Biocides (Amendment) (No. 2) Regulations, 2010

L.N. 314 of 2010

PESTICIDES CONTROL ACT

(CAP. 430)

Biocides (Amendment) (No. 2) Regulations, 2010

IN exercise of the powers conferred by articles 4 and 5 of

the Pesticides Control Act, the Minister for Resources and Rural

Affairs, in consultation with the Prime Minister and with the

Minister for Health, the Elderly and Community Care, has made

the following regulations :-

(1) The title of these regulations is the Biocides

(Amendment) (No. 2) Regulations, 2010 and they shall be read

and construed as one with Biocides Regulations, 2004, hereinafter

referred to as “the principal regulations”.

(2) The scope of these regulations is to transpose

Commission Directive 2009/107/EC of the European Parliament

and of the Council of 16 September 2009 amending Directive 98/8/

EC concerning the placing of biocidal products on the market as

regards the extension of certain time periods.

Regulation 47 of the principal regulations shall be

amended as follows

(a) In sub-regulation (1) thereof, for paragraph (c)

there shall be substituted the following

“(c) in the case of a biocidal product containing

an active substance already on the market on May 14,

2000

(i) until 14 May 2014 for any information

submitted for the purposes of these regulations,

except where such information is already protected

under existing national rules relating to biocidal

products. In such cases, the information shall

continue to be protected until the expiry of any

remaining period of data protection provided for

under national rules, but not beyond 14 May 2014

or, if applicable, not beyond the date to which the

transitional period referred to in regulation 50(1) is

extended in accordance with regulation 50(2);

(ii) for a period of 10 years from the date of

entry of an active substance into Parts I or IA of

the Register of active substances for information

submitted for the first time in support of the first

inclusion in Parts I or IA of the Register of active

substances of either the active substance or an

additional product type for that active substance,”;

and

(b) In sub-regulation (2) thereof, for paragraph (c)

there shall be substituted the following

“(c) in the case of a biocidal product containing

an active substance already on the market on May 14,

2000

(i) until 14 May 2014 for any information

submitted for the purposes of these regulations,

except in the case where data are already protected

according to existing national rules relating to

biocidal products, in which case such data shall

be protected nationally until the expiry of any

remaining period of data protection provided for

under those national rules, but not beyond 14 May

2014 or, if applicable, not beyond the date to which

the transitional period referred to in regulation

50(1) is extended in accordance with regulation

50(2);

(ii) for a period of 10 years form the date of

entry of an active substance onto Parts I or IA of

the Register of active substances, for information

which is submitted for the first time in support of

the inclusion in Parts I or IA of the Register of

active substances either of the active substance

or of an additional product type for that active

substance;”.

Immediately after regulation 49 of the principal

regulations there shall be added the following new regulation

50. (1) By way of further derogating from

the second proviso to regulation 2(5), 4(1)(b) and (d),

9(2) and 17(1) and (4), and without prejudice to sub-

regulations (2) and (3) of this regulation, the Director

may, until 14 May 2014, continue to apply its current

system or practice of placing biocidal products on the

market. If a decision to include an active substance in

Parts I or IA of the Register of active substances sets

a later date than 14 May 2014 for compliance with

regulation 50(3), this derogation shall continue to apply

for products including that active substance until the

date set in that decision. In accordance with national

rules, the Director m a y a u t h o r i s e t h e p l a c i n g o n

the market of a biocidal product containing active

substances not listed in Parts I or IA of the Register

of active substances for that product type. Such active

substances shall be on the market on May 14, 2000 as

active substances of a biocidal product for purposes

other than “scientific research and development” and

“process-oriented research and development” as defined

in regulation 3(1) hereof.

(2) Following the adoption of these regulations,

and after the Commission has commenced a 14-year

work programme for the systematic examination of all

active substances already on the market on May 14, 2000

as active substances of a biocidal product for purposes

other than “scientific research and development”

and “process-oriented research and development” as

defined in regulation 3(1), and from May 14th 2000, it

be decided that an active substance will be included

in Parts I, IA or IB the Register of active substances

and under which conditions, or, in cases where the

requirements of regulations 4(3), (4), (5), (7) and (8),

5(1), 6(2) are not satisfied or the requisite information

and data have not been submitted within the prescribed

period, that such active substance shall not be included

in Parts I, IA or IB of the Register of active substances.

(3) Following such a decision to include or

not to include an active substance in Parts I, IA or IB

of the Register of active substances, it shall be ensured

that authorisations or, where relevant, registrations for

biocidal products containing the active substances and

complying with the provisions of these regulations are

granted, modified or cancelled as appropriate.”.

€0.37