MT
BIOCIDAL PRODUCTS (IMPLEMENTING) REGULATIONS
Table of Provisions (8)
Statutory Text (8 Articles)
BIOCIDAL PRODUCTS (IMPLEMENTING)
SUBSIDIARY LEGISLATION 427.108
BIOCIDAL PRODUCTS (IMPLEMENTING)
REGULATIONS
10th October, 2025
LEGAL NOTICE 230 of 2025.
(1)
The title of these regulations is the Biocidal
Products (Implementing) Regulations.
(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
BIOCIDAL PRODUCTS (IMPLEMENTING)
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
In these regulations, unless the context otherwise
requires
"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
Competition and Consumer Affairs Authority as established by article
19 of the Malta Competition and Consumer Affairs Authority Act,
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 528/2012, the language used on the labels shall be that as indicated
in the Schedule.
(1)
Biocidal products which contain active
ingredients or active substances which are not included in the
approved list specified 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
BIOCIDAL PRODUCTS (IMPLEMENTING)
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.