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Sustainability // REACH

Definitions

Definitions REACH

A full list of REACH definitions can be found on the ECHA website

Phase-in substances
Phase-in substances are substances which are listed on the European Inventory of Existing Commercial Chemical Substances (EINECS), or that have been manufactured in the EU or countries that have acceded to the EU before 2004 but not (yet) placed on the EU market, at least once after 1 June 1992, or are so-called ‘no-longer polymers’ and are commonly referred to as ‘existing substances’.

Non phase-in substances
Non phase-in substances are new substances. They include all substances that do not meet the definition of a phase-in substance.

NONS
Notification of New Substances Regulation. This is one of the pieces of EU legislation replaced by REACH.

PPORD
Product and Process Orientated Research and Development (PPORD) means 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.

SIEF
A Substance Information Exchange Forum (SIEF) is 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.

SIEF Formation Facilitator
The SIEF Formation Facilitator (SFF) is the first potential registrant to indicate their willingness to act as SIEF Formation Facilitator for a substance in REACH-IT during pre-registration of that substance. At the pre-SIEF stage, the SFF is expected to contact all other potential registrants of the substance and check substance identity, and sameness, before the SIEF is established. The SFF may continue to co-ordinate discussions, and information exchange, and organise the SIEF for joint submission until the point at which the Lead Registrant has been determined. At this point, the Lead Registrant will take over activities required to prepare the SIEF for joint submission. The role of SFF should not be underestimated; a substantial REACH expertise will be required, as well as, potentially, significant time and resources.

Consortium
A consortium is a co-operative arrangement among groups or institutions. In terms of REACH, and in consideration of the lack of a legal framework from the REACH Regulation itself, several legal entities regard co-operation in a consortium the most efficient way to protect their interests by building the contractual foundations for co-operation that REACH does not provide. A consortium structure creates a secure and flexible basis for REACH compliance for one or more substances. The operating rules, including cost sharing provisions and rights and ownership of consortium data, are outlined in a consortium agreement. The consortium agreement is therefore a convenient tool to organise compliance with REACH obligations and at the same time safeguard the essential business interests of the participating companies.

Lead Registrant
A company that submits registration information to the Agency on behalf of other members of a joint registration. The information submitted by the lead registrant concerns classification and labelling, study summaries, test proposals and, if necessary, indication of what information was reviewed by an assessor. If the members of the joint registration so decide, the lead registrant may also submit information on safe use and the CSR on behalf of the others. After the lead registrant submits the information, the other members of the joint registration submit the remaining information individually.

Only Representative
According to Article 8 of the REACH Regulation, a natural or legal person established outside the Community who manufactures a substance on its own or in preparations, formulates a preparation or produces an articles imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers regarding the registration of substances. The only representative shall also comply with all other obligations of importers under REACH.
The non-Community exporter must inform the importer(s) within the same supply chain of the appointment. These importers are regarded as downstream users for the purposes of REACH.

Chemical Safety Assessment (CSA)
A Chemical Safety Assessment must be carried out for all registered substances manufactured or imported at 10 tonnes per year or greater. It should address all the identified uses of a substance on its own (including any major impurities and additives), in a preparation and in an article. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The chemical safety assessment 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 and operational conditions.

Chemical Safety Report (CSR)
A CSR should be completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant and is a documentation of the chemical safety assessment (CSA).

Exposure Assessment
The determination or estimation (qualitative or quantitative) of the method, magnitude, frequency, duration, and route of exposure to a substance for the population(s) of interest.

Extended Safety Data Sheet
REACH requires the communication of hazard information down the supply chain for all substances meeting the criteria for classification as dangerous; the Safety Data Sheet (SDS) is the tool that is foreseen for this. In addition, for all substances for which a chemical safety assessment (CSA) is required, the information in the SDS must be consistent with the CSA and the relevant exposure scenarios for the recipient must be annexed to the SDS to make for an extended Safety Data Sheet (or eSDS).

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

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.

Preparation
A mixture or solution composed of two or more substances.

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

CMR
Carcinogenic, mutagenic or toxic to reproduction

PBT
Persistent, bioaccumulative or toxic to the environment.

VPvB
Very persistent or very bioaccumulative.

SVHC
Under REACH a Substances of Very High Concern (SVHC) are:
1. CMR 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

GHS

The Globally Harmonized System of Classification and Labeling of Chemicals or GHS is an internationally agreed upon system set to replace the various different classification and labeling standards used in different countries. The GHS uses consistent criteria for classification and labeling on a global level. The European Union has implemented the United Nations' GHS into EU law as the CLP Regulation. Further information on GHS can be found here

CLP

The Classification, Labelling and Packaging (CLP) Regulation is an EU Regulation which aligns the EU system of classification, labelling and packaging chemical substances and mixtures to the Globally Harmonised System (GHS). It complements the REACH Regulation and replaces the Dangerous Substances Directive and the Dangerous Preparations Directive. The regulation incorporates the classification criteria and labelling rules agreed at UN level, the so called Globally Harmonised System of Classification and Labelling of Chemicals (GHS). It introduces new classification criteria, hazard symbols (pictograms) and labelling phrases, while taking account of elements which are part of the current EU legislation. The regulation requires companies to appropriately classify, label and package their substances and mixtures before placing them on the market. It aims to protect workers, consumers and the environment by means of labeling which reflects possible hazardous effects of a particular chemical. It also takes over provisions of the REACH Regulation regarding the notification of classifications, the establishment of a list of harmonised classifications and the creation of a classification and labelling inventory. Further information on the CLP Regulation can be found here.