Federal Office for Chemicals / Authorisation of Biocides
The Federal Institute for Occupational Safety and Health (BAuA), Federal Office for Chemicals / Authorisation of Biocides, is responsible for implementing statutory regulations the aim of which is to protect humans and the environment from dangerous substances. It has sovereign tasks with international activities in the field of regulating industrial chemicals and authorising and evaluating biocidal products. It operates as a national and international interface.
The tasks of the Federal Office for Chemicals / Authorisation of Biocides comprise in detail:
- The REACH helpdesk,
- Evaluation of chemicals and risk management under the terms of REACH,
- Evaluation of biocidal active substances and authorisation of biocidal products,
- Notification of biocidal products in accordance with the Biocidal Products Notification Ordinance,
- Implementation of special procedures relating to CFCs, PIC (Prior Informed Consent) and POPs (Persistent Organic Pollutants),
- Implementation of the EU Regulation on Classification, Labelling and Packaging (GHS, Globally Harmonized System of Classification and Labelling of Chemicals - CLP, Classification, Labelling and Packaging),
- Exchange of information with the Commission of European Communities, the European Chemicals Agency (ECHA) and with the competent authorities in other Member States,
- Coordination of other Federal Authorities involved in the procedures, and exchange of information with the law enforcement authorities.
REACH stands for the Registration, Evaluation, Authorisation of Chemicals.This new EU centralises and simplifies chemicals legislation throughout Europe and came into force on 1 June 2007. The Regulation repeals the Existing Substances Procedure under the EU Existing Substances Regulation.
The focal points of the REACH Regulation are a general obligation to register for all substances manufactured in or imported into the EU with the European Chemicals Agency (ECHA), the evaluation of these substances through the EU Member States and the further regulation of certain dangerous substances. These are either restricted to certain applications or subjected to a new European authorisation procedure.
With the amendment to the Chemicals Act (ChemG) on 2 July 2008 the BAuA, Federal Office for Chemicals, was designated by law to be the competent authority and national helpdesk with responsibility for implementing the REACH Regulation in Germany.
The Federal Office coordinates the tasks of the Member State Germany in accordance with this Regulation. It participates in the assessment of substances, in the restriction and authorisation procedures and takes part in the new ECHA Committees (for example the Member States Committee - MSC). Within the above-mentioned REACH procedures it carries out the technical assessment of the substance identity and of the physical-chemical properties. As the national helpdesk it provides information and advice to companies affected by REACH.
The Biocidal Products Directive regulates the authorisation and placing on the market of biocidal products on the European market. With the amendment to the Chemicals Act the BAuA is designated as the Authorisation Unit and is in charge of the assessment of the occupational safety and health in the authorization procedure. Moreover, it also processes the routine applications for authorisation and mutual agreement of biocidal products in Germany. Besides its main task of acting as the coordinating body, the Biocides Authorisation Unit assesses the completeness and plausibility of documents submitted and evaluates the efficacy of biocidal products, the chemical identity, and the physical-chemical properties.
As the competent national authority the Biocides Authorisation Unit is represented in the relevant European committees (including the CA meetings of the competent authorities (CA = competent authorities) of all EU Member States and the European Commission) for the harmonised implementation of the Biocidal Products Directive.
The Biocidal Products Notification Ordinance further provides that all biocidal products that are to be marketed in Germany must be notified to the Authorisation Unit.
Under the PIC procedure (Prior Informed Consent) and the CFC (Chlorofluorocarbon) procedure in accordance with Regulation (EC) No 2037/2000, the Federal Office for Chemicals / Authorisation of Biocides carries out the relevant notification procedures and has the duty to report to the European Commission. Such tasks are also allotted to it under the POP (Persistent Organic Pollutants) procedure, of the Stockholm Convention.
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin
Federal Institute for Occupational Safety and Health
Division 5 "Federal Office for Chemicals / Authorisation of Biocides"
Postbox 17 02 02
Fax +49 231 9071-2679