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INTRODUCTION | LEGAL BACKGROUND | HISTORY OF THE LEGISLATION | BASIS OF REACH | EXEMPT MATERIALS | DEFINITIONS | PRE-REGISTRATION | SIEF FORMATION | SUBSTANCE SAMENESS | DATA EVALUATION | CONSIDERING NEW TESTING | THE EXPOSURE SCENARIO | RISK ASSESSMENT | COMMUNICATION |
REGISTRATION PROCESS | SPECIAL CASES | DOWNSTREAM USER OBLIGATIONS | AUTHORISATION AND RESTRICTION | AFTER REGISTRATION | ABBREVIATIONS

HISTORY OF THE LEGISLATION

To put the legal framework into context, you need to go back over 40 years. In 1967, the first major piece of European chemical supply legislation was published which set the framework for the control of dangerous chemicals. With the exception of finished pharmaceuticals, direct food additives, radioactive substances, ammunition etc, the Dangerous Substances Directive 67/548/EEC, and the myriad of Directives spawned from it, formed the basis of all subsequent chemical control Directives.

The key part of Directive 67/548/EEC was to make suppliers of chemicals submit a list of substances they manufactured or imported with details of chemical identity, and the final list was known as EINECS – European Inventory of Existing Chemical Substances. Effectively, this was the same as the ‘pre-registration’ phase of REACH.

Any substance not listed on EINECS (the list closed in 1983) was considered a ‘new substance’ and Notification was necessary. The legacy of this with REACH is that the new substances are now considered registered under REACH and those on EINECS are the ones that need to be reviewed and had to be pre-registered. Unfortunately, there are some complications in the process of transition.

Some of these complications arise from the exemption to Notify if exported from the EU and the exemption if used as an on-site isolated intermediate. A further complication was caused by a change in rules for polymers during the Seventh Amendment to 67/548/EEC, and substance omitted from EINECS as they were then considered polymers, subsequently needed listing as ‘no longer polymers’ (NLP). Interestingly, this list remained open until December 2008 and late pre-registrations can still be made for NLPs.

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