ANNEX IIISupplementary provisions
ANNEX III Annex III to Directive 2002/72/EC is amended as follows: (1) Section A is amended as follows: (a) the following additives are inserted in the appropriate numerical order: Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) ‘38885 002725-22-6 2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine SML = 0,05 mg/kg. For aqueous foods only. 42080 001333-86-4 Carbon black In compliance with the specifications laid down in Annex V. 45705 166412-78-8 1,2-cyclohexanedicarboxylic acid, diisononyl ester 62020 007620-77-1 12-Hydroxystearic acid, lithium salt SML(T) = 0,6 mg/kg ( 8 ) (expressed as lithium) 67180 — Mixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n- octyl ester. SML = 5 mg/kg ( 1 ) 71960 003825-26-1 Perfluorooctanoic acid, ammonium salt Only to be used in repeated use articles, sintered at high temperatures. 74560 000085-68-7 Phthalic acid, benzyl butyl ester To be used only as: (a) plasticizer in repeated use materials and articles; (b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC; (c) technical support agent in concentrations up to 0,1 % in the final product. SML = 30 mg/kg food simulant. 74640 000117-81-7 Phthalic acid, bis (2-ethylhexyl) ester To be used only as: (a) plasticizer in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in concentrations up to 0,1 % in the final product. SML = 1,5 mg/kg food simulant. 74880 000084-74-2 Phthalic acid, dibutyl ester To be used only as: (a) plasticizer in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in polyolefines in concentrations up to 0,05 % in the final product. SML = 0,3 mg/kg food simulant. 75100 068515-48-0 028553-12-0 Phthalic acid, diesters with primary, saturated C 8 -C 10 branched alcohols, more than 60 % C 9 . To be used only as: (a) plasticizer in repeated use materials and articles; (b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC; (c) technical support agent in concentrations up to 0,1 % in the final product. SML(T) = 9 mg/kg food simulant ( 42 ). 75105 068515-49-1 026761-40-0 Phthalic acid, diesters with primary, saturated C 9 -C 11 alcohols more than 90 % C 10 To be used only as: (a) plasticizer in repeated use materials and articles; (b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC; (c) technical support agent in concentrations up to 0,1 % in the final product. SML(T) = 9 mg/kg food simulant ( 42 ). 79920 009003-11-6 106392-12-5 Poly(ethylene propylene) glycol 81500 9003-39-8 Polyvinylpyrrolidone In compliance with the specifications laid down in Annex V. 93760 000077-90-7 Tri-n-butyl acetyl citrate 95020 6846-50-0 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate SML = 5 mg/kg food. To be used in single-use gloves only. 95420 745070-61-5 1,3,5-tris (2,2-dimethylpropanamido)benzene SML = 0,05 mg/kg food.’ (b) for the following additives, the entries in columns 3 ‘Name’ and 4 ‘Restrictions and/or specifications’ are replaced by the following: Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) ‘43480 064365-11-3 Charcoal, activated In compliance with the specifications laid down in Annex V. 45200 001335-23-5 Copper iodide SML(T) = 5 mg/kg ( 7 ) (expressed as copper) and SML = 1 mg/kg ( 11 ) (expressed as iodine) 76845 031831-53-5 Polyester of 1,4-butanediol with caprolactone The restriction for Ref. No 14260 and Ref. No 13720 shall be respected. In compliance with the specifications laid down in Annex V. 81760 — Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron SML(T) = 5 mg/kg ( 7 ) (expressed as copper); SML = 48 mg/kg (expressed as iron) 88640 008013-07-8 Soybean oil, epoxidised SML = 60 mg/kg. However in the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 91/321/EEC or containing processed cereal-based foods and baby foods for infants and young children as defined by Directive 96/5/EC, the SML is lowered to 30 mg/kg. In compliance with the specifications laid down in Annex V.’ (c) the following additive is deleted: Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) ‘35760 001309-64-4 Antimony trioxide SML = 0,04 mg/kg ( 39 ) (expressed as antimony).’ (2) Section B is amended as follows: (a) the following additives are inserted, in the appropriate numerical order: Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) ‘35760 001309-64-4 antimony trioxide SML = 0,04 mg/kg ( 39 ) (expressed as antimony) 47500 153250-52-3 N,N′-Dicyclohexyl-2,6-naphthalene dicarboxamide SML = 5 mg/kg. 72081/10 — Petroleum hydrocarbon resins (hydrogenated) SML = 5 mg/kg ( 1 ) and in compliance with the specifications laid down in Annex V 93970 — Tricyclodecanedimethanol bis(hexahydrophthalate) SML = 0,05 mg/kg.’ (b) for the following additives, the entries in columns 3 ‘Name’ and 4 ‘Restrictions and/or specifications’ are replaced by the following: Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) ‘47600 084030-61-5 Di-n-dodecyltin bis(isooctyl mercaptoacetate) SML(T) = 0,05 mg/kg food ( 41 ) (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride 67360 067649-65-4 Mono-n-dodecyltin tris(isooctyl mercaptoacetate) SML(T) = 0,05 mg/kg food ( 41 ) (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride’ (c) The following additives are deleted: Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) ‘67180 — Mixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n- octyl ester. SML = 5 mg/kg ( 1 ) 76681 — Polycyclopentadiene, hydrogenated SML = 5 mg/kg ( 1 )’