CHAPTER II

APPROVAL OF ACTIVE SUBSTANCES

Conditions for approval
Article 4
1
An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5). An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.
2
The approval of an active substance shall be restricted to those product-types for which relevant data have been submitted in accordance with Article 6.
3
The approval shall specify the following conditions, as appropriate:
a
the minimum degree of purity of the active substance;
b
the nature and maximum content of certain impurities;
c
the product-type;
d
manner and area of use including, where relevant, use in treated articles;
e
designation of categories of users;
f
where relevant, characterisation of the chemical identity with regard to stereoisomers;
g
other particular conditions based on the evaluation of the information related to that active substance;
h
the date of approval and the expiry date of the approval of the active substance.
4
The approval of an active substance shall not cover nanomaterials except where explicitly mentioned.