. It refers to studies in the laboratory usually involving isolated organs, tissues, cell or biochemical systems

In vivo-testing
Studies done with live animals or testing within a live organism

Intermediate
means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):

  • non isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis take place. Such equipment includes the reaction vessel, its ancillary equipment and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture
  • on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities
  • transported isolated intermediate: means an intermedaite not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites

Intermediate packaging
means packaging placed between inner packaging, or articles and outer packaging

IUPAC
International Union for Pure Applied Chemistry - International association for pure applied chemistry. Institute for binding recommendation of nomenclature, symbols, terminology, standardised measurement methods, etc. in chemistry

Letter of access
means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for the purpose of this Regulation

LOEL
The lowest Observed Effect Level is the lowest tested dose or exposure level at which, in a study, a statistically significant effect is observed in the exposed population compared with an appropriate control group

Making available on the market
means any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial acticity, whether in return for payment or free of charge

Manufacturer
means any natural or legal person established within the Community who manufactures a substance wihtin the Community

Manufacturing
means production or extraction of substances in the natural state

M-factor
means a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1 and is used to derive by the summation method the classification of a mixture in which the substance is present

Mixture
means a mixture or solution composed of two or more substances

Monomer
means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process

Nanomaterial
means 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 the 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm

National authorisation
means 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

NLP
No-Longer Polymers - a NLP is a substance, which was considered as notified under Article 8 (1) of the 6th amendment of Directive 67/548/EEC (and hence did not habe to be notified under that Directive), but which does not meet the REACH definition of a polymer (which is the same as the polymer definition introduced by the 7th amendment of Directive 67/548/EEC).

NAOEL
No observed adverse effect level - The No Observed Adverse Effect Lebel is the highest tested dose or exposure level at which there are no statistically significant increases in the frequency or severity of adverse effects between the exposed population and an appropriate control group, some effects may be produced at this level, but they are not considered adverse or precursors of adverse effects

NOEC
No observed effect concentration - The No Observed Effect Concentration is the highest tested concentration at which, in a study, no statistically significant effect is observed in the exposed population compared with an appropriate control group

NOEL
The No Observed Effect Level is the highest tested dose or exposure level at which, in a study, no statistically significant effect is observed in the exposed population compared with an appropriate control group

Not chemically modified substance
means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities

Notifier
means the manufacturer or the importer, or group of manufacturers or importers notifying to the Agency

Only representative of a non-Community manufacturer

  • A natural or legal person established outside the Community who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into the Community may be mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title
  • The representative shall also comply with all other obligations of importers under this Regulation. to this end, he shall have a sufficient background in the partical handling of substances an the information related to them and without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information in the supply of the latest update of the safety data sheet referred to in Article 36
  • If a representative is appointed in accordance with paragraphs 1 and 2. the non-Community manufacturers shall inform the importer(s) within the same chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation

Package
means the complete product of the packing operation, consisting of the packaging and its functions

Packaging
means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions

PBT
Persistent, Bio-Accumulative and Toxic - Annex XIII defindes criteria for the identification of substances that are Persistent, Bio-accumulative and Toxic (PBT) and Annex I lays down general provisions for PBT assessment. PBTs are substances of very high concern (SVHC) and may be included in Annex XIV and by that be made subject to authorisation

PEC
Predicted Environmental Concentration

Phase-in substance
means a substance which meets at least one of the following criteria:

  • it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS)
  • it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on 1 January 2007, but not placed on the market by the manufacturer or importer, at lest once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this
  • it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on 1 January 2007, by the manufacturer or importer before the entry into force of this Regulation and it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/ECC in the version of Article 8(1) resulting from amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this, by any manufacturer or importer between 18 September 1981 and 31 October 1993 inclusive

PIC
Prior Informed Consent, the Rotterdam Convention of Prior Informed Consent sets up a system to control international trade in certain hazardous substances

Placing on the market
means supplying or making available, whether in return for payment of free of charge, to a third party. Import shall be deemed to be placing on the market

PNEC
Predicted No-Effect Concentration - Concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur (REACH Annex I 3.0.1). The French institute INERIS made a database for PNEC-values available

Polymer
means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units

POP
Persistent organic pollutants (POPs) are toxic chemicals that adversely affect human healt and the environment around the world. Because they can be transported by wind and water, most POPs generated in one country can affect people and wildlife far from where they are used and released. They persist for long periods of time in the environment and can accumulate and pass from one species to the next through the food chain. To address this global concern, the United States joined forces with 90 other countries and the European Community to sign a groundbreaking United Nations treaty on Stockholm, Sweden, in May 2001. Under the treaty, known as the Stockholm Convention, countries agree to reduce or eliminate the production, use and/or release of 12 key POPs, known as the "dirty dozen"

Precautionary statement
means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal

Producer of an article
means any natural or legal person who makes or assembles an article within the Community

QSAR
Quantitative Structure Activity Relationship - It is the relationship between the physical and/or chemical properties of a substance and their ability to cause a particular effect. The goal of QSAR studies in toxicology is to develop whereby the toxicity of a substance can be predicted from its chemical structure by analogy with the properties of other, toxic substances of know structure and toxic properties

Recipient of a substance or mixture
means a downstream user or a distributor being supplied with a substance or a mixture

Recipient of an article
means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers

Restriction
means any condition for or prohibition of the manufacture, use or placing on the market

Signal word
means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard. The following two levels are distinguished:

  • "Danger" means a signal word indicating the more severe hazard categories
  • "Warning" means a signal word indicating the less severe hazard categories

SME
means shall and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises

Substance
means a chemcial element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition

Substance which occur in the nature
means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means

Supplier of a substance or a mixture
means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture

Supplier of an article
means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market

SVHC
Substance of Very High Concern

The Agency
means the European Chemical Agency established by Regulation (EC) No 1907/2006

Treated article
means any substance, mixture or article which has been treated with, or intentionally incorporates, one ore more biocidal products

UBA
Federal Envirnment Agency

UN RTDG
means the United Nations Recommendations on the Transport of Dangerous Goods

Union authorisation
means 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

Use
means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation

Use and exposure category
means an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use

UVCB
Substances of unkwon variable composition, complex reaction products or biological materials

VOC
Volatile Organic Compound

vPvB
Very persistent, very bio-accumulative

Waiving
Omission of tests