Core elements of REACH

REACH applies to the manufacture, marketing and application of substances as such, in mixtures or in products. This means: With a few exceptions REACH applies to everything which can be done with chemicals (operations) and everything which can be done from chemicals (products).

Of main importance is the reversal of the burden of proof. Whereas according to the old chemicals act the public authorities were responsible for the evaluation of hazards and risks arising from chemical substances, this responsibility under REACH is now passed on to the producers and importers.

Hazards and risks can only be evaluated if sufficient data for each substance are available. Is a substance susceptible to explosion, is it flammable? Or is it toxic and must therefore be used in closed equipment only? What about environmental compatibility? All these questions will be answered within the frame of registration. This means that the physical-chemical, toxicological and eco-toxicological characteristics of a substance have to be analysed before the substance can be produced or imported.

What if the analysis has shown that the substance entails risks because it is e.g. carcinogenic? Such especially critical substances can be subjected to evaluation by the public authorities. During this evaluation it is analysed whether further data to determine the hazard potential and risk of the substance are necessary. Afterwards the substance might be subject to the authorisation process of REACH. Authorisation means that the use of a substance can be linked with special conditions or will even be completely forbidden.

A European Chemical Agency (ECHA) is in the centre of REACH. This agency is located in Helsinki and has to start its work latest 1st June 2008. It is responsible for the technical, scientific and administrative implementation of REACH and receives the registration documents. Furthermore it takes care that the REACH regulations will be applied in the same way in all EU member states.

At present more than 100.000 substances are in circulation in the EU. Approximately 30.000 of these substances are produced or imported in quantities of more than one ton per year. In view of this high figure it is evident that not all substances can be integrated simultaneously in the new system at the time when REACH is coming into effect. In fact the substances must be integrated gradually in the system. A phasing-in has to be carried out. Thus REACH distinguishes Phase-in substances from Non-Phase-in substances.

Phase-in substances  are substances which are listed in the so-called register of existing substances. These are mainly substances which were available on the EU market already before 1981. The by far largest part of the currently marketed substances belongs to the category Phase-in. In order to introduce the Phase-in substances into the REACH system transition periods of several years to hand in the documents can be made use of. Precondition is, however, the pre-registration of a substance. According to REACH this means an information to the agency that a registration of the substance is aimed for at a later stage.

All substances which have been marketed for the first time in the EU after 1981 are Non-Phase-in substances. Such substances had to be carefully analysed with regard to hazards and risks already according to the old chemicals act. Therefore only approximately 4.000 of these substances are available. For the Non-Phase-in substances no transition period is applicable. They can only be produced or imported after registration.