The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022
| Denominations | Restrictions |
|---|---|
| A. Regenerated cellulose | Not less than 72% (w/w). |
| B. Additives | B. Additives |
| 1. Softeners | Not more than 27% (w/w) in total. |
| —Bis (2-hydroxyethyl) ether [= diethyleneglycol] | Only for films intended to be coated and then used for foodstuffs which are not moist, namely which do not contain water which is physically free at the surface. The total amount of bis(2-hydroxyethyl)ether and ethanediol present in foodstuffs that have been in contact with film of this type may not exceed 30 mg/kg of the foodstuff. |
| —Ethanediol [= monoethyleneglycol] | |
| —1.3-butanediol | |
| —Glycerol | |
| —1.2-propanediol [= 1.2 propyleneglycol] | |
| —Polyethylene oxide [= polyethyleneglycol] | Average molecular weight between 250 and 1200. |
| —1.2-polypropylene oxide [= 1.2 polypropyleneglycol] | Average molecular weight not greater than 400 and free 1.3-propanediol content not greater than 1% (w/w) in substance. |
| —Sorbitol | |
| —Tetraethyleneglycol | |
| —Triethyleneglycol | |
| —Urea | |
| 2.Other additives | Not more than 1% (w/w) in total. |
| First class | The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm² of the uncoated film. |
| —Acetic acid and its NH4, Ca, Mg, K and Na salts | |
| —Ascorbic acid and its NH4, Ca, Mg, K and Na salts | |
| —Benzoic acid and sodium benzoate | |
| —Formic acid and its NH4, Ca, Mg, K and Na salts | |
| —Linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also behenic and ricinoleic acids and the NH4, Ca, Mg, K, Na, Al, Zn salts of these acids | |
| —Citric, d- and l-lactic, maleic, l-tartaric acids and their Na and K salts | |
| —Sorbic acid and its NH4, Ca, Mg, K and Na salts | |
| —Amides of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also the amides of behenic and ricinoleic acids | |
| —Natural edible starches and flours | |
| —Edible starches and flours modified by chemical treatment | |
| —Amylose | |
| —Calcium and magnesium carbonates and chlorides | |
| —Esters of glycerol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and/or with adipic, citric, 12-hydroxystearic (oxystearin), ricinoleic acids | |
| —Esters of polyoxyethylene (8 to 14 oxyethylene groups) with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive | |
| —Esters of sorbitol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive | |
| —Mono-and/or di-esters of stearic acid with ethanediol and/or bis (2-hydroxyethyl) ether and/or triethylene glycol | |
| —Oxides and hydroxides of aluminium, calcium, magnesium and silicon and silicates and hydrated silicates of aluminium, calcium, magnesium and potassium | |
| —Polyethylene oxide [= polyethyleneglycol] | Average molecular weight between 1200 and 4000. |
| —Sodium propionate | |
| Second class | The total quantity of the substances may not exceed 1 mg/dm² of the uncoated film and the quantity of the substance or group of substances in each indent may not exceed 0.2 mg/dm² (or a lower limit where one is specified) of the uncoated film. |
| —Sodium alkyl (C8-C18) benzene sulphonate | |
| —Sodium isopropyl naphthalene sulphonate | |
| —Sodium alkyl (C8-C18) sulphate | |
| —Sodium alkyl (C8-C18) sulphonate | |
| —Sodium dioctylsulphosuccinate | |
| —Distearate of dihydroxyethyl diethylene triamine monoacetate | Not more than 0.05 mg/dm² of the uncoated film. |
| —Ammonium, magnesium and potassium lauryl sulphates | |
| —N,N′-distearoyl diaminoethane, N,N′-dipalmitoyl diaminoethane and N,N′-dioleoyl diaminoethane | |
| —2-heptadecyl-4.4-bis(methylene-stearate) oxazoline | |
| —Polyethylene-aminostearamide ethylsulphate | Not more than 0.1 mg/dm² of the uncoated film. |
| Third class — Anchoring agent | The total quantity of substances may not exceed 1 mg/dm² of the uncoated film. |
| —Condensation product of melamine-formaldehyde unmodified, or which may be modified with one or more of the following products: butanol, diethylenetriamine, ethanol, triethylenetetramine, tetraethylenepentamine, tri-(2-hydroxyethyl) amine, 3.3′-diaminodipropylamine, 4.4′-diaminodibutylamine | Free formaldehyde content not greater than 0.5 mg/dm² of the uncoated film. Free melamine content not greater than 0.3 mg/dm² of the uncoated film. |
| —Condensation product of melamine-urea-formaldehyde modified with tris-(2-hydroxyethyl)amine | Free formaldehyde content not greater than 0.5 mg/dm² of the uncoated film. Free melamine content not greater than 0.3 mg/dm² of the uncoated film. |
| —Cross-linked cationic polyalkyleneamines: polyamide-epichlorhydrin resin based on diaminopropylmethylamine and epichlorhydrin, polyamide-epichlorhydrin resin based on epichlorhydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine, polyamide-epichlorhydrin resin based on adipic acid, diethylenetriamine and epichlorhydrin, or a mixture of epichlorhydrin and ammonia, polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, dimethyl adipate and diethylenetriamine, polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, adipamide and diaminopropylmethylamine | In accordance with relevant legislation. |
| —Polyethyleneamines and polyethyleneimines | Not more than 0.75 mg/dm² of the uncoated film. |
| —Condensation product of urea-formaldehyde unmodified, or which may be modified with one or of the following products: aminomethylsulphonic acid, sulphanilic acid, butanol, diaminobutane, diaminodiethylamine, diaminodipropylamine, diaminopropane, diethylenetriamine, ethanol, guanidine, methanol, tetraethylenepentamine, triethylenetetramine, sodium sulphite | Free formaldehyde content not greater than 0.5 mg/dm² of the uncoated film. |
| Fourth class | The total quantity of substances may not exceed 0.01 mg/dm² of the uncoated film. |
| —Products resulting from the reaction of the amines of edible oils with polyethylene oxide, | |
| —Monoethanolamine lauryl sulphate | |
| Denominations | Restrictions |
| --- | --- |
| A. Regenerated cellulose | See first part. |
| B. Additives | See first part. |
| C. Coating | |
| 1. Polymers | The total quantity of substances may not exceed 50 mg/dm² of the coating on the side in contact with foodstuffs. |
| —Ethyl, hydroxyethyl, hydroxypropyl and methyl ethers of cellulose | |
| —Cellulose nitrate | Not more than 20 mg/dm² of the coating on the side in contact with foodstuffs; nitrogen content between 10.8% (w/w) and 12.2% (w/w) in the cellulose nitrate. |
| 2. Resins | The total quantity of substances may not exceed 12.5 mg/dm² of the coating on the side in contact with foodstuffs and solely for the preparation of regenerated cellulose films with cellulose nitrate based coatings. |
| —Casein | |
| —Colophony and/or its products of polymerization, hydrogenation, or disproportionation and their esters of methyl, ethyl or C2 to C6 polyvalent alcohols, or mixtures of these alcohols | |
| —Colophony and/or its products of polymerization, hydrogenation, or disproportionation condensed with acrylic, maleic, citric, fumaric and/or phthalic acids and/or 2.2 bis (4-hydroxyphenyl) propane formaldehyde and esterified with methyl ethyl or C2 to C6 polyvalent alcohols or mixtures of these alcohols | |
| —Esters derived from bis(2-hydroxyethyl) ether with addition products of betapinene and/or dipentene and/or diterpene and maleic anhydride | |
| —Edible gelatine | |
| —Castor oil and its products of dehydration or hydrogenation and its condensation products with polyglycerol, adipic, citric, maleic, phthalic and sebacic acids | |
| —Natural gum [= damar] | |
| —Poly-beta-pinene [= terpenic resins] | |
| —Urea-formaldehyde resins (see anchoring agents) | |
| 3. Plasticisers | The total quantity of substances may not exceed 6 mg/dm² of the coating on the side in contact with foodstuffs. |
| —Acetyl tributyl citrate | |
| —Acetyl tri(2-ethylhexyl) citrate | |
| —Di-isobutyl adipate | |
| —Di-n-butyl adipate | |
| —Di-n-hexyl azelate | |
| —Dicyclohexyl phthalate | Not more than 4.0 mg/dm² of the coating on the side in contact with foodstuffs. |
| —2-ethylhexyl diphenyl phosphate (synonym: phosphoric acid diphenyl 2 ethylhexyl ester) | The amount of 2-ethylhexyl diphenyl phosphate is not to exceed: 2.4 mg/kg of the foodstuff in contact with this type of film, or 0.4 mg/dm² in the coating on the side in contact with foodstuffs. |
| —Glycerol monoacetate [= monoacetin] | |
| —Glycerol diacetate [= diacetin] | |
| —Glycerol triacetate [= triacetin] | |
| —Di-butyl sebacate | |
| —Di-n-butyl tartrate | |
| —Di-isobutyl tartrate | |
| 4. Other additives | The total quantity of substances are not to exceed 6 mg/dm² in the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs. |
| 4.1. Additives listed in the first part | Same restrictions as in the first part (however the quantities in mg/dm² refer to the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs). |
| 4.2. Specific coating additives | The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm² (or a lower limit where one is specified) of the coating on the side in contact with foodstuffs. |
| —1-hexadecanol and 1-octadecanol | |
| —Esters of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and of ricinoleic acid with ethyl, butyl, amyl and oleyl linear alcohols | |
| —Montan waxes, comprising purified montanic (C26 to C32) acids and/or their esters with ethanediol and/or 1.3 butanediol and/or their calcium and potassium salts | |
| —Carnauba wax | |
| —Beeswax | |
| —Esparto wax | |
| —Candelilla wax | |
| —Dimethylpolysiloxane | Not more than 1 mg/dm² of the coating on the side in contact with foodstuffs. |
| —Epoxidised soya-bean oil (oxirane content 6 to 8%) | |
| —Refined paraffin and microcrystalline waxes | |
| —Pentaerythritol tetrastearate | |
| —Mono and bis(octadecyldiethyleneoxide)-phosphates | Not more than 0.2 mg/dm² of the coating on the side in contact with foodstuffs. |
| —Aliphatic acids (C8 to C20) esterified with mono- or di-(2-hydroxyethyl)amine | |
| —2- and 3-tert.butyl-4-hydroxyanisole [= butylated hydroxyanisole — BHA] | Not more than 0.06 mg/dm² of the coating on the side in contact with foodstuffs. |
| —2.6-di-tert.butyl-4-methylphenol [= butylated hydroxytoluene — BHT] | Not more than 0.06 mg/dm² of the coating on the side in contact with foodstuffs. |
| —Di-n-octyltin-bis(2-ethylhexyl) maleate | Not more than 0.06 mg/dm² of the coating on the side in contact with foodstuffs. |
| 5.Solvents | The total quantity of substances may not exceed 0.6 mg/dm² of the coating on the side in contact with foodstuffs. |
| —Butyl acetate | |
| —Ethyl acetate | |
| —Isobutyl acetate | |
| —Isopropyl acetate | |
| —Propyl acetate | |
| —Acetone | |
| —1-butanol | |
| —Ethanol | |
| —2-butanol | |
| —2-propanol | |
| —1-propanol | |
| —Cyclohexane | |
| —Ethyleneglycol monobutyl ether | |
| —Ethyleneglycol monobutyl ether acetate | |
| —Methyl ethyl ketone | |
| —Methyl isobutyl ketone | |
| —Tetrahydrofuran | |
| —Toluene | Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs. |
SCHEDULE 3 — Insertion of schedule 6 of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013
1
After schedule 5 the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013 insert—
SCHEDULE 6
| Name[^f01038] |
|---|
| (1) An extraction solvent is considered as being used in compliance with good manufacturing practice if its use results only in the presence of residues or derivatives in technically unavoidable quantities presenting no danger to human health. |
| (2) The use of Acetone in the refining of olive-pomace oil is forbidden. |
| Propane |
| Butane |
| Ethyl acetate |
| Ethanol |
| Carbon dioxide |
| Acetone[^f01039] |
| Nitrous Oxide |
| Name | Conditions of use (summary description of extraction) | Maximum residue limits in the extracted foodstuff or food ingredient |
|---|---|---|
| (1) Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C. The combined use of Hexane and Ethylmethylketone is forbidden. | (1) Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C. The combined use of Hexane and Ethylmethylketone is forbidden. | (1) Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C. The combined use of Hexane and Ethylmethylketone is forbidden. |
| (2) The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden. | (2) The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden. | (2) The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden. |
| (3) ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals, in accordance with the relevant requirements of Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin[^f00020]. | (3) ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals, in accordance with the relevant requirements of Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin[^f00020]. | (3) ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals, in accordance with the relevant requirements of Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin[^f00020]. |
| (4) ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of Regulation (EC) No 853/2004[^f00021]. | (4) ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of Regulation (EC) No 853/2004[^f00021]. | (4) ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of Regulation (EC) No 853/2004[^f00021]. |
| Hexane[^f01040] | Production or fractionation of fats and oils and production of cocoa butter | 1 mg/kg in the fat or oil or cocoa butter |
| Hexane[^f01040] | Preparation of defatted protein products and defatted flours | 10 mg/kg in the food containing the defatted protein products and the defatted flours |
| Hexane[^f01040] | 30 mg/kg in the defatted soya products as sold to the final consumer | |
| Hexane[^f01040] | Preparation of defatted cereal germs | 5 mg/kg in the defatted cereal germs |
| Methyl acetate | Decaffeination of, or removal of irritants and bitterings from coffee and tea | 20 mg/kg in the coffee or tea |
| Methyl acetate | Production of sugar from molasses | 1mg/kg in the sugar |
| Ethylmethylketone[^f01041] | Fractionation of fats and oils | 5 mg/kg in the fat or oil |
| Ethylmethylketone[^f01041] | Decaffeination of, or removal of irritants and bitterings from coffee and tea | 20 mg/kg in the coffee or tea |
| Dichloromethane | Decaffeination of, or removal of irritants and bitterings from coffee and tea | 2 mg/kg in the roasted coffee and 5 mg/kg in the tea |
| Methanol | For all uses | 10 mg/kg |
| Propan-2-ol | For all uses | 10 mg/kg |
| Dimethyl ether | Preparation of defatted animal protein products including gelatine [^f01042] | 0.009 mg/kg in the defatted animal protein products including gelatine |
| Dimethyl ether | Preparation of collagen and collagen derivatives, except gelatine[^f01043] | 3 mg/kg in the collagen and collagen derivatives, except gelatine |
| Name | Maximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of flavourings from natural flavouring materials | |
| --- | --- | |
| Diethyl ether | 2 mg/kg | |
| Hexane (*) | 1 mg/kg | |
| Cyclohexane | 1 mg/kg | |
| Methyl acetate | 1 mg/kg | |
| Butan-1-ol | 1 mg/kg | |
| Butan-2-ol | 1 mg/kg | |
| Ethylmethylketone (*) | 1 mg/kg | |
| Dichloromethane | 0.02 mg/kg | |
| Propan-1-ol | 1 mg/kg | |
| 1,1,1,2-tetrafluoroethane | 0.02 mg/kg | |
| Methanol | 1.5 mg/kg | |
| Propan-2-ol | 1 mg/kg | |
| * The combined use of Hexane and Ethylmethylketone is forbidden. | * The combined use of Hexane and Ethylmethylketone is forbidden. |
Signed
MAREE TODD — Authorised to sign by the Scottish Ministers — 13th December 2022
Explanatory note
(This note is not part of the Regulations)
EXPLANATORY NOTE
Regulations 2, 3 and 4 amend Commission Implementing Regulations (EU) No’s 787/2013, 2015/1020 and 2017/2276, respectively, to make minor corrections which relate to amendment to those Commission Implementing Regulations made by the Feed Additives (Authorisations) (Scotland) Regulations 2022.
Regulation 5 makes minor corrections to the Feed Additives (Authorisations) (Scotland) Regulations 2022.
Regulation 6 and schedule 1 amend the Animal Feed (Scotland) Regulations 2010 (2010 Regulations) with the effect that the Annex to Commission Directive 82/475/EEC laying down the categories of feed materials which may be used for the purposes of labelling compound feeding stuffs for pet animals (OJ L 213, 21.7.1982, p. 27–28) is replicated as new schedule 3 of the 2010 Regulations and Annexes 1 and 2 to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10–22) are replicated as new schedules 4 and 5 of the 2010 Regulations.
Regulation 7 and schedule 2 amend the Materials and Articles in Contact with Food (Scotland) Regulations 2012 with the effect that Annexes 1 and 2 to Commission Directive 2007/42/EC relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (OJ L 172, 30.6.2007, p. 71–82) are replicated in a new schedule 6 of those Regulations.
Regulation 8 and schedule 3 amend the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013 with the effect that Annex 1 to Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (OJ L 141, 6.6.2009, p. 3–11) is replicated in a new schedule 6 to those Regulations.
Regulation 9 amends the Food Information (Scotland) Regulations 2014 to remove redundant references to Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers.
A business and regulatory impact assessment has not been produced for this instrument as no significant impact on the private or voluntary sector is foreseen.
Footnotes
[^f00001]: EUR 1831/2003 as relevantly amended by S.I. 2019/654 and 2022/377. Article 9 was substituted by S.I. 2019/654 and amended by S.I. 2022/377. Article 13 was substituted and article 18A was added by S.I. 2019/654. The terms “prescribe” and “appropriate authority” are defined in Article 2 of EUR 1831/2003.
[^f00002]: 2018 c. 16. Section 8 was amended by section 27 of the European Union (Withdrawal Agreement) Act 2020 (c. 1); paragraph 21 of schedule 7 was amended by paragraph 53 of Part 2 of schedule 5 of that Act.
[^f00003]: EUR 178/2002 as amended by S.I. 2019/641. S.I. 2019/641 was amended by S.I. 2020/1504.
[^f00004]: EUR 787/2013.
[^f00005]: EUR 2015/1020.
[^f00006]: EUR 2017/2276.
[^f00007]: S.S.I. 2022/288.
[^f00012]: S.S.I. 2010/373, last amended by S.S.I. 2020/467.
[^f00013]: See article 3(2)(a) of EUR 2009/767 for the meaning of “feed business operator”.
[^f00014]: S.S.I. 2012/318 as relevantly amended by S.S.I. 2019/52.
[^f00015]: S.S.I. 2013/266 as relevantly amended by S.S.I. 2019/53 and S.S.I. 2020/372.
[^f00016]: S.S.I. 2014/312 as relevantly amended by S.S.I. 2015/410, S.S.I. 2016/191 and S.S.I. 2020/156.
[^f00017]: EUR 68/2013.
[^f00018]: EUR 1831/2003 as amended by S.I. 2019/654 and 2022/377.
[^f00019]: EUR 1831/2003 as amended by S.I. 2019/654 and 2022/377.
[^f00020]: EUR 853/2004.
[^f00021]: EUR 853/2004.
Editorial notes
[^key-8c86bfd6e7e67dafb3004f12c1aa65b7]: Sch. 1 para. 1 in force at 9.2.2023, see reg. 1(1)
[^key-d8f4b23947e912782fc458b7003b7715]: Sch. 2 para. 1 in force at 9.2.2023, see reg. 1(1)
[^key-9edc60ece14b3e3b144786a8c60ed94b]: Sch. 3 para. 1 in force at 9.2.2023, see reg. 1(1)
[^key-16ea916ead550d1c2a12412530b03076]: Reg. 2 in force at 9.2.2023, see reg. 1(1)
[^key-6337ff4369d7bb75b02ffeaf60a12668]: Reg. 1 in force at 9.2.2023, see reg. 1(1)
[^key-3d5bda7de5708d46e8c1937d193dd18c]: Reg. 3 in force at 9.2.2023, see reg. 1(1)
[^key-f1921e5e6d573a5a093e513806bc9505]: Reg. 4 in force at 9.2.2023, see reg. 1(1)
[^key-9e3995c50fd59bf8a47461e4e68bb184]: Reg. 5 in force at 9.2.2023, see reg. 1(1)
[^key-04d6a485aa901d59e35c4de9befb2fa9]: Reg. 6 in force at 9.2.2023, see reg. 1(1)
[^key-6e282aac96609a40a0350f0dd8941520]: Reg. 7 in force at 9.2.2023, see reg. 1(1)
[^key-e989f759c4d7ce5ec84e19b5af99a3ec]: Reg. 8 in force at 9.2.2023, see reg. 1(1)
[^key-a9871b441e76d239db36d0330f51d143]: Reg. 9 in force at 9.2.2023, see reg. 1(1)
[^key-bba8c74272d16b4029cb4a251d134a47]: Reg. 5(5)-(14) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 10 para. 7(2)
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