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REACH RELATED WEBSITES & HELPDESKS

European Chemicals Agency (ECHA)Official website for ECHA

Consumer Products Safety & Quality  Unit (CPS&Q)

Formally known as the ECB
Information on the implementation of REACH and REACH Implementation projects (RIPs)

European Chemical Susbstance Information System (ESIS)Website for access to the EC inventory of 'existing substances'.
ECHA HelpdeskECHAs REACH helpdesk.
National REACH HelpdesksAccess to list of EU Member States REACH helpdesks.  

REACH- IT & IUCLID 5  

REACH-IT portal 
IUCLID 5 websiteOfficial IUCLID 5 website for download of IUCLID 5, plug-ins and IUCLID 5 guidance documents
IUCLID 5 HelpdeskTechnical support for users of IUCLID5
IUCLID 5 Guidance & Support, Vol. 1 - End User Manual  
IUCLID 5 Guidance & Support, Vol. 2 - Getting Started Manual  Recommended starting point

LEGISLATION

Access to all current legislation directly related to REACh is also available via the ECHA website

All links connect to appropriate entry of the Official Journal of the European Commission. 

Legislation can be downloaded in pdf format in all official languages of the EU.

 REACH Regulation (EC) No. 1907/2006Concise version of 29th May 2007. 273 pages 
All languages except Bulgarian & Romanian.
 REACH Regulation (EC) No. 1907/2006 Bulgarian & Romanian
 REACH Fee Regulation (EC) No. 340/2008Commission Regulation on the fees and charges payable to the European Chemicals Agency pursuant to Regulation EC 1907/2006 (REACH)
REACH Amendment for accession of Bulgaria & Romania (EC) No. 13554/2007Council Regulation (EC) No. 1354/2007 adapting Regulation EC 1907/2006 (REACH), by reason of the accession of Bulgaria and Romania
Annex IV & V REACH Amendment (EC) No 987/2008Commission Regulation amending Annex IV & V of the REACH Regulation EC 1907/2006
REACH Test Method Regulation (EC) No. 440/2008Council Regulation (EC) No. 440/2008
of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament andof the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
 Waste Directive 2006/12/EC

Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste

TECHNICAL GUIDANCE DOCUMENTS                      

Technical guidance documents (TGDs) on REACH are freely available to access and download from ECHA’s guidance webpage .

ECHA are also preparing Guidance Fact Sheets as guides to some of  the TGDs.  These fact sheets will eventually be available in all EU official languages.

To download the most recent revision of each TGD follow the links below. Note: These are currently only available in English (Jan 09).

Technical Guidance Documents for Industry
Guidance on registrationGuidance fact sheet also available

Guidance on pre-registration

 

There is no formal technical guidance document covering pre-registration, instead ECHA have provided information on their website.

Guidance on data-sharing also includes a chapter on pre-registration.

Guidance on using IUCLID 5 for pre-registration can be found on the IUCLID 5 pre-registration webpage.

Guidance on data-sharing  Guidance fact sheet also available
Guidance on Intermediates 
Guidance for monomers and polymers 
Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD) 

Guidance on information requirements and chemical safety assessment

Concise guidance: 

Part A: Introduction
Part B: Hazard Assessment
Part C: PBT and vPvB Assessment
Part D: Exposure Assessment
Part E : Risk Characterisation
Part F: Chemical Safety Report
Part G: Extension of the SDS

In depth guidance supporting concise guidance:

R.2 - R.7: Information Requirements
R.8 - R.10:Dose or Concentration Response characteristics
R.11: PBT/vPvB Assessment
R.12: Description of Uses
R.13: Conditions of Use (RMM, OC)
R.14 - R.18: Exposure Estimation
R.19: Uncertainty Assessment
R.20: Explanation of Terms

This TGD has been divided into 7 Parts and supporting chapters as shown.  Follow the main link to access / download the documents you need.

Guidance fact sheet also available

Guidance for downstream usersGuidance fact sheet
Guidance on Classification and Labelling notification

Not yet available (Jan 09). Check ECHAs Guidance webpage for update

Guidance on how to comply with the provisions of the new Regulation on Classification Packaging and Labelling of substances and mixturesOn hold pending GHS legislation (Jan 09)
Guidance on the preparation of an application for authorisation              Not yet available. Check ECHAs Guidance webpage for update
Guidance on requirements for substances in articles

Member States are not all in agreement with this guidance document.  Find out more...

Guidance fact sheet also available

Guidance on socio-economic analysis - AuthorisationNot yet available. Check ECHAs Guidance webpage for update
Guidance for identification and naming of substances in REACH  Guidance fact sheet also available

Technical Guidance Documents for ECHA and Member State Competant Authorities
Guidance on priority setting for evaluation
Guidance on Dossier and Substance Evaluation
Guidance for the preparation of an Annex XV Dossier on Harmonised Classification and Labelling
Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern
Guidance on inclusion of substances in Annex XIV (substances subject to Authorisation) 
Guidance for the preparation of an Annex XV dossier for restrictions
Guidance on socio-economic analysis - Restrictions

 SUBSTANCE INFORMATION WEBSITES/DATABASES

The following is a list of databases that can be used either to validate or look for substance information.  Please be aware that not all of these databases are free to access.

Validation of Data / Existing Assessments

 CHEMEXPER 
 ESISEuropean Substance information Suystem - EC Inventory & links to risk assessments performed under the Existing Substances Regulation (ESR)793/93/EEC.
 OECDOrganisation for Economic Co-operation and Development

 GESTIS Substance Database

A national information system for hazardous substances in Germany
 GSBL National Hazardous substances databaseNote: German Site, no English version available
 TOXNET A free web-based system of integrated databases on toxicology, hazardous chemicals, environmental health and related areas. Several databases can be queried through TOXNET: HSDB, IRIS, ITER, GENE-TOX, CCRIS, HazMap, Household Product Database, TOXMAP, TOXLINE, DART, TRI, and ChemIDPlus. The last of these has the facility to perform structural, sub-structural and similarity based searches to retrieve analogues and their associated data. The database contains over 368,000 chemical records, of which 200,000 include chemical structures.
 ChemIDPLUS 

Physicochemical properties  

 Information source

 URL 

(note: may not be unique, other routes may exist)

 HSDB  http://toxnet.nlm.nih.gov/  
Chemical Evaluation Search and Retrieval System (CESARS)  http://www.ccohs.ca/products/databases/cesars.html
Biodegradation and Bioaccumulation Database on Existing Chemicals, Japan (MITI)  http://qsar.cerij.or.jp/cgi-bin/DEGACC/index.cgi?E
OECD SIDS http://cs3-hq.oecd.org/scripts/hpv/
CHEMFATE http://www.syrres.com/esc/efdb.htm
ChemFinder http://chemfinder.cambridgesoft.com/
SRC PhysProp http://www.syrres.com/esc/default1.htm
SRC Environmental Fate database (BIOLOG, BIODEG, CHEMFATE, DATALOG) http://www.syrres.com/esc/efdb.htm  
ISHOW http://www.nisc.com/cis/
Merck Index http://library.dialog.com/bluesheets/html/bl0304.html
IUPAC solubility data series http://www.iupac.org/publications/sds%20/
Beilstein http://www.beilstein-online.de/frameset.htm  
Searchable Physics Information Notices (SPIN) http://www.scitation.aip.org/spinweb
 

Environmental aspects

 Information source  URL (note: may not be unique, other routes may exist)
 Chemical Evaluation Search and Retrieval System (CESARS)  http://www.ccohs.ca/products/databases/cesars.html
 ECETOC Aquatic toxicity database (EAT III)  http://www.ecetoc.org/Content/Default.asp?  
 ECOTOX (US EPA integration of AQUIRE, PHYTOTOX and TERRETOX)  http://www.epa.gov/ecotox/
 Biodegradation and Bioaccumulation Database on Existing Chemicals, Japan (MITI)  http://qsar.cerij.or.jp/cgi-bin/DEGACC/index.cgi?E
 SRC Environmental Fate data base (BIOLOG, BIODEG, CHEMFATE, DATALOG)  http://www.syrres.com/esc/efdb.htm
 TRACE  http://www.bibra-information.co.uk/
 TOXNET (includes TOXLINE SPECIAL, TOXLINE CORE/MEDLINE and HSDB  http://toxnet.nlm.nih.gov/
 BIOSIS http://www.dialog.com/
 Environmental Monitoring Methods Index System  http://www.epa.gov/
 US Environmental Information Management System (EIMS)  http://www.epa.gov/eims/eims.html

Mammalian toxicity

 Information source  URL  (note: may not be unique, other routes may exist)
 TOXNET (TOXLINE CORE, TOXLINE SPECIAL, MEDLINE, DART, GENETOX, IRS, ITER, CCRIS, HSDB, ETIC, EMIC)  http://toxnet.nlm.nih.gov/
 IUCLIDhttp://ecb.jrc.it/
 CANCERLINE (CANCERLIT) http://www.cancer.gov/search/cancer_literature/
 The Toxic Substance Control Act Test Submission database (TSCATS)  http://www.syrres.com/esc/tscats.htm
 Chemical Evaluation Search and Retrieval System (CESARS)  http://www.ccohs.ca/products/databases/cesars.html
 TRACE (indexes the published literature, including primary journals, and toxicity reviews and assessments from JECFA, IARC, JMPR, IUCLID, OECD, IRIS, ATSDR, ACGIH, ECB, IPCS, WHO, CICADs, EHCs, NICNAS, NTP, GINC, MHLW, DECOS, HSE, COC, COM, COT, Japanese chemical toxicity and genotoxicity databases, etc.)  http://www.bibra-information.co.uk/
 EPA GAP  http://www.epa.gov/cludygxb/programs/gap.html
 IRIS  http://www.epa.gov/iris/
 HSDB http://toxnet.nlm.nih.gov/
 OECD SIDS http://cs3-hq.oecd.org/scripts/hpv/
 Registry of Toxic Effects of Chemical Substances (RTECS)  http://www.ccohs.ca/
 US Agency for Toxic Substances and Disease Registry (ATSDR)  http://www.atsdr.cdc.gov/
 ECETOC JACC reports and Inventory of critical reviews  http://www.ecetoc.org/Content/Default.asp
 European Chemicals Bureau  http://ecb.jrc.it/
 International Agency for Research in Cancer (IARC)  http://www.inchem.org/pages/iarc.html
 IPCS, WHO, JECFA, JMPR e.g. CICADS, EHCs, water and air quality guidelines

 http://www.inchem.org/

http://www.who.int/pcs/index.htm

 Australia's National Industrial Chemicals Notification and Assessment Scheme (NICNAS) http://www.nicnas.gov.au/
 US National Toxicology Program (NTP)  http://ntp-server.niehs.nih.gov/
 Global Information Network on Chemicals (GINC)  http://www.nihs.go.jp/GINC/index.html
 Japanese Chemical toxicity database (MHLW)  http://wwwdb.mhlw.go.jp/ginc/html/db1.html
 Gastrointestinal absorption database (GIABS)  http://www.nisc.com/cis/

Exposure

 Information source  URL (note: may not be unique, other routes may exist)
 TOXNET includes  HSDB, TOXLINE SPECIAL, TOXLINE, CORE, HSDB http://toxnet.nlm.nih.gov/
 TRACE  http://www.bibra-information.co.uk/
 NPRI  Canadian National Pollutant Release Inventory http://www.ec.gc.ca/pdb/npri
 US Toxics Release Inventory (TRI)  http://www.epa.gov/tri/
 European Pollutant Emission Register (EPER)  http://www.eper.cec.eu.int/
 POLLUTANT RELEASE AND TRANSFER REGISTER

 http://www.chem.unep.ch/prtr/default.htm

http://www.who.int/iomc/groups/prtr/en/

 AUSTRALIAN NATIONAL POLLUTANT INVENTORY  http://www.npi.gov.au/
 US National Center for Environmental Assessment (NCEA) [Exposure Factors Program]  http://cfpub.epa.gov/ncea/
 Exposure models (EUSES, ConsExpo, HEM, EFAST etc)  http://ecb.jrc.it/ http://www.rivm.nl/
http://www.epa.gov/ttn/fera/ http://www.epa.gov/opptintr/exposure/docs/efast.htm 

(Q)SARS

For guidance on how to use (Q)SARs to predict eco/toxicological endpoints go to  Chemical Toxicology .

  
The REACH proposal (Annex XI) contains some general statements about using non testing methods to predict substance data end points. Regardless of the type of non-test method it should be “reliably and adequately documented”.  In addition results from (Q)SAR modelling may be used only when all of the following conditions are met:

  • the (Q)SAR model is accepted as scientifically valid;
  • the (Q)SAR model is valid for the substance (i.e. not all (Q)SAR models are not valid for all substances, you need to check!);
  • the results are adequate for the purpose of classification and labelling and/or risk assessment.

Further guidance on the validation of (Q)SARs are listed in the OECDQSAR validation principles.

 (Q)SAR Model 
 THE DANISH (Q)SAR DATABASEThe Danish user manual document includes (Q)SAR models which can be used to predict different end points.
 TOXTREEAvailable to download form the ECB website 
 EPISUITEAvailable to download from the US EPA website
 OECD

Organisation for Economic Co-operation & Development. 

Provides information on which (Q)SAR model you need to use for a specific end point

 

Publications

  1. Comparative PBT screening using (Q)SAR tools within REACH legislation”, SAR and QSAR in Environmental Research, 2009, 20 (1–2), 145–157, Mouna Zachary and Gillian Greenway
Last Updated ( Wednesday, 20 May 2009 )
 
© 2017 REACH Regulation: Registration, Evaluation, Authorization and Restriction of Chemicals: REACH Legislation