title: Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (Codified version) (Text with EEA relevance)

text:
               18.6.2008

               EN

               Official Journal of the European Union

               L 158/17

      COMMISSION DIRECTIVE 2008/60/EC
   of 17 June 2008
   laying down specific purity criteria concerning sweeteners for use in foodstuffs
   (Text with EEA relevance)
   (Codified version)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
   Whereas:

               (1)

               Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs (2) has been substantially amended several times (3). In the interest of clarity and rationality the said Directive should be codified.

               (2)

               It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (4).

               (3)

               It is necessary to take into account the specifications and analytical techniques for sweeteners as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

               (4)

               Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.

               (5)

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

               (6)

               This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for sweeteners mentioned in Directive 94/35/EC are set out in Annex I to this Directive.
   Article 2
   Directive 95/31/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 17 June 2008.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive 2006/128/EC (OJ L 346, 9.12.2006, p. 6).

      (3)  See Annex II, Part A.

      (4)  OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive 2006/52/EC (OJ L 204, 26.7.2006, p. 10).

      ANNEX I
      E 420 (i) —   SORBITOL

                     Synonyms

                  D-glucitol, D-sorbitol

                  Definition

                  Chemical name

                  D-glucitol

                  Einecs

                  200-061-5

                  Chemical formula

                  C6H14O6

                  Relative molecular mass

                  182,17

                  Assay

                  Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis.
                  Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer

                     Description

                  White hygroscopic powder, crystalline powder, flakes or granules having a sweet taste

                  Identification

                              A.

                              Solubility

                  Very soluble in water, slightly soluble in ethanol

                              B.

                              Melting range

                  88 to 102 °C

                              C.

                              Sorbitol monobenzylidene derivative

                  To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C

                  Purity

                  Water content

                  Not more than 1 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,1 % expressed on dry weight basis

                  Reducing sugars

                  Not more than 0,3 % expressed as glucose on dry weight basis

                  Total sugars

                  Not more than 1 % expressed as glucose on dry weight basis

                  Chlorides

                  Not more than 50 mg/kg expressed on dry weight basis

                  Sulphates

                  Not more than 100 mg/kg expressed on dry weight basis

                  Nickel

                  Not more than 2 mg/kg expressed on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

                  Heavy metals

                  Not more than 10 mg/kg expressed as Pb on dry weight basis

            E 420 (ii) —   SORBITOL SYRUP

                     Synonyms

                  D-glucitol syrup

                  Definition

                  Chemical name

                  Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides.
                  The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer

                  Einecs

                  270-337-8

                  Assay

                  Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis

                     Description

                  Clear colourless and sweet-tasting aqueous solution

                  Identification

                              A.

                              Solubility

                  Miscible with water, with glycerol, and with propane-1,2-diol

                              B.

                              Melting range

                  To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C

                  Purity

                  Water content

                  Not more than 31 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,1 % expressed on dry weight basis

                  Reducing sugars

                  Not more than 0,3 % expressed as glucose on dry weight basis

                  Chlorides

                  Not more than 50 mg/kg expressed on dry weight basis

                  Sulphates

                  Not more than 100 mg/kg expressed on dry weight basis

                  Nickel

                  Not more than 2 mg/kg expressed on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

                  Heavy metals

                  Not more than 10 mg/kg expressed as Pb on dry weight basis

            E 421 —   MANNITOL

            (I)   MANNITOL

                     Synonyms

                  D-mannitol

                     Definition

                  Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose

                  Chemical name

                  D-mannitol

                  Einecs

                  200-711-8

                  Chemical formula

                  C6H14O6

                  Molecular weight

                  182,2

                  Assay

                  Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis

                     Description

                  White, odourless, crystalline powder

                  Identification

                              A.

                              Solubility

                  Soluble in water, very slightly soluble in ethanol, practically insoluble in ether

                              B.

                              Melting range

                  Between 164 and 169 °C

                              C.

                              Thin layer chromatography

                  Passes test

                              D.

                              Specific rotation

                  [α] 20
                     D: + 23 ° to + 25 ° (borate solution)

                              E.

                              pH

                  Between 5 and 8
                  Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH

                  Purity

                  Loss on drying

                  Not more than 0,3 % (105 °C, four hours)

                  Reducing sugars

                  Not more than 0,3 % (as glucose)

                  Total sugars

                  Not more than 1 % (as glucose)

                  Sulphated ash

                  Not more than 0,1 %

                  Chlorides

                  Not more than 70 mg/kg

                  Sulphate

                  Not more than 100 mg/kg

                  Nickel

                  Not more than 2 mg/kg

                  Lead

                  Not more than 1 mg/kg

            (II)   MANNITOL MANUFACTURED BY FERMENTATION

                     Synonyms

                  D-mannitol

                     Definition

                  Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii

                  Chemical name

                  D-mannitol

                  Einecs

                  200-711-8

                  Chemical formula

                  C6H14O6

                  Molecular weight

                  182,2

                  Assay

                  Not less than 99 % on the dried basis

                     Description

                  White, odourless crystalline powder

                  Identification

                              A.

                              Solubility

                  Soluble in water, very slightly soluble in ethanol, practically insoluble in ether

                              B.

                              Melting range

                  Between 164 and 169 °C

                              C.

                              Thin layer chromatography

                  Passes test

                              D.

                              Specific rotation

                  [α] 20
                     D: + 23 ° to + 25 ° (borate solution)

                              E.

                              pH

                  Between 5 and 8
                  Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH

                  Purity

                  Arabitol

                  Not more than 0,3 %

                  Loss on drying

                  Not more than 0,3 % (105 °C, four hours)

                  Reducing sugars

                  Not more than 0,3 % (as glucose)

                  Total sugars

                  Not more than 1 % (as glucose)

                  Sulphated ash

                  Not more than 0,1 %

                  Chlorides

                  Not more than 70 mg/kg

                  Sulphate

                  Not more than 100 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Aerobic mesophilic bacteria

                  Not more than 103/g

                  Coliforms

                  Absent in 10 g

                     Salmonella

                  Absent in 10 g

                     E. Coli

                  Absent in 10 g

                     Staphylococcus aureus

                  Absent in 10 g

                     Pseudomonas aeruginosa

                  Absent in 10 g

                  Moulds

                  Not more than 100/g

                  Yeasts

                  Not more than 100/g

            E 950 —   ACESULFAME K

                     Synonyms

                  Acesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one,2,2-dioxide

                  Definition

                  Chemical name

                  6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt

                  Einecs

                  259-715-3

                  Chemical formula

                  C4H4KNO4S

                  Molecular weight

                  201,24

                  Assay

                  Content not less than 99 % of C4H4KNO4S on the anhydrous basis

                     Description

                  Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose

                  Identification

                              A.

                              Solubility

                  Very soluble in water, very slightly soluble in ethanol

                              B.

                              Ultraviolet absorption

                  Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water

                              C.

                              Positive test for potassium

                  Passes test (test the residue obtained by igniting 2 g of the sample)

                              D.

                              Precipitation test

                  Add a few drops of a 10 % solution of sodium cobalt nitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced

                  Purity

                  Loss on drying

                  Not more than 1 % (105 °C, two hours)

                  Organic impurities

                  Passes test for 20 mg/kg of UV active components

                  Fluoride

                  Not more than 3 mg/kg

                  Lead

                  Not more than 1 mg/kg

            E 951 —   ASPARTAME

                     Synonyms

                  Aspartyl phenylalanine methyl ester

                  Definition

                  Chemical name

                  N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester

                  Einecs

                  245-261-3

                  Chemical formula

                  C14H18N2O5

                  Relative molecular mass

                  294,31

                  Assay

                  Not less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis

                     Description

                  White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose

                  Identification

                  Solubility

                  Slightly soluble in water and in ethanol

                  Purity

                  Loss on drying

                  Not more than 4,5 % (105 °C, four hours)

                  Sulphated ash

                  Not more than 0,2 % expressed on dry weight basis

                  pH

                  Between 4,5 and 6,0 (1 in 125 solution)

                  Transmittance

                  The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022

                  Specific rotation

                  [α]D
                     20: + 14,5 to + 16,5 °
                  Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

                  Heavy metals

                  Not more than 10 mg/kg expressed as Pb on dry weight basis

                  5-Benzyl-3,6-dioxo-2-piperazineacetic acid

                  Not more than 1,5 % expressed on dry weight basis

            E 952 —   CYCLAMIC ACID AND ITS Na AND Ca SALTS

            (I)   CYCLAMIC ACID

                     Synonyms

                  Cyclohexylsulphamic acid, cyclamate

                  Definition

                  Chemical name

                  Cyclohexanesulphamic acid, cyclohexylaminosulphonic acid

                  Einecs

                  202-898-1

                  Chemical formula

                  C6H13NO3S

                  Relative molecular mass

                  179,24

                  Assay

                  Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis

                     Description

                  A practically colourless, white crystalline powder with a sweet-sour taste. Approximately 40 times as sweet as sucrose

                  Identification

                              A.

                              Solubility

                  Soluble in water and in ethanol

                              B.

                              Precipitation test

                  Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.

                  Purity

                  Loss on drying

                  Not more than 1 % (105 °C, one hour)

                  Selenium

                  Not more than 30 mg/kg expressed as selenium on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

                  Heavy metals

                  Not more than 10 mg/kg expressed as Pb on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Cyclohexylamine

                  Not more than 10 mg/kg expressed on dry weight basis

                  Dicyclohexylamine

                  Not more than 1 mg/kg expressed on dry weight basis

                  Aniline

                  Not more than 1 mg/kg expressed on dry weight basis

            (II)   SODIUM CYCLAMATE

                     Synonyms

                  Cyclamate, sodium salt of cyclamic acid

                  Definition

                  Chemical name

                  Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate

                  Einecs

                  205-348-9

                  Chemical formula

                  C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O

                  Relative molecular mass

                  201,22 calculated on the anhydrous form
                  237,22 calculated on the hydrated form

                  Assay

                  Not less than 98 % and not more than 102 % on the dried basis
                  Dihydrate form: not less than 84 % on the dried basis

                     Description

                  White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose

                  Identification

                  Solubility

                  Soluble in water, practically insoluble in ethanol

                  Purity

                  Loss on drying

                  Not more than 1 % (105 °C, one hour)
                  Not more than 15,2 % (105 °C, two hours) for the dihydrate form

                  Selenium

                  Not more than 30 mg/kg expressed as selenium on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

                  Heavy metals

                  Not more than 10 mg/kg expressed as Pb on dry weight basis

                  Cyclohexylamine

                  Not more than 10 mg/kg expressed on dry weight basis

                  Dicyclohexylamine

                  Not more than 1 mg/kg expressed on dry weight basis

                  Aniline

                  Not more than 1 mg/kg expressed on dry weight basis

            (III)   CALCIUM CYCLAMATE

                     Synonyms

                  Cyclamate, calcium salt of cyclamic acid

                  Definition

                  Chemical name

                  Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate

                  Einecs

                  205-349-4

                  Chemical formula

                  C12H24CaN2O6S2·2H2O

                  Relative molecular mass

                  432,57

                  Assay

                  Not less than 98 % and not more than 101 % on the dried basis

                     Description

                  White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose

                  Identification

                  Solubility

                  Soluble in water, sparingly soluble in ethanol

                  Purity

                  Loss on drying

                  Not more than 1 % (105 °C, one hour)
                  Not more than 8,5 % (140 °C, four hours) for the dihydrate form

                  Selenium

                  Not more than 30 mg/kg expressed as selenium on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

                  Heavy metals

                  Not more than 10 mg/kg expressed as Pb on dry weight basis

                  Cyclohexylamine

                  Not more than 10 mg/kg expressed on dry weight basis

                  Dicyclohexylamine

                  Not more than 1 mg/kg expressed on dry weight basis

                  Aniline

                  Not more than 1 mg/kg expressed on dry weight basis

            E 953 —   ISOMALT

                     Synonyms

                  Hydrogenated isomaltulose, hydrogenated palatinose.

                  Definition

                  Chemical name

                  Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides:

                              6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and

                              1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)

                  Chemical formula

                  6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O11

                  1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O

                  Relative molecular mass

                  6-O-α-D-Glucopyranosyl-D-sorbitol: 344,32
                  1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32

                  Assay

                  Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.

                     Description

                  Odourless, white, slightly hygroscopic, crystalline mass.

                  Identification

                              A.

                              Solubility

                  Soluble in water, very slightly soluble in ethanol.

                              B.

                              Thin layer chromatography

                  Examine by thin layer chromatography using a plate coated with an approximately 0,2 mm layer of chromatographic silica gel. The principal spots in the chromatogram are those of 1,1-GPM and 1,6-GPS.

                  Purity

                  Water content

                  Not more than 7 % (Karl Fischer Method)

                  Sulphated ash

                  Not more than 0,05 % expressed on dry weight basis

                  D-Mannitol

                  Not more than 3 %

                  D-Sorbitol

                  Not more than 6 %

                  Reducing sugars

                  Not more than 0,3 % expressed as glucose on dry weight basis

                  Nickel

                  Not more than 2 mg/kg expressed on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg expressed on dry weight basis.

            E 954 —   SACCHARIN AND ITS Na, K AND Ca SALTS

            (I)   SACCHARIN

                  Definition

                  Chemical name

                  3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide

                  Einecs

                  201-321-0

                  Chemical formula

                  C7H5NO3S

                  Relative molecular mass

                  183,18

                  Assay

                  Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis

                     Description

                  White crystals or a white crystalline powder, odourless or with a faint, aromatic odour, having a sweet taste even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose

                  Identification

                  Solubility

                  Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol

                  Purity

                  Loss on drying

                  Not more than 1 % (105 °C, two hours)

                  Melting range

                  226 to 230 °C

                  Sulphated ash

                  Not more than 0,2 % expressed on dry weight basis

                  Benzoic and salicylic acid

                  To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

                     o-Toluenesulphonamide

                  Not more than 10 mg/kg expressed on dry weight basis

                     p-Toluenesulphonamide

                  Not more than 10 mg/kg expressed on dry weight basis

                  Benzoic acid p-sulphonamide

                  Not more than 25 mg/kg expressed on dry weight basis

                  Readily carbonisable substances

                  Absent

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Selenium

                  Not more than 30 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

            (II)   SODIUM SACCHARIN

                     Synonyms

                  Saccharin, sodium salt of saccharin

                  Definition

                  Chemical name

                  Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate

                  Einecs

                  204-886-1

                  Chemical formula

                  C7H4NNaO3S·2H2O

                  Relative molecular mass

                  241,19

                  Assay

                  Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis

                     Description

                  White crystals or a white crystalline efflorescent powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions

                  Identification

                  Solubility

                  Freely soluble in water, sparingly soluble in ethanol

                  Purity

                  Loss on drying

                  Not more than 15 % (120 °C, four hours)

                  Benzoic and salicylic acid

                  To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

                     o-Toluenesulphonamide

                  Not more than 10 mg/kg expressed on dry weight basis

                     p-Toluenesulphonamide

                  Not more than 10 mg/kg expressed on dry weight basis

                  Benzoic acid p-sulphonamide

                  Not more than 25 mg/kg expressed on dry weight basis

                  Readily carbonisable substances

                  Absent

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Selenium

                  Not more than 30 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

            (III)   CALCIUM SACCHARIN

                     Synonyms

                  Saccharin, calcium salt of saccharin

                  Definition

                  Chemical name

                  Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)

                  Einecs

                  229-349-9

                  Chemical formula

               C14H8CaN2O6S2·3
                     H2O

                  Relative molecular mass

                  467,48

                  Assay

                  Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis

                     Description

                  White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions

                  Identification

                  Solubility

                  Freely soluble in water, soluble in ethanol

                  Purity

                  Loss on drying

                  Not more than 13,5 % (120 °C, four hours)

                  Benzoic and salicylic acid

                  To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

                     o-Toluenesulphonamide

                  Not more than 10 mg/kg expressed on dry weight basis

                     p-Toluenesulphonamide

                  Not more than 10 mg/kg expressed on dry weight basis

                  Benzoic acid p-sulphonamide

                  Not more than 25 mg/kg expressed on dry weight basis

                  Readily carbonisable substances

                  Absent

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Selenium

                  Not more than 30 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

            (IV)   POTASSIUM SACCHARIN

                     Synonyms

                  Saccharin, potassium salt of saccharin

                  Definition

                  Chemical name

                  Potassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate

                  Einecs

                  Chemical formula

                  C7H4KNO3S·H2O

                  Relative molecular mass

                  239,77

                  Assay

                  Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis

                     Description

                  White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose

                  Identification

                  Solubility

                  Freely soluble in water, sparingly soluble in ethanol

                  Purity

                  Loss on drying

                  Not more than 8 % (120 °C, four hours)

                  Benzoic and salicylic acid

                  To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

                     o-Toluenesulphonamide

                  Not more than 10 mg/kg expressed on dry weight basis

                     p-Toluenesulphonamide

                  Not more than 10 mg/kg expressed on dry weight basis

                  Benzoic acid p-sulphonamide

                  Not more than 25 mg/kg expressed on dry weight basis

                  Readily carbonisable substances

                  Absent

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Selenium

                  Not more than 30 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

            E 955 —   SUCRALOSE

                     Synonyms

                  4,1′,6′-Trichlorogalactosucrose

                  Definition

                  Chemical name

                  1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside

                  Einecs

                  259-952-2

                  Chemical formula

                  C12H19Cl3O8

                  Molecular weight

                  397,64

                  Assay

                  Content not less than 98 % and not more than 102 % C12H19Cl3O8 calculated on an anhydrous basis.

                     Description

                  White to off-white, practically odourless, crystalline powder.

                  Identification

                              A.

                              Solubility

                  Freely soluble in water, methanol and ethanol
                  Slightly soluble in ethyl acetate

                              B.

                              Infrared absorption

                  The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard.

                              C.

                              Thin layer chromatography

                  The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0g of sucralose reference standard in 10 ml of methanol.

                              D.

                              Specific rotation

                  [α] 20
                     D + 84,0 ° to + 87,5 ° calculated on the anhydrous basis
                  (10 % w/v solution)

                  Purity

                  Water

                  Not more than 2,0 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,7 %

                  Other chlorinated disaccharides

                  Not more than 0,5 %

                  Chlorinated monosaccharides

                  Not more than 0,1 %

                  Triphenylphosphine oxide

                  Not more than 150 mg/kg

                  Methanol

                  Not more than 0,1 %

                  Lead

                  Not more than 1 mg/kg

            E 957 —   THAUMATIN

                     Synonyms

                  Definition

                  Chemical name

                  Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of the natural strain of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material

                  Einecs

                  258-822-2

                  Chemical formula

                  Polypeptide of 207 amino acids

                  Relative molecular mass

                  Thaumatin I 22209
                  Thaumatin II 22293

                  Assay

                  Not less than 16 % nitrogen on the dried basis equivalent to not less than 94 % proteins (N × 5,8)

                     Description

                  Odourless, cream-coloured powder with an intensely sweet taste. Approximately 2 000 to 3 000 times as sweet as sucrose

                  Identification

                  Solubility

                  Very soluble in water, insoluble in acetone

                  Purity

                  Loss on drying

                  Not more than 9 % (105 °C to constant weight)

                  Carbohydrates

                  Not more than 3 % expressed on dry weight basis

                  Sulphated ash

                  Not more than 2 % expressed on dry weight basis

                  Aluminium

                  Not more than 100 mg/kg expressed on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  3 mg/kg expressed on dry weight basis

                  Microbiological criteria

                  Total aerobic microbial count: Max 1 000/g E. Coli: absent in 1 g

            E 959 —   NEOHESPERIDINE DIHYDROCHALCONE

                     Synonyms

                  Neohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DC

                  Definition

                  Chemical name

                  2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin

                  Einecs

                  243-978-6

                  Chemical formula

                  C28H36O15

                  Relative molecular mass

                  612,6

                  Assay

                  Content not less than 96 % on the dried basis

                     Description

                  Off-white, odourless, crystalline powder having a characteristic, intensive sweet taste. Approximately between 1 000 and 1 800 times as sweet as sucrose

                  Identification

                              A.

                              Solubility

                  Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene

                              B.

                              Ultraviolet absorption maximum

                  282 to 283 nm for a solution of 2 mg in 100 ml methanol

                              C.

                              Neu's test

                  Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced

                  Purity

                  Loss on drying

                  Not more than 11 % (105 °C, three hours)

                  Sulphated ash

                  Not more than 0,2 % expressed on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 2 mg/kg expressed on dry weight basis

                  Heavy metals

                  Not more than 10 mg/kg expressed as Pb on dry weight basis

            E 962 —   SALT OF ASPARTAME-ACESULFAME

                     Synonyms

                  Aspartame-acesulfame, Aspartame-acesulfame salt

                     Definition

                  The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.

                  Chemical name

                  6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid

                  Chemical formula

                  C18H23O9N3S

                  Molecular weight

                  457,46

                  Assay

                  63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis)

                     Description

                  A white, odourless, crystalline powder.

                  Identification

                              A.

                              Solubility

                  Sparingly soluble water; slightly soluble in ethanol

                              B.

                              Transmittance

                  The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022.

                              C.

                              Specific rotation

                  [α] 20
                     D + 14,5 ° to + 16,5 °
                  Determine at a concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame

                  Purity

                  Loss on drying

                  Not more than 0,5 % (105 °C, four hours)

                  5-Benzyl-3,6-dioxo-2-piper-azineacetic acid

                  Not more than 0,5 %

                  Lead

                  Not more than 1 mg/kg

            E 965 (i) —   MALTITOL

                     Synonyms

                  D-Maltitol, hydrogenated maltose

                  Definition

                  Chemical name

                  (α)-D-Glucopyranosyl-1,4-D-glucitol

                  Einecs

                  209-567-0

                  Chemical formula

                  C12H24O11

                  Relative molecular mass

                  344,31

                  Assay

                  Content not less than 98 % D-maltitol C12H24O11 on the anhydrous basis

                     Description

                  Sweet tasting, white crystalline powder

                  Identification

                              A.

                              Solubility

                  Very soluble in water, slightly soluble in ethanol

                              B.

                              Melting range

                  148 to 151 °C

                              C.

                              Specific rotation

                  [α]D
                     20 = + 105,5 ° to + 108,5 ° (5 % w/v solution)

                  Purity

                  Water content

                  Not more than 1 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,1 % expressed on dry weight basis

                  Reducing sugars

                  Not more than 0,1 % expressed as glucose on dry weight basis

                  Chlorides

                  Not more than 50 mg/kg expressed on dry weight basis

                  Sulphates

                  Not more than 100 mg/kg expressed on dry weight basis

                  Nickel

                  Not more than 2 mg/kg expressed on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

            E 965 (ii) —   MALTITOL SYRUP

                     Synonyms

                  Hydrogenated high-maltose-glucose syrup, hydrogenated glucose syrup

                     Definition

                  A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.

                  Assay

                  Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis

                     Description

                  Colourless and odourless, clear viscous liquids or white crystalline masses

                  Identification

                              A.

                              Solubility

                  Very soluble in water, slightly soluble in ethanol

                              B.

                              Thin layer chromatography

                  Passes test

                  Purity

                  Water

                  Not more than 31 % (Karl Fischer)

                  Reducing sugars

                  Not more than 0,3 % (as glucose)

                  Sulphated ash

                  Not more than 0,1 %

                  Chlorides

                  Not more than 50 mg/kg

                  Sulphate

                  Not more than 100 mg/kg

                  Nickel

                  Not more than 2 mg/kg

                  Lead

                  Not more than 1 mg/kg

            E 966 —   LACTITOL

                     Synonyms

                  Lactit, lactositol, lactobiosit

                  Definition

                  Chemical name

                  4-O-β-D-Galactopyranosyl-D-glucitol

                  Einecs

                  209-566-5

                  Chemical formula

                  C12H24O11

                  Relative molecular mass

                  344,32

                  Assay

                  Not less than 95 % on the dry weight basis

                     Description

                  Sweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms

                  Identification

                              A.

                              Solubility

                  Very soluble in water

                              B.

                              Specific rotation

                  [α]D
                     20 = + 13 ° to + 16 ° calculated on the anhydrous basis (10 % w/v aqueous solution)

                  Purity

                  Water content

                  Crystalline products; not more than 10,5 % (Karl Fischer method)

                  Other polyols

                  Not more than 2,5 % on the anhydrous basis

                  Reducing sugars

                  Not more than 0,2 % expressed as glucose on dry weight basis

                  Chlorides

                  Not more than 100 mg/kg expressed on dry weight basis

                  Sulphates

                  Not more than 200 mg/kg expressed on dry weight basis

                  Sulphated ash

                  Not more than 0,1 % expressed on dry weight basis

                  Nickel

                  Not more than 2 mg/kg expressed on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

            E 967 —   XYLITOL

                     Synonyms

                  Xylitol

                  Definition

                  Chemical name

                  D-xylitol

                  Einecs

                  201-788-0

                  Chemical formula

                  C5H12O5

                  Relative molecular mass

                  152,15

                  Assay

                  Not less than 98,5 % as xylitol on the anhydrous basis

                     Description

                  White, crystalline powder, practically odourless with a very sweet taste

                  Identification

                              A.

                              Solubility

                  Very soluble in water, sparingly soluble in ethanol

                              B.

                              Melting range

                  92 to 96 °C

                              C.

                              pH

                  5 to 7 (10 % w/v aqueous solution)

                  Purity

                  Loss on drying

                  Not more than 0,5 %. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hours

                  Sulphated ash

                  Not more than 0,1 % expressed on dry weight basis

                  Reducing sugars

                  Not more than 0,2 % expressed as glucose on dry weight basis

                  Other polyhydric alcohols

                  Not more than 1 % expressed on dry weight basis

                  Nickel

                  Not more than 2 mg/kg expressed on dry weight basis

                  Arsenic

                  Not more than 3 mg/kg expressed on dry weight basis

                  Lead

                  Not more than 1 mg/kg expressed on dry weight basis

                  Heavy metals

                  Not more than 10 mg/kg expressed as Pb on dry weight basis

                  Chlorides

                  Not more than 100 mg/kg expressed on dry weight basis

                  Sulphates

                  Not more than 200 mg/kg expressed on dry weight basis

            E 968 —   ERYTHRITOL

                     Synonyms

                  Meso-erythritol, tetrahydroxybutane, erythrite

                     Definition

                  Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Trichosporonoides megachilensis, followed by purification and drying

                  Chemical name

                  1,2,3,4-Butanetetrol

                  Einecs

                  205-737-3

                  Chemical formula

                  C4H10O4

                  Molecular weight

                  122,12

                  Assay

                  Not less than 99 % after drying

                     Description

                  White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.

                  Identification

                              A.

                              Solubility

                  Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.

                              B.

                              Melting range

                  119-123 °C

                  Purity

                  Loss on drying

                  Not more than 0,2 % (70 °C, six hours, in a vacuum desiccator)

                  Sulphated ash

                  Not more than 0,1 %

                  Reducing substances

                  Not more than 0,3 % expressed as D-glucose

                  Ribitol and glycerol

                  Not more than 0,1 %

                  Lead

                  Not more than 0,5 mg/kg

      ANNEX II
      PART A
      Repealed Directive with list of its successive amendments
      (referred to in Article 2)

                  Commission Directive 95/31/EC

                  (OJ L 178, 28.7.1995, p. 1)

                  Commission Directive 98/66/EC

                  (OJ L 257, 19.9.1998, p. 35)

                  Commission Directive 2000/51/EC

                  (OJ L 198, 4.8.2000, p. 41)

                  Commission Directive 2001/52/EC

                  (OJ L 190, 12.7.2001, p. 18)

                  Commission Directive 2004/46/EC

                  (OJ L 114, 21.4.2004, p. 15)

                  Commission Directive 2006/128/EC

                  (OJ L 346, 9.12.2006, p. 6)

            PART B
      List of time-limits for transposition into national law
      (referred to in Article 2)

                  Directive

                  Time-limit for transposition

                  95/31/EC

                  1 July 1996 (1)

                  98/66/EC

                  1 July 1999

                  2000/51/EC

                  30 June 2001

                  2001/52/EC

                  30 June 2002

                  2004/46/EC

                  1 April 2005

                  2006/128/EC

                  15 February 2008

         (1)  According to Article 2(2) of Directive 95/31/EC, products put on the market or labelled before 1 July 1996 which do not comply with this Directive may be marketed until stocks are exhausted.

      ANNEX III
      Correlation table

                  Directive 95/31/EC

                  This Directive

                  Article 1(1)

                  Article 1

                  Article 1(2)

                  —

                  Article 2

                  —

                  —

                  Article 2

                  Article 3

                  Article 3

                  Article 4

                  Article 4

                  Annex

                  Annex I

                  —

                  Annex II

                  —

                  Annex III


Avis juridique important

|

32003L0081

Commission Directive 2003/81/EC of 5 September 2003 amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances (Text with EEA relevance)

Official Journal L 224 , 06/09/2003 P. 0029 - 0031

Commission Directive 2003/81/ECof 5 September 2003amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/79/EC(2), and in particular Article 6(1) thereof,Whereas:(1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes molinate, thiram and ziram.(2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. For molinate the rapporteur Member State was Portugal, and all relevant information was submitted on 30 November 1998. For thiram the Rapporteur Member State was Belgium, and the relevant information was submitted on 15 January 1998. For ziram the rapporteur Member State was Belgium and the relevant information was submitted on 9 June 1998.(3) Those assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.(4) The reviews of all active substances were finalised on 4 July 2003 in the format of the Commission review reports for molinate, thiram and ziram.(5) The reviews of molinate, thiram and ziram did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.(6) It has appeared from the various examinations made that plant protection products containing molinate, thiram or ziram may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.(7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will resulting from the inclusion.(8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing molinate, thiram or ziram, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC.(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(10) 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 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish by 31 January 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 February 2005.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.Article 31. Member States shall review the authorisation for each plant protection product containing molinate, thiram or ziram to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 31 January 2005 at the latest, they shall amend or withdraw the authorisation.2. Member States shall, for each authorised plant protection product containing molinate, thiram or ziram as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2004 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 July 2008 at the latest, they shall amend or withdraw the authorisation.Article 4This Directive shall enter into force on 1 August 2004.Article 5This Directive is addressed to the Member States.Done at Brussels, 5 September 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 205, 14.8.2003, p. 16.(3) OJ L 366, 15.12.1992, p. 10.(4) OJ L 259, 13.10.2000, p. 27.(5) OJ L 107, 28.4.1994, p. 8.(6) OJ L 225, 22.9.1995, p. 1.ANNEXThe following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC">TABLE>"


title: Council Directive 2006/110/EC of 20 November 2006 adapting Directives 95/57/EC and 2001/109/EC in the field of statistics, by reason of the accession of Bulgaria and Romania

text:
               20.12.2006

               EN

               Official Journal of the European Union

               L 363/418

      COUNCIL DIRECTIVE 2006/110/EC
   of 20 November 2006
   adapting Directives 95/57/EC and 2001/109/EC in the field of statistics, by reason of the accession of Bulgaria and Romania
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community,
   Having regard to the Treaty of Accession of Bulgaria and Romania (1), and in particular Article 4(3) thereof,
   Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,
   Having regard to the proposal from the Commission,
   Whereas:

               (1)

               Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council, unless the Commission adopted the original act.

               (2)

               The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

               (3)

               Directives 95/57/EC (2) and 2001/109/EC (3) should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directives 95/57/EC and 2001/109/EC shall be amended as set out in the Annex.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of accession of Bulgaria and Romania to the European Union at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, 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 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 covered by this Directive.
   Article 3
   This Directive shall enter into force subject to and on the date of the entry into force of the Treaty of Accession of Bulgaria and Romania.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 20 November 2006

            For the Council

            The President

         J. KORKEAOJA

      (1)  OJ L 157, 21.6.2005, p. 11.

      (2)  OJ L 291, 6.12.1995, p. 32.

      (3)  OJ L 13, 16.1.2002, p. 21.

      ANNEX
      STATISTICS

                  1.

                  31995 L 0057: Council Directive 95/57/EC of 23 November 1995 on the collection of statistical information in the field of tourism (OJ L 291, 6.12.1995, p. 32), as amended by:

                              —

                              12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

                              —

                              32003 R 1882: Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29.9.2003 (OJ L 284, 31.10.2003 p. 1),

                              —

                              32004 D 0883: Commission Decision 2004/883/EC of 10.12.2004 (OJ L 373, 21.12.2004, p. 69).

                        In the Annex, the section headed ‘Breakdown by geographical araes’ is replaced by the following text:
                  ‘BREAKDOWN BY GEOGRAPHICAL AREAS
                  1.   Supply side statistics
                  World total
                  Total European Economic Area
                  Total European Union (27)
                  Belgium
                  Bulgaria
                  Czech Republic
                  Denmark
                  Germany
                  Estonia
                  Greece
                  Spain
                  France
                  Ireland
                  Italy
                  Cyprus
                  Latvia
                  Lithuania
                  Luxembourg
                  Hungary
                  Malta
                  Netherlands
                  Austria
                  Poland
                  Portugal
                  Romania
                  Slovenia
                  Slovakia
                  Finland
                  Sweden
                  United Kingdom
                  Total EFTA
                  Iceland
                  Norway
                  Switzerland (incl. Liechtenstein)
                  Total other European countries
                  of which:

                              Russia

                              Turkey

                              Ukraine

                        Total Africa
                  of which:

                              South Africa

                        Total North America
                  of which:

                              United States of America

                              Canada

                        Total South and Central America
                  of which:

                              Brazil

                        Total Asia
                  of which:

                              People's Republic of China

                              Japan

                              Republic of South Korea

                        Total Australia, Oceania and other territories
                  of which:

                              Australia

                        Unspecified
                  2.   Demand side statistics
                  World total
                  Total European Economic Area
                  Total European Union (27)
                  Belgium
                  Bulgaria
                  Czech Republic
                  Denmark
                  Germany
                  Estonia
                  Greece
                  Spain
                  France
                  Ireland
                  Italy
                  Cyprus
                  Latvia
                  Lithuania
                  Luxembourg
                  Hungary
                  Malta
                  Netherlands
                  Austria
                  Poland
                  Portugal
                  Romania
                  Slovenia
                  Slovakia
                  Finland
                  Sweden
                  United Kingdom
                  Total EFTA
                  Iceland
                  Norway
                  Switzerland (incl. Liechtenstein)
                  Total other European countries
                  of which:

                              Russia

                              Turkey

                        Total Africa
                  of which:

                              South Africa

                              Maghreb countries

                        Total North America
                  of which:

                              United States of America

                        Total South and Central America
                  of which:

                              Argentina

                              Brazil

                        Total Asia
                  of which:

                              People's Republic of China

                              Japan

                              Republic of South Korea

                        Total Australia, Oceania and other territories
                  of which:

                              Australia

                        Unspecified’

                  2.

                  32001 L 0109: Directive 2001/109/EC of the European Parliament and of the Council of 19 December 2001 concerning the statistical surveys to be carried out by the Member States in order to determine the production potential of plantations of certain species of fruit trees (OJ L 13, 16.1.2002, p. 21), as amended by:

                              —

                              12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

                              —

                              32006 D 0128: Commission Decision 2006/128/EC of 3.2.2006 (OJ L 51, 22.2.2006, p. 21).

                        The Annex is replaced by the following:

                     ‘ANNEX
                     SPECIES SURVEYED IN THE VARIOUS MEMBER STATES

                                 Apples

                                 Pears

                                 Peaches

                                 Apricots

                                 Oranges

                                 Lemons

                                 Small-fruited
                                 Citrus fruits

                                 Belgium

                                 x

                                 x

                                 Bulgaria

                                 x

                                 x

                                 x

                                 x

                                 Czech Republic

                                 x

                                 x

                                 x

                                 x

                                 Denmark

                                 x

                                 x

                                 Germany

                                 x

                                 x

                                 Estonia

                                 x

                                 Greece

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 Spain

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 France

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 Ireland

                                 x

                                 Italy

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 Cyprus

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 Latvia

                                 x

                                 x

                                 Lithuania

                                 x

                                 x

                                 Luxembourg

                                 x

                                 x

                                 Hungary

                                 x

                                 x

                                 x

                                 x

                                 Malta

                                 x

                                 x

                                 x

                                 Netherlands

                                 x

                                 x

                                 Austria

                                 x

                                 x

                                 x

                                 x

                                 Poland

                                 x

                                 x

                                 x (1)

                                 x (1)

                                 Portugal

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 x

                                 Romania

                                 x (1)

                                 x (1)

                                 x (1)

                                 x (1)

                                 Slovenia

                                 x

                                 x

                                 x

                                 x

                                 Slovakia

                                 x

                                 x

                                 x

                                 x

                                 Finland

                                 x

                                 Sweden

                                 x

                                 x

                                 United Kingdom

                                 x

                                 x

         (1)  surveys are not conducted for: age of trees, density of plantation, variety of fruit’


Avis juridique important

|

31993L0017

Commission Directive 93/17/EEC of 30 March 1993 determining Community grades of basic seed potatoes, together with the conditions and designations applicable to such grades

Official Journal L 106 , 30/04/1993 P. 0007 - 0010 Finnish special edition: Chapter 3 Volume 49 P. 0133  Swedish special edition: Chapter 3 Volume 49 P. 0133

COMMISSION DIRECTIVE 93/17/EEC of 30 March 1993 determining Community grades of basic seed potatoes, together with the conditions and designations applicable to such gradesTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/403/EEC of 14 June 1966 on the marketing of seed potatoes (1), as last amended by Commission Directive 93/3/EEC (2), and in particular Article 3 (3) thereof,  Whereas, in order to implement, in an area without internal frontiers in which the free movement of goods is ensured in accordance with the provisions of the Treaty, the provisions of Directive 66/403/EEC in respect of the marketing of seed potatoes in  all or part of the territory of one or more Member States satisfying more stringent measures than those provided for in Annexes I and II to that Directive, it is appropriate to determine Community grades of basic seed potatoes, as well as the conditions  and designations applicable to such grades;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DECISION: Article 1  1. Community grades of basic seed potatoes are hereby determined. Seed potatoes eligible for these grades are those which qualify for the official certification as 'basic seed potatoes' in accordance with the provisions of Article 2 (1) (a) of Directive  66/403/EEC, and which moreover satisfy the conditions specified in paragraph 2, and which have been found on official examination to satisfy those conditions.  2. The following are the conditions referred to in paragraph 1:  (a) the plant health conditions laid down in:  - Council Directive 69/464/EEC (3),   - Council Directive 69/465/EEC (4),   - Council Directive 77/93/EEC (5),   - Council Directive 80/665/EEC (6);  (b) the seed potatoes shall derive from material satisfying the conditions laid down in Annex I, and satisfy the additional or more stringent conditions laid down in Annex II. Article 2  1. The designation of the Community grades of basic seed potatoes shall be:  (a) 'EEC grade 1' in cases where the conditions laid down in Annex I, other than point 3.3 (b) thereof, and Annex II (1) are met; or (b) 'EEC grade 2' in cases where the conditions laid down in Annex I, other than point 3.3 (a) thereof, and Annex II (2) are met; or (c) 'EEC grade 3' in cases where the conditions laid down in Annex I other than point 3.3 (a) thereof, and Annex II (3) are met.  The designation shall be indicated on the official label provided for in Annex III to Directive 66/403/EEC, under the heading 'grade'.  2. Member States shall inform the Commission of the extent to which they apply the respective Community grades in certifying their own production. Article 3  1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than the date provided for the implementation of Council Directive 91/683/EEC (7). They shall forthwith inform  the Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The procedure for such reference shall be adopted by Member States.  2. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive. Article 4  This Directive is addressed to the Member States.  Done at Brussels, 30 March 1993. For the Commission René STEICHEN Member of the Commission (1) OJ No 125, 11. 7. 1966, p. 2320/66.  (2) OJ No L 54, 5. 3. 1993, p. 21.  (3) OJ No L 323, 24. 12. 1969, p. 1.  (4) OJ No L 323, 24. 12. 1969, p. 3.  (5) OJ No L 26, 31. 1. 1977, p. 20.  (6) OJ No L 180, 14. 7. 1980, p. 30.  (7) OJ No L 376, 31. 12. 1991, p. 29.    ANNEX I  CONDITIONS TO BE SATISFIED BY THE MATERIAL FROM WHICH THE COMMUNITY GRADES OF BASIC SEED POTATOES SHALL DERIVE  1. Where methods of micropropagation, including the meristem technique are used:  1.1. the mother tuber shall be free from the following harmful organisms:  (a) Erwinia carotovora var. atroseptica  (b) Erwinia chrysanthemi  (c) Potato leaf roll virus  (d) Potato virus A  (e) Potato virus M  (f) Potato virus S  (g) Potato virus X  (h) Potato virus Y  Compliance with the above requirements shall be established by official testing or testing under official supervision according to appropriate methods;  1.2. the material multiplied in vitro and derived from the mother tuber shall comply with the conditions laid down in point 1.1 above. However, the requirements of compulsory official testing or testing under official supervision do not apply.  2. Where the method of clonal selection is used, the initial plant and the tubers directly derived from it shall:  2.1. be free from the harmful organisms listed under 1.1 above. Compliance with the requirements in respect of (c) to (h) shall be established by official testing or testing under official supervision according to appropriate methods;  2.2. have been grown in a crop satisfying the requirements under 3 below.  3. The crops shall:  3.1. be raised in a production ground where three years at least have elapsed since potatoes were last grown;  3.2. be isolated from crops of a lower status by an adequate isolation distance. The satisfaction of this requirement shall be checked by official field inspection;  3.3. in respect of blackleg:  (a) be free from blackleg, in the case of 'EEC grade 1'; or  (b) contain not more than 0,25 % of plants affected by blackleg, in the case of 'EEC grade 2', and 'EEC grade 3'.   Compliance with this requirement shall be checked by official field inspection;  3.4. contain not more than 0,1 % of plants showing symptoms of infection by viruses. The compliance with this requirement shall be checked by official field inspection, supplemented in case of doubt by laboratory tests on leaves according to appropriate  methods;  3.5. where an official field inspection is provided for, be subject to at least two official field inspections;  3.6. be subject to as low a limit as possible on the maximum number of multiplications, account being taken of the production conditions.       ANNEX II  ADDITIONAL OR MORE STRINGENT CONDITIONS TO BE SATISFIED BY THE CROP AND THE LOTS OF COMMUNITY GRADES OF BASIC SEED POTATOES  1. 'EEC grade 1' 1.1. The crop shall:  1.1.1. be raised in a production ground where three years at least have elapsed since potatoes were last grown;  1.1.2. be free from plants affected by blackleg. Compliance with this requirement shall be checked by official field inspection;  1.1.3. contain not more than 0,5 % of plants showing symptoms of infection by viruses. Compliance with this requirement shall be checked by official field inspection, supplemented in case of doubt by laboratory tests on leaves according to appropriate  methods;  1.1.4. where official field inspection is provided for, be subject to at least two official field inspections;  1.1.5. be subject to as low a limit as possible on the maximum number of generations, account being taken of the production conditions.  1.2. Lots shall not:  1.2.1. contain more than 1 % by weight of earth and extraneous matter. Compliance with this requirement shall be checked by official examination;  1.2.2. contain more than 0,5 % by weight of tubers infected by dry or wet rot. Compliance with this requirement shall be checked by official examination.  2. 'EEC grade 2' The conditions laid down in point 1, with the exception of 1.1.2, shall apply. The standard in respect of blackleg shall be not more than 0,5 % of plants affected.  3. 'EEC grade 3' The conditions laid down in point 1, with the exception of 1.1.2 and 1.1.3, shall apply.  The standard in respect of blackleg shall be not more than 1 % of plants affected.  The standard in respect of infection by viruses shall be not more than 1 % of plants showing symptoms thereof.