Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,525, 22 ta’ Jannar, 2016

L.N. 35 of 2016

PRODUCT SAFETY ACT

(CAP. 427)

Organic Production and Labelling of Organic Products

Regulations, 2016

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

Safety Act, the Minister for Social Dialogue, Consumer Affairs and

Civil Liberties, on the advice of the Director General (Technical

Regulations), and in consultation with the Minister for Sustainable

Development, the Environment 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, 2016.

(2) These regulations implement the relevant provisions of

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 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.

(3) These regulations shall 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;

"Agricultural Directorate" means the Agricultural Directorate

within the Ministry responsible for Agriculture;

"Commission Regulation" means 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;

"Council Regulation" means 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;

"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;

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

the Constitution of Malta;

"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.

(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 and Article 2

of the Commission Regulation.

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

provisions of the Council Regulation or of the Commission

Regulation, the provisions of the Council Regulation or of the

Commission Regulation respectively shall prevail.

(1)

For the purposes of these regulations, the Council

Regulation and the Commission Regulation, the Agricultural

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 and the

Commission Regulation, the Agricultural 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 the drawing up of reports on the

controls it carries out;

(c)

be responsible for the market surveillance of the

selling and, or advertising of organic products;

(d)

in cases where there is found to be a breach of

these regulations, the Council Regulation or the Commission

Regulation, take any measure it deems fit in order to ensure that

said regulations are adhered to;

(e)

have any other function necessary for the better

implementation of the provisions of these regulations.

(1)

The competent authority may confer, in whole or in Delegation of

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

organic production in accordance with the provisions set out in these

regulations, the Council Regulation and the Commission Regulation

to one or more control authorities or control bodies

Provided that the competent authority shall publish, in the

Gazette, a notice regarding such 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

their 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.

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

withdraw the delegation conferred

Provided that the competent authority shall publish the

withdrawal of delegation 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 without Function of the

prejudice to the functions of the control authorities and, or control control

authorities and,

bodies as established by the Council Regulation and or the or

bodies.

Commission Regulation, if authorised by the competent authority the

control authorities and, or control bodies may be responsible for

(a)

the verification of the operators’ declaration in

accordance with article 63 of the Commission Regulation and

other general and specific documents as outlined in the Council

Regulation and the Commission Regulation;

(b)

the taking of samples and carrying out of analysis

in case of suspicion of non-authorised products and, or

procedures;

(c)

the drawing up of control reports, which reports are

to be made available to the competent authority;

(d)

the keeping of an updated list of names and

addresses of operators under their control, which list should be

made available to the competent authority;

(e)

certifying all operators that comply with all

national and EU legislation pertinent to the organic production

and labelling of organic production and labelling and who also

contribute to the control expenses and to provide documentary

evidence to the operator in case he meets the organic

requirements;

(f)

in cases of non-compliance, prohibiting certified

operators from placing, on the market, products indicating the

organic status;

(g)

maintaining effective and timely communication

with the competent authority and provide the latter with

information requested from it from time to time, both for

reasons of supervision and compiling of reports to be sent to the

European Commission.

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

the competent authority of cases of infringement 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

There shall be a Board to be known as the Organic

Farming Advisory Board, which shall consist of

the Director of the Agricultural Directorate ex

(a)

officio, who shall act as Chairperson;

(b)

two officers from the Agricultural Directorate, one

of whom shall be appointed Deputy Chairperson;

(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 provided that they obtain approval by the

Directorate to sit on the Board.

(2) The Director shall designate an officer from the

Agricultural Directorate to act as Secretary to the Board.

(3) The Board shall

(a)

act in accordance with the terms of reference and

rules of procedure as approved by the Director;

(b)

set up special sub-committees or invite people 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 a member of

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

(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 competent authority in the making of

policies regulating the organic sector;

(b)

to monitor and keep under review the proper

implementation, functioning or attainment, to the highest

standards achievable, of the purpose of these regulations and of

Government policy for the organic sector;

(c)

to participate in ensuring the highest standard

possible for Malta in the organic sector and to co-operate and

co-ordinate as necessary with government departments and

other bodies in the achievement of these aims;

(d)

to provide the Minister and competent authority

with 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 competent authority or by the Minister for the attainment

of the optimum level of organic production and products, and

control and to prepare and maintain the necessary resources and

databases for carrying out this task; and

(f)

to perform any other function or duties and to

exercise such further powers or responsibilities as the Minister

may from time to time determine.

(6) Subject to any rules which the Minister may prescribe, the

Board shall regulate its own procedure.

(7) 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, upon request by any member

of the Board.

(8) The Board shall report to the competent authority and shall

prepare and present to the competent authority and to the Minister an

annual report containing the minutes of each Board meeting, 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 competent authority may designate public

officers to act as authorised officers for the control of the organic

sector.

(2) No person who is engaged directly or indirectly in any

commercial enterprise related to the production of organic-related

products, shall act as an authorised officer, and no public officer shall

be engaged directly or indirectly in any commercial enterprise related

to the production and commercialisation of organic products.

(3) An authorised officer, designated in accordance with sub-

regulation (1) -

(a)

shall have the power, at any reasonable time, to

enter and inspect any premises in or at which he has reason to

believe that any organic product is being produced, processed,

packed, stored, sold or offered for sale, to examine and search

such premises, to inspect any such product and take samples;

(b)

shall have the right to access and inspect

documentation relating to any registers, records and notes kept

in accordance with the provisions of these regulations; and

(c)

may, exercising any power conferred by this

regulation, seize and obtain any records which he has reason to

believe may be required as evidence in proceedings under these

regulations and in the case where the records are kept by means

of a computer, require the records to be printed.

(4) Any authorised officer who 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, be guilty of an offence.

(5) Any person who intentionally obstructs or causes the

obstruction of any person acting in proper exercise of his functions

under these regulations or, 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, shall be guilty of an offence.

(6) Criminal action for such an offence shall be barred by the

lapse of three months.

(1)

No product shall be produced, processed, labelled, Certification.

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

provisions of these regulations, the Council Regulation and the

Commission Regulation.

(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) Further to the provisions of sub-regulation (2), the

competent authority shall establish the necessary procedures in order

for operators to be granted the certification referred to in sub-

regulation (2); applicants shall refer to the competent authority to

initiate the process of certification, and shall subsequently be guided

on certification procedures by the competent authority.

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

years

Provided that every certificate holder shall be subject to a

an inspection in order to ensure compliance with the provisions of

these regulations, the Council Regulation and the Commission

regulation at least once every year

Provided further that the Agricultural Directorate shall,

upon a report from a third party or on its own initiative, carry out on-

the-spot inspections in order to verify that these regulations, the

Council Regulation and the Commission Regulation are being

adhered to

Provided further that each control body and, or authority

issuing the certificate shall carry out an inspection on each certified

operator at least once a year.

The fee charged in order for the certificate to be issued

shall be decided by the competent authority, the control authority or

the control body, as the case may be, and published on the competent

authority’s website.

The authority responsible to receive notifications in terms

of Article 28(3) of the Council Regulation shall be the Agricultural

Directorate.

For the purposes of Article 23(5) of the Commission

Regulation, the period in which runs must be empty shall be of one

month.

The authorisation referred to in Article 29(1)(b) of the

Commission Regulation may be prolonged for a maximum of three

times of twelve months each.

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

Commission Regulation shall be shortened to a period of not less than

one year

Provided that this regulation shall only apply following

these 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 of a

Member State;

(b)

parcels treated with a product not authorised for

organic production as part of scientific tests approved by the

competent authority of a Member State.

(1)

The use of seed or vegetative propagating material Competent

not obtained by organic methods shall only be authorised if not authority

responsible for

available by organic methods.

granting

authorisation for

the use of seed

Provided that the provisions of Article 45(2) to (9) of the or

propagating

Commission Regulation shall apply for the authorisation for the use material not

of seed or vegetative propagating material not obtained by organic obtained

organic

methods.

methods.

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

45(4) of the Commission Regulation, be the authority responsible for

granting authorisation referred to in Article 45(1)(b) of the

Commission Regulation.

(3) The Plant Health Directorate shall, in accordance with

article 54 of the Commission Regulation, send to the competent

authority an annual report covering all authorisations from the

previous calendar year and this by the end of February of each year.

(1)

The Plant Health Directorate shall be responsible Database.

for establishing, managing and updating of a computerised database

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

by organic production methods are available in Malta.

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

produced by organic methods shall follow the provisions laid down in

Articles 49 and 50 of the Commission Regulation.

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

database shall be considered as unavailable and may 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 the Commission Regulation.

(6) For each registered variety the information provided shall

at least include that contained in Article 51 of the Commission

Regulation.

(7) Each registration shall be subject to a fee, which represents

the cost of inserting and maintaining the information in the database

Provided that the fee shall be approved by the competent

authority and published in the Gazette.

(1)

The information contained in the database shall be

available online and free of charge to the users of seed or seed

potatoes and also to the public

Provided further the seed database manager shall, every

December, notify to the users who have notified their activity in

accordance with Article 28(1)(a) of the Council Commission

Regulation, the procedures in place for extracting information from

the seed database.

(1)

Pursuant to Article 28(2) of the Council

Commission Regulation, operators who sell products directly to the

final consumer or user, provided that they do not produce, prepare,

store other than in connection with the point of sale or import such

products or have contracted out such activities to a third party, shall

be exempted from adherence to the control system as established by

virtue of these regulations.

(2) The competent authority shall decide whether an operator

falls within the parameters of sub-regulation (1) or not

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 by the

Agricultural Directorate.

(1)

Where an irregularity is found as regards

compliance with the requirements laid down in these regulations, the

Council Regulation or the Commission Regulation, the competent

authority, the control authority and, or the control body, as the case

may be, shall order that no reference to the organic production

method is made in the labelling and advertising 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.

(2) Where a severe infringement or an infringement with

prolonged effect is found, the competent authority, control authority

or control body shall prohibit the operator concerned from marketing

products which refer to the organic production method in the labelling

and advertising for a period to be agreed with the competent

authority.

(3) (a)

An infringement shall fall under the classification

of a severe infringement if that infringement compromises the organic

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

principles of the organic production method as defined in the Council

Regulation and its Implementing Acts. In cases of irregularities a

warning letter shall be sent by the competent authority setting out the

conditions required to rectify the operators’ position, if such

operators do not comply with these conditions the irregularity shall

also be considered as a severe infringement.

(b)

An infringement with prolonged effect is an

infringement where the action done by an operator does not only

compromise the organic status of the existent product but also that of

future products.

(4) The competent authority, control body or control authority

may suspend or withdraw an operator’s participation in the Organic

certification scheme if it results that the operator has failed to adhere

to the conditions related to the participation in the scheme

Provided that the competent authority, control body or

control authority may if deemed necessary, prior to suspending or

withdrawing an operator’s participation in the scheme, issue a

warning notifying the operator of the infringement and the obligation

to take remedial action.

If an operator’s Organic Status or In-conversion Status is

withdrawn, that operator may not apply for the Organic Certification

for three years from the date of withdrawal.

In addition to the provisions laid down in regulation 19, Penalties.

any person who commits a severe infringement shall be guilty of an

offence and shall 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

Provided further that the Court may, in addition to any

other punishment, sentence the offender to imprisonment for a term

of not less than thirty days and not exceeding two years

Provided further the Court shall, on the demand of the

prosecution, order the forfeiture of any goods to which the offence

relates

Provided further the Court shall, on demand of the

prosecution, in the case of a second or subsequent conviction, order

the suspension of the offender’s certification for a period of not less

than one week and not more than three months, or the cancellation of

any licence or permit held by the offender and relating to any trade or

business to which the offence relates, and shall order that any such

cancelled licence or permit may not be re-issued in respect of the

convicted offender.

The Organic Farming Regulations, 2004, are hereby

revoked without prejudice to anything done or omitted to be done

thereunder.

2004.

2004. €0.54