Establishment of Directorates of the Malta Standards Authority

L.N. 39 of 2008

MALTA STANDARDS AUTHORITY ACT

(CAP. 419)

Establishment of Directorates of the Malta Standards Authority

Order, 2008

IN exercise of the powers conferred by article 21 of the Malta

Standards Authority Act, 2000, 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 Establishment of

Directorates of the Malta Standards Authority Order, 2008.

Regulatory Affairs Directorate

1. Functions and Responsibilities of the Consumer and Industrial Goods

Unit under the Regulatory Affairs Directorate

(a) to draft legislation in relation to the areas indicated in paragraph (e)

hereof and issued by virtue of the Product Safety Act and by any other law<

(b) to advise the Minister, the Authority and other Government agencies

and the private sector, concerning this legislation and other matters ancillary

thereto<

(c) to assist all sectors of industry to understand and meet the essential

requirements imposed by technical regulations, issued by virtue of the Product

Safety Act and by any other law, and the technical, quality and safety requirements

of harmonised European and international standards issued by virtue of the Act<

(d) to co-ordinate and implement the Authority’s regulatory and

standardization programmes in the areas indicated in paragraph (e) hereof and, in

particular, to exercise the advisory functions assigned to the Authority by virtue

of the Product Safety Act and by any other law<

(e) to establish, with the consent of the Minister and of the Chairman of

the Authority, technical committees for the areas of competence hereunder

indicated, and to chair and co-ordinate the work of such committees relating to>

1. Motor vehicles

2. Electrical risk and electrical equipment

3. Electromagnetic compatibility

4. Radio equipment and telecommunications terminal equipment

5. Energy efficiency requirements

6. Mechanical devices

In this Order, the following definitions shall apply, unless the

context otherwise requires –

“the Act” means the Malta Standards Authority Act<

“the Authority” means the Malta Standards Authority<

“Head of Directorate” means the person appointed to that post

according to the provisions of article 3(17) of the Act<

“the Minister” means the Minister responsible for the Malta

Standards Authority.

Functions and Responsibilities of the Standardisation Directorate

(a) to draft standards according the Authority’s programme of

standardization and issue them by virtue of the Act<

(b) to adopt international standards and issue them as national standards

by virtue of the Act according the Authority’s programme of standardization<

(c)

to advise the Authority to repeal conflicting national standards<

(d) to ensure that all interested parties are adequately represented in

standardization activities<

(e) to advise the Minister, the Authority and other Government agencies

and the private sector, concerning standardization issues and other matters ancillary

thereto<

(f) to assist all sectors of industry to understand the importance of standards,

issued by virtue of the Act<

(g) to co-ordinate and implement the Authority’s programme of

standardization and certification such as conformity marking, public enquiry and

surveys on standardization needs, sale of standards, and other matters ancillary

thereto<

(h) to establish, with the consent of the Minister and of the Chairman of

the Authority, technical committees for the areas of competence as the Authority

may identify, and to chair and coordinate the work of such committees<

(i) to act as the focal point for any notification requirements involving the

Authority, for ensuring the free movement of goods principle<

(j) to formulate and give effect to programmes of technical assistance aimed

at business operators for the purpose of facilitating their compliance with relevant

standards<

(k) to communicate to the general public and to interested parties any

information regarding the Authority’s programme of standardization<

(l) to provide training and information on standardization matters and in

other matters ancillary thereto<

(m) to represent the Authority in relevant national and international activities

and express national vote on draft European and International standards<

(n) to carry out such other functions as the Authority may, from time to

time, direct.

There shall be established such Directorates within the

Authority in terms of article 3(14) of the Act, having such functions

and responsibilities as described in the schedule relative to each one of

such Directorates, as follows>

(a)

Regulatory Affairs Directorate (First Schedule)<

(b) Standardisation Directorate (Second Schedule)<

(c)

Metrology Directorate (Third Schedule)<

(d) Market Surveillance Directorate (Fourth Schedule).

Functions and Responsibilities of the Metrology Directorate

The functions and responsibilities of the Metrology Directorate are those assigned

to it under the Metrology Act (Cap.454) and under the Malta Standards Authority

(Establishment of the Metrology Directorate) Order, 2001 (L.N.312 of 2001).

(1) A Head of a Directorate shall be appointed according to

the provisions of article 3(17) of the Act.

(2) In exercising its functions under this Order, the

Directorate shall be functionally independent from the Authority as

regards substantive matters and, more specifically, as regards technical

matters within its area of competence. In particular, the Directorate shall

be independent of any other structure or official within the Authority as

regards the implementation of the functions listed in the relative schedule

to each Directorate.

(3) Without prejudice to subregulation (2), the Directorate

shall operate subject to the administrative and financial control of the

Authority as provided for in the Act and subject to the general policy of

the Authority.

Functions and Responsibilities of the Market Surveillance Directorate

The functions and responsibilities of the Market Surveillance Directorate shall be

those established under Part II, III and Part IV of the Product Safety Act (Cap.427).

(1) The Head of the Directorate may, with the agreement of Technical

Committees.

the Minister and of the Authority, establish technical committees in

order to provide scientific and technical advice as required by article

16(b)(iii) of the Act in the areas of competence indicated in each relative

schedule to this Order.

(2) The members of the technical committees shall be

nominated by the Minister on the advice of the Head of the Directorate.

(3) The Head of the Directorate shall chair and co-ordinate

the technical committees under his responsibility.

(4) The Head of the Directorate shall not have the right of

vote in the technical committees.

(5) The Head of the Directorate shall be responsible for

ensuring the competence, impartiality, transparency and independence

of the technical committees under his responsibility.

(6) The Minister may, on the advice of the Head of the

Directorate, remove, replace or suspend any member of a technical

committee if this is considered necessary by the Minister to maintain

the requirements stated in subregulation (5).

The Establishment of Directorates of the Malta Standards Repeals L.N. 213 of

2000. Authority Order, 2000, is hereby repealed.

Personal protective equipment

Construction products

Recreational seacraft

Medical devices

Pressure vessels

12. Toys

Gas appliances

Noise from vehicles and machinery

Pyrotechnics<

(f) to act as the focal point for any notification requirements involving the

Authority, for ensuring the free movement of goods principle<

(g) to formulate and give effect to programmes of technical assistance aimed

at business operators for the purpose of facilitating their compliance with relevant

technical regulations and standards<

(h) to communicate to the general public and to interested parties any

information regarding the Authority’s regulatory and standardization programmes

in the areas of competence indicated in paragraph (e) hereof<

(i) to provide training and information on technical regulations and

standards in the areas indicated in paragraph (e) hereof<

(j) to represent the Authority in relevant national and international activities<

(k) to perform risk assessment and to co-ordinate market surveillance

activities as prescribed in article 27 of the Product Safety Act (Cap. 427)<

(l) to carry out such other functions as the Minister may, from time to

time, direct.

2. Functions and Responsibilities of the Foodstuffs, Chemicals, Pesticides

and Cosmetics Unit under the Regulatory Affairs Directorate

(a) to draft legislation in relation to the areas indicated in paragraph (e)

hereof and issued by virtue of the Product Safety Act, the Pesticides Control Act

and the Food Safety Act<

(b) to advise the Minister, the Authority and other Government agencies

and the private sector, concerning this legislation and other matters ancillary

thereto<

(c) to assist all sectors of industry to understand and meet the essential

requirements imposed by technical regulations, issued by virtue of the Acts referred

to in paragraph (a) above, and the technical, quality and safety requirements of

harmonised European and international standards issued by virtue of the Act<

(d) to co-ordinate and implement the Authority’s regulatory and

standardization programmes in the areas indicated in paragraph (e) hereof and, in

particular, to exercise the advisory functions assigned to the Authority by virtue

of the Product Safety Act, the Food Safety Act and by any other law<

(e) to establish, with the consent of the Minister and of the Chairman of

the Authority, technical committees for the areas of competence hereunder

indicated, and to chair and co-ordinate the work of such committees relating to>

1. Foodstuffs, including materials for their production

2. Water

3. Alcoholic beverages

4. Fertilisers and animal feedingstuffs

5. Chemical substances, products and preparations

6. Medicinal and pharmaceutical products

7. Cosmetic products

8. Textiles and footwear

9. Glass, wood, paper and metal and products made therefrom

10. Packaging materials<

11. Pesticides<

(f) to act as the focal point for any notification requirements involving the

Authority, for ensuring the free movement of goods principle<

(g) to formulate and give effect to programmes of technical assistance aimed

at business operators for the purpose of facilitating their compliance with relevant

technical regulations and standards<

(h) to communicate to the general public and to interested parties any

information regarding the Authority’s regulatory and standardization programmes

in the areas of competence indicated in paragraph (e) hereof<

(i) to provide training and information on technical regulations and

standards in the areas indicated in paragraph (e) hereof<

(j) to represent the Authority in relevant national and international activities<

(k) to perform those functions of the Food Safety Commission prescribed

under article 7A of the Food Safety Act (Cap. 449)<

(l) to perform duties arising from the Pesticides Control Act (Cap. 430)

and its subsidiary legislation, namely>

1. Plant Protection Products Regulations (L.N.115 of 2004)<

2. Maximum Residue Levels of Pesticides in Produce of Plant Origin

Regulations (L.N.199 of 2004)<

3. Biocides Regulations (L.N.294 of 2004)<

4. European Community Methods of Sampling for Official Control

of Pesticide Residues in and on Products of Plant and Animal Origin

Regulations (L.N. 479 of 2004) (This legal instrument only lays down the

methodology to be used)<

5. Maximum Residue Levels of Pesticides in Produce of Animal Origin

Regulations (L.N.117 of 2005)<

6. Activities concerning the Professional Use of Toxic Products Rules

(L.N.350 of 2005)<

(m) to carry out such other functions as the Minister may, from time to

time, direct.