Regulations, 2004

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,599, 4 ta’ :unju, 2004

L.N. 323 of 2004

PRODUCT SAFETY ACT

(ACT NO. V OF 2001)

Further Provisions for Product Withdrawal and Recall

Regulations, 2004

IN exercise of the powers conferred by articles 38 to 40 of the

Product Safety Act, 2001, the Minister for Competitiveness and

Communications, on the advice of the Malta Standards Authority,

has made the following regulations>-

The title of these regulations is the Further Provisions for Citation.

Product Withdrawal and Recall Regulations, 2004.

These regulations shall apply to any product as defined by Scope.

the Act.

For the purposes of these regulations, all the definitions of Definitions.

the Act shall apply, and in addition>

“dangerous product” means any product which does not

meet the definition of “safe product” in article 2 of the Act<

“MSA Directorates 1 ” means the Consumer and Industrial

Goods Directorate and the Foodstuffs Chemicals and Cosmetics

Directorates of the Malta Standards Authority<

“RAPEX” means the European Community Rapid

Information System<

“recall” means any measure aimed at achieving the return

of a dangerous product that has already been supplied or made

available to consumers by the producer or distributor<

“serious risk” means any serious risk, including those the

effects of which are not immediate, requiring rapid intervention

by the public authorities<

L.N. 213 of 2000 – Malta Standards Authority (Establishment of Directorates) Order, 2000,

published in Government Gazette No. 17,002 of 20th October, 2002.

“the Directive” means Directive 2001#95#EC of the

European Parliament and of the Council of 3 December 2001

on general product safety<

“under normal or foreseeable conditions of use” also

includes, where applicable, the putting into service, the

installation and the maintenance requirements<

“withdrawal” means any measure aimed at preventing the

distribution, display and offer of a product dangerous to the

consumer.

(1) In order to ensure compliance with the general safety

requirements under article 7(1) of the Act or under any other

requirement of the Community rules on the product in question, any

producer or distributor shall immediately forward to the Director

any information in their possession in terms of article 7(1) of the

Act.

(2) In the event of serious risks, this information shall at

least include the following>

(a) information enabling a precise identification of the

product or batch of products in question<

(b) a full description of the risk that the products in

question present<

(c) all available information relevant for tracing the

product<

(d) a description of the action undertaken to prevent risks

to consumers.

(1) Where the Director takes measures which restrict the

placing on the market of products, or which require their withdrawal

or recall, including those provided for in Part III of the Act, he

shall, subject to the provisions of regulation 6 hereunder or any

specific Community legislation, inform the Director of Market

Surveillance of any such measures and of any modification or lifting

thereof.

(2) If the Director considers that the effects of the risk

do not or cannot go beyond the Maltese territory, he shall inform

the Director of Market Surveillance who shall notify such measures

to the Commission as long as such information would be relevant

with regards to product safety, and in particular, if such measures

would have been occasioned by the necessity to respond to a new

risk which has not yet been reported in other notifications.

(3) Where the Director adopts or decides to adopt,

recommends or agrees with producers and distributors, whether on

a compulsory or voluntary basis, measures or actions to prevent,

restrict or impose specific conditions on the possible marketing or

use, within the Maltese territory, of products by reason of a serious

risk, he shall immediately notify the Director of Market Surveillance

of such measures or actions and of any modification or lifting thereof.

(4) If the Director considers that the effects of the risk

do not, or cannot go beyond, its territory he shall follow the procedure

laid down in sub-regulations (1), and (2) hereof, taking into account

the relevant criteria established in regulation 6 (7) of these

regulations.

(5) In the case of a serious risk, the Director shall notify

the Director of Market Surveillance of the voluntary measures laid

down in Article 5 of the Directive and in article 6 (2) of the Act, as

taken by producers and distributors.

(6) Without prejudice to sub-regulation (1) and (3) of

these regulations, before deciding to adopt any measures or take

any action, the Director shall pass on any information in his

possession regarding the existence of a possible serious risk to the

MSA Directorates and to the Director of Market Surveillance.

(7) When the Director, after analysing all technical details

including any possible technical advice given by the MSA

Directorates and after consultation with the Director of Market

Surveillance, decides that there is a serious risk, he shall

communicate such decision to the MSA Directorates and to the

Director of Market Surveillance who in turn shall communicate

such notification to the Commission through the RAPEX system.

(1) RAPEX shall cover products as defined in article 2 Procedures for the

application of

of the Act that pose a serious risk to the health and safety of RAPEX.

consumers.

(2) RAPEX is essentially aimed at a rapid exchange of

information between Member States in the event of a serious risk.

Regulation 6 (7) of these regulations, define specific criteria for

identifying serious risks.

(3) When a notification is being effected under regulation

5 (3) of these regulations, all available details shall be provided in

such manner that -

(a) in particular, the notification shall contain the

information stipulated in the guidelines referred to in regulation

6 (7) of these regulations, and including>

(i)

information enabling the product to be identified<

(ii) a description of the risk involved, including a

summary of the results of any tests and, or analyses and of

their conclusions which are relevant to assessing the level

of risk<

(iii) the nature and the duration of the measures or

action taken or decided on, if applicable<

(iv) information on supply chains and distribution

of the product, in particular on destination countries<

(b) such information shall be transmitted using the special

standard notification form and by the means stipulated in the

guidelines in regulation 6 (7) of these regulations<

(c) when the measure notified pursuant to regulations 5

(1) or 5 (3) of these regulations seeks to limit the marketing or

use of a chemical substance or preparation, either a summary

or the references of the relevant data relating to the substance

or preparation considered and to known and available

substitutes, where such information is available, shall be

provided as soon as possible. The anticipated effects of the

measure on consumer health and safety together with the

assessment of the risk carried out in accordance with the general

principles for the risk evaluation of chemical substances as

referred to in Article 10(4) of Regulation (EEC) No 793#93(3)

in the case of an existing substance or in Article 3(2) of Directive

67#548#EEC – LN 318 of 2001, as last amended - in the case of

a new substance shall also be communicated. The guidelines

referred to in regulation 6 (7) of these regulations, shall define

the details and procedures for the information requested in that

respect.

(4) When the Director has informed the Director of

Market Surveillance, in accordance with regulation 5 (5) of these

regulations, of a serious risk before deciding to adopt measures, the

Director of Market Surveillance shall inform the Commission within

45 days whether this information has been confirmed or modified.

(5) Upon receipt of any notification referred to in

regulation 5 of these regulations, the Director of Market Surveillance

shall inform the Commission, at the latest within the set period of

time stipulated in the guidelines referred to in regulation 6 (7) of

these regulations, of the following>

(a) whether the product has been marketed in the Maltese

territory<

(b) what measures concerning the product in question are

being adopted in the light of the country’s circumstances, stating

the reasons, including any differing assessment of risk or any

other special circumstance justifying the decision, in particular

lack of action or of follow-up<

(c) any relevant supplementary information he has

obtained on the risk involved, including the results of any tests

or analyses carried out>

Provided that the guidelines, referred to in regulation 6

(7) of these regulations, shall provide precise criteria for

notifying measures limited to the national territory and shall

specify how to deal with notifications concerning risks which

are considered by the Member State not to go beyond its

territory.

(6) The Commission shall be immediately informed of

any modification or lifting of any measure or action in question.

(7) Guidelines concerning the management of RAPEX

by the Commission and the Member States shall be prepared and

regularly updated. The procedure used shall be that laid down in

Article 15 (3) of the Directive.

(1) Any export from Malta of dangerous products may Export ban.

be prohibited>

Provided that any export from Malta of dangerous products

which have been the subject of a decision referred to in

paragraph 1 of Article 13 of the Directive, shall be prohibited

unless the decision provides otherwise.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press