A biocide is a substance or mixture consisting of, containing or generating one or more active substances, with the intention of:
- rendering harmless,
- preventing the action of, or otherwise exerting a controlling effect on,
any harmful organism by any means other than mere physical or mechanical action.
There are 22 types of biocidal products, classified according to their actions (PT 1 [or product type 1]: human hygiene; PT 2: disinfectants not intended for direct application to humans or animals; PT 19: repellents and attractants; etc.).
At the European level, biocidal products are governed by Regulation (EU) N° 528/2012 concerning the making available on the market and use of biocidal products. This Regulation has been in effect since 1st September 2013. It replaced Directive 98/8/EC.
In some cases, national legislation applies in addition to the European regulation (procedure for placing products on the market, information to provide on labels, etc.). There are therefore particularities to take into account depending on which Member State the product will be sold in.
Since biocidal products and their active substances can be classed as dangerous, the European regulations governing chemical substances also apply to these products:
Regulation (EC) N° 1272/2008, also called CLP regulation (Classification, Labelling and Packaging of substances and mixtures), influences labelling (pictograms, mandatory information, etc.) among other things.
Regulation (EC) N° 1907/2006, also called REACH regulation, establishes the obligation to compile Safety Data Sheets (SDS).
Pharmanager Development assists you with:
- Verifying/validating the compliance of your biocidal product’s formula (active substances) and labelling with the requirements of European regulations (Regulations N° 528/2012 and N° 1272/2008) and with any applicable national laws.
- Constitution of the marketing authorization application dossiers for biocidal products.
- Achievement of the recordings/statements and other national procedures for placing on the market of biocidal products (national legislation).
- Support for the approval of a new biocidal active substance in accordance with the requirements of Regulation (EC) N° 528/2012.