United Kingdom Statutory Instruments

(i) is not of good technical quality, or

(ii) is not used in accordance with any restrictions and specifications for that additive set out in the corresponding entry in column 4 of Section A or B of that Annex; or

(b) any food additive authorised by Directive 89/107 or any flavouring authorised by Directive 88/388 that migrates into food —

(i) in a quantity that has a technological function in the final food product, or

(ii) where the food is of a type for which the use of any such food additive or flavouring is so authorised, in quantities exceeding the limits provided for in Directive 89/107 or Directive 88/388 as appropriate, or in Annex III, whichever is the lower.

(i) an article which is a container or is comparable to a container or can be filled, having a capacity of less than 500 millilitres or more than 10 litres, or

(ii) sheet, film or other plastic material or article which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the material or article in question and the quantity of food in contact with that surface area.

(i) an article which is a container or is comparable to a container or can be filled, having a capacity of less than 500 millilitres or more than 10 litres, or

(ii) sheet, film or other plastic material or article which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the material or article in question and the quantity of food in contact with that surface area.

(i) an article which is a container or comparable to a container or can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres;

(ii) an article which can be filled and for which it is impracticable to estimate the surface area in contact with food; or

(iii) a cap, gasket, stopper or similar device for sealing,

the appropriate limit is an overall migration limit of 60 milligrams of constituents released per kilogram of food.

(b) In the case of any other plastic material or article, the appropriate limit is an overall migration limit of 10 milligrams per square decimetre of the surface area of the plastic material or article.

(i) on conviction on indictment to a term of imprisonment not exceeding two years or to a fine or both;

(ii) on summary conviction to a term of imprisonment not exceeding six months or to a fine not exceeding the statutory maximum or both;

(b) in the case of any other offence under these Regulations to a term of imprisonment not exceeding three months or to a fine not exceeding level five on the standard scale or both.

(i) he carried out all such checks of the plastic material or article or material or article in question as were reasonable in all the circumstances, or

(ii) it was reasonable in all the circumstances for him to rely on checks carried out by the person who supplied him with the plastic material or article or the material or article in question; and

(c) that he did not know and had no reason to suspect at the time the offence was committed that his act or omission would amount to an offence under these Regulations.

(a) the first sample is to be subjected to the appropriate test according with paragraph 4 and the overall migration determined (M₁);

(b) the second and third samples are to be subjected to the same conditions of temperature but the period of contact is to be respectively two and three times that specified and the overall migration determined in each case (M₂ and M₃).

    (3) Where a modified test has been carried out in accordance with sub-paragraph (2), provided that either M₁ or M₃ – M₂ did not exceed the overall migration limit, the plastic material or article subjected to the test shall be deemed to be in compliance with that limit.

     8. —(1) Any plastic material or article which exceeds its overall migration limit by an amount not exceeding the analytical tolerance specified in sub-paragraph (2) shall be deemed for the purposes of these Regulations not to exceed its overall migration limit.

    (2) The following analytical tolerances shall be applied for limits of overall migration—

(a) 20 mg/kg or, as the case may be, 3 milligrams per square decimetre in migration tests using as a simulant rectified olive oil or substitutes;

(b) 12mg/kg or, as the case may be, 2 milligrams per square decimetre in migration tests using other simulants referred to in Schedule 3.

(a) reduce the number of tests to be carried out to that or those which, in the specific case under examination, is or are generally recognised to be the most severe on the basis of scientific evidence;

(b) omit the migration, the substitute or the alternative tests where —


(i) there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article, or

(ii) the conditions for non-compulsory testing set out in Article 8.2 or 8.3 of the Directive are met.

(a) Iodine value (Wijs) = 80 to 88;

(b) Refractive index at 25°C = 1.4665 to 1.4679;

(c) Acidity (expressed as % of oleic acid) = 0.5% maximum;

(d) Peroxide number (expressed as oxygen milli-equivalents per kg of oil) = 10 maximum.

     4. The fatty food simulants referred to in the Table are —

(a) corn oil with standardised specifications;

(b) sunflower oil, the characteristics of which are —


(i) Iodine value (Wijs) = 120 to 145;

(ii) Refractive index at 20°C = 1.474 to 1.476;

(iii) Saponification number = 188 to 193;

(iv) Relative density at 20°C = 0.918 to 0.925;

(v) Unsaponifiable matter = 0.5% to 1.5% ;



(c) a synthetic mixture of triglycerides the composition of which is as set out in the following tables:


Fatty acid distribution


No of C-atoms in fatty acid residue	6	8	10	12	14	16	18	others
GLC area (% )	˜1	6-9	8-11	45-52	12-15	8-10	8-12	1



Purity


Content of monoglycerides (enzymatically)	≤0.2%
Content of diglycerides (enzymatically)	≤2.0%
Unsaponifiable matter	≤0.2%
Iodine value (Wijs)	≤0.1%
Acid value	≤0.1%
Water content (K Fischer)	≤0.1%
Melting point	28 ± 2°C



Typical absorption spectrum (thickness of layer: d = 1 cm; Reference: water at 35°C)


Wavelength (nm)	290	310	330	350	370	390	430	470	510
Transmittance (% )	˜2	˜15	˜37	˜64	˜80	˜88	˜95	˜97	˜98
At least 10% light transmittance at 310 nm

     5. Where a fatty food simulant specified in paragraph 4 is used in migration testing and the result of that test shows that a plastic material or article does not comply with any migration limit specified in regulation 9 or the Annexes, verification that the plastic material or article does not comply with the specified migration shall be carried out by testing that material or article using olive oil if such testing is technically feasible, and if such testing is not technically feasible the plastic material or article shall be deemed not to comply with the specified migration limit.

(a) the reduction factor specified for each food or group of foods, as appropriate, shall be applied to the test result; and

(b) the plastic material or article shall be treated as being capable of transferring its constituents to food with which it may come into contact in excess of a migration limit specified in regulation 9 or the Annexes if, following application of those specified reduction factors, one or more of the results show that the material or article does not comply with that specified migration limit.

    (2) For the purpose of this paragraph —

(a) a reduction factor is the figure which follows an "X" and oblique stroke in the group of columns headed "Simulants to be used" in the Table to Part 4;

(b) a reduction factor is specified for a food or group of foods where, in the Table to Part 4 —


(i) the food of group of foods is described in the column headed "Description of food", and

(ii) "X" is placed in a column headed by a specified simulant opposite that food or group of foods followed by an oblique stroke and a reduction factor;



(c) a reduction factor shall be applied to a test result by dividing the result by that reduction factor.

     3. Food types are defined in Table 1 below as follows —


Table 1: Food types

Definition	Meaning
Aqueous foods having a pH > 4.5	Foods in relation to which simulant A only is specified in the Table to Part 4
Acidic foods having a pH ≤ 4.5	Foods in relation to which simulant B only is specified in Table to Part 4
Alcoholic foods	Foods in relation to which simulant C only is specified in the Table to Part 4
Fatty foods	Foods in relation to which simulant D only is specified in the Table to Part 4
Dry Foods	Foods in relation to which no simulant is specified in the Table to Part 4

Selection of simulants for testing materials and articles intended for contact with all food types
     4. The simulants to be used in testing a plastic material or article which is intended for contact with all food types are simulant B, simulant C and simulant D which, at the test conditions specified in Part 5, are considered to be more severe.

Selection of simulants for testing materials and articles which are already in contact with a known food
     5. The simulant or simulants to be used in testing a plastic material or article which is already in contact with a known food shall be —

(a) where —


(i) the known food is a specific food or is within a specific group of foods described in column 2 of the Table to Part 4 and,

(ii) for the purposes of that Part, a simulant is, or simulants are, specified in relation to that specific food or specific group of foods,

(b) where —


(i) the known food is neither a specific food, nor

(ii) within a specific group of foods described in the Table to Part 4 of this Schedule,

(a) a reduction factor is the figure which follows an "X" and oblique stroke in the group of columns headed "Simulants to be used" in the Table to this Part;

(b) a reduction factor is specified in relation to a specific food or group of foods where, in the Table —


(i) the food or group of foods is described in the column headed "Description of food"; and

(ii) "X" is placed in a column headed by a specified simulant opposite that food or group of foods allowed by an oblique stroke and a reduction factor.

     3. Where a reduction factor is specified in the Table in relation to a specific food or a specific group of foods, that reduction factor shall be applied to the result of any migration test using the simulant specified in relation to that food or group of foods by dividing the result of the test by the reduction factor.

     4. Where the letter "a" is shown in brackets after the "X", only one of the two simulants specified shall be used in the migration test, that is to say —

(a) if the pH value of the food is higher than 4.5, simulant A shall be used;

(b) if the pH value of the foodstuff is 4.5 or less, simulant B shall be used.

     5. Where a food is listed in the Table under both a specific and a general heading, the simulant relating to the specific heading is the simulant which falls to be used for the migration test.

Reference Number	Description of food	Simulants to be used
		A	B	C	D
01	Beverages
01.01	Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than 5% vol:      — Waters, ciders, fruit or vegetable juices of normal strength or concentrated, musts, fruit nectars, lemonades and mineral waters, syrups, bitters, infusions, coffee, tea, liquid chocolate, beers and other	X(a)	X(a)
01.02	Alcoholic beverages of an alcoholic strength equal to or exceeding 5% vol.      — Beverages shown under heading 01.01 but with an alcoholic strength equal to or exceeding 5% vol.      — Wines, spirits and liqueurs		X(¹)	X(²)
01.03	Miscellaneous: undenatured ethyl alcohol		X(¹)	X(¹)
02	Cereals, cereal products, pastry, biscuits, cakes and other bakers' wares
02.01	Starches
02.02	Cereals, unprocessed, puffed, in flakes (including popcorn, cornflakes and the like)
02.03	Cereal flour and meal
02.04	Macaroni, spaghetti and similar products
02.05	Pastry, biscuits, cakes and other bakers' wares, dry:
	A With fatty substances on the surface				X/5
	B Other
02.06	Pastry, biscuits, cakes and other bakers' wares, fresh
	A With fatty substances on the surface				X/5
	B Other	X
03	Chocolate, sugar and products thereof Confectionery products
03.01	Chocolate, chocolate-coated products, substitutes and products coated with substitutes				X/5
03.02	Confectionery products:
	A in solid form
	— with fatty substances on the surface				X/5
	— Other
	B in paste form:
	— with fatty substances on the surface				X/3
	— moist	X
03.03	Sugar and sugar products
	A In solid form
	B Honey and the like	X
	C Molasses and sugar syrups	X
04	Fruit, vegetable and products thereof
04.01	Whole fruit, fresh or chilled
04.02	Processed fruit:
	A Dried or dehydrated fruit, whole or in the form of flour or powder
	B Fruit in the form of chunks, puree or paste	X(a)	X(a)
	C Fruit preserves (jams and similar products
	– whole fruit or chunks or in the form of flour or powder, preserved in a liquid medium):
	— i) In an aqueous medium	X(a)	X(a)
	— ii) In an oily medium	X(a)	X(a)		X
	— iii) In an alcoholic medium > 5% vol		X(¹)	X
04.03	Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others)
	A Shelled, dried
	B Shelled and roasted				X/5(³)
	C In paste or cream form	X			X/3(³)
04.04	Whole vegetables, fresh or chilled
04.05	Processed vegetables:
	A Dried or dehydrated vegetables whole or in the form of flour or powder
	B Vegetables, cut, in the form of purees	X(a)	X(a)
	C Preserved vegetables:
	— i) In an aqueous medium	X(a)	X(a)
	— ii) In an oily medium	X(a)	X(a)		X
	— iii) In an alcoholic medium (> 5% vol)		X(¹)	X
05	Fats and oils
05.01	Animal 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, salted, smoked	X			X/3(³)
	B In the form of paste	X			X/3(³)
06.02	Crustaceans and molluscs (including oysters, mussels, snails) not naturally protected by their shells	X
06.03	Meat of all zoological species (including poultry and game):
	A Fresh, chilled, salted, smoked	X			X/4
	B In the form of paste, creams	X			X/4
06.04	Processed meat products (ham, salami, bacon and other)	X			X/4
06.05	Preserved and part-preserved meat and fish:
	A In an aqueous medium	X(a)	X(a)
	B In an oily medium	X(a)	X(a)		X
06.06	Eggs not in shell:
	A Powdered or dried
	B Other	X
06.07	Egg yolks:
	A Liquid	X
	B Powdered or frozen
06.08	Dried white of egg
07	Milk products
07.01	Milk:
	A Whole	X
	B Partly dried	X
	C Skimmed or partly skimmed	X
	D Dried
07.02	Fermented milk such as yoghurt, buttermilk and such products in association with fruit and fruit products		X
07.03	Cream and sour cream	X(a)	X(a)
07:04	Cheeses:
	A Whole, with rind
	B Processed cheeses	X(a)	X(a)
	C All others	X(a)	X(a)		X/3(³)
07:05	Rennet:
	A In liquid or viscous form	X(a)	X(a)
	B Powdered or dried
08	Miscellaneous products
08.01	Vinegar		X
08.02	Fried or roasted foods:
	A Fried potatoes, fritters and the like				X/5
	B Of animal origin				X/4
08.03	Preparations for soups, broths in liquid, solid or powder form (extracts, concentrates); homogenized composite food preparations, prepared dishes:
	A Powdered or dried
	— i) With fatty substances on the surface				X/5
	— ii) Other
	B Liquid or paste:
	— i) With fatty substances on the surface	X(a)	X(a)		X/3
	— ii) Other	X(a)	X(a)
08.04	Yeasts and raising agents:
	A In paste form	X(a)	X(a)
	B Dried
08.05	Salt
08.06	Sauces:
	A Without fatty substances on the surface	X(a)	X(a)
	B Mayonnaise, sauces derived from mayonnaise, salad creams and other oil in water emulsions	X(a)	X(a)		X/3
	C Sauce containing oil and water forming two distinct layers	X(a)	X(a)		X
08.07	Mustard (except powdered mustard under heading 08.17)	X(a)	X(a)		X/3(³)
08.08	Sandwiches, toasted bread and the like containing any kind of foodstuff:
	A With fatty substances on the surface				X/5
	B Other
08.09	Ice-creams	X
08.10	Dried foods:
	A With fatty substances on the surface				X/5
	B Other
08.11	Frozen or deep-frozen foods
08.12	Concentrated extracts of an alcoholic strength equal to or exceeding 5% vol		X(¹)	X
08.13	Cocoa:
	A Cocoa powder				X/5(³)
	B Cocoa paste				X/3(³)
08.14	Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered
08.15	Liquid coffee extracts	X
08.16	Aromatic herbs and other herbs: Camomile, mallow, mint, tea, lime blossom and others
08.17	Spices and seasonings in the natural state: Cinnamon, cloves, powdered mustard, pepper, vanilla, saffron and other

⁽¹⁾ Simulant B shall not be used where the pH is more than 4.5.

⁽²⁾ This test shall be carried out in the case of liquids or beverages of an alcoholic strength exceeding 10% vol. with aqueous solutions of ethanol of a similar strength.

⁽³⁾ If it can be demonstrated under regulation 12(2) or proved by means of an appropriate test that there is to be no fatty contact with the plastic material or article, simulant D shall not be used.

(a) a new test specimen shall be used;

(b) the rules prescribed for simulant D in Parts 3, 4 and 5 of this Schedule shall be applied for each test medium;

(c) subject to paragraph 4, compliance with a migration limit shall be determined by selecting the highest value using all the test methods.

     4. Where carrying out a migration test causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article the result of that test shall not be used to ascertain compliance with a migration limit.

     5. Any test conditions in the Table to this Part which are generally recognised on the basis of scientific evidence as not being appropriate for the material or article to be tested shall not be used.

     6. The Table to this Part shall be read with the notes to it.


Conventional conditions for substitute tests

Test conditions with simulant D	Test conditions with isooctane	Test conditions with ethanol 95%	Test conditions with MPPO(1)
10 days at 5°C	0.5 days at 5°C	10 days at 5°C
10 days at 20°C	1 day at 20°C	10 days at 20°C
10 days at 40°C	2 days at 20°C	10 days at 40°C
2 hours at 70°C	0.5 hours at 40°C	2 hours at 60°C
0.5 hours at 100°C	0.5 hours at 60°C(2)	2.5 hours at 60°C	0.5 hours at 100°C
1 hour at 100°C	1 hour at 60°C(2)	3 hours at 60°C(2)	1 hour at 100°C
2 hours at 100°C	1.5 hours at 60°C(2)	3.5 hours at 60°C(2)	2 hours at 100°C
0.5 hours at 121°C	1.5 hours at 60°C(2)	3.5 hours at 60°C(2)	0.5 hours at 121°C
1 hour at 121°C	2 hours at 60°C(2)	4 hours at 60°C(2)	1 hour at 121°C
2 hours at 121°C	2.5 hours at 60°C(2)	4.5 hours at 60°C(2)	2 hours at 121°C
0.5 hours at 130°C	2 hours at 60°C(2)	4 hours at 60°C(2)	0.5 hours at 130°C
1 hour at 130°C	2.5 hours at 60°C(2)	4.5 hours at 60°C(2)	1 hour at 130°C
2 hours at 150°C	3 hours at 60°C(2)	5 hours at 60°C(2)	2 hours at 150°C
2 hours at 175°C	4 hours at 60°C(2)	6 hours at 60°C(2)	2 hours at 175°C

⁽¹⁾ MPPO = Modified polyphenylene oxide

⁽²⁾ The volatile test media are used up to a maximum temperature of 60°C. A precondition of using these tests is that the material or article will withstand the test conditions that would otherwise be used with simulant D. Immerse a test specimen in olive oil under the appropriate conditions. If the physical properties are changed (eg melting, deformation) then the material is considered unsuitable for use at that temperature. If the physical properties are not changed then proceed with the substitute tests using new specimens.

(a) the result obtained in a "comparison test" shows that the values are equal to or greater than those obtained in the test with simulant D; and

(b) the migration occurring in either test specified in paragraph 3 does not, after application of the appropriate reduction factor, exceed the appropriate migration limit.

     2. The condition in sub-paragraph (a) of paragraph 1 does not have to be fulfilled if it can be shown on the basis of the result of scientific experiment that the values obtained in either of the tests specified in paragraph 3 are equal to or greater than those obtained in any of the migration tests specified in Part 3.

     3. The migration tests referred to in paragraphs 2 and 3 are —

(a) a test carried out using volatile media including isooctane, ethanol 95% , other volatile solvents or a mixture of solvents at such contact conditions as would result in values equal to or greater than those obtained in a test using simulant D;

(b) other tests using media having a very strong extraction power under very severe test conditions where, on the basis of scientific evidence, it is generally recognised that the results using these tests are equal to or higher than those obtained in a test using simulant D.

(a) an amendment to the definition of "the Directive" so as to include the amendments made to Commission Directive 2002/72/EC by Commission Directive 2005/79/EC, which introduces new provisions relating to PVC gaskets containing epoxidised soybean oil and makes widespread changes to the Annexes containing lists of authorised monomers (including other starting substances) and additives;

(b) provision for a transitional defence relating to the sale of jars of foods for infants and young children sealed with PVC gaskets containing epoxidised soybean oil; and

(c) the replacement of most of the content of Schedules 1 to 4 of the No. 1 Regulations by the incorporation, by reference to Annexes of Commission Directive 2002/72/EC as amended, of the specifications and lists of authorised substances formerly contained in those Schedules.

     2. The Regulations in Part 2 —

(a) prohibit specified activities in relation to any plastic material or article (as defined in regulation 2) which fails to meet the appropriate required standards set out in the Regulations (regulation 3);

(b) prohibit the use of monomers and additives in the manufacture of plastic materials and articles other than in accordance with specified conditions (regulation 4 and Schedule 1 in the case of monomers and regulation 5 and Schedule 1 in the case of additives);

(c) specify the required standards relating to the capability of a monomer or an additive to confer its constituents to food (regulation 6 for monomers and regulation 7 for additives);

(d) specify the required standard for products obtained by bacterial fermentation (regulation 8);

(e) specify the required standard relating to overall migration limits from plastic materials or articles to food (regulation 9);

(f) specify the required standards relating to the migration of primary aromatic amines from plastic materials or articles to food (regulation 10);

(g) specify the methods for determining the capability of a plastic material or article to transfer its constituents to food, and for detecting the presence of any such constituents in food (regulation 11 and Schedules 2 & 3);

(h) provide that prior to the retail stage plastic materials and articles must be accompanied by certain specified written information, including a declaration of legislative compliance (regulation 12);

(i) provide for the execution and enforcement of Regulation 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food (OJ No. L302, 19.11.2005, p.28), which contains Community provisions relating to the epoxy derivatives known as BADGE, BFDGE and NOGE (regulation 13).

     3. The Regulations in Part 3 —

(a) designate food authorities and port health authorities as the enforcement authorities in their respective areas or districts (regulation 14);

(b) specify the offences that may be committed under these Regulations and set out the maximum penalties on conviction (regulation 15);

(c) provide for defences of a general nature, such as exercise of due diligence etc, to offences under regulation 15 (regulation 16);

(d) provide a defence relating to the sale of glass jars that contain certain foods for infants and young children and that have been sealed with a PVC gasket containing epoxidised soybean oil (regulation 17);

(e) provide for transitional defences in relation to certain plastic materials or articles that have already been manufactured or put into circulation in advance of a change in the law that would otherwise have made their manufacture or circulation unlawful (regulation 18);

(f) specify the procedure to be followed when sending a sample for analysis (regulation 19);

(g) make provision for a reference sample to be analysed by the Laboratory for the Government Chemist (regulation 20).

     4. Part 4 of the Regulations contains provisions relating to the procedure to be followed and the time limit to be observed where a person wishes to apply to the European Food Safety Authority for the authorisation of a new additive (regulation 21).

     5. The principal Directives implemented by these Regulations are —

(a) Council Directive 82/711/EEC (OJ No. L297, 23,10,1982, p.26) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as amended by Commission Directives 93/8/EEC (OJ No. L90, 14.4.1993, p.22) and 97/48/EC (OJ No. L222, 12.8.1997, p.10);

(b) Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (OJ No. L372, 31.12.1985, p.14);

(c) Commission Directive 2002/72/EC (OJ No. L220, 15.8.2002, p.18) relating to plastic materials and articles intended to come into contact with foodstuffs, as amended by Commission Directives 2004/1/EC (OJ No. L7, 13.1.2004, p.45), 2004/19/EC (OJ No. L71, 10.3.2004, p.8) and 2005/79/EC (OJ No. L302, 19.11.2005, p.35).

     6. A full regulatory impact assessment of the effect that this instrument will have on the costs of business has been prepared and placed in the library of each House of Parliament. Copies may be obtained from the Chemical Safety Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.