The Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013

Regulations 3 and 7

SCHEDULE 1 E+W Specified provisions of Regulation 1333/2008

Table 1

Provision of Regulation 1333/2008	Subject matter
Article 4.1 (as read with Articles 11.3 and 11.4, 12, 13.2 and 18.1(a), 18.2 and 18.3)	Requirement that only food additives included in the list in Annex II to Regulation 1333/2008 be placed on the market as such and that they be used in accordance with any conditions specified in those Articles and that Annex.
Article 4.2 (as read with Articles 12, 13.2 and 18.3)	Requirement that only food additives included in the list in Annex III to Regulation 1333/2008 may be used in food additives, food enzymes, food flavourings and nutrients and under the conditions of use specified in that Annex.
Article 4.5	Requirement that food additives comply with the specifications referred to in Article 14 of Regulation 1333/2008.
Article 5	Prohibition on placing on the market of food additives or food containing food additives if the use of the food additive does not comply with Regulation 1333/2008.
Article 11.2	Requirement to use food additives in accordance with the quantum satis principle where no maximum numerical level fixed for the additive concerned.
Article 15	Prohibition on use of food additives in unprocessed foods except where provided for in Annex II to Regulation 1333/2008.
Article 16	Prohibition on use of food additives in foods for infants and young children (including dietary foods for infants and young children for special medical purposes) except where provided for in Annex II to Regulation 1333/2008.
Article 17	Requirement to use only food colours listed in Annex II to Regulation 1333/2008 for the purpose of health marking meat or meat products, decorative colouring of eggshells or stamping of eggshells.
Article 18.1(b) (as read with Article 18.2)	Requirement that food additives be present in food to which a food additive, food enzyme or food flavouring has been added, only if the additive is permitted in the additive, enzyme or flavouring under Regulation 1333/2008, has been carried over to the food via the additive, enzyme or flavouring and has no technological function in the final food.
Article 18.1(c) (as read with Article 18.2)	Requirement that food additives be present in foods to be used solely in the preparation of a compound food only if the compound food complies with Regulation 1333/2008.
Article 18.4	Requirement that food additives be used as sweeteners in compound foods with no added sugars, energy reduced compound foods with no added sugars, energy reduced compound foods, compound dietary foods intended for low calorie diets, non cariogenic compound foods and compound foods with an increased shelf life only if the sweetener is permitted in any of the ingredients of the compound food.
Article 26.1	Requirement that producers and users of food additives inform the [F1 Authority] immediately of any new scientific or technical information which might affect the assessment of the safety of the food additive concerned.

Textual Amendments

F1 Word in Sch. 1 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(5)(a)

Table 2

Provision of Regulation 1333/2008	Subject matter
Article 21.1 (as read with Article 22)	Requirement that food additives not intended for sale to the final consumer be labelled, in accordance with Article 22 of Regulation 1333/2008, visibly, clearly legibly and indelibly and in [F2 English, or in English and Welsh].
Article 23.1 (as read with Article 23.2 and 23.5)	Prohibition on marketing of food additives sold singly or mixed with each other and/or other food ingredients and intended for sale to the final consumer unless their packaging contains specified information.
Article 23.3 (as read with Article 23.5)	Requirement that the labelling of table-top sweeteners containing polyols and/or aspartame and/or aspartame – acesulfame salt bear specified warnings.
Article 23.4	Requirement that manufacturers of table top sweeteners make available by appropriate means the information necessary to allow safe use by consumers.
Article 24.1 (as read with Article 24.2)	Requirement that labelling of the food containing the colours listed in Annex V should contain the additional information specified in that Annex.
Article 26.2	Requirement that producers and users of food additives, at the request of the [F3 Authority], inform it of the actual use of the food additive concerned.

Textual Amendments

F2 Words in Sch. 1 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(5)(b)(i)

F3 Word in Sch. 1 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(5)(b)(ii)

Regulations 4 and 7

SCHEDULE 2 E+W Specified provisions of Regulation 1334/2008

Table 1

Provision of Regulation 1334/2008	Subject matter
Article 4	Requirement that the use of flavourings or food ingredients with flavouring properties does not pose a safety risk or mislead the consumer.
Article 5	Prohibition on the placing on the market of non-compliant flavourings or non-compliant food.
Article 6.1 (as read with Part A of Annex III)	Prohibition on adding certain specified substances as such in foods.
Article 6.2 (as read with Part B of Annex III)	Requirement that certain substances naturally present in flavourings or food ingredients with flavouring properties should not exceed specified levels in compound foods as a result of the use of flavourings or food ingredients with flavouring properties.
Article 7.1 (as read with Part A of Annex IV)	Prohibition on the use of certain source materials to produce flavourings or food ingredients with flavouring properties.
Article 7.2 (as read with Part B of Annex IV)	Restrictions on the use of flavourings or food ingredients with flavouring properties produced from certain source materials.
Article 10	Restriction on the placing on the market or use of flavourings and source materials that are not included on the Union list.
Article 19.2	Requirement that a producer or user of an approved flavouring that is prepared by production methods or using starting materials significantly different from those included in the risk assessment must submit the necessary data to the Commission to allow an evaluation with regard to the modified production method or characteristics before marketing the flavouring
Article 19.3	Requirement on food business operators to inform the Commission immediately if they become aware of any new scientific or technical information that might affect the assessment of the safety of a flavouring substance.

Table 2

Provision of Regulation 1334/2008	Subject matter
Article 14.1 (as read with Articles 15 and 16)	Requirements for the labelling of flavourings not intended for sale to the final consumer.
Article 17 (as read with Articles 15.1(a) and 16)	Requirements for the labelling of flavourings intended for sale to the final consumer.

Regulations 5 and 7

SCHEDULE 3 E+W Specified provisions of Regulation 2065/2003

Table 1

Provision of Regulation 2065/2003	Subject matter
Article 4.2	Prohibition on marketing a smoke flavouring not on the list of authorised smoke flavourings, or any food in or on which such a smoke flavouring is present
Article 4.2	Prohibition on marketing an authorised smoke flavouring, or any food in or on which such a smoke flavouring is present, otherwise than in accordance with any conditions of use laid down in the authorisation
Article 5.1, first subparagraph	Prohibition on using treated wood, unless it can be demonstrated by appropriate certification or documentation that the substance used in treatment does not give rise to potentially toxic substances during combustion
Article 5.1, second subparagraph	Requirement to be able to demonstrate by documentation or certification that the prohibition in the first paragraph of Article 5.1 has been observed
Article 5.2, first sentence	Requirement to observe conditions in Annex I during production of primary products (primary smoke condensates or primary tar fractions)
Article 5.2, second sentence	Prohibition on the use of water-insoluble oily phase during the production of smoke flavourings
Article 9.4	Requirement that an authorisation holder or any other food business operator using an authorised product, or a derived smoke flavouring produced from an authorised product, must comply with any conditions or restrictions attached to the authorisation
Article 9.5	Requirement that an authorisation holder inform the Commission immediately of any new scientific or technical information relating to an authorised product which might influence the assessment of its safety

Table 2

Provision of Regulation 2065/2003	Subject matter
Article 13.1	Requirement that food business operators ensure the specified information is transmitted to the receiving food business operator when the product is first placed on the market
Article 13.2	Requirement that following the first placing on the market, on each subsequent occasion that the product is placed on the market, food business operators placing products on the market transmit the information specified in Article 13.1 to the receiving food business operators

Regulations 6 and 7

SCHEDULE 4 E+W Specified provisions of Regulation 1332/2008

Table 1

Provision of Regulation 1332/2008	Subject matter
Article 4	Requirement that food enzymes may not be placed on the market as such or used in foods unless they appear in the Union list of authorised enzymes provided for in Article 17 and in accordance with the prescribed specifications and conditions of use.
Article 5	Prohibition on placing on the market of non-compliant food enzymes or foods containing such enzymes which do not comply with Regulation 1332/2008 and its implementing measures.
Article 14.1	Requirement that a producer of user of a food enzyme shall inform the Commission immediately of any new scientific or technical information that might affect its safety assessment.
Article 14.2	Requirement that a producer or user of an approved food enzyme that is prepared by production methods or using starting materials significantly different from those included in the risk assessment must submit the necessary data to the Commission to allow an evaluation with regard to the modified production method or characteristics before marketing the enzyme.

Table 2

Provision of Regulation 1332/2008	Subject matter
Article 10.1 (as read with Article 11)	Requirements for labelling of food enzymes and preparations not intended for sale to the final consumer.
Article 12.1	Requirements for labelling of food enzymes and preparations intended for sale to the final consumer.

Regulations 10, 11 and 14

[F4 SCHEDULE 4A E+W Extraction solvents which may be used during the processing of raw materials, of food, of food components or of food ingredients

Textual Amendments

F4 Sch. 4A inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2022 (S.I. 2022/1362), reg. 1, Sch. 2

Modifications etc. (not altering text)

C1 Sch. 4A applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(b), Sch. 2 (with regs. 7, 8)

Table 1

Extraction solvents to be used in compliance with good manufacturing practice for all uses⁽¹⁾

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(2)
Nitrous oxide

Table 2

Extraction solvents for which conditions of use are specified

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.
(2) The level of n-Hexane in this solvent should not exceed 50 mg/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.
(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(1)	Production or fractionation of fats and oils and production of cocoa butter	1 mg/kg in the fat or oil or cocoa butter
	Preparation of defatted protein products and defatted flours	10 mg/kg in the food containing the defatted protein products and the defatted flours
		30 mg/kg in the defatted soya products as sold to the final consumer
	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
	Production of sugar from molasses	1 mg/kg in the sugar
Ethylmethylketone(2)	Fractionation of fats and oils	5 mg/kg in the fat or oil
	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(3)	0.009 mg/kg in the defatted animal protein products including gelatine
	Preparation of collagen(4) and collagen derivatives, except gelatine	3 mg/kg in the collagen and collagen derivatives, except gelatine

Table 3

Extraction solvents for which conditions of use are specified

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.]
Diethyl ether	2 mg/kg
Hexane(1)	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)	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

Regulation 21

SCHEDULE 5 E+W Revocations

Name of instrument	Extent of revocation
The Extraction Solvents in Food Regulations 1993 (S.I. 1993/1658)	The whole Regulations
The Extraction Solvents in Food (Amendment) Regulations 1995 (S.I. 1995/1440)	The whole Regulations
The Extraction Solvents in Food (Amendment) Regulations 1998 (S.I. 1998/2257)	The whole Regulations
The Extraction Solvents in Food (Amendment) (Wales) Regulations 2011 (S.I. 2011/1849 (W.199))	The whole Regulations
The Smoke Flavourings (Wales) Regulations 2005 (S.I. 2005/1350 (W.98))	The whole Regulations
The Food (Suspension of the Use of E128 Red 2G Food Colour) (Wales) Regulations 2007 (S.I. 2007/2315 (W.186))	The whole Regulations
The Food Enzymes Regulations 2009 (S.I. 2009/3377 (W.299))	Regulations 3, 4, 5, 6, 7(2)(b) and 8
The Food Additives (Wales) Regulations 2009 (S.I. 2009/3378 (W.300))	All provisions except regulations 1, 2, 18(4) and 19
The Food Additives (Wales) (Amendment) Regulations 2011 (S.I. 2011/655 (W.93))	The whole Regulations
The Food Additives (Wales) (Amendment) (No.2) Regulations 2011 (S.I. 2011/1450 (W.172))	The whole Regulations
The Food Additives (Wales) (Amendment) and the Extraction Solvents in Food (Amendment) (Wales) Regulations 2012 (S.I. 2012/1198 (W.148))	The whole Regulations
The Flavourings in Food (Wales) Regulations 2010 (S.I. 2010/2922 (W.243))	All provisions except regulations 1, 2 and 7.