What is a biocide ? - Definition
A Biocidal Product (BP) is " any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, 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".
A Biocidal Product Family is " a group of BPs having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products ".
An Active Substance (AS) is a « substance or micro-organism that has an action on or against harmful organisms".
A Treated Article : "substance, mixture or article (within the meaning if REACH) treated with, or intentionally incorporating biocides."
These definitions are from the Biocide Products Regulation (BPR) UE n°528/2012.
The European regulation applies to all European Union Members including Norway, Iceland, Liechtenstein and Switzerland.
The Biocide Regulation objectives are the following :
- Strengthening protection of human and environment
- Speeding up assessment procedure of Active Substances (AS)
- Simplifying Marketing Authorisation (MA) of biocidal products
Does the regulation apply to me?
EcoMundo sums up here your obligations according to four different scenarios classified by geographic aeras and by products and biocidal articles. Do a self-assessment with our checklist to know if you are affected by the biocide regulation and, if yes, obligations related to your business.
Case n°1: Biocidal products manufactured out of EU and sold / used in EU
- If the Active Substance (AS) is approved or is being examined at the EU level for the Product Type (PT) that is relevant for your business without this permission, your AS cannot be placed on the EU market. Do not forget to check the PT.
- If your substance is still under assessment (transitional period), make sure that national procedures for each targeted market are respected. For instance, you must carry out an application in SIMMBAD and have a Synapse application.
- You must be sure that you have designated a representative that is registered in the approved suppliers list (related or not to the name of the company out of the EU).
- The biocidal product must be authorised to be placed on the EU market, once the AS is approved.
NB: You must respect the labeling and advertising of a biocidal product and provide an SDS compliant with CLP regulation.
Case n°2 : Article treated out of EU that you import in EU
- The AS must be approved or be under review at an EU level regarding your uses and for the PT concerned.
- If the AS is not approved or under review, you must file an AS approval application.
- Upon consumers' request, treated articles may be subject to additional request for supplementary information on biocidal treatment. You must answer within the following 45 days and for free.
- You must submit your AS approval application.
NB: You must respect the labeling and advertising of a biocidal product and provide an SDS compliant with CLP regulation.
NB 2: There are no obligations to be in the approved suppliers list if the article is treated out of EU.
Case n°3 : You place on the EU market an article treated in EU
- Check if the AS is approved or under review at a EU level for the PT concerned. Without this permission, your AS cannot be placed on the EU market. Do not forget to check the related PT.
- If you are in a transitional period, the substance is still under review, national procedures of each targeted market must be respected.
- AS suppliers must be in the approved suppliers list.
- Check your compliance with labelling and advertising specific rules for a biocidal product and that you are able to provide SDS with CLP format.
NB : In France, the procedure is anApplication to SIMMBAD (inventories and quantities) and a Synapse Application.
Case n°4 : Biocidal product is manufactured in EU and sold/used in EU
- The AS:PT couple must be approved or bei evaluated at an EU level for the related uses.
- Rules regarding transitional period are also applied, you must check your compliance with national procedures of the targeted markets.
- You must choose a supplier in the approved suppliers list.
- The biocidal product must be authorised (MA) once the AS approved.
NB: Check your conformity to labelling and advertising specific rules for a biocidal product and that you must be able to provide SDS compliant with CLP format.
