We are pleased to offer you scientific and regulatory support in the developing market of nanotechnologies. Our contribution spans from providing you with up-to-date information on your obligations, to the preparation and submission of complete registration dossiers.

 

The new Biocidal Products Regulation that entered into force September 1, 2013 contains specific requirements for nanomaterials. Contact us to ensure that your product gets registration approval.

Study Conduction

Nanomaterials are typically very different than their corresponding bulk materials, therefore adequate techniques have to be identified to generate the information required for regulatory compliance. We are keen to provide you with competent scientific support during all stages of physical-chemical, toxicological and environmental tests. We are in contact with the best laboratories and research institutions who will conduct studies using the most up to date and accurate techniques. Together with them we will design experiments and produce high quality reports which will save both time and money.

Transferable Knowledge

GAB Consulting’s expertise in the preparation of dossiers for the separate categories of industrial chemicals and biocides as well as our other business areas enables you to be ready in the new field of nanomaterials. In addition to the preparation of dossiers under REACH and the Biocidal Product Regulation, we constantly monitor the developments of the regulatory affairs assuring an exhausting fulfilment of your obligations. Where necessary, this can lead to the simultaneous preparation of a product dossier covering multiple categories. We are ready to address the challenges of registration of products containing nanomaterials. We provide you with effective and timely solutions related to the environmental, health and safety aspects of natural and engineered nanomaterials.

Regulatory Aspects

In compliance with the Commission Recommendation 2011/696/EU, nanomaterials are identified as materials for which special provisions can apply. REACH and CLP Regulations now require a thorough analysis of nanomaterials and their properties. Also the new Biocidal Products Regulation (Reg. (EU) 528/2012) explicitly refers to nanomaterials. Active substances in their nano-form as well as biocidal products containing nanomaterials shall be evaluated separately and an ad hoc risk assessment is to be conducted. In addition, regulatory measures are being introduced at a local level: national authorities like France now require companies to notify substances containing nanomaterials that are manufactured, imported or made available in their territory.

Dossier Preparation (selected services)

  • Active substance dossiers for EU approval under REACH and the biocidal products regulation
  • Product dossiers for national / union authorisation under REACH and the biocidal products regulation
  • Preliminary or stand-alone risk assessments
  • Computer modelling and development of exposure scenarios
  • Expert statements
  • Literature research
  • Documentation & submission on CDs, PDF-files

General Consultancy & Project Management (selected services)

  • Identification and evaluation of data gaps in the data package according to current EU requirements (check of completeness) and preliminary risk assessments (human & environmental exposure, risk characterisation human health & environment)
  • Cost analysis for completion of the data package (including statements) and preparation of a registration dossier
  • Time schedule for study conduction and dossier preparation
  • Support in the selection of contract laboratories,
    contracting of studies
  • Scientific support and study monitoring
  • Review and commenting of authorities‘ assessments
  • Expert discussions and negotiations with authorities

"Nano applications are of manifold benefit but require comprehensive risk assessments“

"In one word: we are 'customer-centric'"

  • José Luis Juanes González
  • Head of Physical Chemistry and Analytical Methods
  • Get in Touch