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31984L0156

Council Directive 84/156/EEC of 8 March 1984 on limit values and quality objectives for mercury discharges by sectors other than the chlor-alkali electrolysis industry

Official Journal L 074 , 17/03/1984 P. 0049 - 0054 Finnish special edition: Chapter 15 Volume 4 P. 0183  Spanish special edition: Chapter 15 Volume 5 P. 0020  Swedish special edition: Chapter 15 Volume 4 P. 0183  Portuguese special edition Chapter 15 Volume 5 P. 0020

*****COUNCIL  DIRECTIVE  of 8 March 1984  on limit values and quality objectives for mercury discharges by sectors other than the chlor-alkali electrolysis industry  (84/156/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof,  Having regard to Council Directive 76/464/EEC of 4 May 1976 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community (1), and in particular Articles 6 and 12 thereof,  Having regard to the proposal from the Commission (2),  Having regard to the opinion of the European Parliament (3),  Having regard to the opinion of the Economic and Social Committee (4),  Whereas, in order to protect the aquatic environment of the Community against pollution by certain dangerous substances, Article 3 of Directive 76/464/EEC introduces a system of prior authorization laying down emission standards for discharges of the substances in List I in the Annex thereto; whereas Article 6 of the said Directive provides that limit values shall be laid down for such emission standards and also quality objectives for the aquatic environment affected by discharges of these substances;  Whereas mercury and its compounds are included in List I;  Whereas the Member States are required to apply the limit values except in the cases where they may employ quality objectives;  Whereas, since pollution due to the discharge of mercury into water is caused by a large number of industries, it is necessary to lay down specific limit values according to the type of industry concerned and to lay down quality objectives for the aquatic environment into which mercury is discharged by such industries;  Whereas the purpose of the quality objectives must be to eliminate mercury pollution of the various parts of the aquatic environment which might be affected by mercury discharges;  Whereas such quality objectives must be laid down expressly for this purpose and not with the intention of establishing rules pertaining to consumer protection or to the marketing of products from the aquatic environment;  Whereas a specific monitoring procedure should be laid down to enable Member States to demonstrate that the quality objectives are being complied with;  Whereas provision should be made for the monitoring by Member States of the aquatic environment affected by the aforesaid mercury discharges with a view to effective implementation of this Directive; whereas Article 6 of Directive 76/464/EEC does not provide  for the powers to introduce such monitoring; whereas, since the specific powers have not been provided for in the Treaty, Article 235 thereof should be invoked;  Whereas, in the case of discharges from certain types of plant for which emission standards cannot be established or regularly monitored by reason of the scattered nature of the sources, specific programmes must be devised to avoid or eliminate mercury pollution from these plants; whereas, since the powers have not been provided either by Article 6 of Directive 76/464/EEC or by the specific provisions of the Treaty, Article 235 of the Treaty should be invoked;  Whereas Directive 82/176/EEC (1) lays down limit values for mercury discharges into the aquatic environment by the chlor-alkali electrolysis industry and also sets quality objectives for the aquatic environment into which mercury is discharged;  Whereas it is important that the Commission report every four years on the implementation of this Directive by Member States;  Whereas, since groundwater is the subject of Directive 80/68/EEC (2), it is excluded from the scope of this Directive;  Whereas the level of industrialization is very low in Greenland because of the overall situation of the island, and in particular the fact that it is sparsely populated, its considerable size and its special geographical position; whereas, therefore, this Directive should not apply to Greenland,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. This Directive:  - pursuant to Article 6 (1) of Directive 76/464/EEC, lays down limit values for emission standards for mercury in discharges from industrial plants as defined in Article 2 (e) hereof,  - pursuant to Article 6 (2) of Directive 76/464/EEC, lays down quality objectives for mercury in the aquatic environment,  - pursuant to Article 6 (4) of Directive 76/464/EEC, lays down the time limits for compliance with the conditions specified in the authorizations granted by the competent authorities of Member States in respect of existing discharges,  - pursuant to Article 12 (1) of Directive 76/464/EEC, lays down the reference methods of measurement enabling the mercury content in discharges and in the aquatic environment to be determined,  - pursuant to Article 6 (3) of Directive 76/464/EEC, establishes a monitoring procedure,  - requires Member States to cooperate with one another in the case of discharges affecting the waters of more than one Member State,  - requires the Member States to draw up programmes to avoid or eliminate pollution caused by discharges within the meaning of Article 4.  2. This Directive applies to the waters referred to in Article 1 of Directive 76/464/EEC, with the exception of groundwater.  Article 2  For the purposes of this Directive:  (a) 'mercury' means:  - the chemical element mercury,  - the mercury contained in any of its compounds;  (b) 'limit values' means:  the values specified in Annex I;  (c) 'quality objectives' means:  the requirements specified in Annex II;  (d) 'handling of mercury' means:  any industrial process involving the production or use of mercury, or any other industrial process in which the presence of mercury is inherent;  (e) 'industrial plant' means:  a plant at which mercury or any substance containing mercury is handled, with the exception of the industrial plant referred to in Article 2 (d) of Directive 82/176/EEC;  (f) 'existing plant' means:  an industrial plant which is operational on the date of notification of this Directive;  (g) 'new plant' means:  - an industrial plant which has become operational after the date of notification of this Directive,  - an existing industrial plant whose mercury-handling capacity has been substantially increased since the date of notification of this Directive.  Article 3  1. The limit values, the time limits by which they must be complied with and the monitoring procedure for discharges are laid down in Annex I.  2. The limit values shall normally apply at the point where waste waters containing mercury leave the industrial plant.  When waste waters containing mercury are treated outside the industrial plant at a treatment plant intended for the removal of mercury, the Member State may permit the limit values to be applied at the point where the waste waters leave the treatment plant.  3. The authorizations referred to in Article 3 of Directive 76/464/EEC must contain provisions at least as stringent as those in Annex I to this Directive, except where a Member State is complying with Article 6 (3) of Directive 76/464/EEC on the basis of Annex II to this Directive and Annex IV to Directive 82/176/EEC.  Authorizations shall be reviewed at least every four years.  4. Without prejudice to their obligations arising from paragraph 1, 2 and 3 and to the provisions of Directive 76/464/EEC, Member States may grant authorizations for new plants only if those plants apply the standards corresponding to the best technical means available when that is necessary for the elimination of pollution in accordance with Article 2 of the said Directive or for the prevention of distortion of competition.  Whatever method it adopts, the Member State shall, where for technical reasons the intended measures do not correspond to the best technical means available, provide the Commission, before any authorization, with evidence in support of these reasons.  The Commission shall forward this evidence to the other Member States immediately and shall send all Member States a report as soon as possible giving its opinion on the derogation referred to in the second subparagraph. If necessary, it shall at the same time submit appropriate proposals to the Council.  5. The reference method of analysis to be used in determining the presence of mercury is given in Annex III (1) to Directive 82/176/EEC. Other methods may be used provided that the limits of detection, precision and accuracy of such methods are at least as good as those laid down in Annex III (1) to Directive 82/176/EEC. The accuracy required in the measurement of effluent flow is given in Annex III (2) to that Directive.  Article 4  1. The Member States shall draw up specific programmes for mercury discharges by multiple sources which are not industrial plants and for which the emission standards laid down in Article 3 cannot be applied in practice.  2. The purpose of these programmes shall be to avoid or eliminate pollution. They shall include the most appropriate measures and techniques for the replacement, retention and recycling of mercury. The elimination of waste containing mercury shall be carried out in accordance with Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste (1), as amended by the 1979 Act of Accession.  3. The specific programmes shall apply as from 1 July 1989 and shall be communicated to the Commission.  Article 5  The Member States concerned shall be responsible for monitoring the aquatic environment affected by industrial discharges.  In the case of discharges affecting the waters of more than one Member State, the Member States concerned shall cooperate with a view to harmonizing monitoring procedures.  Article 6  1. The Commission shall report every four years on the implementation of this Directive by Member States on the basis of information supplied to it by them pursuant to Article 13 of Directive 76/464/EEC at its request, which it must submit case by case. The information concerned shall, in particular, comprise:  - details of authorizations laying down emission standards for discharges of mercury,  - the results of the inventory of mercury discharged into the waters referred to in Article 1 (2),  - the results of measurements made by the national network set up to determine concentrations of mercury.  2. In the event of a change in scientific knowledge relating principally to the toxicity, persistence and accumulation of mercury in living organisms and sediments, or in the event of an improvement in the best technical means available, the Commission shall submit appropriate proposals to the Council with the aim of reinforcing, if necessary, the limit values and the quality objectives or of establishing additional limit values and additional quality objectives.  Article 7  1. Member States shall bring into force the measures necessary to comply with this Directive within two years following its notification. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive.  Article 8  This Directive shall not apply to Greenland.  Article 9  This Directive is addressed to the Member States.  Done at Brussels, 8 March 1984.  For the Council  The President  C. LALUMIERE  (1) OJ No L 129, 18. 5. 1976, p. 23.  (2) OJ No C 20, 25. 1. 1983, p. 5.  (3) OJ No C 10, 16. 1. 1984, p. 300.  (4) OJ No C 286, 24. 10. 1983, p. 1.  (1) OJ No L 81, 27. 3. 1982, p. 29.  (2) OJ No L 20, 26. 1. 1980, p. 43.  (1) OJ No L 84, 31. 3. 1978, p. 43.  ANNEX  I  Limit values, time limits by which they must be complied with, and the procedure for monitoring discharges  1. The limit values and the time limits for the industrial sectors concerned are set out together in the table below:  1.2,3.4 //   //   //   //   // Limit value which must be complied with as from:  //   //  1.2.3.4 // Industrial sector (1)  // 1 July 1986  // 1 July 1989  // Unit of measurement  //   //   //   //   // 1. Chemical industries using mercury catalysts:  //   //   //   // (a) in the production of vinyl chloride  // 0,1  //  0,05  //  mg/l effluent  //   // 0,2  // 0,1  // g/t vinyl chloride production capacity  // (b) in other processes  // 0,1  // 0,05  // mg/l effluent  //   // 10  // 5  // g/kg mercury processed  //   //   //   //   // 2. Manufacture of mercury catalysts used in the production of vinyl chloride  // 0,1 1,4  // 0,05 0,7  // mg/l effluent g/kg mercury processed  //   //   //   //   // 3. Manufacture of organic and non-organic mercury compounds (except for products referred to in point 2)  // 0,1 0,1  // 0,05 0,05  // mg/l effluent g/kg mercury processed  //   //   //   //   // 4. Manufacture of primary batteries containing mercury  // 0,1 0,05  // 0,05 0,03  // mg/l effluent g/kg mercury processed  //   //   //   //   // 5. Non-ferrous metal industry (2)  //  //   //   // 5.1. Mercury recovery plants  // 0,1  // 0,05  // mg/l effluent  // 5.2. Extraction and refining of non-ferrous metals  // 0,1  // 0,05  // mg/l effluent  //   //  //   //   // 6. Plants for the treatment of toxic wastes containing mercury  // 0,1  // 0,05  // mg/l effluent  //   //  //   //  (1) Limit values for industrial sectors other than the chlor-alkali electrolysis industry which are not mentioned in this table, such as the paper and steel industries or coal-fired power stations, will, if necessary, be fixed by the Council at a later stage. In the meantime, the Member States will fix emission standards for mercury discharges autonomously in accordance with Directive 76/464/EEC. Such standards must take into account the best technical means available and must not be less stringent than the most nearly comparable limit value in this Annex.  (2) On the basis of experience gained in the implementation of this Directive the Commission will, pursuant to Article 6 (3), submit to the Council proposals for more stringent limit values to be introduced 10 years after the notification of this Directive.  The limit values given in the table correspond to a monthly average concentration or to a maximum monthly load.  The amounts of mercury discharged are expressed as a function of the amount of mercury used or handled by the industrial plant over the same period or as a function of the installed vinyl chloride production capacity. 2. Limit values expressed as concentrations which in principle must not be exceeded are given in the above table for the industrial sectors 1 to 4. In no instance may limit values expressed as maximum concentrations be greater than those expressed as maximum quantities divided by water requirements per kilogram of mercury handled or per tonne of installed vinyl chloride production capacity.  However, because the concentration of mercury in effluents depends on the volume of water involved, which differs for different processes and plants, the limit values, expressed in terms of the quantity of mercury discharged in relation to the quantity of mercury handled or to the installed vinyl chloride production capacity, given in the above table, must be complied with in all cases.  3. The daily average limit values are twice the corresponding monthly average limit values given in the table.  4. A monitoring procedure must be instituted to check whether the discharges comply with the emission standards which have been fixed in accordance with the limit values laid down in this Annex.  This procedure must provide for the taking and analysis of samples and for measurement of the flow of the discharge and, where appropriate, the quantity of mercury handled.  Should the quantity of mercury handled be impossible to determine, the monitoring procedure may be based on the quantity of mercury that may be used in the light of the production capacity on which the authorization was based.  5. A sample representative of the discharge over a period of 24 hours will be taken. The quantity of mercury discharged over a month must be calculated on the basis of the daily quantities of mercury discharged.  However, a simplified monitoring procedure may be instituted in the case of industrial plants which do not discharge more than 7,5 kilograms of mercury per annum.    ANNEX  II  Quality objectives  For those Member States which apply the exception referred to in Article 6 (3) of Directive 76/464/EEC, the emission standards which Member States must establish and ensure are applied, pursuant to Article 5 of that Directive, will be fixed so that the appropriate quality objective or objectives from among those listed in sections 1, 2 and 3 of Annex II to Directive 82/176/EEC is or are complied with in the area affected by discharges of mercury.  The competent authority shall determine the area affected in each case and shall select from among the quality objectives listed in section 1 of Annex II to Directive 82/176/EEC the objective or objectives that it deems appropriate having regard to the intended use of the area affected, while taking account of the fact that the purpose of this Directive is to avoid or eliminate all pollution.  The numerical values of the quality objectives specified in 1.2, 1.3 and 1.4 of Annex II to Directive 82/176/EEC may, as an exception and where this is necessary for technical reasons, be multiplied by 1.5 until 1 July 1989, provided that the Commission has been notified beforehand.


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32000L0024

Commission Directive 2000/24/EC of 28 April 2000 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively

Official Journal L 107 , 04/05/2000 P. 0028 - 0037

Commission Directive 2000/24/ECof 28 April 2000amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectivelyTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Directive 97/41/EC(2), and in particular Article 5 thereof,Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(3), as last amended by Commission Directive 1999/71/EC(4), and in particular Article 10 thereof,Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(5), as last amended by Directive 1999/71/EC, and in particular Article 10 thereof,Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(6), as last amended by Directive 1999/71/EC, and in particular Article 7 thereof,Whereas:(1) For cereals and products of plant origin, including fruit and vegetables, maximum residue levels reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in view of the protection of the environment and in terms of estimated dietary intake. For foodstuffs of animal origin, maximum residue levels reflect the consumption of cereals and products of plant origin treated with pesticides resulting in residues in animals and animal products, as well as taking into account the direct consequences of the use of veterinary medicines where appropriate.(2) Maximum residue levels are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data.(3) Maximum residue levels for pesticides should be kept under review. The levels may be changed to take account of new information and data.(4) Aramite, barban, chlorobenzilate, chlorfenson, chloroxuron, chlorbenside, 1,1-dichloro-2,2-bis (4-ethyl-phenyl-) ethane and diallate are either no longer authorised for use in the Community or are no longer used at Community level. The aramite and chlorfenson residues were deleted from Annex II to Directive 76/895/EEC by Council Directive 82/528/EEC(7) but have not since that time been added to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The chlorbenside and 1,1-dichloro-2,2-bis (4-ethyl-phenyl-) ethane residues were deleted from Annex II to Directive 76/895/EEC by Council Directive 93/58/EEC(8) but have not since that time been added to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. It is necessary to add all of these residues to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of their uses and to protect the consumer.(5) Limited authorisations still exist in the Community for chlorbufam and methoxychlor. The authorised uses would not be expected to give rise to detectable residues in food. Maximum residue levels have been fixed in Annex II to Directive 76/895/EEC for these residues.(6) To establish maximum levels of pesticide residues for barban, chlorbufam, chlorobenzilate, chloroxuron, diallate and methoxychlor at Community level it is necessary to transfer provisions from Directive 76/895/EEC to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. Certain of these provisions should be amended in the light of technical and scientific progress as well as changes in uses and authorisations at national and Community level.(7) Community maximum residue levels and levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. With the exception of chlorobenzilate, no Codex maximum residue limits were set for the active substances covered by this Directive. The Codex maximum residue limits for chlorobenzilate have been withdrawn(9). Authorisations of plant protection products in third countries may require the use of greater quantities of pesticides or shorter pre-harvest intervals than are authorised in the Community and consequently may require higher residue levels. The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered and discussed by the Standing Committee on Plant Health. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the European Community on the basis of the submission of acceptable data.(8) The maximum residue levels established in this Directive may have to be reviewed in the framework of the re-evaluation of active substances provided for in the programme of work established in Article 8(2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(10), as last amended by Commission Directive 1999/80/EC(11).(9) The maximum residue level for cartap in tea was set at 20 mg/kg in Community legislation on the basis of the information contained in the Codex Alimentarius. The 29th meeting of the Codex Committee on Pesticide Residues recommended that all MRLs for the active substance be withdrawn(12).(10) A lack of clarity in the description of CN codes in Annexes I and II to Directive 86/363/EEC has led to problems in classifying samples for the purposes of the notification procedure under Article 7 of Directive 86/363/EEC.(11) DDT is not authorised for use as a plant protection product in the Community. A maximum residue level for DDT in birds' eggs and egg yolks of 0,1 mg/kg was set in Community legislation by Council Directive 93/57/EEC(13) to allow for the possibility that residual environmental contamination may give rise to DDT residues in eggs. Monitoring data for DDT in eggs in Community Member States and in Norway indicate that this maximum level may be reduced.(12) This Directive is in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annex II to Directive 76/895/EEC is hereby amended as follows:1. The entries relating to chlorobenzilate, chloroxuron and methoxychlor shall be deleted.2. The grouping "barban, chlorpropham, chlorbufam" shall be replaced by "chlorpropham".3. The grouping "diallate, triallate" shall be replaced by "triallate".Article 2Directive 86/362/EEC is hereby amended as follows:The following pesticide residues shall be added to Part A of Annex II:>TABLE>Article 3Directive 86/363/EEC is hereby amended as follows:1. The following pesticide residues shall be added to part A of Annex II:>TABLE>2. The following pesticide residues shall be added to part B of Annex II:>TABLE>3. In Annex I, the text in the column "Description" which corresponds to CN code ex 0208 shall be replaced by the text "Other meat and edible meat offal of domestic pigeons, domestic rabbits and game, fresh, chilled or frozen".4. In Annex II, in the tables in Parts A and B, in the column "meat", the text "ex 0201" shall be replaced by the text ">TABLE>0201".5. In Annex II, in the table in Part A, in the column relating to birds' eggs and egg yolks, the value of 0,1 mg/kg for DDT shall be replaced by the value 0,05 mg/kg.Article 4Directive 90/642/EEC is hereby amended as follows:1. The following pesticide residues shall be added to Annex II:>TABLE>2. In the German text, in Annexes I and II, in the group "2.5(a) Salat u. ä.", the term "Kopfsalat" shall be replaced by the term "Salat".3. In the Dutch text, in Annexes I and II, in the group "2.5(a) Sla en dergelijke", the term "Kropsla/ijsbergsla" shall be replaced by the term "Sla".4. In Annex II, the maximum residue level for cartap in tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) shall be fixed at 0,1 (*) mg/kg (where (*) indicates that this level is at the lower limit of analytical determination).Article 51. This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 31 December 2000. They shall immediately inform thereof the Commission.3. They shall apply these measures as from 1 January 2001.4. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. Member States shall adopt the procedure for such reference.Article 6This Directive is addressed to the Member States.Done at Brussels, 28 April 2000.For the CommissionDavid ByrneMember of the Commission(1) OJ L 340, 9.12.1976, p. 26.(2) OJ L 184, 12.7.1997, p. 33.(3) OJ L 221, 7.8.1986, p. 37.(4) OJ L 194, 27.7.1999, p. 36.(5) OJ L 221, 7.8.1986, p. 43.(6) OJ L 350, 14.12.1990, p. 71.(7) OJ L 234, 9.8.1982, p. 1.(8) OJ L 211, 23.8.1993, p. 6.(9) ALINORM 93/24A.(10) OJ L 230, 19.8.1991, p. 1.(11) OJ L 210, 10.8.1999, p. 13.(12) ALINORM 97/24A Annex II.(13) OJ L 211, 23.8.1993, p. 1.


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31976L0768

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 262 , 27/09/1976 P. 0169 - 0200 Greek special edition: Chapter 13 Volume 4 P. 0145  Spanish special edition: Chapter 15 Volume 1 P. 0206  Portuguese special edition Chapter 15 Volume 1 P. 0206  Finnish special edition: Chapter 13 Volume 5 P. 0198  Swedish special edition: Chapter 13 Volume 5 P. 0198

COUNCIL DIRECTIVE  of 27 July 1976  on the approximation of the laws of the Member States relating to cosmetic products  (76/768/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,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas the provisions laid down by law, regulation or administrative action in force in the Member States define the composition characteristics to which cosmetic products must conform and prescribe rules for their labelling and for their packaging ; whereas these provisions differ from one Member State to another;  Whereas the differences between these laws oblige Community cosmetic producers to vary their production according to the Member State for which the products are intended ; whereas, consequently, they hinder trade in these products and, as a result, have a direct effect on the establishment and functioning of the common market;  Whereas the main objective of these laws is the safeguarding of public health and whereas, as a result, the pursuit of the same objective must inspire Community legislation in this sector ; whereas, however, this objective must be attained by means which also take account of economic and technological requirements;  Whereas it is necessary to determine at Community level the regulations which must be observed as regards the composition, labelling and packaging of cosmetic products;  Whereas this Directive relates only to cosmetic products and not to pharmaceutical specialities and medicinal products ; whereas for this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals ; whereas this delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use ; whereas this Directive is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease ; whereas, moreover, it is advisable to specify that certain products come under this definition, whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics;  Whereas in the present state of research, it is advisable to exclude cosmetic products containing one of the substances listed in Annex V from the scope of this Directive;  Whereas cosmetic products must not be harmful under normal or foreseeable conditions of use ; whereas in particular it is necessary to take into account the possibility of danger to zones of the body that are contiguous to the area of application;  Whereas, in particular, the determination of the methods of analysis together with possible modifications or additions which may have to be made to them on the basis of the results of scientific and technical research, are implementing measures of a technical nature ; whereas it is advisable to entrust their adoption to the Commission, subject to certain conditions specified in this Directive, for the purpose of simplifying and accelerating the procedure;  Whereas technical progress necessitates rapid adaptation of the technical provisions defined in this Directive and in subsequent Directives in this field ; whereas it is advisable, in order to facilitate implementation of the measures necessary for this purpose,  (1)OJ No C 40, 8.4.1974, p. 71. (2)OJ No C 60, 26.7.1973, p. 16.   to provide for a procedure establishing close cooperation between the Member States and the Commission within the Committee for adaptation to technical progress of Directives aimed at the removal of technical obstacles to trade in the cosmetic products sector;  Whereas it is necessary, on the basis of scientific and technical research, to draw up proposals for lists of authorized substances which could include antioxidants, hair dyes, preservatives and ultraviolet filters, taking into account in particular the problem of sensitization;  Whereas it could happen that although conforming to the provisions of this Directive and its Annexes, cosmetic products placed on the market might endanger public health ; whereas it is therefore advisable to provide for a procedure intended to remove this danger,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. A "cosmetic product" means any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours.  2. The products to be considered as cosmetic products within the meaning of this definition are listed in Annex I.  3. Cosmetic products containing one of the substances listed in Annex V and cosmetic products containing colouring agents other than those referred to in Annexes III and IV and which are not intended to come into contact with the mucous membranes are excluded from the scope of this Directive. Member States may take such measures as they deem necessary with regard to these products.   Article 2 Cosmetic products put on the market within the Community must not be liable to cause damage to human health when they are applied under normal conditions of use.   Article 3 Member States shall take all necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive and its Annexes may be put on the market.   Article 4 Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing:    (a) substances listed in Annex II;       (b) substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down;       (c) colouring agents other than those listed in the second part of Annex III, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs;       (d) colouring agents listed in the second part of Annex III, beyond the limits and outside the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs.          Article 5 For a period of three years from notification of this Directive, Member States shall accept the marketing of cosmetic products containing:    (a) the substances listed in Part 1 of Annex IV within the limits and under the conditions laid down;       (b) the colouring agents listed in Part 2 of Annex IV within the limits and under the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity, or to the external genital organs;       (c) the colouring agents listed in Part 3 of Annex IV, if these products either are not intended to come into contact with the mucous membranes or are only intended to come into brief contact with the skin.         On expiry of the three year period, these substances and colouring agents shall:    - either be definitively permitted,       - or definitively prohibited (Annex II),        - or retained for a further period of three years in Annex IV,       - or deleted from all Annexes to this Directive.          Article 6 1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if their packaging, containers or labels bear the following information in indelible, easily legible and visible lettering:    (a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who are established within the Community. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. Member States may require that the country of origin be specified for goods manufactured outside the Community;       (b) the nominal content at the time of packaging;       (c) the expiry date for products with a stability of less than three years;       (d) particular precautions to be observed in use, and especially those listed in the column "Conditions of use and warnings which must be printed on the label" in Annexes III and IV, and which must appear on the container ; where this is impossible for practical reasons, this information must appear on the packaging or on an enclosed leaflet, but in the latter case an abbreviated external indication must appear on the container, referring the consumer to the information specified;       (e) the batch number of manufacture or the reference for identifying the goods ; however, where this is impossible for practical reasons because the cosmetic articles are too small, such information need appear only on the multiple retail pack or sleeve of these articles.         2. Member States shall take all measures necessary to ensure that in the labelling, presentation for sale and advertising of cosmetic products, the wording, use of names, trade marks, images or other signs, figurative or otherwise, suggesting a characteristic which the products in question do not possess, shall be prohibited.   Article 7 1. Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements of this Directive and the Annexes thereto.  2. They may, however, require that the particulars provided for in Article 6 (1) (b), (c) and (d) be expressed at least in their own national or official language or languages.  3. Furthermore, a Member State may require, for purposes of prompt and appropriate medicial treatment in the event of difficulties, that adequate and sufficient information regarding substances contained in cosmetic products is made available to the competent authority, which shall ensure that this information is used only for the purposes of such treatment.   Article 8 1. In accordance with the procedure laid down in Article 10 the following shall be determined:    - the methods of analysis necessary for checking the composition of cosmetic products,       - the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria.         2. The amendments necessary for adapting Annex II to technical progress shall be adopted in accordance with the same procedure.   Article 9 1. The Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, hereinafter called "the Committee", is hereby set up. It shall consist of representatives of the Member States with a representative of the Commission as chairman.  2. The Committee shall adopt its own rules of procedure.   Article 10 1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the chairman, either on his own initiative or at the request of the representative of a Member State.   2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit set by the chairman according to the urgency of the matter. Opinions shall be adopted by a majority of 41 votes, the votes of Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.  3.    (a) The Commission shall adopt the proposed measures when they are in accordance with the opinion of the Committee.       (b) Where the proposed measures are not in accordance with the opinion of the Committee, or if no opinion is adopted, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority.       (c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.         Article 11 Without prejudice to Article 5 and not later than one year after expiry of the period laid down in Article 14 (1) for implementation of this Directive by the Member States, the Commission shall, on the basis of the results of the latest scientific and technical research, submit to the Council appropriate proposals establishing lists of permitted substances.   Article 12 1. If a Member State notes, on the basis of a substantiated justification, that a cosmetic product, although complying with the requirements of the Directive, represents a hazard to health, it may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.  2. The Commission shall, within six weeks, consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps.  3. If the Commission is of the opinion that technical adaptations to the Directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 10. In that event, the Member State which has adopted safeguard measures may maintain them until entry into force of the adaptations.   Article 13 Precise reasons shall be stated for any individual measures placing a restriction or ban on the marketing of cosmetic products taken pursuant to this Directive. It shall be notified to the party concerned together with particulars of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies.   Article 14 1. Member States shall bring into force the provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.  2. Member States may, however, for a period of 36 months from notification of this Directive, authorize the marketing in their territory of cosmetic products which do not conform to the requirements of the Directive.  3. Member States shall ensure that the texts of such provisions of national law as 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, 27 July 1976.  For the Council  The President  M. van der STOEL     ANNEX I ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PRODUCTS    - Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).       - Face masks (with the exception of peeling products).       - Tinted bases (liquids, pastes, powders).       - Make-up powders, after-bath powders, hygienic powders, etc.       - Toilet soaps, deodorant soaps, etc.       - Perfumes, toilet waters and eau de Cologne.       - Bath and shower preparations (salts, foams, oils, gels, etc.).       - Depilatories.       - Deodorants and anti-perspirants.       - Hair care products:    - hair tints and bleaches,       - products for waving, straightening and fixing,       - setting products,       - cleansing products (lotions, powders, shampoos),       - conditioning products (lotions, creams, oils),       - hairdressing products (lotions, lacquers, brilliantines).          - Shaving products (creams, foams, lotions, etc.).       - Products for making up and removing make-up from the face and the eyes.       - Products intended for application to the lips.       - Products for care of the teeth and the mouth.       - Products for nail care and make-up.       - Products for external intimate hygiene.       - Sunbathing products.       - Products for tanning without sun.       - Skin-whitening products.       - Anti-wrinkle products.           ANNEX II LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN     1. N-5-Chlorobenzoxazol-2-ylacetamide       2. ß-Acetoxyethyl trimethyl ammonium hydroxide (acetylcholine and its salts)       3. Deanol aceglumate*       4. Spironolactone*       5. [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl] acetic acid and its salts       6. Methotrexate*       7. Aminocaproic acid* and its salts       8. Cinchophen*, its salts, derivatives and salts of these derivatives       9. Thyropropic acid* and its salts       10. Trichloroacetic acid       11. Aconitum napellus L. (leaves, roots and galenical preparations)       12. Aconitine (principal alkaloid of Aconitum napellus L.) and its salts       13. Adonis vernalis L. and its preparations       14. Epinephrine*       15. Rauwolfia serpentina alkaloids and their salts       16. Alkyne alcohols, their esters, ethers and salts       17. Isoprenaline*       18. Allyl isothiocyanate       19. Alloclamide* and its salts       20. Nalorphine*, its salts and ethers       21. Sympathicomimetic amines acting on the central nervous system : any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe       22. Aniline, its salts and its halogenated and sulphonated derivatives       23. Betoxycaine* and its salts       24. Zoxazolamine*       25. Procainamide*, its salts and derivatives       26. Benzidine       27. Tuaminoheptane*, its isomers and salts       28. Octodrine* and its salts       29. 2-Amino-1,2-bis (4-methoxyphenyl)ethanol and its salts       30. 1,3-dimethylpentylamine and its salts  (*) In this Directive, names followed by an asterisk are those published in "Computer print-out 1975, International Non-proprietary Names (INN) for pharmaceutical products, Lists 1-33 of proposed INN", WHO, Geneva, August 1975.        31. 4-Aminosalicylic acid and its salts       32. Toluidines, their isomers, salts and halogenated and sulphonated derivatives       33. Xylidines, their isomers, salts and halogenated and sulphonated derivatives       34. Imperatorin (9-(3-methoxylbut-2-enyloxy) furo [3,2-g] chromen-7-one)       35. Ammi majus and its galenical preparations       36. 2,3-Dichloro-2-methylbutane       37. Substances with androgenic effect       38. Anthracene oil       39. Antibiotics, with the exception of that given in Annex IV       40. Antimony and its compounds       41. Apocynum cannabinum L. and its preparations       42. Apomorphine (5,6,6a 7-tetrahydro-6-methyl-4H-dibenzo [de, g]= quinoline-10,11-dihydric alcohol) and its salts       43. Arsenic and its compounds       44. Atropa belladonna L. and its preparations       45. Atropine, its salts and derivatives       46. Barium salts, with the exception of barium sulphate, 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 Ba       47. Benzene       48. 4,5-Dihydrobenzimidazol-4-one       49. Benzazepines and benzadiazepines, their salts and derivatives       50. 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts (amylocaine)       51. 2,2,6-Trimethyl-4-piperidyl benzoate and its salts (benzamine)       52. Isocarboxazide*       53. Bendroflumethiazide* and its derivatives       54. Beryllium and its compounds       55. Bromine, elemental       56. Bretylium tosilate*       57. Carbromal*       58. Bromisoval*       59. Brompheniramine* and its salts       60. Benzilonium bromide*       61. Tetrylammonium bromide*       62. Brucine       63. Tetracaine* and its salts       64. Mofebutazone*       65. Tolbutamide*       66. Carbutamide*       67. Phenylbutazone*       68. Cadmium and its compounds       69. Cantharides, Cantharis vesicatoria        70. (1R, 2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin)       71. Phenprobamate*       72. Nitroderivatives of carbazol       73. Carbon disulphide       74. Catalase       75. Cephaeline and its salts       76. Chenopodium ambrosioides (essential oil)       77. 2,2,2-Trichloroethane-1,1-diol       78. Chlorine       79. Chlorpropamide*       80. Diphenoxylate* (hydrochloride)       81. 4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)       82. Chlorzoxazone*       83. 2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)       84. Chlorprothixene* and its salts       85. Clofenamide*       86. N N-bis (2-chloroethyl) methylamine N-oxide and its salts       87. Chlormethine* and its salts       88. Cyclophosphamide* and its salts       89. Mannomustine* and its salts       90. Butanilicaine* and its salts       91. Chloromezanone*       92. Triparanol*       93. 2-[2(4-Chlorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-ISO)       94. Chlorphenoxamine*       95. Phenaglycodol*       96. Chloroethane       97. Chromium ; chromic acid and its salts       98. Claviceps purpurea Tul., its alkaloids and galenical preparations       99. Conium maculatum L. (fruit, powder, galenical preparations)       100. Glycyclamide*       101. Cobalt benzenesulphonate       102. Colchicine, its salts and derivatives       103. Colchicoside and its derivatives       104. Colchicum autumnale L. and its galenical preparations       105. Convallatoxin       106. Anamirta cocculus L. (fruit)       107. Croton tiglium (oil)       108. 1-Butyl-3-(N-crotonoylsulphanilyl)urea       109. Curare and curarine       110. Synthetic curarizants       111. Hydrogen cyanide and its salts  112.   >PIC FILE= "T9000996">      113. Cyclomenol* and its salts       114. Sodium hexacyclonate*       115. Hexapropymate*       116. Dextropropoxyphene*       117. O O-Diacetyl-N-allyl-N-normorphine       118. Pipazetate* and its salts     119. >PIC FILE= "T9000997">       120. N N-Pentamethylenebis (trimethylammonium salts), e.g. Pentamethonium bromide*       121. N N'-[Methylimino) diethylene] bis (ethyldimethylammonium) salts, e.g. azamethonium bromide*       122. Cyclarbamate*       123. Clofenotane* ; DDT (ISO)       124. Hexamethylenebis (trimethylammonium salts), e.g. hexamethonium bromide*       125. Dichloroethanes (ethylene chlorides)       126. Dichloroethylenes (acetylene chlorides)       127. Lysergide* and its salts       128. 2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts       129. Cinchocaine* and its salts       130. 3-Diethylaminopropyl cinnamate       131. O O-Diethyl O-4-nitrophenyl phosphorothioate (parathion-ISO)       132. [Oxalylbis(iminoethylene)] bis [(o-chlorobenzyl)diethylammonium salts], e.g. ambenomium chloride*       133. Methyprylon* and its salts       134. Digitaline and all heterosides of Digitalis purpurea L.       135. 7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline (xanthinol)       136. Dioxethedrin* and its salts       137. Piprocurarium*       138. Propyphenazone*       139. Tetrabenazine* and its salts       140. Captodiame*       141. Mefeclorazine* and its salts       142. Dimethylamine       143. 1,1-Bis(dimethylaminomethyl) propyl benzoate and its salts (amydricaine, alypine)       144. Methapyrilene* and its salts       145. Metamfepramone* and its salts       146. Amitriptyline* and its salts       147. Metformin* and its salts       148. Isosorbide dinitrate*       149. Malononitrile       150. Succinonitrile       151. Dinitrophenol isomers     152. Inproquone*      153. Dimevamide* and its salts     154. Diphenylpyraline* and its salts     155. Sulfinpyrazone*     156. N-(3-Carbamoyl-3, 3-diphenylpropyl)-N N-diisopropylmethylammonium salts, e.g. isopropamide iodide*     157. Benactyzine*     158. Benzatropine* and its salts     159. Cyclizine* and its salts     160. 5,5-Diphenyl-4 imidazolidone     161. Probenecid*     162. Disulfiram* ; thiram (ISO)     163. Emetine, its salts and derivatives     164. Ephedrine and its salts     165. Oxanamide* and its derivatives     166. Eserine or physostigmine and its salts     167. Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex IV, Part 1     168. Choline salts and their esters, e.g. choline chloride     169. Caramiphen* and its salts     170. Diethyl 4-nitrophenyl phosphate     171. Metethoheptazine* and its salts     172. Oxpheneridine* and its salts     173. Ethoheptazine* and its salts     174. Metheptazine* and its salts     175. Methylphenidate* and its salts     176. Doxylamine* and its salts     177. Tolboxane*     178. Monobenzone*     179. Parethoxycaine* and its salts     180. Fenozolone*     181. Glutethimide* and its salts     182. Ethylene oxide     183. Bemegride* and its salts     184. Valnoctamide*     185. Haloperidol*     186. Paramethasone*     187. Fluanisone*     188. Trifluperidol*     189. Fluoresone*     190. Fluorouracil*     191. Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex IV, Part 1     192. Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*      193. Galantamine*     194. Progestogens, with the exception of those listed in Annex V     195. 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)     196. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,6,7,8,8a-octahydro-1,4 : 5,8-dimethanonaphthalene (endrin-ISO)     197. Hexachloroethane     198. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4 : 5,8-dimethanonaphthalene (isodrin-ISO)     199. Hydrastine, hydrastinine and their salts     200. Hydrazides and their salts     201. Hydrazine, its derivatives and their salts     202. Octamoxin* and its salts     203. Warfarin* and its salts     204. Ethyl bis(4-hydoxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid     205. Methocarbamol*     206. Propatylnitrate*      207. 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin     208. Fenadiazole*     209. Nitroxoline* and its salts     210. Hyoscyamine, its salts and derivatives     211. Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)     212. Pemoline* and its salts     213. Iodine     214. Decamethylenebis (trimethylammonium salts), e.g. decamethonium bromide*     215. Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)     216. (2-Isopropylpent-4-enoyl)urea (apronalide)     217. >PIC FILE= "T9000998">     218. Lobelia inflata L. and its galenical preparations     219. Lobeline* and its salts     220. Barbiturates     221. Mercury and its compounds, excluding the exceptions listed in Annex IV and Annex V     222. 3,4,5-Trimethoxyphenethylamine and its salts     223. Metaldehyde     224. 2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts     225. Coumetarol*     226. Dextromethorphan* and its salts     227. 2-Methylheptylamine and its salts     228. Isometheptene* and its salts     229. Mecamylamine*     230. Guaifenesin*     231. Dicoumarol*     232. Phenmetrazine*, its derivatives and salts      233. Thiamazole*     234. 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)     235. Carisoprodol*     236. Meprobamate*     237. Tefazoline* and its salts     238. Arecoline     239. Poldine metilsulfate*     240. Hydroxyzine*     241. 2-Naphthol     242. 1-and 2-Naphthylamines and their salts     243. 3 (1-Naphtylmethyl)-2-imidazoline     244. Naphazoline* and its salts     245. Neostigmine and its salts (e.g. neostigmine bromide*)     246. Nicotine and its salts     247. Amyl nitrites     248. Inorganic nitrites, with the exception of sodium nitrite     249. Nitrobenzene     250. Nitrocresols and their alkali metal salts     251. Nitrofurantoin*     252. Furazolidone*     253. Propane-1,2,3-triyl trinitrate     254. Acenocoumarol*     255. Alkali pentacyanonitrosylferrate (2-)     256. Nitrostilbenes, their homologues and their derivatives     257. Noradrenaline and its salts     258. Noscapine* and its salts     259. Guanethidine* and its salts     260. Oestrogens, with the exception of those listed in Annex V     261. Oleandrin     262. Chlortalidone*     263. Pelletierine and its salts     264. Pentachloroethane     265. Pentaerithrityl tetranitrate*     266. Petrichloral*     267. Octamylamine* and its salts     268. Pheno and its alkali salts, excluding the exceptions listed in Annex III     269. Phenacemide*     270. Difencloxazine*     271. 2-Phenylindane-1,3-dione (phenindione)     272. Ethylphenacemide*     273. Phenprocoumon*     274. Fenyramidol*      275. Triamterene* and its salts     276. Tetraethylpyrophosphate ; TEPP (ISO)     277. Tritolyl phosphate     278. Psilocybine*     279. Phosphorus and metal phosphides     280. Thalidomide* and its salts     281. Physostigma venenosum Balf.     282. Picrotoxin     283. Pilocarpine and its salts     284. a-Piperidin-2-yl benzyl acetate laevorotatory threoform (Levophacetoperane) and its salts     285. Pipradrol* and its salts     286. Azacyclonol* and its salts     287. Bietamiverine*     288. Butopiprine* and its salts     289. Lead and its compounds, with the exception of that mentioned in Annex V     290. Coniine     291. Prunus laurocerasus L. ("cherry laurel water")     292. Metyrapone*     293. Radioactive substances (1)     294. Juniperus sabina L. (leaves, essential oil and galenical preparations)     295. Hyoscine, its salts and derivatives     296. Gold salts     297. Selenium and its compounds     298. Solanum nigrum L. and its galenical preparations     299. Sparteine and its salts     300. Glucocorticoids     301. Datura stramonium L. and its galenical preparations     302. Strophantines, their aglucones and their respective derivatives     303. Strophantus species and their galenical preparations     304. Strychnine and its salts     305. Strychnos species and their galenical preparations     306. Narcotics, natural and synthetic : All substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961     307. Sulphonamides (sulphanylamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts     308. Sultiame*     309. Neodymium and its salts  (1)The presence of natural radioactive substances and of radioactive substances caused by artificial contamination from the environment is permitted, provided that the radioactive substances are not enriched for the manufacture of cosmetic products and that their concentration falls within the limits set in the Directive laying down the basic standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiations (OJ No 11, 20.2.1959, p. 221/59).      310. Thiotepa*     311. Pilocarpus jaborandi Holmes and its galenical preparations     312. Tellurium and its compounds     313. Xylometazoline and its salts     314. Tetrachloroethylene     315. Carbon tetrachloride     316. Hexaethyl tetraphosphate     317. Thallium and its compounds     318. Thevetia neriifolia Juss., glycoside extract     319. Ethionamide*     320. Phenothiazine* and its compounds     321. Thiourea and its derivatives, with the exception of those listed in Annex IV, Part 1     322. Mephenesin* and its esters     323. Vaccines, toxins or serums listed in the Annex to the second Council Directive of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ No L 147, 9.6.1975, p. 13)     324. Tranylcypromine* and its salts     325. Trichloronitromethane (chloropicrine)     326. 2,2,2-Tribromoethanol (tribromoethyl alcohol)     327. Trichlormethine* and its salts     328. Tretamine*     329. Gallamine triethiodide*     330. Urginea scilla Stern. and its galenical preparations     331. Veratrine, its salts and galenical preparations     332. Schoenocaulon officinale Lind. (seeds and galenical preparations)     333. Veratrum album L. (roots and galenical preparations)     334. Vinyl chloride monomer     335. Ergocalciferol* and cholecalciferol (vitamins D2 and D3)     336. Salts of O-alkyldithiocarbonic acids     337. Yohimbine and its salts     338. Dimethyl sulfoxide*     339. Diphenhydramine* and its salts     340. 4-tert-Butylphenol     341. 4-tert-Butylpyrocatechol     342. Dihydrotachysterol*     343. Dioxane     344. Morpholine and its salts     345. Pyrethrum album L. and its galenical preparations     346. 2-[4-Methoxybenzyl-N-(2-pyridyl)amino] ethyldimethylamine     347. Tripelennamine*     348. Tetrachlorosalicylanilides     349. Dichlorosalicylanilides      350. Tetrabromosalicylanilides     351. Dibromosalicylanilides, e.g. metabromsalan*, dibromsalan*     352. Bithionol*     353. Thiuram monosulphides     354. Thiuram disulphides     355. Dimethylformamide     356. 4-Phenylbut-3-en-2-one     357. Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used     358. Furo [3,2-g] chromen-7-one and its alkyl-substituted derivatives (e.g. trioxysalan* and 8-methoxypsoralen), except for normal content in natural essences used     359. Oil from the seeds of Laurus nobilis L.     360. Sassafras officinale Nees oil containing safrole     361. 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite      >PIC FILE= "T0009550">    >PIC FILE= "T0009551">    >PIC FILE= "T0009552">    >PIC FILE= "T0009553">   >PIC FILE= "T0009554">          PART 2 >PIC FILE= "T0009555">    >PIC FILE= "T0009556">   >PIC FILE= "T0009557">   >PIC FILE= "T0009558">   >PIC FILE= "T0009559">   >PIC FILE= "T0009560">       >PIC FILE= "T0009561">    >PIC FILE= "T0009562">    >PIC FILE= "T0009563">    >PIC FILE= "T0009564">        PART 2 >PIC FILE= "T0009565">    >PIC FILE= "T0009567">  >PIC FILE= "T0009568">     PART 3  (A) LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH DO NOT COME INTO CONTACT WITH THE MUCOUS MEMBRANES  Reds  12310, 12335, 12420, 12430, 12440, 16140, 16155, 16250, 17200, 18000, 18050, 18055, 18065, 26105, 45100, 50240, E121  Oranges and yellows  11680, 11710, 13065, 15575, 16230, 18690, 18736, 18745, 19120, 19130, 21230, 71105   >PIC FILE= "T9001000">  (B) LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH COME INTO CONTACT ONLY BRIEFLY WITH THE SKIN  Reds  11210, 12090, 12155, 12170, 12315, 12370, 12459, 12460, 13020, 14895, 14905, 16045, 16180, 18125, 18130, 24790, 27300, 27306, 28160, 45220, 60505, 60710, 62015, 73300  Yellows and oranges  11720, 11725, 11730, 11765, 11850, 11855, 11860, 11870, 12055, 12140, 12700, 12740, 12770, 12790, 13900, 14600, 15970, 15975, 18820, 18900, 19555, 21090, 21096, 21100, 21108, 21110, 21115, 22910, 25135, 25220, 26090, 29020, 40215, 40640, 41000, 45376, 47035, 48040, 48055, 56205, 4-(3-chlorphenylazo)-3-hydroxy-2 naphth-0-anisidide, trisodium 3-hydroxypyren-5,8,10- trisulphonate  Blues and greens  10025, 26360, 42052, 42085, 42095, 42100, 50315, 50320, 50400, 50405, 51175, 52015, 52020, 52030, 61505, 61585, 62045, 62100, 62105, 62125, 62130, 62500, 62560, 63010, 64500, 74180  Violets, browns, blacks and whites  12145, 14805, 15685, 17580, 20285, 20470, 21010, 25410, 30045, 30235, 40625, 42510, 42520, 42525, 42535, 42650, 48013, 57020, 60730, 61100, 61105, 61705, 62030, 63165, 63615      ANNEX V LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE    1. Lead acetate (for use in hair treatment products only).       2. Hexachlorophene* (for all uses other than that stated in Part 1 of Annex III).       3. Hormones      (a)        - oestrone,               - oestradiol and its esters,               - oestriol and its esters;                         (b)         - progesterone,  - Ethisterone*.              4. p-Phenylenediamine and its salts.       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.       6. Zirconium and its derivatives.       7. Thiomersal* and phenylmercuric compounds (for use as preservatives in concentrated shampoos and creams containing non-ionic emulsifiers which render other preservatives ineffective ; maximum concentration 0.003 % calculated as Hg).       8. Lidocaine*.       9. Tyrothricin*.