assessments
PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals [
go to this PREAMBLE]
... (30) The requirements for undertaking chemical safety
assessments by
manufacturers and
importers should be defined in detail in a technical annex to allow them to meet their obligations. To achieve fair burden sharing
with their customers,
manufacturers and
importers should in their chemical safety assessment address not only their own uses and the uses for which they place their
substances on the market, but also all uses which their customers ask them to address. ...
... (59) The requirements for undertaking chemical safety
assessments by
downstream users should also be prescribed in detail to allow them to meet their obligations. These requirements should only apply above a
total quantity of one tonne of substance or preparation. In any case, however, the
downstream users should consider the use and identify and apply appropriate risk management measures.
Downstream users should report certain basic information on use to the
Agency. ...
ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures [
go to this ARTICLE]
... Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures ...
ARTICLE-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS [
go to this ARTICLE]
... 0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical dossier
and on other available and relevant information.
Manufacturers or
importers submitting a proposal for testing in accordance with Annexes
IX and
X shall record this under the relevant heading of the chemical safety report. Available information from
assessments carried out under other international and national programmes shall be included. 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 development of, and reflected in, the chemical
safety report. Deviations from such
assessments shall be justified. ...
... 0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical dossier
and on other available and relevant information.
Manufacturers or
importers submitting a proposal for testing in accordance with Annexes
IX and
X shall record this under the relevant heading of the chemical safety report. Available information from
assessments carried out under other international and national programmes shall be included. 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 development of, and reflected in, the chemical
safety report. Deviations from such
assessments shall be justified. ...
... 0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical dossier
and on other available and relevant information.
Manufacturers or
importers submitting a proposal for testing in accordance with Annexes
IX and
X shall record this under the relevant heading of the chemical safety report. Available information from
assessments carried out under other international and national programmes shall be included. 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 development of, and reflected in, the chemical
safety report. Deviations from such
assessments shall be justified. ...
... 0.10. In relation to particular effects, such as ozone depletion, photochemical ozone creation potential, strong odour
and tainting, for which the procedures set out in Sections 1 to 6 are impracticable, the risks associated with such effects
shall be assessed on a case-by-case basis and the manufacturer or
importer shall include a full description and justification of such
assessments in the chemical safety report and summarised in the
safety data sheet. ...
ARTICLE-XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS [
go to this 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 and
32 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. ...
... 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 and
32 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. ...
... 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 and
32 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. ...
... 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 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. ...
... 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. ...