CHAPTER IVGENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

Article 22Content of authorisation

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.