CHAPTER IV

GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

Content of authorisation
Article 22
1
An authorisation shall stipulate the terms and conditions relating to the making available on the market and use of the single biocidal product or the biocidal product family and include a summary of the biocidal product characteristics.
2
Without prejudice to Articles 66 and 67, the summary of the biocidal product characteristics for a single biocidal product or, in the case of a biocidal product family, the biocidal products within that biocidal product family, shall include the following information:
a
trade name of the biocidal product;
b
name and address of the authorisation holder;
c
date of the authorisation and its date of expiry;
d
authorisation number of the biocidal product, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family;
e
qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %;
f
manufacturers of the biocidal product (names and addresses including location of manufacturing sites);
g
manufacturers of the active substances (names and addresses including location of manufacturing sites);
h
type of formulation of the biocidal product;
i
hazard and precautionary statements;
j
product-type and, where relevant, an exact description of the authorised use;
k
target harmful organisms;
l
application doses and instructions for use;
m
categories of users;
n
particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment;
o
instructions for safe disposal of the product and its packaging;
p
conditions of storage and shelf-life of the biocidal product under normal conditions of storage;
q
where relevant, other information about the biocidal product.