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MSDS Glossary
| Abbreviation | Explanation |
| RSL | List that should include chemicals already restricted by EU legislation and which may also contain other chemicals known to harm humans or the environment. |
| RMM | It includes any action, use of tool, change of parameter 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. Such measures thereby control the risks to human health or the environment. Risk management measures include e.g. containment of process, local exhaust ventilation, gloves, waste water treatment, exhaust air filters. |
| SAICM | Policy framework to foster the sound management of chemicals adopted by the International Conference on Chemicals Management (ICCM) on 6 February 2006 in Dubai. SAICM was developed by a multi-stakeholder and multi-sectoral Preparatory Committee and supports the achievement of the goal agreed at the 2002 Johannesburg World Summit on Sustainable Development of ensuring that, by the year 2020, chemicals are produced and used in ways that minimise significant adverse impacts on the environment and human health. |
| OC | Any action, use of tool or parameter state that prevails during manufacture or use of a substance (either in a pure state or in a preparation) that as a side effect may have an impact on exposure of humans and/or the environment. |
| IC | Indicates in which sectors of economy (including private household and public domain) the substance is used. This descriptor is based on the NACE system. |
| IPPC | The European Union defines the obligations with which industrial and agricultural activities with a high pollution potential must comply. It establishes a procedure for authorising these activities and sets minimum requirements to be included in all permits, particularly in terms of pollutants released. The aim is to prevent or reduce pollution of the atmosphere, water and soil, as well as the quantities of waste arising from industrial and agricultural installations, to ensure a high level of environmental protection. |
| ISO | ISO is the world's largest developer and publisher of International Standards, organised as a network of the national standards institutes of 158 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. |
| IUCLID | A database and management system for the administration of data on chemical substances. |
| IUPAC | The International Union of Pure and Applied Chemistry (IUPAC) serves to advance the worldwide aspects of the chemical sciences and to contribute to the application of chemistry in the service of mankind. As a scientific, international, non-governmental and objective body, IUPAC can address many global issues involving the chemical sciences. |
| LCx | Corresponds to the concentration of a tested substance causing x% lethality during a specified time interval. |
| LDx | Corresponds to the dose of a tested substance causing x% lethality during a specified time interval. |
| LOAEC | The lowest tested concentration at which there are statistically significant increases in frequency or severity of adverse effects between the exposed population and an appropriate control group. |
| LOAEL | The lowest tested dose or exposure level at which there are statistically significant increases in frequency or severity of adverse effects between the exposed population and an appropriate control group. |
| LOEC | The lowest tested concentration at which, in a study, a statistically significant effect is observed in the exposed population compared with an appropriate control group. |
| LOEL | 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. |
| MS | A Member State of the European Union is any one of the 27 sovereign nation states that have acceded to the European Union (EU) since its de facto inception in 1951 as the European Coal and Steel Community (ECSC). As from 1 January 2007 the 27 Member States of the EU are Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom. |
| MSC | A European Chemicals Agency committee responsible for resolving potential divergences of opinion on draft decisions proposed by the Agency or the Member States under the evaluation procedures (Title VI) and proposals for identification of substances of very high concern to be subjected to the authorisation procedure. The MSC consists of one representative appointed by each Member State for a renewable term of three years. The Committee members may be accompanied by advisers on scientific, technical or regulatory matters. |
| NOAEC | The highest tested concentration 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. |
| NOAEL | 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 | 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 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. |
| NLP | A substance which was considered as notified under Article 8(1) of the 6th amendment of Directive 67/54/EEC (and hence did not have 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). |
| NGO | A nonprofit group or association organized outside of institutionalized political structures to realize particular social objectives or serve particular constituencies. NGO activities range from research, information distribution, training, local organization, and community service to legal advocacy, lobbying for legislative change, and civil disobedience. NGO's range in size from small groups within a particular community to huge membership groups with a national or international scope. |
| OEL | Value set by competent national authorities or other relevant national institutions as the limit for concentrations of hazardous compounds in workplace air. OELs for hazardous substances represent an important tool for risk assessment and management, and valuable information for occupational safety and health activities concerning hazardous substances. |
| OECD | The OECD brings together the governments of countries committed to democracy and the market economy from around the world to: • support sustainable economic growth; • boost employment; • raise living standards; • maintain financial stability; • assist other countries' economic development; • contribute to growth in world trade. |
| ppm | One ppm is equivalent to 1 milligram of something per litre of water (mg/l) or 1 milligram of something per kilogram of soil (mg/kg). It is a way of expressing very dilute concentrations of substances. |
| PBT | Annex XIII of the REACH Regulation defines criteria for the identification of substances that are Persistent, Bio-accumulative and Toxic (PBTs) 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. |
| PPP | 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: 1) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below; 2) influence the life processes of plants, other than as a nutrient, (e.g. growth regulators); 3) preserve plant products, in so far as such substances or products are not subject to special Council of Commission provisions on preservatives; 4) destroy undesired plants; or 5) destroy parts of plants, check or prevent undesired growth of plants. Under Article 15 (1) of the REACH Regulation, active substances which are used and regulated as plant protection products are regarded as being already registered under REACH. |
| PPORD | 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. |
| PEC | Indication of the expected concentration of a material in the environment, taking into account the amount initially present (or added to) the environment, its distribution, and the probable methods and rates of environmental degradation and removal, either forced or natural. |
| PNEC | Concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur. |
| QSAR | 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 known structure and toxic properties. In practice, QSARs are mathematical models used to predict the properties of substances from their molecular structure. |
| REACH | REACH is a new European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The new law entered into force on 1 June 2007. The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH. |
| RIP | Projects intended for the production of technical guides and IT tools for the use of the Agency, the competent authorities and the industry. |
| R&D | |
| RCR | |
| RC | Final step in chemical safety assessment, it consists of estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted exposure to a substance. It may include a ‘risk estimation’, i.e. the quantification of that likelihood. Risk characterisation is made for each exposure scenario and for each target population or compartment. |
| SIDS | Program operated by the Organization for Economic Co-operation and Development (OECD) focused on developing base level test information, including physicochemical properties, results of environmental fate and effects testing, and health testing, on approximately 600 poorly characterised international HPV chemicals. |
| SIAP | Document that summarises the rationale for the conclusions and clarifies the recommendations further, if appropriate. |
| SIAR | Report that draws conclusions on the potential hazard(s) and recommendations on the need for further work. |
| SMILES | A simplified chemical notation that allows a user to represent a two-dimensional chemical structure in linear textual form for easy entry into a computer application. |
| SDS | The main tool used in industry for communicating information on the hazard of dangerous substances and preparations through the supply chain. Annex II of REACH is based on the Annex to the Safety Data Sheet Directive (91/155/EEC) and explains what information should be included under each of the 16 safety data sheet headings. |
| SR&D | Any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year. |
| SME | The category of micro, small and medium-sized enterprises (SMEs) is made up of enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million. |
| SEA | A methodology to evaluate what costs and benefits an action will create for society by comparing what will happen if this action is implemented as compared to the situation where the action is not implemented. Under REACH, SEA arguments can be made in relation to the decision of whether or not to grant an authorisation for the use(s) of a substance and in relation to the decision whether or not to introduce a restriction. |
| ARfD | An estimate of a chemical substance, expressed on a bodyweight basis, to which a human population (including sensitive subgroups) can be exposed over a short period of time (24 hours or less), without an appreciable risk of deleterious effects during a lifetime. |
| AF | Factor that expresses the difference between effects values derived for a limited number of species from laboratory tests and the PNEC for the environmental sphere. |
| BMD | The BMD concept involves fitting a mathematical model to dose-response data. The BMD is defined as the dose causing a predetermined change in response. |
| BCF | Can be expressed either as the ratio of the concentration of a substance in an organism to the concentration in water once a steady state has been achieved (static BCF), or, on a non-equilibrium basis, as the quotient of the uptake and depuration rate constants (dynamic BCF). Static and dynamic BCFs can be equally used for regulatory purposes. The parameter gives an indication of the accumulation potential of a substance. |
| BMD10 | The benchmark dose associated with a 10% response (for tumours upon lifetime exposure after correction for spontaneous incidence; for other effects in a specified study). |
| BMDL10 | The lower 95% confidence interval of a benchmark dose representing a 10% response (e.g. tumour response upon lifetime exposure), i.e. the lower 95% confidence interval of a BMD10. |
| CMR | Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1 or 2, in accordance with Directive 67/548/EEC, are substances of very high concern2. They may be included in Annex XIV and by that made subject to authorisation requirement. CMRs may be non-threshold (i.e. it is not possible to define a Derived No-Effect Level (DNEL)) or threshold (i.e. it is possible to define a DNEL). |
| CA | The authority or authorities or bodies established by the Member States to carry out the obligations arising from the REACH Regulation. |
| CAS | Service that maintains the most comprehensive list of chemical substances. Each substance registered in the CAS Registry is assigned a CAS Registry Number. The CAS Registry Number (commonly referred to as the CAS number) is widely used as a unique identifier of chemical substances. |
| CSA | Process aimed at determining the risk posed by a substance and, as part of the exposure assessment, develop exposure scenarios including risk management measures to control the risks. Annex I contains general provisions for performing a CSA. The CSA consists of the following steps: • Human health hazard assessment • Human health hazard assessment of physicochemical properties • Environmental hazard assessment • PBT and vPvB assessment If, as a result of this hazard assessment, the registrant concludes that the substance meets the criteria for classification as dangerous according to Directive 67/548/EEC (for substances) or has PBT/vPvB properties, this triggers further steps in the chemical safety assessment: • Exposure assessment • Risk characterization. |
| CSR | Report that documents the chemical safety assessment for a substance on its own, in a preparation or in an article or a group of substances. It details the process and the results of a chemical safety assessment (CSA). Annex I of the REACH Regulation contains general provisions for performing CSAs and preparing CSRs. |
| C&L | |
| RAC | European Chemicals Agency committee responsible for preparing the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions and proposals for classification and labelling under the classification and labelling inventory task and any other questions that may arise from the implementation of the REACH Regulation relating to risks to human health or the environment. The RAC consists of at least one, but no more than two, members from the nominees of each Member State appointed by the Management Board for a renewable term of three years. The Committee members may be accompanied by advisers on scientific, technical or regulatory matters. |
| SEAC | European Chemicals Agency committee responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and any other questions that may arise from the implementation of the REACH Regulation relating to the socioeconomic impact of possible legislative action on substances. The SEAC consists of at least one, but no more than two, members from the nominees of each Member State appointed by the Management Board for a renewable term of three years. The Committee members may be accompanied by advisers on scientific, technical or regulatory matters. |
| CBI | |
| DU | Any natural or legal person established within the Community, other than the 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. |
| DMEL | For non-threshold effects, the underlying assumption is that a no-effect-level cannot be established, so a DMEL therefore expresses an exposure level corresponding to a low, possibly theoretical risk, which should be seen as a tolerable risk. |
| DNEL | Level of exposure to the substance, below which no adverse effects are expected to occur. It is therefore the level of exposure to the substance above which humans should not be exposed. DNEL is a derived level of exposure because it is normally calculated on the basis of available dose descriptors from animal studies such as No Observed Adverse Effect Levels (NOAELs) or benchmark doses (BMDs). |
| ES | 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 importer controls, or recommends downstream users to control exposure of humans and the environment. These exposure scenarios may cover one specific process or use, or several processes or uses as appropriate. |
| ESIS | IT system developed by the European Chemicals Bureau which provides information on chemicals, related to: - EINECS (European Inventory of Existing Commercial chemical Substances), - ELINCS (European List of Notified Chemical Substances), - NLP (No-Longer Polymers), - HPVCs (High Production Volume Chemicals) and LPVCs (Low Production Volume Chemicals), including EU Producers/Importers lists, - C&L (Classification and Labelling), Risk and Safety Phrases, Danger, etc., - IUCLID Chemical Data Sheets, IUCLID Export Files, OECD-IUCLID Export Files, EUSES Export Files, - Priority Lists, Risk Assessment process and tracking system in relation to Council Regulation (EEC) 793/93, also known as the Existing Substances Regulation (ESR). |
| EEA | The European Economic Area (EEA) unites the 27 EU Member States and the three EEA EFTA States (Iceland, Liechtenstein, and Norway) into an Internal Market governed by the same basic rules. These rules aim to enable goods, services, capital, and persons to move freely about the EEA in an open and competitive environment, a concept referred to as the four freedoms. |
| EFTA | Intergovernmental organisation set up for the promotion of free trade and economic integration to the benefit of its four Member States: Iceland, Liechtenstein, Norway and Switzerland. The Association manages the EFTA Convention; EFTA’s worldwide network of free trade and partnership agreements, and the European Economic Area (EEA) Agreement. |
| EINECS | Inventory that lists and defines those chemical substances, which were deemed to be on the European Community market between 1 January 1971 and 18 September 1981. |
| ELR | Additional lifetime risk over the background normal risk (or incidence of disease). |
| GHS | This system addresses classification of chemicals by types of hazard and proposes harmonized hazard communication elements, including labels and safety data sheets. It aims at ensuring that information on physical hazards and toxicity from chemicals be available in order to enhance the protection of human health and the environment during the handling, transport and use of these chemicals. The GHS also provides a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level, an important factor also for trade facilitation. |
| GLP | Quality system concerning the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. |
| HPLC | A form of column chromatography used frequently in biochemistry and analytical chemistry to separate, identify, and quantify compounds. |
| HPVC | A chemical which is defined as being produced or imported in a quantity of at least 1,000 tonnes per year in the EU by at least one industry. |
| GCL | Limit assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous, and which is set for any hazard class in Parts 3, 4 and 5 of Annex I of the CLP Regulation. |
| IR/CSA | Guidance on the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, in the context of the chemical safety assessment. |
| NONS | A scheme to notify ECHA of an intention to import, produce or market new chemical substances. |
| RoI | A list held by ECHA containing information from parties who intend to submit a CLH dossier to it. |
| RCOM | Document gathering the comments from the parties concerned regarding a proposal. |
| RAR | Document drafted by a Member State rapporteur following a detailed risk evaluation of the assessed substances. |
| SCL | Limit assigned to a substance by the manufacturer, importer or downstream user indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous. |
| TC C&L | Former EU body consisting of national experts from the Member States and stakeholder observers, who discussed and agreed on classifications of hazardous substances and their related labelling. |
| TCC | Checking carried out by ECHA on all registration dossiers to establish whether all the elements required by the REACH Regulation have been provided. |
| LEO | A specific element in IUCLID 5 or REACH-IT to store and manage this legal entity information. This information includes the name, address and other contact details, the contact person(s) and legal entity specific identification numbers which may help identifying it in an unambiguous manner. |
| SAR | A (qualitative) association between a chemical substructure and the potential of a chemical containing the substructure to exhibit a certain biological effect. |
| SIEF | A forum, formed after the pre-registration phase, to share data on a given phase-in substance. The principal aims of a SIEF are to: i) facilitate data sharing for the purposes of registration; ii) agree on the classification and labelling of the substance where there is a difference of interpretation between the potential registrants. |
| SVHC | In the context of the REACH Regulation are: 1. CMRs category 1 or 2; 2. PBTs and vPvBs meeting the criteria of Annex XIII; and 3. substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of Annex III – for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points 1 and 2 and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59. |
| UVCB | |
| UNEP | United Nations system’s designated entity for addressing environmental issues at the global and regional level. Its mandate is to coordinate the development of environmental policy consensus by keeping the global environment under review and bringing emerging issues to the attention of governments and the international community for action. |
| UUID | A string of 41 characters created by the IUCLID5 application upon creation of each dossier. The UUID uniquely identifies each dossier. |
| vPvB | Substances of very high concern, which are very persistent (very difficult to break down) and very bioaccumulative in living organisms. Annex XIII of the REACH Regulation defines criteria for the identification of vPvBs, and Annex I lays down general provisions for their assessment. vPvBs may be included in Annex XIV and thereby be made subject to authorisation. |
| ECHA | Agency established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 to manage all REACH and CLP tasks by carrying out or co-coordinating the necessary activities, to ensure a consistent implementation at Community level, and to provide Member States and the European institutions with the best possible scientific advice on questions related to the safety and the socio-economic aspects of the use of chemicals. This is achieved by ensuring a credible decision-making process, using the best possible scientific, technical and regulatory capacities and by working independently in an efficient, transparent and consistent manner. |
| ECx | Concentration of a tested substance causing x% changes in response (e.g. on growth) during a specified time interval. |
| EDx | Dose of a tested substance causing an increased incidence of 10% during a specified time interval. |
| EU | Union established under the Treaty on European Union (Maastricht, 1992) IATE:865789 "to organise, in a manner demonstrating consistency and solidarity, relations between the Member States and between their peoples". |
| BOD | Amount of dissolved oxygen required by organisms for the aerobic decomposition of organic matter present in water. |
| COD | Amount of oxygen consumed by the chemical breakdown of organic and inorganic matter. |
| EC50 | The effective concentration of substance that causes 50% of the maximum response. |
| ErC50 | EC50 in terms of reduction of growth rate. |
| SADT | The lowest temperature at which self-accelerating decomposition may occur with substance as packaged. |
| BD | Document supporting the RAC opinion, and which contains scientific justifications for a CLH proposal. It may be used by the Commission for its decision-making. |
| CARACAL | An expert group which advises the European Commission and ECHA on questions related to REACH and CLP. It was set up as the 'European Commission Working Group on the Practical Preparations for REACH' in May 2004. As of September 2007, it was renamed as 'REACH Competent Authorities (REACH CA)' and, as of March 2009, as 'Competent Authorities for REACH and CLP (CARACAL)'. |
| CAR | Report drafted by the Rapporteur Member State on the evaluation of an existing active substance dossier. |
| DAR | A risk assessment for active substances in plant protection products provided by the rapporteur Member State. |
| EoW | Certain specified waste ceases to be waste within the meaning of point (1) of Article 3 when it has undergone a recovery, including recycling, operation and complies with specific criteria to be developed in accordance with the following conditions: (a) the substance or object is commonly used for specific purposes; (b) a market or demand exists for such substance or object; (c) the substance or object fulfils the technical requirements for the specific purposes and meets the existing legislation and standards applicable to products; and (d) the use of the substance or object will not lead to overall adverse environmental or human health impacts. |
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