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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

THE LEGAL BACKGROUND

European legislation is a nightmare for those in the legal profession as the text is largely written by committees working to come to a compromise. The good news for industry, is that the authors of much of the text are scientists and are not lawyers and the ambiguity that can disturb the legal profession can be a gift to those in industry wanting an interpretation to meet their practical needs.

What we end up with is a text that is full of compromise, vagueness and uncertainty. The letter of the law is not concise and those who try to work to the black and white text will struggle to find answers to many of the questions facing industry; or in some cases, will find two answers. However, come back to the question of what you believe to be right and wrong in terms of aiding hazard and risk communication, and the answer is usually clear to see.

The legal text is found almost entirely in Regulation (EC) No 1907/2006. The other legal documents include the fees Regulation (EC) No 340/2008 and amendments to Annexes IV and V (Regulation (EC) No 987/2008) and Council Regulation (EC) No 440/2008 relating to test methods. Annex XI has been revised in February 2009 (Regulation (EC) No 134/2009) to clarify data waiving. Other amendments may yet follow, but the reality is that that these amendments consider details that perhaps go beyond what to expect in an idiot’s guide.

To check on the latest incarnations of the legal text, the ECHA website is a good place to look http://echa.europa.eu/reach/legislation_en.asp

 

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