Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance

OJ L 302, 19.11.2005, p. 28.

OJ L 330, 5.12.1998, p. 32.

OJ L 253, 20.9.2008, p. 1.

Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

OJ L 158, 18.6.2008, p. 17.

OJ L 83, 22.3.2012, p. 1.

Infant, infant formula and follow-on formula as defined in Article 2(2) of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

2. Group restriction of substances

Table 2 on Group restrictions contains the following information:

Column 1 (Group restriction No): contains the identification number of the group of substances for which the group restriction applies. It is the number referred to in Column 9 in Table 1 of this Annex.

Column 2 (FCM substance No): contains the unique identification numbers of the substances for which the group restriction applies. It is the number referred to in Column 1 in Table 1 of this Annex.

Column 3 (SML (T) [mg/kg]): contains the total specific migration limit for the sum of substances applicable to this group. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate in detectable quantities.

Column 4 (Group restriction specification): contains an indication of the substance whose molecular weight forms the basis for expression of the result.

Table 2

(1)	(2)	(3)	(4)
Group Restriction No	FCM substance No	SML (T) [mg/kg]	Group restriction specification
1	128 211	6	expressed as acetaldehyde
2	89 227 263 1048	30	expressed as ethyleneglycol
3	234 248	30	expressed as maleic acid
4	212 435	15	expressed as caprolactam
5	137 472	3	expressed as the sum of the substances
6	412 512 513 588	1	expressed as iodine
7	19 20 1081	1,2	expressed as tertiary amine
8	317 318 319 359 431 464	6	expressed as the sum of the substances
9	650 695 697 698 726	0,18	expressed as tin
10	28 29 30 31 32 33 466 582 618 619 620 646 676 736	0,006	expressed as tin
11	66 645 657	1,2	expressed as tin
12	444 469 470	30	expressed as the sum of the substances
13	163 285	1,5	expressed as the sum of the substances
14	294	5	expressed as the sum of the substances and their oxidation products
14	368	5	expressed as the sum of the substances and their oxidation products
14	894	5	expressed as the sum of the substances and their oxidation products
14
15	98 196 344	5	expressed as the sum of the substances and their oxidation products	15	expressed as formaldehyde
16	407 583 584 599	6	expressed as boron Without prejudice to the provisions of Directive 98/83/EC
17	4 167 169 198 274 354 372 460 461 475 476 485 490 653	ND	expressed as isocyanate moiety
18	705 733	0,05	expressed as the sum of the substances
19	505 516 519	10	expressed as SO2
20	290 386 390	30	expressed as the sum of the substances
21	347 349	5	expressed as trimellitic acid
22	70 147 176 218 323 325 365 371 380 425 446 448 456 636	6	expressed as acrylic acid
23	150 156 181 183 184 355 370 374 439 440 447 457 482	6	expressed as methacrylic acid
24	756 758	5	expressed as the sum of the substances
25	720 747	0,05	sum of mono-n-dodecyltin tris(isooctylmercaptoacetate), di-n-dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride
26	728 729	1,8	expressed as the sum of the substances
27	188 291	5	expressed as isophthalic acid
28	191 192 785	7,5	expressed as terephthalic acid
29	342 672	0,05	expressed as the sum of 6-hydroxyhexanoic acid and caprolactone
30	254 344 672	5	expressed as 1,4-butanediol
31	73 797	30	expressed as the sum of the substances
32	8 72 73 138 140 157 159 207 242 283 532 670 728 729 775 783 797 798 810 815 1078 1085*	60	expressed as the sum of the substances (plasticisers) *  Diisobutyl phthalate, FCM No 1085, with synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or ‘DIBP’ and CAS number 84-69-5 is not listed as an authorised substance in Table 1. However, it may co-occur with other phthalates as a consequence of its use as an aid to polymerisation and is included in group restrictions with the assignment FCM No 1085.
33	180 874	ND	expressed as eugenol
34	421 988	0,05	Expressed as 1,3-benzenedimethanamine
35	467 744 1059	0,05	expressed as crotonic acid
36	157 159 283 1085*	0,6	sum of phthalic acid, dibutyl ester (DBP), diisobutyl phthalate (DIBP), phthalic acid, benzyl butyl ester (BBP) and phthalic acid, bis(2-ethylhexyl) ester (DEHP) expressed as DEHP equivalents using the following equation: DBP5 + DIBP4 + BBP0,1 + DEHP1. *  See remark on FCM No 1085 in row 32
37	793 1080	0,05	expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine
38	822 1080	0,002	expressed as perchlorate – note 4 of table 3 applies

3. Notes on verification of compliance

Table 3 on notes on verification of compliance contains the following information:

Column 1 (Note No): contains the identification number of the Note. It is the number referred to in Column 11 in Table 1 of this Annex.

Column 2 (Notes on verification of compliance): contains rules that shall be respected when testing for compliance of the substance with specific migration limits or other restrictions or it contains remarks on situations where there is a risk of non-compliance.

Table 3

(1)	(2)
Note No	Notes on verification of compliance
(1)	Verification of compliance by residual content per food contact surface area (QMA) pending the availability of an analytical method.
(2)	There is a risk that the SML or OML could be exceeded in fatty food simulants.
(3)	There is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the final product does not comply with Article 3(1) c of the Framework Regulation (EC) No 1935/2004.
(4)	Compliance testing when there is a fat contact  shall be performed using saturated fatty food simulants as simulant D2.
(5)	Compliance testing when there is a fat contact  shall be performed using isooctane as substitute of simulant D2 (unstable).
(6)	Migration limit might be exceeded at very high temperature.
(7)	If testing in food is performed, Annex V 1.4 shall be taken into account.
(8)	Verification of compliance by residual content per food contact surface area (QMA); QMA = 0,005 mg/6 dm2.
(9)	Verification of compliance by residual content per food contact surface area (QMA) pending the availability of analytical method for migration testing. The ratio surface to quantity of food shall be lower than 2dm2/kg.
(10)	Verification of compliance by residual content per food contact surface area (QMA) in case of reaction with food or simulant.
(11)	Only a method of analysis for the determination of the residual monomer in the treated filler is available.
(12)	There is a risk that the SML could be exceeded from polyolefins.
(13)	Only a method for determination of the content in polymer and a method for determination of the starting substances in food simulants are available.
(14)	There is a risk that the SML could be exceeded from plastics containing more than 0,5 % w/w of the substance.
(15)	There is a risk that the SML could be exceeded in contact with foods with high alcoholic content.
(16)	There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) containing more than 0,3 % w/w of the substance when in contact with fatty foods
(17)	Only a method for determination of the residual content of the substance in the polymer is available
(18)	There is a risk that the SML could be exceeded from low-density polyethylene (LDPE)
(19)	There is a risk that the OML could be exceeded in direct contact with aqueous foods from ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers
(20)	The substance contains aniline as an impurity; verification of compliance with the restriction set for primary aromatic amines in Annex II (2) is necessary
(21)	In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.
(22)	When used in contact with non-alcoholic foods for which Table 2 of Annex III assigns food simulant D1, food simulant C shall be used for verification of compliance instead of food simulant D1.
(23)	When a final material or article containing this substance is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.
(24)	The substance or its hydrolysis products are authorised food additives and compliance with Article 11(3) shall be verified.
(25)	When used as reheat agent in polyethylene terephthalate (PET) verification of compliance with the specific migration limit is not required; in all other cases compliance with the specific migration limit shall be verified in accordance with Article 18; the specific migration limit is expressed as mg tungsten/kg food.
(26)	Migration of stearamide, listed in Table 1 under FCM substance No 306 to which no specific migration limit applies, shall be excluded from verification of the compliance of the migration of the mixture with the specific migration limit laid down for the mixture.
(27)	When a final material or article containing this substance and produced under conditions other than those described in point (a) column 10 of Table 1 is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in point (b) column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.
(28)	A detection limit of 0,002 mg/kg food or food simulant applies
(29)	In polar polymers which swell in contact with foods for which simulant B is assigned in Annex III, there is a risk that under severe contact conditions the migration limits for aluminium and fluoride are exceeded. Under contact conditions above 4 hours at 100 °C this exceedance can be high.
(30)	There is a risk that migration limits may be exceeded; migration increases with the thickness of the plastic in which the substance is contained, and with a decreasing polarity of the polymer and a decreasing degree of esterification of the substance itself.
(31)	Water shall be used for verification of compliance instead of food simulants listed in Table 1 of Annex III.

4. Detailed specification on substances

Table 4 on detailed specifications on substances contains the following information

Column 1 (FCM substance No): contains the unique identification number of the substances referred to in Column 1 in Table 1 of Annex I to which the specification applies.

Column 2 (Detailed specification on the substance): contains the specification on the substance.

Table 4

(1)	(2)	(2)
FCM substance No	Detailed specification on the substance	Detailed specification on the substance
744	Definition	The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wildtype organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster/working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications
	Chemical name	Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
	CAS number	0080181-31-3
	Structural formula	Image omitted; see official source where n/(m + n) greater than 0 and less or equal to 0,25
	Average molecular weight	Not less than 150 000 Daltons (measured by gel permeation chromatography)
	Assay	Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-hydoxy-pentanoate) analysed after hydrolysis as a mixture of 3-D-hydro-xybutanoic and 3-D-hydroxypentanoic acids
	Description	White to off-white powder after isolation
	Characteristics
	Identification tests:
	Solubility	Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water
	Restriction	Specific migration limit for crotonic acid is 0,05 mg/kg food
	Purity	Prior to granulation the raw material copolymer powder must contain:
	— nitrogen,	Not more than 2 500  mg/kg of plastic
	— zinc,	Not more than 100 mg/kg of plastic
	— copper,	Not more than 5 mg/kg of plastic
	— lead,	Not more than 2 mg/kg of plastic
	— arsenic,	Not more than 1 mg/kg of plastic
	— chromium,	Not more than 1 mg/kg of plastic

ANNEX II

Restrictions on plastic materials and articles

The following restrictions on plastic materials and articles apply:

• 1. Plastic materials and articles shall not release the substances in Table 1 below in quantities exceeding the specific migration limits expressed in mg/kg food or simulant specified in column (3), and subject to the remarks in Column (4). Substances listed in Table 1 shall only be used in accordance with the compositional requirements set out in Chapter II. If Chapter II does not provide a basis for the authorised use of such a substance, that substance may only be present as an impurity subject to the restrictions specified in Table 1. Table 1 General list of migration limits for substances migrating from plastic materials and articles (1) (2) (3) (4) Name Salts allowed in accordance with Article 6(3)(a) SML [mg/kg food or food simulant] Remark Aluminium yes 1 Ammonium yes - (1) Antimony no 0,04 (2) Arsenic no ND Barium yes 1 Cadmium no ND (LOD 0,002) Calcium yes - (1) Chromium no ND (3) Cobalt yes 0,05 Copper yes 5 Europium yes 0,05 (4) Gadolinium yes 0,05 (4) Iron yes 48 Lanthanum yes 0,05 (4) Lead no ND Lithium yes 0,6 Magnesium yes - (1) Manganese yes 0,6 Mercury no ND Nickel no 0,02 Potassium yes - (1) Sodium yes - (1) Terbium yes 0,05 (4) Zinc yes 5 ND:  Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4); LOD: specified Limit of Detection. Remarks (1) The migration is subject to Article 11(3) and Article 12 (2) The note in Annex I, Table 1, FCM No 398 applies: SML might be exceeded at very high temperature (3) To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply. (4) The lanthanide substances europium, gadolinium, lanthanum, and/or terbium can be used in accordance with Article 6(3)(a) provided that: (a) The sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg; and (b) analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16.

• 1. Primary aromatic amines (‘PAAs’) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council ([^E0021]) and for which no migration limit is specified in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant. They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine (‘PAA’), in accordance with Article 11(4). For PAAs not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006, but for which no specific migration limit is specified in Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19. The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant.

ANNEX III

Food simulants

1. Food simulants

For demonstration of compliance for plastic materials and articles not yet in contact with food the food simulants listed in Table 1 below are assigned.

Table 1

List of food simulants

Food simulant	Abbreviation
Ethanol 10 % (v/v)	Food simulant A
Acetic acid 3 % (w/v)	Food simulant B
Ethanol 20 % (v/v)	Food simulant C
Ethanol 50 % (v/v)	Food simulant D1
Any vegetable oil containing less than 1 % unsaponifiable matter	Food simulant D2
poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm	Food simulant E

2. General assignment of food simulants to foods

Food simulants A, B and C are assigned for foods that have a hydrophilic character and are able to extract hydrophilic substances. Food simulant B shall be used for those foods which have a pH below 4.5. Food simulant C shall be used for alcoholic foods with an alcohol content of up to 20 % and those foods which contain a relevant amount of organic ingredients that render the food more lipophilic.

Food simulants D1 and D2 are assigned for foods that have a lipophilic character and are able to extract lipophilic substances. Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions. Food simulant D2 shall be used for foods which contain free fats at the surface.

Food simulant E is assigned for testing specific migration into dry foods.

3. Specific assignment of food simulants to foods for migration testing of materials and articles not yet in contact with food

For testing migration from materials and articles not yet in contact with food the food simulants that corresponds to a certain food category shall be chosen according to Table 2 below.

For testing migration from materials and articles intended to come into contact with foods not listed in Table 2 below, or a combination of foods, the general food simulant assignments in point 2 shall be used for specific migration testing, and for overall migration testing the food simulant assignments in point 4 shall be applicable.

Table 2 contains the following information:

• — Column 1 (Reference number): contains the reference number of the food category

• — Column 2 (Description of food): contains a description of the foods covered by the food category

• — Column 3 (Food simulants): contains sub-columns for each of the food simulants

The food simulant for which a cross is contained in the respective sub-column of column 3 shall be used when testing migration of materials and articles not yet in contact with food.

For food categories where in sub-column D2 or E the cross is followed by an oblique stroke and a figure, the migration test result shall be corrected by dividing the result by this figure. The corrected test result shall then be compared to the migration limit to establish compliance. The test results for substances that shall not migrate in detectable quantities shall not be corrected in this way.

For food category 01.04 food simulant D2 shall be replaced by 95 % ethanol.

For food categories where in sub-column B the cross is followed by (*) the testing in food simulant B can be omitted if the food has a pH of more than 4,5.

For food categories where in sub-column D2 the cross is followed by (**) the testing in food simulant D2 can be omitted if it can be demonstrated that there is no ‘fatty contact’ with the plastic food contact material.

Table 2

food category specific assignment of food simulants

(1)	(2)	(3)	(3)	(3)	(3)	(3)	(3)
Reference number	Description of food	Food simulants	Food simulants	Food simulants	Food simulants	Food simulants	Food simulants
Reference number	Description of food	A	B	C	D1	D2	E
01	Beverages
01.01	Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than or equal to 6 % vol.:
	A. Clear drinks: Water, ciders, clear fruit or vegetable juices of normal strength or concentrated, fruit nectars, lemonades, syrups, bitters, infusions, coffee, tea, beers, soft drinks, energy drinks and the like, flavoured water, liquid coffee extract		X(*)	X
	B. cloudy drinks: juices and nectars and soft drinks containing fruit pulp, musts containing fruit pulp, liquid chocolate		X(*)		X
01.02	Alcoholic beverages of an alcoholic strength of between 6 %vol and 20 %.			X
01.03	Alcoholic beverages of an alcoholic strength above 20 % and all cream liquors				X
01.04	Miscellaneous: undenaturated ethyl alcohol		X(*)			Substitute 95 % ethanol
02	Cereals, cereal products, pastry, biscuits, cakes and other bakers’ wares
02.01	Starches						X
02.02	Cereals, unprocessed, puffed, in flakes (including popcorn, corn flakes and the like)						X
02.03	Cereal flour and meal						X
02.04	Dry pasta e.g. macaroni, spaghetti and similar products and fresh pasta						X
02.05	Pastry, biscuits, cakes, bread, and other bakers’ wares, dry:
	A. With fatty substances on the surface					X/3
	B. Other						X
02.06	Pastry, cakes, bread, dough and other bakers’ wares, fresh:
	A. With fatty substances on the surface					X/3
	B. Other						X
03	Chocolate, sugar and products thereof Confectionery products
03.01	Chocolate, chocolate-coated products, substitutes and products coated with substitutes					X/3
03.02	Confectionery products:
	A. In solid form:
	I. With fatty substances on the surface					X/3
	II.  Other						X
	B. In paste form:
	I. With fatty substances on the surface					X/2
	II.  Moist			X
03.03	Sugar and sugar products
	A. In solid form: crystal or powder						X
	B. Molasses, sugar syrups, honey and the like	X
04	Fruit, vegetables and products thereof
04.01	Fruit, fresh or chilled:
04.01	A. unpeeled and uncut						X/10
04.01	B. peeled and/or cut	X	X (*)
04.01
04.02	Processed fruit:
	A. Dried or dehydrated fruits, whole, sliced, flour or powder						X
	B. Fruit in the form of purée, preserves, pastes or in its own juice or in sugar syrup (jams, compote, and similar products)		X(*)	X
	C. Fruit preserved in a liquid medium:
	I. In an oily medium					X
	II.  In an alcoholic medium				X
04.03	Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others):
	A. Shelled, dried, flaked or powdered						X
	B. Shelled and roasted						X
	C. In paste or cream form	X				X
04.04	Vegetables, fresh or chilled:
	A. unpeeled and uncut						X/10
	B. peeled and/or cut	X	X (*)
04.05	Processed vegetables: A. Dried or dehydrated vegetables whole, sliced or in the form of flour or powder.						X
04.05	B. (obsolete)
04.05	C. Vegetables in the form of purée, preserves, pastes or in its own juice (including pickled and in brine).		X (*)	X
04.05	D. Preserved vegetables:
04.05	I. In an oily medium	X				X
04.05	II.  In an alcoholic medium				X
04.05
05	Fats and oils
05.01	Animals and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter)					X
05.02	Margarine, butter and other fats and oils made from water emulsions in oil					X/2
06	Animal products and eggs
06.01	Fish:
	A. Fresh, chilled, processed, salted or smoked including fish eggs	X				X/3(**)
	B. Preserved fish:
	I. In an oily medium	X				X
	II.  In an aqueous medium		X(*)	X
06.02	Crustaceans and molluscs (including oysters, mussels, snails)
	A. Fresh within the shell
	B. Shell removed, processed, preserved or cooked with the shell
	I. In an oily medium	X				X
	II.  In an aqueous medium		X(*)	X
06.03	Meat of all zoological species (including poultry and game):
	A. Fresh, chilled, salted, smoked	X				X/4(**)
	B. Processed meat products (such as ham, salami, bacon, sausages, and other) or in the form of paste, creams	X				X/4(**)
	C. Marinated meat products in an oily medium	X				X
06.04	Preserved meat:
	A. In an fatty or oily medium	X				X/3
	B. In an aqueous medium		X(*)		X
06.05	Whole eggs, egg yolk, egg white
	A. Powdered or dried or frozen						X
	B. Liquid and cooked				X
07	Milk products
07.01	Milk
	A. Milk and milk based drinks whole, partly dried and skimmed or partly skimmed				X
	B. Milk powder including infant formula (based on whole milk powder)						X
07.02	Fermented milk such as yoghurt, buttermilk and similar products		X(*)		X
07.03	Cream and sour cream		X(*)		X
07.04	Cheeses:
	A. Whole cheese with inedible rind						X
	B. Unripened soft cheese (fresh cheese), e.g. cottage cheese, quark, ricotta, cream cheese, fromage frais, and similar cheeses		X (*)		X
	C. Sliced ripened soft, firm or hard cheese or whole with edible rind, e.g. gouda, cheddar, gruyère, parmesan, stilton, tallegio, beaufort, tomino, brie, camembert, and similar cheeses					X/3
	D. Processed cheese, e.g. wedges, spreads and slices					X/3
	E. Brined or fresh cheese in a liquid medium e.g. feta and mozzarella:
	I. in an oily medium					X
	II. in an aqueous medium		X (*)		X
08	Miscellaneous products
08.01	Vinegar		X
08.02	Fried or roasted foods:
	A. Fried potatoes, fritters and the like	X				X/5
	B. Of animal origin	X				X/4
08.03	Preparations for soups, broths, sauces, in liquid, solid or powder form (extracts, concentrates); homogenised composite food preparations, prepared dishes including yeast and raising agents
	A. Powdered or dried:
	I. With fatty character					X/5
	II.  Other						X
	B. any other form than powdered or dried:
	I. With fatty character	X	X(*)			X/3
	II.  Other		X(*)	X
08.04	Sauces:
	A. With aqueous character		X(*)	X
	B. With fatty character e.g. mayonnaise, sauces derived from mayonnaise, salad creams and other oil/water mixtures e.g. coconut based sauces	X	X(*)			X
08.05	Mustard (except powdered mustard under heading 08.14)	X	X(*)			X/3(**)
08.06	Sandwiches, toasted bread pizza and the like containing any kind of foodstuff
	A. With fatty substances on the surface	X				X/5
	B. Other						X
08.07	Ice-creams			X
08.08	Dried foods:
	A. With fatty substances on the surface					X/5
	B. Other						X
08.09	Frozen or deep-frozen foods						X
08.10	Concentrated extracts of an alcoholic strength equal to or exceeding 6 % vol.		X(*)		X
08.11	Cocoa:
	A. Cocoa powder, including fat-reduced and highly fat reduced						X
	B. Cocoa paste					X/3
08.12	Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered						X
08.13	Aromatic herbs and other herbs such as camomile, mallow, mint, tea, lime blossom and others						X
08.14	Spices and seasonings in the natural state such as cinnamon, cloves, powdered mustard, pepper, vanilla, saffron, salt and other						X
08.15	Spices and seasoning in oily medium such as pesto, curry paste					X

4. Food simulant assignment for testing overall migration

For tests to demonstrate compliance with the overall migration limit food simulants shall be chosen as set out in Table 3:

Table 3

Food simulant assignment for demonstrating compliance with the overall migration limit

Foods covered	Food simulants in which testing shall be performed
all types of food	1. distilled water or water of equivalent quality or food simulant A; 2. food simulant B; and 3. food simulant D2.
all types of food except for acidic foods	1. distilled water or water of equivalent quality or food simulant A; and 2. food simulant D2.
all aqueous and alcoholic foods and milk products with a pH ≥ 4,5	food simulant D1
all aqueous and alcoholic foods and milk products with a pH < 4,5	food simulant D1 and food simulant B
all aqueous foods and alcoholic foods up to an alcohol content of 20 %	food simulant C
all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 %	1. food simulant C; and 2. food simulant B.

5. General derogation to the assignment of food simulants

By derogation from the assignments of food simulants in points 2 to 4 of this Annex, where testing with several food simulants is required, a single food simulant shall be sufficient if on the basis of evidence acquired using generally recognised scientific methods this food simulant is shown to be the most severe food simulant for the particular material or article being tested under the applicable time and temperature conditions selected in accordance with Chapters 2 and 3 of Annex V.

The scientific basis on which this derogation is used shall in such cases form part of the documentation required under Article 16 of this Regulation.

ANNEX IV

Declaration of compliance

The written declaration referred to in Article 15 shall contain the following information:

• (1) the identity and address of the business operator issuing the declaration of compliance;

• (2) the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles;

• (3) the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the manufacturing of those materials and articles;

• (4) the date of the declaration;

• (5) confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet the relevant requirements laid down in this Regulation and in Article 3, 11(5), 15 and 17 of Regulation (EC) No 1935/2004;

• (6) adequate information allowing the downstream business operators to ensure compliance with this Regulation relative to the substances used for which restrictions and/or specifications are set out in Annexes I and II, including adequate information on the presence of non-intentionally added substances if present in an amount that could cause non-compliance of a final material with Article 3 of Regulation (EC) No 1935/2004. At intermediate stages, this information shall include the identification and amount of the following substances contained in the intermediate material:
• — substances that are subject to restrictions and/or specifications in Annex II, or
• — substances for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to an individual migration into food from the final plastic material or article exceeding 0,00015 mg/kg food;

• (7) adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;

• (8) specifications on the use of the material or article, such as:
• (i) type or types of food with which it is intended to be put in contact;
• (ii) time and temperature of treatment and storage in contact with the food;
• (iii) the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Article 17 and 18 or equivalent information;

• (9) when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation;

• (10) when the plastic material is a batch of material intended for reprocessing:
• (a) the confirmation that it complies with Articles 10(1) and 10(2) of this Regulation and that it has been collected and used in accordance with point C of the Annex to Regulation (EC) No 2023/2006; and
• (b) as appropriate, a specification of its composition and instructions for reprocessing;

• (11) when the plastic material has been manufactured with one or more substances included in the Union list of authorised substances in accordance with Article 5 of this Regulation that have been manufactured from waste, a confirmation that the substances used are compliant with point (1) of Article 8 of this Regulation.

ANNEX V

COMPLIANCE TESTING

COMPLIANCE TESTING

For testing compliance of migration from plastic food contact materials and articles, an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0022]) shall be selected, applying the following specific performance criteria:

• (i) The analytical method working range of analytical methods shall be at least RL × SML to RU × SML, as described in the relevant guidance documents, where
• — RL is the relative lower method working range threshold,
• — RU is the relative upper method working range threshold,
• — RU shall be 2. RL shall be 0,2 unless 0,2 × SML is below the analytical limit of quantification (LOQ) of the substance then the RL × SML is set at the LOQ of the substance.

• (ii) Prior to the verification of compliance with a SML, the specific migration test result, m, needs to be corrected, if relevant: (1) by the real surface-to-volume ratio ((S/V)real) and the surface-to-volume ratio (S/V)test in accordance with Article 17; and/or (2) by the correction factor (CT2) used in the sub-columns for the food simulants D2 and E in Table 2 of Annex III to Regulation (EU) No 10/2011; and/or (3) by the FRF in accordance with point 4.1 of this Annex. When the results are corrected in application of CT2 in combination with the FRF, in accordance with point 4.1 in Annex V, the combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.

• (iii) The reproducibility coefficient of variation CVR, which can be expressed in percentage if multiplied by 100, is used to calculate the relative standard measurement uncertainty with the purpose to evaluate compliance. The formulas for calculating the CVR are as follows: CVR = 0,22 for mc <0,12 × 10^-6 kg /kg; and, CVR = 2^{(1-½log(mc))}/100 for 0,12 × 10^-6 kg/kg ≤ mc ≤ 0,138 kg/kg. Where mc is the specific migration test result of a substance or, if relevant, the corrected specific migration result that is to be evaluated against the SML set out in this Regulation, the standard measurement uncertainty of mc of a substance, u(mc), shall be determined as follows: u(mc) = CVR × mc.

• (iv) The compliance with the SML shall then be evaluated by applying the following specific performance criterion, where mc is to be evaluated against the SML: If (mc - SML)/[(u(mc)] > 1,64, then mc exceeds the SML.

If mc is higher than the SML the mc of a substance shall be considered non-compliant. In addition, the rules in Chapter 1-4 of this Annex shall apply.

CHAPTER 1

Testing for specific migration of materials and articles already in contact with food

1.1.   Sample preparation

The material or article shall be stored as indicated on the packaging label or under conditions adequate for the packaged food if no instructions are given. The food shall be removed from contact with the material or article before its expiration date or any date by which the manufacturer has indicated the product should be used for reasons of quality or safety.

1.2.   Conditions of testing

The food shall be treated in accordance with the cooking instructions on the package if the food is to be cooked in the package. Parts of the food which are not intended to be eaten shall be removed and discarded. The remainder shall be homogenised and analysed for migration. The analytical results shall always be expressed on the basis of the food mass that is intended to be eaten, in contact with the food contact material.

1.3.   Analysis of migrated substances

The specific migration is analysed in the food using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.

1.4.   Account of substances originating from other sources

In case there is evidence linked to the food sample that a substance partially or wholly originates from a source or sources other than the material or article for which the test is being carried out, the test results shall be corrected for the amount of that substance originating from the other source or sources before comparing the test results to the applicable specific migration limit.

CHAPTER 2

Testing for specific migration of materials and articles not yet in contact with food

2.1.   Verification method

Verification of compliance of migration into foods with the migration limits shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use taking into account paragraphs 1.4, 2.1.1, 2.1.6 and 2.1.7.

Verification of compliance of migration into food simulants with the migration limits shall be carried out using conventional migration tests according to the rules set out in paragraphs 2.1.1 to 2.1.7.

2.1.1.   Sample preparation

The material or article shall be treated as described by accompanying instructions or by provisions given in the declaration of compliance.

Migration is determined on the material or article or, if this is impractical, on a specimen taken from the material or article, or a specimen representative of this material or article. For each food simulant or food type, a new test specimen is used. Only those parts of the sample which are intended to come into contact with foods in actual use shall be placed in contact with the food simulant or the food.

2.1.2.   Choice of food simulant

Materials and articles intended for contact with all types of food shall be tested with food simulant A, B and D2. However, if substances that may react with acidic food simulant or foods are not present testing in food simulant B can be omitted.

Materials and articles intended only for specific types of foods shall be tested with the food simulants indicated for the food types in Annex III.

2.1.3.   Conditions of contact when using food simulants

The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2.

By way of derogation to the conditions set out in Tables 1 and 2, the following rules apply:

• (i) If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place;

• (ii) if the material or article during it intended use is subjected only to precisely controlled time and temperature conditions in food processing equipment, either as part of food packaging or as part of the processing equipment itself, testing may be done using the worst foreseeable contact conditions that can occur during the processing of the food in that equipment;

• (iii) if the material or article is intended to be employed only for hot-fill conditions, only a 2-hour test at 70 °C shall be carried out. However, if the material or article is intended to be used also for storage at room temperature or below, the test conditions set out in Tables 1 and 2 of this Section or in Section 2.1.4 of this Chapter apply depending on the duration of storage.

• (iv) if the plastic material or article intended to come into contact with food of which the compliance must be verified becomes in its final application part of a food processing equipment or an appliance, or a part thereof, the migration tests may be carried out by determining the specific migration into the food or food simulant produced or processed by the whole equipment or appliance, or the part thereof, as appropriate, subject to the following conditions:
• — the food or food simulant is processed during testing by the equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or its part is operated in accordance with its operating instructions, and
• — the migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use. When migration testing is done under the above conditions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the migration limits, the plastic parts or materials present in the equipment or appliance shall be considered to comply with Article 11(1). The testing of the parts used for storage or supply such as reservoirs, containers, capsules or pads shall be under conditions representative of their use, and shall include the foreseeable storage conditions of the food in these parts. The supporting documentation referred to in Article 16 shall clearly document the testing on the whole food processing and/or food producing equipment or appliance, or on parts thereof. It shall demonstrate that the testing was representative of its foreseeable use, and shall indicate for which substances migration testing was carried out and provide all testing results. The manufacturer of individual plastic parts shall ensure the absence of migration for substances for which the Regulation specifies that their migration shall not be detectable at a specified level of detection in accordance with Article 11(4). Compliance documentation supplied in accordance with the Regulation to the producer of the final equipment or appliance, or part thereof, shall list all substances subject to migration limits that might be exceeded under the foreseeable use of the supplied part or material. When the result is not in compliance with the Regulation it shall be determined whether the source of the non-compliance is a plastic part subject to the Regulation or a part made from another material not subject to the Regulation on the basis of documentary evidence or analytical testing. Without prejudice to Article 3 of Regulation (EU) No 1935/2004, non-compliance to the Regulation shall only be established if the migration originates from a plastic part.

If the testing conditions representative for the worst foreseeable conditions of intended use of the material or article, are not technically feasible in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a migration test shall be done using food simulant E if the temperature under the worst foreseeable conditions of intended use exceeds 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.

Table 1

Selection of test time

Contact time in worst foreseeable use	Time to be selected for testing
t ≤ 5 min	5 min
5 min < t ≤ 0,5 hour	0,5 hour
0,5 hours < t ≤ 1 hour	1 hour
1 hour < t ≤ 2 hours	2 hours
2 hours < t ≤ 6 hours	6 hours
6 hours < t ≤ 24 hours	24 hours
1 day < t ≤ 3 days	3 days
3 days < t ≤ 30 days	10 days
Above 30 days	See specific conditions

Table 2

Selection of test temperature

Worst foreseeable contact temperature	Contact temperature to be selected for testing
T ≤ 5 °C	5 °C
5 °C < T ≤ 20 °C	20 °C
20 °C < T ≤ 40 °C	40 °C
40 °C < T ≤ 70 °C	70 °C
70 °C < T ≤ 100 °C	100 °C or reflux temperature
100 °C < T ≤ 121 °C	121 °C [^E0023]
121 °C < T ≤ 130 °C	130 °C [^E0023]
130 °C < T ≤ 150 °C	150 °C [^E0023]
150 °C < T < 175 °C	175 °C [^E0023]
175 °C < T ≤ 200 °C	200 °C [^E0023]
T > 200 °C	225 °C [^E0023]

This temperature shall be used only for food simulants D2 and E. For applications heated under pressure, migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions in Table 1.

2.1.4.   Specific conditions for contact times above 30 days at room temperature and below

For contact times above 30 days (long term) at room temperature and below, the specimen shall be tested in accelerated test conditions at elevated temperature for a maximum of 10 days at 60 °C ([^E0024]).

• (a) Testing for 10 days at 20 °C shall cover all storage times at frozen condition. This test can include the freezing and defrosting processes if labelling or other instructions ensure that 20 °C is not exceeded and the total time above – 15 °C does not exceed 1 day in total during the foreseeable intended use of the material or article.

• (b) Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

• (c) Testing for 10 days at 50 °C shall cover all storage times of up to 6 months at room temperature, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

• (d) Testing for 10 days at 60 °C shall cover storage above 6 months at room temperature and below, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

• (e) For storage at room temperature the testing conditions can be reduced to 10 days at 40 °C if it is shown by scientific evidence that migration of the respective substance in the polymer has reached equilibration under this test condition.

• (f) For worst foreseeable conditions of intended use not covered by the test conditions set out in points (a) to (e), the testing time and temperature conditions shall be based on the following formula: t2 = t1 * Exp (9627 * (1/T2 – 1/T1)) t1 is the contact time t2 is the testing time T1 is the contact temperature in Kelvin. For room temperature storage this is set at 298K (25 °C). For refrigerated conditions it is set at 278K (5 °C). For frozen storage it is set at 258 K (– 15 °C). T2 is the testing temperature in Kelvin.

2.1.5.   Specific conditions for combinations of contact times and temperature

If a material or article is intended for different applications covering different combinations of contact time and temperature the testing shall be restricted to the test conditions which are recognised to be the most severe on the basis of scientific evidence.

If the material or article is intended for a food contact application where it is successively subject to a combination of two or more times and temperatures, the migration test shall be carried out subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.

2.1.6.   Repeated use materials and articles

If the material or article is intended to come into repeated contact with foods, the migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. Compliance of the material or article shall then be verified on the basis of the level of the specific migration observed in the third migration test and on the basis of the stability of the material or article. The specific migration observed in the second migration test shall not exceed the level observed in the first test, and the specific migration in the third test shall not exceed the level observed in the second test.

For the purpose of the first paragraph, the sample shall be considered non-compliant if:

mc, 3 >SML, or,

mc, 1 < mc, 2, or,

mc, 2 < mc, 3, or,

mc, 1 < mc, 3,

where mc, 1, mc, 2, and mc, 3 are respectively the mc during the first, the second and the third migration test carried out in accordance with the first subparagraph.

The compliance with the SML and the stability rule shall be evaluated applying the following criteria:

• — If (mc, 3 – SML)/[(u(mc, 3)] > 1,64, then the third migration is higher than the SML,

• — If (mc, 2 – mc, 1)/[(u(mc, 2) + u(mc, 1)] > 1,64, then the first migration is smaller than the second migration,

• — If (mc, 3 – mc, 2)/[(u(mc, 3) + u(mc, 2)] > 1,64, then the second migration is smaller than the third migration,

• — If (mc, 3 – mc, 1)/[(u(mc, 3) + u(mc, 1)] > 1,64, the first migration is smaller than the third migration.

In case mc is smaller than RL × SML, the mc shall be considered equal to RL × SML. This mc shall be used for determining the corresponding standard measurement uncertainty of the mc and for evaluating the compliance with the performance criteria set out in this point.

However, if there is scientific proof that the level of the specific migration is not increasing as described in the second paragraph above in the course of the second and third migration tests and if the SML is not exceeded during the first migration test, the material or article is considered compliant with the SML laid down in this Regulation.

Irrespective of the above rules, a material or article shall never be considered to comply with this Regulation where in any of the migration tests a substance that is prohibited from migrating or from being released in detectable quantities under Article 11(4) of this Regulation is detected.

2.1.7.   Analysis of migrating substances

At the end of the prescribed contact time, the specific migration is analysed in the food or food simulant using an analytical method in accordance with the applicable performance criteria laid down in this Annex.

2.1.8.   Verification of compliance by residual content per food contact surface area (QMA)

For substances which are unstable in food simulant or food or for which no adequate analytical method is available it is indicated in Annex I that verification of compliance shall be undertaken by verification of residual content per 6 dm² of contact surface. For materials and articles between 500 ml and 10 l the real contact surface is applied. For materials and articles below 500 ml and above 10 l as well as for articles for which it is impractical to calculate the real contact surface the contact surface is assumed to be 6 dm² per kg food.

2.2.   Screening approaches

To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered at least as severe as the verification method described in section 2.1.

2.2.1.   Replacing specific migration by overall migration

To screen for specific migration of non-volatile substances, determination of overall migration under test conditions at least as severe as for specific migration can be applied.

2.2.2.   Residual content

To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the material or article assuming complete migration.

2.2.3.   Migration modelling

To screen for specific migration, the migration potential can be calculated based on the residual content of the substance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed in a way that must never underestimate real levels of migration.

2.2.4.   Food simulant substitutes

To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Section 2.1.2.

2.2.5.   Single test for successive combinations of time and temperature

If the material or article is intended for a food contact application where it is successively subject to two or more time and temperature combinations, a single migration contact test time can be defined based on the highest contact test temperature from Section 2.1.3 and/or 2.1.4 by using the equation as described in point (f) of Section 2.1.4. The reasoning justifying that the resulting single test is at least as severe as the combined time and temperature combinations shall be documented in the supporting documentation provided for in Article 16.

CHAPTER 3

Testing for overall migration

Overall migration testing shall be performed under the standardised testing conditions set out in this chapter.

3.1.   Standardised testing conditions

The overall migration test for materials and articles intended for the food contact conditions described in column 3 of Table 3 shall be performed for the time specified and at the temperature specified in column 2. For test OM5 the test can be performed either for 2 hours at 100 °C (food simulant D2) or at reflux (food simulant A, B, C, D1) or for 1 hour at 121 °C. The food simulant shall be chosen in accordance with Annex III.

If it is found that carrying out the tests under the contact conditions specified in Table 3 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place.

Table 3

Standardised conditions for testing the overall migration

Column 1	Column 2	Column 3
Test number	Contact time in days [d] or hours [h] at Contact temperature in [°C] for testing	Intended food contact conditions
OM0	30 min at 40 °C	Any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes).
OM1	10 d at 20 °C	Any food contact at frozen and refrigerated conditions
OM2	10 d at 40 °C	Any long-term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes.
OM3	2 h at 70 °C	Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long-term room temperature or refrigerated storage.
OM4	1 h at 100 °C or at reflux	High temperature applications for all types of food at temperature up to 100 °C.
OM5	2 h at 100 °C or at reflux or alternatively 1 h at 121 °C	High temperature applications up to 121 °C.
OM6	4 h at 100 °C or at reflux	Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1.
OM7	2 h at 175 °C	High temperature applications with fatty foods exceeding the conditions of OM5.

Test OM 7 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.

Test OM 6 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.

Test OM 5 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.

Test OM 2 covers also food contact conditions described for OM0, OM1 and OM3.

3.2.   Substitute overall migration tests for tests with food simulant D2

If it is not technically feasible to perform one or more of the tests OM0 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest overall migration shall be used to establish compliance with the Regulation.

In case it is technically not feasible to perform OM7 with food simulant D2, either test OM8 or test OM9 shall be selected as a replacement test by selecting the most appropriate of these two tests on the basis of the intended and the foreseeable use of the material or article that is being tested. Subsequently, a migration test shall be done at each of the two test conditions specified for the selected test, using a new test sample for each test condition. The test condition that results in the higher overall migration shall be used to establish compliance with the Regulation.

Test number	Test conditions	Intended food contact conditions	Covers the intended food contact conditions described in
OM8	Food simulant E for 2 hours at 175 °C and food simulant D2 for 2 hours at 100 °C	High temperature applications only	OM1, OM3, OM4, OM5 and OM6
OM9	Food simulant E for 2 hours at 175 °C and food simulant D2 for 10 days at 40 °C	High temperature applications including long term storage at room temperature	OM1, OM2, OM3, OM4, OM5 and OM6

3.3.   Verification of compliance

3.3.1.   Single use articles and materials

At the end of the prescribed contact time, to verify compliance the overall migration is analysed in the food simulant using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.

3.3.2.   Repeated use articles and materials

The applicable overall migration test shall be carried out three times on a single sample using a different portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found during the third test and on the basis of the stability of the material or article i.e. the overall migration during the second test shall not exceed the level observed in the first test, and the overall migration in the course of the third test shall not exceed the level observed during the second test. The compliance shall be evaluated in accordance with the specific performance criteria described in point 2.1.6 in Chapter 2 of Annex V. However, the standard measurement uncertainty of the analytical method as determined by the laboratory shall be used to determine u(m), instead of the standard measurement uncertainty derived on the basis of the approach as specified in the introductory part on compliance testing preceding Chapter 1.

If it is not technically feasible to test the same sample three times, such as when testing in vegetable oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The first migration, the difference between the second and the first migration and the difference between the third and the second migration shall be considered to represent the three successive overall migrations.

However, if there is scientific proof that the level of the migration, as described in point 2.1.6 in Chapter 2 of Annex V, is not increasing during the second and third migration tests and if the migration limit is not exceeded in the course of the first migration test, the material or article is considered compliant with the overall migration limit.

3.4.   Screening approaches

To screen if a material or article complies with the migration limits, any of the following approaches can be applied which are considered at least as severe as the verification method described in Sections 3.1 and 3.2.

3.4.1.   Residual content

To screen for overall migration the migration potential can be calculated based on the residual content of migratable substances determined in a complete extraction of the material or article.

3.4.2.   Food simulant substitutes

To screen for overall migration, food simulants can be replaced if based on scientific evidence the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Annex III.

CHAPTER 4

Correction factors applied when comparing migration test results with migration limits

4.1.   Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF)

For lipophilic substances for which in Annex I it is indicated in column 7 that the FRF is applicable the specific migration can be corrected by the FRF. The FRF is determined according to the formula FRF = (g fat in food/kg of food)/200 = (% fat × 5)/100.

The FRF shall be applied according to the following rules.

The migration test results shall be divided by the FRF before comparing with the migration limits.

The correction by the FRF is not applicable in the following cases:

• (a) when the material or article is or is intended to be brought in contact with food intended for infants and young children as defined by Directives 2006/141/EC and 2006/125/EC;

• (b) for materials and articles for which it is impracticable to estimate the relationship between the surface area and the quantity of food in contact therewith, for example due to their shape or use, and the migration is calculated using the conventional surface area/volume conversion factor of 6 dm²/kg.

The specific migration in food or food simulant shall not exceed 60 mg/kg food before application of the FRF.

When testing is performed in food simulant D2 or E and when the test results are corrected in application of the correction factor laid down in Table 2 of Annex III this correction may be applied in combination with the FRF by multiplying both factors. The combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.

ANNEX VI

Correlation tables