3. Compositional Aspects

Animal Feed
Brazil

This section provides the compositional requirements for the feed category and/or feed products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

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3.2 Raw Material Requirements

3.2.1 Raw Material Compliance

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3.2.2 GMO Regulatory Requirements

General feed

Genetically Modified Organism - GMO: organism whose genetic material - DNA/RNA - has been modified by any genetic engineering technique.

GMO-derived: a product obtained from a GMO which has no autonomous replication capability or which does not contain a viable form of the GMO. [1]

Applications for GMO approval are handled by the National Technical Commission on Biosafety (CTNBio) which publishes authorized GMO events by crops. [2]

The following are GMO events approved for soybeans [3]:

1. GTS-40-3-2
2. BPS-CV127-9
3. A5547-127
4. A2704-12
5. MON 87701 x MON 89788
6. DAS-68416-4
7. FG 72
8. FG72 x A5547-127
9. DAS-44406-6
10. DAS-81419-2
11. MON87708
12. MON87751
13. DP-305423-1
14. DP-305423-1 x MON 04032-6
15. MON 87751 x MON 87708 x MON87701 x MON 89788
16. HB4 (IND-ØØ41Ø-5)
17. HB4 (IND-ØØ41Ø-5) x RR (MON-Ø4Ø32-6
18. GMB151

Category

The category of “Nutritional Additive” should comply with the above regulations for “General Feed” under Section 3.2.2.
 
Product

“Nutritional Additive (Amino acids)” should comply with the above regulations for “General Feed” under Section 3.2.2. 

3.2.2.1 GMO Status

General feed

GMO crop is permitted for use in feed.

Article 40 of the Biosafety Law mentions that "food and food ingredients intended for human or animal consumption that contain or are produced from GMOs or derivatives thereof shall contain information in this regard on their labels", according to regulation. [1] In addition, Normative Resolution N° 32 describes the use of GMOs for food and feed purposes. In addition, the approvals of GMO events also describe this purpose of use, and it is our understanding that the approved GMO events as well as their derivatives are also applicable to animal feed. [2]

In case a GMO crop is not already approved or in the published list [3], an application for the assessment and approval must be submitted following those requirements described above. Otherwise, neither the crop nor its derivative can be used in any animal feed.

Category

The category of “Nutritional Additive” should comply with Section 3.2.2.1 on “General Feed” above.

Product

“Nutritional Additive (Amino Acids)” should comply with Section 3.2.2.1 on “General Feed” above.

Additionally, the below applies: 

The evidence proving that hydrogenated Soybean oil and Soy lecithin are not from a GMO crop shall be submitted. Otherwise, if they are GMO-derived, their use will be rejected if the specific event they came from is not determined [3]. It will be difficult to sell if all GMO information including the origins/identity of the GMO event of the raw material is not provided.

3.3 Fortification

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3.4 Other Permitted Ingredients

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3.5 Permitted Additives

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3.6 Permitted Flavors and Colors 

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3.7 Permitted Processing Aids 

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3.8 Additional Notes 

General feed

Paragraph 3 of Normative Resolution N° 32/2021 [2] states that "derivatives whose GMOs have been approved by the CTNBio shall not be subject to CTNBio's analysis and technical opinion", being understood that they can be used and no new application for GMO assessment shall be needed. 

If the event of interest is not already approved by CTNBio, the following requirements must be filed for the assessment (according to Article 3 of Normative resolution N° 32 [2]):

The applicant shall, after approval by Internal Commission of Biosafety (CIBio), submit the proposal to CTNBio, accompanied by:

1. Application for commercial release dated and signed by the person legally responsible
2. A copy of the technical opinion of the Internal Commission of Biosafety (CIBio) on the proposal
3. A declaration of the veracity of the information provided, signed by the legally responsible party
4. An executive summary, containing a summary of the proposal
5. Information relating to the GMO, as per Attachment I to this Normative Resolution
6. Human and animal health risk assessment, in accordance with Attachment II of this Normative Resolution
7. Simplified risk assessment, in accordance with Exhibit IV hereto, only in the case of GMOs that meet the criteria of article 12 of this Normative Resolution; and
8. Post-commercial release monitoring plan when non-negligible risk is identified or when a request for exemption is submitted, as provided in art. 18.
   

The proposal shall be submitted in Portuguese, with the possibility of sending the file in digital format or by electronic protocol.

For applications for commercial release of combined products in which at least one event has not been released for marketing, the information contained in Annex I must be submitted for events not released, and the information contained in Annexes II and III, with details of the combined product.

Testing to prove the absence of GMO is not enough to confirm that the product is non-GMO as mentioned in Section 3.2.2.1 above. The GMO information of the product including the origins/identity of the GMO event for the raw materials will be required.

Category

The category of “Nutritional Additive” should comply with Section 3.8 on “General Feed” above.

Product

“Nutritional Additive (Amino Acids)” should comply with Section 3.8 on “General Feed” above. 

3.9 References

1. Law N° 11.105 of 2005 "Biosafety Law"

https://www.planalto.gov.br/ccivil_03/_ato2004-2006/2005/lei/l11105.htm

2. Normative Resolution N° 32/32021 Provides for the rules for the commercial release and monitoring of Genetically Modified animals and plants - GMOs and their derivatives of plant and animal origin

http://ctnbio.mctic.gov.br/resolucoes-normativas/-/asset_publisher/OgW431Rs9dQ6/content/resolucao-normativa-n%C2%BA-32-de-15-de-junho-de-2021?redirect=http%3A%2F%2Fctnbio.mctic.gov.br%2Fresolucoes-normativas%3Fp_p_id%3D101_INSTANCE_OgW431Rs9dQ6%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3Dcolumn-2%26p_p_col_count%3D3

3. Commercial releases (Soybeans)

http://ctnbio.mctic.gov.br/liberacao-comercial/-/document_library_display/SqhWdohU4BvU/view/678023?_110_INSTANCE_SqhWdohU4BvU_redirect=http%3A%2F%2Fctnbio.mctic.gov.br%2Fliberacao-comercial%2F-%2Fdocument_library_display%2FSqhWdohU4BvU%2Fview%2F614405%3F_110_INSTANCE_SqhWdohU4BvU_redirect%3Dhttp%253A%252F%252Fctnbio.mctic.gov.br%252Fliberacao-comercial%253Fp_p_id%253D110_INSTANCE_SqhWdohU4BvU%2526p_p_lifecycle%253D0%2526p_p_state%253Dnormal%2526p_p_mode%253Dview%2526p_p_col_id%253Dcolumn-2%2526p_p_col_count%253D3#/liberacao-comercial/consultar-processo