IBAMA BRASIL

BIOREMEDIATORS REGISTRATION

Registration, authorization and consent procedures

Art. 12. Those interested in obtaining the registration of a remedial agent must submit a request
to Ibama in the following manner:

I - Annex I, accompanied by a technical report as provided in Annex II, for bioremediators; O

II - Annex III, for chemical or physical-chemical remedies.

§ 1 The information and documents that make up the request for registration or renewal of
registration, as well as the technical report, must refer to a single product and be organized
according to the elements established in the forms attached to this Normative Instruction.

§ 2 The lack of presentation of information or documents required in the terms of the Annexes of
this Normative Instruction must be technically justified, in view of the corresponding item, even
in cases where the registrant considers that the requirement is inapplicable to the remedial
agent in question.

§ 3 The request for registration and the technical report must be completed by means of a
specific form, available through the electronic application of Ibama, necessarily accompanied by
the supporting documents.

Art. 13. The analysis of the request by Ibama will take place within 30 (thirty) days, counting
from the date of receipt of the complete documentation, unless an extension is expressly
motivated by the same deadline.

§ 1 The term referred to in art. 13 will have its calculation suspended when Ibama requests the
registrant, in writing, documents or information necessary for the analysis, restarting the
calculation from the fulfillment of the request, for the remaining time, plus another 30 (thirty)
days.

§ 2 Total or partial non-compliance on the part of the registrant of the requests within the
deadlines established by Ibama, will give rise to the archivation of the process, in the form
provided for in art. 40 of the Law No. 9.784 of 1999.

Art. 14. The claim will be rejected when the result of the technical analysis of the object
concludes that it does not meet the requirements for its registration.

Art. 15. In case of rejection of the claim, the interested party may appeal the decision within 10
(ten) days of having become aware of it, in terms of Law No. 9.784, of January 29, 1999.
Single paragraph. The appeal must be decided within a maximum period of (30) thirty days,
counting from the receipt of the minutes, with the possibility of extending the period for another
equal period, with express justification.

Art. 16. The tests and tests required in this Normative Instruction to support the request for
registration, must be carried out based on scientifically recognized methodologies and carried
out in a laboratory certified according to the ISO 17025 standard or in laboratories recognized
by the CGCRE-Inmetro (General Coordination of Accreditation of the National Institute of
Metrology, Standardization and Industrial Quality).

Art. 17. The reports of studies and laboratory tests required in this Normative Instruction must
contain, at least, the following elements:

I - name of the laboratory;

II - management of the laboratory;

III - quality certification system submitted to the laboratory;

IV - identification of the contractor;

V - identification of the material submitted to the studio, including: name (trademark), physical
state, color, quantity that composes the sample, manufacturing date, batch number, composition
declared by the interested party I - expiration date, Receipt date sample;

VI - closes the beginning and end of the test;

VII - complete description of the methodology used;

VIII - result; es

IX - identification (full name, title, registration number at the Consejo de Clase Profesional) and
signature of the person(s) responsible for carrying out the studio.

Single paragraph. The information, certificates and declarations must be signed in original or
copy.

Art. 18. The registration of an appeal dictated based on the requirements established in this
Normative Instruction will be valid for 10 (ten) years, and may be renewed for successive
periods of equal duration, at the request of the interested party, in the period before 90 (ninety) )
days from the end of its validity, accompanied by the form, as per Annex IV, which contains the
following information:
I - declaration that the production process, composition and other technical data of the
registered product remain unaltered;

II - new knowledge about the registered product; es

III - Stability report.

§ 1 The renewal request will be made through a specific form, available through the Ibama
electronic request form, necessarily accompanied by the supporting documents.

§ 2º The presentation of a request for renewal of registration in a period inferior to that

mentioned in the caput of this article does not guarantee its fulfillment in closing prior to and