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Phase 4 of REACH 2018
Assess your substance to show safe use
Companies registering the same substance must work together to compile and share information on the hazards and risks of their substance to demonstrate safe use. If new data needs to be generated, alternatives to animal testing must always be considered first.
All information should be reported in a registration dossier and submitted to ECHA by 31 May 2018.
Press release (translated) | REACH 2018 phases | Registration support
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REACH annexes amended – registrants to use alternative test methods
The REACH requirements for skin corrosion/irritation, serious eye damage/eye irritation, acute dermal toxicity and skin sensitisation are changing, making non-animal testing the default requirement. ECHA reminds registrants of their obligations to consider and, where possible, use alternative methods.
News alert (6 June) | EurLex | News alert (5 July)
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Advice on skin and eye irritation testing helps reduce animal tests
ECHA has published advice on using new or revised OECD test guidelines related to serious eye damage/eye irritation and skin corrosion/irritation. Non-animal testing is now the default approach to gather information.
News alert (5 July)
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Considerations for alternative methods need to be included in your testing proposal
Are you proposing to test on vertebrate animals to fulfil an information requirement for your REACH registration? If so, you need to show that you have considered alternative methods first. With the launch of the new version of REACH-IT on 21 June, these considerations need to be documented in your registration dossier and will be subject to completeness check.
News alert (15 June)
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IT tools for registration updated
New versions of IUCLID (for creating REACH and CLP dossiers), REACH-IT (for submitting dossiers) and Chesar have been published in April and June 2016.
 ECHA's Chesar tool will help you to carry out the chemical safety assessments for your chemical safety report, which is needed if you manufacture or import 10 tonnes or more a year. It also generates the exposure scenarios to be attached in the safety data sheets for communication in the supply chain.
 In addition, the OECD QSAR Toolbox has been updated. The toolbox enables you to assess the (eco)toxicity hazards of your chemicals by using computational methodologies to group chemicals into categories and to fill data gaps by read-across, trend analysis or (Q)SARs. Reliable predictions can reduce registration costs and animal tests to comply with REACH.
IUCLID 6 news item (29 April) | Chesar news item | REACH-IT news item (21 June) | QSAR Toolbox news item (6 July) | Chesar webinar material
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REACH guidance updates
ECHA applies a two-year ‘moratorium' on updates to the majority of the Agency's guidance on REACH before the 31 May 2018 deadline. However, some REACH guidance documents are not part of the standstill due to recent regulatory changes.
Draft guidance documents under consultation can be seen on ECHA's website and give an idea of the upcoming changes. Keep up with the latest developments by following our Weekly newsletter.
We have also compiled a list, which shows the status of the documents and when the final version is expected to be published.
Consultations | News item (23 May) | List of documents
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Practical tips & case studies |
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Interview
"There are no shortcuts in safety assessment"
 Putting information together for your registration dossier on the hazards and risks of your substance is the most extensive and time consuming part of the registration process. The basis for generating new data through testing is a comprehensive analysis of where you are and what you need to achieve.
ECHA Newsletter
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Practical advice
Assess your substance to demonstrate safe use
 The fourth step in preparing a successful registration dossier is about assessing the hazards and risks of your chemicals. For this, you need to collect all available information, compare that with the legal requirements, identify any potential data gaps and come up with ways of filling them.
Your ultimate aim is to demonstrate the safe use of your substance, while making sure that testing it on animals is kept as a last resort.
ECHA Newsletter
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Follow, like and share in social media
Are you active in LinkedIn? Follow our pages dedicated to the REACH 2018 deadline to keep up-to-date with relevant news. Invite your friends and colleagues working with chemicals to follow it too.
In Twitter, you can easily find our REACH 2018 related tweets by searching for the hashtag #REACH2018. Retweet and follow @EU_ECHA.
LinkedIn for REACH 2018 | Twitter #REACH2018
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