Registration & Toxicology
for registration and toxicology of chemicals
in particular plant protection products and biocides
BReTox has over 20 years experience with applications to the Dutch competent authority (Ctgb) and knows the details of the so-called ‘overgangsrecht’ for biocides.
Plant Protection Products
BReTox can advise you on the procedures of plant protection products and assist you with the preparation of the product dossiers.
BReTox is your contact for questions relating to the registration and toxicology of chemicals, in particular plant protection products and biocides.
BReTox is your contact for questions relating to the registration and toxicology of chemicals, in particular plant protection products and biocides. BReTox has been founded by Christel Verberk in 2014. With over 20 years of experience in regulatory consultancy, she is a reliable, flexible and efficient choice to assist you in the complete process of registration.
What Bretox can do for you
Preparation of application forms and packages
Preparation of dossier summaries in required formats
Human hazard, exposure and risk assessments
Assistance with preparation of dossier content
Including preparation of expert statements.
Assistance with post-submission support
I.e. addressing questions from competent authorities after submission of the dossier, during the evaluation of the authorities.
BReTox offers the full package for creating a dossier, and is working together with other toxicologists plus experts on environmental toxicity and environmental exposure and risk assessment as well.
- M.Sc. Environmental Health Sciences, University of Maastricht
- Propaeduse Dutch Law plus environmental law modules, University of Maastricht
- Postgraduate Education in Toxicology
Christel’s expertise is with:
- Human toxicology
- Regulatory support
- Human exposure and risk assessment
Some biocidal products are still in a ‘transition period’. This means that their active ingredient(s) are included in the European review program, but a final decision has not yet been taken. As such these products are authorized according to national law until there is a decision taken at European level on its active ingredient(s). BReTox has over 20 years experience with applications to the Dutch competent authority (Ctgb) and knows the details of the so-called ‘overgangsrecht’ for biocides.
When the active ingredient of a biocidal product has reached a final decision at European level and is included in the so-called ‘union list – register’ all biocidal products containing this ingredient have to follow the BPR procedure. For a number of product types you can follow the union application procedure and apply for union approval in the entire EU. For other product types (or if you intend to market your product only in a few member states), you need to follow the national 528/2012 procedure, followed by mutual recognition application in case you intend to include additional member states. BReTox can advise you on the choice of application procedure and assist with the full application according to the EU procedures. This includes submission through R4BP register and preparation IUCLID dossier, SPC document and compiling the PAR summary document including the required risk assessments.
Additionally, all other formulants present in the biocidal product can be checked for being a substance of concern and a screening for endocrine disrupting properties can be done by BReTox.