Plastic) Regulations, 2025

L.N. 126 of 2025

ENVIRONMENT PROTECTION ACT

(CAP. 549)

Extended Producer Responsibility (Tobacco Filters Containing

Plastic) Regulations, 2025

IN EXERCISE of the powers conferred by articles 54 and 55 of

the Environment Protection Act, the Minister responsible for the

environment, after consultation with the Environment and Resources

Authority, has made the following regulations:-

(1) The title of these regulations is the Extended Citation and

Producer Responsibility (Tobacco Filters Containing Plastic) scope.

Regulations, 2025.

(2) The scope of these regulations is to provide for the

requirements of Article 8 of the Directive with respect to tobacco

products with filters and filters marketed for use in combination with

tobacco products.

(regulations 2, 4, 5, 7, 8)

SINGLE-USE PLASTIC PRODUCTS COVERED BY THESE

REGULATIONS

-

Tobacco products with filters and filters marketed for use in

combination with tobacco products.

In these regulations, unless the context otherwise requires

Interpretation.

"Act" means the Environment Protection Act;

"Authority" or "competent authority" means the

Environment and Resources Authority as established by article 6

of the Act;

"collection" shall have the same meaning as assigned to it

in regulation 4 of the Waste Regulations;

"Department" means the Department for Local Government

as established in the Second Schedule to the Public Cap. 595.

Administration Act;

"Directive" means Directive (EU) 2019/904 of the

European Parliament and of the Council of 5 June 2019 on the

reduction of the impact of certain plastic products on the

environment;

"Division" means the Cleansing and Maintenance

Department as established in the Second Schedule to the Public Cap. 595.

Administration Act;

"placing on the market" shall have the same meaning as

assigned to it in regulation 3 of the Single-Use Plastic

Framework Regulations;

"plastic" shall have the same meaning as assigned to it in

regulation 3 of the Single-Use Plastic Framework Regulations;

"producer" means

(a) any natural or legal person established in Malta

that professionally manufactures or imports, irrespective of

the selling technique used, including by means of distance

contracts as defined in regulation 2 of the Consumer Rights

Regulations, and places on the market of Malta the single-

use plastic products listed in Schedule 1; or

(b) any natural or legal person established in one

(1) Member State or in a third country that professionally

sells in Malta directly to private households or to users

other than private households, by means of distance

contracts as defined in regulation 2 of the Consumer Rights

Regulations, the single-use plastic products listed in

Schedule 1;

"producer responsibility organisation" or "PRO" shall have

the same meaning as assigned to it in regulation 3 of the

Extended Producer Responsibility Framework Regulations;

"single-use plastic product" shall have the same meaning as

assigned to it in regulation 3 of the Single-Use Plastic

Framework Regulations;

"tobacco products" shall have the same meaning as

assigned to it in regulation 2 of the Manufacture, Presentation

and Sale of Tobacco and Related Products Regulations;

"treatment" shall have the same meaning as assigned to it in

regulation 4 of the Waste Regulations;

"waste" shall have the same meaning as assigned to it in

regulation 4 of the Waste Regulations.

(regulation 4)

WRITTEN MANDATE DECLARATION

Name of Producer

Address

hereby appoints

Name of legal or natural person established in Malta

Address

as the producer’s authorised representative in Malta in

accordance with regulation 4.

Name of legal or natural person established in Malta

hereby represents and undertakes the responsibilities as the

authorised representative in Malta for

Name of Producer

, in accordance with the Extended Producer Responsibility (Tobacco

2025. Filters Containing Plastic) Regulations.

This mandate, signed by both parties, commences on the date of

signature unless otherwise declared and shall cease once either party

informs the Environment and Resources Authority that this mandate

has been terminated.

On one part,

Name of Producer

Signature

Date

On one other part,

Name of Authorised Representative

Signature

Date

In the event that any provision of these regulations is in

conflict with the provisions of the Waste Management (Packaging and

Packaging Waste) Regulations, the Waste Regulations or the Extended

Producer Responsibility Framework Regulations, these regulations

shall prevail.

(regulation 7)

INFORMATION THAT SHALL BE SUBMITTED ON APPLYING

FOR AN AUTHORISATION TO OPERATE A PRODUCER

RESPONSIBILITY ORGANISATION IN ACCORDANCE WITH

THESE REGULATIONS

Part A: Information that shall be included in an application for

registration of a producer responsibility organisation

(a)

The name of the producer responsibility organisation;

(b) The name of the operator and, where the operator is a

partnership, the names of all the partners;

(c) The address and telephone number of the registered

office of the operator or, if not a company, the main place of

business of the operator and if more there is more than one (1)

operator, all the operators; and

(d) A signed declaration stating that the information

provided is true.

Part B: Information to be contained in the work plan to operate a

producer responsibility organisation

(a) A copy of the Memorandum and Articles of

Association;

(b) A copy of the Certificate of Registration issued by the

Registry of Companies, where applicable;

(c) A business and financial plan in relation to the

proposed organisation;

(d) Quality Control and Quality Assurance measures to

be adopted by the proposed organisation;

(e) Administrative measures to be adopted to ensure

effective control of the process;

(f) A copy of the rules of membership of the producer

responsibility organisation;

(g) A description of the modalities of how the objectives

of regulation 4 shall be achieved together with details of the

membership fee structure;

(h) A description, including projected amounts by weight

and number of items of the single-use plastic products placed on

the national market by the producers participating in the

organisation;

(i) Proposals for the calculation of the costs referred to

in sub-regulations (6) and (7) of regulation 4;

(j) Proposals of how the information under the

provisions of these regulations will be compiled and made

available to the Authority;

(k) Intended public awareness campaigns to be financed

and, or organised by the proposed organisation;

(l)

Projected date of commencement for the activity;

(m) Any other relevant information as required by these

regulations or as requested by the Authority.

(1) Producers placing the single-use plastic products Extended

listed in Schedule 1 on the market in Malta shall have extended producer

responsibility.

producer responsibility in accordance with the Extended Producer S.L.549.141.

Responsibility Framework Regulations.

(2) Producers established in another European Union Member

State and placing such single-use plastic products on the market in

Malta shall appoint a legal or natural person established in Malta as an

authorised representative for the purposes of fulfilling the extended

producer responsibility obligations established in these regulations on

the territory of Malta

Provided that such appointment shall be made by written

mandate by means of a declaration as set out in Schedule 2.

(3) Producers established in Malta who sell such single-use

plastic products in another Member State in which such producer is not

established, shall appoint an authorised representative in that other

Member State. The authorised representative shall be the person

responsible for fulfilling the obligations of such producer on the

territory of that other Member State in accordance with the national

legislation of the said Member State implementing the Directive.

(4) Producers of the single-use plastic products listed in

Schedule 1 shall cover at least the following costs

(a) the costs of awareness raising measures set out in

regulation 12 of the Single-Use Plastic Framework Regulations; S.L. 549.149.

(b) the costs of cleaning up litter resulting from such

products and the subsequent transport and treatment of such

litter;

(c) the costs of data gathering and reporting in

accordance with regulation 6(3)(a)(iii) of the Extended Producer S.L. 549.141.

Responsibility Framework Regulations; and

(d) the costs of waste collection for such products that

are discarded in public collection systems, including the

infrastructure and its operation, and the subsequent transport and

treatment of such waste. The costs may include the setting up of

specific infrastructure for the waste collection for those products,

such as appropriate waste receptacles in common litter hotspots.

(5) In order to achieve the objectives of this regulation in a

cost-effective manner, producers and authorised representatives shall

fulfil their extended-producer responsibility obligations collectively

and, to that end, shall set up a producer responsibility organisation

which shall be authorised in accordance with regulation 7, covering

the single-use plastic products listed in Schedule 1 and the whole

territory of Malta. Such producer responsibility organisation shall

permit all producers and authorised representatives fulfil their

extended-producer responsibility obligations under non-discriminatory

conditions

Provided that if

(a) such PRO is not set up and authorised in accordance

with regulation 7 within six (6) months from the coming into

force of these regulations; or

(b) the authorisation of an authorised PRO is revoked and

no new PRO is set up and authorised in accordance with

regulation 7 within a period of six (6) months from the decision

to revoke the authorisation is notified by the Authority; or

(c) the authorised PRO fails to cover the costs referred to

in sub-regulation (4) on behalf of its members,

the Authority may allocate the costs referred to in sub-

regulation (4) to producers in accordance with the requirements of this

regulation and their market share. In such cases, the Authority may

commission studies at the expense of producers, to quantify such costs

or part thereof

Provided further that the Authority may extend the six (6)

month period by a maximum of an additional six (6) months.

(6) In order to cover the costs referred to in paragraph (a) of

sub-regulation (4) on behalf of its producers, an authorised producer

responsibility organisation shall organise and, or finance effective

information and awareness raising campaigns to incentivise

responsible consumer behaviour and inform consumers in accordance

with regulation 12 of the Single-Use Plastic Framework Regulations

Provided that in case an authorised producer responsibility

organisation finances campaigns organised by other entities, the costs

that shall be covered by such organisation shall be established in a

transparent manner between all actors concerned

Provided further that such campaigns shall be subject to the

prior approval of the Authority.

(7) In order to cover the costs established in paragraphs (b) and

(d) of sub-regulation (4) on behalf of its producer, an authorised

producer responsibility organisation shall make the necessary

arrangements with the Division and the Department, through written

agreements for

(a) the financing of appropriate waste receptacles for the

single-use plastic products listed in Schedule 1 in the territory of

Malta, particularly in common litter hotspots, which costs shall

include the infrastructure and its operation, and the subsequent

transport and treatment of such waste; and

(b) the financing of cleaning up litter resulting from the

single-use plastic products listed in Schedule 1 and the

subsequent transport and treatment of such litter

Provided that such written agreements shall inter alia

establish the terms for the execution of the payments of those financial

contributions by an authorised producer responsibility organisation.

The said terms shall be duly notified to the Authority within one (1)

month following the conclusion of the said written agreements.

(8) The costs referred to in sub-regulation (7) shall not exceed

the costs that are necessary to provide those services in a cost-efficient

way and shall be established in a transparent way between the

Authority, the relevant authorised producer responsibility organisation,

the Division and, or the Department, and any other actors concerned

Provided that the costs referred to in sub-regulation (7)(b)

shall be limited to the activities undertaken by the Local Councils, the

Division or on their behalf

Provided further that the calculation methodology shall be

developed in a way that allows for the costs of cleaning up litter to be

established in a proportionate way, shall take into consideration the

proposals for the calculation of such costs submitted to the Authority

in accordance with regulation 7 and any guidelines published by the

European Commission in accordance with Article 8(4) of the

Directive.

(9) To minimise administrative costs, the Authority in

consultation with the actors referred to in sub-regulation (8) may

determine financial contributions towards the costs of cleaning up

litter by setting appropriate multi-annual fixed amounts.

(regulations 5, 6 and 7)

LIST OF AUTHORISED SIGNATORIES

For the purposes of issuing and signing official documentation

including correspondence, the competent authority shall only accept

documentation from a producer or an authorised producer

responsibility organisation that is signed by either of the following

-

A natural person, if the producer is a natural person;

-

A partner, where the producer or an authorised

producer responsibility organisation is a partnership;

-

A director or company secretary of that company,

where the producer or an authorised producer responsibility

organisation is a company registered in Malta;

A person who has control or management of the body,

where the producer or an authorised producer responsibility

organisation is an unincorporated body;

The president or any other member of the committee

of management, where the producer or an authorised producer

responsibility organisation is a co-operative.

(1) Producers or authorised representatives of the single- Producer

use plastic products listed in Schedule 1 placing such products on the registration.

market within the territory of Malta, shall apply to be registered with

the competent authority and shall be provided with a registration

number upon registration. Producers shall make the registration

number clearly visible on their invoices and fiscal receipts

Provided that producers which already hold a registration

number in accordance with the Waste Management (Packaging and

Packaging Waste) Regulations shall be issued a unique registration

number identifying them as producers of either both packaging and the

single use plastic products listed in Schedule 1, or as producers of any

of these, as applicable.

Provided further that the Authority shall integrate such

information within the register of producers referred to in regulation

20 of the Waste Management (Packaging and Packaging Waste)

Regulations.

(2) Producers registered under sub-regulation (1) shall renew

their registration on an annual basis with the competent authority by

the 31 st March of each year

Provided that as from 1 st April of each year the competent

authority shall accept renewals until the end of the year subject to the

payment of an additional fee of seventy euro (€70) per month or part

thereof, together with the fees prescribed in paragraph (c) of sub-

regulation (3).

(3)

An application for registration or renewal by a producer

shall

(a)

be made either online or in writing;

(b) be signed by any of the authorised signatories

referred to in Schedule 4; and

(c) be accompanied by a fee of ten euro (€10) for online

registration or thirty-five euro (€35) for manual registration.

(4) A producer shall not be deemed to be registered or to have

renewed his registration until an acknowledgement notice is issued by

the competent authority, approving the producer’s application for

registration or renewal. The competent authority shall issue the

acknowledgement notice within

(a) one (1) month of the date of receipt of an application

for registration or renewal; or

(b) one (1) month after the date of receipt of further

information requested by the competent authority in relation to

such application, including the payment of any fees, whichever

is the later.

(5)

Where a producer ceases to place the single-use plastic

products listed in Schedule 1 on the market, the producer shall apply

for deregistration with the competent authority within the following

year of his ceasing to do so. An application for deregistration shall be

signed by any of the authorised signatories referred to in Schedule 4.

(6) Without prejudice to the obligations and liabilities of the

person applying for deregistration relating to the time when the person

was a registered producer, the competent authority shall terminate a

person’s registration with effect from the last day of the year during

which such person ceased to be liable to be registered, and shall notify

that person in writing

Provided that any pending information shall be submitted

by the person to the competent authority upon applying for de-

registration according to sub-regulation (5).

(7) Any producer who fails to apply for registration in

accordance with this regulation or who fails to renew his registration

by the end of the year, shall be subject to an administrative penalty as

prescribed in Schedule 7.

(8) An authorised producer responsibility organisation may

register or renew the registration of a producer on his behalf, subject to

the consent of the said producer. In such cases, the authorised producer

responsibility organisation shall be responsible for adhering to the

provisions of this regulation, including payment of the administrative

penalty mentioned in sub-regulation (7), and the Authority may liaise

with the authorised producer responsibility organisation in relation to

such provisions.

(regulation 6)

INFORMATION THAT SHALL BE CONTAINED IN AN

APPLICATION FOR REGISTRATION OR RENEWAL

Part A: Information that shall be submitted upon registration

(a)

Name and address of the producer and where

(i)

the producer is a company, the registered office;

(ii) the producer is not a company, the principal

place of business.

(b) National identification code of the producer,

including the national tax number and the company number

(where applicable) of the producer;

(c) The NACE Code and the employment size of the

company, where applicable;

(d) The details of the contact person to whom the

competent authority shall address any communication;

(e) Details on the commercial nature of the producer (e.g.

manufacturer, importer or distance seller);

(f)

Type of single-use plastic products listed in Schedule

(g)

A signed declaration stating the information provided

(h)

The date of the application for registration;

(i) Name of the Producer Responsibility Organisation of

which the producer is a member of and a copy of the agreement

with such Organisation.

Part B: Information to be submitted upon renewal

(a) Registration number of the producer and any national

identification code of the producer, including the national tax

number and the company number (where applicable) of the

producer;

(b) The NACE Code and the employment size of the

company, where applicable;

(c) Quantities of the single-use plastic products listed in

Schedule 1 placed on the national market, by weight and number

of items during the specific reporting period in accordance with

the reporting formats to be established by the competent

authority;

(d) A signed declaration stating that the information

provided is true;

(e) The date of the application for renewal of

registration;

(f) An appropriate description of how the data has been

compiled, including any explanation of any estimates used;

(g) Name of the Producer Responsibility Organisation

that the producer is a member of and an affirmation of the

agreement with such organisation.

(1) An application for registration in accordance with Registration and

regulation 5 shall contain the information set out in Part A of Schedule information.

5 and an application for renewal shall contain at least the reporting

information established in Part B of Schedule 5.

(2) In the case the data submitted in accordance with sub-

regulation (1) changes, the relevant producer, or where relevant, the

authorised producer responsibility organisation on his behalf, shall

inform the competent authority thereof not later than one month after

the change.

(3) The information referred to in sub-regulation (1) shall be

submitted online or in writing and shall be signed by any of the

authorised signatories referred to in Schedule 4.

(4) It shall be the responsibility of a registered producer to

retain for a minimum of five (5) years the information referred to in

sub-regulation (1). Such records shall be made available to the

competent authority upon request.

(5) Where a producer, or where relevant, the authorised

producer responsibility organisation on his behalf, fails or refuses to

submit a complete application within one (1) month of the date of a

request by the competent authority for a completed application, the

competent authority shall refuse the application.

(6) The competent authority may take into account the

particular problems of small and medium sized enterprises in

providing detailed data.

(regulation 7)

FEES FOR AN AUTHORISED PRODUCER RESPONSIBILITY

ORGANISATION

The annual fee shall be calculated as follows

A*B = SF

where

"A" is the number of registered producers participating in

the producer responsibility organisation;

"B" is a fee of ten euro (€10) to be charged for each

registered producer participating in the producer responsibility

organisation;

"SF" is the producer responsibility organisation fee.

The fee shall be paid to the competent authority within six (6)

months following the end of the previous operational year.

SCHEDULE 7 (regulation 5)

(1) Without prejudice to the Waste Regulations, any

person who intends to operate a producer responsibility organisation

specifically for fulfilling the obligations imposed by these regulations,

on behalf of producers of the single-use products listed Schedule 1

shall require and obtain a valid authorisation from the competent

authority.

(2) An application for an authorisation under sub-regulation

(1) shall

(a)

be made in writing;

(b)

include the information set out in Part A of Schedule

3;

(c) be signed by any of the authorised signatories

referred to in Schedule 4;

(d) be accompanied by a non-refundable fee of five

hundred euro (€500); and

(e) be accompanied by a work plan providing the

information referred to in Part B of Schedule 3 which has to be

to the satisfaction of the competent authority.

(3) The competent authority may specify the format in which

the work plan referred to in sub-regulation (2) is to be made available.

(4) An authorisation granted by the competent authority shall

be subject to the conditions included in the authorisation, inter alia,

the requirement that the services offered by an authorised producer

responsibility organisation shall be

(a) open to the participation of all producers without any

non-discriminatory conditions and such participation shall not be

refused or revoked without reasonable justification; and

(b) designed so as to avoid any barriers to trade or

distortions of competition in conformity with the relevant

regulations.

(5) An authorisation granted by the competent authority in

accordance with these regulations shall be valid for a period of time

determined in the authorisation itself.

(6) Where an authorisation granted in accordance with sub-

regulation (4) is due to expire, an authorised producer responsibility

organisation that wants to continue to operate as an authorised

producer responsibility organisation shall, not later than six (6) months

before the expiry of the authorisation

(a) submit an application to the competent authority to

renew the authorisation granted in accordance with these

regulations;

(b) provide to the competent authority a revised version

of the work plan for the operation of the producer responsibility

organisation that complies with Part B of Schedule 3, signed by

any of the authorised signatories referred to in Schedule 4.

(7) The renewal of the authorisation to operate a producer

responsibility organisation shall be approved where the competent

authority is satisfied as to the contents of the revised version of the

work plan provided as required by sub-regulation (6)(b).

(8) An authorised producer responsibility organisation is to be

charged a fee as prescribed in Schedule 6 for each operational year.

(1) An authorised producer responsibility organisation Information and

shall submit an annual report to the Authority within four (4) calendar reporting.

months of the closing of the preceding year. The annual reports shall

contain at least the following information

(a) the list of producers participating in the authorised

producer responsibility organisation during the reporting period;

(b) the quantities of the single-use plastic products listed

in Schedule 1 placed on the national market by the producers

who participated in the producer responsibility organisation, by

weight and number of items during the specific reporting period

in accordance with the reporting formats to be established by the

Authority;

(c) the quantities of post-consumption waste of the

single-use plastic products listed in Schedule 1 collected as litter

and through public waste collection systems in accordance with

sub-regulation (7) of regulation 4, by weight and number of

items during the reporting period in accordance with the

reporting formats to be established by the Authority;

(d) the details on the information and awareness-raising

campaigns financed by the producer responsibility organisation

in accordance with sub-regulation (6) of regulation 4;

(e)

any other information as specified by the Authority.

(2) Without prejudice to commercial and industrial

confidentiality, a digital copy of the annual report referred to in sub-

regulation (1) shall be made available in accordance with the Freedom

of Access to information on the Environment Regulations.

(3) An authorised producer responsibility organisation shall

use the services of an independent auditor, approved by the Authority.

The auditor shall be required to certify that all the information reported

to the Authority is in conformity with the obligations of these

regulations and is as specified in the authorisation issued by the

Authority. Furthermore, an authorised producer responsibility

organisation shall ensure that a sound auditing procedure for

traceability, monitoring and control is put into place to appraise

(a) its financial management, including compliance with

the requirements established in sub-regulations (6) and (7) of

regulation 4; and

(b) the quality of data collected and reported in

accordance with these regulations.

(4) An authorised producer responsibility organisation shall

submit the audit report prepared in accordance with sub-regulation (3)

together with the annual report referred to in sub-regulation (1).

(5) Without prejudice to preserving the confidentiality of

commercially sensitive information in conformity with any relevant

legislation, an authorised producer responsibility organisation shall

make publicly available information pertaining to

(a)

its ownership and membership; and

(b) the financial contributions paid by its members, per

unit sold or per tonne of the single-use plastic products listed in

Schedule 1 and placed on the market in Malta.

(6)

An authorised producer responsibility organisation shall

also submit a half yearly report to the Authority within three (3)

calendar months following the end of such period, which report shall

contain at least the information indicated in sub-regulation (1).

REGISTRATION AND NON-RENEWAL

(1) Any producer who fails to apply for registration in

accordance with sub-regulation (1) of regulation 5 shall be liable to an

administrative penalty of thirty euro (€30) per 15,000 single-use

tobacco filters containing plastic placed on the market, from the first

placing of such single-use plastic products on the market until he

applies for registration.

(2) Any producer who fails to renew his registration by the end

of the year in accordance with sub-regulation (2) of regulation 5 shall

be liable to an administrative penalty of thirty euro (€30) per 15,000

single-use tobacco filters containing plastic placed on the market, from

the beginning of the year in which he should have renewed until he

applies for renewal of the registration

Provided that where the authorised producer responsibility

organisation has agreed to register or renew the registration of a

producer on his behalf, the administrative penalty above-mentioned

shall, in either case, be due by the authorised producer responsibility

organisation which failed to apply or renew the registration.

€1.62

Any person shall be guilty of an offence under these Offences.

regulations if he

(a) fails to comply with any provisions of these

regulations or fails to comply with permit conditions or with any

order lawfully given in terms of any provision of these

regulations;

(b) contravenes any restriction, prohibition

or

requirement imposed by, or under these regulations;

(c) acts in contravention of any of the provisions of these

regulations;

(d) conspires, aids or abets any other person by whatever

means, including advertising, counselling or procurement to

carry out any of the breaches indicated in paragraphs (a) to (c);

or

(e) attempts any of the breaches indicated in paragraphs

(a) to (d).

Any person who commits an offence against these Punishments.

regulations shall on conviction be liable

(a) on a first conviction, to a fine (multa) not exceeding

two thousand and three hundred and thirty euro (€2,330);

(b) on a second or subsequent convictions, to a fine

(multa) not exceeding four thousand and six hundred and sixty

euro (€4,660)

Provided that the Court may order any person who has been

found guilty of committing an offence against these regulations to pay

for the expenses incurred by the competent authority as a result of the

said offence, the revocation of the permit issued by the competent

authority and the confiscation of the corpus delicti, if applicable.

The provisions of articles 23 and 30 of the Criminal Code Applicability of

shall apply, mutatis mutandis, to proceedings in respect of offences the

Code.

against these regulations, so however that the disqualification from Cap. 9.

holding or obtaining a licence, permit or authority shall in no case be

for less than one (1) year.