Avis juridique important

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31982L0368

Council Directive 82/368/EEC of 17 May 1982 amending for the second time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 167 , 15/06/1982 P. 0001 - 0032 Spanish special edition: Chapter 15 Volume 3 P. 0148  Portuguese special edition Chapter 15 Volume 3 P. 0148  Finnish special edition: Chapter 13 Volume 12 P. 0040  Swedish special edition: Chapter 13 Volume 12 P. 0040

COUNCIL DIRECTIVE of 17 May 1982 amending for the second time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (82/368/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the implementation of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (4), as amended by Directive 79/661/EEC (5), showed that certain amendments should be made to Annexes II, III, IV and V;  Whereas, in order to protect public health, measures should be taken with regard to mandatory warnings on the labels of cosmetic products containing thioglycollic acid, its salts and esters;  Whereas the use of hydrogen peroxide is not restricted to oxydizing colouring agents for hair dyeing ; whereas the use of this substance should therefore also be authorized for hair care products, with the requirement that certain warnings be printed on the label to safeguard health;  Whereas in certain circumstances it is not necessary to mention the formaldehyde content on the label when this substance is not used as an ingredient of a cosmetic product but is inevitably present as a residue from the processing of raw materials;  Whereas the field of application and/or use of hydroquinone should be specified;  Whereas the maximum authorized concentration of potassium or sodium hydroxide in depilatories should be specified;  Whereas a decision may be taken with regard to the substances listed in Part I of Annex IV to Directive 76/768/EEC, in accordance with Article 5 thereof;  Whereas Parts 2 and 3 of Annex IV to the same Directive do not correspond with the list of colouring  (1) OJ No C 165, 2.7.1979, p. 52. (2) OJ No C 175, 14.7.1980, p. 88. (3) OJ No C 83, 2.4.1980, p. 7. (4) OJ No L 262, 27.9.1976, p. 169. (5) OJ No L 192, 31.7.1979, p. 35.  agents actually used in the preparation of cosmetic products ; whereas this list should therefore be updated;  Whereas a list of substances authorized for use as preservatives can be drawn up on the basis of the latest scientific and technical research;  Whereas a procedure for updating the Annexes rapidly should be introduced;  Whereas the presence of traces of substances which cosmetic products must not contain according to Annex II to Directive 76/768/EEC is technologically inevitable with correct manufacturing processes ; whereas therefore certain provisions should be made in this connection;  Whereas the English, German and Dutch versions of Directive 76/768/EEC of 27 July 1976 contain typographical errors which should be corrected,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 76/768/EEC shall be amended in accordance with the provisions set out hereinafter.   Article 2 Annex II shall be amended as follows:   -  replace the title by:  "List of substances which must not form part of the composition of cosmetic products";  -  replace "46 Barium salts" by:  "Barium salts, with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex III, Part 1, lakes prepared from barium sulphate and pigments prepared from the colouring agents listed in Annex III, Part 2 and Annex IV, Parts 2 and 3 and marked 1 (Ba)";  -  replace "191 Hydrofluoric acid" by:  "Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III, Part 1";  -  replace "221 Mercury and its compounds" by:  "Mercury and its compounds, with the exception of those listed in Annex V and Annex VI, Part 2";  - at 268 delete "Phenol and its alkali salts, excluding the exceptions listed in Annex III" and replace by "Picric acid";   - replace "321 Thiourea and its derivatives, with the exception of those listed in Annex IV, Part 1" by:  "Thiourea and its derivatives, with the exception of the one listed in Annex III, Part 1";  -  replace "350 Tetrabromosalicylanilides" by:  "Tetrabromosalicylanilides except as impurities of tribromosalicylanilide according to the criteria laid down in Annex IV, Part 1";  -  replace "351 Dibromosalicylanilides, e.g. metabromsalan (*) and dibromsalan (*)" by:  "Dibromosalicylanilides, except as impurities of tribromosalicylanilide according to the criteria laid down in Annex IV, Part 1";  -  replace "360 Sassafras officinale Nees oil containing safrole" by:  "Safrole except for normal content in the natural essences used and provided the concentration does not exceed:  100 ppm in the finished product,  50 ppm in products for dental and oral hygiene, and provided that Safrole is not present in toothpastes intended specifically for children".   Article 3 1. Part 1 of Annex III shall be replaced by the Annex given in Annex 1 to this Directive.  2. Part 2 of Annex III shall be amended as follows:  (a) Reds  - In the third and sixth columns delete:   -  "E 180" against colouring agent No 10 corresponding to colour index number 15 850,   - "E 420" against colouring agent No 26 corresponding to colour index number 77 015.   - In the second column, replace:   "15 630 (Ba)" by "15 630 : 1 (Ba)", "15 630 (Sr)" by "15 630 : 3 (Sr)", "15 865 (Sr)" by "15 865 : 3 (Sr)", "45 170 (Ba)" by "45 170 : 1 (Ba)".    (b) Oranges and yellows  For colouring agent No 23, replace the colour index number "45 395" in the second column by "45 396".   (c) Greens and blues  For colouring agent No 4 corresponding to colour index number 44 090 enter the number "E 142" in the third and sixth columns.   (d) Violets, browns, blacks and whites  - Delete colouring agent No 8 corresponding to colour index number 77 005.   - In the third and sixth columns delete "Part of E 153" and "E 153" respectively for colouring agents Nos 12 and 13 corresponding to colour index numbers 77 266 and 77 267.   - Add reference number "26" and enter "Part of E 153" and "E 153" respectively in the third and sixth columns corresponding to this reference number.      (e) Footnote (4)  Add the following sentence:  "They shall continue to be subject to the general criteria set out in Annex III to the Directive of 1962 concerning colouring matter, where the "E" number has been deleted in that Directive."      Article 4 1. Annex IV, Part 1 shall be replaced by the Annex given in Annex 2 to this Directive.  2. Annex IV, Part 2 shall be amended as follows:  (a) Reds  - Delete the following colouring agents: >PIC FILE= "T0021530">    - For reference number 5 replace the numbers "15 500" and "15 500 (Ba)" in the second column by "17 200" and delete the reference to the field of application in the fourth column.   - For colouring agent No 6 replace "15 585 (Ba)" in the second column by "15 585 : 1 (Ba)".      (b) Oranges and yellows  For reference number 2, replace colour index number "45 340" in the second column by "40 850" and add the number "E 161 g" in the third and sixth columns.  (d)  Violets, browns, blacks and whites  Delete colouring agent No 8 corresponding to colour index number 77 718.  (e)  Footnote (4)  Add the following sentence:  "They shall continue to be subject to the general criteria set out in Annex III to the said Directive, where the "E" number has been deleted in that Directive."     3. Annex IV, Part 3 shall be replaced by the Annex given in Annex 3 to this Directive.   Article 5 In Annex V:   -  Replace:  "2. Hexachlorophene (for all uses other than that stated in Part 1 of Annex III)"  by:  "2. Hexachlorophene (for all uses other than that stated in Annex VI, Part 1)";    -  Replace:  "5. Strontium and its salts, with the exception of those used in the colouring agents listed in Part 2 of Annex III and Parts 2 and 3 of Annex IV"  by:  "5. Strontium and its salts, with the exception of strontium sulphide under the conditions laid down in Annex III, Part 1, and strontium salts used in the colouring agents listed in Annex III, Part 2 and Annex IV, Parts 2 and 3, and marked : 3 (Sr)";   -  Replace:  "6. Zirconium and its derivatives"  by:  "6. Zirconium and its compounds";   -  Add:  "10. Chloroform.  11. Hydroquinone, for use as a skin-lightener."   Article 6 An Annex VI shall be added, listing the substances which may be used as preservatives in the manufacture of cosmetic products under the conditions set out in the said Annex and in the preamble thereto.   Article 7 Article 4 shall be amended as follows:  "Article 4 1. Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing:  (a) (unchanged)   (b) (unchanged)   (c) (unchanged)   (d) (unchanged)   (e) preservatives other than those listed in Annex VI, Part 1;   (f) preservatives listed in Annex VI, Part 1, beyond the limits and outside the conditions laid down, unless other concentrations are used for specific purposes apparent from the presentation of the product.     2. The presence of traces of the substances listed in Annex II shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and that it conforms with Article 2."   Article 8 Article 5 shall be amended as follows:  "Article 5  Until 31 December 1985 Member States shall allow the marketing of cosmetic products containing:  (a) (unchanged)   (b) (unchanged)   (c) (unchanged)   (d) the preservatives listed in Annex VI, Part 2, within the limits and under the conditions laid down ; however, these substances may be used in other concentrations for specific purposes apparent from the presentation of the product.     On 1 January 1986 these substances, colouring agents and preservatives shall be:  - definitively permitted,   - or definitively prohibited (Annex II),   - or retained for a period as specified in Annex IV or VI,   - or deleted from all Annexes to this Directive."      Article 9 In Article 6 (1) (d) the words "in Annexes III and IV" shall be replaced by the words "in Annexes III, IV and VI".   Article 10 Article 8 shall be replaced by the following:  "Article 8 1. (unchanged)  2. The amendments necessary for adapting Annexes II to VI to technical progress shall be adopted in accordance with the same procedure, after consultation of the Scientific Committee for Cosmetology at the initiative of the Commission or of a Member State.  However, in the case of Annexes III to VI this procedure will apply until 31 December 1988. No later than six months before that date, the Council acting unanimously on a Commission proposal shall take the appropriate measures."   Article 11 The following Article shall be inserted:  "Article 8a 1. Notwithstanding Article 4 and without prejudice to Article 8 (2), a Member State may authorize the use within its territory of other substances not contained in the lists of substances allowed, for certain cosmetic products specified in its national authorization, subject to the following conditions:  (a) the authorization must be limited to a maximum period of three years;   (b) the Member State must carry out an official check on cosmetic products manufactured from the substance or preparation use of which it has authorized;   (c) cosmetic products thus manufactured must bear a distinctive indication which will be defined in the authorization.     2. The Member State shall forward to the Commission and to the other Member States the next of any authorization decision taken pursuant to paragraph 1 within two months of the date on which it came into effect.  3. Before expiry of the three-year period provided for in paragraph 1, the Member State may submit to the Commission a request for the inclusion in a list of permitted substances of the substance given national authorization in accordance with paragraph 1. At the same time, it shall supply supporting documents setting out the grounds on which it deems such inclusion justified and shall indicate the uses for which the substance or preparation is intended. Within 18 months of submission of the request, a decision shall be taken on the basis of the latest scientific and technical knowledge, after consultation, at the initiative of the Commission or of a Member State, of the Scientific Committee for Cosmetology and in accordance with the procedure laid down in Article 10 as to whether the substance in question may be included in a list of permitted substances or whether the national authorization should be revoked. Notwithstanding paragraph 1 (a), the national authorization shall remain in force until a decision is taken on the request for inclusion in the list."   Article 12 1. The English language version is corrected in accordance with Annex 5.  2. The German language version is corrected in accordance with Annex 6.  3. The Dutch language version is corrected in accordance with Annex 7.   Article 13 1. Member States shall take all necessary measures to ensure that as from 1 January 1986 neither manufacturers nor importers established in the Community place on the market products which do not satisfy the requirements of this Directive.  2. Member States shall take all necessary measures to ensure that the products referred to in the first paragraph can no longer be sold or disposed of to the final consumer after 31 December 1987.   Article 14 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive not later than 31 December 1983 and shall forthwith inform the Commission thereof.  2. Member States shall ensure that the texts of the provisions of national law which they adopt in the field  governed by this Directive are communicated to the Commission.   Article 15 This Directive is addressed to the Member States.     Done at Brussels, 17 May 1982.  For the Council  The President  P. de KEERSMAEKER   ANNEX 1  >PIC FILE= "T0021531">    >PIC FILE= "T0021532">    >PIC FILE= "T0021533">    >PIC FILE= "T0021534">    >PIC FILE= "T0021535">    >PIC FILE= "T0021536">    >PIC FILE= "T0021537">    >PIC FILE= "T0021538">    >PIC FILE= "T0021539">    >PIC FILE= "T0021540">      ANNEX 2 >PIC FILE= "T0021541">    ANNEX 3    "ANNEX IV  PART 3  A. LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH DO NOT COME INTO CONTACT WITH THE MUCOUS MEMBRANES  Reds  11 215, 12 310, 12 420, 16 150, 18 050, 18 065, 18 810, 26 105, 45 100, 50 240 and Acid Red 195.  Oranges and yellows  11 020, 11 021, 11 680, 11 700, 11 710, 13 065, 16 230, 18 690, 18 736, 19 120, 21 230, 71 105.  Blues and greens  10 006, 10 020, 42 045, 42 080, 44 025, 62 095, 63 000, 74 100, 74 220, 74 350, 77 420, Bromothymol Blue, Bromocrenol Green.  Violets, browns, blacks and whites  12 010, 12 480, 42 555, 46 500, 50 420, 51 319, 61 710, Brown FK.  B. LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH COME INTO CONTACT ONLY BRIEFLY WITH THE SKIN  Reds  11 210, 12 370, 12 459, 12 485, 12 512, 12 513, 12 715, 14 895, 14 905, 16 045, 18 125, 18 130, 23 266, 24 790, 27 300, 27 306, 28 160, 45 110, 45 150, 45 220, 60 710, 62 015, 69 025, 71 100, 73 312, 73 905, 73 915, Pigment Red 144, Pigment Red 166, Pigment Red 170, Pigment Red 188  Yellows and oranges  11 725, 11 730, 11 765, 11 767, 11 855, 11 870, 12 055, 12 140, 12 700, 12 790, 14 600, 14 690, 15 970, 18 820, 20 040, 21 096, 21 100, 21 105, 21 108, 21 110, 21 115, 22 910, 23 900, 25 135, 25 220, 26 090, 29 020, 40 215, 48 040, 48 045, 48 055, 56 205, 75 660, 77 199, 77 878, Acid yellow 127, Pigment Yellow 93, Pigment Yellow 98, Pigment Orange 31, 77 955.  Blues and greens  12 775, 34 230, 42 052, 42 085, 42 095, 42 100, 50 315, 50 405, 52 015, 52 020, 61 135, 61 505, 61 525, 61 585, 62 005, 62 045, 62 105, 62 560, 69 810, 74 180, 74 255, Solvent Blue 2, Solvent Blue 19, Acid Blue 82, Acid Blue 181, Acid Blue 272.  Violets, browns, blacks and whites  14 805, 17 580, 20 285, 20 470, 21 010, 25 410, 42 510, 42 520, 42 535, 42 650, 45 175, 50 325, 60 010, 60 730, 61 105, 62 030, Acid Brown 19, Acid Brown 82, Disperse Violet 23, Acid Brown 104, Acid Brown 106, Pigment Violet 37, Pigment Brown 30".    ANNEX 4   "ANNEX VI   LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN  PREAMBLE   1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.   2. The substances marked with the symbol (*) may also be added to cosmetic products in concentrations other than those laid down in this Annex for other specific purposes apparent from the presentation of the product, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.   3. Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in this Annex.   4. For the purposes of this list:  - "Salts" is taken to mean : salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines ; salts of the anions chloride, bromide, sulphate, acetate.   - "Esters" is taken to mean : esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.        >PIC FILE= "T0021542">    >PIC FILE= "T0021543">    >PIC FILE= "T0021544">    >PIC FILE= "T0021545">    >PIC FILE= "T0021546">    >PIC FILE= "T0021547">    >PIC FILE= "T0021548">    >PIC FILE= "T0021549">    >PIC FILE= "T0021550">     ANNEX 5 List referred to in Article 12 (1)    «ANNEX II (the following points read as indicated):  2. 2-Acetoxyethyltrimethylammonium hydroxide (acetylcholine) and its salts  5. [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts  29. 2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts  34. Imperatorin (9-(3-methylbut-2-enyloxy)furo[3,2-g]chromen-7-one)  39. Antibiotics, with the exception of that given in Annex V  42. Apomorphine (R 5, 6, 6a, 7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol) and its salts  48. Benzimidazol-2(3H)-one  49. Benzazepines and benzodiazepines  50. 1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts 51. 2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts  52. Isocarboxazid*  72. Nitroderivatives of carbazole  80. Diphenoxylate* hydrochloride  86. N,N-bis(2-chloroethyl)methylamine N-oxide and its salts  91. Chlormezanone*  95. 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophacinone - ISO) >PIC FILE= "T0021638">   117. O,O'-Diacetyl-N-allyl-N-normorphine >PIC FILE= "T0021639">   120. N,N'-Pentamethylenebis (trimethylammonium) salts, e.g. pentamethonium bromide*  121. N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e.g. azamethonium bromide*  124. N,N'-Hexamethylenebis(trimethylammonium) salts, e.g. hexamethonium bromide*  128. 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts  131. O,O'-Diethyl O-4-nitrophenyl phosphorothioate (parathion-ISO)  132. [Oxalylbisiminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts, e.g. ambenomium cloride*  143. 1,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine) and its salts  156. N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts, e.g. isopropamide iodide*  160. 5,5-Diphenyl-4-imidazolidone   196. (1R, 4S, 5R, 8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8-dime thanonaphthalene (endrin - ISO)  204. Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid  207. 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin  214. Decamethylenebis(trimethylammonium) salts, e.g. decamethonium bromide >PIC FILE= "T0021640">   234. 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H, 5H, pyrano[3,2-c]-[1]benzopyran-5-one (cyclocoumarol)  243. 3-(1-Naphthyl)-4-hydroxycoumarin  271. 2-Phenylindan-1,3-dione (phenindione)  276. Tetraethyl pyrophosphate ; TEPP (ISO) >PIC FILE= "T0021641">   307. Sulphonamides (sulphanilamide and its derivatives ...) and their salts (rest of entry is correct)  313. Xylometazoline* and its salts  346. 2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate  358. Furo[3,2-g]chromen-7-one and its ... (rest of entry is correct)   ANNEX 6 List referred to in Article 12 (2)  «Nachstehende Punkte werden wie folgt berichtigt:  ANHANG II 51. 2,2,6-Trimethyl-piperidin-4-yl-benzoat  67. Phenylbutazonum*  72. Nitroderivate des Carbazols  81. 2,4-Diaminoazobenzol-hydrochlorid-citrat (Chrysoidin-hydrochlorid-citrat)  128. 2-Diathylaminoäthyl-4-phenyl-3-hydroxy-benzoat und seine Salze  130. 3-Diäthylaminopropyl-cinnamat  132. N,N'-Bis-(diäthyl)-N,N'-bis- (o-chlorbenzyl)-N,N'-(4,5-dioxo-3,6-diaza-octamethylen)-diammonium-Salze (z.B. Ambenonii chloridum*)  143. 1,1-Bis-(dimethylaminomethyl)-propyl-benzoat (Amydricaine) und seine Salze  156. N-(4-Amino-4-oxo-3,3-diphenyl-butyl)- ...  196. ... (Endrin)   204. Äthyl-2,2-bis-(4-hydroxy-3-cumarinyl)- ...  216. 2-Isopropyl-4-pentenoyl-harnstoff (Apronalid)  234. 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c] [1] benzopyran-5-on (Cyclocumarol)  254. Acenocoumarolum*  281. Physostigma venenosum Balf. >PIC FILE= "T0021642">   318. Glycoside der Thevetia neriifolia Juss.  340. p-tert.-Butyl-phenol und seine Derivate  341. p-tert.-Butyl-brenzcatechin  347. Pyribenzaminum*  351. Dibromsalicylanilide ...  358. Eurocumarine [z.B. Trioxysalenum* 8-Methoxypsoralen], ausgenommen normale Gehalte in natürlichen ätherischen Ölen  ANHANG III - Teil 2 >PIC FILE= "T0021551"> ANHANG IV - Teil 2 Fußnote 2 zur Überschrift:  ..., daß der Farbstoff nicht zur Herstellung von kosmetischen Mitteln verwendet werden darf, die mit den Schleimhäuten des Auges in Berührung kommen können ... >PIC FILE= "T0021552">   ANHANG V 4. p-Phenylendiamin und seine Salze     ANNEX 7 List referred to in Article 12 (3)  >PIC FILE= "T0021553">


Avis juridique important

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31970L0524

Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs

Official Journal L 270 , 14/12/1970 P. 0001 - 0017 Danish special edition: Series I Chapter 1970(III) P. 0743  English special edition: Series I Chapter 1970(III) P. 0840  Greek special edition: Chapter 03 Volume 6 P. 0060  Spanish special edition: Chapter 03 Volume 4 P. 0082  Portuguese special edition Chapter 03 Volume 4 P. 0082  Finnish special edition: Chapter 3 Volume 3 P. 0118  Swedish special edition: Chapter 3 Volume 3 P. 0118

COUNCIL DIRECTIVE  of 23 November 1970  concerning additives in feeding-stuffs  (70/524/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament (1);  Having regard to the Opinion of the Economic and Social Committee;  Whereas livestock production occupies a very important place in the agriculture of the European Economic Community ; whereas satisfactory results depend to a large extent on the use of appropriate good-quality feeding-stuffs;  Whereas the existence of rules concerning feeding-stuffs is essential to an increase in agricultural productivity;  Whereas animal feeding increasingly involves the use of additives;  Whereas the provisions laid down in the Member States by law, regulation or administrative action concerning additives in feeding-stuffs, insofar as they exist, differ as regards their basic principles ; whereas it follows that they directly affect the establishment and functioning of the common market and should therefore be harmonised;  Whereas, as a general rule, "additives" means substances which improve both the feeding-stuffs in which they are incorporated and livestock production ; whereas, for this reason, antibiotics should also be regarded as additives since, when used in small quantities, they have a physiological nutritional effect, although when used in large quantities they have a medicinal effect;  Whereas these substances must not be used in feeding-stuffs for the prime purpose of diagnosing, treating or preventing disease ; whereas they should, however be authorised for the sole purpose of improving feeding-stuffs by preventing nutritional deficiencies;  Whereas, furthermore, certain purely medicinal substances such as coccidiostats should, during a first stage, be regarded in relation to feeding-stuffs as additives, since most Member States have been using them for collective prophylaxis, principally in poultry-farming ; whereas, however, they will be examined further if a directive on medicinal feeding-stuffs is drawn up;  Whereas the basic principle underlying rules in this field must be that only those additives which are named in this Directive may be contained in feeding-stuffs and only subject to the requirements set out herein, and that such additives may not, subject to the exceptions provided for, be used in any other way for the purposes of animal feeding;  Whereas it is necessary, at the time when additives are authorised, to make sure that they have a favourable effect on the characteristics of the feeding-stuffs to which they are added or on livestock production ; whereas they must not endanger animal or human health nor harm the consumer of livestock products ; whereas, subject to the exceptions provided for, it is advisable to examine whether such additives may now be used for the treatment or prevention of disease or whether there are still serious reasons for restricting their use to medical or veterinary purposes;  (1)OJ No C 135, 14.12.1968, p. 20.   Whereas, because of the special situation of certain Member States, and in particular because of their different systems of animal feeding, it is necessary in certain cases to allow derogations from the above-mentioned principles to an extent acceptable for animal and human health;  Whereas Member States should also retain the power to suspend the use of certain additives or to lower their maximum levels if animal or human health is being endangered ; whereas Member States should not, however, be able to have recourse to that power in order to hinder the free movement of the various products;  Whereas provision should be made for feeding-stuffs containing additives to be specially labelled so that the user may know the nature of the additive and be protected against fraud ; whereas this provision refers particularly to supplimentary feeding-stuffs containing concentrates of certain additives;  Whereas Community rules should not apply to feeding-stuffs intended for export to third countries, as the latter generally apply different rules;  Whereas, in order to ensure that the requirements laid down in respect of additives are satisfied during marketing, Member States must make provision for appropriate control arrangements;  Whereas feeding-stuffs satisfying these requirements must be subject only to the marketing restrictions provided for in this Directive;  Whereas, in order to facilitate implementation of this Directive, a procedure should be applied which establishes close co-operation between Member States and the Commission within the Standing Committee for Feeding-stuffs;  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive shall apply to additives in feeding-stuffs.   Article 2 For the purpose of this Directive the following definitions shall apply:    (a) Additives : substances which, when incorporated in feeding-stuffs, are likely to affect their characteristics or livestock production;       (b) Feeding-stuffs : organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding;       (c) Daily ration : the average total quantity of feeding-stuffs, calculated on a moisture content of 12 %, required daily by an animal of a given species, age category and yield, to satisfy all its needs;       (d) Complete feeding-stuffs : mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration;       (e) Supplementary feeding-stuffs : mixtures of feeding-stuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily ration only if they are used in combination with other feeding-stuffs;       (f) Premixtures : additive concentrates intended for the industrial manufacture of compound animal feeding-stuffs.          Article 3 1. The Member States shall provide that, as regards feeding-stuffs, only those additives which are listed in Annex I may be incorporated in feeding-stuffs and only subject to the requirements set out therein. These additives may not be used in any other way for the purposes of animal feeding.  2. The maximum and minimum contents listed in Annex I refer to complete feeding-stuffs.  3. The mixing of additives named in this Directive shall be permitted in feeding-stuffs only where, in relation to the effects desired, there is physical and chemical compatibility between the components of the mixture.  4. An antibiotic (Annex I (A) and Annex II (A)) may be mixed with only one single other antibiotic, unless the mixture to be produced is already provided for in those Annexes. The components may not belong to the same chemical group. The maximum authorised level of each component shall be that fixed by this Directive, reduced to a level proportional to its percentage in the mixture.  5. Coccidiostats and other medicinal substances (Annex I (D) and Annex II (B) may not be mixed together unless the mixture is already provided for in those Annexes.  6. Member States may, for experimental or scientific purposes, provide for derogations from the provisions of paragraph 1, 3, 4 or 5 on condition that there is adequate official supervision.   7. By way of derogation from paragraph 1, Member States may, during a period of five years following notification of this Directive, increase, for their own territory, the maximum authorised antibiotic level (Annex I (A)), except in the case of substances E 709, E 711 and E 712, as follows:    A. Oleandomycin, up to 25 ppm of the complete feeding-stuff:      (a) for poultry, excluding ducks and geese, from the time of hatching until the end of the fourth week;           (b) for swine, from birth until the end of the eighth week;                  B. All other antibiotics, up to 50 ppm of the complete feeding-stuff:     (a) for poultry, excluding ducks and geese, from the time of hatching until the end of the fourth week;       (b) for calves, lambs and kids, from birth until the end of the sixteenth week;       (c) for swine, from birth until the end of the eighth week;       (d) for animals bred for their fur.         Article 4 1. By way of derogation from Article 3 (1), Member States may authorise the use of the following within their territory:    (a) during a period of five years following notification of this Directive, substances belonging to groups other than those listed in Annex I, provided that tests show that the conditions set out in Article 6 (2) (A) are satisfied. This derogation shall not apply to substances having a hormonal or anti-hormonal effect;       (b) during a period of five years following notification of this Directive, substances listed in Annex II, provided that tests show that the conditions set out in Article 6 (2) (A) are satisfied;       (c) urea for adult ruminants, provided that tests show that the conditions set out in Article 6 (2) (A) are satisfied;       (d) molybdenum, up to 2.5 ppm of the complete feeding-stuff;       (e) selenium, up to 0.5 ppm of the complete feeding-stuff;       (f) saccharin.         2. Member States shall inform the other Member States and the Commission within two months of all measures taken under paragraph 1 and shall furnish the documents which they consider justify their authorisation.   Article 5 Within a reasonable period following authorisation of an additive by a Member State under Article 4 (1) (a), the Commission shall consider whether, in view of the provisions of Article 6, the additive may be included in Annex I or whether authorisation should be revoked. The Commission shall make the appropriate proposals to the Council, which shall act as prescribed in Article 6.   Article 6 1. The Council shall, acting on a proposal from the Commission and in the light of scientific and technical knowledge:    - fix criteria of purity for the additives with which this Directive is concerned,       - adopt any amendments to be made to Annex I.         2. When amending Annex I, the Council shall apply the following principles:    A. A substance shall be included in Annex I only if:      (a) it has a favourable effect on the characteristics of those feeding-stuffs or on livestock production when incorporated in such feeding-stuffs;           (b) at the level permitted in feeding-stuffs it does not endanger animal or human health nor harm the consumer by altering the characteristics of livestock products;           (c) its nature and level in feeding-stuffs can be controlled;           (d) at the level permitted in feeding-stuffs, treatment or prevention of animal disease is excluded ; this condition does not apply to substances of the kind listed in Annex I (D);           (e) for serious reasons concerning human or animal health its use must not be restricted to medical or veterinary purposes.                  B. A substance shall be deleted from Annex I if any of the conditions listed under A is no longer satisfied.           Article 7 1. Where the use in feeding-stuffs of one of the additives listed in Annex I or the maximum level fixed for such additive might endanger animal or human health, a Member State may, for a maximum period of four months, suspend the authorisation to use that additive or may reduce the fixed maximum level. It shall forthwith inform the Commission, which shall consult the Member States within the Standing Committee for Feeding-stuffs set up by the Council Decision of 20 July 1970 (1).  2. The Council, acting unanimously on a proposal from the Commission shall decide without delay whether Annex I should be amended and, if so, adopt by directive the necessary amendments. The Council, acting by a qualified majority on a proposal from the Commission, may also, if necessary, extend for a maximum period of one year the period set in paragraph 1.   Article 8 The Member States shall require that supplementary feeding-stuffs, diluted as specified, may not contain levels of the additives named in this Directive which exceed those fixed for complete feeding-stuffs.   Article 9 1. The Member States shall require that the levels of antibiotics (Annex I (A)), antioxidants (Annex I (B)), coccidiostats and other medicinal substances (Annex I (D)), vitamins D (Annex I (H) No 1) and of trace elements (Annex I (I)) in supplementary feeding-stuffs and premixtures may exceed the maximum levels fixed for complete feeding-stuffs only in the case of:    (a) materials which are delivered to manufacturers of compound feeding-stuffs or to their suppliers;       (b) supplementary feeding-stuffs which a Member State has authorised to be made available to all users on condition that their level of antibiotics, vitamins D or trace elements does not exceed five times the fixed maximum level;       (c) supplementary feeding-stuffs which are intended for certain species of animal and which a Member State is permitted to authorise to be made available within its territory to all users because of special feeding systems, on condition that their level does not exceed:     - for antibiotics, 1000 ppm;       - for antioxidants, coccidiostats and other medicinal substances, five times the fixed maximum level;       - for vitamins D, 200 000 IU/kg.        This provision shall not apply in the case of authorisation granted under subparagraph (b).  2. Authorisation under paragraph 1 (b) or (c) may be granted only if the feeding-stuff contains compositional characteristics (as regards, for example, proteins or minerals) which in practice ensure that the level of additives fixed for complete feeding-stuffs is not exceeded and that the feeding-stuff is not used for species of animal other than those for which it was intended. Authorisation of such feeding-stuffs shall be determined by prior consultation between the Member States and the Commission within the Standing Committee for Feeding-stuffs.   Article 10 1. The Member States shall require that feeding-stuffs containing any of the substances listed below may be placed on the market only if the substance is specified on the packaging, either directly or by means of a label giving the following details:    (a) antibiotics : nature, level and expiry date of the guarantee of that level;       (b) substances having antioxidant effects : nature;       (c) coccidiostats and other medicinal substances (Annex I (D)) : nature, level and conditions of use as specified in the Annex;       (d) colouring matter, including pigments, listed in Annex I (F) No 2 : nature;       (e) Vitamins A, D and E : nature, level and expiry date of the guarantee of that level;       (f) copper : level expressed as Cu, if it exceeds 50 ppm;       (g) additives authorised under Article 4 (1) (a) : nature and level.         These substances shall be referred to by the customary terminology.  2. In the case of goods in bulk the details mentioned in paragraph 1 may be given on a document attached to the goods.  3. The presence of trace elements and of vitamins other than vitamins A, D and E, of provitamins and  (1)OJ No L 170, 3.8.1970, p. 1.   other similar active substances may be indicated if the amounts of these substances present can be determined by official methods of analysis. In such cases the following details shall be given:    (a) for trace elements : nature and level;       (b) for other substances : nature, level and expiry date of the guarantee of that level.         4. Any reference to additives other than in the form provided for in this Directive shall be prohibited.   Article 11 1. The Member States shall require that supplementary feeding-stuffs which contain additives in excess of the maximum levels fixed for complete feeding-stuffs may be placed on the market only if the packaging:    (a) bears the words "supplementary feeding-stuffs" and indicates the nature of the feeding-stuff;       (b) gives directions for use and the following additional instruction:  "This feeding-stuff may be used only for... (species and age category of the animal)... up to a quantity of... grammes per kilogramme of daily ration."  These details must be in accordance with the provisions of Annex I. This provision shall not apply to materials delivered to manufacturers of compound feeding-stuffs or to their suppliers.  2. The declaration referred to in paragraph 1 (b) shall be so formulated that, when it is correctly followed, the proportion of additives does not exceed the maximum level fixed for complete feeding-stuffs.   Article 12 Where feeding-stuffs are marketed in other Member States the details referred to in Articles 10 and 11 shall be given in at least one of the official languages of the country of destination.   Article 13 The Member States shall ensure that feeding-stuffs which conform to the provisions of this Directive shall be subject, as regards the presence or absence of additives and as regards marking, to no marketing restrictions other than these provided for in this Directive.   Article 14 The Member States shall ensure that livestock products are not subject to any marketing restriction as a result of the application of this Directive.   Article 15 The Member States shall take all necessary measures to ensure that feeding-stuffs put on the market are officially controlled, at least by check sampling, to verify whether the conditions laid down in this Directive are satisfied.   Article 16 This Directive shall not apply to feeding-stuffs which are shown, at least by an appropriate indication, to be for export to third countries.   Article 17 Member States shall, within two years following notification thereof, bring into force the laws, regulations, or administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.   Article 18 This Directive is addressed to the Member States.     Done at Brussels, 23 November 1970.  For the Council  The President  W. SCHEEL     ANNEX I >PIC FILE= "T0002278""PIC FILE= "T0002279">    >PIC FILE= "T0002280">    >PIC FILE= "T0002281">    >PIC FILE= "T0002282">    >PIC FILE= "T0002283">    >PIC FILE= "T0002284">    >PIC FILE= "T0002285">    >PIC FILE= "T0002286">    >PIC FILE= "T0002287">     ANNEX II >PIC FILE= "T0002288""PIC FILE= "T0002289">


title: Directive 2009/15/EC of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations and for the relevant activities of maritime administrations (Text with EEA relevance)

text:
               28.5.2009

               EN

               Official Journal of the European Union

               L 131/47

      DIRECTIVE 2009/15/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 23 April 2009
   on common rules and standards for ship inspection and survey organisations and for the relevant activities of maritime administrations
   (Recast)
   (Text with EEA relevance)
   THE 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,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Having regard to the opinion of the Committee of the Regions (2),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty, in the light of the Joint text approved by the Conciliation Committee on 3 February 2009 (3),
   Whereas:

               (1)

               Council Directive 94/57/EC of 22 November 1994 on common rules and standards for ship inspection and survey organisations and for the relevant activities of maritime administrations (4) has been substantially amended several times. Since further amendments are to be made, it should be recast in the interests of clarity.

               (2)

               In view of the nature of the provisions of Directive 94/57/EC it seems appropriate that its provisions be recast in two different Community legal instruments, namely a Directive and a Regulation.

               (3)

               In its Resolution of 8 June 1993 on a common policy on safe seas, the Council set the objective of removing all substandard vessels from Community waters and gave priority to Community action designed to secure the effective and uniform implementation of international rules by drawing up common standards for classification societies.

               (4)

               Safety and pollution prevention at sea may be effectively enhanced by strictly applying international conventions, codes and resolutions while furthering the objective of freedom to provide services.

               (5)

               The control of compliance of ships with the uniform international standards for safety and prevention of pollution of the seas is the responsibility of flag and port States.

               (6)

               Member States are responsible for the issuing of international certificates for safety and the prevention of pollution provided for under conventions such as the International Convention for the Safety of Life at Sea of 1 November 1974 (SOLAS 74), the International Convention on Load Lines of 5 April 1966 and the International Convention for the Prevention of Pollution from Ships of 2 November 1973 (Marpol), and for the implementation of those conventions.

               (7)

               In compliance with such conventions all Member States may authorise to a varying extent recognised organisations for the certification of such compliance and may delegate the issue of the relevant certificates for safety and the prevention of pollution.

               (8)

               Worldwide a large number of the existing organisations recognised by International Maritime Organisation (IMO) Contracting Parties do not ensure either adequate implementation of the rules or sufficient reliability when acting on behalf of national administrations as they do not have reliable and adequate structures and experience to enable them to carry out their duties in a highly professional manner.

               (9)

               In accordance with SOLAS 74 Chapter II-1, Part A-1, Regulation 3-1, Member States are responsible for ensuring that ships flying their flag are designed, constructed and maintained in compliance with the structural, mechanical and electrical requirements of organisations, recognised by administrations. These organisations therefore produce and implement rules for the design, construction, maintenance and inspection of ships and they are responsible for inspecting ships on behalf of the flag States and certifying that those ships meet the requirements of the international conventions for the issue of the relevant certificates. To enable them to carry out that duty in a satisfactory manner they need to have strict independence, highly specialised technical competence and rigorous quality management.

               (10)

               Ship inspection and survey organisations play an important role in Community legislation concerning maritime safety.

               (11)

               Ship inspection and survey organisations should be able to offer their services throughout the Community and compete with each other while providing equal levels of safety and of environmental protection. The necessary professional standards for their activities should therefore be uniformly established and applied across the Community.

               (12)

               The issue of the cargo ship safety radio certificate may be entrusted to private bodies having sufficient expertise and qualified personnel.

               (13)

               A Member State may restrict the number of recognised organisations it authorises in accordance with its needs, based on objective and transparent grounds, subject to control exercised by the Commission in accordance with a committee procedure.

               (14)

               This Directive should ensure freedom to provide services in the Community; accordingly the Community should agree with those third countries where some of the recognised organisations are located, to ensure equal treatment for the recognised organisations located in the Community.

               (15)

               A tight involvement of the national administrations in ship surveys and in the issue of the related certificates is necessary to ensure full compliance with the international safety rules even if the Member States rely upon recognised organisations, which are not part of their administration for carrying out statutory duties. It is appropriate, therefore, to establish a close working relationship between the administrations and the recognised organisations authorised by them, which may require that the recognised organisations have a local representation on the territory of the Member State on behalf of which they perform their duties.

               (16)

               When a recognised organisation, its inspectors, or its technical staff issue the relevant certificates on behalf of the administration, Member States should consider enabling them, as regards these delegated activities, to be subject to proportionate legal safeguards and judicial protection, including the exercise of appropriate rights of defence, apart from immunity, which is a prerogative that can only be invoked by Member States as an inseparable right of sovereignty and therefore that cannot be delegated.

               (17)

               Divergence in terms of financial liability regimes among the recognised organisations working on behalf of the Member States would impede the proper implementation of this Directive. In order to contribute to solving this problem it is appropriate to bring about a degree of harmonisation at Community level of the liability arising out of any marine casualty caused by a recognised organisation, as decided by a court of law, including settlement of a dispute through arbitration procedures.

               (18)

               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).

               (19)

               In particular the Commission should be empowered to amend this Directive in order to incorporate subsequent amendments to the international conventions, protocols, codes and resolutions related thereto. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (20)

               Member States should nevertheless be left with the possibility of suspending or withdrawing their authorisation of a recognised organisation while informing the Commission and the other Member States of their decisions and giving substantiated reasons therefor.

               (21)

               Member States should periodically assess the performance of the recognised organisations working on their behalf and provide the Commission and all the other Member States with precise information related to such performance.

               (22)

               As port authorities, Member States are required to enhance safety and prevention of pollution in Community waters through priority inspection of ships carrying certificates of organisations which do not fulfil the common criteria, thereby ensuring that ships flying the flag of a third State do not receive more favourable treatment.

               (23)

               At present there are no uniform international standards to which all ships must conform either at the building stage or during their entire lifetime, as regards hull, machinery and electrical and control installations. Such standards may be fixed according to the rules of recognised organisations or to equivalent standards to be decided by the national administrations in accordance with the procedure laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (6).

               (24)

               Since the objective of this Directive, namely to establish measures to be followed by the Member States in their relationship with organisations entrusted with the inspection, survey and certification of ships, operating in the Community, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, 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 that objective.

               (25)

               The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with the Directive 94/57/EC. The obligation to transpose the provisions which are unchanged arises under that Directive.

               (26)

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

               (27)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (7), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables, illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

               (28)

               Measures to be followed by ship inspection and survey organisations are laid down in Regulation (EC) No 391/2009 of the European Parliament and the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations (recast) (8),

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   This Directive establishes measures to be followed by the Member States in their relationship with organisations entrusted with the inspection, survey and certification of ships for compliance with the international conventions on safety at sea and prevention of marine pollution, while furthering the objective of freedom to provide services. This includes the development and implementation of safety requirements for hull, machinery and electrical and control installations of ships falling under the scope of the international conventions.
   Article 2
   For the purpose of this Directive the following definitions shall apply:

               (a)

               ‘ship’ means a ship falling within the scope of the international conventions;

               (b)

               ‘ship flying the flag of a Member State’ means a ship registered in and flying the flag of a Member State in accordance with its legislation. Ships not corresponding to this definition are assimilated to ships flying the flag of a third country;

               (c)

               ‘inspections and surveys’ means inspections and surveys that are mandatory under the international conventions;

               (d)

               ‘international conventions’ means the International Convention for the Safety of Life at Sea of 1 November 1974, (SOLAS 74) with the exception of chapter XI-2 of the Annex thereto, the International Convention on Load Lines of 5 April 1966 and the International Convention for the Prevention of Pollution from Ships of 2 November 1973 (Marpol), together with the protocols and amendments thereto, and the related codes of mandatory status in all Member States, in their up-to-date version;

               (e)

               ‘organisation’ means a legal entity, its subsidiaries and any other entities under its control, which jointly or separately carry out tasks falling under the scope of this Directive;

               (f)

               ‘control’means, for the purpose of point (e), rights, contracts or any other means, in law or in fact, which, either separately or in combination confer the possibility of exercising decisive influence on a legal entity or enable that entity to carry out tasks falling under the scope of this Directive;

               (g)

               ‘recognised organisation’ means an organisation recognised in accordance with Regulation (EC) No 391/2009;

               (h)

               ‘authorisation’ means an act whereby a Member State grants an authorisation or delegates powers to a recognised organisation;

               (i)

               ‘statutory certificate’ means a certificate issued by or on behalf of a flag State in accordance with the international conventions;

               (j)

               ‘rules and procedures’ means a recognised organisation’s requirements for the design, construction, equipment, maintenance and survey of ships;

               (k)

               ‘class certificate’ means a document issued by a recognised organisation certifying the fitness of a ship for a particular use or service in accordance with the rules and procedures laid down and made public by that recognised organisation;

               (l)

               ‘cargo ship safety radio certificate’ means the certificate introduced by the 1988 Protocol amending SOLAS, adopted by the International Maritime Organisation (IMO).

         Article 3
   1.   In assuming their responsibilities and obligations under the international conventions, Member States shall ensure that their competent administrations can ensure appropriate enforcement of the provisions thereof, in particular with regard to the inspection and survey of ships and the issue of statutory certificates and exemption certificates as provided for by the international conventions. Member States shall act in accordance with the relevant provisions of the Annex and the Appendix to IMO Resolution A.847(20) on guidelines to assist flag States in the implementation of IMO instruments.
   2.   Where for the purpose of paragraph 1 a Member State decides with respect to ships flying its flag:

               (i)

               to authorise organisations to undertake fully or in part inspections and surveys related to statutory certificates including those for the assessment of compliance with the rules referred to in Article 11(2) and, where appropriate, to issue or renew the related certificates; or

               (ii)

               to rely upon organisations to undertake fully or in part the inspections and surveys referred to in point (i);

         it shall entrust these duties only to recognised organisations.
   The competent administration shall in all cases approve the first issue of the exemption certificates.
   However, for the cargo ship safety radio certificate these duties may be entrusted to a private body recognised by a competent administration and having sufficient expertise and qualified personnel to carry out specified safety assessment work on radio-communication on its behalf.
   3.   This Article does not concern the certification of specific items of marine equipment.
   Article 4
   1.   In applying Article 3(2), Member States shall in principle not refuse to authorise any of the recognised organisations to undertake such functions, subject to the provisions of paragraph 2 of this Article and Articles 5 and 9. However, they may restrict the number of organisations they authorise in accordance with their needs provided there are transparent and objective grounds for so doing.
   At the request of a Member State, the Commission shall, in accordance with the regulatory procedure referred to in Article 6(2), adopt appropriate measures to ensure the correct application of the first subparagraph of this paragraph as regards refusal of authorisation and of Article 8 as regards those cases where authorisation is suspended or withdrawn.
   2.   In order for a Member State to accept that a recognised organisation located in a third State is to carry out fully or in part the duties mentioned in Article 3 it may request the third State in question to grant reciprocal treatment to those recognised organisations which are located in the Community.
   In addition, the Community may request the third State where a recognised organisation is located to grant reciprocal treatment to those recognised organisations which are located in the Community.
   Article 5
   1.   Member States which take a decision as described in Article 3(2) shall set out a ‘working relationship’ between their competent administration and the organisations acting on their behalf.
   2.   The working relationship shall be regulated by a formalised written and non-discriminatory agreement or equivalent legal arrangements setting out the specific duties and functions assumed by the organisations and including at least:

               (a)

               the provisions set out in Appendix II of IMO Resolution A.739(18) on guidelines for the authorisation of organisations acting on behalf of the administration, while drawing inspiration from the Annex, Appendices and Attachment to IMO MSC/Circular 710 and MEPC/Circular 307 on a model agreement for the authorisation of recognised organisations acting on behalf of the administration;

               (b)

               the following provisions concerning financial liability:

                           (i)

                           if liability arising out of any marine casualty is finally and definitely imposed on the administration by a court of law or as part of the settlement of a dispute through arbitration procedures, together with a requirement to compensate the injured parties for loss of or damage to property or personal injury or death, which is proved in that court of law to have been caused by a wilful act or omission or gross negligence of the recognised organisation, its bodies, employees, agents or others who act on behalf of the recognised organisation, the administration shall be entitled to financial compensation from the recognised organisation to the extent that that loss, damage, injury or death was, as decided by that court, caused by the recognised organisation;

                           (ii)

                           if liability arising out of any marine casualty is finally and definitely imposed on the administration by a court of law or as part of the settlement of a dispute through arbitration procedures, together with a requirement to compensate the injured parties for personal injury or death, which is proved in that court of law to have been caused by any negligent or reckless act or omission of the recognised organisation, its employees, agents or others who act on behalf of the recognised organisation, the administration shall be entitled to financial compensation from the recognised organisation to the extent that that personal injury or death was, as decided by that court, caused by the recognised organisation; the Member States may limit the maximum amount payable by the recognised organisation, which must, however, be at least equal to EUR 4 million;

                           (iii)

                           if liability arising out of any marine casualty is finally and definitely imposed on the administration by a court of law or as part of the settlement of a dispute through arbitration procedures, together with a requirement to compensate the injured parties for loss of or damage to property, which is proved in that court of law to have been caused by any negligent or reckless act or omission of the recognised organisation, its employees, agents or others who act on behalf of the recognised organisation, the administration shall be entitled to financial compensation from the recognised organisation, to the extent that that loss or damage was, as decided by that court, caused by the recognised organisation; the Member States may limit the maximum amount payable by the recognised organisation, which must, however, be at least equal to EUR 2 million;

               (c)

               provisions for a periodical audit by the administration or by an impartial external body appointed by the administration into the duties the organisations are undertaking on its behalf, as referred to in Article 9(1);

               (d)

               the possibility for random and detailed inspections of ships;

               (e)

               provisions for compulsory reporting of essential information about their classed fleet, and changes, suspensions and withdrawals of class.

         3.   The agreement or equivalent legal arrangement may require the recognised organisation to have a local representation on the territory of the Member State on behalf of which it performs the duties referred to in Article 3. A local representation with legal personality under the law of the Member State and subject to the jurisdiction of its national courts may satisfy such a requirement.
   4.   Each Member State shall provide the Commission with precise information on the working relationship established in accordance with this Article. The Commission shall subsequently inform the other Member States thereof.
   Article 6
   1.   The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) established by Regulation (EC) No 2099/2002 of the European Parliament and of the Council (9).
   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 laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
   3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   Article 7
   1.   This Directive may, without broadening its scope, be amended in order to:

               (a)

               incorporate, for the purposes of this Directive, subsequent amendments to the international conventions, protocols, codes and resolutions related thereto referred to in Articles 2(d), 3(1) and 5(2), which have entered into force;

               (b)

               alter the amounts specified in points (ii) and (iii) of Article 5(2)(b).

         These measures designed to amend non-essential elements of this Directive shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(3).
   2.   Following the adoption of new instruments or protocols to the international conventions referred to in Article 2(d), the Council, acting on a proposal from the Commission, shall decide, taking into account the Member States’ parliamentary procedures as well as the relevant procedures within the IMO, on the detailed arrangements for ratifying those new instruments or protocols, while ensuring that they are applied uniformly and simultaneously in the Member States.
   The amendments to the international instruments referred to in Article 2(d) and Article 5 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002.
   Article 8
   Notwithstanding the minimum criteria specified in the Annex I of Regulation (EC) No 391/2009, where a Member State considers that a recognised organisation can no longer be authorised to carry out on its behalf the tasks specified in Article 3 it may suspend or withdraw such authorisation. In such case the Member State shall inform the Commission and the other Member States of its decision without delay and shall give substantiated reasons therefor.
   Article 9
   1.   Each Member State shall satisfy itself that the recognised organisations acting on its behalf for the purpose of Article 3(2) effectively carry out the functions referred to in that Article to the satisfaction of its competent administration.
   2.   In order to carry out the task referred to in paragraph 1, each Member State shall, at least on a biennial basis, monitor every recognised organisation acting on its behalf and shall provide the other Member States and the Commission with a report on the results of such monitoring activities at the latest by 31 March of the year following the year in which the monitoring was carried out.
   Article 10
   In exercising their inspection rights and obligations as port States, Member States shall report to the Commission and to other Member States, and inform the flag State concerned, if they find that valid statutory certificates have been issued by recognised organisations acting on behalf of a flag State to a ship which does not fulfil the relevant requirements of the international conventions, or in the event of any failure of a ship carrying a valid class certificate and relating to items covered by that certificate. Only cases of ships representing a serious threat to safety and the environment or showing evidence of particularly negligent behaviour of the recognised organisations shall be reported for the purposes of this Article. The recognised organisation concerned shall be advised of the case at the time of the initial inspection so that it can take appropriate follow-up action immediately.
   Article 11
   1.   Each Member State shall ensure that ships flying its flag are designed, constructed, equipped and maintained in accordance with the rules and procedures relating to hull, machinery and electrical and control installation requirements of a recognised organisation.
   2.   A Member State may decide to use rules it considers equivalent to the rules and procedures of a recognised organisation only on the proviso that it immediately notifies them to the Commission in conformity with the procedure under Directive 98/34/EC and to the other Member States and they are not objected to by another Member State or the Commission and are held, through the regulatory procedure referred to in Article 6(2) of this Directive, not to be equivalent.
   3.   Member States shall cooperate with the recognised organisations they authorise in the development of the rules and procedures of those organisations. They shall confer with the recognised organisations with a view to achieving consistent interpretation of the international conventions.
   Article 12
   The Commission shall, on a biennial basis, inform the European Parliament and the Council of progress in the implementation of this Directive in the Member States.
   Article 13
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 June 2011. They shall forthwith inform the Commission thereof.
   When they are adopted by Member States, these measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the directives repealed by this Directive shall be construed as references to this Directive. The methods of making such references shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 14
   Directive 94/57/EC, as amended by the Directives listed in Annex I, Part A, shall be repealed with effect from 17 June 2009, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex I, Part B.
   References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex II.
   Article 15
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 16
   This Directive is addressed to the Member States.

      Done at Strasbourg, 23 April 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         P. NEČAS

      (1)  OJ C 318, 23.12.2006, p. 195.

      (2)  OJ C 229, 22.9.2006, p. 38.

      (3)  Opinion of the European Parliament of 25 April 2007 (OJ C 74 E, 20.3.2008, p. 633), Council Common Position of 6 June 2008 (OJ C 184 E, 22.7.2008, p. 11), Position of the European Parliament of 24 September 2008 (not yet published in the Official Journal), Council Decision of 26 February 2009 and Legislative Resolution of the European Parliament of 11 March 2009 (not yet published in the Official Journal).

      (4)  OJ L 319, 12.12.1994, p. 20.

      (5)  OJ L 184, 17.7.1999, p. 23.

      (6)  OJ L 204, 21.7.1998, p. 37.

      (7)  OJ C 321, 31.12.2003, p. 1.

      (8)  See page 11 of this Official Journal.

      (9)  OJ L 324, 29.11.2002, p. 1.

      ANNEX I

         PART A

         Repealed Directive with its successive amendments

      (referred to in Article 14)

                  Council Directive 94/57/EC

                     OJ L 319, 12.12.1994, p. 20

                  Commission Directive 97/58/EC

                     OJ L 274, 7.10.1997, p. 8

                  Directive 2001/105/EC of the European Parliament and of the Council

                     OJ L 19, 22.1.2002, p. 9

                  Directive 2002/84/EC of the European Parliament and of the Council

                     OJ L 324, 29.11.2002, p. 53

         PART B

         List of time limits for transposition into national law

      (referred to in Article 14)

                  Directive

                  Time limit for transposition

                  94/57/EC

                  31 December 1995

                  97/58/EC

                  30 September 1998

                  2001/105/EC

                  22 July 2003

                  2002/84/EC

                  23 November 2003

      ANNEX II

         Correlation table

                  Directive 94/57/EC

                  This Directive

                  Regulation (EC) No 391/2009

                  Article 1

                  Article 1

                  Article 1

                  Article 2(a)

                  Article 2(a)

                  Article 2(a)

                  Article 2(b)

                  Article 2(b)

                  —

                  Article 2(c)

                  Article 2(c)

                  —

                  Article 2(d)

                  Article 2(d)

                  Article 2(b)

                  Article 2(e)

                  Article 2(e)

                  Article 2(c)

                  —

                  Article 2(f)

                  Article 2(d)

                  Article 2(f)

                  Article 2(g)

                  Article 2(e)

                  Article 2(g)

                  Article 2(h)

                  Article 2(f)

                  Article 2(h)

                  Article 2(i)

                  Article 2(g)

                  Article 2(i)

                  Article 2(k)

                  Article 2(i)

                  —

                  Article 2(j)

                  Article 2(h)

                  Article 2(j)

                  Article 2(l)

                  —

                  Article 2(k)

                  —

                  Article 2(j)

                  Article 3

                  Article 3

                  —

                  Article 4(1) first phrase

                  —

                  Article 3(1)

                  Article 4(1) second phrase

                  —

                  Article 3(2)

                  Article 4(1) third phrase

                  —

                  —

                  Article 4(1) fourth phrase

                  —

                  Article 4(1)

                  —

                  —

                  Article 3(3)

                  —

                  —

                  Article 4(2), (3), (4)

                  —

                  —

                  Article 5

                  —

                  —

                  Article 6

                  —

                  —

                  Article 7

                  Article 5(1)

                  Article 4(1)

                  —

                  Article 5(3)

                  Article 4(2)

                  —

                  Article 6(1), (2), (3), (4)

                  Article 5 (1), (2), (3), (4)

                  —

                  Article 6(5)

                  —

                  —

                  Article 7

                  Article 6

                  Article 12

                  Article 8(1) first indent

                  Article 7(1), point (a) of first subparagraph

                  —

                  Article 8(1) second indent

                  —

                  Article 13(1)

                  Article 8(1) third indent

                  Article 7(1), point (b) of first subparagraph

                  —

                  —

                  Article 7(1) second subparagraph

                  Article 13(1) (second subparagraph)

                  Article 8(2)

                  Article 7(2)

                  —

                  Article 8(2) second subparagraph

                  —

                  Article 13(2)

                  Article 9(1)

                  —

                  —

                  Article 9(2)

                  —

                  —

                  Article 10(1) introductory wording

                  Article 8

                  —

                  Article 10(1)(a), (b), (c), (2), (3), (4)

                  —

                  —

                  Article 11(1),(2)

                  Article 9(1), (2)

                  —

                  Article 11(3), (4)

                  —

                  Article 8(1), (2)

                  Article 12

                  Article 10

                  —

                  Article 13

                  —

                  —

                  Article 14

                  Article 11(1), (2)

                  —

                  —

                  Article 11(3)

                  —

                  —

                  Article 12

                  —

                  —

                  —

                  Article 9

                  Article 15(1)

                  —

                  —

                  —

                  —

                  Article 10(1), (2)

                  Article 15(2)

                  —

                  Article 10(3)

                  Article 15(3)

                  —

                  Article 10(4)

                  Article 15(4)

                  —

                  Article 10(5)

                  Article 15(5)

                  —

                  Article 10(6) first, second, third, fifth subparagraphs

                  —

                  Article 10(6) fourth subparagraph

                  Article 16

                  Article 13

                  —

                  Article 17

                  Article 16

                  —

                  —

                  Article 14

                  —

                  —

                  Article 15

                  —

                  —

                  —

                  Article 11

                  —

                  —

                  Article 14

                  —

                  —

                  Article 15

                  —

                  —

                  Article 16

                  —

                  —

                  Article 17

                  —

                  —

                  Article 18

                  —

                  —

                  Article 19

                  Annex

                  —

                  Annex I

                  —

                  Annex I

                  —

                  —

                  Annex II

                  Annex II


Avis juridique important

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31987L0344

Council Directive 87/344/EEC of 22 June 1987 on the coordination of laws, regulations and administrative provisions relating to legal expenses insurance

Official Journal L 185 , 04/07/1987 P. 0077 - 0080 Finnish special edition: Chapter 6 Volume 2 P. 0161  Swedish special edition: Chapter 6 Volume 2 P. 0161

*****COUNCIL  DIRECTIVE  of 22 June 1987  on the coordination of laws, regulations and administrative provisions relating to legal expenses insurance  (87/344/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 57 (2) thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (4), as last amended by Directive 87/343/EEC (5), eliminated, in order to facilitate the taking-up and pursuit of such activities, certain differences existing between national laws;  Whereas, however, Article 7 (2) (c) of Directive 73/239/EEC provides that 'pending further coordination, which must be implemented within four years of notification of this Directive, the Federal Republic of Germany may maintain the provision prohibiting the simultaneous undertaking in its territory of health insurance, credit and suretyship insurance or insurance in respect of recourse against third parties and legal defence, either with one another or with other classes';  Whereas the present Directive provides for the coordination of legal expenses insurance as envisaged in Article 7 (2) (c) of Directive 73/239/EEC;  Whereas, in order to protect insured persons, steps should be taken to preclude, as far as possible, any conflict of interests between a person with legal expenses cover and his insurer arising out of the fact that the latter is covering him in respect of any other class of insurance referred to in the Annex to Directive 73/239/EEC or is covering another person and, should such a conflict arise, to enable it to be resolved;  Whereas legal expenses insurance in respect of disputes or risks arising out of, or in connection with, the use of sea-going vessels should, in view of its specific nature, be excluded from the scope of this Directive;  Whereas the activity of an insurer who provides services or bears the cost of defending the insured person in connection with a civil liability contract should also be excluded from the scope of this Directive if that activity is at the same time pursued in the insurer's own interest under such cover;  Whereas Member States should be given the option of excluding from the scope of this Directive the activity of legal expenses insurance undertaken by an assistance insurer where this activity is carried out in a Member State other than the one in which the insured person normally resides and where it forms part of a contract covering solely the assistance provided for persons who fall into difficulties while travelling, while away from home or while away from their permanent residence;  Whereas the system of compulsory specialization at present applied by one Member State, namely the Federal Republic of Germany, precludes the majority of conflicts; whereas, however, it does not appear necessary, in order to obtain this result, to extend that system to the entire Community, which would require the splitting-up of composite undertakings;  Whereas the desired result can also be achieved by requiring undertakings to provide for a separate contract or a separate section of a single policy for legal expenses insurance and by obliging them either to have separate management for legal expenses insurance, or to entrust the management of claims in respect of legal expenses insurance to an undertaking having separate legal personality, or to afford the person having legal expenses cover the right to choose his lawyer from the moment that he has the right to claim from his insurer;  Whereas, whichever solution is adopted, the interest of persons having legal expenses cover shall be protected by equivalent safeguards;  Whereas the interest of persons having legal expenses cover means that the insured person must be able to choose a lawyer or other person appropriately qualified according to national law in any inquiry or proceedings and whenever a conflict of interests arises;  Whereas Member States should be given the option of exempting undertakings from the obligation to give the insured person this free choice of lawyer if the legal expenses insurance is limited to cases arising from the use of road vehicles on their territory and if other restrictive conditions are met;  Whereas, if a conflict arises between insurer and insured, it is important that it be settled in the fairest and speediest manner possible; whereas it is therefore appropriate that provision be made in legal expenses insurance policies for an arbitration procedure or a procedure offering comparable guarantees;  Whereas the second paragraph of point C of the Annex to Directive 73/239/EEC provides that the risks included in classes 14 and 15 in point A may not be regarded as risks ancillary to other classes; whereas an insurance undertaking should not be able to cover legal expenses as a risk ancillary to another risk without having obtained an authorization in respect of the legal expenses risk; whereas, however, Member States should be given the option of regarding class 17 as a risk ancillary to class 18 in specific cases; whereas, therefore, point C of the said Annex should be amended accordingly,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The purpose of this Directive is to coordinate the provisions laid down by law, regulation or administrative action concerning legal expenses insurance as referred to in paragraph 17 of point A of the Annex to Council Directive 73/239/EEC in order to facilitate the effective exercise of freedom of establishment and preclude as far as possible any conflict of interest arising in particular out of the fact that the insurer is covering another person or is covering a person in respect of both legal expenses and any other class in that Annex and, should such a conflict arise, to enable it to be resolved.  Article 2  1. This Directive shall apply to legal expenses insurance. Such consists in undertaking, against the payment of a premium, to bear the costs of legal proceedings and to provide other services directly linked to insurance cover, in particular with a view to:  - securing compensation for the loss, damage or injury suffered by the insured person, by settlement out of court or through civil or criminal proceedings,  - defending or representing the insured person in civil, criminal, administrative or other proceedings or in respect of any claim made against him.  2. This Directive shall not, however, apply to:  - legal expenses insurance where such insurance concerns disputes or risks arising out of, or in connection with, the use of sea-going vessels,  - the activity pursued by the insurer providing civil liability cover for the purpose of defending or representing the insured person in any inquiry or proceedings if that activity is at the same time pursued in the insurer's own interest under such cover,  - where a Member State so chooses, the activity of legal expenses insurance undertaken by an assistance insurer where this activity is carried out in a Member State other than the one in which the insured person normally resides, where it forms part of a contract covering solely the assistance provided for persons who fall into difficulties while travelling, while away from home or while away from their permanent residence. In this event the contract must clearly state that the cover in question is limited to the circumstances referred to in the foregoing sentence and is ancillary to the assistance.  Article 3  1. Legal expenses cover shall be the subject of a contract separate from that drawn up for the other classes of insurance or shall be dealt with in a separate section of a single policy in which the nature of the legal expenses cover and, should the Member State so request, the amount of the relevant premium are specified.  2. Each Member State shall take the necessary measures to ensure that the undertakings established within its territory adopt, in accordance with the option imposed by the Member State, or at their own choice, if the Member State so agrees, at least one of the following solutions, which are alternatives:  (a) the undertaking shall ensure that no member of the staff who is concerned with the management of legal expenses claims or with legal advice in respect thereof carries on at the same time a similar activity  - if the undertaking is a composite one, for another class transacted by it,  - irrespective of whether the undertaking is a composite or a specialized one, in another having financial, commercial or administrative links with the first undertaking and carrying on one or more of the other classes of insurance set out in Directive 73/239/EEC;  (b) the undertaking shall entrust the management of claims in respect of legal expenses insurance to an undertaking having separate legal personality. That undertaking shall be mentioned in the separate contract or separate section referred to in paragraph 1. If the undertaking having separate legal personality has links with an undertaking which carries on one or more of the other classes of insurance referred to in point A of the Annex to Directive 73/239/EEC, members of the staff of the undertaking who are concerned with the processing of claims or with legal advice connected with such processing may not pursue the same or a similar activity in the other undertaking at the same time. In addition, Member States may impose the same requirements on the members of the management body;  (c) the undertaking shall, in the contract, afford the insured person the right to entrust the defence of his interests, from the moment that he has the right to claim from his insurer under the policy, to a lawyer of his choice or, to the extent that national law so permits, any other appropriately qualified person.  3. Whichever solution is adopted, the interest of persons having legal expenses cover shall be regarded as safeguarded in an equivalent manner under this Directive.  Article 4  1. Any contract of legal expenses insurance shall expressly recognize that:  (a) where recourse is had to a lawyer or other person appropriately qualified according to national law in order to defend, represent or serve the interests of the insured person in any inquiry or proceedings, that insured person shall be free to choose such lawyer or other person;  (b) the insured person shall be free to choose a lawyer or, if he so prefers and to the extent that national law so permits, any other appropriately qualified person, to serve his interests whenever a conflict of interests arises.  2. Lawyer means any person entitled to pursue his professional activities under one of the denominations laid down in Council Directive 77/249/EEC of 22 March 1977 to facilitate the effective exercise by lawyers of freedom to provide services (1).  Article 5  1. Each Member State may provide exemption from the application of Article 4 (1) for legal expenses insurance if all the following conditions are fulfilled:  (a) the insurance is limited to cases arising from the use of road vehicles in the territory of the Member State concerned;  (b) the insurance is connected to a contract to provide assistance in the event of accident or breakdown involving a road vehicle;  (c) neither the legal expenses insurer nor the assistance insurer carries out any class of liability insurance;  (d) measures are taken so that the legal counsel and representation of each of the parties to a dispute is effected by completely independent lawyers when these parties are insured for legal expenses by the same insurer.  2. The exemption granted by a Member State to an undertaking pursuant to paragraph 1 shall not affect the application of Article 3 (2).  Article 6  Member States shall adopt all appropriate measures to ensure that, without prejudice to any right of appeal to a judicial body which might be provided for by national law, an arbitration or other procedure offering comparable garantees of objectivity is provided for whereby, in the event of a difference of opinion between a legal expenses insurer and his insured, a decision can be taken on the attitude to be adopted in order to settle the dispute.  The insurance contract must mention the right of the insured person to have recourse to such a procedure.  Article 7  Whenever a conflict of interests arises or these is disagreement over the settlement of the dispute, the legal expenses insurer or, where appropriate, the claims settlement office shall inform the person insured of  - the right referred to in Article 4,  - the possibility of having recourse to the procedure referred to in Article 6.  Article 8  Member States shall abolish all provisions which prohibit an insurer from carrying out within their territory legal expenses insurance and other classes of insurance at the same time.  Article 9  The second subparagraph of point C of the Annex to Directive 73/239/EEC shall be replaced by the following text:  'However, the risks included in classes 14, 15 and 17 in point A may not be regarded as risks ancillary to other classes.  Nonetheless, the risk included in class 17 (legal expenses insurance) may be regarded as an ancillary risk of class 18 where the conditions laid down in the first subparagraph are fulfilled, where the main risk relates solely to the assistance provided for persons who fall into difficulties while travelling, while away from home or while away from their permanent residence.  Legal expenses insurance may also be regarded as an ancillary risk under the conditions set out in the first subparagraph where it concerns disputes or risks arising out of, or in connection with, the use of sea-going vessels.'  Article 10  Member States shall take the measures necessary to comply with this Directive by 1 January 1990. They shall forthwith inform the Commission thereof.  They shall apply these measures from 1 July 1990 at the latest.  Article 11  Following notification (1) of this Directive, Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.  Article 12  This Directive is addressed to the Member States.  Done at Luxembourg, 22 June 1987.  For the Council  The President  L. TINDEMANS  (1) OJ No C 198, 7. 8. 1979, p. 2.  (2) OJ No C 260, 12. 10. 1981, p. 78.  (3) OJ No C 348, 31. 12. 1980, p. 22.  (4) OJ No L 228, 16. 8. 1973, p. 3.  (5) See page 72 of this Official Journal.  (1) OJ No L 78, 26. 3. 1977, p. 17.  (1) This Directive was notified to the Member States on 25 June 1987.