0. 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

1. 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

2. 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

3. 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

4. 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 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

5. € 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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.

12. 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.

13. Get in touch
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