Avis juridique important

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32004L0060

Commission Directive 2004/60/EC of 23 April 2004 amending Council Directive 91/414/EEC to include quinoxyfen as active substance (Text with EEA relevance)

Official Journal L 120 , 24/04/2004 P. 0039 - 0042

Commission Directive 2004/60/ECof 23 April 2004amending Council Directive 91/414/EEC to include quinoxyfen as active substance(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/82/EC(2), and in particular Article 6(1) thereof,Whereas:(1) In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 1 August 1995 an application from Dow Elanco Europe (now Dow Agro Sciences), for the inclusion of the active substance quinoxyfen in Annex I to Directive 91/414/EEC. Commission Decision 96/457/EEC(3) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.(2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The nominated rapporteur Member State, submitted a draft assessment report concerning the substance to the Commission on 11 October 1996.(3) The draft assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 28 November 2003 in the format of the Commission review report for quinoxyfen.(4) The documents and information were also submitted to the Scientific Committee for Plants for separate consultation. The Committee was asked to comment on the accumulation of the substance in soil and on its potential environmental impact. In its opinion(4), the Committee noted that the available studies and the field study on organic matter degradation (litter bag study) in particular did not convincingly demonstrate an acceptable impact on the environment, mainly due to insufficient statistical power of the experimental design. The Committee further noted that a fraction of the applied quinoxyfen may volatilise after application to a crop. Although available results indicate a rapid decomposition of the substance in air, the Committee suggested that measurements of the half-life should be repeated after appropriate schemes have been developed for assessing the environmental risks of atmospheric transport of plant protection products. This recommendation of the Committee was taken into account in the review report of the active substance.The insufficient field study on organic matter breakdown was repeated with an upgraded test protocol. No effect of quinoxyfen on organic matter decomposition was detected.(5) In accordance with Article 6(4) of Directive 91/414/EEC and in view of a possible unfavourable decision for quinoxyfen the Commission organised a tripartite meeting with the main data submitter and the rapporteur Member State on 13 February 2003. The main data submitter provided further data in order to meet the initial concerns.(6) It has appeared from the various examinations made that plant protection products containing quinoxyfen may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include quinoxyfen in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.(7) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information within the meaning of Article 14 of Directive 91/414/EEC, should be kept available or made available by the Member States for consultation by any interested parties.(8) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing quinoxyfen and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish, by 28 February 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 March 2005.When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 31. Member States shall review the authorisation for each plant protection product containing quinoxyfen to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw the authorisation in accordance with Directive 91/414/EEC before 28 February 2005.2. Member States shall, for each authorised plant protection product containing quinoxyfen as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2004, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 28 February 2006 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.Article 4This Directive shall enter into force on 1 September 2004.Article 5This Directive is addressed to the Member States.Done at Brussels, 23 April 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 77, 13.3.2004, p. 50.(3) OJ L 189, 30.7.1996, p. 112.(4) Opinion of the Scientific Committee on Plants regarding the inclusion of quinoxyfen in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market. (SCP/QUINOX/002-final, adopted 7 March 2001).ANNEXIn Annex I the following row is added at the end of the table:">TABLE>"


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32001L0060

Commission Directive 2001/60/EC of 7 August 2001 adapting to technical progress Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (Text with EEA relevance)

Official Journal L 226 , 22/08/2001 P. 0005 - 0006

Commission Directive 2001/60/ECof 7 August 2001adapting to technical progress Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(1), and in particular Article 20 thereof,Whereas:(1) Commission Directive 98/98/EC(2) adapting to technical progress for the 25th time Council Directive 67/548/EEC(3), as last amended by Directive 2000/33/EC(4), provides for new criteria and a new R phrase (R67) for vapours which may cause drowsiness and dizziness. The provisions set out in Annex V to Directive 1999/45/EC should therefore be supplemented.(2) Commission Directive 2001/59/EC(5) introduces new wording for R phrase R40 when it is assigned to carcinogens of category 3. Consequently, the old wording of R phrase R40 will now be referred to as R68 and will continue to be used for mutagens of category 3 and for certain substances with non-lethal irreversible effects. It is therefore necessary to amend the references to R40 in Annex II to Directive 1999/45/EC.(3) Directive 2001/59/EC introduces into Annex VI to Directive 67/548/EEC clearer advice on the classification of substances and preparations for corrosive effects. It is therefore necessary to supplement Annex II to Directive 1999/45/EC accordingly.(4) It is known that cement preparations containing chromium (VI) may cause allergic reactions in certain circumstances. It is therefore desirable to require such preparations to display a warning label by supplementing Annex V to Directive 1999/45/EC.(5) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations established under Article 20 of Directive 1999/45/EC,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 1999/45/EC is amended as follows:1. In Annex II, Part A:- in paragraph 3.3, the term "R40" is replaced by "R68",- in paragraph 8.2, the term "R40" is replaced by "R68" each time it occurs.2. In Annex II, Part B:- in paragraph 2.1 (including Table II), the term "R40" is replaced by "R68" each time it occurs,- in paragraph 2.2 (including Table II A), the term "R40" is replaced by "R68" each time it occurs,- in paragraph 6.1, the term "R40" is replaced by "R68" the second time it occurs (i.e. in relation to mutagenic category 3),- in Table VI, the term "R40" is replaced by "R68" in the fourth row, columns 1 and 3 (i.e. in relation with mutagenic category 3),- in paragraph 6.2, the term "R40" is replaced by "R68" the second time it occurs (i.e. in relation to mutagenic category 3),- in Table VI A, the term "R40" is replaced by "R68" in the fourth row, columns 1 and 3 (i.e. in relation with mutagenic category 3).3. In Annex II, Part B, Tables IV and IV A are supplemented with the following note: ">TABLE>NB:Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive."Article 2Annex V(B) to Directive 1999/45/EC is supplemented by the addition of new paragraphs 11 and 12 as in Annex I to this Directive.Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 July 2002 at the latest. They shall forthwith inform the Commission thereof.2. Member States shall apply the laws, regulations and administrative provisions referred to in paragraph 1:(a) to preparations not within the scope of Council Directive 91/414/EEC(6) on the placing of plant protection products on the market, or European Parliament and Council Directive 98/8/EC(7) on the placing of biocidal products on the market as from 30 July 2002;(b) and to preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC as from 30 July 2004.3. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 4This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 7 August 2001.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 200, 30.7.1999, p. 1.(2) OJ L 355, 30.12.1998, p. 1.(3) OJ 196, 16.8.1967, p. 1.(4) OJ L 136, 8.6.2000, p. 90.(5) OJ L 225, 21.8.2001, p. 1.(6) OJ L 230, 19.8.1991, p. 1.(7) OJ L 123, 24.4.1998, p. 1.ANNEXThe following paragraphs 11 and 12 are added to Annex V(B) to Directive 1999/45/EC: "11. Preparations containing a substance assigned phrase R67: vapours may cause drowsiness and dizzinessWhen a preparation contains one or more substances assigned the phrase R67, the label of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the total concentration of these substances present in the preparation is equal to or higher than 15 %, unless:- the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or R39/26,- or the preparation is in a package not exceeding 125 ml.12. Cements and cement preparationsThe packaging of cements and cement preparations containing more than 0,0002 % soluble chromium (VI) of the total dry weight of the cement must bear the inscription: "Contains chromium (VI). May produce an allergic reaction" unless the preparation is already classified and labelled as a sensitiser with phrase R43."


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31985L0467

Council Directive 85/467/EEC of 1 October 1985 amending for the sixth time (PCBs/PCTs) Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations

Official Journal L 269 , 11/10/1985 P. 0056 - 0058 Spanish special edition: Chapter 13 Volume 19 P. 0017  Portuguese special edition Chapter 13 Volume 19 P. 0017  Finnish special edition: Chapter 13 Volume 14 P. 0189  Swedish special edition: Chapter 13 Volume 14 P. 0189

*****COUNCIL  DIRECTIVE  of 1 October 1985  amending for the sixth time (PCBs/PCTs) Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations  (85/467/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas polychlorinated biphenyls (PCBs) and polychlorinated terphenyls (PCTs) may constitute serious risks to health and to the environment;  Whereas it has been ascertained that, despite the restriction on the use of PCBs and PCTs introduced by Directive 76/769/EEC (3), as last amended by Directive 83/478/EEC (4), there is generally no indication that pollution of the environment by PCBs and PCTs has lessened significantly; whereas highly toxic substances may be given off in the event of fires; whereas therefore the threshold laid down in Directive 76/769/EEC of 0,1 % by weight of PCBs and PCTs in preparations must be substantially lowered;  Whereas, since Directive 76/769/EEC was adopted, substitutes have been developed which are considered less dangerous to human beings and the environment; whereas the continued marketing of PCBs and PCTs is therefore no longer justified under present circumstances, except in certain exceptional cases of limited duration;  Whereas the use of PCBs and PCTs in certain plant and equipment in service at present should continue to be authorized until they have been disposed of or until the end of the service life of the plant and equipment; whereas Member States may nevertheless ban the use of PCBs and PCTs within their territory before the end of the service life of the plant and equipment;  Whereas the Member States should be permitted to authorize exceptions to the ban on the use of PCBs and PCTs as primary and intermediate products were certain conditions are fulfilled, in particular where they consider that there is no danger to public health and the environment;  Whereas a more general ban on the use of PCBs and PCTs is not feasible at this stage; whereas, however, this Directive constitutes an important step towards such a ban,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. Point 1 of Annex I to Directive 76/769/EEC is hereby replaced by the text in the Annex to this Directive.  2. Annex II to Directive 76/769/EEC is hereby amended as follows:  - the existing Annex II shall become Annex II, part A;  - part B below shall be added:  'B. Specific provisions relating to the labelling of products containing PCBs and PCTs  Without prejudice to the provisions of other Directives relating to the labelling of dangerous substances and preparations, Member States may require equipment and plant containing PCBs or PCTs also to display instructions concerning the disposal of PCBs and PCTs and the maintenance and use of equipment and plant containing them. These instructions must be capable of being read horizontally when the object containing the PCBs or PCTs is installed in the normal way. The inscription must stand out clearly from its background.  Member States may require the inscription to be in a language which is understood in their territory.'  Article 2  1. Member States shall take the measures necessary to comply with this Directive by 30 June 1986 at the latest. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.  Article 3  This Directive is addressed to the Member States.  Done at Luxembourg, 1 October 1985.  For the Council  The President  J. F. POOS  (1) OJ No C 141, 10. 6. 1985, p. 76.  (2) OJ No C 104, 25. 4. 1985, p. 1.  (3) OJ No L 262, 27. 9. 1976, p. 201.  (4) OJ No L 263, 24. 9. 1983, p. 33.  ANNEX  1.2 //   //   // Designation of the substance, of the groups of substances or of the preparation  // Conditions of restriction  //   //   // 1. - Polychlorinated biphenyls (PCB) except mono- and dichlorinated biphenyls - Polychlorinated terphenyls (PCTs) - Preparations, including waste oils, with a PCB or PCT content higher than 0,01 % by weight.  // May not be used. However, the following categories may be used under the following conditions: 1. until 30 June 1986 at the latest: closed-system electrical equipment transformers, resistors and inductors; 2. until 30 June 1986 at the latest: large condensers ( 1 kg total weight); 3. until 30 June 1986 at the latest: small condensers (provided that the PCB has a maximum chlorine content of 43 % and does not contain more than 3,5 % of penta- and higher chlorinated biphenyls);  //   // 4. until 30 June 1986 at the latest: heat-transmitting fluids in closed-circuit heat-transfer installations:  //   // 5. until 30 June 1986 at the latest: hydraulic fluids for underground mining equipment;  //   // - The use of equipment, plant and fluids referred to in points 1 to 5 above which are in service on 30 June 1986 shall continue to be authorized until they are disposed of or reach the end of their service life.  //   // - Member States may, for reasons of protection of health and the environment, prohibit within their territory the use of such equipment, plant and fluids before they are disposed of or reach the end of their service life.  //   // - The placing on the second-hand market of such equipment, plant and fluids which are not intended for disposal shall be prohibited from 30 June 1986 onwards.  //   // - Where the Member States consider that it is not possible for technical reasons to use substitute products, they may continue to authorize the use of PCBs, PCTs and preparations thereof where the latter are solely intended, in the normal conditions of maintenance of equipment, to supplement the level of liquids containing PCBs in properly functioning existing plant purchased before the entry into force of this Directive.  //   // 6. until 30 June 1986 at the latest: primary and intermediate products for further processing into other products not prohibited by Directive 76/769/EEC and the Directives amending it; after 30 June 1986 Member States may, provided prior notification stating the reasons is sent to the Commission, grant derogations from the ban on the marketing and use of such primary and intermediate products, in so far as they consider that these derogations have no deleterious effects on health and the environment.  //  //


title: Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Recast) (Text with EEA relevance)

text:
               6.6.2009

               EN

               Official Journal of the European Union

               L 141/3

      DIRECTIVE 2009/32/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 23 April 2009
   on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients
   (Recast)
   (Text with EEA relevance)
   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 Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity.

               (2)

               Differences between national laws relating to extraction solvents hinder the free movement of foodstuffs and may create conditions of unequal competition, thereby directly affecting the functioning of the internal market.

               (3)

               The approximation of those laws is therefore necessary if the free movement of foodstuffs is to be achieved.

               (4)

               Laws relating to extraction solvents for use in foodstuffs should take account primarily of human health requirements but also, within the limits required for the protection of health, of economic and technical needs.

               (5)

               Such approximation should involve the establishment of a single list of extraction solvents for the preparation of foodstuffs or food ingredients. General purity criteria should also be specified.

               (6)

               The use of an extraction solvent under conditions of good manufacturing practice should result in the removal of all or the major part of the solvent residues from the foodstuff or food ingredient.

               (7)

               Under such conditions, the presence of residues or derivatives in the final foodstuff or food ingredient may be unintentional but technically unavoidable.

               (8)

               Although in general a specific limitation is useful, it need not be laid down for substances listed in Part I of Annex I which have been found acceptable from the point of view of safety to the consumer when used under conditions of good manufacturing practice.

               (9)

               To take account of protection of public health, the conditions of use of other extraction solvents listed in Parts II and III of Annex I and maximum residue values permitted in food and food ingredients should be established.

               (10)

               Specific purity criteria for extraction solvents and methods of analysis and sampling of extraction solvents in and on foodstuffs should be established.

               (11)

               Should the use of an extraction solvent provided for in this Directive appear to constitute a health risk as a result of new information, Member States should be able to suspend or limit such use, or to reduce existing limits, pending a decision at Community level.

               (12)

               The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5).

               (13)

               In particular, the Commission should be empowered to amend the list of extraction solvents which may be used during the processing of the raw materials, of foodstuffs, of food components or of food ingredients, and the specification of their conditions of use and maximum residue limits, and to adopt specific purity criteria for extraction solvents and the methods of analysis necessary to verify compliance with the general and specific purity criteria as well as methods of analysis and sampling of extraction solvents in and on foodstuffs. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (14)

               On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of amendments of the list of extraction solvents which may be used during the processing of the raw materials, of foodstuffs, of food components or of food ingredients, and the specification of their conditions of use and maximum residue limits, and for the adoption of specific purity criteria for extraction solvents.

               (15)

               When, on imperative grounds of urgency, in particular where a risk to human health exists, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments of the list of extraction solvents which may be used during the processing of the raw materials, of foodstuffs, of food components or of food ingredients, and the specification of their conditions of use and maximum residue limits, and for the adoption of specific purity criteria for extraction solvents, as well as for the adoption of amendments to this Directive when it is established that the use in foodstuffs of any substance listed in Annex I or the level of one or more of the components referred to in Article 3 contained in such substances might endanger human health although it complies with the conditions laid down in this Directive.

               (16)

               The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.

               (17)

               This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   1.   This Directive applies to extraction solvents used or intended for use in the production of foodstuffs or food ingredients.
   This Directive shall not apply to extraction solvents used in the production of food additives, vitamins and other nutritional additives, unless such food additives, vitamins or nutritional additives are listed in Annex I.
   However, the Member States shall ensure that the use of food additives, vitamins and other nutritional additives does not result in foodstuffs containing extraction solvent residue levels dangerous to human health.
   This Directive shall apply without prejudice to the provisions adopted under more specific Community rules.
   2.   For the purposes of this Directive:

               (a)

               ‘solvent’ means any substance for dissolving a foodstuff or any component thereof, including any contaminant present in or on that foodstuff;

               (b)

               ‘extraction solvent’ means a solvent which is used in an extraction procedure during the processing of raw materials, of foodstuffs, or of components or ingredients of these products and which is removed but which may result in the unintentional, but technically unavoidable, presence of residues or derivatives in the foodstuff or food ingredient.

         Article 2
   1.   Member States shall authorise the use as extraction solvents in the manufacture of foodstuffs or food ingredients of those substances and materials listed in Annex I, under the conditions of use and where appropriate within the maximum residue limits specified in that Annex.
   Member States may not prohibit, restrict or obstruct the marketing of foodstuffs or food ingredients on grounds relating to the extraction solvents used or their residues if these comply with the provisions of this Directive.
   2.   Member States shall not authorise the use of other substances and materials as extraction solvents, nor extend the conditions of use or permitted residues of the extraction solvents listed in Annex I beyond those specified therein.
   3.   Water to which substances regulating acidity or alkalinity may have been added and other food substances which possess solvent properties are authorised as extraction solvents in the manufacture of foodstuffs or food ingredients.
   Article 3
   Member States shall take all necessary measures to ensure that the substances and materials listed as extraction solvents in Annex I comply with the following general and specific purity criteria:

               (a)

               they shall not contain a toxicologically dangerous amount of any element or substance;

               (b)

               subject to any exceptions deriving from the specific purity criteria adopted in accordance with point (d) of Article 4, they shall not contain more than 1 mg/kg of arsenic or more than 1 mg/kg of lead;

               (c)

               they shall satisfy the specific purity criteria adopted in accordance with point (d) of Article 4.

         Article 4
   The Commission shall adopt the following:

               (a)

               the necessary amendments to Annex I in the light of scientific and technical progress in the field of the use of solvents, their conditions of use and maximum residue limits;

               (b)

               the methods of analysis necessary to verify compliance with the general and specific purity criteria provided for in Article 3;

               (c)

               the procedure for taking samples and the methods for qualitative and quantitative analysis of the extraction solvents listed in Annex I and used in foodstuffs or food ingredients;

               (d)

               if necessary, the specific purity criteria for the extraction solvents listed in Annex I, and in particular maximum permitted limits of mercury and cadmium in the extraction solvents.

         The measures referred to in points (b) and (c) of the first subparagraph, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(2).
   The measures referred to in points (a) and (d) of the first subparagraph, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(3).
   Where necessary, the measures referred to in points (a) and (d) of the first subparagraph shall be adopted in accordance with the urgency procedure referred to in Article 6(4).
   Article 5
   1.   Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has detailed grounds for establishing that the use in foodstuffs of any substance listed in Annex I or the level of one or more of the components referred to in Article 3 contained in such substances might endanger human health although it complies with the conditions laid down in this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.
   2.   The Commission shall examine as soon as possible the evidence given by the Member State concerned and consult the Committee referred to in Article 6(1), and shall then deliver its opinion forthwith and take the appropriate measures, which may replace the measures referred to in paragraph 1 of this Article.
   3.   If the Commission considers that amendments to this Directive are necessary in order to resolve the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall adopt those amendments.
   Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 6(4).
   Any Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force in its territory.
   Article 6
   1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (6).
   2.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   3.   Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   The periods laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively.
   4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   Article 7
   1.   Member States shall take all necessary measures to ensure that the substances listed in Annex I and intended for use as extraction solvents in foodstuffs may not be marketed unless their packaging, containers or labels carry the following particulars in such a way as to be easily visible, clearly legible and indelible:

               (a)

               the commercial name as indicated in Annex I;

               (b)

               a clear indication that the material is of a quality suitable for use for the extraction of food or food ingredients;

               (c)

               a reference by which the batch or lot may be identified;

               (d)

               the name or business name and address of the manufacturer or packer or of a seller established within the Community;

               (e)

               the net quantity given as units of volume;

               (f)

               if necessary, the special storage conditions or conditions of use.

         2.   By way of derogation from paragraph 1, the particulars specified in points (c), (d), (e) and (f) of that paragraph may appear only on the trade documents relating to the batch or lot which are to be supplied with or prior to the delivery.
   3.   This Article shall be without prejudice to more precise or more extensive Community provisions regarding weights and measures or provisions applying to the classification, packaging and labelling of dangerous substances and mixtures.
   4.   Member States shall refrain from laying down requirements more detailed than those already contained in this Article concerning the manner in which the particulars provided are to be shown.
   Each Member State shall, however, ensure that the sale of extraction solvents within its territory is prohibited if the particulars provided for in this Article do not appear in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such particulars from being indicated in various languages.
   Article 8
   1.   This Directive shall also apply to extraction solvents used or intended for use in the production of foodstuffs or food ingredients imported into the Community.
   2.   This Directive shall not apply to extraction solvents or foodstuffs intended for export outside the Community.
   Article 9
   Directive 88/344/EEC, as amended by the acts listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
   Article 10
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 11
   This Directive is addressed to the Member States.

      Done at Strasbourg, 23 April 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         P. NEČAS

      (1)  OJ C 224, 30.8.2008, p. 87.

      (2)  Opinion of the European Parliament of 23 September 2008 (not yet published in the Official Journal) and Council Decision of 23 March 2009.

      (3)  OJ L 157, 24.6.1988, p. 28.

      (4)  See Annex II, Part A.

      (5)  OJ L 184, 17.7.1999, p. 23.

      (6)  OJ L 31, 1.2.2002, p. 1.

      ANNEX I

         EXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF FOOD INGREDIENTS

      PART I

         Extraction solvents to be used in compliance with good manufacturing practice for all uses
          (1)

      Name:

                  Propane

                  Butane

                  Ethyl acetate

                  Ethanol

                  Carbon dioxide

                  Acetone (2)

                  Nitrous oxide

            PART II

         Extraction solvents for which conditions of use are specified

                  Name

                  Conditions of use
                  (summary description of extraction)

                  Maximum residue limits in the extracted foodstuff or food ingredient

                  Hexane (3)

                  Production or fractionation of fats and oils and production of cocoa butter

                  1 mg/kg in the fat or oil or cocoa butter

                  Preparation of defatted protein products and defatted flours

                  10 mg/kg in the food containing the defatted protein products and the defatted flours

                  30 mg/kg in the defatted soya products as sold to the final consumer

                  Preparation of defatted cereal germs

                  5 mg/kg in the defatted cereal germs

                  Methyl acetate

                  Decaffeination of, or removal of irritants and bitterings from coffee and tea

                  20 mg/kg in the coffee or tea

                  Production of sugar from molasses

                  1 mg/kg in the sugar

                  Ethylmethylketone (4)

                  Fractionation of fats and oils

                  5 mg/kg in the fat or oil

                  Decaffeination of, or removal of irritants and bitterings from coffee and tea

                  20 mg/kg in the coffee or tea

                  Dichloromethane

                  Decaffeination of, or removal of irritants and bitterings from coffee and tea

                  2 mg/kg in the roasted coffee and 5 mg/kg in the tea

                  Methanol

                  For all uses

                  10 mg/kg

                  Propan-2-ol

                  For all uses

                  10 mg/kg

            PART III

         Extraction solvents for which conditions of use are specified

                  Name

                  Maximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of flavourings from natural flavouring materials

                  Diethyl ether

                  2 mg/kg

                  Hexane (5)

                  1 mg/kg

                  Cyclohexane

                  1 mg/kg

                  Methyl acetate

                  1 mg/kg

                  Butan-1-ol

                  1 mg/kg

                  Butan-2-ol

                  1 mg/kg

                  Ethylmethylketone (5)

                  1 mg/kg

                  Dichloromethane

                  0,02 mg/kg

                  Propan-1-ol

                  1 mg/kg

                  1,1,1,2-tetrafluoroethane

                  0,02 mg/kg

         (1)  An extraction solvent is considered as being used in compliance with good manufacturing practice if its use results only in the presence of residues or derivatives in technically unavoidable quantities presenting no danger to human health.

         (2)  The use of Acetone in the refining of olive-pomace oil is forbidden.

         (3)  Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C. The combined use of Hexane and Ethylmethylketone is forbidden.

         (4)  The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden.

         (5)  The combined use of Hexane and Ethylmethylketone is forbidden.

      ANNEX II
      PART A

         Repealed Directive with list of its successive amendments

         (referred to in Article 9)

                  Council Directive 88/344/EEC
                  (OJ L 157, 24.6.1988, p. 28)

                  Council Directive 92/115/EEC
                  (OJ L 409, 31.12.1992, p. 31)

                  Directive 94/52/EC of the European Parliament and of the Council
                  (OJ L 331, 21.12.1994, p. 10)

                  Directive 97/60/EC of the European Parliament and of the Council
                  (OJ L 331, 3.12.1997, p. 7)

                  Regulation (EC) No 1882/2003 of the European Parliament and of the Council
                  (OJ L 284, 31.10.2003, p. 1)

                  Point 9 of Annex III only

            PART B

         Time-limits for transposition into national law

         (referred to in Article 9)

                  Directive

                  Time-limit for transposition

                  88/344/EEC

                  13 June 1991

                  92/115/EEC

                              a.

                           1 July 1993

                              b.

                           1 January 1994 (1)

                  94/52/EC

                  7 December 1995

                  97/60/EC

                              a.

                           27 October 1998

                              b.

                           27 April 1999 (2)

         (1)  In accordance with Article 2(1) of Directive 92/115/EEC:
      ‘Member States shall amend their laws, regulations and administrative provisions in such a way as to:

                  —

                  permit trade in products complying with this Directive at the latest by 1 July 1993,

                  —

                  prohibit trade in products not complying with this Directive with effect from 1 January 1994.’

         (2)  In accordance with Article 2(1) of Directive 97/60/EC:
      ‘Member States shall amend their laws, regulations and administrative provisions so as to:

                  —

                  authorise trade in products complying with Directive 88/344/EEC, as amended by this Directive by 27 October 1998 at the latest;

                  —

                  ban trade in products not complying with Directive 88/344/EEC, as amended by this Directive, as from 27 April 1999. However, products placed on the market or labelled before that date and not complying with Directive 88/344/EEC, as amended by this Directive, may be marketed until stocks are used up.’

      ANNEX III

         Correlation Table

                  Directive 88/344/EEC

                  This Directive

                  Article 1(1)

                  Article 1(1)

                  Article 1(3)

                  Article 1(2)

                  Article 2(1)

                  Article 2(1)

                  Article 2(2)

                  Article 2(2)

                  Article 2(3)

                  —

                  Article 2(4)

                  Article 2(3)

                  Article 3

                  Article 3

                  Article 4

                  Article 4

                  Article 5

                  Article 5

                  Article 6(1)

                  Article 6(1)

                  Article 6(2)

                  —

                  Article 6(3)

                  —

                  —

                  Article 6(2)

                  —

                  Article 6(3)

                  —

                  Article 6(4)

                  Article 7

                  Article 7

                  Article 8

                  Article 8

                  Article 9

                  —

                  —

                  Article 9

                  —

                  Article 10

                  Article 10

                  Article 11

                  Annex

                  Annex I

                  —

                  Annex II

                  —

                  Annex III


title: Council Directive 2010/88/EU of 7 December 2010 amending Directive 2006/112/EC on the common system of value added tax, with regard to the duration of the obligation to respect a minimum standard rate

text:
               10.12.2010

               EN

               Official Journal of the European Union

               L 326/1

         COUNCIL DIRECTIVE 2010/88/EU
   of 7 December 2010
   amending Directive 2006/112/EC on the common system of value added tax, with regard to the duration of the obligation to respect a minimum standard rate
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 113 thereof,
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national Parliaments,
   Having regard to the opinion of the European Parliament,
   Having regard to the opinion of the European Economic and Social Committee,
   Acting in accordance with a special legislative procedure,
   Whereas:

               (1)

               Article 97(1) of Council Directive 2006/112/EC (1) provides that from 1 January 2006 until 31 December 2010, the standard rate may not be less than 15 %.

               (2)

               The standard rate of value added tax (VAT) currently in force in various Member States, combined with the mechanism of the transitional system has ensured that this system has functioned to an acceptable degree. With new rules on the place of supply of services which favour taxation at the place of consumption, the possibilities for exploiting differences in VAT rates through relocation have been limited further and potential distortions of competition reduced.

               (3)

               To prevent a growing divergence in the standard rates of VAT applied by the Member States from leading to structural imbalances in the European Union and distortions of competition in some sectors of activity, it is common practice in the field of indirect taxes to set minimum rates. It is still necessary to do so for VAT.

               (4)

               Pending the outcome of consultations on a new VAT strategy which is expected to address future arrangements and corresponding levels of harmonisation, it would be premature to set a permanent standard rate level or to consider changing the minimum rate level.

               (5)

               It is therefore appropriate to maintain the current minimum standard rate at 15 % for a further period long enough to ensure legal certainty, while allowing further review.

               (6)

               This does not preclude a further revision of VAT legislation before 31 December 2015 to address the outcome of the new VAT strategy.

               (7)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (2), Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public.

               (8)

               Directive 2006/112/EC should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Article 97 of Directive 2006/112/EC is replaced by the following:

      ‘Article 97
      From 1 January 2011 until 31 December 2015, the standard rate may not be lower than 15 %.’.

   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 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, 7 December 2010.

            For the Council

            The President

         D. REYNDERS

      (1)  OJ L 347, 11.12.2006, p. 1.

      (2)  OJ C 321, 31.12.2003, p. 1.


Avis juridique important

|

32003L0016

Commission Directive 2003/16/EC of 19 February 2003 adapting to technical progress Annex III to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 046 , 20/02/2003 P. 0024 - 0024

Commission Directive 2003/16/ECof 19 February 2003adapting to technical progress Annex III to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic productsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), as last amended by Commission Directive 2003/1/EC(2), and in particular Article 8(2) thereof,After consulting the Scientific Committee on Cosmetic Products and Non-food Products Intended for Consumers (SCCNFP),Whereas:(1) The Scientific Committee for Cosmetic Products and Non-food Products Intended for Consumers (SCCNFP) recommends that musk xylene can be safely used in cosmetic products, excluding oral care products, up to a maximum daily theoretically absorbed dose of about 10μg/kg/day.(2) The SCCNFP recommends that musk ketone can be safely used in cosmetic products, excluding oral care products, up to a maximum daily theoretically absorbed dose of about 14μg/kg/day.(3) Pending completion of the risk assessment of these two substances in accordance with Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(3), these two substances have been provisionally included, until 28 February 2003, in Part 2 of Annex III to Directive 76/768/EEC.(4) The risk assessment has not yet been completed in accordance with the abovementioned Regulation. Therefore, the period of inclusion of musk xylene and musk ketone in Part 2 of Annex III to Directive 76/768/EEC should be extended.(5) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of Directives on the removal of technical barriers to trade in the cosmetic products sector,HAS DECIDED AS FOLLOWS:Article 1The date "28.2.2003" is replaced by "30.9.2004" for reference numbers 61 and 62 in Part 2, column g, of Annex III to Directive 76/768/EEC.Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2003 at the latest. They shall forthwith inform the Commission thereof.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 3This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 19 February 2003.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 262, 27.9.1976, p. 169.(2) OJ L 5, 10.1.2003, p. 14.(3) OJ L 84, 5.4.1993, p. 1.


title: Commission Directive 2005/42/EC of 20 June 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II, IV and VI thereto to technical progress   (Text with EEA relevance)

text:
               21.6.2005

               EN

               Official Journal of the European Union

               L 158/17

      COMMISSION DIRECTIVE 2005/42/EC
   of 20 June 2005
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II, IV and VI 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)

               On the basis of the assessment of the cutaneous toxicities of costus root oil (Saussurea lappa Clarke), 7-Ethoxy-4-methylcoumarin, hexahydrocoumarin and peru balsam (Myroxylon pereirae), the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) is of the opinion that those substances should not be used as fragrance ingredients in cosmetic products. They should therefore be included in Annex II to Directive 76/768/EEC.

               (2)

               Azo-dyes CI 12150, CI 20170 and CI 27290 are included in Part 1 of Annex IV to Directive 76/768/EEC as colouring agents which are allowed for use in cosmetic products. The safety of those colorants has been questioned on the ground that they may form carcinogenic amines during metabolism. The SCCNFP is of the opinion, based on the available information, that the use of the colorants CI 12150, CI 20170 and CI 27290 poses a risk to the health of the consumer as they may release one or more carcinogenic aromatic amines. Those colorants should therefore be excluded from Part 1 of Annex IV to Directive 76/768/EEC.

               (3)

               Benzethonium chloride is included as reference number 53 in Part 1 of Annex VI to Directive 76/768/EEC as a preservative which may be employed in rinse-off cosmetic products up to a concentration of 0,1 %. It is the opinion of the SCCNFP that Benzethonium chloride should also be allowed to be employed in leave-on cosmetic products other than for oral care use up to a concentration of 0,1 %. The entry under the reference number 53 in Part 1 of Annex VI to Directive 76/768/EEC should therefore be amended accordingly.

               (4)

               The SCCNFP is of the opinion that Methylisothiazolinone does not pose a risk to the health of consumers if employed in finished cosmetic products as a preservative up to a concentration of 0,01 %. Methylisothiazolinone should therefore be included in Part 1 of Annex VI to Directive 76/768/EEC as reference number 57.

               (5)

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

               (6)

               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, IV and VI to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall take the necessary measures to ensure that from 31 March 2006 cosmetic products which fail to comply with Annexes II and IV of Directive 76/768/EEC as amended by this Directive are not 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 31 December 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table 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 twentieth 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, 20 June 2005.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/9/EC (OJ L 27, 29.1.2005, p. 46).

      ANNEX
      The Annexes to Directive 76/768/EEC are amended as follows:

                  1.

                  in Annex II, the following reference numbers are added:

                              ‘1133.

                              Costus root oil (Saussurea lappa Clarke) (CAS No 8023-88-9), when used as a fragrance ingredient

                              1134.

                              7-Ethoxy-4-methylcoumarin (CAS No 87-05-8), when used as a fragrance ingredient

                              1135.

                              Hexahydrocoumarin (CAS No 700-82-3), when used as a fragrance ingredient

                              1136.

                              Peru balsam (INCI name: Myroxylon pereirae; CAS No 8007-00-9), when used as a fragrance ingredient’

                  2.

                  in Part 1 of Annex IV, colouring agents CI 12150, CI 20170 and CI 27290 are deleted.

                  3.

                  Part 1 of Annex VI is amended as follows:

                              (a)

                              the reference number 53 is replaced by the following:

                                          Reference number

                                          Substance

                                          Maximum authorised concentration

                                          Limitations and requirements

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

                                          a

                                          b

                                          c

                                          d

                                          e

                                          ‘53

                                          Benzethonium Chloride (INCI)

                                          0,1 %

                                                      (a)

                                                      Rinse-off products,

                                                      (b)

                                                      Leave-on products other than for oral care use’

                              (b)

                              the following entry is added as reference number 57:

                                          Reference number

                                          Substance

                                          Maximum authorised concentration

                                          Limitations and requirements

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

                                          a

                                          b

                                          c

                                          d

                                          e

                                          ‘57

                                          Methylisothiazolinone (INCI)

                                          0,01 %’


title: Commission Directive 2007/68/EC of 27 November 2007 amending Annex IIIa to Directive 2000/13/EC of the European Parliament and of the Council as regards certain food ingredients (Text with EEA relevance)

text:
               28.11.2007

               EN

               Official Journal of the European Union

               L 310/11

      COMMISSION DIRECTIVE 2007/68/EC
   of 27 November 2007
   amending Annex IIIa to Directive 2000/13/EC of the European Parliament and of the Council as regards certain food ingredients
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1), and in particular third subparagraph of Article 6(11) and Article 21 thereof,
   Whereas:

               (1)

               Annex IIIa to Directive 2000/13/EC establishes a list of food ingredients which must be indicated on the label of foodstuffs as they are likely to cause adverse reactions in susceptible individuals.

               (2)

               Directive 2000/13/EC provides for the possibility of excluding from the labelling requirement ingredients or substances derived from ingredients listed in Annex IIIa for which it has been scientifically established that they are not likely, under specific circumstances, to trigger adverse reactions.

               (3)

               Commission Directive 2005/26/EC (2) establishes the list of food ingredients or substances provisionally excluded from the labelling requirement until the 25 November 2007.

               (4)

               A number of applications for permanent exemption from the labelling requirement have been submitted to the European Food Safety Authority (EFSA). Those applications concern substances for which provisional exemptions were granted by Directive 2005/26/EC. On the basis of the EFSA opinions and other available information, it can be concluded that certain ingredients or substances derived from those ingredients listed in Annex IIIa to Directive 2000/13/EC are not likely, under specific circumstances, to cause adverse reactions in susceptible individuals.

               (5)

               Those ingredients or substances derived from those ingredients should therefore be permanently excluded from Annex IIIa to Directive 2000/13/EC.

               (6)

               Annex IIIa of Directive 2000/13/EC should be amended accordingly.

               (7)

               Directive 2005/26/EC should be repealed on 26 November 2007 in view of the deadline set by Article 6(11), second subparagraph of Directive 2000/13/EC.

               (8)

               In order to avoid disruption of the market, it is necessary for this Directive to apply from the 26 November 2007.

               (9)

               It was expected that this Directive could be adopted and published well in advance of the date of 26 November 2007 in order to give time to the industry to adapt to the new rules. Since this has not been possible in practice, temporary measures appear therefore necessary to facilitate the application of the new rules. Indeed changes in labelling rules will affect industry, mainly small and medium enterprises, which need an adaptation period to smooth the transition towards new labelling requirements.

               (10)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IIIa to Directive 2000/13/EC is replaced by the text in the Annex to this Directive as from 26 November 2007.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 May 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table 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 3
   Directive 2005/26/EC shall be repealed on 26 November 2007.
   Member States shall allow foodstuffs placed on the market or labelled before 31 May 2009 that comply with the provisions of Directive 2005/26/EC to be marketed until stocks are exhausted.
   Article 4
   This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 27 November 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 109, 6.5.2000, p. 29. Directive as last amended by Commission Directive 2006/142/EC (OJ L 368, 23.12.2006, p. 110).

      (2)  OJ L 75, 22.3.2005, p. 33. Directive as amended by Directive 2005/63/EC (OJ L 258, 4.10.2005, p. 3).

      ANNEX

            ‘ANNEX IIIa
            Ingredients referred to in Article 6(3a), (10) and (11)

                        1.

                        Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof, except:

                                    (a)

                                    wheat-based glucose syrups including dextrose (1);

                                    (b)

                                    wheat-based maltodextrins (1);

                                    (c)

                                    glucose syrups based on barley;

                                    (d)

                                    cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.

                        2.

                        Crustaceans and products thereof.

                        3.

                        Eggs and products thereof.

                        4.

                        Fish and products thereof, except:

                                    (a)

                                    fish gelatine used as carrier for vitamin or carotenoid preparations;

                                    (b)

                                    fish gelatine or Isinglass used as fining agent in beer and wine.

                        5.

                        Peanuts and products thereof.

                        6.

                        Soybeans and products thereof, except:

                                    (a)

                                    fully refined soybean oil and fat (1);

                                    (b)

                                    natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources;

                                    (c)

                                    vegetable oils derived phytosterols and phytosterol esters from soybean sources;

                                    (d)

                                    plant stanol ester produced from vegetable oil sterols from soybean sources.

                        7.

                        Milk and products thereof (including lactose), except:

                                    (a)

                                    whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;

                                    (b)

                                    lactitol.

                        8.

                        Nuts, i.e. almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoiesis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia nuts and Queensland nuts (Macadamia ternifolia), and products thereof, except:

                                    (a)

                                    nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.

                        9.

                        Celery and products thereof.

                        10.

                        Mustard and products thereof.

                        11.

                        Sesame seeds and products thereof.

                        12.

                        Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.

                        13.

                        Lupin and products thereof.

                        14.

                        Molluscs and products thereof.’

         (1)  And products thereof, insofar as the process that they have undergone is not likely to increase the level of allergenicity assessed by the EFSA for the relevant product from which they originated.