ANNEX BASIC DATA

The only in vitro studies fully validated and included in the EU test methods (a.2) are for skin corrosivity and phototoxicity, but efforts are underway to speed up validation for other endpoints. An original aim was that there would be no animal studies for the basic level of registration, but as there is currently no suitable in vitro test for skin sensitisation, the mouse local lymph node assay is included in Annex V of the Regulation (Table 9). The in vitro tests for skin and eye irritation are not fully validated, so as a compromise they are accepted for registration at up to 10 tonnes per annum (i.e., they are in Annex V), but if the results are negative they have to be confirmed by a standard animal test at 10 tonnes per annum (i.e., the Annex VI data, as shown in Table 10). 

The latter deadline is set nearly 20 years after the ministerial call for a new chemicals policy in the EU. Above 10 t, a Chemical Safety Report with data on a relatively large set of parameters, including data on intrinsic properties, exposure scenarios and risk management measures, is to be included in the registration (Article 14, Annex 1). For substances in quantities of 1-10 t, a technical dossier with more basic data (Article 10) is stated to be sufficient. Concerning so-called non-phase-in substances , i.e. basically those not being produced or marketed before REACH, the registration provisions entered into force on 1 June, 2008 (Article 141). 

For most of the products currently registered within EU only conservative standard environmental risk assessments were conducted which showed that expected risk was acceptable. Basic data requirements according to Annex II (active substances) and Annex III (formulated products) for most important groups of organisms are [2] ... 

Brief summaries of the SMPR designs offered or proposed by the various vendors in alphabetical order are shown in Annex I together with basic data and information on suppliers provenness and readiness. These summaries are necessarily brief in the context of this report but could be supplemented by extensive reports from the suppliers, upon request. Key parameters for the SMPR designs presented here are summarized in Table 3.1. 

This annex shows the design summaries, drawings, basic data and suppliers provenness and readiness of the concepts given in the table hereunder. The concepts are classified in the alphabetical order of countries and alphabetical order of suppliers in each country (see table of contents). But to permit a better overview of the concepts the table hereunder gives a classification according to the type of NSSS... 

Two appendices and an annex provide additional information. Appendix 1 provides suggested criteria to indicate whether individual monitoring is necessary. Appendix 11 defines procedmos for calculating detection limits for measurement methods. The Annex provides, for ease of reference, some basic data relevant to the assessment of occupational exposttre due to intakes of radionuclides, namely tissue weighting factors and dose coefficients (committed doses per unit intake) and derived air concentrations (DACs) for selected chemical forms of some common radionuclides. 

In accordance with the requirements of Annex VI of 91/414/EEC [7], where the basic principles for decision-making are laid down, Toxicity/Exposure Ratios (TER) are to be calculated. Uncertainty factors of 10 (chronic risk) and 100 (acute risk) must be applied for aquatic organisms. For terrestrial organisms, imcertainty factors of 5 and 10 are to be used, respectively. Different approaches exist for the in-crop area and non-target arthropods and bees in general. Uncertainty arises mainly from the fact that only for a few representative species toxicity data are available. If these trigger values are not breached, a listing of an active substance on Annex I or an authorization of a formulated product respectively are possible. 

Other requirements refer to system behaviour upon detection of a fault (basically, specified actions have to achieve or maintain a safe state of the EUC when a dangerous fault is detected) data commimication processes (taking into accoimt transmission errors, repetitions, delays etc.) and special architectures for integrated circuits with on-chip redimdancy, if relevant (Part 2 Annex E). 

Although each technique on its own may not completely fulfill the quality criteria (e.g., by disturbed ion ratios) the combination of these techniques may give enough analytical evidence to prove the presence of the analyte beyond any reasonable doubt. In the new EC criteria, to be published in 2000 [10], a system of identification points is proposed to interpret the analytical data. For the confirmation of substances listed in Groups A and B of Annex I of Council Directive 96/23/EC, minimums of 4 and 3 identification points, respectively, are required. In Table 1, the number of identification points that each of the basic mass spectrometric techniques can earn is given. 

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