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GLOSSARY
| 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 |
The Authorization (REACH proceedings) = for articles with substances of very high concern (SVHC) such as CMR 1&2, PBT, vPvB, or endocrine disrupters that are in concentration > 0.1% (weight/weight) in a homogeneous material and without any threshold of tonnage.
The authorization is delivered if the registrant can show:
- Adequate control of risks, or
- Social and economic benefits outweigh the risks and no substitution
Authorization (REACH proceedings) = substances of very high concern will be gradually included in Annex XIV of the REACH Regulation. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless the company is granted an authorisation. Downstream users may only use such a substance for uses which have been authorised.
The authorisation process consists of 4 steps:
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| 1. | Identification of substances of very high concern | by authorities | |
| 2. | Prioritisation process | by authorities | |
| 3. | Applications for authorisation | by industry | |
| 4. | Granting of authorisations | by European Commission |
Opposite to registration there is no tonnage threshold for a substance to be subject to authorisation.
Authorisation will be granted if the registrant can show:
- Adequate control of risks OR
- Social economic benefits outweigh the risks and no substitution is possible
All authorisations will be reviewed after a certain time-limit which will be set on a case-by-case basis.
CMR = substances which present at least one of the following properties: Carcinogen, Mutagen, Reprotoxic (Toxic to reproduction).
Component = Substance intentionally added to form a preparation
Constituent = Any single species present in a substance that can be characterised by its unique chemical identity.
CSA = Chemical Safety Assessment
Concerns all possible uses of the substances, as it is or included in another product. It must cover the whole life cycle of the substance. If any suspicion of potential risk for the health or the environment, the ECHA can request additional analyses.
The chemical safety assessment (CSA) of a manufacturer shall address the manufacture of a substance and all the identified uses. The CSA of an importer shall address all identified uses. The CSA shall consider the use of the substance on its own (including any major impurities and additives), in a preparation and in an article, as defined by the identified uses. The CSA shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The CSA shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures (RMM) and operational conditions.
CSA = Human health / Physicochemical / Environmental hazard assessment - PBT / vPvB assessment - Exposure assessment if substances classified as SVHC
Candidate list = List of substances of very high concern for potential inclusion in Annex XIV REACH, which itself lists substances subject to authorisation (Article 59 REACH).
CSR = Chemical Safety Report
The CSR shall document the CSA which shall be conducted for all substances subject to registration if the registrant manufactures or imports such a substance in quantities of 10 tonnes or more per year.
- CSR are documents that details the hazards associated with a particular chemical and provide industry with a tool for demonstrating that it can use chemicals safely. Downstream users may require their manufacturers or importers to address their use in the CSR (called an identified use). Alternatively, they may decide to preserve the confidentiality of their use from their manufacturer or importer, and - in case their use is not covered in the exposure scenario annexed to the SDS – prepared their own CSR.
CSR Format:
Part A
- Summary of Risk Management Measures
- Declaration that Risk Management Measures are implemented
- Declaration that Risk Management Measures are communicated
Part B
- Identity of the substance and physical and chemical properties
- Manufacture and uses
- Classification and labelling
- Environmental fate properties
- Human health hazard assessment of physico-chemical properties
- Environmental hazard assessment
- PBT and vPvB assessment
- Exposure assessment
- Risk characterisation
Consortium = In the concept of REACH it is a more organized and formal type of co-operation between parties (implying either a signed agreement or the adoption of operating rules, or reference to an agreed set of general rules) to work together in terms of REACH (e.g. data sharing, joint submission of data, chemical safety report, …)
It is voluntary and may not necessarily regroup all participants to a particular SIEF, but can regroup only some of them or participants of more than one SIEF.
It may be formed at any stage of the REACH process (e.g. before pre-registration, to ease the process of checking the identity and sameness in view of the formation of a SIEF and afterwards).
CAS = Chemical Abstracts Service
A directive = “is binding, as to the result to be achieved, upon each member state to which it is addressed, but shall leave to the national authorities the choice of form and methods”
(Reference: Mcleod, I., Legal method, 5th edn, 2005, New York: Palgrave Macmillan)
A distributor = any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties.
A downstream user (DU) = any natural or legal person established within the Community, other than manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user.
EC inventory = The three European lists of substances from the previous EU chemicals regulatory framework, EINECS, ELINCS and the NLP-list, in combination are called the EC Inventory. The EC inventory is the source for the EC Number as an identifier of substances.
ECHA = The European Chemicals Agency manages the technical, scientific and administrative aspects of the REACH system at Community level, aiming to ensure that REACH functions well and has credibility with all.
EIF = Enter In Force
EINECS = European Inventory of Existing Commercial chemical Substances = 100 106 substances, which were deemed to be on the European Community market between 1 January 1971 and 18 September 1981.
ELINCS = European List of Notified Chemical Substances
Evaluation (REACH proceedings):
- Dossier evaluation: assessment of registration dossiers
- examination of testing proposals: main objective is to check that reliable and adequate data are produced and to prevent unnecessary animal testing
- compliance check of registrations: to ensure that legal requirements are fulfilled and the quality of the submitted dossiers is sufficient
- Substance evaluation: aims to clarify a concern that a given substance constitutes a risk to human health or the environment. Any information obtained shall be considered for its suitability for preparing an annex XV dossier to propose and justify the identification of a SVHC to initiate the restriction of the manufacture, placing on the market or use of a substance within the Community and/or to propose a harmonised classification and labelling
Existing Substances = substances listed in EINECS
Exposure scenario = “the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its lifecycle and how the manufacturer or importer 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” (Article 3.37 REACH)
GLP = Good Laboratory Practises
According to 2004/10/EC, Good Laboratory Practice (GLP) is defined as a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. The main objective of GLP is to ensure test data produced by different laboratories can be mutually recognized so as to avoid repeat testing. GLP provides an assurance to regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.
Member States of the European Union have to take measures to comply with the principle of GLP when evaluating chemicals safety according to 67/548/EEC. SGS has a worldwide network of laboratories that are GLP compliant contractual laboratories for physico-chemical, toxicological and ecotoxicological tests (France, Germany…)
GHS = Globally Harmonised System of Classification and Labelling
It addresses classification of chemicals by types of hazards and proposes harmonized hazards communication elements, including labels and Safety Data Sheets. The GHS also provides a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level. The Plan of Implementation of the World Summit on Sustainable Development (WSSD), adopted in Johannesburg in 2002, encourages countries to implement the GHS as soon as possible with a view to having a system fully operational by 2008.
Indeed, chemicals, through the different steps from their production to their handling, transport and use, are a real danger for human health and the environment. The need of an internationally-harmonized approach to classification and labelling was recognized.
Part 1: Introduction
Part 2: Physical Hazards
Part 3: Health Hazards
Part 4: Environmental Hazards
Annexes
Annex 1: Allocation of label elements
Annex 2: Classification and labelling summary tables
Annex 3: Precautionary statements and precautionary pictograms
Annex 4: Guidance on the preparation of Safety Data Sheets
Annex 5: Consumer product labelling based on the likelihood of injury
Annex 6: Comprehensibility testing methodology
Annex 7: Examples of arrangements of the GHS label elements
Annex 8: An example of classification in the Globally Harmonized Systems
Annex 9: Guidance on hazards to the aquatic environment
Annex 10: Guidance on transformation/dissolution of metals and metal compounds
Identified use = a use of a substance on its own or in a preparation, or a use of a preparation 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.
An importer = any natural or legal person established within the Community who is responsible for import.
Impurity = An unintended constituent present in a substance as produced. It may originate from the starting materials or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance it was not intentionally added.
Intended release (for articles) = release of the substances is intended to be under normal or reasonably foreseeable conditions during the service life of the article.
Release is deliberately planned and has a specific function for the article, which is frequently not the main but an accessory function of the object e.g. scented eraser (function = to erase; added value = quality to smell good)
Following releases are not considered to be intended:
- Release occurs during removal of ‘impurities’ from a semi-finished or finished article during its production process
- Release occurs during use or maintenance of the article and is meant to improve the product quality in a wide sense or the safety as a side effect but the released substances do not contribute to the function of the article (e.g. washing of clothes)
- Release is an unavoidable side-effect of the function of the article. Without the release, the article would not work, but the release is not directly intended (e.g. break linings, tyres)
- Release of substances formed during chemical reaction of any kind (e.g. ozone release from copy machines)
- Release is incidental, could be forced by undue use or in an accident (e.g. thermometer which drops and breaks)
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"):
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| (a) | Non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes 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 pipe work for transfer from one 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; |
| (b) | 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. |
| (c) | Transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other site. |
IUCLID (International Uniform Chemical Information Database) is a database and management system for the administration of data on chemical substances.
IUPAC names = chemical nomenclature according to the International Union of Pure and Applied Chemistry.
A manufacturer = any natural or legal person established within the Community who manufactures a substance within the Community.
Main constituent = A constituent, not being an additive or impurity, in a substance that makes a significant part of that substance and is therefore used in substance naming and detailed substance identification.
Manufacturing is production and extraction of substances in the natural state.
Monomer: 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.
Monomer unit = reacted form of a monomer substance in a polymer.
Mono-constituent substance = a substance, defined by its composition, in which one main constituent is present to at least 80% (w/w).
Multi-constituent substance = a substance, defined by its composition, in which more than one main constituent is present in a concentration ≥ 10% and < 80% (w/w).
Notification (REACH proceedings) = Notification of substances in articles is required when SVHC that have been included on the candidate list for authorisation are present in articles in quantities above 1 tonne per year and in concentration above 0.1% weight by weight. Notification is not required if the substance has already been registered for that use.
Additionally a notification may be required under other circumstances (See the ECHA Glossary for details).
Not chemically modified substance = a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation e.g. to remove impurities.
PBT = substances which are Persistent, Bioaccumulative and Toxic
Per year = per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least 3 consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years.
Phase-in substance = means a substance which meets at least one of the following criteria:
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| (a) | It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS); |
| (b) | It was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this; |
| (c) | It was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this. |
Placing on the market = supplying or making a product available to a third party (against payment or free of charge). Import through Customs of European Community is considered as “placing on the market”.
Polymer = 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.
A polymer comprises:
- A simple weight majority of molecules containing at least 3 monomer units which are covalent bound to at least one other monomer unit or other reactant
- Less than simple weight majority of molecules of the same molecular weight
PPORD (Product and Process Orientated Research & Development): any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance.
Producer of an article = any natural or legal person who makes or assembles an article within the Community.
Pre-registration (REACH proceedings: only applicable for Phase-in substances.
Pre-registration allows manufacturers of phase-in substances to benefit from extended deadlines if they have pre-registered their substances between 1 June and 1 December 2008.
Registration deadlines are as follows:
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| ● | Substances ≥ 1000 t/year, CMR 1&2 ≥ 1 t/year, R50-53 ≥ 100 t/year | 1/12/2010 | ||
| ● | Substances between 100-1000 t/year | 1/06/2013 | ||
| ● | Substances between 1-100 t/year | 1/06/2018 |
After pre-registration the registrant becomes automatically a member of the Substance Information Exchange Forum (SIEF) for his substance.
Pre-registration is also possible for manufacturers or importers who place – for the first time - a phase-in on the market after 1/12/2008. Pre-registration then has to be submitted within 6 months of first manufacturing, importing or using the substance in quantities of 1 tonne or more per year and no later than 12 months before the relevant deadline(s).
A preparation = mixture or solution composed of two or more substances. For instance: paint, detergent, cosmetic…
(Q)SAR = (Quantitative) Structure Activity Relationship - Are theoretical models that can be used to predict the physicochemical, biological and environmental fate properties of molecules.
Are estimation methods used for REACH in the interests of time- and cost-effectiveness and animal welfare.
REACH = Registration, Evaluation, Authorization of CHemicals
A registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance;
Read across (approach) = use data from structurally related substances to predict the properties of the substance to be registered.
Recipient of an article = an industrial or professional user, or a distributor, being supplied with an article but does not include consumers.
Registration (REACH proceedings) applies for substances manufactured and/or imported in quantities 1 ≥ t/year, except if substances are exempted from REACH or from registration.
It starts from 1 June 2008 unless it concerns phase-in substances which can benefit from extended registration deadlines if they are pre-registered.
Registration means submitting a Registration dossier containing information in accordance with article 10 of the regulation, such as
- A technical dossier (containing amongst others information on physico-chemical, toxicological and ecotoxicologica properties of the substance and assessment of the risks)
- A Chemical Safety Report (for quantities > 10 t/year)
The Restriction (REACH proceedings) = any condition for or prohibition of the manufacture, use or placing on the market (restrictions are mentioned in annex XVII of REACH).
A regulation = “shall have general application [and] … shall be binding in its entirety and directly applicable in all member states” (Reference: Mcleod, I., Legal method, 5th edn, 2005, New York: Palgrave Macmillan)
RMM = Risk Management Measure
Measures that control the emission of a substance and/or exposure to it, thereby controlling the risks to human health or the environment. RMMs include e.g. containment of process, local exhaust ventilation, gloves, waste water treatment, exhaust air filters.
More general: RMMs include any action, use of tool, change of parameters state that is introduced during manufacture or use of a substance (either in a pure state or in a preparation) in order to prevent, control, or reduce exposure of humans and/or the environment.
Robust study summary = detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report.
Scientific research & development = any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year.
SDS = Safety Data Sheets
A Safety Data Sheet is a form containing data regarding properties of a particular substance/preparation. It is intended to provide workers and emergency personnel with procedures for handling and working with the substance in a safe manner and includes information such as physical data, toxicity, health effects, first aids, reactivity, storage, disposal, protective equipment, spill handling procedures, transport regulations, classification & labelling, …
Reach significantly improves the quality of SDSs in terms of comprehensiveness and thoroughness. Where chemical safety assessments are performed, relevant exposure scenarios shall be annexed to the SDS and shall thus be passed down the supply chain.
SIEF (Substance Information Exchange Forum) = regroups all pre-registrants of the same substance (and other data holders where relevant) and participation to a SIEF is mandatory for SIEF participants under REACH.
The aims of the SIEF are to:
- facilitate data sharing for the purposes of Registration, thereby avoiding the duplication of studies
- agree on the classification and labelling of the substances concerned where there is difference in the classification and labelling of the substance between potential registrants
Site = a single location, in which, if there is more than one manufacturer of (a) substance(s) certain infrastructure and facilities are shared.
SME = Small and Medium-sized Enterprises as defined in the Commission Recommendation of 6 May 2003 concenring the definition of Micro, Small and Medium-sized Enterprises.
A substance = a chemical element and its compounds, in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent, which may be separated without affecting the stability of the substance or changing its composition.
For instance: Cadmium, Formaldehyde …
Substances which occur in nature = naturally occuring substance as such, unprocessed or processed by manual, mechanical gravitational means; by dissolution in water; by flotation; by extraction with water; by steam distillation or by heating solely to remove water; which is extracted from air by any means.
Substitution = Replacement of a substance, or physical appearance of a preparation or a technique with an alternative (less hazardous or lower exposure potential).
The registrant of a substance under REACH will usually not recommend the substitution of a substance as a RMM. However he can advise against a certain use of the substance or limit the uses covered in his exposure scenario. In this way he may initiate substitution further down the supply chain.
Substances of Very High Concern (SVHC) =
- Substances meeting the criteria for classification in accordance with Directive 67/548/EEC as
- Carcinogenic (category 1 & 2)
- Mutagenic (category 1 & 2)
- Toxic for the reproduction (category 1 & 2)
- Substances which are persistent, bioaccumulative and toxic (PBT) or very persistant and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII of REACH
- Substances having endocrine disrupting properties or substances
Supplier of an article = any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market.
TGD = Technical Guidance Document
The Commission prepared, in close co-operation with Member States, industry and other stakeholders, Technical Guidance Documents for industry and authorities to facilitate the implementation of the REACH regulation.
The available Guidance Documents are published on http://reach.jrc.it/guidance_en.htm
Use = 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.
UVCB = Substances of Unknown or Variable composition, Complex reaction products or Biological materials.
These substances cannot be sufficiently identified by their chemical composition because
- The number of constituents is relatively large and/or
- The composition is, to a significant part unknown and/or
- The variability of composition is relatively large and/or unpredictable
Other types of information will be needed for their identification (in addition to what is known about their chemical composition). Main identifiers of UVCB substances are related to the source of the substance and the process used
E.g. clay, tars, petroleum substances, slags, enzymes …
vPvB = substances that are very Persistent and very Bioaccumulative.
