Law Draft
 
 
 
Disposes on the registration, evaluation 
and control of 
industrial chemicals
.
 
 
 
The PRESIDENT OF THE REPUBLIC,
 
decree and 
sanction the following law:
 
 
 
Art
icle 
1. This law establishes the registration, evaluation and control of 
industrial 
ch
emicals, in order to minimize adverse impacts on health and the environment from
 
its 
production, import and use in the country.
 
 
Art
icle
 
2
. 
For the purpo
ses of this law are 
considered.
 
 
I 
-
 
Additive: a chemical substance 
intentionally added to stabilize the chemical that is 
desired to end the process
;
 
 
II
 
-
 
Impurity: constituent
 
not 
intentionally
 
present in a chemical substance after its 
manufacture, and 
that 
may have
 
be
 
originated in the raw materials used or result from
 
a 
secondary or incomplete reactions during the production process. Despite being present in 
the final 
substanc
e
,
 
is not intentionally added
;
 
III 
-
 
Intentional Mixture: intentional combination of two or m
ore 
chemical 
substances, 
without chemical reaction 
occur
ring
 
between them
;
 
IV 
-
 
Finished 
(Final)
 
product: product intended for the
 
use of
 
final
 
consu
mer and that 
does not require modification 
or preparations to be
 
placed in the market
;
 
V
-
 
Industrial 
Chemical
: 
a chemical element and its compounds in the natural state or 
obtained by a manufacturing process, including any additive necessary to preserve its sta-
bility and any impurity deriving from the process used, but excluding any solvent which may 
be s
eparated without affecting the stability of the substance , or changing its composition;
 
VI 
-
 
Chemical in development or intended for research: 
chemical 
extracted, devel-
oped, produced or imported
,
 
directly used in study or research in the country, 
including the 
phases of testing.
 
S
uch 
chemicals 
substances may not be available for sale or trade in any 
form.
 
Article 
3
. Excluded from the application of this law:
 
I
-
 
radioactive chemicals;
 
II
-
 
chemicals under development or intended exclusively for resea
rch, observing the 
quantity set out in
 
the secondary
 
law
;
  
 
III not isolated
 
intermediaries
 
of
 
reaction
s
, impurities, contaminants and
 
chemicals
 
substances produced by unintended reactions, including those produced on storage or due 
to environmental factors
;
 
IV
 
-
 
ores and 
its 
concentrates, as well as other rocks and minerals, including coal and 
coke, crude oil, natural gas, liquefied petroleum gas, natural condensate
 
gas, gas
es and 
mineral components from minerals 
production
 
processes, except for those which
 
are 
chemically modified or which are formed or 
contain chemicals
 
substances classified as 
hazardous
,
 
according to the criteria and requirements
 
of GHS (
Globally Harmonize
d System
 
of Classification and Labelling
 
of Chemical
s
)
;
 
V
-
 
metals and
 
its
 
alloys in th
e form of plates, sheets, strips, billets, ingots, beams and 
others similar forms
 
used in structural p
u
rposes;
 
VI
-
 
active ingredients of agrochemicals, 
if used exclusively
 
for this purpose;
 
VII 
-
 
active ingredients of drugs, 
if used exclusively
 
for this purpose;
 
VIII 
-
 
active ingredients of veterinary products, 
if used exclusively
 
for this purpose;
 
Art
icle
 
4. 
 
It is 
established the National 
System for
 
Register of Industrial
 
Chemicals
, 
to 
be implemented
 
and maintained by the federal agenc
y
 
responsible for
 
the 
environmental 
sector.
 
Article 5. 
The 
producers and importers of industrial chemicals
 
as such or present in 
intentional mixtures, in an amount equal to or greater than 
1 (
one
)
 
ton per year
 
are required 
to provide
 
the following
 
information i
n
 
the
 
National 
System for Register of Industrial Chemi-
cals
:
 
I
-
 
identification of the producer 
or
 
importer company
;
 
II
-
 
identity of the
 
industrial
 
chemical, according to
 
the
 
name and registration number 
in
 
the
 
Chemical Abstracts Service (CAS) 
a
nd, where applicable, its structu
ral formula
;
 
III
-
 
quantity 
range 
of production or import
 
per year;
 
IV
-
 
uses of the 
industrial 
chemical
;
 
V
-
 
hazard
 
classification regarding
 
health and th
e environment, according to GHS.
 
 
§ 
1
.
 
The Deliberative Committee 
for
 
Industrial Chemicals can, based on 
the 
risk
 
that 
some industrial chemicals could 
cause to 
health or environment, stablish lower 
quantities
 
than 1 ton per year for the registry in the 
National 
System for Register of Industrial Chemi-
cals.
 
§ 2. 
When it comes to intentional mixtures, just the industrial chemicals 
that compose 
it should be registered in the 
National 
System for Register of Industrial Chemicals.
 
  
 
 
Article 6. The period for registry in the 
National 
System for Register of Industrial
 
Chemicals
 
will be 3 (three) years, from the day of 
its 
creation,
 
without any 
prejudice 
of cur-
rent production or importat
 
activities.
 
 
§ 
1
.
 
The production and import 
of 
industrial 
chemical
s 
as such or present in inten
tional 
mixtures shall be subject to 
prior registration
 
in the 
National 
System for Register of Industrial 
Chemicals after the period of 3 years mentioned.
 
§ 
2
. The 
i
nformation
 
in the 
National 
System for Register of Industrial Chemicals 
must 
be updated 
every time
 
occurs changes 
on the
 
use
 
of the 
industrial 
chemical
, 
on the
 
annually
 
quantity
 
range 
of production or import
 
and
 
on the 
hazard
 
classification
.
 
§ 
3.
 
It 
is ensured publicity to the contents of 
the 
National 
System for Register of In-
dustrial Chemicals
, 
safeguarded 
the secrets and 
confidentiality
 
of personal information, in-
dustr
ial
 
and trade, according to current law
 
regarding this issue
.
 
Art
icle
 
7.
 
Industrial 
Chemicals 
subjected
 
to this 
law shall 
be classified and labeled 
by 
the 
producers
 
and importers 
accor
d
ing to GHS
, 
detailed in
 
the secondary law.
 
Art
icle 8.
 
The f
ederal 
agencies
 
in charge
 
of 
environment
,
 
health, labor
 
and industry
 
sectors
 
will 
form
 
the Technical Committee for
 
Industrial 
Chemicals
, 
in order to select and 
evaluate, 
regarding
 
the risk to the
 
e
nvironment and human 
health
,
 
the industrial 
  
c
hemicals 
present 
in 
the 
National 
System for Register of Industrial Chemicals
.
 
 
Article 9. 
The criteria for selecting the 
industrial 
chemicals to be evaluated 
by the 
Technical Committee for
 
Industrial 
Chemicals
 
are:
 
I
-
 
 
persistence
, bioaccumulation 
or
 
toxicity to the environment;
 
II
-
 
carcinogenicity, mutagenicity or reproductive toxicity;
 
III
-
 
endocrine disruptors characteristics
, based on scientific evidences
;
 
IV
-
 
significant potential for human exposure or the environment;
 
V
-
 
to
 
be control
led 
under some warning, intern
ational agreement or convention
 
that 
Brazil is signatory
.
 
§ 
1. 
The industrial chemicals 
which do not fulfil the criteria above
,
 
but for which there 
is scientific evidence of probable serious effects to human health or the environment
,
 
which 
give rise to an equivalent level of concern to those of other 
industrial chemical
 
listed in the 
above points and which are identified on a cas
e
-
by
-
case basis
, could be object of selection 
and evaluation by the
 
Technical Committee for
 
Industrial 
Chemicals
, in accordance with the 
secondary law
.
  
 
§
 
2 The 
producers and importers of industrial
 
chemicals subject to 
evaluation
 
will 
be 
demanded
 
to provide
 
additional
 
information, studies and safety data sheets
 
to support the 
risk assessment.
 
Art
icle 10
.
 
The f
ederal 
agencies
 
in charge
 
of 
environment
,
 
health, labor
 
and industry
 
sectors
 
will 
form the Deliberative Committee for
 
Industrial Chemicals
, 
in order to 
stablish
 
the
 
risk management measures to be
 
adopted for 
evaluated
 
industrial 
chemicals
, in view of
 
eliminate or reduce the risks to 
health and the environment. It 
may 
be 
adopt
ed
 
one or more 
of the following measures:
 
I
-
 
voluntary agreements 
between government and industry to achieve the objectives
 
of protectio
n of health and the environment;
 
II
-
 
setting lower 
quantities than 1 ton 
of production or import 
per year
 
to provide infor-
mation on 
the
 
National 
System for Register of Industrial Chemica
ls
;
 
I
I
I
-
 
ban on production, import, export, trade and use of the 
industrial chemical
;
 
IV
-
 
restriction
 
on
 
production, import, export, trade and use of the 
industrial chemical
;
 
V
-
 
limit the
 
concentration 
of
 
the industrial 
chemical in 
final 
products
 
or
 
i
ntentio
nal 
m
ixture
s
;
 
V
I
-
 
requirement of prior authorization for the production and import 
of a 
industrial 
chemical
.
 
§ 1 
F
ederal 
institutions
 
responsible for sectors that may be impacted by 
the 
risk man-
agement measures 
shall be consulted prior the decision of the 
Deliberative Committee for
 
Industrial Chemicals.
 
§ 2. Producers and importers of chemical substances subject to risk management 
measures 
must
 
provide periodic information on
 
the 
National 
System for Register of I
ndustrial 
Chemicals
, with frequency and information to be requested 
defined 
by the 
Deliberative Com-
mittee for
 
Industrial 
Chemicals
.
 
Art
icle 11. The risk management measures defined by the 
Deliberative Committee 
for
 
Industrial 
Chemicals
 
shall be met by:
 
I
-
 
Producers and importe
r
s
 
of industrial chemicals subjected
 
to risk management 
measures;
 
II
-
  
Importers of intentional mixtures and final products which have in its composition 
industrial chemicals 
subjected to risk management measures;
  
 
III
-
 
producers of 
intentional mixtures and final products which have in its composition 
industrial chemicals 
subjected to risk management measures;
 
Article 12. 
Failure to comply with obligations under this law shall subject the violator 
to 
the 
sancti
ons: 
 
 
I
-
 
warning;
 
II
-
 
fine;
 
III
-
 
partial or total suspension of activities;
 
IV
-
 
recoil
 
of 
the industrial 
chemical
, intentional mixture 
or 
final
 
product;
 
V
-
 
destruction of 
the 
chemical 
substance
,
 
intentional mixture 
or 
final
 
product;
 
VI
-
 
promotion of
 
programs
 
projects and studies 
in order to improve
 
industrial
 
chemi-
cals
 
management.
 
VII 
-
 
evaluation and 
damage
 
repair to human health and the environment.
 
Article 13
. It is subject to the application of sanctions those who:
 
I
-
 
do not register in the 
National 
System for Register of Industrial Chemicals
 
infor-
mation regarding
 
the industrial chemicals as such or present in intentional mixtures that 
produce or import;
 
II
-
 
to provide false, misleading or 
omit
 
information in 
National 
System for Register of 
Industrial
 
Chemicals
;
 
III
-
 
to fail in updating
 
the information in 
National 
System for Register of Industrial 
Chemicals
 
when new data become available;
 
IV
-
 
to present false, misleading or omitted studies to support the evaluation of the 
industrial 
chemical;
 
V
-
 
do
 
not 
comply with
 
the risk management measures
 
defined
.
 
VI
-
 
to produce, import, put into market, donate or use 
industrial 
chemicals in 
non
com-
pliance with the provisions of this law and its 
secondary law
.
 
Art
icle 14
. 
The inspections regarding the compliance 
with this law will be carried out 
by the federal agencies 
in charge
 
of 
environment
,
 
health, labor
 
and industry
 
sectors, accord-
ing to the secondary law.
 
Art
icle 15.
 
The Executive 
Power
 
shall regulate this law within 180 days from the date 
of its publication.
 
Art
icle 16
 
The 
secondary law will
 
establish procedures for the registration, evaluation 
and definition of risk management measures for
 
industrial 
chemicals.
 
Art
icle 17
.
 
This Law 
shall enter into force on the date of its publication.