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									National Sanitary Surveillance Agency

www.anvisa.gov.br




     Public Consultation No 85 of 13 December 2004.

     Diário Oficial da União (Brazilian Official Journal) of 17 December 2004.

     The Collegiate Directorate of the National Health Surveillance Agency,
pursuant to the powers conferred on it by Article 11(IV) of the ANVISA Regulation
approved by Decree No 3029 of 16 April 1999, and Article 111(I)(e) of the Internal
Regulation approved by Order No 593 of 25 August 2000 published in the Official
Journal of Brazil of 22 December 2000, meeting on 6 December 2004,

     Whereas:

     There is a need for sanitary controls of foodstuffs to be constantly improved in
order to protect public health;

     Hereby adopts the following Public Consultation, and I, the Director-President,
order its publication:

     Criticism and suggestions concerning the attached proposal for a TECHNICAL
REGULATION ON VEGETABLE OILS AND FATS may be submitted up to 90 (sixty)
days from the date of publication of this Public Consultation.

     Article 2

     The abovementioned proposal shall be available on the Internet throughout the
consultation period at http://www.anvisa.gov.br/divulga/consulta/index.htm. Suggestions
should be made from that site, by letter addressed to the Agência Nacional de Vigilância
Sanitária, Gerência-Geral de Alimentos, SEPN 515, Bloco “B”, Ed. Ômega, Asa Norte,
Brasília-DF, CEP 70.770.502, by fax to: (61) 448-6274, or by e-mail to:
gpesp@anvisa.gov.br.

     Article 3

     After the period stipulated in Article 1 has elapsed, the National Health
Surveillance Agency will contact the bodies and entities involved and any others who
have expressed an interest to enable them to appoint representatives for the
subsequent discussions on consolidating the final text.

                                        CLÁUDIO MAIEROVITCH PESSANHA HENRIQUES

                                           ANNEX
     Resolution of the Collegiate Directorate - RDC No

     The Collegiate Directorate of the National Health Surveillance Agency,
pursuant to the powers conferred on it by Article 11(IV) of the ANVISA Regulation
approved by Decree No 3029 of 16 April 1999, and Article 111(I)(e) of the Internal
Regulation approved by Order No 593 of 25 August 2000, republished in the Official
Journal of Brazil of 22 December 2000, meeting on ............................... 200...,

     Whereas:

     There is a need for sanitary controls of foodstuffs to be constantly improved in
order to protect public health;

      There is a need to bring the health legislation on foodstuffs up to date with regard
to risk assessment and prevention of danger to public health.

     The priority of ANVISA technical regulations on identity and quality standards for
foodstuffs must be on the sanitary parameters;

     Measures regarding the surveillance of public health must be focused on the
regulation and inspection of the manufacturing process with regard to the quality of the
end product;

     Has adopted the following Collegiate Board Resolution and I, the Director-
President, order its publication:

     Article 1

     The TECHNICAL REGULATION ON VEGETABLE OILS AND FATS contained in
the Annex to this Resolution is hereby approved.

     Article 2

      Businesses have 180 (one hundred and eighty) days from the date of publication of
this Regulation to bring their products into compliance with it.

     Article 3

      Failure to fulfil the terms of this Resolution constitutes a sanitary infraction subject
to the penalties set out in Law No 6437 of 20 August 1977 and to any other applicable
measures.

     Article 4

     All measures contrary to this Resolution are hereby revoked, in particular Orders
(Ministry of Health/DINAL - National Division for Sanitary Surveillance of Foodstuffs) Nos
04/89 and 05/89; Order (Ministry of Health/Sanitary Surveillance Secretariat) No 193/99;
and Resolution (Ministry of Health/ANVS – National Agency for Sanitary Surveillance)
No 482/99.
     Article 5

     This Resolution shall take effect on the date of its publication.

                                           ANNEX

             TECHNICAL REGULATION ON VEGETABLE OILS AND FATS

1. SCOPE

To define vegetable oils, vegetable fats and vegetable fat emulsions and lay down the
minimum quality standards with which they must comply.

2. DEFINITIONS

2.1. Vegetable oils and vegetable fats: products consisting mainly of fatty acid glycerides
from plants. They may contain small amounts of other lipids such as phospholipids,
unsaponifiable components and free fatty acids naturally present in oil and fat.

2.2. Mixed or composite oils: products obtained by mixing two or more vegetable oils
                                 o
which are in a liquid state at 25 C.

2.3. Vegetable oils with additional ingredients: oils to which condiments and/or spices
and/or other ingredients have been added to increase flavour or aroma, with the
exception of flavourings.

2.4. Modified vegetable oils or fats: products obtained from oils or fats which have been
subjected to physical or chemical processes such as fractioning, hydrogenation or
interesterification.

2.5. Vegetable fat emulsion: products which take the form of a semisolid or liquid
emulsion, consisting mainly of water and vegetable oil and/or fat, to which other
ingredients may be added provided that they do not denature the product. The total lipid
content may range from a minimum of 10 g/100 g to a maximum of 90 g/100 g.

3. NAMES

3.1. Vegetable oils and vegetable fats must be labelled “Oil” or “Fat”, followed by the
common name of the plant species from which they are derived. The name may also
include terms describing the production process.
                                                       o
3.1.1. “Oil” describes products which are liquid at 25 C, while a “fat” is a product which is
                        o
solid or semisolid at 25 C.

3.1.2. “Olive Oil” describes oil from the fruit of the olive tree (Olea europaea).

3.1.3. “Refined Olive Pomace and/or Stone Oil” describes oil from the pomace or stone
of the fruit of the olive tree (Olea europaea).
3.1.4. “Palm Oil” describes only unrefined oil from the oil palm (Elaeis guineensis).

3.1.5. “Virgin” and “Extra Virgin” describe only products extracted solely by physical
means.

3.2. Mixed or composite oils must be labelled “Mixed Oil” or “Composite Oil”, followed by
the common names of the plant species from which they are derived in decreasing order
of content.

3.3. Vegetable oils with additional ingredients must be labelled “Oil” followed by the
common names of the plant species used and/or of the additional ingredients.

3.4. Modified vegetable oils or fats must be labelled “Modified Oil” or “Modified Fat”
followed by terms describing the production process and/or its end use, as well as the
common names of the plant species used.

3.5. Vegetable fat emulsions must be labelled “Vegetable Fat Emulsion” followed by
terms describing the end use and/or specific characteristics and/or ingredient which
characterises the product.

4. REFERENCES

4.1. BRAZIL. Decree No 55 871 of 26 March 1965 modifying Decree No 50 040 of 24
January 1961 laying down standards regulating the use of food additives, as amended
by Decree No 691 of 13 March 1962. Official Journal of Brazil. Brasilia, DF, 9 April 1965.
Section I.

4.2. BRAZIL. Decree-Law No 986 of 12 October 1969 laying down basic standards for
foodstuffs. Official Journal of Brazil. Brasilia, DF, 21 October 1969. Section I.

4.3. BRAZIL. Resolution No 4 of 24 November 1988 approving revisions to Tables I, III,
IV and V on intentional food additives and to Annexes I, II, III and VII, all from Decree No
55 871 of 26 March 1965. Official Journal of Brazil. Brasilia, DF, 19 December 1988.
Section I.

4.4. BRAZIL. Consumer code.        Law No 8 078 of 11 September 1990. Official Journal
of Brazil. Brasilia, DF, 12 September 1990 supplement.

4.5. BRAZIL. Order (Ministry of Health/Sanitary Surveillance Secretariat) No 1 428 of 26
November 1993. Technical Regulation on the Health Inspection of Foodstuffs. Official
Journal of Brazil. Brasilia, DF, 2 December 1993. Section I.

4.6. BRAZIL. Order (Ministry of Health/Sanitary Surveillance Secretariat) No 326 of 30
July 1997. Technical Regulation on the Sanitary and Hygiene Conditions and
Manufacturing Best Practice for Establishments Producing/Manufacturing Foodstuffs.
Official Journal of Brazil. Brasilia, DF, 1 August 1997. Section I.
4.7. BRAZIL. Order (Ministry of Health/Sanitary Surveillance Secretariat) No 27 of 13
January 1998. Technical Regulation on Additional Facts on Nutrition. Official Journal of
Brazil. Brasilia, DF, 16 January 1998. Section I.

4.8. BRAZIL. Order (Ministry of Health/Sanitary Surveillance Secretariat) No 29 of 13
January 1998. Technical Regulation on Foodstuffs for Special Purposes. Official Journal
of Brazil. Brasilia, DF, 15 January 1998. Section I.

4.9. BRAZIL. Order (Ministry of Health/Sanitary Surveillance Secretariat) No 685 of 27
August 1998. Technical Regulation on General Principles for Establishing Maximum
Limits on Chemical Contaminants in Foodstuffs and its Annex: Maximum Tolerances for
Inorganic Contaminants. Official Journal of Brazil. Brasilia, DF, 28 August 1998. Section
I.

4.10. BRAZIL. Resolution (Ministry of Health/ANVISA) No 17 of 30 April 1999 Technical
Regulation establishing the basic guidelines for risk assessment and the safety of
foodstuffs. Official Journal of Brazil. Brasilia, DF, 3 May 2004. Section I.

4.11. BRAZIL. Resolution (Ministry of Health/ANVISA) No 386 of 5 August 1999.
Technical Regulation approving the use of food additives according to good
manufacturing practice and their purpose. Official Journal of Brazil. Brasilia, DF, 9
August 1999. Section 1, pt. 1.

4.12. BRAZIL. Resolution (Ministry of Health/ANVS) No 22 of 15 March 2000 on the
Procedures for the Registration and Exemption of the Obligatory Registration of
Imported Foodstuffs and Related Products. Official Journal of Brazil. Brasilia, DF, 16
March 2000. Section 1, pt.

4.13. BRAZIL. Resolution (Ministry of Health/ANVS) No 23 of 15 March 2000 on the
Manual of Basic Procedures for the Registration and Exemption of the Obligatory
Registration of Foodstuffs and Related Products. Official Journal of Brazil, Brasilia, 16
March 2000. Section 1, pt. 1.

4.14. BRAZIL. RDC Resolution (Ministry of Health/ANVISA) No 12 of 2 January 2001.
Technical Regulation on Microbiological Standards for Foodstuffs. Official Journal of
Brazil. Brasilia, DF, 10 January 2001. Section I.

4.15. BRAZIL. RDC Resolution (Ministry of Health/ANVISA) No 234 of 19 August 2002.
Technical Regulation approving the use of food additives according to good
manufacturing practice and their purpose. Official Journal of Brazil. Brasilia, DF, 21
August 2002. Section I.

4.16. BRAZIL. RDC Resolution (Ministry of Health/ANVISA) No 259 of 20 September
2002. Technical Regulation on the Labelling of Packaged Foods. Official Journal of
Brazil. Brasilia, DF, 23 September 2002. Section I.

4.17. BRAZIL. RDC Resolution (Ministry of Health/ANVISA) No 275 of 21 October 2002.
Technical Regulation on Standardised Operating Procedures Applicable to
Establishments Producing/Manufacturing Foodstuffs and the List of Verified Good
Manufacturing Practices in Establishments Producing/Manufacturing Foodstuffs . Official
Journal of Brazil. Brasilia, DF, 6 November 2002. Section I.

4.18. BRAZIL. Law No 10 674 of 16 May 2003 requiring that Foodstuffs Placed on the
Market Provide Information on the Presence of Gluten as a Preventive Measure to
Control Celiac Disease. Official Journal of Brazil. Brasilia, DF, 19 May 2003. Section 1.

4.19. BRAZIL. BRAZIL. RDC Resolution (Ministry of Health/ANVISA) No 175 of 8 July
2003. Technical Regulation on the Assessment of Macroscopic and Microscopic
Substances which are Harmful to Human Health in Packaged Goods. Official Journal of
Brazil, Brasilia, 9 July 2003. Section 1.

4.20. RDC Resolution (Ministry of Health/ANVISA) No 359 of 23 December 2003.
Technical Regulation for Nutritional Labelling of Packaged Portions of Foodstuffs.
Official Journal of Brazil, Brasilia, 26 December 2003. Section 1.

4.21. BRAZIL. RDC Resolution (Ministry of Health/ANVISA) No 360 of 23 December
2003. Technical Regulation on the Nutritional Labelling of Packaged Foods. Official
Journal of Brazil, Brasilia, 26 December 2003. Section 1.

4.22. Codex Alimentarius (FAO/WHO), Codex Standard for Named Vegetable Oils,
CODEX STAN 210-1999. Codex Alimentarius, v.8-2001. Rome, Italy, p.11-25.

4.23. Codex Alimentarius (FAO/WHO). Summary of the 18th meeting of the Codex
Committee on Fats and Oils. Alinorm 03/17. February 2003. London, United Kingdom,
63 p.

5. SPECIFIC REQUIREMENTS

5.1. Acidity expressed as oleic acid:

- Refined Oils and Fats: maximum 0.3 g/100 g

- Refined Olive Oil: maximum 0.3 g/100g

- Extra Virgin Olive Oil: maximum 0.8 g/100g

- Virgin Olive Oil: maximum 3.3 g/100g

- Refined Olive Pomace and/or Stone Oil: maximum 0.3 g/100g

- Raw Palm Oil or Fat: maximum 5.0 g/100g

- Raw Sesame Oil: maximum 2.0 g/100g

5.2. Peroxide Value (PV)

- Refined Oils and Fats (except refined olive oil): maximum 10 meq/kg
- Refined Olive Oil: maximum 5 meq/kg

- Virgin Olive Oil: maximum 20 meq/kg

- Refined Olive Pomace and/or Stone Oil: maximum 5 meq/kg

6. GENERAL REQUIREMENTS

6.1. Products must be made from ingredients that are healthy, clean and contain no
impurities and that have been processed, packaged, stocked, transported and stored
under conditions that do not produce, bring into contact or develop physical, chemical or
biological substances that put consumer health at risk. The legislation in force on good
manufacturing practice must be complied with.

6.2. The products must comply with the specific Technical Regulations on: Food
Additives and Technological Coadjuvants for manufacturing; Contaminants;
Macroscopic, Microscopic and Microbiological Characteristics; Labelling of Packaged
Foods; Nutritional Labelling of Packaged Foods; Additional Nutritional Information,
where applicable; and other relevant regulations.

6.3. All products except for virgin olive oil, extra virgin olive oil, raw palm oil, sesame oil
and pequi oil, must have undergone refinement.

6.4. Any additional nutritional information (declaration of nutritional properties) which
describes characteristics inherent to the product, must be accompanied by a clarification
next to it, printed in characters that are equally prominent and visible, that all foods of
the same type also possess those characteristics.

6.5. For mixtures of olive oil with any other vegetable oils, the percentage (%) of olive oil
must be stated on the label next to the product name.

6.6. As a temporary measure until a specific technical regulation is issued, the use of oil
or fat from plant species which are not traditionally used as foods is authorised provided
that their safety has been proven.

6.7. The definitions of oils and fats must comply with the compositional requirements
with regard to fatty acids set out in the standards in the Codex Alimentarius.



DINAL – National Division for Sanitary Surveillance of Foodstuffs
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