Materials and Articles in Contact with Foodstuffs Regulations

MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 1 SUBSIDIARY LEGISLATION 231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS REGULATIONS 1st January, 1997 Legal Notice 4 of 1996. Title.1. The title of these Regulations is Materials and Articles in Contact with Foodstuffs Regulations. Scope.2. (1) These regulations shall apply to materials and articles which, in their finished state, are brought or are intended to be brought into contact with foodstuffs or with water which, in either case, are intended for human consumption. (2) These regulations shall not apply to: (a) covering or coating substances, including the substances covering cheese rinds, prepared meat products or fruit, which form part of foodstuffs and may be consumed together with those foodstuffs; (b) fixed public or private water supply equipment. Interpretation.3. In these regulations, unless the context otherwise requires "ceramic articles" means articles manufactured from a mixture of inorganic materials with a generally high argillaceous or silicate content to which small quantities of organic materials may have been added; these articles are first shaped, the shape thus obtained being permanent ly f ixed by f i r ing and they may be glazed, enamelled and/or decorated; "EEC" as used in these regulations and in the Schedules thereto means the European Economic Community; Cap. 231. "foodstuffs" has the same meaning as is attributed to "food" in article 2 of the Food, Drugs and Drinking Water Act; "N-nitrosatable substances" means substances capable of being converted into N-nitrosamines; "not detectable" means that the analyte should not be detected by a validated method of analysis which should detect i t at the detection limit specified; "plast ics" means the organic macromolecular compounds obtained by polymerization, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules, and includes silicones and other similar macromolecular compounds to which other substances or matter may be added, but does not include: varnished or unvarnished regenerated cellulose film; elastomers and natural and synthetic rubber; paper and paperboard, whether modified or not by the 2 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS addition of plastics; surface coatings obtained from: paraffin waxes, including synthetic paraffin waxes and/or micro-crystalline waxes; or mixtures of such waxes with each other and/or with plastics; ion-excnange resins; "regenerated cellulose film" means a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton and to which suitable substances may be added either in the mass or on the surface to meet technical requirements and which may be coated on one or both sides; "validated method" means an analytical method which is proven to give precise and accurate results. Manufacture of materials and articles. 4. Materials and articles must be manufactured in compliance with good manufacturing practice so that, under their normal or foreseeable conditions of use, they do not transfer their constituents to foodstuffs in quantities which could (i) endanger human health; (ii) bring about an unacceptable change in the composition of the foodstuff or a deterioration in the organoleptic characteristics thereof. Groups of materials and articles. 5. The groups of materials and articles listed in the First Schedule and, where appropriate, combinations of these materials and articles, shall be subject to the provisions of these regulations. Materials and articles not already in contact with foodstuffs. 6. (1) Without prejudice to any exceptions provided for in these regulations, materials or articles intended to come into, but not already in contact with foodstuffs may not be sold or imported unless accompanied by a label or other indication bearing: (a) the words "for food use", or a specific indication as to their use, such as coffee-machine, wine bottle, soup spoon, or a symbol as indicated in the Second Schedule (b) where appropriate, any special conditions to be observed when they are being used; (c) either the name or trade name and address or registered office, or the registered trade mark of the manufacturer or processor, or of a seller established in Malta. (2) At the retail stage to the ultimate consumer, particulars listed in sub-regulation (1) must be conspicuous, clearly legible and indelible and shall appear (a) on the materials or articles or on their packaging; or (b) on labels affixed to the materials or articles or to their packaging; or MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 3 (c) on a notice in the immediate vicinity of the materials and articles and clearly visible to the purchasers: Provided that, in respect of those particulars referred to in sub-regulation (1)(c), the option in sub-regulation (2)(c) shall only apply if these particulars or a label bearing them, cannot, for technical reasons, be affixed to the said materials or articles. (3) At the marketing stages other than the retail stage to the ultimate consumer the following provisions shall apply: (a) materials or articles must be accompanied by a written declaration attesting that they comply with the rules applicable to them, and (b) in addition, the particulars listed in sub-regulation (1) shall appear: (i) on the accompanying documents, and (ii) on the labels or packaging, or (iii) on the materials or articles themselves. (4) The particulars listed in sub-regulation (1)(a) and the provis ion re fe r red to in sub- regula t ion (3) (a ) sha l l no t be compulsory for materials or articles which by their nature are clearly intended to come into contact with foodstuffs. (5) The particulars provided for in sub-regulation (1)(a) and (b) shall be confined to materials or articles which comply (a) with the criteria laid down in regulation 4, and (b) with those provisions in these regulations relating to the specific group of materials or articles. (6) The particulars required in this regulation shall be given in, at least, one of the official languages of Malta. This requirement does not however preclude the use of other languages in addition to the language or languages of Malta. Limits for vinyl chloride monomer. 7. (1) Materials or articles prepared with vinyl chloride polymers or copolymers must not contain vinyl chloride monomer in a quantity exceeding 1 milligram per kilogram in the final product. (2) Materials or articles referred to in sub-regulation (1) must not pass on to foodstuffs which are in or have been brought into contact with such materials or articles, any vinyl chloride in a quantity equal to or in excess of 0.01 mg per kilogram of the foodstuff. (3) The methods of analysis for the determination of the vinyl chloride levels referred to in sub-regulations (1) and (2) shall be as laid down in the European Community Directives 80/766/EEC and 81/432/EEC respectively. The determination of vinyl chloride released by materials or articles to foodstuffs referred to in sub regulation (2) shall preferably be determined in the foodstuffs themselves, except that, when such determination is shown to be impossible for technical reasons, determination by simulants for these particular foodstuffs is permitted. 4 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS Plastic materials and articles. 8. (1) Materials or articles consisting exclusively of plastics, or composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhes ives o r by any o the r means , sha l l no t t r ans fe r t he i r constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre (mg/dm2) of surface area of material or article (overall migration limit): Provided that, this limit shall be 60 milligrams of the constituents released per kilogram of foodstuff in the following cases: articles which are containers or are comparable to containers or which can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres; articles which can be filled and for which it is impracticable to estimate the surface area in contact with foodstuffs; caps, gaskets, stoppers or similar devices for sealing. (2) The provisions of this regulation shall not apply to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics. (3) (a) Only those monomers and other starting substances listed in Sections A and B of the Third Schedule may be used for the manufacture of plastic materials and articles subject to the restrictions specified therein: Provided that the starting substances listed in Section B of the said Schedule shall not be so used after the 1st January 1997. (b) The quantities specified in column 4 of Sections A and B of the Third Schedule shall be determined by a validated method of analysis at the specified limit. (4) An initial list of additives which may be used for the manufacture of plastic materials and articles is set out in the Fourth Schedule. (5) The specific migration limits laid down in the list set out in the Third Schedule are expressed in milligrams per kilogram (mg/ kg). Such limits are expressed in milligrams per square decimetre (mg/dm2) in the following cases: articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 millilitres or more than 10 litres; sheet, film or other materials which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such materials and the quantity of foodstuff in contact therewith. In these cases, the limits set out in the Third Schedule MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 5 expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2. (6) Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in European Community Directives 82/711/EEC, 85/572/EEC and 90/128/EEC. (7) Verification of compliance with the specific migration limits laid down in the Third Schedule shall not be compulsory, if it can be established that compliance with the overall migration limit laid down in sub-regulation (1) implies that the specific migration limits are not exceeded; or if it can be established that, by assuming complete migration of the residual substance in the material or article, it cannot exceed the specific limit of migration. Regenerated cellulose film. 9. (1) The provisions of this regulation shall apply to regenerated cellulose film, which either constitutes a finished product in itself; or forms part of a finished product containing other materials, and which is intended to come into contact with foodstuffs, or which, by virtue of its purpose, does come into such contact. (2) The provisions of this regulation shall not apply to: regenerated cellulose film which on the side intended to come into contact with foodstuffs or which, by virtue of its purposes does come into such contact, has a coating exceeding 50mg/dm2; synthetic casings of regenerated cellulose. (3) Only those substances or groups of substances listed in the Fifth Schedule may be used for the manufacture of regenerated cellulose film and only under the conditions laid down therein: Provided that, substances other than those listed in the Fifth Schedule may be used when these substances are employed as colouring matter (dyes and pigments) or as adhesives, provided that there is no trace of migration of the substances into or onto foodstuffs, detectable by a validated method. (4) Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs. Ceramics.10. (1) The quantities of lead and cadmium transferred from ceramic articles shall not exceed the limits laid down in sub regulation (3). Such quantities shall be determined by the methods laid down in European Community Directive 84/500/EEC. (2) Where a ceramic article consists of a vessel fitted with a ceramic lid, the lead and/or cadmium limit which may not be exceeded (in mg/dm2 or mg/l) shall be that which applies to the vessel alone. The vessel alone and the inner surface of the lid shall be tested separately and under the same conditions. The sum of the two lead and/or cadmium extraction levels thus obtained shall be related as appropriate to the surface area or the volume of the 6 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS vessel alone. (3) A ceramic article shall be recognised as satisfying the requirements of this regulation if the quantities of lead and/or cadmium extracted as described in the preceding sub-regulations do not exceed the following limits: Category 1: This category comprises: (i) articles which cannot be filled, and (ii) articles which can be filled, the internal depth of which, measured from the lowest point to the horizontal plane passing through the upper rim, does not exceed 25 mm: 0.8 mg/dm2 for lead 0.07 mg/dm2 for cadmium Category 2: All other articles which can be filled: 4.0 mg/l for lead 0.3 mg/l for cadmium Category 3: This category comprises: (i) cooking ware, and (ii) packaging and storage vessels having a capacity of more than three litres. 1.5 mg/1 for lead 0.1 mg/1 for cadmium Provided that, if a ceramic article exceeds the above quantities by less than 50%, that article shall nevertheless be recognised as satisfying the requirements of this regulation, if, at leas t three other ar t ic les wi th the same shape, d imensions , decoration and glaze are subjected to a test carried out as described in the preceeding sub-regulations, and the average quantities of lead and/or cadmium extracted from those articles do not exceed the limits set, with none of those articles exceeding those limits by more than 50%. Teats and soothers. 11. Teats and soothers made of elastomer or rubber must not pass on to the release-test liquid (saliva test solution) under the conditions specified in European Community Directive 93/11/EEC any N-nitrosamine and N-nitrosatable substance detectable by a validated method which can detect the following quantities: 0.01 mg in total of N-nitrosamines released per kilogram of the parts of teat or soother made of elastomer or rubber; 0.1 mg in total of N-nitrosatable substances per kilogram of the parts of teat or soother made of elastomer or rubber. Compliance with these regulations. 12. (1) No person may import, sell, keep for sale, or supply by way of compensation or otherwise, any material or article or any foodstuff which has been or is in contact with such material or article in either case unless the material or article is in compliance with the provisions of these regulations. MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 7 (2) No person may manufacture any material or article or put, wrap or pack any foodstuff in such material or article which in either case does not comply with the provisions of sub-regulation (1). FIRST SCHEDULE (Regulation 5) List of groups of materials and articles Plastics, including varnish and coatings Regenerated cellulose Elastomers and rubber Paper and board Ceramics Glass Metals and alloys Wood, including cork Textile products Paraffin waxes and micro-crystalline waxes SECOND SCHEDULE (Regulation 6) Symbol that may accompany materials and articles intended to come into contact with foodstuffs I I 8 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS THIRD SCHEDULE (Regulation 8) List of Monomers and other Starting Substances which may be used in the manufacture of Plastic Materials and Articles General introduction 1. This Schedule contains the list of monomers or other starting substances. The list includes: substances undergoing polymerization, which includes polycondensation, polyaddition or any other similar process, to manufacture macromolecules, natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or the other starting substances required to synthesize them are not included in the list, substances used to modify existing natural or synthetic macromolecular substances. 2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorized acids, phenols or alcohols which are also authorized. However, names containing ".... acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In such cases the meaning of the term "salts" is "salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc". 3. The list also does not include the following substances although they may be present: (a) substances which could be present in the finished product as: impurities in the substances used, reaction intermediates, decomposition products; (b) oligomers and natural or synthetic macromolecular substances as well as their mixtures, if the monomers or starting substances required to synthesize them are included in the list; (c) mixtures of the authorized substances. The materials and articles which contain the substances indicated under (a), (b) and (c) shall comply with the requirements stated in regulation 4. 4. Substances shall be of good technical quality as regards the purity criteria. 5. The list contains the following information: column 1 (PM/REF No): the EEC packaging material reference number of the substances of the list, column 2 (CAS No): the CAS (Chemical Abstracts Service) Registry number, column 3 (Name): the chemical name, column 4 (Restrictions). These restrictions in column 4 may include: specific migration limit (SML) MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 9 maximum permitted quantity of the "residual" substance in the material or article (QM), any other restriction specifically mentioned. 6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound. 7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS (the European Inventory of Existing Commercial Chemical Substances) and the CAS Registry, the CAS number in the CAS Registry shall apply. 8. A number of abbreviations or expressions are used in column 4 of the table, the meanings of which are as follows: DL = detection limit of the method of analysis; FP = finished material or article; NCO = isocyanate moiety; ND = not detectable; QM = maximum permitted quantity of the "residual" substance in the material or article; QM (T) = maximum permitted quantity of the "residual" substance in the material or article expressed as total of moiety or substance(s) indicated; SML = specific migration limit in food or in food simulant, unless it is specified otherwise; SML (T) = specific migration limit in food or in food simulant expressed as total of moiety or substance(s) indicated. 10 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS PM/Ref.:-.ro. (I) 10030 JO()(;! 10090 10120 10150 10210 10630 10660 10690 10750 10780 10810 10840 11470 11590 11680 11710 11830 11890 l 1980 12100 l2i30 12280 12310 12340 12375 12670 12788 12789 12820 12970 13000 13090 13150 13390 11480 13510 SECTION A List of Authorized Monomers and other Starting Substances CASNo. (2) 000514-10-3 00007 5-07-0 000064-19-7 000108-05-4 000108-24-7 ()(}0074-86-2 000079-06- 1 015214-89-8 000079-10-7 002495-35-4 000141-32-2 002998-08-5 001663-39-4 000140-88-5 000818-61-1 000106-63-8 000689-12-3 000096-33-3 000818-61-1 002499-59-4 000925-60-0 000107-13-l 000124-04-9 002035-7 5-8 002<'\55-13-2 002432-99-7 007 664-41-7 000123-99-9 004196-95-6 001477-55-0 000065-85-0 000100-51-6 000111-46-6 000077-99-6 000105-08-8 000080-05-7 001675-54-3 000 I 10-98-5 005124-30-1 Abietic acid Acetaldehyde Acetic aci<l Nc1mc (3J Acetic acid. vinyl ester Acetic anhydride Acetylene Acrybmidc 2-Acry lamido-2-methylprop:mesulphonic acid Acrylic acid Acrylic acid. bcnzyl ester Acrylic acid. n-butyl ester Acrylic acid, sec-butyl ester Acrylic acid. tert-butyl ester Acrylic acid. ethyl ester Acrylic acid, hydroxyethyl ester Acrylic acid, isohutyl ester Acrylic acid, i~opropyl ester Acrylic acid, methyl e-;ter Acrylic acid, monoester with ethylcncglycol Acrylic acid. n-octyl ester Acrylic acid. propyl e~ter Acrylonitrile Adipic acid Adipic anhydride Albumin Albumin. coaguiated by formaldehyde Alcohols, aliphatic, monohydric, saturated. linear. primary (C4-C22) l -Amino-3-aminomethyl-3 ,5 .5 trimethylcyclohexane 11-Aminoundccanic acid Ammonia Azelmc acid Azclaic anhydride l J-Benzenedimethanamine Benzoic acid Benzyl alcohol Bi~(2-hydroxyethyl) ether 2.2-Bi-'>(hydroxymcthyl)- J -butanol 1,4-Bis(hydroxymethyl) cyclohexune 2.2-Bh(4-hydroxyphcnyl) propane 2.2-Bi~(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether Bis(hydroxypropyl) ether Bi:.(4-isocyanotocyclohexyl) methane Restrictions (4) SML = 12 mg/kg SML = ND (DL = 0,oJ mg/kg) SML = 0.05 mg/kg See • Acrylic acid, monoester with ethyleneglycol' SML = not <letectahle (DL = 0Jl20 mg/kg anal ytical tolerance included) SML = 6 mg/kg SML = 5 mg/kg SML = 0.05 mg/kg See 'Diethyleneglycol" Sec '1.1,1-Trimethylolpropanc' SML = 3 mg/kg Q).1 = 1 mg/lg in FP or SML = not detectable (DL = 0.020 mg/kg, analytical tolerance included) Sec 'Dipropyleneglycol' See 'Dicyclohexylmethane 4,4' -di isocyanate' MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 11 13530 038103-06-9 2,2-Bis(4-hydroxyphenyl) propane SML = 0,05 mg/kg bis(phralic anhydride) 13600 047465-97-4 3,3-Bis(3-methyl-4-hydroxyphenyl)-2- SML= 1,8 mg/kg indolinone 000080-05-7 BisphenoJ A See '2,2-Bis(4-hydroxyphenyl) propane' 001675-54-3 Bisphenol A bis(2,3-epoxypropyl) ether See '2,2-Bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether' 13614 038 l03-06-9 Bisphenol A bis(phtalic anhydride) See 13530 13630 000106-99-0 Butadiene QM = 1 mg/kg in FP or SML = not detectable (DL = 0,020 mg/kg, analytical tolerance included) 13690 000l07-88-0 1,3-Buranediol 13840 000071-36-3 1-Buranol 13870 000106-98-9 I-Butene 13900 000107-01-7 2-Butene 14110 000123-72-8 Bu1yraldebyde 14140 000l07-92-6 Butyric acid 14170 000106-31-0 Bu1yric anhydride 14200 000 l05-60-2 Caprolactam SML(T) = 15 mg/kg 14230 002123-24-2 Caprolactam, sodium salt SML(T) = 15 mg/kg (expressed as caprolacram) 14320 000124-07-2 Caprylic acid 14350 000630-08-0 Carbon monoxide 14380 000075-44-5 Carbonyl chloride QM = 1 mg/kg in FP 14411 008001-79-4 Castor oil 14500 009004-34-6 Cellulose 14530 007782-50-5 Chlorine 000106-89-8 I-Chloro-2,3-cpoxypropane See 'Epichlorohydrin' 14680 000077-92-9 Citric Acid 14710 000108-39-4 m-Cresol 14740 000095-48-7 <>-Cresol 14770 000106-44-5 p-Cresol 000 !05-08-8 I .4-Cyclohexanedimethanol See '1.4-Bis(hydroxymethyl) cyclohexane' 14950 003173-53-3 Cyclohexyl isocyanate QM(I') = I mg/kg in FP (expressed as NCO) 15070 001647-16-1 1,9 - Decadiene SML = 0.05 mg/kg 15095 000334-48-5 Dccanoic acid 15100 000ll2-30-l 1-Decanol 000107-15-3 1.2-Diaminoethane See 'Ethylenediamine' 000124-09-4 1,6-Diaminohexane See 'HexamethyJenediamine' 15250 000110-60-1 l ,4-Diaminobutane 15565 000106-46-7 1.4-Dichlorobenzene SML= 12mg/kg 15700 005124-30-1 Dicyclohexylmelhane-4,4' -di isocyanate QM(I') = 1 mg/kg in FP (expressed as NCO) 15760 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg alone or with ethyleneglycol 15790 000111-40-0 Diethylenetriamine SML=5mg/kg 12 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS l ~820 1:588() 15910 15940 15970 ]600:) 16150 1624() 16600 16630 i666(1 16750 16780 16950 16960 16990 : /005 ; 70~0 J'7C50 ! 'i] 60 ]':'-70 1-:.:::oc i723C 17260 :-:290 00()1-t'i-92 6 0001 20-.':\0-9 UUOl0S-46-3 000123-3l.-9 000611-99-4 C{)()092-88-6 000108-01-0 000091-97-4 iYJ0126-58-9 004128-73-8 00587 3.5.::.. J 000101-68-8 000110-98-5 cuo 106-89-8 000064-17-5 000074-85-1 000107-15-3 000107-21-!. ooo:51-56---4 000075-2;-8 00)104-76-7 00{)097-53-0 06] 788- ➔ 7-4 068308-53-2 061790-[2-3 \KKJOS0-1.'0-0 OCl{L 10-:7-8 Q()fli:J.'.'f,1-99- 7 COO! ('dJJ(l~-55-4 IW1'.ll:'i'i-Sl-5 11•M.:;,i 1.5-~S-6 (f( {ll)cJC).l,l(,-7 I 11'1}]] 5-1] -7 on 145y c.J3 .4 Nnmc (3) 4-4 · -Difluorohcnzophcnom: 1.2-Dihydroxybenzene 1,3-Dihydroxybcnzene 1,4-Dihydroxybenzene 4,4' -Dihydroxybcnzophenone 4,4' -Dihydroxybiphenyl Dimethylaminoethanol 3,3' -Dimethyl-4,4' -diisocyanatobiphenyl Di;Jentacrythritol Diphenyl ether 4,4' -diisocyanate Diphcnylmethane 2,4' -di isocyanate Diphenylmethanc 4,4' -diisocyanate Dipropyleneglyco\ Epichlorohydrin Ethanol Ethylene Ethylenediaminc Ethyleneglycol Ethyleneimine Ethylene oxide 2-Ethyl-1-hexanol Eugene! Fatty acids, coco Fatty acids, soya Fatty acids, tall oil Formaldehyde Fumaric acid Glucose Glutaric add Glutaric anhydride Cilyccrol l kx,11:l1lor<1endomcthylenc,tclr<1 hydruphtha liv ;1cid Hex: ac h /orocndomct h }' /cnctdrn lry d rophthal ic anhydridt: I,! kxadccanol ffo,1llucmipropylc11c He;,.c1mcthy lcncdi,111i inc H,.;:;,.amcthyknc diiwcyar1alL' Hcx::i.methy lcnctctra111i11e 11y<lroquirnmc P-Hydroxyhenzoic acid lc:nhu1cnc [sophthalic acid, dimethyl ester J{cstnct1on~ (4) SML -0,05 mg/kg SML=6mg/kg SML = 2,4 mg/kg SML = 0,6 mg/kg SML= 6 mg/kg SML =6 mg/kg SML= 18 mg/kg QM(T) = 1 mg/kg in FP (expressed as NCO) QM(T) = 1 mg/kg In FP (expressed as NCO) QM(T) = 1 mg/kg In FP ( expressed as NCO) QM(T) = 1 mg/kg In FP (expressed as NCO) QM= 1 mg/kg In FP SML = 12 mg/kg SML(T):::: 30 mg/kg alone or with dicthyleneglycol SML = ND (DL::: 0.01 mg/kg) QM = 1 mg/kg in FP SML = 30 mg/kg SML = 0,01 mg/kg SML"" 15 mg/kg SML=ND(l)l.-0.()1 Sl'v!L.:...: :,.,m (VL c----OJ/1 SML = 2,4 mg/kg QM(Ti -c:c 1 mg/kg m Fl' 1exprcsse.d as NCO) SML ('I')= 15 mg/kg fe.xprcs,t~d as forrnaldchyde'i See' J ,4Dihydrnx yben;.-c·T· SML=0.05 mg/kg MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 13 PM/Ref.No. CASNo, Name Restrictions (I} (2) (3) (4) 19270 000097-65-4 Itaconic acid 19470 000143-07-7 Laurie acid 19510 011132~73-3 Lignocellulose 19540 000110-16-7 Malcic acid SML(T) = 30 mg/kg 19960 000108-31-6 l\1aleic anhydride SML(T) = 30 mg/kg (expressed as malcic acid) 0001 ()8-78-1 \tfelamine See '2,4,6.-Triamino-1 Jj triazine· 20020 000079-41-4 Methacrylic acid 20080 002495-37-6 Methacrylic acid, benzyl ester 20110 000097-88-1 Methacrylic acid, butyl ester 20140 002998-18-7 Mcthacrylic acid, sec-butyl ester 20170 000585-07-9 Merhacrylic acid, tert-butyl ester 211890 000097-63-2 Methacrylic acid, ethyl ester 21010 000097-86-9 Methacrylic acid, isobutyl ester 21 JOO 004655-34-9 Merhacrylic acid, isopropyl ester 21130 000080 62-6 l\-kthacrylic acid. methyl ester 21 I 9() 000868-77-9 Mcthacrylic acid, monocster with ethyleneglycol 21280 002177-70-0 Methacrylic acid. phenyl ester 21:HO 002210-28-8 Mctbacrylic acid. propyl ester 21460 000760-93-0 .tvtcthacrylic anhydride 21490 000126-98-7 Mcthacrylonitrile SML = not detectable (DL = 0,020 mg/kg, analytical tolerance included) 21550 000067 · 56-1 Methanol 21940 000924-4-2-5 N-.r,,..tethylolacrylamide SML=ND(DL=0,01 mg/kg) 22150 000691-37-2 4-Methyl-1-pentene SML = 0,02 mg/kg 22350 000544-63-8 Myristic acid 22390 000840-65-3 2,(,-Naphtalenedic:.irboxylk acid, SML=0,05 mg/kg di methyl ester 22420 003 l 73-72-6 1,5-Naphthalene diisocyanate M(T) = I mg/kg in FP (expressed as NCO) 22450 009004-70-0 Nitrocellulose 22480 000143-08-8 1-Nonanol 22570 000112-96-9 Octadecyl isocyanate QM(T) = ! mg/kg in FP (expressed as NCO) 22600 000111-87-5 1-0ctanol 22660 000 11 I -66-0 1-0ctene SML = I 5 mg/kg 22763 000112-80-1 Oleic acid 22780 000057-10-3 Palmitic acid 22840 000115-77-5 Pcntacrythrirol 22870 000071-41-0 l-Pentanol 22960 000 I 08-95-2 Phenol 23050 000108-45-2 l ,J-Phenylenediamine QM= I m,?ikg in FP 000075-44-5 Phosgene Sec 'Carbonyl chloride' 23170 007664-38-2 Phosphoric acid Phthalic acid See 'Terephthalic acid' 23200 000088-99-3 11-Phthalic acid 23230 000131-17-9 Phthalic acid, diallyl ester SML = ND (DL = 0.01 mg/kg) 23380 000085-44-9 Phthalic anhydride 23470 000080-56-8 alpha-Pinene 23500 000127-91-3 beta- Pinene 23590 025322-68-3 Polyethyleneglycol 14 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS PM/Ref.No. CASNo. Name Restrictions (1) (2) (3) (4) 23650 025322-69-4 Polypropyleneglycol (Molecular weight greater than 400) 23740 000057-55-6 1,2-Propanediol 23800 000071-23-8 1-Propanol 23830 000067-63-0 2-Propanol 23860 000123-38-6 Propionaldehyde 23890 000079-09-4 Propionic acid 23950 000123-62-6 Propionic anhydride 23980 000115-07-1 Propylene 24010 000075-56-9 Propylene oxide QM = 1 mg/kg in FP 000120-80-9 Pyrocaiechol See '1 ;2-Dihydroxybenzene' 24057 000089-32-7 Pyromellitic anhydride SML = 0,05 mg/kg (expressed as pyromellitic acid) x..:.,;; 24070 073138-82-6 Resin acids and rosin acids 000108-46-3 Resorcinol See '1-3-Dihydroxybenzene' 24100 008050-09-7 Rosin 24130 008050-09-7 Rosin gum see 'Rosin' 24160 008052-10-6 Rosin tall oil 24190 009014-63-5 Rosin wood 24250 009006-04-6 Rubber, natural 24270 000069-72-7 Sa1icylic acid 24280 000111-20-6 Sebacic acid 24430 002561-88-8 Sebacic anhydride 24475 001313-82-2 Sodium sulphide 24490 000050-70-4 Sorbitol 24520 008001-22-7 Soybean oil 24540 009005-25-8 Starch.edible 24550 000057-11-4 Stearic acid 24610 000100-42-5 Styrene 24820 00011 ()..15-6 Succinic acid 24850 000108-30-5 Succinic anhydride 24880 000057-50-1 Sucrose 24887 006362-79-4 5-Sulphoisophthalic acid, monosodium salt SML=5 mg/kg 24888 003965-55-7 5-Sulphoisophthalic acid, monosodium SML = 0,05 mg/kg salt, dimethyl ester 24910 000100-21-0 Terephthalic acid SML=7,5 mg/kg 24940 000100-20-9 Terephthalic acid dichloride SML (T) = 7 ,5 mg/kg (expressed as terephthalic acid) 24970 000120-61-6 Terephthalic acid, dimethyl ester 25090 000112-60-7 Tetraethyleneglycol 25120 000116-14-3 Tetrafluoroethylene SML = 0,05 mg/kg 25150 000109-99-9 Tetrahydrofuran SML = 0,6 mg/kg 25180 000102-60-3 N ,N ,N' ,N' -Tetrakis (2-hydroxypropyl) ethylenediamine 25210 000584-84-9 2,4-Toluene diisocyanate QM(T) = I mg/kg in FP (expressed as NCO) 25240 000091-08-7. 2,6-Toluene diisocyanate QM(T) = I mg/kg in FP (expressed as NCO) 25270 026747-90-0 2,4-Toluene diisocyanate dimer QM(T) = I mg/kg in FP (expressed as NCO) MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 15 PM/Ref.No. CAS No. (I) (2) 25360 25420 0IXl! 08-78-1 25510 000112-27-6 25600 000077-99-6 25910 0248()()-44-0 25%0 000057-13-6 26050 000075-01-4 26110 000075-35-4 26!40 Name (3) Trialkyl (C5-C15) aceric acid, 2J-cpoxypropyl ester 2,4,6-Triamino-l ,3 ,5-triazine Triethyleneglycol l ,1.1-Trimethylolpropane Triprupyleneglynil Urea Vinyl chloride Yinylidcne chloride \'inyiidene fluoride Restrictions (4) Sl\-1L = 6 mg/kg SML = 30 mg/kg SML=6mg/kg St>e Council Directive 78/142/EEC QM = 5 mg/kg in FP or SML = not detectable (DL = 0,05 mg/kg) s:vtL = s rng/kg 16 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS SECTION B I ,ist of Monomers and other Starting Substances which may continue to be used pending a Decision on Inclusion in Section A (1) 10160 10162 10480 10510 10599,70 CAS:--lo 000542-02-9 002206-94-2 010521-96-7 l0599/90A 061 788-89-4 10599191 061788-89-4 10599/92A 068783-41-5 !0599/93 10930 11000 1 ID.50 11180 11195 : l 2-i-5 ! 1500 11520 115:~ri 1 l!W l 1620 J Jf/50 11 (,')5 1114-11 068783-41-5 003066-71-5 050976-02-8 001070-70-8 017831-7;.9 068901-05-3 002156-97-0 000103-11-7 00291 ~-23-2 0(-0999-61-1 nr1J:'1,}'.l-t'il-(; 02959()-42-9 111ci 21-1-,1.1 l1] li,1( 1)-1 ?•-.l (1,-124":X- l i L:·) (1):',~J3-l!~-6 114/){J--:'4-(19-i o:=n1 ::.1-1,-;.-, ()9-'.. I 6D-2-'1-'1 00299)-()..:.. J (J{I() l{ l).ll/ . ) (12; 1 ;~ 16-1 ()()012J-7Y-S 004()';...;.. 1.l(i-2 !\"ame Acetoguanamine Acids, a:1phatic, rnonocarboxy Ee, unsan:.rated (C3-C24 l Acids, t'att) unsaturated (Cl 8) Acid:,,, fatty, 1nsaturated (Cl S). dirr:e;>s, distilled d:r:1ers, dimers, acic' .. dieste'.' with tetrn~thylene g'.ycol •\cry Ii:: acid. diester wi:h t:ipropylene gl;co'. \crvlic c..c1G.. :2 ~ulphocthyl cot,:r sulpi;c,pn->r:,l c>::..tLT 1,r:i,l, 11i.'s[e; ~lycerril tr:::. 12-h;,lr\l\)rrnr; ') ;·Iller ,\cylic anJ. tri'.:'~tt'"'." w1:h I .1.1-lr1mcth:,. k•l p1·,)p.1nc ( .:'.-hyJrl11,.) ;:-1h; I J ctkr Adip1c :1ciJ.1Ji; ill:,' AJipic· (K'iJ, di1Lcy Ad1pic ;1, ·iJ. rfo~i.,dcc;! ,\c!1p1c :1cid, d10ct:d cm:r Al'.,p1c ;icid. C:i\rny! e!;ter Rest:ic:ions See '2A-Diamino-6-methyl l ,3..5-Lriazine' MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 17 PM/Ref.No. CASNo. Name Restrictions (I) (2) (3) (4) 12370 Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22) 12610 000107-18-6 Allylalcohol 12700 000150-13-0 p-Aminobenzoic acid 12790 000080-46-6 p-tert-Amylphenol 12850 029602-44-6 Azelaic acid, bis (2-hydroxyethyl) ester 12910 001732-10-1 Azelaic acid, dimethyl ester 000528-44-9 1,2,4--Benzenetricarboxylic acid See 'Trimellitic acid' 13060 004422-95-1 1,3,5-Benzenetricarboxylic acid trichloride 000091-76-9 Benzoguanamine See '2,4-Diamino-6-phenyl 1,3,5-triazine' 13328 000104-38-1 Bis(2-hydroxyethyl) ether of hydroquinone 13660 000584-03-2 1,2-Butanediol 13720 000110-63-4 1,4-Butanediol 13750 000513-85-9 2,3-Butanediol 13780 002425-79-8 1.4-Butanediol bis (2,3-epoxypropyl) QM(T) = 5 mg/kg in FP ether (expressed as epoxy) 13810 000505-65-7 1,4-Butanediol formal 13932 000598-32-3 3-Buten-2-ol 13960 001852-16-0 N-(Butoxymethyl) acrylamide 14020 000098-54-4 4-tert-Buty1phenol 14260 000502-44-3 Caprolactone 000115-28-6 Chlorendic acid See 'Hexachloroendomethyle netetrahyphthalic acid' 14800 003724-65-0 Crotonic acid 15020 002 I 82-05-0 Cyclohexyl vinyl ether 15130 000872-05-9 1-Decene 15280 000542-02-9 2,4-Diamino-6-methyl-1,3,5-triazine 15310 000091-76-9 2,4-Diamino-6-phenyl-I ,3.S-triazine 15340 000109-76-2 1.3-Diaminopropane 15370 003236-53-1 1,6-Diamino-2,2,4-trimethylhexane 15400 003236-54-2 l ,6-Diamino-2,4,4-trimethylhexane 15490 002215-89-6 4,4' -Dicarboxydiphenyl ether 15580 001653-19-6 2,3-Dichloro-I ,3-butadiene 15610 000080-07-9 4,4' -Dichlorodiphenyl sulphone 15730 000077-73-6 Dicyclopentadiene 16090 000080-09-1 4,4 '-Dihydroxydiphenyl sulphone 16210 006864-37-5 3,3'-Dimethyl-4,4'-diaminodicyclohexyl methane 16270 000526-75-0 2,3-Dimethylphenol 16300 000105-67-9 2,4-Dimethylphenol 16330 000095-87-4 2,5-Dimethylphenol 16360 000576-26-1 2,6~Dimethylphenol 16390 000126-30-7 2,2-Dimethyl-1,3-propanediol 16450 000646-06-0 1,3-Dioxolane 16540 000102-09-0 Diphenyl carbonate 16690 001321-74-0 Divinylbenzene 16697 000693-23-2 Dodecanedioic acid 17040 000149-57-5 2-Ethylhexanoic acid 17110 016219-75-3 5-Ethylidenebicyclo [2.2.1] hept~2~ene 17350 000105-75-9 Fumaric acid, dibutyl ester 18220 068564-88-5 N-Heptylaminoundecanoic acid 18370 000592-45-0 1,4-Hexadiene 18400 000592-42-7 1,5-Hexadiene 18441 000085-42-7 Hexahydrophthalic anhydride 18700 000629-11-8 1,6-Hexanediol 18 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS PM/Ref.No CASNo. Name Restrictions (l) (2) (3) (4) 18820 000592-41-6 1-Hexene 18905 002628-17-3 4-Hydroxystyrene 18970 000078-83-1 Isobutanol 19030 016669-59-3 N-(lsobutoxymethyl) acrylamide 19060 000109-53-5 Isobutyl vinyl ether 19090 000078-84-2 lsobutyraldehyde 19120 025339-17-7 lsodecanol 19130 026896-18-4 Isononanoic acid 19150 000121-91-5 Isophthalic acid 19180 000099-63-8 lsophthalic acid dichloride 000078-79-5 lsoprene See '2-Methyl-1,3-butadiene• 19490 000947-04-6 Laurolactam 19570 000999-21-3 Maleic acid, diallyl ester 19600 000105-76--0 Maleic acid, dibutyl ester 19936 007423-42-9 Maleic acid, mono (2-ethylhexyl) ester 19990 000079-39-0 Methacrylamide 20050 000096--05-9 Methacrylic acid, allyl ester 20260 000101-43-9 Methacrylic acid, cyclohexyl ester 20380 001189-08-8 Methacrylic acid, diester with 1,3-butanediol 20410 002082-81-7 Methacrylic acid, di ester with 1,4-butanediol 20440 000097-90-5 Methacrylic acid, diester with ethyleneglycol 20470 025852-47-5 Methacrylic acid, diester with polyethyleneglycol 20530 002867-47-2 Methacrylic acid, 2-(dimethylamino) ethyl ester 20590 000106-91-2 Methacrylic acid, 2,3-epoxypropyl ester QM(T) = 5 mg/kg in FP (expressed as epoxy) 20740 039670-09-2 Methacrylic acid, ester with ethoxytriethyleneglycol 20950 000923-26-2 Methacrylic acid, 2-hydroxypropyl ester 21115 000816-74-0 Methacrylic acid, methallyl ester 21220 032360-05-7 Methacrylic acid, octadecyl ester 21370 010595-80-9 Methacrylic acid, 2-sulphoethyl ester 21400 054276-35-6 Methacrylic acid, sulphopropyl ester 21520 001561-92-8 Methallysulphonic acid, sodium salt QM = 5 mg/kg in FP 21640 000078-79-5 2-Methyl-1,3-butadiene 21730 000563-45-1 3-Methyl-1-butene 21760 000694-91-7 5-Methylenebicyclo[2.2. I ]hept-2-ene 000505-65-7 1,4-(Methylenedioxy) butane See •t,4-Butanediolformal' 21837 001116-90-1 4-Methyl-l ,4-hexadiene SML = ND (DL = 0,05 mg/kg) 21970 000923-02-4 N-Methylolmethacrylamide 22210 000098-83-9 alpha-Methylstyrene 22240 000622-97-9 p-Methylstyrene 22270 000107-25-5 Methyl vinyl ether 22360 001141-38-4 2,6-Naphthalenedicarboxylic acid 000126-30-7 Neopentylglycol See '2,2-Dimethyl 1,3-propanediol' 22428 051000-52-3 Neodecanoic acid, vinyl ester 22540 000 i04-40-5 4-Nonylphenol 000498-66-8 Norbomene See 'Bicyclo[2.2.l]hept-2-ene' 22585 003710-30-3 1,7-0ctadiene 22720 000140-66-9 4-tert-Octylphenol MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 19 i)i\\)j(l\) 1i--:-1 (1() J 1 S ":' ( ) ~-:'-, 1111J(i2Vl>-S 1-Pc·11k11 P1:rilw~r\Y- t.:!h; 11; Q \·l -~ m Ff' 20 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS FOURTH SCHEDULE (Regulation 8(4)) Initial list of additives which may be used in the manufacture of plastic materials and articles General introduction 1. This schedule contains the list of: (a) substances which are incorporated into plastics to achieve a technical effect in the finished product. They are intended to be present in the finished articles; (b) substances used to provide a suitable medium in which polymerization occurs (e.g. emulsifiers, surfactants, buffering agents, etc.). The list does not include the substances which directly influence the formation of polymers (e.g. the catalytic system). 2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorized acids, phenols or alcohols which are also authorized. However, names containing ".... acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In such cases the meaning of the term "salts" is "salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc". 3. The list also does not include the following substances although they may be present: (a) substances which could be present in the finished product as: impurities in the substances used, reaction intermediates, decomposition products; (b) mixtures of the authorized substances. The materials and articles which contain the substances indicated under (a) and (b) shall comply with the requirements stated in regulation 4. 4. Substances shall be of good technical quality as regards the purity criteria. 5. The list contains the following information: column 1 (PM/REF No): the EEC packaging material reference number of the substances of the list, column 2 (CAS No): the CAS (Chemical Abstracts Service) Registry number, column 3 (Name): the chemical name, column 4 (Restrictions). These may include: specific migration limit (SML), maximum permitted quantity of the "residual" substance in the material or article (QM), any other restriction specifically mentioned. 6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound. MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 21 7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS (the European Inventory of Existing Commercial Chemical Substances) and the CAS Registry, the CAS number in the CAS Registry shall apply. Initial list of additives PM/Ref.No CASNo. Name Restrictions (1) (2) (3) (4) 30000 000064-19-7 Acetic acid 30045 000123-86-4 Acetic acid, butyl ester 30140 000141-78-6 Acetic acid, ethyl ester 30280 000108-24-7 Acetic anhydride 30295 000067-64-l Acetone 30370 - Acetylacetic acid, salts 30400 - Acetylated glycerides 30960 - Acids. aliphatic, monocarboxylic (C6-C22), esters with polyglycerol 31328 - Acids, fatty, from animal or vegetable food fats and oils 31730 000124-04-9 Adipic acid 33120 - Alcohols, aliphatic, monohydric, saturated, linear.primary (C,-C,.) 33350 009005-32-7 Alginic acid 34480 - Aluminium fibers, flakes and powders 34560 021645-51-2 Aluminium hydroxide 34690 011097-59-9 Aluminium magnesium carbonate hydroxide 34720 001344-28-1 Aluminium oxide 35120 013560-49-1 3-Aminocrotonic acid, diesterwith thiobis (2-hydroxyethyl) ether 35320 007664-41-7 Ammonia 35440 012124-97-9 Ammonium bromide 35600 001336-21-6 Ammonium hydroxide 35840 000506-30-9 Arachidic acid 35845 007771-44-0 Arachidonic acid 36000 000050-81-7 Ascorbic acid 36080 000137-66-6 Ascorbyl palmitate 36160 010605-09-1 Ascorbyl stearate 36880 008012-89-3 Beeswax 36960 003061-75-4 Behenamide 37040 000112-85-6 Behenic acid 37280 001302-78-9 Bentonite 37600 000065-85-0 Benzoic acid 37680 000136-60-7 Benzoic"acid, butyl ester 37840 000093-89-0 Benzojc acid. ethyl ester 38080 000093-58-3 Benzoic acid, methyl ester 38160 002315-68-6 Benzoic acid, propyl ester 38950 079072-96-l Bis (4-ethylbenzylidene) sorbitol 39890 087826-41-3 Bis (methylbenzylidene) sorbitol 069158-41-4 054686-97-4 40400 010043-11-5 Boron nitride 40570 000106-97-8 Butane 41040 005743-36-2 Calcium butyrate 41280 001305-62-0 Calcium hydroxide 41520 001305-78-8 calcium oxide 41600 012004-14-7 calcium sulphoaluminate 037293-22-4 22 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS PM/Ref.No. CASNo. Name Restrictions (l) (2) (3) (4) 41760 008006-44-8 Candelilla wax 41960 000124-07-2 Caprylic acid 42160 000124-38-9 Carbon dioxide 42500 Carbonic acid, salts 42640 00900Q. ll-7 Carboxymethylcellulose 42720 008015-86-9 Carnauba wax 42800 00900(). 7 l-9 Casein 42960 064 I 47-40-6 Castor oil, dehydrated 43200 Castor oil, mono- and diglycerides 43280 009004-34-6 Cellulose 43300 009004-36-8 Cellulose acetate butyrate 43360 068442-85-3 Celulose. regenerated 43440 008001-75-0 Ceresin 44160 000077-92-9 Citric acid 44640 000077-93-0 Citric acid, triethyl ester 45280 Cotton fibers 45560 014464-46- I Cristobalite 45760 000108-91-8 Cyclohexylamine 45920 009000-16-2 Dammar 45940 000334-48-5 n-Decanoic acid 46070 010016-20-3 alpha-Dextrin 46080 007585-39-9 beta-Dextrin 46375 06 I 790-53-2 Diatomaceous earth 46480 032647-67-9 Dibenzylidene sorbitol 46790 004221-80- I 3.S-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di tert-butylphenyl ester 46800 067845-93-6 3.S-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester 46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxybenzylphospho nic acid, dioctadecyl ester 47440 000461-58-5 Dicyanodiamide 49540 000067-68-5 Dimethyl sulphoxide 51200 000 I 26-58-9 Dipentaerythritol 51760 025265-71-8 Dipropyleneglycol 000 I 10-98-5 52640 016389-88-1 Dolomite 52730 000112-86-7 Erucic acid 52800 000064-17-5 Ethanol 53270 037205-99-5 Ethylcarbox.ymethylcellulose 53280 009004-57-3 Ethylcellulose 53360 000110-31-6 N ,N' -EthyJenebisoleamide 53440 005518-18-3 N,N' -Ethylenebispalmitamide 53520 000 I 10-30-5 N,N' -Ethylenebisstearamide 53600 000060-00-4 Ethylenediaminetetraacetic acid 54005 005136-44-7 Ethylene-N-palmitamide-N' -stearamide 54260 009004-58-4 Ethylhydrox.yethylcellulose 54270 Ethylhydroxymethylcellµlose 54280 Ethylhydroxypropylcellulose ',54450 Fats and oils, from animal or vegetable food sources 54480 Fats and oils, hydrogenated, from animal or vegetable food sources MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 23 PM/Ref.No CASNo. Name Restrictions (I) (2) (3) (4) 55040 000064-18-6 Formic acid 55120 000110-17-8 Fumaric acid 55190 029204-02-2 Gadoleic acid 55440 009000-70-8 Gelatin 55680 000110-94-1 Glutaricacid 55920 000056-81-5 Glycerol 56020 099880-64-5 Glycerol dibehenate 56360 - Glycerol, esters with acetic acid 56487 - Glycerol, esters with butyric acid 56490 - Glycerol, esters with erucic acid 56495 - Glycerol, esters with 12-hydroxystearic acid 56500 - Glycerol, esters with lauric acid 56510 - Glycerol, esters with linoleic acid 56520 - Glycerol, esters with myristic acid 56540 - Glycerol, esters with oleic acid 56550 - Glycerol, esters with palmitic acid 56565 - Glycerol, esters with nonanoic acid 56570 - Glycerol, esters with propionic acid 56580 - Glycerol, esters with ricinoleic acid 56585 - Glycerol, esters with stearic acid 56610 030233-64-8 Glycerol monobehenate 56720 026402-23-3 Glycerol monohexanoate 56800 030899-62-8 Glycerol monolaurate diacetate 56880 026402-26-6 Glycerol monooctanoate 57040 - Glycerol rnonooleate, ester with ascorbic acid 57120 - Glycerol monooleate, ester with citric acid 57200 - Glycerol monopalmitate, ester with ascorbic acid 57280 - Glycerol monopalmitate, ester with citric acid 57600 - Glycerol monostearate, ester with ascrobic acid 57680 - Glycerol monostearate, ester with citric acid 57920 000620-67-7 Glycerol triheptanoate 58300 - Glycine, salts 58320 007782-42-5 Graphite 58400 009000-30-0 Guargum 58480 009000-01-5 Gum arabic 58720 000111-14-8 Heptanoic acid 59360 000142-62-1 Hexanoic acid 59760 019569-21-2 Huntite 59990 007647-01-0 Hydrochloric acid 60030 012072-90-I Hydromagnesite 60080 012304-65-3 Hydrotalcite 60160 000120-47-8 4-Hydroxybenzoic acid, ethyl ester 60180 004191-73-5 4-Hydroxybenzoic acid. isopropyl ester 60200 000099-76-3 4-Hydroxybenzoic acid, methyl ester 60240 000094'-13-3 4-Hydroxybenzoic acid, propyl ester 60560 009004-62-0 Hydroxyethylcellulose 60880 009032-42-2 Hydroxyethylmethylcellulose 61120 009005-27-0 Hydroxyethyl starch 61390 037353-59-6 Hydroxymethylcellulose 24 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS PM/Ref.No. CASNo. Name Resttictions (I) (2) (3) (4) 61680 009004-64-2 Hydroxypropylcellulose 61800 009049-76-7 Hydroxypropyl starch 61840 000106-14-9 12•Hydroxystearic acid 62140 006303-21-5 Hypophosphorous acid 62240 001332-37-2 Iron oxide 62450 000078-78-4 lsopentane 62640 008001-39-6 Japan wax 62720 001332-58-7 Kaolin 62800 - Kaolin, calcined 62960 000050-21-5 Lactic acid 63040 000138-22-7 Lactic acid, butyl ester 63280 000143-07-7 Laurie acid 63760 008002-43-5 Lecithin 63840 000123-76-2 Levulinic acid 63920 000557-59-5 Lignoceric acid 64015 000060-33-3 Linoleic acid 64150 028290-79-1 Linolenic acid 64500 - Lysine, salts 64640 001309-42-8 Magnesium hydroxide 64720 001309-48-4 Magnesium oxide 65020 006915-15-7 Malic acid 65040 000141-82-2 Malonic acid 65520 000087-78-5 Mannitol 66200 037206-01-2 Methylcarboxymethylcellulose 66240 009004-67-5 Methylcellulose 66640 009004-59-5 Methylethylcellulose 66695 - Methylhydroxymethylcellulose 66700 009004-65-3 Methylhydroxypropylcellulose 67120 012001-26-2 Mica 67200 001317-33-5 Molybdenum disulphide 67840 - Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol 67850 008002-53-7 Montan wax 67891 000544-63-8 Myristicacid 68040 003333-62-8 7-[2H-Naphtho-(l;l.-D)triazol-2-yl]-3 phenylcoumarin 68125 068 I 87-64-4 Nepheline syenite 69040 000112-80-1 Oleic acid 69760 000143-28-2 Oley! alcohol 70000 070331-94-1 2;1.' -Oxamidobis[ ethyl-3-(3 ,5-di-tert-butyl 4-hydroxypehnyl)-propionate] 70240 012198-93-5 Ozokerite 70400 000057-10-3 Palmitic acid 71020 000373-49-9 Palmitoleic acid 71440 009000-69-5 Pectin 71600 000115-77-5 Pentaerythritol 71680 006683- I 9-8 Pentaerythritol tetrakis[3-(3,5-di-tert-butyl 4-hydroxypehnyl)-propionate] 71720 000109-66-0 Pentane 72640 007664-38-2 Phosphoric acid MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 25 PM/Ref.No. CASNo. Name Restrictions (I) (2) (3) (4) 74240 031570-04-4 Phosphorous acid, tris(2,4-di-ten butylphenyl) ester 74480 000088-99-3 o-Phthalic acid 76320 000085-44-9 Phthalic anhydride 76720 009016-00-6 Polydimethylsiloxane 063148-62-9 76960 025322-68-3 Polyethyleneglycol 77600 061788-85-0 Polyethyleneglycol ester of hydrogenated castor oil 77702 - Polyethyleneglycol esters of aliphatic mono carboxylic acids (C6-C22). and their ammonium and sodium sulphates 79040 009005-64-5 Polyethyleneglycol sorbitan monolaurate 79120 009005-65-6 Polyethyleneglycol sorbitan monooleate 79200 009005-66-7 Polyethyleneglycol sorbitan monopalmitate 79280 009005-67-8 Polyethyleneglycol sorbitan monostearate 79360 009005-70-3 Polyethyleneglycol sorbitan trioleate 79440 009005-71-4 Polyethyleneglycol sorbitan tristearate 80240 029894-35-7 Polyglycerol ricinoleate 80640 - Polyoxyalkyl(C2-C4)dimethylpolysiloxane 80720 008017-16-1 Polyphosphoric acids 81520 007758-02-3 Potassium bromide 81600 001310-58-3 Potassium hydroxide 81840 000057-55-6 1,2-Propanediol 81882 000067-63-0 2-Propanol 82000 000079-09-4 Propionic acid 82080 009005-37-2 1,2-Propyleneglycol alginate 82240 022788-19-8 l ,2•Propyleneglycol dilaurate 82400 000105-62-4 1,2-Propyleneglycol dioleate 82560 033587-20-1 1,2-Propyleneglycol dipalmitate 82720 006182-11-2 1 ,2.Propyleneglycol distearate 82800 027194-74-7 1,2-Propyleneglycol monolaurate 82960 001330-80-9 1,2-Propyleneglycol monooleate 83120 029013-28-3 I ;2-Propyleneglycol monopalmitate 83300 001323-39-3 1 ;2-Propyleneglycol monostearate 83320 - Propylhydroxyethylcellulose 83325 - Propylhydroxymethylcellulose 83330 - Propylhydroxypropylcellulose 83440 002466-09-3 Pyrophosphoric acid 83455 013445-56-2 Pyrophosphorous acid 83460 012269-78-2 Pyrophyllite 83470 014808-60-7 Quartz 83610 073138-82-6 Resin acids and rosin acids 83840 008050-09-7 Rosin 84000 008050-31-5 Rosin, ester with glycerol 84080 008050-26-8 Rosin, ester with pe-E taerythritol 84210 065997-06-0 Rosin, hydrogenated 84240 065997-13-9 Rosin, hydrogenated, ester with glycerol 84320 008050-15-S Rosin, hydrogenated, ester with methanol 84400 064365-17-9 Rosin, hydrogenated, ester with pentaery thritol 84560 009006-04-6 Rubber, natural 26 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS Name Salicylic acid Si!i~;\(I':-., n<ttllral Silicic arn.L salts Silinc ac1d, silyhlled Silicon cc1r\lide Silicon dioxide Sorbitan Jll!lll(1l1cl1enatc Snrhilim monoolcatc Sorbit;m monop,1lmi1:1\e Sorhita11 mo11Dslearati: Sorhitt.lH lctra.stcarate Sorhiun tnoleatc :Srcaw vl-2-lactylic ac1d, calcium salt Sncdni,- acid Sucrn.se accrate isohutyrat~ Sucro1se octaacetate S\1\pl1,tr Swlphuric acid T;.1lc l"iu1ari~· acid T:rnri11c, s,dt:. Tcrephthalic acid. dic.;-:;1cr with 2.2- -rnethyie ncbiM 4-mc1 liy 1~6-tnt -butylphemi!J Woo<l flour and fibers, untreated Xan(nan guru Zinc hydroxide Zinc oxide Zinc sulphide MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 27 FIFTH SCHEDULE (Regulation 9) List of Substances authorized in the Manufacture of Regenerated Cellulose Film The percentages in this Schedule, 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 substances used shall be of good technical quality as regards the purity criteria. FIRST PART Uncoated Regenerated Cellulose Film Denominations A. Regenerated cellulose B. Additives 1. Sofreners Bis (2-hydroxyethyl) ether [ = diethy leneglycol] Ethancdiol [ = monoethyleneglyco]l 1,3-butanc<liol Glycerol 1,2-propanediol { = 1.2 propyJeneglycol] Polyethylene oxide I= polycthylcneglycol] 1,2-polypropylene oxide [ = 1,2 poly propyleneglycol] Sorbitol Tetraethyleneglycol Triethy!encglycol Urea 2. Other additives FIRST CLASS Acetic acid and its NH4• Ca, Mg. Kand Na salts Restrictions Not less than 72% (w/w) Not more than 27% (w/w) in total Only for films intended to be coated and then used for foodstuffs which arc not moist, i.e., which do not contain water which is physically free at the surface. The total amount of bis(2-hydroxyethyl)ethcr and ethanediol present in foodstuffs that have been in contact with film of this type may not exceed 30 mg/kg of the food.stuff. Average molecular weight between 250 and 1200 Avcrage molecular weight not greater than 400 and free 1.3-propanediol content not greater than 1 % (w/w) in substance Noc more than l % (w/w) in total The quantity of the substance or group of suhstances in each indent may not exceed 2 mg/dm2 of the uncoated film 28 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS Denominations Ascorbic acid and its NH4• Ca, Mg, Kand Na salts Benzoic acid and sodium benzoatc Formic acid and its NH"', Ca, Mg, Kand 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, Z.n salts of these acids Citric, d and I lactic, maleic, I-tartaric acids and their Na and K salts Sorbicacidandits NH4, ca, Mg, Kand 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 ricinolcic acids Natural edible starches and flours Edible starches and flours modified by chemical treatment Amylase 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 Esrers of polyo'lyethylene (8 to 14 oxy ethylene groups) with linear fatty acids, saturated or unsaturated. with an even number of carbon atoms from 8 to 20 inclusive Esters of sorbitol with \ ear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 co 20 inclusive MOnc,.and/or di-esters of stearic acid with ethanediol and/or bis (2-hydroxyethyl) ether and/or lriethylene glycol Oxides and hydroxides of aluminium, calcium. magnesium and silicon and siUcates and hydrated silicates of alumin• ium, calcium, magnesium and potassium Restrictions Polyethylene oxide [ = polyethyleneglycol] Average molecular weight between 1200 and 4000 Sodium propionate MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 29 SECOI\U Cl ,,\SS Smi:un~ alk\' 1 1c, c;,; \ul11 11,11e 2)oc1iurn 1(, 111 C:;) \uhh(1J1.l!c S1Hliurn Ji; x:lyl,ulpho~ucci11~1t(· Dislearn!e of diilydr,,\ ,, thy! J1etl1\-klh' 1\,11 m,:,re thJ.n !JJ)S lll" din: .Jt lhc:: 1\lm tnamine m,:.110,:l'•:t:ilL· Amm1rn111·:· Liury] ::;ul;::,hate.~ ~ N,:i\'-C1sr~·aro:l 11 c,minc,cth.1:-c. '\J.'\/' dipalrnitn:vl :liar,.inon:h .rnc ,rnJ :\.!\ dinlcqy! di:1mi1hJdh:rne ::-hcp\·c',Je:.:·il ,n::J;,;cilinc Cn11dc,>c1t1nn rroJuct ill rnclumi1h'-1or- ·•,g/drnc n1:1ldd1yJ, , unm-,1d1:"1cJ. n · whkf1 mJ.V lh:m mg.'rl rw of :01hydrin 30 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS Denominations (c) polyamide-epichlorhydrin resin based on adipic acid, diethylenetriamine and epichlorhydrin, or a mixture of epichlor hydrin and ammonia (d) polyamide-polyamine-cpich!orhydrin resin ba.scd on epichlorhydrin, dimethyl adipate and diethylenetriamine (e) polyamide-polyaminc-epichlorhydrin resin based on epichlorhydrin, adipamidc and diaminopropy!mcthylamine Restrictions Polycthyleneamines and polyethyleneimines Not more than 0,75 mg/dm2 of the uncoate.d film Condcnsmion product ofurea-fom1aldehydc Free formaldehyde content not greater than 0,5 mg/dm2 unmodifcd, or which may be modified with of the uncoated film one or more of the following products: arninomethylsulphonic acid. wlphanilic acid, butanol, diaminobutane, diamino diethylamine, diaminodipropylamine, diaminopropane, diethy lenctriamine, ethanol. guanidinc, methanol. retraethy 1 enepentami ne, t riet h y lenet etramine, sodium sulphite FOURTH CLASS Products resulting: from the reaction of the amines of edible oils with polyethylene oxide Monocrhanolamine lauryl sulphate The total quantity of substances may not exceed 0,01 mg/Jmi of the uncoate.d film MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 31 SECOND PART Coated Regenerated Cellulose Film Denominations Restrictions A. Regenerated cellulose Sec first part of this Schedule B. Additives Si.;c first part of this Schedule C. Coaling Not more than 50 mg of coaring/drn' of film on the side in contact with foodstuffs 1. Polymers The total quantity of substances may not exceed 50 mg/ Ethyl, hydroxyethyl, hydroxypropyl and dm2 of the coating on the side in contact with foodstuffs methyl ethers of cellulose Cellulose nitrate Polymers, copolymers and their mixtures made with the following monomers· vinyl acetals derived from saturated aldehydes (C: to C4) vinyl acetate alkyl (C 1 to C4) vinyl ethers acrylic, crotonic, itaconlc, ma!eic, metha crylic acids and their cswrs but,:1diene styrene methylst yrcnc vinylidene chloride acrylonitrile methacrylonitrile ethylene, propylene, 1- and 2-butylene vinyl chloride 2. Resins Casein and/or its products of poly hydrogcnation. or dispropor tionation and their esters of methyl, ethyl polyvalem alcohols, or mixtures Colophony and/or its products of poly merization. hydrogenation, or dispropor tionation condensed with acrylic. rnalek, citric. fumaric and/or phthalic acids and/ Not more than 20 mg/dm2 of the coaling on the ~ide in contact with foodstuffs; nitrogen content between 10.8% (w/wJ and 12,2% (w/v-.-) in the cellulose nitrate in accordance with European Community directives, if applicable In accordance with regulation 7 of these regulations 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 film::, with cellulose nitrate or vinyl chloride <1nd vinyl acetate copolymer based coatings 32 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS Denominations or 2.2 bis (4-hydroxphenyl propane for maldehyde and esterificd 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 muleic anhydride Edible gelatine Castor oil and its products of dehydration or hydrogenation and its condensation products with polyglycero!, adipic, citric. makic, phtha!ic and sabacic acids Natural gum[= damarj Poly-beta-pinene f= terpenic resins] lirl·a-formaldchyde resins (see ;i.nchoring agents) 3. Pfo1·1icizers Acetyl Lrihutyl citrate Acetyl tri(2-eLhylhexyl) citrate Di-isobutyl aJipate Di-n-butyl adipate Di-n-hexyl azelate Butylbenzylphthal::lte Di-n-hutyl phthalmc Dicyclohexyl phtha!ate 2-ethylhexyl di phenyl phosphate Glycerol monoace1ate [= monoacetin] GlyCL~rol diacetate l= diacetin] Glycerol triacetate [ = triacetin] Di-butyl sebacalc Di(2-cthylhcxal) sebacate [= dioctyl sebacatc] Di-n-butyl tartralc Di-i:-.obutyl tartrate Restrictions The total quantity of substances may not exceed 6 mi: dm2 of the coating on the side in contact with foodstuft l'iot more than 2.0 mg/dm2 of the coating on the side i1 contact with foodstuffs l\ot more than 3,0 mg/dm' of the coating on the side i1 contact wi lh foodstuffs Not more than 4,0 mg/dm2 of Lhe coating on the side h contact with foodstuffs Not more than 2.5 mg/dm' ot' the coating on the side i1 contact with foodstuffs MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS [S.L.231.31 33 lkw1m,nati<.1t1s n>i!!/n;; uddi!1v1'.1·· f:qcrs llf. linrJr fotty <JCids, s;111ir;11l:tl 01 uns.,1t11,.,c1tcd, with an even nnmhcr1)f carbon irnrn X to '.20 inclusive and ol ncino!ci:.: ,1:·id wi!h ethyl, butyl, amyl am] (•lcyl li11t·c...r -➔ kohols tnrriprising purified nwn acid!. and/or their csh~rs. ;mJJor \ .3 butarwtliol ;u1d) rn· thr: · ~-aluun1 :ind po111.,;sium sails c:01,<1-h:an oil (uxirane content Rci'inccl fldrc1ffin :mu micmcrystalline 1,vaxes P~ntacn-thntoJ ·.,;;1r,1s1c.,1rate Tlw tnLII WJcmt1tv 1if s',:hs\; c,~~, n',;1y rn,! \",'-Ced 1, m:,:: d111' in the uncoaied rl· gcneratcd n:!lii 11 ,.s.L· I ilm. 1nL· I·: of the coaling on the side in crn1!:icl with h,csJs1uft\ S.rnw restriction~ as in Hie firq p:111 qu:mtilics in rng/Jrn' rclcr lo lhe u1HJJ<1tl'd cellulose (ilrn. mclusivc of th: coatn:;C on rhc ,i.k 1r1 co111,1cl with loc,d:,1111'1.,) of the ltil th:: \Jono :md ·-,-~.-n~:1adccylthethylc11coxidG)- Not more than 0,2 rng/drr/ of the n,aun; tk r,:;u,,ph:ik, contact with foodstuff:. :: and .l-1cn.l ":1y) • .,t.flydmxyanisol,: /--;;;buty- Not more than 0,()(i 1ng/dm; 0t'tlls: co.011c;; n:·1 tk '-idc rn lah! h:,drc,xyc1.nisnk.- BHAJ comue1 wi1t1 fooJstut'fs 2.6-;Ji-ten.hcityf.+-nicthylphenol [= buty bted hy.jrox;,wluenc-- HJITJ Di -11-.-,ct; l'.in-h~(,::. ethylhcxyl) nialcatc. The total quantity ot suhstunccs nrn) dm2 of the coating on the sidt:: in i:unUJ.ct with 34 [S.L.231.31 MATERIALS AND ARTICLES IN CONTACT WITH FOODSTUFFS EOl\'] JL'Ct:ill' hi>pnr,:vl :tL'-::t,1!.e Pr11pyl ;1, ·tc1:e J:1h.mul :-t-uurnoi ~-rrop:-JlJ(\I l •prop,moJ Cyclohexane Ethyleneg:yco: monobutyl ether Ethylenegl)col monobnyl ether acetate E:hyleneglycol monoei::yl ether Et:1} !eneglycol rno;-ioe.thy 1 ether acetate Etl1ykr:eg:lycol monorneih:. e:her Ethyleneg:yco: rr.onomc:h:l etJer a'-:ew.te \1et:-.yl e:hy: ketone 1\-letl1y! isob:..:ty'. ketone Tctrn.hy:Jrof:.,:-an T,7L:enc ::caring on the s.iCe in