The Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013
Words in Sch. 1 Table 1 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(4)(a)(ii)(bb)
Words in Sch. 1 Table 1 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(4)(b)(ii)(aa)
Words in Sch. 1 Table 1 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(4)(b)(ii)(bb)
Words in Sch. 1 Table 1 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(4)(c)(ii)
Words in Sch. 1 Table 1 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(4)(d)(ii)
Words in Sch. 2 Table 1 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(5)(b)
Words in Sch. 3 Table 1 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(6)(b)
Words in Sch. 4 Table 1 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(7)(b)
Word in Sch. 2 substituted (31.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(3), 13(6)(b)
Word in Sch. 2 substituted (31.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(3), 13(6)(c)
Word in Sch. 3 substituted (31.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(3), 13(7)
Word in Sch. 4 substituted (31.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(3), 13(8)(b)
Word in Sch. 4 substituted (31.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(3), 13(8)(c)
Words in reg. 2(1) 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. 11 para. 4(2)(a)(ii)(aa)
Words in reg. 2(1) 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. 11 para. 4(2)(a)(ii)(bb)
Words in reg. 2(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(2)(b)(ii)(aa)
Word in reg. 2(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 11 para. 4(2)(b)(ii)(bb)
Words in reg. 4 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. 11 para. 4(3)(b)
Offence of contravening EU requirements on food enzymes
Improvement notices – application of subsections (1) and (2) of section 10 of the Food Safety Act 1990
Appeal against improvement notice – application of subsections (1) and (6) of sections 37 and section 39 of the Food Safety Act 1990
Transitional provision: withdrawal from the EU
22
- (1) An authorised officer must not serve on a person an improvement notice relating to a failure to comply with regulation 13(2), in respect of the requirement set out in regulation 14(1)(d), if—
- (a) the improvement notice would relate to a product that was placed on the market before 1 January 2024; and
- (b) the matter would not have constituted a failure to comply with those provisions of these Regulations as they had effect immediately before IP completion day.
- (2) In this regulation, “improvement notice” means an improvement notice pursuant to regulation 7.
SCHEDULE4A — Extraction solvents which may be used during the processing of raw materials, of food, of food components or of food ingredients
| Name: |
|---|
| (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)Acetone is not permitted for use in the refining of olive-pomace oil. |
| Propane |
| Butane |
| Ethyl Acetate |
| Ethanol |
| Carbon dioxide |
| Acetone[^f01001] |
| 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. Combined use of Hexane and Ethymethylketone is not permitted. | (1)Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64°C and 70°C. Combined use of Hexane and Ethymethylketone is not permitted. | (1)Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64°C and 70°C. Combined use of Hexane and Ethymethylketone is not permitted. |
| (2)The level of n-Hexane in this solvent should not exceed 50mg/kg. Combined use of Hexane and Ethymethylketone is not permitted. | (2)The level of n-Hexane in this solvent should not exceed 50mg/kg. Combined use of Hexane and Ethymethylketone is not permitted. | (2)The level of n-Hexane in this solvent should not exceed 50mg/kg. Combined use of Hexane and Ethymethylketone is not permitted. |
| (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. | (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. | (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. |
| (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. | (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. | (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. |
| Hexane[^f01002] | Production or fractionation of fats and oils and production of cocoa butter | 1mg/kg in the fat or oil or cocoa butter |
| Hexane[^f01002] | Preparation of defatted protein products and defatted flours | 10mg/kg in the food containing the defatted proteinproducts and the defatted flours |
| Hexane[^f01002] | Preparation of defatted protein products and defatted flours | 30 mg/kg in the defatted soya products as sold to the final consumer |
| Hexane[^f01002] | Preparation of defatted cereal germs | 5mg/kg in the defatted cereal germs |
| Methyl acetate | Decaffeination of, or removal of irritants and bitterings from coffee and tea | 20mg/kg in the coffee or tea |
| Methyl acetate | Production of sugar from molasses | 1mg/kg in the sugar |
| Ethylmethylketone[^f01003] | Fractionation of fats and oils | 5mg/kg in the fat or oil |
| Ethylmethylketone[^f01003] | Decaffeination of, or removal of irritants and bitterings from coffee and tea | 20mg/kg in the coffee or tea |
| Dichloromethane | Decaffeination of, or removal of irritants and bitterings from coffee and tea | 2mg/kg in the roasted coffee and 5mg/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[^f01004] | 0.009 mg/kg in the defatted animal protein products including gelatine |
| Dimethyl ether | Preparation of collagen[^f01005] and collagen derivatives, except gelatine | 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 | |
| --- | --- | |
| (1)Combined use of Hexane and Ethymethylketone is not permitted. | (1)Combined use of Hexane and Ethymethylketone is not permitted. | |
| Diethyl ether | 2 mg/kg | |
| Hexane[^f01006] | 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[^f01006] | 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 |
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