SCHEDULE 1SPECIFIED PROVISIONS OF REGULATION 10/2011
Specified provision | Subject matter |
|---|---|
Article 4(e) as read with Articles 17 and 18 | Prohibition on placing on the market plastic materials or articles if they do not meet specified compositional and declaration requirements |
Article 5(1) and Annex I, as read with Article 6 | Requirement, subject to certain derogations, to use only authorised substances in the manufacture of plastic layers in plastic materials and articles |
Article 8, first sentence | General quality and purity standards that must be observed for substances used in the manufacture of plastic layers in plastic materials and articles |
Article 9 as read with Annex I | Particular restrictions and specifications for substances used in the manufacture of plastic layers in plastic materials and articles |
Article 10 as read with Annex II | General restrictions on plastic materials and articles |
F1Article 11(1) and Annex I, as read with Article 11(3) and (4) | Specific limits on the degree to which constituents of plastic materials and articles are permitted to migrate into foods |
Article 12 | Overall limits on the permitted level of migration of the constituents of plastic materials and articles into food simulants |
Article 13(1),(3),(4) and (5) and Annex I, as read with Article 13(2) | Particular restrictions and specifications for the composition of each plastic layer in plastic multi-layer materials and articles |
Article 14(1) and (5) and Annex 1, as read with Article 14(2), (3) and (4) | Particular restrictions and specifications for the composition of each plastic layer in multi-material multi-layer materials and articles |
Article 15 and Annex IV | Requirements that written declaration of compliance for plastic materials and articles, for products from the intermediate stages of their manufacture and for substances intended for the manufacture of those materials or articles should be available at the marketing stages other than the retail stage |
SCHEDULE 2REVOCATIONS
Regulations revoked | References |
|---|---|
The Ceramic Articles in Contact with Food (Scotland) Regulations 2006 | S.S.I. 2006/230 |
The Plastic Materials and Articles in Contact with Food (Scotland) Amendment Regulations 2008 | S.S.I. 2008/261 |
The Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2009 | S.S.I. 2009/30 |
The Materials and Articles in Contact with Food (Scotland) Regulations 2010 | S.S.I. 2010/327 |
The Plastic Materials and Articles in Contact with Food (Scotland) Amendment Regulations 2011 | S.S.I. 2011/100 |
F2SCHEDULE 3BASIC RULES FOR DETERMINING THE MIGRATION OF LEAD AND CADMIUM
1.
Test liquid (‘simulant’) 4 % (v/v) acetic acid, in a freshly prepared aqueous solution.
2.
Test conditions
(a)
Carry out the test at a temperature of 22 ± 2 °C for a duration of 24 ± 0,5 hours
(b)
When the migration of lead is to be determined, cover the sample by an appropriate means of protection and expose it to the usual lighting conditions in a laboratory. When the migration of cadmium or of lead and cadmium is to be determined, cover the sample so as to ensure that the surface to be tested is kept in total darkness.
3.
Filling
(a)
Samples which can be filled—
Fill the article with a 4 % (v/v) acetic acid solution to a level no more than 1 mm from the overflow point; the distance is measured from the upper rim of the sample. Samples with a flat or slightly sloping rim should be filled so that the distance between the surface of the liquid and the overflow point is no more than 6 mm measured along the sloping rim.
(b)
Samples which cannot be filled—
The surface of the sample which is not intended to come into contact with foodstuffs is first covered with a suitable protective layer able to resist the action of the 4 % (v/v) acetic acid solution. The sample is then immersed in a recipient containing a known volume of acetic acid solution in such a way that the surface intended to come into contact with foodstuffs is completely covered by the test liquid.
4.
Determination of the surface area The surface area of the articles in category 1 in regulation 10(5) is equal to the surface area of the meniscus formed by the free liquid surface obtained by complying with the filling requirements set out in paragraph 3.
SCHEDULE 4METHODS OF ANALYSIS FOR DETERMINATION OF THE MIGRATION OF LEAD AND CADMIUM
Object and field of application
1.
The method allows the specific migration of lead or cadmium (or both) to be determined.
Principle
2.
The determination of the specific migration of lead or cadmium (or both) is carried out by an instrumental method of analysis that fulfils the performance criteria of paragraph 4.
Reagents
3.
All reagents must be of analytical quality, unless otherwise specified.
Where reference is made to water, it shall always mean distilled water or water of equivalent quality.
(a)
4 % (v/v) acetic acid, in aqueous solution.
Add 40 ml of glacial acetic acid to water and make up to 1 000 ml.
(b)
Stock solutions.
Prepare stock solutions containing 1 000 mg/litre of lead and at least 500 mg/litre of cadmium respectively in a 4 % acetic acid solution, as referred to in paragraph 3(a).
4.
Performance criteria of the instrumental method of analysis
(a)
The detection limit for lead and cadmium must be equal to or lower than— 0,1 mg/litre for lead, 0,01 mg/litre for cadmium.
The detection limit is defined as the concentration of the element in the 4 % acetic acid solution, as referred to in paragraph 3(a) which gives a signal equal to twice the background noise of the instrument.
(b)
The limit of quantification for lead and cadmium must be equal to or lower than— 0,2 mg/litre for lead, 0,02 mg/litre for cadmium.
(c)
Recovery - the recovery of lead and cadmium added to the 4 % acetic acid solution, as referred to in paragraph 3(a) must lie within 80-120 % of the added amount.
(d)
Specificity - the instrumental method of analysis used must be free from matrix and spectral interferences.
5.
Method
(a)
Preparation of the sample
The sample must be clean and free from grease or other matter likely to affect the test.
Wash the sample in a solution containing a household liquid detergent at a temperature of approximately 40 °C. Rinse the sample first in tap-water and then in distilled water or water of equivalent quality. Drain and dry so as to avoid any stain. The surface to be tested is not to be handled after it has been cleaned.
(b)
Determination of lead or cadmium (or both)
The sample prepared in accordance with paragraph 5(a) is tested under the conditions laid down in schedule 3.
Before taking the test solution for determining lead or cadmium (or both), homogenise the content of the sample by an appropriate method, which avoids any loss of solution or abrasion of the surface being tested.
Carry out a blank test on the reagent used for each series of determinations.
Carry out determinations for lead or cadmium (or both) under appropriate conditions.
SCHEDULE 5DECLARATION OF COMPLIANCE
1.
The declaration referred to in regulation 10A must contain the following information—
(a)
the identity and address of the company which manufactures the finished ceramic article and of the importer who imports it into the United Kingdom,
(b)
the identity of the ceramic article,
(c)
the date of the declaration, and
(d)
the confirmation that the ceramic article meets relevant requirements in these Regulations and Regulation (EC) No 1935/2004.
2.
The declaration must permit an easy identification of the goods for which it is issued and shall be renewed when substantial changes in the production bring about changes in the migration of lead and cadmium.
F3SCHEDULE 6LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM
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.
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:
| 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 | |
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:
|
—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. |