Avis juridique important

|

31998L0091

Directive 98/91/EC of the European Parliament and of the Council of 14 December 1998 relating to motor vehicles and their trailers intended for the transport of dangerous goods by road and amending Directive 70/156/EEC relating to the type approval of motor vehicles and their trailers

Official Journal L 011 , 16/01/1999 P. 0025 - 0036

DIRECTIVE 98/91/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 December 1998 relating to motor vehicles and their trailers intended for the transport of dangerous goods by road and amending Directive 70/156/EEC relating to the type approval of motor vehicles and their trailersTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),Having regard to Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (4), which transposes into Community law the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR),Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital must be ensured;Whereas total harmonisation regarding the technical requirements for vehicles intended for the transport of dangerous goods by road is necessary in order fully to achieve that objective;Whereas technical barriers to trade regarding the provisions for EC type approval of vehicles intended for the transport of dangerous goods by road should be eliminated in order to allow the market organisation in question to operate smoothly;Whereas it is therefore necessary in the context of the internal market to harmonise the standards for means of transport of dangerous goods by road;Whereas it is necessary to harmonise the approval procedures in the Member States;Whereas this Directive will be one of the separate Directives which must be fulfilled in order to comply with the EC type-approval procedure which has been established by Directive 70/156/EEC (5) and in order to ensure the conformity of vehicles with the requirements of the EC type-approval procedure established by that Directive; whereas, therefore, the provisions of Directive 70/156/EEC relating to vehicles apply to this Directive;Whereas, in particular, Article 3(4) and Article 4(3) of Directive 70/156/EEC require each separate Directive to have an information document attached to it incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type approval may be computerised,HAVE ADOPTED THIS DIRECTIVE:Article 1 This Directive shall apply to vehicles of categories 'N` and 'O`, as defined in Article 2 and Annex II to Directive 70/156/EEC, intended for the transport of dangerous goods by road within or between Member States.The scope, definition, classification and requirements relating to such vehicles and the administrative provisions for EC type approval thereof are set out in Annexes I and II respectively to this Directive.Article 2 For the purposes of this Directive:- 'dangerous goods` shall mean substances and articles as defined in Article 2 of Directive 94/55/EC,- 'transport` shall mean road transport operation as defined in Article 2 of Directive 94/55/EC.Article 3 Directive 70/156/EEC shall be amended by the addition of:(a) the following item to Annex I:>START OF GRAPHIC>'14. SPECIAL PROVISIONS FOR VEHICLES INTENDED FOR THE TRANSPORT OF DANGEROUS GOODS14.1. Electrical equipment according to Directive 94/55/EC14.1.1. Protection against overheating of conductors:14.1.2. Type of circuit breaker:14.1.3. Type and operation of battery master switch:14.1.4. Description and location of safety barrier for tachograph:14.1.5. Description of permanently energised installations. Indicate the EN standard applied:14.1.6. Construction and protection of electrical installation situated to the rear of the driver's compartment:14.2. Prevention of fire risks14.2.1. Type of not readily flammable material in the driver's compartment:14.2.2. Type of heat shield behind the driver's compartment (if applicable):14.2.3. Position and heat protection of engine:14.2.4. Position and heat protection of the exhaust system:14.2.5. Type and design of the endurance braking systems heat protection:14.2.6. Type, design and position of combustion heaters:14.3. Special requirements for bodywork, if any, according to Directive 94/55/EC14.3.1. Description of measures to comply with the requirements for Type EX/II and Type EX/III vehicles:14.3.2. In the case of Type EX/III vehicles, resistance against heat from the outside:`;>END OF GRAPHIC>(b) the following item in Part I of Annex IV:>TABLE>Article 4 1. Member States may not:- refuse, in respect of a type of vehicle, to grant EC type approval or to grant national type approval, or- prohibit the registration, sale or entry into service of base vehicles or complete vehicles as defined in Article 2 of Directive 70/156/EECon grounds relating to the transport of dangerous goods if the requirements of the Annexes to this Directive are fulfilled.2. Member States may not prohibit the registration, sale or entry into service of a vehicle completed from a base vehicle as defined in Article 2 of Directive 70/156/EEC on grounds relating to the base vehicle and to the transport of dangerous goods:- if for the base vehicle the requirements of the Annexes to this Directive are fulfilled and if the completion of the base vehicle has not invalidated this compliance, or- if for the completed vehicle the requirements of the Annexes to this Directive are fulfilled.Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 16 January 2000 at the latest, and shall forthwith inform the Commission thereof.When the Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.Member States shall communicate to the Commission the texts of the main provisions of the national law which they adopt in the field governed by this Directive.Article 6 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 7 This Directive is addressed to the Member States.Done at Brussels, 14 December 1998.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentW. MOLTERER(1) OJ C 29, 30. 1. 1997, p. 17, and OJ C 207, 3. 7. 1998, p. 18.(2) OJ C 296, 29. 9. 1997, p. 1.(3) Opinion of the European Parliament of 19 February 1998 (OJ C 80, 16. 3. 1998, p. 209), Council Common Position of 29 June 1998 (OJ C 262, 19. 8. 1998, p. 1) and Decision of the European Parliament of 20 October 1998 (OJ C 341, 9. 11. 1998). Council Decision of 7 December 1998.(4) OJ L 319, 12. 12. 1994, p. 7. Directive as amended by Directive 96/86/EC (OJ L 335, 24. 12. 1996, p. 43).(5) Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (OJ L 42, 23. 2. 1970, p. 1). Directive as last amended by Directive 98/14/EC (OJ L 91, 25. 3. 1998, p. 1).ANNEX I SCOPE, DEFINITION, CLASSIFICATION, REQUIREMENTS 1. SCOPE 1.1. This Directive shall apply to any vehicle, whether complete (e.g. one stage built vans, lorries, tractors, trailers), incomplete (e.g. chassis cab, trailer chassis), or completed (e.g. chassis, chassis cab fitted with a body work), intended for the transport of dangerous goods by road.2. DEFINITION 2.1. A 'type of vehicle` shall consist of vehicles which do not differ in at least the following essential aspects:- manufacturer,- manufacturer's type designation,- category,- essential aspects of construction and design in relation with the 'Technical provisions` in Appendix B2 to Annex B to Directive 94/55/EC.3. CLASSIFICATION OF VEHICLES INTENDED FOR THE TRANSPORT OF DANGEROUS GOODS BY ROAD 3.1. Vehicles intended for the transport of dangerous goods by road are classified according to marginal 220 301 of Annex B to Directive 94/55/EC as follows:3.1.1. EX/II for vehicles intended for the carriage of explosives as type II transport units;3.1.2. EX/II Ifor vehicles intended for the carriage of explosives as type III transport units;3.1.3. FL for vehicles intended for the carriage of liquids with a flashpoint of not more than 61 °C or flammable gases, in tank-containers of more than 3 000 litres capacity, fixed tanks or demountable tanks and for battery vehicles of more than 1 000 litres capacity intended for the carriage of flammable gases;3.1.4. OX for vehicles intended for the carriage of substances of class 5.1, marginal 2501, item 1(a), in tank-containers of more than 3 000 litres capacity, fixed tanks or demountable tanks;3.1.5. AT for vehicles, other than those of types FL or OX, intended for the carriage of dangerous goods in tank-containers of more than 3 000 litres capacity, fixed tanks or demountable tanks and for battery vehicles of more than 1 000 litres capacity other than those of type FL.4. REQUIREMENTS The requirements regarding the construction of vehicles intended for the carriage of dangerous goods by road, including the provisions for their type approval, where appropriate, laid down in marginals 220 500 to 220 540 of Annex B to Directive 94/55/EC, shall be fulfilled.ANNEX II ADMINISTRATIVE PROVISIONS FOR EC TYPE APPROVAL 1. APPLICATION FOR EC TYPE APPROVAL 1.1. The application for EC type approval pursuant to Article 3(4) of Directive 70/156/EEC of a vehicle type intended for the transport of dangerous goods by road shall be submitted by the manufacturer.1.2. A model of the information document is given in Appendix 1.1.3. A vehicle or vehicles conforming to the characteristics described in Appendix 1 to this Directive and selected to the satisfaction of the technical service in charge of the approval tests or checks as being representative of the type to be approved, must be submitted to that technical service.2. GRANTING OF EC TYPE APPROVAL 2.1. If the relevant requirements are satisfied, EC type approval pursuant to Article 4(3) and, if applicable, Article 4(4) of Directive 70/156/EEC shall be granted.2.2. A model of the EC type-approval certificate is given in Appendix 2.2.3. An approval number in accordance with Annex VII to Directive 70/156/EEC shall be assigned to each type of vehicle approved. The same Member State shall not assign the same number to another type of vehicle.3. MODIFICATION OF THE TYPE AND AMENDMENTS TO APPROVALS 3.1. In the case of modification of a vehicle type-approved pursuant to this Directive, the provisions of Article 5 of Directive 70/156/EEC shall apply.3.2. A partial test as defined by the technical service in relation to the modifications made may be carried out.4. CONFORMITY OF PRODUCTION Measures to ensure the conformity of production shall be taken in accordance with the provisions laid down in Article 10 of Directive 70/156/EEC.Appendix 1 INFORMATION DOCUMENT No . . . pursuant to Annex I to Directive 70/156/EEC relating to the EC type approval of a vehicle intended for the transport of dangerous goods by road >START OF GRAPHIC>The following information, if applicable, must be supplied in triplicate and include a list of contents. Any drawings must be supplied in appropriate scale and in sufficient detail on size A4 (210 mm × 297 mm) or on a folder of A4 format. Photographs, if any, must show sufficient detail.If the systems, components or separate technical units have electronic controls, information concerning their performance must be supplied.0.GENERAL0.1.Make (trade name of manufacturer):0.2.Type:0.2.1.General commercial name(s) (if applicable):0.3.Means of identification of type, if marked on the vehicle (b) (1):0.3.1.Location of that marking:0.4.Category of vehicle (c):0.4.1.Classification(s) according to the dangerous goods which the vehicle is intended to transport:0.5.Name and address of manufacturer:0.8.Address(es) of assembly plant(s):1.GENERAL CONSTRUCTION CHARACTERISTICS OF THE VEHICLE1.1.Photographs and/or drawings of a representative vehicle:1.6.Position and arrangement of the engine:2.MASSES AND DIMENSIONS (e) (in kg and mm)2.8.Technically permissible maximum laden mass stated by the manufacturer (y) (maximum and minimum for each variant):2.9.Technically permissible maximum load/mass on each axle:2.10.Technically permissible maximum load/mass on each axle group:3.POWER PLANT (q)3.2.Internal combustion engine3.2.2.Fuel: diesel oil/petrol/LPG/any other (2)3.2.3.1.Service Fuel tanks3.2.3.1.2.Drawing and technical description of the tank(s) with all connections and all lines of the breathing and venting system, locks, valves, fastening devices:(1) The item numbers and footnotes used in this information document correspond to those set out in Annex I to Directive 70/156/EEC. Items not relevant for the purpose of Directive 70/156/CEE are omitted.(2) Delete where not applicable.3.2.3.1.3.Drawing clearly showing the position of the tank (s) in the vehicle:3.2.3.2.Reserve fuel tanks3.2.3.2.2.Drawing and technical description of the tank (s) with all connections and all lines of the breathing and venting system, locks, valves, fastening devices:3.2.3.2.3.Drawing clearly showing the position of the tank (s) in the vehicle:8.BRAKES8.5.Anti-lock braking system: Yes/No/optional (1)8.5.1.For vehicles with anti-lock systems, description of system operation (including any electronic parts), electric block diagram, hydraulic or pneumatic circuit plan:8.9.Brief description of the braking devices (according to item 1.6 of the Addendum to Appendix 1 of Annex IX to Directive 71/320/EEC):8.11.Particulars of the type (s) of endurance braking system (s):9.BODYWORK9.1.Type of bodywork:9.2.Materials used and method of construction:12.MISCELLANEOUS12.6.Speed limiters12.6.1.Manufacturer (s):12.6.2.Type (s):12.6.3.Approval number (s), if available:14.SPECIAL PROVISIONS FOR VEHICLES INTENDED FOR THE TRANSPORT OF DANGEROUS GOODS14.1.Electrical equipment according to Directive 94/55/EC:14.1.1.Protection against overheating of conductors:14.1.2.Type of circuit breaker:14.1.3.Type and operation of battery master switch:14.1.4.Description and location of safety barrier for tachograph:14.1.5.Description of permanently energised installations. Indicate the EN standard applied:14.1.6.Construction and protection of electrical installation situated to the rear of the driver's compartment:14.2.Prevention of fire risks:14.2.1.Type of not readily flammable material in the driver's compartment:(1) Delete where not applicable.14.2.2.Type of heat shield behind the driver's compartment (if applicable):14.2.3.Position and heat protection of engine:14.2.4.Position and heat protection of the exhaust system:14.2.5.Type and design of the endurance braking systems heat protection:14.2.6.Type, design and position of combustion heaters:14.3.Special requirements for bodywork, if any, according to Directive 94/55/EC:14.3.1.Description of measures to comply with the requirements for Type EX/II and Type EX/III vehicles:14.3.2.In the case of Type EX/III vehicles, resistance against heat from the outside:>END OF GRAPHIC>Appendix 2 MODEL(maximum format: A4 (210 × 297 mm))EC TYPE-APPROVAL CERTIFICATE >START OF GRAPHIC>Stamp of AdministrationCommunication concerning the:- type approval (1),- extension of type approval (1),- refusal of type approval (1),- withdrawal of type approval (1),of a type of vehicle/component/separate technical unit (1) with regard to Directive 98/91/EC relating to motor vehicles and their trailers intended for the transport of dangerous goods by road and amending Directive 70/156/EEC relating to the type approval of motor vehicles and their trailers.EC type approval No:Reason for extension:SECTION I0.1.Make (trade name of manufacturer):0.2.Type:0.2.1.Commercial name (s) (if applicable):0.3.Means of identification of type, if marked on the vehicle/component/separate technical unit (2):0.3.1.Location of that marking:0.4.Category of vehicle (3):0.5.Name and address of manufacturer:Name and address of manufacturer of the latest-built stage of the vehicle:0.8.Name (s) and address (es) of assembly plant (s):(1) Delete where not applicable.(2) If the means of identification of type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this type-approval certificate, such characters shall be represented in the documentation by the symbol '?` (e.g. ABC??123??).(3) As defined in Annex II.A to Directive 70/156/EEC.SECTION II1.Additional information (where applicable) see Addendum2.Technical service responsible for carrying out the tests:3.Date of test report:4.Number of test report:5.Any remarks (see Addendum):6.Place:7.Date:8.Signature:9.The index to the type-approved file submitted to the component authorities, which may be obtained on request, is attached.Addendumto EC type-approval certificate No . . . concerning the type approval of a vehicle intended for the transport of dangerous goods by road with regard to Directive 98/91/EC1.Additional information (1)1.1.Classification in accordance with paragraph 3 of Annex I:1.2.Brief description of the vehicle type as regards its structure, dimensions, and constituent materials:1.3.Location of engine (for Types EX/II and EX/III including location forward of the front of the loading compartment or under the loading compartment):5.Remarks: `.(1) If necessary, reference can be made to the information document.>END OF GRAPHIC>


title: Commission Directive 2010/3/EU of 1 February 2010 amending, for the purpose of adaptation to technical progress, Annexes III and VI to Council Directive 76/768/EEC concerning cosmetic products

text:
               2.2.2010

               EN

               Official Journal of the European Union

               L 29/5

         COMMISSION DIRECTIVE 2010/3/EU
   of 1 February 2010
   amending, for the purpose of adaptation to technical progress, Annexes III and VI to Council Directive 76/768/EEC concerning cosmetic products
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Safety,
   Whereas:

               (1)

               The Scientific Committee on Consumer Products (SCCP), subsequently replaced by the Scientific Committee on Consumer Safety (SCCS) by Commission Decision 2008/721/EC (2), concluded in its opinion of 15 April 2008 that Ethyl Lauroyl Arginate HCl is safe for the consumers, when used up to a maximum authorised concentration of 0,8 % in soap, anti-dandruff shampoos, and non-spray deodorants. It should therefore be included in Annex III to Directive 76/768/EEC.

               (2)

               The SCCP concluded in the same opinion that Ethyl Lauroyl Arginate HCl is safe for the consumers, when used up to a maximum authorised concentration of 0,4 % as a preservative in cosmetic products. However, the Committee considered that it should not be used in lip products, oral products and spray due to mucosal and respiratory tract irritation potential. It should therefore be included along with these restrictions in Annex VI to Directive 76/768/EEC.

               (3)

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

               (4)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes III and VI to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 1 September 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply those provisions from 1 March 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 1 February 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 262, 27.9.1976, p. 169.

      (2)  OJ L 241, 10.9.2008, p. 21.

      ANNEX

                  1.

                  In the table set out in Part 1 of Annex III to Directive 76/768/EEC, the following entry is added:

                              Reference number

                              Substance

                              Restrictions

                              Conditions of use and warnings which must be printed on the label

                              Field of application and/or use

                              Maximum authorised concentration in the finished cosmetic product

                              Other limitations and requirements

                              a

                              b

                              c

                              d

                              e

                              f

                              ‘207

                              Ethyl Lauroyl Arginate HCl (INCI) (1)

                              Ethyl-Να-dodecanoyl-L-arginate hydrochloride
                              CAS No 60372-77-2
                              EC No 434-630-6

                                          (a)

                                          soap

                                          (b)

                                          anti-dandruff shampoos

                                          (c)

                                          deodorants, not in form of spray

                              0,8 %

                              For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

                  2.

                  In the table set out in Part 1 of Annex VI to Directive 76/768/EEC, the following entry is added:

                              Reference number

                              Substance

                              Maximum authorised concentration

                              Limitations and requirements

                              Conditions of use and warnings which must be printed on the label

                              a

                              b

                              c

                              d

                              e

                              ‘58

                              Ethyl Lauroyl Arginate HCl (INCI) (*) (2)

                              Ethyl-Να-dodecanoyl-L-arginate hydrochloride
                              CAS No 60372-77-2
                              EC No 434-630-6

                              0,4 %

                              Not to be used in lip products, oral products and spray products.

         (1)  For use as a preservative, see Annex VI, Part 1, entry No 58.’

         (2)  For other uses than preservatives, see Annex III, Part I, entry No 207.’


Avis juridique important

|

31987L0112

Commission Directive 87/112/EEC of 23 December 1986 adapting to technical progress for the second time Council Directive 84/631/EEC on the supervision and control within the European Community of the transfrontier shipment of hazardous waste

Official Journal L 048 , 17/02/1987 P. 0031 - 0032

*****COMMISSION  DIRECTIVE  of 23 December 1986  adapting to technical progress for the second time Council Directive 84/631/EEC on the supervision and control within the European Community of the transfrontier shipment of hazardous waste  (87/112/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste (1), and in particular Article 18 thereof,  Having regard to Council Directive 84/631/EEC of 6 December 1984 on the supervision and control within the European Community on the transfrontier shipment of hazardous waste (2), as last amended by Council Directive 86/279/EEC (3), and in particular Articles 3, 4, 5, 7, 15 and 17 thereof,  Whereas, in order to ensure effective supervision and control, it is necessary that the holder of waste intending to ship it or to have it shipped from one Member State to another or through one or more Member States or to ship it to a Member State from a third State or from a Member State to a third State should inform the competent authorites of the Member States concerned;  Whereas such notificaiton must be made by means of a uniform consignment note the contents of which are set out in Annex I to Directive 84/631/EEC as amended by Directive 85/469/EEC (4) in accordance with the procedure described in Annex IV thereto;  Whereas in the case of shipments of waste to countries outside the Community it is necessary to amend the general instructions concerning the uniform consignment note;  Whereas in the case of non-ferrous metal waste intended for re-use, regeneration or recycling on the basis of a contractual agreement regarding such operations only declarations on a uniform document are required as described in Annex II to Directive 85/469/EEC;  Whereas in the case of shipments to countries outside the Community the procedure for using this document as described therein should be amended;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of Directive 78/319/EEC on toxic and dangerous waste,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annexes II and IV to Directive 85/469/EEC are hereby amended as follows:  1. In Annex II, paragraph 3 of the instructions concerning the form entitled 'Declarations concerning waste from non-ferrous metals for re-use, regeneration or recycling' is replaced by the following text in the four copies of the form:  '3. The holder of the waste must keep copy 3 of the form and, before the shipment is carried out, send copy 4 to the competent authority of the Member State of destination or, in the case of waste exported from the Community, to the competent authority of the Member State of dispatch and the Member State where the waste will leave the Community (photocopy).'  2. In Annex IV, in the section entitled 'General instructions concerning the uniform consignment note',  (a) paragraphs A. 2, A. 3 and A. 4 are replaced by the following text:  '2. in the case of a single shipment of waste, the disposal of which will take place outside the Community, the three copies of the form to the competent authority of the Member State of dispatch, or to the competent authority of the Member State of exit from the Community where disposal of the waste takes place in a third State bordering on the latter and that Member State exercises its right to issue the acknowledgement of receipt in accordance with the last subparagraph of Article 4 (2) of Directive 84/631/EEC as amended by Directive 86/279/EEC;  3. in the case of a single shipment of waste from a third State routed through the Community for disposal outside the Community, the three copies of the form to the competent authority of the Member State of exit from the Community;  4. in the case of several shipments (general notification), copies 1 and 2 of the form and a number of copies 3 corresponding to the number of shipments to be carried out, to the competent authorities referred to under A.1, A.2 or A.3;  5. in all the cases referred to under 1 to 4, a photocopy of copy 1 of the form to the competent authorities of all the other States concerned: Member States of dispatch and transit, third State(s) of transit and destination.'  (b) the last sentence of point B is replaced by the following text:  'The competent authority of the Member State making the acknowledgment sends a photocopy of copy 2 to the competent authorities of the other Member States concerned and, where appropriate, to the third State of destination and to the third State or States of transit and to the consignee.'  (c) the second sentence of point E is replaced by the following text:  'In the case of a shipment of waste the disposal of which will take place outside the Community, copy 3 must be lodged with the customs office through which the waste finally leaves the Community.'  (d) point G is replaced by the following text:  'G. In the case of export of waste from the Community for disposal outside the Community the holder of the waste must certify to the competent authority of the Member State which issued the acknowledgement of the notification of shipment, not later than six weeks after the waste has left the Community, that the waste has reached its destination and shall indicate the last customs office through which the waste finally left the Community.'  3. In Annex IV, in the section entitled 'Instructions for filling in the form', subsection B entitled 'Instructions for filling in copies 1, 2 and 3 of the form', the paragraph entitled 'Box 8' is replaced by the following text:  'Box 8 Attach the information, signed by the consignee, relating to the contractual agreement between the holder and the consignee concerning the waste referred to in the notification in question. If applicable, attach:  - lists of producers/carriers (boxes 5 and 6),  - details concerning the waste (box 22),  - proof of the agreement to the shipment of the third State of destination, in the case of shipment of waste from a Member State for disposal in the third State.'  Article 2  Member State shall take the measures necessary to comply with this Directive as from 1 January 1987. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 23 December 1986.  For the Commission  Stanley CLINTON DAVIS  Member of the Commission  (1) OJ No L 84, 31. 3. 1978, p. 43.  (2) OJ No L 326, 13. 12. 1984, p. 31.  (3) OJ No L 181, 4. 7. 1986, p. 13.  (4) OJ No L 272, 12. 10. 1985, p. 1.


Avis juridique important

|

31993L0073

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products

Official Journal L 231 , 14/09/1993 P. 0034 - 0053 Finnish special edition: Chapter 13 Volume 25 P. 0013  Swedish special edition: Chapter 13 Volume 25 P. 0013

FIFTH COMMISSION DIRECTIVE 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic productsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 93/35/EEC (2), and in particular Article 8 (1) thereof,  Whereas Directive 76/768/EEC provides for the official testing of cosmetic products with the aim of ensuring that the conditions laid down by Community provisions concerning the composition of cosmetic products are satisfied;  Whereas all the necessary methods of analysis should be laid down as quickly as possible; whereas four steps have already been taken by Commission Directive 80/1335/EEC (3), as amended by Directive 87/143/EEC (4), Commission Directive 82/434/EEC (5), as  amended by Directive 90/207/EEC (6) and Commission Directives 83/514/EEC (7) and 85/490/EEC (8); whereas the identification and determination of silver nitrate, the identification and determination of silver nitrate, the identification and determination  of selenium disulphide in anti-dandruff shampoos, the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes, the identification and determination of benzyl alcohol, the identification of zirconium, and the  determination of zirconium, aluminium and chlorine in non-aerosol antiperspirants and the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine, constitute a fifth step;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation of Directive 76/768/EEC to technical progress,  HAS ADOPTED THIS DIRECTIVE:   Article 1  Member States shall take all necessary steps to ensure that during official testing of cosmetic products, the:  - identification and determination of silver nitrate,  - identification and determination of selenium disulphide in anti-dandruff shampoos,  - determination of soluble barium and soluble strontium in pigments in the form of salts or lakes,  - identification and determination of benzyl alcohol,  - identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol antiperspirants,  - identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine,  shall be carried out in accordance with the methods described in the Annex.   Article 2  1. Member States shall bring into force the laws, regulations or administrative provisions needed to comply with this Directive no later than 30 September 1994. The shall forthwith inform the Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.   Article 3  This Directive is addressed to the Member States Done at Brussels, 9 September 1993.  For the Commission Christiane SCRIVENER Member of the Commission  (1) OJ No L 262, 27. 9. 1976, p. 169.  (2) OJ No L 151, 23. 6. 1993, p. 32.  (3) OJ No L 383, 31. 12. 1980, p. 27.  (4) OJ No L 57, 27. 2. 1987, p. 56.  (5) OJ No L 185, 30. 6. 1982, p. 1.  (6) OJ No L 108, 28. 4. 1990, p. 92.  (7) OJ No L 291, 24. 10. 1983, p. 9.  (8) OJ No L 295, 7. 11. 1985, p. 30.     ANNEX  IDENTIFICATION AND DETERMINATION OF SILVER NITRATE IN COSMETIC PRODUCTS A. Identification 1. Scope and field of application  This method describes the identification of silver nitrate as silver in aqueous cosmetic products.  2. Principle  Silver is identified by the characteristic white precipitate formed with chloride ions.  3. Reagents  All reagents must be of analytical purity.  3.1. Hydrochloric acid solution, 2 M 3.2. Ammonia solution: dilute concentrated ammonium hydroxide solution (d20 = 0,88 g/ml) with an equal quantity of water and mix.  3.3. Nitric acid solution, 2 M 4. Apparatus 4.1. Normal laboratory equipment 4.2. Centrifuge 5. Procedure 5.1. To about 1 g of sample in a centrifuge tube add 2 M hydrochloric acid solution (3.1) dropwise until precipitation is complete; mix and centrifuge.  5.2. Discard the supernatant liquid and wash the precipitate once with five drops of cold water. Reject the washings.  5.3. Add a quantity of water equal to the bulk of precipitate in the centrifuge tube. Heat to boiling and stir.  5.4. Centrifuge hot; discard the supernatant liquid.  5.5. To the precipitate add a few drops of ammonia solution (3.2); mix and centrifuge.  5.6. To one drop of the supernatant liquid on a glass slide add a few drops of 2 M nitric acid solution (3.3).  5.7. A white precipitate indicates the presence of silver.   B. Determination 1. Scope and field of application  This method is suitable for the determination of silver nitrate as silver in cosmetic products intended to dye eyelashes or eyebrows.  2. Principle  Silver is determined in the product by atomic absorption spectrometry.  3. Reagents  All reagents must be of analytical purity.  3.1. Nitric acid solution, 0,02 M 3.2. Silver standard solutions 3.2.1. Stock silver standard solution, 1 000 mg/ml in 0,5 M nitric acid solution ('SpectrosoL' or equivalent) 3.2.2. Silver standard solution, 100 mg/ml: transfer by pipette 10 ml of the stock silver standard solution (3.2.1) into a 100-ml volumetric flask. Make up to volume with 0,02 M nitric acid solution (3.1) and mix. This standard solution should be  freshly prepared and stored in a dark-coloured glass bottle 4. Apparatus 4.1. Normal laboratory equipment 4.2. Atomic absorption spectrophotometer equipped with a silver hollow-cathode lamp 5. Procedure 5.1. Sample preparation  Weigh accurately approximately 0,1 g (m gram) of an homogenous sample of the product. Transfer quantitatively into a one-litre volumetric flask and make up to volume with 0,02 M nitric acid solution (3.1) and mix.  5.2. Conditions for atomic absorption spectrometry  Flame: air-acetylene  Wavelength: 338,3 nm  Background correction: yes  Fuel condition: lean; for maximum absorbance, optimization of burner height and fuel conditions will be necessary.  5.3. Calibration 5.3.1. Into a series of 100-ml volumetric flasks transfer by pipette 1,0, 2,0, 3,0, 4,0 and 5,0 ml of the silver standard solution (3.2.2). Make up each flask to volume with 0,02 M nitric acid solution (3.1) and mix. These solutions contain 1,0, 2,0,  3,0, 4,0 and 5,0 mg silver per millilitre, respectively.  5.3.2. Measure the absorbance of a 0,02 M nitric acid solution (3.1) and use the value obtained as the zero silver concentration for the calibration curve. Measure the absorbance of each silver calibration standard (5.3.1). Plot a calibration curve  relating absorbance values to silver concentration.  5.4. Determination  Measure the absorbance of the sample solution (5.1). From the calibration curve read off the concentration of silver corresponding to the absorbance value obtained for the sample solution.  6. Calculation  Calculate the silver nitrate content of the sample, in percentage by mass (% m/m), using the formula:    % (m/m) of silver nitrate = 1,5748 × c 10 × m in which:  m = mass in grams of the sample taken for analysis (5.1); and c = concentration of silver in the sample solution (5.1), in micrograms per millilitre, obtained from the calibration curve. 7. Repeatability (1)  For a silver nitrate content of 4 % (m/m) the difference between the results of two determinations carried out in parallel on the same sample should not exceed 0,05 % (m/m).   IDENTIFICATION AND DETERMINATION OF SELENIUM DISULPHIDE IN ANTI-DANDRUFF SHAMPOOS  A. Identification 1. Scope and field of application  This method describes the identification of selenium disulphide as selenium in anti-dandruff shampoos.  2. Principle  Selenium is identified by the characteristic yellow to orange colour produced on reaction with urea and potassium iodide.  3. Reagents  All reagents must be of analytical purity.  3.1. Nitric acid, concentrated (d20 = 1,42 g/ml) 3.2. Urea 3.3. Potassium iodide solution, 10 % (m/v): dissolve 10 g of potassium iodide in 100 ml of water 4. Apparatus 4.1. Normal laboratory equipment 4.2. Digestion tube, 100-ml capacity 4.3. Heated-block digestor 4.4. Filter paper (Whatman No 42 or equivalent) or a 0,45 mm membrane filter 5. Procedure 5.1. To approximately 1 g of shampoo in a digestion tube (4.2) add 2,5 ml of concentrated nitric acid (3.1) and digest at 150° C for 30 minutes on a heated-block digestor (4.3).  5.2. Dilute the digested sample to 25 ml with water and filter through a filter paper or a 0,45 mm membrane filter (4.4).  5.3. To 2,5 ml of the filtrate add 5 ml water, 2,5 g urea (3.2) and boil. Cool and add 1 ml of potassium iodide solution (3.3).  5.4. A yellow to orange colour which darkens rapidly on standing indicates the presence of selenium.   B. Determination 1. Scope and field of application  This method is suitable for the determination of selenium disulphide as selenium in anti-dandruff shampoos containing up to 4,5 % (m/m) selenium disulphide.  2. Principle  The sample is digested with nitric acid and the selenium in the resultant digest determined by means of atomic absorption spectrometry.  3. Reagents  All reagents must be of analytical purity.  3.1. Nitric acid, concentrated (d20 = 1,42 g/ml) 3.2. Nitric acid solution, 5 % (v/v): add 50 ml concentrated nitric acid (3.1) to 500 ml of water in a beaker, stirring continuously. Transfer this solution to a one-litre volumetric flask and make up to volume with water.  3.3. Stock selenium standard solution, 1 000 mg/ml in 0,5 M nitric acid solution ('SpectrosoL' or equivalent) 4. Apparatus 4.1. Normal laboratory equipment 4.2. Digestion tube, 100-ml capacity 4.3. Heated-block digestor 4.4. Filter paper (Whatman No 42 or equivalent) or a 0,45 mm membrane filter 4.5. Atomic absorption spectrophotometer equipped with a selenium hollow-cathode lamp 5. Procedure 5.1. Sample preparation 5.1.1. Weigh accurately approximately 0,2 g (m gram) of an homogenous sample of shampoo into a digestion tube (4.2).  5.1.2. Add 5 ml of concentrated nitric acid (3.1) and digest at 150 °C for one hour on a heated-block digestor (4.3).  5.1.3. Allow solution to cool and dilute to 100 ml with water. Filter through a filter paper or a 0,45 mm membrane filter (4.4) and retain the filtered solution for the determination.  5.2. Conditions for atomic absorption spectrometry  Flame: air-acetylene  Wavelength: 196,0 nm  Background correction: yes  Fuel condition: lean; for maximum absorbance, optimization of burner height and fuel conditions will be necessary.  5.3. Calibration 5.3.1. Into a series of 100-ml volumetric flasks, transfer by pipette 1,0, 2,0, 3,0, 4,0 and 5,0 ml of the stock selenium standard solution (3.3). Make up each flask to volume with 5 % (v/v) nitric acid solution (3.2) and mix. These solutions contain  10, 20, 30, 40 and 50 mg selenium per millilitre, respectively.  5.3.2. Measure the absorbance of a 5 % (v/v) nitric acid solution (3.2) and use the value obtained as the zero selenium concentration for the calibration curve. Measure the absorbance of each selenium calibration standard (5.3.1). Plot a calibration  curve relating absorbance values to selenium concentration.  5.4. Determination  Measure the absorbance of the sample solution (5.1.3). From the calibration curve read off the concentration of selenium corresponding to the absorbance value obtained for the sample solution.  6. Calculation  Calculate the selenium disulphide content of the sample, in percentage by mass (% m/m), using the formula:    % (m/m) of selenium disulphide = 1,812 × c 100 × m in which:  m = mass in grams of the sample taken for analysis (5.1.1); and c = concentration of selenium in the sample solution (5.1.3), in micrograms per millilitre, obtained from the calibration curve. 7. Repeatability (2)  For a selenium disulphide content of 1 % (m/m) the difference between the results of two determinations carried out in parallel on the same sample should not exceed 0,05 % (m/m).   DETERMINATION OF SOLUBLE BARIUM AND STRONTIUM IN PIGMENTS IN THE FORM OF SALTS OR LAKES  A. Determination of soluble barium 1. Scope and field of application  This method describes the procedure for extracting and determining soluble barium from pigments in the form of salts or lakes.  2. Principle  The pigment is extracted with 0,07 M hydrochloric acid solution under defined conditions and the amount of barium in the extractant determined by atomic absorption spectrometry.   3. Reagents  All reagents must be of analytical purity.  3.1. Ethanol, absolute 3.2. Hydrochloric acid solution, 0,07 M 3.3. Hydrochloric acid solution, 0,5 M 3.4. Potassium chloride solution, 8 % (m/v): dissolve 16 g of potassium chloride in 200 ml of 0,07 M hydrochloric acid solution (3.2).  3.5. Barium standard solutions 3.5.1. Stock barium standard solution, 1 000 mg/ml in 0,5 M nitric acid solution, ('SpectrosoL' or equivalent) 3.5.2. Barium standard solution, 200 mg/ml: transfer by pipette 20,0 ml of the stock barium standard solution (3.5.1) into a 100-ml volumetric flask. Make up to volume with 0,07 M hydrochloric acid solution (3.2) and mix.  4. Apparatus 4.1. Normal laboratory equipment 4.2. pH meter with an accuracy of ± 0,02 units 4.3. Wrist-action flask-shaker 4.4. Membrane filter with a pore size of 0,45 mm 4.5. Atomic absorption spectrophotometer equipped with a barium hollow-cathode lamp 5. Procedure 5.1. Sample preparation 5.1.1. Weigh accurately approximately 0,5 g (m gram) of pigment into a conical flask. To ensure sufficient volume for effective agitation a flask of capacity less than 150-ml shall not be used.  5.1.2. Add by pipette 1,0 ml of ethanol (3.1) and rotate the flask to ensure thorough wetting of the pigment. Add from a burette the exact quantity of 0,07 M hydrochloric acid solution (3.2) required to give a volume-of-acid to mass-of-pigment ratio of  exactly 50 millilitres per gram. Let the total volume of extractant including the ethanol be V ml. Swirl the contents of the flask for five seconds to ensure thorough mixing of the contents.  5.1.3. Using a pH meter (4.2) measure the pH of the resultant suspension and, if it is above 1,5, add 0,5 M hydrochloric acid solution (3.3) dropwise until in the range 1,4 to 1,5.  5.1.4. Stopper and immediately shake the flask for 60 minutes using a wrist-action flask-shaker (4.3). The shaker must be operated at a sufficiently high speed to produce a foam. Filter through a 0,45 mm membrane filter (4.4) and collect the filtrate.  Do not centrifuge the extract before filtering. Transfer by pipette 5,0 ml of the filtrate to a 50-ml volumetric flask; make up to volume with 0,07 M hydrochloric acid solution (3.2) and mix. This solution is also used for the determination of strontium  (Part B).  5.1.5. Into a 100-ml volumetric flask transfer by pipette 5,0 ml potassium chloride solution (3.4) and an aliquot (WBa ml) of the diluted filtrate (5.1.4) to give an expected concentration of between 3 and 10 mg barium per millilitre. (An aliquot of 10  ml should be a satisfactory starting point.) Make up to volume with 0,07 M hydrochloric acid solution (3.2) and mix.  5.1.6. Determine the barium concentration of the solution (5.1.5) by atomic absorption spectrometry on the same day.  5.2. Conditions for atomic absorption spectrometry  Flame: nitrous oxide/acetylene  Wavelength: 553,5 nm  Background correction: no  Fuel condition: lean; for maximum absorbance, optimization of burner height and fuel conditions will be necessary.  5.3. Calibration 5.3.1. Into a series of 100-ml volumetric flasks transfer by pipette 1,0, 2,0, 3,0, 4,0 and 5,0 ml of the barium standard solution (3.5.2). To each flask transfer by pipette 5,0 ml potassium chloride solution (3.4); make up to volume with 0,07 M  hydrochloric acid solution (3.2) and mix. These solutions contain 2,0, 4,0, 6,0, 8,0 and 10,0 mg barium per millilitre, respectively.   Similarly, prepare a blank solution omitting the barium standard solution.  5.3.2. Measure the absorbance of the blank solution (5.3.1) and use the value obtained as the zero barium concentration for the calibration curve. Measure the absorbance of each barium calibration standard (5.3.1). Plot a calibration curve relating  absorbance values to barium concentration.  5.4. Determination  Measure the absorbance of the sample solution (5.1.5). From the calibration curve read off the concentration of barium corresponding to the absorbance value obtained for the sample solution.  6. Calculation  The soluble barium content (% m/m) of the pigment is given by the formula:    % (m/m) of soluble barium = c × V 10WBa × m in which:  m = mass in grams of the sample taken for analysis (5.1.1); c = concentration of barium in the sample solution (5.1.5), in micrograms per millilitre, obtained from the calibration curve; V = total volume of extractant in millilitres (5.1.2); and WBa =  volume of extract, in millilitres, taken in 5.1.5. 7. Repeatability  The best available estimate of the repeatability (ISO 5725) for this method is 0,3 % for a soluble barium content of 2 % (m/m).  8. Remarks 8.1. Under certain conditions the barium absorbance can be enhanced by the presence of calcium. This can be countered by the addition of magnesium ion at a concentration of 5 g per litre (3).  8.2. The use of inductively-coupled plasma - optical emission spectrometry is permitted as an alternative to flame atomic absorption spectrometry.   B. Determination of soluble strontium 1. Scope and field of application  This method describes the procedure for extracting and determining soluble strontium from pigments in the form of salts or lakes.  2. Principle  The pigment is extracted with 0,07 M hydrochloric acid solution under defined conditions and the amount of strontium in the extractant determined by atomic absorption spectrometry.  3. Reagents  All reagents must be of analytical purity.  3.1. Ethanol, absolute 3.2. Hydrochloric acid solution, 0,07 M 3.3. Potassium chloride solution, 8 % (m/v): dissolve 16 g of potassium chloride in 200 ml of 0,07 M hydrochloric acid solution (3.2).  3.4. Strontium standard solutions 3.4.1. Stock strontium standard solution, 1 000 mg/ml in 0,5 M nitric acid solution ('SpectrosoL' or equivalent) 3.4.2. Strontium standard solution, 100 mg/ml: transfer by pipette 10,0 ml of the stock strontium standard solution (3.4.1) into a 100-ml volumetric flask. Make up to volume with 0,07 M hydrochloric acid solution (3.2) and mix.  4. Apparatus 4.1. Normal laboratory equipment 4.2. Membrane filter with a pore size of 0,45 mm 4.3. Atomic absorption spectrophotometer equipped with a strontium hollow-cathode lamp 5. Procedure 5.1. Sample preparation  The solution prepared in A.5.1.4 is used to determine the soluble strontium content.  5.1.1. Into a 100-ml volumetric flask transfer by pipette 5,0 ml potassium chloride solution (3.3) and an aliquot (WSr ml) of the diluted filtrate (A.5.1.4) to give an expected concentration of between 2 and 5 mg strontium per millilitre. (An aliquot of  25 ml should be a satisfactory starting point.) Make up to volume with 0,07 M hydrochloric acid solution (3.2) and mix.  5.1.2. Determine the strontium concentration of the solution (5.1.1) by atomic absorption spectrometry on the same day.  5.2. Conditions for atomic absorption spectrometry  Flame: nitrous oxide/acetylene  Wavelength: 460,7 nm  Background correction: no  Fuel condition: lean; for maximum absorbance, optimization of burner height and fuel conditions will be necessary.  5.3. Calibration 5.3.1. Into a series of 100-ml volumetric flasks transfer by pipette 1,0, 2,0, 3,0, 4,0 and 5,0 ml of the strontium standard solution (3.4.2). To each flask transfer by pipette 5,0 ml potassium chloride solution (3.3); make up to volume with 0,07 M  hydrochloric acid solution (3.2) and mix. These solutions contain 1,0, 2,0, 4,0, and 5,0 mg strontium per millilitre, respectively.   Similarly, prepare a blank solution omitting the strontium standard solution.  5.3.2. Measure the absorbance of the blank solution (5.3.1) and use the value obtained as the zero strontium concentration for the calibration curve. Measure the absorbance of each strontium calibration standard (5.3.1). Plot a calibration curve  relating peak absorbance values to strontium concentration.  5.4. Determination  Measure the absorbance of the sample solution (5.1.1). From the calibration curve read off the concentration of strontium corresponding to the absorbance value obtained for the sample solution.  6. Calculation  The soluble strontium content ( % m/m) of the pigment is given by the formula:    % (m/m) of soluble strontium = c × V 10WSr × m in which:  m = mass in grams of the sample taken for analysis (A.5.1.1); c = concentration of strontium in the sample solution (5.1.1), in micrograms per millilitre, obtained from the calibration curve; V = volume of extractant in millilitres (A.5.1.2); and WSr =  volume of extract, in millilitres, taken in 5.1.1. 7. Repeatability  The best available estimate of the repeatability (ISO 5725) for this method is 0,09 % for a soluble strontium content of 0,6 % (m/m).  8. Remark  The use of inductively-coupled plasma - optical emission spectrometry is permitted as an alternative to flame atomic absorption spectrometry. IDENTIFICATION AND DETERMINATION OF BENZYL ALCOHOL IN COSMETIC PRODUCTS  A. Identification 1. Scope and field of application  This method describes the identification of benzyl alcohol in cosmetic products.  2. Principle  Benzyl alcohol is identified by means of thin-layer chromatography on silica gel plates.  3. Reagents  All reagents must be of analytical purity.  3.1. Benzyl alcohol 3.2. Chloroform 3.3. Ethanol, absolute 3.4. n-Pentane 3.5. Development solvent: diethyl ether 3.6. Standard solution of benzyl alcohol: weigh 0,1 g of benzyl alcohol (3.1) into a 100-ml volumetric flask, make up to volume with ethanol (3.3) and mix.  3.7. Thin-layer chromatography plates, glass, 100 × 200 mm or 200 × 200 mm, coated with a 0,25 mm layer of silica gel 60 F254.  3.8. Visualizing agent: 12-molybdophosphoric acid, 10 % (m/v) in ethanol (3.3).  4. Apparatus 4.1. Normal apparatus for thin-layer chromatography 4.2. Chromatography tank, double trough chamber, overall dimensions of approximately 80 mm × 230 mm × 240 mm 4.3. Chromatography paper: Whatman, or equivalent 4.4. Ultra-violet lamp, wavelength 254 nm.  5. Procedure 5.1. Sample preparation  Weigh 1,0 g of the product to be analysed into a 10-ml volumetric flask. Add 3 ml of chloroform (3.2) and shake vigorously until the product has dispersed. Make up to volume with ethanol (3.3) and shake vigorously to produce a clear, or almost clear,  solution.  5.2. Thin-layer chromatography 5.2.1. Saturate the chromatography tank (4.2) with n-pentane (3.4) as follows: line the wall of the chamber adjacent to the back through with chromatography paper (4.3), ensuring that the lower edge of the paper is in the trough. Transfer 25 ml of  n-pentane (3.4) into the back trough by pouring this solvent over the exposed surface of the chromatography paper lining. Immediately replace the lid and allow the tank to stand for 15 minutes.  5.2.2. Deposit 10 ml of the sample solution (5.1) and 10 ml of the benzyl alcohol standard solution (3.6) at suitable points on the start line of a thin-layer chromatography plate (3.7). Allow to dry.  5.2.3. Pipette 10 ml of diethyl ether (3.5) into the front through of the tank and immediately afterwards place the plate (5.2.2) into the same trough. Quickly replace the lid of the tank, and develop the plate over a distance of 150 mm. Remove the  plate from the chromatography tank and allow it to dry at room temperature.   5.2.4. Observe the plate (5.2.3) under ultra-violet light and mark the position of the violet spots. Spray the plate with the visualizing agent (3.8) and then heat the plate at 120 °C for about 15 minutes. Benzyl alcohol appears as a dark blue spot.  5.2.5. Calculate the Rf value obtained from the benzyl alcohol standard solution. A dark blue spot with the same Rf value obtained from the sample solution indicates the presence of benzyl alcohol.   Detection limit: 0,1 mg benzyl alcohol  B. Determination 1. Scope and field of application  This method describes the determination of benzyl alcohol in cosmetic products.  2. Definition  The amount of benzyl alcohol determined by this method is expressed as a percentage by mass (% m/m).  3. Principle  The sample is extracted with methanol and the amount of benzyl alcohol in the extract determined by high-performance liquid chromatography (HPLC).  4. Reagents  All reagents must be of analytical purity and suitable for HPLC, where appropriate.  4.1. Methanol 4.2.4. 4-Ethoxyphenol 4.3. Benzyl alcohol 4.4. Mobile phase: methanol (4.1)/water (45: 55; v/v) 4.5. Benzyl alcohol stock solution: weigh accurately approximately 0,1 g of benzyl alcohol (4.3) into a 100-ml volumetric flask. Make up to volume with methanol (4.1) and mix.  4.6. Internal standard stock solution: weigh accurately approximately 0,1 g of 4-ethoxyphenol (4.2) into a 100-ml volumetric flask. Make up to volume with methanol (4.1) and mix.  4.7. Standard solutions: into a series of 25-ml volumetric flasks, transfer by pipette amounts of benzyl alcohol stock solution (4.5) and internal standard stock solution (4.6) according to the table set out below. Make up to volume with methanol (4.1)  and mix.    /* Tables: see OJ */      5.1. Normal laboratory equipment 5.2. High-performance chromatography equipment with a variable wavelength ultra-violet detector and 10 ml injection loop 5.3. Analytical column: 250 mm × 4,6 mm stainless steel column packed with 5 mm Spherisorb ODS, or equivalent.  5.4. Water-bath 5.5. Ultrasonic bath 5.6. Centrifuge 5.7. Centrifuge tubes, 15-ml capacity 6. Procedure 6.1. Sample preparation 6.1.1. Weigh accurately approximately 0,1 g (m gram) of sample into a centrifuge tube (5.7) and add 5 ml methanol (4.1).  6.1.2. Heat for 10 minutes in a water-bath (5.4) maintained at 50 °C, then place the tube in an ultrasonic bath (5.5) until the sample is thoroughly dispersed.  6.1.3. Cool, then centrifuge at 3 500 rpm for five minutes.  6.1.4. Transfer the supernatant liquid to a 25-ml volumetric flask.  6.1.5. Re-extract the sample with a further 5 ml methanol (4.1). Combine the extracts in the 25-ml volumetric flask.  6.1.6. Transfer by pipette 2,0 ml of internal standard stock solution (4.6) into the 25-ml volumetric flask. Make up to volume with methanol (4.1) and mix. This solution is used in the determination stage of the analysis described in 6.4.  6.2. Chromatography 6.2.1. Set up the high-performance liquid chromatography equipment (5.2) in the usual manner. Adjust the flow rate of the mobile phase (4.4) to 2,0 ml per minute.  6.2.2. Set the wavelength of the UV detector (5.2) to 210 nm.  6.3. Calibration 6.3.1. Inject 10 ml of each of the benzyl alcohol standard solutions (4.7) and measure the areas of the benzyl alcohol and the 4-ethoxyphenol peaks.  6.3.2. For each benzyl alcohol standard solution (4.7) calculate the peak-area ratio of benzyl alcohol to 4-ethoxyphenol. Plot a calibration curve using these ratios as the ordinate and the corresponding concentrations of benzyl alcohol in mg per  millilitre as abscissa.  6.4. Determination 6.4.1. Inject 10 ml of the sample solution (6.1.6) and measure the areas of the benzyl alcohol and the 4-ethoxyphenol peaks. Calculate the peak-area ratio of benzyl alcohol to 4-ethoxyphenol. Repeat this process with further 10 ml aliquots of the sample  solution until consistent results are obtained.  6.4.2. From the calibration curve (6.3.2) read off the concentration of benzyl alcohol corresponding to the peak area ratio of benzyl alcohol to 4-ethoxyphenol.  7. Calculation  Calculate the benzyl alcohol content of the sample, as a percentage by mass, using the formula:    % (m/m) of benzyl alcohol = c 400 × m in which:  m = mass in grams of the sample taken for analysis (6.1.1); and c = concentration of benzyl alcohol in the sample solution (6.1.6), in micrograms per millilitre, obtained from the calibration curve. 8. Repeatability (4)  For a benzyl alcohol content of 1 % (m/m) the difference between the results of two determinations carried out in parallel on the same sample should not exceed 0,10 %.   IDENTIFICATION OF ZIRCONIUM, AND DETERMINATION OF ZIRCONIUM, ALUMINIUM AND CHLORINE IN NON-AEROSOL ANTIPERSPIRANTS  The method comprises five stages:   A. Identification of zirconium  B. Determination of zirconium  C. Determination of aluminium  D. Determination of chlorine  E. Calculation of the ratios of aluminium atoms to zirconium atoms, and of aluminium plus zirconium atoms to chlorine atoms  A. Identification of zirconium 1. Scope and field of application  The method describes the identification of zirconium in non-aerosol antiperspirant cosmetic products. No attempt has been made to describe methods suitable for the identification of the aluminium zirconium chloride hydroxide complex  [AlxZr(OH)yClz.nH2O].  2. Principle  Zirconium is identified by the characteristic red-violet precipitate produced with alizarin red S under strongly acidic conditions.  3. Reagents  All reagents must be of analytical purity.  3.1. Hydrochloric acid, concentrated (d20 = 1,18 g/ml) 3.2. Alizarin red S (CI. 58005) solution: 2 % (m/v) aqueous sodium alizarin sulphonate.  4. Apparatus 4.1. Normal laboratory equipment 5. Procedure 5.1. To about 1 g of sample in a test tube add 2 ml of water. Stopper and shake.  5.2. Add three drops of alizarin red S solution (3.2) followed by 2 ml of concentrated hydrochloric (3.1). Stopper and shake.  5.3. Leave to stand for approximately two minutes.  5.4. A red-violet coloured supernatant solution and precipitate indicates the presence of zirconium.   B. Determination of zirconium 1. Scope and field of application  This method is suitable for the determination of zirconium in aluminium zirconium chloride hydroxide complexes up to a maximum concentration of 7,5 % (m/m) zirconium in non-aerosol antiperspirants.  2. Principle  Zirconium is extracted from the product under acidic conditions and determined by flame atomic absorption spectrometry.  3. Reagents  All reagents must be of analytical purity.  3.1. Hydrochloric acid, concentrated (d20 = 1,18 g/ml) 3.2. Hydrochloric acid solution, 10 % (v/v): add 100 ml concentrated hydrochloric acid (3.1) to 500 ml of water in a beaker, stirring continuously. Transfer this solution to a one-litre volumetric flask and make up to volume with water.  3.3. Stock zirconium standard solution, 1 000 mg/ml in 0,5 M hydrochloric acid solution ('SpectrosoL' or equivalent).  3.4. Aluminium chloride (hydrated) [AlCl3.6H2O]: reagent: dissolve 22,6 g of aluminium chloride hexahydrate in 250 ml of 10 % (v/v) hydrochloric acid solution (3.2).  3.5. Ammonium chloride reagent: dissolve 5,0 g of ammonium chloride in 250 ml of 10 % (v/v) hydrochloric acid solution (3.2).  4. Apparatus 4.1. Normal laboratory equipment 4.2. Heater with magnetic stirrer 4.3. Filter paper (Whatman No 41 or equivalent) 4.4. Atomic absorption spectrophotometer equipped with a zirconium hollow-cathode lamp 5. Procedure 5.1. Sample preparation 5.1.1. Weigh accurately approximately 1,0 g (m gram) of an homogeneous sample of the product into a 150-ml beaker. Add 40 ml of water and 10 ml of concentrated hydrochloric acid (3.1).  5.1.2. Place the beaker on a heater with a magnetic stirrer (4.2). Commence stirring and heat to boiling. To prevent rapid drying place a watch-glass on top of the beaker. Boil for five minutes, remove beaker from heat and cool to room temperature.  5.1.3. Using the filter paper (4.3), filter the contents of the beaker into a 100-ml volumetric flask. Rinse the beaker with two 10-ml portions of water and add the washings after filtration to the flask. Make up to volume with water and mix. This  solution is also used for the determination of aluminium (Part C).  5.1.4. Into a 50-ml volumetric flask transfer by pipette 20,00 ml of the sample solution (5.1.3), 5,00 ml of the aluminium chloride reagent (3.4), and 5,00 ml of the ammonium chloride reagent (3.5). Make up to volume with 10 % (v/v) hydrochloric acid  solution (3.2) and mix.  5.2. Conditions for atomic absorption spectrometry  Flame: nitrous oxide/acetylene  Wavelength: 360,1 nm  Background correction: no  Fuel condition: rich; for maximum absorbance, optimization of burner height and fuel conditions will be necessary.  5.3. Calibration 5.3.1. Into a series of 50-ml volumetric flasks transfer by pipette 5,00, 10,00, 15,00, 20,00 and 25,00 ml of the stock zirconium standard solution (3.3). To each volumetric flask transfer by pipette 5,00 ml of the aluminium chloride reagent (3,4) and  5,00 ml of the ammonium chloride reagent (3.5). Make up to volume with 10 % (v/v) hydrochloric acid solution (3.2) and mix. These solutions contain 100, 200, 300, 400 and 500 mg of zirconium per millilitre respectively.   Similarly, prepare a blank solution omitting the zirconium standard solution.  5.3.2. Measure the absorbance of the blank solution (5.3.1) and use the value obtained as the zero zirconium concentration for the calibration curve. Measure the absorbance of each zirconium calibration standard (5.3.1). Plot a calibration curve  relating absorbance values to zirconium concentration.  5.4. Determination  Measure the absorbance of the sample solution (5.1.4). From the calibration curve read off the concentration of zirconium corresponding to the absorbance value obtained for the sample solution.  6. Calculation  Calculate the zirconium content of the sample, in percentage by mass, using the formula:    % (m/m) of zirconium = c 40 × m in which:  m = mass in grams of the sample taken for analysis (5.1.1); and c = concentration of zirconium in the sample solution (5.1.4), in micrograms per millilitre, obtained from the calibration curve.  7. Repeatability (5)  For a zirconium content of 3,00 % (m/m) the difference between the results of two determinations carried out in parallel on the same sample should not exceed 0,10 % (m/m).  8. Remark  The use of inductively-coupled plasma - optical emission spectrometry is permitted as an alternative to flame atomic absorption spectrometry.   C. Determination of aluminium 1. Scope and field of application  This method is suitable for the determination of aluminium present in aluminium zirconium chloride hydroxide complexes up to a maximum concentration of 12 % (m/m) aluminium in non-aerosol anti-perspirants.  2. Principle  Aluminium is extracted from the product under acidic conditions and determined by flame atomic absorption sepctrometry.  3. Reagents  All reagents must be of analytical purity.  3.1. Hydrochloric acid, concentrated (d20 = 1,18 g/ml) 3.2. Hydrochloric acid solution, 1 % (v/v): add 10 ml concentrated hydrochloric acid (3.1) to 500 ml of water in a beaker, stirring continuously. Transfer this solution to a one litre volumetric flask and make up to volume with water.  3.3. Stock aluminium standard solution, 1 000 mg/ml in 0,5 M nitric acid solution ('SpectrosoL' or equivalent).  3.4. Potassium chloride reagent: dissolve 10,0 g of potassium chloride in 250 ml of 1 % (v/v) hydrochloric acid solution (3.2).  4. Apparatus 4.1. Normal laboratory equipment 4.2. Atomic absorption spectrophotometer equipped with an aluminium hollow-cathode lamp.  5. Procedure 5.1. Sample preparation  The solution prepared in B.5.1.3 is used to determine the aluminium content.  5.1.1. Into a 100-ml volumetric flask transfer by pipette 5,00 ml of the sample solution (B.5.1.3) and 10,00 ml of the potassium chloride reagent (3.4). Make up to volume with 1 % (v/v) hydrochloric acid solution (3.2) and mix.  5.2. Conditions for atomic absorption spectrometry  Flame: nitrous oxide/acetylene  Wavelenght: 309,3 nm  Background correction: no  Fuel condition: rich; for maximum absorbance, optimization of burner height and fuel conditions will be necessary.  5.3. Calibration 5.3.1. Into a series of 100 ml volumetric flasks transfer by pipette 1,00, 2,00, 3,00, 4,00 and 5,00 ml of the stock aluminium standard solution (3.3). To each volumetric flask transfer by pipette 10,00 ml of the potassium chloride reagent (3.4) and  make up to volume with 1 % (v/v) hydrochloric acid solution (3.2) and mix. These solutions contain 10, 20, 30, 40 and 50 mg of aluminium per millilitre.   Similarly, prepare a blank solution omitting the aluminium standard solution.  5.3.2. Measure the absorbance of the blank solution (5.3.1) and use the value obtained as the zero aluminium concentration for the calibration curve. Measure the absorbance of each aluminium calibration standard. Plot a calibration curve relating  absorbance valued to aluminium concentration.  5.4. Determination  Measure the absorbance of the sample solution (5.1.1). From the calibration curve read off the concentration of aluminium corresponding to the absorbance value obtained for the sample solution.  6. Calculation  Calculate the aluminium content of the sample, in percentage by mass, using the formula:    % (m/m) of aluminium = c 5 × m in which:  m = mass in grams of the sample taken for analysis (B.5.1.1); and c = concentration of aluminium in the sample solution (5.1.1), in micrograms per millilitre, obtained from the calibration curve. 7. Repeatability (6)  For an aluminium content of 3,5 % (m/m) the difference between the results of two determinations carried out in parallel on the same sample should not exceed 0,10 % (m/m).  8. Remark  The use of inductively-coupled plasma - optical emission spectrometry is permitted as an alternative to flame atomic absorption spectrometry.   D. Determination of chlorine 1. Scope and field of determination  This method is suitable for the determination of chlorine present as chloride ion in aluminium zirconium chloride hydroxide complexes in non-aerosol anti-perspirants.  2. Principle  Chloride ion in the product is determined by potentiometric titration against standard silver nitrate solution.  3. Reagents  All reagents must be of analytical purity.  3.1. Nitric acid, concentrated (d20 = 1,42 g/ml) 3.2. Nitric acid solution, 5 % (v/v): add 25 ml concentrated nitric acid (3.1) to 250 ml of water in a beaker, stirring continuously. Transfer this solution to a 500-ml volumetric flask and make up to volume with water.  3.3. Acetone 3.4. Silver nitrate, 0,1 M volumetric solution ('AnalaR' or equivalent).  4. Apparatus 4.1. Normal laboratory equipment 4.2. Heater with magnetic stirrer 4.3. Silver electrode 4.4. Calomel reference electrode 4.5. pH/millivolt meter suitable for potentiometric titration  5. Procedure 5.1. Sample preparation 5.1.1. Weigh accurately into a 250-ml beaker approximately 1,0 g (m gram) of an homogenous sample of the product. Add 80 ml of water and 20 ml of 5 % (v/v) nitric acid solution (3.2).  5.1.2. Place the beaker on a heater with a magnetic stirrer (4.2). Commence stirring and heat to boiling. To prevent rapid drying, place a watch-glass on top of the beaker. Boil for five minutes, remove beaker from heat and cool to room temperature.  5.1.3. Add 10 ml of acetone (3.3), dip electrodes (4.3 and 4.4) below surface of solution and commence stirring. Titrate potentiometrically against 0,1 M silver nitrate solution (3.4) and plot a differential curve to determine the endpoint (V ml).  6. Calculation  Calculate the chlorine content of the sample, in percentage by mass, using the formula:    % (m/m) of chlorine = 0,3545 × V m in which:  m = mass in grams of the sample taken for analysis (5.1.1) and v = volume of 0,1 M silver nitrate, in millilitres, titrated at the endpoint (5.1.3). 7. Repeatability (7)  For a chlorine content of 4 % (m/m) the difference between the results of two determinations carried out in parallel on the same sample should not exceed 0,10 % (m/m).   E. Calculation of the ratios of aluminium atoms to zirconium atoms, and of aluminium plus zirconium atoms to chlorine atoms 1. Calculation of ratio of aluminium atoms to zirconium atoms  Calculate the Al: Zr ratio using the formula:    Al: Zr ratio = Al % (m/m) × 91,22 Zr % (m/m) × 26,98 2. Calculation of the ratio of aluminium plus zirconium atoms to chlorine atoms  Calaculate the (Al+Zr): Cl ratio using the formula:      Al % (m/m) 26,98 + Zr % (m/m) 91,22   (Al + Zr): Cl ratio =      Cl % (m/m) 35,45  IDENTIFICATION AND DETERMINATION OF HEXAMIDINE, DIBROMOHEXAMIDINE, DIBROMOPROPAMIDINE AND CHLORHEXIDINE  1. Scope and field of application  This method describes the qualitative and quantitative determination of:   - hexamidine and its salts, including the isethionate and the 4-hydroxybenzoate,   - dibromohexamidine and its salts, including the isethionate,   - dibromopropamidine and its salts, including the isethionate,   - chlorhexidine diacetate, digluconate and dihydrochloride in cosmetic products.  2. Definition  The concentrations of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine determined by this method are expressed as a percentage by mass (% m/m).  3. Principle  The identification and determination is carried out by ion-pair, reversed-phase high-performance liquid chromatography (HPLC) followed by ultra-violet spectrophotometric detection. Hexamidine, dibromohexamidine, dibromopropramidine and chlorhexidine  are identified by their retention times on the chromatographic column.  4. Reagents  All reagents must be of analytical purity and suitable for HPLC, where appropriate.  4.1. Methanol 4.2. 1-Heptanesulphonic acid, sodium salt, monohydrate 4.3. Acetic acid, glacial (d20 = 1,05 g/ml) 4.4. Sodium chloride 4.5. Mobile phases 4.5.1. Solvent I: 0,005 M solution of 1-heptanesulphonic acid, sodium salt, monohydrate (4.2) in methanol (4.1), adjusted to an apparent pH of 3,5 with glacial acetic acid (4.3).  4.5.2. Solvent II: 0,005 M solution of 1-heptanesulphonic acid, sodium salt, monohydrate (4.2) in water, adjusted to a pH of 3,5 with glacial acetic acid (4.3).   Note: If necessary to improve the shape of the peaks, the mobile phases may be modified and prepared as follows:   - solvent I: dissolve 5,84 g sodium chloride (4.4) and 1,1013 g of 1-heptanesulphonic acid, sodium salt, monohydrate (4.2) in 100 ml water. Add 900 ml methanol (4.1) and adjust to an apparent pH of 3,5 with glacial acetic acid (4.3), - solvent II: dissolve 5,84 g sodium chloride (4.4) and 1,1013 g of 1-heptanesulphonic acid, sodium salt, monohydrate (4.2) in one litre of water and adjust to a pH of 3,5 with glacial acetic acid (4.3).  4.6. Hexamidine diisethionate [C20H26N4O2.2C2H6O4S] 4.7. Dibromohexamidine diisethionate [C20H24Br2N4O2.2C2H6O4S] 4.8. Dibromopropamidine diisethionate [C17H18Br2N4O2.2C2H6O4S] 4.9. Chlorhexidine diacetate [C22H30Cl2N10.2C2H4O2] 4.10. Reference solutions: prepare 0,05 % (m/v) solutions of each of the four preservatives (4.6 to 4.9) in solvent I (4.5.1).  4.11. 3,4,4& prime;-Trichlorocarbanilide (triclocarban) 4.12. 4,4& prime;-Dichloro-3-(trifluoromethyl)carbanilide (halocarban) 5. Apparatus 5.1. Normal laboratory equipment 5.2. High-performance liquid chromatograph with variable-wavelength UV detector 5.3. Analytical column: stainless steel, length 30 cm, internal diameter 4 mm, packed with m-Bondapack C18, 10 mm, or equivalent 5.4. Ultrasonic bath 6. Identification 6.1. Sample preparation  Weigh approximately 0,5 g of sample into a 10-ml volumetric flask and make up to volume with solvent I (4.5.1). Place the flask in an ultrasonic bath (5.4) for 10 minutes. Filter or centrifuge the solution. Collect the filtrate or supernatant for  chromatography.  6.2. Chromatography 6.2.1. Mobile-phase gradient  temperature to 35 °C.  6.2.3. Set the detector wavelength to 264 nm.  6.2.4. Inject 10 ml of each of the reference solutions (4.10) and record their chromatograms.  6.2.5. Inject 10 ml of the sample solution (6.1) and record its chromatogram.  6.3. Identify whether hexamidine, dibromohexamidine, dibromopropamidine or chlorhexidine is present by comparing the retention time(s) of the peak(s) recorded in 6.2.5 with those obtained from the reference solutions in 6.2.4.  7. Determination 7.1. Determination  Preparation of standard solutions.   Use one of the preservatives (4.6 to 4.9) which is absent from the sample as an internal standard. If this is not possible, triclocarban (4.11), or halocarban (4.12), may be used.  7.1.1. A 0,05 % (m/v) stock solution in solvent I (4.5.1) of the preservative identified in 6.3.  7.1.2. A 0,05 % (m/v) stock solution in solvent I (4.5.1) of the preservative chosen as in internal standard.  7.1.3. For each identified preservative, prepare four standard solutions by transferring into a series of 10-ml volumetric flasks amounts of the stock solution of the identified preservative (7.1.1) and appropriate amounts of the stock solution of the  internal standard (7.1.2) according to the table set out below. Make each flask up to volume with solvent I (4.5.1) and mix.    /* Tables: see OJ */      7.2.1. Weigh accurately approximately 0,5 g (p gram) of sample into a 10-ml volumetric flask, add 1,0 ml of the internal standard solution (7.1.2) and 6 ml of solvent I (4.5.1) and mix.  7.2.2. Place the flask in an ultrasonic bath (5.4) for 10 minutes. Cool. Make up to volume with solvent I and mix. Centrifuge or filter through a folded filter paper. Collect the supernatant or the filtrate, as the case may be, for chromatography.  7.3. Chromatography 7.3.1. Adjust the mobile-phase gradient, flow rate, column temperature and detector wavelength of the HPLC equipment (5.2) to the conditions as required in the identification stage (6.2.1 to 6.2.3).  7.3.2. Inject 10 ml of the sample solution (7.2.2) and measure the peak areas. Repeat this process with further 10 ml aliquots of the sample solution until consistent results are obtained. Calculate the ratio of the peak area produced by the compound to  be analysed to the peak area produced by the internal standard.  7.4. Calibration 7.4.1. Inject 10 ml of each of the standard solutions (7.1.3) and measure the peak areas.  7.4.2. For each standard solution (7.1.3), calculate the ratio of the hexamidine, dibromohexamidine, dibromopropamidine or chlorhexidine peak area to the internal standard peak area. Plot a calibration curve using these ratios as the ordinate and the  corresponding concentrations of the identified preservative in the standard solutions, in micrograms per millilitre, as the abscissa.  7.4.3. From the calibration curve (7.4.2) read off the concentration of the identified preservative corresponding to the peak area ratio calculated in 7.3.2.  8. Calculation 8.1. Calculate the hexamidine, dibromohexamidine, dibromopropamidine or chlorhexidine content of the sample, as a percentage by mass, using the formula:    % (m/m) = c 1000 × p × MW1 MW2 in which:  p = mass in grams of the sample taken for analysis (7.2.1); c = concentration of the preservative in the sample solution, in micrograms per millilitre, obtained from the calibration curve; MW1 = molecular weight of the basic form of the preservative  present; and MW2 = molecular weight of the corresponding salt (see point 10). 9. Repeatability (8)  For a hexamidine, dibromohexamidine, dibromopropamidine or chlorhexidine concentration of 0,1 % (m/m) the difference between the results of two determinations carried out in parallel on the same sample should not exceed 0,005 %.  10. Table of formula weights  Hexamidine C20H26N4O2 354,45  Hexamidine diisethionate C20H26N4O2 · 2C2H6O4S 606,72  Hexamidine di-p-hydroxybenzoate C20H26N4O2 · 2C7H6O3 630,71  Dibromohexamidine C20H24Br2N4O2 512,24  Dibromohexamidine diisethionate C20H24Br2N4O2 · 2C2H6O4S 764,51  Dibromopropamidine C17H18Br2N4O2 470,18  Dibromopropamidine diisethionate C17H18Br2N4O2 · 2C2H6O4S 722,43  Chlorhexidine C22H30Cl2N10 505,45  Chlorhexidine diacetate C22H30Cl2N10 · 2C2H4O2 625,56  Chlorhexidine digluconate C22H30Cl2N10 · 2C6H12O7 897,76  Chlorhexidine dihydrochloride C22H30Cl2N10 · 2HCl 578,37   (1) ISO 5725.  (2) ISO 5725.  (3) 'Magnesium as modifier for the determination of barium by flame atomic emission spectrometry'. Jerrow, M. et al., Analytical Proceedings, 1991, 28, 40.  (4) ISO 5725.  (5) ISO 5725.  (6) ISO 5725.  (7) ISO 5725.  (8) ISO 5725.


Avis juridique important

|

31990L0364

Council Directive 90/364/EEC of 28 June 1990 on the right of residence

Official Journal L 180 , 13/07/1990 P. 0026 - 0027 Finnish special edition: Chapter 6 Volume 3 P. 0058  Swedish special edition: Chapter 6 Volume 3 P. 0058

*****COUNCIL  DIRECTIVE  of 28 June 1990  on the right of residence  (90/364/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 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 Article 3 (c) of the Treaty provides that the activities of the Community shall include, as provided in the Treaty, the abolition, as between Member States, of obstacles to freedom of movement for persons;  Whereas Article 8a of the Treaty provides that the internal market must be established by 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured in accordance with the provisions of the Treaty;  Whereas national provisions on the right of nationals of the Member States to reside in a Member State other than their own must be harmonized to ensure such freedom of movement;  Whereas beneficiaries of the right of residence must not become an unreasonable burden on the public finances of the host Member State;  Whereas this right can only be genuinely exercised if it is also granted to members of the family;  Whereas the beneficiaries of this Directive should be covered by administrative arrangements similar to those laid down in particular in Directive 68/360/EEC (4) and Directive 64/221/EEC (5);  Whereas the Treaty does not provide, for the action concerned, powers other than those of Article 235,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. Member States shall grant the right of residence to nationals of Member States who do not enjoy this right under other provisions of Community law and to members of their families as defined in paragraph 2, provided that they themselves and the members of their families are covered by sickness insurance in respect of all risks in the host Member State and have sufficient resources to avoid becoming a burden on the social assistance system of the host Member State during their period of residence.  The resources referred to in the first subparagraph shall be deemed sufficient where they are higher than the level of resources below which the host Member State may grant social assistance to its nationals, taking into account the personal circumstances of the applicant and, where appropriate, the personal circumstances of persons admitted pursuant to paragraph 2.  Where the second subparagraph cannot be applied in a Member State, the resources of the applicant shall be deemed sufficient if they are higher than the level of the minimum social security pension paid by the host Member State.  2. The following shall, irrespective of their nationality, have the right to install themselves in another Member State with the holder of the right of residence:  (a) his or her spouse and their descendants who are dependants;  (b) dependent relatives in the ascending line of the holder of the right of residence and his or her spouse.  Article 2  1. Exercise of the right of residence shall be evidenced by means of the issue of a document known as a 'Residence permit for a national of a Member State of the EEC', the validity of which may be limited to five years on a renewable basis. However, the Member States may, when they deem it to be necessary, require revalidation of the permit at the end of the first two years of residence. Where a member of the family does not hold the nationality of a Member State, he or she shall be issued with a residence document of the same validity as that issued to the national on whom he or she depends.  For the purpose of issuing the residence permit or document, the Member State may require only that the applicant present a valid identity card or passport and provide proof that he or she meets the conditions laid down in Article 1.  2. Articles 2, 3, 6 (1) (a) and (2) and Article 9 of Directive 68/360/EEC shall apply mutatis mutandis to the beneficiaries of this Directive.  The spouse and the dependent children of a national of a Member State entitled to the right of residence within the territory of a Member State shall be entitled to take up any employed or self-employed activity anywhere within the territory of that Member State, even if they are not nationals of a Member State.  Member States shall not derogate from the provisions of this Directive save on grounds of public policy, public security or public health. In that event, Directive 64/221/EEC shall apply.  3. This Directive shall not affect existing law on the acquisition of second homes.  Article 3  The right of residence shall remain for as long as beneficiaries of that right fulfil the conditions laid down in Article 1.  Article 4  The Commission shall, not more than three years after the date of implementation of this Directive, and at three-yearly intervals thereafter, draw up a report on the application of this Directive and submit it to the European Parliament and the Council.  Article 5  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 1992. They shall forthwith inform the Commission thereof.  Article 6  This Directive is addressed to the Member States.  Done at Luxembourg, 28 June 1990.  For the Council  The President  M. GEOGHEGAN-QUINN  (1) OJ No C 191, 28. 7. 1989, p. 5; and  OJ No C 26, 3. 2. 1990, p. 22.  (2) Opinion delivered on 13 June 1990 (not yet published in the Official Journal).  (3) OJ No C 329, 30. 12. 1989, p. 25.  (4) OJ No L 257, 19. 10. 1968, p. 13.  (5) OJ No 56, 4. 4. 1964, p. 850/64.