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