REGISTRATION, EVALUATION, AUTHORISATION AND RESTRICTION OF CHEMICALS ENFORCEMENT (E-REACH) COMMITTEE (e-reach)

(E-REACH) COMMITTEE

SUBSIDIARY LEGISLATION 427.67

REGISTRATION, EVALUATION, AUTHORISATION

AND RESTRICTION OF CHEMICALS

ENFORCEMENT (E-REACH) COMMITTEE

REGULATIONS

12th September, 2008

LEGAL NOTICE 207 of 2008.

The title of these regulations is the Registration,

Evaluation, Authorisation and Restriction of Chemicals

Enforcement (E-REACH) Committee Regulations.

The objectives of these regulations is to set up a committee

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

hol istic mu lti -par ti te app ro ach f or the im plem ent at ion 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

requires

"Ministe r" means the M inister res po nsi bl e fo r t he Ma lt a

Standards Authority;

"Act" means 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

(E-REACH) COMMITTEE

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.

(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, 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

m a d e u p o f r e p r e s e n t a t i v e s f r o m t h e i n d u s t r y, c o n s u m e r

associations and non-governmental organisations to assist the

(E-REACH) COMMITTEE

Committee as he may deem necessary.

The judicial and legal representation of the Committee

shall 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 (1),

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

(1); such exemption from liability shall extend to all persons

publishing, printing, recording, broadcasting, communicating or

reproducing such information in any form whatsoever.

(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.

(E-REACH) 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)

advise the competent authority on the nomination of experts for the

Risk Assessment and Socio-economic Analysis Committees of the

(E-REACH) COMMITTEE

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.