Download Phase-in substances Phase-in substances are substances

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:
http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html
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:
http://ec.europa.eu/enterprise/sectors/chemicals/documents/classification/index_en.htm
http://guidance.echa.europa.eu/docs/guidance_document/clp_introductory_en.pdf