REACH Glossary A

ACC See "American Chemistry Council"

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

Agency the European Chemicals Agency as established by this Regulation

Alloy a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means

AmCham American Chamber of Commerce

American Chemistry Council US Chemical Industry Associations

Article 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

Authorisation Pre-market approval procedure for substances of very high concern

B

BDI German Federal association of the Industry German associations of sectorial industry associations

BOA Business Organizations & Associations, e.g., Cefic, ACC

C

CAS Chemical Abstract Services

CCPA Canadian Chemical Producers' Association

Cefic Conseil Europen de lIndustrie Chimique European chemical industry association

CFP see "Country Focal Point"

Chemical Industry Association UK chemical industry association

Chemical Safety Assessment addresses the manufacture of a substance on its own (including any major impurities and additives), in a preparation and in an article, as defined by the identified uses

Chemical Safety Report documents the Chemical Safety Assessment and details the hazards associated with a particular chemical

Chemicals management The entire process of managing chemical products during their lifetime, from design up to and including disposal at the end of their lives, in such a way that optimal balance is obtained between acceptable risk and maximum benefit for society in the short, medium and long-term

CIA See "Chemical Industry Association"

CM See "Chemicals management"

CMR Carcinogenic, Mutagenic or Reprotoxic (toxic to reproduction)

Competent authority the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation

Consortium when a substance is manufactured within the European Community by two manufacturers or more and/or imported by two importers or more, manufacturers or importers can gather in order to share data and costs for registration

Country Focal Point Responsible for product regulatory management in a European country or area

CS Case Study

CSA see "Chemical Safety Assessment"

CSR see "Chemical Safety Report"

D

Dangerous Preparations Directive European Council directive relating to the classification, packaging and labelling of dangerous preparations

Dangerous Substances Directive European Council directive relating to the classification, packaging and labelling of dangerous substances

Dederchimica Italian chemical industry federation

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

Downstream Legislation other obligations in EU legislation triggered by the classification of substances and preparations

Downstream user 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 (a distributor or a consumer is not a downstream user)

Downstream Users of Chemicals Coordination Group coalition of downstream users of chemicals

DUCC see "Downstream Users of Chemicals Coordination Group"

E

ECETOC see "European Centre for Ecotoxicology and Toxicology of Chemicals"

ECHA see "European Chemicals Agency"

ECI Enterprise Critical Issue

EEE Evaluating the Environmental Effectiveness of REACH

EIF Enter in Force

EINECS European Inventory of Existing Commercial Chemical Substances

ELINCS European List of Notified Chemical Substances

ES see "Exposure Scenario"

eSDS extended Safety Data Sheet

EU see "European Union"

EU Commission the executive or administrative body of the EU

EU Council one of the two legislative bodies of the EU; represents the EU member states

EU Parliament one of the two legislative bodies of the EU; represents the people of the EU

European Centre for Ecotoxicology and Toxicology of Chemicals

Scientific institute with membership from chemical and related industries

European Chemicals Agency European Union Agency that manages the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency

European Inventory of Existing Commercial Chemical Substances

a list of existing chemical substances that have been commercially available in the European Community between January 1, 1971 and September 18, 1981 (approximately 100,000 entries)

European Union Association of European Countries, moving towards common economic, foreign, and social policies

Evaluation check data compliance and validation, check industrials proposal of test strategy. Substance evaluation: examine information on a substance according to the risk and danger that are inherent to the substance. Information to other parts of REACH: submission to Authorization or Restriction?

Existing Substances substances listed in EINECS

Exposure Scenario the set of conditions 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 exposures of humans and the environment

Exposure scenario 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 importer controls, or recommends downstream users to control, exposures of humans and the environment

F

Fedichem Fdration des Industries Chimiques de Belgique Belgian

chemical industry federation

Feique Spanish chemical industry federation

Full study report a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed

G

GHS Globally Harmonised System of Classification and Labelling of Chemicals

Globally Harmonised System of Classification and Labelling of Chemicals

International criteria agreed by the United Nations Economic and Social Council for the classification and labelling of hazardous substances and mixtures

GLP see "Good Laboratory Practices"

Good Laboratory Practices 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

GPL Global Product Leader

H

HPV chemicals High Production Volume chemicals

I

ICCA see "International Council of Chemical Associations"

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

IH Industrial Hygiene

impact assessment studies have been carried out to determine the costs of REACH for businesses and the European economy at large

Import the physical introduction into the customs territory of the Community

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

Intermediate a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance

International Council of Chemical Associations a council of trade associations representing chemicals manufacturers worldwide

International Uniform Chemical Information Database the basic tool for the data collection and evaluation in the frame of the European Risk Assessment Programme on Existing Substances; software for the submission of dossiers, which will be used by industry, the European Chemical Agency and Member States authorities

IUCLID International Uniform Chemical Information Database

J

JCIA Japanese Chemical Industry Association

L labelling the name, address and telephone number of the supplier, product

identifiers, hazard pictograms, signal words, hazard statments and precautionary statements as well as supplemental information on hazards not yet included in the GHS and the nominal quantity in the package, as placed on the market to the general public

M

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

Manufacturing production or extraction of substances in the natural state

Mixture, also called preparation a mixture or solution of two or more substances that do not react

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

N

New Chemical any chemical substance which has been marketed after 18 September, 1981 (listed in ELINCS)

NGO Non-Governmental Organization

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, for instance to remove impurities

Notification Articles with substances of very high concern in concentration > 0.1% (weight/weight) in a homogeneous material

Notified substance a substance for which a notification has been submitted and which could be placed on the market

P

P&K see "Plast and Kemiforetagen"

packaging safety measures for containers and other packages

PBT 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 three consecutive years

Phase-in substance a substance that meets at least one of the following criteria: (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 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 available, whether in return for payment or free of charge, to a third party (import is considered placing on the market)

Plast and Kemiforetagen Swedish chemical industry association

PMO Program Management Office

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 molecular weights differences in the number of monomer units

PPORD Product and Process Oriented Research and Development

Preparation, also called mixture a mixture or solution composed of two or more substances

Pre-registration 1 June until 30 November 2008; submission of the name of the substance, name and address of the potential registrant and the name of the contact person, the envisaged deadline for the registration and the tonnage band and cross reference to similar substances (relevant for read across and for category building)

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

Product and process orientated research and 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

Product and Process Oriented Research and Development Any scientific development relating to product development or the further development of a substance (on its own, in preparations or in articles) that involves a pilot plant or production trials to develop the production process and/or to test the fields of application of the substance

PS Product Stewardship

PSS Product Stewardship Specialist

Q

QSAR see "Quantitative Structure Activity Relationship"

Quantitative Structure Activity Relationship results of such relationships may be used instead of testing when certain conditions are met. Guidance from the Agency to follow

R

R&D See "Research and Development"

RA Risk Assessment

REACH Registration, Evaluation and Authorization of Chemicals

Recipient of a substance or a preparation a downstream user or a distributor being supplied with a substance or a preparation

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

Registrant the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance

Registrant's own use an industrial or professional use by the registrant

Registration Any manufacturer or importer of a substance (on its own or in one or more preparations, including substances in articles if intentionally released) in quantities of 1 tonne or more must follow the procedure under Title II of REACH, which requires submitting information to the Agency

Registration, Evaluation and Authorization of Chemicals Implementation of the United Nations' Globally Harmonised System of Classification and Labelling of Chemicals in the EU

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)

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

RM Risk Management

RMEC Regulatory Management Expertise Center

RMM Risk Management Measure

RMWP Requirements Management Work Process

Robust study summary a 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

S

Safety Data Sheet Directive European Council directive relating to defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations and dangerous substances (replaced by REACH on 1 June 2007)

Safety data sheets the main tool for communication under the REACH Regulation

Safety Data Sheets document that includes identity of the substance/preparation, uses, classification, composition, handling and storage requirements, first aid/fire measures to be taken, accidental release measures, exposure controls and personal protection and means of disposal

SAICM Strategic Approach for International Chemicals Management

Scientific research and development any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year

SD Sustainable Development

SDS see Safety Data Sheets

SIEF see Substance Information Exchange Forum

Site a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared

Small and Medium-sized Enterprises small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises

SME Subject Matter Expert or see "Small and medium-sized enterprises"

Study summary a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study

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

Substance Information Exchange Forum all potential registrants, downstream users and third parties who have pre-registered phase-in substances or whose substances have been regarded as registered due to applicable plant protection/biocidal products legislation, or registrants who have submitted a registration before the applicable phase-in substance deadline, become participants in a substance-specific SIEFand are subject to data sharing/data generation obligations

Substances that occur in nature 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 preparation any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation

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

SVHC Substance of Very High Concern

T

Technical Guidance Document contains general information on the properties, uses and on the classification of a substance and also guidance on safe use

TERC Toxicology and Environmental Research Consulting

TGD Technical Guidance Document

U

UIC See "Union des Industries Chimiques"

UIPAD names chemical nomenclature according to the International Union of Pure and Applied Chemistry

UN Committee of Experts on the Transport of Dangerous Goods

an ECOSOC subsidiary body serviced by the UNECE secretariat

UN ECOSOC Economic and Social Committee of the United Nations

UNICE European association of secorial industry associations

Union des Industries Chimiques French chemical industry federation

US TSCA US Toxic Substance Control Act

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

Use and exposure category 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

V

Vereniging nederlandse chemicsche industrie Dutch chemical industry association

VNCI See "Vereniging nederlandse chemicsche industrie"

VNO NCW Dutch association of sectorial industry associations

vPvB very Persistent and very Bioaccumulative

W

World Trade Organization Organization that was formed in 1995 to control trade agreements between countries and to set rules on international trade

WP White Paper

WTO See "World Trade Organization"