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Dr Colin Hewlett DGSA consultant
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Chemicals
and Transport Limited
REACHREACH (Registration, Evaluation and Authorisation
of Chemicals): REACH came into law
as a direct-acting EU regulation in June 2007 and comes fully into effect in June 2008 when the first
stage of pre-registration of chemicals begins (see http://europa.eu.int/comm/enterprise/reach/index.htm). REACH targets are:
GHS The Globally Harmonised System of
Classification and Labelling of Chemicals (GHS) has been the subject of more
than a decade of work; its aim is to provide a framework to bring together
the various national and regional hazard communication systems which control the supply of
hazardous chemicals in much the same way that the ‘Orange Book’ offers a
global framework for the transport of dangerous goods. The purpose of GHS is to provide a
single globally harmonized system to address classification of chemicals,
labels, and safety data sheets.The first edition of GHS was published in July
2003 as the ‘Purple Book’ and revisions published bi-annually; these can be
downloaded from the unece website http://www.unece.org/trans/danger/publi/ghs/ghs_rev01/01files_e.html.
REACH when fully
developed will adopt much of the recommendations of GHS. The REACH
Regulations in detail REACH, the
European Union regulation for the Registration, Evaluation and Authorisation of Chemicals,
which entered into force on 1st June 2007, requires companies to
determine and report the risks posed by the use of chemicals that they supply
in order to protect human health and the environment. It introduces a single
system for both ‘existing’ and ‘new’ substances. REACH is a direct acting European regulation so has
immediate effect in the UK (unlike a European Directive which has first to be
enacted as a UK regulation) but the majority of duties will not start until
1st June 2008 and various requirements of the regulation are being introduced
in stages over a 11 year period. The introduction of REACH will mean that the
UK CHIP Regulations will need to be substantially amended. REACH will
require manufacturers or importers of substances to register them with a
central European Chemicals Agency (ECHA) which will be set up in Authorisation is
an important feature of REACH; a list of 'substances of very high concern’ will
be created which cannot be supplied or used unless an authorisation has been
granted. Any substance that poses a particular threat can be restricted.
Restrictions take many forms, for example, from a total ban to not being
allowed to supply it to the general public. The REACH authorisation system
will strongly encourage companies to switch to safer alternatives. All
applications for an authorisation will need to include an analysis of
alternatives and a substitution plan where a suitable alternative exists. The
classification and labelling of chemicals according to their hazardous
properties currently follows an established system (the CHIP Regulations in
the The passage of
information up and down the supply chain is a key feature of REACH. Users
should be able to understand what manufacturers and importers know about the
dangers involved in using chemicals and how to control risks. However, in
order for suppliers to be able to assess these risks they need information
from the downstream users about how they are used. REACH provides a framework
in which information can be passed both up and down supply chains. A
downstream user will be required to inform its supplier(s) of “identified
uses” it wishes to have covered in a Chemical Safety Report (CSR). The CSR
documents the hazards and classification of a substance and also describes “exposure scenarios”
which are sets of conditions that describe how substances are manufactured or
used during their life-cycle and how the manufacturer or importer controls,
or recommends to control, exposures to humans and the environment. They must
also include the appropriate risk management measures and operational
conditions that, when properly implemented, ensure that the risk from
substances are adequately controlled. They should cover all the manufacturers’
or importers’ own uses and uses made known to the manufacturer or importer by
their downstream users. In such cases, the downstream user must provide
sufficient information to their supplier to enable them to develop an
exposure scenario (ES) for the identified
use. Downstream users also need to ensure that they comply with any
restrictions that have been placed on the chemical and that they apply any
risk reduction measures that are recommended by the supplier. It is essential
that companies who use chemicals inform their suppliers of the intended end
use – the supplier needs this so that they can include the intended
applications as an “identified use” to be covered in the Chemical Safety
Report (CSR) which will be prepare for the chemicals and users will also need
to provide such information as the suppliers require to develop an exposure
scenario (ES) for the identified use. If downstream users don’t want to
reveal their intended application to their suppliers, or if suppliers will
not cooperate, then users will have to prepare a chemical safety report for a use outside the
conditions described in the supplier’s exposure scenario or for any use his
supplier advises against. Downstream users
also need to be assured that their suppliers are not intending to discontinue
any raw materials or to fail to register them for REACH REACH adopts and
builds on the previous system for passing information – the Safety Data Sheet
(SDS); this document accompanies materials down through the supply chain,
providing the information that users need to ensure chemicals are safely
managed. The obligation to label and supply Safety Data Sheets continues
under REACH although the detailed requirements will change in the next few
years. The main rules on when a SDS is required, who needs to prepare a SDS
and to whom and when it is to be submitted do not change. The main change is
that eventually the Exposure Scenarios developed by registrants as part of a
chemical safety assessment need to be annexed to the SDS. In addition, the
order of Chapters 2 and 3 of SDS is reversed. Hazards Identification is now
Chapter 2 and Composition/Information on ingredients is now Chapter 3.
Section 1 must now state whether the emergency telephone number provided is
24 hours or office hours only and must also include the email address of the
‘responsible person’ who compiled the SDS. Section 15 will eventually record
whether a CSA (Chemicals Safety Assessment) has been carried out for a
substance or substances in a preparation and Exposure Scenarios if required will be
added to the SDS as annexes. Current advice from HSE is that new
substances or preparations brought on to the market for the first time after
1 June 2007 should have an SDS created in accordance with the REACH
annex requirements and this also applies for existing substances
and preparations for which a revised safety data sheet is required but
existing SDSs are OK for the next year at least. Eventually, when REACH
encompasses the GHS system, SDSs and also labels will need to be changed but
this is expected to be delayed until 2014. The principal
burden of compliance will fall upon manufacturers and importers of chemical
substances with certain exemptions such as polymers (note: REACH does not apply only to hazardous
substances) where annual quantities are 1 tonne or more; importers of
preparations and articles will be responsible for registering the individual
substances present in them. Note that ‘manufacture’ does not include blending
or mixing operations – blending companies are ‘downstream users’. Chemicals
imported into the EU must be registered by either the importer or by a EU-based ‘Only Representative’ appointed by the non-EU
supplier. Each potential registrant of a phase-in substance (those listed in
EINECS) manufactured or imported in quantities of 1 tonne or more per year
must take part in the pre-registration process in order to benefit from the
delayed registration deadlines The timetable
for registration is as follows (note: quantities are per manufacturer or per
importer): ·
Pre-registration
of phase-in substances: 1 June - 1 December 2008 ·
Potential
registrants who for the first time manufacture or import a phase-in substance
in a quantity of ≥1 tpy after the
pre-registration deadline (later than 1 December 2008) may submit a
pre-registration dossier within six months of first manufacturing or
importing or using the substance and no later than 12 months before the
relevant registration deadline
·
Substances
which have not previously been placed on the EU market (non-phase-in
substances) and
phase-in substances which have not been pre-registered must be
registered before manufacture or import. A technical
dossier shall be prepared for all registrations in the IUCLID (International
Uniform Chemical Information Database) format and a chemical safety report
(CSR) is required if the quantity manufactured or imported reaches or exceeds
the 10 tonnes per year threshold. For substances manufactured or imported in
quantities between 1 tonne per year and 10 tonnes per year some specific
exposure information will have to be provided in addition to the information
in the technical dossier. The data reported must be from certified glp laboratories. Note that in cases of notification as a new substance, only the notifier benefits from being considered registered; any
other parties manufacturing or importing the substance but who have not
notified it, must register, unless there is another exemption that applies to
them. Each
manufacturer, importer or ‘only representative’ is individually obliged to
submit a registration for each of his substances. However in cases where a
substance is manufactured or imported by more than one company, they are
required to submit certain information together; the registration process is
based on the principal of one substance-one registration (OSOR). Hence all
firms which pre-register the same substance will be encouraged to work
together to register the substance which includes the sharing of data.
Registrants are required to jointly submit information on the hazardous
properties of the substance and its classification and labelling and a
testing proposal (if any), and can, if they agree, also jointly submit the
chemical safety report and guidance on safe use. It will be compulsory to
join a sief (substance information exchange
forum) where there are multiple pre-registrations. A manufacturer/importer who does
not pre-register cannot expect to rely on the support from SIEFs (which are formed by pre-registrants
after the pre-registration phase ends) and potential consortia: these will
most likely time their activities to meet the deadlines given by the
transitional periods and will not necessarily be prepared to provide input at
earlier stages of the process. Only phase-in substances can be
pre-registered. A manufacturer/importer who manufactures or imports a
phase-in substance for the first-time after the end of the pre-registration
phase is entitled to rely on the transitional periods given above provided
that he submits the same information required for pre-registration to the
Agency
A non-EU manufacturer is not automatically an importer in the
sense of REACH unless he has a registered company base in the European Union.
An importer can only be a company which is legally established in the EU. The
importer role can be taken by an affiliate company, a dealer, an agent, or a
customer and as discussed above, the non-EU manufacturer can appoint a
EU-based ‘only representative’ who must have a sufficient background in the
practical handling of chemical substances. He needs to keep available and
up-to-date information on quantities imported and customers sold to, as well
as the latest updates of the Safety Data Sheet (SDS) and the registration
dossier This technical bulletin reflects the
current position to the best of our knowledge but REACH legislation is still evolving
and the full text of the latest updates of the legislation should be
consulted. For updates refer to the official websites
of the EU (http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm
and http://ec.europa.eu/echa/home_en.html),
HSE (http://www.hse.gov.uk/reach/index.htm, and DEFRA (http://www.defra.gov.uk/environment/chemicals/reach/index.htm) CRITERIA FOR THE IDENTIFICATION OF PERSISTENT,
BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE
SUBSTANCES This Annex lays down the criteria for the identification of: (i) persistent, bioaccumulative
and toxic substances (PBT-substances), and (ii) very persistent and very bioaccumulative substances (vPvB-substances). A substance is identified as a PBT substance if it fulfils the
criteria in Sections 1.1, 1.2 and 1.3. A substance is identified as a vPvB substance if it fulfils the criteria in Sections 2.1
and 2.2. This annex shall not apply to inorganic substances, but shall apply
to organo-metals. 1. PBT-SUBSTANCES A substance that fulfils all three of the criteria of the
sections below is a PBT substance. 1.1. Persistence A substance fulfils the persistence criterion (P-) when: — the half-life in marine water is
higher than 60 days, or — the half-life in fresh- or
estuarine water is higher than 40 days, or — the half-life in marine sediment
is higher than 180 days, or — the half-life in fresh- or
estuarine water sediment is higher than 120 days, or — the half-life in soil is higher than 120 days. The assessment of the persistency in the environment shall be
based on available half-life data collected under the adequate conditions,
which shall be described by the registrant. 1.2. Bioaccumulation A substance fulfils the bioaccumulation criterion (B-) when: — the bioconcentration factor (BCF) is
higher than 2 000. The assessment of bioaccumulation shall be based on measured data
on bioconcentration in aquatic species. Data from
freshwater as well as marine water species can be used. 1.3. Toxicity A substance fulfils the toxicity criterion (T-) when: — the long-term no-observed effect
concentration (Noec) for marine or freshwater
organisms is less than 0,01 mg/l, or — the substance is classified as
carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for
reproduction (category 1, 2, or 3), or — there is other evidence of chronic toxicity, as identified by the
classifications: T, R48, or Xn, R48 according to Directive
67/548/EEC. 2. vPvB-SUBSTANCES A substance that fulfils the criteria of the sections below is a vPvB substance. 2.1. Persistence A substance fulfils the very persistence criterion (vP-) when: — the half-life in marine, fresh-
or estuarine water is higher than 60 days, or — the half-life in marine, fresh-
or estuarine water sediment is higher than 180 days, or — the half-life in soil is higher than 180. 2.2. Bioaccumulation A substance fulfils the very bioaccumulative
criterion (vB-) when: — the bioconcentration
factor is greater than 5 000.
Last updated: September 2007 |
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