
2022 No. 373
Agriculture
Food
The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022
Made 13th December 2022
Laid before the Scottish Parliament 15th December 2022
Coming into force 9th February 2023

The Scottish Ministers make these Regulations in exercise of the powers conferred by Articles 9(1), 13(6) and 18A(3) of Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition and paragraph 1(1) and (3) of schedule 2 and paragraph 21(b) of schedule 7 of the European Union (Withdrawal) Act 2018( and all other powers enabling them to do so.

There has been consultation as required by Article 9 of Regulation (EC) 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 safety.
PART 1 Introduction
Citation, commencement and extent
1 

(1) These Regulations may be cited as the Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 and come into force on 9 February 2023.
(2) These Regulations extend to Scotland only.
PART 2 Amendment of feed additives authorisations legislation
Amendment of Commission Implementing Regulation (EU) No. 787/2013
2 

(1) Commission Implementing Regulation (EU) No. 787/2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.) is amended in accordance with this regulation.
(2) In the Annex, in the table, in the column headed “Additive”, for “Bacillus velezensis” substitute “Bacillus velezensis”.
Amendment of Commission Implementing Regulation (EU) 2015/1020
3 

(1) Commission Implementing Regulation (EU) 2015/1020 concerning the authorisation of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying (holder of the authorisation Kemin Europa NV) is amended in accordance with this regulation.
(2) In the Annex, in the table, in the column headed “Additive”, for “Bacillus velezensis” substitute “Bacillus velezensis”.
Amendment of Commission Implementing Regulation (EU) 2017/2276
4 

(1) Commission Implementing Regulation (EU) 2017/2276 concerning the authorisation of a new use of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europa N.V.) is amended in accordance with this regulation.
(2) In the Annex, in the table, in the column headed “Composition, chemical formula, description, analytical method”, for “Bacillus velezensis” substitute “Bacillus velezensis”.
Amendment of the Feed Additives (Authorisations) (Scotland) Regulations 2022
5 

(1) The Feed Additives (Authorisations) (Scotland) Regulations 2022 are amended in accordance with this regulation.
(2) In regulation 8(3) (transitional provision: Saccharomyces cerevisiae (identification number 4b1702)) after ““the prior authorisation” means” insert “an authorisation contained in”.
(3) In regulation 9(5) (transitional: Bacillus velezensis (identification number 4b1823)) after ““the prior authorisation” means” insert “an authorisation contained in”.
(4) In regulation 10(2) (transitional: Decoquinate (Deccox®) (identification number 51756i (formerly E756))) after ““the prior authorisation” means” insert “an authorisation contained in”.
(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(12) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(14) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 Amendment of miscellaneous food and feed legislation
Amendment of the Animal Feed (Scotland) Regulations 2010
6 

(1) The Animal Feed (Scotland) Regulations 2010 are amended in accordance with this regulation.
(2) In regulation 2 (interpretation and scope)—
(a) in paragraph (1)—
(i) omit the definition of “Directive 82/475”,
(ii) omit the definition of “Directive 2002/32”,
(b) in paragraph (3) omit “Directive 82/475, Directive 2002/32,”.
(3) In regulation 4(2) (enforcement of requirements of Regulation 767/2009) for “the Annex to Directive 82/475” substitute “schedule 3”.
(4) In regulation 8 (interpretation of Part 4 of the Regulations) omit paragraph (a).
(5) In regulation 9 (control of animal feeds containing undesirable substances)—
(a) in paragraph (1)—
(i) in sub-paragraph (a) for “feed that is specified in column 2 of Annex I” substitute “products intended for animal feed that are specified in column 2 of a table in schedule 4”,
(ii) in the words after sub-paragraph (b), for “Annex” substitute “table”,
(b) in paragraph (2)—
(i) in sub-paragraph (a) for “Annex I” substitute “a table in schedule 4”,
(ii) in sub-paragraph (b) for “Annex” substitute “table”,
(c) in paragraph (3)—
(i) for “Annex I” substitute “a table in schedule 4”,
(ii) for “Annex”, in the second place it occurs, substitute “table”,
(d) in paragraph (5)—
(i) for “Annex I” substitute “a table in schedule 4”,
(ii) for “Annex”, in the second place it occurs, substitute “table”,
(e) in paragraph (7)—
(i) omit the “and” at the end of sub-paragraph (c),
(ii) after sub-paragraph (d) insert—“; and
(e) peat; leonardite”,
(f) after paragraph (8) insert—“
(9) In order to reduce or eliminate sources of undesirable substances in products intended for animal feed, the feed authority must, in cooperation with feed business operators, carry out investigations to identify the sources of undesirable substances, in cases where the maximum levels are exceeded and in cases where increased levels of such substances are detected, taking into account background levels; for the purpose of ensuring a uniform approach in cases of increased levels, action thresholds to trigger investigations are set out in table in schedule 5.”.
(6) Schedule 1 has effect.
Amendment of the Materials and Articles in Contact with Food (Scotland) Regulations 2012
7 

(1) The Materials and Articles in Contact with Food (Scotland) Regulations 2012 are amended in accordance with this regulation.
(2) In regulation 2 (interpretation)—
(a) in paragraph (1)—
(i) omit the definition of “Directive 84/500/EEC”,
(ii) omit the definition of “Directive 2007/42/EC”,
(b) in paragraph (3)—
(i) omit “or to any Annex to Directive 2007/42/EC”,
(ii) omit “or that Annex”.
(3) In regulation 11(interpretation of this part) omit paragraph (3).
(4) In regulation 12 (controls and limits)—
(a) in paragraph (1)—
(i) in both places where it occurs, for “Annex II” substitute “schedule 6”,
(ii) for “that Annex” substitute “that schedule”,
(b) in paragraph (2) for “Annex II” substitute “schedule 6”.
(5) Schedule 2 has effect.
Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013
8 

(1) The Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013 are amended in accordance with this regulation.
(2) In regulation 2 (interpretation)—
(a) in paragraph (1) omit the definition of “Directive 2009/32”,
(b) in paragraph (2) omit “EU”,
(c) in paragraph (3) omit “EU”,
(d) in paragraph (4) for “EU instruments are Directive 2009/32,” substitute “instruments are”,
(e) in paragraph (5) in the definition of “the EU Regulations” before “EU” insert “retained”.
(3) Omit regulation 7 (controls on extraction solvents).
(4) In regulation 8(a), for “Annex I” substitute “schedule 6”.
(5) In regulation 9(a)—
(a) in sub-paragraph (i), for “Annex I” substitute “schedule 6”,
(b) in sub-paragraph (ii), for “that Annex” substitute “schedule 6”,
(c) in sub-paragraph (iii), insert “and” at the end,
(d) in sub-paragraph (iv), omit “and” at the end,
(e) omit sub-paragraph (v).
(6) In regulation 12(1)(a), for “Annex I” substitute “schedule 6”.
(7) In regulation 14 (enforcement authorities), before “EU Regulations” insert “retained”.
(8) In regulation 17(2) (application of various provisions of the Food Safety Act 1990), before “EU Regulations” insert “retained”.
(9) Schedule 3 has effect.
Amendment of the Food Information (Scotland) Regulations 2014
9 

(1) The Food Information (Scotland) Regulations 2014 are amended in accordance with this regulation.
(2) In schedule 3 (specified provisions of FIC, Regulation 828/2014 and Regulation 2018/775), in the table in Part 1 (specified FIC provisions applying on and from 13th December 2014), omit—
(a) the entry relating to Article 17(2) (use of the name used for food in member State of production in another member State: need for other descriptive information in addition to the name of the food in certain cases),
(b) the entry relating to Article 17(3) (prohibition in certain exceptional cases of the use of a name used for a food in a member State of production when marketing that food in another member State).
MAREE TODD
Authorised to sign by the Scottish Ministers
St Andrew’s House,
Edinburgh
13th December 2022
SCHEDULE 1
Insertion of schedules 3, 4 and 5 of the Animal Feed (Scotland) Regulations 2010
Regulation 6(6)
1 
After schedule 2 (revocations) of the Animal Feed (Scotland) Regulations 2010 insert—“
SCHEDULE 3
Categories of feed materials which may be indicated in place of individual feed materials on the packaging, container or label of compound feedingstuffs for pet animals
Regulation 4(2)


Description of the category Definition
1. Meat and animal derivatives All the fleshy parts of slaughtered warm-blooded land animals, fresh or preserved by appropriate treatment, and all
 products
 and
 derivatives of the processing of the carcase or parts of the carcase of warm-blooded land animals

2. Milk and milk derivatives All milk products, fresh or preserved by appropriate treatment, and derivatives from their processing
3. Eggs and egg derivatives All egg products fresh or preserved by appropriate treatment and derivatives from their processing
4. Oils and fats All animal and vegetable oils and fats
5. Yeasts All yeasts, the cells of which have been killed and dried
6. Fish and fish derivatives Fish or parts of fish, fresh or preserved by appropriate treatment, and derivatives from their processing
7. Cereals All types of cereal, regardless of their presentation, or products made from the starchy endosperm
8. Vegetables All types of vegetables and legumes, fresh or preserved by appropriate treatment
9. Derivatives of vegetable origin Derivatives resulting from the treatment of vegetable products, in particular cereals, vegetables, legumes and oil seeds
10. Vegetable protein extracts All products of vegetable origin in which the proteins have been concentrated by an adequate process to contain at least 50% crude protein, as related to the dry matter, and which may be restructured (textured)
11. Minerals All inorganic substances suitable for animal feed
12. Various sugars All types of sugar
13. Fruit All types of fruit, fresh or preserved by appropriate treatment
14. Nuts All kernels from shells
15. Seeds All types of seeds as such or roughly crushed
16. Algae Algae, fresh or preserved by appropriate treatment
17. Molluscs and crustaceans All types of molluscs, crustaceans, shellfish, fresh or preserved by appropriate treatment, and their processing derivatives
18. Insects All types of insects and their stages of development
19. Bakery products All bread, cakes, biscuits and pasta products
SCHEDULE 4
Maximum levels of undesirable substances
Regulation 9


Table 1: INORGANIC CONTAMINANTS AND NITROGENOUS COMPOUNDS
Undesirable substance Products intended for animal feed Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
1. Arsenic
 Feed materials 2
 with the exception of: 
 — meal made from grass, from dried lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp, 4
 — palm kernel expeller, 4
 — peat; leonardite, 5
 — phosphates, calcareous marine algae, 10
 — calcium carbonate; calcium and magnesium carbonate
(2); calcareous marine shells,
 15
 — magnesium oxide; magnesium carbonate, 20
 — fish, other aquatic animals and products derived from them, 25
 — seaweed meal and feed materials derived from seaweed. 40
 Iron particles used as tracer. 50
 Feed additives belonging to the functional group of compounds of trace elements 30
 with the exception of: 
 — cupric sulphate pentahydrate; cupric carbonate; dicopper chloride trihydroxide; ferrous carbonate; dimanganese chloride trihydroxide, 50
 — zinc oxide; manganous oxide; cupric oxide. 100
 Complementary feed 4
 with the exception of: 
 — mineral feed, 12
 — complementary feed for pet animals containing fish, other aquatic animals and products derived from them and/or seaweed meal and feed materials derived from seaweed, 10
 — long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed, 30
 Complete feed 2
 with the exception of: 
 — complete feed for fish and fur animals, 10
 — complete feed for pet animals containing fish, other aquatic animals and products derived from them and/or seaweed meal and feed materials derived from seaweed. 10
2. Cadmium Feed materials of vegetable origin. 1
 Feed materials of animal origin. 2
 Feed materials of mineral origin 2
 with the exception of: 
 — phosphates. 10
 Feed additives belonging to the functional group of compounds of trace elements 10
 with the exception of: 
 — cupric oxide, manganous oxide, zinc oxide and manganous sulphate monohydrate. 30
 Feed additives belonging to the functional groups of binders and anti-caking agents. 2
 Premixtures. 15
 Complementary feed 0.5
 with the exception of: 
 — mineral feed 
 – – containing < 7% phosphorus 5
 – – containing ≥ 7% phosphorus 0.75 per 1% phosphorus
, with a maximum of 7.5
 — complementary feed for pet animals, 2
 — long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed. 15
 Complete feed 0.5
 with the exception of: 
 — complete feed for cattle (except calves), sheep (except lambs), goats (except kids) and fish, 1
 — complete feed for pet animals. 2
3. Fluorine
 Feed materials 150
 with the exception of: 
 — feed materials of animal origin except marine crustaceans such as marine krill; calcareous marine shells, 500
 — marine crustaceans such as marine krill, 3 000
 — phosphates, 2 000
 — calcium carbonate, calcium and magnesium carbonate, 350
 — magnesium oxide, 600
 — calcareous marine algae. 1 250
 Vermiculite (E 561). 3 000
 Complementary feed: 
 — containing ≤ 4% phosphorus, 500
 — containing > 4% phosphorus. 125 per 1% phosphorus
 Complete feed 150
 with the exception of: 
 — complete feed for pigs, 100
 — complete feed for poultry (except chicks) and fish, 350
 — complete feed for chicks, 250
 — complete feed for cattle, sheep and goats 
 – – in lactation, 30
 – – other. 50
4. Lead Feed materials 10
 with the exception of: 
 — forage, 30
 — phosphates, calcareous marine algae and calcareous marine shells, 15
 — calcium carbonate, calcium and magnesium carbonate, 20
 — yeasts. 5
 Feed additives belonging to the functional group of compounds of trace elements 100
 with the exception of: 
 — zinc oxide, 400
 — manganous oxide, ferrous carbonate, cupric carbonate, copper (I) oxide. 200
 Feed additives belonging to the functional groups of binders and anti-caking agents 30
 with the exception of: 
 — clinoptilolite of volcanic origin; natrolite-phonolite. 60
 Premixtures. 200
 Complementary feed 10
 with the exception of: 
 — mineral feed, 15
 — long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed. 60
 Complete feed. 5
5. Mercury Feed materials 0.1
 with the exception of: 
 — fish, other aquatic animals and products derived from them intended for the production of compound feed for food producing animals, 0.5
 — fish, other aquatic animals and products derived from them intended for the production of compound feed for dogs, cats, ornamental fish and fur animals, 1.0
 — fish, other aquatic animals and products derived from them as canned wet feed material for direct feeding of dogs and cats, 0.3
 — calcium carbonate, calcium and magnesium carbonate. 0.3
 Compound feed 0.1
 with the exception of: 
 — mineral feed, 0.2
 — compound feed for fish, 0.2
 — compound feed for dogs, cats, ornamental fish and fur animals. 0.3
6. Nitrite Feed materials 15
 with the exception of: 
 — fishmeal, 30
 — silage, —
 — products and by-products from sugar beet and sugarcane and from starch and alcoholic drink production. —
 Complete feed 15
 with the exception of: 
 — complete feed for dogs and cats with a moisture content exceeding 20%. —
7. Melamine Feed 2.5
 with the exception of: 
 — canned pet food, 2.5
 — the following feed additives: 
 — guanidino acetic acid (GAA), 20
 — urea, —
 — biuret. —













Table 2: MYCOTOXINS
Undesirable substance Products intended for animal feed Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
1. Aflatoxin B1 Feed materials 0.02
 Complementary and complete feed 0.01
 with the exception of: 
 — compound feed for dairy cattle and calves, dairy sheep and lambs, dairy goats and kids, piglets and young poultry animals, 0.005
 — compound feed for cattle (except dairy cattle and calves), sheep (except dairy sheep and lambs), goats (except dairy goats and kids), pigs (except piglets) and poultry (except young animals). 0.02
2. Rye ergot (Claviceps purpurea) Feed materials and compound feed containing unground cereals. 1 000

Table 3: INHERENT PLANT TOXINS
Undesirable substance Products intended for animal feed Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
1. Free gossypol Feed materials 20
 with the exception of: 
 — cottonseed, 6 000
 — cottonseed cakes and cottonseed meal. 1 200
 Complete feed 20
 with the exception of: 
 — complete feed for cattle (except calves), 500
 — complete feed for sheep (except lambs) and goats (except kids), 300
 — complete feed for poultry (except laying hens) and calves, 100
 — complete feed for rabbits, lambs, kids and pigs (except piglets). 60
2. Hydrocyanic acid Feed materials 50
 with the exception of: 
 — linseed, 250
 — linseed cakes, 350
 — manioc products and almond cakes. 100
 Complete feed 50
 with the exception of: 
 — complete feed for young chickens (< 6 weeks). 10
3. Theobromine Complete feed 300
 with the exception of: 
 — complete feed for pigs, 200
 — complete feed for dogs, rabbits, horses and fur animals. 50
4. vinyl thiooxazolidone (5-vinyloxazolidine-2-thione) Complete feed for poultry 1 000
 with the exception of: 
 — complete feed for laying hens. 500
5. Volatile mustard oil Feed materials 100
 with the exception of: 
 — Camelina seed and products derived from it, products derived from mustard seed, rape seed and products derived from them. 4 000
 Complete feed 150
 with the exception of: 
 — complete feed for cattle (except calves), sheep (except lambs) and goats (except kids), 1 000
 — complete feed for pigs (except piglets) and poultry. 500



Table 4: ORGANOCHLORINE COMPOUNDS (EXCEPT DIOXINS AND PCBs)
Undesirable substance Products intended for animal feed Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
1. Aldrin Feed materials and compound feed 0.01
 with the exception of: 
 — fats and oils, 0.1
 — compound feed for fish. 0.02
2. Dieldrin Feed materials and compound feed 0.01
 with the exception of: 
 — fats and oils, 0.1

 — compound feed for fish. 0.02

3. Camphechlor (toxaphene) – sum of indicator congeners CHB 26, 50 and 62 Fish, other aquatic animals and products derived from them 0.02
 with the exception of: 
 — fish oil. 0.2
 Complete feed for fish. 0.05
4. Chlordane (sum of cis- and trans-isomers and of oxychlordane, expressed as chlordane) Feed materials and compound feed 0.02
 with the exception of: 
 — fats and oils. 0.05
5. DDT (sum of DDT-, DDD- (or TDE-) and DDE-isomers, expressed as DDT) Feed materials and compound feed 0.05
 with the exception of: 
 — fats and oils. 0.5
6. Endosulfan (sum of alpha- and beta-isomers and of endosulfansulphate expressed as endosulfan) Feed materials and compound feed 0.1
 with the exception of: 
 — cotton seed and products derived from its processing, except crude cotton seed oil, 0.3
 — soybean and products derived from its processing, except crude soybean oil, 0.5
 — crude vegetable oil, 1.0
 — complete feed for fish except for Salmonids, 0.005
 — complete feed for Salmonids. 0.05
7. Endrin (sum of endrin and of delta-ketoi-endrin, expressed as endrin) Feed materials and compound feed 0.01
 with the exception of: 
 — fats and oils. 0.05
8. Heptachlor (sum of heptachlor and of heptachlorepoxide, expressed as heptachlor) Feed materials and compound feed 0.01
 with the exception of: 
 — fats and oils. 0.2
9. Hexachlorobenzene (HCB) Feed materials and compound feed 0.01
 with the exception of: 
 — fats and oils. 0.2
10. Hexachlorocyclo-hexane
 (HCH)  
— alpha-isomers Feed materials and compound feed 0.02
 with the exception of: 
 — fats and oils. 0.2
— beta-isomers Feed materials 0.01
 with the exception of: 
 — fats and oils. 0.1
 Compound feed 0.01
 with the exception of: 
 — compound feed for dairy cattle. 0.005
— gamma-isomers Feed materials and compound feed 0.2
 with the exception of: 
 — fats and oils. 2.0



CHB 26: 2-endo,3-exo,5-endo,6-exo,8,8,10,10-octochlorobornane,
CHB 50: 2-endo,3-exo,5-endo,6-exo,8,8,9,10,10-nonachlorobornane,
CHB 62: 2,2,5,5,8,9,9,10,10-nonachlorobornane.

Table 5 (Part 1): DIOXINS AND PCBs
Undesirable substance Products intended for animal feed Maximum content in ng WHO-PCDD/F-TEQ/kg (ppt) relative to a feed with a moisture content of 12%
1. Dioxins (sum of polychlorinated dibenzo-
para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)) Feed materials of plant origin 0.75
 with the exception of: 
 — vegetable oils and their by-products. 0.75
 Feed materials of mineral origin. 0.75
 Feed materials of animal origin: 
 — Animal fat, including milk fat and egg fat, 1.50
 — Other land animal products including milk and milk products and eggs and egg products, 0.75
 — Fish oil, 5.0
 — Fish, other aquatic animals, and products derived from them with the exception of fish oil, hydrolysed fish protein containing more than 20% fat
 and crustacea meal, 1.25
 — Hydrolysed fish protein containing more than 20% fat; crustacea meal. 1.75
 Feed additives belonging to the functional groups of binders and anti-caking agents. 0.75
 Feed additives belonging to the functional group of compounds of trace elements. 1.0
 Premixtures. 1.0
 Compound feed 0.75
 with the exception of: 
 — compound feed for pet animals and fish, 1.75
 — compound feed for fur animals. —
Undesirable substance Products intended for animal feed. Maximum content in ng WHO-PCDD/F-PCB-TEQ/kg (ppt) relative to a feed with a moisture content of 12%.
2. Sum of dioxins and dioxin-like PCBs (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors), 2005) Feed materials of plant origin 1.25
 with the exception of: 
 — vegetable oils and their by-products. 1.5
 Feed materials of mineral origin. 1.0
 Feed materials of animal origin: 
 — Animal fat, including milk fat and egg fat, 2.0
 — Other land animal products including milk and milk products and eggs and egg products, 1.25
 — Fish oil, 20.0
 — Fish, other aquatic animals, and products derived from them with the exception of fish oil and fish protein, hydrolysed, containing more than 20% fat, 4.0
 — Fish protein, hydrolysed, containing more than 20% fat. 9.0
 Feed additives belonging to the functional groups of binders and anti-caking agents.
 1.5
 Feed additives belonging to the functional group of compounds of trace elements. 1.5
 Premixtures. 1.5
 Compound feed 1.5
 with the exception of: 
 — compound feed for pet animals and fish, 5.5
 — compound feed for fur animals. —
Undesirable substance Products intended for animal feed. Maximum content in μg/kg (ppb) relative to a feed with a moisture content of 12%.
3. Non-dioxin-like PCBs (sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (ICES – 6)) Feed materials of plant origin. 10
 Feed materials of mineral origin. 10
 Feed materials of animal origin: 
 — Animal fat, including milk fat and egg fat, 10
 — Other land animal products including milk and milk products and eggs and egg products, 10
 — Fish oil, 175
 — Fish, other aquatic animals and products derived from them with the exception of fish oil and fish protein, hydrolysed, containing more than 20% fat, 30
 — Fish protein, hydrolysed, containing more than 20% fat. 50
 Feed additives belonging to the functional groups of binders and anti-caking agents. 10
 Feed additives belonging to the functional group of compounds of trace elements. 10
 Premixtures. 10
 Compound feed 10
 with the exception of: 
 — compound feed for pet animals and fish, 40
 — compound feed for fur animals. —






Table 5 (Part 2): Table of TEF (toxic equivalency factors) for dioxins, furans and dioxin-like PCBs
Congener TEF value
Dibenzo-para-dioxins (‘PCDDs’) and Dibenzo-para-furans (PCDFs) 
2,3,7,8-TCDD 1
1,2,3,7,8-PeCDD 1
1,2,3,4,7,8-HxCDD 0.1
1,2,3,6,7,8-HxCDD 0.1
1,2,3,7,8,9-HxCDD 0.1
1,2,3,4,6,7,8-HpCDD 0.01
OCDD 0.0003
2,3,7,8-TCDF 0.1
1,2,3,7,8-PeCDF 0.03
2,3,4,7,8-PeCDF 0.3
1,2,3,4,7,8-HxCDF 0.1
1,2,3,6,7,8-HxCDF 0.1
1,2,3,7,8,9-HxCDF 0.1
2,3,4,6,7,8-HxCDF 0.1
1,2,3,4,6,7,8-HpCDF 0.01
1,2,3,4,7,8,9-HpCDF 0.01
OCDF 0.0003
‘Dioxin-like’ PCBs: Non-ortho PCBs + Mono-ortho PCBs 
Non-ortho PCBs 
PCB 77 0.0001
PCB 81 0.0003
PCB 126 0.1
PCB 169 0.03
Mono-ortho PCBs 
PCB 105 0.00003
PCB 114 0.00003
PCB 118 0.00003
PCB 123 0.00003
PCB 156 0.00003
PCB 157 0.00003
PCB 167 0.00003
PCB 189 0.00003
Abbreviations used: ‘T’ = tetra; ‘Pe’ = penta; ‘Hx’ = hexa; ‘Hp’ = hepta; ‘O’ = octa; ‘CDD’ = chlorodibenzodioxin; ‘CDF’ = chlorodibenzofuran; ‘CB’ = chlorobiphenyl.

Table 6: HARMFUL BOTANICAL IMPURITIES
Undesirable substance Products intended for animal feed Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
1. Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including Feed materials and compound feed. 3 000
— Datura sp.  1 000
2. Crotalaria spp. Feed materials and compound feed. 100
3. Seeds and husks from 
Ricinus communis L., Croton tiglium L. and Abrus precatorius L. as well as their processed derivatives, separately or in combination
 Feed materials and compound feed. 10
4. Unhusked beech mast — Fagus sylvatica L. Feed materials and compound feed. Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable.
5. Purghera — Jatropha curcas L. Feed materials and compound feed. Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable.
6. Seeds from Ambrosia spp. Feed materials 50
 with the exception of: 
 – Millet (grains of Panicum miliaceum L.) and sorghum (grains of Sorghum bicolor (L) Moench s.l.) not directly fed to animals. 200
 Compound feed containing unground grains and seeds. 50
7. Seeds from— Indian mustard — 
Brassica juncea (L.) Czern. and Coss. ssp. integrifolia (West.) Thell.— Sareptian mustard — 
Brassica juncea (L.) Czern. and Coss. ssp. juncea— Chinese mustard — 
Brassica juncea (L.) Czern. and Coss. ssp. juncea var. lutea Batalin— Black mustard — 
Brassica nigra (L.) Koch— Ethiopian mustard — 
Brassica carinata A. Braun Feed materials and compound feed. Seeds may only be present in feed in trace amounts not quantitatively determinable.



—the consignment is transported as a whole to the milling or crushing plant, and the milling or crushing plant is informed in advance of the presence of high levels of Ambrosia spp. seeds in order to take additional prevention measures to avoid dissemination into the environment,
—solid evidence is provided that prevention measures are taken to avoid dissemination of Ambrosia spp. seeds into the environment during transport to the crushing or milling plant, and
—the competent authority agrees to the transport, after having ensured that the abovementioned conditions are fulfilled.
In case these conditions are not fulfilled, the consignment must be cleared before any transport into the country and the screenings must be appropriately destroyed.

Table 7: AUTHORISED FEED ADDITIVES IN NON-TARGET FEED FOLLOWING UNAVOIDABLE CARRY-OVER
Coccidiostat Products intended for animal feed Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
1. Decoquinate Feed materials. 0.4
 Compound feed for: 
 — laying birds and chickens reared for laying (> 16 weeks), 0.4
 — other animal species. 1.2
 Premixtures for use in feed in which the use of decoquinate is not authorised. 
2. Diclazuril Feed materials. 0.01
 Compound feed for: 
 — laying birds and chickens reared for laying (> 16 weeks), 0.01
 — rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed), 0.01
 — other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening, guinea fowl and turkeys for fattening. 0.03
 Premixtures for use in feed in which the use of diclazuril is not authorised. 
3. Halofuginone hydrobromide Feed materials. 0.03
 Compound feed for: 
 — laying birds, chickens reared for laying and turkeys (> 12 weeks), 0.03
 — chickens for fattening and turkeys (< 12 weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed), 0.03
 — other animal species. 0.09
 Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised. 
4. Lasalocid A sodium Feed materials. 1.25
 Compound feed for: 
 — dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 16 weeks) and chickens reared for laying (> 16 weeks), 1.25
 — chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed), 1.25
 — pheasants, guinea fowl, quails and partridges (except laying birds) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed), 1.25
 — other animal species. 3.75
 Premixtures for use in feed in which the use of lasalocid A sodium is not authorised. 
5. Maduramicin ammonium alpha Feed materials. 0.05
 Compound feed for: 
 — equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks), 0.05
 — chickens for fattening and turkeys (< 16 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed), 0.05
 — other animal species. 0.15
 Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised. 
6. Monensin sodium Feed materials. 1.25
 Compound feed for: 
 — equine species, dogs, small ruminants (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 16 weeks), 1.25
 — chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (withdrawal feed), 1.25
 — other animal species. 3.75
 Premixtures for use in feed in which the use of monensin sodium is not authorised. 
7. Narasin Feed materials. 0.7
 Compound feed for: 
 — turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks), 0.7
 — other animal species. 2.1
 Premixtures for use in feed in which the use of narasin is not authorised. 
8. Nicarbazin Feed materials. 1.25
 Compound feed for: 
 — equine species, laying birds and chickens reared for laying (> 16 weeks), 1.25
 — other animal species. 3.75
 Premixtures for use in feed in which the use of nicarbazin (alone or in combination with narasin) is not authorised. 
9. Robenidine hydrochloride Feed materials. 0.7
 Compound feed for: 
 — laying birds and chickens reared for laying (> 16 weeks), 0.7
 — chickens for fattening, rabbits for fattening and breeding and turkeys for the period before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed), 0.7
 — other animal species. 2.1
 Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised. 
10. Salinomycin sodium Feed materials. 0.7
 Compound feed for: 
 — equine species, turkeys, laying birds and chickens reared for laying (> 12 weeks), 0.7
 — chickens for fattening, chickens reared for laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed), 0.7
 — other animal species. 2.1
 Premixtures for use in feed in which the use of salinomycin sodium is not authorised. 
11. Semduramicin sodium Feed materials. 0.25
 Compound feed for: 
 — laying birds and chickens reared for laying (> 16 weeks), 0.25
 — chickens for fattening for the period before slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed), 0.25
 — other animal species. 0.75
 Premixtures for use in feed in which the use of semduramicin sodium is not authorised. 


SCHEDULE 5
Action thresholds triggering investigations: dioxins and PCBs
Regulation 9(9)


Table 1: DIOXINS AND PCBS
Undesirable substances Products intended for animal feed Action threshold in ng WHO-PCDD/F TEQ/kg (ppt) relative to a feedingstuff with a moisture content of 12% Comments and additional information (e.g. nature of investigations to be performed)
1. Dioxins (sum of polychlorinated dibenzo-
para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)) Feed materials of plant origin 0.5 
 with the exception of:  
 — vegetable oils and their by-products. 0.5 
 Feed materials of mineral origin. 0.5 
 Feed materials of animal origin:  
 — Animal fat, including milk fat and egg fat, 0.75 
 — Other land animal products including milk and milk products and eggs and egg products, 0.5 
 — Fish oil, 4.0 
 — Fish, other aquatic animals and products derived from them, with the exception of fish oil, hydrolysed fish protein containing more than 20% fat and crustacea meal, 0.75 
 — Hydrolysed fish protein containing more than 20% fat, crustacea meal. 1.25 
 Feed additives belonging to the functional groups of binders and anti-caking agents. 0.5 
 Feed additives belonging to the functional group of compounds of trace elements. 0.5 
 Premixtures. 0.5 
 Compound feed 0.5 
 with the exception of:  
 — compound feed for pet animals and fish, 1.25 
 — compound feed for fur animals. — 
2. Dioxin-like PCBs (sum of polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)) Feed materials of plant origin 0.35 
 with the exception of:  
 — vegetable oils and their by-products. 0.5 
 Feed materials of mineral origin. 0.35 
 Feed materials of animal origin:  
 — Animal fat, including milk fat and egg fat, 0.75 
 — Other land animal products including milk and milk products and eggs and egg products, 0.35 
 — Fish oil, 11.0 
 — Fish, other aquatic animals and products derived from them, with the exception of fish oil and fish protein, hydrolysed, containing more than 20% fat, 2.0 
 — Fish protein, hydrolysed, containing more than 20% fat. 5.0 
 Feed additives belonging to the functional groups of binders and anti-caking agents. 0.5 
 Feed additives belonging to the functional group of compounds of trace elements. 0.35 
 Premixtures. 0.35 
 Compound feed 0.5 
 with the exception of:  
 — compound feed for pet animals and fish, 2.5 
 — compound feed for fur animals. — 





Table 2: Table of TEF (toxic equivalency factors) for dioxins, furans and dioxin-like PCBs
Congener TEF value
Dibenzo-para-dioxins (‘PCDDs’) and Dibenzo-para-furans (PCDFs) 
2,3,7,8-TCDD 1
1,2,3,7,8-PeCDD 1
1,2,3,4,7,8-HxCDD 0.1
1,2,3,6,7,8-HxCDD 0.1
1,2,3,7,8,9-HxCDD 0.1
1,2,3,4,6,7,8-HpCDD 0.01
OCDD 0.0003
2,3,7,8-TCDF 0.1
1,2,3,7,8-PeCDF 0.03
2,3,4,7,8-PeCDF 0.3
1,2,3,4,7,8-HxCDF 0.1
1,2,3,6,7,8-HxCDF 0.1
1,2,3,7,8,9-HxCDF 0.1
2,3,4,6,7,8-HxCDF 0.1
1,2,3,4,6,7,8-HpCDF 0.01
1,2,3,4,7,8,9-HpCDF 0.01
OCDF 0.0003
‘Dioxin-like’ PCBs: Non-ortho PCBs + Mono-ortho PCBs 
Non-ortho PCBs 
PCB 77 0.0001
PCB 81 0.0003
PCB 126 0.1
PCB 169 0.03
Mono-ortho PCBs 
PCB 105 0.00003
PCB 114 0.00003
PCB 118 0.00003
PCB 123 0.00003
PCB 156 0.00003
PCB 157 0.00003
PCB 167 0.00003
PCB 189 0.00003
Abbreviations used: ‘T’ = tetra; ‘Pe’ = penta; ‘Hx’ = hexa; ‘Hp’ = hepta; ‘O’ = octa; ‘CDD’ = chlorodibenzodioxin; ‘CDF’ = chlorodibenzofuran; ‘CB’ = chlorobiphenyl.”.
SCHEDULE 2
Insertion of schedule 6 of the Materials and Articles in Contact with Food (Scotland) Regulations 2012
Regulation 7(5)
1 
After schedule 5 of the Materials and Articles in Contact with Food (Scotland) Regulations 2012 insert—“
SCHEDULE 6
LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM
Regulation 12(1)
1. 
In this schedule “regenerated cellulose film” means a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.
2. 
Notes——The percentages in this schedule, in the first and second parts, are expressed in weight/weight (w/w) and are calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film.—The usual technical denominations are given in square brackets.—The substances used shall be of good technical quality as regards the purity criteria.

First Part: Uncoated regenerated cellulose film
Denominations Restrictions
A. Regenerated cellulose Not less than 72% (w/w).
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:
(a) polyamide-epichlorhydrin resin based on diaminopropylmethylamine and epichlorhydrin,
(b) polyamide-epichlorhydrin resin based on epichlorhydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine,
(c) polyamide-epichlorhydrin resin based on adipic acid, diethylenetriamine and epichlorhydrin, or a mixture of epichlorhydrin and ammonia,
(d) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, dimethyl adipate and diethylenetriamine,
(e) 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 

Second Part: Coated regenerated cellulose film
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:
(a) 2.4 mg/kg of the foodstuff in contact with this type of film, or
(b) 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
Regulation 8(9)
1 
After schedule 5 the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013 insert—“
SCHEDULE 6
Extraction solvents which may be used during the processing of raw materials, of foodstuffs, of food components or of food ingredients
Regulation 8(a)


Table 2: Extraction solvents to be used in compliance with good manufacturing practice for all uses
Name
Propane
Butane
Ethyl acetate
Ethanol
Carbon dioxide
Acetone
Nitrous Oxide



Table 3: 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
Hexane 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 1mg/kg in the sugar
Ethylmethylketone 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
 0.009 mg/kg in the defatted animal protein products including gelatine
Preparation of collagen and collagen derivatives, except gelatine 3 mg/kg in the collagen and collagen derivatives, except gelatine





Table 4: 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
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.”.