Product Authorisation. Further considerations. Workshop on REACH and EU Biocidal Product Legislation in practice (Experiences from EU Industry) INT MARKT 48493 Belgrade, Serbia Raf Bruyndonckx 1 June 2012. Outline. Treated Articles Products containing non-EU evaluated AS source
Workshop on REACH and EU Biocidal Product Legislation in practice
(Experiences from EU Industry)
INT MARKT 48493
1 June 2012
Frame formulation – BPD
Specifications for a group of biocidal products having the same use and user type.
This group of products must contain the same active substances of the same specifications, and their compositions must present only variations from a previously authorised biocidal product, which do not affect the level of risk associated with them and their efficacy.
In this context, a variation is the allowance of a reduction in the percentage of the active substance and/or an alteration in percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes, perfumes by others presenting the same or lower risk, and which do not decrease the efficacy.
Biocidal Product Family – BPR
a group of biocidal products 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;
a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product shall be the same (exception for a concentrate for professional use and ready-to-use products obtained through dilution).
Biocidal Product Family
The risk envelope approach is a concept that exploits the idea that within a group of biocidal products and use patterns or for a product with multiple use patterns (i.e. product-types), there will be certain use patterns which represent the worst-case or critical situation in each area of risk assessment.
The assessment of these worst-case/critical products/uses will cover all other situations where the use pattern is less critical or the same.
* Hydrochloric acid - 1 May 2014