Important legal notice

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32003L0043

Council Directive 2003/43/EC of 26 May 2003 amending Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species

Official Journal L 143 , 11/06/2003 P. 0023 - 0032

Council Directive 2003/43/ECof 26 May 2003amending Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine speciesTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 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 European Economic and Social Committee(3),After consulting the Committee of the Regions,Whereas:(1) Directive 88/407/EEC(4) lays down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species.(2) In the light of the new scientific data available, it is necessary to amend the animal health conditions applying to entry of bulls into artificial insemination centres, in particular concerning infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) and bovine viral diarrhoea/mucosal diarrhoea (BVD/MD).(3) The same requirements for storage should apply to all establishments whether or not they are associated with a production unit.(4) The procedure for updating the list of semen collection or storage centres in third countries from which the importation of semen is authorised should be simplified.(5) Necessary measures should be adopted for the implementation of Directive 88/407/EEC in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5),HAS ADOPTED THIS DIRECTIVE:Article 1Directive 88/407/EEC is hereby amended as follows:1. the following subparagraph shall be added to Article 1:"This Directive shall not affect Community and/or national zootechnical provisions governing the organisation of artificial insemination in general and the distribution of semen in particular.";2. Article 2(b) is replaced by the following:"(b) - 'Semen collection centre' means an officially approved and officially supervised establishment situated in the territory of a Member State or third country, in which semen is produced for use in artificial insemination;- 'Semen storage centre' means an officially approved and officially supervised establishment situated in the territory of a Member State or third country in which semen is stored for use in artificial insemination;"3. Article 3(a) shall be replaced by the following:"(a) it must have been collected and processed and/or stored if need be in a collection or storage centre or centres approved for the purpose in accordance with Article 5(1), with a view to artificial insemination and for the purposes of intra-Community trade;"4. Article 4(1) and (2) shall be deleted;5. in Articles 5, 9(2) and 9(3), the words "semen collection centre(s)" shall be replaced by the words "semen collection or storage centre(s)";6. Article 9(1) shall be replaced by the following:"1. The lists of semen collection and storage centres from which Member States shall authorise the importation of semen originating in third countries shall be prepared and updated in accordance with this Article.An establishment may be placed on such a list only if the competent authority of the third country of origin guarantees that the conditions referred to in paragraphs 2 and 3(b) to (e) are met.The competent authorities of the third countries appearing on lists drawn up and updated in accordance with Article 8 shall guarantee that lists of semen collection and storage centres from which the semen may be dispatched to the Community are drawn up, kept up-to-date and communicated to the Commission.The Commission shall provide the contact points designated by Member States with regular notifications concerning new or updated lists that it has received from the competent authorities of the third countries concerned in accordance with subparagraph 3.If no Member State objects to the new or updated list within 20 working days of the Commission's notification, imports shall be authorised from establishments appearing on the list 10 working days after the day on which the Commission makes it available to the public.Where written comments are made by at least one Member State or whenever it considers that amendments to a list are necessary in the light of relevant information such as Community inspection reports or the results of the controls carried out under Article 12, the Commission shall inform all Member States and include the matter on the agenda for the relevant sector at the next meeting of the Standing Committee on the Food Chain and Animal Health for decision in accordance with the procedure referred to in Article 18(2).The Commission shall arrange for up-to-date versions of all lists to be made available to the public.";7. Article 17 shall be replaced by:"Article 17Annex A shall be amended by the Council, acting by qualified majority on a proposal from the Commission, in particular to adapt it to advances in technology.Annexes B, C and D shall be amended in accordance with the procedure laid down in Article 18(2).";8. Article 18 shall be replaced by:"Article 181. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Regulation (EC) No 178/2002(6).2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC(7) shall apply.The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.";9. Article 19 shall be deleted;10. in Articles 5, 8, and 10, the words "the procedure laid down in Article 18" shall be replaced by the words "the procedure referred to in Article 18(2)";11. in Articles 8, 11 and 16, the words "the procedure laid down in Article 19" shall be replaced by the words "the procedure referred to in Article 18(2)";12. Annexes A, B, C and D to Directive 88/407/EEC shall be replaced by the text in the Annex to this Directive.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive by 1 July 2004. They shall forthwith inform the Commission thereof.When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.2. However, up until 31 December 2004, Member States shall authorise intracommunity trade in and imports of semen that have been collected, processed and stored according to the former provisions of Directive 88/407/EEC and that are accompanied by the former specimen certificate.After that date, Member States shall not authorise intra-Community trade in and imports of semen in accordance with the provisions formerly in force unless it was collected, processed and stored before 31 December 2004.3. Member States shall inform the Commission of the text of the main provisions of national law which they adopt in the area governed by this Directive.Article 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 26 May 2003.For the CouncilThe PresidentG. Drys(1) OJ C 20 E, 28.1.2003, p. 46.(2) Opinion delivered on 8 April 2003 (not yet published in the Official Journal).(3) Opinion delivered on 11 December 2002 (not yet published in the Official Journal).(4) OJ L 194, 22.7.1988, p. 10. Directive as last amended by the 1994 Act of Accession.(5) OJ L 184, 17.7.1999, p. 23.(6) OJ L 31, 1.2.2002, p. 1.(7) OJ L 184, 17.7.1999, p. 23.ANNEX'ANNEX ACHAPTER I CONDITIONS FOR THE OFFICIAL APPROVAL OF CENTRES1. Semen collection centres must:(a) be placed under the permanent supervision of a centre veterinarian authorised by the competent authority;(b) have at least:(i) animal housing, including isolation facilities;(ii) semen collection facilities, including a separate room for the cleaning and disinfection or sterilisation of equipment;(iii) a semen processing room which need not necessarily be on the same site;(iv) a semen storage room which need not necessarily be on the same site;(c) be so constructed or isolated that contact with livestock outside is prevented;(d) be so constructed that the animal housing and the semen collecting, processing and storage facilities can be readily cleaned and disinfected;(e) have isolation accommodation which has no direct communication with the normal animal accommodation;(f) be so designed that the animal accommodation is physically separated from the semen processing room and both are separated from the semen storage room.2. Semen storage centres must:(a) be placed under the permanent supervision of a centre veterinarian authorised by the competent authority;(b) be so constructed or isolated that contact with livestock outside is prevented;(c) be so constructed that the storage facilities can be readily cleaned and disinfected.CHAPTER II CONDITIONS RELATING TO THE OFFICIAL SUPERVISION OF CENTRES1. Collection centres must:(a) be so supervised that they contain only animals of the species whose semen is to be collected. Other domestic animals which are strictly necessary for the normal operation of the collection centre may nonetheless also be admitted, provided that they present no risk of infection to those species whose semen is to be collected, and that they fulfil the conditions laid down by the centre veterinarian;(b) be so supervised that a record is kept of all bovine animals at the centre, giving details of the breed, date of birth and identification of each of the animals, and also a record of all checks for diseases and all vaccinations carried out for each animal;(c) be regularly inspected by an official veterinarian, at least twice a year, in the context of standing checks on the conditions of approval and supervision;(d) be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors must be required to comply with the conditions laid down by the centre veterinarian;(e) employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to the control of the spread of disease;(f) be so supervised that:(i) only semen collected at an approved centre is processed and stored in approved centres, without coming into contact with any other consignment of semen. However, semen not collected in an approved centre may be processed in approved collection centres provided that:- such semen is produced from bovine animals which fulfil the conditions laid down in Chapter I.1(d) of Annex B,- processing is carried out with separate equipment or at a different time from semen intended for intra-Community trade, the equipment in the latter case being cleaned and sterilised after use,- such semen may not be the subject of intra-Community trade and cannot at any time come into contact with, or be stored with, semen intended for intra-Community trade,- such semen is identifiable by a marking different from that provided for in point (vii);Deep-frozen embryos may also be stored in approved centres provided that:- such storage is authorised by the competent authority,- the embryos meet the requirements of Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species(1),- the embryos are stored in separate storage containers in the premises for storing approved semen;(ii) collection, processing and storage of semen takes place only on the premises set aside for the purpose and under the strictest conditions of hygiene;(iii) all instruments which come into contact with the semen or the donor animal during collection and processing are properly disinfected or sterilised prior to use, except for single-use instruments;(iv) products of animal origin used in the processing of semen - including additives or a diluent - are obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented;(v) storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers;(vi) the cryogenic agent used has not been previously used for other products of animal origin;(vii) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the breed and identification of the donor animal and the approval number of the centre can be readily established; each Member State shall communicate to the Commission and other Member States the characteristics and form of the marking used in its territory;(viii) the storage unit must comply with specific conditions relating to the supervision of semen storage centres provided for in point 2.2. Storage centres must:(a) be so supervised that a record is kept of all movement of semen (in and out the centre) and of the status of the donor bulls whose semen is stored there, and which must comply with the requirements of this Directive;(b) be regularly inspected by an official veterinarian, at least twice a year, in the context of the standing checks on the conditions of approval and supervision;(c) be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors must be required to comply with the conditions laid down by the centre veterinarian;(d) employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to the control of the spread of disease;(e) be so supervised that:(i) only semen collected at collection centres approved in accordance with this Directive is stored in approved storage centres, without coming into contact with any other semen.In addition, only semen coming from an approved collection or storage centre and transported in conditions offering every possible health guarantee, having had no contact with any other semen, may be brought into an approved storage centre.Deep-frozen embryos may also be stored in approved centres provided that:- such storage is authorised by the competent authority,- the embryos meet the requirements of Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species,- the embryos are stored in separate storage containers in the premises for storing approved semen;(ii) storage of semen takes place only on the premises set aside for the purpose and under the strictest conditions of hygiene;(iii) all instruments which come into contact with the semen are properly disinfected or sterilised prior to use, except for single-use instruments;(iv) storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers;(v) the cryogenic agent used has not been previously used for other products of animal origin;(vi) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the breed and identification of the donor animal and the approval number of the collection centre can be readily established; each Member State shall communicate to the Commission and other Member States the characteristics and form of the marking used in its territory.(1) OJ L 302, 19.10.1989, p. 1. Directive as last amended by Commission Decision 94/113/EC (OJ L 53, 24.2.1994, p. 23).ANNEX BCHAPTER I CONDITIONS APPLYING TO THE MOVEMENT OF ANIMALS INTO APPROVED SEMEN COLLECTION CENTRES1. For all bovine animals admitted to a semen collection centre the following requirements shall apply:(a) they must have been subjected to a period of quarantine of at least 28 days in accommodation specifically approved for the purpose by the competent authority of the Member State, and where only other cloven-hoofed animals having at least the same health status are present;(b) prior to their stay in the quarantine accommodation described in (a), they must have belonged to a herd which is officially tuberculosis free and officially brucellosis free in accordance with Directive 64/432/EEC. The animals shall not previously have been kept in a herd of a lower status;(c) they must come from a herd officially free of enzootic bovine leukosis as defined in Directive 64/432/EEC, or have been produced by dams which have been subjected, with negative results, to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC, after removal of the animals from their dam. In the case of animals derived by embryo transfer, "dam" means the recipient of the embryo;If this requirement cannot be fulfilled, the semen shall not be the subject of trade until the donor has reached the age of two years and has been tested in accordance with Chapter II.1(c) with a negative result;(d) within the 28 days preceding the period of quarantine specified in (a), they have been subjected to the following tests with negative results in each case, except for the BVD/MD antibody test mentioned in (v):(i) for bovine tuberculosis, an intradermal tuberculin test carried out in accordance with the procedure laid down in Annex B to Directive 64/432/EEC;(ii) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC;(iii) for enzootic bovine leukosis, a serological test carried out in accordance with the procedure laid down in Annex D (Chapter II) to Directive 64/432/EEC;(iv) for IBR/IPV, a serological test (whole virus) on a blood sample if the animals do not come from an IBR/IPV free herd as defined in Article 2.3.5.3. of the International Animal Health Code;(v) for BVD/MD,- a virus isolation test or a test for virus antigen, and- a serological test to determine the presence or absence of antibodies.The competent authority may give authorisation for the tests referred to in (d) to be carried out on samples collected in the quarantine station. In this case, the period of quarantine referred to in (a) may not commence before the date of sampling. However, should any of the tests listed in (a) prove positive, the animal concerned shall be immediately removed from the isolation unit. In the event of group isolation, the quarantine period referred to in (a) may not commence for the remaining animals until the animal which tested positive has been removed.(e) within the period of quarantine specified in (a), and at least 21 days after being admitted to quarantine (at least seven days after being admitted to quarantine to search for Campylobacter fetus ssp. venerealis and Trichomonas foetus), they have been subjected to the following tests with negative results in each case, except for the BVD/MD antibody test (see point (iii) below):(i) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC;(ii) for IBR/IPV, a serological test (whole virus) on a blood sample;If any animals test positive, these animals shall be removed immediately from the quarantine station and the other animals of the same group shall remain in quarantine and be retested, with negative results, not less than 21 days after removal of the positive animal(s).(iii) for BVD/MD,- a virus isolation test or a test for virus antigen, and- a serological test to determine the presence or absence of antibodies.Any animal (seronegative or seropositive) may only be allowed entry to the semen collection facilities if no sero-conversion occurs in animals which tested seronegative before entry into the quarantine station.If sero-conversion occurs, all animals that remain seronegative shall be kept in quarantine over a prolonged time, until there is no more sero-conversion in the group for a period of three weeks. Serologically positive animals may be allowed entry into the semen collection facilities;(iv) for Campylobacter fetus ssp. venerealis:- in the case of animals less than six months old or kept since that age in a single sex group prior to quarantine, a single test on a sample of artificial vagina washings or preputial specimen;- in the case of animals aged six months or older that could have had contact with females prior to quarantine, a test three times at weekly intervals on a sample of artificial vagina washings or preputial specimen;(v) for Trichomonas foetus:- in the case of animals less than six months old or kept since that age in a single sex group prior to quarantine, a single test on a sample of preputial specimen;- in the case of animals aged six months or older that could have had contact with females prior to quarantine, a test three times at weekly intervals on a sample of preputial specimen.If any of the above tests is positive, the animal must be removed forthwith from the isolation accommodation. In the case of group isolation, the competent authority must take all necessary measures to re-establish the eligibility of the remaining animals for entry into the collection centre in accordance with the Annex.(f) prior to the initial dispatch of semen from BVD/MD serologically positive bulls, a semen sample from each animal shall be subjected to a virus isolation or virus antigen ELISA test for BVD/MD. In the event of a positive result, the bull shall be removed from the centre and all of its semen destroyed.2. All tests must be carried out in a laboratory approved by the Member State.3. Animals may only be admitted to the semen collection centre with the express permission of the centre veterinarian. All movements, both in and out, must be recorded.4. No animal admitted to the semen collection centre may show any clinical sign of disease on the day of admission. All animals must, without prejudice to paragraph 5, have come from isolation accommodation, as referred to in paragraph 1(a), which on the day of consignment officially fulfils the following conditions:(a) is situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days;(b) has for at least three months been free from foot-and-mouth disease and brucellosis;(c) has for at least 30 days been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E to Directive 64/432/EEC.5. Provided that the conditions laid down in paragraph 4 are satisfied and the routine tests referred to in Chapter II have been carried out during the previous 12 months, animals may be transferred from one approved semen collection centre to another of equal health status, without isolation or testing if transfer is direct. The animal in question must not come into direct or indirect contact with cloven-hoofed animals of a lower health status and the means of transport used must have been disinfected before use. If the movement from one semen collection centre to another takes place between Member States it must take place in accordance with Directive 64/432/EEC.CHAPTER II ROUTINE TESTS WHICH MUST BE APPLIED TO ALL BOVINE ANIMALS IN AN APPROVED SEMEN COLLECTION CENTRE1. All bovine animals kept at an approved semen collection centre must be subjected at least once a year to the following tests, with negative results:(a) for bovine tuberculosis, an intradermal tuberculin test, carried out in accordance with the procedure laid down in Annex B to Directive 64/432/EEC;(b) for bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC;(c) for enzootic bovine leukosis, a serological test carried out in accordance with the procedure described in Annex D (Chapter II) to Directive 64/432/EEC;(d) for IBR/IPV, a serological test (whole virus) on a blood sample;(e) for BVD/MD, a serological antibody which is applied only to seronegative animals;Should an animal become serologically positive, every ejaculate of that animal collected since the last negative test shall be either discarded or tested for virus with negative results.(f) for Campylobacter fetus ssp. venerealis, a test on a sample of preputial specimen. Only bulls on semen production or having contact with bulls on semen production need to be tested. Bulls returning to collection after a lay-off of more than six months shall be tested not more than 30 days prior to resuming production;(g) for Trichomonas foetus, a test on a sample of preputial specimen. Only bulls on semen production or having contact with bulls on semen production need to be tested. Bulls returning to collection after a lay-off of more than six months shall be tested not more than 30 days prior to resuming production.2. All tests must be carried out in a laboratory approved by the Member State.3. If any of the above tests is positive, the animal must be isolated and the semen collected from it since the last negative test may not be the subject of intra-Community trade with the exception, for BVD/MD, of semen from every ejaculate which has been tested BVD/MD virus negative.Semen collected from all other animals at the centre since the date when the positive test was carried out shall be held in separate storage and may not be the subject of intra-Community trade until the health status of the centre has been restored.ANNEX CCONDITIONS WHICH SEMEN FOR INTRA-COMMUNITY TRADE OR IMPORTED INTO THE COMMUNITY MUST SATISFY1. Semen must be obtained from animals which:(a) show no clinical signs of disease on the day the semen is collected;(b) (i) have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection, or(ii) have been vaccinated against foot-and-mouth disease during the 12 months prior to collection, in which case 5 % (with a minimum of five straws) of each collection shall be submitted to a virus isolation test for foot-and-mouth disease with negative results;(c) have not been vaccinated against foot-and-mouth disease within 30 days immediately prior to collection;(d) have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately prior to the collection of the semen in the case of collections of fresh semen;(e) are not allowed to serve naturally;(f) are kept in semen collection centres which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection or, in the case of fresh semen, until the date of dispatch, and which are situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days;(g) have been kept in semen collection centres which, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, have been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E(I) to Directive 64/432/EEC.2. Antibiotics as listed below must be added to produce these concentrations in the final diluted semen:not less than:- 500 μg streptomycin per ml final dilution,- 500 IU penicillin per ml final dilution,- 150 μg lincomycin per ml final dilution,- 300 μg spectinomycin per ml final dilution.An alternative combination of antibiotics with an equivalent effect against campylobacters, leptospires and mycoplasmas may be used.Immediately after their addition the diluted semen must be kept at a temperature of at least 5 °C for a period of not less than 45 minutes.3. Semen for intra-Community trade must:(a) be stored in approved conditions for a minimum period of 30 days prior to dispatch. This requirement shall not apply to fresh semen.(b) be transported to the Member State of destination in containers which have been cleaned and disinfected or sterilised before use and which have been sealed and numbered prior to dispatch from the approved storage facilities.ANNEX D>PIC FILE= "L_2003143EN.003202.TIF">


Avis juridique important

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31992L0008

Fourteenth Commission Directive 92/8/EEC of 18 February 1992 adapting to technical progress Annexes III, IV, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 070 , 17/03/1992 P. 0023 - 0024 Finnish special edition: Chapter 13 Volume 22 P. 0006  Swedish special edition: Chapter 13 Volume 22 P. 0006

FOURTEENTH COMMISSION DIRECTIVE 92/8/EEC  of 18 February 1992  adapting to technical progress Annexes III, IV, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to 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 91/184/EEC (2), and in particular Article 8 (2) thereof,  Whereas, on the basis of the available information, the substances, colouring agents, preservatives, and ultraviolet filters whose date of admission expired on 31 December 1991 should continue to be used in cosmetic products for a further six months;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in the cosmetic products sector,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 76/768/EEC is hereby amended as follows:  1. In Annex III, Part 2, the date of 31 December 1991 in the 'allowed until' column is replaced by that of 30 June 1992 for the following substance:  2.1,1,1-Trichloroethane (methyl chloroform);  2. In Annex IV, Part 2, the date of 31 December 1991 in the 'allowed until' column is replaced by that of 30 June 1992 for the following numbers and denominations: 26 100, 73 900, 74 189, Solvent Yellow 98 and 15 585;  3. In Annex VI, Part 2, the date of 31 December 1991 in the 'allowed until' column is replaced by that of 30 June 1992 for the following substances:  2. Chlorphenesin (INN)  15. Benzethonium chloride (INN) (+)  16. Benzalkonium chloride (INN), bromide and saccharinate (+)  20. Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate) (+)  21. Benzylhemiformal (a 1: 1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol)  26. Glutaraldehyde  27. 3-Decyloxy 2-hydroxy-1-amino propane-hydro-chloride (Decominol) (INN);  4. In Annex VII, Part 2, the date of 31 December 1991 in the 'allowed until' is replaced by that of 30 June 1992 for the following substances:  1. N-Propoxylated ethyl-4-aminobenzoate (mixed isomers)  2. Ethoxylated ethyl-4-aminobenzoate  4. Glycerol 1-(4-aminobenzoate)  5. 2-Ethylhexyl 4-dimethylaminobenzoate  6. 2-Ethylhexyl salicylate  12. Isopentyl-4-methoxycinnamate (mixed isomers)  13. 2-Ethylhexyl 4-methoxycinnamate  16. 2-Hydroxy-4-methoxy-4-methylbenzophenone (mexenone)  17. 2-Hydroxy-4-methoxybenzophenone-5 sulphonic acid and sodium salt (Sulisobenzone and Sulisobenzone sodium)  24. Alpha-(2-Oxoborn-3-ylidene) toluene-4-sulphonic acid and its salts  25. 3(4-Methylbenzylidene)-d-1-camphor  26. 3-Benzylidene camphor  28. 4-Isopropyl-dibenzoylmethane  29. 4-Isopropylbenzyl salicylate  31. 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)  propane-1-3-dione  32. 2,4,6-Trianilino-(p-carbo-2-ethylhexyl-1-oxi)-  1,3,5-triazine.  Article 2  1. Regardless of the dates of admission mentioned in Article 1, Member States shall take all the necessary measures to ensure that as from 1 July 1992, for the substances referred to in Article 1, neither manufacturers nor importers  established in the Community shall place on the market products which do not comply with the requirements of this Directive.  2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances referred to in Article 1 cannot be sold or otherwise disposed of to the final consumer after 30 June 1993 if they do not  comply with the requirements of this Directive.  Article 3  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1992. They shall forthwith inform the Commission thereof.  When the 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 texts of the provisions of national law which they adopt in the field covered by this Directive.  Article 4  This Directive is addressed to the Member States. Done at Brussels, 18 February 1992.For the Commission  Karel VAN MIERT  Member of the Commission    (1) OJ No L 262, 27. 9. 1976, p. 169.  (2) OJ No L 91, 12. 4. 1991, p. 59.


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31998L0040

Commission Directive 98/40/EC of 8 June 1998 adapting to technical progress Council Directive 74/346/EEC relating to rear-view mirrors for wheeled agricultural or forestry tractors (Text with EEA relevance)

Official Journal L 171 , 17/06/1998 P. 0028 - 0029

COMMISSION DIRECTIVE 98/40/EC of 8 June 1998 adapting to technical progress Council Directive 74/346/EEC relating to rear-view mirrors for wheeled agricultural or forestry tractors (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 74/346/EEC of 25 June 1974 on the approximation of the laws of the Member States relating to rear-view mirrors for wheeled agricultural or forestry tractors (1), as last amended by Directive 97/54/EC of the European Parliament and of the Council (2), and in particular Article 4 thereof,Whereas, in view of the growing complexity of the task performed by tractors, thought should be given to the rear-view mirrors used to monitor implements not designed for on-road use;Whereas, in order to increase safety, the conditions under which rear-view mirrors are set by drivers should be set out in detail; whereas Directive 74/346/EEC should therefore be amended accordingly;Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on adaptation to technical progress set up by Council Directive 74/150/EEC (3), as last amended by Directive 97/54/EC,HAS ADOPTED THIS DIRECTIVE:Article 1 The Annex to Directive 74/346/EEC is amended as follows:1. the following sentence is added to Item 1.1: 'The additional mirrors and rear-view mirrors designed in order to monitor the implements while working in the fields are not necessarily open to component type-approval but must be located in accordance with the setting requirements contained in Items 2.3.3 to 2.3.5.`;2. in Item 2.4.2, the first sentence is replaced by the following:'The driver must be able to adjust the exterior rear-view mirror without leaving the driving position.`Article 2 1. From 1 May 1999, no Member State may:- refuse, in respect of a type of tractor, to grant EC type-approval, to issue the document referred to in the third indent of Article 10(1) of Directive 74/150/EEC, or to grant national type approval, or- prohibit the entry into service of tractors,if those tractors meet the requirements of Directive 74/346/EEC, as amended by this Directive.2. From 1 October 1999, Member States:- may no longer issue the document referred to in the third indent of Article 10(1) of Directive 74/150/EEC for a type of tractor that does not meet the requirements of Directive 74/346/EEC, as amended by this Directive,- may refuse to grant national type-approval in respect of a type of tractor which does not meet the requirements of Directive 74/346/EEC, as amended by this Directive.Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive not later than 30 April 1999. They shall forthwith inform the Commission thereof.When the 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 send the Commission the text of the essential provisions of national law that they adopt in the area covered by this Directive.Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 5 This Directive is addressed to the Member States.Done at Brussels, 8 June 1998.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ L 191, 15. 7. 1974, p. 1.(2) OJ L 277, 10. 10. 1997, p. 24.(3) OJ L 84, 28. 3. 1974, p. 10.


Avis juridique important

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31986L0179

Seventh Commission Directive 86/179/EEC of 28 February 1986 adapting to technical progress Annexes II, III, IV and V to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 138 , 24/05/1986 P. 0040 - 0048 Finnish special edition: Chapter 13 Volume 15 P. 0064  Swedish special edition: Chapter 13 Volume 15 P. 0064

 SEVENTH COMMISSION DIRECTIVE    of 28 February 1986    adapting to technical progress Annexes II , III , IV   and V to Council Directive 76/768/EEC on the   approximation of the laws of the Member States relating   to cosmetic products     ( 86/179/EEC )    THE COMMISSION OF THE EUROPEAN COMMUNITIES ,    Having regard to the Treaty establishing the   European Economic Community ,    Having regard to Council Directive 76/768/EEC   of 27 July 1976 on the approximation of the laws   of the Member States relating to cosmetic products   (1) , as last amended by Directive 85/391/EEC (2) ,   and in particular Articles 5 and 8 ( 2 ) thereof ,    Whereas , in order to protect public health ,   it is necessary to prohibit chloroform ,   2,3,7,8-tetrachlorodibenzo-p-dioxin ,   2,6-dimethyl-1,3-dioxan-4-yl acetate ( Dimethoxane )   and pyrithione sodium ( INNM ) in cosmetic products ;    Whereas on the basis of the latest findings of   scientific and technical research the use of   1,3-bis(hydroxymethyl)imidazolidine-2-thione may   be authorized for nail care under certain conditions ;    Whereas , on the basis of the available information ,   certain provisionally permitted colouring agents   and substances may be definitively permitted ,   while others must be definitively prohibited or be   permitted for a further specified period ;    Whereas the measures laid down in this Directive   are in accordance with the opinion of the Committee   on the Adaptation to Technical Progress of the   Directives on the Removal of Technical Barriers to   Trade in the Cosmetic Products Sector ,    HAS ADOPTED THIS DIRECTIVE :    Article 1    Directive 76/768/EEC is hereby amended as follows :    1 . In Annex II , the following numbers are added :     " 366 . Chloroform    367 . 2,3,7,8-Tetrachlorodibenzo-p-dioxin except   as an impurity of hexachlorophene , subject to the   conditions laid down in Annex VI - Part 1 , under No 6    368 . 2,6-Dimethyl-1,3-dioxan-4-yl acetate   ( Dimethoxane )    369 . Pyrithione sodium ( INNM ) " .    2 . Annex III , Part 1 is amended as follows :     " a * b * c * d * e * f *    44 * 1,3-Bis (hydroxymethyl)imidazolidine-2-thione *   ( a ) Hair-care preparations * ( a ) Up to 2 % *   ( a ) Prohibited in aerosol dispensers ( sprays ) *   Contains 1,3-bis(hydroxymethyl)imidazolidine-2-thione *     * * ( b ) Nail-care preparations * ( b ) Up to   2 % * ( b ) The pH of the product as applied must be   less than 4 * *    51 * Quinolin-8-ol and bis ( 8-hydroxyquinolinium )   sulphate * Stabilizer for hydrogen peroxide in   rinse-off hair-care preparations * 0,3 % calculated   as base " * * *    3 . Annex III , Part 2 , Annex IV , Parts 2 and 3 , are   replaced by Annexes 1 and 2 to this Directive .    4 . Annex V is amended as follows :     - No 10 - Chloroform is deleted ,     - In Nos 5 and 6 , the footnote reference (5)   is replaced by (3) .    Article 2    1 . Member States shall take the necessary measures   to ensure that from 1 January 1988 neither   manufactures nor importers established in the   Community place on the market products which do   not satisfy the requirements of this Directive .    2 . Member States shall take the necessary measures   to ensure that the products referred to in paragraph 1   can no longer be sold or disposed of to the final   consumer after 31 December 1989 .    Article 3    1 . Member States shall bring into force the   laws , regulations and administrative provisions necessary   to comply with the provisions of this Directive   not later than 31 December 1986 . They shall   forthwith inform the Commission thereof .    2 . Member States shall communicate to the Commission   the texts of the provisions of national law which   they adopt in the field governed by this Directive .    Article 4    This Directive is addressed to the Member States .    Done at Brussels , 28 February 1986 .    For the Commission    Grigoris VARFIS    Member of the Commission    (1) OJ No L 362 , 27 . 9 . 1976 , p. 169 .    (2) OJ No L 224 , 22 . 8 . 1985 , p. 40 .    ANNEX I     " ANNEX III    PART 2    LIST OF COLOURING AGENTS ALLOWED FOR USE IN   COSMETIC PRODUCTS (1)    Field of application    Column 1 = Colouring agents allowed in all cosmetic   products .    Column 2 = Colouring agents allowed in all cosmetic   products except those intended to be applied in the   vicinity of the eyes , in particular eye make-up and   eye-make-up remover .    Column 3 = Colouring agents allowed exclusively   in cosmetic products intended not to come into   contact with the mucous membranes .    Column 4 = Colouring agents allowed exclusively in   cosmetic products intended to come into contact only   briefly with the skin .    Colour index number or denomination * Colour *   Field of application * Other limitations and   requirements (2) *     * * 1 * 2 * 3 * 4 * *    10006 * Green * * * * X * *    10020 * Green * * * X *  *    10316 (3) * Yellow * * X * * * *    11680 * Yellow * * * X * * *    11710 * Yellow * * * X * * *    11725 * Orange * * * * X * *    11920 * Orange * X * * * * *    12010 * Red * * * X * * *    12075 (3) * Orange * X * * * * *    12085 (3) * Red * X * * * * 3 % maximum concentration   in the finished product *    12120 * Red * * * * X * *    12150 * Red * X * * * * *    12370 * Red * * * * X * *    12420 * Red * * * * X * *    12480 * Brown * * * * X * *    12490 * Red * X * * * * *    12700 * Yellow * * * * X * see Annex IV , Part 2 *    13015 * Yellow * X * * * * E 105 *    13065 * Yellow * * * * X * see Annex IV , Part 2 *    14270 * Orange * X * * * * E 103 *    14700 * Red * X * * * * *    14720 * Red * X * * * * E 122 *    Colour index number or denomination * Colour *   Field of application * Other limitations and   requirements (2) *     * * 1 * 2 * 3 * 4 * *    14815 * Red * X * * * * E 125 *    15510 (3) * Orange * * X * * * *    15525 * Red * X * * * * *    15580 * Red * X * * * * *    15585 (3) * Red * * X * * * *    15620 * Red * * * * X * *    15630 (3) * Red * X * * * * 3 % maximum concentration   in the finished product *    15800 * Red * * * X * * see Annex IV , Part 2 *    15850 (3) * Red * X * * * * *    15865 (3) * Red * X * * * * *    15880 * Red * X * * * * *    15980 * Orange * X * * * * E 111 *    15985 (3) * Yellow * X * * * * E 110 *    16035 * Red * X * * * * *    16185 * Red * X * * * * E 123 *    16230 * Orange * * * X * * *    16255 (3) * Red * X * * * * E 124 *    16290 * Red * X * * * * E 126 *    17200 * Red * X * * * * *    18050 * Red * * * X * * *    18130 * Red * * * * X * *    18690 * Yellow * * * * X * *    18736 * Red * * * * X * *    18820 * Yellow * * * * X * *    18965 * Yellow * X * * * * *    19140 (3) * Yellow * X * * * * E 102 *    20040 * Yellow * * * * X * maximum 3,3'-dimethylbenzidine   concentration in the colouring agent : 5 ppm *    20170 * Orange  * * X * * *    20470 * Black * * * * X * see Annex IV , Part 2 *    21100 * Yellow * * * * X * maximum 3,3'-dimethylbenzidine   concentration in the colouring agent : 5 ppm *    21108 * Yellow * * * * X * ditto *    21230 * Yellow * * * X * * *    24790 * Red * * * * X * *    27290 (3) * Red * * * * X * *    27755 * Black * X * * * * E 152 *    28440 * Black * X * * * * E 151 *    40215 * Orange * * * * X * *    40800 * Orange * X * * * * *    40820 * Orange * X * * * * E 160 e *    40825 * Orange * X * * * * E 160 f *    40850 * Orange * X * * * * E 161 g *    42045 * Blue * * * * X * see Annex IV , Part 2 *    42051 (3) * Blue * X * * * * E 131 *    42053 * Green * X * * * * *    42080 * Blue * * * * X * *    Colour index number or denomination * Colour *   Field of application * Other limitations and requirements   (2) *     * * 1 * 2 * 3 * 4 * *    42090 * Blue * X * * * * *    42100 * Green * * * * X * *    42170 * Green * * * * X * see Annex IV , Part 2 *    42510 * Violet * * * X * * *    42520 * Violet * * * * X * 5 ppm maximum   concentration in the finished product *    42640 * Violet * X * * * * *    42735 * Blue * * * X * * *    44045 * Blue * * * * X * see Annex IV , Part 2 *    44090 * Green * X * * * * E 142 *    45100 * Red * * * * X * *    45170 (3) * Red * X * * * * *    45170:1 * * * X * * * *    45190 * Violet * * * * X * see Annex IV , Part 2 *    45220 * Red * * * * X * *    45350 * Yellow * X * * * * 6 % maximum concentration   in the finished product *    45370 (3) * Orange * X * * * * not more than 1 %   2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid   and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)   benzoic acid *    45380 (3) * Red * X * * * * ditto *    45396 * Orange * X * * * * when used in lipstick , the   colouring agent is allowed only in free acid form   and in a maximum concentration of 1 % *    45405 * Red * * X * * * not more than 1 %   2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and   2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)   benzoic acid *    45410 (3) * Red * X * * * * ditto *    45425 * Red * X * * * * not more than 1 %   2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid   and 3 % 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl)   benzoic acid *    45430 (3) * Red * X * * * * E 127 , ditto *    47000 * Yellow * * * X * * see Annex IV , Part 2 *    47005 * Yellow * X * * * * E 104 *    50325 * Violet * * * * X * *    50420 * Black * * * X * * *    51319 * Violet * * * * X * *    58000 * Red * X * * * * *    59040 * Green * * * X * * *    60724 * Violet * * * * X * *    60725 * Violet * X * * * * *    60730 * Violet * * * X * * *    61565 * Green * X * * * * *    61570 * Green * X * * * * *    61585 * Blue * * * * X * *    62045 * Blue * * * * X * *    69800 * Blue * X * * * * E 130 *    69825 * Blue * X * * * * *    71105 * Orange * * * X * * *    73000 * Blue * X * * * * *    73015 * Blue * X * * * * E 132 *    Colour index number or denomination * Colour *   Field of application * Other limitations and requirements   (2) *     * * 1 * 2 * 3 * 4 * *    73360 * Red * X * * * * *    73385 * Violet * X * * * * *    73900 * Violet * * * * X * see Annex IV , Part 2 *    73915 * Red * * * * X * *    74100 * Blue * * * * X * *    74160 * Blue * X * * * * *    74180 * Blue * * * * X * see Annex IV , Part 2 *    74260 * Green * * X * * * *    75100 * Yellow * X * * * * *    75120 * Orange * X * * * * E 160 b *    75125 * Yellow * X * * * * E 160 d *    75130 * Orange * X * * * * E 160 a *    75135 * Yellow * X * * * * E 161 d *    75170 * White * X * * * * *    75300 * Yellow * X * * * * E 100 *    75470 * Red * X * * * * E 120 *    75810 * Green * X * * * * E 140 and E 141 *    77000 * White * X * * * * E 173 *    77002 * White * X * * * * *    77004 * White * X * * * * *    77007 * Blue * X * * * * *    77015 * Red * X * * * * *    77120 * White * X * * * * *    77163 * White * X  * * * *    77220 * White * X * * * * E 170 *    77231 * White * X * * * * *    77266 * Black * X * * * * *    77267 * Black * X * * * * *    77268:1 * Black * X * * * * E 153 *    77346 * Green * X * * * * *    77400 * Brown * X * * * * *    77480 * Brown * X * * * * E 175 *    77489 * Orange * X * * * * E 172 *    77491 * Red * X * * * * E 172 *    77492 * Yellow * X * * * * E 172 *    77499 * Black * X * * * * E 172 *    77510 * Blue * X * * * * free from cyanide ions *    77713 * White * X * * * * *    77742 * Violet * X * * * * *    77745 * Red * X * * * * *    77820 * White * X * * * * E 174 *    77891 * White * X * * * * E 171 *    77947 * White * X * * * * *    Lactoffavin * Yellow * X * * * * E 101 *    Caramel * Brown * X * * * * E 150 *    Capaanthin , capsorubin * Orange * X * * * * E 160 c *    Colour index number or denomination * Colour *   Field of application * Other limitations and requirements   (2) *     * * 1 * 2 * 3 * 4 * *    Beetroot red * Red * X * * * * E 162 *    Anthocyanins * Red * X * * * * E 103 *    Aluminium , zinc , magnesium and calcium stearates *   White * X * * * * *    Bromothymol blue * Blue * * * * X * *    Bromocresol green * Green * * * * X * *    (1) Lakes or salts of these colouring agents   using substances not prohibited under Annex II   or not excluded under Annex V from the scope of this   Directive are equally allowed .    (2) Colouring agents whose number is preceded by   the letter " E " in accordance whith the EEC Directive   of 1962 concerning foodstuffs and colouring matters must   fulfil the purity requirements laid down in those   Directives . They continue to be subject to the   general criteria set out in Annex III to the 1962   Directive concerning colouring matters where the   letter " E " has been deleted therefrom .    (3) The insoluble barium , strontium and zirconium lakes ,   salts and pigments of these colouring agents shall also   be permitted . They must pass the test for insolubility   which will be determined by the procedure laid down   in Article 8 . "    ANNEX 2     " ANNEX IV    PART 2    LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR   USE IN COSMETIC PRODUCTS (1)    Field of application    Column 1 = Colouring agents allowed in all cosmetic   products .    Column 2 = Colouring agents allowed in all   cosmetic products except those intended to be   applied in the vicinity of the eyes , in particular   eye make-up and eye-make-up remover .    Column 3 = Colouring agents allowed exclusively in   cosmetic products intended not to come into contact   with the mucous membranes .    Column 4 = Colouring agents allowed exclusively   in cosmetic products intended to come into contact   only briefly with the skin .    Colour index number or denomination * Colour *   Field of application * Other limitations and requirements   (2) * Authorization valid until *     * * 1 * 2 * 3 * 4 * * *    12700 * Yellow * * * X * * see Annex III , Part 2 *   31 . 12 . 1987 *    13065 * Yellow * * * X * * see Annex III , Part 2 *   31 . 12 . 1987 *    15800 * Red * X * * * * see Annex III , Part 2 *   31 . 12 . 1988 *    19120 * Yellow * * * * X * * 31 . 12 . 1988 *    20470 * Black * * * X * * see Annex III , Part 2 *   31 . 12 . 1988 *    21110 * Orange * * * * X * maximum 3,3'-dichlorobenzidine   concentration in the colouring agent : 5 ppm *   31 . 12 . 1987 *    21115 * Orange * * * * X * maximum 3,3'-dichlorobenzidine   concentration in the colouring agent : 5 ppm *   31 . 12 . 1988 *    26100 * Red * X * * * * * 31 . 12 . 1988 *    42045 * Blue * * * X * * see Annex III , Part 2 *   31 . 12 . 1988 *    42170 * Green * * * X * * see Annex III , Part 2 *   31 . 12 . 1988 *    42535 * Violet * * * X * * * 31 . 12 . 1987 *    44025 * Green * * * * X * * 31 . 12 . 1987 *    44045 * Blue * * * X * * see Annex III , Part 2 *   31 . 12 . 1987 *    45190 * Violet * * * X * * see Annex III , Part 2 *   31 . 12 . 1988 *    47000 * Yellow * X * * * * see Annex III , Part 2 *   31 . 12 . 1988 *   Colour index number or denomination * Colour *   Field of application * Other limitations andrequirements (2) * Authorization valid until *     * * 1 * 2 * 3 * 4 * * *    61554 * Blue * * * X * * only in hair-care   preparations in a maximum concentration of 50 ppm *   31 . 12 . 1987 *    73312 * Red * * * * X * * 31 . 12 . 1987 *    73900 * Violet * * * X * * see Annex III , Part 2 *   31 . 12 . 1987 *    73905 * Red * * * * X * * 31 . 12 . 1988 *    74180 * Blue * * * X * * see Annex III , Part 2 *   31 . 12 . 1988 *    75660 * Yellow * * * * X * * 31 . 12 . 1988 *    77288 * Green * X * * * * free from chromate ions *   31 . 12 . 1986 *    77289 * Green * X * * * * free from chromate ions *   31 . 12 . 1986 *    Acid red 195 * Red * * * X * * * 31 . 12 . 1987 *    (1) Lakes or salts of these colouring agents   using substances not prohibited under Annex II or   not excluded under Annex V from the scope of this   Directive are equally allowed .    (2) Colouring agents whose number is preceded by   the letter " E " in accordance with the EEC Directive   of 1962 concerning foodstuffs and colouring matters   must fulfil the purity requirements laid down in   those Directives . They continue to be subject to the   general criteria set out in Annex III to the   1962 Directive concerning colouring matters where   the letter " E " has been deleted therefrom . "


title: Commission Directive (EU) 2015/1127 of 10 July 2015 amending Annex II to Directive 2008/98/EC of the European Parliament and of the Council on waste and repealing certain Directives (Text with EEA relevance)

text:
               11.7.2015

               EN

               Official Journal of the European Union

               L 184/13

         COMMISSION DIRECTIVE (EU) 2015/1127
   of 10 July 2015
   amending Annex II to Directive 2008/98/EC of the European Parliament and of the Council on waste and repealing certain Directives
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (1) and in particular Article 38(1) thereof,
   Whereas:

               (1)

               Annex II to Directive 2008/98/EC sets out a non-exhaustive list of recovery operations.

               (2)

               The R1 operation in Annex II to Directive 2008/98/EC applies to waste replacing fuel or other means to generate energy. This includes incineration facilities dedicated to the processing of municipal solid waste only where their energy efficiency meet the threshold established by using the energy efficiency formula (R1 formula) referred to in Annex II to Directive 2008/98/EC.

               (3)

               It results from technical evidence that local climate conditions in the Union influence the amounts of energy that can technically be used or produced in the form of electricity, heating, cooling or processing steam by incineration facilities dedicated to the processing of municipal solid waste.

               (4)

               A report from the Joint Research Centre of the European Commission has shown that in order to achieve a level playing field in the Union it is reasonable to compensate incineration facilities affected by the impact of local climatic conditions with a climate correction factor (CCF) applicable to the R1 formula. Such factor should be based on the reference document on Best Available Techniques for waste incineration.

               (5)

               As a result of the application of a CCF some disposal incineration installations would meet the R1 formula threshold and thus automatically become recovery incineration facilities. Notwithstanding that, the application of such a correction factor should remain an incentive for incineration plants to achieve high efficiency of energy production from waste in line with the objectives and the waste hierarchy laid down in Directive 2008/98/EC.

               (6)

               The CCF applicable to the R1 formula should be based on climatic conditions for the incineration facility location.

               (7)

               Directive 2008/98/EC should therefore be amended accordingly.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 39 of Directive 2008/98/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex II to Directive 2008/98/EC is amended as set out in the Annex.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2016, at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 10 July 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 312, 22.11.2008, p. 3.

      ANNEX
      In Annex II to Directive 2008/98/EC, the following text is added under footnote (*):
      ‘The energy efficiency formula value will be multiplied by a climate correction factor (CCF) as shown below:

                  1.

                  CCF for installations in operation and permitted in accordance with applicable Union legislation before 1 September 2015.
                  CCF = 1 if HDD >= 3 350
                  CCF = 1,25 if HDD <= 2 150
                  CCF = – (0,25/1 200) × HDD + 1,698 when 2 150 < HDD < 3 350

                  2.

                  CCF for installations permitted after 31 August 2015 and for installations under 1 after 31 December 2029:
                  CCF = 1 if HDD >= 3 350
                  CCF = 1,12 if HDD <= 2 150
                  CCF = – (0,12/1 200) × HDD + 1,335 when 2 150 < HDD < 3 350

            (The resulting value of CCF will be rounded at three decimal places).
      The value of HDD (Heating Degree Days) should be taken as the average of annual HDD values for the incineration facility location, calculated for a period of 20 consecutive years before the year for which CCF is calculated. For the calculation of the value of HDD the following method established by Eurostat should be applied: HDD is equal to (18 °C — Tm) × d if Tm is lower than or equal to 15 °C (heating threshold) and is nil if Tm is greater than 15 °C; where Tm is the mean (Tmin + Tmax/2) outdoor temperature over a period of d days. Calculations are to be executed on a daily basis (d = 1), added up to a year.’


Avis juridique important

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31995L0035

Commission Directive 95/35/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market

Official Journal L 172 , 22/07/1995 P. 0006 - 0007

COMMISSION DIRECTIVE 95/35/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the  placing of plant protection products on the market (Text with EEA relevance)THE  COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant  protection products on the market  (1), as last amended by Commission Directive 94/79/EC  (2), and  in particular Article 18  (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC set out the requirements for the dossier to be  submitted by applicants respectively for the inclusion of an active substance in Annex I and for  the authorization of a plant protection product; Whereas it is necessary, in Annexes II and III to Directive 91/414/EEC, to indicate to the  applicants as precisely as possible any details on the required information, such as the  circumstances, conditions and technical protocols under which certain data has to be generated;  whereas those details should be introduced as soon as available in order to permit applicants to  use them in the preparation of their dossiers; Whereas the introductions to Annexes II and III to Directive 91/414/EEC currently refer to the  application of the principles of good laboratory practice (GLP) where testing is conducted to  obtain data on the properties and safety of the substances and preparations; whereas therefore,  without prejudice to the provisions of Article 9  (1), third subparagraph thereof, GLP should in  principle be applied to residue studies, in particular when they are necessary for the dossiers to  be submitted with a view to the inclusion of active substances in Annex I to the said Directive; Whereas, however, it has become evident that in certrain Member States the necessary infrastructure  is not yet available for applying GLP requirements to residue studies from supervised trials on  crops, food or feedingstuffs; whereas on the other hand Member States already applying GLP  requirements should be allowed to continue to do so in trials performed on their territory; whereas  this principle should also be clarified for the purpose of the derogations from GLP already  contained in the Directive; Whereas it is necessary to provide for a temporary derogation for the application of GLP  requirements for active substances already on the market two years after notification of Directive  91/414/EEC whenever a number of precautionary conditions are satisfied; whereas, however, it is not  necessary to provide for such a derogation service for active substances not brought onto the  market two years after the notification of the said Directive; Whereas the measures provided for in this Directive are in accordance with the opinion of the  Standing Committee on Plant Health, HAS ADOPTED THIS DIRECTIVE: Article 1 Annexes II and III to Directive 91/414/EEC are amended as set out in  the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive by 30 June 1996. They shall immediately inform  the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or  shall be accompanied by such a reference at the time of their official publication. The procedure  for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on 1 July 1995. Article 4 This Directive is addressed to the Member States. Done at Brussels, 14 July 1995. For the Commission Ritt BJERREGAARD Member of the Commission  ANNEX Annexes II and III to Directive 91/414/EEC are amended as follows: 1.  Annex II is amended as follows: (a)  Point 2.2 of the introduction is replaced by the following: '2.2  By way of derogation from point 2.1, Member States may provide that tests and analyses,  performed on their territory in order to obtain data on the properties and/or safety of the  substances with respect to honey-bees and beneficial arthropods other than bees shall be conducted  by official or officially-recognized testing facilities or organizations which satisfy at least the  requirements as set out under points 2.2 and 2.3 of the introduction to Annex III. This derogation applies to trials actually started on or before 31 December 1999.` (b)  The following point 2.3 is added to the introduction: '2.3  By way of derogation from point 2.1, Member States may provide that supervised residue trials  performed on their territory in accordance with the provisions of Section 6 'Residues in or on  treated products, food and feed` on plant protection products containing active substances already  on the market two years after notification of the Directive shall be conducted by official or  officially-recognized testing facilities or organizations which satisfy at least the requirements  under points 2.2 and 2.3 of the introduction to Annex III. This derogation applies for supervised residue trials actually started on or before 31 December  1997.` 2.  Annex III is amended as follows: (a)  Point 2.4 of the introduction is replaced by the following: '2.4  By way of derogation from point 2.1, Member States may apply the provisions of points 2.2 and  2.3, by extension, to tests and analyses performed on their territory in order to obtain data on  the properties and/or safety of the preparations with respect to honey-bees and beneficial  arthropods other than bees and actually started on or before 31 December 1999.` (b)  The following point 2.5 is inserted into the introduction: '2.5  By way of derogation from point 2.1, Member States may apply the provisions of points 2.2 and  2.3, by extension, to supervised residue trials performed on their territory in accordance with the  provisions of Section 8 'Residues in or on treated products, food and feed` with plant protection  products containing active substances already on the market two years after notification of the  Directive and actually started on or before 31 December 1997.`


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32000L0052

Commission Directive 2000/52/EC of 26 July 2000 amending Directive 80/723/EEC on the transparency of financial relations between Member States and public undertakings

Official Journal L 193 , 29/07/2000 P. 0075 - 0078

Commission Directive 2000/52/ECof 26 July 2000amending Directive 80/723/EEC on the transparency of financial relations between Member States and public undertakingsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, and in particular Article 86(3) thereof,Whereas:(1) Commission Directive 80/723/EEC(1), as last amended by Directive 93/84/EEC(2), requires Member States to ensure that financial relations between public authorities and public undertakings are transparent. Directive 80/723/EEC requires certain financial information to be retained by Member States and supplied to the Commission when requested, while other information has to be supplied in the form of annual reports.(2) Various sectors of the economy which were characterised in the past by the existence of national, regional or local monopolies have been or are being opened partly or fully to competition in application of the Treaty or by rules adopted by the Member States and the Community. This process has highlighted the importance of ensuring that the rules on competition contained in the Treaty are fairly and effectively applied in these sectors, in particular that there is no abuse of a dominant position within the meaning of Article 82 of the Treaty, and no State aid within the meaning of Article 87 of the Treaty unless it is compatible with the common market, without prejudice to the possible application of Article 86(2) of the Treaty.(3) In such sectors Member States often grant special or exclusive rights to particular undertakings, or make payments or give some other kind of compensation to particular undertakings entrusted with the operation of services of general economic interest. These undertakings are often also in competition with other undertakings.(4) According to Article 86(2) and (3) of the Treaty it is, in principle, for the Member States to entrust certain undertakings with the operation of services of general economic interest that they define, the Commission being responsible for ensuring the proper application of the provisions of that Article.(5) Article 86(1) of the Treaty requires that, in the case of public undertakings and undertakings to which Member States grant special or exclusive rights, Member States must neither enact nor maintain in force any measure contrary to the rules contained in the Treaty. Article 86(2) of the Treaty applies to undertakings entrusted with the operation of services of general economic interest. Article 86(3) of the Treaty requires the Commission to ensure the application of the provisions of Article 86 and to address appropriate directives or decisions to Member States. The interpretative provisions annexed to the Treaty by the Protocol on the system of public broadcasting in the Member States state that the provisions of the Treaty establishing the European Community shall be without prejudice to the competence of the Member States to provide for the funding of public service broadcasting in so far as such funding is granted to broadcasting organisations for the fulfilment of the public service remit conferred, defined and organised by each Member State, and in so far as such funding does not affect trading conditions and competition in the Community to an extent which would be contrary to the common interest, while the realisation of the remit of that public service shall be taken into account. In order to ensure the application of the provisions of Article 86 of the Treaty the Commission must have the necessary information. This entails defining the conditions for achieving transparency.(6) Complex situations linked to the diverse forms of public and private undertakings granted special or exclusive rights or entrusted with the operation of services of general economic interest as well as the range of activities that might be carried on by a single undertaking and the different degrees of market liberalisation in the various Member States could complicate application of the competition rules, and particularly Article 86 of the Treaty. It is therefore necessary for Member States and the Commission to have detailed data about the internal financial and organisational structure of such undertakings, in particular separate and reliable accounts relating to different activities carried on by the same undertaking. Such information is not always available or is not always sufficiently detailed or reliable.(7) Such accounts should show the distinction between different activities, the costs and revenues associated with each activity and the methods of cost and revenue assignment and allocation. Such separate accounts should be available in relation to, on the one hand, products or services in respect of which the Member State has granted a special or exclusive right or entrusted the undertaking with the operation of a service of general economic interest, as well as, on the other hand, for each other product or service in respect of which the undertaking is active. The obligation of separation of accounts should not apply to undertakings whose activities are limited to the provision of services of general economic interest and which do not operate activities outside the scope of these services of general economic interest. It does not seem necessary to require separation of accounts within the area of services of general economic interest or within the area of the special or exclusive rights, as far as this is not necessary for the cost and revenue allocation between these services and products and those outside of the services of general economic interest or the special or exclusive rights.(8) Requiring Member States to ensure that the relevant undertakings maintain such separate accounts is the most efficient means by which fair and effective application of the rules on competition to such undertakings can be assured. The Commission has adopted a Communication on services of general interest in Europe(3) in which it emphasises their importance. It is necessary to take account of the importance of the sectors concerned, which may involve services of general interest, the strong market position that the relevant undertakings may have and the vulnerability of emerging competition in the sectors being liberalised. In accordance with the principle of proportionality it is necessary and appropriate for the achievement of the basic objective of transparency to lay down rules on such separate accounts. This Directive confines itself to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty.(9) In certain sectors provisions adopted by the Community require Member States and certain undertakings to maintain separate accounts. It is necessary to ensure an equal treatment for all economic activities throughout the Community and to extend the requirement to maintain separate accounts to all comparable situations. This Directive should not amend specific rules established for the same purpose in other Community provisions and should not apply to activities of undertakings covered by those provisions.(10) In view of the limited potential impact on competition and in order to avoid imposing an excessive administrative burden it is not necessary, at this time, to require enterprises with a total annual net turnover of less than EUR 40 million to maintain separate accounts. In view of the limited potential for an effect on trade between Member States, it is not necessary, at this time, to require separate accounts in relation to the supply of certain categories of services. This Directive should apply without prejudice to any other rules concerning the provision of information by Member States to the Commission.(11) In cases where the compensation for the fulfilment of services of general economic interest has been fixed for an appropriate period following an open, transparent and non-discriminatory procedure it does not seem necessary at this time to require such undertakings to maintain separate accounts.(12) Article 295 of the Treaty provides that the Treaty is in no way to prejudice the rules in Member States governing the system of property ownership. There should be no unjustified discrimination between public and private undertakings in the application of the rules on competition. This Directive should apply to both public and private undertakings.(13) The Member States have differing administrative territorial structures. This Directive should cover public authorities at all levels in each Member State.(14) Directive 80/723/EEC should therefore be amended accordingly,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 80/723/EEC is amended as follows:1. The title is replaced by the following:"Commission Directive 80/723/EEC of 25 June 1980 on the transparency of financial relations between Member States and public undertakings as well as on financial transparency within certain undertakings."2. Articles 1 and 2 are replaced by the following:"Article 11. The Member States shall ensure that financial relations between public authorities and public undertakings are transparent as provided in this Directive, so that the following emerge clearly:(a) public funds made available directly by public authorities to the public undertakings concerned;(b) public funds made available by public authorities through the intermediary of public undertakings or financial institutions;(c) the use to which these public funds are actually put.2. Without prejudice to specific provisions laid down by the Community the Member States shall ensure that the financial and organisational structure of any undertaking required to maintain separate accounts is correctly reflected in the separate accounts, so that the following emerge clearly:(a) the costs and revenues associated with different activities;(b) full details of the methods by which costs and revenues are assigned or allocated to different activities.Article 21. For the purpose of this Directive:(a) 'public authorities' means all public authorities, including the State and regional, local and all other territorial authorities;(b) 'public undertakings' means any undertaking over which the public authorities may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it;(c) 'public undertakings operating in the manufacturing sector' means all undertakings whose principal area of activity, defined as being at least 50 % of total annual turnover, is in manufacturing. These undertakings are those whose operations fall to be included in Section D - Manufacturing (being subsection DA up to and including subsection DN) of the NACE (Rev.1) classification(4);(d) 'undertaking required to maintain separate accounts' means any undertaking that enjoys a special or exclusive right granted by a Member State pursuant to Article 86(1) of the Treaty, or that is entrusted with the operation of a service of general economic interest pursuant to Article 86(2) of the Treaty and receives State aid in any form whatsoever, including any grant, support or compensation, in relation to such service and which carries on other activities;(e) 'different activities' means, on the one hand, all products or services in respect of which a special or exclusive right is granted to an undertaking or all services of general economic interest with which an undertaking is entrusted and, on the other hand, each other separate product or service in respect of which the undertaking is active;(f) 'exclusive rights' means rights that are granted by a Member State to one undertaking through any legislative, regulatory or administrative instrument, reserving it the right to provide a service or undertake an activity within a given geographical area;(g) 'special rights' means rights that are granted by a Member State to a limited number of undertakings, through any legislative, regulatory or administrative instrument, which, within a given geographical area:- limits to two or more the number of such undertakings, authorised to provide a service or undertake an activity, otherwise than according to objective, proportional and non-discriminatory criteria, or- designates, otherwise than according to such criteria, several competing undertakings, as being authorised to provide a service or undertake an activity, or- confers on any undertaking or undertakings, otherwise than according to such criteria, any legal or regulatory advantages which substantially affect the ability of any other undertaking to provide the same service or to operate the same activity in the same geographical area under substantially equivalent conditions.2. A dominant influence on the part of the public authorities shall be presumed when these authorities, directly or indirectly in relation to an undertaking:(a) hold the major part of the undertaking's subscribed capital; or(b) control the majority of the votes attaching to shares issued by the undertakings; or(c) can appoint more than half of the members of the undertaking's administrative, managerial or supervisory body."3. In Article 3, "Article 1" is replaced by "Article 1(1)"4. The following Article 3a is inserted:"Article 3a1. To ensure the transparency referred to in Article 1(2), the Member States shall take the measures necessary to ensure that for any undertaking required to maintain separate accounts:(a) the internal accounts corresponding to different activities are separate;(b) all costs and revenues are correctly assigned or allocated on the basis of consistently applied and objectively justifiable cost accounting principles;(c) the cost accounting principles according to which separate accounts are maintained are clearly established.2. Paragraph 1 shall only apply to activities which are not covered by specific provisions laid down by the Community and shall not affect any obligations of Member States or undertakings arising from the Treaty or from such specific provisions."5. Articles 4 and 5 are replaced by the following:"Article 41. As far as the transparency referred to in Article 1(1) is concerned, this Directive shall not apply to financial relations between the public authorities and(a) public undertakings, as regards services the supply of which is not liable to affect trade between Member States to an appreciable extent;(b) central banks;(c) public credit institutions, as regards deposits of public funds placed with them by public authorities on normal commercial terms;(d) public undertakings whose total annual net turnover over the period of the two financial years preceding that in which the funds referred to in Article 1(1) are made available or used has been less than EUR 40 million. However, for public credit institutions the corresponding threshold shall be a balance sheet total of EUR 800 million.2. As far as the transparency referred to in Article 1(2) is concerned, this Directive shall not apply(a) to undertakings, as regards services the supply of which is not liable to affect trade between Member States to an appreciable extent;(b) to undertakings whose total annual net turnover over the period of the two financial years preceding any given year in which it enjoys a special or exclusive right granted by a Member State pursuant to Article 86(1) of the Treaty, or in which it is entrusted with the operation of a service of general economic interest pursuant to Article 86(2) of the Treaty is less than EUR 40 million; however, for public credit institutions the corresponding threshold shall be a balance sheet total of EUR 800 million;(c) to undertakings which have been entrusted with the operation of services of general economic interest pursuant to Article 86(2) of the Treaty if the State aid in any form whatsoever, including any grant, support or compensation they receive was fixed for an appropriate period following an open, transparent and non-discriminating procedure.Article 51. Member States shall ensure that information concerning the financial relations referred to in Article 1(1) be kept at the disposal of the Commission for five years from the end of the financial year in which the public funds were made available to the public undertakings concerned. However, where the same funds are used during a later financial year, the five-year time limit shall run from the end of that financial year.2. Member States shall ensure that information concerning the financial and organisational structure of undertakings referred to in Article 1(2) be kept at the disposal of the Commission for five years from the end of the financial year to which the information refers.3. Member States shall, where the Commission considers it necessary so to request, supply to it the information referred to in paragraphs 1 and 2, together with any necessary background information, notably the objectives pursued."6. In Article 5a(3), "ECU" is replaced by "EUR".7. In Article 6(1), "Article 5(2)" is replaced by "Article 5(3)".Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2001 at the latest. They shall forthwith inform the Commission thereof.Article 1(2) of Directive 80/723/EEC, as amended by this Directive, shall apply with effect from 1 January 2002.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 3This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 26 July 2000.For the CommissionMario MontiMember of the Commission(1) OJ L 195, 29.7.1980, p. 35.(2) OJ L 254, 12.10.1993, p. 16.(3) OJ C 281, 26.9.1996, p. 3.(4) OJ L 83, 3.4.1993, p. 1.


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31995L0045

Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs

Official Journal L 226 , 22/09/1995 P. 0001 - 0045

COMMISSION DIRECTIVE  95/45/ECof 26 July 1995laying down specific purity criteria concerning colours for use in  foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN  COMMUNITIESHaving regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws  of the Member States concerning food additives authorized for use in foodstuffs intended for human  consumption (1), as last amended by Directive 94/34/EC (2), and in particular Article 3 (3) (a)  thereof, After consulting the Scientific Committee for Food, Whereas it is necessary to establish purity criteria for all colours mentioned in European  Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (3); Whereas it is necessary to revise the purity criteria for colours mentioned in the Council  Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the  colouring matters authorized for use in foodstuffs intended for human consumption (4), as last  amended by Directive 85/7/EEC (5); Whereas it is necessary to take into account the specifications and analytical techniques for  colours as set out in the Codex Alimentarius and the Joint FAO/WHO Expert Committee on Food  Additives (JECFA); Whereas food additives, prepared by production methods or starting materials significantly  different from those included in the evaluation of the Scientific Committee for Food, or different  from those mentioned in this Directive, shall be submitted for evaluation by the Scientific  Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria; Whereas the measures provided for in this Directive are in accordance with the opinion of the  Standing Committee on Foodstuffs, HAS ADOPTED THIS DIRECTIVE: Article 1The purity criteria referred to in Article 3 (3) (a) of Directive  89/107/EEC for colours mentioned in Directive 94/36/EC are set out in the Annex hereto. Article 8 and Annex III to the Directive of 23 October 1962 are hereby deleted. Article 21. Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive not later than 1 July 1996. They shall  immediately inform the Commission thereof. When Member States adopt these provisions, they 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. Products put on the market or labelled before 1 July 1996 which do not comply with this  Directive may, however, be marketed until stocks are exhausted. Article 3This Directive shall enter into force on the third day following that of its  publication in the Official Journal of the European Communities. Article 4This Directive is addressed to the Member States. Done at Brussels, 26 July 1995. For the CommissionMartin BANGEMANNMember of the Commission(1) OJ No L 40,  11. 2. 1989, p. 27. (2) OJ No L 237, 10. 9. 1994, p. 1. (3) OJ No L 237, 10. 9. 1994, p. 13. (4) OJ No 115, 11. 11. 1962, p. 2645/62. (5) OJ No L 2, 3. 1. 1985, p. 22.  ANNEX A. General specifications for aluminium lakes of colours >TABLE>B.  SPECIFIC CRITERIA OF PURITY >TABLE>