Welcome to a 7 minute presentation on how to manage the 2013 deadline REACH deadline 2013 Welcome to a 7 minute presentation on how to manage the 2013 deadline

REACH Registration Timeline ECHA Deadline ECHA Deadline ECHA Deadline 1 – 100 t/y 100 – 1000 t/y >1000 t/y The REACH registration timeline is advancing quickly. The deadline for registration of substances imported in large quantities (over 1000 tonnes a year) has passed. Our experience of this deadline illustrates how much work there is to do before June 2013 and June 2018. 1st Dec 2010 1st June 2013 1st June 2018

REACH Registration Timeline months 21 No data – No market Capacity 22 months is not a long time to complete a complex and involved process such as REACH registration. Leaving the process to the last minute will cause problems. Not only will there be reduced testing and consultation capacity, but there will be less time to deal with complications, should they occur. Failing to complete registration is not an option: no data – no market. ECHA has recently issued guidance, advising that by the end of 2011, companies should be preparing to move into chemical testing stages. J F M A S O N D 2012 2013 2011

REACH Registration Process Register Substance Create Safety Report Fill Data Gaps Evaluate Existing SIEF Meetings Evaluate Existing Data Fill Data Gaps Create Safety Report SIEF Meetings Register Substance Register Substance Create Safety Report Fill Data Gaps Evaluate Existing SIEF Meetings

i i SIEF Meetings REACH-IT REACH-IT data can be used to make contact with other organisations, and as much networking should be done as possible. Discussions should be started through email or face-to-face contact, with a view to sharing information or even a consortium approach. ECHA places an obligation on organisations to share data where possible. Register Substance Create Safety Report Fill Data Gaps Evaluate Existing SIEF Meetings

€ ACT NOW SIEF Meetings CONFIDENTIAL One such instance, is where identical substances are manufactured by multiple companies. Sharing resources in this way not only has benefits in terms of reducing costs, but also minimises the volume of animal testing that needs to be done. A united approach is crucial to successfully meeting REACH requirements, but formalising contractual relations and confidentiality agreements takes time. Act now to secure these relationships. Register Substance Create Safety Report Fill Data Gaps Evaluate Existing SIEF Meetings

Evaluate Existing Data SIEF members Data owners Literature ? i ≠ = ≈ Existing data should be collected, shared and evaluated. This will include data from all SIEF members, data owners and related literature. Once the data has been collated, it can be evaluated in light of the dossier requirements. This will identify gaps in the information that will need to be filled. A deadline for the data collection process should be agreed upon to prevent discoveries later on, that will slow the process down. At this time, substance sameness reviews should be completed, to identify where time and resources could be saved. It is also advisable to gain agreement on use mapping of substances. This can be a lengthy and time-consuming process. Data must be gathered from the whole of the supply chain. Beginning now will avoid slowing down the process in later stages. Evaluate Existing Data Evaluate Existing Data Fill Data Gaps Fill Data Gaps Create Safety Report SIEF Meetings SIEF Meetings Register Substance Register Substance

Fill Data Gaps 1st June 2013 Annex VII SIEF Annex VIII Annex IX SIEF PROPOSAL Annex IX Annex X Once data gaps have been identified, they can be filled with new data from different sources. These might include, test results from similar substances, data from mathematical modelling or new testing. The 2013 deadline makes different requirements for Annex 7 and 8, and Annex 9 and 10 endpoints. By this date, for Lower tonnages, SIEF approval must have been secured and all necessary testing completed. For higher tonnages in Annex 9 and 10, SIEF approval should also have been secured, and a testing proposal should have been completed and submitted, pending ECHA approval. Evaluate Existing Data Evaluate Existing Data Fill Data Gaps Fill Data Gaps Create Safety Report SIEF Meetings SIEF Meetings Register Substance Register Substance

Chemical Safety Report ? First tier assessment Pragmatic refinement Management measures Safe use ? i If all data has been collected, we can move onto use mapping, to feed into the safety report. Complications can arise if testing has revealed that the substance in question is actually classified. This requires additional work to be done, collecting additional test data, more information on use mapping and a more comprehensive safety report. It is essential to plan ahead of time, to avoid and prepare for unexpected problems. The final element of the safety report is the risk assessment. Begin with a first tier (worse case) assessment. Refine this assessment using pragmatic (common sense) scenarios. Decide on appropriate management measures. Finalise agreement on safe use. Evaluate Existing Data Evaluate Existing Data Fill Data Gaps Fill Data Gaps Create Safety Report SIEF Meetings SIEF Meetings Register Substance Register Substance

Register Substance REACH-IT The final stage of the process is to submit the documentation and register the substance. Before doing so, a completeness check should be carried out to highlight any errors. Once done, this can be uploaded to the REACH-IT servers. Evaluate Existing Data Evaluate Existing Data Fill Data Gaps Fill Data Gaps Create Safety Report SIEF Meetings SIEF Meetings Register Substance Register Substance

REACH Registration Process Complex SIEF Meetings Evaluate Existing Data Fill Data Gaps Create Safety Report Register Substance Evaluate Existing Data Evaluate Existing Data Evaluate Existing Data Fill Data Gaps Fill Data Gaps Fill Data Gaps Create Safety Report Create Safety Report Create Safety Report SIEF Meetings SIEF Meetings SIEF Meetings Register Substance Register Substance Register Substance Etc. This process is complex and time-consuming. But help is available. Time-consuming

NOTOX Data evaluation Testing Risk assessment Completeness check NOTOX can help. We’ll guide you through every stage of the process, from initial data collation and evaluation, all the way through to final registration and beyond and every stage in between. Notox can be with you all the way through.

NOTOX Excellent value Quicker registration Smoother process REACH-IT More accurate Simple communication Communicating with other companies is crucial, but can be extremely complex. Notox can simplify the process, making it easier and more effective. We can speed up the process of registration with our depth of experience. We can make the process go more smoothly with our approach to planning and management. We can simplify the communication process by being your single point of contact. We are proud of our reputation for accurate results, which will reduce the time and resources you need to invest. We provide excellent value for money – both by being competitive on price and by getting it right first time.

Get in touch Contact us at REACH@notox.nl http://www.notox.nl Tel. +31736406700