1. Background and Objectives
Members of ATIEL (Technical Association of the European Lubricants Industry/Association Technique de L'Industrie Européenne Des Lubrifiants) have been working with members of ATC (Technical Committee of the Petroleum Additives Industry in Europe) to develop and communicate information on use descriptors and generic exposure scenarios (GES) for common lubricant end uses to all those involved in the lubricants supply chain.
The information provided in these web pages is targeted at suppliers to the lubricants industry, especially EU manufacturers and/or importers of substances and/or formulated products and to our downstream users (customers). In particular it is aimed at substance manufacturers and importers who need to prepare Chemical Safety Assessments & Reports (CSA/CSR) for REACH registrations and to anyone developing extended Safety Data Sheets (eSDS) for lubricant additives and finished lubricants. Downstream users may wish to use this site to verify the types of lubricant applications that are likely to be covered by registrants of substances present in finished lubricants.
The objective of the ATIEL/ATC Generic Exposure Scenario Working Group (ATIEL/ATC GES WG) in developing these generic exposure scenarios (GES – see Glossary for definition) is to offer everyone in the lubricants supply chain a standardised format for their exposure scenarios and a standardised language and terminology to use in those documents. No one is obliged to follow these recommendations but we believe that by doing so you will greatly improve communication with your downstream users and/or your upstream suppliers. In doing so, it is expected that they will receive documents in a format and using a set of terms with which they are already familiar. Using these recommendations should also make it very much easier for you to develop Exposure Scenarios for your own products (if necessary) and prepare the extended Safety Data Sheet (eSDS). The goal of this project is therefore to standardise communication in the lubricants supply chain and considerably reduce your workload thereby saving you time and effort.
The first version of these web pages was posted in June 2009. The information will be updated and expanded over the coming months. In order to continually improve the information provided here, the ATIEL/ATC GES WG welcomes comments, questions and suggestions from trade organisations or individual companies involved in the lubricants supply chain. Please send comments (clearly marked for the attention of the ATIEL/ATC GES WG) to: info@atiel.org.
TOP of page
2. Outline of Content and Update History
| 1. |
Background and Objectives |
Version 1 posted June 2009 |
| 2. |
Outline of Content and Update History |
Version 1 posted June 2009 |
| 3. |
ATIEL/ATC GES Working Group ‘Workflow’ |
Version 1 posted June 2009 |
| 4. |
Requirement for Exposure Scenarios |
Version 1 posted June 2009 |
| 5. |
How to Use this Information - General |
Version 1 posted June 2009 |
| 6. |
Information for Suppliers |
|
| 6.1 |
Step by Step Guide |
Version 1 posted June 2009
Updated July 2009 |
| 6.2 |
Lubricant Applications Table |
Version 1 posted June 2009 |
| 6.3 |
Lubricant Use Descriptions for Tier 1 Exposure Assessment Tables |
|
| 6.3.1 |
Workers (Industrial/Professional) |
Version 1 posted June 2009 |
| 6.3.2 |
Consumers |
Expected 3Q 2009 |
| 6.3.3 |
Environment |
Expected 2Q 2010 |
| 6.4 |
Additional Guidance for Suppliers |
Summary of Use Descriptor Codes for each ATIEL ATC Lubricant Use Group inserted in July 2009 |
| 7. |
Information for Customers |
|
| 7.1 |
Step by Step Guide |
Version 1 posted June 2009 |
| 7.2 |
Lubricants Application Table |
Version 1 posted June 2009 |
| 7.3 |
Lubricant Use Descriptions for Tier 1 Exposure Assessment Table |
|
| 7.3.1 |
Workers (Industrial/Professional) |
Version 1 posted June 2009 |
| 7.3.2 |
Consumers |
Expected 3Q 2009 |
| 7.3.3 |
Environment |
Expected 3Q 2009 |
| 8. |
Generic Exposure Scenarios |
|
| 8.1 |
Lubricant Use Group A |
Expected 1Q 2010 |
| 8.2 |
Lubricant Use Group B |
Expected 1Q 2010 |
| 8.3 |
Lubricant Use Group C |
Expected 1Q 2010 |
| 8.4 |
Lubricant Use Group D |
Expected 1Q 2010 |
| 8.5 |
Lubricant Use Group E |
Expected 1Q 2010 |
| 8.6 |
Lubricant Use Group F |
Expected 1Q 2010 |
| 8.7 |
Additional Valiation Information Supporting Use of GES |
Expected 1Q 2010 |
| 9. |
Acronyms/Glossary |
Version 1 posted June 2009 |
| 10. |
Useful Links |
Version 1 posted June 2009 |
| 11. |
Q&As |
Posted Nov 2009 |
3. ATIEL/ATC Generic Exposure Scenario Working Group – Workflow
The working group has been active for over 2 years. Progress to date and ongoing activities which will lead to updates to these web pages are summarised below.
|
WORKFLOW STEP |
Status as of October 2009 |
| 1. |
Create a comprehensive list of all lubricant applications (in industrial/professional and consumer settings) |
Complete |
| 2. |
Assign high level ‘exposure determinants’ to all lubricant applications |
Complete |
| 3. |
Group applications by similar ‘exposure determinants’ |
Complete |
| 4. |
Test groupings and generate ‘Lubricant use descriptions for Tier 1 Exposure Assessment’ (using standard terminology found in Guidance on Information Requirements and Chemical Safety Assessments) – see Section 6.3 and 7.3 |
|
|
a. Workers (industrial / professional), |
Complete |
|
b. Consumers and |
In progress |
|
c. Environmental Compartments |
In progress |
| 5. |
Add use descriptions for other relevant life cycle stages: |
|
|
a. Blending, |
Complete |
|
b. waste disposal |
In progress |
| 6. |
Communicate use descriptors in DUCC format |
Complete |
| 7. |
Add information on typical operational conditions and risk management measures |
In progress |
| 8. |
Publish initial information on ATIEL public website, including separate guidance for Suppliers and Downstream Users on their recommended use of this information |
Complete |
| 9. |
Request feedback from the Suppliers and Downstream Users on potential gaps, errors and suggested amendments |
In progress |
| 10. |
Create Generic Exposure Scenarios( based on current good practice) for grouped applications |
In progress |
| 11. |
Use recommended tools (e.g. DPD+ Methodology) to validate the Generic Exposure Scenario for each grouped application |
In progress |
| 12. |
Use recommended tools (e.g. ECETOC TRA) to characterise the risk for a typical lubricant additive to demonstrate the use of the information by manufacturers/importers and to ensure validity of the process |
In progress |
| 13. |
For each grouped application propose adequate risk modifiers for Tier 2 Exposure Assessment, where Tier 1 default values are shown to be inappropriate |
Not started |
| 14. |
Environmental exposure scenarios |
In progress |
4. Requirement for Exposure Scenarios
REACH requires EU manufacturers and importers to register each of their chemical substances with the European Chemicals Agency (ECHA). Each registration must include a full toxicological assessment of the hazards that the substance presents to man and the environment and for hazardous substances an assessment of risk to man and the environment. The risk assessment must cover the manufacturing process (if produced in the EU), each supported (Identified) use and its final disposal as waste. REACH refers to these risk assessments as Chemical Safety Assessments (CSA) and their output as a Chemical Safety Report (CSR).
All registered substances will be evaluated for their hazard. If a substance is determined to be non-hazardous an Exposure Scenario is not required. If the substance is determined to be hazardous however (including a PBT or vPvB) then an Exposure Scenario will be required if the substance is produced and/or imported at 10 MT or greater.
The first stage in this process is the creation of an Exposure Scenario (ES) for each phase of the life cycle of the substance. The Exposure Scenario describes the life cycle phase being assessed (e.g. substance manufacture), breaking it down into individual process steps, identifying the degree to which humans or the environment are exposed to the substance at each step and finally how that exposure can be controlled by applying appropriate Operational Conditions and Risk Management Measures. There will therefore be a separate Exposure Scenario for the manufacturing stage (if required), for each different Identified use of the substance and for the final disposal of the substance as waste. (1)
In an attempt to simplify this process for companies in the lubricants supply chain, the WG has used the methods described in the European Chemicals Agency (ECHA) guidance on Information Requirements and Chemical Safety Assessments to condense several hundred different applications of lubricants and lubricant additives to a much smaller number of generic uses. This was possible because many of these applications, though ostensibly different, are actually very similar in terms of human and environmental exposure and can therefore share the same set of Use Descriptors.
(1) Although “wastes” are controlled under the European Waste regulations rather than by REACH, the CSA/CSR should include an assessment of the extent to which humans and the environment are exposed to the substance during final disposal.
In an attempt to simplify this process for companies in the lubricants supply chain, the WG has used the methods described in the European Chemicals Agency (ECHA) guidance on Information Requirements and Chemical Safety Assessments to condense several hundred different applications of lubricants and lubricant additives to a much smaller number of generic uses. This was possible because many of these applications, though ostensibly different, are actually very similar in terms of human and environmental exposure and can therefore share the same set of Use Descriptors.
5. How to Use this Information – General Guidance
The communication of uses according to the Use Descriptor System is an essential step in developing a Chemical Safety Assessment. In view of the complexity of the registration process (i.e. significant numbers of substances, manufacturers/importers and uses), a common framework is considered necessary to harmonize communication within the lubricants supply chain to ensure effective and efficient information exchange on Identified Uses between Manufacturers/Importers and Downstream Users.
The following two sections advise on how Suppliers (Section 6) and Downstream Users (Section 7) within the lubricants supply chain can use the information provided in these web pages (in conjunction with the ECHA guidance if necessary) to ensure that the registration dossiers of substances used in the lubricant industry sector cover all the relevant Identified Uses and aid in the generation of Exposure Scenarios.
The guidance is divided between Suppliers and Downstream Users since it is anticipated that the information will be used differently depending on your position within the lubricants supply chain. It is recognised that individual companies can be both a Supplier and a Downstream User and so might need access to both sections of this site.
6. Information for Suppliers
6.1 Step by Step Guide
It is expected that suppliers to the lubricant supply chain will be aware of approximately 80% of the uses of their substances/products. The ATIEL/ATC GES WG therefore recommends that EU manufacturers and/or importers responsible for the registration of substances and formulators adopt the CEFIC/FECC-endorsed “top-down” communication workflow for Identified Uses and associated Exposure Scenarios. The following steps should help you to establish the Identified Uses which you may be asked to cover in your registration dossier for substances you manufacture or import (or pass up the supply chain to the manufacturer/importer if you are a formulator).
Step 1: Identify the lubricant applications (family and specific application) in which your substance/product is used (e.g. Metalworking, Corrosion protection – water based) by referring to the Lubricants Application Table (Section 6.2). Make a note of the Grouping (A – F) that has been allocated by the WG to each application. For example:
| LUBRICANT APPLICATION |
ATIEL-ATC
LUBRICANT USE GROUP |
| Family |
Specific application |
|
| Metalworking |
Corrosion protection - water based - diluted |
C |
Step 2: Refer to the spreadsheet titled ‘ATIEL ATC Exposure Scenario Information in DUCC Format’ in Section 6.4 and identify the use descriptors - Sector of Use (SU), Process Category (PROC), Product Category (PC) and Environmental Release Category (ERC) - that have been assigned to the Groups you selected.
Additional information to assist with the construction of Exposure Scenarios for workers is given in the ‘Lubricant Use Description for Tier 1 Exposure Assessment’ Table (Section 6.3.1) Similar information for consumer uses and environmental release will be given in sections 6.3.2 and 6.3.3 in a future update to these web pages.
Step 3: Confirm within your own organisation that you intend to develop Exposure Scenarios covering these Identified Uses in your registration dossier, or that this will be included by the substance manufacturer/importer if you are a formulator.
Step 4: Communicate the Identified ‘Uses and Exposure Scenarios’ you intend to support (or your supplier intends to support) to your Downstream Users as soon as possible and at the latest by the end of 3Q2009 for substances to be registered by 01 December 2010.
Suppliers to the lubricants industry should note that all substances used in lubricant applications will need to be registered for the Identified Uses allocated to Group A (Formulation) in the Lubricant Use Descriptions for Tier 1 Exposure Assessment Table (Section 6.3.1) and at least one other from Groups B to F.
6.2 Lubricant Applications Table
6.3 Lubricant Use Descriptor for Tier 1 Exposure Assessment Tables
6.3.1 Workers (Industrial/Professional)
6.3.2 Consumers
Under REACH,
lubricant products need
to be registered for
consumer use. This is
covered by the Use
Descriptor PC24
(Lubricants, greases,
and release products).
The ECETOC TRA tool (www.ecetoc.org/tra),
which is the preferred
screening tool for
estimating exposures
under REACH, provides
the ability to estimate
exposures for consumer
lubricants in liquid,
paste and spray forms.
ATIEL is working with
ATC and other lubricant
suppliers to obtain
habits and practices
information that are
representative of these
Uses and that can be
used, in conjunction
with the TRA, to derive
more accurate estimates
of consumer exposure to
lubricants.
6.3.3 Environment
ATIEL/ATC is working closely with other industry bodies such as CONCAWE, CEFIC and AISE to ensure that specific environmental release categories ("SPERCS") cover lubricants uses. These SPERCS will supersede the ERCs which are mentioned in RIP guidance R.12, and which are very conservative in their assumptions about environmental releases. Building upon these SPERCs, ATIEL/ATC is developing Environmental Exposure Scenarios that will demonstrate how lubricant uses A-F can each be achieved safely. This involves collating use information such as the typical operating conditions (OCs) and environmental risk management measures (RMMS) employed, and typical formulations for each use group. Calculations are being done to demonstrate that such OCs and RMMs are adequate to control risk (or, if necessary, that more stringent control measures are required). These environmental exposure scenarios are expected to be available by the end of February 2010.
6.4 Additional Guidance for Suppliers
The following table summarises use descriptor codes for each of the ATIEL-ATC Lubricant Use Groups using the format recommended by the Downstream Users of Chemicals Coordination group (DUCC).
7. Information for Customers/Downstream Users
7.1 Step by Step Guide
It is expected that suppliers to the lubricant supply chain will be aware of approximately 80% of the uses of their substances/products. The ATIEL/ATC GES WG therefore recommends that EU manufacturers and/or importers responsible for the registration of substances and formulators adopt the CEFIC/FECC-endorsed “top-down” communication workflow for Identified Uses and associated Exposure Scenarios. It is the intention of the ATIEL/ATC GES WG members to cover, and/or encourage their suppliers to cover, the supported lubricant applications and Use descriptors included in the Lubricant Applications Table (Section 7.2) and the the Lubricant Use Description for Tier 1 Exposure Assessment Tables (Section 7.3) in their registration dossiers.
The following steps should help you identify whether your use of a substance/product supplied to you has been assessed as part of this project and assigned a set of Lubricant Use Descriptors by the WG:
Step 1: Refer to the Lubricants Application Table (Section 7.2) to identify the Group (B – F) that has been allocated by the ATIEL/ATC GES WG for your Lubricant Application (i.e. Family and Specific Application). For example, the lubricant application ‘Metalworking, Corrosion protection – water based - diluted’ has been assigned to Group C as per below extract from the Lubricants Application table.
| LUBRICANT APPLICATION |
ATIEL-ATC
LUBRICANT USE GROUP |
| Family |
Specific application |
|
| Metalworking |
Corrosion protection - water based - diluted |
C |
Step 2: Refer to the Lubricant Use Description for Tier 1 Exposure Assessment Tables (Secton 7.3.1) to identify the Sector of Use (SU) and Process Category (PROC) that has been assigned to the Group you selected. (Note that additional information on consumer uses and Environmental Release Category (ERC) will be provided in section 7.3.2 and 7.3.3 in a future update to these web pages).
Step 3: If your lubricant application is covered by the provided Use Descriptors, there is no need to take further action since it is likely that your Use will be covered by the upstream suppliers in their registration dossier. In this case it is highly recommended that you do not contact your supplier at this stage but instead wait for them to communicate this information to you in line with the CEFIC/FECC “top-down” communication workflow. [Important note - it is expected that you should receive such information from your immediate supplier by the end of 3Q2009. If you have not received any information from them by then it would be appropriate to check with them that your particular use will be covered].
Step 4: If your lubricant application is not adequately described by Steps 1-3 then it is recommended that you contact your Supplier as soon as possible if you want the manufacturer/importer to include your specific use in their registration dossier. In accordance with REACH you, as a Downstream User, can ask the manufacturer/importer (even if it is by way of your supplier who may be a formulator) to include your use in the registration dossier. However, this communication has to be completed at least 12 months before the respective registration deadline and meaning that for substances with a 1st December 2010 registration deadline this has to be completed by end November 2009 at the latest. If you decide not to make your particular use known to the manufacturer/importer, or the manufacturer/importer has already informed you that they will not support a particular use because it is deemed not safe, then you may have to develop your own CSA for this use and inform ECHA (see Guidance for Downstream Users), assuming you would like to continue the particular use.
Please note that Step 4 is also a feedback loop that will help in the development of the Lubricant Applications Table. The ATIEL/ATC GES WG has used their best endeavours to ensure that this table covers all the different applications of lubricants and lubricant additives but it is understood that language and nomenclature may differ between individual companies across this sector and so identification of your specific use in the table may be problematic. If you are unable to identify your specific use in the table and you would like to see your particular application included in this project then you should contact your supplier for further discussions.
7.2 Lubricant Applications Table
7.3 Lubricant Use Description for Tier 1 Exposure Assessment Tables
7.3.1 Workers (Industrial/Professional)
7.3.2 Consumers
Under REACH,
lubricant products need to
be registered for consumer
use. This is covered by the
Use Descriptor PC24
(Lubricants, greases, and
release products). The
ECETOC TRA tool (www.ecetoc.org/tra),
which is the preferred
screening tool for
estimating exposures under
REACH, provides the ability
to estimate exposures for
consumer lubricants in
liquid, paste and spray
forms. ATIEL is working with
ATC and other lubricant
suppliers to obtain habits
and practices information
that are representative of
these Uses and that can be
used, in conjunction with
the TRA, to derive more
accurate estimates of
consumer exposure to
lubricants.
7.3.3 Environment
See comments in section 6.3.3
TOP of page
8. Generic Exposure Scenarios for Lubricant Use Groups A – F
Expected 1Q 2010
9. Acronyms/Glossary
List of acronyms used and what they mean:
| Acronym |
Title |
Description |
| SU |
Sector of Use |
Describes the area of use, (e.g. manufacture, public domain, private use, etc.) and also the type of industry (e.g. large scale chemical manufacture) |
| ES |
Exposure Scenario |
Covers the set of conditions [usually based around a Process Category (PROC code) for workers, Product Category (PC Code) or Article Category (AC) for consumers or Environmental Release Category (ERC) for the environment] that describe how a substance can be safely used, and which include the necessary operational conditions (OCs) and risk management measures (RMMs) which the M/I considers should be implemented to control the risks to human health and the environment associated with the use. An ES is specific to a substance or product. |
| GES |
Generic Exposure Scenario |
Describes the necessary operational conditions (OCs) and risk management measures (RMMs) which should be implemented to control the risks to human health and the environment associated with the use (or uses) of a group of substances/products with a similar risk profile within a general area of industry (and may extend across several PROCs, PCs/ACs or ERCs). By definition, it aggregates the individual Exposure Scenarios for the various tasks and activities that constitute the general use of the substance/product within a specific sector. It is developed by M/Is in partnership with DU associations. |
| UD |
Use Descriptor |
The term used in REACH to describe the PROCs, PCs, ERCs and SUs. |
| PROC |
Process category |
How the substance is being used (e.g. spraying in industrial settings or applications). |
| PC |
Product category |
Type of product (e.g. hydraulic fluid). |
| AC |
Article category |
Type of article (e.g. rubber product: tyres). |
| ERC |
Environmental release category |
A conservative set of exposure conditions that is intended to ensure that releases to the environment from an use (e.g. industrial use of substances in closed systems) do not represent a cause for concern |
| SPERC |
Specific ERC |
An ERC, developed by industry, and based on realistic data and assumptions for a particular use. |
| OC |
Operational conditions |
What happens during manufacture or use (e.g. pumped transfer from closed mixing vessel to drum) |
| RMM |
Risk management measures |
Actions taken to reduce exposure to an identified hazard (e.g. use of closed vessel to prevent exposure to vapours) |
| ECETOC (TRA) |
Targeted Risk Assessment |
ECETOC is a scientific forum for chemical companies to harness their specialist expertise to research, review and assess the ecotoxicology and toxicology of chemicals. |
| DUCC |
Downstream Users of Chemicals
Co-ordination |
Downstream Users of Chemicals Co-ordination Group. An informal platform of European associations representing a range of downstream industries. |
10. Useful Links
The REACH regulation
www.eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2007:136:SOM:EN:HTML
ATC Additives Technical Committee
www.atc-europe.org
CEFIC
www.cefic.org
CEFIC guidance documents
www.cefic.be/Templates/shwPublications.asp?HID=750
ECHA – European Chemicals Agency
www.echa.europa.eu
ECETOC
www.ecetoc.org
DUCC
www.duccplatform.org/home.html
Any links you select direct you to a website that is not controlled by ATIEL. ATIEL does not endorse, adopt, certify or otherwise validate the information and material contained on the linked website.
11. Q&As
| NUMBER |
QUESTION |
ANSWER |
| 1 |
I cannot access some of the tables on the website |
Contact info@atiel.org |
| 2 |
What should I do if I cannot find my use on the website? |
Contact your supplier directly for further information. This information should not be sent directly to ATIEL or ATC |
| 3 |
My use is
confidential and I
do not want to
tell my supplier.
What should I do? |
The
regulation allows
downstream users
to keep a use
confidential.
In these
circumstances the
downstream user
should prepare his
own Chemical
Safety Assessment for that particular use and record
it in a Chemical
Safety Report -
CSR (if the total
amount used is 1
tonne/year or
more). This CSR
has to be made
available to local
REACH enforcement
authorities on
request and ECHA
has to be
notified. The
notification to
ECHA needs to
indicate the name
of the substance,
the use for which
an assessment has
been carried out,
and the identity
of the supplier.
ECHA should be
notified within
six months
following the
receipt of a
registration
number from your
supplier that you
have prepared your
own CSA. There is
no requirement to
send the CSA you
have prepared to
ECHA.
Please also refer to Q & A
number 10 as
options 1 and 3
may also provide a
solution for a
downstream user in
these
circumstances. |
| 4 |
Am I obliged to
register all uses
identified by my
downstream user? |
No,
suppliers do not
need to support
all uses
identified by
downstream users
that they consider
inappropriate.
However, suppliers
are obligated to
inform downstream
users and ECHA of
uses which they
advise against for
reasons of safety.
Additionally, a
supplier may
choose not to
cover a use e.g.
because he
considers the
assessment as not
feasible or
economical. In
this case, the
supplier should
inform the user of
his/her decision
and both parties
should work
together to
identify a
solution that is
in line with legal
obligations.
|
| 5 |
If I am a
manufacturer of a
component used in
the identified
applications what
do I need to
do? |
For
continued use in
these applications
you need to
register the
relevant uses as
identified in the
DUCC table. |
| 6 |
Will all
substances used in
lubricants be
registered for all
ATIEL use groups A
to F as some are
identified as 'out
of scope'?
|
No,
only identified
uses allocated to
group A
(Formulation) will
automatically be
covered. Use in
the other groups B
to F, needs to be
specifically
identified. Those
identified as 'out
of scope' are
adequately covered
by other trade
association, for
example,
|
| 7 |
If my use is not typical and I cannot find it on the
website what
should I do? |
You should contact your supplier. |
| 8 |
Do
I as a downstream
user need to
communicate any
information on how
I handle the
substance? |
At this time we are gathering information through ATIEL,
ATC & other
trade associations
and we will
contact you if we
need further use
and exposure
information to
enable an accurate
exposure scenario
to be prepared.
However,
you are welcome to
input to this
process via the
ATIEL contact
email info@atiel.eu. |
| 9 |
Im not sure if I am an (I)ndustrial or (P)rofessional
end user |
See
the website
summary document
for further
explanation.
The
automotive example
below may clarify
this for you.
Automotive
manufacturing
site
|
|
Car
dealer /
workshop or
local garage
|
|
D-I-Y
Oil change
|
|
|
|
|
|
|
Industrial
|
|
Professional
|
|
Consumer
|
|
| 10 |
By what deadline to I have to communicate my uses to my
suppliers? |
This
should be done 12
months prior to
the relevant
registration
deadline. For
substances with
2010 registration
deadline this
means that the
communication
deadline has
technically
passed. However we
recommend you
contact your
supplier as soon
as possible as
they may still be
willing to
consider your use.
In cases where
your supplier is
unwilling to
consider your use
at this late stage
you have a number
of options
including:
- Adapt your conditions of use to those operating
conditions and
risk
management
measures
described in
the
suppliers
eSDS.
- Perform your own chemical safety assessment for
that
particular use
and record it
in a Chemical
Safety Report
- CSR (if the
total amount
used is 1
tonne/year or
more). This
CSR has to be
made available
to local REACH
enforcement
authorities on
request and
ECHA has to be
notified. The
notification
to ECHA needs
to indicate
the name of
the substance,
the use for
which an
assessment has
been carried
out, and the
identity of
the supplier.
ECHA should be
notified
within six
months
following the
receipt of a
registration
number from
your supplier
that you have
prepared your
own CSA. There
is no
requirement to
send the CSA
you have
prepared to
ECHA
- Switch to another supplier of the substance if
that supplier
covers your
specific use
in his eSDS.
Many
substances have
later registration
deadlines and so
you are still able
to provide this
use information to
your supplier who
is required to
consider this use
as part of his
registration |
| 11 |
I have reviewed your use descriptor information and
dont agree with
the assignment of
PROCs and ERCs. |
By
definition
assignment of use
descriptors is
subjective. The
use descriptors
assigned are based
on the consensus
view of the
Lubricants and
Fuel Additive
Industry experts
represented by the
ATIEL ATC GES
Working Group.
If however
you feel these
PROCs and ERCs do
not describe your
life cycle step
adequately please
contact info@atiel.org
with a reasoned
argument as to
your alternative
suggestion.
Please
note however that
having published
this information
already we will be
reluctant to make
minor changes at
this late stage
due to the complex
nature of the
supply chain. |
| 12 |
Why
are there no PROCs
assigned to consumer
uses? |
PROCs
are used to
describe worker
exposure and so
are not applicable
to consumers.
Consumer exposure
is adequately
described by
Product Category. |
| 13 |
Why does ATIEL Group B not include the following two PROCS…
PROC 17 Lubrication at high energy conditions and in partly open process, Industrial or non-industrial setting;
PROC 18 Greasing at high energy conditions, Industrial or non-industrial setting; |
The selection of PROCs is by necessity subjective however this is the opinion of industry experts as represented by the ATIEL / ATC REACH GES Working Group. Group B includes filling and draining of containers and enclosed machinery (including engines). It is intended to cover the use of engine oils and similar within closed systems. Both PROC 17 and PROC 18 apply to open systems in which there is significant exposure potential. PROC17 is generally applied to describe metal machining and similar operations. (Ref: Jan 2010 minutes of ATIEL / ATC GES WG meeting). Specifically PROC 18 is not used to describe the use of greases in this context because the defaults in the ECETOC TRA indicate that this PROC does not apply to closed systems (Ref: Dec 2009 minutes of ATIEL / ATC GES WG). |
| 14 |
For a product purchased I have noticed that not all the CAS and or EC numbers in Section 3 of the Safety Data Sheet appear on the ECHA listing of active SIEF's with a Lead Registrant assigned. Should I be concerned that the product I purchase will comply with the REACH requirements and will continue to be available post November 30th 2010. |
There are a number of legitimate reasons why some substances identified in Section 3 of a Safety Data Sheet are not listed on ECHA's list of active SIEF's. These include:
1. The CAS number may relate to a substance which does not have a 2010 registration deadline in which case the SIEF may not yet be active.
2. There is no legal requirement for a Lead Registrant to advise ECHA of their status and so the SIEF maybe active but ECHA have not been advised.
3. As a result of REACH activities, especially substance sameness discussions, some pre-SIEFS split or merged resulting in changes to substance identities. If this is the case it will become clear when an updated Safety Data Sheet is issued by your supplier.
4. Your supplier may be using generic identifiers in section 3 of the Safety Data Sheet which satisfies the product stewardship obligations to report hazardous substances but for REACH registration purposes more precise identifiers are required.
If you remain concerned then you should contact your supplier directly for further information. |
For a comprehensive list of general REACH Q&As please refer to the CEFIC website.
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