title: Commission Directive 2011/59/EU of 13 May 2011 amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products  Text with EEA relevance

text:
               14.5.2011

               EN

               Official Journal of the European Union

               L 125/17

         COMMISSION DIRECTIVE 2011/59/EU
   of 13 May 2011
   amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Safety,
   Whereas:

               (1)

               Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, subsequently replaced by the Scientific Committee on Consumer Products (‘SCCP’), pursuant to Commission Decision 2004/210/EC (2), concluded that the potential risks were of concern. The SCCP recommended that the Commission take further steps to control the use of hair dye substances.

               (2)

               The SCCP further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.

               (3)

               Following the opinions of the SCCP, the Commission agreed with Member States and stakeholders on an overall strategy to regulate substances used in hair dye products according to which the industry was required to submit files, containing updated scientific data on the safety of hair dye substances, for a risk assessment by the SCCP.

               (4)

               The SCCP, subsequently replaced by the Scientific Committee on Consumer Safety (‘SCCS’) pursuant to Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (3), assessed the safety of individual substances for which updated files had been submitted by industry.

               (5)

               The last step of the safety assessment strategy was to evaluate possible consumer health risk by reaction products formed by oxidative hair dye substances during the hair dyeing process. In its opinion of 21 September 2010 the SCCS did not raise any major concern regarding genotoxicity and carcinogenicity of hair dyes and their reaction products currently used in the Union.

               (6)

               Some hair dye substances are provisionally authorised for use in hair dye products until 31 December 2010 under the restrictions and conditions laid down in Part 2 of Annex III to Directive 76/768/EEC.

               (7)

               In the light of the risk assessment of the submitted safety data and the final opinions given by the SCCS on the safety of individual substances and of the reaction products, it is appropriate to include in Part 1 of Annex III to Directive 76/768/EEC provisionally authorised hair dye substances, currently listed in Part 2 of that Annex.

               (8)

               The safety assessment by the SCCS concerning the substances hydroxyethyl-2-nitro-p-toluidine and HC Red No 10 + HC Red No 11, listed in Part 2 of Annex III to Directive 76/768/EEC, could not be finalised before 31 December 2010. Therefore, the provisional use of the substances should be prolonged until 31 December 2011.

               (9)

               Concerning the substance o-aminophenol, the SCCS stated in its opinion of 22 June 2010 that based on the available data no final conclusion on the safety of that substance could be drawn. Based on that opinion o-aminophenol cannot be considered safe when used in hair dye products and should therefore be listed in Annex II to Directive 76/768/EEC.

               (10)

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

               (11)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 3 January 2012 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 3 January 2012.
   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, 13 May 2011.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 66, 4.3.2004, p. 45.

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

      ANNEX
      Directive 76/768/EEC is amended as follows:

                  (1)

                  in Annex II, the following entry is added:

                              Ref. No

                              Chemical name

                              CAS No/EC No

                              ‘1372

                              2-Aminophenol (o-Aminophenol; CI 76520) and its salts

                              CAS No 95-55-6/67845-79-8/51-19-4
                              EC No 202-431-1/267-335-4’

                  (2)

                  Annex III is amended as follows:

                              (a)

                              Part 1 is amended as follows:

                                          (i)

                                          the following entries are added:

                                                      Ref. No

                                                      Substance

                                                      Restrictions

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

                                                      Field of application and/or use

                                                      Max. authorised concentration in the finished cosmetic product

                                                      Other limitations and requirements

                                                      ‘215

                                                      4-amino-3-nitrophenol (CAS No 610-81-1) (EC No 210-236-8)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,0 %

                                                                  (b)

                                                                  As mentioned in reference number 208, column f

                                                      216

                                                      2,7-Naphthalenediol (CAS No 582-17-2) (EC No 209-478-7)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,0 %

                                                      217

                                                      m-Aminophenol (CAS No 591-27-5) (EC No 209-711-2) and its salts
                                                      m-Aminophenol HCl (CAS No 51-81-0) (EC No 200-125-2)
                                                      m-Aminophenol sulphate (CAS No 68239-81-6) (EC No 269-475-1)
                                                      sodium m-Aminophenol (CAS No 38171-54-9)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 %

                                                      As mentioned in reference number 205, column f (a)

                                                      218

                                                      2,6-Dihydroxy-3,4-dimethylpyridine (CAS No 84540-47-6) (EC No 283-141-2)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %

                                                      As mentioned in reference number 205, column f (a)

                                                      222

                                                      2-Hydroxyethyl picramic acid (CAS No 99610-72-7) (EC No 412-520-9)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  2,0 %

                                                      223

                                                      p-Methylaminophenol (CAS No 150-75-4) (EC No 205-768-2) and its sulphate
                                                      p-Methylaminophenol sulphate (CAS No 55-55-0/1936-57-8) (EC No 200-237-1/217-706-1)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % (as sulphate)

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      As mentioned in reference number 205, column f (a)

                                                      225

                                                      Ethanol, 2-[4-[Ethyl[(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-, (CAS No 104516-93-0) and its hydrochloride
                                                      HC Blue No 12 (CAS No 132885-85-9) (EC No 407-020-2)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 % (as hydrochloride)

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,5 % (as hydrochloride)

                                                      227

                                                      3-Amino-2,4-dichlorophenol (CAS No 61693-42-3) (EC No 262-909-0) and its hydrochloride
                                                      3-Amino-2,4-dichlorophenol HCl (CAS No 61693-43-4)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as hydrochloride)

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,5 % (as hydrochloride)

                                                      230

                                                      Phenyl methyl pyrazolone (CAS No 89-25-8) (EC No 201-891-0)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %

                                                      As mentioned in reference number 205, column f (a)

                                                      232

                                                      2-Methyl-5-hydroxyethylaminophenol (CAS No 55302-96-0) (EC No 259-583-7)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      As mentioned in reference number 205, column f (a)

                                                      234

                                                      Hydroxybenzomorpholine (CAS No 26021-57-8) (EC No 247-415-5)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      As mentioned in reference number 205, column f (a)

                                                      237

                                                      2,2’-[(4-Amino-3-nitrophenyl)imino]bisethanol (CAS No 29705-39-3) and its hydrochloride
                                                      HC Red No 13 (CAS No 94158-13-1) (EC No 303-083-4

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 % (as hydrochloride)

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  2,5 % (as hydrochloride)

                                                      238

                                                      2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-78-3 (free base)) and its hydrochloride
                                                      2,6-Dimethoxy-3,5-pyridinediamine HCl (CAS No 56216-28-5) (EC No 260-062-1)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % (as hydrochloride)

                                                      As mentioned in reference number 205, column f (a)

                                                      239

                                                      HC Violet No 1 (CAS No 82576-75-8) (EC No 417-600-7)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  0,28 %

                                                                  (b)

                                                                  As mentioned in reference number 208, column f

                                                      241

                                                      1,5-Naphthalenediol (CAS No 83-56-7) (EC No 201-487-4

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,0 %

                                                      242

                                                      Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) (CAS No 128729-30-6) and its tetrahydrochloride
                                                      Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) HCl (CAS No 128729-28-2) (EC No 416-320-2)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,4 % (as tetrahydrochloride)

                                                      As mentioned in reference number 205, column f (a)

                                                      243

                                                      4-Amino-2-hydroxytoluene (CAS No 2835-95-2) (EC No 220-618-6)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %

                                                      As mentioned in reference number 205, column f (a)

                                                      244

                                                      2,4-Diaminophenoxyethanol (CAS No 70643-19-5), its hydrochloride and its sulphate
                                                      2,4-Diaminophenoxyethanol HCl (CAS No 66422-95-5) (EC No 266-357-1)
                                                      2,4-Diaminophenoxyethanol sulphate (CAS No 70643-20-8) (EC No 274-713-2)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (as hydrochloride)

                                                      As mentioned in reference number 205, column f (a)

                                                      245

                                                      2-Methylresorcinol (CAS No 608-25-3) (EC No 210-155-8)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 %

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,8 %

                                                      246

                                                      4-Amino-m-cresol (CAS No 2835-99-6) (EC No 220-621-2)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %

                                                      As mentioned in reference number 205, column f (a)

                                                      248

                                                      2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) (EC No 280-733-2) and its sulphate
                                                      2-Amino-4-hydroxyethylaminoanisole sulphate (CAS No 83763-48-8) (EC No 280-734-8)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as sulphate)

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      As mentioned in reference number 205, column f (a)

                                                      249

                                                      Hydroxyethyl-3,4-methylenedioxyaniline and its hydrochloride
                                                      Hydroxyethyl-3,4-methylenedioxyaniline HCl (CAS No 94158-14-2) (EC No 303-085-5)

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      As mentioned in reference number 205, column f (a)

                                                      250

                                                      3-Nitro-p-hydroxyethylaminophenol (CAS No 65235-31-6) (EC No 265-648-0)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,0 %

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating systems

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,85 %

                                                                  (b)

                                                                  As mentioned in reference number 208, column f

                                                      251

                                                      4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) (EC No 410-700-1)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  0,5 %

                                                      252

                                                      2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) (EC No 228-762-1)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  2,0 %

                                                                  (b)

                                                                  As mentioned in reference number 208, column f’

                                          (ii)

                                          the entry with reference number 201 is replaced by the following:

                                                      ‘201

                                                      2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) (EC No 411-440-1)

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %

                                                            (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)’

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  3,0 %

                              (b)

                              Part 2 is amended as follows:

                                          (i)

                                          the entries with reference numbers 3 to 6, 11, 12, 16, 19 to 22, 25, 27, 31 to 39, 44, 48, 49, 55 and 56 are deleted;

                                          (ii)

                                          in the entries with reference numbers 10 and 50, in column g, the date ‘31.12.2010’ is replaced by ‘31.12.2011’.


title: Commission Directive 2007/37/EC of 21 June 2007 amending Annexes I and III to Council Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (Text with EEA relevance)

text:
               22.6.2007

               EN

               Official Journal of the European Union

               L 161/60

      COMMISSION DIRECTIVE 2007/37/EC
   of 21 June 2007
   amending Annexes I and III to Council Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (1) and in particular second indent of Article 13(2) thereof,
   Whereas:

               (1)

               Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air-conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (2) is one of the separate directives under the EC type-approval procedure which was established by Directive 70/156/EEC.

               (2)

               Directive 2006/40/EC requires vehicles fitted with an air-conditioning system designed to contain fluorinated greenhouse gases with a global warming potential higher than 150 to be type-approved with regard to emissions from an air-conditioning system.

               (3)

               Following the introduction of that EC type-approval procedure and the adoption of Commission Regulation (EC) No 706/2007 of 21 June 2007 laying down, pursuant to Directive 2006/40/EC of the European Parliament and of the Council, administrative provisions for the EC type-approval of vehicles, and a harmonised test for measuring leakages from certain air conditioning systems (3), it is necessary to add new elements to the list of information in Annex I to Directive 70/156/EEC and the information document requirements for the purposes of vehicle EC type-approval in Annex III to that Directive.

               (4)

               In order to ensure the coherence of the EC type-approval procedure, the new requirements introduced by this Directive should apply from the same date as the measures adopted pursuant to Directive 2006/40/EC and to Regulation (EC) No 706/2007.

               (5)

               Directive 70/156/EEC should be therefore amended accordingly.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I and III to Directive 70/156/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 4 January 2008 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 5 January 2008.
   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.

      Done at Brussels, 21 June 2007.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 42, 23.2.1970, p. 1. Directive as last amended by Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).

      (2)  OJ L 161, 14.6.2006, p. 12.

      (3)  See page 33 of this Official Journal.

      ANNEX
      Directive 70/156/EEC is amended as follows:

                  1.

                  in Annex I, the following points are inserted:
                  9.10.8.   Gas used as refrigerant in the air-conditioning system: …
                  9.10.8.1   The air-conditioning system is designed to contain fluorinated greenhouse gases with a global warming potential higher than 150: YES/NO (1)
                  9.10.8.2   If YES, fill in the following sections:
                  9.10.8.2.1   Drawing and brief description of the air-conditioning system, including the reference or part number and material of the leak components:
                  9.10.8.2.2   Leakage of the air-conditioning system:
                  9.10.8.2.3   In case of component testing: list of leak components including the corresponding reference or part number and material, with their respective yearly leakages and information about the test (e.g. test report no., approval no., etc.): …
                  9.10.8.2.4   In case of vehicle testing: reference or part number and material of the components of the system and information about the test (e.g. test report no., approval no., etc.): …
                  9.10.8.3   Overall leakage in g/year of the entire system: …’

                  2.

                  in Annex III, the following points are inserted:
                  9.10.8   Gas used as refrigerant in the air-conditioning system: …
                  9.10.8.1   The air-conditioning system is designed to contain fluorinated greenhouse gases with a global warming potential higher than 150: YES/NO (1)
                  If yes, overall leakage in g/year of the entire system: …’


title: Commission Directive 2006/65/EC of  19 July 2006  amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress   (Text with EEA relevance)

text:
               20.7.2006

               EN

               Official Journal of the European Union

               L 198/11

      COMMISSION DIRECTIVE 2006/65/EC
   of 19 July 2006
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and 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 Cosmetic Products and Non-Food Products intended for Consumers,
   Whereas:

               (1)

               Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (the SCCNFP) concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye chemicals.

               (2)

               The SCCNFP recommended in addition an overall safety assessment strategy for hair dyes including the requirements for testing hair dye cosmetic ingredients for their potential genotoxicity/mutagenicity.

               (3)

               Following the opinions of the SCCNFP, the Commission together with Member States and stakeholders agreed on an overall strategy to regulate hair dyes according to which the industry was required to submit the files with scientific data on hair dyes to be evaluated by the SCCNFP.

               (4)

               As a first step in the implementation of the strategy it was decided to give priority to permanent hair dye substances for which no explicit interest was expressed during the public consultation in defence of their use in hair dyes. Those substances should therefore be banned.

               (5)

               According to the opinion of the SCCNFP, certain azo dyes pose a risk to the health of the consumer. They were therefore deleted from the positive list of colouring agents allowed for use in cosmetic products in Annex IV to Directive 76/768/EEC. For the same reason they should also be banned for use in hair dyes.

               (6)

               For hair dye substances provisionally allowed in part 2 of Annex III to Directive 76/768/EEC the provisional period should be extended.

               (7)

               Annexes II and III to Directive 76/768/EEC should therefore be amended accordingly.

               (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
   Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall take all necessary measures to ensure that from 1 December 2006 at the latest no cosmetic products which fail to comply with this Directive are placed on the market by Community manufacturers or by importers established within the Community, nor sold or disposed of to the final consumer.
   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation between those provisions and this Directive.
   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 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, 19 July 2006.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/80/EC (OJ L 303, 22.11.2005, p. 32).

      ANNEX
      Directive 76/768/EEC is amended as follows:

                  (1)

                  In Annex II the following reference numbers 1212 to 1233 are added:

                              Ref. No

                              Chemical name

                              CAS No

                              ‘1212

                              6-Methoxy-2,3-Pyridinediamine and its HCl salt, when used as a substance in hair dye products

                              94166-62-8

                              1213

                              2,3-Naphthalenediol, when used as a substance in hair dye products

                              92-44-4

                              1214

                              2,4-Diaminodiphenylamine, when used as a substance in hair dye products

                              136-17-4

                              1215

                              2,6-Bis(2-Hydroxyethoxy)-3,5-Pyridinediamine and its HCl salt, when used as a substance in hair dye products

                              117907-42-3

                              1216

                              2-Methoxymethyl-p-Aminophenol and its HCl salt, when used as a substance in hair dye products

                              29785-47-5

                              1217

                              4,5-Diamino-1-Methylpyrazole and its HCl salt, when used as a substance in hair dye products

                              20055-01-0

                              1218

                              4,5-Diamino-1-((4-Chlorophenyl)Methyl)-1H-Pyrazole Sulfate, when used as a substance in hair dye products

                              163183-00-4

                              1219

                              4-Chloro-2-Aminophenol, when used as a substance in hair dye products

                              95-85-2

                              1220

                              4-Hydroxyindole, when used as a substance in hair dye products

                              2380-94-1

                              1221

                              4-Methoxytoluene-2,5-Diamine and its HCl salt, when used as a substance in hair dye products

                              56496-88-9

                              1222

                              5-Amino-4-Fluoro-2-Methylphenol Sulfate, when used as a substance in hair dye products

                              163183-01-5

                              1223

                              N,N-Diethyl-m-Aminophenol, when used as a substance in hair dye products

                              91-68-9

                              1224

                              N,N-Dimethyl-2,6-Pyridinediamine and its HCl salt, when used as a substance in hair dye products

                              1225

                              N-Cyclopentyl-m-Aminophenol, when used as a substance in hair dye products

                              104903-49-3

                              1226

                              N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt, when used as a substance in hair dye products

                              72584-59-9

                              1227

                              2,4-Diamino-5-methylphenetol and its HCl salt, when used as a substance in hair dye products

                              113715-25-6

                              1228

                              1,7-Naphthalenediol, when used as a substance in hair dye products

                              575-38-2

                              1229

                              3,4-Diaminobenzoic acid, when used as a substance in hair dye products

                              619-05-6

                              1230

                              2-Aminomethyl-p-aminophenol and its HCl salt, when used as a substance in hair dye products

                              79352-72-0

                              1231

                              Solvent Red 1 (CI 12150), when used as a substance in hair dye products

                              1229-55-6

                              1232

                              Acid Orange 24 (CI 20170), when used as a substance in hair dye products

                              1320-07-6

                              1233

                              Acid Red 73 (CI 27290), when used as a substance in hair dye products

                              5413-75-2’

                  (2)

                  Column g in Part 2 of Annex III is amended as follows:

                              (a)

                              the reference numbers 17, 23, 40, 42 are deleted;

                              (b)

                              in reference numbers 1, 2, 8, 13, 15, 30, 34, 41, 43, 45, 46, 51, 52, 53, 54, 57, 59, 60 the date ‘31.8.2006’ is replaced by ‘31.12.2007’;

                              (c)

                              in reference numbers 3, 4, 5, 6, 7, 9, 10, 11, 12, 14, 16, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 31, 32, 33, 35, 36, 37, 38, 39, 44, 47, 48, 49, 50, 55, 56 and 58 the date ‘31.12.2006’ is replaced by ‘31.12.2007’.


Avis juridique important

|

31987L0343

Council Directive 87/343/EEC of 22 June 1987 amending, as regards credit insurance and suretyship insurance, First Directive 73/239/EEC on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance

Official Journal L 185 , 04/07/1987 P. 0072 - 0076 Finnish special edition: Chapter 6 Volume 2 P. 0157  Swedish special edition: Chapter 6 Volume 2 P. 0157

*****COUNCIL  DIRECTIVE  of 22 June 1987  amending, as regards credit insurance and suretyship insurance, First Directive 73/239/EEC on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance  (87/343/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 57 (2) 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 First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (4), as amended by Directive 76/580/EEC (5), eliminated a number of divergencies in the laws of the Member States in order to facilitate the taking-up and pursuit of that business;  Whereas, however, Article 2 (2) (d) of the said Directive states that it does not apply, 'pending further coordination, which shall be implemented within four years of notification of this Directive', to 'export credit insurance operations for the account of or with the support of the State'; whereas, since the protection of insured persons normally provided by the Directive is provided by the State itself where export credit insurance operations are carried out for the account of or with the guarantee of the State, such operations should continue to be excluded from the scope of the said Directive pending further coordination;  Whereas Article 7 (2) (c) of the said Directive states that 'pending further coordination, which must be implemented within four years of notification of this Directive, the Federal Republic of Germany may maintain the provision prohibiting the simultaneous undertaking in its territory of health insurance, credit and suretyship insurance or insurance in respect of recourse against third parties and legal defence, either with one another or with other classes'; whereas it follows from this that there are barriers to the establishment of agencies and branches; whereas the present Directive is intended to remedy this situation;  Whereas the interests of insured persons are sufficiently safeguarded, as regards suretyship insurance, by the said Directive; whereas the prohibition in the Federal Republic of Germany on the simultaneous undertaking of suretyship insurance and other classes should be lifted;  Whereas insurance undertakings whose credit insurance business amounts to more than a small proportion of their total business require an equalization reserve which does not form part of the solvency margin; whereas that reserve should be calculated according to the methods laid down in this Directive, which are recognized as equivalent;  Whereas in view of the cyclical nature of claims in credit insurance, the latter should, for the purposes of calculating the average burden of claims within the meaning of Article 16 (2) of Directive 73/239/EEC, be treated on the same basis as insurance against storm, hail and frost risks;  Whereas the nature of the risk in credit insurance is such that undertakings which transact such business ought to form a higher guarantee fund than is at present provided for in the said Directive;  Whereas a sufficient period of time should be granted to undertakings which are required to meet that obligation;  Whereas it is unnecessary to impose this obligation on undertakings whose operations in this class of insurance do not exceed a certain volume;  Whereas, in view of the provisions of this Directive in respect of credit insurance, the maintenance by the Federal Republic of Germany of the prohibition of the simultaneous undertaking of credit insurance and other classes is no longer justified, and such prohibition should therefore be removed,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Council Directive 73/239/EEC is hereby amended as follows:  1. Article 2 (2) (d) shall be replaced by the following:  '(d) pending further coordination, export credit insurance operations for the account of or guaranteed by the State, or where the State is the insurer.'  2. In the second subparagraph of Article 7 (2) (c), the words 'credit and suretyship insurance' shall be deleted.  3. The following Article shall be inserted:  'Article 15a  1. Each Member State shall require undertakings established on its territory and underwriting risks included under class 14 in point A of the Annex (hereinafter referred to as "credit insurance") to set up an equalization reserve for the purpose of offsetting any technical deficit or above-average claims ratio arising in that class for a financial year.  2. The equalization reserve must be calculated, under the rules laid down by each Member State, in accordance with one of the four methods set out in point D of the Annex which shall be regarded as being equivalent.  3. Up to the amount calculated in accordance with the methods set out in point D of the Annex, the equalization reserve shall be disregarded for purposes of calculating the solvency margin.  4. Member States may exempt establishments from the obligation to set up an equalization reserve for credit insurance business where the premiums or contributions receivable in respect of credit insurance are less than 4 % of the total premiums or contributions receivable by them and less than 2 500 000 ECU.'  4. In Article 16 (2), the second sentence shall be replaced by the following text:  'In the case, however, of undertakings which essentially underwrite only one or more of the risks of credit, storm, hail or frost, the last seven financial years shall be taken as the reference period for the average burden of claims.'  5. The first indent of Article 17 (2) (a) shall be replaced by the following indents:  '- 1 400 000 ECU in the case where all or some of the risks included in the class listed in point A of the Annex under No 14 are covered. This provision shall apply to every undertaking for which the annual amount of premiums or contributions due in this class for each of the last three financial years exceeded 2 500 000 ECU or 4 % of the total amount of premiums or contributions receivable by the undertaking concerned;  - 400 000 ECU in the case where all or some of the risks included in one of the classes listed in point A of the Annex under Nos 10, 11, 12, 13 and 15 and, insofar as the first indent does not apply, No 14.'  6. The following subparagraph shall be added to Article 17 (2):  '(d) Where an undertaking carrying on credit insurance is required to increase the fund referred to in subparagraph (a), first indent, to 1 400 000 ECU, the Member State concerned shall allow such undertaking:  - a period of three years in which to bring the fund up to 1 000 000 ECU,  - a period of five years to bring the fund up to 1 200 000 ECU,  - a period of seven years to bring the fund up to 1 400 000 ECU.  These periods shall run from the date from which the conditions referred to in the first indent of subparagraph (a) are fulfilled.'  7. The following shall be inserted in Article 19:  '1a. In respect of credit insurance, the undertaking shall make available to the supervisory authority accounts showing both the technical results and the technical reserves relating to that business.'  8. Point D in the Annex to this Directive shall be added to the Annex. Article 2  Member States shall take the measures necessary to comply with this Directive by 1 January 1990. They shall forthwith inform the Commission thereof.  They shall apply these measures from 1 July 1990 at the latest.  Article 3  Following notification (1) of this Directive, Member States shall communicate to the Commission the texts of the main provisions of national legislation which they adopt in the field governed by this Directive.  Article 4  This Directive is addressed to the Member States.  Done at Luxembourg, 22 June 1987.  For the Council  The President  L. TINDEMANS  (1) OJ No C 245, 29. 9. 1979, p. 7 and  OJ No C 5, 7. 1. 1983, p. 2.  (2) OJ No C 291, 10. 11. 1980, p. 70.  (3) OJ No C 146, 16. 6. 1980, p. 6.  (4) OJ No L 228, 16. 8. 1973, p. 3.  (5) OJ No L 189, 13. 7. 1976, p. 13.  (1) This Directive was notified to the Member States on 25 June 1987.  ANNEX  'D. Methods of calculating the equalization reserve for the credit insurance class  Method No 1  1. In respect of the risks included in the class of insurance in point A No 14 (hereinafter referred to as 'credit insurance'), the undertaking shall set up an equalization reserve to which shall be charged any technical deficit arising in that class for a financial year.  2. Such reserve shall in each financial year receive 75 % of any technical surplus arising on credit insurance business, subject to a limit of 12 % of the net premiums or contributions until the reserve has reached 150 % of the highest annual amount of net premiums or contributions received during the previous five financial years.  Method No 2  1. In respect of the risks included in the class of insurance listed in point A No 14 (hereinafter referred to as 'credit insurance') the undertaking shall set up an equalization reserve to which shall be charged any technical deficit arising in that class for a financial year.  2. The minimum amount of the equilization reserve shall be 134 % of the average of the premiums or contributions received annually during the previous five financial years after subtraction of the cessions and addition of the reinsurance acceptances.  3. Such reserve shall in each of the successive financial years receive 75 % of any technical surplus arising in that class until the reserve is at least equal to the minimum calculated in accordance with paragraph 2.  4. Member States may lay down special rules for the calculation of the amount of the reserve and/or the amount of the annual levy in excess of the minimum amounts laid down in this Directive.  Method No 3  1. An equalization reserve shall be formed for class 14 in point A (hereinafter referred to as 'credit insurance') for the purpose of offsetting any above-average claims ratio for a financial year in that class of insurance.  2. The equalization reserve shall be calculated on the basis of the method set out below.  All calculations shall relate to income and expenditure for the insurer's own account.  An amount in respect of any claims shortfall for each financial year shall be placed to the equalization reserve until it has reached, or is restored to, the required amount.  There shall be deemed to be a claims shortfall if the claims ratio for a financial year is lower than the average claims ratio for the reference period. The amount in respect of the claims shortfall shall be arrived at by multiplying the difference between the two ratios by the earned premiums for the financial year.  The required amount shall be equal to six times the standard devition of the claims ratios in the reference period from the average claims ratio, multiplied by the earned premiums for the financial year.  Where claims for any financial year are in excess, an amount in respect thereof shall be taken from the equalization reserve. Claims shall be deemed to be in excess if the claims ratio for the financial year is higher than the average claims ratio. The amount in respect of the excess claims shall be arrived at by multiplying the difference between the two ratios by the earned premiums for the financial year.  Irrespective of claims experience, 3,5 % of the required amount of the equalization reserve shall be first placed to that reserve each financial year until its required amount has been reached or restored.  The lenght of the reference period shall be not less than 15 years and not more than 30 years. No equalization reserve need be formed if no underwriting loss has been noted during the reference period.  The required amount of the equalization reserve and the amount to be taken from it may be reduced if the average claims ratio for the reference period in conjunction with the expenses ratio show that the premiums include a safety margin.  Method No 4  1. An equalization reserve shall be formed for class 14 in point A (hereinafter referred to as 'credit insurance') for the purpose of offsetting any above-average claims ratio for a financial year in that class of insurance. 2. The equalization reserve shall be calculated on the basis of the method set out below.  All calculations shall relate to income and expenditure for the insurer's own account.  An amount in respect of any claims shortfall for each financial year shall be placed to the equalization reserve until it has reached the maximum required amount.  There shall be deemed to be a claims shortfall if the claims ratio for a financial year is lower than the average claims ratio for the reference period. The amount in respect of the claims shortfall shall be arrived at by multiplying the difference betwen the two ratios by the earned premiums for the financial year.  The maximum required amount shall be equal to six times the standard deviation of the claims ratio in the reference period from the average claims ratio, multiplied by the earned premiums for the financial year.  Where claims for any financial year are in excess, an amount in respect thereof shall be taken from the equalization reserve until it has reached the minimum required amount. Claims shall be deemed to be in excess if the claims ratio for the financial year is higher than the average claims ratio. The amount in respect of the excess claims shall be arrived at by multiplying the difference between the two ratios by the earned premiums for the financial year.  The minimum required amount shall be equal to three times the standard deviation of the claims ratio in the reference from the average claims ratio multiplied by the earned premiums for the financial year.  The length of the reference period shall be not less than 15 years and not more than 30 years. No equalization reserve need be formed if no underwriting loss has been noted during the reference period.  Both required amounts of the equalization reserve and the amount to be placed to it or the amount to be taken from it may be reduced if the average claims ratio for the reference period in conjunction with the expenses ratio show that the premiums include a safety margin and that safety margin is more than one-and-a-half times the standard deviation of the claims ratio in the reference period. In such a case the amounts in question shall be multiplied by the quotient or one-and-a-half times the standard deviation and the safety margin.


title: Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency

text:
L 396/850         EN              Official Journal of the European Union                 30.12.2006
                DIRECTIVE 2006/121/EC OF THE EUROPEAN PARLIAMENT
                                     AND OF THE COUNCIL
                                        of 18 December 2006
                             amending Council Directive 67/548/EEC
                   on the approximation of laws, regulations and administrative
                provisions relating to the classification, packaging and labelling of
           dangerous substances in order to adapt it to Regulation (EC) No 1907/2006
             concerning the Registration, Evaluation, Authorisation and Restriction
             of Chemicals (REACH) and establishing a European Chemicals Agency
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 proposal from the Commission,
Having regard to the Opinion of the European Economic and Social Committee1,
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty2,
1
        OJ C 294, 25.11.2005, p. 38.
2
        Opinion of the European Parliament of 17 November 2005 (OJ C 280 E, 18.11.2006,
        p. 440), Council Common Position of 27 June 2006 (OJ C 276 E, 14.11.2006, p. 252) and
        Position of the European Parliament of 13 December 2006 (not yet published in the Official
        Journal).
 ---pagebreak--- 30.12.2006           EN                Official Journal of the European Union               L 396/851
Whereas:
In view of the adoption of Regulation (EC) No 1907/20061, Directive 67/548/EEC2 should be
adapted and its rules on the notification and risk assessment of chemicals deleted,
HAVE ADOPTED THIS DIRECTIVE:
                                                     Article 1
Directive 67/548/EEC is hereby amended as follows:
1)       in Article 1, paragraph 1, points (a), (b) and (c) shall be deleted;
2)       in Article 2, paragraph 1, points (c), (d), (f) and (g) shall be deleted;
3)       Article 3 shall be replaced by the following:
         "Article 3
         Testing and assessment of the properties of substances
         Tests on substances carried out within the framework of this Directive shall be conducted
         according to the requirements of Article 13 of Regulation (EC) No 1907/2006 of the
         European Parliament and of the Council of 18 December 2006 concerning the Registration,
         Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a
         European Chemicals Agency*.
         _____________________________
         *
                   OJ L"; 396, 30.12.2006, p. 1.
1
        See page 1 of this Official Journal.
2
        OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC
        (OJ L 152, 30.4.2004, p. 1). Corrected in OJ L 216, 16.6.2004, p. 3.
 ---pagebreak--- L 396/852         EN                 Official Journal of the European Union                         30.12.2006
4)        Article 5 shall be amended as follows:
          (a)   in paragraph 1, the first subparagraph shall be replaced by the following:
                "Member States shall take all the necessary measures to ensure that substances
                cannot be placed on the market on their own or in preparations unless they have been
                packaged and labelled in accordance with Articles 22 to 25 of this Directive and with
                the criteria in Annex VI of this Directive, and, for registered substances, in
                accordance with the information obtained through the application of Articles 12
                and 13 of Regulation (EC) No 1907/2006, save in the case of preparations where
                provisions exist in other Directives.";
          (b)   paragraph 2 shall be replaced by the following:
                "2.    The measures referred to in the first subparagraph of paragraph 1 shall apply
                       until the substance is listed in Annex I or until a decision not to list it has been
                       taken in accordance with the procedure laid down in Article 29.";
5)        Articles 7 to 15 shall be deleted;
6)        Article 16 shall be deleted;
7)        Articles 17 to 20 shall be deleted;
8)        Article 27 shall be deleted;
 ---pagebreak--- 30.12.2006       EN                 Official Journal of the European Union                          L 396/853
9)       Article 32 shall be replaced by the following:
         "Article 32
         References
         References to Annexes VII A, VII B, VII C, VII D and VIII of this Directive shall be
         construed as references to the corresponding Annexes VI, VII, VIII, IX, X and XI of
         Regulation (EC) No 1907/2006.";
10)      Annex V shall be deleted;
11)      Annex VI shall be amended as follows:
         (a)   in sections 1.6.2, 1.7.2, 1.7.3, 2.1, 2.2.1, 2.2.2, 2.2.2.1, 2.2.3, 2.2.4, 2.2.5, 3.1.1,
               3.1.5.1, 3.1.5.2, 3.2.1, 3.2.2, 3.2.3, 3.2.5, 3.2.6.1, 3.2.6.2, 3.2.7.2, 4.2.3.3, 5.1.3,
               9.1.1.1, 9.1.1.2, 9.3 and 9.5 of this Annex, the words "Annex V" and "Annex V to
               this Directive", shall be replaced by the words "the Commission Regulation on test
               methods as specified in Article 13(2) of Regulation (EC) No 1907/2006";
 ---pagebreak--- L 396/854       EN                 Official Journal of the European Union                      30.12.2006
          (b) section 1.6.1, point (a) shall be replaced by the following:
              "(a) as regards substances for which the information specified in Annexes VI, VII
                    and VIII of Regulation (EC) No 1907/2006 is required, most of the necessary
                    data for classification and labelling appear in the base set. This classification
                    and labelling must be reviewed, if necessary, when further information is
                    available (Annexes IX and X of Regulation (EC) No 1907/2006);";
          (c) in section 5.1, the second paragraph shall be replaced by the following:
              "The criteria set out below follow directly from the test methods set out in the
              Commission Regulation on test methods as specified in Article 13(2) of
              Regulation (EC) No 1907/2006 in so far as they are mentioned. The test methods
              required for the base set referred to in Annexes VII and VIII of Regulation (EC)
              No 1907/2006 are limited and the information derived from them may be insufficient
              for an appropriate classification. Classification may require additional data derived
              from Annexes IX or X of Regulation (EC) No 1907/2006 or other equivalent studies.
              Furthermore, classified substances may be subject to review in the light of other new
              data.";
 ---pagebreak--- 30.12.2006       EN                 Official Journal of the European Union                   L 396/855
         (d)   in section 5.2.1.2, second paragraph, the second sentence shall be replaced by the
               following:
               "Such additional scientific evidence should normally be based on the studies required
               by Annex IX of Regulation (EC) No 1907/2006, or studies of equivalent value, and
               could include:";
12)      Annexes VII A, VII B, VII C, VII D and VIII shall be deleted.
                                                  Article 2
1.        Member States shall bring into force the laws, regulations and administrative provisions
         necessary to comply with this Directive with effect from 1 June 2008. They shall forthwith
         inform the Commission thereof.
         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 the Member States.
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.
 ---pagebreak--- L 396/856         EN               Official Journal of the European Union                     30.12.2006
                                                 Article 3
This Directive shall enter into force on the twentieth day following its publication in the Official
Journal of the European Union.
It shall apply from 1 June 2008.
Notwithstanding the second paragraph of this Article, Article 1 point 6 shall apply from 1 August
2008.
                                                 Article 4
This Directive is addressed to the Member States.
Done at Brussels, 18 December 2006.
For the European Parliament                     For the Council
The President                                   The President
J. BORRELL FONTELLES                            M. VANHANEN
                                    _________________________


title: Commission Directive 2007/8/EC of 20 February 2007 amending Annexes to Council Directives 76/895/EEC, 86/362/EEC and 90/642/EEC as regards maximum residue levels for phosphamidon and mevinphos (Text with EEA relevance )

text:
               1.3.2007

               EN

               Official Journal of the European Union

               L 63/9

      COMMISSION DIRECTIVE 2007/8/EC
   of 20 February 2007
   amending Annexes to Council Directives 76/895/EEC, 86/362/EEC and 90/642/EEC as regards maximum residue levels for phosphamidon and mevinphos
   (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), 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 (2), 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 (3), and in particular Article 7 thereof,
   Whereas:

               (1)

               In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides and, where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected.

               (2)

               MRLs for pesticides are kept under review and changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data.

               (3)

               The Commission was informed that for phosphamidon and mevinphos current MRLs may need to be revised in the light of the availability of new information on the toxicology and consumer intake. The Commission asked the relevant rapporteur Member States to make proposals for the review of Community MRLs. Such proposals were submitted to the Commission.

               (4)

               The lifetime and short-term exposure of consumers to the pesticides referred to in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation (4). On that basis, it is appropriate to fix new MRLs, which will ensure that there is no unacceptable consumer exposure.

               (5)

               Where relevant, the acute exposure of consumers to those pesticides via each of the food products that may contain residues has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the new MRLs will not cause acute toxic effects.

               (6)

               Through the World Trade Organisation, the Community's trading partners have been consulted about the new MRLs and their comments on these levels have been taken into account.

               (7)

               The Annexes to Directives 76/895/EEC, 86/362/EEC and 90/642/EEC should therefore be amended accordingly.

               (8)

               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
   In Annex II to Directive 76/895/EEC the entries relating to phosphamidon and mevinphos are deleted.
   Article 2
   Directive 86/362/EEC is amended as follows in accordance with Annex I to this Directive.
   Article 3
   Directive 90/642/EEC is amended in accordance with Annex II to this Directive.
   Article 4
   1.   Member States shall adopt and publish, by 1 September 2007 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 2 September 2007.
   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 5
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 20 February 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2006/92/EC (OJ L 311, 10.11.2006, p. 31).

      (2)  OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2006/92/EC.

      (3)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2006/92/EC.

      (4)  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).

      ANNEX I
      In part A of Annex II to Directive 86/362/EEC the following lines for phosphamidon and mevinphos are added:

                     Pesticide residues

                     Maximum levels in mg/kg

                     ‘Phosphamidon

                     0,01 (1)

                     Cereals

                     Mevinphos, sum of E- and Z-isomers

                     0,01 (1)

                     Cereals

         (1)  Indicates lower limit of analytical determination’

      ANNEX II
      In part A of Annex II to Directive 90/642/EEC the following columns for phosphamidon and mevinphos are added:

                     Pesticide residue and maximum residue level (mg/kg)

                     Groups and examples of individual products to which the MRLs would apply

                     Phosphamidon

                     Mevinphos, sum of E- and Z-isomers

                                 ‘1.

                                 Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts

                     0,01 (1)

                     0,01 (1)

                                 (i)

                                 CITRUS FRUIT

                     Grapefruit

                     Lemons

                     Limes

                     Mandarins (including clementines and other hybrids)

                     Oranges

                     Pomelos

                     Others

                                 (ii)

                                 TREE NUTS (shelled or unshelled)

                     Almonds

                     Brazil nuts

                     Cashew nuts

                     Chestnuts

                     Coconuts

                     Hazelnuts

                     Macadamia

                     Pecans

                     Pine nuts

                     Pistachios

                     Walnuts

                     Others

                                 (iii)

                                 POME FRUIT

                     Apples

                     Pears

                     Quinces

                     Others

                                 (iv)

                                 STONE FRUIT

                     Apricots

                     Cherries

                     Peaches (including nectarines and similar hybrids)

                     Plums

                     Others

                                 (v)

                                 BERRIES AND SMALL FRUIT

                                 (a)

                                 Table and wine grapes

                     Table grapes

                     Wine grapes

                                 (b)

                                 Strawberries (other than wild)

                                 (c)

                                 Cane fruit (other than wild)

                     Blackberries

                     Dewberries

                     Loganberries

                     Raspberries

                     Others

                                 (d)

                                 Other small fruit and berries (other than wild)

                     Bilberries

                     Cranberries

                     Currants (red, black and white)

                     Gooseberries

                     Others

                                 (e)

                                 Wild berries and wild fruit

                                 (vi)

                                 MISCELLANEOUS

                     Avocados

                     Bananas

                     Dates

                     Figs

                     Kiwi

                     Kumquats

                     Litchis

                     Mangoes

                     Olives (table consumption)

                     Olives (oil extraction)

                     Papaya

                     Passion fruit

                     Pineapples

                     Pomegranate

                     Others

                                 2.

                                 Vegetables, fresh or uncooked, frozen or dry

                     0,01 (1)

                     0,01 (1)

                                 (i)

                                 ROOT AND TUBER VEGETABLES

                     Beetroot

                     Carrots

                     Cassava

                     Celeriac

                     Horseradish

                     Jerusalem artichokes

                     Parsnips

                     Parsley root

                     Radishes

                     Salsify

                     Sweet potatoes

                     Swedes

                     Turnips

                     Yam

                     Others

                                 (ii)

                                 BULB VEGETABLES

                     Garlic

                     Onions

                     Shallots

                     Spring onions

                     Others

                                 (iii)

                                 FRUITING VEGETABLES

                                 (a)

                                 Solanacea

                     Tomatoes

                     Peppers

                     Aubergines

                     Okra

                     Others

                                 (b)

                                 Cucurbits — edible peel

                     Cucumbers

                     Gherkins

                     Courgettes

                     Others

                                 (c)

                                 Cucurbits-inedible peel

                     Melons

                     Squashes

                     Watermelons

                     Others

                                 (d)

                                 Sweet corn

                                 (iv)

                                 BRASSICA VEGETABLES

                                 (a)

                                 Flowering brassica

                     Broccoli (including Calabrese)

                     Cauliflower

                     Others

                                 (b)

                                 Head brassica

                     Brussels sprouts

                     Head cabbage

                     Others

                                 (c)

                                 Leafy brassica

                     Chinese cabbage

                     Kale

                     Others

                                 (d)

                                 Kohlrabi

                                 (v)

                                 LEAF VEGETABLES AND FRESH HERBS

                                 (a)

                                 Lettuce and similar

                     Cress

                     Lamb's lettuce

                     Lettuce

                     Scarole (broad-leaf endive)

                     Ruccola

                     Leaves and stems of brassica

                     Others

                                 (b)

                                 Spinach and similar

                     Spinach

                     Beet leaves (chard)

                     Others

                                 (c)

                                 Water cress

                                 (d)

                                 Witloof

                                 (e)

                                 Herbs

                     Chervil

                     Chives

                     Parsley

                     Celery leaves

                     Others

                                 (vi)

                                 LEGUME VEGETABLES (fresh)

                     Beans (with pods)

                     Beans (without pods)

                     Peas (with pods)

                     Peas (without pods)

                     Others

                                 (vii)

                                 STEM VEGETABLES (fresh)

                     Asparagus

                     Cardoons

                     Celery

                     Fennel

                     Globe artichokes

                     Leek

                     Rhubarb

                     Others

                                 (viii)

                                 FUNGI

                                 (a)

                                 Cultivated mushrooms

                                 (b)

                                 Wild mushrooms

                                 3.

                                 Pulses

                     0,01 (1)

                     0,01 (1)

                     Beans

                     Lentils

                     Peas

                     Lupines

                     Others

                                 4.

                                 Oilseeds

                     0,01 (1)

                     0,01 (1)

                     Linseed

                     Peanuts

                     Poppy seed

                     Sesame seed

                     Sunflower seed

                     Rape seed

                     Soya bean

                     Mustard seed

                     Cotton seed

                     Hemp seed

                     Others

                                 5.

                                 Potatoes

                     0,01 (1)

                     0,01 (1)

                     Early potatoes

                     Ware potatoes

                                 6.

                                 Tea (dried leaves and stalks, fermented or other-wise, Camellia sinensis)

                     0,02 (1)

                     0,02 (1)

                                 7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                     0,02 (1)

                     0,02 (1)

         (1)  Indicates lower limit of analytical determination.’