G/TBT/N/BRA/1383  
25 May 2022  
(22-4005) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Brazilian Health Regulatory Agency (ANVISA)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br  
Web-site: www.inmetro.gov.br/barreirastecnicas   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Organic 
surface -active agents (other than soap); surface -active preparations, washing 
preparations (including auxiliary washing preparations) and cleaning prepar ations, 
whether or not containing soap, other than those of heading 34.01. (HS code(s): 3402)  
5. Title, number of pages and language(s) of the notified document:  Resolution 
number 703, 16 May 2022; (20 page(s), in Portuguese)  
6. Description of content:  This Resolution contains provisions on enzymatic detergents for 
restricted use in health care establishments with indication for cleaning medical devices.  
In order to obtain the sanitary authorization of the products covered by this Resolution, 
the following documents must be presented documentation from the supplier of all 
enzymes contained in the formulation, informing the nomenclature adopted by the 
International Union or Biochemistry and Molecular Biology - IUBMB, including the 
complete code numb er and description of the biological origin containing the genus and 
species.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Resolution aims to establish definitions, general characteristics, 
technical and label ing requirements for the marktet authorization of products categorized 
as enzymatic detergents for restricted use in health care establishments with indication 
for cleaning medical devices, in order to minimize the risk to health.; Protection of human 
health or safety  
8. Relevant documents:  - G/TBT/N/BRA/1383  
 
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  9. Proposed date of adoption:  1 June 2022  
Proposed date of entry into force:  1 June 2022  
10. Final date for comments:  Not Applicable  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www. anvisa.gov.br  
The final text is available only in Portuguese and can be downloaded at:  
http://antigo.anvisa.gov.br/documents/10181/6431325/RDC_703_2022_.pdf/6c4f353d -
e930-4260-9fd9-90a6595a3aae