Registration and preregistration

The general principle of registration can be easily summarized: "No Data - No Market". This is also the title of article 5 of REACH which determines the general liability of registration.

The registration of a substance helps to gather information about the inherent properties of a substance. These properties reflect the risks. The information that a substance is a strong acid gives hint to its hazardous, caustic effect. The caustic effect of an acid can, of course, only become evident when the acid gets in contact with sensitive surfaces, e.g. the human skin. For evaluating the risk of a substance not only the hazardous properties but also the way it might affects people and environment are of importance. REACH talks about the exposure. It is only the interaction between hazardous properties and exposure which becomes a risk which has to be evaluated. In case the strong acid in its glass bottle remains in the closed cabinet for chemicals there will be no risk. Only the release and contact with human beings and the environment conceals the risk. Therefore the application of the substance has to be indicated for the registration process so that possible contact with human beings and environment become evident. In case there are more than one application possibilities for one substance all these applications have to be disclosed and considered for registration.

All substances which are produced or imported in the EU in quantities of ≥ 1 ton per year and producer/importer are subject to the general obligation for registration. The quantity and type of information per substance which have to be submitted for the registration process is independent of the produced or imported quantity of this substance. Since the determination of physical-chemical properties and the execution of toxicological and eco-toxicological studies is very expensive and takes a lot of time, the time and financial frame of such a registration will vary from substance to substance.

It will not be possible that all companies will have their documents for registration available by 1st June 2008. This would also mean that the enormous quantity of approximately 30.000 substances to be registered would result in a considerably overloaded agency. Therefore companies who have to register Phase-in substances are allowed to make use of transition periods of several years. Precondition is, however, to inform the agency of the intention to carry out a complete registration at a later stage. According to REACH this is called pre-registration. A pre-registration for which relatively few data have to be notified to the agency is no obligation for a subsequent registration. It only opens the way to save some years for the registration. During this time the substance in question can be produced and imported. REACH provides a very tight time frame for the pre-registration. Only from 1st June until 30th November 2008 Phase-in substances can be pre-registered. On 1st January 2009 the agency will publish a list of pre-registered substances in the Internet. In this list only the substances and not the companies which have the intention to register a substance are mentioned.

Since all companies which have to register one and the same substance are all in the same boat, they automatically participate in a type of registration consortium. According to REACH these registration consortia are called "Substance Information Exchange Forum", or shorter: SIEF. The SIEFs have the target to make the registration more cost effective for each member company. Sharing of data on the substance to be registered by the SIEF shall become easier in the SIEF. In case data are available which have been obtained from studies at vertebrates, these data must be shared in the SIEF. All other data can be shared. This procedure is intended to help especially small and medium sized companies for their registration process.

The reason for a further simplification of registration is that in part the registration documents can be handed to the agency by a leading registrant on behalf of the other registrants. In that case the other registrants hand in only those parts of the registration which are applicable for them. This means less labour input.

When a company has pre-registered a Phase-in substance it is possible to produced or import this substance for a certain transition period even without final registration. This transition period depends on the produced or imported quantity as well as on the hazard aspects of the substance. The different transition periods will expire

• 30.11.2010 for substances which are produced or imported in quantities ≥ 1.000 t per year as well as for certain alarming substances which are produced or imported in smaller quantities
• 31.05.2013 for substances which are produced or imported in quantities of ≥ 100 t per year
• 31.05.2018 for substances which are produced or imported in quantities of ≥ 1 t per year