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ENOfficial Journal of the European Union
ANNEX XII

GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICALSAFETY REPORTS
INTRODUCTION
The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from thesubstance(s) they use are adequately controlled during their use for a use not covered by the Safety Data Sheet supplied tothem and that other users further down the supply chain can adequately control the risks. The assessment shall cover thelife-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 anarticle.
In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall takeaccount of information received from the supplier of the chemical in accordance with Article 31 and 32 of this Regulation. Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessmentscompleted under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and bereflected 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:

STEP 1: DEVELOPMENT OF EXPOSURE SCENARIO(S)The downstream user shall develop exposure scenarios for uses not covered in a Safety Data Sheet supplied to him inaccordance 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 beappropriate, then no further hazard assessment or PBT and vPvB 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 inaccordance with Article 38. He shall explain why he considers that additional information is necessary. While waiting forresults 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 theSafety 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 protectionof 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.

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EN

Official Journal of the European Union

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 chain.

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