Products Regulations, 2018

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 19,934, 12 ta’ Jannar, 2018

Taqsima B

L.N. 15 of 2018

PRODUCT SAFETY ACT

(CAP. 427)

Organic Production and Labelling of Organic

Products Regulations, 2018

IN exercise of the powers conferred by article 38 of the Product

Safety Act, the Minister for Justice, Culture and Local Government on

the advice of the Director General (Technical Regulations), and in

consultation with the Minister for the Environment, Sustainable

Development and Climate Change has made the following regulations:-

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

scope.

Production and Labelling of Organic Products Regulations, 2018.

(2) These regulations provide for the implementation of the

provisions of

(a) Council Regulation (EC) No 834/2007 of 28 June

2007 on organic production and labelling of organic products

and repealing Regulation (EEC) No 2092/91, and any

amendments thereto, hereinafter referred to as "Council

Regulation"; and

(b) Commission Regulation (EC) 889/2008 of 5

September 2008 laying down detailed rules for the

implementation of Council Regulation (EC) No 834/2007 on

organic production and labelling of organic products with regard

to organic production, labelling and control, as may be amended

from time to time, hereinafter referred to as "Regulation (EC)

889/2008"; and

(c) Commission Regulation (EC) No 1235/2008 of 8

December 2008 laying down rules for the implementation of

Council Regulation (EC) No 834/2007 as regards the

arrangements for imports of organic products from third

countries, and any amendments thereto, hereinafter referred to as

"Regulation (EC) 1235/2008".

(3) These regulations concern the measures to be taken to

control the organic production and labelling of agricultural products

referred to in Article 1(2) of the Council Regulation.

(1)

In these regulations, unless the context otherwise Interpretation.

requires

"Act" means the Product Safety Act;

"Directorate" means the Agricultural Directorate within the

Ministry responsible for Agriculture;

"Director" means the Director of Agriculture and includes, to the

extent of the authority given, any officer authorised by him in writing,

to act on his behalf for any of the purposes of these regulations;

"infringement with a prolonged effect" means an infringement

where the action done by an operator does not only compromise the

organic status of the existing product but also that of future products;

"Malta" has the same meaning as assigned to it by article 124 of

the Constitution;

"Minister" means the Minister responsible for Agriculture and

includes, to the extent of the authority given, any officer authorised by

him, in writing, to act on his behalf for any of the purposes of these

regulations;

"organic production" has the same meaning as in Article 2(a) of

the Council Regulation;

"severe infringement" means an infringement that compromises

the organic status of the product, that is, it directly goes against the

basic principles of the organic production method.

(2) Unless the context otherwise requires, words and

expressions used in these regulations shall have the same meaning

assigned to them in Article 2 of the Council Regulation, Article 2 of

the Regulation (EC) 889/2008, and Article 2 of Regulation (EC) 1235/

2008. (3) In the event that any of these regulations conflict with the

provisions of the Council Regulation, Regulation (EC) 889/2008, or

Regulation (EC) 1235/2008, the provisions of the latter shall prevail.

(1) For the purposes of these regulations, the Council

Regulation, Regulation (EC) 889/2008, and Regulation (EC) 1235/2008

the Directorate is hereby being designated as the competent authority.

(2) Without prejudice to the functions of the competent

authority as established by the Council Regulation, Regulation (EC)

889/2008, and Regulation (EC) 1235/2008, the Directorate shall

(a) have the power to carry out official controls in the

field of organic production in accordance with documented

procedures;

(b) be responsible for drawing up of reports on the

controls it carries out;

(c) be responsible for the market surveillance of retail

and, or advertising of organic products;

(d) in cases where there is a breach of these regulations,

the Council Regulation, Regulation (EC) 889/2008, or

Regulation (EC) 1235/2008, take any measure it deems fit in

order to ensure that the said regulations are adhered to;

(e) have any other function necessary for the

implementation of the provisions of these regulations.

(3) The Director may issue guidelines regarding compliance

with the provisions of these regulations which directly or indirectly

regulate the organic sector

Provided that these guidelines shall be published in the

Gazette and shall be read in conjunction with these regulations and

shall be legally binding.

(1) The competent authority may confer in whole or in Delegation of

part, its competence for the inspection and certification in the field of functions.

organic production in accordance with the provisions set out in these

regulations, the Council Regulation, Regulation (EC) 889/2008, and

Regulation (EC) 1235/2008 to one or more control authorities or

control bodies

Provided that the competent authority shall publish in the

Gazette, a notice regarding such conferral of delegation.

(2) Whenever the competent authority appoints a control

authority or control body to perform control tasks in terms of this

regulation, it shall attribute a code number to each control authority.

(3) The control authorities and, or control bodies shall offer

adequate guarantees of objectivity and impartiality and shall have at

their disposal the qualified staff and resources necessary to carry out

its functions.

(4) The competent authority shall be responsible for the

delegation of control tasks to the control bodies and, or control

authorities and shall also be responsible for their supervision as

defined in Article 92c of Regulation (EC) 889/2008.

(5) The competent authority may if it deems necessary to do

so, withdraw the delegation conferred

Provided that such withdrawal of delegation shall be

published in the Gazette.

(6) Control authorities and, or control bodies appointed by the

competent authority shall not have the authority to

(a) perform supervision and audits of other control

bodies; or

(b) grant exceptions to operators.

(1) Without prejudice to regulation 4 and to the functions

of the control authorities and, or control bodies as established by the

Council Regulation, Regulation (EC) 889/2008, and Regulation (EC)

1235/2008, if authorised by the competent authority the control

authorities and, or control bodies shall be responsible for the

(a) verification of the operators' declaration in

accordance with Article 63 of Regulation (EC) 889/2008 and

other general and specific documents as outlined in the Council

Regulation, Regulation (EC) 889/2008, and Regulation (EC)

1235/2008;

(b) taking and analysing of samples for the detection of

products not authorised for organic production, and for checking

production techniques not in conformity with the organic

production rules;

(c) drawing up of control reports, which reports are to be

made available to the competent authority;

(d) keeping of an updated list of names and addresses of

operators under their control, which list should be made

available to interested parties;

(e) certifying all operators that comply with all national

and EU legislation pertinent to the organic production and

labelling of organic products and to provide documentary

evidence to the operators in case they meet the organic

requirements, as referred to in Article 29 of the Council

Regulation;

(f) in cases of non-compliance, prohibiting certified

operators from placing on the market products indicating the

organic status, and any other necessary action as listed in the

catalogue of measures referred to in Article 92d of Regulation

(EC) 889/2008;

(g) maintaining effective and timely communication with

the competent authority and providing the latter any relevant

information as may be requested from time to time, both for

reasons of supervision and for reporting purposes.

(2) Every control authority and, or control body shall inform

the competent authority of cases of infringements and, or irregularities

which compromise the organic status of a product by not later than two

working days from the discovery of such infringement and, or

irregularity.

(1) There shall be established an Organic Farming Organic

Advisory Board, as appointed by the Minister, which shall consist of: Farming

Advisory Board.

(a) the Director ex officio, who shall act as Chairperson;

(b) two officers from the Directorate, one of whom shall

be appointed Deputy Chairman;

(c) one member from every control authority and control

body;

(d) a certified organic operator;

(e) two members from organisations directly involved in

organic farming.

(2) The Director shall designate an officer from the Directorate

to act as Secretary to the Board.

(3)

The Board shall

(a) regulate its own procedure as it deems fit;

(b) set up special sub-committees or invite technical

experts as the Board may deem fit, for the purpose of dealing

with matters requiring specialised knowledge or experience.

(4) A person shall not be eligible to be appointed as a member

of the Board, or to continue to be a member of the Board, if such

(a) is a member of the House of Representatives; or

(b) is legally incapacitated; or

(c) has been declared bankrupt or has made a

composition with his creditors; or

(d) has been convicted of

(i)

any crime affecting public trust; or

(ii) theft; or

(iii) fraud; or

(iv) knowingly receiving property obtained by theft or

fraud; or

(v) any offence against the Act or any regulations

made thereunder.

(5)

The functions of the Board shall be

(a)

to advise the Minister on any matters with which

these regulations are concerned and the formulation of policies

in this regard;

(b) to monitor and regularly review the implementation,

functioning or attainment, to the highest standards achievable, of

the provisions and policies relevant to the organic sector;

(c) to ensure a high standard in the organic sector by

addressing pertinent matters arising from the application of these

regulations;

(d) to provide technical and scientific advice in the field

of organic production and related issues, as the Minister may

from time to time request;

(e) to initiate and participate in research, surveys,

programmes, and other activities as may be deemed necessary by

the Minister, for the attainment of the optimum level of organic

production and products;

(d) to perform any other function or duty and to exercise

such further powers or responsibilities as the Minister may from

time to time determine.

(6) The Board shall meet when convened by the Chairperson,

of his own motion or upon request by any member of the Board, or in

his absence, by the Deputy Chairperson.

(7) The Board shall prepare and present to the Minister by the

31st December of each year, a summary of the main outcomes of these

meetings, and put forward proposals as to organic production and

labelling in Malta for the following year.

(1) The Director may designate public officers to act as

authorised officers for the control of these regulations.

(2) No public officer who is engaged directly or indirectly in

any commercial enterprise related to the production of organic related

products shall act as an authorised officer.

(3)

An authorised officer may

(a) at any reasonable time, enter premises in which he

has reason to believe that any organic product is being produced,

processed, packed, stored, sold or offered for sale, and to

examine and search such premises, and to inspect any such

product;

(b) stop and, or board any vehicle or vessel that the

officer has reasonable grounds to believe is transporting organic

products;

(c) inspect the premises, any plant, machinery or

equipment, containers and organic products found on the

premises;

(d) have access to, examine and copy any documentation,

records, registers or other information to which these regulations

may apply, in whatever form they are held, and remove them to

enable them to be copied or require computer records to be

produced in a form in which they may be easily accessed and

taken away by the officer;

(e) take samples of any product in relation to these

regulations and carry out any examination, investigation or test;

and

(f) take photographs, measurements, or recordings.

(1) No product shall be produced, processed, labelled, Certification.

marketed or sold in Malta as being organic unless it conforms with the

provisions of these regulations, the Council Regulation, Regulation

(EC) 889/2008, and Regulation (EC) 1235/2008.

(2) No operator shall produce, process, prepare, sell or market

any product labelled as organic unless this operator has obtained the

relevant certification from the competent authority, control authority

or control body as indicated by the competent authority.

(3) The competent authority shall establish the necessary

procedures in order for operators to be granted the certification

referred to in sub-regulation (2). Applicants must refer to the

competent authority to initiate the process of certification, and shall

subsequently be guided on certification procedures.

(4) Each certificate issued shall be valid for a period of three

years

Provided that every certificate holder shall be subject to at

least an annual inspection in order to ensure compliance with the

provisions of these regulations, the Council Regulation, Regulation

(EC) 889/2008, and Regulation (EC) 1235/2008 once every year

Provided further that the Directorate shall, upon a report from

a third party or on its own initiative carry out inspections in order to

verify that these regulations are being adhered to.

(5) The fee to be charged to operators submitting their

undertaking to the control system shall be decided by the competent

authority, the control authority or the control body as the case may be,

and published on the website of the relevant authority.

(6) No operator shall change the control authority or control

body, under which he has been granted certification, until any pending

irregularities have been resolved through the necessary measures.

The authority responsible to receive notifications in terms

of article 28 of the Council Regulation shall be the Directorate.

For the purposes of Article 23(5) of Regulation (EC) 889/

2008, the period in which poultry runs must be empty shall be that of

one month.

The provisional authorisation period referred to in Article

29 (1)(b) of Regulation (EC) 889/2008 may be renewed for a

maximum of three times of 12 months each, by the competent

authority as the case may be.

The conversion period referred to in Article 36(4) of

Regulation (EC) 889/2008 may be shortened to a period of not less

than one year, depending on the case concerned

Provided that this regulation shall only apply in the following

two cases

(a) parcels treated with a product not authorised for

organic production as part of a compulsory disease or pest

control measure imposed by the competent authority;

(b) parcels treated with a product not authorised for

organic production as part of scientific pests approved by the

competent authority

Provided further that that harvest following the treatment may

not be sold with reference to the organic production methods.

(1) The use of seed or vegetative propagating material

not

obtained

by the organic production methods shall only be

authorised if not available by organic methods

Provided that the provisions of Article 45, sub-paragraphs

(2) to (9) of Regulation (EC) 889/2008 shall apply.

(2) The competent authority shall, in accordance with Article

45(4) of Regulation (EC) 889/2008, be the authority responsible for

granting authorisations referred to in Article 45(1)(b) of Regulation

(EC) 889/2008.

(1) For the purposes of Article 48 of Regulation (EC)

889/2008, the directorate responsible for plant protection shall be

responsible for establishing, managing and updating of a computerised

database for the listing of the varieties for which seed or seed potatoes

obtained by the organic production methods are available in Malta.

(2) Registration of the varieties of seed or seed potatoes

produced by the organic production methods shall follow the

provisions laid down in Article 49(1) and Article 50(1) of Regulation

(EC) 889/2008.

(3) Any seed variety which has not been registered in the

database shall be considered as unavailable and shall not be used by

organic operators in Malta.

(4) The database shall be updated for each species or group of

species cultivated in Malta, every three months.

(5) The manager of the database may, with the approval of the

competent authority refuse a supplier’s application for registration or

delete a previously accepted registration if the supplier does not

comply with the requirements set out in these regulation, the Council

Regulation or Regulation (EC) 889/2008.

(6) For each registered variety, the information provided shall

at least include the information set out in Article 51 of Regulation

(EC) 889/2008.

(7) A supplier shall be charged a fee for registering

information in the database

Provided that the fee shall be approved by the competent

authority and published in the Gazette.

(8) The information in the database shall be made available

online and free of charge, to the users of seed or seed potatoes and to

the public

Provided that the seed database manager shall every

December notify the users referred to in this sub-regulation, the

procedures in place for extracting the information.

(1) Pursuant to Article 28(2) of the Council Regulation, Exemption from

operators who sell products directly to the final consumer or user, requirement

adhere to the

provided that they do not produce, prepare, store other than in control system.

connection with the point of sale, or import such products, or have

contracted out such activities to a third party, may be exempted from

adherence to the control system as established by virtue of these

regulations.

(2) The competent authority may define parameters to

determine which type of operators may avail of the exemption

provided for in sub-regulation (1)

Provided that an operator shall be deemed to be exempted

only if he is declared as such in writing by the competent authority.

Operators importing organic products from third countries

shall adhere to the requirements and procedures laid down in these

regulations and in Regulation (EC) 1235/2008 or as may be defined by

the competent authority from time to time.

(1) Where an irregularity is found as regards to

compliance with the requirements laid down in these regulations, the

Council Regulation, Regulation (EC) 889/2008, or Regulation (EC)

1235/2008, the competent authority, the control authority and/or the

control body as the case may be, shall order in writing that no

reference to the organic production method is made in the labelling,

advertising, and retail of the entire lot or production run affected by

this irregularity

Provided that this would be proportionate to the relevance

of the requirement that has been violated and to the nature and

particular circumstances of the irregular activity.

(1) In cases whereby the competent authority, control

authority or control body consider the irregularity not to be of a severe

nature, a warning notice shall be sent by the competent authority,

control authority or control body, as the case may be, setting out the

conditions required to rectify the operator's position and shall include

the information specified in regulation 19(2)(a) to (d) of these

regulations. If such operator does not comply with such conditions, the

irregularity shall be considered as a severe infringement and the

provisions established in regulation 19 shall apply.

(2) Where the competent authority, control authority and, or

control body has reasonable cause to believe that any person has

contravened or failed to comply with any of these regulations,

whereby a severe infringement, or an infringement with a prolonged

effect has been carried out, the competent authority, control authority

and, or control body shall prohibit the operator concerned from

marketing products which refer to the organic production method in

the labelling, advertising and retail, for a period to be agreed with the

competent authority and the provisions established in regulation 19

shall apply.

(1) Where any person fails to comply with a warning notice

served in accordance with regulation 18(1) within the time specified

therein, or in cases of a severe nature as referred to in regulation 18(2),

the Director may issue an enforcement notice in accordance with sub-

regulation (2) to be served on that person

(2) An enforcement notice served terms of sub-regulation (1)

shall specify

(a) the date and nature of the offence;

(b) the facts upon which the allegation that an offence

has been committed is based;

(c) the measures that, in the Director’s opinion, must be

taken in order to ensure compliance;

(d) the period within which any such measures must be

taken, as is reasonable in the circumstances

Provided that in addition to the enforcement notice, the

competent authority, control authority, or control body may prohibit

through a suspension, any certified operator from marketing products

which refer to the organic production method in the labelling,

advertising and retail, for a period to be agreed with the competent

authority.

(3) Any enforcement notice sent by the Director shall be

deemed to have been delivered and duly notified if it is physically

delivered or sent by registered top post to the person at this place of

residence or business or place of work or postal address of such

person.

(1) Where any person fails to comply with an Administrative

enforcement notice served in accordance to regulation 19 within the penalties.

time specified therein, the Director may cause a notice in writing in

accordance with sub-regulation (2) to be served on that person.

(2)

A notice under sub-regulation (1) shall specify

(a) the date and nature of the offence;

(b) a summary of the facts upon which the allegation that

an offence has been committed is based (being a sufficient

summary fully and fairly to inform the person of the allegation

against him);

(c) any other matter (not being previous convictions) that

the Director considers relevant to the imposition of a penalty;

(d) the amount of the penalty due and, where the penalty

due depends on a previous conviction, the date of such

conviction, and shall be endorsed on a statement setting out the

provisions of this regulation

Provided that in addition to the notice of

administrative penalties, in case of certified operators having an

organic status or in-conversion status, the competent authority,

control authority, or control body may withdraw such

certification and organic status, and if so withdrawn it shall be

for a period of three years from the date of withdrawal.

(3) Any person on whom a notice under sub-regulation (1) is

served may, within thirty days after such service, by notice in writing

served on the Director, require that proceedings in respect of the

alleged offence shall be dealt with by the Court, in which case the

following provisions shall apply

(a) no further proceedings shall be taken under this

regulation by the Director; and

(b) nothing in this regulation shall be construed as

preventing the institution of any proceedings in respect of the

alleged offence or the conviction of the person for the offence by

the Court or the imposition of any penalty or forfeiture under

these regulations upon such conviction.

(4) Any person on whom a notice under sub-regulation (1) is

served who does not wish that proceedings in respect of the alleged

offence be dealt with by the Court may, within thirty days after such

service, by notice in writing served on the Director

(a) admit the offence;

(b) pay the amount of the penalty to the Director within

thirty days after the penalty notice is served or after such

subsequent period as the Director may determine; and

(c) where applicable take any necessary remedial actions

to ensure conformity with these regulations.

(5) Where under this regulation a person admits an offence, the

Director shall impose a monetary penalty on that person in respect of

the offence amounting to one third of the maximum penalty to which

the person would be liable if he were convicted of the offence by the

Court.

(6) The penalty imposed under sub-regulation (5) shall be due

as civil debt enforceable by the competent Court of civil jurisdiction in

favour of the Government and the declaration by the person on whom

the penalty is imposed that he admits the charge shall constitute an

executive title for the purposes of article 253 of the Code of

Organization and Civil Procedure in the same manner as if it were a

judgement of the competent Court of civil jurisdiction.

(7) Notwithstanding any other provision of these regulations or

of any other enactment, where an offence has been admitted under this

article no charge may be laid in respect of the offence against any

person by whom it has been admitted.

(8) Where a person on whom a notice under sub-regulation(1)

is served does not, within thirty days after the notice is served on him,

admit the offence, the Director shall institute proceedings or cause

proceedings to be instituted before the Court in respect of the alleged

offence.

(1) Any person shall be guilty of an offence under these Offences and

penalties.

regulations if he

(a) fails to comply with, or contravenes, or fails to

comply with any order lawfully given in terms of, any of the

provisions of these regulations, the Council Regulation,

Regulation (EC) 889/2008, or Regulation (EC) 1235/2008;

(b) intentionally obstructs or causes the obstruction of

any person acting in the proper exercise of his functions under

these regulations and, or fails to allow an inspection authorised

under these regulations;

(c) without reasonable cause, fails to give to any person,

acting in the exercise of his functions under these regulations,

any assistance or information which he may be required to give

under these regulations or any other law, or gives false or

misleading information;

(d) conspires or attempts, or aids, or abets, any other

person by whatever means, including advertising, counselling or

procurement to contravene the provisions of these regulations or

to fail to comply with any such provisions, including any order

lawfully given in terms of any of the provisions of these

regulations, or to contravene any restriction, prohibition or

requirement imposed by or under the said regulations;

(e) alters, forges, counterfeits or destroys any document

presented to or issued by the Director under these regulations;

(f) in case of an authorised officer, discloses to any

person any information obtained by him in the course of his

duties with regards to any trade secret shall, without prejudice to

any other liability under any other law, unless the disclosure is

made necessary in the performance of his duty.

(2) Any person who is found guilty of an offence against the

provisions of these regulations shall, on conviction, be liable

(a) on a first conviction to a fine (multa) of not less than

five hundred euro (€500) but not exceeding one thousand five

hundred euro (€1,500);

(b) on a second conviction or subsequent conviction, to a

fine (multa) of not less than one thousand five hundred euro

(€1,500) but not exceeding two thousand and five hundred euro

(€2,500) or to a fine calculated on the profit made by the

offender in connection with the transaction in contravention to

these regulations, whichever is the higher

Provided that, when the fine is so calculated, it may not

exceed five times the profit made by the offender.

(3) Where any person is convicted of an offence against these

regulations, the Court may, in addition to any other penalty that it may

impose

(a) sentence the offender to imprisonment for a term of

not less than thirty days and not exceeding two years;

(b) order the forfeiture to the Government of any goods

to which the offence relates, and if so forfeited shall be disposed

of in such a manner as the Court may determine on the advice of

the Director;

(c) order the suspension or withdrawal as the Court may

deem proper, of the offender’s certification, for a period not

being less than one month and not more than three years, or the

suspension of any licence or permit held by the offender and

related to any trade or business to which the offence relates, and

may in addition order that any such licence or permit may not be

re-issued in respect of the convicted offender.

In any proceedings for an offence under these regulations

consisting of a failure to comply with these regulations, the Council

Regulation, Regulation (EC) 889/2008, or Regulation (EC) 1235/2008,

it shall be for the accused to prove (as the case may be) that all the

necessary precautions and due diligence were in fact done to satisfy

the duty or requirement.

(1) The Organic Production and Labelling of Organic

Products Regulations, are hereby repealed and replaced by these

regulations, and any references in any law to the repealed Regulations,

shall be construed as references to these regulations

Provided that any orders and measures taken by virtue of

the repealed Regulations shall remain in force as if made under these

regulations.

(2)

Legal Notice 1 of 2018 is hereby repealed.

€0.63