6. Registration Processes
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6. Registration Processes
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General Foods
Brazil
This section provides information on any product notification or registration and manufacturing site registration processes.
6.1 Product Notification
Packaged food and raw materials
Product and raw materials notification with ANVISA is required for industrialized packaged products that are exempted from registration [1].
The company responsible for the product exempted from registration must fill in the Manufacture Start Communication Form (Annex X of Resolution No. 23/2000 [2]- refer to ANNEX 1 sheet - 4a) or Import Communication Form (Annex I of Resolution No. 22/2000 [3] - refer to ANNEX 1 sheet - 4b), according to case.
The completed form must be delivered to the health surveillance agency (state or municipal) where the responsible company for the product is located.
Documents required:
- Sanitary License for manufacturers
- Original Label or Label Layout
- Company Registration Form
- Product Technical File
- CNPJ or CPF
- DIF (State registration)
When the establishment of the importer or the manufacturer's representative constitutes a commercial office, the Sanitary Permit(s) or Operating License(s) of the warehouse(s) where the product(s) subject to the registration request will be stored.
In the case of foods manufactured nationally, the health authority must be informed, within a maximum period of up to 10 days of the start date of manufacture of the products exempt from registration. The sanitary surveillance agency has a period of up to 60 days to inspect the establishment, in order to verify compliance with Good Manufacturing Practices. The local Health Surveillance may define additional requirements, according to local legislation.
It is important to emphasize that the exemption from registration does not release the manufacturer or importer from meeting the requirements set out in the legislation in force and does not release the product from being subject to monitoring by the Health Surveillance agency.
There is no cost for the notification/communication in the list of fees [4].
From the delivery of the communication by the company [5], the sanitary surveillance has a period of 60 days to proceed with the inspection of the establishment, in order to verify compliance with Good Manufacturing Practices, in addition to analyzing the documents presented together with the form of notice of the start of manufacture. If any non-conformity is identified, the company will be summoned to provide the correction to continue the process, whose other deadlines will be defined.
Non-packaged food and food preparations
In the specific case of non-packaged products (e.g. donuts, coffee beverages, etc.), they do not require notification or registration, as they are still considered food preparations, which are only governed by the GMP implementation of the establishment where they are prepared and sold. Based on this, the information described above shall only be applicable to packaged products or raw materials used in food preparations.
6.2 Product Registration
Packaged food and raw materials
Product registration is required with ANVISA for certain food categories that are not exempted from registration which includes foodstuffs and raw materials with functional and/or health claims and novel foods/ingredients. So, if the product of interest (or any of the ingredients used in its preparation) falls under these categories, they must apply for registration.
Registration is done through an online application through ANVISA's portal. The process will depend on the food category to which the product or raw material belongs [1].
For product Registration of products bearing claims, in addition to the requirements described in Section 5.3.2 (Functional & Health Claim Registration), the following documents will be required [2]:
- A document containing the summary of the request.
- Petition Forms 1 and 2 duly completed. Observe clarifications in "GENERAL GUIDELINES APPLICABLE TO ALL REGISTERED FOODS" available on the Anvisa portal.
- Claims and other labeling information or draft labels.
- Company Registration Form (FCE) - for the requesting company of the registration not yet registered with Anvisa.
- Copy of the sanitary license or valid equivalent document. Present the license of each manufacturing unit, if applicable. For imported food, present the license of storage locations. If the license does not have a deadline, indicate this situation and forward a valid document.
The cost depends on the size of the company responsible for the registration process in Brazil, currently is R$10,637.00 = USD 2,085.69 (Empresa Grande Porte 1) [4].
Duration: Submitting the registration via the request system takes approximately 30 minutes. As for process finalization, it can take from 6 months up to 2 years, depending on the quality of the data, questions from the Authorities, and service demand [4].
The product/raw material registration is valid for 05 (five) years, throughout the national territory. The revalidation of the registration must be requested within a period of up to 60 (sixty) days, before the expiration date.
When the establishment of the importer or the manufacturer's representative constitutes a commercial office, the Sanitary Permit(s) or Operating License(s) of the warehouse(s) where the product(s) subject to the registration request will be stored.
More details about the registering process (steps and forms) can be found in Portuguese at: https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/alimentos/arquivos/OrientaesparaApresentaodeDocumentosnoPeticionaentodeRegistroePsRegistrodeAlimentos_230621.pdf
Non-packaged food and food preparations
In the specific case of non-packaged products (e.g. donuts, coffee beverages, etc.), they do not require notification or registration, as they are still considered food preparations, which are only governed by the GMP implementation of the establishment where they are prepared and sold. Based on this, the information described above shall only be applicable to packaged products or raw materials used in food preparations.
6.3 Other Notes or Requirements
The procedures and forms for registration and exemption from the obligation to register imported products will be the same as those established for national products, according to specific technical regulations [2][3].
The registration application must be made by the importer, subsidiary company or manufacturer's representative legally based in Brazil with the corresponding national tax identification number.
6.4 Manufacturing Site Registration and Food Service Authorization
Packaged/Non-packaged food and raw materials
There is a requirement for manufacturing site registration and this is handled by ANVISA.
The cost is as follows [4]:
- Certification of Good Manufacturing and Control Practices for each establishment or manufacturing unit, by type of activity and production or marketing line for food industries. Cost - R$ 38.406,77 = USD 7,532.22 (consider cost in Real, conversion just as a reference).
- Other countries (in case of imported products) - R$ 108,611.71 = USD 21,300.59.
Duration is not specified as this will depend on how much this service is in demand.
Food preparations
All food establishments, including food services (restaurants, bars, cafeterias, etc.) must be previously licensed by the competent state, district, or municipal sanitary authority, by means of an authorization or license. For this purpose, the interested party should contact the local health surveillance body where the establishment will be located to find out about the required documents and the health legislation governing the products and the intended activity, as the states, the Federal District, and the municipalities may issue regulations that complement the federal rules.
The cost and timeline will depend on the type of establishment and on the rates imposed by the local authorities which can vary from one municipality/state to another (municipal/state taxes may be involved).
There are no defined requirements legislated for food service establishments. The following is a general list (non-official) required to start a food service business in Brazil:
- Operation Permit
- Fire Department Inspection Certificate (AVCB)
- Municipal Health Surveillance Register (CMVS)
- National Register of Legal Entities (CNPJ)
- Certified copy of the General Register (RG) and Individual Taxpayer Registry (CPF)
- Copy of the Rental or Purchase and Sale Agreement
- Among other documents specific to the city
- Mirror sheet of the Individual Income Tax (IRPF)
- Property Tax (IPTU) of the property
- Good Manufacturing Practices Manual
- Standard Operating Procedures (SOPs)
- Food purchasing records
It is worth mentioning that additional information may be required depending on the state and or municipality in which the establishment is based in Brazil.
6.4.1 Standard/Rules for Manufacturing Site and Food Service Authorization
Packaged/Non-packaged food and raw materials
The standards, rules, and criteria are regulated by the 2 legislations below:
- The ORDINANCE No. 326/1997 [6] establishes general (essential) hygiene and good manufacturing practices requirements for food produced/manufactured for human consumption.
- The RESOLUTION - RDC No. 275/2002 [7] provides for the Technical Regulation of Standard Operating Procedures applied to Food Producing/Industrializing Establishments and the Checklist of Good Manufacturing Practices in Food Producing/Industrializing Establishments.
Food preparations
Resolution N° 216/2004 [8] that provides on Technical Regulation on Good Practices for Food Services.
6.4.2 Other Notes or Requirements for Manufacturing Site Registration and Food Service Authorization
Packaged/Non-packaged food and raw materials
In addition to those mentioned in Section 6.3 above (Other notes or requirements for product registration), the importers and distribution companies of food products must implement and have a Manual of Good Manufacturing/Storage Practices and in the other stages of the production process under their responsibility.
Also, they must keep the formulas of products exempt from registration updated, being available to the health authority, whenever requested by the authorities.
Food preparations
None.
6.5 References
1. Resolution of the Collegiate Board of Directors - RDC No. 27/2010 - Provides for the categories of exempt food and packaging and with mandatory health registration
http://antigo.anvisa.gov.br/legislacao#/visualizar/28564
2. RESOLUTION No. 23/2000 - Provides for The Basic Procedures Manual for Registration and Waiver of the Mandatory Registration of Products Relevant to the Food Area
3. RESOLUTION - RDC No. 22/2000 - Provides for the Basic Procedures for Registration and Waiver of the Mandatory Registration of Imported Products Relevant to the Food Area
4. Resolution RDC N° 222/2006 (updated 2017). Provides for the electronic petition and collection procedures within the scope of the National Health Surveillance Agency - ANVISA and its State and Municipal Health Surveillance Coordination Offices and makes other provisions
5. Communication of import and start of manufacture of food product - Updated on 08/03/2022 at 15:36
https://www.saude.df.gov.br/comunicacao-de-importacao-e-inicio-de-fabricacao-de-produto-alimenticio
6. ORDINANCE No. 326/1997 - Establishes general (essential) hygiene and good manufacturing practices requirements for food produced/manufactured for human consumption
7. RESOLUTION - RDC No. 275/2002 - Provides for the Technical Regulation of Standard Operating Procedures applied to Food Producing/Industrializing Establishments and the Checklist of Good Manufacturing Practices in Food Producing/Industrializing Establishments. https://www.gov.br/agricultura/pt-br/assuntos/inspecao/produtos-vegetal/legislacao-1/biblioteca-de-normas-vinhos-e-bebidas/resolucao-rdc-no-275-de-21-de-outubro-de-2002.pdf/view
8. Resolution N° 216/2004 – Provides on Technical Regulation on Good Practices for Food Services
https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2004/res0216_15_09_2004.html
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