Labelling registration for dairy products in Brazil (July...
Transcript of Labelling registration for dairy products in Brazil (July...
Labeling Registration
for Dairy Products in
Brazil
Carla Susana Rodrigues
Secretaria de Defesa
Agropecuária (SDA)
Departamento de
Inspeção de Produtos
de Origem Animal
(DIPOA)
Coordenação Geral de
Programas Especiais
(CGPE)
Coordenação Geral de
Inspeção (CGI)
Divisáo de Inspeção
de Carnes Bovina
(DICAR)
Divisão de Inspeção
de Carne Suína (DICS)
Divisão de Inspeção
de Carnes de Aves e
de Ovos (DICAO)
Divisão de Inspeção
de Leite e Derivados,
Mel e Produtos
Apícolas (DILEI)
Divisão de Inspeção
de Pescado (DIPES)
1. Approval of exprorting establishments
Portaria DIPOA/SDA nº 183/1998
2. Registration of products
Ofício Circular DIPOA/SDA nº 42/2010
Steps to export dairy products to Brazil
1. Equivalence of inspection systems;2. Authorisation of establishments;3. Product registration.
Etapas para exportação de produtos
lácteos para o Brasil
• Forwarding replies to the questionnaire;• Assessment by MAPA of the replies to the
technical questionnaire;• Performing a mission (audit);
Process for equivalence recognition
of inspection systems
�Document requesting the approval issued by the official authorithy of the exporting country:
• Name of the establishment;• Full address;• Identification number of the establishment;• Products to be exported by the establishment;
Approval of establishments
�Important: If the product is not in the list of authorized products to export to Brazil, the labeling registration will not be approved.
• RIISPOA – Regulation on the industrial and health inspection of products of animal origin
• Ofício Circular DIPOA/SDA nº 42/2010 – instructions for completing the registration form of the label
• Instrução Normativa nº 22/2005 – Regulation on labeling of products of animal origin
Legislation on labeling registration
Art. 794: Foresees that all products of animal origin, in order to be marketed, have to be identified with a registered label
Art. 834: Foresees that the establishments can only use the label approved and registered by DIPOA
Legislação para registro de produtos
RIISPOA
Brazilian Legislation
� FEDERAL LAWS
� MAPAMinistry of Agriculture (Ministério da Agricultura, Pecuária e Abastecimento)
� MJMinistry of Justice (Ministério da Justiça)
�ANVISANational Agency for Health Survailance (Agência Nacional de Vigilância Sanitária)� INMETRONational Institute of Metrology (Instituto Nacional de Meteorologia)
� MSMinistry of Health (Ministério da Saúde)
• Legislation available at:
www.planalto.gov.br
www.agricultura.gov.br - SISLEGIS
www.anvisa.gov.br - VISALEGIS
www.inmetro.gov.br
– Repeals “Ofício Circular nº 125/98” and “Ofício Circular nº 14/10”;
– Amends the “Form for Registration of Labels of Imported Products of Animal Origin”;
– Applicable from:• 01/04/11: new requests of registration;• 01/04/12: adequacy of existing records;
– All the registers obtained with the Ofício Circular nº125/98 (pre May 2010) are no longer valid;
Ofício Circular DIPOA/SDA nº 42/2010
Request for label registration
Ofício Circular DIPOA/SDA nº 42/2010
� Documents to obtain the registration:�Form: 2 originals�Label on its original format and color or the actual
dimensions indicated
The label should be printed in Portuguese or alternatively, it can be used a tag printed in Portuguese over a label printed in a foreign language:
- In this case, the model of the original label must be sent with the indication of where the tag will be applied.
- The label may be applied after product arrival to Brazil, but before its marketing.
Request for label registration
Ofício Circular DIPOA/SDA nº 42/2010
� Validity of label registration: 10 years from the approval.
� Change in composition, manufacturing process, labeling or newlegislation: if there is a need to fit the labels already approved, theyshould be changed and sent for analysis in DIPOA.
� Send to the following address:Departamento de Inspeção de Produtos de Origem AnimalMinistério da Agricultura, Pecuária e AbastecimentoEsplanada dos Ministérios, Bloco D, Anexo A70043-900 Brasília – Distrito Federal – Brasil
Number of product registration: sequential, in ascending order, by product (composition, manufacturing process, packaging, brand)
TO BE COMPLETED BY DIPOA
INFORM THE FULL ADDRESS
AB 1234
0001/AB 1234
REGISTRATION – Request for product registration.
CHANGE IN COMPOSITION / MANUFACTURINGPROCESS - Applies to cases of changes in the compositionor in the manufacturing process of a product alreadyregistered. The registration number is maintained.
CHANGE OF LABEL - Applies only to change the sketch
Example 1) blocks weighing approximately 4 kg - Stated on the label the package weight and the words MUST BE WEIGHTED IN THE PRESENCE OF CONSUMER
Example 2) Package net weight 200 g
Describe the place on the label where the dates will be informed and how they will be indicated (dd/mm/yy, dd/mm/yyyy, mm/yyyy)
inform the characteristics of the label and / or packing
QUEIJO GOUDA
XYZ
AB 1234
0001/AB 1234
Inform all ingredients, including food additives and technological
coadjuvants
Observe mandatory and optional ingredients, food additives permitted and limits
Food Additives: provide full name, INS and main function it plays in the product
Describe the manufacturing process from milk reception to shipping the product.
Describe all steps of the process and its control parameters.Note the description of the steps which are distinctive of the manufacturing process of each product.
Example: cheesemaking - curd cooking, pressing, maturation (conditions in which it is performed, time and temperature)
Describe the manufacturing process in a clear, systematic and detailed manner.
Describe how the product is packaged in primary packaging and other packaging if any.
Describe the storage conditions of the product until the time of his expedition. Inform the storage temperature for products under refrigeration.
Inform the technical specifications of the product.
Note that the physicochemical and microbiological requirements established by Brazilian legislation must be met.
Describe the quality control procedures used by the industry during all phases of the industrialization process.
Describe every stage and care with the transportation of the product to its final destination.
In case of exclusive importer: inform the data of the importer (name and address).If there is no exclusive importer: describe the place on the label where it will be informed the data of the importer and how that information will be affixed on the label.
Fill in name of the town, country and date when the document was completed and signed
List the documents attached: technical specification sheet of the product, technical and scientific literature, flow chart of the manufacturing process,
among others.
Fill in name of the town, country and date when the document was completed and signed
Sketch
� Failing to attach the sketch in original size, inform the actual dimensions of the label to be used.
� When the required information are given through the use of tags, attach also the sketch of the label/original packaging, indicating the location of affixing the tags.
Stamp model to be stamped on label sketch analyzed in DIPOA
APPROVED WITH RESTRICTIONThe label may be used only after complying with all observations.
� The information should be described in the official language of the country ofconsumption.
� The font size for the mandatory information should not be less than 1mm.
� The information must be accurate, clear and precise. Should not leadconsumers to mistake, error, confusion or deception.
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
– Establishes inscriptions not allowed on the labeling:
• Graphical representations that can lead to incorrect information or mislead consumers;
• Effects or properties that cannot be demonstrated;• Presence or absence of intrinsic of food components
of the same nature or of aggregate components in all foods of similar technology of manufacturing process;
• Qualities related to medicinal or therapeutic properties.
Sketch - Instrução Normativa nº 22/2005
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
Shelf denomination of the productList of ingredientsNet contentIdentification of originName or commercial name and address of the establishmentName or commercial name and address of the importerCNPJConservation of the productBrand name of the productDate of manufactureExpiry datelotExpress label registrationcompositionInstructions on the preparation and use of the product
Sketch
Compulsory Information
MUSSARELA CHEESE
Ingredients: pasteurized milk, salt (sodium chloride), rennet, lactic starter
Must be weighed in the presence of the consumerPackage weight: 5g
Brazilian Industry
ABCED Company LdaRua Europa, 376, Brasília-DF00.000.000/0000-00Imported by:
Store chiled frpom 0 to 5 ºCOnce opened consume within 5 days
Manufactured in: 01/01/2012Valid until: 01/04/2013Lot: 120101
Registred by Ministério da Agricultura SIF/DIPOA with nº 0001/AB 1234 UE
BRAND
NUTRITIONAL INFORMATION Portion 30 g (2 slices)
Quantity per portion
% VD (*)
Quantity per portion % VD (*)
Energeticvalue91kcal = 437kJ
5 Saturate Fat5,0g
22
carbohydrates0,2g
0 Trans fat 0,3g
Proteins7,1g
9 Dietary fiber 0g 0
Total fat 7,0g 13 Sodium 14,49mg 1
* % Daily reference Values based on a diet of 2,000 kcal or 8400 kJ. Your dailyvalues may be higher or lower depending on your calorie needs.
GLUTEN FREE
Sketch
Compulsory Information
PROCESSED MOZZARELLA CHEESE
ingr.: mozzarella cheese(pasteurized milk, salt (sodiumchloride), rennet, lactic starter), cream, sodium phosphatestabilizer and flavoring
Net weight: 200g
Indústria BrasileiraABCED Company LdaRua Europa, 376, Brasília-DF00.000.000/0000-00Imported by:
Store under refrigeration 0 to 5 ° COnce opened consume within 5 days
Manufactured in: 01/01/2012Valid until: 01/04/2013Lot: 120101
Registered by Ministério da Agricultura SIF/DIPOA with nº 0001/AB 1234 UE
brand
Nutritional Information: Portion 30g (2 slices) Calories 91kcal = 437kJ (5% DV), Carbohydrate 0.2g (0% DV), Protein 7.1 g (9% DV), Total Fat 7.0g (13% DV) , Saturated fat 5.0g (22% DV), trans Fat 0.3g, Dietary Fiber 0g (% 0VD); Sodium14,49mg (1%VD).
*% Daily Values based on a diet of 2,000 kcal or 8400 kJ. Your daily values may be higher or lower depending on your calorie needs.
GLUTEN FREE
• Sales denomination:
� Specific name that indicates the true nature of the product.
� As provided in the Technical Regulation of Identity and Quality or RIISPOA.
� Main panel of the label, in characters highlighted, uniform in color and body, with no intercalation of other sayings.
� Font size should be proportional to the size used for the indication of the brand.
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
• List of ingredients:
– Preceded by the words: "ingredients:" or “ingr.:"
– The ingredients must be declared in descending order of
proportion.
– Additives shall be declared after the ingredients: main
function + full name
– Additives with the same function may be grouped: Stabilisers
sodium citrate and sodium phosphate
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
• List of ingredients
INGREDIENTS: Skimmed milk and/or reconstituted skimmed milk, liquid
sugar, dextrosis monohydrate, lactic ferments and flavouring agent.
INGR.: Skimmed milk and/or reconstituted skimmed milk, prepared
strawberry (invert liquid sugar, pieces of fruit, water, stabilising
modified starch, natural colouring cochineal carmine, strawberry
flavouring identical to natural, artificial colouring bordeaux-s,
preservative potassium sorbate and stabilising citric pectin), sugar,
skimmed milk powder, modified starch, stabilisers powdered gelatine
and methylcellulose, strawberry flavouring identical to natural, artificial
colouring red ponceau and lactic ferment.
• Identification of origin:
– Name of the establishment
– Full address
– Registration number or identification code of the
establishment given by the official body.
– “Made in Belgium” or “Product of Belgium” or “Belgian
industry”
– Full name and address of the importer
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
• Date of manufacture
• Expiry date
– “valid until...”
– “validity...”
– “val:...”
• Batch (Lot)
– May be preceded by the letter “L”
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
• Expression of registration of the label:
Registration with Ministério da Agricultura SIF/DIPOA under nº xxxxx/yyyyy
Sequential number of the label registration
Number of veterinary/sanitary control of production establishment
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
• Preservation: for products requiring special conditions for their
preservation.
� Minimum and maximum temperature
� Maximum temperature — as specific RTIQ provisions.
� Validity and instructions for preservation when the package is
opened.
� Comply with recommendations for caned products.
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
• Instructions on the preparation and use:
� Instructions for the appropriate use of the product.
� Must not be ambiguous, nor allow for false
interpretations.
� Shall ensure the proper use of the product of animal
origin.
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
• Indication of a net content: Portaria INMETRO nº 157/2002
� For premeasured products.� Products marketed in mass units: kg and g
NET WEIGHT Net weight
NET CONTENT Net cont.
NET CONT.
� Products marketed in units of volume: L and mlCONTENT Net volume
Content
� Premeasured products which present two phases:NET WEIGHT and DRAINED WEIGHT
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
• Indication of the net content: Portaria INMETRO nº 25/1986:
� Cheese and curd which cannot have a standardised quantity and/or
may have a pronounced weight lose.
SHALL BE WEIGHED IN THE PRESENCE OF THE CONSUMER
WEIGHT OF THE PACKAGING
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
Compulsory information on themain panel of the label
� Sales denomination� Brand� Net content� CONTAINS VEGETABLE FAT (just below the name, in uniform
characters in font size and colour, without intercalation of drawings orsayings, in bold and large type letters)
Main panel: Visible to the buyer in normal conditions ofexposure to sale.
Sketch - Compulsory Information
Instrução Normativa nº 22/2005
Main panel: Visible to the buyer in normal conditions of exposure to sale.
Compulsory information on the main panel:�Sales denomination�Brand�Net content
• RIISPOA, Chapter IV, Articles 598 to 632
• Technical Regulation on the identity and quality of cheeses: Portaria MA/SDA nº 146/1996
– Definition
– Classification
– Compulsory and optional ingredients
– Food additives
– Microbiological requirements
• Technical regulations on identity and quality standards
Cheeses
Cheeses
• Cheeses made from unpasteurized milk should undergo maturation at temperatures above 5 ̊C for at least 60 days.
• Addition of condiments - inform in the sales denomination. PROCESSED CHEESE SEASONED or PROCESSED CHEESE WITH FINE HERBS
• Form of presentation is not part of the sales denomination, but must be indicated on the label. Example: piece, ball, roller, wedge, sliced , braid.
• For cheese made from milk of more than one species is necessary to inform on the list of ingredients of the label the name of the species and the relative percentage. Example: goat's milk (60%), sheep milk (35%).
Cheeses
Gorgonzola and Blue
• Gorgonzola: RIISPOA, article 608
– Made from cow's milk;
– Matured for at least 3 months
• Blue: Instrução Normativa nº 45/2007
– Made from cow's milk, goat and sheep, alone or in combination;
– Matured for at least 35 days
SALES DENOMINATION WEIGHT OF
THE PIECES
TIME OF
MATURATION
PARMESÃO CHEESE 4 to 8 kg 6 months
PARMESANO CHEESE > 20 kg 12 months
REGGIANO CHEESE 10 to 20 kg 8 months
REGGIANITO CHEESE 5 to 10 kg 6 months
SBRINZ CHEESE 5 to 10 kg 6 months
• Portaria MA/SDA nº 353/97 - CHEESES PARMESAN, PARMESANO, REGGIANO, REGGIANITO E SBRINZ
Cheeses
Parmesan
• Portaria MA/SDA nº 356/97 - PROCESSED CHEESE
• Definition: obtained by grinding, mixing, melting and emulsion bymeans of heat and emulsifying agents of one or more varieties ofcheese, with or without the addition of other milk products,spices, seasonings, in which the cheese is the major milkingredient.
• Sales denomination:
� At least 75 % of the same variety of cheese in the mixture ofcheeses.
Example: 75% Cheddar type cheese in the mixture of cheeses –CHEDDAR TYPE PROCESSED CHEESE.
� Use of flavouring to give or highlight the taste of a cheese —PROCESSED CHEESE TASTE CHEDDAR
Cheeses
processed or molten
MARCAQueijo Processado Sabor Cheddar
250 g
Ing.: Queijo Estepe (Leite Pasteurizado, Fermento Lático, Cloreto de Sódio (Sal), Cloreto de Cálcio, Coalho), Creme de leite, Estabilizante Polifosfato de Sódio e Aromatizante.
CHEDDAR
• Cheeses not having specifications in Brazilian legislation: CodexAlimentarius and technical literature
• General Regulation of cheeses – Portaria MA/SDA nº 146/1996regarding the classification, food additives, microbiologicalrequirements
Cheeses
• PORTARIA MA/SDA Nº 146/96
• Fat is to be composed exclusively of milk fat.
• Sales denomination:� BUTTER or UNSALTED BUTTER
� SALTED BUTTER ou BUTTER WITH SALT
• According to their classification may be called:� BUTTER EXTRA ou UNSALTED BUTTER EXTRA
� SALTED BUTTER EXTRA ou BUTTER EXTRA WITH SALT
� FIRST QUALITY BUTTER or FIRST QUALITY UNSALTED BUTTER
� SALTED FIRST QUALITY BUTTER ou FIRST QUALITY BUTTER WITH SALT
BUTTER
• MILK POWDER – PORTARIA MA/SDA Nº 369/97
• Whole milk powder
� Minimum 26% fat
• Partly skimmed milk powder
� 1,5% to 25,9% fat
• Semi-skimmed milk powder
� 12% a 14% fat
• Skimmed milk powder
� Maximum 1,5% fat
• Instantaneous – umictability and dispersability paterns
Milk powder
Lei nº 11.265, of 03 january 2006
• Article 13
• Expression warnings: main panel, legible and easy to see —wording given by Lei nº 11.474, de 15/05/2007.
� Skimmed and semi-skimmed milk:
IMPORTANT NOTICE: This product is not to be used as childrenfood, unless otherwise expressly indicated by a doctor ornutritionist. Breastfeeding, prevents infections and allergies andis recommended until 2 (two) years old or more.
Milk
Pictures of infants and young children, humanized images
• PORTARIA MA/SDA Nº 146/1996
• Sales denomination
� EDIBLE CASEIN ACID
� FOOD RENNET CASEIN
� EDIBLE CASEIN LACTIC
• Sales denomination
� CASEINATE OF (cation added) (drying process)
Example: CALCIUM CASEINATE DRIED BY ROLLER
Casein and caseinates
Lei nº 10.674, of 16 May 2003
• All processed food shall include on its label and leaflet, theinscriptions CONTAIN GLUTEN or GLUTEN FREE, as appropriate.
• The warning shall be printed in highlighted characters, clear andeasily legible.
� Wheat, oats, barley, rye and malt and their derivatives.
Information on gluten
• Technical Regulation on nutritional labeling of packaged foods.
• Scope: Feedingstuffs produced and marketed, packaged in the
customer’s absence and ready to be offered to consumers.
Shall not apply to:
– Fruit, vegetable, fresh meat.
– Food in packaging with a visible surface for labeling equal to or less
than 100 cm². Other than foodstuffs for special purposes or with
declaration of additional nutritional information
Nutritional labeling
ANVISA RDC nº 360/2003
• Declaration of the energy value and nutrients:
� Energy value
� Carbohydrates
� Protein
� Total fat
� Saturated fat
� Trans fats
� Dietary fibre
� Sodium
Nutritional labeling
ANVISA RDC nº 360/2003
• Optionally, vitamins and minerals listed in Annex A may bedeclared — when these are present in quantities equal to ormore than 5 % of the RDI per portion shown on the label.
Vitamin A Vitamin B12 Phosphorus
Vitamin D Biotine Fluor
Vitamin C Pantotenic Acid Copper
vitamin E Calcium Selenium
Tiamine Iron Molybdenum
Riboflavine Magnesium Chrome
Niacine Zinc Manganese
vitamineB6 Iodo Choline
Folic Acid Vitamin K
Nutritional labeling
ANVISA RDC nº 360/2003
ANNEX B: VERTICAL MODEL A
NUTRITIONAL INFORMATION portion g or ml (household measure)
Quantity per portion % VD (*)
Energetic value kcal = kJ
Carbohydrates g
Proteins g
Total fat g
Saturated fat g
Trans fat g (Do not declare)
Dietary fiber g
Sodium mg
* % Daily Values are based on a diet of 2,000 kcal or 8400 kJ. Your daily values may be
higher or lower depending on your calorie needs.
Nutritional labeling
ANVISA RDC nº 360/2003
ANNEX B: VERTICAL MODEL B
NUTRITIONAL
INFORMATION
portion g or ml
(householdmeasure)
Quantity perportion
% VD (*) Quantity perportion
% VD (*)
Energetic
valuekcal = kJ
Saturated fat g
Carbohydratesg
Trans fat g (Do notdeclare)
Proteins g Dietary fiber g
Total fat g Sodium mg
* % Daily Values are based on a diet of 2,000 kcal or 8400 kJ. Your daily values may be
higher or lower depending on your calorie needs.
Nutritional labeling
ANVISA RDC nº 360/2003
ANNEX B: LINEAR MODEL
Nutritional Information: Portion__ g or ml; (household measure) Energeticvalue ... kcal = ... kJ (...%VD); Carbohydrates ... g (...%VD); Proteins ...g (...%VD); Total fat ... g (...%VD); Saturated fat ... g (%VD); Trans fat ... g; Dietary fiber... g (%VD); Sodium ... mg (%VD).
* % Daily Values are based on a diet of 2,000 kcal or 8400 kJ. Your daily values may be higher or lower depending on your calorie needs.
Nutritional labeling
ANVISA RDC nº 360/2003
Portion (g / ml)
Fluid milk 200 ml 1 cup
Evaporated milk Enough to prepare 200
ml
x spoons
corresponding
Grated cheese 10 1 tablespoon
Cottage cheese, ricota, minas cheese,
skimmed curd and petit suisse
50 2 tablespoons
Other cheeses (cottage cheese, cream
cheese, melted, semi-hard)
30 x spoons / slice
corresponding
Milk powder Enough to prepare 200
ml
x spoons
corresponding
butter 10 1 tablespoon
Milk cream 15 1,5 tablespoons
Sweet milk 20 1 tablespoon
Household MeasureTABLE 4 – MILK AND DAIRY PRODUCTS
Nutritional labeling
ANVISA RDC nº 359/2003
Declaration of fats and fatty
acids
• Technical Regulation on additional nutritional information.
• Scope: Food produced, packaged and marketed ready for theconsumer.Is an optional basis.
• Definitions:
• Additional nutritional information: any representation thatstates, suggests or implies that a food has one or more particularnutrition properties, regarding their energy value, proteincontent, fat, carbohydrates, dietary fiber, vitamins and/orminerals.
Additional Nutrition Labelling
ANVISA RDC nº 54/2012
• Terms used: Light, source, rich, low
• Observe the criteria laid down for the use of the term concerned.
• Labels showing those terms but do not take into account thecriteria of RDC nº 54/2012 shall cover them with tag.
Rotulagem Nutricional Complementar
ANVISA RDC nº 54/2012
MOST FREQUENT PROBLEMS
• Establishment not authorised
• Product not authorised
• Incomplete description of the manufacturing
• Maturation time of cheeses
• Use of additives not permitted or above the maximum level
• Incorrect sales description
• Lack of compulsory information on the label
Thank you
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