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- Ensure technical equivalence before applying for an EU or national authorisation for a biocidal product
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- ENES5: Focus on mixtures
- How to find information about chemicals on ECHA's website
- First substance evaluation decisions to be finalised
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- ECHA Science: Evaluation of grouping and read-across
- Wanted: practical examples from industry
- Member States agree on the practical actions of the SVHC Roadmap 2020
- Brazil interested in learning from ECHA's experiences
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Article related to: Communicating about safety
ENES5: Focus on mixtures
The safe use of mixtures was the main topic of the fifth meeting of the Exchange Network on Exposure Scenarios (ENES) held in Brussels at the end of November. The meeting learnt that around 15 different approaches are currently being developed by different industry sectors to gather safe use information for mixtures based on information generated under REACH. The aim now is to further refine these methods down to two to three generic ones that can be used by the majority of formulators.
"Industry set an objective for our next meeting (ENES6) to come up with a limited number of methods. This means that in six months we would take a big step forward in connecting the safety of mixtures to the REACH processes for mixtures' safety. That would be a quite an achievement," says ECHA's Andrew Murray.
Industry has worked on the mixture issue intensively since the May ENES meeting. It set up a taskforce that conducted a survey on all the different ways in which mixture formulators are putting together pieces of information from the substance safety data sheets and picking out the essential parts for communicating the safe use of their particular mixture downstream.
"At ENES4 we were aware of about three different methods. Now, after this survey, industry presented an overview of around 15 different methods; whether they were company led or sector led, as well as what the main features, outputs and potential stumbling blocks that need to be resolved are. Fortunately, there were some very common standard features to all of them. Refining the methods down to two or three would benefit a big community of mixture formulators by providing consistency to the approaches, harmonisation of information structure and confidence in the outcomes," says Dr Murray.
Industry's challenges for generating safe use information for mixtures were already presented in the October issue of the ECHA Newsletter.
Reporting back on the CSR/ES Roadmap
ENES5 dedicated a session on the activities of the Chemical safety report/Exposure scenario Roadmap, published in July.
One main area of work during the autumn has been the short titles for exposure scenarios, which help to create a table of content for the extended safety data sheet and thereby help downstream users to quickly identify which information is relevant to their uses. "In principle, the guidelines for short titles were accepted by the ENES participants but we still want more companies to test them with their substances in order to gain more confidence that the information generated is useful for those who actually receive the extended safety data sheets. I hope that by ENES6 we will have workable solutions," Andrew Murray explains.
The second implementation plan for the roadmap, looking through 2014, was also discussed. Altogether, 18 of the roadmap's 21 actions are expected to start or to be on-going in 2014.
"Our aim is to publish the second draft implementation plan in early 2014. This plan will set the tasks for the rest of the year, to which the core organisations are committed to and to which we also hope to attract more contributors."
Two-year project on exposure scenario communication
During the meeting, the European Chemical Industry Council (Cefic) presented its plans to develop the exposure scenario communication (ESCom) package over the next two years.
The ESCom package consists of the phrase catalogue which will be constantly updated, and the ESCom XML standard which is used to exchange information on exposure scenarios. The catalogue of agreed phrases is used to describe the uses of a substance and the conditions of use in an exposure scenario. Having a harmonised catalogue of phrases allows these phrases to be translated for safety data sheets.
"Industry and the IT-providers, supported by ECHA, have signed a memorandum of understanding governing the development of the phrase catalogue. In practice, this agreement will allow the use and exchange of ESCom phrases in any software the companies are using without a fee," Dr Murray points out.
Industry and the IT providers have also agreed on the structure and working procedures that will be implemented. For example, stakeholders can propose phrases to be included in the catalogue by submitting their proposals online. The phrases are then reviewed by a working group made up of Cefic, ECHA, the Downstream Users of Chemicals Coordination Group (DUCC), the Federation of German Industries (BDI) and IT providers.
Currently, the development of the ESCom package is a two-year commitment between industry, ECHA and the IT providers. "Ultimately, the expectation is that the project will continue. We will evaluate the outcomes in 2015 with a view to prolonging the project to support the 2018 registrants," Dr Murray highlights.
Progress on SCEDs
Following up on ENES4, industry and competent authorities have made good progress on the specific consumer exposure determinants (SCEDs), which are harmonised sets of data that the registrants can use to better estimate the exposure of consumers to a substance.
"We are convinced that the SCED concept will deliver more consistent and more realistic consumer exposure estimates, once broadly implemented across the different sectors producing consumer products," Dr Murray mentions of the benefits.
As the Member State competent authorities monitor and enforce the legislation and check how the registrants have carried out their assessment, they have an interest in developing SCEDs. "The authorities want to see transparency in terms of the data set, where it comes from and what the justifications are."
The work on SCEDs will continue. Currently, the group of leading oil companies, Concawe, and DUCC are updating their SCEDs template and guidance on how to complete the document.
ECHA, on the other hand, is developing a solution to make the import of SCED data possible in the Agency's assessment tool for registrants - Chesar. "One aspect of this work relies heavily on downstream users, particularly on formulators, to provide data to registrants who can be quite far from consumer products, so that they can carry out their consumer exposure assessment. This is another illustration of why it is important to get the communication working both up and down the supply chain," Dr Murray concludes.
The next meeting of ENES will be held in spring 2014.
From our stakeholders:
|Mixtures, the CSR/ES Roadmap, exposure scenario communication and specific consumer exposure determinants were on the agenda of ENES5. The next meeting, ENES6, will be held in spring 2014. Image: Cefic, 2013.|
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- An industry perspective: Challenges for generating safe use information for mixtures
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Text by Hanna-Kaisa Torkkeli.
Top image: Cefic, 2013.
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)