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registration evaluation authorisation restriction
 

REACh Targets

Standardised Process for Evaluating Existing and New Substances
 
The primary goal of the chemical legislation reform is to achieve a standardised process within the EU for evaluating the risks of existing and new substances to both human health and the environment. The registration process as set down in EU Directive 67/548/EEC has been providing an EU-wide regulation for new substances for some time, supplying enough information on the possible dangers to allow an evaluation of the risks involved to take place. However, no such regulation is currently in place for existing substances which means that insufficient information on their risk potential is currently available. The REACh Regulation treats both existing and new substances according to the same guidelines.
 
Improved Protection of Human Health and the Environment
 
The registration process means that detailed information on the dangers presented by a substance now has to be submitted for approx. 30,000 existing substances. The information previously available on these substances was insufficient. On the basis of this information risk minimisation measures are then to be developed and conveyed to the respective recipients of the substances. Additionally, in certain circumstances, new limits, so-called DNEL and PNEC limits, are to be derived by the respective producer. These have to be observed both during the production and application of the substance. The aim is to better protect human health and the environment.
 
Minimising Animal Testing / Promotion of Alternative Test Methods
 
The REACh Regulation also aims at improving animal protection by reducing the level of animal testing. Directly linked to this is the promotion of alternative test methods. On the one hand, the number of animal tests is to be restricted based on the principle “one substance - one registration”. The goal is to do only one study on the dangerous qualities of a substance during the substance registration process. On the other hand, exchanging information between registrants will help determine which studies have already been carried out in order to avoid the repetition of animal tests. The development of new, alternative testing methods (e.g. in vitro tests) should also make it possible to do without animal testing.
 
Increased Responsibility on the Part of the Producer / Importer and Professional Users
 
Finally, the aim is to transfer a greater level of responsibility in controlling the risks when handling chemical substances over to the companies. This is manifested in the reversal of the burden of proof (please refer to REACh Principles) and in the obligation to apply risk reduction measures in order to eliminate adverse effects on human health and the environment or to reduce the risk to an acceptable level.