OpenLegislation

Annex III X1

United Kingdom

Original text. Later amendments are not shown.

Annex III to Directive 2002/72/EC is amended as follows:

  1. (1)

    Section A is amended as follows:

    1. (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:

      1. (a)

        plasticizer in repeated use materials and articles;

      2. (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;

      3. (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:

      1. (a)

        plasticizer in repeated use materials and articles contacting non-fatty foods;

      2. (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:

      1. (a)

        plasticizer in repeated use materials and articles contacting non-fatty foods;

      2. (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:

      1. (a)

        plasticizer in repeated use materials and articles;

      2. (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;

      3. (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:

      1. (a)

        plasticizer in repeated use materials and articles;

      2. (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;

      3. (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. ’
    2. (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. ’

    3. (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. (2)

    Section B is amended as follows:

    1. (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. ’
    2. (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’
    3. (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 )’

Annotations

Editorial notes

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).