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Editor-in-chief: Maurizio Roncaccia
Editors: Paul Trouth and Päivi Jokiniemi
Moving forward with exposure scenarios
The third meeting of the Exchange Network on Exposure Scenarios (ENES) in November discussed topics such as exposure scenarios for mixtures, preparing and communicating good quality chemical safety assessments, scaling, and the progress made since the previous meeting in May 2012.
The meeting concluded that significant development has been made by industry on exposure scenarios as well as communication in the supply chain. Nevertheless, effort is still needed to raise awareness of the work and share best practice to an even wider group of sectors to make the benefits of REACH have an impact in the long term.
Helping mixture formulators in preparing safety data sheets
Although REACH regulates substances, its legal duties also apply to the millions of mixtures placed on the market that may pose a risk to human health or the environment. One of the legal duties of formulators is to communicate enough information down the supply chain to allow the safe use of their products.
Formulators receive a wealth of safety information about the specific substances they use as ‘ingredients' in their mixtures from the extended safety data sheet. This combines the traditional safety data sheet with an exposure scenario. The challenge that mixture formulators are facing is to understand, consolidate and communicate this information down the supply chain to promote the safe use of their mixture. ECHA tabled some principles for discussion at the meeting that may help formulators to work through this task systematically.
The ENES3 meeting looked at four case studies from different sectors on how to support formulators in processing and communicating the information they receive from manufacturers. The sectors exemplified were the lubricants, coatings and adhesives sectors.
Although one approach does not fit all, the meeting concluded that the presented case studies were an incentive to start developing sector specific solutions. For example, the approach taken by the lubricants sector, which is due to be published by the end of the year, is based on generic exposure scenarios for the main use groups and typical compositions. This approach could be relevant for similar industry sectors which have a mature
product range, a short supply chain and a reasonably well defined and structured sector.
New tools developed
Since the ENES meeting in May, the industry sectors have made a lot of progress in providing tools to help those who have to carry out safety assessment and exposure scenarios. ENES3 discussed the specific environmental release categories (SpERCs), the specific consumer exposure determinants (SCEDs) as well as the use mapping library.
The SpERCs will help companies to refine the inputs for the exposure estimation for the environment, so that people have a more accurate estimation of the environmental impact and how to control it. The SCEDs are a similar approach for products which will go into the consumer domain.
The use mapping library, developed by the European Chemical Industry Council (Cefic) and the Downstream Users of Chemicals Coordination Group (DUCC), helps registrants who prepare the chemical safety assessment and report in the technical dossier by encouraging downstream users to provide registrants with a broader set of information on how and under what conditions they use the substances. This will eventually improve the quality of communication down the supply chain in the form of safety data sheets. In addition, downstream users can be more assured that their use is covered by the registrant submitting the REACH dossier.
Scaling remains a challenge
Despite the advancements made in developing supporting tools and sharing best practice, the meeting was not all plain sailing. Downstream users are currently struggling with the exposure scenarios received from suppliers from the first registration deadline and are unsure whether they are able to cover their conditions of use with the registrants' exposure scenario. This is where the concept of scaling comes in. Scaling is about the risk boundaries of the exposure scenario. It is a mathematical tool to assess whether the downstream user can still use the substance within a boundary of adequate control described in the exposure scenario.
The ENES3 meeting concluded that the issue of scaling needs further work and that a clear understanding needs to be achieved before ECHA revises its guidance for downstream users in 2013.
Looking beyond 2013
Many of the topics discussed at the ENES meetings aim to help registrants prepare for the 2013 deadline or to assist registrants who have to update their dossiers. However, a long term perspective is needed to also ensure a target-oriented development beyond 2013. To that end, the meeting participants received an update from the ENES coordination group on setting a road map and a long term action plan. The road map and action plan include ideas from the different players - authorities, the industry sectors and Member States – on what improvements can still be made on exposure scenarios. The road map and the action plan will be published by summer 2013.
Further information
New tools developed
Cefic
- The overview table of all sector associations' activities related to ES/CSA can be found on the Libraries website.
- Information on the ESCOM, SpERCs etc. under Cefic guidance and tools
Downstream users (DUCC)
- All guidance and tools published by DUCC, including the UseR template
 | Did you know? ENES aims to identify good industry practice on drafting exposure scenarios and building a dialogue between supply chain actors to improve the protection of human health and the environment. ECHA, the European Chemical Industry Council (Cefic), Eurometaux, CONCAWE (the oil companies' European association), the European Association of Chemical Distributors (Fecc) and the International Association for Soaps, Detergents and Maintenance Products (AISE) on behalf of the Downstream Users of Chemicals Coordination Group (DUCC), have established the cross-sector collaborative network to share knowledge, techniques and approaches to building and applying (REACH) exposure scenarios. Safety data sheets include information about: the properties of a substance; its hazards; instructions for handling; disposal and transport; and also first-aid, fire-fighting and exposure control measures. They are the main tool for ensuring that manufacturers and importers communicate enough information along the supply chain to allow safe use of their substances and mixtures. An exposure scenario contains the appropriate risk management measures and operational conditions to ensure that all the risks arising from the use of a substance can be controlled adequately. Exposure scenarios may appear in an annex of the safety data sheet, in which case the document is referred to as an 'extended safety data sheet'. |
Our stakeholders' views on ENES
"The collaboration between industry, ECHA and other stakeholders through the ENES workshops has come a long way and resulted in many accomplishments, such as improvement in the quality of chemical safety report authoring; development, harmonisation and sharing of best practices for exposure scenarios for substances; realisation of specific environmental release categories (SpERCs); the ongoing work to catalogue standard phrase libraries and codes; and the evolution of common views between industry, ECHA and the Member States on the concept and boundaries of scaling."
Dr Steven Signs, the Lubrizol Corporation
"The major added value of ENES is in providing all stakeholders with an overview of the current deficiencies and the different initiatives to overcome the practical difficulties for implementation of the communication of exposure scenarios in the supply chain. ENES also allows streamlining the work towards improvements in the supply chain communication based on the common accord gained within the network. The work on a cross stakeholder road map will help in making this valuable progress of ENES more concrete and tangible to a broader audience of affected stakeholders."
Eugen Anwander, Vorarlberg State Government, Austrian enforcement authority
"I am impressed by the positive atmosphere in the meeting. And I realize the importance of ENES as part of ECHA in relation to the practical use of chemicals."
Janna Koppe, Women in Europe for a Common Future (WECF)
"In view of the complexity of the subject and all facets of it, the network has made significant progress since the start. Further promotion of what has already been achieved and formalising good practice, even standard-setting, should further happen."
Sylvie Lemoine, A.I.S.E.
"From an authority point of view, it has been really instructive to better understand where industry met problems while building their exposure scenarios and to have the opportunity to share our comments and experience during substance evaluation in order to improve the quality of these exposure scenarios. It has also been a good opportunity for exposure experts from different Member States to meet and to communicate their difficulties. This network is not only a network between manufacturers, downstream users and end users, it has also become a place where Member States can exchange views."
Dr Cécile Rousseau, ANSES, mandated national institution on behalf of the French competent authority
Text by Hanna-Kaisa Torkkeli
Image copyright: Cefic
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Events
November 2018 - February 2019
Committee for Risk Assessment:
20-23 November
27-30 November
Committee for Socio-Economic
Analysis:
27-29 November
Biocidal Products Committee:
11-14 December
Member State Committee:
10-14 December
4-8 February (tentative)
Management Board meeting:
13-14 December
Webinars
Webinar schedule
International cooperation - Speaking engagements
Chemical Watch Regulatory Summit Asia
21-22 November
Singapore21-22 November
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