BIOCIDAL PRODUCTS (IMPLEMENTATION OF REGULATION (EU) No. 528/2012) REGULATIONS *

SUBSIDIARY LEGISLATION 430.09

BIOCIDAL PRODUCTS (IMPLEMENTATION OF

REGULATION (EU) No. 528/2012)

REGULATIONS *

1st September, 2013 †

LEGAL NOTICE 348 of 2013, as amended by Legal Notice 325 of 2015.

(1) The title of these regulations is the Biocidal Products

(Implementation of Regulation (EU) No 528/2012) Regulations.

(2)

(a) These regulations implement the provisions 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, hereinafter referred to as

"Regulation (EU) No 528/2012".

(b) These regulations implement the provisions of Article

95 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, hereinafter referred to as

"Regulation (EU) No 528/2012".

In these regulations, unless the context otherwise requires

"dealer" means anyone involved in any activity in the

manufacture, import, export, transport, storage, distribution,

presenting for sale or sale of any biocidal product;

"DG" means the Director General of the Technical Regulations

Division within the Malta Competition and Consumer Affairs

Authority;

"supplier of the active substance or product " refers to the

submitter of the dossier.

The Technical Regulations Division as established by the

Malta Competition and Consumer Affairs Authority Act, within the

Malta Competition and Consumer Affairs Authority, is responsible

for the application for 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 as indicated

in the Schedule.

(1) Biocidal products that contain active ingredients or

active substances that are not included in the approved list

specified in Article 9.2 of Regulation (EU) No 528/2012, and are

*These regulations have been repealed by Legal Notice 230 of 2025.

†see regulation 1(3) of these Regulations, as originally promulgated.

u n d e rg o i n g e v a l u a t i o n , s h a l l b e n o t i f i e d t o t h e Te c h n i c a l

Regulations Division before being placed on the market.

(2) The application shall, as a minimum, contain the following

requirements

(a) safety data sheets of all the hazardous ingredients;

(b) original product labels;

(c) copy of authorisation certificate issued by an EU

Member State;

(d) declaration of chemical composition;

(e) letter of access;

(f)

filled-in and signed application form;

The applicant must moreover provide documented evidence

that the supplier of the active substance or product is included in

the latest version of the list referred to in Article 95 of Regulation

(EU) No 528/2012, for the product type to which the product

belongs.

(3) The DG shall determine the application within a reasonable

period of time, not exceeding forty-five working days from the date

of receipt of an application

Provided that this time limit may be suspended until all

relevant information is submitted.

(1)

No person shall deal in any

(a) active substance unless this is

authorized

in

accordance with these regulations;

(b) biocidal product unless this is authorized for placing

on the market in Malta in accordance with these

regulations;

(c) biocidal products containing active ingredients that are

under evaluation, unless there is notification of these

products.

(2) No person shall deal in any active substance or biocidal

product unless he is in possession of an authorisation to deal in

active substances or biocidal products granted to him in accordance

with regulation 7.

(1) Any application for the granting of an authorisation to

deal in biocidal products or active substances shall be made in

writing to the DG and shall contain such information, and be

accompanied by such documents, samples and other material as the

DG may require.

(2) Any application shall, as a minimum, contain the following

requirements

(a) the nature of any activity related to the dealing of

active substances and biocidal products which the

applicant wishes to undertake;

(b) the place where such activity is to take place, and

suitable information, documentation and evidence as

may be required in order to show that such place is

suitable and sufficient for that purpose;

(c) evidence to show that the place where such activity is

to take place has the necessary equipment and control

facilities as may be required by the DG;

(d) evidence to show that the health and safety of staff

shall be protected and ensured at all times;

(e) the name and postal address and any other contact

details of the applicant;

(f)

the name of the person who will be effectively

responsible for carrying out the activity, in the case of

an application for the manufacture of a biocidal

product, the name of the biocidal product and any

formulation which is to be, or intended to be

manufactured, assembled or in any way modified

including details of the type and concentration of any

active substance to be found within the formulation.

(3) The DG shall determine the application within a reasonable

period of time, not exceeding forty-five working days from the date

of receipt of an application

Provided that this time limit can be suspended until all

relevant information is submitted.

(4) Where an application has been made to the DG for the

granting of an authorisation to deal in accordance with this

regulation, the DG may, before determining the application, request

the applicant to submit such further information relating to the

application as he may consider requisite and where any such

request has been made, the provisions of sub-regulation (5) shall be

suspended until the additional information has been submitted.

(5) Any authorisation issued in accordance with this regulation

shall be made in writing and be subject to any such condition the

DG may deem necessary so that the business of dealing shall be

carried out in accordance with the provisions of the Act or made

under the Act.

The penalties applicable for infringement of the provisions

of Article 87 of Regulation (EU) No 528/2012 shall be according to

article 9 of the Pesticides Control Act.

BIOCIDAL PRODUCTS (IMPLEMENTATION

OF REGULATION (EU) No. 528/2012)

Schedule

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

Both Maltese and English *

PT 3

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

Both Maltese and English *

PT 10

PT 11

Maltese or English

Both Maltese and English *

PT 12

PT 13

Maltese or English

Both Maltese and 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

PT 21

Maltese or English

PT 22

Maltese or English

* Either Maltese or English may be used if the product is intended for

professional use only.