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REACH Implementation Project

1) REACH Process description

RIP 1 explains the processes and procedures set out in the initial Commission REACH Proposal from 2003, aiming at helping industry, authorities and policy makers to better understand it.

Flowcharts provide an overview of the main procedures under REACH and of the main stakeholder roles and duties - at a glance.

A detailed process description explains in detail the processes of Registration, Information through the Supply Chain, Downstream users, Evaluation, Authorisation, Restrictions and the Classification and Labelling Inventory.

Furthermore, a set of Questions and Answers and 'REACH in brief' was developed.

For further details please visit the website of the European Chemicals Bureau.

2) REACH-IT

The objective of the REACH-IT project is to ensure that the REACH processes in the Agency, Member States, industry, Commission and other stakeholders are supported by appropriate IT systems.

The REACH workflow is automated by an IT system and the submission of a registration dossier is mainly organised through it. The REACH dossier creation and management is supported by version 5 of IUCLID (International Uniform ChemicaL Information Database), already well introduced in the stakeholder community as well as globally (e.g. the OECD chemicals programme) in its version 4.

Non-confidential REACH data will be publicly availableon the website of the European Chemicals Agency.

For further details please visit the website of the European Chemicals Bureau.

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)

4) Guidance Documents for authorities

RIP 4.1: Dossier Evaluation and RIP 4.2: Substance Evaluation

RIP 4.1 and 4.2 have been merged together as there are many interlinked issues.

The guidance document specifies when and how the Agency should conduct a dossier evaluation (testing proposal and compliance check) as well as how substance evaluation should be conducted under REACH.

RIP 4.3: Inclusion of Substances into Annex XIV (list of substances subject to Authorisation)

RIP 4.3 developed a Guidance Document that describes the procedures and methodology to be used by the Agency when prioritising substances for authorisation and proposals for adaptation of Annex XIV.

RIP 4.4 Preparation of Annex XV Dossiers

RIP 4.4 developed a Guidance Document that should enable Member States Competent Authorities or the Agency (on behalf of the Commission) to justify proposals on harmonised Classification & Labelling, identification of PBT and vPvB substances and substances of similar concern, and for restrictions following the general principles outlined in Annex XV (Dossiers).

The identification of a substance of equivalent concern is also discussed within this project.

RIP 4.5: Priority Setting for Evaluation

RIP 4.5 will develop a Guidance Document on the criteria for prioritising which substances should be fed into the substance evaluation process. Member States should use these criteria for preparing their so-called "rolling plans".

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.

5/6) Establishment of the European Chemicals Agency

RIP 5/6 dealt at the establishment of the European Chemicals Agency, ensuring that it can effectively, efficiently, and transparently carry out the tasks allocated to it.

For further details and for information on the job opportunities please visit the website of the European Chemicals Agency.