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The purpose of this Annex is to set out how downstream users
are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use
for a use not covered by the Safety Data Sheet
supplied to them and that other users further down the supply
chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the
downstream user, for his own uses and for his identified uses further down the supply
chain. The assessment shall consider the use of the substance on its own, in a preparation or in an article.
In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take account
of information received from the supplier
of the chemical in accordance with Article 31
of this Regulation. Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessments
completed under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and be reflected
in the Chemical Safety Report. Deviations from such assessments
shall be justified. Assessments
carried out under other international and national programmes may also be taken into account.
The process which the downstream user goes through in carrying out the chemical safety assessment and in producing his Chemical
Safety Report, involves three steps:
The downstream user shall develop exposure scenarios for uses not covered in a Safety Data Sheet
supplied to him in accordance with Section 5 of Annex I
STEP 2: IF NECESSARY, A REFINEMENT OF THE HAZARD ASSESSMENT BY THE SUPPLIER
If the downstream user considers the hazard and PBT assessments
reported in the Safety Data Sheet
supplied to him to be appropriate, then no further hazard assessment or PBT
assessment is necessary. In this case he shall use the relevant information reported by the supplier
for the risk characterisation. This shall be stated in the Chemical Safety Report.
If the downstream user considers the assessments
reported in the Safety Data Sheet
supplied to him to be inappropriate, then he shall carry out the relevant assessments
in accordance with Sections 1 to 4 of Annex I
as appropriate to him.
In those cases where the downstream user considers that information in addition to that provided by the supplier
is necessary for producing his Chemical Safety Report the downstream user shall gather this information. Where this information
can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the Agency
in accordance with Article 38
. He shall explain why he considers that additional information is necessary. While waiting for results of further testing,
he shall record in his chemical safety report the risk management measures intended to manage the risks being explored that
he has put in place.
On completion of any additional testing, the downstream user shall revise the Chemical Safety Report, and his Safety Data Sheet
if he is required to prepare one, as appropriate.
STEP 3: RISK CHARACTERISATION
A risk characterisation shall be carried out for each new exposure scenario
as prescribed in Section 6 of Annex I
. The risk characterisation shall be presented under the relevant heading of the Chemical Safety Report and summarised in
the Safety Data Sheet
under the relevant heading(s).
When generating an exposure scenario
it will be necessary to make initial assumptions about the operating conditions and risk managements measures. If the initial
assumptions lead to a risk characterisation indicating inadequate protection of human health and the environment, then it
shall be necessary to carry out an iterative process with amendment of one or a number of factors until adequate control can
be demonstrated. This may require the generation of additional hazard or exposure information or appropriate alteration of
the process, operating conditions or risk management measures. Therefore, iterations may be made between on the one hand developing
and revising an (initial) exposure scenario
, which includes developing and implementing risk management measures, and on the other hand generating further information
to produce the definitive exposure scenario
. The purpose of generating further information is to establish a more precise risk characterisation, based on a refined hazard
assessment and/or exposure assessment.
The downstream user shall produce a Chemical Safety Report detailing his chemical safety assessment using Part B, Sections
9 and 10, of the format set out in Section 7 of Annex I
and the other sections of this format, if appropriate.
Part A of the Chemical Safety Report shall include a declaration that the risk management measures outlined in the relevant
exposure scenarios are implemented by the downstream user for his own uses and that the risk management measures outlined
in the exposure scenarios for the identified uses are communicated down the supply