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Maltese Laws |
PRODUCT SAFETY ACT
To repeal and to replace the Quality Control (Exports, Imports and
Local Goods) Act, Cap. 225.
1st March, 2001
ACT V of 2001, as amended by Legal Notice 426 of 2007; and Acts XXIX
of 2007 and VI of 2011.
"advertisement" includes any no tice, device, circular, label, packaging, invoice, document, representation, broadcast or
public announcement, visual or acousti c p re sent ati on or b ot h, an d "to advertise" shall be construed accordingly;
"consumer" shall have the meaning assigned to it by article 2 of the Consu m er Af fairs Act and shall include any person wh o otherwise than in the course of a business, trade or profession, buys or otherwise purchases or
otherwise acquires products;
"cour t" mean s th e Co urt of Magi strates sit tin g as a cou r t o f criminal judicature;
"Dire c tor Genera l" me ans the Director Gene ra l (Technical Regulations) as appointed by article 19 of the Malta Competition and Consumer Affairs Authority Act;
"dist r i but or" in clud es any pe rson in th e sup p l y ch ain who s e activity does not affect the safety properties
of a product and shall i n c l ud e wh ol es a l er s , r e t a il er s , commission ag en ts an d ot her intermediaries;
"foodstuff" means any substance or product, whether processed, pa rtially processed or unprocesse d, in tended to be inge
sted by humans, with the exception of:
(a) medicinal products, that is any substance or combination of substances presented for treating or preventing
disease in human beings or animals; it also includes any substance or combination of substances which may be administered
to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological
functions in human beings or in animals;
(b) tobacco products, that is products for the purpose of smoking, sniffing, sucking or chewing, inasmuch as they are, even partly,
made of tobacco;
(c) water intended for human consumption, that is all water used for that purpose, either in its original state
Short title.
Definitions. Amended by: XXIX. 2007.7; VI. 2011.157.
Cap. 378.
Cap. 510.
or after treatment, regardless of origin, whether supplied for consumption, or whether used in a food production undertaking
for the manufacture, processing, preservation or marketing of products or substances intended for human consumption
and affecting the wholesomeness of the foodstuff in its finished form;
(d) natural mineral waters, that is microbiologically wholesome water, originating in an underground water table or deposit
and emerging from a spring tapped at one or more natural or bore exits, and which can be clearly distinguished from ordinary drinking
water by its nature and by its original state, both characteristics having been preserved intact because of the
underground nature of such water;
(e) narcotic or psychotropic substances, as the term is defined in the United Nations Convention against Illicit Traffic
in Narcotic Drugs and Pyschotropic Substances, adopted on the 19th December, 1988 in Vienna, to which Malta is a party;
"licence" includes trading licences and any other commercial or operating licences;
''Malta" has the same meaning as is assigned to it by article 124 of the Constitution;
"Minister" means the Minister responsible for consumer affairs and includes, to the extent of the authority given, any person
or authority authorised by him to act in that behalf for any purpose of this Act;
" premises" includes any stall, s tand, kiosk, vehi cle, aircraft, seacraft and any other place other than premises used
for dwelling pu rposes, wh ere a trade or bu si ness is carried out or m a y take place, and shall also includ e vending m achines,
whether or not situated on business premises;
"producer" means:
(a) the manufacturer of the product, when he is established in Malta, and any other person presenting himself as the
manufacturer by affixing to the product his name, trade mark or other distinctive mark, or
(b) the person who reconditions the product; or
(c) the manufacturer ’s representative, when the manufacturer is not established in Malta or, if there is no representative
established in Malta, the importer of the product; or
(d) others in the supply chain, in so far as their activities may affect the safety aspects of a product placed on the market;
"product" includes any manufactured article, item or substance which is intended or offered for use by consumers or is likely
to be used by consumers, supplied whether for consideration or not in the
cour se of a t r ade o r busin ess an d wh eth e r new , used or reconditioned, but excludes -
(a) second-hand products supplied as antiques;
(b) products which are to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the
persons to whom he supplies the product to that effect;
(c) medicinal products, as the term is defined in this Part of this Act;
(d) foodstuffs, as the term is defined in this Part of this
Act:
Provided however that in so far as quality control, geographical or product designation or compositional requirements
are concerned, foodstuffs shall be considered as products and shall be regulated by the provisions of this Act;
"proprietor", in relation to a manufacturing undertaking, means the person or persons by whom the trade or business is carried
on, and in cl ud es o w ners an d o c cu piers of premises where such undertaking is carried out and holders of licences in respect
of any such undertaking or premises;
"safe product" means any product which, under normal or reasonably foreseeable conditions of use, including duration, and,
where applicable, putting into service, installation and maintenance requirements does not present any risk or only the minimum risks,
com p atible with the product’s use, which are considered as acceptable and consistent with a high level of protection for the
safety and health of persons, taking into account in particular the following factors:
(a) the characteristics of the product, including its composition, packaging, instructions for assembly and maintenance;
(b) the effect on other products, where it is reasonably foreseeable that it will be used with other products;
(c) the presentation of the product, the labelling, any instructions for its use and disposal and any other indication
or information provided by the producer;
(d) the categories of consumers at risk when using the product, in particular children, the disabled and the elderly:
Provided that the possibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree
of risk shall not constitute grounds for considering a product to be an unsafe product;
"sale" includes -
(a) the supply of products sold, hired or supplied or offered for sale or hire in the course of a trade or business,
and any other activity concerning products which the Minister may, from time to time, specify by
Cap. 510. Cap. 510.
regulations made under this Act;
(b) the supply of any product which, for marketing or advertising purposes, is offered as a prize or reward or is otherwise
given in connection with any public entertainment, whether such entertainment is provided against payment or gratuitously;
and
(c) the supply of products in the course of the provision of a service to a consumer by a third party;
"standard" shall have the same meaning as assigned to it in the
Malta Competition and Consumer Affairs Authority Act;
"Techn ical Regu lation s Di visio n " means t h e Techni cal R egul ati ons Di visi on, as estab li shed by artic le
1 9 of th e M alta Competition and Consumer Affairs Authority;
''unsafe product'' means any product that does not conform to the definition of "safe product".
Consumer’s right. 3. (1) A consumer has the right -
(a) to have consumer products placed on the market which are safe;
(b) to receive adequate information regarding the safety aspects and the proper use of such products; and
(c) to be adequately informed with regard to products which give rise to risks to the health and safety of consumers
and which are sold or offered for sale to him.
(2) The provisions of subarticle (1) shall not be directly enforceable in any court or tribunal, but shall be adhered to
in the interpretation and implementation of this Act and any regulations made thereunder.
Safe products. 4. (1) Producers shall be obliged to only place safe products on the market.
(2) The provisions of this Act shall apply equally to products manufactured in or imported into Malta.
(3) Any person who contravenes the provisions of this article shall be guilty of an offence under this Act.
General product safety.
(2) Where specific rules contain provisions imposing safety requirements on a particular product, the requirements of this
Act in respect of general produ ct sa fety shall n o t appl y to su ch a product.
(3) Where specific requirements are made under any law
governing only certain aspects of product safety or categories of risk for a particular product, those requirements shall apply to
such a product with regard to the relevant safety aspects or risks to the exclusion of the provisions of this Act relating to general
product safet y, and t h e requir e ments o f th i s Act in resp ect of general product safety with regard to other safety aspects
or risks shall continue to apply.
(4) Subject to the provisions of subarticles (1) to (3), the provisions of this Act in respect of general product safety
shall prevail over anything to the contrary in any other law.
Act, producers and importers shall -
(a) provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the
normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings;
(b) take those precautions necessary to prevent or minimise such risks;
(c) adopt measures commensurate with the characteristics of the products which they supply, to enable consumers to
be informed of risks which these products might present and to take appropriate action including, if necessary, withdrawing
the product in question from the market to avoid these risks.
(2) The measures indicated in subarticle (1) may include, whenever appropriate, marking of the products or product batches
i n such a way that th ey can be ident i fied , sample testing of ma rk ete d pr od uct s , i n v e sti g at i ng co mp la in ts,
a n d k eepi n g distributors informed of such monitoring.
(3) Any person who contravenes any of the provisions of this article shall be guilty of an offence under this Act.
Obligations of producers and importers.
trad e, b u siness or o c cu pati on, do not com p ly wi th such requirement.
(2) Any distributor who supplies products which he knows or should, as practitioner in the relevant trade, business or occupation,
know to be unsafe, or who otherwise contravenes the provisions of subarticle (1) shall be guilty of an offence against this Act.
Compliance with general safety requirement by distributors.
Monitoring safety of products.
Assessment of general safety requirement. Amended by: VI. 2011.158.
Cap. 510.
(a) any relevant voluntary National Standards giving effect to a European Standard; or
(b) to any relevant European technical specifications, if any; or
(c) failing the above, to any other relevant National Standards as well as to codes of good practice in respect of
health and safety, the state of the art and technology in the sector concerned, and to the standards of safety which
consumers are reasonably entitled to expect.
(2) In this article, the terms "National Standard", "European Standard" and "technical specifications"
shall have the meaning attributed to them in the Malta Competition and Consumer Affairs Authority Act.
Director General may impose restrictions. Amended by:
VI. 2011.157.
10. (1) Notwithstanding that a product conforms with the pro visions mentioned in article 9(1)(a), ( b) or (c), th e Director General may take such appropriate measures imposing restrictions on its being placed on the market or requiring its
withdrawal from the market where he has reas on to bel i eve that , desp ite it s conformity, the product would still be dangerous
to the health and safety of consumers.
(2) The Director General shall, whenever feasible, give the parti e s con c ern e d an op por tun i t y t o subm it th
ei r v i ews befor e adopting the measures under subarticle (1):
Provided that where, because of the urgency of the m easures t o b e taken , the D irect or General has t aken measures
before giving such an opportunit y, he shall do so as soon as practi c abl e , after the measur e has b e en taken by th e Di rect
or General.
(3) The Director General shall, whenever he considers it possible and reasonable to do so, first seek to achieve voluntary
compliance by the producers or distributors involved.
Notification. Amended by: VI. 2011.157.
Cap. 378. (2) The provisions of articles 97, 98 and 99 of the Consumer Affairs Act shall apply mutatis mutandis to measures taken by the Director General.
General offences. 12. Any person who -
(a) sells, hires, exposes or offers for sale or hire or has in his possession for the purposes of such sale, hire, exposure
or offer, any product which does not comply with the provisions of this Act or of any regulation made under this Act; or
(b) deposits with, or otherwise supplies to, any other
person any such product, under whatever title, whether for consideration or not, for the purpose of such sale, hire, offer or exposure,
shall be guilty of an offence under this Act.
Failure of any product to comply with requirements.
Failure to give information. Amended by: VI. 2011.157.
(a) to prohibit, by order in writing, the placing on the market of any product which is unsafe or which does not comply
with the provisions of this Act or any regulations made thereunder;
(b) to prohibit, by order in writing, for such time as may be necessary for tests to be carried out, any person from supplying,
offering or otherwise exposing any product or product batches whenever it appears in his discretion that there exist
reasonable grounds to believe a product to be unsafe;
(c) to require, by order in writing, the immediate withdrawal of unsafe products from the market and, whenever he
deems it necessary, to order the destruction of such products under such conditions as he may deem appropriate;
(d) to take such measures as he may consider to be necessary to suppress or prevent practices which are detrimental to product
safety;
(e) to impose, by order in writing, conditions on product marketing, advertising, labelling and marking as may be necessary in the
interest of public safety;
(f) to publish copies of orders issued by him under any of the provisions of this Act;
(g) to carry out or to cause to be carried out, on an adequate scale up to the final stage, of use all product control
activities, including inspections, analyses, examinations or other investigations concerning the safety properties of
products, even after such products have been placed on the market as safe; and
(h) to exercise any other functions as may be assigned to
Functions of Director General. Amended by:
VI. 2011.157.
him by or under this Act or any other law.
Enforcement of
Act.
Amended by:
VI. 2011.157.
(2) Any officer or other person, authorised as aforesaid, shall, when requir ed, pr oduce the written author ization signed by
the Director General.
(3) Any reference in this Act other than in article 22 to an authorised officer or to an authorised public officer shall
be deemed to include a reference to a person authorised in accordance with subarticle (1).
Power of inspection. Amended by: VI. 2011.157.
(a) enter and search any such premises and carry out therein any inspection as may be necessary;
(b) seize any unsafe products found therein:
Provided that where the Director General has reasonable cause to suspect that such unsafe products are likely to be removed, destroyed
or the evidence of the commission of any offence under this Act may be otherwise suppressed, he may himself in writing aut horise
any pub lic o f fi cer t o exercise, in relation to such premises, any of the powers mentioned in this subarticle, and the aut horit
y so gi ven by the Director G eneral shall have the same effect as a warrant issued by a Magistrate.
(2) No entry and search shall be effected outside the normal business hours of the establishment concerned, unless the Director
G eneral has cause t o b eliev e th at d elay coul d cau se th e lo ss or suppression of any evidence or may oth e rwise prejudice
the outcome of the search.
(3) In the course of any entry and search under this Part of this
Act, the Director General may request the assistance of the Police.
Inspection of products.
(a) has been sold or is offered for sale or consumption or use by consumers; or
(b) is in the possession of, or under the control of, any producer or distributor, or which has been deposited with or otherwise
delivered to any person for the
purpose of sale or of preparation for sale, wherever the product is to be found.
Officer may be accompanied.
Other powers of authorised officer.
(a) purchase a sample of any product or any material capable of being used in the preparation, manufacture or assembly of
such product;
(b) break open any door and remove any impediment or obstruction to such entry, search or seizure;
(c) require any person carrying on a trade or business or employed in connection with a trade or business to produce any
books or documents, including those stored in a computer or in any other information network, relating to the trade
or business, and to take copies thereof;
(d) seize and detain, without paying any consideration, any goods or a sample thereof, or any other material, which appears
to him to be intended for sale, or to have been sold, or is found by him on or in the premises, for the purpose of ascertaining
whether an offence under this Act has been committed;
(e) seize and detain any goods, or any sample, component or material, or documents for the purpose of gathering evidence concerning
the possible commission of an offence under this Act or which may be required as evidence in proceedings under any of the provisions
of this Act or of regulations made under it; and
(f) where necessary, in order to ensure compliance with the provisions of this Act, require any person having authority to do so,
to open any container or vending machine, and if that person does not comply with the requirement, the authorised officer may proceed
to do so himself, if necessary by breaking open such container or machine.
(2) In the case of goods seized from a vending machine, the authorised officer shall inform the person whose name and address are stated on the machine as being that of the proprietor or, if no name and address are so stated, the occupier, if any, of the premises on which the machine stands or to which it is affixed.
Receipt for seized goods.
Applicability of Professional Secrecy Act. Amended by: XXIX. 2007.9; VI. 2011.157. Cap. 377.
Obstructing or giving false information. Amended by: VI. 2011.157.
Written notice. Amended by: VI. 2011.157.
Disposal of products.
Failure of operator to comply with the provisions of this Act.
Amended by: VI. 2011.157.
22. Nothing contained in the Professional Secrecy Act shall be constru e d as preclu ding or othe rwis e re stric t ing the Director G e neral, o r any pu bli c o fficer duly authoris e d by the Director General in terms o f art i cle 1 7 , from commu nicati ng to th e consumer, whose com p laint regarding such matter has been in vest ig ated , in fo rmat i on con cerni ng find in gs rel a ted t o such matter directly resulting from such investigation.
Provided that the Director General shall, as soon as practicable, but not later than two months from the service of such notice,
on the person responsible, determine the safety or otherwise of the product and shall -
(a) if it is established that the product is safe, withdraw the notice; or
(b) if the product is established to be unsafe, prohibit its further use or sale, order its seizure and confiscation, as well as
retention of the product in such premises as the Director General may specify at the expense of the producer.
(a) specify the provision or regulation which the proprietor has failed to comply with and specify the matters which
constitute the proprietor ’s failure to comply;
(b) specify remedial measures which are required to be taken; and
(c) require that the proprietor implement such measures or equivalent measures, within such a period of time as may be specified
in the notice.
(2) Any person who fails to comply with a notice shall be
guilty of an offence under this Act.
(a) to establish and periodically update sectoral surveillance programmes in respect of all categories of products
and risks;
(b) to follow up and update scientific knowledge concerning the safety of products, as well as periodical reports on surveillance
activities, findings and results achieved;
(c) to periodically review and assess the functioning of the control activities and their effectiveness, and, if necessary,
revise the surveillance approach and organisation put in place.
Responsibilities of the Technical Regulations Division. Substituted by: XXIX. 2007.8. Amended by:
VI. 2011.159.
(a) products which are or may be unsafe;
(b) the producers and distributors of such products;
(c) those producers, distributors or other persons, whose practices or activities in relation to particular products may adversely
affect the interests of consumers in terms of this Act; or
(d) any other matter that may adversely affect the safety of consumers.
(2) The provisions of subarticle (1) in relation to product s a fety shall prevail ov er t h e p r o v isio ns of articl
e 8(1) of th e Consumer Affairs Act.
(3) The provisions of article 8(2) and (3) of the Consumer Affairs Act shall apply to public statements made or issued
under this article.
Issue of public statement. Amended by: XXIX. 2007.10;
VI. 2011.157, 160.
Cap. 419.
Cap. 378.
29. (1) The Director General may, instead of initiating proceedings in respect of the violation of any of the provisions
of this Act, require any person who has violated any of the provisions of this Act or any regulations made thereunder, to undertake
in writing to refrain from such conduct and to take any remedial or other action as the Director General may specify and the provisions
of arti cl e 12 of the Consumer Affairs Act shall ap ply mut a tis mutandis to undertakings made under this Act.
(2) Any person who acts in contravention of an undertaking made in accordance with subarticle (1) shall be guilty of an offence
under this Act.
Undertakings in respect of contraventions against this Act. Amended by:
VI. 2011.157.
Cap. 378.
Proceedings. Amended by: VI. 2011.157.
conduct the prosecution before the Court.
Prescription. 31. Criminal actions for offences under this Act shall be prescribed by the lapse of two years.
Fines.
Amended by:
L.N. 426 of 2007.
32. (1) A person found guilty of an offence under article 23 shall, on conviction, be liable to a fine (multa) of not less than four hundred and sixty-five euro and eighty-seven cents (465.87) and not exceeding two thousand and three hundred
and twenty-nine euro and thirty-seven cents (2,329.37), or to imprisonment for a
term not exceeding six months or to both such fine and imprisonment.
(2) A person found guilty of any other offence under this Act shall be liable, on conviction, to a fine (multa) of not less than one thousand and one hundred and sixty-four euro and sixty-nine cents (1,164.69) but not exceeding eleven thousand
and six hundred and forty-six euro an d ei ght y-seven cents (1 1 , 6 46.87 ) o r to imprisonment for a term not exceeding
three years or to both such fine and imprisonment.
(3) A person found guilty of a second or subsequent offence shall, on conviction, be liable to a fine (multa) of not less than one thousand and seven hundred and forty-seven euro and three cents (1,747.03) but not exceeding twenty-thre e
thousand and two hundred and ninety-three euro and seventy-three cents (23,293.73) or to imprisonment not exceeding four years or
to both such fine and imprisonment.
(4) The Court may, upon conviction for any offence committed under this Act, with the exception of offences committed under article
23, if it feels that circumstances so warrant, additionally orde r the suspension or cancella tion of a ny licence or licence s
issued in favour of the person charged or in respect of the premises involved in the proceedings.
(5) Without prejudice to the generality of the foregoing, any person convicted in relation to an offence under articles 26 or 29
shall additionally be liable to the additional fine (multa) of not more than four hundred and sixty-five euro and eighty-seven cents (465.87) for each day that a notice or undertaking has
not been complied with.
Reimbursement to the Director General.
Amended by: VI. 2011.157.
Right to appeal. 34. The Attorney General shall have the right to appeal from any judgement given in proceedings instituted under this Act or in connection with regulations made thereunder.
35. Nothing in this Act shall be construed as adversely affect ing the ri ghts of consumers arisin g fro m the p r ovi si ons regulating liability for defective products under Part VII of the Consumer Affairs Act.
(a) establishing or authorising charges that may be imposed by the Director General in the exercise of any of the functions
assigned to him under this Act or regulations made under it; and
(b) prescribing the form of any document to be used for any of the purposes of this Act.
Applicability of Consumer Affairs Act.
Cap. 378.
Regulations in respect of charges and forms of documents. Amended by:
VI. 2011.157.
(a) by delivering it to that person or by leaving it or sending it addressed to him at his usual or last known residence;
or
(b) in the case of a company or other body or association of persons, by delivering it to the registered or principal office.
(2) Where the document is to be given or served on the owner or the o ccupier of any p r emises and it is not practicab le,
after reasonable enquiry, to ascertain the name and address of the person to or on whom it should be given or served or the premises
are unoccupied, the document may be given or served by addressing it to the person concerned by addressing it to "the owner"
or "the occupier" of the premises and, if there is no person on the premises to whom it can be delivered, by affixing it,
or a copy of it, to some conspicuous part of the premises.
(Technical Regulations), make regulations -
(a) prescribing levels of minimum permissible quality in relation to any class, category or type of product, including the
packaging thereof;
(b) prescribing mandatory requirements with respect to the design, methods of manufacture, construction, safety, finishing,
testing, quality control, labelling, classification, packaging, grading, storage, transportation and environmental
impact of any class, category or type of goods, materials, substances, plant, installations or structures;
(c) adopting and implementing any commitments and obligations relating to products arising out of or under any treaty,
convention or other international agreement, whether bilateral, regional or multilateral, to which Malta is a party;
Service of documents.
Regulations with respect to products. Amended by:
XXIX. 2007.11; VI. 2011.161.
(d) concerning the matters to be taken into account in determining whether, and at what times, samples should be procured;
(e) regarding the manner of procuring samples, including the steps to be taken to ensure that the samples procured are
fair and adequate samples;
(f) regarding the method of dealing with samples, including, where appropriate, their division into parts;
(g) regarding the persons to whom the samples or parts of the samples are to be delivered and the persons by whom they are to
be retained;
(h) regarding the notices which are to be given to, and the information which is to be furnished by, the persons responsible for
any product;
(i) regarding the methods which are to be used in analysing or examining samples, or in classifying and evaluating
the results of analyses or examinations;
(j) regarding the circumstances in which an analyst or examiner is to be precluded, by reason of conflict of interest, from
analysing or examining a particular sample;
(k) establishing the processes whereby particular products may be said to have undergone a reconditioning process for any
of the purposes of this Act; and
(l) designating any manufactured article, item or substance as a "product" for all or any purposes of this
Act.
Regulations with respect of market surveillance.
(a) the establishment of systems and procedures for the exchange of information with other countries and international organisations
on product safety issues;
(b) the setting up of procedures to allow the rapid exchange of information in respect of the safety of a product;
(c) forms and methods of notification, co-operation and collaboration in respect of product safety issues with other countries
and international organisations, whether on a multilateral or regional basis or otherwise;
(d) the establishment of systems and procedures for the exchange of information and administrative co- ordination and
collaboration with regard to product safety between government departments, public authorities and other entities
under the general control of Government;
(e) prescribing the categories of persons that may be authorised in accordance with article 16.
(2) In the event of conflict or incompatibility between the Maltese and English texts of any regulations made under this Act, the English language version shall prevail.
Language of regulations.
Saving. Cap. 225.
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