Biocidal Products Regulations (Northern Ireland) 2001

Notification of new information

21.—(1) A person to whom an authorisation or a registration has been granted in accordance with these Regulations shall immediately notify the Executive of any information of which he is aware or may reasonably be expected to be aware concerning—

(a) the biocidal product; or

(b) an active substance contained in the biocidal product,

to which the authorisation or the registration relates, which may affect that authorisation or registration.

(2) The information referred to in paragraph (1) shall include—

(a) new knowledge or information on the effects of that biocidal product, or the active substance which the biocidal product contains, on humans, animals or the environment;

(b) changes in the source or composition of the active substance which the biocidal product contains;

(c) changes in the composition of the biocidal product;

(d) development of resistance to the biocidal product in the harmful organisms which it is intended to control;

(e) changes of an administrative nature; or

(f) changes in the nature of the packaging.

(3) A notification made pursuant to paragraph (1) shall include—

(a) a statement that the notification is made in compliance with this regulation; and

(b) the number of the authorisation or registration relating to the biocidal product with which the notification is concerned.

(4) The Executive shall immediately notify member States and the Commission of any information it receives by virtue of paragraph (1) relating to—

(a) potentially harmful effects for humans, animals or the environment of—

(i) a biocidal product,

(ii) an active substance, an impurity or a co-formulant which a biocidal product contains, or

(iii) a residue of a biocidal product; and

(b) changes in the composition of a biocidal product, including changes in the active substance which a biocidal product contains.