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Dr Colin Hewlett DGSA consultant
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Chemicals
and Transport Limited
REACH
REACH (Registration, Evaluation and Authorisation
of Chemicals): REACH came into law
as a direct-acting EU regulation in June 2007 and fully into effect in June 2008 when the first stage of
pre-registration of chemicals began (see http://europa.eu.int/comm/enterprise/reach/index.htm). REACH :
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. CLP The Classification Labelling
and Packaging regulation will introduce GHS criteria to the supply of
chemicals in 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 had
immediate effect in the REACH has required
manufacturers or importers of substances to register them with a central
European Chemicals Agency (ECHA) 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 acceptable
at present. 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: January 2009 |
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