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REACH Authorisation
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Glossary

A glossary of all technical and socio-economic terms used within the guidance is provided below.

Actors in the supply chain:
All manufacturers and/or importers (M/I) and/or downstream users (DU) in a supply chain (Art 3(17)). The term is also used to include consumers and the supply chain for articles. It may additionally refer to actors in the supply chains for alternative substances as well as alternative techniques. See also Supply chain.
Adequate control route:
An Authorisation shall be granted if it is demonstrated that the risk to human health and the environment from the use of a substance; arising from the intrinsic properties specifi ed in Annex XIV is adequately controlled in accordance with section 6.4 of Annex I {Art. 60(2)} and taking into account Article 60(3). See also Guidance on the preparation of an application for Authorisation.
Alternative:
An alternative is a possible replacement for an Annex XIV substance. It should be able to replace the function that the Annex XIV substance performs. The alternative could be another substance(s) or it could be a technology (i.e. a process, procedure, device, or modifi cation in end product) or a combination of technical and substance alternatives. For example, a technical alternative could be a physical means of achieving the same function of the Annex XIV substance or perhaps changes in production, process or product that removes the need for the Annex XIV substance altogether.
Analysis of alternatives:
A systematic search for alternatives that can be documented and presented in an application for Authorisation. This analysis is the applicant’s evidence to demonstrate that the technical and economic feasibility of substitution of the possible alternatives has been analysed and their risks compared to the Annex XIV substance. The aim of this analysis should be to determine if use of the alternative would lead to an overall reduction in risk. Guidance on conducting an analysis of alternatives can be found in the Guidance on the preparation of an application for Authorisation.
Annex XIV:
Annex XIV of REACH lists all substances that are subject to Authorisation under REACH. After the “sunset date” it is prohibited to use and place on the market substances listed in Annex XIV unless an Authorisation has been granted for that use or unless an exemption applies.
Annex XV:
Annex XV of REACH lays down general principles for preparing Annex XV dossiers to propose and justify (a) harmonised classification and labelling of CMRs, respiratory sensitizers and other eff ects (b) the identifi cation of a Substance of Very High Concern i.e. as a CMR, PBT, vPvB or a substance of equivalent concern (c) restrictions on the manufacture, sale or use of a substance within the European Union and the European Economic Area. Proposals for restrictions and identifi cation of Substances of Very High Concern can be prepared by a Member State Competent Authority or by ECHA on a request from the European Commission. A Member State Competent Authority can prepare proposals for harmonised classifi cation and labelling.
Annex XV dossier:
A dossier produced in accordance with Annex XV. The dossier consists of two parts, an Annex XV technical dossier and the Annex XV report.
Applicant:
The legal entity or group of legal entities submitting the Authorisation application.
Applied for use scenario:
Term that commonly describes the “baseline” or “business as usual” situation that would arise if the Authorisation is granted
Article:
Article means an object that, during production, is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
Authorisation:
REACH Regulation sets up a system under which the use of substances with properties of very high concern and their placing on the market can be made subject to an Authorisation requirement. Such substances are included in Annex XIV of the Regulation and may not be placed on the market or used without an Authorisation. This Authorisation requirement ensures that risks from the use of such substances are either adequately controlled or outweighed by socio-economic benefi ts. An analysis of alternative substances or technologies will be a fundamental component of the Authorisation process.
Authorisation application:
The documentation submitted to the Agency applying for use of substances included in Annex XIV. See also Guidance on the preparation of an application for Authorisation.
Available (alternative):
Accessible and able to replace the Annex XIV substance.
Baseline scenario:
Term that describes the “business as usual” situation that would arise if no additional action was taken. In the application for Authorisation this is called “applied for use” scenario.
Benefits:
The positive implications,both direct and indirect, resulting from an action. This includes both fi nancial and non-fi nancial implications.
Broad Information on Uses (BIU):
In accordance with Article 64.2 of REACH, ECHA makes available on its web-site broad information on uses for which applications have been received and for reviews of Authorisations, with a deadline (60 days usually) by which information on alternative substances or technologies may be submitted by interested third parties. The information ECHA invites third parties to provide should help the rapporteurs of RAC and SEAC to assess
Broad Information on Uses (BIU):
In accordance with Article 64.2 of REACH, ECHA makes available on its web-site broad information on uses for which applications have been received and for reviews of Authorisations, with a deadline (60 days usually) by which information on alternative substances or technologies may be submitted by interested third parties. The information ECHA invites third parties to provide should help the rapporteurs of RAC and SEAC to assess the alternatives that may be associated with the use(s) described in the application for Authorisation: risks, availability, technical/economical feasibility.
Chemical safety assessment (CSA):
Chemical Safety Assessment is the process aimed at determining the risk posed by a substance and, as part of the exposure assessment, developing exposure scenarios including risk management measures to control the risks. Annex I contains general provisions for performing a CSA which consists of:
  • 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
Chemical safety report (CSR):
The chemical safety report documents the chemical safety assessment for a substance on its own, in a mixture or in an article or a group of substances. The CSR is a document which details the process and the results of a chemical safety assessment (CSA).
Comitology procedure:
Each legislative instrument specifies the scope of the implementing powers conferred on the Commission by the Council of the European Union. In this context, the Treaty provides for the European Commission to be assisted by a committee, in line with the procedure known as "comitology". Further details at: http://europa.eu/scadplus/glossary/comitology_en.htm Authorisation Decisions under REACH will be adopted by comitology. See also Regulatory procedure.
Committee for Socio-economic Analysis (SEAC):
The Committee for Socio-economic Analysis (SEAC) is an ECHA committee that is responsible for preparing ECHA’s opinion on applications for Authorisation, proposals for restrictions, and any other questions that arise from the operation of the REACH Regulation relating to the socio economic impact of possible legislative action on substances.
Competent Authorities:
The competent authorities designated under REACH ECHA's cooperation partners in the Member States. They are also involved in the different procedures such as Authorisation. Many of them are ministries or agencies in the environmental sector. Some countries have also nominated organisations working with financial, health or labour issues to be responsible.
Compliance costs:
The difference in the cost to the applicant and the up and downstream users (i.e. the supply chain) of complying with a “non-use” scenario as compared to the 'applied for use' scenario. Compliance costs include the capital and operating costs that would accrue to the sectors aff ected by the “non-use” scenario.
CoRAP:
The Community Rolling Action Plan lists substances for evaluation by the Member States Competent Authorities under the substance evaluation process of the REACH Regulation (EC) No 1907/2006 (Articles 44 to 48). The plan contains substances for which there is a suspicion that their manufacture and/ or use could pose risks to human health or the environment. Substance evaluation is the process under REACH that allows for clarification of such risks. Following the evaluation by Member States, further information may be requested from the registrants of the substances to clarify the suspected risks. Alternatively, it may be concluded that the substance does not constitute a risk based on the available knowledge at the time and no further data is needed with respect to this evaluation activity.
Cost benefit analysis (CBA):
Analysis which quantifi es, in monetary terms where possible, costs and benefits of a possible action, including items for which the market does not provide a satisfactory measure of economic value.
Cost eff ectiveness analysis (CEA):
CEA is widely used to determine the least cost means of achieving pre-set targets or goals (though it is not restricted to this use). CEA can be used to identify the least cost option among a set of alternative options that all achieve the targets. In more complicated cases, CEA can be used to identify combinations of measures that will achieve the specified target.
Distributor:
Any natural or legal person established within the Community, including a retailer, who only stores and sells a substance, either on its own or in a preparation, for third parties.
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 mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user.
Economic feasibility:
Analysis of the economic implications of the adoption of an alternative. Economic feasibility is normally defi ned as a situation where the economic benefits exceed the economic costs.
Economic impacts:
Costs and benefi ts to manufacturers, importers, downstream users, distributors, consumers and society as a whole. In principle, social and environmental impacts should be included in a truly economic analysis. In much literature, e.g. the EU guidelines for Impact Assessment (European Commission 2005a), a distinction between economic, social and environmental impacts is made – i.e. providing a more narrow interpretation of the term economic. In order to facilitate a comparison with EU literature, we employ this distinction between impact categories in this guidance.
Environmental impacts:
Impacts on all environmental compartments. This covers all use and non-use values of the aff ected environmental compartments.
Function:
The basic principle determining the use of the substance, such as, for a metal-containing chemical .in a plating bath, the provision of metal ions needed to deposit a protective layer on an article.
Hazard assessment:
Using the information about the intrinsic properties of the substance to make an assessment of hazard in the following areas:
  • Human health hazard assessment
  • Human health hazard assessment of physicochemical properties
  • Environmental hazard assessment
  • PBT and vPvB assessment
Health impacts:
Impacts on human health including morbidity and mortality eff ects. Covers health related welfare effects, lost production due to workers' sickness and health care costs.
Impacts:
All possible eff ects – positive or negative – including economic, human health, environmental, social and wider impacts on trade, competition and economic development.
Importer:
Any natural or legal person established within the Community who is responsible for importing.
Intermediate:
A substance that is manufactured for, and consumed in or used for, chemical processing in order to be transformed into another substance.
IUCLID:
International Uniform Chemical Information Database. This is the basic data collection and evaluation tool within the framework of the European Risk Assessment Programme on Existing Substances.
Manufacturing:
The production or extraction of substances in their natural state.
Latest application date (LAD):
Annex XIV (list of substances subject to Authorisation) will specify for each substance included in that Annex a date or dates, at least 18 months before the sunset date(s), by which applications for Authorisation must be submitted if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date(s), until a decision on the application for Authorisation is taken.
LManufacturer /Importer (M/I):
Any natural or legal person established within the Community who manufactures a substance within the Community (manufacturer) or who is responsible for import (importer) (Art 3(9) and (11)). Multi-criteria analysis (MCA): A technique that involves assigning weights to criteria, and then scoring options in terms of how well they perform against those weighted criteria. Weighted scores are then summed, and can then be used to rank options.
Non-threshold substance:
A substance for which it is not possible to determine a threshold for eff ects (DNEL or PNEC) in accordance with Annex I of the REACH Regulation Non-use scenario: Scenario in which an Authorisation application for use of a substance is not granted.
Only Representative (OR):
This is a natural or legal person established in the EU, with suffi cient background in the practical handling of substances and the information related to them, who is appointed by one or more non-EU manufacturers to fulfill the obligations of EU importers.Besides registration obligations, the Only Representative shall also comply with all other obligations under REACH, keeping available and up-to-date information on quantities imported and customers sold to as well as communicating updates of the latest Safety Data Sheet.
Phase-in substance:
A substance which is already available in the EU.
Preparation:
A mixture or solution composed of two or more substances.
Regulatory procedure:
rocedure for the adoption of implementing legislation that involves a vote by a Committee composed of the representatives of the Member States. The Council and the European Parliament have a role to play in accordance with Article 5 of Council Decision 1999/468/EC as amended by Council Decision 2006/512/ EC. Authorisation proposals under REACH will be adopted in accordance with this regulatory procedure.
Restriction:
Restrictions limit or ban the manufacture, placing on the market or use of certain substances that pose an unacceptable risk to human health and the environment. A Member State, or ECHA on request of the European Commission, can propose restrictions. When a Restriction proposal is submitted:
  • Stakeholder comments on a restriction proposal are welcomed from the EU or beyond and the public consultation lasts for six months.
  • RAC provides its opinion on appropriateness of the Restriction to reduce the risk to human health or the environment, within nine months
  • SEAC balances the pros and cons for Society and its draft opinion is subject to a Public Consultation of sixty days.
  • ECHA forwards the two opinions of RAC and SEAC to the European Commission. The Commission will draft an amendment to the list of restrictions (Annex XVII of REACH) within three months. A new restriction or a revision of an existing restriction will be adopted if the European Council of Ministers or the European Parliament do not oppose the restriction (cf. Comitology).
Review period:
RAC and SEAC recommend a review period that is either "normal" (7 years), "short" (shorter than “normal”, may be 4 years) or "long"(12 years) depending on a set of criteria and considerations.
Risk assessment:
A procedure for determining the risk that a substance poses to health and the Environment
Risk Assessment Committee (RAC):
RAC assesses the risk of a substance arising from its uses when an application for Authorisation is submitted. This includes an assessment of the appropriateness and eff ectiveness of the risk management measures as described in the Authorisation application, and if relevant, of the risks of possible alternatives. Third party contributions linked to the application will also be assessed.
R & D Plan:
The Application for Authorisation has to contain a plan for R & D when no suitable alternatives have been identified. Applicants must commit to continue their quest for an alternative to the substance use they apply for.
Risk management measure (RMM) and Operational Conditions (OCs):
These terms are used for concrete risk management measures and operational conditions taken by Industry to control the exposure to the substance of concern. RMMs include e.g. containment of process, local exhaust ventilation, gloves, waste water treatment, exhaust air filters. More generally risk management measures include 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 mixture) in order to prevent, control, or reduce exposure of humans and/or the environment.
OCs include e.g. physical appearance of a mixture, duration and frequency of use/exposure, amount of substance, room size and ventilation rate. More generally the operational conditions include 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 mixture) that as a side effect might have an impact on exposure of humans and/or the environment. Registrants document, where required, risk management measures and operational conditions in an Exposure Scenario (ES) as a part of their Chemical Safety Report (CSR).
Social costs:
They cover the opportunity cost to society and also include external costs or externalities.
Social impacts:
All relevant impacts, which may affect workers, consumers and the general public and are not covered under health, environmental or economic impacts (e.g. employment, working conditions, job satisfaction, education of workers and social security).
Socio-economic analysis (SEA):
The socio-economic analysis (SEA) is a tool 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 the REACH Authorisation procedure, an SEA is a compulsory part of an application for Authorisation whenever the risks to human health or the environment from the use of an Annex XIV substance are not adequately controlled. Also when adequate control can be shown, the applicant may produce an SEA to strengthen his case. Any third party may also produce an SEA, in support of information on alternatives.
Socio-economic route (Authorisation):
An Authorisation may be granted if it can be demonstrated that the risk to human health or the environment from the use of the Annex XIV substance is outweighed by the socio-economic benefits and if there are no suitable alternative substances or technologies {Art. 60(4)}.
Substance:
A chemical element and its compounds, either in its 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.
Substances in articles:
Hazardous substances that are released from articles as part of their function will generally have to be registered. If the release is not intentional, the substances may have to be notified. Substance function: The function of the Annex XIV substance for the use(s) being applied for is the task or job that the Annex XIV substance performs.
Substances of very high concern (SVHC):
  • CMRs category 1 or 2
  • PBTs and vPvBs meeting the criteria of Annex XIII and
  • substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties (but not fulfilling the criteria of Annex XIII), 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. Such ‘substances of equivalent concern’ will be identified on a case-by-case basis in accordance with the procedure set out in Article 59 of the REACH Regulation.
Substitution plan:
A commitment to take the actions needed to substitute the Annex XIV substance with an alternative substance or technology within a specified timetable. Guidance on developing a substitution plan can be found in the Guidance on the preparation of an application for Authorisation.
Suitable alternative:
An alternative that is technically and economically feasible for replacement of the Annex XIV substance where transferral to the alternative results in reduced overall risks to human health and the environment (as compared to the Annex XIV substance) taking into account risk management measures and operational conditions. It must also be available (e.g. can be accessed in sufficient quantity and quality) for transferral. See also Guidance on the preparation of an application for Authorisation.
Sunset date:
Annex XIV (list of substances subject to Authorisation) will specify for each substance included in that Annex the date (called “the sunset date”) from which the placing on the market and the use of that substance shall be prohibited. That is unless an exemption applies or an Authorisation is granted or an Authorisation application has been submitted before the latest application date also specified in Annex XIV, but the Commission decision on the application for Authorisation has not yet been taken.
Supply chain:
In this context, the supply chain is the system of organisations, people, activities, information and resources involved in moving a substance from supplier to customer i.e. manufacture/importers (M/I) to downstream users and consumers, including use of articles containing the Annex XIV/ alternative substance. It also refers to supply chains for alternative techniques.
Technical feasibility:
Relates to an alternative substance or technology which is capable of fulfilling or replacing the function of the Annex XIV substance, without compromising the functionality delivered by the substance and its use in the final product. See also Guidance on the preparation of an application for Authorisation.
Third party or Interested Third Party:
Any organisation, individual, authority or company other than the applicant or the Agency/Commission with a potential interest in submitting information on alternatives or other information, e.g. on socio-economic benefits arising from use of the Annex XIV substance and socio-economic implications of a refusal to authorise.
Unsuitable alternative:
An alternative that has been analysed as part of the Analysis of Alternatives where it is demonstrated that it is not technically or economically feasible, is not available for use or does not reduce risks.
Upstream supplier:
Suppliers of raw materials or intermediates required in order to manufacture a substance.
Use:
Article 3 of REACH defines use as “any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other use”. An exhaustive description of uses in the supply chain will have to consider the main uses (processes) but also the secondary uses (storage, repackaging etc.).
Very Persistent and very Bioaccumulative (vPvB):
The criteria for vPvB substances are defined in Annex XIII of the REACH Regulation.
Wider economic impacts:
Impacts that have macroeconomic implications. Such impacts may include trade, competition, economic growth, inflation, taxes and other macroeconomic effects.

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