Authorisation and registration

Within the European single market, the authorisation and registration of substances has been harmonised by European legislation. The performance of studies follows well-defined standard methods (formerly described in Annex V of Directive 67/548/EEC) based on corresponding OECD Guidelines for the Testing of Chemicals. Since 2008 these methods have been transferred into Regulation (EC) No 440/2008 laying down the test methods pursuant to REACH. The Risk Assessment is conducted according to standardized rules depending on the allocation of a substance to a defined substance class and the corresponding use pattern.

A comparable quality of test data forms the basis for the mutual acceptance of data among different member states. By establishing the principles of Good Laboratory Practice (GLP), a uniform quality system is available and applied for the non-clinical safety testing of pharmaceuticals, pesticides, cosmetics, veterinary drugs, food and feed additives, and industrial chemicals. GLP is a standardized quality system specifying the organisational process and the conditions, by which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. By this, double testing can be avoided, thereby saving time and resources.

The principles of Good Laboratory Practice are described in Directive 2004/10/EC of the European Parliament and of the Council dated February 11th 2004.

In cooperation with three other competent partners Hydrotox offers „all-inclusive“ services in registration/authorisation of biocidal active substances and biocidal products.

Hydrotox GmbH provides appropriate testing services in the following regulatory areas. On request Hydrotox offers to transfer the data documented in final reports into the respective IUCLID VI templates. The "IUCLID - International Uniform Chemical Information Database" is a software application, especially developed for REACH, for capturing information on chemical substance properties. Hereby double work for the transfer of data is avoided.