Ordinance
on the Placing on the Market and Handling of Biocidal Products
(Ordinance on Biocidal Products, OBP)

¹ If the pro­tec­tion peri­od spe­cified in Art­icle 28 has ex­pired, the ap­plic­ant may re­quest that the data from an ex­ist­ing au­thor­isa­tion be used by the No­ti­fic­a­tion Au­thor­ity for his be­ne­fit, if he provides evid­ence:

a.

where the pro­tec­tion peri­od has ex­pired for data on the act­ive sub­stance used: that it is tech­nic­ally equi­val­ent to the act­ive sub­stance in a biocid­al product already au­thor­ised, in­clud­ing the de­gree of pur­ity and the nature of any im­pur­it­ies;

b.

where the pro­tec­tion peri­od has ex­pired for data on the biocid­al product:

1.

that it is the same as the biocid­al product already au­thor­ised, or

2.

that the dif­fer­ences are not sig­ni­fic­ant in re­la­tion to the risk as­sess­ment and the act­ive sub­stances are tech­nic­ally equi­val­ent as defined in let­ter a.

² The No­ti­fic­a­tion Au­thor­ity shall is­sue a gen­er­al rul­ing, pub­lished in the Fed­er­al Gaz­ette. It shall in­form the hold­er of the ex­ist­ing au­thor­isa­tion and, if known, the own­er of the data on the act­ive sub­stance or the biocid­al product.

³ De­pend­ing on the par­tic­u­lar case, the ap­plic­ant shall sub­mit the fol­low­ing data to the No­ti­fic­a­tion Au­thor­ity:

a.

all the data re­quired for the iden­ti­fic­a­tion of the biocid­al product, in­clud­ing its com­pos­i­tion;

b.

the data re­quired to identi­fy the act­ive sub­stance and to es­tab­lish tech­nic­al equi­val­ence;

c.

the data re­quired to demon­strate that the biocid­al product is com­par­able to the au­thor­ised biocid­al product with re­gard to risks and ef­fic­acy.