Controls and Official Activities Regulations, 2021

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,665, 16 ta’ Lulju, 2021 B 2283

L.N. 304 of 2021

PLANT QUARANTINE ACT

(CAP. 433)

Protective Measures Against Pests of Plants and Related Official

Controls and Official Activities Regulations, 2021

IN EXERCISE of the powers conferred by article 32 of the

Plant Quarantine Act, the Minister responsible for Agriculture,

Fisheries, Food and Animal Rights has made the following

regulations:-

The title of these regulations is the Protective Measures Title.

Against Pests of Plants and Related Official Controls and Other

Official Activities Regulations, 2021.

The scope of these regulations is to provide provisions in Scope.

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;

(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); and

(c)

the implementing and delegated acts that have been

and shall be issued under the above mentioned regulations and

which deal with plant health matters.

(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;

"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.

(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

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

(g)

production and marketing of plant reproductive

(2) The Director may apply exemptions from registration of a

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

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;

(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 S.L. 433.03

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

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.

(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

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

(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) Any person found guilty of an offence against any

provision of these regulations, the Official Controls Regulation and

the Plant Health Regulation shall, on conviction, be liable to penalties

established under the Act.

€0.45