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NOTÍCIAS

Lifesciences

National Health Surveillance Agency classifies as exempt from registry the personal hygiene products, cosmetics and perfumes for children

Came into force National Health Surveillance Agency’sthe RDC No. 237/2018, issued by the National Health Surveillance Agency (“ANVISA”), which establishes setting forth technical requirements for the regularization of personal hygiene products, cosmetics and perfumes (“HPPC” in the Portuguese acronym).

ANVISA has been understood that HPPC products for children are considered of low sanitary risk by its own nature and the exemption of its registry follows a global tendency.

However, it is emphasized that the register exemption does not imply in the reduction of necessary technical requirements or manufacturer responsibility. On the contrary, the manufacturer must possess hold updated all the data and documents supporting the quality, safety and effectiveness supporting documents of its products in order toto comply with the legislation.

Products exempt from registry must be regularized in the ANVISA’s Cosmetic Products Automated System. Companies have until the end of the validity term of the current register to adjust to the new Resolution.

Insect repellents of child use and sunscreen for kids remains subjected to register before ANVISA.

Infrastructure

New Law of State of Rio de Janeiro requires that Concessionaires of Public Services inform in real time its service interruptions

Came into force State Law No. 8,099/2018, which instituted the obligation for Concessionaires of Public Services to inform through all possible means of communication, including social media, about its service interruptions by natural or provoked causes.

Such Law defines that the Concessionaires must inform the reason of the interruption and re-establishment estimative. In case of scheduled interruptions, the Concessionaire must inform the fact within 24 hours of advance.

In case of noncompliance, the Concessionaire may subject to the fines set forth in the Consumer Defense Code.

Environmental Law

Public Civil Actions filed by IBAMA may increase

Federal Institute for the Environment and Renewable Natural Resources (“IBAMA”) has published the Ordinance No. 2.723/2018, on September 19, 2018, with the purpose of regulating and planning the filing of Public Civil Actions to verify civil liability originated by environmental infractions.

The main objectives defined are ensuring the effectiveness of Annual Environment Protection Plan and to promote the civil environmental liability of the major national offenders.

Counterclaims for the purposes of civil environmental liability of offenders do not qualify to the Ordinance mentioned. This type of action already is regulated by other specific Ordinance of IBAMA.
The KLA environmental team is available for any clarifications.

Administrative and Public Law

Supreme Court decides that entry of judgment issued in writ of mandamus without hearing the Public Prosecutor is not null

The Brazilian Writ of Mandamus Law (Law No. 12,016/2009) establishes a simple procedure: (i) complaint; (ii) information from the Public Authority responsible for the coercive act; (iii) opinion of the Public Prosecutor Office; and (iv) court decision.

However, the Supreme Court had to decide, among other points, if the court decision in a writ of mandamus was null by the absence of Public Prosecutor’s hearing – it is worth noting that the Public Prosecutor’s Office did not figure as the Public Authority responsible for the coercive act.

The outcome was interesting: ratifying a position already adopted by the Supreme Court in other precedents, the Second Chamber of the Supreme Court decided, by majority vote, that the absence of a Public Prosecutor’s hearing does not constitute nullity when dealing with matter with solid former court decisions in the Court.

The material refers to process RMS 32,482/DF. Trial: August 21, 2018.

New Decree regulates the inspection of products controlled by the Army

The Federal Decree No. 9,493/2018 (“New Decree”), published on September 9, will regulate the inspection of products controlled by the Army – revoking the Decree No. 3,665/2000.

New Decree is smaller in relation to the previous one, especially since many points that were regulated by Decree 3,665/2000 were delegated to the Army’s regulations, such as issues related to traffic and transportation of controlled products, among others.

New Decree also regulates the existing Controlled Products Inspection System, expanding its activities through the characterization of some entities as auxiliaries in the inspection process and seeking to promote greater efficiency in the processes and management. New Decree also aims greater integration between the Army and Civil Police of the States and the Federal District.

In relation to penalties, the New Decree provided that generic recidivism in infractions involving Army’s controlled products will be considered as aggravating circumstance if carried out in the period of 3 years counted from a decision that cannot be reversed in an administrative proceeding, supplying the lack of definition in the previous Decree.

Despite the changes promoted by the New Decree, the administrative procedures for granting, revalidating, filling and canceling the registration in the Army for the exercise of activities with controlled products remain under the provisions of Ordinance 56 of the Logistic Command, and there is no innovation in this regard.

Among other points, the Decree also: (i) amended provisions related to the possession and import of firearms; (ii) imposed new restrictions on the use of weapons and accessories; and (iii) created new regulations in relation to the collection of weapons.

The Decree will enter into force on March 5, 2019.

Tax Law

Federal Revenue updates rules of Offshore Voluntary Disclosure Program (RERCT)

By means of Normative Instruction RFB No. 1832/18, published on September 24th, the Federal Revenue added, among offenses tantamount to exclusion from the Offshore Voluntary Disclosure Program (RERCT), the rendering of false statements regarding criminal convictions, tax domicile, as well as falsely informing whether or not the beneficiary, his spouse or relatives held public office at that time.

The RERCT was established in 2016, with the objective of encouraging the regularization of undeclared assets legally acquired by Brazilian taxpayers and held abroad. The RERCT originally included only the rendering of false statements or documents regarding the ownership of these assets or their market value as offenses tantamount to exclusion.

New binding precedents officially published by CARF

At the beginning of September, the results of the meeting of the Plenary Meeting of the Administrative Council of Tax Appeals (CARF) were published, marking the beginning of the applicability and enforceability of twenty-one new binding precedents, as well as the cancellation of one of the precedents previously applicable and the modification of nine others.

CARF binding precedents are published to unify the Council’s understandings, reducing administrative litigation. In general, these new rules relate to consolidated legal understandings by CARF. Although binding in administrative tax proceedings, binding CARF precedents may still be overturned by the Judiciary.

New Brazil-Argentina Double Tax Treaty Protocol enters into force

On July 21, 2017, the Protocol amending the Double Tax Treaty (DTT) entered into between the Federative Republic of Brazil and the Argentine Republic was signed.

The Protocol came into force in Brazil with the publication of Presidential Decree No. 9.482, of August 27, 2018, with the purpose of modernizing the DTT, in a scenario of increasing mobility of commercial activities and internationalization of companies of both countries.

The new text contains the minimum standards required by the Base Erosion and Profit Shifting (BEPS) Project, championed by the G20 and the Organization for Economic Cooperation and Development (OECD), such as the inclusion of a Limitation of Benefits clause (LoB), a Principal Purpose Test (PPT) and the adoption of beneficial ownership language.

Among the changes, it is worth mentioning the introduction of limits on the taxation of interest and royalties, which did not exist until now. The tax rate has been limited to 15%, varying from 10% to 15% for royalties, depending on the case. In addition, a limitation on the taxation of dividends at source by both countries was introduced, varying from 10% to 15%, as well as a reduction on the taxation of imports of services between Brazil and Argentina.

Currently, Argentina is Brazil’s third largest trading partner and the main destination for Brazilian exports of industrialized products.

This new text prevents possibilities of abusive tax planning as well as abusive use of the DTT, stimulating reciprocal productive investment flows between countries and strengthening bilateral trade.

 

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