Avis juridique important

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31994L0054

Commission Directive 94/54/EC of 18 November 1994 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EEC

Official Journal L 300 , 23/11/1994 P. 0014 - 0015 Finnish special edition: Chapter 15 Volume 13 P. 0250  Swedish special edition: Chapter 15 Volume 13 P. 0250

COMMISSION DIRECTIVE 94/54/EC of 18 November 1994 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EECTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1), as last amended by Commission Directive 93/102/EC (2), and in particular Article 4 (2) thereof,Whereas, having regard to the scope and effects of the proposed action, the Community measures introduced by this Directive are essential if the objectives set are to be attained; whereas those objectives cannot be attained by the Member States acting individually; whereas, moreover, Directive 79/112/EEC already provides for the attainment of such objectives at Community level;Whereas, in order to ensure that consumers receive adequate information, it is necessary to provide for compulsory indication, for certain foodstuffs, of other particulars in addition to those provided for in Article 3 of Directive 79/112/EEC;Whereas packaging gases used in packaging certain foodstuffs should not be regarded as ingredients for the purposes of Article 6 (1) of Directive 79/112/EEC and therefore should not be included in the list of ingredients on the label;Whereas, however, consumers should be informed of the use of such gases inasmuch as this information enables them to understand why the foodstuff they have purchased has a longer shelf-life than similar products packaged differently;Whereas, in order to prevent new barriers to trade being created by unilateral measures taken by Member States, it is necessary to adopt Community provisions;Whereas, in accordance with the procedure of Article 17 of Council Directive 79/112/EEC, this Directive was submitted to the Standing Committee for Foodstuffs which was unable to express an opinion; whereas, under the same procedure, the Commission submitted to the Council a proposal relating to the measures to be taken;Whereas, since the Council has not adopted any measures by the end of the three months it was given, the Commission should adopt the proposed measures,HAS ADOPTED THIS DIRECTIVE:Article 1 Without prejudice to the provisions of Article 3 of Directive 79/112/EEC, the labelling of the foodstuffs listed in the Annex to this Directive shall include additional particulars, as set out in that Annex.Article 2 Member States shall, where necessary, amend their laws, regulations and administrative provisions by 30 June 1995 in such a way so as to:- permit trade in products complying with this Directive no later than 1 July 1995,- prohibit trade in products not complying with this Directive with effect from 1 January 1997; however, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out.They shall forthwith inform the Commission thereof.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Done at Brussels, 18 November 1994.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ No L 33, 8. 2. 1979, p. 1.(2) OJ No L 291, 25. 11. 1993, p. 14.ANNEX List of foodstuffs for which the labelling must include one or more additional particulars >TABLE>


title: Commission Directive 2005/80/EC of 21 November 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II and III thereto to technical progress   (Text with EEA relevance)

text:
               22.11.2005

               EN

               Official Journal of the European Union

               L 303/32

      COMMISSION DIRECTIVE 2005/80/EC
   of 21 November 2005
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II and III thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 4b and Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Products,
   Whereas:

               (1)

               Directive 76/768/EEC, as amended by Directive 2003/15/EC of the European Parliament and of the Council (2), prohibits the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1, 2 and 3, under Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (3), but allows the use of substances classified in category 3 pursuant to Directive 67/548/EEC subject to evaluation and approval by the Scientific Committee on Cosmetic products and Non-Food Products intended for consumers SCCNFP, replaced by the Scientific Committee on Consumer Products (SCCP) by Commission Decision 2004/210 (4).

               (2)

               Directive 67/548/EEC has been amended by Directive 2004/73/EC, and it is therefore necessary to adopt measures so as to bring Directive 76/768/EEC in line with the provisions of Directive 67/548/EEC.

               (3)

               In so far as some of the substances classified as CMR of category 1 and 2 under Annex I to Directive 67/548/EEC are not yet listed in Annex II to Directive 76/768/EEC, it is necessary to include them in that Annex. Substances classified as CMR of category 3 under Annex I to Directive 67/548/EEC should also be included in Annex II to Directive 76/768/EEC, except if they have been evaluated by the SCCP and found acceptable for use in cosmetic products.

               (4)

               Substances classified as CMR of category 1 and 2 listed in Annex III, Part 1 to Directive 76/768/EEC should be deleted, since these substances are now listed in Annex II to Directive 76/768/EEC and therefore must not form part of the composition of cosmetic products.

               (5)

               Commission Directive 2004/93/EC (5) provided for the insertion in Annex II to Directive 76/768/EEC of certain substances which were already listed there. That Annex should therefore be amended for the sake of clarity.

               (6)

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

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes II and III to Directive 76/768/EEC are amended in accordance with the text set out in the Annex to this Directive.
   Article 2
   Member States shall take all necessary measures to ensure that from 22 August 2006 cosmetic products which fail to comply with this Directive are not placed on the market by Community manufacturers or by importers established within the Community.
   Member States shall take all necessary measures to ensure that those products are not sold or disposed of to the final consumer after 22 November 2006.
   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 22 May 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 21 November 2005.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/52/EC (OJ L 234, 10.9.2005, p. 9).

      (2)  OJ L 66, 11.3.2003, p. 26.

      (3)  OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).

      (4)  OJ L 66, 4.3.2004, p. 45.

      (5)  OJ L 300, 25.9.2004, p. 13.

      ANNEX
      Annexes II and III to Directive 76/768/EEC are amended as follows:

                  1.

                  Annex II is amended as follows:

                              (a)

                              the entries under reference numbers 615 and 616 are deleted;

                              (b)

                              the entry under reference number 687 is replaced by the following:

                                          ‘687.

                                          dinitrotoluene, technical grade (Cas No 121-14-2)’;

                              (c)

                              the following reference numbers 1137 and 1211 are added:

                                          Ref. No

                                          Chemical name

                                          CAS No
                                          EC No

                                          ‘1137

                                          isobutyl nitrite

                                          542-56-3

                                          1138

                                          isoprene (stabilized)
                                          (2-methyl-1,3-butadiene)

                                          78-79-5

                                          1139

                                          1-bromopropane
                                          n-propyl bromide

                                          106-94-5

                                          1140

                                          chloroprene (stabilized)
                                          (2-chlorobuta-1,3-diene)

                                          126-99-8

                                          1141

                                          1,2,3-trichloropropane

                                          96-18-4

                                          1142

                                          ethylene glycol dimethyl ether
                                          (EGDME)

                                          110-71-4

                                          1143

                                          dinocap (ISO)

                                          39300-45-3

                                          1144

                                          diaminotoluene, technical product -mixture of [4-methyl-m-phenylene diamine] (1) and [2-methyl-m-phenylene diamine] (2)

                                          methyl-phenylenediamine

                                          25376-45-8

                                          1145

                                             p-chlorobenzotrichloride

                                          5216-25-1

                                          1146

                                          diphenylether; octabromo derivate

                                          32536-52-0

                                          1147

                                          1,2-bis(2-methoxyethoxy)ethane
                                          triethylene glycol dimethyl ether (TEGDME)

                                          112-49-2

                                          1148

                                          tetrahydrothiopyran-3-carboxaldehyde

                                          61571-06-0

                                          1149

                                          4,4′-bis(dimethylamino)benzophenone
                                          (Michler's ketone)

                                          90-94-8

                                          1150

                                          oxiranemethanol, 4-methylbenzene-sulfonate, (S)-

                                          70987-78-9

                                          1151

                                          1,2-benzenedicarboxylic acid, dipentylester, branched and linear [1]

                                          84777-06-0 [1]

                                          n-pentyl-isopentylphthalate [2]

                                          -[2]

                                          di-n-pentyl phthalate [3]

                                          131-18-0 [3]

                                          diisopentylphthalate [4]

                                          605-50-5 [4]

                                          1152

                                          benzyl butyl phthalate
                                          (BBP)

                                          85-68-7

                                          1153

                                          1,2-benzenedicarboxylic acid di-C 7-11, branched and linear alkylesters

                                          68515-42-4

                                          1154

                                          a mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl) pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate and trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate

                                          EC No 402-660-9

                                          1155

                                          (methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1′-dipyridinium dichloride dihydrochloride

                                          EC No 401-500-5

                                          1156

                                          2-[2-hydroxy-3-(2-chlorophenyl) carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)-2-[2-hydroxy-3-(3-methylphenyl)-carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)-carbamoyl-1-naphthylazo]fluoren-9-one

                                          EC No 420-580-2

                                          1157

                                          azafenidin

                                          68049-83-2

                                          1158

                                          2,4,5-trimethylaniline [1]

                                          137-17-7 [1]

                                          2,4,5-trimethylaniline hydrochloride [2]

                                          21436-97-5 [2]

                                          1159

                                          4,4′-thiodianiline and its salts

                                          139-65-1

                                          1160

                                          4,4′-oxydianiline (p-aminophenyl ether) and its salts

                                          101-80-4

                                          1161

                                             N,N,N′,N′-tetramethyl-4,4′-methylendianiline

                                          101-61-1

                                          1162

                                          6-methoxy-m-toluidine
                                          (p-cresidine)

                                          120-71-8

                                          1163

                                          3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine

                                          143860-04-2

                                          1164

                                          a mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione and a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione

                                          EC No 421-550-1

                                          1165

                                          2-nitrotoluene

                                          88-72-2

                                          1166

                                          tributyl phosphate

                                          126-73-8

                                          1167

                                          naphthalene

                                          91-20-3

                                          1168

                                          nonylphenol [1]

                                          25154-52-3 [1]

                                          4-nonylphenol, branched [2]

                                          84852-15-3 [2]

                                          1169

                                          1,1,2-trichloroethane

                                          79-00-5

                                          1170

                                          pentachloroethane

                                          76-01-7

                                          1171

                                          vinylidene chloride
                                          (1,1-dichloroethylene)

                                          75-35-4

                                          1172

                                          allyl chloride
                                          (3-chloropropene)

                                          107-05-1

                                          1173

                                          1,4-dichlorobenzene
                                          (p-dichlorobenzene)

                                          106-46-7

                                          1174

                                          bis(2-chloroethyl) ether

                                          111-44-4

                                          1175

                                          phenol

                                          108-95-2

                                          1176

                                          bisphenol A
                                          (4,4′-isopropylidenediphenol)

                                          80-05-7

                                          1177

                                          trioxymethylene
                                          (1,3,5-trioxan)

                                          110-88-3

                                          1178

                                          propargite (ISO)

                                          2312-35-8

                                          1179

                                          1-chloro-4-nitrobenzene

                                          100-00-5

                                          1180

                                          molinate (ISO)

                                          2212-67-1

                                          1181

                                          fenpropimorph

                                          67564-91-4

                                          1182

                                          epoxiconazole

                                          133855-98-8

                                          1183

                                          methyl isocyanate

                                          624-83-9

                                          1184

                                          N,N-dimethylanilinium tetrakis(pentafluorophenyl)borate

                                          118612-00-3

                                          1185

                                          O,O′-(ethenylmethylsilylene) di[(4-methylpentan-2-one) oxime]

                                          EC No 421-870-1

                                          1186

                                          a 2:1 mixture of: 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinol-4-yl-tris(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate) and 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinolbis(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate)

                                          140698-96-0

                                          1187

                                          a mixture of: reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:2) and reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxonaphthalenesulfonate (1:3)

                                          EC No 417-980-4

                                          1188

                                          malachite green hydrochloride [1]

                                          569-64-2 [1]

                                          malachite green oxalate [2]

                                          18015-76-4 [2]

                                          1189

                                          1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol

                                          107534-96-3

                                          1190

                                          5-(3-butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one

                                          138164-12-2

                                          1191

                                          trans-4-phenyl-L-proline

                                          96314-26-0

                                          1192

                                          bromoxynil heptanoate (ISO)

                                          56634-95-8

                                          1193

                                          a mixture of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl) azo]-2,5-diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acid and 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-[(3-phosphonophenyl) azo]benzoic acid

                                          163879-69-4

                                          1194

                                          2-{4-(2-ammoniopropylamino)-6-[4-hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-2-aminopropyl formate

                                          EC No 424-260-3

                                          1195

                                          5-nitro-o-toluidine [1]

                                          99-55-8 [1]

                                          5-nitro-o-toluidine hydrochloride [2]

                                          51085-52-0 [2]

                                          1196

                                          1-(1-naphthylmethyl)quinolinium

                                          65322-65-8

                                          1197

                                          (R)-5-bromo-3-(1-methyl-2-pyrrolidinyl
                                          methyl)-1H-indole

                                          143322-57-0

                                          1198

                                          pymetrozine (ISO)

                                          123312-89-0

                                          1199

                                          oxadiargyl (ISO)

                                          39807-15-3

                                          1200

                                          chlorotoluron
                                          (3-(3-chloro-p-tolyl)-1,1-dimethylurea)

                                          15545-48-9

                                          1201

                                          N-[2-(3-acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl] acetamide

                                          EC No 416-860-9

                                          1202

                                          1,3-bis(vinylsulfonylacetamido)-propane

                                          93629-90-4

                                          1203

                                             p-phenetidine (4-ethoxyaniline)

                                          156-43-4

                                          1204

                                             m-phenylenediamine and its salts

                                          108-45-2

                                          1205

                                          residues (coal tar), creosote oil distn., if it contains > 0,005 % w/w benzo[a]pyrene

                                          92061-93-3

                                          1206

                                          creosote oil, acenaphthene fraction, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene

                                          90640-84-9

                                          1207

                                          creosote oil, if it contains > 0,005 % w/w benzo[a]pyrene

                                          61789-28-4

                                          1208

                                          creosote, if it contains > 0,005 % w/w benzo[a]pyrene

                                          8001-58-9

                                          1209

                                          creosote oil, high-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene

                                          70321-79-8

                                          1210

                                          extract residues (coal), creosote oil acid, wash oil extract residue, if it contains > 0,005 % w/w benzo[a]pyrene

                                          122384-77-4

                                          1211

                                          creosote oil, low-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene

                                          70321-80-1

                  2.

                  Annex III, part one, is amended as follows:

                              (a)

                              the entry under reference number 19 is deleted;

                              (b)

                              under reference number 1a, column b the words ‘Boric acid, borates and tetraborates’ are replaced by ‘Boric acid, borates and tetraborates with the exception of substance No in Annex II’;

                              (c)

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

         (1)  for the individual ingredient see reference number 364 in Annex II.

         (2)  for the individual ingredient see reference number 413 in Annex II.’


Avis juridique important

|

32003L0042

Directive 2003/42/EC of the European Parliament and of the Council of 13 June 2003 on occurrence reporting in civil aviation

Official Journal L 167 , 04/07/2003 P. 0023 - 0036

Directive 2003/42/EC of the European Parliament and of the Councilof 13 June 2003on occurrence reporting in civil aviationTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Following consultation of the Committee of the Regions,Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 9 April 2003,Whereas:(1) The rate of accidents in civil aviation has remained fairly constant in the last decade; nevertheless there is concern that the forecasted traffic increase could lead to an increase in the number of accidents in the near future.(2) Council Directive 94/56/EC of 21 November 1994 establishing the fundamental principles governing the investigation of civil aviation accidents and incidents(4), aims at preventing accidents by facilitating the expeditious holding of investigations.(3) Experience has shown that often before an accident occurs, a number of incidents and numerous other deficiencies have shown the existence of safety hazards.(4) The improvement of the safety of civil aviation requires a better knowledge of these occurrences to facilitate analysis and trend monitoring in order to initiate corrective action.(5) When an occurrence involves aircraft registered in a Member State or operated by an undertaking established in a Member State, this occurrence should be reported even when it happened outside the territory of the Community.(6) Each Member State should set up mandatory reporting systems.(7) Various categories of personnel working in civil aviation observe occurrences of interest for the prevention of accidents and should therefore report them.(8) The efficiency of detection of potential hazard would be greatly enhanced by the exchange of information on such occurrences.(9) Supporting software for the exchange of information between different systems is necessary.(10) Safety information should be available to entities entrusted with regulating civil aviation safety or investigating accidents and incidents within the Community and, as appropriate, to the people who may learn from them and take or initiate the necessary action to improve safety.(11) The sensitive nature of safety information is such that the way to ensure its collection is by guaranteeing its confidentiality, the protection of its source and the confidence of the personnel working in civil aviation.(12) The public should be provided with general information on the level of aviation safety.(13) Appropriate measures should be put in place to enable the setting up of confidential reporting schemes.(14) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5).(15) Consistency should be ensured with the technical reporting requirements developed by national experts in Eurocontrol and the Joint Aviation Authorities Organisation. The list of reportable occurrences should take into account the work of these two European organisations. Developments in the framework of the International Civil Aviation Organisation should also be taken into account.(16) Since the objective of the proposed action, namely the improvement of air safety, cannot be sufficiently achieved by the Member States because reporting systems operated by Member States in isolation are less efficient than a coordinated network with exchange of information enabling an earlier identification of possible safety problems, and can, therefore, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,HAVE ADOPTED THIS DIRECTIVE:Article 1ObjectiveThe objective of this Directive is to contribute to the improvement of air safety by ensuring that relevant information on safety is reported, collected, stored, protected and disseminated.The sole objective of occurrence reporting is the prevention of accidents and incidents and not to attribute blame or liability.Article 2DefinitionsFor the purpose of this Directive:1. "occurrence" means an operational interruption, defect, fault or other irregular circumstance that has or may have influenced flight safety and that has not resulted in an accident or serious incident, hereinafter referred to as "accident or serious incident", as defined in Article 3(a) and (k) of Directive 94/56/EC;2. "disidentification" means removing from reports submitted all personal details pertaining to the reporter and technical details which might lead to the identity of the reporter, or of third parties, being inferred from the information.Article 3Scope1. This Directive shall apply to occurrences which endanger or which, if not corrected, would endanger an aircraft, its occupants or any other person. A list of examples of these occurrences appears in Annexes I and II.2. The Commission may, in accordance with the procedure laid down in Article 10(2), decide to amend the Annexes in order to expand upon, or change, the examples.3. The application of this Directive to the airport of Gibraltar is understood to be without prejudice to the respective legal positions of the Kingdom of Spain and the United Kingdom with regard to the dispute over sovereignty over the territory in which the airport is situated.4. Application of this Directive to the airport of Gibraltar shall be suspended until the arrangements in the Joint Declaration made by the Foreign Ministers of the Kingdom of Spain and the United Kingdom on 2 December 1987 have come into operation. The Governments of Spain and the United Kingdom will inform the Council of such date of entry into operation.Article 4Mandatory reporting1. Member States shall require that occurrences covered by Article 3 are reported to the competent authorities referred to in Article 5(1) by every person listed below in the exercise of his/her functions:(a) the operator or commander of a turbine-powered or a public transport aircraft used by an operator for which a Member State ensures safety oversight of operations;(b) a person who carries on the business of designing, manufacturing, maintaining or modifying a turbine-powered or a public transport aircraft, or any equipment or part thereof, under the oversight of a Member State;(c) a person who signs a certificate of maintenance review, or of release to service in respect of a turbine-powered or a public transport aircraft, or any equipment or part thereof, under the oversight of a Member State;(d) a person who performs a function which requires him to be authorised by a Member State as an air traffic controller or as a flight information officer;(e) a manager of an airport covered by Council Regulation (EEC) No 2408/92 of 23 July 1992 on access for Community air carriers to intra-Community air routes(6);(f) a person who performs a function connected with the installation, modification, maintenance, repair, overhaul, flight-checking or inspection of air navigation facilities for which a Member State ensures responsibility;(g) a person who performs a function connected with the ground-handling of aircraft, including fuelling, servicing, loadsheet preparation, loading, de-icing and towing at an airport covered by Regulation (EEC) No 2408/92.2. Member States may encourage voluntary reporting on occurrences mentioned in Article 3(1) by every person who exercises, in other civil aviation operations, functions similar to those listed in paragraph 1.Article 5Collection and storage of information1. Member States shall designate one or more competent authorities to put in place a mechanism to collect, evaluate, process and store occurrences reported in accordance with Article 4.The following authorities, working with impartiality, may be entrusted with that responsibility:(a) the national civil aviation authority; and/or(b) the investigating body or entity established under Article 6 of Directive 94/56/EC; and/or(c) any other independent body or entity entrusted with this function.If a Member State designates more than one body or entity, it shall designate one of these as point of contact for the exchange of information mentioned in Article 6(1).2. The competent authorities shall store the reports collected in their databases.3. Accidents and serious incidents shall also be stored in these databases.Article 6Exchange of information1. Member States shall participate in an exchange of information by making all relevant safety-related information stored in the databases mentioned in Article 5(2) available to the competent authorities of the other Member States and the Commission.The databases shall be compatible with the software described in paragraph 3.2. The competent authority designated in accordance with Article 5(1) receiving an occurrence report shall enter it into the databases and notify, whenever necessary, the competent authority of the Member State where the occurrence took place, where the aircraft is registered, where the aircraft is manufactured and/or where the operator is certificated.3. The Commission shall develop specific software for the purpose of this Directive. In so doing, it shall take into account the need for compatibility with existing softwares in the Member States. The competent authorities may use this software for running their own databases.4. The Commission shall take appropriate measures to facilitate the exchange of information mentioned in paragraph 1 in accordance with the procedure set out in Article 10(2).Article 7Dissemination of information1. Any entity entrusted with regulating civil aviation safety or with investigating civil aviation accidents and incidents within the Community shall have access to information on occurrences collected and exchanged in accordance with Articles 5 and 6 to enable it to draw the safety lessons from the reported occurrences.2. Without prejudice to the public's right of access to the Commission's documents as laid down in Regulation (EC) No 1049/2001 of the European Parliament and the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(7), the Commission shall adopt on its own initiative and, in accordance with the procedure referred to in Article 10(2), measures for the dissemination to interested parties of the information referred to in paragraph 1 and the associated conditions. These measures, which can be general or individual, shall be based on the need:- to provide persons and organisations with the information they need to improve civil aviation safety,- to limit the dissemination of information to what is strictly required for the purpose of its users, in order to ensure appropriate confidentiality of that information.The decision to disseminate information under this paragraph shall be limited to what is strictly required for the purpose of its user, without prejudice to the provisions of Article 8.3. Member States may publish at least annually a safety review containing information on the types of occurrences collected by their national mandatory occurrence-reporting system to inform the public of the level of safety in civil aviation. Member States may also publish disidentified reports.Article 8Protection of information1. Member States shall, according to their national legislation, take necessary measures to ensure appropriate confidentiality of the information received by them pursuant to Articles 6(1) and 7(1). They shall use this information solely for the objective of this Directive.2. Regardless of the type or classification of occurrence and accident or serious incident, names or addresses of individual persons shall never be recorded on the database mentioned in Article 5(2).3. Without prejudice to the applicable rules of penal law, Member States shall refrain from instituting proceedings in respect of unpremeditated or inadvertent infringements of the law which come to their attention only because they have been reported under the national mandatory occurrence-reporting scheme, except in cases of gross negligence.4. In accordance with the procedures defined in their national laws and practices, Member States shall ensure that employees who report incidents of which they may have knowledge are not subjected to any prejudice by their employer.5. This Article shall apply without prejudice to national rules related to access to information by judicial authorities.Article 9Voluntary reporting1. In addition to the system of mandatory reporting established under Articles 4 and 5, Member States may designate one or more bodies or entities to put in place a system of voluntary reporting to collect and analyse information on observed deficiencies in aviation which are not required to be reported under the system of mandatory reporting, but which are perceived by the reporter as an actual or potential hazard.2. If a Member State chooses to put in place a system of voluntary reporting, it shall establish the conditions for the disidentification, by the one or more bodies or entities that it has designated under paragraph 1, of voluntary reports presented under such system.3. Member States shall ensure that relevant disidentified safety information deriving from the analysis of confidential reporting is stored and made available to all parties so that it can be used for improving safety in aviation.Article 10Committee1. The Commission shall be assisted by the committee instituted by Article 12 of Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation(8).2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 11Implementation1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 4 July 2005. They shall forthwith inform the Commission thereof.When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.Article 12Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 13AddresseesThis Directive is addressed to the Member States.Done at Luxembourg, 13 June 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentV. Papandreou(1) OJ C 120 E, 24.4.2001, p. 148 and OJ C 332 E, 27.11.2001, p. 320.(2) OJ C 311, 7.11.2001, p. 8.(3) Opinion of the European Parliament of 14 June 2001 (OJ C 53 E, 28.2.2002, p. 324), Council Common Position of 17 June 2002 (OJ C 197 E, 20.8.2002, p. 16) and Decision of the European Parliament of 23 October 2002 (not yet published in the Official Journal). Decision of the European Parliament of 13 May 2003 and Decision of the Council of 13 May 2003.(4) OJ L 319, 12.12.1994, p. 14.(5) OJ L 184, 17.7.1999, p. 23.(6) OJ L 240, 24.8.1992, p. 8. Regulation as last amended by the 1994 Act of Accession.(7) OJ L 145, 31.5.2001, p. 43.(8) OJ L 373, 31.12.1991, p. 4. Regulation as last amended by Commission Regulation (EC) No 2871/2000 (OJ L 333, 29.12.2000, p. 47).ANNEX IList of aircraft operations, maintenance, repair, and manufacture-related occurrences to be reportedNote 1: Although this Annex lists the majority of reportable occurrences, it cannot be completely comprehensive. Any other occurrences, which are judged by those involved to meet the criteria, should also be reported.Note 2: This Annex does not include accidents. In addition to other requirements covering the notification of accidents, they should also be recorded in the database mentioned in Article 5(2).Note 3: This Annex contains examples of reporting requirements covering aircraft operations, maintenance, repair and manufacture.Note 4: Occurrences to be reported are those where the safety of operation was or could have been endangered or which could have led to an unsafe condition. If in the view of the reporter an occurrence did not endanger the safety of the operation but if repeated in different but likely circumstances would create a hazard, then a report should be made. What is judged to be reportable on one class of product, part or appliance may not be so on another and the absence or presence of a single factor, human or technical, can transform an occurrence into an accident or serious incident.Note 5: Specific operational approvals, e.g. RVSM, ETOPS, RNAV, or a design or maintenance programme, may have specific reporting requirements for failures or malfunctions associated with that approval or programme.CONTENTS>TABLE>A. AIRCRAFT FLIGHT OPERATIONS(i) Operation of the aircraft(a) avoidance manoeuvres:- risk of collision with another aircraft, terrain or other object or an unsafe situation when avoidance action would have been appropriate;- an avoidance manoeuvre required to avoid a collision with another aircraft, terrain or other object;- an avoidance manoeuvre to avoid other unsafe situations.(b) Take-off or landing incidents, including precautionary or forced landings. Incidents such as under-shooting, overrunning or running off the side of runways. Take-offs, rejected take-offs, landings or attempted landings on a closed, occupied or incorrect runway. Runway incursions.(c) Inability to achieve predicted performance during take-off or initial climb.(d) Critically low fuel quantity or inability to transfer fuel or use total quantity of usable fuel.(e) Loss of control (including partial or temporary) regardless of cause.(f) Occurrences close to or above V1 resulting from or producing a hazardous or potentially hazardous situation (e.g. rejected take-off, tail strike, engine-power loss etc.).(g) Go around producing a hazardous or potentially hazardous situation.(h) Unintentional significant deviation from airspeed, intended track or altitude (more than 300 ft) regardless of cause.(i) Descent below decision height/altitude or minimum descent height/altitude without the required visual reference.(j) Loss of position awareness relative to actual position or to other aircraft.(k) Breakdown in communication between flight crew (CRM) or between flight crew and other parties (cabin crew, ATC, engineering).(l) Heavy landing - a landing deemed to require a "heavy landing check".(m) Exceedance of fuel imbalance limits.(n) Incorrect setting of an SSR code or of an altimeter subscale.(o) Incorrect programming of, or erroneous entries into, equipment used for navigation or performance calculations, or use of incorrect data.(p) Incorrect receipt or interpretation of radio-telephony messages.(q) Fuel system malfunctions or defects, which had an effect on fuel supply and/or distribution.(r) Aircraft unintentionally departing from a paved surface.(s) Collision between an aircraft and any other aircraft, vehicle or other ground object.(t) Inadvertent and/or incorrect operation of any controls.(u) Inability to achieve the intended aircraft configuration for any flight phase (e.g. landing gear and gear doors, flaps, stabilisers, slats etc.).(v) A hazard or potential hazard which arises as a consequence of any deliberate simulation of failure conditions for training, system checks or training purposes.(w) Abnormal vibration.(x) Operation of any primary warning system associated with manoeuvring the aircraft e.g. configuration warning, stall warning (stick shaker), over-speed warning etc. unless:1. the crew conclusively established that the indication was false and provided that the false warning did not result in difficulty or hazard arising from the crew response to the warning; or2. operated for training or test purposes.(y) GPWS/TAWS "warning" when:1. the aircraft comes into closer proximity to the ground than had been planned or anticipated; or2. the warning is experienced in instrument meteorological conditions or at night and is established as having been triggered by a high rate of descent (mode 1); or3. the warning results from failure to select landing gear or landing flaps by the appropriate point on the approach (mode 4); or4. any difficulty or hazard arises or might have arisen as a result of crew response to the "warning" e.g. possible reduced separation from other traffic. This could include warning of any mode or type i.e. genuine, nuisance or false.(z) GPWS/TAWS "alert" when any difficulty or hazard arises or might have arisen as a result of crew response to the "alert".(aa) ACAS RAs.(bb) Jet or prop blast incidents resulting in significant damage or serious injury.(ii) Emergencies(a) Fire, explosion, smoke or toxic or noxious fumes, even though fires were extinguished.(b) The use of any non-standard procedure by the flight or cabin crew to deal with an emergency when:1. the procedure exists but is not used;2. the procedure does not exist;3. the procedure exists but is incomplete or inappropriate;4. the procedure is incorrect;5. the incorrect procedure is used.(c) Inadequacy of any procedures designed to be used in an emergency, including when being used for maintenance, training or test purposes.(d) An event leading to an emergency evacuation.(e) Depressurisation.(f) The use of any emergency equipment or prescribed emergency procedures in order to deal with a situation.(g) An event leading to the declaration of an emergency ("Mayday" or "panne").(h) Failure of any emergency system or equipment, including all exit doors and lighting, to perform satisfactorily, including when being used for maintenance, training or test purposes.(i) Events requiring any use of emergency oxygen by any crew member.(iii) Crew incapacitation(a) Incapacitation of any member of the flight crew, including that which occurs prior to departure if it is considered that it could have resulted in incapacitation after take-off.(b) Incapacitation of any member of the cabin crew which renders them unable to perform essential emergency duties.(iv) InjuryOccurrences, which have or could have led to significant injury to passengers or crew but which are not considered reportable as an accident.(v) Meteorology(a) A lightning strike which resulted in damage to the aircraft or loss or malfunction of any essential service.(b) A hail strike which resulted in damage to the aircraft or loss or malfunction of any essential service.(c) Severe turbulence encounter, an encounter resulting in injury to occupants or deemed to require a "turbulence check" of the aircraft.(d) A windshear encounter.(e) Icing encounter resulting in handling difficulties, damage to the aircraft or loss or malfunction of any essential service.(vi) Security(a) Unlawful interference with the aircraft including a bomb threat or hijack.(b) Difficulty in controlling intoxicated, violent or unruly passengers.(c) Discovery of a stowaway.(vii) Other occurrences(a) Repetitive instances of a specific type of occurrence which in isolation would not be considered "reportable" but which due to the frequency with which they arise, form a potential hazard.(b) A bird strike which resulted in damage to the aircraft or loss or malfunction of any essential service.(c) Wake-turbulence encounters.(d) Any other occurrence of any type considered to have endangered or which might have endangered the aircraft or its occupants on board the aircraft or on the ground.B. AIRCRAFT TECHNICAL(i) StructuralNot all structural failures need to be reported. Engineering judgment is required to decide whether a failure is serious enough to be reported. The following examples can be taken into consideration:(a) damage to a principal structural element (PSE) that has not been designated as damage-tolerant (life-limited element). PSEs are those which contribute significantly to carrying flight, ground, and pressurisation loads, and the failure of which could result in a catastrophic failure of the aircraft;(b) defect or damage exceeding admissible damages to a PSE that has been designated as damage-tolerant;(c) damage to or defect exceeding allowed tolerances of a structural element, the failure of which could reduce the structural stiffness to such an extent that the required flutter, divergence or control reversal margins are no longer achieved;(d) damage to or defect of a structural element, which could result in the liberation of items of mass that may injure occupants of the aircraft;(e) damage to or defect of a structural element, which could jeopardise proper operation of systems. See (ii) below;(f) loss of any part of the aircraft structure in flight.(ii) SystemsThe following general criteria applicable to all systems are proposed:(a) loss, significant malfunction or defect of any system, subsystem or set of equipment when standard operating procedures, drills etc. could not be satisfactorily accomplished;(b) inability of the crew to control the system, for example:1. uncommanded actions,2. incorrect and/or incomplete response, including limitation of movement or stiffness,3. runaway,4. mechanical disconnection or failure;(c) failure or malfunction of the exclusive function(s) of the system (one system could integrate several functions);(d) interference within or between systems;(e) failure or malfunction of the protection device or emergency system associated with the system;(f) Loss of redundancy of the system.(g) Any occurrence resulting from unforeseen behaviour of a system.(h) For aircraft types with single main systems, subsystems or sets of equipment:loss, significant malfunction or defect in any main system, subsystem or set of equipment.(i) For aircraft types with multiple independent main systems, subsystems or sets of equipment:the loss, significant malfunction or defect of more than one main system, subsystem or set of equipment.(j) Operation of any primary warning system associated with aircraft systems or equipment unless the crew conclusively established that the indication was false, provided that the false warning did not result in difficulty or hazard arising from the crew response to the warning.(k) Leakage of hydraulic fluids, fuel, oil or other fluids which resulted in a fire hazard or possible hazardous contamination of aircraft structure, systems or equipment, or risk to occupants.(l) Malfunction or defect of any indication system when this results in the possibility of misleading indications to the crew.(m) Any failure, malfunction or defect if it occurs at a critical phase of the flight and is relevant to the system operation.(n) Significant shortfall of the actual performances compared to the approved performance which resulted in a hazardous situation (taking into account the accuracy of the performance-calculation method) including braking action, fuel consumption etc.(o) Asymmetry of flight controls; e.g. flaps, slats, spoilers etc.The Appendix to this Annex gives a list of examples of reportable occurrences resulting from the application of these general criteria to specific systems.(iii) Propulsion (including engines, propellers and rotor systems) and auxiliary power units (APUs)(a) Flameout, shutdown or malfunction of any engine.(b) Overspeed or inability to control the speed of any high-speed rotating component (for example: APU, air starter, air cycle machine, air turbine motor, propeller or rotor).(c) Failure or malfunction of any part of an engine or powerplant resulting in any one or more of the following:1. non-containment of components/debris;2. uncontrolled internal or external fire, or hot gas breakout;3. thrust in a direction different from that demanded by the pilot;4. thrust-reversing system failing to operate or operating inadvertently;5. inability to control power, thrust or rpm;6. failure of the engine mount structure;7. partial or complete loss of a major part of the powerplant;8. dense visible fumes or concentrations of toxic products sufficient to incapacitate crew or passengers;9. inability, by use of normal procedures, to shutdown an engine;10. inability to restart a serviceable engine.(d) An uncommanded thrust/power loss, change or oscillation which is classified as a loss of thrust or power control (LOTC):1. for a single-engine aircraft; or2. where it is considered excessive for the application; or3. where this could affect more than one engine in a multi-engine aircraft, particularly in the case of a twin-engine aircraft; or4. for a multi-engine aircraft where the same, or similar, engine type is used in an application where the event would be considered hazardous or critical.(e) Any defect in a life-controlled part causing its withdrawal before completion of its full life.(f) Defects of common origin which could cause an in-flight shut-down rate so high that there is the possibility of more than one engine being shut down on the same flight.(g) An engine limiter or control device failing to operate when required or operating inadvertently.(h) Exceedance of engine parameters.(i) FOD resulting in damage.Propellers and transmission(j) Failure or malfunction of any part of a propeller or powerplant resulting in any one or more of the following:1. an overspeed of the propeller;2. the development of excessive drag;3. a thrust in the opposite direction to that commanded by the pilot;4. a release of the propeller or any major portion of the propeller;5. a failure that results in excessive imbalance;6. the unintended movement of the propeller blades below the established minimum in-flight low-pitch position;7. an inability to feather the propeller;8. an inability to change propeller pitch;9. an uncommanded change in pitch;10. an uncontrollable torque or speed fluctuation;11. the release of low-energy parts.Rotors and transmission(k) Damage or defect of main rotor gearbox/attachment which could lead to in-flight separation of the rotor assembly and/or malfunctions of the rotor control.(l) Damage to tail rotor, transmission and equivalent systems.APUs(m) Shut down or failure when the APU is required to be available by operational requirements, e.g. ETOPS, MEL.(n) Inability to shut down the APU.(o) Overspeed.(p) Inability to start the APU when needed for operational reasons.(iv) Human factorsAny incident where any feature or inadequacy of the aircraft design could have led to an error of use that could contribute to a hazardous or catastrophic effect.(v) Other occurrences(a) Any incident where any feature or inadequacy of the aircraft design could have led to an error of use that could contribute to a hazardous or catastrophic effect.(b) An occurrence not normally considered as reportable (e.g., furnishing and cabin equipment, water systems), where the circumstances resulted in endangering the aircraft or its occupants.(c) A fire, explosion, smoke or toxic or noxious fumes.(d) Any other event which could endanger the aircraft, or affect the safety of the occupants of the aircraft, or people or property in the vicinity of the aircraft or on the ground.(e) Failure or defect of passenger address system resulting in loss of, or inaudible, passenger address system.(f) Loss of pilot seat control during flight.C. AIRCRAFT MAINTENANCE AND REPAIR(i) Incorrect assembly of parts or components of the aircraft found during an inspection or test procedure not intended for that specific purpose.(ii) Hot bleed air leak resulting in structural damage.(iii) Any defect in a life-controlled part causing retirement before completion of its full life.(iv) Any damage or deterioration (e.g. fractures, cracks, corrosion, delamination, disbonding etc.) resulting from any cause (e.g. as flutter, loss of stiffness or structural failure) to:(a) a primary structure or a PSE (as defined in the manufacturers' Repair Manual) where such damage or deterioration exceeds allowable limits specified in the Repair Manual and requires a repair or complete or partial replacement;(b) a secondary structure which consequently has or may have endangered the aircraft;(c) the engine, propeller or rotorcraft rotor system.(v) Any failure, malfunction or defect of any system or equipment, or damage or deterioration thereof found as a result of compliance with an airworthiness directive or other mandatory instruction issued by a regulatory authority, when:(a) it is detected for the first time by the reporting organisation implementing compliance;(b) on any subsequent compliance, it exceeds the permissible limits quoted in the instruction and/or published repair/rectification procedures are not available.(vi) Failure of any emergency system or equipment, including all exit doors and lighting, to perform satisfactorily, including when being used for maintenance or test purposes.(vii) Non-compliance or significant errors in compliance with required maintenance procedures.(viii) Products, parts, appliances and materials of unknown or suspect origin.(ix) Misleading, incorrect or insufficient maintenance data or procedures that could lead to maintenance errors.(x) Any failure, malfunction or defect of ground equipment used for testing or checking of aircraft systems and equipment when the required routine inspection and test procedures did not clearly identify the problem, where this results in a hazardous situation.D. AIR NAVIGATION SERVICES, FACILITIES AND GROUND SERVICES(i) Air navigation services (ANS)See Annex II, list of reportable ANS-related occurrences.(ii) Aerodrome and aerodrome facilities(a) Significant spillage during fuelling operations.(b) Loading of incorrect fuel quantities likely to have a significant effect on aircraft endurance, performance, balance or structural strength.(iii) Handling of passengers, baggage and cargo(a) Significant contamination of aircraft structure, systems and equipment arising from the carriage of baggage or cargo.(b) Incorrect loading of passengers, baggage or cargo, likely to have a significant effect on aircraft mass and/or balance.(c) Incorrect stowage of baggage or cargo (including hand baggage) likely in any way to endanger the aircraft, its equipment or occupants or to impede emergency evacuation.(d) Inadequate stowage of cargo containers or other substantial items of cargo.(e) Carriage or attempted carriage of dangerous goods in contravention of applicable regulations, including incorrect labelling and packaging of dangerous goods.(iv) Aircraft ground handling and servicing(a) Failure, malfunction or defect of ground equipment used for the testing or checking of aircraft systems and equipment when the required routine inspection and test procedures did not clearly identify the problem, where this results in a hazardous situation.(b) Non-compliance or significant errors in compliance with required servicing procedures.(c) Loading of contaminated or incorrect type of fuel or other essential fluids (including oxygen and potable water).Appendix to ANNEX IThe following subparagraphs give examples of reportable occurrences resulting from the application of the general criteria to specific systems listed in paragraph B(ii) of Annex I.1. Air conditioning/ventilation(a) complete loss of avionics cooling(b) depressurisation.2. Autoflight system(a) failure of the autoflight system to achieve the intended operation while engaged(b) significant reported crew difficulty to control the aircraft linked to autoflight system functioning(c) failure of any autoflight system disconnect device(d) uncommanded autoflight mode change.3. Communications(a) failure or defect of passenger address system resulting in loss of or inaudible passenger address(b) total loss of communication in flight.4. Electrical system(a) loss of one electrical distribution system (AC/DC)(b) total loss or loss of more than one electrical generation system(c) failure of the back up (emergency) electrical generation system.5. Cockpit/Cabin/Cargo(a) pilot seat control loss during flight(b) failure of any emergency system or equipment, including emergency evacuation signalling system, all exit doors, emergency lighting, etc.(c) loss of retention capability of the cargo loading system.6. Fire protection system(a) fire warnings, except those immediately confirmed as false(b) undetected failure or defect of fire/smoke detection/protection system, which could lead to loss or reduced fire detection/protection(c) absence of warning in case of actual fire or smoke.7. Flight controls(a) asymmetry of flaps, slats, spoilers, etc.(b) limitation of movement, stiffness or poor or delayed response in the operation of primary flight control systems or their associated tab and lock systems(c) flight control surface runaway(d) flight control surface vibration felt by the crew(e) mechanical flight control disconnection or failure(f) significant interference with normal control of the aircraft or degradation of flying qualities.8. Fuel system(a) fuel quantity indicating system malfunction resulting in total loss or wrong indication of fuel quantity on board(b) leakage of fuel which resulted in major loss, fire hazard, significant contamination(c) malfunction or defects of the fuel jettisoning system which resulted in inadvertent loss of significant quantity, fire hazard, hazardous contamination of aircraft equipment or inability to jettison fuel(d) fuel system malfunctions or defects which had a significant effect on fuel supply and/or distribution(e) inability to transfer or use total quantity of usable fuel.9. Hydraulics(a) loss of one hydraulic system (ETOPS only)(b) failure of the isolation system(c) loss of more than one hydraulic circuit(d) failure of the back-up hydraulic system(e) inadvertent ram air turbine extension.10. Ice detection/protection system(a) undetected loss or reduced performance of the anti-ice/de-ice system(b) loss of more than one of the probe-heating systems(c) inability to obtain symmetrical wing de-icing(d) abnormal ice accumulation leading to significant effects on performance or handling qualities(e) crew vision significantly affected.11. Indicating/warning/recording systems(a) malfunction or defect of any indicating system when the possibility of significant misleading indications to the crew could result in an inappropriate crew action on an essential system(b) loss of a red warning function on a system(c) for glass cockpits: loss or malfunction of more than one display unit or computer involved in the display/warning function.12. Landing gear system/brakes/tyres(a) brake fire(b) significant loss of braking action(c) asymmetrical braking action leading to significant path deviation(d) failure of the landing gear free fall extension system (including during scheduled tests)(e) unwanted landing gear or gear doors extension/retraction(f) multiple tyre burst.13. Navigation systems (including precision approach systems) and air data systems(a) total loss or multiple navigation equipment failures(b) total or multiple air data system equipment failures(c) significant misleading indications(d) significant navigation errors attributed to incorrect data or a database coding error(e) unexpected deviations in lateral or vertical path not caused by pilot input(f) problems with ground navigational facilities leading to significant navigation errors not associated with transitions from inertial navigation mode to radio navigation mode.14. Oxygen for pressurised aircraft(a) loss of oxygen supply in the cockpit(b) loss of oxygen supply to a significant number of passengers (more than 10 %), including when found during maintenance or training or test purposes.15. Bleed air system(a) hot bleed air leak resulting in fire warning or structural damage(b) loss of all bleed air systems(c) failure of bleed air leak detection system.ANNEX IIList of air navigation services related occurrences to be reportedNote 1: Although this Annex lists the majority of reportable occurrences, it cannot be completely comprehensive. Any other occurrences, which are judged by those involved to meet the criteria, should also be reported.Note 2: This Annex does not include accidents and serious incidents. In addition to other requirements covering the notification of accidents, they should also be recorded in the databases mentioned in Article 5(2).Note 3: This Annex includes ANS occurrences which pose an actual or potential threat to flight safety, or can compromise the provision of safe ANS services.Note 4: The contents of this Annex shall not preclude the reporting of any occurrence, situation or condition which, if repeated in different but likely circumstances or allowed to continue uncorrected, could create a hazard to aircraft safety.(i) Near collision incidents (encompassing specific situations where one aircraft and another aircraft/the ground/a vehicle/person or object are perceived to be too close to each other):(a) separation minima infringement;(b) inadequate separation;(c) near-controlled flight into terrain (near CFIT);(d) runway incursion where avoiding action was necessary.(ii) Potential for collision or near collision (encompassing specific situations having the potential to be an accident or a near collision, if another aircraft is in the vicinity):(a) runway incursion where no avoiding action is necessary;(b) runway excursion;(c) aircraft deviation from ATC clearance;(d) aircraft deviation from applicable air traffic management (ATM) regulation:1. aircraft deviation from applicable published ATM procedures;2. unauthorised penetration of airspace;3. deviation from aircraft ATM-related equipment carriage and operations, as mandated by applicable regulation(s).(iii) ATM-specific occurrences (encompassing those situations where the ability to provide safe ATM services is affected, including situations where, by chance, the safe operation of aircraft has not been jeopardised). This shall include the following occurrences:(a) inability to provide ATM services:1. inability to provide air traffic services;2. inability to provide airspace management services;3. inability to provide air traffic flow management services;(b) failure of Communication function;(c) failure of Surveillance function;(d) failure of Data Processing and Distribution function;(e) failure of Navigation function;(f) ATM system security.Appendix to ANNEX IIThe following subparagraphs give examples of reportable ATM occurrences resulting from the application of the general criteria listed in paragraph (iii) of Annex II to aircraft operations.1. Provision of significantly incorrect, inadequate or misleading information from any ground sources, e.g. air traffic control (ATC), automatic terminal information service (ATIS), meteorological services, navigation databases, maps, charts, manuals, etc.2. Provision of less than prescribed terrain clearance.3. Provision of incorrect pressure reference data (i.e. altimeter setting).4. Incorrect transmission, receipt or interpretation of significant messages when this results in a hazardous situation.5. Separation minima infringement.6. Unauthorised penetration of airspace.7. Unlawful radio communication transmission.8. Failure of ANS ground or satellite facilities.9. Major ATC/ATM failure or significant deterioration of aerodrome infrastructure.10. Aerodrome movement areas obstructed by aircraft, vehicles, animals or foreign objects, resulting in a hazardous or potentially hazardous situation.11. Errors or inadequacies in marking of obstructions or hazards on aerodrome movement areas resulting in a hazardous situation.12. Failure, significant malfunction or unavailability of airfield lighting.


Avis juridique important

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31988L0299

Council Directive 88/299/EEC of 17 May 1988 on trade in animals treated with certain substances having a hormonal action and their meat, as referred to in Article 7 of Directive 88/146/EEC

Official Journal L 128 , 21/05/1988 P. 0036 - 0038

*****COUNCIL  DIRECTIVE  of 17 May 1988  on trade in animals treated with certain substances having a hormonal action and their meat, as referred to in Article 7 of Directive 88/146/EEC  (88/299/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 88/146/EEC of 7 March 1988 prohibiting the use in livestock farming of certain substances having a hormonal action (1), and in particular Article 7 thereof,  Having regard to the proposal from the Commission,  Whereas Directive 88/146/EEC prohibited the use in livestock farming of certain substances having a hormonal action, while permitting those exceptions already laid down in Article 4 of Council Directive 81/602/EEC of 31 July 1981, concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action (2), as last amended by Directive 85/358/EEC (3);  Whereas, in order to ensure the correct operation of the scheme as a whole, trade in animals which have treated, and of their meat has, in general, been prohibited; whereas, however, pursuant to Article 7 of Directive 88/146/EEC, derogations may be allowed in respect of intra-Community trade and importation from third countries of animals intended for reproduction and reproductive animals at the end of their career, which, in the course of their existence, have been treated under Article 4 of Directive 81/602/EEC and in respect of meat from those various animals;  Whereas such derogations may be allowed where satisfactory guarantees can be provided such as would not cause distortions of trade; whereas these guarantees must be given as regards the products which may be used, the conditions of their use and the control of such conditions in particular, regarding compliance with the necessary waiting period; whereas these requirements should be established in accordance with a Community procedure;  Whereas equivalent guarantees must be accepted, in accordance with a Community procedure, in respect of importations from third countries, taking into account the guarantees given by the third country concerned,  HAS ADOPTED THIS DIRECTIVE:  Article 1  This Directive lays down the conditions for applying the derogations provided for in Article 7 of Directive 88/146/EEC from the prohibition on trade in certain categories of animals and their meat.  Article 2  Notwithstanding Article 5 of Directive 88/146/EEC, Member States shall authorize trade in animals intended for reproduction and reproductive animals at the end of their career which, during their reproductive career, have undergone one of the treatments referred to in Article 4 of Directive 81/602/EEC, or shall authorize the affixing of the Community stamp to meat from such animals, provided the following conditions are complied with:  1. Only one of the following substances or products has been administered to the animals:  (a) for therapeutic treatment, oestradiol 17 B, testosterone and progesterone and those derivatives which readily yield the parent compound on hydrolysis after absorption at the site of application and which, in accordance with Article 3 of Directive 88/146/EEC, appear on the list of products to be drawn up in compliance with the other conditions laid down in Article 3 (1) (a) and (b);  (b) for synchronization of oestrus, termination of unwanted gestation, the improvement of fertility and the preparation of donors and recipients for the implantation of embryos, the substances mentioned in Article 4 (1) of Directive 81/602/EEC, provided that the products in which they are contained appear on a list drawn up in accordance with the procedure provided for in Article 8 of Directive 88/146/EEC after the Committee for Veterinary Medicinal Products has given its opinion, and in accordance with the conditions set out in point 2 below.  2. In the case referred to in point 1 (b):  - the conditions of use, in particular the conditions under which these products are made available to breeders, the necessary waiting period and detailed provisions concerning the monitoring of those conditions of use, shall be laid down in accordance with the procedure referred to in point 1 (b),  - the means of identification of animals shall be laid down in accordance with the procedure provided for in Article 8 of Directive 88/146/EEC.  Pending the decisions referred to in point 1 (a) and (b), products which have already received authorization to be placed on the market shall continue to be so authorized.  3. The following criteria shall be considered at the time of adoption of the lists of products referred to in point 1 which may be administered to the animals defined in that point and intended for intra-Community trade:  - possibility of monitoring that that product is used in conformity with the provisions of this Directive,  - the need to exclude sustained-release products or salts or esters with long half-life, where the therapeutic objective could be achieved by using products with a shorter half-life which, by reason of their composition, do not act as a deposit, so as to preclude the use of hormones as growth factors and reduce the risk of residues,  - the need to exclude products with a waiting period exceeding 15 days after the end of the treatment,  - the availability of reagents and materials required for the methods of analysis for detecting the presence of residues exceeding the permitted limits.  Products authorized pursuant to the above paragraph shall be subject to Articles 24 to 50 of Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (1).  4. The veterinarian directly responsible must keep a register of at least the following particulars:  - nature of the treatment,  - nature of the products authorized,  - date of the treatment,  - identity of the animals treated.  These particulars shall be made available to the competent authority at its request.  Article 3  1. Member States shall ensure that the animals mentioned in Article 2 are sent from their territory to the territory of another Member State only if:  (a) the general conditions laid down in this Directive and in particular the waiting period laid down pursuant to the second indent of Article 3 (a) of Directive 88/146/EEC and to Article 2 (2) of this Directive have been complied with;  (b) in the case of reproductive animals at the end of their career, they have not received any of the treatments referred to in Article 4 of Directive 81/602/EEC with any of the products authorized in accordance with Article 2 (1) (a) or (b) or Article 6 during the fattening period following the end of their breeding life.  2. However, trade in high-value horses, particularly racehorses, competition horses, circus horses or horses intended for stud purposes or for exhibitions, including horses in these categories to which oral preparations containing allyl Trenbolone have been administered for the purposes mentioned in Article 2 (1) (b), may take place before the end of the waiting period, provided that the other conditions of Article 2 are fulfilled and that the nature and date of the treatment are mentioned on the certificate accompanying the horses.  Article 4  Without prejudice to the application to the requirements of Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (2), and by way of derogation from the first paragraph of Article 5 of Directive 88/146/EEC, Member States shall authorize trade in meat of animals intended for reproduction and of reproductive animals at the end of their career which might have been the subject of intra-Community trade in accordance with Article 3 (1) of this Directive.  The Community stamp may be affixed to the meat only if the waiting time has ended before the animals are slaughtered.  Article 5  By way of derogation from Article 6 (1) of Directive 88/146/EEC and for the purposes of applying Article 7 (2) of Directive 86/469/EEC, guarantees at least equivalent to those laid down by this Directive shall be established in accordance with the procedure provided for in Article 8 of Directive 88/146/EEC, which imports from third countries of animals intended for reproduction and reproductive animals at the end of their career or the meat of such animals must satisfy.  Article 6  Pending the decisions provided for in Article 2 (1) (a) and (b), the following transitional measures shall apply:  - Member States shall monitor compliance of the substances or products which have been the subject of a national authorization for placing on the market with the requirements of Article 2 (3). They shall notify the Commission and the other Member States of their findings, within the Standing Veterinary Commitee,  - on the basis of these findings, the Commission shall, under the procedure laid down in Article 11 of Directive 85/358/EEC draw up a provisional list of substances or products which may be used for the requirements of this Directive, and the conditions and means laid down in Article 2 (2).  Animals treated with these substances or products included in the provisional list or lists, and the meat of those animals, cannot be the subject of trade barriers.  The provisional lists shall cease to be valid after 31 December 1991.  Article 7  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1988 at the latest. They shall forthwith inform the Commission thereof.  Article 2 (1) and Articles 3, 4 and 6 shall apply from the notification (1) of this Directive.  Article 8  This Directive is addressed to the Member States.  Done at Brussels, 17 May 1988.  For the Council  The President  I. KIECHLE  (1) OJ No L 70, 16. 3. 1988, p. 16.  (2) OJ No L 222, 7. 8. 1981, p. 32.  (3) OJ No L 191, 23. 7. 1985, p. 46.  (1) OJ No L 317, 6. 11. 1981, p. 1.  (2) OJ No L 275, 26. 9. 1986, p. 36.  (1) This Directive was notified to the Member States on 20 May 1988.


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31991L0126

Commission Directive 91/126/EEC of 13 February 1991 amending the Annexes to Council Directive 74/63/EEC on undesirable substances and products in animal nutrition

Official Journal L 060 , 07/03/1991 P. 0016 - 0017 Finnish special edition: Chapter 3 Volume 36 P. 0195  Swedish special edition: Chapter 3 Volume 36 P. 0195

COMMISSION DIRECTIVE  of 13 February 1991  amending the Annexes to Council Directive 74/63/EEC on undesirable substances and products in animal nutrition  (91/126/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (1), as last amended by Directive 87/519/EEC (2), and in particular Article 7 thereof,  Whereas Directive 74/63/EEC provides for a regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge;  Whereas there are grounds to reduce the level of aflatoxin in certain straight feedingstuffs and complementary feedingstuffs for dairy cattle, with the aim of limiting as far as possible the transfer of this mycotoxin in milk;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The Annex I to Directive 74/63/EEC is hereby amended as set out in the Annex hereto.  Article 2  Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with Article 1 by 30 November 1991. They shall immediately inform the Commission thereof.  When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 13 February 1991. For the Commission  Ray MAC SHARRY  Member of the Commission  (1) OJ No L 38, 11. 2. 1974, p. 31. (2) OJ No L 304, 27. 10. 1987, p. 38.    ANNEX  In Annex I part B 'Products', against item 1 'Aflatoxin B1':  1. The words 'Straight feedingstuffs' shown in the column 2 and the figure '0,05' shown in the column 3 are replaced by the following:   Substances, products  Feedingstuffs  Maximum content in mg/kg (ppm) of feedingstuff, at a moisture content of 12 %      (1)  (2)  (3)       Straight feedingstuffs with the exception of:  0,05   - Groundnut, copra, palm-kernel, cotton seed,  babassu, maize and products derived from the processing thereof  0,02     2. The figure '0,01' shown in column 3 for 'Other complementary feedingstuffs' in column 2 is replaced by the figure '0,005'.


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31983L0191

Second Commission Directive 83/191/EEC of 30 March 1983 adapting to technical progress Annexes II, III, IV and V to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 109 , 26/04/1983 P. 0025 - 0027 Spanish special edition: Chapter 15 Volume 4 P. 0124  Portuguese special edition Chapter 15 Volume 4 P. 0124  Finnish special edition: Chapter 13 Volume 12 P. 0171  Swedish special edition: Chapter 13 Volume 12 P. 0171

SECOND COMMISSION DIRECTIVE of 30 March 1983 adapting to technical progress Annexes II, III, IV and V to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (83/191/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 82/368/EEC (2), and in particular Article 8 (2) thereof,  Whereas, on the basis of studies carried out, the barium, strontium and zirconium lakes, salts and pigments of a limited number of colouring agents may be authorized;  Whereas, on the basis of existing scientific knowledge, the use of 6-methylcoumarin in cosmetic products may be authorized subject to certain conditions;  Whereas to safeguard public health, measures should be adopted in respect of silver nitrates;  Whereas, on the basis of information received, certain complexes of zirconium may be provisionally authorized as antiperspirants subject to certain conditions;  Whereas the French and Italian versions of the Annexes to Directive 76/768/EEC contain typographical errors that should be corrected;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 76/768/EEC is hereby amended as follows:    1. In Annex II, the wording relating to substance No 46 is replaced by the following:  "46. Barium salts, with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex III, Part 1, and lakes, salts and pigments prepared from the colouring agents listed with the reference (5) in Annex III, Part 2 and Annex IV, Part 2."       2. The following is added to Part 1 of Annex III: >PIC FILE= "T0023070">   (1) OJ No L 262, 27.9.1976, p. 169. (2) OJ No L 167, 15.6.1982, p. 1.        3. Part 2 of Annex III is amended as follows:  - the following colour index numbers are deleted:  15 630 : 1 (Ba) 15 630 : 3 (Sr) 15 865 : 3 (Sr);      - delete "(Ba)" in "45 170 : 1 (Ba)";           - reference (5) is inserted after the following colour index numbers: >PIC FILE= "T0023071">            - the following footnote is added:  "(5) The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8."                  4. The following is added to Part 1 of Annex IV: >PIC FILE= "T0023072">         5. Part 2 of Annex IV is amended as follows:      - the following colour index number is deleted: 15 585 : 1 (Ba)           - reference (5) is inserted after the following colour index number : 27 290           - the following footnote is added:  "(5) The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8."       6. Part 3B of Annex IV is amended as follows:  - under the heading "Violets, browns, blacks and whites", "Disperse violet 23" is replaced by "60 724".       7. In Annex V the wording relating to substances numbers 5 and 6 is replaced by:  "  5. Strontium and its compounds, with the exception of strontium sulphide under the conditions laid down in Annex III, Part 1, and of strontium salts, lakes and pigments of the colouring agents listed with reference (5) in Annex III, Part 2, and in Annex IV, Part 2.   6. Zirconium and its compounds, with the exception of the complexes under reference number 7 in Annex IV, Part 1, and of zirconium lakes, salts and pigments of colouring agents listed with reference (5) in Annex III, Part II, and in Annex IV, Part 2. "          Article 2 1. The French version of Annex IV, Part 1, to Directive 76/768/EEC is corrected as follows:    - in column d, relating to the substance designated by the reference number 4, read "35 %" instead of "3,5 %";       - in column b, relating to the substance designated by the reference number 5, the word between brackets must read. "Tribromsalan" and not "Tribomsalan".         2. In the Italian version, footnote (3) to Annex III, Part 1, and to Annex IV, Part 2, to Directive 76/768/EEC should read as follows:  "(3) Sono ammessi anche le lacche o i sali di tali coloranti che contengono sostanze non vietate dall'allegato II o non escluse dal campo di applicazione della direttiva in base all'allegato V."   Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1984. They shall forthwith inform the Commission thereof.   Article 4 This Directive is addressed to the Member States.     Done at Brussels, 30 March 1983.  For the Commission  Karl-Heinz NARJES  Member of the Commission


title: Commission Directive 2006/142/EC of 22 December 2006 amending Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council listing the ingredients which must under all circumstances appear on the labelling of foodstuffs   (Text with EEA relevance)

text:
               23.12.2006

               EN

               Official Journal of the European Union

               L 368/110

      COMMISSION DIRECTIVE 2006/142/EC
   of 22 December 2006
   amending Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council listing the ingredients which must under all circumstances appear on the labelling of foodstuffs
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1) and in particular Article 6(11), third paragraph, thereof,
   Having regard to the opinions of the European Food Safety Authority of 6 December 2005 and 15 February 2006,
   Whereas:

               (1)

               Annex IIIa of Directive 2000/13/EC lists the ingredients which must under all circumstances appear on the labelling of foodstuffs, as they are likely to cause adverse reactions in susceptible individuals.

               (2)

               Article 6(11), first paragraph, of the aforementioned Directive stipulates that the list in Annex IIIa will be systematically re-examined and, where necessary, updated on the basis of the most recent scientific knowledge.

               (3)

               As part of this re-examination, the Commission asked the European Food Safety Authority (EFSA) to give its opinion on the possible inclusion in Annex IIIa of a number of other products.

               (4)

               As far as lupin is concerned, the EFSA states in its opinion of 6 December 2005 that this leguminous plant, of which there are 450 species, has long been consumed in its current state but that lupin flour is being added for a number of years in wheat flour for the production of bakery products. Cases of direct allergic reactions, some of them severe, have been documented and studies show that there is a relatively high risk of a cross-allergy to lupin in between 30 % and 60 % of persons who are allergic to peanuts.

               (5)

               In the case of molluscs (gastropods, bivalves or cephalopods), the EFSA states in its opinion of 15 February 2006 that they are most often consumed in their current state but are also used as ingredients, after any processing, in a number of preparations and in products such as surimi. Allergic reactions, which can be serious, affect up to 0,4 % of the population, i.e. 20 % of all cases of allergic reactions to seafood. The main allergenic protein in molluscs is tropomyosin, which is the same as that in crustaceans, and cases of cross-allergies between molluscs and crustaceans occur frequently.

               (6)

               It can be concluded from these observations that lupin and molluscs should be added to the list in Annex IIIa of Directive 2000/13/EC.

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The following ingredients shall be added to Annex IIIa of Directive 2000/13/EC:

      ‘Lupin and products thereof
      Molluscs and products thereof.’

   Article 2
   1.   The Member States shall, as from 23 December 2007, authorise the sale of foodstuffs which comply with this Directive.
   2.   The Member States shall, as from 23 December 2008, prohibit the sale of foodstuffs which fail to comply with this Directive. However, the sale of foodstuffs which fail to comply with this Directive and which have been labelled prior to this date shall be authorised until stocks run out.
   Article 3
   1.   The Member States shall, by 23 December 2007 at the latest, adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those provisions to the Commission together with a correlation table of those provisions and this Directive.
   When the Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
   2.   The Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 22 December 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

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