BR112018006807B1 - Processo para a separação e concentração de um óleo compreendendo ésteres de ácidos graxos poli-insaturados - Google Patents

Processo para a separação e concentração de um óleo compreendendo ésteres de ácidos graxos poli-insaturados Download PDF

Info

Publication number
BR112018006807B1
BR112018006807B1 BR112018006807-1A BR112018006807A BR112018006807B1 BR 112018006807 B1 BR112018006807 B1 BR 112018006807B1 BR 112018006807 A BR112018006807 A BR 112018006807A BR 112018006807 B1 BR112018006807 B1 BR 112018006807B1
Authority
BR
Brazil
Prior art keywords
oil
weight
less
process according
epa
Prior art date
Application number
BR112018006807-1A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112018006807A2 (en
Inventor
Alfred ROLLE
Ralf Proplesch
Chris Luigart
Jaroslav Kralovec
Mark Oxford
Erick Reyes-Suarez
Michael Lenn Stefanski
Original Assignee
Dsm Ip Assets B.V.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=58488476&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112018006807(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Dsm Ip Assets B.V. filed Critical Dsm Ip Assets B.V.
Publication of BR112018006807A2 publication Critical patent/BR112018006807A2/en
Publication of BR112018006807B1 publication Critical patent/BR112018006807B1/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING OR TREATMENT THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS
    • A23D9/00—Other edible oils or fats, e.g. shortenings or cooking oils
    • A23D9/02—Other edible oils or fats, e.g. shortenings or cooking oils characterised by the production or working-up
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS
    • A23D9/00—Other edible oils or fats, e.g. shortenings or cooking oils
    • A23D9/02—Other edible oils or fats, e.g. shortenings or cooking oils characterised by the production or working-up
    • A23D9/04—Working-up
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D3/00—Distillation or related exchange processes in which liquids are contacted with gaseous media, e.g. stripping
    • B01D3/14—Fractional distillation or use of a fractionation or rectification column
    • B01D3/143—Fractional distillation or use of a fractionation or rectification column by two or more of a fractionation, separation or rectification step
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11B—PRODUCING, e.g. BY PRESSING RAW MATERIALS OR BY EXTRACTION FROM WASTE MATERIALS, REFINING OR PRESERVING FATS, FATTY SUBSTANCES, e.g. LANOLIN, FATTY OILS OR WAXES; ESSENTIAL OILS; PERFUMES
    • C11B3/00—Refining fats or fatty oils
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11B—PRODUCING, e.g. BY PRESSING RAW MATERIALS OR BY EXTRACTION FROM WASTE MATERIALS, REFINING OR PRESERVING FATS, FATTY SUBSTANCES, e.g. LANOLIN, FATTY OILS OR WAXES; ESSENTIAL OILS; PERFUMES
    • C11B3/00—Refining fats or fatty oils
    • C11B3/001—Refining fats or fatty oils by a combination of two or more of the means hereafter
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11B—PRODUCING, e.g. BY PRESSING RAW MATERIALS OR BY EXTRACTION FROM WASTE MATERIALS, REFINING OR PRESERVING FATS, FATTY SUBSTANCES, e.g. LANOLIN, FATTY OILS OR WAXES; ESSENTIAL OILS; PERFUMES
    • C11B3/00—Refining fats or fatty oils
    • C11B3/02—Refining fats or fatty oils by chemical reaction
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11B—PRODUCING, e.g. BY PRESSING RAW MATERIALS OR BY EXTRACTION FROM WASTE MATERIALS, REFINING OR PRESERVING FATS, FATTY SUBSTANCES, e.g. LANOLIN, FATTY OILS OR WAXES; ESSENTIAL OILS; PERFUMES
    • C11B3/00—Refining fats or fatty oils
    • C11B3/12—Refining fats or fatty oils by distillation
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11C—FATTY ACIDS FROM FATS, OILS OR WAXES; CANDLES; FATS, OILS OR FATTY ACIDS BY CHEMICAL MODIFICATION OF FATS, OILS, OR FATTY ACIDS OBTAINED THEREFROM
    • C11C3/00—Fats, oils, or fatty acids by chemical modification of fats, oils, or fatty acids obtained therefrom
    • C11C3/003—Fats, oils, or fatty acids by chemical modification of fats, oils, or fatty acids obtained therefrom by esterification of fatty acids with alcohols
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Landscapes

  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nutrition Science (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Birds (AREA)
  • Dermatology (AREA)
  • Pediatric Medicine (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Fats And Perfumes (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Cosmetics (AREA)
  • Dairy Products (AREA)
  • Edible Oils And Fats (AREA)
BR112018006807-1A 2015-10-05 2016-10-05 Processo para a separação e concentração de um óleo compreendendo ésteres de ácidos graxos poli-insaturados BR112018006807B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562237320P 2015-10-05 2015-10-05
US62/237,320 2015-10-05
PCT/US2016/055599 WO2017062523A2 (en) 2015-10-05 2016-10-05 Oil compositions and methods of making

Publications (2)

Publication Number Publication Date
BR112018006807A2 BR112018006807A2 (en) 2018-10-16
BR112018006807B1 true BR112018006807B1 (pt) 2023-02-14

Family

ID=58488476

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018006807-1A BR112018006807B1 (pt) 2015-10-05 2016-10-05 Processo para a separação e concentração de um óleo compreendendo ésteres de ácidos graxos poli-insaturados

Country Status (13)

Country Link
US (1) US20190071618A1 (enExample)
EP (2) EP4663725A2 (enExample)
JP (1) JP6947370B2 (enExample)
KR (1) KR102728376B1 (enExample)
CN (1) CN108289470A (enExample)
AU (2) AU2016336354B2 (enExample)
BR (1) BR112018006807B1 (enExample)
CA (1) CA3001018C (enExample)
HK (1) HK1258568A1 (enExample)
IL (1) IL258381A (enExample)
MX (1) MX2018004128A (enExample)
SG (1) SG10202003063WA (enExample)
WO (1) WO2017062523A2 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102018010277B4 (de) 2018-03-29 2022-01-13 Hegla Boraident Gmbh & Co. Kg Entschichtungsverfahren und Verwendung einer Entschichtungseinrichtung zum Entschichten von Glastafeln, vorzugsweise Verbundglastafeln
FR3103355B1 (fr) * 2019-11-26 2024-05-31 Polaris Composition d’huile de micro-organismes enrichie en acides gras polyinsaturés
FR3108622B1 (fr) * 2020-03-27 2024-08-23 Polaris Procédé de fractionnement d’acides gras à deux carbones de différence par distillation moléculaire
LU102019B1 (de) * 2020-08-26 2022-02-28 K D Pharma Bexbach Gmbh Verfahren zur Herstellung von Öl aus einem Mikroalgenerzeugnis
CN115350493A (zh) * 2022-09-15 2022-11-18 江苏海莱康生物科技有限公司 一种分离提纯鱼油中的二十碳五烯酸乙酯的方法及精馏装置

Family Cites Families (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE440012A (enExample) 1939-12-11
US4792418A (en) * 1985-08-14 1988-12-20 Century Laboratories, Inc. Method of extraction and purification of polyunsaturated fatty acids from natural sources
IT1205043B (it) * 1987-05-28 1989-03-10 Innova Di Ridolfi Flora & C S Procedimento per l'estrazione di esteri di acidi grassi poliinsaturi da olii di pesce e composizioni farmaceutiche e dietetiche contenenti detti esteri
US5215630A (en) * 1991-06-04 1993-06-01 Nippon Suisan Kaisha, Ltd. Method of purifying eicosapentaenoic acid or the ester derivative thereof by fractional distillation
JP3400466B2 (ja) * 1991-10-28 2003-04-28 日本水産株式会社 高純度エイコサペンタエン酸またはそのエステルの製造方法
JP3614177B2 (ja) * 1992-07-21 2005-01-26 日本水産株式会社 高純度ドコサヘキサエン酸またはそのエステルの 製造方法
JPH09302380A (ja) 1996-05-10 1997-11-25 Nippon Wax Polymer Kaihatsu Kenkyusho:Kk エイコサペンタエン酸又はそのエステルの精製方法
JPH11246888A (ja) * 1998-12-14 1999-09-14 Nippon Suisan Kaisha Ltd 高純度エイコサペンタエン酸またはそのエステルの製造方法
US6395778B1 (en) 2000-01-11 2002-05-28 Omegatech, Inc. Process for making an enriched mixture of polyunsaturated fatty acid esters
AU2002323409A1 (en) * 2001-08-24 2003-03-10 Martek Biosciences Boulder Corporation Products containing highly unsaturated fatty acids for use by women and their children during stages of preconception, pregnancy and lactation/post-partum
NO319194B1 (no) * 2002-11-14 2005-06-27 Pronova Biocare As Lipase-katalysert forestringsfremgangsmate av marine oljer
DE102005003625A1 (de) 2005-01-26 2006-07-27 Nutrinova Nutrition Specialties & Food Ingredients Gmbh Verfahren zur Herstellung einer DHA-haltigen Fettsäure-Zusammensetzung
EP3508572A1 (en) * 2005-06-16 2019-07-10 DSM Nutritional Products AG Immobilized enzymes and methods of using thereof
US20070298083A1 (en) * 2006-06-23 2007-12-27 Haile Mehansho Concentrated omega-3 fatty acids and mixtures containing them
US20080145475A1 (en) * 2006-08-29 2008-06-19 Martek Biosciences Corporation Use of DPA(n-6) Oils in Infant Formula
ITMI20070157A1 (it) * 2007-01-31 2008-08-01 Adorkem Technology Spa Processo di arricchimento enzimatico di una miscela contenente omega 3
MX374545B (es) * 2007-06-29 2025-03-06 Dsm Ip Assets Bv Produccion y purificacion de esteres de acidos grasos poliinsaturados.
WO2009139641A1 (en) * 2008-05-15 2009-11-19 Pronova Biopharma Norge As Krill oil process
US20100272792A1 (en) 2009-04-28 2010-10-28 Avema Pharma Solution, Division of PL Developments Stability additives for dry dha dosage forms
CL2009001343A1 (es) * 2009-06-02 2009-07-10 Golden Omega S A Proceso de obtencion concentrado de esteres de epa y dha a partir de aceite marino, que comprende agregar al aceite alcali y agua a menos de 100 grados celsius, agregar solvente, separar fase de refinado, agregar acido, separar la fase no acuosa y agregar alcohol y un catalizador a menos de 150 grados celsius, desolventilizar y destilar.
EP2519332B1 (en) * 2009-12-30 2014-03-05 BASF Pharma (Callanish) Limited Simulated moving bed chromatographic separation process for the purification of polyunsaturated fatty acids
EP2673371A1 (en) * 2011-02-11 2013-12-18 E.I. Du Pont De Nemours And Company An eicosapentaenoic acid concentrate
KR101605595B1 (ko) * 2011-03-08 2016-03-22 코그니스 아이피 매니지먼트 게엠베하 지방산 에스테르의 증류 방법
US20140323569A1 (en) * 2011-07-21 2014-10-30 Krishna Raman Microbial oils enriched in polyunsaturated fatty acids
US20140335580A1 (en) * 2011-09-21 2014-11-13 Board Of Supervisors Of Lousiana State University And Agricultural And Mechanical College Method for Enrichment of Eicosapentaenoic Acid and Docosahexaenoic Acid in Source Oils
CN103509651B (zh) * 2012-06-27 2015-01-07 浙江海洋学院 一种从鱼油精炼副产物中提取富集乙酯型鱼油的方法
CN102994236B (zh) * 2012-12-11 2015-03-25 成都圆大生物科技有限公司 一种制备Omega-3大于90%的脂肪酸乙酯的方法
WO2014152283A1 (en) * 2013-03-15 2014-09-25 Heliae Development, Llc Direct transesterification of algal biomass for synthesis of fatty acid ethyl esters (faee)
CN103242969B (zh) * 2013-05-24 2014-11-19 四川欣美加生物医药有限公司 甘油三酯型鱼油制备方法及制备的甘油三酯型鱼油
CN103864614B (zh) * 2014-03-20 2015-11-25 江苏中邦制药有限公司 从微生物发酵的dha油脂中分离纯化dha乙酯的方法
CN103951556B (zh) * 2014-05-09 2015-09-09 福州大学 一种从深海鱼油中分离epa、dpa和dha的蒸馏工艺
CN106795452A (zh) 2014-09-17 2017-05-31 日本水产株式会社 含有二十碳五烯酸烷基酯的组合物及其制造方法

Also Published As

Publication number Publication date
BR112018006807A2 (en) 2018-10-16
MX2018004128A (es) 2018-05-17
EP4663725A2 (en) 2025-12-17
KR102728376B1 (ko) 2024-11-11
IL258381A (en) 2018-05-31
EP3358960A2 (en) 2018-08-15
EP3358960A4 (en) 2019-07-03
JP2018532015A (ja) 2018-11-01
WO2017062523A3 (en) 2017-05-18
SG10202003063WA (en) 2020-05-28
EP3358960B1 (en) 2025-12-24
JP6947370B2 (ja) 2021-10-13
AU2016336354B2 (en) 2021-04-15
CA3001018C (en) 2024-11-05
US20190071618A1 (en) 2019-03-07
WO2017062523A2 (en) 2017-04-13
CA3001018A1 (en) 2017-04-13
AU2016336354A1 (en) 2018-05-10
CN108289470A (zh) 2018-07-17
AU2021205085B2 (en) 2024-01-25
KR20180063217A (ko) 2018-06-11
AU2021205085A1 (en) 2021-08-12
NZ741784A (en) 2023-09-29
HK1258568A1 (zh) 2019-11-15

Similar Documents

Publication Publication Date Title
AU2021205085B2 (en) Oil compositions and methods of making
JP2010519311A (ja) 長鎖多価不飽和脂肪酸由来のオキシリピンならびにその作製およびその使用方法
ES2872449T3 (es) Aceite microbiano, procedimiento para fabricar aceite microbiano, aceite microbiano concentrado y procedimiento para fabricar aceite microbiano concentrado
JP2014195460A (ja) 乳幼児用調合乳におけるＤＰＡ（ｎ−６）油の使用
JP2008520739A (ja) 長鎖多価不飽和脂肪酸由来のオキシリピンならびにその作製および使用方法
JP2010532418A (ja) 多価不飽和脂肪酸のエステルの製造方法および精製方法
JP7242769B2 (ja) 遊離多価不飽和脂肪酸含有組成物及びその製造方法
WO2011103514A1 (en) Dha triglyceride emulsions
BR112020002448A2 (pt) processo para produção de óleos de ácido graxo poli-insaturado concentrado
Ahmmed et al. Fish roe phospholipids and health: Composition, extraction, storage and brain health application
JP7394748B2 (ja) 微生物油及び微生物油の製造方法
WO2012112902A1 (en) Methods of preparing free polyunsaturated fatty acids
WO2011103510A1 (en) Dha ester emulsions
NZ741784B2 (en) Oil compositions and methods of making
HK40088310A (en) Microbial oil and method for producing microbial oil
Liên et al. Biomass and lipid production of marine diatom Chaetoceros ChTA at different nutrient concentrations
CN117737145A (zh) 一种sn2-DHA藻油及其制备方法
KR20150060221A (ko) 미세조류를 이용한 도코사헥사엔산의 증진된 생산방법

Legal Events

Date Code Title Description
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/10/2016, OBSERVADAS AS CONDICOES LEGAIS