Page 96 - Anuário Abihpec

Anuário ABIHPEC 2016
The highlights in the advances made by ABIHPEC in In November of 2015, the regulated sector was again
favor of the Cosmetics, Toiletries and Perfumary (CT&F) surprised by the Agency with the presentation of a
industn/ in the area of Technical and Regulaton/ Affair tax notification due to the absence of TFVS collection,
between 2015 and 2016 are directly related to the which was a collection of amounts retroactive to 2010
actions that minímized economic impacts in the face of in a single installment (until then they were tax-free),
regulatory changes in a time of crisis in Brazil. generating a million account in the order of R$ 70 million
The beginning of this phase in September of 2015 was reported by about 45% of member companies.
strongly marked by a monetary update in the order of In view of this scenario, ABIHPEC again filed a lawsuit
190% in Anvisas sanitan/ sun/eillance fiscalization rates seeking to defend its members and, in December of
(TFVS), promoted by the Treasury Department. 2015, was accepted a preliminary injunction suspending
However, in December of that year, through Law the retroactive collection and prohibition of enrollment
13.202/15, the Executive Power established that the first in Cadin and Active Debt tor companies affiliated with
monetary update of the value of federal taxes will be the entity that participated in the Iawsuit.
limited to half of the total value of the recomposition, but
to date the decree has not been regulated and the TFVS ELECTRONIC SYSTEM
still has a 190% increase for all companies and products
subject to sanitary surveillance. In April of 2015 the list of petitions awaiting review by
"ln view of the unstab/e scenario in Brazil, in addition Anvisa's Cosmetics Management (GECOS) became
to legal uncertainty, it was necessary to seek in defense available on the Agency's website, allowing greater
or' the ¡nterests of the members the rights to comp/y transparency and synergy between the regulator and the
with the values determined in Resolution RDC222/0ó industry so that companies could have predictabílity in
still in torce, until the new costs are set faith by the releasing their products.
Treasuiy Department - which were ensured by means With this dísclosure, there were approximately 1458
ot' an preliminary injunction," said João Carlos Basilio, cases (registration, post-registration and revalidation)
executive president of ABIHPEC. that are at GECOS awaiting evaluation, with an average
Also in this time, another resolution was provided ~ time of review of new products registration for 171 days
RDC No. 15/2015, which submits new laws related to and publication post registration of 250 days, "The main
Iabeling warnings for Children's products - adjustment obstacle thatprevents the advance ofthe HPPCinclust/y
that concerned companies in the industry because of the is still the requirement of registration of the products"
economic crisis, explained Basilio,
"ln order to minimize other negative economic impacts It must be noted that after the successive and
tor the CT&F industry, AB/HPEC dea/t with Anvisa a gradual advances in administrative improvement for
retroactive extension of the six-month deadline, which regularization of products occurred in 2014 and 2015,
was readih/ met by the Agency, allowing more time for only five categories have remained subject to previous
the packaging flowing", says Basilio. review (gel repellents, antiseptic forthe hands, Children's
products, sunscreen and hair smoothing). According
IMPROVEMENT IN THE REGULARIZATION OF to the area of Technical and Regulatory Affairs of the
PRODUCTS AND THE CHALLENGES FACED BY THE Association, the technical review periods practiced by
INDUSTRY: GECOS for these items are higher than those practiced
in 2014, even with the simplification of more than 77%
Since Anvisa's creation, by means of Law 9782/99, of the cases subject to technical review.
products subject to simplification of sanitary regulation Renata Amaral also points out that "we are talking
were not taxable and regulated by resolutions published about products of great importance for the protection
by its board of directors. otpub/ic health and all ot' them with low health risk. ln
However, in 2013 the Federal Attorney Generals Office addition, they are manufactured with their safety of use
argued that the legislation in force only allows exemption as a finished product”,
from collections through the publication of a specific
law a which did not happen. Therefore, Anvisa, through IMPACTS ON UPDATING THE SANITATION
Resolution RDC 07/15, submitted these products to REGULATORY FRAMEWORK
the administrative procedure called "exempt from
registration", which focus on TFVS. TThe period was marked by the absence of Mercosur
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