FURTHER PROVISIONS FOR PRODUCT WITHDRAWAL AND RECALL REGULATIONS

SUBSIDIARY LEGISLATION 427.55

FURTHER PROVISIONS FOR PRODUCT

WITHDRAWAL AND RECALL REGULATIONS

4th June, 2004

LEGAL NOTICE 323 of 2004.

The title of these regulations is the Further Provisions for

Product Withdrawal and Recall Regulations.

These regulations shall apply to any product as defined by

the Product Safet Act, hereinafter referred to as "the Act".

For the purposes of these regulations, all the definitions of

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" means the Consumer and Industrial Goods

D i r e c t o r a t e a n d t h e F o o d s t u ff s C h e m i c a l s a n d C o s m e t i c s

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;

"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 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 subregulations (1) and (2), taking into account the relevant

criteria established in regulation 6(7).

(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 subregulation (1) and (3), 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

i ncl ud in g any p ossi bl e 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 of

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

consumers.

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

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

Subregulations (3) to (7) defines specific criteria for identifying

serious risks.

(3) When a notification is being effected under regulation 5(3),

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

subregulation (7), 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 subregulation (7);

(c) when the measure notified pursuant to regulation 5(1)

or 5(3) 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 - transposed by

virtue of the Dangerous Substances (Notification)

Regulations - in the case of a new substance shall also

be communicated. The guidelines referred to in

subregulation (7) 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 a serious risk

before d eci di ng to ad op t me as ures, the Director of Market

Surveillance shall inform the Commission within forty-five days

whether this information has been confirmed or modified.

(5)

Upon receipt of any notification referred to in regulation 5,

the Director of Market Surveillance shall inform the Commission,

a t th e l a t e s t w i th in t he s e t p e r io d of ti m e s t ip ul a t e d in t he

guidelines referred to in subregulation (7), 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 subregulation

(7), 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.

Any export from Malta of dangerous products may 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.