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.
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
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.
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.
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.
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.
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.
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.
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.