The Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1996 No. 694


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Statutory Instruments

1996 No. 694

FOOD

The Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1996

Made

11th March 1996

Laid before Parliament

11th March 1996

Coming into force

1st April 1996

The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly, in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and 48(1) of the Food Safety Act 1990(1), and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designated(2) for the purposes of section 2(2) of the European Communities Act 1972(3) in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) and of all other powers enabling them in that behalf, and after consultation in accordance with section 48(4) of the Act of 1990 with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations (in so far as the Regulations are made in exercise of the powers conferred by the said Act of 1990), hereby make the following Regulations:-

Title, commencement, extent and interpretation

1.-(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1996 and shall come into force on 1st April 1996.

(2) These Regulations shall not extend to Northern Ireland.

(3) In these Regulations "the principal Regulations" means the Plastic Materials and Articles in Contact with Food Regulations 1992(4).

Amendment of the principal Regulations

2. The principal Regulations shall be amended as follows-

(a)in regulation 2(1)-

(i)after the definition of "the 1987 Regulations", there shall be inserted the following definition-

(ii)after the definition of "food" there shall be inserted the following definition-

""good technical quality" means good technical quality as regards the purity criteria;";

(b)after regulation 13 there shall be inserted the following regulations-

"Use, sale and importation until 1st April 1998

14. Until 1st April 1998 a plastic material or article which has been manufactured using one or more of the monomers identified by PM/REF No., CAS No. and name respectively in columns 1, 2, 3 of Section E of Part I of Schedule 1-

(a)may be used in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption,

(b)may be sold for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption, or

(c)may be imported for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption,

provided that such monomer is of good technical quality.

Additives

15.-(1) Subject to the following paragraphs of this regulation, no person shall use in the manufacture of plastic materials or articles any additive identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2, 3 of Part I of Schedule 3 which is not of good technical quality.

(2) Paragraph (1) of this regulation shall not be taken to prohibit the presence in any plastic material or article of any substance which is a mixture of additives of good technical quality identified in Part I of Schedule 3.

(3) In any proceedings for an offence under these Regulations, where it is alleged that the commission of the offence is due to the manufacture of a plastic material or article with any additive identified in Part I of Schedule 3 which is not of good technical quality, it shall be a defence for the person charged to prove that each such additive is present in the finished plastic material or article as an impurity, a reaction intermediate or a decomposition product.";

(c)in the column headed "Item" in Section A of Part 1 of Schedule 1 for Item number and letter "66A" and "91A" there shall be substituted, respectively, "66B" and "91B";

(d)the Item number and letter, PM/REF No., CAS No., name and restriction (if any) for each monomer identified in Schedule 1 to these Regulations shall be inserted in Section A of Part 1 of Schedule 1 at the place corresponding to the number and letter specified for that monomer in the column headed "Item" in Schedule 1 to these Regulations;

(e)in Section A of Part 1 of Schedule 1, opposite and corresponding to Item 57, for the entry in column 1 (PM/REF No.) there shall be substituted the entry "14411" and in column 3 (Name) the words "(food grade quality)" shall be deleted;

(f)in column 4 (Restrictions) of Section A of Part 1 of Schedule 1-

(i)opposite and corresponding to Item 166, there shall be inserted the following entry "see `Rosin'"; and

(ii)in the entry opposite and corresponding to Item 180, for "0.05" there shall be substituted "5";

(g)in Section B of Part 1 of Schedule 1 the entries in columns 1 (PM/REF No.), 2 (CAS No.), 3 (Name) and 4 (Restrictions) (if any) opposite and corresponding to Items 11, 60, 83, 102 and 161 respectively, shall be deleted;

(h)the contents of Schedule 2 to these Regulations shall be inserted after Section D of Part 1 of Schedule 1; and

(i)the contents of Schedule 3 to these Regulations shall be inserted after Schedule 2.

Angela Browning

Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food

11th March 1996

Signed by the authority of the Secretary of State for Health

Cumberlege

Parliamentary Under-Secretary of State,

Department of Health

4th March 1996

Lindsay

Paliamentary Under-Secretary of State, Scottish Office

4th March 1996

Signed by authority of the Secretary of State for Wales

Rod Richards

Parliamentary Under-Secretary of State, Welsh Office

7th March 1996

Regulation 2(d)

SCHEDULE 1

1234
ItemPM/REF No.CAS No.NameRestrictions
7A.10660015214-89-8, 2-Acrylamido-2methylpropanesulphonic acidThe specific migration of this substance shall not exceed 0.05mg/kg.
26A.12789007664-41-7Ammonia
66A.15070001647-16-1Dec-1,9-dieneThe specific migration of this substance shall not exceed 0.05mg/kg.
91A.17050000104-76-72-Ethylhexan-l-olThe specific migration of this substance shall not exceed 30mg/kg.
110B.19270000097-65-4Itaconic acid
197.26140000075-38-7Vinylidene fluorideThe specific migration of this substance shall not exceed 5mg/kg.

Regulation 2(h)

SCHEDULE 2

"SECTION EMonomers authorised until 1st April 1998

123
ItemPM/REF No.CAS No.Name
1.10660015214-89-82-Acrylamido-2-methylpropanesulphonic acid
2.15070001647-16-1Dec-1,9-diene
3.17050000104-76-72-Ethylhexan-1-o1"

Regulation 2(i)

SCHEDULE 3

"SCHEDULE 3

PART IADDITIVES

123
ItemPM/REF No.CAS No.Name
130000000064-19-7Acetic acid
230045000123-86-4Acetic acid,butyl ester
330140000141-78-6Acetic acid,ethyl ester
430280000108-24-7Acetic anhydride
530295000067-64-1Acetone
630370-Acetylacetic acid, salts
730400-Acetylated glycerides
830960-Acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol
931328-Acids, fatty, from animal or vegetable food fats and oils
1031730000124-04-9Adipic acid
1133120-Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)
1233350009005-32-7Alginic acid
1334480-Aluminium fibers, flakes and powders
1434560021645-51-2Aluminium hydroxide
1534690011097-59-9Aluminium magnesium carbonate hydroxide
1634720001344-28-1Aluminium oxide
1735120013560-49-13-Aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether
1835320007664-41-7Ammonia
1935440012124-97-9Ammonium bromide
2035600001336-21-6Ammonium hydroxide
2135840000506-30-9Arachidic acid
2235845007771-44-0Arachidonic acid
2336000000050-81-7Ascorbic acid
2436080000137-66-6Ascorbyl palmitate
2536160010605-09-1Ascorbyl stearate
2636880008012-89-3Beeswax
2736960003061-75-4Behenamide
2837040000112-85-6Behenic acid
2937280001302-78-9Bentonite
3037600000065-85-0Benzoic acid
3137680000136-60-7Benzoic acid, butyl ester
3237840000093-89-0Benzoic acid, ethyl ester
3338080000093-58-3Benzoic acid, methyl ester
3438160002315-68-6Benzoic acid, propyl ester
3538950079072-96-1Bis(4-ethylbenzylidene) sorbitol
3639890087826-41-3Bis(methylbenzylidene) sorbitol
069158-41-4" " "
054686-97-4" " "
3740400010043-11-5Boron nitride
3840570000106-97-8Butane
3941040005743-36-2Calcium butyrate
4041280001305-62-0Calcium hydroxide
4141520001305-78-8Calcium oxide
4241600012004-14-7Calcium sulphoaluminate
037293-22-4" "
4341760008006-44-8Candelilla wax
4441960000124-07-2Caprylic acid
4542160000124-38-9Carbon dioxide
4642500-Carbonic acid, salts
4742640009000-11-7Carboxymethylcellulose
4842720008015-86-9Carnauba wax
4942800009000-71-9Casein
5042960064147-40-6Castor oil, dehydrated
5143200-Castor oil, monoand diglycerides
5243280009004-34-6Cellulose
5343300009004-36-8Cellulose acetate butyrate
5443360068442-85-3Cellulose, regenerated
5543440008001-75-0Ceresin
5644160000077-92-9Citric acid
5744640000077-93-0Citric acid, triethyl ester
5845280-Cotton fibers
5945560014464-46-1Cristobalite
6045760000108-91-8Cyclohexylamine
6145920009000-16-2Dammar
6245940000334-48-5n-Decanoic acid
6346070010016-20-3alpha-Dextrin
6446080007585-39-9beta-Dextrin
6546375061790-53-2Diatomaceous earth
6646480032647-67-9Dibenzylidene sorbitol
6746790004221-80-13,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tertbutylphenyl ester
6846800067845-93-63,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester
6946870003135-18-03,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester
7047440000461-58-5Dicyanodiamide
7149540000067-68-5Dimethyl sulphoxide
7251200000126-58-9Dipentaerythritol
7351760025265-71-8Dipropyleneglycol
000110-98-5"
7452640016389-88-1Dolomite
7552730000112-86-7Erucic acid
7652800000064-17-5Ethanol
7753270037205-99-5Ethylcarboxymethylcellulose
7853280009004-57-3Ethylcellulose
7953360000110-31-6N,N'-Ethylenebisoleamide
8053440005518-18-3N,N'-Ethylenebispalmitamide
8153520000110-30-5N,N'-Ethylenebisstearamide
8253600000060-00-4Ethylenediaminetetraacetic acid
8354005005136-44-7Ethylene-N-palmitamide-N1-stearamide
8454260009004-58-4Ethylhydroxyethylcellulose
8554270-Ethylhydroxymethylcellulose
8654280-Ethylhydroxypropylcellulose
8754450-Fats and oils from animal or vegetable food sources
8854480-Fats and oils, hydrogenated, from animal or vegetable food sources
8955040000064-18-6Formic acid
9055120000110-17-8Fumaric acid
9155190029204-02-2Gadoleic acid
9255440009000-70-8Gelatin
9355680000110-94-1Glutaric acid
9455920000056-81-5Glycerol
9556020099880-64-5Glycerol dibehenate
9656360-Glycerol, esters with acetic acid
9756487-Glycerol, esters with butyric acid
9856490-Glycerol, esters with erucic acid
9956495-Glycerol, esters with 12-hydroxystearic acid
10056500-Glycerol, esters with lauric acid
10156510-Glycerol, esters with linoleic acid
10256520-Glycerol, esters with myristic acid
10356540-Glycerol, esters with oleic acid
10456550-Glycerol, esters with palmitic acid
10556565-Glycerol, esters with nonanoic acid
10656570-Glycerol, esters with propionic acid
10756580-Glycerol, esters with ricinoleic acid
10856585-Glycerol, esters with stearic acid
10956610030233-64-8Glycerol monobehenate
11056720026402-23-3Glycerol monohexanoate
11156800030899-62-8Glycerol monolaurate diacetate
11256880026402-26-6Glycerol monooctanoate
11357040-Glycerol monooleate, ester with ascorbic acid
11457120-Glycerol monooleate, ester with citric acid
11557200-Glycerol monopalmitate, ester with ascorbic acid
11657280-Glycerol monopalmitate, ester with citric acid
11757600-Glycerol monostearate, ester with ascorbic acid
11857680-Glycerol monostearate, ester with citric acid
11957920000620-67-7Glycerol triheptanoate
12058300-Glycine, salts
12158320007782-42-5Graphite
12258400009000-30-0Guar gum
12358480009000-01-5Gum arabic
12458720000111-14-8Heptanoic acid
12559360000142-62-1Hexanoic acid
12659760019569-21-2Huntite
12759990007647-01-0Hydrochloric acid
12860030012072-90-1Hydromagnesite
12960080012304-65-3Hydrotalcite
13060160000120-47-84-Hydroxybenzoic acid, ethyl ester
13160180004191-73-54-Hydroxybenzoic acid, isopropyl ester
13260200000099-76-34-Hydroxybenzoic acid, methyl ester
13360240000094-13-34-Hydroxybenzoic acid, propyl ester
13460560009004-62-0Hydroxyethylcellulose
13560880009032-42-2Hydroxyethylmethylcellulose
13661120009005-27-0Hydroxyethyl starch
13761390037353-59-6Hydroxymethylcellulose
13861680009004-64-2Hydroxypropylcellulose
13961800009049-76-7Hydroxypropyl starch
14061840000106-14-912-Hydroxystearic acid
14162140006303-21-5Hypophosphorous acid
14262240001332-37-2Iron oxide
14362450000078-78-4Isopentane
14462640008001-39-6Japan wax
14562720001332-58-7Kaolin
14662800-Kaolin, calcined
14762960000050-21-5Lactic acid
14863040000138-22-7Lactic acid, butyl ester
14963280000143-07-7Lauric acid
15063760008002-43-5Lecithin
15163840000123-76-2Levulinic acid
15263920000557-59-5Lignoceric acid
15364015000060-33-3Linoleic acid
15464150028290-79-1Linolenic acid
15564500-Lysine, salts
15664640001309-42-8Magnesium hydroxide
15764720001309-48-4Magnesium oxide
15865020006915-15-7Malic acid
15965040000141-82-2Malonic acid
16065520000087-78-5Mannitol
16166200037206-01-2Methylcarboxymethylcellulose
16266240009004-67-5Methylcellulose
16366640009004-59-5Methylethylcellulose
16466695-Methylhydroxymethylcellulose
16566700009004-65-3Methylhydroxypropylcellulose
16667120012001-26-2Mica
16767200001317-33-5Molybdenum disulphide
16867840-Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol
16967850008002-53-7Montan wax
17067891000544-63-8Myristic acid
17168040003333-62-87-[2H-Naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin
17268125068187-64-4Nepheline syenite
17369040000112-80-1Oleic acid
17469760000143-28-2Oleyl alcohol
17570000070331-94-12,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4hydroxyphenyl)-propionate]
17670240012198-93-5Ozokerite
17770400000057-10-3Palmitic acid
17871020000373-49-9Palmitoleic acid
17971440009000-69-5Pectin
18071600000115-77-5Pentaerythritol
18171680006683-19-8Pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4hydroxyphenyl)-propionate]
18271720000109-66-0Pentane
18372640007664-38-2Phosphoric acid
18474240031570-04-4Phosphorous acid, tris(2,4-di-tert-butylphenyl)ester
18574480000088-99-3o-Phthalic acid
18676320000085-44-9Phthalic anhydride
18776720009016-00-6 063148-62-9Polydimethylsiloxane
18876960025322-68-3Polyethyleneglycol
18977600061788-85-0Polyethyleneglycol ester of hydrogenated castor oil
19077702-Polyethyleneglycol esters of aliphatic monocarboxylic acids (C6-C22), and their ammonium and sodium sulphates
19179040009005-64-5Polyethyleneglycol sorbitan monolaurate
19279120009005-65-6Polyethyleneglycol sorbitan monooleate
19379200009005-66-7Polyethyleneglycol sorbitan monopalmitate
19479280009005-67-8Polyethyleneglycol sorbitan monostearate
19579360009005-70-3Polyethyleneglycol sorbitan trioleate
19679440009005-71-4Polyethyleneglycol sorbitan tristearate
19780240029894-35-7Polyglycerol ricinoleate
19880640-Polyoxyalkyl(C2-C4)dimethylpolysiloxane
19980720008017-16-1Polyphosphoric acids
20081520007758-02-3Potassium bromide
20181600001310-58-3Potassium hydroxide
20281840000057-55-61,2-Propanediol
20381882000067-63-02-Propanol
20482000000079-09-4Propionic acid
20582080009005-37-21,2-Propyleneglycol alginate
20682240022788-19-81,2-Propyleneglycol dilaurate
20782400000105-62-41,2-Propyleneglycol dioleate
20882560033587-20-11,2-Propyleneglycol dipalmitate
20982720006182-11-21,2-Propyleneglycol distearate
21082800027194-74-71,2-Propyleneglycol monolaurate
21182960001330-80-91,2-Propyleneglycol monooleate
21283120029013-28-31,2-Propyleneglycol monopalmitate
21383300001323-39-31,2-Propyleneglycol monostearate
21483320-Propylhydroxyethylcellulose
21583325-Propylhydroxymethylcellulose
21683330-Propylhydroxypropylcellulose
21783440002466-09-3Pyrophosphoric acid
21883455013445-56-2Pyrophosphorous acid
21983460012269-78-2Pyrophyllite
22083470014808-60-7Quartz
22183610073138-82-6Resin acids and rosin acids
22283840008050-09-7Rosin
22384000008050-31-5Rosin, ester with glycerol
22484080008050-26-8Rosin, ester with pentaerythritol
22584210065997-06-0Rosin, hydrogenated
22684240065997-13-9Rosin, hydrogenated, ester with glycerol
22784320008050-15-5Rosin, hydrogenated, ester with methanol
22884400064365-17-9Rosin, hydrogenated, ester with pentaerythritol
22984560009006-04-6Rubber, natural
23084640000069-72-7Salicylic acid
23185600-Silicates, natural
23285980-Silicic acid, salts
23386000-Silicic acid, silylated
23486160000409-21-2Silicon carbide
23586240007631-86-9Silicon dioxide
23686560007647-15-6Sodium bromide
23786720001310-73-2Sodium hydroxide
23887200000110-44-1Sorbic acid
23987280029116-98-1Sorbitan dioleate
24087520062568-11-0Sorbitan monobehenate
24187600001338-39-2Sorbitan monolaurate
24287680001338-43-8Sorbitan monooleate
24387760026266-57-9Sorbitan monopalmitate
24487840001338-41-6Sorbitan monostearate
24587920061752-68-9Sorbitan tetrastearate
24688080026266-58-0Sorbitan trioleate
24788160054140-20-4Sorbitan tripalmitate
24888240026658-19-5Sorbitan tristearate
24988320000050-70-4Sorbitol
25088600026836-47-5Sorbitol monostearate
25188800009005-25-8Starch, edible
25288880068412-29-3Starch, hydrolysed
25389040000057-11-4Stearic acid
25490720058446-52-9Stearoylbenzoylmethane
25590800005793-94-2Stearoyl-2-lactylic acid, calcium salt
25690960000110-15-6Succinic acid
25791200000126-13-6Sucrose acetate isobutyrate
25891360000126-14-7Sucrose octaacetate
25991840007704-34-9Sulphur
26091920007664-93-9Sulphuric acid
26192080014807-96-6Talc
26292160000087-69-4Tartaric acid
26392195-Taurine, salts
26492205057569-40-1Terephthalic acid, diester with 2,2'-methylenebis(4methyl-6-tert-butylphenol)
26592350000112-60-7Tetraethyleneglycol
26692640000102-60-3N,N,N',N'-Tetrakis(2-hydroxypropyl)ethylenediamine
26793440013463-67-7Titanium dioxide
26893520000059-02-9alpha-Tocopherol
" "
26993680009000-65-1Tragacanth gum
27094320000112-27-6Triethyleneglycol
27195200001709-70-21,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4hydroxybenzyl)benzene
27295905013983-17-0Wollastonite
27395920-Wood flour and fibers, untreated
27495935011138-66-2Xanthan gum
27596190020427-58-1Zinc hydroxide
27696240001314-13-2Zinc oxide
27796320001314-98-3Zinc sulphide

PART IISUPPLEMENTARY

1. In regulation 15 and Part I of this Schedule-

(a)the PM/REF No. of any additive is its EEC packaging material reference number;

(b)the CAS No. of any additive is its CAS (Chemical Abstracts Service) Registry Number, and

(c)the name of any additive is its chemical name,

and to the extent that there is any inconsistency between the CAS No. and the name, the name shall take precedence over the CAS No.

2. If an additive appearing in Part I of this Schedule as an individual compound also falls within a generic term which appears therein, the restriction (if any) applying to that additive shall be that indicated for the individual compound and the entry applying to the generic term shall be treated as varied to such extent (if any) as is necessary therefor.

3. If a substance-

(a)identified in Part I of this Schedule is an acid, a phenol or an alcohol and has salts (including double salts) of one or more of the following names (that is to say salts (including double salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then any such salts (including double salts) shall be treated as included in the specification of that substance; and

(b)is identified in Part I of this Schedule as an acid salt and has salt of one or more of the following names (that is to say, salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance."

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Plastic Materials and Articles in Contact with Food Regulations 1992 (S.I. 1992/3145) ("the principal Regulations") and implement Commission Directive 95/3/EEC (OJ No. L41, 23.2.95, p.44), amending Commission Directive 90/128/EEC (OJ No. L75, 21.3.90, p.19, to be read with the corrigendum in OJ No. L349, 13.12.90, p.26) relating to plastic materials and articles intended to come into contact with foodstuffs.

The Regulations-

(a)add definitions of the terms "additive" and "good technical quality" in the principal Regulations (regulation 2(a));

(b)permit the use, sale or importation of plastic materials and articles manufactured using one or more of the monomers in Section E as inserted in Part I of Schedule 1 to the principal Regulations by these Regulations, until 1 April 1998 (regulation 2(b) and (h));

(c)prohibit use in the manufacture of plastic materials or articles of specified additives unless they are of good technical quality (regulation 2(b) and (i));

(d)amend the Item number and letter for two monomers in Section A of Part 1 of Schedule 1 to the principal Regulations (regulation 2(c));

(e)add specified monomers with restrictions as appropriate to those listed in Section A of Part 1 of Schedule 1 to the principal Regulations (monomers authorised without time limit) (regulation 2(d) and (e));

(f)amend the restrictions at items 166 and 180 respectively (Rosin gum and 5-Sulphoisophthalic acid, monosodium salt) in Section A of Part 1 of Schedule 1 to the principal Regulations (regulation 2(f)); and

(g)delete one monomer from Section A of Part 1 of Schedule 1 (monomers authorised without time limit), and delete five monomers from Section B (monomers authorised up to the end of 1996) of Part 1 of Schedule 1 to the principal Regulations (regulation 2(e) and (g)).

A copy of the Compliance Cost Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament and further copies can be obtained from Food Contaminants Division B of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.

(1)

1990 c. 16; "the Ministers" is defined in section 4(1) of the Act.

(2)

S.I. 1976/2141.

(4)

S.I. 1992/3145, amended by S.I. 1995/360.


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