REACH
Restriction dossier on lead stabilisers in PVC
ECHA intends to submit the Annex XV restriction dossier by 16 December 2016, instead of October, as indicated earlier. The extra time is needed to ensure the incorporation of the latest evidence regarding the risks and impacts arising from exposure to lead stabilisers in PVC.
Restriction intentions
CLP
Registry of Intentions updated
A new intention for harmonised classification and labelling was submitted by Germany for dibenzo[def,p]chrysene (EC 205-886-4; CAS 191-30-0).
Current CLH intentions
Biocides
Active substance not yet in the Review Programme? Last opportunity on 1 September
Several deadlines are approaching in September and October:
- Active substances used to treat products – 1 September.
- Active substances excluded from scope under previous biocides directive – 1 September.
- Products excluded based on advice given in the repelled Manual of decisions – 3 October.
Upcoming deadlines
Consultation on eight anticoagulant rodenticides closes on 12 September
ECHA has been collecting information to help the European Commission and Member States decide whether to renew the approval of eight anticoagulant rodenticide active substances. The final day to give your comments is 12 September.
Public consultation
Biocides Stakeholders' Day: registration closes today
Only a week to go to our Biocides Stakeholders’ Day on 1 September. Today is your last opportunity to book your seat. If you can’t make it in person, tune in to follow the event online. This is your chance to get the latest news and advice from ECHA and the European Commission on biocidal products and to hear case studies from guest speakers on submitting an application for in situ substances and on enforcement from a company and Member State perspective. You will also be able to submit questions online.
Event page | Programme
Board of Appeal
The Board of Appeal adopts its first decision on data sharing under the BPR
The decision concerns ECHA’s decision to grant a company a permission to refer to certain studies owned by another company when applying to be included in the Article 95 list of the Biocidal Product Regulation.
The Board of Appeal annulled the contested decision in which the Agency had considered that the data owner had failed to make every effort to reach an agreement on data sharing. The Board of Appeal found that the every effort criterion requires the Agency to assess, in a balanced manner, the efforts of both parties to a data sharing dispute.
News item | Decision
Guidance
Guidance on occupational exposure assessment updated
The Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.14 (Occupational exposure assessment) has been updated following a comprehensive review. The scope of the guidance has been extended from exposure estimation to exposure assessment as a whole. This change aims to better link the exposure estimation with the identification and communication of suitable risk management measures (RMMs) for the substance. This includes, for example, the proper description of protective equipment and engineering controls. Also, the information regarding modelling tools has been re-organised and updated, keeping the general information in the main body of the guidance while the detailed information on specific tools is now found in an appendix. This includes more details on the uncertainties to be considered when using estimation tools and the domain of applicability of the tools.
Moreover a new section on exposure assessment for applications for authorisation has been created. The new section highlights specific considerations for the exposure assessment required in the authorisation process, built on practical learnings from the applications for authorisation processed to date.
Guidance on Information Requirements and Chemical Safety Assessment
Guidance on framework for exposure assessment updated
The Guidance on Information Requirements and Chemical Safety Assessment (IR&CSA), Part D (Framework for exposure assessment) has been fully revised. The main aims were:
- to produce a more concise document explaining the key principles and content elements to be considered when carrying out an exposure assessment under REACH, and
- to reflect the experience from the registration process so far.
The updated guidance integrates information from other IR&CSA guidance documents including relevant sections from the now obsolete Part F. To reflect the revised scope, the guidance title has also changed (from “exposure scenario building” to “framework for exposure assessment”).
Guidance on Information Requirements and Chemical Safety Assessment
Guidance on active micro-organisms and biocidal products updated
This update consists mainly of a revision and further development of a number of issues flagged during the “transitional procedure” which led to the publication of the first version in August 2015. Important issues such as infectivity, sensitisation, genotoxicity, opportunistic pathogens, and metabolites/toxins have been addressed without changing the general structure of the guidance.
Guidance on active micro-organisms and biocidal products
Events
Webinar: How to use alternative methods to animal testing in your REACH registration
Want to stay on top of the recent developments in alternative methods and how to use these in your REACH registration? This webinar focuses on the alternative methods and approaches to address endpoints such as skin corrosion and irritation, serious eye damage and eye irritation, skin sensititation and acute toxicity. It will also give you an update on the recent changes in the REACH annexes. The webinar will take place on 22 September.
Register | Webinar information
Webinar: How to prepare your registration as a IUCLID dossier
Are you are registering a substance for the first time for REACH 2018 and want to know how to use IUCLID to create your registration dossier? Register now for the fifth webinar in our REACH 2018 series, which will take place on 4 October.
Register | Webinar information
‘Train the trainers’ event on Chesar
ECHA is organising training on the new Chesar tool from 27 to 28 September 2016 in Helsinki. It is meant for companies and organisations that plan to offer training on Chesar in the coming months. The aim is to improve the support available for industry by training those who can then use their knowledge to train others. There are a limited number of seats available. Read more about the event and how to register on our website.
Event page
Demonstration of the OECD Substitution and Alternatives Assessment (SAAT) Toolbox
The US Environmental Protection Agency and Abt Associates is organising a webinar to demonstrate the OECD Substitution and Alternatives Assessment Toolbox on 8 September, 2016, 10:00-11:00 am, PDT. The toolbox is designed as a comprehensive resource portal for information relevant to conducting an alternatives assessment. It is intended for a broad range of users with varying levels of expertise in the field.
Register
Calls for information
There are no new consultations this week. Have a look at the 15 currently open consultations on our home page.
All open consultations
