ILMA Compoundings – February 2019 - 13

data, that addresses the hazard/risk potential associated with
the chemical. Manufacturers and importers of chemicals
that are not associated with any of the referenced hazard/
risk criteria may also be selected for evaluation that requires
submittal of the same additional relevant data, including
study data.
EXCLUDED CHEMICAL SUBSTANCES
If adopted as currently drafted, the law will exclude the
following types of chemicals from its scope:
* Radioactive substances;
* Chemical substances in development or destined exclusively for the research, observing the quantitative ones
established in regulation;
* Non-isolated reaction intermediates, impurities, contaminants and chemicals produced by unintentional
reactions, including those produced in storage or due to
environmental factors;
* Chemical substances, mixtures and articles subject to
customs control that are in temporary storage, in free
zones or free warehouses with a view to their re-export,
or those in transit;
* Narcotic, psychotropic and immunosuppressive substances regulated under specific legislation;
* Substances used exclusively as tobacco ingredients and
derivatives;
* Metal alloys and metals in the form of plates, sheets,
strips, billets, ingots, beams and the like for structural
purposes;
* Explosives and their accessories; and
* Waste.
* The following products, subject to control under
specific legislation:
a. Agrochemicals and related substances, premixtures
and technical products;
b. Medicines and medical gases;
c. Cosmetics, toiletries and perfumes;
d. Sanitizers;
e. Products for veterinary use;
f. Food, food additives and processing aids;
g. Products intended for animal feed;
h. Fertilizers, inoculants and correctives;
i. Wood preservatives; and
j. Environmental remediators.

CONFIDENTIALITY
One meaningful risk associated with this law, if adopted as
drafted, concerns confidentiality of the chemical substances
themselves, as well as the data submitted when required. The
draft version of the law indicates that confidentiality will not
be provided to the data submitted, including the chemical
identity, except in rare circumstances.
This comment is troubling, as many companies routinely
clean confidentiality concerning the substances they manufacture or import. This alone may become strong impetus for
foreign suppliers to directly handle registration of substances
imported by Brazilian customers (discussed below).
NEW CHEMICAL SUBSTANCES
The draft law also provides that once the national inventory
is established, any "new chemical substance" (not inventory
listed) that is manufactured or imported at a volume of
greater than 1 ton per year (including non-PLC polymers)
must be registered with CONASQ. Full details concerning
registration requirements are not discussed in the draft
legislation, but the document does indicate that substantial
chemical data, including mammalian toxicological and
eco-toxicological data, will be required. Manufacturers
and importers (or foreign suppliers) also may submit a risk
assessment in addition to the data elements required.
Once new chemical substances are registered, they will be
added to the national chemical inventory immediately after
submittal, seemingly without the requirement of approval by
the regulator. However, to the extent that registration includes
nonpublic data, inclusion in the national inventory will be
suspended until the registrant provides a letter of access to the
nonpublic data, or until 10 years have elapsed since the time
of registration. Here, as with existing chemicals earlier discussed, confidentiality is not intended to be fluidly available.
COMPLIANCE BY FOREIGN SUPPLIERS
So far, the regulatory thought process includes facilitation of
foreign suppliers that desire to directly perform compliance
concerning their chemical substances in products. At present,
the authorities intend to provide two methods in support.
First, the draft permits foreign suppliers to appoint authorized
Brazilian agents to perform the required activities. In addition,
the document contemplates a direct port by which foreign
suppliers may register their substances directly, including the
submittal of supporting data that is required. However, nothing has yet been indicated concerning the ability to provide
registration data in English as opposed to Portuguese.
Eggenschwiler, an ILMA consultant, is an international
trade attorney and director of Global Trade for the
Redstone Group LLC. He can be reached at 614-923-7472
or jeggenschwiler@redstonegrp.com.

ILMA Compoundings – February 2019

Table of Contents for the Digital Edition of ILMA Compoundings – February 2019