Part IIIBiocidal Products

Research and development

16.—(1) This regulation shall not apply to the placing on the market of a relevant product for use in an experiment or test in Northern Ireland which may involve or result in the release into the environment of that relevant product.

(2) A person shall not place on the market a relevant product for use in an experiment or test for the purposes of scientific research and development, or process-orientated research and development, unless that person compiles a dossier containing all available information on the possible effects of the relevant product on human or animal health and on the environment.

(3) A person shall not place on the market a relevant product for use in an experiment or test for the purposes of scientific research and development unless that person draws up and maintains a written record of the following information relating to that relevant product, namely—

(a)its identity;

(b)any data on which the information on its label should be based;

(c)the quantity placed on the market; and

(d)the name and address of the person who receives it.

(4) A person, who places on the market a relevant product for use in an experiment or test for the purposes of scientific research and development, which is to be conducted in Northern Ireland, shall provide to the Executive on request the written record and dossier relating to that relevant product which he is required to compile and maintain in accordance with paragraphs (2) and (3).

(5) A person, who intends to place on the market a relevant product for use in an experiment or test for the purpose of process-orientated research and development in Northern Ireland, shall provide to the Executive before the relevant product is placed on the market—

(a)the dossier relating to the relevant product which he is required to compile in accordance with paragraph (2); and

(b)the following information relating to the relevant product namely—

(i)its identity,

(ii)any data on which the information on its label should be based,

(iii)the quantity of the relevant product to be placed on the market, and

(iv)the name and address of the person who is to receive the relevant product.

(6) If an experiment or test referred to in paragraph (2) or (3) is liable to have harmful effects on human or animal health or an unacceptable adverse influence on the environment, the Executive may—

(a)prohibit the experiment or test; or

(b)impose such conditions regarding the conduct of the experiment or test as it considers necessary to prevent such harmful effects or such adverse influence.

(7) A person shall not conduct an experiment or test which the Executive has prohibited under paragraph (6)(a).

(8) Where the Executive has imposed conditions regarding the conduct of an experiment or test under paragraph (6)(b), the person conducting the experiment or test shall comply with the conditions, or shall ensure that the conditions are complied with.

(9) In this regulation—

(a)“unauthorised biocidal product” means a biocidal product which—

(i)has not been authorised in accordance with regulation 9, 11, 13 or 17 or registered in accordance with regulation 10, 12 or 14, or

(ii)has been authorised in accordance with regulation 9, 11, 13 or 17 or registered in accordance with regulation 10, 12 or 14, but which, by virtue of the conditions or restrictions to which the authorisation, or, as the case may be, the registration is subject, cannot be used in the experiment or test in question;

(b)“relevant product” means—

(i)an unauthorised biocidal product, or

(ii)an active substance intended exclusively for use in a biocidal product.