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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 Öffnet externen Link in neuem FensterOECD Guidelines for the Testing of Chemicals. Since 2008 these methods have been transferred into Regulation (EC) No 440/2008 laying down the Öffnet externen Link in neuem Fenstertest 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 Leitet Herunterladen der Datei einDirective 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 "Öffnet externen Link in neuem FensterIUCLID - 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.

  • Pharmaceuticals

    The occurrence of medicinal products (e.g. drugs) and their metabolites in the environment is of increasing concern and one main focus of current environmental research...

  • Construction Products
  • Biocides

    Biocidal products are active substances and preparations containing one or more active substances, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmable organism by chemical or biological means...

  • Detergents

    Hydrotox GmbH has analysed far more than 200 surfactants in the past years for customers of the chemical industry and has gained substantial experience and routine...

  • Global Harmonised System (GHS)

    On 20 January 2009 the new Regulation on classification, labelling and packaging of substances and mixtures entered into force (CLP-Regulation)...

  • Cosmetics

    Cosmetic products are "substances or preparations of substances intended to be placed in contact with the various external parts of the human body or in the oral cavity with a view to cleaning them, keeping them in good condition, changing their appearance or perfuming them"...

  • Ecolabels

    Eco-labelling of products and services helps consumers to select environmentally friendly products, while meeting high demands on occupational health, safety and usability...

  • Plant protection products

    The authorisation of plant protection products in Europe follows a harmonised approach based on Commission Regulation (EC) No 1107/2009...

  • REACH

    With REACH Regulation (EC) No 1907/2006 the different approaches of the European Chemical laws was harmonized. REACH stand for "Registration, Evaluation and Authorisation of Chemicals"...

  • Water hazard classes and mixtures

    Classification of preparations in risk phrases and of substances and preparations in water hazard classes...