NOTIFICATION OF PRODUCTS REGULATIONS

SUBSIDIARY LEGISLATION 427.87

NOTIFICATION OF PRODUCTS REGULATIONS

20th September, 2013

LEGAL NOTICE 281 of 2013.

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

Products Regulations.

(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

(E C ) N o 19 07 /20 06 o f th e E u ro pe a n P a r li a me nt a nd o f th e

European Council of 18 December 2006 concerning the

R e gi s t r a t i on , E v a l u a t i on , A ut h or i s a ti o n a nd R e s t r ic t io n o f

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

(E C ) N o 19 07 /20 06 o f th e E u ro pe a n P a r li a me nt a nd o f th e

European Council of 18 December 2006 concerning the

R e gi s t r a t i on , E v a l u a t i on , A ut h or i s a ti o n a nd R e s t r ic t io n o f

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

(E C ) N o 19 07 /20 06 o f th e E u ro pe a n P a r li a me nt a nd o f th e

European Council of 18 December 2006 concerning the

R e gi s t r a t i on , E v a l u a t i on , A ut h or i s a ti o n a nd R e s t r ic t io n o f

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.

The Regulatory Affairs Directorate within the Malta

C o m p e t i t i o n a n d C o n s u m e r A ff a i r s A u t h o r i t y i s t h e b o d y

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

"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.

(1) 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

product;

(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 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 referred

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