MT
Biocidal Products (Implementing) Regulations, 2025
Table of Provisions (9)
Statutory Text (9 Articles)
Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 21,519, 10 ta’ Ottubru, 2025
L.N. 230 of 2025
PRODUCT SAFETY ACT
(CAP. 427)
Biocidal Products (Implementing) Regulations, 2025
IN EXERCISE of articles 38 and 39 of the Product Safety Act, the
Minister responsible for consumer affairs, on the advice of the Director
General (Technical Regulations), has made the following regulations:-
(1) The title of these regulations is the Biocidal Products Citation and
scope.
(Implementing) Regulations, 2025.
(2) The scope of these regulations is to implement the
requirements of Regulation (EU) No 528/2012 of the European
Parliament and of the Council of 22 May 2012 concerning the making
available on the market and use of biocidal products.
(regulation 4)
Labelling Requirements according to the Product Type
Product Type (PT)
Language Requirements
(According to Annex V of Regulation
(EU) No 528/2012)
PT 1
Maltese or English
PT 2
Maltese or English
PT 3
Both Maltese and English*
PT 4
Maltese or English
PT 5
Maltese or English
PT 6
Maltese or English
PT 7
Maltese or English
PT 8
Maltese or English
PT 9
Maltese or English
PT 10
Both Maltese and English*
PT 11
Maltese or English
PT 12
Both Maltese and English*
PT 13
Maltese or English
PT 14
Both Maltese and English*
PT 15
Both Maltese and English*
PT 16
Both Maltese and English*
PT 17
Both Maltese and English*
PT 18
Both Maltese and English*
PT 19
Both Maltese and English*
PT 20
Both Maltese and English*
PT 21
Maltese or English
PT 22
Maltese or English
*Either Maltese or English may be used provided that the product is
intended for professional use only.
€0.18
In these regulations, unless the context otherwise requires
Interpretation.
"Act" means the Product Safety Act;
"Director General" shall have the same meaning as
assigned to it in the Act;
"Regulation (EU) No 528/2012" means Regulation (EU)
No 528/2012 of the European Parliament and of the Council of
22 May 2012 concerning the making available on the market and
use of biocidal products.
The Technical Regulations Division within the Malta Establishment
Competition and Consumer Affairs Authority as established by article of
competent
19 of the Malta Competition and Consumer Affairs Authority Act, authority.
shall be the competent authority responsible for the application of
these regulations within the meaning of Article 81 of Regulation (EU)
No 528/2012.
With reference to Articles 27 and 53 of Regulation (EU) No Language
528/2012, the language used on the labels shall be that as indicated in requirements
labelling of
the Schedule.
biocidal
products.
(1) Biocidal products which contain active ingredients or Notification of
active substances which are not included in the approved list specified biocidal
products.
in Article 9(2) of Regulation (EU) No 528/2012 and which are
undergoing evaluation, shall be notified by means of an application to
the Technical Regulations Division before being placed on the market.
(2) The application referred to in sub-regulation (1) shall at
least include the following information
(a) safety data sheets of all the hazardous ingredients of
the product;
(b)
original labels of the product;
(c) a copy of the authorisation certificate issued by an
EU Member State;
(d)
a declaration of the chemical composition of the
product;
(e) a letter of access as defined in point (t) of Article 3 of
Regulation (EU) No 528/2012.
(3) The applicant shall also provide documented evidence that
the supplier is included in the updated version of the list referred to in
Article 95 of Regulation (EU) No 528/2012 regarding the product type
to which the product belongs.
(4) The Director General shall determine the application within
a reasonable period which shall not exceed forty-five (45) working
days from the date of receipt of an application
Provided that such period may be suspended until all
relevant information has been submitted.
Part IV of the Act shall apply to any offence carried out in
breach of Regulation (EU) No 528/2012 and these regulations.
The Biocidal Products (Implementation of Regulation (EU)
No 528/2012) Regulations are hereby repealed without prejudice to
anything done or omitted to be done thereunder.