title: Commission Directive 2009/10/EC of 13 February 2009 amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)

text:
               14.2.2009

               EN

               Official Journal of the European Union

               L 44/62

      COMMISSION DIRECTIVE 2009/10/EC
   of 13 February 2009
   amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners
   (Text with EEA relevance)
   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 authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
   After consulting the Scientific Committee on Food (SCF) and the European Food Safety Authority (EFSA),
   Whereas:

               (1)

               Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (2) sets out the purity criteria for the additives mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (3).

               (2)

               The European Food Safety Authority (hereinafter EFSA) concluded in its opinion of 20 October 2006 (4) that nisin produced through a modified production process using a sugar-based medium is equivalent with respect to health protection to the one produced by the original milk-based medium process. On the basis of that opinion, the existing specifications for E234 nisin should be amended in order to adapt the definition and the purity criteria set out for that additive.

               (3)

               Formaldehyde is used as a preservative during the manufacture of alginic acid, alginate salts and esters of alginic acid. It has been reported that residual formaldehyde, up to 50 mg/kg, may be present in the final gelling additives. At the request of the Commission, EFSA assessed the safety in use of formaldehyde as a preservative during the manufacture and preparation of food additives (5). EFSA in its opinion of 30 November 2006 concluded that the estimated exposure to gelling additives containing residual formaldehyde at the level of 50 mg/kg of additive would be of no safety concern. Therefore the existing purity criteria for E400 alginic acid, E401 sodium alginate, E402 potassium alginate, E403 ammonium alginate, E404 calcium alginate, and E405 propane-1,2-diol alginate should be amended in such a way that the maximum level of formaldehyde is set at 50 mg/kg.

               (4)

               Formaldehyde is not currently used in the processing of seaweeds for the production of E407 carrageenan and E407a processed eucheuma seaweed. However, it may be naturally occurring in marine algae and be consequently present as an impurity in the finished product. It is therefore appropriate to fix a maximum level of adventitious presence of the above substance in those food additives.

               (5)

               Guar gum is authorised as a food additive for use in foodstuffs by Directive 95/2/EC. In particular, it is used as thickener, emulsifier, and stabiliser. A request to use a partially depolymerised guar gum as a food additive, produced from native guar gum by one of the three manufacturing processes consisting of heat treatment, acid hydrolysis or alkaline oxidation, was submitted to the Commission. EFSA assessed the safety in use of that additive and, in its opinion of 4 July 2007 (6), estimated that partially depolymerised guar gum has been shown to be very similar to native guar gum with respect to the composition of the final product. It also concluded that partially depolymerised guar gum is of no safety concern for its use as thickener, emulsifier or stabiliser. However, in the same opinion, EFSA recommended that the specifications for E412 guar gum should be adjusted to take into account the increased level of salts and the possible presence of undesirable by-products that may result from the manufacturing process. On the basis of the recommendations issued by EFSA, the specifications of guar gum should be amended.

               (6)

               It is necessary to adopt specifications for E504(i) magnesium carbonate authorised as a food additive for use in foodstuffs through Directive 95/2/EC.

               (7)

               On the basis of data provided by the European Lime Association, it appears that the manufacturing of lime products from available raw materials does not permit them to comply with the existing purity criteria set for E526 calcium hydroxide and E529 calcium oxide, as regards the level of magnesium and alkali salts. Taking into account that magnesium salts are of no safety concern and the specifications as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (hereafter JECFA), it is appropriate to adjust the levels of magnesium and alkali salts for E526 calcium hydroxide and E529 calcium oxide to the lowest achievable values, which remain lower or equal to the levels set by JECFA.

               (8)

               In addition, it is necessary to take into account the specifications as set out in the Codex Alimentarius drafted by JECFA with regard to the level of lead for E526 calcium hydroxide and E529 calcium oxide. However, due to the natural high background of lead contained in the raw material (calcium carbonate) extracted in some Member States, and from which those additives are derived, it appears difficult to align the level of lead contained in those food additives with the upper limit of lead set by JECFA. Therefore the current level of lead should be reduced to the lowest achievable threshold.

               (9)

               E 901 beeswax is authorised as a food additive in Directive 95/2/EC. EFSA in its opinion of 27 November 2007 (7) confirmed the safety in use of this food additive. However, it also indicated that the presence of lead should be restricted to the lowest possible level. Taking into account the revised specifications for beeswax as set out in the Codex Alimentarius as drafted by JECFA, it is appropriate to amend the existing purity criteria for E901 beeswax in order to lower the maximum permitted level of lead.

               (10)

               Highly refined waxes deriving from synthetic hydrocarbon feedstock (synthetic waxes) and from petroleum based feedstock were jointly evaluated by the Scientific Committee on Food (hereinafter SCF) (8) and an opinion on mineral and synthetic hydrocarbons was issued on 22 September 1995. The SCF considered that sufficient data had been provided to allocate a full group ADI (acceptable daily intake), covering both types of waxes, i.e. waxes deriving from petroleum based or synthetic hydrocarbon feed stocks. When purity criteria for E905 microcrystalline wax were established, the synthetic hydrocarbon waxes were omitted and not included in the specifications. The Commission considers it therefore necessary to amend the purity criteria for E905 microcrystalline wax in order to also cover waxes derived from synthetic hydrocarbon feedstocks.

               (11)

               E230 (biphenyl) and E233 (thiabendazole) are no longer permitted as food additives in the EU legislation. These substances have been removed respectively by Directive 2003/114/EC and Directive 98/72/EC. Consequently, the Annex I to Directive 2008/84/EC should be updated accordingly and the specifications to E230 and E233 should be withdrawn.

               (12)

               It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius drafted by the JECFA. In particular where appropriate, the specific purity criteria need to be adapted to reflect the limits for individual heavy metals of interest.

               (13)

               Directive 2008/84/EC should therefore be amended accordingly.

               (14)

               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
   The Annex I to Directive 2008/84/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 February 2010 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   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, 13 February 2009.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 40, 11.2.1989, p. 27.

      (2)  OJ L 253, 20.9.2008, p. 1.

      (3)  OJ L 61, 18.3.1995, p. 1.

      (4)  http://www.efsa.europa.eu/en/science/afc/afc_opinions/ej314b_nisin.html

      (5)  Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request from the Commission related to use of formaldehyde as a preservative during the manufacture and preparation of food additives; Question No EFSA Q-2005-032.
   http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620766610.htm

      (6)  Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food on a request from the Commission related to an application on the use of partially depolymerised guar gum as a food additive; Question No EFSA-Q-2006-122.
   http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178638739757.htm

      (7)  Beeswax (E 901) as a glazing agent and as carrier for flavours; Scientific Opinion of the Panel on food additives, flavourings, processing aids and materials in contact with food (AFC); Question No EFSA-Q-2006-021.
   http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178672652158.htm

      (8)  http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_37.pdf

      ANNEX
      The Annex I to Directive 2008/84/EC is amended as follows:

                  1.

                  The text concerning E 234 nisin is replaced by the following:
                  ‘E 234 NISIN

                                 Definition

                              Nisin consists of several closely related polypeptides produced during the fermentation of a milk or sugar medium by certain natural strains of Lactococcus lactis subsp.lactis

                                 Einecs

                              215-807-5

                              Chemical formula

                              C143H230N42O37S7

                              Molecular weight

                              3 354,12

                              Assay

                              Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk proteins or fermented solids and a minimum sodium chloride content of 50 %

                              Description

                              White powder

                              Purity

                              Loss on drying

                              Not more than 3 % when dried to constant weight at 102 °C to 103 °C

                              Arsenic

                              Not more than 1 mg/kg

                              Lead

                              Not more than 1 mg/kg

                              Mercury

                              Not more than 1 mg/kg’

                  2.

                  The text concerning E 400 alginic acid is replaced by the following:
                  ‘E 400 ALGINIC ACID

                                 Definition

                              Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)

                                 Einecs

                              232-680-1

                              Chemical formula

                              (C6H8O6)n

                              Molecular weight

                              10 000-600 000 (typical average)

                              Assay

                              Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculated on equivalent weight basis of 200)

                              Description

                              Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless

                              Identification

                                          A.

                                          Solubility

                              Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate

                                          B.

                                          Calcium chloride precipitation test

                              To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum

                                          C.

                                          Ammonium sulphate precipitation test

                              To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch

                                          D.

                                          Colour reaction

                              Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple

                              Purity

                              pH of a 3 % suspension

                              Between 2,0 and 3,5

                              Loss on drying

                              Not more than 15 % (105 °C, 4 hours)

                              Sulphated ash

                              Not more than 8 % on the anhydrous basis

                              Sodium hydroxide (1 M solution)

                              Not more than 2 % on the anhydrous basis insoluble matter

                              Formaldehyde

                              Not more than 50 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and moulds

                              Not more than 500 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g’

                  3.

                  The text concerning E 401 sodium alginate is replaced by the following:
                  ‘E 401 SODIUM ALGINATE

                              Definition

                              Chemical name

                              Sodium salt of alginic acid

                              Chemical formula

                              (C6H7NaO6)n

                              Molecular weight

                              10 000-600 000 (typical average)

                              Assay

                              Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)

                              Description

                              Nearly odourless, white to yellowish fibrous or granular powder

                              Identification

                              Positive test for sodium and alginic acid

                              Purity

                              Loss on drying

                              Not more than 15 % (105 °C, 4 hours)

                              Water-insoluble matter

                              Not more than 2 % on the anhydrous basis

                              Formaldehyde

                              Not more than 50 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and moulds

                              Not more than 500 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g’

                  4.

                  The text concerning E 402 potassium alginate is replaced by the following:
                  ‘E 402 POTASSIUM ALGINATE

                              Definition

                              Chemical name

                              Potassium salt of alginic acid

                              Chemical formula

                              (C6H7KO6)n

                              Molecular weight

                              10 000-600 000 (typical average)

                              Assay

                              Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)

                              Description

                              Nearly odourless, white to yellowish fibrous or granular powder

                              Identification

                              Positive test for potassium and for alginic acid

                              Purity

                              Loss on drying

                              Not more than 15 % (105 °C, 4 hours)

                              Water-insoluble matter

                              Not more than 2 % on the anhydrous basis

                              Formaldehyde

                              Not more than 50 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and moulds

                              Not more than 500 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g’

                  5.

                  The text concerning E 403 ammonium alginate is replaced by the following:
                  ‘E 403 AMMONIUM ALGINATE

                              Definition

                              Chemical name

                              Ammonium salt of alginic acid

                              Chemical formula

                              (C6H11NO6)n

                              Molecular weight

                              10 000-600 000 (typical average)

                              Assay

                              Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)

                              Description

                              White to yellowish fibrous or granular powder

                              Identification

                              Positive test for ammonium and alginic acid

                              Purity

                              Loss on drying

                              Not more than 15 % (105 °C, 4 hours)

                              Sulphated ash

                              Not more than 7 % on the dried basis

                              Water-insoluble matter

                              Not more than 2 % on the anhydrous basis

                              Formaldehyde

                              Not more than 50 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and moulds

                              Not more than 500 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g’

                  6.

                  The text concerning E 404 calcium alginate is replaced by the following:
                  ‘E 404 CALCIUM ALGINATE

                              Synonyms

                              Calcium salt of alginate

                              Definition

                              Chemical name

                              Calcium salt of alginic acid

                              Chemical formula

                              (C6H7Ca1/2O6)n

                              Molecular weight

                              10 000-600 000 (typical average)

                              Assay

                              Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)

                              Description

                              Nearly odourless, white to yellowish fibrous or granular powder

                              Identification

                              Positive test for calcium and alginic acid

                              Purity

                              Loss on drying

                              Not more than 15,0 % (105 °C, 4 hours)

                              Formaldehyde

                              Not more than 50 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and moulds

                              Not more than 500 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g’

                  7.

                  The text concerning E 405 propane-1,2-diol alginate is replaced by the following:
                  ‘E 405 PROPANE-1,2-DIOL ALGINATE

                              Synonyms

                              Hydroxypropyl alginate
                              1,2-propanediol ester of alginic acid
                              Propylene glycol alginate

                              Definition

                              Chemical name

                              Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule

                              Chemical formula

                              (C9H14O7)n (esterified)

                              Molecular weight

                              10 000-600 000 (typical average)

                              Assay

                              Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2 of carbon dioxide

                              Description

                              Nearly odourless, white to yellowish brown fibrous or granular powder

                              Identification

                              Positive test for 1,2-propanediol and alginic acid after hydrolysis

                              Purity

                              Loss on drying

                              Not more than 20 % (105 °C, 4 hours)

                              Total propane-1,2-diol content

                              Not less than 15 % and not more than 45 %

                              Free propane-1,2-diol content

                              Not more than 15 %

                              Water-insoluble matter

                              Not more than 2 % on the anhydrous basis

                              Formaldehyde

                              Not more than 50 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and moulds

                              Not more than 500 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g’

                  8.

                  The text concerning E 407 carrageenan is replaced by the following:
                  ‘E 407 CARRAGEENAN

                                 Synonyms

                              Products of commerce are sold under different names such as:
                              Irish moss gelose
                              Eucheuman (from Eucheuma spp.)
                              Iridophycan (from Iridaea spp.)
                              Hypnean (from Hypnea spp.)
                              Furcellaran or Danish agar (from Furcellaria fastigiata)
                              Carrageenan (from Chondrus and Gigartina spp.)

                                 Definition

                              Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaeceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded. Formaldehyde may be present as an adventitious impurity up to a maximum level of 5 mg/kg

                                 Einecs

                              232-524-2

                              Description

                              Yellowish to colourless, coarse to fine powder which is practically odourless

                              Identification

                              Positive tests for galactose, for anhydrogalactose and for sulphate

                              Purity

                              Methanol, ethanol, propane-2-ol content

                              Not more than 0,1 % singly or in combination

                              Viscosity of a 1,5 % solution at 75 °C

                              Not less than 5 mPa.s

                              Loss on drying

                              Not more than 12 % (105 °C, four hours)

                              Sulphate

                              Not less than 15 % and not more than 40 % on the dried basis (as SO4)

                              Ash

                              Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C

                              Acid-insoluble ash

                              Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)

                              Acid-insoluble matter

                              Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid)

                              Low molecular weight carrageenan
                              (Molecular weight fraction below 50 kDa)

                              Not more than 5 %

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 2 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and moulds

                              Not more than 300 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g’

                  9.

                  The text concerning E 407a processed eucheuma seaweed is replaced by the following:
                  ‘E 407a PROCESSED EUCHEUMA SEAWEED

                                 Synonyms

                              PES (acronym for processed eucheuma seaweed)

                                 Definition

                              Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consist chiefly of the potassium salt of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded. Formaldehyde may be present as an adventitious impurity up to a maximum level of 5 mg/kg.

                                 Description

                              Tan to yellowish, coarse to fine powder which is practically odourless

                              Identification

                                          A.

                                          Positive tests for galactose, for anhydrogalactose and for sulphate

                                          B.

                                          Solubility

                              Forms cloudy viscous suspensions in water. Insoluble in ethanol

                              Purity

                              Methanol, ethanol, propane-2-ol content

                              Not more than 0,1 % singly or in combination

                              Viscosity of a 1,5 % solution at 75 °C

                              Not less than 5 mPa.s

                              Loss on drying

                              Not more than 12 % (105 °C, four hours)

                              Sulphate

                              Not less than 15 % and not more than 40 % on the dried basis (as SO4)

                              Ash

                              Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C

                              Acid-insoluble ash

                              Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)

                              Acid-insoluble matter

                              Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)

                              Low molecular weight carrageenan
                              (Molecular weight fraction below 50 kDa)

                              Not more than 5 %

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 2 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and moulds

                              Not more than 300 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g’

                  10.

                  The text concerning E 412 guar gum is replaced by the following:
                  ‘E 412 GUAR GUM

                                 Synonyms

                              Gum cyamopsis
                              Guar flour

                                 Definition

                              Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobur (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as a galactomannan. The gum may be partially hydrolysed by either heat treatment, mild acid or alkaline oxidative treatment for viscosity adjustment.

                                 Einecs

                              232-536-0

                              Molecular weight

                              Consists mainly of a high molecular weight hydrocolloidal polysaccharide (50 000-8 000 000)

                              Assay

                              Galactomannan content not less than 75 %

                              Description

                              A white to yellowish-white, nearly odourless powder

                              Identification

                                          A.

                                          Positive tests for galactose and for mannose

                                          B.

                                          Solubility

                              Soluble in cold water

                              Purity

                              Loss on drying

                              Not more than 15 % (105 °C, 5 hours)

                              Ash

                              Not more than 5,5 % determined at 800 °C

                              Acid-insoluble matter

                              Not more than 7 %

                              Protein (N × 6,25)

                              Not more than 10 %

                              Starch

                              Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution (no blue colour is produced)

                              Organic peroxides

                              Not more than 0,7 meq active oxygen/kg sample

                              Furfural

                              Not more than 1 mg/kg

                              Lead

                              Not more than 2 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg’

                  11.

                  After the entry E 503(ii), the following text concerning E 504(i) is added:
                  ‘E 504(i) MAGNESIUM CARBONATE

                                 Synonyms

                              Hydromagnesite

                                 Definition

                              Magnesium carbonate is a basic hydrated or a monohydrated magnesium carbonate or a mixture of the two

                              Chemical name

                              Magnesium carbonate

                              Chemical formula

                              MgCO3.nH2O

                                 Einecs

                              208-915-9

                              Assay

                              Not less than 24 % and not more than 26,4 % of Mg

                              Description

                              Odourless, light, white friable masses or as a bulky white powder

                              Identification

                                          A.

                                          Solubility

                              Practically insoluble both in water or ethanol

                                          B.

                                          Positive tests for magnesium and for carbonate

                              Purity

                              Acid insoluble matter

                              Not more than 0,05 %

                              Water soluble matter

                              Not more than 1 %

                              Calcium

                              Not more than 0,4 %

                              Arsenic

                              Not more than 4 mg/kg

                              Lead

                              Not more than 2 mg/kg

                              Mercury

                              Not more than 1 mg/kg’

                  12.

                  The text concerning E 526 calcium hydroxide is replaced by the following:
                  ‘E 526 CALCIUM HYDROXIDE

                                 Synonyms

                              Slaked lime, hydrated lime

                              Definition

                              Chemical name

                              Calcium hydroxide

                                 Einecs

                              215-137-3

                              Chemical formula

                              Ca(OH)2

                              Molecular weight

                              74,09

                              Assay

                              Content not less than 92 %

                              Description

                              White powder

                              Identification

                                          A.

                                          Positive tests for alkali and for calcium

                                          B.

                                          Solubility

                              Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

                              Purity

                              Acid insoluble ash

                              Not more than 1,0 %

                              Magnesium and alkali salts

                              Not more than 2,7 %

                              Barium

                              Not more than 300 mg/kg

                              Fluoride

                              Not more than 50 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 6 mg/kg’

                  13.

                  The text concerning E 529 calcium oxide is replaced by the following:
                  ‘E 529 CALCIUM OXIDE

                                 Synonyms

                              Burnt lime

                              Definition

                              Chemical name

                              Calcium oxide

                                 Einecs

                              215-138-9

                              Chemical formula

                              CaO

                              Molecular weight

                              56,08

                              Assay

                              Content not less than 95 % on the ignited basis

                              Description

                              Odourless, hard, white or greyish white masses of granules, or white to greyish powder

                              Identification

                                          A.

                                          Positive test for alkali and for calcium

                                          B.

                                          Heat is generated on moistening the sample in water

                                          C.

                                          Solubility

                              Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

                              Purity

                              Loss on ignition

                              Not more than 10 % (ca. 800 °C to constant weight)

                              Acid insoluble matter

                              Not more than 1 %

                              Barium

                              Not more than 300 mg/kg

                              Magnesium and alkali salts

                              Not more than 3,6 %

                              Fluoride

                              Not more than 50 mg/kg

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 7 mg/kg’

                  14.

                  The text concerning E 901 beeswax is replaced by the following:
                  ‘E 901 BEESWAX

                                 Synonyms

                              White wax, yellow wax

                              Definition

                              Yellow beeswax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter
                              White beeswax is obtained by bleaching yellow beeswax

                                 Einecs

                              232-383-7 (beeswax)

                              Description

                              Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour

                              Identification

                                          A.

                                          Melting range

                              Between 62 °C and 65 °C

                                          B.

                                          Specific gravity

                              About 0,96

                                          C.

                                          Solubility

                              Insoluble in water
                              Sparingly soluble in alcohol
                              Very soluble in chloroform and ether

                              Purity

                              Acid value

                              Not less than 17 and not more than 24

                              Saponification value

                              87-104

                              Peroxide value

                              Not more than 5

                              Glycerol and other polyols

                              Not more than 0,5 % (as glycerol)

                              Ceresin, paraffins and certain other waxes

                              Absent

                              Fats, Japan wax, rosin and soaps

                              Absent

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 2 mg/kg

                              Mercury

                              Not more than 1 mg/kg’

                  15.

                  The text concerning E 905 microcrystalline wax is replaced by the following:
                  ‘E 905 MICROCRYSTALLINE WAX

                                 Synonyms

                              Petroleum wax, hydrocarbon wax, Fischer-Tropsch wax, synthetic wax, synthetic paraffin

                              Definition

                              Refined mixtures of solid, saturated hydrocarbons, obtained from petroleum or synthetic feedstocks

                              Description

                              White to amber, odourless wax

                              Identification

                                          A.

                                          Solubility

                              Insoluble in water, very slightly soluble in ethanol

                                          B.

                                          Refractive Index

                              nD
                                 100 1,434-1,448
                              Alternative: nD
                                 120 1,426-1,440

                              Purity

                              Molecular weight

                              Average not less than 500

                              Viscosity

                              Not less than 1,1 × 10-5 m2 s-1 at 100 °C
                              Alternative: Not less than 0,8 × 10-5 m2 s-1 at 120 °C, if solid at 100 °C

                              Residue on ignition

                              Not more than 0,1 wt %

                              Carbon number at 5 % distillation point

                              Not more than 5 % of molecules with carbon number less than 25

                              Colour

                              Passes test

                              Sulphur

                              Not more than 0,4 wt %

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 3 mg/kg

                              Polycyclic aromatic compounds

                              The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:

                                          Nm

                                          Maximum absorbance per cm path length

                                          280-289

                                          0,15

                                          290-299

                                          0,12

                                          300-359

                                          0,08

                                          360-400

                                          0,02

                                    Alternative, if solid at 100 °C
                              PAC method as per 21 CFR& 175.250;
                              Absorbency at 290 nm in decahydronaphthalene at 88 °C: Not exceeding 0,01’

                  16.

                  The text concerning E 230 and E 233 is deleted.


title: Commission Directive 2007/50/EC of 2 August 2007 amending Council Directive 91/414/EEC to include beflubutamid and Spodoptera exigua nuclear polyhedrosis virus as active substances (Text with EEA relevance)

text:
               3.8.2007

               EN

               Official Journal of the European Union

               L 202/15

      COMMISSION DIRECTIVE 2007/50/EC
   of 2 August 2007
   amending Council Directive 91/414/EEC to include beflubutamid and Spodoptera exigua nuclear polyhedrosis virus 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), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 27 June 2000 an application from a Task Force consisting of UBE Europe GmbH and Stähler Agrochemie GmbH & Co. KG (UBE Europe GmbH having later left the Task Force) for the inclusion of the active substance beflubutamid in Annex I to Directive 91/414/EEC. Commission Decision 2000/784/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 12 July 1996 an application from Biosys (now: Certis USA) for the inclusion of the active substance Spodoptera exigua nuclear polyhedrosis virus (hereinafter Spodoptera exigua NPV) in Annex I to Directive 91/414/EEC. Commission Decision 97/865/EC (3) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 13 August 2002 (beflubutamid) and 1 November 1999 (Spodoptera exigua NPV) respectively.

               (4)

               For those substances the draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 15 May 2007 in the format of the Commission review reports for beflubutamid and Spodoptera exigua NPV.

               (5)

               It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) 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 beflubutamid and Spodoptera exigua NPV in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.

               (6)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing beflubutamid or Spodoptera exigua NPV to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (7)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (8)

               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
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish by 31 May 2008 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 from 1 June 2008.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall 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
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing beflubutamid or Spodoptera exigua NPV as active substance by 31 May 2008. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to beflubutamid or Spodoptera exigua NPV, respectively, are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing beflubutamid or Spodoptera exigua NPV 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 30 November 2007 at the latest, Member States shall 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 and taking into account part B of the entry in Annex I to that Directive concerning beflubutamid or Spodoptera exigua NPV. 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.
   Following that determination Member States shall:

               (a)

               in the case of a product containing beflubutamid or Spodoptera exigua NPV as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2009 at the latest; or

               (b)

               in the case of a product containing beflubutamid or Spodoptera exigua NPV as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2009 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 December 2007.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 2 August 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

      (2)  OJ L 311, 12.12.2000, p. 47.

      (3)  OJ L 351, 23.12.1997, p. 67.

      ANNEX
      In Annex I to Directive 91/414/EEC the following rows are added at the end of the table:

                     No

                     Common name, identification numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘164

                     Beflubutamid
                     CAS No 113614-08-7
                     CIPAC No 662

                        (RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide

                     ≥ 970 g/kg

                     1 December 2007

                     30 November 2017

                     Part A
                     Only uses as herbicide may be authorised.
                     Part B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.
                     In this overall assessment Member States:

                                 —

                                 must pay particular attention to the risk to aquatic organisms.

                           Conditions of use shall include risk mitigation measures, where appropriate.

                     165

                        Spodoptera exigua nuclear polyhedrosis virus
                     CIPAC No
                     Not allocated

                     Not applicable

                     1 December 2007

                     30 November 2017

                     Part A
                     Only uses as insecticide may be authorised.
                     Part B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Spodoptera exigua NPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.’

         (1)  Further details on identity and specification of active substances are provided in the review report.


Avis juridique important

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32003L0084

Commission Directive 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam as active substances (Text with EEA relevance)

Official Journal L 247 , 30/09/2003 P. 0020 - 0025

Commission Directive 2003/84/ECof 25 September 2003amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam 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) In accordance with Article 6(2) of Directive 91/414/EEC the authorities of France received on 15 February 1994 an application from Rhône-Poulenc Agro France (now Bayer CropScience) for the inclusion of the active substance flurtamone in Annex I to Directive 91/414/EEC. Commission Decision 1996/341/EC(3) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.(2) France received an application under Article 6(2) of Directive 91/414/EEC on 1 February 1996 an application from Bayer AG (now Bayer CropScience) concerning flufenacet (former name: fluthiamide). This application was declared complete by Commission Decision 97/362/EC(4).(3) Germany received an application under Article 6(2) of Directive 91/414/EEC on 14 December 1998 from Hoechst Schering AgrEvo GmbH (now Bayer CropScience) concerning iodosulfuron (as parent substance of iodosulfuron-methyl-sodium). This application was declared complete by Commission Decision 1999/392/EC(5).(4) Germany received an application under Article 6(2) of Directive 91/414/EEC on 16 April 1999 from BASF AG concerning dimethenamid-p. This application was declared complete by Commission Decision 1999/555/EC(6).(5) Ireland received an application under Article 6(2) of Directive 91/414/EEC on 26 May 1999 from Zeneca Agrochemicals (now Syngenta) concerning picoxystrobin. This application was declared complete also by Commission Decision 1999/555/EC.(6) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 5 March 1996 from ISK Biosciences Europe SA concerning fosthiazate. This application was declared complete by Commission Decision 97/362/EC.(7) Ireland received an application under Article 6(2) of Directive 91/414/EEC on 14 December 1998 from Monsanto Crop Protection concerning silthiofam (former name: silthiopham). This application was declared complete by Commission Decision 1999/392/EC.(8) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The nominated rapporteur Member States submitted a draft assessment report concerning the substance to the Commission on 21 May 1997 (flurtamone), 6 January 1998 (flufenacet), 30 May 2000 (iodosulfuron), 26 September 2000 (dimethenamid-p), 11 June 2001 (picoxystrobin), 18 March 1998 (fosthiazate), and 2 October 2000 (silthiofam).(9) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 4 July 2003 in the format of the Commission review report for flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam.(10) The review of iodosulfuron, dimethenamid-p, picoxystrobin and silthiofam did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.(11) For flurtamone, the documents and information were also submitted to the Scientific Committee for Plants for separate consultation. The Scientific Committee for Plants was consulted twice, mainly to assess the potential leaching of two metabolites of the active substance, 3-trifluoromethylbenzoic acid (TFMBA) and trifluoroacetic acid (TFAA). In a first opinion(7), the Scientific Committee recommended with respect to TFMBA the inclusion of soils with pH values between 7 and 8 in the sorption studies with this metabolite. As regards the metabolite TFAA, the Committee found the available data insufficient to assess the risk of contamination of groundwater. Subsequently, further studies were undertaken by the applicant for both metabolites. In its second opinion(8) the Scientific Committee concluded that concentrations of TFMBA leaching to groundwater from soils with pH above 5 may exceed 0,1 g/l in a small percentage of cases/situations. The Committee further concluded that the metabolite TFAA does not represent an unacceptable risk to aquatic organisms via groundwater but the toxicological information made available to the Committee was still insufficient. The recommendations of the Scientific Committee were taken into account during the further review and in this Directive and in the Review Report. After the missing information was subsequently delivered by the applicant and evaluated by the rapporteur Member State. The evaluation within the Standing Committee concluded that there would be no unacceptable influence of the metabolites TFMBA and TFAA on the environment if appropriate risk mitigation measures are applied.(12) As regards flufenacet, the Scientific Committee for Plants was asked to comment on two degradation products (M2 and M4) of the active substance, which were detected in lysimeters leachates, and on the exposure of operators. In its opinion(9) the Committee found for the M2 and M4 metabolites that the risk to non-target terrestrial organisms were not yet adequately assessed and also identified other degradation products for which the risk to non-target organisms needed further evaluation. The Committee was of the opinion that operator risk assessment of flufenacet has been adequately addressed but noted that the sensitising potential of the formulation deserves proper attention. The recommendations of the Scientific Committee were taken into account during the further review and in this Directive and in the Review Report. After the missing information was subsequently delivered by the applicant and evaluated by the rapporteur Member State. The evaluation within the Standing Committee concluded that the risk by all identified degradation products for non-target organisms would be acceptable and that the sensitising risk would also be acceptable if appropriate risk mitigation measures are applied.(13) As regards fosthiazate, the Scientific Committee was asked to comment on the potential for leaching to groundwater, on the risk to soil dwelling non-target organisms, on the risk to birds and wild mammals, and on the possible risk of organophosphate-induced delayed polyneuropathy (OPIDP) in humans following severe poisoning incidents. In its opinion(10) the Committee found that based on the available information no safe use scenario could be identified which poses no unacceptable risk to groundwater. The Committee noted that it is possible that lysimeter studies demonstrate lack of leaching for one or more use scenarios but none were reported. Also the risk of the different metabolites to soil organisms had not been sufficiently addressed. The Committee further considered that the potential for exposure of birds and wild mammals by all the routes mentioned above required further consideration. Finally, the Committee was of the opinion that NTE (neuropathy target esterase) inhibition by fosthiazate and its isomers had not been adequately assessed. The recommendations of the Scientific Committee were taken into account during the further review and in this Directive and in the Review Report. After the missing information was subsequently delivered by the applicant and evaluated by the rapporteur Member State and taking into account appropriate measures of risk mitigation measures, the evaluation within the Standing Committee concluded that no harmful effects are to be expected from NTE inhibition by fosthiazate and its isomers. The evaluation within the Standing Committee further concluded that the risk by the parent substances and the identified degradation products for the groundwater, soil organisms, birds and wild mammals would be acceptable if appropriate risk mitigation measures are applied.(14) It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) 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 flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam 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.(15) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.(16) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(17) 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 30 June 2004 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 July 2004.When Member States adopt those provisions, they shall contain a reference to this Directive or shall 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 flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate or silthiofam to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 30 June 2004 at the latest.2. For each authorised plant protection product containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate or silthiofam 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 December 2004 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI, on the basis of a dossier satisfying the requirements of Annex III thereto. 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 30 June 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.Article 4This Directive shall enter into force on 1 January 2004.Article 5This Directive is addressed to the Member States.Done at Brussels, 25 September 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 228, 12.9.2003, p. 11.(3) OJ L 130, 31.5.1996, p. 20.(4) OJ L 152, 11.6.1997, p. 31.(5) OJ L 148, 15.6.1999, p. 44.(6) OJ L 210, 10.8.1999, p. 22.(7) Opinion of the Scientific Committee on Plants regarding the inclusion of flurtamone in Annex I to Directive 91/414/EEC concerning the placing of plant protection products on the market (SCP/FLURT/004-Final, adopted on 18 December 1998).(8) Opinion of the Scientific Committee on Plants regarding the inclusion of flurtamone in Annex I to Directive 91/414/EEC concerning the placing of plant protection products on the market (SCP/FLURT/018-Final, adopted on 26 January 2001).(9) Opinion of the Scientific Committee on Plants on specific questions from the Commission concerning the evaluation of flufenacet [FOE 5043] in the context of Directive 91/414/EEC, (SCP/FLUFEN/002-Final, adopted 17 October 2001).(10) Opinion on specific questions from the Commission concerning the evaluation of fosthiazate [IKKI-1145/TO-1145] in the context of Directive 91/414/EEC, (SCP/FOSTHIAZ/002-Final, adopted 20 December 2001).ANNEXIn Annex I the following rows are added at the end of the table">TABLE>"


Avis juridique important

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31989L0680

Council Directive 89/680/EEC of 21 December 1989 amending directive 77/536/EEC on the approximation of the laws of the member states relating to the roll-over protection structures of wheeled agricultural or forestry tractors

Official Journal L 398 , 30/12/1989 P. 0026 - 0026 Finnish special edition: Chapter 13 Volume 19 P. 0124  Swedish special edition: Chapter 13 Volume 19 P. 0124

COUNCIL DIRECTIVEof 21 December  1989amending Directive 77/536/EEC on the approximation of the laws of the Member States relating  to the roll-over protection structures of wheeled agricultural or forestry  tractors(89/680/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas it is necessary to adopt measures with the aim of progressively establishing the internal  market over a period expiring on 31 December 1992; whereas the internal market comprises an area  without internal frontiers in which the free movement of goods, persons, services and capital is  ensured; Whereas Article 9 of Directive 77/536/EEC (4), as last amended by Directive 87/354/EEC (5), limits  the scope of the said Directive to wheeled agricultural or forestry tractors with a mass of between  1,5 and 4,5 tonnes; whereas an increase of 1,5 tonnes in the maximum mass as laid down at present  would not entail any major disadvantages from the standpoint of safety on the roads and safety at  work on the land; Whereas the roll-over protection structures of tractors with a mass of between 4,5 and 6 tonnes can  be treated in the same way as those of tractors with a mass of between 1,5 and 4,5 tonnes and hence  can be accorded the benefit of the same rules, HAS ADOPTED THIS DIRECTIVE: Article 1In the first line of the fourth indent of Article 9 of Directive  77/536/EEC, 'mass between 1,5 and 4,5 tonnes' is replaced by 'mass between 1,5 and 6 tonnes'. Article 2Member States shall bring into force the laws, regulations and administrative provisions  necessary to comply with this Directive not later than 12 months from 3 January 1990. They shall  forthwith inform the Commission thereof. Article 3This Directive is addressed to the Member States. Done at Brussels, 21 December 1989. For the CouncilThe PresidentE. CRESSONOJ N° C 256,  9. 10. 1989, p. 75. (1) OJ N° C 324, 17. 12. 1988, p. 14. (2) OJ N° C 120, 16. 5. 1989, p. 17, and (3) OJ N° C 102, 24. 4. 1989, p. 8. (4) OJ N° L 220, 29. 8. 1977, p. 1. (5) OJ N° L 192, 11. 7. 1987, p. 43.


title: Commission Directive 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance   (Text with EEA relevance)

text:
               12.12.2006

               EN

               Official Journal of the European Union

               L 349/27

      COMMISSION DIRECTIVE 2006/133/EC
   of 11 December 2006
   amending Council Directive 91/414/EEC to include flusilazole as active substance
   (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), 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 (2), 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 flusilazole.

               (2)

               For flusilazole 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 notifier. 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 (3), Ireland was designated as Rapporteur Member State. Ireland submitted the relevant assessment report and recommendations to the Commission on 30 April 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.

               (3)

               The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.

               (4)

               As regards flusilazole two questions were submitted to the Scientific Committee on Plants (the Scientific Committee). The first concerned the adequacy of the proposed NOEC (No Observed Effect Concentration) for ensuring a sufficient protection from adverse effects on reproduction and, more generally, the comparative sensitivity of the early life stage test compared to the full fish life cycle study. The second question related to the potential impact on organic matter decomposition. In both cases, the recommendations of the Scientific Committee (4) have been taken into consideration in formulating this Directive and the relevant review report.

               (5)

               It has appeared from the various examinations made that plant protection products containing flusilazole may be expected to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, with regard to the uses which were examined and detailed in the Commission review report, provided that adequate risk mitigation measures are applied. As flusilazole is a hazardous substance, its use should not be unrestricted. In particular there are concerns about its intrinsic toxic effects, including potential endocrine disrupting properties. There is at present no scientific consensus on the exact extent of the risk. Applying the precautionary principle, and taking into account the current state of scientific knowledge, risk mitigation measures should be imposed in order to achieve the high level of protection of human and animal health and the environment chosen in the Community.

               (6)

               Articles 5(4) and 6(1) of Directive 91/414/EEC provide that inclusion of a substance in Annex I may be subject to restrictions and conditions. In this case, restrictions on the inclusion period and on the authorised crops are deemed necessary. The original measures presented to the Standing Committee on the Food Chain and Animal Health, proposed the restriction of the inclusion period to seven years, so that Member States would give priority to reviewing plant protection products already on the market containing flusilazole. In order to avoid discrepancies in the high level of protection sought, the inclusion in Annex I to Directive 91/414/EEC was intended to be limited to the uses of flusilazole that have been actually assessed within the Community evaluation and for which the proposed uses were considered to comply with the conditions of Directive 91/414/EEC. This implies that other uses, which were not or only partially covered by this assessment, had first to be subject to a complete assessment, before their inclusion in Annex I of Directive 91/414/EEC could be considered. Finally, due to the hazardous nature of flusilazole, it was considered necessary to provide for a minimum harmonisation at Community level of certain risk mitigation measures that were to be applied by Member States when granting authorisations.

               (7)

               Under the procedures laid down by Directive 91/414/EEC, the approval of active substances, including the definition of risk management measures, is decided by the Commission. Member States bear the responsibility for the implementation, application and control of the measures intended to mitigate the risks generated by plant protection products. Concerns expressed by several Member States reflect their judgment that additional restrictions are necessary to reduce the risk to a level that can be considered acceptable and consistent with the high level of protection that is sought within the Community. At present, it is a question of risk management to set the adequate level of safety and protection for the continued production, commercialisation and use of flusilazole.

               (8)

               As a consequence of the above, the Commission re-examined its position. In order to correctly reflect the high level of protection of human and animal health and a sustainable environment sought in the Community, it considered appropriate, in addition to the principles set out in recital 6, to further reduce the period of inclusion to 18 months instead of seven years. This further reduces any risk by ensuring a priority re-assessment of this substance.

               (9)

               It may be expected that plant protection products containing flusilazole satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, with regard to the uses which were examined and detailed in the Commission review report and providing that the necessary risk mitigation measures are applied.

               (10)

               Without prejudice to the conclusion that plant protection products containing flusilazole may be expected to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, it is appropriate to obtain further information on certain specific points. The potential endocrine disrupting properties of flusilazole have been assessed in tests which follow the best currently available practice. The Commission is aware that the Organisation for Economic Cooperation and Development (OECD) is developing test guidelines in order to further refine the assessment of potential endocrine disrupting properties. Therefore it is appropriate to require that flusilazole should be subjected to such further testing as soon as agreed OECD Test Guidelines exist and that such studies should be presented by the notifier. In addition, Member States should require authorisation holders to provide information on the use of flusilazole including any information on incidences on operator health.

               (11)

               As with all substances included in Annex I to Directive 91/414/EEC, the status of flusilazole could be reviewed under Article 5(5) of that Directive in the light of any new data becoming available. Equally, the fact that the inclusion of this substance in Annex I expires on a particular date does not prevent the inclusion being renewed according to the procedures laid down in the Directive.

               (12)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (13)

               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 result from the inclusion.

               (14)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing flusilazole to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. Given the hazardous properties of flusilazole, the period for Member States to verify whether plant protection products containing flusilazole, alone or in combination with other authorised active substances, comply with the provisions of Annex VI should not exceed 18 months.

               (15)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (16)

               The Standing Committee on the Food Chain and Animal Health did not deliver an opinion within the time limit laid down by its Chairman and the Commission therefore submitted to the Council a proposal relating to these measures. On the expiry of the period laid down in the second subparagraph of Article 19(2) of Directive 91/414/EEC, the Council had neither adopted the proposed implementing act nor indicated its opposition to the proposal for implementing measures and it is accordingly for the Commission to adopt these measures,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 30 June 2007 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 from 1 July 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.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing flusilazole as an active substance by 30 June 2007. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to flusilazole are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.
   2.   By derogation from paragraph 1, for each authorised plant protection product containing flusilazole, Member States shall 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 and taking into account part B of the entry in Annex I to that Directive concerning flusilazole. 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.
   Following that determination Member States shall for products containing flusilazole, where necessary, amend or withdraw the authorisation by 30 June 2008.
   Article 4
   This Directive shall enter into force on 1 January 2007.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 11 December 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/85/EC (OJ L 293, 24.10.2006, p. 3).

      (2)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).

      (3)  OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regulation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

      (4)  Opinion of the Scientific Committee on Plants on specific questions from the Commission concerning the evaluation of flusilazole in the context of Council Directive 91/414/EEC (Opinion adopted by the Scientific Committee on Plants on 18 July 2002).

      ANNEX
      The following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘147

                     Flusilazole
                     CAS No 85509-19-9
                     CIPAC No 435

                     Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane

                     925 g/kg

                     1 January 2007

                     30 June 2008

                     PART A
                     Only uses as fungicide on the following crops may be authorised:

                                 —

                                 cereals other than rice,

                                 —

                                 maize,

                                 —

                                 rape seed,

                                 —

                                 sugar beet,

                           at rates not exceeding 200 g active substance per hectare per application.
                     The following uses must not be authorised:

                                 —

                                 air application,

                                 —

                                 knapsack and hand-held applications, neither by amateur nor by professional users,

                                 —

                                 home gardening.

                           Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

                                 —

                                 aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,

                                 —

                                 birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,

                                 —

                                 operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

                           PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account.
                     Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained.
                     Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.’

         (1)  Further details on identity and specification of active substance are provided in the review report.