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

¹ Without pre­ju­dice to Art­icle 11g, a biocid­al product shall be gran­ted au­thor­isa­tion A_L or A_nL if the fol­low­ing con­di­tions are met:

a.

It is es­tab­lished, ac­cord­ing to the com­mon prin­ciples spe­cified in An­nex VI to Reg­u­la­tion (EU) No 528/2012⁷⁷, that:

1.

the biocid­al product is suf­fi­ciently ef­fect­ive;

2.

it has no un­ac­cept­able ef­fects on tar­get or­gan­isms, such as un­ac­cept­able res­ist­ance or cross-res­ist­ance, or un­ne­ces­sary suf­fer­ing or pain for ver­teb­rates;

3.

no im­me­di­ate or delayed un­ac­cept­able ef­fects are to be ex­pec­ted, from the biocid­al product or its residues, on the health of hu­mans, and in par­tic­u­lar that of vul­ner­able groups, or an­im­als, either dir­ectly or in­dir­ectly, through drink­ing wa­ter, food, feed, air, or through oth­er in­dir­ect ef­fects; and

4.

no un­ac­cept­able ef­fects are to be ex­pec­ted, from the biocid­al product or its residues, on the en­vir­on­ment, hav­ing par­tic­u­lar re­gard to the fol­low­ing con­sid­er­a­tions:

–

the fate and dis­tri­bu­tion of the biocid­al product in the en­vir­on­ment,

–

con­tam­in­a­tion of sur­face wa­ters (in­clud­ing es­tu­ar­ial and sea­wa­ter), ground­wa­ter and drink­ing wa­ter, air and soil, tak­ing in­to ac­count loc­a­tions dis­tant from its use fol­low­ing long-range en­vir­on­ment­al trans­port­a­tion,

–

the im­pact of the biocid­al product on non-tar­get or­gan­isms,

–

the im­pact of the biocid­al product on biod­iversity and the eco­sys­tem.

b.⁷⁸

The chem­ic­al iden­tity, quant­ity and tech­nic­al equi­val­ence of act­ive sub­stances in the biocid­al product and, where ap­pro­pri­ate, any tox­ic­o­lo­gic­ally or eco­tox­ic­o­lo­gic­ally sig­ni­fic­ant and rel­ev­ant im­pur­it­ies and non-act­ive sub­stances, and its residues of tox­ic­o­lo­gic­al or en­vir­on­ment­al sig­ni­fic­ance, which res­ult from uses to be au­thor­ised, can be de­term­ined us­ing ana­lyt­ic­al meth­ods re­ferred to in An­nexes II and III to Reg­u­la­tion (EU) No 528/2012.

c.

The phys­ic­al and chem­ic­al prop­er­ties are ac­cept­able for pur­poses of use, trans­port and stor­age.

d.

The risk to hu­man health and the en­vir­on­ment posed by nan­o­ma­ter­i­als used in the biocid­al product has been as­sessed sep­ar­ately.

e.

Ex­ist­ing or, where ap­pro­pri­ate, newly spe­cified max­im­um con­cen­tra­tions, max­im­um residue levels or spe­cif­ic mi­gra­tion lim­its in or on food or feed, in ac­cord­ance with the fol­low­ing pro­vi­sions, are com­plied with:

1.

Art­icle 49 para­graphs 3 and 4 let­ter c and 10 para­graph 4 let­ter e FUO⁷⁹;

2.

Art­icle 36 para­graph 1 of the FsO⁸⁰.

² Biocid­al products with act­ive sub­stances lis­ted in An­nex 1 or 2 must ad­di­tion­ally meet the re­quire­ments spe­cified for the act­ive sub­stances in these lists.

³ If biocid­al products con­tain act­ive sub­stances which are not lis­ted in An­nex 1 or 2 or in­cluded in the list of no­ti­fied act­ive sub­stances, the act­ive sub­stances must meet the re­quire­ments spe­cified in Art­icles 4 and 5 of Reg­u­la­tion (EU) No 528/2012.

⁴ Biocid­al products in­ten­ded for dir­ect ap­plic­a­tion to the hu­man body may only con­tain non-act­ive sub­stances des­ig­nated by the FDHA as per­miss­ible for the cat­egory con­cerned in ac­cord­ance with Art­icle 54 FUO.⁸¹ This does not ex­clude the pres­ence of tech­nic­ally un­avoid­able residues, provided that they do not pose a health risk.

⁵ Biocid­al products con­sist­ing of or con­tain­ing ge­net­ic­ally mod­i­fied or­gan­isms must meet the re­quire­ments of the RO⁸².