G/TBT/N/BRA/822  
 
18 June 2018  
(18-3766) Page: 1/4 
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 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas   
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=33294  
3. Notified under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Maximum 
limits of the relevant impurities  
5. Title, number of pages and language(s) of the notified document: Draft Resolution 
nº 534 of 12 June 2018 (12 page(s), in Portuguese)    
6. Description of content: The Secretary of Agricultural Defense of the Ministry of 
Agriculture, Livestock and Food Supply, the Director -President of the Brazilian Health 
Regulatory Agency - ANVISA and the President of the Brazilian Institute of the Environment 
and Renewable Natural Resources - IBAMA, in the use of their legal and in view of the 
provisions of Law n. 7,802 of 11 July 1989, and in items II and X of art. 2, as well as in 
art. 68 and 69 of Decree n. 4,074 dated 4 January 2002 and considering the need to 
establish acceptable maximum limits for toxicological and environmentally relevant 
impurities present in agrochemicals, their components and the like, resolve:  
Article 1 To approve the regulation that establishes the maximum limits of the relevant 
impurities to be investigated in the studies of five batch and controlled after registration, 
and gives other measures.  
Article 2 This Normative Instruction applies to applicants an d holders of registration of 
technical products, premixtures and formulated products.  
§1 Technical products under registration must demonstrate compliance with the maximum 
limits established in the Annex of this Normative Instruction.  
§2 The holders of r egistration of technical products, premixtures or formulated products 
must guarantee the maximum limits of relevant impurities stipulated in the Annex of this 
Normative Instruction.  G/TBT/N/BRA/822  
 
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  Article 3 For the purpose of this Normative Instruction, any impurities th at, in comparison 
to the active ingredient, may produce a significant toxic adverse effect on health or the 
environment are considered relevant impurity.  
§ 1 An impurity that occurs in two different active ingredients may be considered as 
relevant to one a nd non -relevant to the other, or have different acceptable maximum 
limits for different active ingredients.  
§2 The effects of acute oral toxicity, skin or ocular corrosion / irritation, skin sensitization, 
mutagenicity, carcinogenicity, reproductive toxici ty or other toxicological or 
ecotoxicologically significant effects are considered to be toxic adverse effects of the 
relevant impurities.  
§ 3 Impurities of toxicological or ecotoxicological concern are those impurities structurally 
similar to the substanc es or classes of substances listed in the Annex, requiring a technical 
evaluation, based on additional data, to consider them as relevant impurities.  
Article 4 The holders of registration of technical products produced in the country or 
imported and of pre mixes and formulated products imported, based on active ingredients 
listed in the Annex, shall guarantee:  
I - that the sampling is carried out lot by lot and is statistically representative of the 
quantities produced or imported, not being accepted the sam pling methodology composed 
of more than one batch or batch; and  
II - that the analyzes for the control of the relevant impurities are conducted with 
traceability and making use of appropriate parameters and methods.  
Single paragraph. The collection and sam pling methodologies will be subject to specific 
regulation.  
Article 5 The analyzes for the control of the relevant impurities must be carried out with 
the technical product.  
Paragraph 1 By means of justified justification, the analyzes may be carried out i n the 
premix or in the formulated product, when imported or when it is an integrated production, 
and the results must be expressed according to the quantity of technical product.  
Paragraph 2 When the analyzes are carried out outside the quality control uni t of the 
manufacturer of the product, they must be carried out by an accredited laboratory in the 
ABNT NBR / IEC 17025, ISO 17025 or in Good Laboratory Practices - GLP, by the National 
Institute of Metrology, Quality and Technology - INMETRO, with valid ce rtificate, 
considering the tests carried out.  
Article 6 Certificates of analysis shall contain the following items:  
I - batch or batch identification, date of manufacture, validity;  
II - name and address of the manufacturer;  
III - content of active ingredi ent and the relevant impurity (s), with their respective limits 
established in the Annex of this Normative Instruction;  
IV - identification of the analytical method (s) used, with their respective quantification 
limits, for both active ingredient and impur ity (s);  
V- name and address of the laboratory where the analyzes were carried out;  
VI - dates of receipt of the sample by the laboratory and date of the analysis and  
VII - names, functions and signatures of the persons responsible for issuing the certificate.  
Single paragraph. All analysis certificate information shall be readily identifiable and 
traceable, including data imputed directly to computer systems.  
Article 7 The certificates of analysis must be kept vernacular under the custody of the 
holders of registration of the products.  
Paragraph 1 When requested, registrants must present the raw data of the analyzes.  
Paragraph 2 Certificates of analysis and their raw d ata must be finalized and available for 
inspection within 30 (thirty) days of the date of production in the country or importation G/TBT/N/BRA/822  
 
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  (clearance), remaining under the custody and control of the holders of the registration for 
the minimum period of five (5) ye ars. 
Article 8 The registration holder shall maintain control over the destination of each lot or 
batch of the technical product or formulated, produced or imported, including the 
identification of the companies for which the product has been supplied, and  this data shall 
remain at the disposal of the authorities for a period of at least five (5) years, counted 
from the date of local manufacture or importation (clearance).  
Article 9 It is the responsibility of the owner of the registration to guarantee the quality of 
the control of impurities in the product, even when the manufacture, production, 
manipulation or importation of the product is performed by third parties.  
Paragraph 1 The batch or batch of technical product, premix or formulated product based 
on active ingredient listed in the Annex to this INC may only be used or marketed after 
confirmation that the relevant impurity is within the limit established in this standard.  
Paragraph 2 If the results of the analyzes of the imported lots indicate any relevant 
impurity above the maximum permitted limit, it is the responsibility of the registration 
holder to proceed with the appropriate measures for the return of the product.  
Paragraph 3 In case the results of the analyzes of the batches produced in the country 
indicate any relevant impurity above the maximum permitted limit, the holder of the 
registration must:  
I - promote preliminary investigation, including the evaluation of the need for the 
application of precautionary measures and corrective actions;  
II - adopt measures, according to its own procedure, for the treatment of non -compliance 
or disposal, as the case may be; and  
III - to keep all the documents related to the procedure used, for a period of five years, 
from the date of execution of the proc edure.  
Article 10 The Annex of this Normative Instruction will be updated whenever other 
impurities relevant to the establishment of their respective maximum limits are identified.  
Paragraph 1 Relevant impurities identified in products based on new active ingredients 
shall have their maximum limits defined in the registration process until their forecast is 
expressed in an update of the Annex of this Normative Instruction.  
Paragraph 2 In the case of identification of new impurities relevant to products base d on 
active ingredients already registered, these should be controlled according to the 
maximum limit already established by recognized national or international organisms, until 
updating of the Annex of this Normative Instruction.  
Article 11 Non -complianc e with the provisions contained in this Normative Instruction 
constitutes an infraction, without prejudice to the applicable civil, administrative and penal 
liabilities.  
Article 12 This Normative Instruction shall enter into force within thirty (30) days a fter the 
date of its publication and revokes Normative Instructions No. 2 of 20 June 2008 and No. 2 
of 15 August 2014.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  Brazilian Official Journal 113, 14 June 2018 (Diário Oficial da União 
de 14 de Junho de 2018); (3) Brazilian Official Journal (Diário Oficial da União); (4) Not 
stated   
9. Proposed date of adoption: On the date of its publication  
Proposed date of entry i nto force: 30 days after its publication  
10. Final date for comments: 20 July 2018  G/TBT/N/BRA/822  
 
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  11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
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    
http://portal.anvisa.gov.br/documents/10181/4537751/Minuta+da+Consulta+P%C3%BAb
lica+534 -2018.pdf/86d05e06 -d33c-4860-bbdf-fdd25 252d1e1