Article 6 , Sixth Amendment

Articles 5-8 and Annexes VII and VIII in the Sixth Amendment ) contain the key provisions of the EEC s premarket notification program. Articles 2, 9-13, and 20-23 also are particularly relevant. 

Article 6(1) of the Sixth Amendment requires PMN s to contain information and data necessary for evaluating the potential risks of new substances to humans and the environment. This specifically includes certain exposure information listed in Annex VII, concerning proposed uses and estimated yearly production volumes (in ranges, and broken down by use categories). Further, Article 6(1) requires submission of "a declaration concerning the unfavourable effects of the substance in terms of the various uses envisaged," which appears to require statements of the risks that may be associated with the use categories provided under Annex VII.(26)... 

Article 8(1) of the Sixth Amendment specifies three different types of exemptions for R D substances. The third appears to be analogous to the TSCA 5(h)(1) exemption for test marketing activities. 

EINECS European Inventory of Existing Commercial Chemical Substances. This is the inventory of existing substances required by Article 13(1) of the Sixth Amendment. 

Article 13 of the Sixth Amendment simply required the authorities to inventory existing chemicals. Over a decade later, the assessment of those existing chemicals began with the promulgation of the Existing Substances Regulation. 

Council Directive 97/42/EC of 27 June 1997 amending for the first time Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC), Official Journal L 179,08/07/1997 P. 0004 - 0006. 

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