Notification of Products Regulations, 2013

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19, 140, 20 ta’ Settembru, 2013

Taqsima B

L.N. 281 of 2013

PRODUCT SAFETY ACT

(CAP. 427)

Notification of Products Regulations, 2013

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

Safety Act, the Minister for Social Dialogue, Consumer Affairs and

Civil Liberties, on the advice of the Malta Competition and Consumer

Affairs Authority, has made the following regulations

(1)

The title of these regulations is the Notification of Title and scope.

Products Regulations, 2013.

(2) These regulations implement the provisions of

(a)

Article 45 of Regulation (EC) No 1272/2008 of the

European Parliament and of the Council of 16 December 2008

on classification, labelling and packaging of substances and

mixtures, amending and repealing Directives 67/548/EEC and

1999/45/EC, and amending Regulation (EC) No 1907/2006;

(b)

Article 9 of Regulation (EC) No 648/2004 of the

European Parliament and of the Council of 31 March 2004 on

detergents; and

(c)

Article 68 of Regulation (EC) No 1107/2009 of the

European Parliament and of the Council of 21 October 2009

concerning the placing of plant protection products on the

market and repealing Council Directives 79/117/EEC and 91/

414/EEC.

List of products that need to be notified

"Substance" as defined in paragraph 1 of Article 3 in Regulation

(EC) No 1907/2006 of the European Parliament and of the

European 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;

"Mixture" as defined in paragraph 2 of Article 3 in Regulation

(EC) No 1907/2006 of the European Parliament and of the

European 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;

"Polymer" as defined in paragraph 5 of Article 3 in Regulation

(EC) No 1907/2006 of the European Parliament and of the

European 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;

"Detergent" as defined in paragraph 1 of Article 2 in Regulation

(EC) No 648/2004 of the European Parliament and of the

European Council of 31 March 2004 on detergents;

"Biocidal product" as defined in Article 3 1(a) of Regulation

(EU) No 528/2012 of the European Parliament and of the Council

of 22 May 2012 concerning the making available on the market

and use of biocidal products;

"Plant protection products" as defined in paragraph 1 of Article

2 in Regulation (EC) No 1107/2009 of the European Parliament

and of the Council of 21 October 2009 concerning the placing of

plant protection products on the market and repealing Council

Directives 79/117/EEC and 91/414/EEC and "active substances

and co-formulants" manufactured or imported for use in plant

protection products only and included either in Commission

Regulation (EEC) No 3600/92, Commission Regulation (EC) No

703/2001, Commission Regulation (EC) No 1490/2002, or

Commission Decision 2003/565/EC and for any substance for

which a Commission Decision on the completeness of the dossier

has been taken pursuant to Article 6 of Directive 91/414/EEC.

€0.27

The Regulatory Affairs Directorate within the Malta Establishment

Competition and Consumer Affairs Authority is the body responsible of

responsible.

within the meaning of Article 45(1) of Regulation (EC) No 1272/

2008 of the European Parliament and of the Council of 16 December

2008 on classification, labelling and packaging of substances and

mixtures, amending and repealing Directives 67/548/EEC and 1999/

45/EC, and amending Regulation (EC) No 1907/2006.

For the purposes of these regulations

Definitions.

"the body responsible" means the Malta Competition and

Consumer Affairs Authority;

"the notifier" means any natural or legal person established in

the European Community that makes available the products, as

defined in the Schedule, for the first time, in Malta;

"product" shall mean one of the products listed in the Schedule.

The notifier shall notify to the body responsible the

information referred to in sub-regulation (2). The information

gathered shall constitute the database of the products.

(2) Any notifier of chemical products shall submit, by

electronic means, using the format provided by the body responsible,

the following information for each product to the body responsible

(a)

the name or names or trademarks of the product;

(b)

the name and address, telephone and fax numbers

and, if available, the e-mail address, of the responsible person

that makes the product available on the Maltese market;

(c)

the country of origin in the case of import from

outside the European Community;

(d)

the qualitative and quantitative composition of the

(e)

the physical-chemical properties of the product;

(f)

any field of application and use;

(g)

the labelling of the product, as applicable,

according to one of the following

(i) Regulation (EC) No 1272/2008 of the

European Parliament and of the Council of 16 December

2008 on classification, labelling and packaging of

substances and mixtures, including the hazard pictograms,

the signal words, the hazard statements, and the

precautionary statements;

(ii)

The Dangerous Substances Regulations; or

(iii) The Dangerous Substances and Preparations

Regulations;

(h)

a copy of the original label of the final product; and

(i)

the safety data sheet according to the Registration,

Evaluation, Authorisation and Restriction of Chemicals

(REACH) (Implementation) (Amendment) Regulations, 2009 S.L. 427. 66.

and according to 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.

(3) For the purpose of sub-regulation (2)(d) the submission of

concentration ranges shall suffice.

(4) Each notifier shall be assigned a "company code" and each

product shall be assigned a "product code". At the marketing stages

other than the retail stage, the product code shall be displayed on the

accompanying documents which may include the invoice.

(5) Information and data, contained in the database referred to

in sub-regulation (2), shall only be used for health purposes in view

of formulating preventive or curative measures, in particular in the

event of emergency health response.

(1)

The notifier must supply information and data Transitional

referred to in regulation 4(2), within 30 days from the date they are provisions.

first made available on the Maltese market. For the products that were

made available before the date of publication of these regulations, the

following shall apply

(a)

plant protection products and active substances

manufactured or imported for use in biocidal products shall be

notified within 90 days from the date of publication of these

regulations;

(b)

inks and polymers shall be notified within 120 days

from the date of publication of these regulations;

(c

detergents and fertilisers shall be notified within

six months from the date of publication of these regulations;

(d)

chemicals used, for paints and varnishes, for

cleaning and maintenance, for adhesives and sealants, shall be

notified within eight months from the date of publication of

these regulations;

(e)

other chemical products not mentioned in

paragraphs (a) to (d) shall be notified within 1 year from the

date of publication of these regulations.

The penalties applicable for infringement of the provisions

within these regulations shall be those provided for in Part IV of the

Product Safety Act.