Social security contribution on payroll re-enacted for 39 sectors

Law n. 13.670/18, passed on May 30th, brings back the payroll collecting method for social security contributions to 17 of the 56 sectors of the economy originally contemplated in the previous regime (22 had already been re-subjected to this collecting method). The payroll collecting method requires taxpayers to collect 20% social security contribution over their monthly payroll, as opposed to the previous method which was based on their gross revenue, at the rate of 2% to 4%.

In addition, the law reduces tax incentives for exporters, chemical industry and the soft drinks sector. The measures aim to offset government spending on diesel price benefits, granted in the context of the truck drivers’ strike.

Due to the 90-days anteriority rule, this Law will be in-force in September 2018.

STJ eliminates R$ 1 million limit for simplified installment program

In a recent ruling, the First Panel of the Supreme Court of Justice (STJ) decided that taxpayers with debts over R$ 1 million may join the Simplified Installment Program set forth by Law 10.522/02. The STJ ruled against Art. 29 of Joint Ordinance PGFN / RFB nº 15/2009, considering that the Ordinance went beyond the legal mandate in imposing the R$ 1 million limit for inclusion of tax debts in Simplified Installment Program.

Unlike the Ordinary Installment Program, the Simplified Installment Program allow the inclusion of tax debts regarding the income tax withheld at the source (IRRF), the tax on financial transactions (IOF) and taxes due on import. Furthermore, the Simplified Installment Program allows the inclusion of new tax debts as they surface, without additional entry payments.

PGFN Ordinance nº 360/18 authorizes negotiation between the attorney general’s office and taxpayers

PGFN Ordinance nº 360/18, issued on June 13th, authorizes federal prosecutors to negotiate with taxpayers matters related to compliance with judicial decisions, withdrawal of appeals and the inclusion of social security liabilities in the general list of creditors. This Ordinance aims to regulate Articles 190 and 191 of the Code of Civil Procedure, which allow the parties, exclusively regarding alienable or waivable rights, to agree on their procedural powers, duties and limitations before or during the course of the proceedings.

Since the tax credit is an unavailable right, the Ordinance will have a limited scope. Even so, the measure is seen a a positive step, since it allows a faster and more economic resolution of procedural conflicts, such as the presentation of calculations and the inclusion of assets for attachment.

The Federal revenue service alters standards for customs clearance

Through Normative Instruction n. 1813, published in the Federal Official Gazette on July 17th, the Federal Revenue Service (RFB) altered customs clearance imports rules. In an attempt to make the procedure more flexible, the new rule allows import declarations to be analyzed in places other than the places where the clearance was issued, a procedure commonly known as a “jurisdiction breakage”.

In addition, the period to assess import companies in cases of divergence in customs clearance was extended from three to eight days. The short three-day period to analyze the goods tended to result in the seizure of the goods for the time the Treasury deemed necessary to draft the Audit. With the longer deadline, it is expected that the customs authority will be compelled to finalize the procedure within the eight days, thus reducing the number of writs of mandamus requesting the release of seized goods.

Approved new regulation for food supplements in Brazil

The National Health Surveillance Agency’s Collegiate Board (“ANVISA”) approved, on 07/17/2018, a new regulatory framework for food supplements. In order to enter into force, the regulation still needs to be published in the Official Gazette of the Union. With the approval of such proposals, 11 normative acts will be revoked. In addition, other Ordinances will be published on the general health requirements, additives and adjuvants of technology allowed, studies necessary to prove the safety and efficacy of probiotics, composition, quality, safety and labeling of these products. ANVISA will also issue a Normative Instruction containing a list of permitted ingredients.

Due to the fragmentation of current regulation and the strong advertising appeal of food supplements, a proposal was drawn up bringing together, in a single category, most of the products that today fall within the categories of food and medicines. Before regulating the matter, ANVISA held meetings with interested sectors and made public consultations with civil society

Among the changes on the matter, ANVISA reported the following:

  1. Adjustments in the definitions of nutrients, bioactive substances and enzymes, with a view to ensuring greater regulatory coherence and greater regulatory convergence with the provisions of the Codex Alimentarius. Until then, definitions of bioactive substances were present in ANVISA’s Ordinance (RDC) No. 02/2002, but these were not intended for vitamin and mineral supplements. The definitions of enzymes were provided in ANVISA’s Ordinance (RDC) No. 54/2014, but were not intended for use as ingredients in supplements and other foods.
  2. Adequate rules for the use of other ingredients in supplements, in order to provide greater clarity and avoid the use of substances with no history of use and no evidence of safety in these products. In this change, it is clear the concern of ANVISA with the protection of the consumer. ANVISA will focus its regulation to verify that the substances used in the supplements are within acceptable safety limits.
  3. Extension of the list of references for specification of identity, quality and purity of ingredients used in food supplements with the inclusion of the European Food Safety Authority (“EFSA”). In Europe, EFSA regulates the specific rules for vitamins and minerals as well as all the ingredients that can be used in the manufacture of food supplements. In the European Union dietary supplements may contain vitamins, minerals, amino acids, essential fatty acids, fiber, and other ingredients such as plants and herbal extracts.
  4. The adoption of a differentiated treatment of food supplements intended exclusively for health programs of the Ministry of Health, as regards the minimum and maximum quantities of nutrients supplied, in order to ensure that these products are appropriate to the characteristics of those programs. This measure will assist in the implementation of NutriSUS as a strategy to combat nutritional deficiencies in the country. Thus, companies interested in supplying supplements to the State should comply with the new standards and have specific procedures to do so.
  5. Extension of the list of ingredients authorized for use in supplements with the inclusion of 103 constituents, to be divulged by ANVISA.
  6. Reduction of vitamin D limits according to the contributions of health professionals who warned of the need to adopt a more conservative approach to supplementation of this nutrient, considering the recent increase in the practice of the use of super portions of this nutrient. In the European Union, the dose of vitamin D recommended and approved by EFSA is 5μg for adults.
  7. Possibility of specific medicines based on nutrients to be considered exempt from medical prescription, in compliance with ANVISA’s Ordinance (RDC) No. 98/2016.
  8. The companies will have five years, from the publication of the new Regulation, to adapt the products that are already in the market to the new standard. New food supplements should already be marketed under the new rules.

The new standard has not yet been published. The main points highlighted above, despite being informed by ANVISA, were confirmed by the KLA from the main vote of the administrative proceeding which object is the edition of this new regulation.

The KLA will keep following the publication and entry into force of the new Regulation of such unique relevance for the Brazilian market.

Anvisa published the entire nutricional labelling process

The entire regulatory process for nutritional labeling of food is already available on Anvisa’s website. Among the innovations, stands out the complete disclosure of the corresponding administrative process. Aiming to give greater transparency to the regulatory process, some internal documents elaborated by the Agency have been made available, such as external documents, received as contributions. Check all the documents and steps to the administrative nutritional labeling food process, as well as their role and their need at:

Published new models for declaration of the holder about the product regularization

The National Health Surveillance Agency (Anvisa) published, at its website, new models for Declaration of the Holder about the Product Regularization (DDR), document that authorizes the importation of products by third parties. Check all the new models at:

Published new codes for renewal of certificate of correct manufacturing, distribution and storage of products

Since 06/18/2018, 11 new subject codes for renewal of Certificate of Correct Manufacturing for health, cosmetic and sanitary products and Certificate of Correct Distribution and Storage of health products request are available at Anvisa’s website. With this improvement, the distribution and analysis of renewal requests will be more efficient, giving that the renewal requests will now be considered as secondary petitions, linked to the last certification process issued by ANVISA.

Bar code becomes mandatory for traceability labels of stents and hip and knee implants

Becomes mandatory, under the terms of RDC No. 232/2018, the inclusion of a linear or two-dimensional bar code on traceability labels for single identification of stents for coronary arteries, pharmacological stents for coronary arteries, and implants for hip and knee arthroplasty. The traceability labels containing the bar code on medical device packaging must be made by the manufacturer or importer, and the failure to comply with such measures will constitute a sanitary infraction.

Anvisa publishes new rules about drugs and biological products outsourcing

Anvisa published, on 06/25/2018, the RDC No. 234, which provides for the outsourcing of production stages, analyzes of quality control, transport and storage of drugs and biological products. From that date, biological products will be characterized in such outsourcing procedures along with other drugs.

This resolution is applicable to manufacturers, packers, importers, distributors, logistics operators, carriers, warehouses and quality control laboratories for drugs and biological products, as well as outsourcing quality control analyzes of pharmaceutical inputs, for manufacturers of drugs and biological products.

From the publication of the resolution, and provided that the outsourcing contract is duly formalized and clearly defined under the terms of the RDC, all stages can be outsourced, which until then was not allowed.

In addition, the contracted entity may subcontract, in whole or in part, the object of the contract, if there is a prior assessment and approval by the contracting entity, a previously forbidden practice. Depending on the stage to be outsourced, the subcontracted entity must have the specific licenses and/or authorizations, when necessary.

Legislative committee approves new legislation on the registration and use of agrochemicals

The special committee of the House of Representatives approved on 06/25/2018, a report that changes the text of the legislation on the use and registration of pesticides in Brazil. To enter into force, the text still needs to be approved by a Plenary Session of the House of Representatives and then by the Senate. Then it follows to the presidential sanction.

The main changes are listed below:

1) agrochemicals come to be referred in law as “agricultural pesticides”;
2) the deadline to start production and marketing of the new product, given the registration, becomes two years;
3) temporary registration authorization may be granted for products already registered in three other OCDE countries that adopt the FAO code, even without the complete review by the Brazilian regulatory agencies;
4) the authorization of the registrations is now centralized in the Ministry of Agriculture – Anvisa and Ibama now only homologate the registrations;
5) authorizes the approval of products with teratogenic, carcinogenic or mutagenic characteristics, once proven the low risk;
6) predicts that the amounts collected with the registration evaluation fee may constitute resources to the Federal Agricultural Fund (FFAP);
7) the prior registration of the pesticide in a federal agency is limited to its active principle
8) the Federal Government will legislate on the destruction of packaging;
9) in the risk analysis, only products with “unacceptable risk” are now barred.

New law requires blue color cup for sugar-free drinks in the state of São Paulo

The Law No. 16.796/2018 requires that all commercial establishments in the State provide predominantly blue color disposable cups, with the visible inscription “zero sugar”, for use in soda machines. This measure is intended to avoid errors with diabetic customers.

New law in the state of Rio de Janeiro prohibits municipality of receiving medicines that are less than 80% of the validity limit date

After Law No. 6.378/2018 come into force, the municipality of Rio de Janeiro is prohibited from receiving medicines that have exceeded 20% percent of its validity in onerous purchases. This measure was created to reduce the waste of such products.

Waiting queue for the analysis of generic drugs registration requests will clear

Anvisa announced on 07/05/2018 that the waiting queue for the analysis of generic drugs registration requests will be eliminated until the end of August. According to Anvisa, the elimination of the queue is a consequence of the improvement of the registration analysis process and a series of strategies adopted to improve its performance, complying with the Law No. 13.411/2016, which provides transparency and predictability to the processes of concession and renewal registration and post-registration change.

New rules for regularization of personal hygiene products, cosmetics and perfumes are published

In accordance with RDC No. 237, published on 07/17/2018, the following products shall be considered as grade 2, (subject to registration): (i) suntan lotion, (ii) sunscreen, (iii) children’s sunscreen (iv) antiseptic hand gel, (v) hair straightening product, (vi) hair straightening and dyeing product, (vii) insect repellent, and (viii) children’s insect repellent.

The Resolution establishes several innovations in the process of regularization of mentioned products, such as the fact that the holder of a registered product may that wants to regularize it as exempt from registration should re-register it as such.

The standard comes into force 60 days after its publication, on 09/15/2018.

Resolution on procedures for importation, in character of exceptionality, of products subject to sanitary surveillance without registration in anvisa is republicated

According to the decision of Anvisa’s Board of Directors at a Public Ordinary Meeting (ROP 016/2018), held on 07/03/2018, the Resolution RDC No. 203/2017 was republished. Such resolution provides on the criteria and procedures for importation, in character of exceptionality, of products subject to sanitary surveillance without registration in Anvisa,. Now, in the list of products authorized for importation, the term “vaccines” has been changed to “immunobiological”, giving a wider range to other products, such as serum and immunoglobulin, for example.

Resolution that regulates the ethical specificities of clinical research of strategic interest for the SUS is published

The National Health Council (“CNS”) published the Resolution No. 580/2018 of the, which regulates the specificities of item XIII.4 of Resolution CNS No. 466/2012, on the ethical aspects of research of strategic interest to the System Unified Health System (SUS).

Among the innovations brought by the new standard, stands out that, from its publication, the researches considered of strategic interest for the SUS will be sent for initial appreciation in the National Commission of Ethics in Research (CONEP) and may have special treatment and urgency nature.

This differentiated procedure will be used for research protocols that address public health emergencies and/or that subsidize the implementation of health policies, actions, programs and services that respond to issues of public interest in the health area.

The standard also states that the researches should have its first evaluation carried out in up to 10 business days.

Bill of law in Minas Gerais prohibits use of animals in cosmetic tests

Bill of Law No. 23.863/18 of the Legislative Assembly of Minas Gerais (“ALMG”) prohibits the use in the State of animals for the development, experimentation and testing of perfumes and cosmetics and personal hygiene products and its components.

At first, the bill had been vetoed by the governor because, in his opinion, it is the responsibility of the National Council for the Control of Animal Experimentation (Concea) to deal with standards for the use of animals for testing, but in July, ALMG overturned the veto and forwarded the bill for promulgation by the governor.






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