On 21 Mar 2016, ANVISA issued a technical note regarding the information required for pesticide label and leaflet during the registration and post-registration process and further explained the company obligation under pesticide labeling.

As stipulated by the Article 48 and Article 9 of the Decree 4074 of 2 Jan 2002, pesticide and similar product marketed in Brazil are required display specified information on its label and leaflet, which was established in the Annex VIII and Annex IV of the Decree.

Pesticide Label

• Label material should be resistant to the usual handling condition;

• Black letters with white background (except the multi-layer and cardboard package);

• Should contain manufacturing and expiry date;

• Label should be divided into three column;

• Color band corresponding to its toxicological class, which was determined under the standard established by the Ministry of Health;

• A diameter containing a skull and tow crossbones in black with white background, with the words: CAUTION;

• Specific pictograms should be placed along the color band, which should be internationally accepted;

• Information Mandatorily Contained on Central and Side Columns of Pesticide Label
  Central Column
  Side Columns

• Precaution on environmental impact;

• Precaution on the use and warning about environmental protection;

• Storage instruction for conservation and accident prevention;

• Instruction on the disposal of empty package;

• Telephone number of the person empowered to provide all necessary  information to the user and seller;

• Use precaution and general recommendation on first aid, antidotes and treatment regarding human health;

• Trade Name;

• Product composition;

• Content;

• Class and type of formulation;

• the term: "Indication and usage restriction: See package leaflet and recipe";

• the term "Restriction in state, Federal District and Municipal: See product manual";

• name ,address, company registration identity, of the registrant, manufacturer, formulator, handler and importer;

• registration number and the symbol of the registration authority;

• batch number or starting number;

• recommendation for the user to read the label, manual and pesticide recipe before using the product;

• manufacturing and expiry date;

• indication if the formulation is explosive, flammable, oxidizing, corrosive, irritant or whether the product is for end-use;

• toxicological and environmental hazard classification;

• the term “it is required to use personal protective equipment” and the “it is required to return the empty package”;

The low toxicity pesticide may be exempted from inclusion the skull and crossbones on its label if it was defined by the federal authority of health sector in additional rules.

Product Manual

Pesticide manual should contain product use instruction and detailed information on human and environmental protection:

Company Obligation

ANVISA stressed that the above information should be included in pesticide label and manual and company should submit the template for review. The verification on the presence of the above required information will directly determine the result of ANVISA’s technical and health review on pesticide label and leaflet, which is essential for pesticide registration. All information on label and product leaflet should be consistent with the technical report for pesticide registration application. If any absence of any required information was identified, ANVISA may request the company to correct.

It is also highlighted the obligation of the registration holders, who should present all the validate information and ensure that the information is appropriate and sufficient for health protection purpose. They will also be responsible of providing medical information on pesticide label and whether or not to use personal protective equipment, as well as taking the consequence of dressing or removal of the equipment. Furthermore, the inclusion of the terms such as “with the recommendation approved by the health authorities-ANVISA/MS” into pesticide label will not be accepted.