title: Commission Directive 2005/79/EC of 18 November 2005 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food   (Text with EEA relevance)

text:
               19.11.2005

               EN

               Official Journal of the European Union

               L 302/35

      COMMISSION DIRECTIVE 2005/79/EC
   of 18 November 2005
   amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 5(2) thereof,
   After consulting the European Food Safety Authority,
   Whereas:

               (1)

               Commission Directive 2002/72/EC (2) establishes a list of monomers and other starting substances, which may be used for the manufacture of plastic materials and articles. On the basis of new information related to the risk assessment of such substances, certain monomers provisionally admitted at national level as well as new monomers should be included in the Community list of permitted substances in that Directive.

               (2)

               Directive 2002/72/EC also contains an incomplete list of additives which may be used in the manufacture of plastic materials and articles. That list should be amended so as to include other additives evaluated by the European Food Safety Authority (the Authority).

               (3)

               For certain substances, the restrictions already established at Community level should be amended on the basis of the new information available. In particular for epoxidised soybean oil (ESBO) the Authority recommended to decrease its specific migration limit (SML) for PVC gaskets containing that substance which are used to seal glass jars containing infant formulae and follow-on formulae or containing processed cereal-based foods and baby foods for infants and young children. In fact the Authority noted that the exposure of infants who regularly eat such foods may exceed the TDI. Therefore the SML for ESBO is decreased for these particular applications from 60 to 30 mg/kg of food or food simulant while it remains unchanged for all other applications.

               (4)

               A transitional period should be provided for in respect of PVC gaskets containing epoxidised soybean oil, used to seal glass jars, which are brought into contact with food before the 19 November 2006.

               (5)

               Directive 2002/72/EC should therefore be amended accordingly.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes II, III, V and VI of Directive 2002/72/EC are amended in accordance with Annexes I to IV to this Directive.
   Article 2
   PVC gaskets containing epoxidised soybean oil, with reference number 88640 in section A of Annex III to Directive 2002/72/EC, which are used to seal glass jars containing infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC (3) or containing processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 96/5/EC (4), filled before 19 November 2006 and which comply with the restrictions and/or specifications provided for in Section A of Annex III to Directive 2002/72/EC as amended by Directive 2004/19/EC, may continue to be placed on the market provided that the date of filling appears on the materials and articles.
   The date of filling may be replaced by another indication, provided that that indication permits the identification of the date of filling. Upon request the date of filling shall be made available to the competent authorities and any person enforcing the requirements of this Directive.
   The first and second subparagraphs shall apply without prejudice to Directive 2000/13/EC of the European Parliament and of the Council (5).
   Article 3
   1.   Member States shall adopt and publish, by 19 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions in such a way as to:

               (a)

               permit the trade in and use of plastic materials and articles intended to come into contact with food and complying with this Directive, from 19 November 2006;

               (b)

               prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food and which do not comply with this Directive, from 19 November 2007.

         When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 18 November 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 338, 13.11.2004, p. 4.

      (2)  OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive 2004/19/EC (OJ L 71, 10.3.2004, p. 8).

      (3)  OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).

      (4)  OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

      (5)  OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

      ANNEX I
      Annex II to Directive 2002/72/EC is amended as follows:

                  1.

                  point 2 of the general introduction is replaced by the following:

                              ‘2.

                              The following substances are not included even if they are intentionally used and are authorised:

                                          (a)

                                          salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in the lists, if the corresponding free acid(s) is (are) not mentioned;

                                          (b)

                                          salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:

                                                      (i)

                                                      substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,

                                                      (ii)

                                                      substances referred to in note 38 of Annex VI.’;

                  2.

                  section A is amended as follows:

                              (a)

                              the following lines are inserted in the table in numerical order:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘11005

                                          012542-30-2

                                          Acrylic acid, dicyclopentenyl ester

                                          QMA = 0,05 mg/6 dm2

                                          11500

                                          000103-11-7

                                          Acrylic acid, 2-ethylhexyl ester

                                          SML = 0,05 mg/kg

                                          12786

                                          000919-30-2

                                          3-Aminopropyltriethoxysilane

                                          Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler. To be used only for the reactive surface treatment of inorganic fillers

                                          13317

                                          132459-54-2

                                          N,N′-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide

                                          SML = 0,05 mg/kg. Purity > 98,1 % (w/w). To be used only as co-monomer (max 4 %) for polyesters (PET, PBT)

                                          14260

                                          000502-44-3

                                          Caprolactone

                                          SML = 0,05 mg/kg (expressed as the sum of caprolactone and 6-hydroxyhexanoic acid)

                                          16955

                                          000096-49-1

                                          Ethylene carbonate

                                          Residual content = 5 mg/kg of hydrogel at a maximum ratio of 10 g of hydrogel to 1 kg of food. The hydrolysate contains ethyleneglycol having an SML = 30 mg/kg

                                          21370

                                          010595-80-9

                                          Methacrylic acid, 2-sulphoethyl ester

                                          QMA = ND (DL = 0,02 mg/6 dm2)

                                          22210

                                          000098-83-9

                                          alpha-Methylstyrene

                                          SML = 0,05 mg/kg

                                          22932

                                          001187-93-5

                                          Perfluoromethyl perfluorovinyl ether

                                          SML = 0,05 mg/kg. Only to be used for anti-stick coatings

                                          24903

                                          068425-17-2

                                          Syrups, hydrolysed starch, hydrogenated

                                          In compliance with the specifications laid down in Annex V

                                          25540

                                          000528-44-9

                                          Trimellitic acid

                                          SML(T) = 5 mg/kg (35)

                                          25550

                                          000552-30-7

                                          Trimellitic anhydride

                                          SML(T) = 5 mg/kg (35) (expressed as trimellitic acid)’

                              (b)

                              in the following lines the content of the columns ‘CAS No’ or ‘Restrictions and/or specifications’ is replaced by the following:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘10690

                                          000079-10-7

                                          Acrylic acid

                                          SML(T) = 6 mg/kg (36)

                                          10750

                                          002495-35-4

                                          Acrylic acid, benzyl ester

                                          SML(T) = 6 mg/kg (36)

                                          10780

                                          000141-32-2

                                          Acrylic acid, n-butyl ester

                                          SML(T) = 6 mg/kg (36)

                                          10810

                                          002998-08-5

                                          Acrylic acid, sec-butyl ester

                                          SML(T) = 6 mg/kg (36)

                                          10840

                                          001663-39-4

                                          Acrylic acid, tert-butyl ester

                                          SML(T) = 6 mg/kg (36)

                                          11470

                                          000140-88-5

                                          Acrylic acid, ethyl ester

                                          SML(T) = 6 mg/kg (36)

                                          11590

                                          000106-63-8

                                          Acrylic acid, isobutyl ester

                                          SML(T) = 6 mg/kg (36)

                                          11680

                                          000689-12-3

                                          Acrylic acid, isopropyl ester

                                          SML(T) = 6 mg/kg (36)

                                          11710

                                          000096-33-3

                                          Acrylic acid, methyl ester

                                          SML(T) = 6 mg/kg (36)

                                          11830

                                          000818-61-1

                                          Acrylic acid, monoester with ethyleneglycol

                                          SML(T) = 6 mg/kg (36)

                                          11890

                                          002499-59-4

                                          Acrylic acid, n-octyl ester

                                          SML(T) = 6 mg/kg (36)

                                          11980

                                          000925-60-0

                                          Acrylic acid, propyl ester

                                          SML(T) = 6 mg/kg (36)

                                          13720

                                          000110-63-4

                                          1,4-Butanediol

                                          SML(T) = 5 mg/kg (24)

                                          20020

                                          000079-41-4

                                          Methacrylic acid

                                          SML(T) = 6 mg/kg (37)

                                          20080

                                          002495-37-6

                                          Methacrylic acid, benzyl ester

                                          SML(T) = 6 mg/kg (37)

                                          20110

                                          000097-88-1

                                          Methacrylic acid, butyl ester

                                          SML(T) = 6 mg/kg (37)

                                          20140

                                          002998-18-7

                                          Methacrylic acid, sec-butyl ester

                                          SML(T) = 6 mg/kg (37)

                                          20170

                                          000585-07-9

                                          Methacrylic acid, tert-butyl ester

                                          SML(T) = 6 mg/kg (37)

                                          20890

                                          000097-63-2

                                          Methacrylic acid, ethyl ester

                                          SML(T) = 6 mg/kg (37)

                                          21010

                                          000097-86-9

                                          Methacrylic acid, isobutyl ester

                                          SML(T) = 6 mg/kg (37)

                                          21100

                                          004655-34-9

                                          Methacrylic acid, isopropyl ester

                                          SML(T) = 6 mg/kg (37)

                                          21130

                                          000080-62-6

                                          Methacrylic acid, methyl ester

                                          SML(T) = 6 mg/kg (37)

                                          21190

                                          000868-77-9

                                          Methacrylic acid, monoester with ethyleneglycol

                                          SML(T) = 6 mg/kg (37)

                                          21280

                                          002177-70-0

                                          Methacrylic acid, phenyl ester

                                          SML(T) = 6 mg/kg (37)

                                          21340

                                          002210-28-8

                                          Methacrylic acid, propyl ester

                                          SML(T) = 6 mg/kg (37)

                                          21460

                                          000760-93-0

                                          Methacrylic anhydride

                                          SML(T) = 6 mg/kg (37)

                                          24190

                                          008050-09-7

                                          Rosin wood

                                          See “Rosin” (Reference No 24100)’

                              (c)

                              the following line is deleted:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘11000

                                          050976-02-8

                                          Acrylic acid, dicyclopentadienyl ester

                                          QMA = 0,05 mg/6 dm2’

                  3.

                  in section B the following lines are deleted:

                              Reference No

                              CAS No

                              Name

                              Restrictions and/or specifications

                              (1)

                              (2)

                              (3)

                              (4)

                              ‘11500

                              000103-11-7

                              Acrylic acid, 2-ethylhexyl ester

                              14260

                              000502-44-3

                              Caprolactone

                              21370

                              010595-80-9

                              Methacrylic acid, 2-sulphoethyl ester

                              22210

                              000098-83-9

                              alpha-Methylstyrene

                              25540

                              000528-44-9

                              Trimellitic acid

                              QM(T) = 5 mg/kg in FP

                              25550

                              000552-30-7

                              Trimellitic anhydride

                              QM(T) = 5 mg/kg in FP (expressed as trimellitic acid)’

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

                  1.

                  point 2 is replaced by the following:

                              ‘2.

                              The following substances are not included even if they are intentionally used and are authorised:

                                          (a)

                                          salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in the lists, if the corresponding free acid(s) is (are) not mentioned;

                                          (b)

                                          salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:

                                                      (i)

                                                      substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,

                                                      (ii)

                                                      substances referred to in note 38 of Annex VI.’;

                  2.

                  section A is amended as follows:

                              (a)

                              the following lines are inserted in numerical order:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘30340

                                          330198-91-9

                                          12-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester

                                          30401

                                          —

                                          Acetylated mono- and diglycerides of fatty acids

                                          31542

                                          174254-23-0

                                          Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters

                                          QM = 0,5 % (w/w) in FP

                                          43480

                                          064365-11-3

                                          Charcoal, activated

                                          In compliance with the specifications laid down in Annex V, Part B

                                          62245

                                          012751-22-3

                                          Iron phosphide

                                          For PET polymers and copolymers only

                                          64990

                                          025736-61-2

                                          Maleic anhydride-styrene, copolymer, sodium salt

                                          In compliance with specifications laid down in Annex V

                                          66905

                                          000872-50-4

                                          N-Methylpyrrolidone

                                          66930

                                          068554-70-1

                                          Methylsilsesquioxane

                                          Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane

                                          67155

                                          —

                                          Mixture of 4-(2-Benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbene)

                                          Not more than 0,05 % w/w (quantity of substance used/quantity of the formulation). In compliance with the specifications laid down in Annex V

                                          76415

                                          019455-79-9

                                          Pimelic acid, calcium salt

                                          76815

                                          —

                                          Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids

                                          In compliance with the specifications laid down in Annex V

                                          76845

                                          031831-53-5

                                          Polyester of 1,4-butanediol with caprolactone

                                          In compliance with the specifications laid down in Annex V

                                          77370

                                          070142-34-6

                                          Polyethyleneglycol-30 dipolyhydroxystearate

                                          79600

                                          009046-01-9

                                          Polyethyleneglycol tridecyl ether phosphate

                                          SML = 5 mg/kg. For materials and articles intended for contact with aqueous foods only. In compliance with the specification laid down in Annex V

                                          80000

                                          009002-88-4

                                          Polyethylene wax

                                          81060

                                          009003-07-0

                                          Polypropylene wax’

                              (b)

                              in the following lines the content of the columns ‘Name’ and ‘Restrictions and/or specifications’ is replaced by the following:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘30080

                                          004180-12-5

                                          Acetic acid, copper salt

                                          SML(T) = 5 mg/kg (7) (expressed as Copper)

                                          35760

                                          001309-64-4

                                          Antimony trioxide

                                          SML = 0,04 mg/kg (39) (expressed as Antimony)

                                          40580

                                          000110-63-4

                                          1,4-Butanediol

                                          SML(T) = 5 mg/kg (24)

                                          42320

                                          007492-68-4

                                          Carbonic acid, copper salt

                                          SML(T) = 5 mg/kg (7) (expressed as Copper)

                                          45195

                                          007787-70-4

                                          Copper bromide

                                          SML(T) = 5 mg/kg (7) (expressed as Copper)

                                          45200

                                          001335-23-5

                                          Copper iodide

                                          SML(T) = 5 mg/kg (7) (expressed as Copper)

                                          53610

                                          054453-03-1

                                          Ethylenediaminetetraacetic acid, copper salt

                                          SML(T) = 5 mg/kg (7) (expressed as Copper)

                                          81515

                                          087189-25-1

                                          Poly(zinc glycerolate)

                                          SML(T) = 25 mg/kg (38) (as Zinc)

                                          81760

                                          —

                                          Powders, flakes and fibers of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron

                                          SML(T) = 5 mg/kg (7) (expressed as Copper)

                                          88640

                                          008013-07-08

                                          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 Commission 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

                                          89200

                                          007617-31-4

                                          Stearic acid, copper salt

                                          SML(T) = 5 mg/kg (7) (expressed as Copper)

                                          92030

                                          010124-44-4

                                          Sulphuric acid, copper salt

                                          SML(T) = 5 mg/kg (7) (expressed as Copper)

                                          96190

                                          020427-58-1

                                          Zinc hydroxide

                                          SML(T) = 25 mg/kg (38) (as Zinc)

                                          96240

                                          001314-13-2

                                          Zinc oxide

                                          SML(T) = 25 mg/kg (38) (as Zinc)

                                          96320

                                          001314-98-3

                                          Zinc sulphide

                                          SML(T) = 25 mg/kg (38) (as Zinc)’

                              (c)

                              the following lines are deleted:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘30400

                                          —

                                          Acetylated glycerides

                                          38320

                                          005242-49-9

                                          4-(2-Benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene

                                          In compliance with the specifications laid down in Annex V’

                  3.

                  section B is amended as follows:

                              (a)

                              the following lines are inserted in numerical order:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘31500

                                          025134-51-4

                                          Acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer

                                          SML(T) = 6 mg/kg (36) (expressed as acrylic acid) and SML = 0,05 mg/kg (expressed as acrylic acid, 2-ethylhexyl ester)

                                          38505

                                          351870-33-2

                                          cis-endo-Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, disodium salt

                                          SML = 5 mg/kg. Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %

                                          38940

                                          110675-26-8

                                          2,4-Bis(dodecylthiomethyl)-6-methylphenol

                                          SML(T) = 5 mg/kg (40)

                                          49595

                                          057583-35-4

                                          Dimethyltin bis(ethylhexyl mercaptoacetate)

                                          SML(T) = 0,18 mg/kg (16) (expressed as Tin)

                                          63940

                                          008062-15-5

                                          Lignosulphonic acid

                                          SML = 0,24 mg/kg and to be used only as dispersant for plastics dispersions

                                          66350

                                          085209-93-4

                                          2,2′-Methylenebis(4,6-di-tert-butylphenyl) lithium phosphate

                                          SML = 5 mg/kg and SML(T) = 0,6 (8) (expressed as Lithium)

                                          67515

                                          057583-34-3

                                          Monomethyltin tris(ethylhexyl mercaptoacetate)

                                          SML(T) = 0,18 mg/kg (16) (expressed as Tin)

                                          69160

                                          014666-94-5

                                          Oleic acid, cobalt salt

                                          SML(T) = 0,05 mg/kg (14) (expressed as Cobalt)

                                          76681

                                          —

                                          Polycyclopentadiene, hydrogenated

                                          SML = 5 mg/kg (1)

                                          85950

                                          037296-97-2

                                          Silicic acid, magnesium-sodium-fluoride salt

                                          SML = 0,15 mg/kg (expressed as fluoride). Only to be used in layers of multilayers materials not coming into direct contact with food

                                          95265

                                          227099-60-7

                                          1,3,5-Tris(4-benzoylphenyl) benzene

                                          SML = 0,05 mg/kg’

                              (b)

                              in the following lines the content of the columns ‘Name’ and ‘Restrictions and/or specifications’ is replaced by the following:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘40020

                                          110553-27-0

                                          2,4-Bis(octylthiomethyl)-6-methylphenol

                                          SML(T) = 5 mg/kg (40)

                                          50160

                                          —

                                          Di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50240

                                          010039-33-5

                                          Di-n-octyltin bis(2-ethylhexyl maleate)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50320

                                          015571-58-1

                                          Di-n-octyltin bis(2-ethylhexyl mercaptoacetate)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50360

                                          —

                                          Di-n-octyltin bis(ethyl maleate)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50400

                                          033568-99-9

                                          Di-n-octyltin bis(isooctyl maleate)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50480

                                          026401-97-8

                                          Di-n-octyltin bis(isooctyl mercaptoacetate)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50560

                                          —

                                          Di-n-octyltin 1,4-butanediol bis(mercaptoacetate)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50640

                                          003648-18-8

                                          Di-n-octyltin dilaurate

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50720

                                          015571-60-5

                                          Di-n-octyltin dimaleate

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50800

                                          —

                                          Di-n-octyltin dimaleate, esterified

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50880

                                          —

                                          Di-n-octyltin dimaleate, polymers (n = 2-4)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          50960

                                          069226-44-4

                                          Di-n-octyltin ethyleneglycol bis(mercaptoacetate)

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          51040

                                          015535-79-2

                                          Di-n-octyltin mercaptoacetate

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          51120

                                          —

                                          Di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate

                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)

                                          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)’

                              (c)

                              The following line is deleted:

                                          Reference No

                                          CAS No

                                          Name

                                          Restrictions and/or specifications

                                          (1)

                                          (2)

                                          (3)

                                          (4)

                                          ‘76680

                                          068132-00-3

                                          Polycyclopentadiene, hydrogenated

                                          SML = 5 mg/kg (1)’

      ANNEX III
      In Part B of Annex V, the following lines are inserted in numerical order:

                     Reference No

                     OTHER SPECIFICATIONS

                     ‘24903

                     Syrups, hydrolysed starch, hydrogenated
                     In compliance with the purity criteria for maltitol syrup E 965(ii) (Commission Directive 95/31/EC (OJ L 178, 28.7.1995, p. 1) as last amended by 2004/46/EC (OJ L 114, 21.04.2004, p. 15))

                     43480

                     Charcoal, activated
                     To be used only in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC ((OJ L 226, 22.9.1995, p. 1). Directive as last amended by Directive 2004/47/EC (OJ L 113, 20.4.2004, p. 24)) with exception of ash content which can be up to 10 % (w/w).

                     64990

                     Maleic anhydride-styrene, copolymer, sodium salt
                     MW fraction < 1 000 is less than 0,05 % (w/w)

                     67155

                     Mixture of 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, 4,4'-bis(2-benzoxazolyl) stilbene and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene
                     Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %): (13-17 %).

                     76845

                     Polyester of 1,4-butanediol with caprolactone
                     MW fraction < 1 000 is less than 0,05 % (w/w)

                     76815

                     Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids
                     MW fraction < 1 000 is less than 5 % (w/w)

                     79600

                     Polyethyleneglycol tridecyl ether phosphate
                     Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether’

      ANNEX IV
      Annex VI is amended as follows:

                  1.

                  the notes (8), (14) and (16) are replaced by the following:

                              ‘(8)

                              SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 38000, 42400, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725.

                              (14)

                              SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 44960, 68078, 69160, 82020 and 89170.

                              (16)

                              SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 49595, 49600, 67520, 67515 and 83599.’;

                  2.

                  the following notes are added:

                              ‘(35)

                              SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 25540 and 25550.

                              (36)

                              SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 10690, 10750, 10780, 10810, 10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980 and 31500.

                              (37)

                              SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 20020, 20080, 20110, 20140, 20170, 20890, 21010, 21100, 21130, 21190, 21280, 21340 and 21460.

                              (38)

                              SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 81515, 96190, 96240 and 96320 as well as of salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. The same restriction for Zn applies to the names containing “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned.

                              (39)

                              Migration limit might be exceeded at very high temperature.

                              (40)

                              SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 38940 and 40020.’


title: Commission Directive 2009/130/EC of 12 October 2009 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress (Text with EEA relevance)

text:
               13.10.2009

               EN

               Official Journal of the European Union

               L 268/5

      COMMISSION DIRECTIVE 2009/130/EC
   of 12 October 2009
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Safety,
   Whereas:

               (1)

               Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, currently the Scientific Committee on Consumer Safety (hereinafter SCCS) (2), concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye substances.

               (2)

               The SCCS further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.

               (3)

               Following the opinions of the SCCS, the Commission, together with Member States and stakeholders, agreed on an overall strategy to regulate substances used in hair dye products, according to which the industry was required to submit files containing the scientific data on hair dye substances to be evaluated by the SCCS.

               (4)

               Substances p-Phenylenediamine (PPD) and toluene-2,5-diamine (PTD) are currently regulated under generic entries 8 and 9 in part 1 of Annex III to Council Directive 76/768/EEC. The SCCS classified these substances as extreme sensitisers contributing to a great extent to the incidence of skin allergies among consumers to hair dye products. The risk assessment of the submitted additional data on PPD and PTD, and final decisions made by the SCCS on the safety of these substances might still require a considerable amount of time. As a precautionary measure to reduce the risk of allergies to hair dye products among consumers, the maximum authorised concentrations of PPD and PTD should be immediately decreased to the levels for which the industry submitted the safety files.

               (5)

               Since substances PPD and PTD are currently regulated under generic entries in part 1 of Annex III separate reference numbers should be created for these substances with decreased maximum authorised concentrations.

               (6)

               Commission Directive 2008/88/EC (3) banned the use of hydroquinone in oxidative hair dye products by deleting the respective field of application in column ‘c’ of reference number 14 in Annex III, part 1. For the sake of clarity, the authorised concentration of 0,3 % in column ‘d’ and the conditions of use and warnings which must be printed on the label listed in paragraph (a) in column ‘f’ of reference number 14 should be deleted as well.

               (7)

               Directive 76/768/EEC should therefore be amended accordingly.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex III to Directive 76/768/EEC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 15 April 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply the provisions set out in the Annex to this Directive from 15 July 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 12 October 2009.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169.

      (2)  The name of the committee was changed by Commission Decision 2008/721/EC (OJ L 241, 10.9.2008, p. 21).

      (3)  OJ L 256, 24.9.2008, p. 12.

      ANNEX
      Directive 76/768/EEC is amended as follows:
      Part 1 of Annex III is amended as follows:

                  (a)

                  In column ‘b’ of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’ are replaced by the following:
                  ‘N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.

                  (b)

                  The following reference number 8a is inserted after reference number 8:

                              Reference number

                              Substance

                              Restrictions

                              Conditions of use and warnings which must be printed on the label

                              Field of application and/or use

                              Maximum authorised concentration in the finished cosmetic product

                              Other limitations and requirements

                              a

                              b

                              c

                              d

                              e

                              f

                              ‘8a

                              p-Phenylenediamine and its salts (5)
                              CAS No 106-50-3
                              Einecs 203-404-7
                              p-Phenylenediamine HCl
                              CAS No 624-18-0
                              Einecs 210-834-9
                              p-Phenylenediamine sulphate
                              CAS No 16245-77-5
                              Einecs 240-357-1

                              Hair dye substance in oxidative hair dye products

                                          (a)

                                          general use

                                          (b)

                                          professional use

                              (a) and (b) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % calculated as free base.

                                          (a)

                                          Can cause an allergic reaction. Contains phenylenediamines. Do not use to dye eyelashes or eyebrows.

                                          (b)

                                          For professional use only. Contains phenylenediamines. Can cause an allergic reaction. Wear suitable gloves.’

                  (c)

                  In column ‘b’ of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’ are replaced by the following:
                  ‘Methylphenylenediamines, their N-substituted derivatives and their salts (1), with the exception of the substance under reference number 9a in this Annex and substances under reference numbers 364, 1310 and 1313 in Annex II’.

                  (d)

                  The following reference number 9a is inserted after reference number 9:

                              Reference number

                              Substance

                              Restrictions

                              Conditions of use and warnings which must be printed on the label

                              Field of application and/or use

                              Maximum authorised concentration in the finished cosmetic product

                              Other limitations and requirements

                              a

                              b

                              c

                              d

                              e

                              f

                              ‘9a

                              Toluene-2,5-diamine and its salts (1)
                              CAS No 95-70-5
                              Einecs 202-442-1
                              Toluene-2,5-diamine sulphate
                              CAS No 615-50-9
                              Einecs 210-431-8

                              Hair dye substance in oxidative hair dye products

                                          (a)

                                          general use

                                          (b)

                                          professional use

                              (a) and (b) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 4 % calculated as free base.

                              As mentioned in reference number 9, column f.’

                  (e)

                  In reference number 14, the maximum authorised concentration in the finished cosmetic product of 0,3 % in column ‘d’ and paragraph (a) in column ‘f’ are deleted.


Avis juridique important

|

32000L0040

Directive 2000/40/EC of the European Parliament and of the Council of 26 June 2000 on the approximation of the laws of the Member States relating to the front underrun protection of motor vehicles and amending Council Directive 70/156/EEC

Official Journal L 203 , 10/08/2000 P. 0009 - 0028

Directive 2000/40/EC of the European Parliament and of the Councilof 26 June 2000on the approximation of the laws of the Member States relating to the front underrun protection of motor vehicles and amending Council Directive 70/156/EECTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) By Decision 97/836/EC(4), the Council, with the assent of the European Parliament, authorised the Community to accede to the Agreement of the United Nations Economic Commission for Europe (ECE) concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions, done at Geneva on 20 March 1958, as revised on 16 October 1995.(2) Through its accession to the said Agreement, the Community subscribed to a defined list of Regulations established pursuant to that Agreement. This list includes UN/ECE Regulation No 93(5).(3) In order to reduce the number of European road accident casualties, it is necessary to introduce without delay the measures established by UNE/ECE Regulation No 93 into the EC type-approval procedure set up by Council Directive 70/156/EEC(6), so as to improve the protection of the occupants of passenger cars and light vans from injury in the event of a collision with the front of heavy goods vehicles and to allow manufacturers of such devices and of vehicles equipped with such devices to obtain an EC type-approval if they meet the technical requirements of that Regulation.(4) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, the objectives of this Directive cannot be sufficiently achieved by the Member States on account of the scale and effect of the action proposed in the relevant sector, and can therefore be better achieved by the Community. This Directive does not go beyond what is necessary for the attainment of its objective, namely EC type-approval.(5) This Directive is one of the separate directives which must be complied with in order to conform to the EC type-approval procedure. Consequently, the provisions laid down in Directive 70/156/EEC relating to vehicles, vehicle systems, components and separate technical units apply to this Directive.(6) In view of the considerable number of road accidents involving commercial vehicles having a mass of more than 3,5 tonnes, and consequently in order to increase road safety, the provisions concerning such vehicles should be made mandatory by this Directive without awaiting any further supplements to EC type-approval for this category of vehicles.(7) Directive 70/156/EEC should be amended in consequence,HAVE ADOPTED THIS DIRECTIVE:Article 1For the purposes of this Directive:(a) "vehicle" means any motor vehicle as defined in Section A of Annex II to Directive 70/156/EEC;(b) "front underrun protective device" means a front underrun protective device which is intended to be part of a vehicle and which can be approved as a separate technical unit in accordance with Article 2 of Directive 70/156/EEC.Article 21. With effect from 10 August 2001 or, if the publication referred to in Article 3 is delayed beyond 10 February 2001, six months after the date of the said publication, Member States may not, on grounds relating to the front underrun protection of a vehicle:(a) refuse, in respect of a type of vehicle, or a type of a front underrun protective device considered as a separate technical unit, to grant EC type-approval or national type-approval; or(b) prohibit the registration, sale or entry into service of vehicles or front underrun protective devices considered as a separate technical unit;if the vehicles or separate technical units comply with the requirements of this Directive.2. With effect from 10 August 2003, Member States:(a) shall no longer grant EC type-approval or national type-approval for a type of vehicle or a type of front underrun protective device as a separate technical unit;(b) shall refuse the registration, sale or entry into service of new vehicles or new front underrun protective devices as separate technical units;on grounds relating to the front underrun protection if the requirements of this Directive are not complied with.3. The administrative provisions governing EC type-approval shall be as set out in Annex I.The scope of this Directive, and the technical requirements to be fulfilled for the award of EC type-approval, shall be as laid down in Annex II.Article 3Regulation No 93 of the United Nations Economic Commission for Europe shall be published in the Official Journal of the European Communities before 10 February 2001.Article 4Directive 70/156/EEC is amended as follows:1. Annex I shall be amended as follows:(a) Item 2.3.4 shall be replaced by the following:"2.3.4. Width of the foremost axle (measured at the outermost part of the tyres excluding the bulging of the tyres close to the ground): ...".(b) The following items shall be inserted:"9.22. Front underrun protection9.22.1. Drawing of the vehicle parts relevant to the front underrun protection, i.e. drawing of the vehicle and/or chassis with position and mounting of the widest front axle, drawing of the mounting and/or fitting of the front underrun protection. If the underrun protection is no special device, the drawing must clearly show that the required dimensions are met: ...9.22.2. In the case of special device, full description and/or drawing of the front underrun protection (including mountings and fittings), or, if approved as a separate technical unit, type-approval number: ...".2. Annex V shall be amended as follows:(a) In Part I, the following item shall be added:">TABLE>"(b) In Part II, the following item shall be added:">TABLE>"Article 51. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 10 August 2001. However, if the publication referred to in Article 3 is delayed beyond 10 February 2001, Member States shall fulfil this obligation within six months of the said publication. They shall forthwith inform the Commission thereof.Member States shall apply these measures as from 10 August 2001 or, if the publication referred to in Article 3 is delayed beyond 10 February 2001, six months after the said publication.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.Article 6This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 7This Directive is addressed to the Member States.Done at Luxembourg, 26 June 2000.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentJ. Coelho(1) OJ C 89, 30.3.1999, p. 11.(2) OJ C 209, 22.7.1999, p. 8.(3) Opinion of the European Parliament of 27.10.1999 (OJ C 154, 5.6.2000, p. 50), Council Common Position of 27.3.2000 (OJ C 178, 27.6.2000, p. 1), and Decision of the European Parliament of 17.5.2000.(4) OJ L 346, 17.12.1997, p. 78.(5) UN Economic Commission for Europe, document E/ECE/324.(6) OJ L 42, 23.2.1970, p. 1. Directive as last amended by Directive 98/91/EC of the European Parliament and of the Council (OJ L 11, 16.1.1999, p. 25).LIST OF ANNEXES>TABLE>ANNEX IADMINISTRATIVE PROVISIONS FOR EC TYPE-APPROVAL1. APPLICATION FOR TYPE-APPROVAL1.1. Application for EC type-approval of a front underrun protective device as a separate technical unit1.1.1. Application for EC type-approval pursuant to Article 3(4) of Directive 70/156/EEC in respect of a front underrun protective device considered to be a separate technical unit within the meaning of Article 2 of Directive 70/156/EEC shall be submitted by the manufacturer of the front underrun protective device.1.1.2. A model for the information document is given in Appendix 1.1.1.3. A representative sample of the type of device to be approved shall be submitted to the technical service responsible for conducting the type-approval tests. That service may, if it is considered necessary, request a further sample. The samples shall be clearly and indelibly marked with the applicant's trade name or mark and the type designation.1.2. Application for EC type-approval of a vehicle type with regard to the installation of front underrun protective devices which have been type-approved as separate technical unit1.2.1. Application for EC type-approval pursuant to Article 3(1) of Directive 70/156/EEC shall be submitted by the vehicle manufacturer.1.2.2. A model for the information document is given in Appendix 2.1.2.3. A vehicle representative of the type to be approved as well as a front underrun protection for the installation, which has been approved as a separate technical unit, shall be submitted to the technical service responsible for conducting the approval tests.1.3. Application for EC type-approval of a vehicle type with regard to its front underrun protection1.3.1. Application for EC type-approval pursuant to Article 3(1) of Directive 70/156/EEC shall be submitted by the vehicle manufacturer.1.3.2. A model for the information document is given in Appendix 3.1.3.3. A vehicle representative of the type to be approved shall be submitted to the technical service responsible for conducting the approval tests.2. GRANTING OF EC TYPE-APPROVAL2.1. If the relevant requirements are satisfied, EC type-approval pursuant to Article 4(3) and, if applicable 4(4) of Directive 70/156/EEC shall be granted.2.2. A model for the EC type-approval certificate is given:2.2.1. for a front underrun protective device as a separate technical unit in Appendix 4;2.2.2. for a vehicle type with regard to the installation of a front underrun protective device which has been type-approved as separate technical unit in Appendix 5;2.2.3. for a vehicle type with regard to its front underrun protection in Appendix 6.2.3. An approval number in accordance with Annex VII to Directive 70/156/EEC shall be assigned to each type of front underrun protective device or each type of vehicle approved. The same Member State shall not assign the same number to another type of front underrun protective device or to another type of vehicle.3. EC TYPE-APPROVAL MARKING FOR SEPARATE TECHNICAL UNITS3.1. Every front underrun protective device conforming to the type approved under this Directive as a separate technical unit shall bear an EC type-approval mark.3.2. This mark shall consist of a rectangle surrounding the letter "e" followed by the distinguishing number of the Member State which has granted type-approval:1 for Germany2 for France3 for Italy4 for the Netherlands5 for Sweden6 for Belgium9 for Spain11 for the United Kingdom12 for Austria13 for Luxembourg17 for Finland18 for Denmark21 for Portugal23 for Greece24 for IrelandIt must also include in the vicinity of the rectangle the "base approval number" contained in Section 4 of the type-approval number referred to in Annex VII to Directive 70/156/EEC, preceded by the two figures indicating the sequence number assigned to the most recent major technical amendment to Directive 2000/40/EC on the date EC type-approval was granted. In this Directive the sequence number is 00.3.3. The EC type-approval mark must be affixed to the front underrun protective device in such a way as to be indelible and clearly legible even if the device is fitted to a vehicle.3.4. An example of the EC type-approval mark is shown in Appendix 7.4. MODIFICATION OF THE TYPE AND AMENDMENTS TO APPROVALS4.1. In the case of modification of a vehicle type approved pursuant to this Directive, the provisions of Article 5 of Directive 70/156/EEC shall apply.5. CONFORMITY OF PRODUCTION5.1. Measures to ensure the conformity of production shall be taken in accordance with the provisions laid down in Article 10 of Directive 70/156/EEC.Appendix 1INFORMATION DOCUMENT No ...relating to the EC type-approval of a front underrun protective device as a separate technical unit(Directive 2000/40/EC, as last amended by Directive .../.../EC)>PIC FILE= "L_2000203EN.001502.EPS">Appendix 2INFORMATION DOCUMENT No ...pursuant to Annex I of Council Directive 79/156/EEC(1), relating to the EC type-approval of a vehicle type with regard to the installation of front underrun protective devices which have been type-approved as a separate technical unit(Directive 2000/40/EC, as last amended by Directive .../.../EC)>PIC FILE= "L_2000203EN.001602.EPS">>PIC FILE= "L_2000203EN.001701.EPS">(1) The item numbers and footnotes used in this Information Document correspond to those set out in Annex I to Directive 70/156/EEC. Items not relevant for the purposes of this Directive are omitted.Appendix 3INFORMATION DOCUMENT No ...pursuant to Annex I of Council Directive 70/156/EEC(1), relating to the EC type-approval of a vehicle type with regard to its front underrun protection(Directive 2000/40/EC, as last amended by Directive .../.../EC)>PIC FILE= "L_2000203EN.001802.EPS">>PIC FILE= "L_2000203EN.001901.EPS">(1) The item numbers and footnotes used in this Information Document correspond to those set out in Annex I to Directive 70/156/EEC. Items not relevant for the purposes of this Directive are omitted.Appendix 4MODEL(maximum format: A4 (210 mm × 297 mm))EC TYPE-APPROVAL CERTIFICATE>PIC FILE= "L_2000203EN.002002.EPS">>PIC FILE= "L_2000203EN.002101.EPS">Appendix 5MODEL(maximum format: A4 (210 mm × 297 mm))EC TYPE-APPROVAL CERTIFICATE>PIC FILE= "L_2000203EN.002202.EPS">>PIC FILE= "L_2000203EN.002301.EPS">Appendix 6MODEL(maximum format: A4 (210 mm × 297 mm))EC TYPE-APPROVAL CERTIFICATE>PIC FILE= "L_2000203EN.002402.EPS">>PIC FILE= "L_2000203EN.002501.EPS">Appendix 7MODEL FOR THE EC TYPE-APPROVAL MARK>PIC FILE= "L_2000203EN.002602.TIF">The front underrun protective device bearing the above EC type-approval mark is a device which has been approved in Germany (e 1) under the base approval number 2439 on the basis of this Directive.The figures used are only indicative.ANNEX IISCOPE AND TECHNICAL REQUIREMENTS1. SCOPE1.1. This Directive applies to:1.1.1. front underrun protective devices as separate technical units intended to be fitted to vehicles of categories N2 and N3(1);1.1.2. vehicles of category N2 and N3 with regard to the installation of front underrun protective devices which have been type-approved as separate technical units;1.1.3. vehicles of category N2 and N3 with regard to their front underrun protection.1.2. Vehicles of categories N2 with a maximum mass not exceeding 7,5 tonnes shall comply only with the ground clearance requirement of 400 mm as set out in this Directive.1.3. The requirements of this Directive do not apply to:1.3.1. off-road vehicles of categories N2 and N3;1.3.2. vehicles such that their use is incompatible with the provisions of front underrun protection.2. DEFINITIONSFor the purpose of this Directive:2.1. "maximum mass" of the vehicle means the technically permissible maximum laden mass defined in item 2.8 of Annex I to Directive 70/156/EEC;2.2. "unladen vehicle", means the vehicle in running order having the mass defined in item 2.6 of Annex I to Directive 70/156/EEC;2.3. "type of front underrun protection device", means front underrun protective devices which do not differ with respect to the essential characteristics such as shape, dimensions, attachment, materials and the markings cited in item 1.1.3 of Annex I;2.4. "front underrun protection" means the presence at the front of the vehicle of either:a special front underrun protection device; orbody work, chassis parts or other components, such that by virtue of their shape and characteristics, these elements can be regarded as fulfilling the function of the front underrun protection device;2.5. "vehicle type" means vehicles which do not essentially differ in such aspects as:2.5.1. the width of the foremost axle measured at the outermost part of the tyres excluding the bulging of the tyres close to the ground;2.5.2. the structure, the dimensions, the shape and materials of the front part of the vehicle in so far as they have a bearing on the requirements of the relevant part of this Directive;2.5.3. the approved front underrun protective device fitted to the vehicle;2.5.4. the maximum mass of the vehicle type.3. TECHNICAL REQUIREMENTSThe technical requirements which have to be complied with in order to obtain a type-approval in accordance with this Directive are those set out in paragraphs 6, 8 and 10, together with Annex 5 to UN/ECE Regulation No 93, with the following exceptions:3.1. in item 8.2, the term "communication document contained in annex 1" has to be regarded as "EC type-approval certificate contained in Annex 1, Appendix 5";3.2. in item 8.3, the term in brackets "(annex 1, item 9.)" has to be regarded as "(Annex I, Appendix 4, Addendum, paragraph 1.4)";3.3. in item 8.6, the term in brackets "(annex 1, item 8.)" has to be regarded as "(Annex I, Appendix 1, paragraph 2.3)";3.4. in item 3.5.1 of Annex V the term "for applications pursuant to Part III" has to be regarded as "for applications pursuant to Annex I, paragraph 1.3".(1) As defined in Section A of Annex II to Directive 70/156/EEC.


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31970L0050

Commission Directive 70/50/EEC of 22 December 1969 based on the provisions of Article 33 (7), on the abolition of measures which have an effect equivalent to quantitative restrictions on imports and are not covered by other provisions adopted in pursuance of the EEC Treaty

Official Journal L 013 , 19/01/1970 P. 0029 - 0031 Danish special edition: Series I Chapter 1970(I) P. 0010  English special edition: Series I Chapter 1970(I) P. 0017

COMMISSION DIRECTIVE  of 22 December 1969  based on the provisions of Article 33 (7), on the abolition of measures which have an effect equivalent to quantitative restrictions on imports and are not covered by other provisions adopted in pursuance of the EEC Treaty  (70/50/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the provisions of the Treaty establishing the European Economic Community, and in particular Article 33 (7) thereof;  Whereas for the purpose of Article 30 et seq. "measures" means laws, regulations, administrative provisions, administrative practices, and all instruments issuing from a public authority, including recommendations;  Whereas for the purposes of this Directive "administrative practices" means any standard and regularly followed procedure of a public authority ; whereas "recommendations" means any instruments issuing from a public authority which, while not legally binding on the addressees thereof, cause them to pursue a certain conduct;  Whereas the formalities to which imports are subject do not as a general rule have an effect equivalent to that of quantitative restrictions and, consequently, are not covered by this Directive;  Whereas certain measures adopted by Member States, other than those applicable equally to domestic and imported products, which were operative at the date of entry into force of the Treaty and are not covered by other provisions adopted in pursuance of the Treaty, either preclude importation or make it more difficult or costly than the disposal of domestic production;  Whereas such measures must be considered to include those which make access of imported products to the domestic market, at any marketing stage, subject to a condition which is not laid down for domestic products or to a condition differing from that laid down for domestic products, and more difficult to satisfy, so that a burden is thus placed on imported products only;  Whereas such measures must also be considered to include those which, at any marketing stage, grant to domestic products a preference, other than an aid, to which conditions may or may not be attached, and where such measures totally or partially preclude the disposal of imported products;  Whereas such measures hinder imports which could otherwise take place, and thus have an effect equivalent to quantitative restrictions on imports;  Whereas effects on the free movement of goods of measures which relate to the marketing of products and which apply equally to domestic and imported products are not as a general rule equivalent to those of quantitative restrictions, since such effects are normally inherent in the disparities between rules applied by Member States in this respect;  Whereas, however, such measures may have a restrictive effect on the free movement of goods over and above that which is intrinsic to such rules;  Whereas such is the case where imports are either precluded or made more difficult or costly than the disposal of domestic production and where such effect is not necessary for the attainment of an objective within the scope of the powers for the regulation of trade left to Member States by the Treaty ; whereas such is in particular the case where the said objective can be attained just as effectively by other means which are less of a hindrance to trade ; whereas such is also the case where the restrictive effect of these provisions on the free movement of goods is out of proportion to their purpose;  Whereas these measures accordingly have an effect equivalent to that of quantitative restrictions on imports;   Whereas the customs union cannot be achieved without the abolition of such measures having an equivalent effect to quantitative restrictions on imports;  Whereas Member States must abolish all measures having equivalent effect by the end of the transitional period at the latest, even if no Commission Directive expressly requires them to do so;  Whereas the provisions concerning the abolition of quantitative restrictions and measures having equivalent effect between Member States apply both to products originating in and exported by Member States and to products originating in third countries and put into free circulation in the other Member States;  Whereas Article 33 (7) does not apply to measures of the kind referred to which fall under other provisions of the Treaty, and in particular those which fall under Articles 37 (1) and 44 of the Treaty or form an integral part of a national organisation of an agricultural market;  Whereas Article 33 (7) does not apply to the charges and taxation referred to in Article 12 et seq. and Article 95 et seq. or to the aids mentioned in Article 92;  Whereas the provisions of Article 33 (7) do not prevent the application, in particular, of Articles 36 and 223;  HAS ADOPTED THIS DIRECTIVE:    Article 1 The purpose of this Directive is to abolish the measures referred to in Articles 2 and 3, which were operative at the date of entry into force of the EEC Treaty.   Article 2 1. This Directive covers measures, other than those applicable equally to domestic or imported products, which hinder imports which could otherwise take place, including measures which make importation more difficult or costly than the disposal of domestic production.  2. In particular, it covers measures which make imports or the disposal, at any marketing stage, of imported products subject to a condition-other than a formality-which is required in respect of imported products only, or a condition differing from that required for domestic products and more difficult to satisfy. Equally, it covers, in particular, measures which favour domestic products or grant them a preference, other than an aid, to which conditions may or may not be attached.  3. The measures referred to must be taken to include those measures which:    (a) lay down, for imported products only, minimum or maximum prices below or above which imports are prohibited, reduced or made subject to conditions liable to hinder importation;       (b) lay down less favourable prices for imported products than for domestic products;       (c) fix profit margins or any other price components for imported products only or fix these differently for domestic products and for imported products, to the detriment of the latter;       (d) preclude any increase in the price of the imported product corresponding to the supplementary costs and charges inherent in importation;       (e) fix the prices of products solely on the basis of the cost price or the quality of domestic products at such a level as to create a hindrance to importation;       (f) lower the value of an imported product, in particular by causing a reduction in its intrinsic value, or increase its costs;       (g) make access of imported products to the domestic market conditional upon having an agent or representative in the territory of the importing Member State;       (h) lay down conditions of payment in respect of imported products only, or subject imported products to conditions which are different from those laid down for domestic products and more difficult to satisfy;       (i) require, for imports only, the giving of guarantees or making of payments on account;       (j) subject imported products only to conditions, in respect, in particular of shape, size, weight, composition, presentation, identification or putting up, or subject imported products to conditions which are different from those for domestic products and more difficult to satisfy;       (k) hinder the purchase by private individuals of imported products only, or encourage, require or give preference to the purchase of domestic products only;       (l) totally or partially preclude the use of national facilities or equipment in respect of imported products only, or totally or partially confine the use of such facilities or equipment to domestic products only;       (m) prohibit or limit publicity in respect of imported products only, or totally or partially confine publicity to domestic products only;        (n) prohibit, limit or require stocking in respect of imported products only ; totally or partially confine the use of stocking facilities to domestic products only, or make the stocking of imported products subject to conditions which are different from those required for domestic products and more difficult to satisfy;       (o) make importation subject to the granting of reciprocity by one or more Member States;       (p) prescribe that imported products are to conform, totally or partially, to rules other than those of the importing country;       (q) specify time limits for imported products which are insufficient or excessive in relation to the normal course of the various transactions to which these time limits apply;       (r) subject imported products to controls or, other than those inherent in the customs clearance procedure, to which domestic products are not subject or which are stricter in respect of imported products than they are in respect of domestic products, without this being necessary in order to ensure equivalent protection;       (s) confine names which are not indicative of origin or source to domestic products only.           Article 3 This Directive also covers measures governing the marketing of products which deal, in particular, with shape, size, weight, composition, presentation, identification or putting up and which are equally applicable to domestic and imported products, where the restrictive effect of such measures on the free movement of goods exceeds the effects intrinsic to trade rules.  This is the case, in particular, where:    - the restrictive effects on the free movement of goods are out of proportion to their purpose;       - the same objective can be attained by other means which are less of a hindrance to trade.           Article 4 1. Member States shall take all necessary steps in respect of products which must be allowed to enjoy free movement pursuant to Articles 9 and 10 of the Treaty to abolish measures having an effect equivalent to quantitative restrictions on imports and covered by this Directive.  2. Member States shall inform the Commission of measures taken pursuant to this Directive.    Article 5 1. This Directive does not apply to measures:    (a) which fall under Article 37 (1) of the EEC Treaty;       (b) which are referred to in Article 44 of the EEC Treaty or form an integral part of a national organisation of an agricultural market not yet replaced by a common organisation.         2. This Directive shall apply without prejudice to the application, in particular, of Articles 36 and 223 of the EEC Treaty.    Article 6 This Directive is addressed to the Member States.     Done at Brussels, 22 December 1969.  For the Commission  The President  Jean REY


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31969L0464

Council Directive 69/464/EEC of 8 December 1969 on control of Potato Wart Disease

Official Journal L 323 , 24/12/1969 P. 0001 - 0002 Finnish special edition: Chapter 3 Volume 2 P. 0249  Danish special edition: Series I Chapter 1969(II) P. 0545  Swedish special edition: Chapter 3 Volume 2 P. 0249  English special edition: Series I Chapter 1969(II) P. 0561  Greek special edition: Chapter 03 Volume 5 P. 0019  Spanish special edition: Chapter 03 Volume 3 P. 0170  Portuguese special edition Chapter 03 Volume 3 P. 0170

COUNCIL DIRECTIVE  of 8 December 1969  on control of Potato Wart Disease  (69/464/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the European Parliament (1); Having regard to the Opinion of the Economic and Social Committee; Whereas potato production occupies an important place in Community agriculture; Whereas the potato yield is constantly threatened by harmful organisms; Whereas, through the protection of potato cultivation against such harmful organisms, not only should productive capacity be maintained but also agricultural productivity increased; Whereas protective measures to prevent the introduction of harmful organisms into individual Member States would have only a limited effect if such organisms were not controlled simultaneously and methodically throughout the Community and were not prevented from spreading; Whereas one of the organisms most harmful to potatoes in Synchytrium endobioticum (Schilb.) Perc., the pathogenic agent of the cryptogamic "Potato Wart" disease; Whereas this disease has occurred in several Member States and some limited sources of infection exist within the Community; Whereas there is a permanent risk to potato cultivation throughout the Community if effective measures are not taken to control this disease and prevent it from spreading; Whereas, in order to eradicate this harmful organism, minimum provisions must be adopted for the Community ; whereas Member States must be able to adopt additional or stricter provisions where necessary; Whereas potato varieties which are resistant to certain races of this organism play an important role ; whereas their use, particularly in the safety zones surrounding contaminated plots, is of prime importance ; whereas it is therefore in the general interest to publish periodic lists of such varieties; Whereas, for determining the presence of contamination and the resistance of varieties, it appears necessary to apply appropriate methods to which Member States raise no objection; HAS ADOPTED THIS DIRECTIVE:Article 1This Directive concerns the minimum measures to be taken within the Member States to control Potato Wart Disease and to prevent this cryptogamic disease from spreading.     Article 2  1. When an occurrence of Synchytrium endobioticum (Schilb.) Perc., the pathogenic agent of Potato Wart Disease is recorded, Member States shall demarcate the contaminated plot and a safety zone large enough to ensure the protection of surrounding areas.  (1) OJ No 28, 17.2.1967, p. 454/67.    2. A plot shall be regarded as being contaminated when symptoms of Potato Wart Disease have been found on at least one plant from that plot.     Article 3  The Member States shall provide that potato tubers and haulms which came from contaminated plots be treated in such a way that the harmful organism is destroyed. If it is no longer possible to determine the place from which contaminated tubers and haulms came, the whole of the batch in which the contaminated tubers or haulms have been found must be treated.     Article 4  The Member States shall provide that on contaminated plots: (a) no potatoes may be grown; (b) no plant intended for transplanting may be grown, stored in the ground or otherwise.     Article 5  1. The Member States shall provide that in the safety zone potatoes may be grown only if they are of a variety which is resistant to the races of Synchytrium endobioticum found on the contaminated plot.   2. A potato variety shall be regarded as being resistant to a particular race of Synchytrium endobioticum when it reacts to contamination by the pathogenic agent of that race in such a way that there is no danger of secondary infection.     Article 6  The Member States shall revoke the measures taken to control Potato Wart Disease or to prevent it from spreading only if Synchytrium endobioticum is no longer found to be present.     Article 7  The Member States shall prohibit the holding of cultures of Synchytrium endobioticum.     Article 8  Member States may authorise derogations from the measures referred to in Articles 3, 4, 5 and 7 for scientific purposes, tests and selection work provided that such derogations do not prejudice the control of Potato Wart Disease and create no risk of the spread of this disease.     Article 9  Member States may adopt such additional or stricter provisions as may be required to control Potato Wart Disease or to prevent it from spreading;     Article 10  1. The Member States shall communicate to the Commission before 1 January each year a list of all the varieties of potato accepted by them for marketing and which they have found, by official investigation, to be resistant to Synchytrium endobioticum. They shall state the races to which the varieties are resistant.   2. The Commission shall ensure that a list of resistant varieties, based on the communications from the Member States, is published each year, if possible before 1 February.     Article 11  The Member State shall ensure that contamination by Synchytrium endobioticum and the resistance of potato varieties to this organism are determined by appropriate methods to which Member States raise no objection.     Article 12  Member States shall bring into force the measures necessary to comply with this Directive within two years following its notification and shall forthwith inform the Commission thereof.     Article 13  This Directive is addressed to the Member States.       Done at Brussels, 8 December 1969. For the Council The President J.M.A.H. LUNS