REACH Implementation Project 3 (RIP 3)
Guidance Documents for industry
The following areas have been identified
as key for the development of guidance documents on REACH
for industry:
RIP 3.1: Registration dossier
RIP 3.1 developed a Guidance Document for
manufacturers and importers on how they can prepare their
dossiers for registration under REACH.
RIP 3.2: Chemical safety report and SDS
RIP 3.2 will develop a Guidance Document
for manufacturers, importers and down-stream users of chemicals
on how they can carry out the chemical safety assessment and
document it in a chemical safety report and how to communicate
information using the safety data sheet (SDS) according to
REACH.
RIP 3.3: Information Requirements on Intrinsic
Properties of substances
RIP 3.3 will develop a Guidance Document
for industry on how they can fulfil the information requirements
on intrinsic properties of substances.
This should in particular give a better insight
on how to use alternatives to in-vivo data such as
(Q)SARs, chemical category approach, in-vitro data
and how information on exposure can be taken into account.
RIP 3.4: on Data sharing
RIP 3.4 will develop a Guidance Document
for manufacturers and importers on how to share vertebrate
animal data following the pre-registration of phase-in substances
and inquiries for non-phase in substances.
RIP 3.5: Downstream-User Requirements
RIP 3.5 will develop a Guidance Document
for downstream users on what their obligations are under the
REACH legislation regarding use of substances and exposure
scenarios and what information they should have available,
identify and communicate up/down the supply chain.
RIP 3.6: GHS
RIP 3.6 will develop a Guidance Document
on Classification and Labelling under the Global Harmonised
System, which is expected to be introduced in the EU legislation
in parallel with REACH.
RIP 3.7: Authorisations
RIP 3.7 will develop a Guidance Document
for industry on the process to be followed when applying for
an authorisation for manufacture and use of prioritised substances
of very high concern.
RIP 3.8: Substances in Articles
RIP 3.8 will develop a Guidance Document
that enables producers/importers of articles (and everyone
else, including the enforcing authority) to judge whether
a substance in an article should be registered/notified or
not.
RIP 3.9: Socio-economic analyses
RIP 3.9 will develop a Guidance Document
on when and how to conduct a socio-economic analysis (SEA)
under REACH.
The guidance should strive for making SEA
outputs as comprehensive, consistent and user-friendly for
the SEA committee as possibly taking into account the broad
range of chemicals, uses, alternatives, etc. to be analysed
and the various parties and processes to be covered by the
guidance.
RIP 3.10: Substance Identity
Substances within the definition of REACH
are typically the product of chemical manufacture and may
contain multiple distinct constituents and/or impurities and
additives.
RIP 3.10 developed a Guidance Document addressing
the issue of characterisation and checking of substance identity.
Specific guidance for various types of substances is given.
Guidance is also given on identifying equivalent substances,
as this is important for data sharing and consortium formation.
For further details please visit the website
of the European
Chemicals Bureau or download the available guidance documents
from the website of the European
Chemicals Agency.
Results of the workshop: REACH
Implementation Project 3 - Development of REACH Guidance for
Industry (25/09/2006)
RIP 1 | RIP
2 | RIP 3 | RIP 4 | RIP
5/6
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