2007 No. 412
FOOD

The Miscellaneous Food Additives and the Sweeteners in Food Amendment (Scotland) Regulations 2007

Made
Laid before the Scottish Parliament
Coming into force
The Scottish Ministers make the following Regulations in exercise of the powers conferred by sections 16(1)(a), 17(1), 26(1) and (3), and 48(1) of the Food Safety Act 19901 and all other powers enabling them to do so.
In accordance with section 48(4A)2 of that Act they have had regard to relevant advice given by the Food Standards Agency.
There has been consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety3.

Citation, commencement and extent

1.

(1)

These Regulations may be cited as the Miscellaneous Food Additives and the Sweeteners in Food Amendment (Scotland) Regulations 2007 and come into force on 1st October 2007.

(2)

These Regulations extend to Scotland only.

Amendments to the Miscellaneous Food Additives Regulations 1995

2.

The Miscellaneous Food Additives Regulations 19954 (“the Additives Regulations”) are amended in accordance with regulations 3 to 13 below.

3.

In regulation 2(1) (interpretation)–

(a)

in the definition of “carrier” and “carrier solvent”, after “miscellaneous additive,”, insert “flavouring,”;

(b)

in the definition of “Directive 95/2/EC”, for “and European Parliament and Council Directive 2003/114/EC”, substitute “, European Parliament and Council Directive 2003/114/EC5 and European Parliament and Council Directive 2006/52/EC6;”; and

(c)

in the definition of “Directive 96/77/EC”, for “and Commission Directive 2004/45/EC” substitute “, Commission Directive 2004/45/EC and Commission Directive 2006/129/EC7;”; and

(d)

after the definition of “food additive”, insert–

““food supplement” means a foodstuff the purpose of which is to supplement the normal diet and which is a concentrated source of vitamins or minerals or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop-dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities;”.

4.

In regulation 11 (transitional provision and exemptions), after paragraph (1F), insert–

“(1G)

In any proceedings for an offence under these Regulations in respect of any food additive or food, it shall be a defence to prove that–

(a)

the food additive or food concerned was put on the market or labelled before 15th August 2008; and

(b)

the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made by regulations 5(a), 6(a), (b) and (d), or 8 of the Miscellaneous Food Additives and the Sweeteners in Food Amendment (Scotland) Regulations 2007 had not been made when the food additive or food was placed on the market or labelled.”.

5.

In Schedule 1 (miscellaneous additives generally permitted for use in foods not referred to in Schedule 6, 7 or 8)–

(a)

as Note (5), insert–

“(5)

The substances E 400, E 401, E 402, E 403, E 404, E 406, E 407, E 407a, E 410, E 412, E 413, E 414, E 415, E 417, E 418 and E 440 may not be used in jelly cups, defined for the purpose of these Regulations as jelly confectionery of a firm consistency, contained in semi-rigid mini-cups or mini-capsules, intended to be ingested in a single bite by exerting pressure on the mini-cup or mini-capsule so as to project the confectionery into the mouth.”;

(b)

after the entry relating to E 461, insert–

E 462

Ethyl cellulose

6.

In Schedule 2 (conditionally permitted preservatives and antioxidants), Part A (sorbates, benzoates and p-hydroxybenzoates)–

(a)

in the first table, omit the entries for E 216 Propyl p-hydroxybenzoate and E 217 Sodium propyl p-hydroxybenzoate;

(b)

in the second table, omit the entries for “Shrimps, cooked” and “Crayfish tails, cooked, and pre-packed marinated cooked molluscs”;

(c)

in the first column (Food) of the second table, for “Dietetic foods intended for special medical purposes”, substitute “Dietary foods for special medical purposes as defined in Directive 1999/21/EC8”; and

(d)

at the end of the second table, insert–

“Crustaceans and molluscs, cooked

1000

2000

Food supplements supplied in liquid form

2000”

7.

In Schedule 2, Part B (sulphur dioxide and sulphites), in the second table–

(a)

for the entries relating to crustaceans and cephalopods, substitute–

“Crustaceans and cephalopods:

fresh, frozen and deep frozen

150*

crustaceans, Panaeidae, Solenoceridae, Aristaeidae family:

— ≤ 80 units

150*

— > 80 units but ≤ 120 units

200*

— > 120 units

300*

Cooked

50*

cooked crustaceans, Panaeidae, Solenoceridae, Aristaeidae family:

— ≤ 80 units

135*

— > 80 units but ≤ 120 units

180*

— > 120 units

270*

* In edible parts”

(b)

for “Starches (excluding starches for weaning foods, follow-on formulae and infant formulae)”, substitute “Starches (excluding starches in infant formulae, follow-on formulae and processed cereal-based foods and baby foods)”;

(c)

at the end, insert–

“Salsicha fresca

450

Table grapes

10

Fresh lychees

10 (measured on edible parts)”

8.

In Schedule 2, Part C (other preservatives), for the table relating to E 249, E 250, E 251 and E 252, substitute the table set out in Schedule 1 to these Regulations.

9.

In Schedule 2, Part D (other antioxidants), for the table, substitute the table set out in Schedule 2 to these Regulations.

10.

In Schedule 3 (other permitted miscellaneous additives)–

(a)

in the third (Food) and fourth (Maximum level) columns of the entry relating to E 385, insert the following entry–

“Libamáj, egészben és tömbben

250 mg/kg”

(b)

after the entry relating to E 967, insert–

“E 968

Erythritol

Food in general (except drinks and those foods referred to in Article 2(3) of Directive 95/2/EC)

quantum satis

Frozen and deep-frozen unprocessed fish, crustaceans, molluscs and cephalopods

quantum satis

Liqueurs

quantum satis

For purposes other than sweetening”

(c)

after the entry relating to E 425, insert–

“E 426

Soybean hemicellulose

Dairy-based drinks intended for retail sale

5 g/l

Food supplements

1.5 g/l

Emulsified sauces

30 g/l

Pre-packaged fine bakery wares intended for retail sale

10 g/kg

Pre-packaged ready-to-eat oriental noodles intended for retail sale

10 g/kg

Pre-packaged ready-to-eat rice intended for retail sale

10 g/kg

Pre-packaged processed potato and rice products (including frozen, deep-frozen, chilled and dried processed products) intended for retail sale

10 g/kg

Dehydrated, concentrated, frozen and deep-frozen egg products

10 g/kg

Jelly confectionery, except jelly mini-cups

10 g/kg”

(d)

in the third column of the entry relating to E 468, for “Solid dietary supplements”, substitute “Food supplements supplied in solid form”;

(e)

in the third column of the entry relating to E 338 to E 452, for “Dietary supplements”, substitute “Food supplements”;

(f)

in the third column of the entries relating to E 405, E 416, E 432 to E 436, E 473 and E 474, E 475, E 491 to E 495, E 551 to E 559 and E 901 to E 904, for “Dietary food supplements”, substitute “Food supplements”;

(g)

in the third column of the entries relating to E 1201 and E 1202, for “Dietary food supplements in tablet and coated form”, substitute “Food supplements in tablet and coated form”;

(h)

in the third column of the entries relating to E 405, E 432 to E 436, E 473 and E 474, E 475, E 477, E 481 and E 482, and E 491 to E 495, for “Dietetic foods intended for special medical purposes”, substitute “Dietary foods for special medical purposes as defined in Directive 1999/21/EC”;

(i)

in the fourth column of the entries relating to E 1505 to E 1520, after “In the case of beverages,” insert “with the exception of cream liqueurs,”; and

(j)

at the end of the table, insert the following entries–

“E 1204

Pullulan

Food supplements in capsule and tablet form

quantum satis

Breath freshening micro-sweets in the form of films

quantum satis

E 1452

Starch Aluminium Octenyl Succinate

Encapsulated vitamin preparations in food supplements

35 g/kg in food supplement”

11.

In Schedule 4 (permitted carriers and carrier solvents)–

(a)

after the entry relating to E 967, in the first column, insert “E 968” and in the second column, insert the corresponding entry “Erythritol”;

(b)

after the entry relating to E 461, in the first column, insert “E 462” and in the second column, insert the corresponding entry “Ethyl cellulose”; and

(c)

in the third column of the entry relating to E 551 and E 552, after “Emulsifiers and colours, max. 5%” insert “For E 551: in E 171 titanium dioxide and E 172 iron oxides and hydroxides (max. 90% relative to the pigment).”.

12.

In Schedule 7 (foods in which a limited number of miscellaneous additives listed in Schedule 1 may be used)–

(a)

for the entry relating to ripened cheese, substitute–

“Ripened cheese

E 170 Calcium carbonate

quantum satis

E 504 Magnesium carbonates

E 509 Calcium chloride

E 575 Glucono-delta-lactone

E 500ii Sodium hydrogen carbonate

quantum satis (only for sour milk cheese)”

(b)

in the entry relating to “pain courant français”, in the first column, insert “Friss búzakenyér, fehér és félbarna kenyerek”; and

(c)

in the entry relating to “foie gras, foie gras entier, blocs de foie gras”, in the first column, insert “Libamáj, libamáj egészben, libamáj tömbben”.

13.

In Schedule 8 (miscellaneous additives permitted in foods for infants and young children)–

(a)

in paragraphs 1, 1A and 1B of the introductory notes, for “weaning foods”, substitute “processed cereal-based foods and baby foods”;

(b)

in Part 3 (miscellaneous additives permitted in weaning foods for infants and young children in good health), where it appears in the title and in the third column of the entries relating to E 170 to E 526, E 500 to E 503, E 338, E 410 to E 440, E 1404 to E 1450, and E 1451, for “weaning foods”, substitute “processed cereal-based foods and baby foods”; and

(c)

in Part 4 (miscellaneous additives permitted in dietary foods for infants and young children for special medical purposes as defined in Directive 1999/21/EC),

  • after the entry relating to E 472c, insert–

    “E 473

    Sucrose esters of fatty acids

    120 mg/l

    Products containing hydrolysed proteins, peptides and amino acids”

Amendments to the Sweeteners in Food Regulations 1995

14.

(1)

The Sweeteners in Food Regulations 19959 are amended in accordance with paragraphs (2) and (3).

(2)

In regulation 2(1) (interpretation)–

(a)

in the definition of Directive 94/35/EC, for the expression “and by Directive 2003/115/EC of the European Parliament and of the Council”, substitute “by Directive 2003/115/EC of the European Parliament and of the Council10 and by Directive 2006/52/EC of the European Parliament and of the Council11”; and

(b)

in the definition of “Directive 95/31/EC”, for the expression “and Directive 2004/46/EC” substitute “and Directives 2004/46/EC and 2006/128/EC12”.

(3)

In Schedule 1 (permitted sweeteners and the foods in or on which they may be used)–

(a)

in column 1, after “E 967”, insert “E 968”; and

(b)

in column 2, after “Xylitol”, insert “Erythritol”.

S ROBISON
Authorised to sign by the Scottish Ministers

St Andrew’s House,

Edinburgh

SCHEDULE 1Entries to be substituted in Schedule 2, Part C of the Additives Regulations

Regulation 8

ECNo.

Name

Food

Maximum amount that may be added during manufacture (expressed as NaNO2)

Maximum residual level (expressed as NaNO2)

mg/kg

mg/kg

E 249

Potassium nitrite(x)

Meat Products

150

E 250

Sodium nitrite(x)

Sterilised meat products

(Fo > 3,00)(y)

100

Traditional immersion cured meat products(1):
Wiltshire bacon(1.1);

175

Entremeada, entrecosto, chispe, orelheira e cabeça (salgados) Toucinho fumado(1.2);

and similar products

Wiltshire ham(1.1);

and similar products

100

Rohschinken, nassgepökelt(1.6);

and similar products

50

Cured tongue(1.3)

50

Traditional dry cured meat products(2):
Dry cured bacon(2.1);

and similar products

175

Dry cured ham(2.1);

100

Jamón curado, paleta curada, lomo embuchado y cecina(2.2);
Presunto, presunto da pá and paio do lombo(2.3);

and similar products

Rohschinken, trockengepökelt(2.5);

and similar products

50

Other traditionally cured meat products(3);

Vysočina

Selský salám

Turistický trvanlivý salám

Poličan

Herkules

Lovecký salám

Dunajská klobása

Papriká(3.5);

and similar products

180

Rohschinken, trocken-/nassgepökelt(3.1);

and similar products

50

Jellied veal and brisket(3.2)

EC No.

Name

Food

Maximum amount that may be added during manufacture (expressed as NaNO3)

Maximum residual level (expressed as NaNO3)

mg/kg

mg/kg

E 251

Potassium nitrate(z)

Non-heat-treated meat products

150

E 252

Sodium nitrate(z)

Traditional immersion cured meat products(1);

Kylmäsavustettu poronliha/Kallrökt renkött(1.4);

300

Wiltshire bacon and Wiltshire ham(1.1)

Entremeada, entrecosto, chispe, orelheira a cabeça (salgados), Toucinho fumado(1.2);

Rohschinken, nassgepökelt(1.6);

and similar products

250

Bacon, Filet de bacon(1.5); and similar products

250 without added E 249 or E 250

Cured tongue(1.3)

10

Traditional dry cured meat products(2);

Dry cured bacon and Dry cured ham(2.1);

250

Jamón curado, paleta curada, lomo embuchado y cecina(2.2);

Presunto, presunto da pá and paio do lombo(2.3);

Rohschinken, trockengepökelt(2.5);

and similar products

Jambon sec, jambon sel sec et autres pièces maturées séchées similaires(2.4)

250 without added E 249 or E 250

Other traditionally cured meat products(3):

Rohwürste (Salami and Kantwurst)(3.3);

300 (without added E 249 or E 250)

Rohschinken, trocken-/nassgepökelt(3.1) ;

and similar products

250

Salchichón y chorizo tradicionales de larga curación(3.4);
Saucissons secs(3.6);

and similar products

250 (without added E 249 or E 250)

Jellied veal and brisket(3.2);

10

Hard, semi-hard and semi-soft cheese

Dairy-based cheese analogue

150 in the cheese milk or equivalent level if added after removal of whey and addition of water

Pickled herring and sprat

500

(x)

When labelled “for food use”, nitrite may be sold only in a mixture with salt or a salt substitute.

(y)

Fo-value 3 is equivalent to 3 minutes heating at 121°C (reduction of the bacterial load of one billion spores in each 1,000 cans to one spore in a thousand cans).

(1)

Meat products are immersed in curing solution containing nitrites and/or nitrates, salt and other components. The meat products may undergo further treatments e.g. smoking.

(1.1)

Meat is injected with curing solution followed by immersion curing for 3 to 10 days. The immersion brine solution also includes microbiological starter cultures.

(1.2)

Immersion cured for 3 to 5 days. Product is not heat-treated and has a high water activity .

(1.6)

Curing time depending on the shape and weight of meat pieces for approximately 2 days/kg followed by stabilisation/maturation.

(1.3)

Immersion cured for at least 4 days and pre-cooked.

(2)

Dry curing process involves dry application of curing mixture containing nitrites and/or nitrates, salt and other components to the surface of the meat followed by a period of stabilisation/maturation. The meat products may undergo further treatments eg. smoking.

(2.1)

Dry curing followed by maturation for at least 4 days.

(2.2)

Dry curing with a stabilisation period of at least 10 days and a maturation period of more than 45 days.

(2.3)

Dry cured for 10 to 15 days followed by a 30 to 45 day stabilisation period and a maturation period of at least 2 months.

(2.5)

Curing time depending on the shape and weight of meat pieces for approximately 10 to 14 days followed by stabilisation/maturation.

(3)

Immersion and dry cured processes used in combination or where nitrite and/or nitrate is included in a compound product or where the curing solution is injected into the product prior to cooking. The products may undergo further treatments eg. smoking.

(3.5)

Dried product cooked to 70°C followed by 8 to 12 day drying and smoking process. Fermented product subject to 14 to 30 day three-stage fermentation process followed by smoking.

(3.1)

Dry curing and immersion curing used in combination (without injection of curing solution). Curing time depending on the shape and weight of meat pieces for approximately 14 to 35 days followed by stabilisation/maturation.

(3.2)

Injection of curing solution followed, after a minimum of 2 days, by cooking in boiling water for up to 3 hours.

(z)

Nitrates may be present in some heat-treated meat products resulting from natural conversion of nitrites to nitrates in a low-acid environment.

(1.4)

Meat is injected with curing solution followed by immersion curing. Curing time is 14 to 21 days followed by maturation in cold-smoke for 4 to 5 weeks.

(1.5)

Immersion cured for 4 to 5 days at 5 to 7°C, matured for typically 24 to 40 hours at 22°C, possibly smoked for 24 hrs at 20 to 25°C and stored for 3 to 6 weeks at 12 to 14°C.

(2.4)

Dry cured for 3 days + 1 day/kg followed by a one week post-salting period and an ageing/ripening period of 45 days to 18 months.

(3.3)

Product has a minimum 4-week maturation period and a water/protein ratio of less than 1.7.

(3.4)

Maturation period of at least 30 days.

(3.6)

Raw fermented dried sausage without added nitrites. Product is fermented at temperatures in the range of 18 to 22°C or lower (10 to 12°C) and then has a minimum ageing/ripening period of 3 weeks. Product has a water/protein ratio of less than 1:7.

SCHEDULE 2Entries to be substituted in Schedule 2, Part D of the Additives Regulations

Regulation 9

ECNo.

Name

Food

Maximum level (mg/kg)

E 310

Propyl gallate

Fats and oils for the professional manufacture of heat-treated foods

200* (gallates, TBHQ and BHA, individually or in combination)

E 311

Octyl gallate

Frying oil and frying fat, excluding olive pomace oil

100* (BHT), both expressed on fat

E 312

Dodecyl gallate

E 319

Tertiary-butyl hydroquinone (TBHQ)

Lard; fish oil; beef, poultry and sheep fat

E 320

Butylated hydroxyanisole (BHA)

Cake mixes; cereal-based snack foods; milk powder for vending machines

200 (gallates, TBHQ and BHA, individually or in combination) expressed on fat

E 321

Butylated hydroxytoluene (BHT)

Dehydrated soups and broths; sauces; dehydrated meat; processed nuts; pre-cooked cereals

Seasonings and condiments

200 (gallates and BHA, individually or in combination) expressed on fat

Dehydrated potatoes

25 (gallates, TBHQ and BHA, individually or in combination)

Chewing gum; food supplements

400 (gallates, TBHQ, BHT and BHA, individually or in combination)

Essential oils

1,000 (gallates, TBHQ and BHA, individually or in combination)

Flavourings other than essential oils

100* (gallates, individually or in combination)

200* (TBHQ and BHA, individually or in combination)

E 315

Erythorbic acid

Cured meat products and preserved meat products

500 expressed as erythorbic acid

E 316

Sodium erythorbate

Preserved and semi-preserved fish products; frozen and deep-frozen fish with red skin

1,500 expressed as erythorbic acid

E 586

4-Hexylresorcinol

Fresh, frozen and deep-frozen crustaceans

2 as residues in crustacean meat

* When combinations of gallates, TBHQ, BHA and BHT are used, the individual levels must be reduced proportionally

(This note is not part of the Regulations)

These Regulations, which extend to Scotland only, amend the Miscellaneous Food Additives Regulations 1995 (S.I. 1995/3187 as amended) (“the Additives Regulations”) in order to provide for the implementation of–

(a)

Directive 2006/52/EC of the European Parliament and of the Council amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs (O.J. No. L 204, 26.7.06, p.10), as corrected by a Corrigendum (O.J. No. L 78, 17.3.07, p.32); and

(b)

Commission Directive 2006/129/EC amending and correcting Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (O.J. No. L 346, 9.12.06, p.15).

These Regulations also amend the Sweeteners in Food Regulations 1995 (S.I. 1995/3123 as amended) in order to provide for the implementation of Directive 2006/52/EC mentioned above and of Commission Directive 2006/128/EC amending and correcting Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs (O.J. No. L 346, 9.12.06, p.6).

In particular these Regulations amend the Additives Regulations by–

(a)

amending certain definitions used in the Additives Regulations, including updating references to recently amended EC legislation (regulation 3);

(b)

making a transitional provision to permit the marketing of food additives or food placed on the market or labelled before 15th August 2008 if such marketing would have been lawful under the Additives Regulations before they were amended by these Regulations (regulation 4);

(c)

specifying certain additives that may not be used in the manufacture of jelly cups (regulation 5(a));

(d)

adding a new substance to the permitted additives listed in Schedule 1, which concerns miscellaneous additives generally permitted for foods not referred to in Schedules 6, 7 or 8 (regulation 5(b));

(e)

altering certain limits, removing certain substances and adding others to the conditionally permitted preservatives and anti-oxidants in Part A of Schedule 2 (regulation 6);

(f)

amending the entries relating to crustaceans and cephalopods, amending references to foods for infants and young children and adding two new entries to Part B of Schedule 2, which deals with sulphur dioxide and sulphites (regulation 7);

(g)

replacing, with amendments, Part C of Schedule 2 which relates to the use of potassium nitrite and nitrate and sodium nitrite and nitrate (regulation 8 and Schedule 1);

(h)

replacing, with amendments, Part D of Schedule 2 which relates to the use of certain anti-oxidants (regulation 9 and Schedule 2);

(i)

adding certain substances and amending conditions of use for some already permitted substances in Schedule 3, which concerns other permitted miscellaneous additives, and amending certain defined expressions used in that Schedule (regulation 10);

(j)

adding two substances and amending the conditions of use for one already permitted in Schedule 4, which concerns permitted carriers and carrier solvents (regulation 11);

(k)

amending Schedule 7, concerning foods in which a limited number of additives may be used, by the addition of certain foods and the addition of one additive to those permitted in one particular food (regulation 12); and

(l)

amending a defined expression for a class of foods where it appears in Schedule 8, which concerns miscellaneous additives permitted in foods for infants and young children, and adding a permitted substance to that Schedule (regulation 13).

These Regulations amend the Sweeteners in Food Regulations 1995 by–

(a)

updating references to recently amended by EC legislation (regulation 14(2)); and

(b)

adding a substance to Schedule 1, which concerns permitted sweeteners and the foods in or on which they may be used (regulation 14(3)).

A full regulatory impact assessment of the effect that this instrument will have on business costs has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency Scotland, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen, AB11 6NJ.