Notification Procedure Regulations, 2003

L.N. 373 of 2003

MALTA STANDARDS AUTHORITY ACT

(CAP 419)

Notification Procedure Regulations, 2003

IN exercise of the powers conferred by regulation 21(f) of the Malta

Standards Authority Act, hereinafter referred to as “the Act”, the Minister

of Finance and Economic Affairs, after consultation with the Malta

Standards Authority, has made the following regulations>-

(1) The title of these regulations is the Notification Procedure

Regulations, 2003.

(2)

These regulations shall become operative upon

publication.

Provided that regulations 5 to 10, regulation 11 (6) and 12 to 15

shall become operative on 1 st May, 2004.

For the purposes of these regulations all the definitions of the

Act shall apply, and in addition>

“competent authority” means any public authority or agency

which prescribe any>

(a)

technical regulations< and,or

(b) rules on Information Services>

Provided that the Authority may identify those local or regional

councils which have to notify technical regulations and, when this is

the case, the Authority shall submit a list of these local or regional

councils to the European Commission<

“draft standard” means a document containing the text of the

technical specifications concerning a given subject, which is being

considered for adoption in accordance with the national standards

procedure, as that document stands after the preparatory work and

as circulated for public comment or scrutiny<

“draft technical regulation” means the text of a technical

specification or other requirement or of a rule on services, including

administrative provisions formulated with the aim of enacting it

or of ultimately having it enacted as a technical regulation, the

text being at a stage of preparation at which substantial amendments

can still be made, and, in any case, prior to the submission of the

text for signature by the Minister into whose portfolio the competent

authority drawing up the text falls<

“European standardization body” is a body referred to in

Schedule I<

“national standardization body” is a body referred to in

Schedule II<

“other requirements” means a requirement other than a

technical specification, imposed on a product for the purpose of

protecting, in particular, consumers or the environment, and which

affects its life cycle after it has been placed on the market, such as

conditions of use, recycling, reuse or disposal where such

conditions can significantly influence the composition or nature

of the product or its marketing<

“product” means any industrially manufactured product and

any agricultural product, including fish products<

“rule on services” means a requirement of general nature

relating to the taking-up and pursuit of service activities within

the meaning of the definition of “service” in this regulation, in

particular provisions concerning the service provider, the services

and the recipient of services, excluding any rules which are not

specifically aimed at the services defined in that point.

“service” means any Information Society service, that is to

say, any service normally provided for remuneration, at a distance,

by electronic means and at the individual request of a recipient of

services.

For the purposes of this definition>

i. “at a distance” means that the service is provided without

the parties being simultaneously present<

ii. “by electronic means” means that the service is sent

initially and received at its destination by means of electronic

equipment for the processing (including digital compression) and

storage of data, and entirely transmitted, conveyed and received

by wire, by radio, by optical means or by other electromagnetic

means<

iii. “at the individual request of a recipient of services”

means that the service is provided through the transmission of data

on individual request.

An indicative list of services not covered by this definition is set

out in Schedule III<

“standard” means a technical specification approved by a

recognized standardization body for repeated or continuous

application, with which compliance is not compulsory and which

is one of the following>

i. international standards> that is, a standard adopted

by an international standardization organization and made

available to the public,

ii. European standard> a standard adopted by a

European standardization body and made available to the

public,

iii. national standard> a standard adopted by a national

standardization body and made available to the public<

“standards programme”, a work programme of a recognized

standardization body listing the subjects on which standardization

work is being carried out.

“technical regulation” means technical specifications and

other requirements or rules on services, including the relevant

administrative provisions, the observance of which is compulsory,

de jure or de facto, in the case of marketing, provision of a service,

establishment of a service operator or use in a Member State or a

major part thereof, as well as laws, regulations or administrative

provisions of Member States, except those provided for in

regulation 10, prohibiting the manufacture, importation, marketing

or use of a product or prohibiting the provision or use of a service,

or establishment as a service provider.

De facto technical regulations include>

i. laws, regulations or administrative provisions of a Member

State which refer either to technical specifications or to other

requirements or to rules on services, or to professional codes or

codes of practice which in turn refer to technical specifications or

to other requirements or to rules on services, compliance with which

confers a presumption of conformity with the obligations imposed

by the aforementioned laws, regulations or administrative

provisions<

ii. Voluntary agreements to which a public authority is a

contract party and which provide, in the general interest, for

compliance with technical specifications or other requirements or

rules on services, excluding public procurement tender

specifications<

iii. Technical specifications or other requirements or rules

on services which are linked to fiscal or financial measures affecting

the consumption of products or services by encouraging compliance

with such technical specifications or other requirements or rulers

on services< technical specification or other requirements or rules

on services linked to national social security systems are not

included.

“technical specification”, a specification contained in a

document which lays down the characteristics required of a product

such as levels of quality, performance, safety or dimensions,

including the requirements applicable to the products as regards

the name under which the product is sold, terminology, symbols,

testing and test methods, packaging, marking or labeling and

conformity assessment procedures.

“technical specification” shall also cover production methods

and processes used in respect of agricultural products as referred

to Article 38 (1) to the Treaty, products intended for human and

animal consumption, and medicinal products as defined in article

1 of Directive 65#65#EEC as well as production methods and

processes relating to other products, where these have an effect on

their characteristics<

(1) These regulations shall not apply to those measures which

Malta shall consider necessary under the Treaty for the protection of

persons, in particular workers, when products are used, provided that

such measures do not affect the products.

(2) These regulations shall not apply to>

i.

radio broadcasting

ii. television broadcasting services covered by point (a) of

article 1 of Directive 89#522#ECC.

(3) These regulations shall not apply to rules relating to

matters which are covered by Community legislation in the field of

telecommunications services, as defined by Directive 90#387#EEC.

(4) These regulations shall also not apply to rules relating

to matters which are covered by Community legislation in the field of

financial services, as listed non-exhaustively in Schedule IV.

(5) With the exception of regulation 8 (3), these regulations

shall not apply to rules enacted by or for regulated markets within the

meaning of Directive 93#22#EEC or by or for other markets or bodies

carrying out clearing or settlement functions for those markets.

(6) For the purposes of sub-regulation (5) hereof>

i. a rule shall be considered to be specifically aimed at

Information Society services where, having regard to its statement

of reasons and its operative part, the specific aim and object of all

or some of its individual provision is to regulate such services in

an explicit and targeted manner,

ii. a rule shall not be considered to be specifically aimed at

Information Society services if it affects such services only in an

implicit or incidental manner.

For the purposes of these regulations, the Malta Standards Notification Point.

Authority is hereby being designated as Malta’s “Notification Point”

for technical standards, regulations and for rules on Information Society

Services.

(1) The Commission and the standardization bodies referred Information to be

Given.

to in Schedules I and II shall be informed of the new subjects for which

the national bodies referred to in Schedule II have decided, by including

them in their standards programme, to prepare or amend a standard,

unless it is an identical or equivalent transposition of an international or

European standard.

(2) The information referred to in the previous sub-

regulation shall indicate, in particular, whether the standard concerned>

i. will transpose an international standard without being the

equivalent,

ii. will be a new national standard, or

iii.

will amend a national standard.

(3) Upon request of the Commission, the Authority shall

communicate to it all or part of the standards programmes.

(4) The Authority shall also make this information available

to the Member States in a form which allows the different programmes

to be assessed and compared.

(1) The Authority shall send to the standardization bodies

referred to in Schedules I and II and the Commission all draft standards

on request.

(2) They shall also be kept informed by the body concerned

of the action taken on any comments they have made relating to drafts.

(1)

The Authority shall take all the necessary steps to ensure

that it>

(a) communicates information in accordance with

regulations 5 and 6 hereof<

(b) publishes the draft standards in such a way that

comments may also be obtained from parties established in other

Member States<

(c) grants the other bodies referred to in Schedule II the

right to be involved passively or actively (by sending an observer)

in the planned activities<

(d) does not object to a subject for standardization in their

work programme being discussed at European level in accordance

with the rules laid down by the European standardization bodies

and undertake no action which may prejudice a decision in this

regard.

(2) In particular, any act of recognition, approval or use by

reference to a national standard adopted in breach of regulations 5 to 7

of these regulations, is prohibited.

(1) During the preparation of a European standard or after

its approval, the Authority shall not take any action which could

prejudice the harmonization intended and, in particular, that it does not

publish in the field in question a new or revised national standard which

is not completely in line with an existing European standard.

(2) For the purposes of this regulation, the term “preparation

of a European standard” shall refer to the request by the Commission to

the European standards institution to draw up a European standard within

a given time limit.

Regulation 8 shall not apply to the work of the Authority Exception.

undertaken at the request of the competent authority to draw up technical

specifications or a standard for specific products for the purpose of

enacting a technical regulation for such products.

(1) The Authority shall communicate all requests of the Communication of

Requirements.

kind referred to in regulation 9 to the Commission as draft technical

regulations and shall state the grounds for their enactment.

(2) The provisions of regulation 11 (6) shall apply to the

communication referred to in the previous sub-regulation.

(1) The competent authority shall communicate to the Further

Communications.

Authority any draft technical regulation forthwith and it shall also let

the Authority have a statement of the grounds which make the enactment

of such a technical regulation necessary, where these have not already

been made clear in the draft.

(2) The provision of the previous sub-regulation shall not

apply where the draft technical regulation merely transposes the full

text of an international or European standard, in which case, information

regarding the relevant standard shall suffice.

(3) Where appropriate, and unless it has already been sent

with a prior communication, the competent authority shall

simultaneously communicate the text of the basic legislative or

regulatory provisions principally and directly concerned, should

knowledge of such text be necessary to assess the implications of the

draft technical regulations.

(4) The competent authority shall communicate the draft

again under the foregoing provisions of this regulation, if they make

changes to the draft that have the effect of significantly altering its scope,

shortening the timetable originally envisaged for implementation, adding

specifications or requirements or making the latter more restrictive.

(5) Where, in particular the draft seeks to limit the marketing

or use of a chemical substance, preparation or product on grounds of

public health or of the protection of consumers or the environment, the

competent authority shall also forward either a summary or the

references of all relevant data relating to the substance, preparation or

product concerned and to known and available substitutes, where such

information may be available and communicate the anticipated effects

of the measures on public health and the protection of the consumer

and the environment, together with an analysis of the risk carried out as

appropriate 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 in the case of an existing substance or

article 3 (2) of Directive 67#548#EEC in the case of a new substance.

(6) The Authority shall be bound to communicate forthwith

to the Commission the information received by the competent authority

under the foregoing provisions of this regulation and, in any case, not

later than the first working day following that of the reception of the

information as aforesaid.

(7) Without prejudice and subject to regulation 11 (6), the

Authority shall regulate its own procedure on dealing with the

information received by the competent authorities.

(8) Such procedure shall be published and communicated

to all the competent authorities.

Responsible person.

(1) For the purposes of regulation 11, each competent

authority shall appoint a person, who shall be responsible for all the

communication which would have to be made between the competent

authority and the Authority pursuant to these regulations.

(2) Such person shall also be responsible for all the

correspondence between the Authority and the competent authority.

Provided that for the purposes of this regulation, “correspondence”

shall strictly refer to all the correspondence, electronic or otherwise,

arising out of the obligations under these regulations.

(1) Following communication to the Commission of a draft

technical regulation under the provisions of regulation 11, the Authority

shall receive comments which would have been made by the

Commission or the Member States, should this be the case.

(2) The Authority shall forward such comments to the

competent authority responsible for the draft technical regulation and

such competent authority shall take such comments into account as far

as possible in the subsequent preparation of the technical regulations.

(3) The competent authority shall communicate the

definitive text of a technical regulation to the Authority without delay.

(4) The Authority shall be bound to communicate forthwith

to the Commission the definitive text of technical regulation received

and the provisions of regulation 11 (3) shall apply mutatis mutandis to

such communication.

(5) All the information supplied under regulation 11 and

13 shall not be confidential except at the express request of the notifying

competent authority. Any such request shall be supported by reasons.

(6) In such cases, if necessary precautions are taken, the

Authority may seek expert advice from persons in the physical or legal

sectors.

(7) When draft technical regulations form part of measures

which are required to be communicated to the Commission at the draft

stage under another Community act, the competent authority may make

a communication to the Authority in terms of regulation 11 (6) under

that other Community act, provided that they formally indicate that the

said communication also constitutes a communication for the purposes

of this Directive.

(8) Such communication shall be made to the Authority and

the Authority shall forward such communication to the Commission.

(9) The provision of regulation 11 (6) shall apply mutatis

mutandis to the communication mentioned in the last preceding sub-

regulation.

(1) The competent authority shall postpone the publication Publication shall be

postponed.

of the draft technical regulation by three months from the date of receipt

by the Commission of the Communication referred to in regulation 11

(6).

(2) Such period shall be reckoned to start running from the

day following the day on which the Commission receives from the

Authority the communication in terms of regulation 11 (6).

(3) The competent authority shall postpone>

(i) for four months the adoption of a draft technical

regulation in the form of a voluntary agreement within the meaning

of the explanation of the de facto technical regulations in regulation

2. (ii) without prejudice to regulation 14 (7), (8) and (9) for

six months the adoption of any other draft technical regulation

(except for draft rules on services)

to be reckoned from the date of receipt by the Commission of the

communication referred to in regulation 11 (6) if the Commission or

another Member State delivers a detailed opinion within three months

of such date of receipt of communication by the Commission, to the

effect that the measures envisaged may create obstacles to the free

movement of goods within the internal market<

(iii)

without prejudice to regulation 14 (8) and (9), for four

months the adoption of any draft rule on services, from the date of

receipt by the Commission of the communication referred to

regulation 11 (6) if the Commission or another Member State

delivers a detailed opinion, within three months of such

communication, to the effect that the measure envisaged may create

obstacles to the free movement of services or to the freedom of

establishment of service operators within the internal market.

(4) With regard to draft rules on services, detailed opinions

from the Commission or Member State shall not affect any cultural

policy measures, in particular in the audiovisual sphere, which might

be adopted in accordance with Community law, taking account of their

linguistic diversity, their specific national and regional characteristics

and their cultural heritage.

(5) The competent authority concerned shall communicate

to the Authority the action it proposes to take on such detailed opinions.

(6) With respect to rules on services, however, the

competent authority concerned shall communicate to the Authority,

where appropriate, the reasons why the detailed opinions cannot be

taken into account.

(7) The provisions of regulation 11 (6) shall apply to the

communications listed in regulations 14 (4) and (5).

(8) With the exclusion of draft rules relating to services,

the competent authority shall postpone the publication of a draft technical

regulation for twelve months from the date of receipt by the Commission

of the communication referred to in regulation 11 (6), if within three

months of the receipt by the Commission of the communication by the

Authority in terms of regulation 11 (6), the commission announced its

intention of proposing or adopting a directive, regulation or decision

on the matter in accordance with article 189 of the Treaty.

(9) The competent authority shall postpone the publication

of a draft technical regulation for 12 months from the date of receipt by

the Commission of the communication referred to in regulation 11 (6),

if, within the three months following that date, the Commission

announces its findings that the draft technical regulation concerns a

matter which is covered by proposal for a directive, regulation or decision

presented to the Council in accordance with article 189 of the Treaty.

(10) If the Council adopts a common position during the

standstill period referred to in the two previous sub-regulations, the

period shall, subject to regulation 14 (10), be extended to 18 months.

(11) The obligations referred to in regulations 14 (7), (8)

and (9) shall lapse>

(i) when the Authority is informed by the Commission that

the latter no longer intends to propose or adopt a binding

Community act<

(ii) when the Authority is informed by the Commission of

the withdrawal of its draft or proposal<

(iii) when the Commission or the Council has adopted a

binding Community act.

(12) The provisions of this regulation shall not apply in cases

where>

(i) for urgent reasons, occasioned by serious and

unforeseeable circumstances relating to the protection of public

health or safety, the protection of animals or the preservation of

plants, and for rules on services, also for public policy, notably the

protection of minors, a Member State is obliged to prepare technical

regulations in a very short space of time in order to enact and

introduce them immediately without any consultations being

possible<

(ii)

for urgent reasons occasioned by serious

circumstances relating to the protection of the security and the

integrity of the financial system, notably the protection of

depositors, investors and insured persons, the competent authority

is obliged to enact and implement rules on financial services

immediately.

(13) In the communication mentioned in regulation 11 (1),

the competent authority shall give reasons for the urgency of the

measures taken, which reasons shall be communicated to the

Commission under the provisions of regulation 11 (6).

(14) The Commission shall give its views on the communication

as soon as possible and it shall be incumbent on the Authority to forward

this communication as soon as it is received by it.

(1) Regulations 11 and 14 shall not apply to those laws,

regulations and administrative provisions which>

(i) comply with binding Community acts which result in

the adoption of technical specifications or rules on services<

(ii) fulfill the obligations arising out of international

agreements which result in the adoption of common technical

specifications or rules on services in the Community<

(iii)

make use of safeguard clauses provided for in binding

Community acts<

(iv)

apply article 8(1) of Directive 92#59#EEC<

(v)

restrict themselves to implementing a judgment of the

Court of Justice of the European Communities<

(vi)

restrict themselves to amending a technical regulation

within the meaning of the definition of “technical regulations” listed

in regulation 2, in accordance with a Commission request, with a

view to removing an obstacle to trade or, in the case of rules on

services to the free movement of services or the freedom of

establishment of services operators.

(2) Regulation 14 shall not apply to laws, regulations and

administrative provisions prohibiting manufacture insofar as they do

not impede the free movement of products.

(3) Regulations 14 (7), (8) and (9) shall not apply to

voluntary agreements in terms of within the meaning of the explanation

of the second indent of the de facto technical regulations in regulation

2. (4) regulation 14 shall not apply to the technical

specifications or other requirements or the rules on services within the

meaning of the explanation of the second indent of the de facto technical

regulations in regulation 2.

(1) When a competent authority publishes a technical Technical

regulation.

regulation, it shall contain a reference to Directive 98#34 accompanied

by such reference on the occasion of its official publication.

(2) The Authority shall prescribe the methods of making

such reference.

The Minister shall take all appropriate action possible in cases Action to be taken

where improper use is made of the procedures contemplated in any part by the Minister.

of these regulations.

These regulations repeal the Procedure for the Provision of Repeal of L.N. 65

Information in the field of Technical Standards and Regulations and of of 2001.

Rules of Information Society Services Regulations, 2001.

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