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REACH 2018 special e-News: Assess your substance to show safe use

 

 

This is an occasional update from ECHA that focuses on the last REACH registation deadline.
REACH 2018 Special e-News

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

What information you need

To be ready for registration, you first need to understand what information you have to collect.

In general, you need to provide information on the physicochemical, toxicological and ecotoxicological properties of your substance.

What information you need | Requirements for 1-10 tonnes registration | Reduced requirements | Requirements for 10-100 tonnes registration | Adaptations

How to avoid unnecessary testing on animals

Under REACH, testing on vertebrate animals can only be used as a last resort to fulfil information requirements for registration.

There are multiple ways to avoid unnecessary animal testing and to reduce the number of tests. For each individual information requirement you should:

  • Gather and share existing data;
  • Consider waiving data or adaptations; and
  • Consider non-animal approaches to generate new data.

How to avoid unnecessary testing on animals | Weight of evidence | QSAR models | In vitro methods | Grouping of substances and read-across

Strategy for gathering data

There are four steps to follow to gather data for registering your substance. You should agree with your co-registrants how to divide the work or to outsource some or all of it.

Step 1. Collect all available information
Step 2. Consider your information needs
Step 3. Identify information gaps
Step 4. Generate information

Strategy for gathering your data | Practical considerations before testing | Collecting information on uses

Webinar

REACH 2018
webinar - last call

Webinar: Assess hazard and risk
20 July 2016, 11:00 Helsinki time
Register now | Agenda

Upcoming

Webinar - phase 5: Prepare your registration as a IUCLID dossier
4 October 2016
More

 

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Media material

Material for media

What is REACH 2018 about?

 

Comms Network

Help us spread the word

Does your organisation represent companies that deal with chemicals? Is it a non-profit or public interest organisation? If so, help us communicate about the last registration deadline - join the REACH 2018 Communicators' Network

News

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)

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)

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)

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.

Chesar logoECHA'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.

QSAR logoIn 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

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

Stakeholders' Day material online

ECHA's May Stakeholders' Day focused on REACH 2018. If you missed the event, you can still see the video recording and the presentations online.

Event page | Presentation: Meeting your information requirements

 
Practical tips & case studies
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

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

Social media

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

Important links
ECHA
European Chemicals Agency
P.O.Box 400 FI-00121 Helsinki, Finland
echa.europa.eu/reach-2018

 

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