- Registration
- Evaluation
- Authorization of
- Chemicals
The intended purpose of the new chemicals law is to protect people and the environment against harmful influences of dangerous substances und preparations, especially to make them discernible, to avert them and to obviate their coming into existence. One of the fundamental changes is the reversal of the borden of proof:
The industry or rather the distributor or producer of the substance (who will be treated equally from now on) have to prove that it is not dangerous, whereas previously it was the duty of the authorities to prove that it was dangerous.
Furthermore a substance can be re-evaluated if there is a reasonable suspicion regarding an unrealised dangerousness. Thus it is considered that it often takes years or decades until certain characteristics appear dangerous. Consequently a classification is not definite any longer.
The whole supply chain from the producer/importer to the fabricator and to the trader and the final consumer is integrated in this directive. In the future the fabricator has to inform the producer about the fate of a substance, so that the substance can be registered for a certain application. This is entered in the extended material safety data sheet (eMSDS) together with the registration number. If an application is not indicated, it can be registered by the producer of the substance or the user or rather be named to the European Chemicals Agency (ECHA).
The directive came into force on 01.06.2007. The so-called “new substances”, that means substances which were available on the European market after 18.09.1981, are considered to be registered from that point onward. All other “old substances”, existent before 18.09.1981) had to be pre-registered between 01.06.2008 and 01.12.2008 at the ECHA in Helsinki in order to continue with their production and distribution. Within this term 2,7 million pre-registrations of about 65000 companies were made for these about 100000 old substances. These old substances are allowed to be traded and used together with the “old new substances” continuously. All other substances (not pre-registered or so far not existent) are considered to be (new) new substances, no matter how long they have already been known, and have to be registered before use and run through all the administrative regulations. After the pre-registration it is not compulsory to make a registration. Polymers are subject to exception.
The pre-registered substances may still be used within certain transition periods. The terms depend on the annually traded/produced quantity and the dangerousness of the substance.