TITLE IV
CONTAMINANTS AND RESIDUES[1]
Paragraph I
Heavy Metals
ARTICLE 160.- The elements listed below shall not exceed, in the foods mentioned, the following maximum limits:
MAXIMUM LIMIT(mg/kg of final product)
ARSENIC
Edible oils and fats / 0.1
Mayonnaise / 0.3
White sugar, dextrose
(anhydrous, monohydrate
and powdered), glucose syrup,
lactose, fructose / 1.0
Powdered sugar / 2.0
Mollusks, crustaceans, and gastropods / 2,0 *
Fresh, chilled, frozen, and canned fish / 1.0
Fruit and vegetable juices / 0.2
Concentrated fruit juice / 0.2 in the reconstituted product
Fruit nectars / 0.2
Cocoa butter, chocolate,
sweet cocoa butter
0.5
Unsweetened chocolate, composite
and filled chocolate / 1.0
Cocoa powder and dry mixtures of cocoa and sugar; cocoa without shell or germ, cocoa paste; cocoa press cake, cocoa dust (cocoa fines) / 1.0
Cereals, legumes, and pulses / 0.5
Edible salt / 0.5
Table mineral water / 0.05
Other liquid products / 0.12
Other solid products / 1.0
CADMIUM
Edible salt / 0.5
Table mineral water / 0.01 [2]
COPPER
Edible acid casein and caseinates
Edibles / 5.0
Edible oils and fats / 0.1 non-virgin
0.4 virgin
Margarine / 0.1
Mayonnaise / 2.0
White sugar / 1.0
Powdered sugar, dextrose (anhydrous, monohydrate, powdered), lactose, fructose / 2.0
Glucose syrup / 5.0
Fruit and vegetable juices / 5.0 (1)
Concentrated fruit juices / 5.0 (1) in the reconstituted product
Fruit nectars / 5.0 (1)
Cocoa butters / 0.4
Chocolates, sweet cocoa butter / 15.0
Unsweetened chocolate / 30.0
Composite and filled chocolate / 20.0
Cocoa powder and dry mixtures of cocoa and sugar; cocoa press cake / 50.0
Cocoa without shell or germ; cocoa paste / 30.0
Dairy spreads, low in fat / 0.1
Sweet whey powder and acid whey powder, food grade / 5.0
Edible rennet casein / 2.0
Butter oil / 0.05
Edible salt / 2.0
Table mineral water / 1.0
Other products / 10.0
TIN
Canned fruits and vegetables / 250
Table olives / 250
Canned fish and shellfish / 250
Fruit and vegetable juices, except apple, grape, and blackcurrant / 200
Apple, grape, and blackcurrant juices / 150
Concentrated fruit juices, except apple, grape, and blackcurrant / 250 in the reconstituted product.
Concentrated juices of apple, grape, and blackcurrant / 150 in the reconstituted product
Fruit nectars:
apricot, peach, pear, guava, and citrus / 250
blackcurrant and small fruits / 150
Corned beef, cooked cured ham, cooked cured pork shoulder, cooked cured ground meat,
in tin containers / 200
in other containers / 50
IRON
Edible acid casein / 20.0
Edible caseinates / 20.0 in spray-dried products
50.0 in products dehydrated in drying cylinders
Edible oils and fats / 5.0 virgin
1.5 non-virgin
Fruit and vegetable juices / 15.0 (1)
Concentrated fruit juices / 15.0 (1) in the reconstituted product
Fruit nectars / 15.0 (1)
Cocoa butters / 2.0
Butter oil / 0.2
Dairy spreads, low in fat / 1.5
Sweet whey powder and acid whey powder, food grade / 20.0 in spray-dried products.
50.0 in products dehydrated in drying cylinders
Edible rennet casein / 5.0
MERCURY
Cereals, legumes, and pulses / 0.05
Canned fish and shellfish / 1.0
Fresh, chilled, and frozen fish:
small size / 0.5
large size such as shark and albacore / 1.5
Fresh shellfish / 0.5
Edible salt / 0.1
Table mineral water / 0.001
LEAD
Edible acid casein and edible caseinates / 2.0
Canned fruits and vegetables, except tomato concentrate / 1.0
Tomato concentrate / 1.5
Table olives / 1.0
Cocoa butters / 0.5
Chocolate, composite and filled chocolate / 1.0
Unsweetened chocolate / 2.0
Edible oils and fats / 0.1
Mayonnaise / 0.3
White sugar / 1.0
Powdered sugar dextrose (anhydrous, monohydrate, dehydrated), glucose syrup, lactose / 2.0
Fructose / 0.5
Broths and soups / 1.0 in dry product
0.5 in canned product
Cocoa powder and dry mixtures of cocoa and sugar; cocoa without shell or germ; cocoa paste; cocoa press cake, cocoa dust (cocoa fines) / 2.0
Sweet cocoa butter / 1.0
Fruit and vegetable juices, except lemon / 0.3
Lemon juice / 1.0
Concentrated fruit juices / 0.3 in the reconstituted product
Fruit nectars, except apricot, peach, pear, and guava / 0.2
Nectars of apricot, peach, pear, and guava / 0.3
Dairy spreads, low in fat / 0.1
Sweet whey powder and acid whey powder, food grade / 2.0
Edible rennet casein / 2.0
Corned beef, cooked cured ham, cooked cured pork shoulder, cooked cured ground meat / 0.5
Cereals, legumes, and pulses / 0.5
Canned fish and shellfish, fresh, chilled, and frozen fish and shellfish / 2.0
Edible salt / 2.0
Table mineral water / 0.05
Other products / 2.0
SELENIUM
In liquid products / 0.05
In solid products / 0.30
Table mineral water / 0.01
ZINC
Fruit and vegetable juices / 5.0 (1)
Concentrated fruit juices / 5.0 (1) in the reconstituted product
Fruit nectars / 5.0 (1)
Table mineral water / 5.0
Other products / 100.0
(1) Total Zn, Fe, and Cu: up to 20 mg/kg
* Inorganic arsenic
ARTICLE 161.- In the event that sanitary and technical background make it appropriate to introduce amendments to the lists set out in the preceding article, the Ministry of Health shall propose the corresponding supreme modifying decree to the President of the Republic.
Paragraph II
Pesticide residues.[3]
ARTICLE 162.- The Ministry of Health, through the issuance of the relevant technical standard, shall determine the tolerances of pesticide residues allowed in foods. [4] [5]
Paragraph III
Radionuclides[6]
ARTICLE 163.- For the purposes of these regulations, the following definitions shall apply:
Becquerel (Bq): a unit of activity equivalent to one disintegration per second of any radionuclide.
Sievert (Sv): unit of equivalent dose. This is the selected absorbed dose which is equivalent to the energy delivered by radiation per gram of irradiated material.
Diagnostic reference level (DRL): annual equivalent dose. Corresponds to 1 mSv/year.
Dose conversion factor (DCF): factor relating the equivalent dose per unit of activity ingested. It is expressed in Sv/Bq.
Food consumption rate (FCR): average mass of food consumed annually per capita in the country. It is expressed in kg/year.
Derived intervention level (DIL): concentration of a radionuclide in a given food. It is calculated by dividing the diagnostic reference level by the dose conversion factor and by the rate of food consumption. Expressed in Bq/kg.
ARTICLE 164.- Control of the derived intervention levels (DIL) shall be conducted in those foods contaminated by radionuclides released in a nuclear or radiological accident and not for those cases where they are naturally present as part of the environmental background radiation.
ARTICLE 165.- The radionuclides of interest are classified into three groups according to their radioactivity, whose values of dose conversion (DCF) are as follows:[7] [8]
DCFmilks and formulas / DCF
other dairy foods
I.- ( α) Americium (241Am)
Plutonium (39Pu)
Other actinides / 10-5 / 10-6
II.- (β) Strontium (90Sr)
Strontium (89Sr)
Other beta emitters / 10-7 / 10-7
III.- (γ) Iodine (131I)
Cesium (134Cs)
Cesium (137Cs) / 10-8 / 10-8
ARTICLE 166.- Radionuclide contamination shall not exceed the derived intervention levels (DIL) by food groups as indicated:[9] [10]
Group I (α) / Group II (β) / Group III (γ)Food groups / (Bq/kg) / (Bq/kg) / (Bq/kg)
Cereals / 6. / 60 / 600
Roots and tubers / 20 / 200 / 2000
Vegetables / 15 / 150 / 1500
Fruits / 15 / 150 / 1500
Meat / 30 / 300 / 3000
Fish / 35 / 350 / 3500
Dairy products / 10 / 100 / 1000
Milks / 10 Bq/L / 100 Bq/L / 1000 Bq/L
Infant formulas / 1 Bq/L / 10 Bq/L / 100 Bq/L
ARTICLE 167.- For purposes of calculating the contamination of infant milks and formulas, 131I is considered as belonging to group II. DIL values for both fluid milks, powdered milk as well as for infant formulas are expressed in Bq/L of the product ready for consumption. [11]
ARTICLE 168.- The derived intervention levels set out in Article 166 have been calculated on the basis of a food contaminated with only one radionuclide. If more than one category of food is contaminated and/or if multiple radionuclides are present, the competent authority shall establish new DILs, according to the internationally recommended methodology.
Paragraph IV[12]
Mycotoxins
ARTICLE 169.- The mycotoxins indicated below may not exceed the following limits:
Total aflatoxins (Bi B 2 Gi G 2) / 5 / ppbAflatoxin M1 / 0.05 / ppb
Zearalenone / 200 / ppb
Paragraph V[13]
Other contaminants and residues
ARTICLE 170.- The maximum contents of Dioxins and Coplanar Polychlorinated Biphenyls (PCBs) in the foods listed below are as follows: [14]
Food / Maximum Content of Dioxins and Coplanar PCBs / UnitPork meat and derived products / 2.0 / (pg WHO-TEQ/g of fat)
Poultry meat and derived products / 3.5 / (pg WHO-TEQ/g of fat)
Bovine and ovine meat and derived products / 6.0 / (pg WHO-TEQ/g of fat)
Fish and derived products / 2.0 / (pg WHO-TEQ/g of fresh weight)
Eggs and derived products / 3.0 / (pg WHO-TEQ/g of fat)
Milk and derived products / 6.0 / (pg WHO-TEQ/g of fat)
For the purposes of these regulations, the following definitions shall apply:
- Dioxins: Family of structurally and chemically interrelated chlorinated compounds, formed by Polychlorinated dibenzo-para-dioxins (PCDDs) and Polychlorinated dibenzofurans (PCDFs).
- Coplanar Polychlorinated Biphenyls: Certain PCBs which possess toxic properties similar to dioxins.
- Toxic Equivalency (TEQ): relative value calculated by multiplying the concentration of a compound similar to dioxins by the toxic equivalency factor (TEF).
- WHO-TEQ: Toxic Equivalency of the World Health Organization for Dioxins and coplanar PCBs, based on toxic equivalency factors (TEFs).
- Toxic Equivalency Factor (TEF): estimates of the toxicity of dioxin-like compounds in relation to the toxicity of 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD), which is assigned a TEF of 1.
Table of Toxic Equivalency FactorsCompound (congener) / Abbreviation / TEF
Polychlorinated Dibenzodioxins
2,3,7,8-Tetrachlorodibenzodioxin / TCDD / 1
1,2,3,7,8-Pentachlorodibenzodioxin / 1,2,3,7,8-PeCDD / 1
1,2,3,4,7,8-Hexachlorodibenzodioxin / 1,2,3,4,7,8-HxCDD / 0.1
1,2,3,6,7,8-Hexachlorodibenzodioxin / 1,2,3,6,7,8-HxCDD / 0.1
1,2,3,6,7,9-Hexachlorodibenzodioxin / 1,2,3,6,7,9-HxCDD / 0.1
1,2,3,4,6,7,8-Heptachlorodibenzodioxin / 1,2,3,4,6,7,8-HxCDD / 0.01
Octachlorodibenzodioxin / OCDD / 0.0001
Polychlorinated Dibenzofurans
2,3,7,8-Tetrachlorodibenzofuran / 2,3,7,8-TCDF / 0.1
1,2,3,7,8-Pentachlorodibenzofuran / 1,2,3,7,8-PeCDF / 0.05
2,3,4,7,8-Pentachlorodibenzofuran / 2,3,4,7,8-PeCDF / 0.5
1,2,3,4,7,8-Hexachlorodibenzofuran / 1,2,3,4,7,8-HxCDF / 0.1
1,2,3,6,7,8-Hexachlorodibenzofuran / 1,2,3,6,7,8-HxCDF / 0.1
1,2,3,7,8,9-Hexachlorodibenzofuran / 1,2,3,7,8,9-HxCDF / 0.1
2,3,4,6,7,8-Hexachlorodibenzofuran / 2,3,4,6,7,8-HxCDF / 0.1
1,2,3,4,6,7,8-Heptachlorodibenzofuran / 1,2,3,4,6,7,8-HpCDF / 0.01
1,2,3,4,7,8,9-Heptachlorodibenzofuran / 1,2,3,4,7,8,9-HpCDF / 0.01
Octachlorodibenzofuran / OCDF / 0.0001
"Non-ortho" Polychlorinated Biphenyls
3,3',4',4'-Tetrachlorobiphenyl / 3,3',4,4'-TCB / 0.0001
3,4,4',5,-Tetrachlorobiphenyl / 3,4,4',5-TCB / 0.0001
3,3',4,4',5-Pentachlorobiphenyl / 3,3',4,4',5-PeCB / 0.1
3,3',4,4',5,5'-Hexachlorobiphenyl / 3,3',4,4',5,5'-HxCB / 0.01
"Mono-ortho" Polychlorinated Biphenyls
2,3,3',4,4'-Pentachlorobiphenyl / 2,3,3',4,4'-PeCB / 0.0001
2,3,4,4',5-Pentachlorobiphenyl / 2,3,4,4',5-PeCB / 0.0005
2,3',4,4',5-Pentachlorobiphenyl / 2,3',4,4',5-PeCB / 0.0001
2,3',4,4',5'-Pentachlorobiphenyl / 2,3',4,4',5'-PeCB / 0.0001
2,3,3',4,4',5-Hexachlorobiphenyl / 2,3,3',4,4',5-HxCB / 0.0005
2,3,3',4,4',5'-Hexachlorobiphenyl / 2,3,3',4,4',5'-HxCB / 0.0005
2,3',4,4',5,5'-Hexachlorobiphenyl / 2,3',4,4',5,5'-HxCB / 0.00001
2,3,3',4,4',5,5'-Heptachlorobiphenyl / 2,3,3',4,4',5,5'-HpCB / 0.00001"
[1]Designation substituted, as shown in the text, by Article 1, No. 1 of Decree 64/09, of the Ministry of Health, published in the Official Gazette on 12/11/09
[2]Article amended, as shown in the text, by Decree 475/99, of the Ministry of Health, published in the Official Gazette on 01/13/00
127Paragraph inserted, as shown in the text, by Article 1, No. 2 of Decree 64/09, of the Ministry of Health, published in the Official Gazette on 12/11/09
[4]Article substituted, as shown in the text, by Decree 475/99, of the Ministry of Health, published in the Official Gazette on 01/13/00
[5]Exempt Resolution No. 33/10, of the Ministry of Health, published in the Official Gazette on 02/05/10, sets maximum tolerances of pesticide residues in foods
[6]Paragraph amended, as shown in the text, by Article 1, No. 3 of Decree 64/09, of the Ministry of Health, published in the Official Gazette on 12/11/09
[7]Article amended, as shown in the text, by Decree 475/99, of the Ministry of Health, published in the Official Gazette on 01/13/00
[8]Article amended, as shown in the text, by Article 1, II, No. 3, of Decree 214/05, of the Ministry of Health, published in the Official Gazette on 02/04/06
[9]Article amended, as shown in the text, by Decree 475/99, del Ministerio de Salud, publicado en el Diario Oficial de 13.01.00
[10]Article amended, as shown in the text, by Article 1, II, No. 5.-, of Decree 214/05, of the Ministry of Health, published in the Official Gazette on 02/04/06
[11]Article amended, as shown in the text, by Article 1, II, No. 6.-, of Decree 214/05, of the Ministry of Health, published in the Official Gazette on 02/04/06
[12]Paragraph amended, as shown in the text, by Article 1, No. 4 of Decree 64/09, of the Ministry of Health, published in the Official Gazette on 12/11/09
[13]137 Paragraph inserted, as shown in the text, by Article 1, No. 5 of Decree 64/09, of the Ministry of Health, published in the Official Gazette on 12/11/09
[14]Article substituted, as shown in the text, by Article 1, No. 6 of Decree 64/09, of the Ministry of Health, published in the Official Gazette on 12/11/09