REACH
REACH is a huge and partly technically complex piece of legislation consisting of 141 articles and seventeen annexes. Its legal basis is an article corresponding to the current Article 114 TFEU on the functioning of the internal market, but it has a much broader purpose than to harmonise legislation for the benefit of market actors. REACH aims to ensure a high level of protection of human health and the environment as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. The environmental objective includes the promotion of methods for assessment of hazards of substances that do not involve testing on animals. (Art 1.)
The Regulation lays down provisions on substances, defined as chemical elements and their compounds, obtained by a manufacturing process or in their natural state, and, since an amendment in 2008, mixtures, that is, mixtures or solutions composed of two or more substances. These provisions relate to manufacture, placing on the market, and use of substances and mixtures. To a limited extent, REACH also regulates substances in articles. An ‘article’, as opposed to a substance or a mixture, is an object which during production is given a special shape, surface, or design which determines its function to a greater degree than does its chemical composition (Arts 1 and 3). To understand that it may sometimes be difficult to draw the line between on the one hand a substance or mixture (in a container) and on the other an article, one needs only think of a crayon, a battery, or an ink cartridge.12
As the title indicates, REACH establishes a European Chemicals Agency (ECHA) for the purposes of managing and in some cases carrying out the technical, scientific, and administrative aspects of the Regulation (Art 75). ECHA is located in Helsinki, Finland.
REACH is based on the principle that it is for manufacturers, importers, and downstream users^ to ensure that they manufacture, place on the market, or use such substances that do not adversely affect human health or the environment. How this principle translates into substantive obligations will be discussed in the following sections. The Regulation also makes explicit that its provisions are underpinned by the precautionary principle.[1] [2] (Art 1.)
Exempted from the Regulation’s scope are, inter alia, radioactive substances regulated by Euratom, non-isolated intermediates,^ and the carriage of dangerous substances by rail, road, inland waterway, sea, or air. Wastes, as defined in what is now Directive 2008/98/EC on waste, is not a substance, mixture, or article, as understood by REACH. But exposure assessments for chemical substances, which are further discussed in a subsequent section, must nonetheless include the waste stage of the substance’s life cycle.
Certain other EU legislation in effect takes precedence over REACH, since that legislation is not to be prejudiced by the application of REACH. This is particularly significant since it applies with respect to all EU workplace and environmental legislation. (Art 2.) The consequences of this are discussed further presently.
- [1] On the role of the precautionary principle in the implementation of REACH see C Klika ‘Riskand the Precautionary Principle in the Implementation of REACH’ (2015) 6 European Journal of RiskRegulation 111—20.
- [2] Intermediates are substances that are manufactured for and consumed in or used for chemicalprocessing in order to be transformed into another substance.
