Biocidal Products (Implementation of Regulation

L.N. 348 of 2013

PESTICIDES CONTROL ACT

(CAP. 430)

Biocidal Products (Implementation of Regulation

(EU) No 528/2012) Regulations, 2013

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

Pesticides Control Act, the Minister for Sustainable Development, the

Environment and Climate Change, in consultation with the Minister

for Health, has made the following regulations:-

(1) The title of these regulations is the Biocidal

Products (Implementation of Regulation (EU) No 528/2012)

Regulations, 2013.

(2) 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".

(3) These regulations shall apply as from the 1st of

September 2013.

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.

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 Notification of

active substances that are not included in the approved list specified biocidal

products.

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

evaluation, shall be notified to the Technical 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.

(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

Dealing in

biocidal

products.

(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 Application for

to deal in biocidal products or active substances shall be made in an

to deal.

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 Penalties.

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

article 9 of the Pesticides Control Act.

The Biocide Regulations, 2010 shall be revoked with Revokes the

Biocide

effect from the 1st September 2013.

Regulations,

2010. L.N. 525 of

Schedule

Regulation 4

Labelling Requirements according to the Product Type

Product Type (PT)

(According to Annex V

Language Requirements

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.

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