Chemicals Enforcement (E-REACH) Committee Regulations,

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,308, 12 ta’ Settembru, 2008

L.N. 207 of 2008

PRODUCT SAFETY ACT

(CAP. 427)

Registration, Evaluation, Authorisation and Restriction of

Chemicals Enforcement (E-REACH) Committee Regulations,

IN exercise of the powers conferred by article 39 of the Product

Safety Act, the Minister of Finance, Economy and Investment, on the

advice of the Malta Standards Authority has made the following

regulations>-

(1) The title of these regulations is the Registration, Citation and

Evaluation, Authorisation and Restrictions of Chemicals Enforcement commencement.

(E-REACH) Committee Regulations, 2008.

(2) These regulations shall come into force on such date as

the Minister responsible for the Malta Standards Authority may by notice

in the Gazette appoint, and different dates may be so appointed for

different provisions and different purposes of these regulations.

The objectives of these regulations is to set up a committee to Objectives.

assist the Malta Standards Authority, with the aim to achieve a holistic

multi-partite approach for the implementation and management of the

enforcement of Regulation (EC) No 1907#2006 of The European

Parliament and of The Council of 18 December 2006 concerning the

Registration, Evaluation, Authorisation and Restriction of Chemicals

(REACH), establishing a European Chemicals Agency, amending

Directive 1999#45#EC and repealing Council Regulation (EEC) No

793#93 and Commission Regulation (EC) No 1488#94 as well as Council

Directive 76#769#EEC and Commission Directives 91#155#EEC,

93#67#EEC, 93#105#EC and 2000#21#EC.

(1)

In these regulations, unless the context otherwise Definitions.

requires>

“Minister” means the minister responsible for the Malta

Standards Authority<

“Act” mean the Product Safety Act<

“Chairman” means the Chairman of the Committee<

“competent authority” means the Malta Standards Authority<

“committee” means the Registration, Evaluation,

Authorisation and Restrictions of Chemicals Enforcement (E-

REACH) Committee<

“chemical” means a substance or preparation<

“substance” means a chemical element and its compounds in

the natural state or obtain by any manufacturing proves, including

any additive necessary to preserve its stability and any impurity

derived from the process used, but excluding any solvent which

may be separated without affecting the stability of the substance

or changing its composition<

“preparation” means a mixture or solution composed of two

or more substances<

“Council Regulation” means Regulation (EC) No 1907#2006

of The European Parliament and of The Council of 18 December

2006 concerning the Registration, Evaluation, Authorisation and

Restriction of Chemicals (REACH), establishing a European

Chemicals Agency, amending Directive 1999#45#EC and repealing

Council Regulation (EEC) No 793#93 and Commission Regulation

(EC) No 1488#94 as well as Council Directive 76#769#EEC and

Commission Directives 91#155#EEC, 93#67#EEC, 93#105#EC and

2000#21#EC.

(2) Any other terminology shall be understood to have the

same meaning ascribed to it under the Council Regulation.

The Registration, Evaluation, Authorisation and Restrictions

of Chemicals Enforcement (E-REACH) Committee shall be established

under these regulations.

(1) The composition, terms of reference and procedure of

the Committee shall be respectively those shown in Schedules I, II and

III to these regulations.

(2)

The Minister shall appoint a Board secretary to the

Committee.

(3) The members of the Committee shall be so appointed

for a term of three years>

Provided that>

(a) the Chairman and the other members of the Committee

may resign their office at any time by giving notice in writing to

the Minister< and

(b) the Minister may at any time remove the Chairman and,

or any of the members of the Committee on grounds of disability

to perform their functions, of bankruptcy or neglect of duty.

(4) Without prejudice to any of these regulations and

Schedule III to these regulations, the Committee shall regulate its own

procedures and meetings.

(5) The quorum necessary for meetings of the Committee

shall be the Chairperson and not less than half the other members.

Provided that the Committee may act notwithstanding any

vacancy among its members.

(6) The decisions of the Committee shall be taken by a

majority of votes of members present at the meeting. The Chairperson

of the Committee shall have an original vote and, in the case of equality

of votes, also a second or casting vote.

(7) If the powers conferred on the members of the

Committee under this regulation contradict or, in any way, come into

conflict with any of the powers conferred on the same members under

any legislation governing these members, the prevailing powers shall

be those set out under the other legislation governing these members.

The Chairman may set up any consultative committee made Consultative

up of representatives from the industry, consumer associations and non- committees.

governmental organisations to assist the Committee as it may deem

necessary.

The judicial and legal representation of the Committee shall Judicial and legal

representation.

vest in the Chairperson>

Provided that the Committee may appoint any one or more of the

other members to appear in the name and on behalf of the Committee in

any judicial proceedings, and in any act, contract, instrument or other

transaction whatsoever.

(1) The committee may make or issue public statements

identifying and giving warnings or information about any of the

following>

(a) chemicals that are injurious to health or to the

environment<

(b) the supply of chemicals, by whomsoever supplied, which

are or which may potentially cause injury to the health or which

are harmful to the environment, and the persons engaged in the

supply of chemicals<

(c) practices, conducted in relation to any chemical

operation, which are detrimental to the interests of consumers, the

environment and, or the persons who engage in such practices<

(d) any other matter that adversely affects or may adversely

affect the environment or health of those persons in connection

with the acquisition or use of chemicals.

(2) When making a statement as is referred to in subarticle

8(1) above, the Committee shall adhere to the principles of

confidentiality consistency, fairness and objectivity, and shall not make

such statements unless it is in the public interest to do so.

(3) The Government, the Committee and any public officer

acting on the instructions or authority of the Committee, shall not be or

become liable for any acts done in good faith under subarticle 8(1)<

such exemption from liability shall extend to all persons publishing,

printing, recording, broadcasting, communicating or reproducing such

information in any form whatsoever.

Conduct of business

(1) The Minister may appoint a body to periodically advise,

supervise and audit the functions of the Committee.

(2) The Minister may make, amend or revoke regulations

for the proper conduct of the business of the Committee.

Schedule 1

Composition of the Registration, Evaluation, Authorisation and Restrictions of

Chemicals Enforcement (E-REACH) Committee

The Registration, Evaluation, Authorisation and Restrictions of Chemicals

Enforcement (E-REACH) Committee shall consist of>

(a) The Director responsible for chemicals within the Malta Standards

Authority, designated by the Chairman of that Authority, who shall act as

Chairman<

(b) The Director (or his delegate) for environment protection, designated

by the Minister responsible for environment protection<

(c) The Director (or his delegate) of the Market Surveillance Directorate

within the Malta Standards Authority<

(d) The Comptroller of Customs (or his delegate).

The Occupational Health and Safety Authority and the Public Health Department

shall be consulted by the Committee in matters affecting their respective area of

competence.

The Chairman may also invite any other representatives as required by the

Committee, to attend Committee proceedings without voting rights.

Schedule II

Terms of reference of the Registration, Evaluation, Authorisation and

Restrictions of Chemicals Enforcement (E-REACH) Committee

The terms of reference of the Registration, Evaluation, Authorisation and

Restrictions of Chemicals Enforcement (E-REACH) Committee shall include>

(a) The monitoring and coordination of enforcement of the Council

Regulation and any other relevant legislation, standards and practices in relation

to chemical operations, chemical premises and actors in the supply chain operating

in the chemical sector<

(b) Formulate and implement policies and strategies with short-term and

long-term objectives, in relation to all matters relating to chemicals, including

the development of a national surveillance and enforcement plan for chemical

safety and to ensure the effective, transparent and comprehensive implementation

of such plan<

(c) Carry out studies, research or investigation on any matter relating to

the usage of chemicals within the scope of the Council Regulation and for such

purposes shall require the submission of any information and shall analyse and

interpret any data or information submitted to it<

(d) Ensure that proper records and registers are kept to ensure the persons

responsible for any chemical may be identified<

(e) Carry out such other duties as may be conductive to the better

performance of its function under these regulations<

(f) Advice the Competent Authority on the nomination of experts for the

Risk Assessment and Socio-economic analysis Committees of the Agency<

(g) Provide the nominated experts of the Risk Assessment and Socio-

economic analysis Committees with regards to requested information, research

and secretarial support<

(h) Propose and advise upon the appropriate legal and administrative

framework to implement the Council Regulation<

(i) Management of chemicals affecting the environment, human health

and safety<

(j) Gathering of information from actors in the supply chain<

(k) Evaluating the risks of chemicals without prejudice to other provisions

adopted<

(l) Setting up an information system on chemicals and the protection of

health and the environment.

Schedule III

Procedure of the Registration, Evaluation, Authorisation and Restrictions of

Chemicals Enforcement (E-REACH) Committee

(a) The Committee shall affectively apply the precautionary principle when

a signification chemical risk to the environment, human health and safety is

identified or reasonably suspected<

(b) The Chairman shall submit to the committee a draft of the measures to

be taken. The committee shall deliver its opinion in the draft within a time-limit

which the Chairman may lay down according to the urgency of the matter. The

opinion shall be delivered by the majority as laid down in regulation 5(6)<

(c) The Competent Authority shall adopt the measures envisaged if it is in

accordance with the opinion of the Committee.

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