Background information about tasks have to be done in 2009
Regulation for further pre-registration
After the deadline for pre-registration (1 December 2008) further pre-registration is possible exclusively for those, who have just entered the market and it is the first time that the company produces and/or imports the given article at least in 1 tonne/year quantity.
According to paragraph (6) Article 28: potential registrants who manufacture or import for the first time a phase-in substance in quantities of one tonne or more per year or use for the first time a phase-in substance in the context of production of articles or import for the first time an article containing a phase-in substance that would require registration, after 1 December 2008, shall be entitled to submit the information to the Agency within six months of first manufacturing, importing or using the substance in quantities of one tonne or more per year and no later than 12 months before the relevant deadline.
Registration deadlines:
| Above 1000 tonnes: |
1 December 2010 |
| Above 1 tonne carcinogenic (mutagenic cat. 1-2): |
1 December 2010 |
| Above 100 tonnes, if the substance is classified as R50/53: |
1 December 2010 |
| Above 100 tonnes: |
1 December 2013 |
| Above 1 tonne: |
1 June 2013 |
| Below 1 tonne |
No obligation |
SIEF:
All those parties became the member of the Substance Information Exchange Forum (SIEF) who:
- are potential registrants, downstream users and third parties which have information at the Agency database,
- submitted information to the same substance
- pre-registered.
The aim of the SIEFs:
- to ease the exchange of the necessary information among the potential registrants,
- to reach an agreement about the classification and labelling,
- to share the existing papers and information with eachother and to reach an agreement about the range of necessary test and their schedule.
The operation of SIEFs:
The formation of SIEFs have just started in these days. Firstly, the members contact eachother and nominate the so called Facilitator, which entity will be responsible for the formation of the SIEF. By the time the communication and the common work has started, the members will appoint the so called Lead Registrant. The SIEFs are operational untill 1 June 2018.
About the individual submission
According to 1907/2006/EC REACH regulation, the registrant may choose to submit the dossier individually if:
- it would be disproportionately costly for him to submit this information jointly; or
- submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or
- he disagrees with the lead registrant on the selection of this information.
Advantages of the individual registration:
- the company can fulfill the requirements in its own pace, from its own sources,
- confidential data will not be available for non-competent people,
- the company can miss the SIEF bureaucracy - can save time
Disadvantages of individual submission:
- the company has to collect and sort all the necessary information about the substance on its own,
- there will not be any possibility for cost-sharing,
- the company will be responsible for choosing, organising, evaluating the necessary toxicology tests.
Important! The choice of individual submission has to be considered thoroughly.
The Quantitative Structure-Activity Relationship (QSAR) test
The QSAR (which is a quantitative correlation between the structure and the activity of a given substance) is a tool of ecotoxicology to forecast the effect and the ecological behaviour of a given substance.
The QSAR method makes it possible to forecast the effects of a given substance for the environment, based on its chemical sturcture. If a toxicology or ecotoxicology data is not available for a given substance, we can find a similar structured substance with available data and we can estimate the effects of the unknown substance (its toxicity, mutagenity, other harmful properties, mechanism of action, diffusion, distribution in phases, mobilisation, its propensity for degradation, bioaccumulation, its degradation products and their effects.)
The QSAR is not only important for cost-saving, but important for protection of animals, because with the help of this method less animal tests are required.
Read-across:
The main point of the read-across method is the idea that substances with similar chemical structures have similar properties. If it can be justified scientifically, than the data available for the first substance can be used in the case of the other substance, so we can eliminate lot of money and time consuming tests.
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