registration of products of animal origin - trade...

Registration of Products of Animal Origin

-Meat and Meat Products–

Alessandro Figueiredo TorresCoordenação Geral de Inspeção - DIPOA

Sintesis of presentation1. Basic labelling Legislation2. Technical regulations of qualithy identithy

a. Composition/formulationb. Use on non-meat proteinsc. Hidratation of vegetal proteinsd. Use of skinse. Use of colagen fibersf. Use of CMSg. Starch and linking agentsh. Offali. Flavoringsj. Smoke flavorings

Sintesis4. Presenting a register aplication5. Use of aditivs

1. Sodium\potassium nitrite and nitrate2. Principle of additives transfer

6. Particularities

Labelling Legislation

I. Federal Legislation

1. Law 10.674, of 16 may 2003 – Compulsory information on the presence of gluten on food in the market, as a preventive and control measure of coeliac disease.

2. Law 8.078, of 11 september 1990 – Code of Consumer Defense

3. RIISPOA – Art. 794

II. MAPA Legislation

1. IN 19 of 2009 – Mecanisms for control and information of organic qualithy.

2. IN 51 of 29 december 2006 – Adopts the echnical Regulation for atribution of aditives and its limits, for the following categories of food 8: Meat and meat products

Labelling Legislation

II. MAPA Legislation (cont.)

3. IN 22 of 24 november 2005 – Aproves Technical Regulation for labelling of packed products of animal origine

4. IN 83 of 21 november 2003 – Aproves RTIQs for Corned Beef and minced beef

5. IN 06 of 15 february 2001 – Aproves RTIQs for Paleta Cozida, Produtos Cárneos Salgados, Empanados, Presunto Tipo Serrano, Prato Elaborado Pronto ou Semi-Pronto contendo produtos de Origem Animal

6. IN 04 of 31 march 2000 – Aproves RTIQs of CMS, Mortadela, Lingüiça e Salsicha

Labelling LegislationII. MAPA Legislation (cont.)

7. IN 20 of 31 july 2000 – Aproves RTIQs de Almôndega, Apresuntado, Fiambre, Hambúrger, Kibe, Presunto Cozido e Presunto

8. IN 21 of 31 july 2000 – Aproves RTIQs de Patê, Bacon e Barriga Defumada e de Lombo

9. IN 22 of 31 july 2000 – Aproves RTIQs de Copa, Jerked Beef, Presunto Tipo Parma, Presunto Cru, Salame, Salaminho, Saleme Tipo Alemão, Salame Tipo Calabres, Salame Tipo Friolano, Salame Tipo Napolitano, Salame Tipo Hamburguês, Salame Tipo Italiano, Salame Tipo Milano, Lingüiça Colonial e Pepperoni

10. IN 55 of 08 july 2000 – Amends and replaces nº 4.2.2, of annexes V, VI, VII, VIII, IX, X, XI, XII and XIII, of IN 22 of 31 july 2000

11. Portaria nº 612, of 05 october 1989 - Aproves the National Classification System for bovine carcases (*Relevant for age references in labells)


13. Portaria nº 05, of 08 november 1988 - Aproves the Standardization of bovine meat cuts

14. Portaria nº 9, of 26 february 1986 - Aproves the instructions for label registration and descriptive memory on pruducts of animal oririn (*Estabishes the validithy deadlines of previous registers and approvals)

15. Resolução - CISA/MA/MS Nº 10, of 31 july 1984 – Instructions for preservation during transport, marketing and consumption of pericible food, industrialized or improved, packed (*estabishes minimum and maximum temperatures for frozen and chiled products)

16. Resolução nº 01, of 09 january 2003 – Aproves the standardiztion of the nomenclature of meat products não formulados in use for poultry and rabits, swine, caprines, ovines, bubalines, equines, eggs and other animal species

17. Resolução nº 08, of 24 september 2001 – Labeling information requested by other bodies (eg.: nutritional table)


18. Circular nº 031/2006/DIPOA/SDA, of 22 august 2006 – Hydratation of non-meat proteins in products of animal origin (*Repeals Circular DIPOA nº 026/2006)

19. Ofício Circular nº 15/2009, of 08 may 2009 –use of preservatives/additives in meat products: procedures for registeration and official control

20. Circular nº 009/DIPOA/SDA, of 22 february 2006 – Clarifications on the application of IN 22/2005/MAPA)

Labelling LegislationII. MAPA legislation (cont.)

21. Ofício Circular 13 of 08/07/2011 – Use of colagenic proteins.

– Circular nº 053/DICAR, of 19 may 1988 –Criteria adopted to produce “Chiled Meat” (or frozen) of bovines, bonnless (matured cut) -“commercial maturation”

Labelling LegislationIII. INMETRO legislation

1. Portaria INMETRO nº 157, of 19 august 2002 - Aproves Technical Metrological Regulation, establishing the way to express the net content to be used on pre-measured products.

2. Portaria nº 019, of 19 march 1997 – Establishes references for net content in meat and meat products, on the shelves

IV. ANVISA legislation / Health Ministry

1. Resolução - RDC nº 2, of 15 january 2007 – Aproves the technical regulation on additives and flavourings

i. Informe Técnico nº 26, of 14 june 2007 – procedures for indication of flavour in food labelling

Labelling LegislationIV. ANVISA legislation / Health Ministry (cont.)

2. Resolução - RDC nº 359, of 23 december 2003 – Table of Reference Values for Portions of packed Food and Beverages for Nutritional Labelling Purposes

3. Resolução - RDC nº 360, of 23 december 2003 – Aproves Technical Regulation for Nutritional Labelling of Packed Products, making nutritional labelling compulsory (*Not applicable to meat “in natura”, chiled and frozen)

Resolução - RDC nº 13, of 2 january 2001 – Labelling of Raw Poutry Meat and Offals, Chilled of Frozen

2. Portaria nº 540 - SVS/MS, of 27 october 1997 – Aproves Technical Regulation: Food Additives - definitions, classification and use (*principle of additives transfer with no tecnological purpose)

Products registration – RIISPOA Legislation

– Art. 794: Foresees that all products of animal origine, in order to be placed on the market, needs to be identified with a registered label;

– Art. 834: Foresees that establishments can only use labels approved and registered by DIPOA;

Steps to export meat and meat products to Brazil

1. Equivalence of inspection systems for products of animal origine;

2. Approval of establishments;

3. Products registration

Equivalence of inspection systems

Resolução 001/1999, of 15 january 1999• Countries intersted in exporting should

reply to a questionaire• Responsible for information - official

sanitary autorities

Equivalence of inspection systems

• If the coutry is considered equivalent, it is not necessary to audit each individual plant

• The questionaire should be forward by diplomatic means.

Products registration – LegislationOfício Circular DIPOA/SDA Nº 42/2010

– Repeals “Circular nº 125/98” and “Ofício Circular nº 14/10”;

– Amends “Formulário de Registro de Rótulo de Produto de Origem Animal Importado”;

– Aplicable from:• 01/04/11: New requests to register;• 01/04/12: ammend existing registers;

– In 01/04/12 all registers obtained whith Circular nº125/98 were canceled;

Approval of establishments

The products should be placed by classes. Exemples: Meat frozen/chiled

Meat productsCanned products

Approval of establishments

• Key point: if the product intended to export to Brazil is not in the class of products for approval, will not be registered

www.agricultura.gov.br

systems

Management information system of the Federal Inspection Service - sigsif

List of foreign establishments approved to export to Brazil

Exports of products

The importer requests the import licence –LI.

MAPA verifiy the approval of the plant and the product approval.

PERIOD OF VALIDITY

• The registers have a period of validity of ten years.

• Portaria nº 9, of 26 de february 1986

Products registeration — legislation Ofício Circular DIPOA/SDA Nº 42/2010

– Labels of primary packaging will be registered, which are exposed to the consumer.

Products registeration — legislationOfício Circular DIPOA/SDA Nº 42/2010

The other packaging will not be registered, althow must contain the following information:

• Sell designation of the product;• Name or commercial register and health

approval number;• Conditions for preservation of the product;• Manufacture and expiry date;• Official stamp (if available)


Documents for obtaining the registration (1):

• “Formulário de Registro de Rótulo de Produto de Origem Animal Importado” (Form for Labelling Registration of Imported Product of Animal Origin”) completed, signed and stamped by the legal representative and technical officer of the establishment – 2 original documents.

3.Products registeration — legislation

Ofício Circular DIPOA/SDA Nº 42/2010

Documents for obtaining the registration (2):• Specimen of the label, in original shape and colours or

with their actual dimensions indicated;• Labels should be in printed in Portuguese, or it may be

used a label in Portuguese over a package in a foreign language:

• In this case, the model of the original packaging should be sent with indication of the place where the label shall be applied;

• The label could be placed on the package after the arrival of the product in Brazil, however, before marketing


Documents for obtaining the registration (3):

-Other documents necessary according to the type of product, for example:

-Calculation of thermal penetration of preserved products;

-Scientific and technical literature about the product

A number of important points

Files approved by " Formulário do Oficio 14/2010" do not require further approval.

If there is a change of name of the plant, it is needed to update of the registration process

General principles of labelling

Packed animal products should not be described or have a label which:

a) Use words, signs, names, symbols, badges, illustrations or othergraphic representations which may make the information false, incorrect, inadequate, or likely to mislead the consumer to confusion error or misunderstanding in relation to the real nature, composition, origin, type, quality, quantity, validity, or use of the product of animal origin;

b) Allocates effects or properties which it does not possess or cannot be demonstrated;

c) Emphasises the presence or absence of components which are intrinsic or of animal products of the same nature, except in cases provided for in specific technical regulations;

General principles of labelling

d) Highlights, in certain types of processed products of animal origin, the presence of any components which are added as ingredients in allproducts of animal origin with similar technology of manufacture;

e) Highlights qualities which may induce the mistake in relation toactual or therapeutic properties that some components or ingredients have or may have when consumed different from those in the animal product or when consumed under pharmaceutical form;

f) Indicates that the product of animal origin has medical or terapeutic properties;

g) advise their consumption as stimulating, to improve health, to prevent diseases or with curative action

Compulsory information

• IN 22/2005/MAPA– Name of product– Company name,– Batch, the date of manufacture and expiry date– Registration number– List of ingredients– Preservation

• Net content– Form of manufacture– Stamp of the inspection service– Brant– Indication of origin– Name and address of the importer

• Lei 10.674/2003– “CONTAIN GLUTEN” or “DO NOT CONTAIN GLUTEN”

• Resolução RDC nº 360 – ANVISA– Table of nutritional information

2. Compulsory information

Most common errorsAbsence of mandatory informationAbsence of nutritional information, when required for the productNot according with "law of gluten”Incorrect registration numberInadequate presentation of mandatory information

Name of the product• IN 22/2005, item 5

– The name of the product of animal origin shall be indicated in the main panel of the label in bold characters, uniform in body and colour, without intercalation of drawings and other statements. The size of the font used must be proportionate to the size used for the indication of the trade mark or logo if any;

– Item 7.61 do Ofício Circular 31/09 – minimum 1/3 of the major inscription of the label.

The name of the product must be easily visible to the consumer

Fantasy name

• IN 22/2005, item 6.1, leter b:– -May be employed a name, invented name or

a registered brent, where it is accompanied by the name of the product of animal origin, as set out in the RTIQ

– Example

MAXBURGUERBeef hamburguer

Fantasy name

IMPORTANT!The invented name, when used, must not

mislead the consumer to error, confusion or mistake of the nature, quality, quantity, etc.

List of ingredients

• Compulsory, except when the PAO consists of a single ingredient (e.g. Pasteurised milk, meat chilled)

• All ingredients (compulsory and optional) shall be named in descending order of proportion

• The water shall be declared in the list of ingredients, except when is part of sauces and soups and these are declared in the list of ingredients as such

• Is not necessary to declare the water evaporated in the manufacturing process — e.g. water used for humid salting jerked beef (control of humidity content in end product)

List of ingredients

• Additives — always declare the function of the additive and the name and/or number of INS– E.g.: Preservative: sodium nitrite or Preservative: INS

250 or Preservative: Sodium nitrite (INS 250)

• -The additives should be declared after the ingredients in descending order

Technical regulations on identity and quality

I. Composition/formulationPhysicochemical requirements established in the Technical Regulation RTIQ:

i. - Water activity (Wa)ii. - Moisture content (max)iii. - Fat (max)iv. - Protein (min)v. - Total carbohydrates (max) starch (max)vi. - Animal proteinvii. - Vegetable protein

Table (compiled data))


Use of non-meat protein

Only in products of animal origin with estimates of use in RTIQ, within the limits laid down

Non-meat protein may be used as a carrier of flavourings, additives and/or spice mix — observe during the analysis of the composition of the products that do not exceed the limit laid down in RTIQ


Hydration of vegetable proteinCircular 031/2006 DIPOA/SDA, provides:

Maximum 4 parts of water for 1 part of proteinThe water used for hydrating (4: 1) shall apply irrespective of the water permitted in the composition of the product by Art. 376 do RIISPOA (3% water for embedded not undergone cooking and 10% water for boiled products)Products must comply with the physico-chemical characteristics established in RTIQs


Use of hides and skinsThe use of skin (porcine or poultry) as an isolated ingredient is only allowed in products whose RTIQs allow addition of skin — always check RTIQThe use of skins naturally linked to cuts may be permitted Exception: breaded in poultry meat –Circular 05/2010/CGI/DIPOA


Use of colagen products

Ofício Circular 13/2011Has to be foreseen in RTIQHydration of 4:1Maximum of 1.5 % of total weight


VII. Use of MSMThe use of mechanically separated meat is restricted to products subjected to heat treatment (boiled or sterilised), within the limits laid down in the RTIQs

When used in sausages:• Max. 20%• Compulsory to appear on the label: “Contains mechanically

separated meat of... (animal species)”, in addition to be mentioned in the list of ingredients

According to the manufactured product, its use may determine the change of the name of the product (RTIQ which provides for the declaration of the animal species in the name)

• E.g.: Bovine meatballs on sauce (sterile) — if MSM of chicken is used in the formula the name will be “meatballs of bovine and chicken meat on sauce”


Use of starch, linking agents and breadcrumbs

Take into account the limits set in the RTIQs, where permitted

.


Use of offalOnly on products foreseen in the RTIQ, according to the limitsThe establishment must inform, in the composition, which offal will be used, the animal species and quantitiesThe offal shall be declared on the list of ingredients on the label.

• E.g.: Ingredients: Bovine meat, bovine offal (stomachs and brains), pig offal (heart and kidneys),...

Comply with item 7.30 of Ofício Circular 31/09 .


IX. Use of flavourings

The establishment must inform under the composition, the classification of the flavourings used (natural, synthetic or artificial)Take into account Informe Técnico nº 26, of 14 June 2007 — Procedures for the indication of the use of flavouring in food labelling:

Finalidade do Aroma no produto

Classificação do Aroma

Designação ou Painel Principal

Painel Principal

Definir / Conferir sabor a um alimento

Natural Sabor... Contém Aromatizante

Artificial Sabor artificial de... Aromatizado Artificialmente

Idêntico ao Natural Sabor... Contém aromatizante sintético idêntico ao natural

Reforçar ou reconstituir sabor de um alimento

Natural Nome do Produto Contém Aromatizante

Artificial Nome do Produto Aromatizado Artificialmente

Idêntico ao Natural Nome do Produto Contém aromatizante sintético idêntico ao natural

Conferir sabor não específico

A indicação do uso de aroma deve constar na lista de ingredientes conforme determina item 6.2.4 da Resolução RDC nº 259/2002.

Informe Técnico nº 26, de 14/06/2004 - Tabela


IX. Use of flavourings (cont.)Examples:Burger meat of bovine animals

“flavour Picanha” (note — the main panel)Chicken sausage

“flavour Churrasco” (note — the main panel)Mortadella

“artificial smoke flavour” (note — the main panel).

Products registration – LegislationOfício Circular DIPOA/SDA Nº 42/2010

• "Form for registration of label of imported product of animal origin"

Documento

4. Applying for registration1. Composition

Declare all ingredients (compulsory and optional), in descending order)Use of mixture of ingredients —should be informed under composition, all ingredients and additives present in the “mixture”

Example: Seasoning to sausage (contains: Salt, black pepper, nutmeg, natural flavouring: garlic, onion and grass sweet)

Use of mixture of additives — should be informed under composition, all ingredients and additives present in “mixture”and those having limit of use must have quantities specified.

Example: Mixture of curing salts to sausage (contains: salt, monosodium glutamate, starch - 3%, sodium nitrite - 4%, sodium nitrate - 6 %)

4. Applying for registration

1. - Composition (cont.)Must be observed if the ingredients used for the product are permitted as defined in RTIQs and within the limits laid down.

• Incluir o slide• Slide 12 da outra apresentação

4. Applying for registration

2. Manufacturing process

Look for specific processing for characterisation of the products. E.g.: Smoking (mandatory for manufacture of bacon), baking, etc)The non-compliance of the compulsory procedure mischaracterizes the product set out in the RTIQ

5. Use of additivesTake into account IN 51/2006/MAPA – Establishes limits of additives for meat and meat products

Some additives has limited use for specific productsIdentify adequately the category of the product

a. Fresh industrialised meat products embedded or not embedded b. Meat products industrialised dried, cured and/or matured or notc. Industrialised cooked meat products embedded or notd. Salted raw meat productse. Salted cooked meat productsf. Preserved, mixed preserved and semi-preserved meat products

5. Use of additivesOfício Circular nº 15/2009, of 08 may 2009 –use of preservatives/additives in meat products: procedures for the registration and control

If the company uses in formulating nitrite or sodium nitrate above the limit of intended use (150 ppm -nitrite / 300 ppm - nitrate) should state in applying for registration (method of quality control) that the final product will comply with the limit set, on the basis of a specific self-control programmeFor products not subject to processes for the reduction of nitrite the limit of 150 ppm must be used for the formulation (e.g.: fresh sausage)

5. Use of additivesPrinciple of transfer of food additives (Portaria SVS 540/1997)a. All food additive which had been used in the raw materials or other

ingredients (including food additives) is transferred to a food, shall be exempted from declaration in the list of ingredients if:i. The additive is permitted in raw materials or other ingredients according to

specific legislation in forceii. The quantity of the additive in raw materials or other ingredients does not exceed

the maximum allowed limits in the food.iii. The food for which the additive is transferred does not contain this additive at a

rate greater than it could be introduced for the use of ingredients under appropriate technological conditions or good production practices.

iv. The transferred additive be present at a non-functional level, i.e. a level significantly lower than the normally required to achieve an efficient technological function in the food

b. An additive transferred to a food in a significant concentration or sufficient to exert a technological function in that food, and originated for the use of raw materials or other ingredients where the additive has been used, must be declared on the list of ingredients

c. Preservation

• Indicate maximum and minimum temperatures

• All information must be clear and precise in order not to misleadE.g.: Keep frozen at -12°CE.g.: keep chilled between 0 °C e 5 °C

c. Preservation (cont.)Most common errors

1. Inadequate use of terms“This product keeps its best features if... (frozen at -12°C)”

2. Imprecise and/or dubious information: “keep frozen at -12°C .... This product should be transported and marketed and maximum -8°C”

3. Information for preservation inconsistent with the product:

“frozen beef .... Keep chilled between 0°C e 5°C”

d. Expiry date• The period of validity shall include at least:

– The day and the month for products which have a period of validity not exceeding three months;

– The month and the year for products which have validity period for more than three months. Whether the month of expiry is december, it shall be sufficient to indicate the year, with the words “end of...’ (year);

• Forms of indication:– - “use before... “;” valid until... ";" validity... “;” Val:...”;

"expires... “.• The terms above shall be accompanied by:

– Period of validity or clear indication of where the validity period is indicated*

• E.g.: validity: 01/01/2011 orManufacture, validity and batch: printed in the top of the

can

e. Net content• Premeasured foods:

– Label should indicate the net content• Products with varying weights:

– Give the weight of the packaging• Products marketed in units:

– It may be indicated the number of units and/or other data for marketing

E.g.: Natural casings salted — ‘contains XX sets of 30 metres’

* INMETRO has specific requirements on the font size to be used for the indication of a net content

6. Particularities

3. Additional nutritional informationOnly apply to products READY for consumptionComparison of data, where carried out, shall be with the same type of productNot applicable to products “in natura”

g. Table of nutrition information

Most common errors

Absence of the table of nutritional information, where necessaryTable does not meet requirements of the

competent authority for: presentation of the nutrition information, portion size

4. Main causes of refusal

1. Additives2. Composition not in accordance with

RTIQ3. Quality terms4. Compulsory information5. Inadequate manufacturing process6. Not compliant with previous opinions

Contacts

[email protected]@agricultura.gov.br

[email protected]