title: Commission Directive 2014/81/EU of 23 June 2014 amending Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards bisphenol A  Text with EEA relevance

text:
               24.6.2014

               EN

               Official Journal of the European Union

               L 183/49

         COMMISSION DIRECTIVE 2014/81/EU
   of 23 June 2014
   amending Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards bisphenol A
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (1), and in particular Article 46(2) thereof,
   Whereas:

               (1)

               Directive 2009/48/EC establishes general requirements for substances which are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (2). Such substances may not be used in toys, in components of toys or in micro-structurally distinct parts of toys, except if inaccessible to children, permitted by a Commission decision or contained in individual concentrations equal to or smaller than the relevant concentrations established for the classification of mixtures containing them as CMRs. To further protect children's health, specific limit values for such substances can be set out, when appropriate, for toys intended for use by children under three years old or other toys intended to be placed in the mouth.

               (2)

               The substance bisphenol A is a high volume chemical that is widely used in the production of a large variety of consumer products. Bisphenol A is used as a monomer in the manufacture of polycarbonate plastics. Polycarbonate plastics are used, amongst others, in the manufacture of toys. Moreover, bisphenol A has been found in certain toys.

               (3)

               Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys (3) governed the essential safety requirements for chemical properties of toys until 19 July 2013. European standard EN 71-9:2005+A1:2007 provides a migration limit of 0,1 mg/l for bisphenol A. European standards EN 71-10:2005 and EN 71-11:2005 provide the relevant test methods. The limits and methods for bisphenol A set out in EN 71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005 are used by the toy industry as a reference to ensure that there is no unsafe exposure from bisphenol A in toys. Yet, those standards do not constitute harmonised standards.

               (4)

               Bisphenol A is classified under Regulation (EC) No 1272/2008 as toxic for reproduction category 2. In the absence of any specific requirements, bisphenol A can be contained in toys in concentrations equal to or smaller than the relevant concentration established for the classification of mixtures containing it as CMRs, namely 5 % as from 20 July 2013 and 3 % as from 1 June 2015 respectively. It cannot be excluded that that concentration may lead to increased exposure of small children to bisphenol A, compared to the migration limit of 0,1 mg/l for bisphenol A set by European standards EN 71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005.

               (5)

               Bisphenol A was comprehensively evaluated in 2003 and 2008 under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (4). The final risk assessment report, entitled ‘Updated European Union Risk Assessment Report 4,4'-isopropylidenediphenol (bisphenol-A)’, found, among other things, that bisphenol A has endocrine modulating activity in a number of in vitro and in vivo screening assays and concluded that further research was needed to resolve the uncertainties surrounding the potential for bisphenol A to produce adverse effects on development at low doses. Nevertheless, a high level of protection of children against risks caused by chemical substances in toys, in the light of the particular needs of children, who are a vulnerable group of consumers, warrants incorporating the migration limit of 0,1 mg/l for bisphenol A into Directive 2009/48/EC.

               (6)

               The effects of bisphenol A are under evaluation in scientific fora including the European Food Safety Authority. The migration limit laid down by this Directive should be reviewed if relevant new scientific information becomes available in the future.

               (7)

               Directive 2009/48/EC should therefore be amended accordingly.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Toy Safety Committee,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Appendix C of Annex II to Directive 2009/48/EC is replaced by the following:

         ‘Appendix C
         Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth adopted in accordance with Article 46(2)

                     Substance

                     CAS No

                     Limit value

                     TCEP

                     115-96-8

                     5 mg/kg (content limit)

                     TCPP

                     13674-84-5

                     5 mg/kg (content limit)

                     TDCP

                     13674-87-8

                     5 mg/kg (content limit)

                     Bisphenol A

                     80-05-7

                     0,1 mg/l (migration limit) in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005.’

   Article 2
   1.   Member States shall adopt and publish, by 21 December 2015 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 21 December 2015.
   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, 23 June 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 170, 30.6.2009, p. 1.

      (2)  OJ L 353, 31.12.2008, p. 1.

      (3)  OJ L 187, 16.7.1988, p. 1.

      (4)  OJ L 84, 5.4.1993, p. 1.


Avis juridique important

|

31986L0199

Eighth Commission Directive 86/199/EEC of 26 March 1986 adapting to technical progress Annexes II, IV and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 149 , 03/06/1986 P. 0038 - 0045 Finnish special edition: Chapter 13 Volume 15 P. 0150  Swedish special edition: Chapter 13 Volume 15 P. 0150

*****EIGHTH  COMMISSION DIRECTIVE  of 26 March 1986  adapting to technical progress Annexes II, IV and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products  (86/199/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 86/179/EEC (2), and in particular Articles 5 and 8 (2) thereof,  Whereas, in order to protect public health, it is necessary to lay down purity criteria for hexachlorophene and triclocarban;  Whereas, on the basis of the available information, certain provisionally-permitted substances and preservatives may be definitively permitted, while others must be definitively prohibited or be permitted for a further specified period;  Whereas the measures laid down in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 76/768/EEC is hereby amended as follows:  1. In Annex II, number 221 is replaced by: '221. Mercury and its compounds, except those special cases included in Annexes V and VI, Part 1'.  2. Annex IV, Part 1 and Annex VI, Parts 1 and 2, are replaced by Annexes 1 and 2 to this Directive.  Article 2  1. Member States shall take the necessary measures to ensure that from 1 January 1988 neither manufacturers nor importers, established in the Community, place on the market products which do not satisfy the requirements of this Directive.  2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 can no longer be sold or disposed of to the final consumer after 31 December 1989.  Article 3  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive not later than 31 December 1986 and shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.  Article 4  This Directive is addressed to the Member States.  Done at Brussels, 26 March 1986.  For the Commission  Grigoris VARFIS  Member of the Commission  (1) OJ No L 262, 27. 9. 1976, p. 169.  (2) OJ No L 138, 24. 5. 1986, p. 40.  ANNEX 1  'ANNEX IV  PART ONE  LIST OF SUBSTANCES PROVISIONALLY ALLOWED  1.2.3,5.6.7 //  //  //  //  //  // Reference number  // Substance  // Restrictions  // Conditions of use and warnings which must be printed on the label  // Allowed until  //  // 1.2.3.4.5.6.7 //  //  // Field of application and/or use  // Maximum authorized concentration in the finished cosmetic product  // Other limitations and requirements  //  //  //  //  //  //  //  //  //  // a   // b  // c  // d  // e  // f  // g   //    //   //   //   //   //   //   // 1  // Methanol   // Denaturant for ethanol and isopropyl alcohol  // 5 % calculated as a % of ethanol and isopropyl alcohol  //   //   // 31. 12. 1987   //    //   //   //   //   //   //  // 2   // 1,1,1-Trichloroethane (methyl chloroform)  // Aerosol spray   // 35 % When mixed with dichloromethane, total concentration must not exceed 35 %   //   // Do not spray on a naked flame or any incandescent material   // 31. 12. 1987   //    //   //   //   //   //   //   // 3   // 3,4,5 Tribromosalicylanilide (Tribromsalan (*))   // Deodorant soap  // 1 %   // Purity criteria: 3,4,5 Tribromosalicylanilide: 98,5 % minimum Other bromosalicylanilides: 1,5 % maximum 4,5 dibromosalicylanilide: 0,1 % maximum Inorganic bromide: 0,1 % maximum expressed as NaBr   // Contains tribromosalicylanilide  // 31. 12. 1987   //    //   //   //   //   //   //   // 4  // 2,2-Dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate   // Only for hair-care products rinse off   // 1 %   // As preservative, see Annex VI, Part 2, No 13   //   // 31. 12. 1986   //    //   //   //   //   //  //   // 5   // 1-Phenoxypropan-2-ol   // - Rinse-off products only - Prohibited in oral hygiene products   // 2 %   // As preservative, see Annex VI, Part 2, No 14   //   // 31. 12. 1986'   //    //   //   //   //   //   //  ANNEX 2  'ANNEX VI  LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN  PREAMBLE  1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.  2. The substances marked with the symbol (*) may also be added to cosmetic products in concentration other than those laid down in this Annex for other specific purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.  3. Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in this Annex.  4. For the purposes of this list:  - "Salts" is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.  - "Esters" is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.  5. All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning "contains formaldehyde" where the concentration of formaldehyde in the finished product exceeds 0,05 %.  PART 1  LIST OF PRESERVATIVES ALLOWED  1.2.3.4.5 //  //  //  //  //  // Reference number  // Substance  // Maximum authorized concentration  // Limitations and requirements  // Conditions of use and warnings which must be printed on the label  //  //  //  //  //  // a   // b  // c  // d  // e  //  //  //  //  //  //  //  //  //  //  // 1   // Benzoic acid, its salts and esters (*)   // 0,5 % (acid)   //   //  //    //   //   //   //   // 2   // Propionic acid and its salts (*)   // 2 % (acid)   //   //   //    //   //   //   //  // 3   // Salicylic acid and its salts (*)   // 0,5 % (acid)  // Not to be used in preparations for children under three years of age, except for shampoos   // Not to be used for children under three years of age (1)   //    //   //   //  //   // 4   // Sorbic acid (hexa-2,4-dienoic acid) and its salts (*)   // 0,6 % (acid)   //   //   //    //   //   //  //   // 5   // Formaldehyde paraformaldehyde   // 0,2 % (except for products for oral hygiene) 0,1 % (products for oral hygiene) expressed as free formaldehyde   // Prohibited in aerosol dispensers (sprays)   //   //    //   //   //   //  // 6   // Hexachlorophene (INN)   // 0,1 %   // - Prohibited in products for children under three years of age, and intimate hygiene products - Purity criterion: absence of 2,3,7,8-tetrachlorodibenzo-p-dioxin   // Not to be used for children under three years of age. Contains hexachlorophene  //    //   //   //   //   // 7   // Biphenyl-2-ol (o-phenylphenol) and its salts (*)   // 0,2 % expressed as the phenol   //   //   //    //   //   //   //   // 8  // Pyrithione zinc (INN) (*)   // 0,5 %   // Authorized in products rinsed off Forbidden in products for oral hygiene  //   //    //   //   //   //   // 9   // Inorganic sulphites and hydrogen- sulphites (*)   // 0,2 % expressed as free SO2  //   //   //    //   //   //   //   // 10   // Sodium iodate  // 0,1 %   // Rinse-off products only   //   //  1,5 // (1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.  //  //  //  // 1.2.3.4.5 //  //  //  //  //  // Reference number  // Substance  // Maximum authorized concentration  // Limitations and requirements  // Conditions of use and warnings which must be printed on the label  //  //  //  //  //  // a   // b  // c  // d  // e  //  //  //  //  //  //  // 11   // Chlorobutanol (INN)  // 0,5 %   // Prohibited in aerosol dispensers (sprays)  // Contains chlorobutanol   //    //   //   //   //   // 12  // 4-Hydroxybenzoic acid and its salts and esters (*)   // 0,4 % (acid) for 1 ester, 0,8 % (acid) for mixtures of esters   //  //   //    //   //   //   //   // 13  // 3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydracetic acid) and its salts   // 0,6 % (acid)   // Prohibited in aerosol dispensers (sprays)   //   //    //   //   //   //   // 14  // Formic acid (*)   // 0,5 % (acid)   //   //   //    //  //   //   //   // 15  // 3,3-Dibromo-4,4-hexamethylene-dioxydibenzamidine (Dibromohexamidine) and its salts (including isethionate)  // 0,1 %   //   //   //    //   //   //   //   // 16  // Thiomersal (INN)   // 0,007 % (of Hg) If mixed with other mercurial compounds authorized by this Directive, the maximum concentration of Hg remains fixed at 0,007 %   // For eye make-up and eye make-up remover only   // Contains thiomersal  //    //   //   //   //   // 17   // Phenylmercuric salts (including borate)   // Ditto   // Ditto   // Contains phenylmercuric compounds   //    //   //   //   //   // 18  // Undec-10-enoic acid and salts (*)   // 0,2 % (acid)  // See Annex VI, Part 2, No 8   //   //    //   //   //   //  // 19   // Hexetidine (INN) (*)   // 0,1 %   // Rinse-off products only See Annex VI, Part 2, No 18   //   //    //   //  //   //   // 20   // 5-Bromo-5-nitro-1,3-dioxane   // 0,1 %  // Rinse-off products only Avoid formation of nitrosamines See Annex VI, Part 2, No 7   //   //    //   //   //   //   // 21  // Bronopol (INN) (*)   // 0,1 %   // Avoid formation of nitrosamines   //   //    //   //   //   //   // 22  // 2,4-Dichlorobenzyl alcohol (*)   // 0,15 %   //   //   //  //   //   //   //   // 23   // Triclocarban (INN) (*)   // 0,2 %   // Purity criteria: 3,3,4,4-Tetrachloroazobenzene <1 ppm 3,3,4,4-Tetrachloroazoxybenzene <1 ppm   //   //    //   //  //   //  //  //  //  //  //  // Reference number   // Substance  // Maximum authorized concentration  // Limitations and requirements  // Conditions of use and warnings which must be printed on the label  //  //  //  //  //  // a   // b  // c  // d  // e  //  //  //  //  //  //  // 24  // 4-Chloro-m-cresol (*)   // 0,2 %   // Prohibited in the products intended to come into contact with mucous membranes  //   //    //   //   //   //   // 25   // Tricolosan (INN) (*)   // 0,3 %   //   //   //    //   //   //   //   // 26  // 4-Chloro-3,5-xylenol (*)   // 0,5 %   //   //   //    //  //   //   //   // 27   // 3,3-Bis (1-hydroxymethyl-2,5-dioxoimida- zolidin-4-yl)-1,1-methylenediurea ("Imidazolidinyl urea") (*)  // 0,6 %   //   //   //    //   //   //   //   // 28   // Poly (1-hexamethylenebiguanide hydrochloride (*)   // 0,3 %   //  //   //    //   //   //   //   // 29   // 2-Phenoxyethanol (*)   // 1 %   //   //   //    //   //   //   //   // 30  // Hexamethylenetetramine (*) (methenamine) (INN)   // 0,15 %  //   //   //    //   //   //   //   // 31   // Methenamine 3-chloroallylochloride (INNM)   // 0,2 %   //   //   //    //  //   //   //   // 32  // 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3- dimethylbutan-2-one (*)   // 0,5 %   //   //   //    //   //  //   //   // 33   // 1,3-Bis (hydroxymethyl)-5,5-dimethylimi- dazolidine-2,4-dione (*)   // 0,6 %   //   //   //    //   //  //   //   // 34   // Benzyl alchohol (*)   // 1 %   //   //  //    //   //   //   //   // 35  // 1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl)  2-pyridon and its monoethanolamine salt (*)   // 1,0 % 0,5 %   // Products rinsed off For other products   //   //    //   //   //   //  // 36   // 1,2-Dibromo-2,4-dicyanobutane   // 0,1 %   //  // Not to be used in cosmetic sunscreen products   //    //  //   //   //   // 37  // 6,6-Dibromo-4,4-dichloro2,2-methylene- diphenol (Bromochlorophen) (*)   // 0,1 %   //   //   //    //   //  //   //   // 38   // 4-Isopropyl-m-cresol   // 0,1 %   //  //   //    //   //   //   //   // 39   // Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate   // 0,003 % (of a mixture in the ratio 3: 1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one   //   //   //    //   //   //  //  PART 2  LIST OF PRESERVATIVES PROVISIONALLY ALLOWED  1.2.3.4.5.6 //  //  //  //  //  //  // Reference number  // Substance  // Maximum authorized concentration  // Limitation and requirements  // Conditions of use and warnings which must be printed on the label  // Allowed until  //    //   //   //   //   //   // a   // b  // c  // d  // e  // f   //    //   //   //   //   //   //   //   //   //   //  //   // 1   // Boric acid (*)   // (a) 0,5 %   // (a) Products for oral hygiene   //   // 31. 12. 1988   //   //   // (b) 3 %  // (b) Other products   //   //   //    //   //   //   //  //   // 2   // Chlorphenesin (INN) (*)   // 0,5 %   //   //  // 31. 12. 1987   //    //   //   //   //   //   // 3  // Dibromopropamidine (INN) and its salts (including isethionate (INN))   // 0,1 %   //   //   // 31. 12. 1988   //   //   //   //   //   //   // 4   // Alkyl (C12-C22) trimethyl-ammonium bromide and chloride (including Cetrimonium bromide (INN) (*))   // 0,1 %   //   //   // 31. 12. 1988   //   //   //   //   //   //   // 5  // 3-Heptyl-2-(3-heptyl-4-methyl-4-thiazolin-2- ylidenemethyl)-4-methyl-thiazolinium iodide   // 0,002 %  // Creams, toilet lotions, shampoos   //   // 31. 12. 1988  //    //   //   //   //   //   // 6  // 4,4-Dimethyl-1,3-oxazolidine   // 0,1 %   // Rinse-off products only. The pH of the finished product shall not be lower than 6   //   // 31. 12. 1989   //    //   //   //   //  //   // 7   // 5-Bromo-5-nitro-1,3-dioxane   // 0,1 %   // Non rinse-off products. Avoid formation of nitrosmaines. See Annex VI, Part 1, No 20   //   // 31. 12. 1987   //    //   //   //  //   //   // 8   // Undec-10-enoic acid: esters, the amide, the mono- and bis (2-hydroxethyl) amides and their sulphosuccinates (*)   // 0,2 % (acid)   // See Annex VI, Part 1, No 18   //   // 31. 12. 1987   //    //   //   //   //   //  // 9   // Clorofene (INN)   // 0,2 %   //   //   // 31. 12. 1987   //    //   //   //   //   //   // 10  // 2-Chloro-N-(hydroxymethyl) acetamide   // 0,3 % expressed as the chloracetamide   // Products rinsed off   //   // 31. 12. 1987   //    //   //   //   //   //   // 11   // Pyrithione aluminium camsilate (INNM)   // 0,2 %   //   //   // 31. 12. 1986   //    //   //   //   //   //  //  //  //  //  //  //  // Reference number   // Substance  // Maximum authorized concentration  // Limitation and requirements  // Conditions of use and warnings which must be printed on the label  // Allowed until   //    //   //   //  //   //   // a   // b  // c  // d  // e  // f   //    //   //  //   //   //   //   // 12   // N-(Trichloromethylthio) cyclohex-4-ene-1,2- dicarboximide (Captan - ISO))   // 0,06 %  // Prohibited in the products intended to come into contact with mucous membranes   //   // 31. 12. 1986   //    //   //  //   //   //   // 13   // 2,2-Dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate   // 0,2 %  // Products rinsed off   //   // 31. 12. 1986   //    //   //  //   //   //   // 14   // 1-Phenoxypropan-2-ol   // 1 %  // Rinse-off products only   //   // 31. 12. 1986   //    //  //   //   //   //   // 15   // Benzethonium chloride (INN) (*)   // 0,1 %   // Prohibited in the products intended to come into contact with mucous membranes   //   // 31. 12. 1986   //   //   //   //   //   //   // 16   // Benzalkonium chloride (INN), bromide and saccharinate (*)   // 0,25 %   //   //  // 31. 12. 1986   //    //   //   //   //   //   // 17  // 1-[1,3-Bis (hydroxymethyl)-2,5-dioxoimidazoli- din-1-yl]-1,3-bis (hydroxymethyl) urea   // 0,5 %   //   //  // 31. 12. 1987   //    //   //   //   //   //   // 18  // Hexetidine (INN)   // 0,1 %   // See Annex VI, Part I, No 19   //   // 31. 12. 1987   //    //   //   //   //   //  // 19   // 4-Hydroxybenzoic acid benzyl ester   // 0,1 % (acid)   //   //   // 31. 12. 1988   //    //   //   //   //  //   // 20   // Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate) (*)   // 0,1 %   //   //  // 31. 12. 1988   //    //   //   //   //   //   // 21  // Benzylformal (a 1: 1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol)   // 0,2 %   //   //   // 31. 12. 1987   //    //   //   //   //   //   // 22  // 2-Chloroacetamide   // 0,3 %   //   // Contains chloroacetamide   // 31. 12. 1987   //    //   //   //   //  //   // 23   // 1-Dodecylguanidinium acetate (Dodine - ISO) (*)   // 0,5 %   // Products rinsed off   //   // 31. 12. 1986  //   //   // 0,1 %   // For other products   //   //   //  //   //   //   //   //   // 24   // Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (*)   // 0,3 %  //   //   // 31. 12. 1987   //    //   //   //   //   //  // 25   // 1,3,5-Tris (2-hydroxyethyl) hexahydro-1,3,5-triasine   // 0,2 %   // Only for products rinsed off   // Contains 1,3,5-Tris (2-hydroxyethyl) hexahydro-1,3,5- triasine   // 31. 12. 1988   //    //   //  //   //   //   //NOT TO BE USED IN COSMETIC SUNSCREEN PRODUCTS   //   //  //  //  //  37  6,6-DIBROMO-4,4-DICHLORO2,2-METHYLENE - DIPHENOL ( BROMOCHLOROPHEN ) (*)  0,1 %   //  //  //   //  //  //  //  38  4-ISOPROPYL-M-CRESOL  0,1 %   //  //  //   //  //  //  //  39  MIXTURE OF 5-CHLORO-2-METHYL-ISOTHIAZOL-3(2H)-ONE AND 2-METHYLISOTHIAZOL-3(2H)-ONE WITH MAGNESIUM CHLORIDE AND MAGNESIUM NITRATE  0,003 % ( OF A MIXTURE IN THE RATIO 3 : 1 OF 5-CHLORO-2-METHYLISOTHIAZOL 3(2H)-ONE AND 2-METHYLISOTHIAZOL-3 ( 2H)-ONE   //  //  //   //  //  //  //  PART 2  LIST OF PRESERVATIVES PROVISIONALLY ALLOWED  1.2.3.4.5.6REFERENCE NUMBER  SUBSTANCE  MAXIMUM AUTHORIZED CONCENTRATION  LIMITATION AND REQUIREMENTS  CONDITIONS OF USE AND WARNINGS WHICH MUST BE PRINTED ON THE LABEL  ALLOWED UNTIL   //   //  //  //  //  //  A  B  C  D  E  F   //   //  //  //  //  //  //  //  //  //  //  //  1  BORIC ACID (*)  ( A ) 0,5 %  ( A ) PRODUCTS FOR ORAL HYGIENE   //  31 . 12 . 1988   //  //  ( B ) 3 %  ( B ) OTHER PRODUCTS   //  //  //   //  //  //  //  //  2  CHLORPHENESIN ( INN ) (*)  0,5 %   //  //  31 . 12 . 1987   //   //  //  //  //  //  3  DIBROMOPROPAMIDINE ( INN ) AND ITS SALTS ( INCLUDING ISETHIONATE ( INN ))  0,1 %   //  //  31 . 12 . 1988   //   //  //  //  //  //  4  ALKYL ( C12-C22 ) TRIMETHYL-AMMONIUM BROMIDE AND CHLORIDE ( INCLUDING CETRIMONIUM BROMIDE ( INN ) (*))  0,1 %   //  //  31 . 12 . 1988   //   //  //  //  //  //  5  3-HEPTYL-2-(3-HEPTYL-4-METHYL-4-THIAZOLIN-2 - YLIDENEMETHYL)-4-METHYL-THIAZOLINIUM IODIDE  0,002 %  CREAMS, TOILET LOTIONS, SHAMPOOS   //  31 . 12 . 1988   //   //  //  //  //  //  6  4,4-DIMETHYL-1,3-OXAZOLIDINE  0,1 %  RINSE-OFF PRODUCTS ONLY . THE PH OF THE FINISHED PRODUCT SHALL NOT BE LOWER THAN 6   //  31 . 12 . 1989   //   //  //  //  //  //  7  5-BROMO-5-NITRO-1,3-DIOXANE  0,1 %  NON RINSE-OFF PRODUCTS . AVOID FORMATION OF NITROSMAINES . SEE ANNEX VI, PART 1, NO 20   //  31 . 12 . 1987   //   //  //  //  //  //  8  UNDEC-10-ENOIC ACID : ESTERS, THE AMIDE, THE MONO - AND BIS ( 2-HYDROXETHYL ) AMIDES AND THEIR SULPHOSUCCINATES (*)  0,2 % ( ACID )  SEE ANNEX VI, PART 1, NO 18   //  31 . 12 . 1987   //   //  //  //  //  //  9  CLOROFENE ( INN )  0,2 %   //  //  31 . 12 . 1987   //   //  //  //  //  //  10  2-CHLORO-N-(HYDROXYMETHYL ) ACETAMIDE  0,3 % EXPRESSED AS THE CHLORACETAMIDE  PRODUCTS RINSED OFF   //  31 . 12 . 1987   //   //  //  //  //  //  11  PYRITHIONE ALUMINIUM CAMSILATE ( INNM )  0,2 %   //  //  31 . 12 . 1986   //   //  //  //  //  //  REFERENCE NUMBER  SUBSTANCE  MAXIMUM AUTHORIZED CONCENTRATION  LIMITATION AND REQUIREMENTS  CONDITIONS OF USE AND WARNINGS WHICH MUST BE PRINTED ON THE LABEL  ALLOWED UNTIL   //   //  //  //  //  //  A  B  C  D  E  F   //   //  //  //  //  //  //  12  N-(TRICHLOROMETHYLTHIO ) CYCLOHEX-4-ENE-1,2 - DICARBOXIMIDE ( CAPTAN - ISO ))  0,06 %  PROHIBITED IN THE PRODUCTS INTENDED TO COME INTO CONTACT WITH MUCOUS MEMBRANES   //  31 . 12 . 1986   //   //  //  //  //  //  13  2,2-DITHIOBIS ( PYRIDINE 1-OXIDE ), ADDITION PRODUCT WITH MAGNESIUM SULPHATE TRIHYDRATE  0,2 %  PRODUCTS RINSED OFF   //  31 . 12 . 1986   //   //  //  //  //  //  14  1-PHENOXYPROPAN-2-OL  1 %  RINSE-OFF PRODUCTS ONLY   //  31 . 12 . 1986   //   //  //  //  //  //  15  BENZETHONIUM CHLORIDE ( INN ) (*)  0,1 %  PROHIBITED IN THE PRODUCTS INTENDED TO COME INTO CONTACT WITH MUCOUS MEMBRANES   //  31 . 12 . 1986   //   //  //  //  //  //  16  BENZALKONIUM CHLORIDE ( INN ), BROMIDE AND SACCHARINATE (*)  0,25 %   //  //  31 . 12 . 1986   //   //  //  //  //  //  17  1-(1,3-BIS ( HYDROXYMETHYL)-2,5-DIOXOIMIDAZOLI - DIN-1-YL)-1,3-BIS ( HYDROXYMETHYL ) UREA  0,5 %   //  //  31 . 12 . 1987   //   //  //  //  //  //  18  HEXETIDINE ( INN )  0,1 %  SEE ANNEX VI, PART I, NO 19   //  31 . 12 . 1987   //   //  //  //  //  //  19  4-HYDROXYBENZOIC ACID BENZYL ESTER  0,1 % ( ACID )   //  //  31 . 12 . 1988   //   //  //  //  //  //  20  HEXAMIDINE ( INN ) AND ITS SALTS ( INCLUDING ISETHIONATE AND 4-HYDROXYBENZOATE ) (*)  0,1 %   //  //  31 . 12 . 1988   //   //  //  //  //  //  21  BENZYLFORMAL ( A 1 : 1 MIXTURE OF BENZYLOXYMETHANOL AND ( BENZYLOXYMETHOXY ) METHANOL )  0,2 %   //  //  31 . 12 . 1987   //   //  //  //  //  //  22  2-CHLOROACETAMIDE  0,3 %   //  CONTAINS CHLOROACETAMIDE  31 . 12 . 1987   //   //  //  //  //  //  23  1-DODECYLGUANIDINIUM ACETATE ( DODINE - ISO ) (*)  0,5 %  PRODUCTS RINSED OFF   //  31 . 12 . 1986   //  //  0,1 %  FOR OTHER PRODUCTS   //  //  //   //  //  //  //  //  24  CHLORHEXIDINE ( INN ) AND ITS DIGLUCONATE, DIACETATE AND DIHYDROCHLORIDE (*)  0,3 %   //  //  31 . 12 . 1987   //   //  //  //  //  //  25  1,3,5-TRIS ( 2-HYDROXYETHYL ) HEXAHYDRO-1,3,5-TRIASINE  0,2 %  ONLY FOR PRODUCTS RINSED OFF  CONTAINS 1,3,5-TRIS ( 2-HYDROXYETHYL ) HEXAHYDRO-1,3,5 - TRIASINE  31 . 12 . 1988   //   //  //  //  //  //


Avis juridique important

|

32003L0118

Commission Directive 2003/118/EC of 5 December 2003 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for acephate, 2,4-D and parathion-methyl (Text with EEA relevance)

Official Journal L 327 , 16/12/2003 P. 0025 - 0032

Commission Directive 2003/118/ECof 5 December 2003amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for acephate, 2,4-D and parathion-methyl(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Directive 2003/60/EC(2), and in particular Article 5 thereof,Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(3), as last amended by Commission Directive 2003/62/EC(4), and in particular Article 10 thereof,Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(5), as last amended by Directive 2003/60/EC, and in particular Article 10 thereof,Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(6), as last amended by Directive 2003/69/EC(7), and in particular Article 7 thereof,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(8), as last amended by Commission Directive 2003/84/EC(9), and in particular Article 4(1)(f) thereof,Whereas:(1) For the existing active substances acephate and parathion-methyl, decisions were taken not to include them in Annex I to Directive 91/414/EEC by Commission Decisions 2003/219/EC(10) and 2003/166/EC(11) respectively. These Decisions provided that plant protection products containing these active substances shall no longer be authorised for use in the Community.(2) In order to allow legitimate expectations to be fulfilled for existing stocks of pesticides to be used, the Commission Decisions cited in recital 1, allowed a phasing-out period, and it is appropriate that maximum residue levels (MRLs) premised on the notion that use of the substance concerned is not authorised in the Community should not apply until the end of the phasing-out period applying to that substance.(3) Community MRLs and the levels recommended by the Codex Alimentarius(12) are fixed and evaluated following similar procedures. There are a limited number of Codex MRLs for acephate and parathion-methyl. These have been considered in the setting of the MRLs fixed in this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The MRLs based on Codex MRLs having been evaluated in the light of the risks for the consumers, no risk was established.(4) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination.(5) It is therefore necessary to add all of the pesticide residues arising from use of those plant protection products to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer.(6) MRLs for parathion-methyl should be set in Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. Provisions of Directive 76/895/EEC which set MRLs for that substance should consequently be deleted.(7) Where no Community MRL or provisional community MRL exists, as is the case for 2,4-D on citrus by Commission Directive 2002/97/EC(13), Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised. Data have been submitted by a Member State that demonstrated that a higher MRL can be set for citrus, reflecting the use of 2,4-D in some third countries. Data have been submitted showing that these residues do not pose a risk to consumers in the Community.(8) The relevant Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended 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 1In Annex II to Directive 76/895/EEC the entries relating to parathion-methyl shall be deleted.Article 2In part A of Annex II to Directive 86/362/EEC the following rows are added:">TABLE>"Article 3In part B of Annex II to Directive 86/363/EEC the following rows are added:">TABLE>"Article 4Annex II to Directive 90/642/EEC is amended as follows:1. The maximum pesticide residue levels (MRLs) as shown in the Annex to this Directive are added to Annex II to Directive 90/642/EEC.2. The maximum pesticide residue level for 2,4-D (sum of 2,4-D and its esters expressed as 2,4-D) on citrus fruit shall be amended to "1 (p) mg/kg".Article 5Member States shall adopt and publish the provisions necessary to comply with this Directive by 30 November 2004 at the latest, with the exception of the provision pursuant to Article 4(2), which shall be adopted and published by the Member States by 31 March 2004 at the latest. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 December 2004 with the exception of the provision pursuant to Article 4(2), which shall be applied by 1 April 2004.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 6This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 7This Directive is addressed to the Member States.Done at Brussels, 5 December 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 340, 9.12.1976, p. 26.(2) OJ L 155, 24.6.2003, p. 15.(3) OJ L 221, 7.8.1986, p. 37.(4) OJ L 154, 21.6.2003, p. 70.(5) OJ L 221, 7.8.1986, p. 43.(6) OJ L 350, 14.12.1990, p. 71.(7) OJ L 175, 15.7.2003, p. 37.(8) OJ L 230, 19.8.1991, p. 1.(9) OJ L 247, 30.9.2003, p. 20.(10) OJ L 82, 29.3.2003, p. 40.(11) OJ L 67, 10.3.2003, p. 18.(12) http://apps.fao.org/CodexSystem/ pestdes/pest_q-e.htm.(13) OJ L 343, 18.12.2002, p. 23.ANNEX>TABLE>


Avis juridique important

|

31999L0071

Commission Directive 1999/71/EC of 14 July 1999 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)

Official Journal L 194 , 27/07/1999 P. 0036 - 0044

COMMISSION DIRECTIVE 1999/71/ECof 14 July 1999amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Commission Directive 1999/65/EC(2), and in particular Article 10 thereof,Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(3), as last amended by Comission Directive 98/82/EC(4), and in particular Article 10 thereof,Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(5), as last amended by Directive 1999/65/EC, and in particular Article 7 thereof,Having regard to Council Directive 91/414/EEC concerning the placing of plant protection products on the market(6), as last amended by Directive 99/1/EC(7), and in particular Article 4(1) (f) thereof,(1) Whereas the new active substance, azoxystrobin, was included in Annex I to Directive 91/414/EEC by Commission Directive 98/47/EC(8) for use as fungicide only, but without specifying particular conditions having an impact on crops which may be treated with plant protection products containing azoxystrobin;(2) Whereas the said inclusion in Annex I was based on assessment of the information submitted concerning proposed use as fungicide on cereals and vines; whereas information relating to uses on cereals, vines and bananas has been submitted by certain Member States in accordance with the requirements of Article 4(1) (f) of Directive 91/414/EEC; whereas the information available has been reviewed and is sufficient to fix certain maximum residue levels;(3) Whereas where no Community maximum residue level or provisional MRL exists Member States shall establish a national provisional maximum residue level in accordance with Article 4(1) (f) of Directive 91/414/EEC before the authorisation may be granted;(4) Whereas at the inclusion in Annex I to Directive 91 /414/EEC the technical and scientific evaluation of azoxystrobin was finalised on 22 April 1998 in the format of the Commission review report for azoxystrobin; whereas in this review report the acceptable daily intake (ADI) for azoxystrobin was set at 0.1 mg/kg bw/day; whereas the lifetime exposure of consumers of food products treated with azoxystrobin has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(9) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of this ADI;(5) Whereas acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion which preceded the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC;(6) Whereas for certain agricultural products the use conditions for azoxystrobin have already been defined in a manner which permits the establishing of definitive maximum residue levels;(7) Whereas to ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set provisional maximum residue levels at the lower limit of analytical determination for all those products covered by Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC; whereas the setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for azoxystrobin in accordance with Article 4(1) (f) of Directive 91/414/EEC and in accordance with Annex VI to Directive 91/414/EEC in particular part B, Section 2.4.2.3 to this Annex; whereas four years is considered a sufficient period of time during which to establish most further uses of azoxystrobin; whereas after that period these provisional maximum residue levels should become definitive;(8) Whereas the Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered; whereas the possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data;(9) Whereas the opinion of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account;(10) Whereas this Directive is in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1The following pesticide residues shall be added to part A of Annex II to Directive 86/362/EEC:>TABLE>Article 2The following pesticide residues shall be added to part B of Annex II to Directive 86/363/EEC:>TABLE>Article 3The following pesticide residues shall be added to Annex II to Directive 90/642/EEC:>TABLE>Article 41. For those agricultural products listed in part A of Annex II to Directive 86/362/EEC, and in Annex II to Directive 90/642/EEC where the maximum residue levels for azoxystrobin are indicated as "(p)", this shall mean that they are provisional (p) in accordance with the provisions of Article 4(1) (f) of Directive 91/414/EEC.2. Four years after the entry into force of this Directive, provisional maximum residue levels for azoxystrobin in the Annexes shall cease to be provisional and shall become definitive in the sense of Article 4(1) of Directives 86/362/EEC and 86/363/EEC or Article 3 of Directive 90/642/EEC respectively.Article 51. This Directive shall enter into force on 1 August 1999.2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 31 January 2000. They shall immediately inform the Commission thereof. These measures shall apply as from 1 February 2000.3. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 6This Directive is addressed to the Member States.Done at Brussels, 14 July 1999.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 221, 7.8.1986, p. 37.(2) OJ L 172, 8.7.1999, p. 40.(3) OJ L 221, 7.8.1986, p. 43.(4) OJ L 290, 29.10.1998, p. 25.(5) OJ L 350, 14.12.1990, p. 71.(6) OJ L 230, 19.8.1991, p. 1.(7) OJ L 21, 21.1.1999, p. 21.(8) OJ L 191, 7.7.1998, p. 50.(9) Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/food programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97.7).


Avis juridique important

|

31996L0032

Council Directive 96/32/EC of 21 May 1996 amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables and Annex II to Directive 90/642/EEC relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels

Official Journal L 144 , 18/06/1996 P. 0012 - 0034

COUNCIL DIRECTIVE 96/32/EC of 21 May 1996 amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables and Annex II to Directive 90/642/EEC relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levelsTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), and in particular Article 5 thereof,Having regard to Council Directive 90/642/EEC of 27 November 1990 relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (2), and in particular Article 1 thereof,Having regard to the proposal from the Commission,Whereas, in order to establish mandatory maximum levels of pesticide residues at Community level, it is necessary to transfer provisions from Directive 76/895/EEC to Directive 90/642/EEC relating to the pesticides chlormequat, diazinon, dicofol, endosulfan, fentin and propoxur; whereas certain of those provisions should be amended in the light of technical and scientific progress;Whereas the Commission has received a mandate in the framework of Directive 90/642/EEC to prepare the list of pesticide residues and their maximum levels for approval by the Council;Whereas Directive 90/642/EEC provided for the establishment of a list of maximum levels for certain pesticide residues, including a maximum pesticide residue level for the herbicide glyphosate in and on soya bean (3), and for the fungicide fenarimol in and on bananas (4); whereas it is appropriate to amend to maximum pesticide residue levels for soya bean and bananas in order to reflect the authorized uses in certain third countries; whereas the new levels provided for are acceptable from a dietary intake point of view; whereas these levels should facilitate international trade;Whereas Directive 90/642/EEC provided for the establishment of maximum pesticide residue levels for iprodione in and on rhubarb, and for benomyl in and on rhubarb and courgettes; whereas new data are available on these pesticide residue/product combinations; whereas on consideration of these data it is now appropriate to amend the maximum pesticide residue levels for rhubarb and courgettes; whereas the new levels provided for are acceptable from a dietary intake point of view;Whereas pesticide residues may arise in products of plant origin including fruit and vegetables as a result of agricultural practices; whereas it is necessary to take into account relevant data for both authorized pesticide uses and supervised trials;Whereas, in order better to estimate dietary intake of pesticide residues, it is prudent to establish simultaneously, where appropriate, maximum residue levels for individual pesticides in all major components of the diet; whereas these levels represent the use of minimum quantities of pesticide to achieve adequate control, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable;Whereas it is now appropriate that maximum levels be fixed for certain pesticide residues in products of plant origin, namely disulfoton, fenbutatin oxide, mecarbam, phorate, propyzamide, triazophos and triforine; whereas, however, it is not possible to establish maximum pesticide residue levels for all pesticide residue product combinations due to insufficient data;Whereas, however, data are insufficient by current standards to establish maximum pesticide residue levels for certain pesticide residue/product combinations; whereas, in such cases, a period of time not exceeding four years would seem reasonable for the generation of the necessary data; whereas, therefore, maximum levels should be established on the basis of such data by 30 April 2000 at the latest; whereas failure to provide satisfactory data should normally result in the establishment of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate the necessary data must be given within one year of the adoption of this Directive;Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evalutation of active substances provided for in the work programme established in Article 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (5),HAS ADOPTED THIS DIRECTIVE:Article 1 Annex II to Directive 76/895/EEC is hereby amended as follows:1. The entries relating to the following pesticide residues shall be deleted:chlormequatdiazinondicofolendosulfanfentinpropoxur.2. The following entries shall be inserted:>TABLE>3. The entries provided for in point 2 shall be deleted no later than 30 April 2000.Article 2 1. Annex II to Directive 90/642/EEC is hereby amended as follows:GLYPHOSATEIn the column under the heading 'Glyphosate`, the figure '20,0` shall be added opposite the following product entry:- in group '4. Oil seeds`, 'Soya bean`.FENARIMOLIn the column under the heading 'Fenarimol`, the figure '0,3` shall be added opposite the following product entry:- in group '1. (vi) Miscellaneous`, 'Bananas`.IPRODIONEIn the column under the heading 'Iprodione`, the figure '0,2` shall be added opposite the following product entry:- in group '2. (vii) Stem vegetables`, 'Rhubarb`.BENOMYLIn the column under the heading 'Benomyl`, the figure '2,0` shall be added opposite the following product entry:- in group '2. (vii) Stem vegetables`, 'Rhubarb`.In the column under the heading 'Benomyl`, the figure '0,3` shall be added opposite the following product entry:- in group '2. (iii) Fruiting vegetables`, 'Courgettes`.2. If maximum residue levels are not adopted for the pesticide/product combinations listed in point 2 of Article 1 by 30 April 2000, a maximum level of 0,05 (6*) shall be introduced for each of those pesticide/product combinations.Article 3 The following pesticide residues shall be added to Annex II to Directive 90/642/EEC:>TABLE>>TABLE>>TABLE>>TABLE>>TABLE>Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 April 1997.When Member States adopt those measures, they shall contain references to this Directive or shall be accompanied by such references on the occasion of their publication. The methods of making such references shall be laid down by the Member States.Article 5 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 6 This Directive is addressed to the Member States.Done at Brussels, 21 May 1996.For the CouncilThe PresidentM. PINTO(1) OJ No L 340, 9. 12. 1976, p. 26. Directive as last amended by the 1994 Act of Accession.(2) OJ No L 350, 14. 12. 1990, p. 71. Directive as last amended by Directive 95/61/EC (OJ No L 292, 7. 12. 1995, p. 27).(3) OJ No L 211, 23. 8. 1993, p. 6.(4) OJ No L 189, 23. 7. 1994, p. 70.(5) OJ No L 230, 19. 8. 1991, p. 1.(6*) Indicates lower limit of analytical determination.(7*) Indicates lower limit of analytical determination.(8x) See Article 1 and Article 2 (2).(9a) 0,05 (7*)(10b) 0,02 (8*)(11c) 0,1 (9*)(12d) 0,01 (10*)


Avis juridique important

|

31995L0039

Council Directive 95/39/EC of 17 July 1995 amending the Annexes to Directives 86/362/EEC and 86/363/EEC on the fixing of maximum levels for pesticide residues in and on cereals and foodstuffs of animal origin

Official Journal L 197 , 22/08/1995 P. 0029 - 0031

COUNCIL DIRECTIVE 95/39/EC of 17 July 1995 amending the Annexes  to Directives 86/362/EEC and 86/363/EEC on the fixing of maximum levels for pesticide residues in  and on cereals and foodstuffs of animal originTHE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for  pesticide residues in and on cereals  (1), and in particular Article 11 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for  pesticide residues in and on foodstuffs of animal origin  (2), and in particular Article 11  thereof, Having regard to the proposal from the Commission, Whereas the Commission has been instructed, within the framework of Council Directives 86/362/EEC  and 86/363/EEC, to prepare a list of pesticide residues and their maximum levels for approval by  the Council; Whereas pesticide residues may be found in cereals and foodstuffs of animal origin as a result of  agricultural practices; whereas it is necessary to take into account relevant data for both types  of authorized pesticide use and, as appropriate, supervised trials and animal feeding studies; Whereas in order better to estimate the maximum potential dietary intake of pesticide residues, it  is prudent to establish simultaneously, when it is appropriate, maximum residue levels for  individual pesticides in all major components of diet; whereas these levels represent the use of  minimum quantities of pesticide necessary to achieve adequate control, applied in such a manner  that the amount of residue is the smallest possible or is toxicologically acceptable; Whereas, in the light of technical and scientific progress and the requirements of public health  and agriculture, Directives 86/362/EEC and 86/363/EEC should be amended by adding provisions  relating to further pesticide residues for cereals and foodstuffs of animal origin, namely  methidathion, methomyl thiodicarb, amitraz, pirimiphos-methyl, aldicarb and thiabendazole; Whereas, however, the available data are insufficient by current standards to establish maximum  pesticide residue levels for certain pesticide residue/product combinations; whereas in such cases  a period of time not exceeding four years would seem reasonable for the generation of the necessary  data; whereas maximum levels should therefore be established on the basis of such data by 1 July  2000 at the latest; whereas failure to provide satisfactory data will result in the establishment  of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate  the necessary data must be given within one year of adoption of this Directive; Whereas the maximum residue levels established in this Directive will have to be reviewed in the  framework of the re-evaluation of active substances provided for in the work programme referred to  in Article 8 (2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant  protection products on the market  (3), HAS ADOPTED THIS DIRECTIVE: Article 1 The following pesticide residues shall be added to Part A of Annex II  to Directive 86/362/EEC: >TABLE> Article 2 1.  The following pesticide residues shall be added to Part A of Annex II to Directive  86/363/EEC: >TABLE> 2.  The following pesticide residues shall be added to Section B of Annex II to Directive  86/363/EEC: >TABLE> Article 3 Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive not later than 22 August 1996. 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 4 This Directive is addressed to the Member States. Done at Luxembourg, 17 July 1995. For the Council The President L. ATIENZA SERNA


title: Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 amending Directive 2014/65/EU on markets in financial instruments (Text with EEA relevance)

text:
                  30.6.2016

                  EN

                  Official Journal of the European Union

                  L 175/8

            DIRECTIVE (EU) 2016/1034 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
      of 23 June 2016
      amending Directive 2014/65/EU on markets in financial instruments
      (Text with EEA relevance)
      THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
      Having regard to the Treaty on the Functioning of the European Union, and in particular Article 53(1) thereof,
      Having regard to the proposal from the European Commission,
      After transmission of the draft legislative act to the national parliaments,
      Having regard to the opinion of the European Central Bank (1),
      Having regard to the opinion of the European Economic and Social Committee (2),
      Acting in accordance with the ordinary legislative procedure (3),
      Whereas:

                  (1)

                  Regulation (EU) No 600/2014 of the European Parliament and of the Council (4) and Directive 2014/65/EU of the European Parliament and of the Council (5) (together, ‘the new legal framework’) are major financial legislative acts adopted in the wake of the financial crisis as regards securities markets, investment intermediaries and trading venues. The new legal framework reinforces and replaces Directive 2004/39/EC of the European Parliament and of the Council (6).

                  (2)

                  The new legal framework governs the requirements applicable to investment firms, regulated markets, data reporting services providers and third country firms providing investment services or activities in the Union. It harmonises the position limits regime for commodity derivatives to improve transparency, to support orderly pricing and to prevent market abuse. It also introduces rules on high-frequency algorithmic trading and improves the oversight of financial markets by harmonising administrative sanctions. Building on the rules already in place, the new legal framework also strengthens the protection of investors by introducing robust organisational and conduct requirements. Member States are to transpose the Directive 2014/65/EU by 3 July 2016.

                  (3)

                  The new legal framework requires trading venues and systematic internalisers to provide competent authorities with financial instrument reference data that describe in a uniform manner the characteristics of every financial instrument that is subject to Directive 2014/65/EU. Those data are also used for other purposes, for instance for the calculation of transparency and liquidity thresholds, as well as for the reporting of positions in commodity derivatives.

                  (4)

                  In order to collect data in an efficient and harmonised manner, a new data collection infrastructure, the Financial Instruments Reference Data System (‘FIRDS’), is being developed by the European Securities and Markets Authority (‘ESMA’) in conjunction with national competent authorities (‘NCAs’). FIRDS will cover a wide range of financial instruments brought into the scope of Regulation (EU) No 600/2014 and it will link data feeds between ESMA, NCAs and trading venues across the Union. The vast majority of the new IT-systems underpinning FIRDS will need to be built from scratch, based on new parameters.

                  (5)

                  Member States are to apply the measures transposing Directive 2014/65/EU from 3 January 2017. However, due to the size and complexity of the data to be collected and processed for the new legal framework to become operational, in particular for transaction reporting, transparency calculations and the reporting of positions in commodity derivatives, stakeholders, such as trading platforms, ESMA and NCAs are not in a position to ensure that the necessary data collection infrastructures will be in place and become operational by that date.

                  (6)

                  The absence of the necessary data collection infrastructures would have implications across the entire scope of the new legal framework. Without data, it would not be feasible to establish a precise delineation of financial instruments that fall within the scope of the new legal framework. Furthermore, it would not be possible to tailor the pre-trade and post-trade transparency rules, in order to determine which instruments are liquid and when waivers or deferred publication should be granted.

                  (7)

                  In the absence of the necessary data collection infrastructures, trading venues and investment firms would not be able to report executed transactions to competent authorities. In the absence of the reporting of positions in commodity derivatives, it would be difficult to enforce position limits on such commodity derivatives. With no position reporting, there would be limited ability to effectively detect breaches of the position limits. Many of the requirements in relation to algorithmic trading are also dependent on data.

                  (8)

                  The absence of the necessary data collection infrastructures would also make it difficult for investment firms to apply best execution rules. Trading venues and systematic internalisers would not be able to publish data relating to the quality of execution of transactions on those venues. Investment firms would not be provided with important execution data to help them determine the best way to execute client orders.

                  (9)

                  In order to ensure legal certainty and avoid potential market disruption, it is necessary and justified to take urgent action to extend the entry into application of the new legal framework in its entirety, including all delegated and implementing acts adopted thereunder.

                  (10)

                  The implementation process for the data collection infrastructures involves five steps: business requirements, specifications, development, testing and deployment. ESMA estimates that those steps will be completed by January 2018, provided that there is legal certainty on the final requirements under the relevant regulatory technical standards by June 2016.

                  (11)

                  In light of the exceptional circumstances and in order to enable ESMA, NCAs and stakeholders to complete the operational implementation, it is appropriate to defer the date by which the Member States need to apply the measures transposing Directive 2014/65/EU and the date by which the repeal of Directive 2004/39/EC is to take effect by 12 months until 3 January 2018. Reports and reviews should be deferred accordingly. It is also appropriate to defer the date by which the Member States need to transpose Directive 2014/65/EU to 3 July 2017.

                  (12)

                  The exemption set out in point (d) of Article 2(1) of Directive 2014/65/EU should be extended to include non-financial entities who are members of or participants in a regulated market or a multilateral trading facility (MTF), or have direct electronic access to a trading venue when executing transactions on a trading venue which are objectively measurable as reducing risks directly relating to the commercial activity or treasury financing activity of those non-financial entities or their groups.

                  (13)

                  Directive 2014/65/EU should therefore be amended accordingly,

            HAVE ADOPTED THIS DIRECTIVE:
      Article 1
      Directive 2014/65/EU is amended as follows:

                  (1)

                  in Article 2(1), point (d)(ii) is replaced by the following:

                              ‘(ii)

                              are members of or participants in a regulated market or an MTF, on the one hand, or have direct electronic access to a trading venue, on the other hand, except for non-financial entities who execute transactions on a trading venue which are objectively measurable as reducing risks directly relating to the commercial activity or treasury financing activity of those non-financial entities or their groups;’;

                  (2)

                  in point (a) of Article 25(4), the second subparagraph is replaced by the following:
                  ‘For the purpose of this point, a third-country market shall be considered to be equivalent to a regulated market if the requirements and the procedure laid down under the third and the fourth subparagraphs are fulfilled.
                  At the request of the competent authority of a Member State, the Commission shall adopt equivalence decisions in accordance with the examination procedure referred to in Article 89a(2), stating whether the legal and supervisory framework of a third country ensures that a regulated market authorised in that third country complies with legally binding requirements which are, for the purpose of the application of this point, equivalent to the requirements resulting from Regulation (EU) No 596/2014, from Title III of this Directive, from Title II of Regulation (EU) No 600/2014 and from Directive 2004/109/EC, and which are subject to effective supervision and enforcement in that third country. The competent authority shall indicate why it considers that the legal and supervisory framework of the third country concerned is to be considered equivalent and shall provide relevant information to that end.
                  Such third-country legal and supervisory framework may be considered equivalent where that framework fulfils at least the following conditions:

                              (i)

                              the markets are subject to authorisation and to effective supervision and enforcement on an ongoing basis;

                              (ii)

                              the markets have clear and transparent rules regarding the admission of securities to trading so that such securities are capable of being traded in a fair, orderly and efficient manner, and are freely negotiable;

                              (iii)

                              security issuers are subject to periodic and ongoing information requirements ensuring a high level of investor protection; and

                              (iv)

                              market transparency and integrity are ensured by the prevention of market abuse in the form of insider dealing and market manipulation.’;

                  (3)

                  in the second subparagraph of Article 69(2), the date ‘3 July 2016’ is replaced by ‘3 July 2017’;

                  (4)

                  in the third subparagraph of Article 70(1), the date ‘3 July 2016’ is replaced by ‘3 July 2017’;

                  (5)

                  the following article is inserted:
                  ‘Article 89a
                  Committee procedure
                  1.   The Commission shall be assisted by the European Securities Committee established by Commission Decision 2001/528/EC (*). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council (**).
                  2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

                     (*)  Commission Decision 2001/528/EC of 6 June 2001 establishing the European Securities Committee (OJ L 191, 13.7.2001, p. 45)."

                     (**)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’;"

                  (6)

                  Article 90 is amended as follows:

                              (a)

                              in paragraph 1, the date ‘3 March 2019’ is replaced by ‘3 March 2020’;

                              (b)

                              in paragraph 2 the date ‘3 September 2018’ is replaced by ‘3 September 2019’ and the date ‘3 September 2020’ is replaced by ‘3 September 2021’;

                              (c)

                              in paragraph 4, the date ‘1 January 2018’ is replaced by ‘1 January 2019’;

                  (7)

                  in Article 93(1), the date ‘3 July 2016’ is replaced by ‘3 July 2017’, the date ‘3 January 2017’ is replaced by ‘3 January 2018’ and the date ‘3 September 2018’ is replaced by ‘3 September 2019’;

                  (8)

                  in Article 94, the date ‘3 January 2017’ is replaced by ‘3 January 2018’;

                  (9)

                  in Article 95(1), the date ‘3 July 2020’ is replaced by ‘3 January 2021’ and the date ‘3 January 2017’ is replaced by ‘3 January 2018’.

            Article 2
      This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.
      Article 3
      This Directive is addressed to the Member States.

         Done at Brussels, 23 June 2016.

               For the European Parliament

               The President

            M. SCHULZ

               For the Council

               The President

            A.G. KOENDERS

         (1)  Opinion of 29 April 2016 (not yet published in the Official Journal).

         (2)  Opinion of 26 May 2016 (not yet published in the Official Journal).

         (3)  Position of the European Parliament of 7 June 2016 (not yet published in the Official Journal) and Council decision of 17 June 2016 (not yet published in the Official Journal).

         (4)  Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84).

         (5)  Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349).

         (6)  Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC (OJ L 145, 30.4.2004, p. 1).


Avis juridique important

|

31982L0528

Council Directive 82/528/EEC of 19 July 1982 amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables

Official Journal L 234 , 09/08/1982 P. 0001 - 0004 Finnish special edition: Chapter 3 Volume 15 P. 0132  Spanish special edition: Chapter 03 Volume 26 P. 0038  Swedish special edition: Chapter 3 Volume 15 P. 0132  Portuguese special edition Chapter 03 Volume 26 P. 0038

COUNCIL DIRECTIVE of 19 July 1982 amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (82/528/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), as last amended by Directive 81/36/EEC (2), and in particular Article 5 thereof,  Having regard to the proposal from the Commission (3),  Whereas Article 5 of Directive 76/895/EEC provides that the contents of the Annexes be regularly amended and that in making amendments account shall be taken of technical and scientific progress as well as of the requirements of health and agriculture;  Whereas, since it is sufficient to identify pesticide residues by their common names and chemical formulae, it seems desirable to simplify the presentation of Annex II to the said Directive accordingly;  Whereas the pesticides aramite and chlorfenson are no longer of economic importance and their residues are unlikely to occur in foodstuffs ; whereas it is therefore appropriate to delete them from the said Annex II;  Whereas, in the light of the development of technical and scientific knowledge, it is necessary to amend the provisions, particularly the maximum levels, contained in Annex II relating to atrazine, azinphos-ethyl, azinphos-methyl, barban, binapacryl, carbaryl, chlorbenzilate, diallate, endosulphan, lindane, parathion including paraoxon and folpet;  Whereas, for the same reasons, it seems desirable to bring the Directive up to date by adding provisions relating to further pesticides whose residues may occur in fruit and vegetables, namely, bromophos-ethyl, bromopropylate, captafol, chlorpropham, chlorbufam, chlorfenvinphos, chlormequat, DDT, diazinon, dichlofluanid, dichlorvos, dicofol, dioxathion, diquat, fentin, heptachlor, methyl bromide, paraquat, pyrethrins, triallate, vamidothion and chinomethionat;  Whereas it also seems desirable, in accordance with current international practice, to replace the maximum levels relating to amitrole, endrin and TEPP, hitherto expressed as "zero", by finite levels set at or about the lower limit of determination;  Whereas, having regard to the errors, particularly of sampling and analysis, inherent in the control of maximum levels, the latter should be expressed to an appropriate number of significant figures ; whereas the levels relating to chlorbenside and methyl parathion including methyl-paraoxon should therefore be corrected,  (1) OJ No L 340, 9.12.1976, p. 26. (2) OJ No L 46, 19.2.1981, p. 33. (3) OJ No C 95, 16.4.1982, p. 6.   HAS ADOPTED THIS DIRECTIVE:    Article 1 Annex II to Directive 76/895/EEC is hereby amended as follows:    1. The column headed "EEC No (1)" and footnote 1 shall be deleted;       2. The entries "aramite" and "chlorfenson" shall be deleted;       3. For the pesticide residues set out below, the particulars contained in the Table, with the exception of the chemical formulae, which remain unchanged, shall be replaced by the following: >PIC FILE= "T0021997">         4. The following pesticide residues together with their corresponding particulars shall be inserted: >PIC FILE= "T0021998">    >PIC FILE= "T0021999">        5. The headings "barban" and "diallate" shall be replaced by groups relating respectively to "barban, chlorpropham, chlorbufam", and "diallate, triallate" as follows: >PIC FILE= "T0022000">           Article 2 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1 not later than 1 July 1984. They shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 19 July 1982.  For the Council  The President  B. WESTH