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Commission Directive 2007/19/ECShow full title
Commission Directive 2007/19/EC of 2 April 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
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Changes over time for: ANNEX III
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[X1ANNEX III U.K.
Editorial Information
X1 Substituted by Corrigendum to Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (Official Journal of the European Union L 91 of 31 March 2007).
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 )]’ |
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