PROTECTIVE MEASURES AGAINST PESTS OF PLANTS AND RELATED OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES REGULATIONS

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

SUBSIDIARY LEGISLATION 433.35

PROTECTIVE MEASURES AGAINST PESTS OF

PLANTS AND RELATED OFFICIAL CONTROLS AND

OTHER OFFICIAL ACTIVITIES REGULATIONS

16th July, 2021

LEGAL NOTICE 304 of 2021, as amended by Legal Notice 102 of

2023.

The title of these regulations is the Protective Measures

Against Pests of Plants and Related Official Controls and Other

Official Activities Regulations.

The scope of these regulations is to provide provisions

in relation to

(a)

Regulation (EU) 2016/2031 of the European

Parliament and of the Council of the 26 October 2016 on

protective measures against pests of plants, amending

Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU)

No 1143/2014 of the European Parliament and of the Council

and repealing Council Directives 69/464/EEC, 74/647/EEC,

93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/

EC as may be amended from time to time;

(b)

Regulation (EU) 2017/625 of the European

Parliament and of the Council of 15 March 2017 on official

controls and other official activities performed to ensure the

application of food and feed law, rules on animal health and

welfare, plant health and plant protection products, amending

Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No

1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No

652/2014, (EU) 2016/429 and (EU) 2016/2031 of the

European Parliament and of the Council, Council Regulations

(EC) No 1/2005 and (EC) No 1099/2009 and Council

Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC

and 2008/120/EC, and repealing Regulations (EC) No 854/

2004 and (EC) No 882/2004 of the European Parliament and

of the Council, Council Directives 89/608/EEC, 89/662/EEC,

90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/ EC

and Council Decision 92/438/EEC (Official Controls

Regulation)as may be amended from time to time; and

(c)

the implementing and delegated acts that have

been and shall be issued under the above mentioned

regulations and as may be amended from time to time and

which deal with plant health matters.

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

(1)

In these regulations, unless the

context

otherwise requires, the following definitions shall apply

"Act" means the Plant Quarantine Act;

"Directorate" means the Directorate or Department

responsible for plant health;

"Director" means the Director responsible for the

Directorate;

"Official Controls Regulation" means the Regulation

(EU) 2017/625 of the European Parliament and of the Council

of 15 th March 2017 on official controls and other official

activities performed to ensure the application of food and feed

law, rules on animal health and welfare, plant health and plant

protection products as may be amended from time to time;

"Plant Health Regulation" means the Regulation (EU)

2016/2031 of the European Parliament and of the Council of

the 26 th October 2016 on protective measures against pests of

plants as may be amended from time to time.

(2) Other definitions according to Article 3 of the Official

Controls Regulation and Article 2 of the Plant Health Regulation shall

apply.

The national competent authority as referred to in the

Official Controls Regulation (with respect to plant health) and the

Plant Health Regulation is the Plant Protection Directorate.

(1)

The "Official Plant Health Officer" as referred

to in definition (33) of Article 3 of the Official Controls Regulation

shall be the "inspector" appointed under article 26 of the Act.

(2) The "Certifying Officer" as referred to in definition (26)

of the Official Controls Regulation and in Article 88 of the same

Regulation shall be the Official Plant Health Officer or an authorised

officer as defined under article 2 (1) of the Act capable to perform the

required duties.

(1)

Professional operators that carry out any of the

following activities shall be registered in the Malta Official Register

(MOR), established and held by the Directorate, under the provisions

of these regulations, the Plant Health Regulation and the Official

Controls Regulation

(a)

introducing into, or moving within the Union,

plants, plant products and other objects for which a

phytosanitary certificate or a plant passport is required on the

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

basis of the implementing acts adopted pursuant to Article

72(1), Article 73, Article 74(1), Article 79(1) and Article 80(1)

of the Plant Health Regulation;

(b)

are authorised to issue plant passports in

accordance with Article 89 of the Plant Health Regulation;

(c)

requesting the Directorate to issue the

certificates referred to in Articles 100 (Phytosanitary

certificate for export from the Union), 101 (Phytosanitary

certificate for re-export from the Union) and 102 (Pre-export

certificates) of the Plant Health Regulation;

(d)

in the context of the Plant Health Regulation,

are authorised to apply the mark on wood packaging material

referred to in Article 98, authorised to issue the attestations

other than the mark on wood packaging material referred to in

Article 99, providing information to travellers and clients of

postal services in accordance with Articles 45 or 55 (providing

information to travellers and clients of postal services as

regards protected zones), introducing plants, plant products or

other objects to frontier zones in accordance with Article 46(1)

or Article 56, or carrying out activities concerning the relevant

plants in demarcated areas, unless those operators are listed in

another official register which is accessible to the competent

authorities; and, or

(e)

carry out activities other than the ones referred

to in sub-paragraphs (a) to (d) of this sub-regulation, if so

required by implementing acts adopted pursuant to Article

28(1), Article 30(1), Article 41(2), Article 49(1), Article 53(2)

or Article 54(2) of the Plant Health Regulation;

(f)

are involved in one of the below activities

(i)

management of collective warehouses or

dispatching centers of tubers of Solanum tuberosum L.,

other than seed potatoes;

(ii) management of collective warehouses or

dispatching centers of fruits of Citrus L., Fortunella

Swingle, Poncirus Raf. and their hybrids; and, or

(iii) production of plants of Palmae, intended

for planting, having a diameter of the stem at the base of

over 5 cm and belonging to the following genera

Brahea Mart., Butia Becc., Chamaerops L., Jubaea

Kunth, Livistona R. Br., Phoenix L., Sabal Adans.,

Syagrus Mart., Trachycarpus H. Wendl., Trithrinax

Mart., Washingtonia Raf;

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

(g)

production and marketing of plant reproductive

material.

(2) The Director may apply exemptions from registration of

a professional operator as per point 3 of Article 65 of the Plant Health

Regulation.

(1)

Professional operators falling within the scope

of regulation 6 shall submit an application for registration in the MOR

to the Directorate in such form, in such manner and during such time

as Director may establish in the Government Gazette. The application

for registration shall include the following elements

(a)

the name, legal form, address in the territory of

Malta , legally valid identification document number and

contact details of the professional operator;

(b)

a statement concerning the intention of the

professional operator to exercise one or more of the activities

referred to in Article 65(1) of the Plant Health Regulation

concerning plants, plant products and other objects, including

activities undertaken by means of distance communication;

(c)

a statement concerning the intention of the

professional operator to carry out, as applicable, one or more of

the following activities

(i)

issuing of plant passports for plants, plant

products and other objects pursuant to Article 84(1) of

the Plant Health Regulation;

(ii) placing of the mark on wood packaging

material referred to in Article 96(1) of the Plant Health

Regulation;

(iii) issuing of any other attestation referred to

in Article 99(1) of the Plant Health Regulation;

(d)

address of the premises and, where applicable,

the location of land plots used by the professional operator in

the territory of Malta to carry out the activities referred to in

Article 65(1) of the Plant Health Regulation, for the purpose of

the registration;

(e)

the commodity types, families, genera or

species of the plants and plant products and, where appropriate,

the nature of other objects concerned by the activities of the

professional operator, as referred to in Article 65(1) of the Plant

Health Regulation;

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

(f)

the person who will be effectively managing or

controlling the activity or activities, hereinafter in these

regulations referred to as the authorised person;

(g)

the stage of growth at which plants and plant

products are marketed;

(h)

such other information as the Directorate may

require.

(2) On receiving an application for registration, the

Directorate shall evaluate such application and shall ascertain that the

application form for registration contains the elements set out in sub-

regulation (1). For such purpose, the Directorate may request other

information and the production of any documents when required

(a)

by way of derogation from sub-regulation (1)

the Directorate shall register a professional operator without

the submission of an application for registration if that

operator is registered in accordance with regulations 6 and 7 of

Plant Quarantine (Harmful Organisms) Regulations and if all

elements set out in sub-regulation (1) are available to the

Directorate. Where relevant, the professional operator

concerned shall submit an update of those elements in such

form, in such manner and during such time as Director may

establish in the Gazette;

(b)

the Directorate may grant or refuse an

application for registration and in case of refusal, the

Directorate shall inform the applicant in writing stating the

reasons for such refusal;

(c)

the Directorate shall issue a certificate with the

respective registration number.

(3) (a)

Registered operators shall, where relevant,

submit annually an update concerning any changes to the statements

referred to in paragraphs (b) and (c) of sub-regulation (1) and in the

data referred to in paragraphs (d) and (e) of sub-regulation (1). That

submission shall take place by 30 April of each year with regards to

the updating of the data of the preceding year.

(b)

In case of an indefinite or temporary closure or

a definite closure of an activity the professional operator shall inform

the Directorate in writing by filling the appropriate form, where

necessary requesting de-registration from the Malta Official Register,

in such form, in such manner and during such time as Director may

establish in the Gazette.

(c)

Any registered operator shall notify the

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

Directorate, by submitting an application for updating the data

referred in paragraph (a) of sub-regulation (1) of regulation 7 and

paragraph (b) of sub-regulation 3 of regulation 7 no later than 30 days

after the change in those data.

(4) Where the Directorate becomes aware that the registered

operator no longer carries out the activities referred to in Article 65(1)

of the Plant Health Regulation and Article 15(5) of the Official

Controls Regulation and that the elements included in the application

submitted by the registered operator in accordance with sub-

regulation (1) are no longer correct, it shall request that operator to

correct those elements immediately and within a specified period of

time.

(5) Where the registered operator does not correct those

elements within the period of time set by the Directorate, the

Directorate shall, as appropriate amend or revoke the registration of

that operator to correct those elements immediately and within

another specified period of time.

(6) The authorised person as referred to in paragraph (f) of

sub-regulation (1) shall follow obligatory bi-annual training organised

by the Directorate on plant health, official controls and other related

matters. Provided that if the authorised person does not follow such

training, the Directorate may revoke the MOR compliance certificate

or refuse to issue such certificate as the case may be.

(1)

A professional operator to whom plants, plant

products or other objects are supplied and that are subject to

requirements or conditions pursuant to points (a) to (d) of the first

sub-paragraph of Article 28(1), Article 28(2) and (3), Article 30(1),

(3) and (4), Article 37(2), Article 41(2) and (3), Article 46(1) and (3),

Article 48(1) and (2), Article 49(1), Article 54(2) and (3), Articles 56,

57 and 58 and Article 79(1) of the Plant Health Regulation shall keep

a record allowing that operator to identify, for each trade unit of plant,

plant product or other object supplied, the professional operator/s who

supplied it.

(2) A professional operator supplying plants, plant products

or other objects that are subject to requirements or conditions pursuant

to points (a) to (d) of the first sub-paragraph of Article 28(1), Article

28(2), and (3), Article 30(1), (3) and (4), Article 37(2), Article 41(2)

and (3), Article 46(1) and (3), Article 47(1), Article 48(1) and (2),

Article 49(1), Article 54(2) and (3), Articles 56, 57 and 58 and Article

79(1) of the Plant Health Regulation shall keep a record allowing that

operator to identify, for each trade unit of plant, plant product or other

object it supplied, the professional operator/s to whom it was

supplied.

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

(3) When an authorised operator issues a plant passport

pursuant to Article 84(1) and when the competent authority issues a

plant passport pursuant to Article 84(2) for a registered operator

under the Plant Health Regulation, that operator shall ensure, for the

purpose of ensuring traceability pursuant to sub-regulations (1) and

(2) that the following information is recorded as regards that plant

passport

(a)

where applicable, the professional operator

who supplied the trade unit concerned;

(b)

the professional operator/s to whom the trade

unit concerned was supplied; and

(c)

relevant information relating to the plant

passport.

(4) Professional operators shall keep the records referred to

in sub-regulations (1), (2) and (3) for at least three (3) years after the

date on which the plant, plant product or other object concerned was

supplied to or by them.

(5) On request, the professional operators referred to in sub-

regulation (4) shall communicate the information in the records

referred to in regulations (1), (2) and (3) to the Directorate.

(6) The regulations (1), (2), (3), (4) and (5) shall not apply

to the professional operators referred to in paragraphs (c) and (d) of

regulation 6(1), the exempted from registration of professional

operators.

(1)

The professional operators who are supplied

with, or supply, the plants, plant products or other objects referred to

in Article 69(1) and (2) of the Plant Health Regulation shall have in

place traceability systems or procedures to allow identification of the

movements of those plants, plant products and other objects within

and between their own premises.

This sub-regulation shall not apply to the professional

operators referred to in paragraphs (c) and (d) of regulation 6(1), the

exempted from registration of professional operators.

(2) The information identified by the systems or procedures

referred to in sub-regulation (1) on the movement of the plants, plant

products and other objects within and between the premises of the

professional operators referred to in that regulation shall be made

available to the Directorate on request.

For the purposes of the regulations and other services

related to Plant Health Regulation and the Official Controls

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

Regulation, the official business hours of the Directorate shall be as

follows

From 1 st October to the 15 th June

-

Monday to Fridays (except public holidays)

from 7.30 a.m. to 12:30pm and from 1:00pm to 3.30

p.m.;

From 16 th June to 30 th September

-

Monday to Fridays (except public holidays)

from 7.30 a.m. to 1.00 p.m.

(1)

It shall be the duty of the Directorate to ensure

compliance with the provisions of these regulations, the Official

Controls Regulation and the Plant Health Regulation in Malta and for

such purposes, it shall perform investigations, checks, verifications,

inspections, follow-ups and other activities during such time or times

as may be necessary. For the purposes of the foregoing provisions, the

Directorate shall have access to all premises where a regulated

activity is being carried out and shall have access to all relevant

information and records. Furthermore, collection of samples of plants,

plant products and other objects, laboratory testing and other relevant

checks thereon may be also carried out by the Directorate.

(2) Without prejudice to the provisions of these regulations,

the Directorate may by notice in the Government Gazette publish

guidelines establishing the minimum measures to be taken to rectify

breaches or to take action on recommendations by the Directorate.

(3) Where it is established, through official controls and

other official activities carried out in accordance with these

regulations, the Official Controls Regulation and the Plant Health

Regulation, that plants, plant products or other objects present a risk

of spreading harmful organisms, they shall be the subject of any

measures deemed appropriate to ensure compliance to Article 138 of

the Official Controls Regulation.

(4) In those cases where the Directorate has reasonable

belief that an offence against these regulations, the Official Control

Regulation and the Plant Health Regulation has been committed by

any person and it results that such person has not previously

committed an offence against the Act, the Director may serve an

enforcement notice on such person in accordance with sub-paragraph

(b) below

(5) An enforcement notice served upon a person in terms of

sub-regulation (4) shall

AND RELATED OFFICIAL CONTROLS AND OTHER

OFFICIAL ACTIVITIES

(a)

require the person upon whom it is served to

carry out such works or to take such steps as the Director may

determine in order to remedy or to prevent the continuation or

repetition of, any contravention to which the enforcement

notice relates; and

(b)

state the time period within which any such

requirement is to be complied with.

(6) The time period stated in the enforcement notice for

compliance with any such requirement shall be such period as is

reasonable in the particular circumstances.

(7)

The Director may at any time

(a)

withdraw the enforcement notice;

(b)

extend the time period for compliance with any

remedies specified in the enforcement notice; or

(c)

modify the remedies of the enforcement notice.

(8) The Directorate may, when deemed appropriate, issue

guidelines, measures or operative procedures for the implementation

of these regulations, the Official Controls Regulation and the Plant

Health Regulation.

(9) Without prejudice to the generality of sub-regulation (8),

the Director may by notice published in the Gazette lay down the

minimum measures to be taken to control and prevent the spread of

harmful organisms.

(10) Without prejudice to the provisions of article 29A of the

Act, any person found guilty of an offence against any provision of

these regulations, the Official Controls Regulation, the Plant Health

Regulation and any implementing and delegated acts issued under the

aforementioned regulations, as may be amended from time to time,

shall, on conviction, be liable to the penalties established under the

Act.

(11) Where the Director has reasonable cause to believe that

an offence against these regulations has been committed and that it

would be appropriate to impose an administrative penalty under

article 29A of the Act, the Director shall proceed in accordance with

the provisions of the said article 29A of the Act, which shall be

applicable also in relation to offences against these regulations.