Fields - Biocides

Context:

In order to register a new biocidal substance or preparation within the European Union, you must submit, according to the requirements of Directive 98/8/EC, a data package with supporting studies and trials. These are necessary on one hand to conduct risk assessments on Human Health and on the Environment, and on the other hand to evaluate the biological efficacy of your product.

All active substances with a biocidal use that were on the EU market before May 14th, 2000 have to be reviewed according to the requirements of Directive 98/8/EC and EC Regulations No. 1896/2000 (Phase I) and No. 1451/2007 (Phase II).

It should be noted that the following chemical products are not considered as biocides: medicinal products for human or veterinary uses, food additives, cosmetic products and plant protection products.

At your request, A.S.C. can:

• evaluate your product portfolio, estimate the resources necessary and build a reverse planning of the different actions needed for your dossier,


• manage the compulsory declaration forms for biocidal products with the French INRS (National Research and Safety Institute) as well as the electronic declarations asked for by the French MEDDTL (French Ministry of Ecology and Sustainable Development) for the inventory of biocides,


• evaluate the existing studies and identify the missing ones, in order to provide a complete data package

• obtain approvals for a biocidal product in France or different European countries during transitional period while current national regulations still prevail,

• prepare or revise the classification and the French Safety Data Sheets (SDS),

• prepare or revise French labels according to article 10 of French National Order of 19 May 2004 and to the French labelling guide for biocidal products,

• submit Mutual Recognition dossiers in France or in other European countries,

• monitor physical-chemical, toxicological, environmental fate and ecotoxicological studies under Good Laboratory Practice (GLP), and/or efficacy trials,


• prepare the Active Substance dossier (A) and/or the biocidal Product Dossier (B) by using the TNsG (Technical Notes for Guidance):
• document(s) IV-A and/or IV-B: to gather the studies in the required order,
• document(s) III-A and/or III-B: to summarise the studies in a database via IUCLID 5 software
• documents II-A and/or II-B and II-C: to prepare the Human and Environmental risk assessments as well as the efficacy assessment of the biocidal product by using the TNsG and the ESDs (Emission Scenario Documents) specific to each type of product, and the appropriate models (ConsExpo, EUSES, FOCUS,...),
• document I : to write and compile the dossier summary.


• manage Dossier Submission and subsequent correspondence with the relevant Official Authorities in order to achieve a smooth procedure,


• manage the request of new requirements, prepare any waiver or exemption demand until the substance is listed and/or the approval of the product is granted.