Data requirements REACH

Keywords Classification Data requirements REACH Risk assessment Risk management... 

Before collecting data, at least two lean/rich cycles of 15-min lean and 5-min rich were completed for the given reaction condition. These cycle times were chosen so as the effluent from all reactors reached steady state. After the initial lean/rich cycles were completed, IR spectra were collected continuously during the switch from fuel rich to fuel lean and then back again to fuel rich. The collection time in the fuel lean and fuel rich phases was maintained at 15 and 5 min, respectively. The catalyst was tested for SNS at all the different reaction conditions and the qualitative discussion of the results can be found in [75], Quantitative analysis of the data required the application of statistical methods to separate the effects of the six factors and their interactions from the inherent noise in the data. Table 11.5 presents the coefficient for all the normalized parameters which were statistically significant. It includes the estimated coefficients for the linear model, similar to Eqn (2), of how SNS is affected by the reaction conditions. 

Table 5.1 Data requirements for different tonnage bands and substance categories in the previous legislation and within REACH Previous legislation REACH... 

Table 5.2 A summary of major European data requirements before REACH and in REACH...

Compared to pre-REACH legislation on new chemicals , the data requirements have been lowered for all quantities. However, with regard to existing substances, for which no general data requirements were stipulated in previous law, REACH provides completely new requirements over time.12 Furthermore, data requirements have been completely abolished for quantities below 11, thereby leaving the clear majority of all industrial chemicals outside of REACH registration (the previous notification limit was 10 kg). Also in the span 1-101, data requirements are very low. 

A simplified set of registration data requirements would be demanded for safe or permissible uses14 using a basic tick box approach . Safe uses would not be subject to further risk management under REACH unless evidence indicated that registered data are incorrect. Permissible uses would not be prioritised for evaluations or other decision-making, and would be issued with time-limited exceptions during restriction and authorisation. 

The Interpretation of Experimental Results. Once the user has deduced the set of techniques which can serve as a crucial test for the first model, the actual experiments have to be performed. The spectra of those techniques which can be fully simulated have to be transferred to CACSS via the laboratory computer network. This enables a combined interpretation, in its simplest form by using the results of one technique as constraints for the interpretation of the other. For the remaining techniques a standard format has to be defined in which the reduced data are presented to CACSS. These data are produced by specialized software on the dedicated computers of the analytical instruments. This approach is preferred to incorporating all the data reduction steps into the CACSS system because interpretation of the raw data requires the experience of the expert in the individual technique. If, however, a stage of interpretation has been reached where presumptions about the model of the material have to be made, the results have to be transferred to CACSS. 

This demonstrates a significant improvement on the predictions made with the previous calculation scheme and data, in particular by calculating the values of the core experiments directly without the need for separate calculation and application of numerous additional corrections (e.g. the control rod worth calculation with the old scheme and data required some 50 basic calculations to reach the method biases necessary, while only 3 are needed with the new tools). 

An intermediate can be registered under REACH with a minimum set of data requirements. Intermediates are also exempt from Authorisation. 

Despite the fact that exposure is one of the two primary variables, along with effects, used in assessing the hazard potential of a particular chemical substance, data often are not available on which to make a quantitative determination. This is because monitoring programs are often directed toward the already regulated pollutants and even when monitoring data are available, they rarely, if ever, contain the type of mass balance data required to reach a quantitative conclusion. Emphasis is therefore needed to refocus the efforts, both federal and private, which collect data related to exposure, to assure that they are maximally functional. 

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