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31980L0876

Council Directive 80/876/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to straight ammonium nitrate fertilizers of high nitrogen content

Official Journal L 250 , 23/09/1980 P. 0007 - 0011 Finnish special edition: Chapter 13 Volume 11 P. 0003  Spanish special edition: Chapter 13 Volume 11 P. 0071  Swedish special edition: Chapter 13 Volume 11 P. 0003  Portuguese special edition Chapter 13 Volume 11 P. 0071

COUNCIL DIRECTIVE  of 15 July 1980  on the approximation of the laws of the Member States relating to straight ammonium nitrate fertilizers of high nitrogen content  (80/876/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (4) has already laid down Community rules on the designation, composition, labelling and packaging of the most important straight and compound fertilizers in the Community ; whereas ammonium nitrate based fertilizers are the particular concern of that Directive ; whereas it seems necessary, however, having regard to the particular nature of this type of fertilizer and to the requirements it entails regarding public safety, health and protection of workers, to lay down additional Community rules for these fertilizers;  Whereas ammonium nitrate is the essential ingredient of a variety of products, some of which are intended for use as fertilizers and others as explosives ; whereas, by reason of the divergencies between national provisions on the classification of products used as fertilizer as against other products based on ammonium nitrate, the regulations controlling the marketing of ammonium nitrate based fertilizers differ from one Member State to another ; whereas by reason of such divergencies they hinder trade in straight ammonium nitrate fertilizers of high nitrogen content within the European Economic Community;  Whereas such obstacles to the establishment of the common market can be reduced and even eliminated if the same requirements are adopted by all the Member States either in addition to or in place of their present laws;  Whereas certain of the products covered by this Directive could in certain instances be used for purposes other than those for which they were intended, which could well endanger the security of persons and property ; whereas the Member States should therefore not be prevented from taking appropriate steps to avoid such use;  Whereas it is above all necessary, to this end and in the interest of public safety, to determine at Community level the characteristics and properties distinguishing straight ammonium nitrate fertilizers of high nitrogen content from varieties of ammonium nitrate used in the manufacture of products used as explosives;  (1)OJ No C 16, 23.1.1976, p. 4. (2)OJ No C 125, 8.6.1976, p. 43. (3)OJ No C 204, 30.8.1976, p. 10. (4)OJ No L 24, 30.1.1976, p. 21.   Whereas straight ammonium nitrate fertilizers of high nitrogen content should conform to certain characteristics to ensure that they are harmless ; whereas, moreover, several Member States wish to be free to subject such fertilizers to a test of resistance to detonation before or after they are marketed;  Whereas the determination of the methods of analysis and supervision, as well as any changes or additions to be made thereto to take account of technical progress, constitute measures of a technical nature whose adoption should be made the responsibility of the Commission so that the procedure may be simplified and expedited;  Whereas technical progress necessitates the prompt adaptation of the technical requirements of this Directive ; whereas a procedure has already been established under Articles 10 and 11 of Directive 76/116/EEC for the purpose of adapting Directives on fertilizers to technical progress,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. Without prejudice to the application of Directive 76/116/EEC, this Directive shall apply to straight ammonium nitrate fertilizers of high nitrogen content placed on the market in the Member States of the Community.  2. For the purposes of this Directive, "fertilizers" means ammonium nitrate based products manufactured chemically for use as fertilizer and containing more than 28 % by weight of nitrogen, which may contain inorganic additives or inert substances such as ground limestone or ground dolomite, calcium sulphate, magnesium sulphate and kieserite.  3. Inorganic additives or inert substances, other than those mentioned in paragraph 2, which are used in the compounding of the fertilizer must not increase its sensitivity to heat or its tendency to detonate.   Article 2 To be eligible for the description "EEC fertilizer", the fertilizer must conform to the characteristics and limits laid down in Annex I. The person responsible for marketing the fertilizer, established within the Community, shall certify its conformity by use of the description "EEC fertilizer".   Article 3 Only packaged fertilizer may be made available to the final user.  International rules on the carriage of dangerous substances shall continue to apply for the carriage of fertilizers.   Article 4 No Member State may, on grounds relating to the requirements laid down in this Directive, prohibit, restrict or hinder the marketing of a fertilizer bearing the description "EEC fertilizer" and complying with the requirements of this Directive.   Article 5 The provisions of this Directive shall not preclude the taking of measures which are justified on grounds of public security to prohibit, restrict or hinder the marketing of fertilizers.   Article 6 Member States shall take all necessary measures to ensure that fertilizers placed on the market under the description "EEC fertilizer" comply with the provisions of this Directive and Annex I hereto.   Article 7 1. Without prejudice to the measures referred to in Article 6, Member States may if they so desire carry out additional checks on "EEC fertilizer". Such checks may be carried out either before the fertilizers are placed on the market, or after marketing, or at both stages concurrently.  2. For these checks, only the test described in Annex II shall be used.  3. "EEC fertilizer" which satisfies the requirements of this Directive and, where required by the Member State, the test of resistance to detonation described in Annex II, shall not be made subject to national provisions - in particular as regards storage - which are as stringent as those applying to products which do not satisfy these requirements.   Article 8 1. The following shall be established in accordance with the procedure laid down in Article 11 of Directive 76/116/EEC:    - the method of checking compliance with the requirements of points 1, 2 and 6 of Annex I and the method of carrying out the test described in Annex II;       - the number of thermal cycles laid down in Annex II to be undergone by the fertilizer. There shall be at least two thermal cycles;       - analysis and sampling methods;       - the maximum permissible level of heavy metals.          2. Any amendments necessary to adapt to technical progress the methods of determining the composition and the properties of fertilizers and the method of carrying out the test of resistance to detonation shall be adopted by the same procedure.  3. By the same procedure a decision shall be taken three years after implementation of this Directive on whether the requirement of two thermal cycles should be retained for the test referred to in Section 1 of Annex I.   Article 9 1. Where a Member State has good grounds for believing that a fertilizer, although satisfying the requirements of this Directive, constitutes a hazard to safety or health, it may temporarily prohibit the marketing of the fertilizer in its territory or make it subject to special conditions. It shall immediately inform the other Member States and the Commission thereof, giving the reasons for its decision.  2. The Commission shall, within six weeks, consult the Member States concerned, then give its view without delay and take the appropriate steps.  3. If the Commission considers that technical adaptations to this Directive are necessary, such adaptations shall be adopted, either by the Commission or by the Council, in accordance with the procedure laid down in Article 8. In this event, the Member State which has taken precautionary measures may retain them until such adaptations come into force.   Article 10 1. Member States shall adopt and publish the provisions necessary to comply with this Directive within eighteen months of its notification and shall forthwith inform the Commission thereof.  They shall apply these provisions from 1 January 1984.  2. Member States shall ensure that the Commission is informed of the texts of the provisions of national law which they adopt in the field governed by this Directive.   Article 11 This Directive is addressed to the Member States.     Done at Brussels, 15 July 1980.  For the Council  The President  J. SANTER     ANNEX I CHARACTERISTICS OF AND LIMITS FOR STRAIGHT AMMONIUM NITRATE FERTILIZERS OF HIGH NITROGEN CONTENT    1. Porosity (oil retention)  The oil retention of the fertilizer, which must first have undergone two thermal cycles of a temperature ranging from 25 to 50 ºC, must not exceed 4 % by weight.       2. Combustible ingredients  The percentage by weight of combustible material measured as carbon must not exceed 0 72 % for fertilizers having a nitrogen content of at least 31 75 % by weight and must not exceed 0 74 % for fertilizers having a nitrogen content of at least 28 % but less than 31 75 % by weight.       3. pH  A solution of 10 g of fertilizer in 100 ml of water must have a pH of at least 4 75.       4. Particle size analysis  Not more than 5 % by weight of the fertilizer must pass through a 1 mm mesh sieve and not more than 3 % by weight must pass through a 0 75 mm mesh sieve.       5. Chlorine  The maximum chlorine content is set at 0 702 % by weight.       6. Heavy metals  Heavy metals should not be added deliberately, and any traces which are incidental to the production process should not exceed the limit fixed by the Committee.           ANNEX II DESCRIPTION OF THE TEST OF RESISTANCE TO DETONATION REFERRED TO IN ARTICLE 7  The test must be carried out on a representative sample of fertilizer. Before being tested for resistance to detonation, the whole mass of the sample is to be thermally cycled not more than five times.  The fertilizer must be subjected to the test of resistance to detonation in a horizontal steel tube under the following conditions: >PIC FILE= "T0013761">   placed at 150 mm intervals and supporting the tube horizontally. The test is to be carried out twice. The test is deemed conclusive if in both tests one or more of the supporting lead cylinders is crushed by less than 5 %.


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31991L0269

Commission Directive 91/269/EEC of 30 April 1991 adapting to technical progress Council Directive 82/130/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp

Official Journal L 134 , 29/05/1991 P. 0051 - 0055 Finnish special edition: Chapter 13 Volume 20 P. 0111  Swedish special edition: Chapter 13 Volume 20 P. 0111

COMMISSION DIRECTIVE  of 30 April 1991  adapting to technical progress Council Directive 82/130/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines  susceptible to firedamp  (91/269/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 82/130/EEC of 15 February 1982 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp (1) as last amended by  Directive 88/35/EEC (2), and in particular Article 7 thereof,  Whereas in view of the present state of technical progress, it is now necessary to adapt the contents of the harmonized standards referred to in Annex A of Directive 82/130/EEC;  Whereas in view of experience gained since Directive 82/130/EEC was adopted, it seems appropriate to amend Annex C thereto;  Whereas in view of the nature of equipment mentioned above, it is necessary to provide for a transition period in order to allow for the industry to adapt to the amendments of standards;  Whereas the measures provided for in this Directive are in accordance with the opinion delivered by the Restricted Committee of the Safety and Health Commission for the Mining and other Extractive industries,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 82/130/EEC is hereby amended as follows:  1. Annexes A and C are replaced by Annexes A and C in the Annex to this Directive.  2. Annex B is amended in accordance with Annex B in the Annex to this Directive.  Article 2  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1992 and 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.  Member States shall communicate to the Commission the text of the national measures which they adopt pursuant to this Directive.  2. However, until 31 December 2009, Member States shall continue to apply the measures provided for in Article 4 of Directive 82/130/EEC as regards the equipment for which conformity to the harmonized standards is attested by the certificate of  conformity referred to in Article 8 of Directive 82/130/EEC, provided that this certificate was issued before 1 January 1993.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 30 April 1991. For the Commission  Vasso PAPANDREOU  Member of the Commission  (1) OJ No L 59, 2. 3. 1982, p. 10. (2) OJ No L 20, 26. 1. 1988, p. 28.    ANNEX  'ANNEX A  HARMONIZED STANDARDS  The harmonized standards to which equipment must conform, depending on the type of protection, are the European Standards referred to in the table below.  Certificates drawn up in accordance with this Directive shall be referred to as "generation C certificates". The letter C shall appear at the beginning of the serial number of each such certificate.  EUROPEAN STANDARDS  (drawn up by Cenelec, 2 rue Brederode, PO Box 5, B-1000 Brussels)   Number  Title  Edition  Date           EN 50014  Electrical equipment for use in potentially explosive atmospheres:     general requirements  1  March 1977   Amendment 1   July 1979   Amendment 2   June 1982   Amendments 3 and 4   December 1982    Amendment 5   February 1986  EN 50015  Electrical equipment for use in potentially explosive atmospheres:     oil immersion "o"  1  March 1977   Amendment 1   July 1979  EN 50016  Electrical equipment for use in potentially explosive atmospheres:      pressurized apparatus "p"  1  March 1977   Amendment 1   July 1979  EN 50017  Electrical equipment for use in potentially explosive atmospheres:     powder filling "q"  1  March 1977   Amendment 1   July 1979  EN 50018  Electrical equipment for use  in potentially explosive atmospheres:     flameproof enclosure "d" "  1  March 1977   Amendment 1   July 1979   Amendment 2   December 1982   Amendment 3   November 1985  EN 50019  Electricval equipment for use in potentially explosive atmospheres:      increased safety "e"  1  March 1977   Amendment 1   July 1979   Amendment 2   September 1983   Amendment 3   December 1985  EN 50020  Electrical equipment for use in potentially explosive atmospheres:     intrinsic safety "i"  1  March 1977    Amendment 1   July 1979   Amendment 2   December 1985  En 50028  Electrical apparatus for potentially explosive atmospheres:     encapsulation "m"  1  February 1987'        ANNEX B  Amendments and supplements made to the European Standards listed in Annex A  Appendix 1  ELECTRICAL APPARATUS FOR POTENTIALLY EXPLOSIVE ATMOSPHERES OF GROUP I  GENERAL REQUIREMENTS  (European standard EN 50014)  Replace the text of 6.3.1 of amendment 3 (December 1982) to European Standard EN 50014 by the following text:  '6.3.1 Electrical apparatus of Group I  Enclosures of plastic materials with a surface area projected in any direction of more than 100 cm2, or containing exposed metallic parts with a capacitance to earth of more than 3 pF, under the most unfavourable conditions in practice, shall be so  designed that under normal conditions of use, maintenance and cleaning, danger of ignition due to electrostatic charges is avoided.  This requirement shall be satisfied:  - either by suitable selection of the material: its insulation resistance, measured according to the method given in 22.4.7.8 of this European standard, shall not exceed:  - 1 GÙ at 23 ± 2 °C and 50 ± 5 % relative humidity,  or  - 100 GÙ under extreme service conditions of temperature and humidity specified for the electrical apparatus; the '÷' shall then be placed after the certificate reference, as indicated in 26.2.9;  - or by the size, shape, layout or by other protective methods. The non-appearance of dangerous electrostatic charges shall then be verified by actual tests for ignition of an air-methane mixture containing 8,5 ± 0,5 % of methane.  If, however, the danger of ignition cannot be avoided in the design, a warning label shall indicate the safety measures to be applied in service.'   Appendix 2  Delete the text of Appendix 2 of Annex B to Directive 82/130/EEC.   Appendix 3  Retain the text of Appendix 3 of Annex B to Directive 82/130/EEC without change.    ANNEX C  ELECTRICAL APPARATUS FOR POTENTIALLY EXPLOSIVE ATMOSPHERES OF GROUP I  I. DISTINCTIVE COMMUNITY MARK                                         II. MARKING OF ELECTRICAL APPARATUS COVERED BY AN INSPECTION CERTIFICATE  If a type of electrical apparatus which is not in conformity with the harmonized standards has been granted an inspection certificate as provided for in Article 9, the distinctive Community mark must be supplemented at least by the following:  1. The symbol 'S' signifying that it is an electrical apparatus suitable for gassy mines covered by an inspection certificate. This symbol shall immediately follow the distinctive Community mark as indicated below.  2. The last two digits of the year of issue of the inspection certificate.  3. The serial number of the inspection certificate for that year.  4. The name or symbol of the body approved to issue the certificate.  5. The name of the manufacturer or his registered trade mark.  6. The manufacturer's type identification.  7. The manufacturer's serial number.  8. If the testing station considers that it is necessary to indicate special conditions for safe use, the sign '÷' shall be placed after the certificate reference.  9. Any marking normally required by the construction standards for the electrical apparatus.  10. Any supplementary marking considered necessary by the body approved to issue the certificates.  '


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32002L0061

Directive 2002/61/EC of the European Parliament and of the Council of 19 July 2002 amending for the nineteenth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants)

Official Journal L 243 , 11/09/2002 P. 0015 - 0018

Directive 2002/61/EC of the European Parliament and of the Councilof 19 July 2002amending for the nineteenth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposals 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 251 of the Treaty(3),Whereas:(1) Work on the internal market should gradually improve the quality of life, health protection and consumer safety. The measures provided for in this Directive ensure a high level of health and consumer protection.(2) Textile and leather articles containing certain azodyes have the capacity to release certain arylamines, which may pose cancer risks.(3) Limitations already adopted or planned by certain Member States on the use of azodyed textile and leather articles concern the completion and functioning of the internal market. It is therefore necessary to approximate the laws of the Member States in this field and, consequently, to amend Annex I to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(4).(4) The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), after being consulted by the Commission, has confirmed that cancer risks posed by textile and leather goods coloured by certain azodyes, give cause for concern.(5) In order to protect human health, the use of dangerous azodyes and the placing on the market of some articles coloured with such dyes should be prohibited.(6) For textile articles made of recycled fibres, a maximum concentration of 70 ppm for the amines listed in point 43 in the appendix to Directive 76/769/EEC should be applied. This should be the case for a transitional period until 1 January 2005 if the amines are released by the residues deriving from the previous dyeing of the same fibres. This will allow for the recycling of textiles, which has overall benefits for the environment.(7) Harmonised testing methods are necessary for the application of this Directive. The Commission, in accordance with Article 2a of Directive 76/769/EEC, should establish such methods. The testing methods should preferably be developed at European level, if appropriate by the European Committee for Standardisation (CEN).(8) In the light of new scientific knowledge, testing methods should be reviewed, including testing methods for analysing 4-amino azobenzene.(9) In the light of new scientific knowledge, the provisions on certain azocolourants should be reviewed, in particular with regard to the need to include other materials not covered by this Directive, as well as other aromatic amines. Special attention should be paid to possible risks to children.(10) This Directive applies without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC(5) and in individual directives based thereon, in particular Council Directive 90/394/EEC(6) and Directive 98/24/EC of the European Parliament and of the Council(7),HAVE ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.Article 2Testing methods for the application of point 43 of Annex I to Directive 76/769/EEC shall be adopted by the Commission in accordance with the procedure laid down in Article 2a of that Directive.Article 31. Member States shall adopt and publish, not later than 11 September 2003, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply these provisions from 11 September 2003.2. When 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 reference shall be laid down by Member States.Article 4This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 19 July 2002.For the European ParliamentThe PresidentP. CoxFor the councilThe PresidentT. Pedersen(1) OJ C 89 E, 28.3.2000, p. 67 andOJ C 96 E, 27.3.2001, p. 269.(2) OJ C 204, 18.7.2000, p. 90.(3) Opinion of the European Parliament of 7 September 2000 (OJ C 135, 7.5.2001, p. 257), Council Common Position of 18 February 2002 (OJ C 119 E, 22.5.2002, p. 7) and Decision of the European Parliament of 11 June 2002 (not yet published in the Official Journal).(4) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2001/91/EC (OJ L 286, 30.10.2001, p. 27).(5) OJ L 183, 29.6.1989, p. 1.(6) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).(7) OJ L 131, 5.5.1998, p. 11.ANNEXAnnex I to Directive 76/769/EEC is amended as follows:1. The following point shall be added: >TABLE>2. The following point shall be added to the Appendix: "Point 43 - AzocolourantsList of aromatic amines>TABLE>"


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31983L0463

Commission Directive 83/463/EEC of 22 July 1983 introducing temporary measures for the designation of certain ingredients in the labelling of foodstuffs for sale to the ultimate consumer

Official Journal L 255 , 15/09/1983 P. 0001 - 0006 Finnish special edition: Chapter 13 Volume 13 P. 0084  Spanish special edition: Chapter 13 Volume 14 P. 0162  Swedish special edition: Chapter 13 Volume 13 P. 0084  Portuguese special edition Chapter 13 Volume 14 P. 0162

COMMISSION DIRECTIVE of 22 July 1983 introducing temporary measures for the designation of certain ingredients in the labelling of foodstuffs for sale to the ultimate consumer (83/463/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (1), and in particular Article 19 thereof,  Whereas, pursuant to the second indent of Article 6 (5) (b) of Directive 79/112/EEC, ingredients belonging to one of the categories listed in Annex II thereof must be designated in the list of ingredients by the name of that category, followed by their specific name or EEC number;  Whereas, as Community legislation currently stands, not all of the ingredients in question have been assigned an EEC number ; whereas full advantage cannot therefore be taken of the choice offered by the abovementioned labelling rule;  Whereas the Community is required to complete its rules relating to the categories of ingredients listed in Annex II to Directive 79/112/EEC ; whereas, as new Community provisions are adopted in these areas, EEC numbers that can be used in the labelling of foodstuffs will become available;  Whereas, as an interim measure aimed at facilitating the application of Directive 79/112/EEC, a temporary numbering system for those ingredients that have not yet received an EEC number should be made available to those responsible for labelling foodstuffs, pending the adoption of these new provisions;  Whereas a system of this kind is not intended to affect the provisions under which the use of the ingredients in question is authorized, prohibited or limited;  Whereas this Directive can relate only to ingredients belonging to the categories of use listed in Annex II to Directive 79/112/EEC ; whereas if, however, other categories were added to that Annex, it could also prove necessary to assign numbers to ingredients belonging to such categories;  Whereas, due to the scientific and technical developments in progress on artificial sweeteners, the ingredients in that category cannot yet all be enumerated and in view of this difficulty it is not yet appropriate to include these ingredients in the temporary arrangements introduced by this Directive;  Whereas, pursuant to Article 23 (1) (a) of Directive 79/112/EEC, Member States may make it optional to designate the specific name or EEC number of  (1) OJ No L 33, 8.2.1979, p. 1.  ingredients belonging to one of the categories listed in Annex II thereof ; whereas this provision is not affected by this Directive;  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 1 Pending the implementation of Community provisions introducing new EEC numbers, the numbers listed in the Annex may, in accordance with the second indent of Article 6 (5) (b) of Directive 79/112/EEC, be used in place of the specific name to designate the corresponding ingredients where the latter's technological function classifies them in one or more of the categories listed in Annex II to Directive 79/112/EEC.   Article 2 Member States shall make such amendments to their laws as may be necessary to comply with this Directive and shall forthwith inform the Commission thereof.  Without prejudice to the provisions under which the use of the corresponding ingredients is authorized, prohibited or limited, Member States shall, not later than 1 July 1984, allow the numbers listed in the Annex to be used.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 22 July 1983.  For the Commission  Karl-Heinz NARJES  Member of the Commission     ANNEX >PIC FILE= "T0024979">    >PIC FILE= "T0024980">    >PIC FILE= "T0024981">    >PIC FILE= "T0024982">


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31973L0404

Council Directive 73/404/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to detergents

Official Journal L 347 , 17/12/1973 P. 0051 - 0052 Finnish special edition: Chapter 15 Volume 1 P. 0162  Greek special edition: Chapter 15 Volume 1 P. 0013  Swedish special edition: Chapter 15 Volume 1 P. 0162  Spanish special edition: Chapter 13 Volume 3 P. 0106  Portuguese special edition Chapter 13 Volume 3 P. 0106

COUNCIL DIRECTIVE  of 22 November 1973  on the approximation of the laws of the Member States relating to detergents  (73/404/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament (1);  Having regard to the Opinion of the Economic and Social Committee (2);  Whereas the laws in force in the Member States for ensuring the biodegradability of surfactants differ from one Member State to another, which results in a hindrance to trade;  Whereas the increasing use of detergents is one of the causes of pollution of the natural environment in general and the pollution of waters in particular;  Whereas one of the pollutant effects of detergents on waters, namely the formation of foam in large quantities restricts contact between water and air, renders oxygenation difficult, causes inconvenience to navigation, impairs the photosynthesis necessary to the life of aquatic flora, exercises an unfavourable influence on the various stages of processes for the purification of waste waters, causes damage to waste water purification plants and constitutes an indirect microbiological risk due to the possible tranference of bacteria and viruses;  Whereas it is desirable to maintain an average level of biodegradability of detergents of 90 % and whereas technology and industrial practicalities make this possible, and whereas it is desirable nevertheless to safeguard against uncertainties of test methods which could lead to rejection decisions having important economic consequences,  HAS ADOPTED THIS DIRECTIVE:    Article 1 For the purposes of this Directive, detergent shall mean the composition of which has been specially studied with a view to developing its detergent properties, and which is made up of essential constituents (surfactants) and, in general, additional constituents (adjuvants, intensifying agents, fillers additives and other auxiliary constituents).   Article 2 Member States shall prohibit the placing on the market and use of detergents where the average level of biodegradability of the surfactants contained therein is less than 90 % for each of the following categories : anionic, cationic, non-ionic and ampholytic.  The use of surfactants with an average level of biodegradability of not less than 90 % must not, under normal conditions of use, be harmful to human or animal health.   Article 3 No Member State may, on grounds of the biodegradability or toxicity of surfactants, prohibit or restrict or hinder the placing on the market and use of detergents which comply with the provisions of this Directive.   Article 4 Compliance with the requirements of Article 2 shall be established by the methods of testing provided for in other Council Directives, which take due account of the unreliability of such methods and lay down the relevant tolerances.   Article 5 1. If a Member State should establish, by test procedures carried out on the basis of the Directives  (1)OJ No C 10, 5.2.1972, p. 29. (2)OJ No C 89, 23.8.1972, p. 13.   referred to in Article 4, that a detergent does not comply with the requirements laid down in Article 2, the Member State shall prohibit the placing on the market and use of that detergent in its territory.  2. In the event of that Member State taking the decision to prohibit a detergent, it shall immediately inform the Member State from which the product comes and the Commission to that effect, stating the reasons for its decision and details of the tests referred to in paragraph 1.  If the State from which the detergent comes raises objections to the decision, the Commission shall consult without delay both the Member States concerned and, if appropriate, any other Member States.  If it is not possible to reach agreement, the Commission shall, within three months from the date of receiving the information provided for in the first subparagraph obtain the opinion of one of the laboratories referred to in Article 6, but not one of the laboratories notified by the two Member States concerned under that Article.  The opinion shall be issued using the reference methods laid down in the directives referred to in Article 4.  The Commission shall transmit the opinion of the laboratory to the Member States concerned which may, within one month, forward their comments to the Commission. The Commission may at the same time hear any comments from the interested parties on that opinion.  After taking note of those comments, the Commission shall make any necessary recommendations.   Article 6 Each Member State shall notify the other Member States and the Commission of the laboratory or laboratories authorized to carry out the tests in accordance with the reference methods referred to in Article 5 (2).   Article 7 1. The following information must appear in legible, visible and indelible characters on the packging in which the detergents are put up for sale to the consumer:    (a) the name of the product,       (b) the name or trade name and address or trademark of the party responsible for placing the product on the market.         The same information must appear on all documents accompanying detergents transported in bulk.  2. Member States may make the placing on the market of detergents in their territory subject to the use of their national languages for the information specified in paragraph 1.   Article 8 1. Member States shall put into force the laws, regulations and administrative provisions necessary for compliance with this Directive within eighteen months of its notification and shall forthwith inform the Commission thereof.  2. Member States shall ensure that the texts of the main provisions of national law in the field covered by this Directive are communicated to the Commission.   Article 9 This Directive is addressed to the Member States.     Done at Brussels, 22 November 1973.  For the Council  The President  J. KAMPMANN


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31967L0043

Council Directive 67/43/EEC of 12 January 1967 concerning the attainment of freedom of establishment and freedom to provide services in respect of activities of self-employed persons concerned with: 1. Matters of 'real estate' (excluding 6401) (ISIC Group ex 640) 2. The provision of certain 'business services not elsewhere classified' (ISIC Group 839)

Official Journal 010 , 19/01/1967 P. 0140 - 0143 Finnish special edition: Chapter 6 Volume 1 P. 0047  Danish special edition: Series I Chapter 1967 P. 0003  Swedish special edition: Chapter 6 Volume 1 P. 0047  English special edition: Series I Chapter 1967 P. 0003  Greek special edition: Chapter 06 Volume 1 P. 0064  Spanish special edition: Chapter 06 Volume 1 P. 0069  Portuguese special edition Chapter 06 Volume 1 P. 0069

COUNCIL DIRECTIVE of 12 January 1967 concerning the attainment of freedom of establishment and freedom to provide services in respect of activities of self-employed persons concerned with : 1. matters of "Real Estate" (excluding 6401) (ISIC Group ex 640) 2. the provision of certain "Business services not elsewhere classified" (ISIC Group 839) (67/43/EEC)  THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY,  Having regard to the Treaty establishing the European Economic Community and in particular Articles 54 (2) and (3), and 63 (2) and (3) thereof;  Having regard to the General Programme for the abolition of restrictions on freedom of establishment, 1 and in particular Title IV A thereof;  Having regard to the General Programme for the abolition of restrictions on freedom to provide services, 2 and in particular Title V C thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament 3;  Having regard to the Opinion of the Economic and Social Committee 4;  Whereas the General Programmes provide for the abolition, before the end of the second year of the second stage, of all discriminatory treatment based on nationality as regards establishment and provision of services in matters of real estate and in respect of business services not elsewhere classified;  Whereas it is possible to simplify the procedure for attaining freedom of establishment and freedom to provide services by combining these two fields of activity in a single Directive;  Whereas certain activities pertaining to matters of real estate or to the provision of business services not elsewhere classified are not covered by this Directive, either because they belong to branches of activity for which separate Directives are to be adopted or because, in accordance with the General Programmes, they are to be liberalised at a later date;  Whereas certain activities economically related to those covered by this Directive but belonging to branches falling within other Groups of the ISIC Nomenclature have been or will be the subject of separate Directives;  Whereas the provisions of this Directive concerning employment agencies do not apply to public employment offices;  Whereas separate Directives, (5) applicable to all activities of self-employed persons, concerning provisions relating to the movement and residence of beneficiaries, and where necessary Directives on the co-ordination of the safeguards required by Member States of companies or firms for the protection of the interests of members and of others, have been or will be adopted;  Whereas the General Programme for the abolition of restrictions on freedom of establishment provides that restrictions on the right to join professional or trade organisations should be abolished where the professional activities of the person concerned necessarily involve the exercise of this right;  Whereas the position of paid employees accompanying a person providing services or acting on his 1 OJ No 2, 15.1.1962, p. 36/62.  2 OJ No 2, 15.1.1962, p. 36/62.  3 OJ No 96, 2.6.1965, p. 1704/65.  4 OJ No 33, 1.3.1965, p. 507/65.    behalf will be governed by the provisions laid down in pursuance of Articles 48 and 49 of the Treaty;  Whereas in the fields covered by this Directive it does not seem appropriate to adopt at this moment measures concerning the co-ordination of provisions and the recognition of diplomas, certificates and other evidence of formal qualifications, but whereas transitional measures may be adopted if necessary;  HAS ADOPTED THIS DIRECTIVE:    Article 1 Member States shall abolish, in respect of the natural persons and companies or firms covered by Title I of the General Programmes for the abolition of restrictions on freedom of establishment and freedom to provide services (hereinafter called "beneficiaries"), the restrictions referred to in Title III of those General Programmes affecting the right to take up and pursue the activities specified in Articles 2 and 3 of this Directive.   Article 2 (Real Estate)  1. The provisions of this Directive shall apply to activities of self-employed persons in matters concerning immoveable property as referred to in Annex I to the General Programme for the abolition of restrictions on freedom of establisment (Group ex 640, excluding the activities of a land surveyor).  2. This Group includes all operations relating to immoveable property carried on by individuals, companies or firms who in the course of their trade or profession derive income from:    - the purchase, sale, letting or management:       - of immoveable property, whether or not built  upon, and in particular of premises used for  industrial, commercial, or other trade or  professional purposes, or for residential purposes ;  or       - of rights relating to such property;       - or from the pursuit of activities as an expert or an  agent in respect of transactions relating to such  property or rights.         3. Restrictions affecting such professional or trade activities shall be abolished irrespective of the description applied to the persons pursuing those activities.  The customary descriptions currently used in the Member States are as follows:  in Belgium:    - agents immobiliers, marchands de biens, conseils  immobiliers,  makelaars-handelaars in onroerende goederen,  raadgevers in onroende zaken,       - lotisseurs,  verkavelaars,       - administrateurs de biens, gérants et régisseurs  d'immeubles,  beheerders van onroerende goederen,       - syndics de copropriété,  syndici van medeëigendom,       - agences de location,  verhuuragentschappen,       - promoteurs d'opérations de construction,  promotoren van bouwverrichtingen,       - sociétés immobilières sous leurs diverses formes,  vennootschappen in onroerende goederen onder  hun verschillende vormen,       - experts immobiliers,  deskundigen inzake onroerende goederen;         in Germany:    - Immobilien-, Hypotheken- und Finanzmakler,       - Immobilientaxatoren, Immobilienschätzer, Immobiliensachverständige,       - Immobilienhändler,  Grundstücksverwertungsgesellschaften,       - Baubetreuer,       - Immobilien-, Haus- und Vermögensverwalter;         in France:    - marchands de biens et agents immobiliers,       - lotisseurs,       - administrateurs de biens, gérants et régisseurs  d'immeubles,       - syndics de copropriété,       - agences de location,       - promoteurs d'opérations de construction,       - sociétés immobilières sous leurs diverses formes,       - experts immobiliers et fonciers;          in Italy:    - intermediari nell'acquisto, nella vendita o nell'affitto  o nella locazione di terreni urbani e fondi  rustici,       - intermediari nell'acquisto, nella vendita o locazione  di fabbricati ad uso di abitazione, albergo,  pensione, autorimessa o ad uso commerciale, industriale  o professionale,       - agenzie od imprese per la compra-vendita di immobili  per gli usi predetti,       - agenzie od imprese di riscossione di canoni di affitto,  di fondi rustici o di locazione di immobili  urbani,       - amministratori e gerenti di immobili;         in Luxembourg:    - agences immobilières,       - gérances d'immeubles,       - sociétés immobilières,       - experts immobiliers et fonciers;         in the Netherlands:    - makelaars in onroerende goederen, tussenpersonen  in onroerende goederen (niet zijnde makelaars),  taxateurs in onroerende goederen,       - woningbureaus, woningruilcentrales, bouw- en  bemiddelingsbureaus, administratiekantoren van  onroerende goederen, bouw- en exploitatiemaatschappijen  (waaronder begrepen bouwfondsen,  bouwkassen en woningbouwcoöperaties).          Article 3 (Business services not elsewhere classified)  1. The provisions of this Directive shall apply also to activities of self-employed persons engaging in business services not elsewhere classified as referred to in Annex I to the General Programme for the abolition of restrictions on freedom of establishment (ISIC Group 839, but excluding the following activities):    - journalism;       - activities of customs agents;       - advice on economic, financial, commercial, statistical  and labour and employment matters;       - debt collection.         2. Pursuant to paragraph 1 of this Article, the following groups of activities fall within the scope of this Directive:    (a) private employment agencies;       (b) enquiry agencies, security services;       (c) publicity services, advertising agencies;       (d) organisation of private trade events (in particular  fairs, exhibitions, trade days, etc.);       (e) agencies specialising in auxiliary office services,  including the letting out for hire of mechanical  and electronic machines, and translation services;       (f) advice on business organisation and methods;       (g) literary and artistic activities;       (h) valuation activities, excluding insurance;       (i) interpreting services;       (j) press-cuttings services.          Article 4 The provisions of this Directive shall not apply in the Member State concerned to activities involving in that State the exercise of official authority (Article 55 (1) of the Treaty)    (a) in all Member States : the occupations of rural  policeman, forest-ranger, gamekeeper and water  bailiff;       (b) in Italy : the occupation of sworn watchman  (guardia giurata).          Article 5 1. Member States shall in particular abolish the following restrictions:    (a) those which prevent beneficiaries from establishing  themselves or providing services in the host  country under the same conditions and with the  same rights as nationals of that country;       (b) those existing by reason of administrative practices  which result in treatment being applied to  beneficiaries that is discriminatory by comparison  with that applied to nationals.         2. The restrictions to be abolished shall include in particular those arising out of measures which prevent or limit establishment or provision of services by beneficiaries by the following means:    (a) in Belgium : the obligation to hold a carte professionnelle  (Article 1 of the law of 19 February  1965);        (b) in France : the obligation to hold a carte d'identité  d'étranger commerçant (Décret-loi of 12  November 1938, Décret of 2 February 1939, Law  of 8 October 1940, Law of 10 April 1954, Décret  No 58-852 of 9 July 1959);       (c) in Italy : the requirement that a person shall be of  Italian nationality:      - in order to exercise the professions of valuer  (stimatore pubblico) and expert (perito ed  esperto) (Article 32, No 3, of Regio Decreto  No 2011 of 20 September 1934);           - in order to be eligible for enrolment in the  Ruolo dei mediatori (Law No 253 of 21  March 1958);           - in order to exercise the profession of interpreter  (interprete indipendente) (Article 123  of the consolidated text of the Leggi di Pubblica  Sicurezza approved by Regio Decreto  No 773 of 18 June 1931 ; Articles 234, 236,  239 of the Regolamento implementing the  consolidated text approved by Regio Decreto  No 635 of 6 May 1940);           - in order to carry on the business of an agency  providing commercial information to private  individuals (Article 134 of the consolidated  text of the Leggi di Pubblica Sicurezza).                  (d) in Luxembourg : the limited period of validity of  authorisations granted to foreign nationals pursuant  to Article 21 of the Luxembourg Law of 2  June 1962 (Mémorial A No 31 of 19 June 1962).          Article 6 1. Member States shall ensure that the beneficiaries under this Directive have the right to join professional or trade organisations under the same conditions and with the same rights and obligations as their own nationals.  2. In the case of establishment, the right to join professional or trade organisations shall entail eligibilty for election or appointment to high office in such organisations. However, such posts may be reserved for nationals where, in pursuance of any provision laid down by law or regulation, the organisation concerned is involved in the exercise of official authority.  3. In the Grand Duchy of Luxembourg, membership of the Chambre de commerce or of the Chambre des métiers shall not give beneficiaries under this Directive the right to take part in the election of the administrative organs of those Chambers.   Article 7 No Member State shall grant to any of its nationals who go to another Member State for the purpose of pursuing the activity referred to in Article 2 or in Article 3 any aid liable to distort the conditions of establishment.   Article 8 1. Where a host Member State requires of its nationals wishing to take up or pursue any activity referred to in Article 2 or in Article 3 proof of good repute and proof that they have not previously been declared bankrupt, or proof of either one of these, that State shall accept as sufficient evidence, in respect of nationals of other Member States, the production of an extract from the "judicial record" or, failing this, of an equivalent document issued by a competent judicial or administrative authority in the country of origin or the country whence the foreign national comes showing that these requirements have been met.  2. Where a host Member State requires of its nationals wishing to take up or pursue any activity referred to in Article 2 or in Article 3 proof that they have not previously been the subject of professional or administrative disciplinary measures (for example, withdrawal of the right to hold certain offices, suspension from practice or striking off), that State shall accept as sufficient evidence in respect of nationals of other Member States a document issued by a competent judicial or administrative authority in the country of origin or the country whence the foreign national comes showing that this requirement has been met.  3. Where, as regards proof of no previous bankruptcy or proof that the person concerned has not been the subject of disciplinary measures, the country of origin or the country whence that person comes does not issue documents such as those referred to in paragraphs 1 and 2, such documents may be replaced by a declaration on oath made by the person concerned before a judicial or administrative authority, a notary, or a competent professional or trade body, in the country of origin or in the country whence that person comes.  4. Documents issued in accordance with paragraphs 1 and 2 of this Article may not be produced more than three months after their date of issue.  5. Member States shall, within the time limit laid down in Article 10, designate the authorities and bodies competent to issue these documents, and shall forthwith inform the other Member States and the Commission thereof.   6. Where in the host Member State proof of financial standing is required, that State shall regard certificates issued by banks in the country or origin or in the country whence the foreign national comes as equivalent to certificates issued in its own territory.   Article 9 Those Member States where the taking up of a trade or profession is conditional upon the taking of an oath shall ensure that the current form of the oath is such that it can also be sworn by foreign nationals. Where this is not the case, Member States shall provide for a suitable and equivalent form.   Article 10 Member States shall adopt the measures necessary to comply with this Directive within six months of its notification and shall forthwith inform the Commission thereof.   Article 11 This Directive is addressed to the Member States.     Done at Brussels, 12 January 1967.  For the Council  The President  R. VAN ELSLANDE


title: Commission Directive 2009/129/EC of 9 October 2009 amending Council Directive 76/768/EEC concerning cosmetic products for the purposes of adapting Annex III thereto to technical progress (Text with EEA relevance)

text:
               10.10.2009

               EN

               Official Journal of the European Union

               L 267/18

      COMMISSION DIRECTIVE 2009/129/EC
   of 9 October 2009
   amending Council Directive 76/768/EEC concerning cosmetic products for the purposes of adapting Annex III thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Products,
   Whereas:

               (1)

               The compounds containing fluorine are currently regulated under reference numbers 26 to 43, and reference numbers 47 and 56 in Part 1 of Annex III to Directive 76/768/EEC. Their maximum authorised concentration in toothpastes refers to the content of elemental fluorine (0,15 % calculated as F, i.e. 1 500 ppm).

               (2)

               The Scientific Committee on Consumer Products replaced by the Scientific Committee on Consumer Safety (hereinafter ‘SCCS’) (2) stated in its opinion SCCP/0882/08 that the maximum permitted concentration of 0,15 % (1 500 F- ppm) fluoride does not pose a safety concern when used by children under the age of six years, based on the available scientific evidence. The data used were generated from studies primarily on sodium fluoride.

               (3)

               Based on the scientific conclusions of the SCCS, Commission Directive 2007/53/EC of 29 August 2007 amending Council Directive 76/768/EEC concerning cosmetic products for the purposes of adapting Annex III thereto to technical progress (3) introduced for the regulated compounds containing fluorine a requirement for warning which must be printed on the label of toothpastes containing fluoride. This requirement refers to the content of fluoride instead of elemental fluorine. As a result, not all fluorine containing compounds listed in Part 1 of Annex III to Directive 76/768/EEC were covered by the introduced labelling requirement.

               (4)

               Upon request of the Commission, the SCCS clarified that in opinions SCCNFP/0653/03 and SCCP/0882/05, it was pointed out that an extrapolation to other compounds containing fluorine listed in Part 1 of Annex III to Directive 76/768/EEC could only be made with respect to fluorosis. However, for the purpose of the reference to compounds containing fluorine in Part 1 of Annex III to Directive 76/768/EEC, introduced by Directive 2007/53/EC, the SCCS considered that the terms ‘fluorine’ and ‘fluoride’ were equivalent and interchangeable.

               (5)

               To ensure legal certainty, it is necessary to clarify that the labelling requirement refers to all 20 compounds containing fluorine listed in Part 1 of Annex III to Directive 76/768/EEC, and not only to those containing fluoride.

               (6)

               Therefore, the condition for labelling which must be printed on the label of toothpastes containing fluorine compounds listed in Part 1 of Annex III to Directive 76/768/EEC should refer to the content of fluorine instead of fluoride. Directive 76/768/EEC should therefore be amended accordingly.

               (7)

               In view of a smooth transition, Member States should not prohibit the marketing of products complying with this Directive before its date of application.

               (8)

               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
   Annex III to Directive 76/768/EEC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 15 April 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 15 October 2010.
   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
   Member States shall not prohibit the marketing of toothpaste labelled in accordance with the provisions transposing this Directive before the date set out in the second subparagraph of Article 2(1).
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 9 October 2009.

            For the Commission

         Günter VERHEUGEN

            Vice-President

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

      (2)  The name of the committee was changed by Commission Decision 2008/721/EC (OJ L 241, 10.9.2008, p. 21).

      (3)  OJ L 226, 30.8.2007, p. 19.

      ANNEX
      In column ‘f’ corresponding to reference numbers 26 to 43, 47 and 56 of Part 1 of Annex III to Directive 76/768/EEC, the text after the first sentence is replaced by the following sentences:

         ‘For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
         “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor”.’


title: Commission Directive 2004/99/EC of 1 October 2004 amending Council Directive 91/414/EEC to include acetamiprid and thiacloprid as active substances(Text with EEA relevance)

text:
               6.10.2004

               EN

               Official Journal of the European Union

               L 309/6

      COMMISSION DIRECTIVE 2004/99/EC
   of 1 October 2004
   amending Council Directive 91/414/EEC to include acetamiprid and thiacloprid as active substances
   (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), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               In accordance with Article 6(2) of Directive 91/414/EEC Greece received on 22 October 1999 an application from Nisso Chemical Europe GmbH for the inclusion of the active substance acetamiprid in Annex I to Directive 91/414/EEC. Commission Decision 2000/390/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (2)

               The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 11 September 1998 from Bayer plc. (now Bayer CropScience AG) concerning thiacloprid. Commission Decision 2000/181/EC (3) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 19 March 2001 (acetamiprid) and 22 November 2000 (thiacloprid).

               (4)

               The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 29 June 2004 in the format of the Commission review reports for acetamiprid and thiacloprid.

               (5)

               The review of acetamiprid and thiacloprid did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.

               (6)

               It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include acetamiprid and thiacloprid in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.

               (7)

               After the inclusion of acetamiprid and thiacloprid in Annex I to Directive 91/414/EEC, Member States should be allowed a reasonable period to implement the provisions of that Directive as regards plant protection products containing those substances and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.

               (8)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (9)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish by 30 June 2005 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 and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 July 2005.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall 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
   1.   Member States shall review the authorisation for each plant protection product containing acetamiprid or thiacloprid to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 30 June 2005 at the latest.
   2.   For each authorised plant protection product containing acetamiprid or thiacloprid as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2004 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing acetamiprid or thiacloprid as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2006 at the latest; or

               (b)

               in the case of a product containing acetamiprid or thiacloprid as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2006 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 January 2005.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 1 October 2004.

            For the Commission

         David BYRNE

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/71/EC (OJ L 127, 29.4.2004, p. 104).

      (2)  OJ L 145, 20.6.2000, p. 36.

      (3)  OJ L 57, 2.3.2000, p. 35.

      ANNEX
      In Annex I to Directive 91/414/EEC the following rows are added at the end of the table:

                     No

                     Common name, identification numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘92

                     Acetamiprid
                     CAS No 160430-64-8
                     CIPAC No Not yet allocated

                     (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine

                     ≥ 990 g/kg

                     1 January 2005

                     31 December 2014

                     Only uses as insecticide may be authorised.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Acetamiprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account.
                     In this overall assessment Member States

                                 —

                                 should pay particular attention to worker exposure,

                                 —

                                 should pay particular attention to the protection of aquatic organisms.

                           Risk mitigation measures should be applied where appropriate.

                     93

                     Thiacloprid
                     CAS No 111988-49-9
                     CIPAC No 631

                     (Z)-N-{3-[(6-Chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-yliden}cyanamide

                     ≥ 975 g/kg

                     1 January 2005

                     31 December 2014

                     Only uses as insecticide may be authorised.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Thiacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account.
                     In this overall assessment Member States

                                 —

                                 should pay particular attention to the protection of non-target arthropods,

                                 —

                                 should pay particular attention to the protection of aquatic organisms,

                                 —

                                 should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

                           Risk mitigation measures should be applied where appropriate.

         (1)  Further details on identity and specification of active substances are provided in the review report.’


Avis juridique important

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32004L0058

Commission Directive 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to include alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as active substances (Text with EEA relevance)

Official Journal L 120 , 24/04/2004 P. 0026 - 0029

Commission Directive 2004/58/ECof 23 April 2004amending Council Directive 91/414/EEC to include alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as active substances(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), and in particular Article 6(1) thereof,Whereas:(1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(2), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham.(2) For those active substances the effects on human health and the environment has been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the Rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(3), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. For alpha-cypermethrin the rapporteur Member State was Belgium, and all relevant information was submitted on 16 September 1999. For benalaxyl the rapporteur Member State was Portugal, and all relevant information was submitted on 27 April 2000. For bromoxynil the rapporteur Member State was France, and all relevant formation was submitted on 16 March 2000. For desmedipham the rapporteur Member State was Finland, and all relevant information was submitted on 8 May 2000. For ioxynil the rapporteur Member State was France, and all relevant information was submitted on 16 March 2000. For phenmedipham the rapporteur Member State was Finland, and all relevant information was submitted on 5 January 2000.(3) Those assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.(4) The reviews of all active substances were finalised on 13 February 2004 in the format of the Commission review reports for alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham.(5) The reviews of alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.(6) It has appeared from the various examinations made that plant protection products containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.(7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.(8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil or phenmedipham, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. For efficiency reasons and considering the short deadlines it is appropriate that the rapporteur Member State coordinate such reviews between Member States. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC.(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish by 31 August 2005 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 and a correlation table between those provisions and this Directive.They shall apply those provisions from 1 September 2005.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 31. Member States shall review the authorisation for each plant protection product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 31 August 2005 at the latest, they shall amend or withdraw the authorisation.The respective rapporteur Member State shall organise the co-operation between Member States when carrying out such review.2. For each authorised plant protection product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 28 February 2005 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.Following that determination Member States shall:(a) in the case of a product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil or phenmedipham as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2009 at the latest; or(b) in the case of a product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil or phenmedipham as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2009 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.Article 4This Directive shall enter into force on 1 March 2005.Article 5This Directive is addressed to the Member States.Done at Brussels, 23 April 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/60/EC (See page 39 of this Official Journal).(2) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).(3) OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regulation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).ANNEXThe following entries shall be added at the end of the table in Annex I to Directive 91/414/EC.">TABLE>"


title: Commission Directive 2012/3/EU of 9 February 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include bendiocarb as an active substance in Annex I thereto  Text with EEA relevance

text:
               10.2.2012

               EN

               Official Journal of the European Union

               L 37/65

         COMMISSION DIRECTIVE 2012/3/EU
   of 9 February 2012
   amending Directive 98/8/EC of the European Parliament and of the Council to include bendiocarb as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes bendiocarb.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, bendiocarb has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

               (3)

               The United Kingdom was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 1 April 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 22 September 2011, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing bendiocarb may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include bendiocarb in Annex I to that Directive.

               (6)

               Not all potential uses have been evaluated at Union level. For example, the assessment only considers professional use, and does not cover direct application to soil or application on food or feedstuff or on surfaces that will come in contact with food or feedstuff. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In view of the risks identified for the aquatic environment due to wet cleaning of treated surfaces, resulting in emissions of a certain scale to surface waters, it is appropriate to require that products not be authorised for use on surfaces that are prone to frequent wet cleaning, other than crack and crevice or spot treatments, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

               (8)

               In view of the risks identified for human health, it is appropriate to require that products authorised for industrial or professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.

               (9)

               In view of the potential risk to honey bees, it is appropriate to require that, where relevant, action is taken to prevent foraging bees gaining access to treated nests by removing the combs or blocking the nest entrances.

               (10)

               The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance bendiocarb and also to facilitate the proper operation of the biocidal products market in general.

               (11)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (12)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (13)

               Directive 98/8/EC should therefore be amended accordingly.

               (14)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 January 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2014.
   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, 9 February 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘53

                        bendiocarb

                     2,2-dimethyl-1,3-benzodioxol-4-yl methylcarbamate
                     CAS-No: 22781-23-3
                     EC No: 245-216-8

                     970 g/kg

                     1 February 2014

                     31 January 2016

                     31 January 2024

                     18

                     The Union level risk assessment did not address all potential uses, but concerned, for example, application by professionals only, and excluded contact with feed or food and direct application on soil. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 Products shall not be used for the treatment of surfaces that are prone to frequent wet cleaning, other than crack and crevice or spot treatment, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

                                 Products authorised for industrial or professional use shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.

                                 Where relevant, measures shall be taken to prevent foraging bees from gaining access to treated nests by removing the combs or blocking the nest entrances.’

         (1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm


title: Commission Directive 2012/16/EU of 10 May 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include hydrochloric acid as an active substance in Annex I thereto  Text with EEA relevance

text:
               11.5.2012

               EN

               Official Journal of the European Union

               L 124/36

         COMMISSION DIRECTIVE 2012/16/EU
   of 10 May 2012
   amending Directive 98/8/EC of the European Parliament and of the Council to include hydrochloric acid as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes hydrochloric acid.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, hydrochloric acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 2, private area and public health area disinfectants and other biocidal products, as defined in Annex V to that Directive.

               (3)

               Latvia was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 16 October 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 9 December 2011, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as private area and public health area disinfectants and other biocidal products, in accordance with the said product-type 2, and containing hydrochloric acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include hydrochloric acid in Annex I to that Directive.

               (6)

               Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In view of the corrosivity of the substance as well as the possible measures identified to mitigate the related risk, it is appropriate to require that exposure during non-professional use is minimised through the design of the packaging, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.

               (8)

               The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance hydrochloric acid and also to facilitate the proper operation of the biocidal products market in general.

               (9)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (10)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (11)

               Directive 98/8/EC should therefore be amended accordingly.

               (12)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 30 April 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 May 2014.
   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 May 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common name

                     IUPAC name
                     Identification numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘56

                     Hydrochloric acid

                     Hydrochloric acid
                     CAS No: not applicable
                     EC No: 231-595-7

                     999 g/kg

                     1 May 2014

                     30 April 2016

                     30 April 2024

                     2

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations of products for non-professional use are subject to the packaging being designed to minimise user exposure, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.’

         (1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm