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

Summary: Safe food processing: common standards for extraction solvents Safe food processing: common standards for extraction solvents SUMMARY OF: 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) (OJ L 141, 6.6.2009, pp. 3-11). Link to consolidated version. SUMMARY Solvent extraction is a way of separating a substance from one or more others by applying a solvent*. It is used in the food industry and must be regulated to ensure human health is protected and the products that result from the technique can be sold freely across the European Union. WHAT DOES THE DIRECTIVE DO? It replaces earlier legislation and establishes a single list of the extraction solvents* which can be used in the processing of food, food ingredients and raw materials according to good manufacturing practice. KEY POINTS Permitted extraction solvents are: — propane, — butane, — ethyl acetate, — ethanol, — carbon dioxide, — acetone and — nitrous oxide. EU countries may not prohibit, restrict or obstruct the sale of food or ingredients if these solvents have been used in compliance with the legislation. EU countries may not authorise the use of other substances or materials as extraction solvents. National authorities may temporarily suspend or restrict the use of a permitted extraction solvent if it has detailed grounds to suspect that its use in food could endanger human health. They must immediately inform other EU countries and the European Commission, which will investigate the evidence supplied for their decision. Substances used as extraction solvents must provide certain visible, legible and indelible details on their packaging, containers or labels. These include: — commercial name; — clear indication of suitability to extract food or food ingredients; and — any special storage conditions. WHEN DOES THE DIRECTIVE APPLY? From 26 June 2009. KEY TERMS * Solvent: any substance that dissolves a foodstuff. * Extraction solvent: a substance used during processing of food and which is then removed. It may leave unintentional, but technically unavoidable, residues or derivatives in the food. last update 26.10.2015


30.4.2009 EN Official Journal of the European Union L 109/10 DIRECTIVE 2009/35/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2009 on the colouring matters which may be added to medicinal products (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 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products (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) The primary purpose of any laws concerning medicinal products must be to safeguard public health. However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community. (3) Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (5) established a single list of colouring matters authorised for use in foodstuffs, but disparities between the laws of Member States concerning the colouring of medicinal products still exist. (4) Those disparities tend to hinder trade in medicinal products within the Community and trade in colouring matters which may be added to those products. Such disparities therefore directly affect the functioning of the internal market. (5) Experience has shown that there is no reason, on health grounds, why the colouring matters authorised for use in foodstuffs should not also be authorised for use in medicinal products. Consequently, Annex I to Directive 94/36/EC as well as the Annex to Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (6) should also apply for medicinal products. (6) However, when the use of a colouring matter in foodstuffs and medicinal products is prohibited in order to safeguard public health, technological and economic disturbances should be avoided as far as is possible. To this end a procedure should be provided for which establishes close cooperation between the Member States and the Commission within a committee for the adjustment to technical progress of the Directives on the elimination of technical barriers to trade in the sector of colouring matters which may be added to medicinal products. (7) 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 (7). (8) In particular, the Commission should be empowered to amend the limited period of use of medicinal products. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, 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. (9) The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States. (10) 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 I, Part B, HAVE ADOPTED THIS DIRECTIVE: Article 1 Member States shall not authorise, for the colouring of medicinal products for human and veterinary use as defined in Article 1 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (8) and in Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (9), any colouring matters other than those covered by Annex I to Directive 94/36/EC. Article 2 Member States shall take all measures necessary to ensure that the colouring matters covered by Annex I to Directive 94/36/EC satisfy the general specifications for aluminium lakes of colours and the specific criteria of purity laid down in the Annex to Directive 95/45/EC. Article 3 The methods of analysis needed to verify that the general and specific criteria of purity adopted pursuant to the First Commission Directive 81/712/EEC of 28 July 1981 laying down Community methods of analysis for verifying that certain additives used in foodstuffs satisfy criteria of purity (10) are satisfied shall also apply for the purpose of this Directive. Article 4 Where a colouring matter is deleted from Annex I to Directive 94/36/EC but the marketing of foodstuffs containing this colouring matter is permitted to continue for a limited period, this provision shall also apply to medicinal products. This limited period of use may however be amended by the Commission as regards medicinal products. Those measures designed to amend non-essential elements of this Directive, by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 5(2). Article 5 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 6 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 7 Directive 78/25/EEC, as amended by the acts listed in Annex I, 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 I, 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 II. Article 8 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 9 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 162, 25.6.2008, p. 41. (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 11, 14.1.1978, p. 18. (4) See Annex I, Part A. (5) OJ L 237, 10.9.1994, p. 13. Directive repealed prospectively by Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16.). (6) OJ L 226, 22.9.1995, p. 1. Directive repealed prospectively by Regulation (EC) No 1333/2008. (7) OJ L 184, 17.7.1999, p. 23. (8) OJ L 311, 28.11.2001, p. 1. (9) OJ L 311, 28.11.2001, p. 67. (10) OJ L 257, 10.9.1981, p. 1. Directive repealed prospectively by Regulation (EC) No 1333/2008. ANNEX I PART A Repealed Directive with list of its successive amendments (referred to in Article 7) Council Directive 78/25/EEC (OJ L 11, 14.1.1978, p. 18) 1979 Act of Accession, Annex I, Section X, point D (OJ L 291, 19.11.1979, p. 108) Council Directive 81/464/EEC (OJ L 183, 4.7.1981, p. 33) 1985 Act of Accession, Annex I, Section IX, point C (OJ L 302, 15.11.1985, p. 217) Council Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36) Annex III, point 25 only PART B List of time-limits for transposition into national law (referred to in Article 7) Directive Time-limit for transposition 78/25/EEC 15 June 1979 (1) 81/464/EEC 30 September 1981 (1) Pursuant to Article 7(2) of Directive 78/25/EEC: ‘2. However, any Member State may permit, on its own territory, until the end of a period of four years from the notification of this Directive, the marketing of medicinal products containing colouring matters which do not comply with the requirements of this Directive so long as these colouring matters were authorised in that Member State before the adoption of the Directive.’ ANNEX II Correlation table Directive 78/25/EEC This Directive Article 1, first paragraph Article 1 Article 1, second paragraph — Articles 2 and 3 Articles 2 and 3 Article 4, first sentence Article 4, first paragraph Article 4, second sentence, first part Article 4, second paragraph Article 4, second sentence, second part Article 4, third paragraph Articles 5(1) and 6(1) and (2) Article 5 Article 6(3) — Article 7(1), (2) and (3) — Article 7(4) Article 6 — Article 7 — Article 8 Article 8 Article 9 — Annex I — Annex II

Summary: Colouring matters for medicinal products (recast) Colouring matters for medicinal products (recast) In the light of the many disparities between Member States’ legislation on colouring matters for medicinal products, the European Commission considered it necessary to recast Directive 78/25/EC. It is important not to hamper the development of the pharmaceutical industry or trade in medicinal products within the Community. ACT Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance). SUMMARY This Directive gives specifications on colouring matters for medicinal products. Only the colouring matters listed in Annex I to Directive 94/36/EC may be used to colour medicinal products for human and veterinary use. The colouring matters referred to in Annex I must meet the general specifications for aluminium lakes of colours and the specific criteria of purity laid down in Annex I to Directive 95/45/EC. The methods of analysis needed to verify these criteria are framed by Directive 81/712/EC. When a colouring matter is deleted from Annex I to Directive 94/36/EC, but the marketing of foodstuffs containing this colouring matter is permitted to continue for a limited period, this additional period of use also extends to medicinal products. However, the Commission may amend the duration of this additional period. The Commission shall be assisted by a committee for the adjustment to technical progress of the Directives composed of representatives from Member States and chaired by a Commission representative. This Directive repeals Directive 78/25/EC. References Act Entry into force Deadline for transposition in the Member States Official Journal Directive 2009/35/EC 20.5.2009 - OJ L109 of 30.4.2009 Last updated: 12.10.2009


28.4.2009 EN Official Journal of the European Union L 106/7 DIRECTIVE 2009/34/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (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 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological control (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) In each Member State, mandatory provisions determine the technical characteristics of measuring instruments and the methods of metrological control. Those requirements differ from one Member State to another. Those differences hinder trade and may create unequal conditions of competition within the Community. (3) One of the objectives of controls in each Member State is to give assurance to customers that quantities delivered correspond to the price paid. Consequently, the aim of this Directive should not be to abolish those controls but to eliminate differences between rules in so far as these constitute a hindrance to trade. (4) Those hindrances to the functioning of the internal market can be reduced and eliminated if the same requirements apply in Member States, initially complementing national provisions in force and later, when the necessary conditions exist, replacing those provisions. (5) Even during the period when they coexist with national provisions, the Community requirements will enable firms to manufacture products which have uniform technical characteristics and can therefore be marketed and used throughout the Community after they have undergone EC controls. (6) Community technical requirements for design and functioning should ensure that instruments continuously give measurements that are sufficiently accurate for their intended purpose. (7) Compliance with technical requirements is usually confirmed by Member States before measuring instruments are placed on the market or used for the first time, and where appropriate when they are in service, such confirmation being effected in particular by means of pattern approval and verification procedures. In order to achieve free movement of such instruments within the Community, it is also necessary to provide for mutual recognition of controls among Member States and to establish appropriate EC pattern approval and initial verification procedures for this purpose as well as EC methods of metrological control in accordance with this Directive and with the relevant separate Directives. (8) The presence, on a measuring instrument or a product, of signs or marks showing that it has undergone the appropriate controls indicates that such instrument or product satisfies the relevant technical requirements of the Community, and therefore that when the instrument or product is imported or put into operation it is unnecessary to repeat the controls which have already been carried out. (9) National metrological rules cover numerous categories of measuring instruments and products. This Directive lays down the general provisions dealing, in particular, with EC pattern approval and initial verification procedures, as well as EC methods of metrological control. Implementing Directives covering the various categories of instruments and products will lay down the technical requirements as to design, functioning and accuracy, the control procedures and, where appropriate, the conditions under which Community technical requirements are to replace the national provisions in force. (10) 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). (11) In particular, the Commission should be empowered to amend Annexes I and II to this Directive and the annexes to the separate Directives. Since those measures are of general scope and are designed to amend non-essential elements of this Directive and the separate Directives, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (12) The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States. (13) 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 III, Part B, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I BASIC PRINCIPLES Article 1 1. This Directive shall apply to: (a) instruments as defined in paragraph 2; (b) units of measurement, the harmonisation of methods of measurement and metrological control and, where appropriate, the means required for application of such methods; (c) the prescription, methods of measurement, metrological control and marking of quantities of pre-packaged products. 2. For the purpose of this Directive, ‘instruments’ shall mean measuring instruments, components of measuring instruments, additional devices and measurement equipment. 3. No Member State may, on the basis of this Directive and the separate Directives relating to it, prevent, prohibit, or restrict the placing on the market and/or entry into service of an instrument or of a product described in paragraph 1 if that instrument or product bears EC marks and/or signs in accordance with the conditions laid down in this Directive and in the separate Directives relating to the instrument or product in question. 4. Member States shall attach the same value to EC pattern approval and initial verification as to the corresponding national measures. 5. The separate Directives concerning the matters referred to in paragraph 1 shall specify: — in particular, the measurement procedures and characteristics of, and the technical requirements for, their design and functioning, as regards the instruments referred to in paragraph 1(a), — the requirements concerning points (b) and (c) of paragraph 1. 6. The separate Directives may fix the date on which the existing national provisions are to be replaced by Community provisions. CHAPTER II EC PATTERN APPROVAL Article 2 1. Member States shall grant EC pattern approval in accordance with the provisions of this Directive and of the relevant separate Directives. 2. EC pattern approval of instruments shall constitute their admission to EC initial verification and, where the latter is not required, the authorisation to place them on the market and/or to put them into service. If the separate Directive(s) applicable to a category of instruments exempt(s) that category from EC pattern approval, the instruments in that category shall be admitted directly to EC initial verification. 3. If their inspection equipment so permits, Member States shall grant EC pattern approval for every instrument which satisfies the requirements laid down in this Directive and the separate Directives relating to the instrument in question. 4. An application for EC pattern approval may be made only by the manufacturer or his representative established within the Community. For one and the same instrument, application may be made in one Member State only. 5. A Member State which has granted EC pattern approval shall take the necessary steps to ensure that it is kept informed of any modification of, or addition to, the approved pattern. It shall inform the other Member States of such alterations. Modifications of, or additions to, an approved pattern must receive additional EC pattern approval from the Member State which granted EC pattern approval, where such changes influence or might influence measurement results or the prescribed conditions for use of the instrument. However, in the case of a modified pattern, a new EC pattern approval shall be granted instead of an addition to the original EC pattern approval certificate if the pattern is modified after the provisions of this Directive or of the relevant separate Directive have been amended or adapted in such a way that the modified pattern could be approved only pursuant to the new provisions. Article 3 When EC pattern approval is granted for ancillary equipment, the approval shall specify: (a) the patterns of instrument to which this equipment may be attached or in which it may be incorporated; (b) the general conditions for the overall functioning of the instruments for which it is approved. Article 4 When an instrument has successfully completed the EC pattern approval examination laid down in this Directive and in the separate Directives relating to that instrument, the Member State which carried out that examination shall draw up an EC pattern approval certificate. That Member State shall forward that certificate to the applicant. In the cases provided for in Article 11 of this Directive or in a separate Directive, the applicant must, and in all other cases may, affix or cause to be affixed on each instrument conforming to the approved pattern the EC approval sign shown in the certificate. Article 5 1. EC pattern approval shall be valid for 10 years. It may be extended for successive periods of 10 years. The number of instruments which may be manufactured in accordance with the approved pattern shall not be limited. EC pattern approvals granted on the basis of the provisions of this Directive and of a separate Directive may not be extended after the date of the entry into force of any amendment to, or adaptation of, those Community provisions, in cases where such EC pattern approvals could not have been granted on the basis of the new provisions. When EC pattern approval is not extended, that approval shall nevertheless continue to apply to instruments already in service. 2. Where use is made of new techniques not provided for in a separate Directive, EC pattern approval with limited effect may be granted, after prior consultation of the other Member States. It may include the following restrictions: (a) a limit on the number of instruments which may be covered by the approval; (b) an obligation to notify the competent authorities of the places of installation; (c) restrictions on use; (d) special restrictions concerning the technique used. However, it may not be granted unless: (a) the separate Directive for that category of instruments has come into force; (b) no derogation has been made from the maximum permissible errors laid down in the separate Directives. The period of validity of such approval shall not exceed two years. It may be extended by up to three years. 3. The Member State which has granted the limited EC pattern approval referred to in paragraph 2 shall apply for adjustment to technical progress of Annexes I and II to this Directive, where appropriate, and of the separate Directives, in accordance with the procedure referred to in Article 17(2), as soon as it considers that a new technique has proved to be satisfactory. Article 6 When EC pattern approval is not required for a category of instruments which meets the requirements of a separate Directive, the manufacturer may, on his own responsibility, affix to the instruments in this category the special sign described in point 3.3 of Annex I. Article 7 1. The Member State which has granted EC pattern approval may withdraw it: (a) if instruments for which this approval was granted do not conform to the approved pattern or to the provisions of the relevant separate Directive; (b) if the metrological requirements specified in the certificate of approval or the provisions of Article 5(2) are not met; (c) if it ascertains that approval was granted in an improper manner. 2. The Member State which has granted EC pattern approval must withdraw it if the instruments constructed according to an approved pattern reveal in service a defect of a general nature which makes them unsuitable for their intended use. 3. If the Member State which granted an EC pattern approval is informed by another Member State of the occurrence of one of the cases covered by paragraphs 1 and 2, it shall also take the measures provided for in those paragraphs, after consulting with that other Member State. 4. The Member State which declares that the case referred to in paragraph 2 has arisen may forbid the placing on the market and putting into service of the instruments concerned until further notice. It shall immediately inform the other Member States and the Commission, stating the reasons on which its decision is based. The same procedure shall apply in the cases referred to in paragraph 1, with respect to instruments which have been exempted from EC initial verification, if the manufacturer, after due warning, does not bring the instruments into conformity with the approved pattern or with the requirements of the relevant separate Directive. 5. If the Member State which granted the EC pattern approval disputes that the case referred to in paragraph 2 of which it has been informed has arisen, or disputes that the measures taken pursuant to paragraph 4 are justified, the Member States concerned shall endeavour to settle the dispute. The Commission shall be kept informed. It shall, where necessary, hold appropriate consultations with the aim of reaching a settlement. CHAPTER III INITIAL VERIFICATION Article 8 1. EC initial verification constitutes the examination of a new or reconditioned instrument and the confirmation of its conformity to the approved pattern and/or to the requirements of this Directive and the separate Directives relating to the instrument in question. It is certified by the EC initial verification mark. 2. EC initial verification of instruments may be carried out by a method other than unit checking in the cases specified in the separate Directives and in accordance with the procedures adopted. 3. If their equipment so permits, Member States shall carry out EC initial verification of instruments submitted as having the measurement characteristics and satisfying the technical construction and functioning requirements laid down by the separate Directives relating to that category of instruments. 4. In the case of instruments bearing the EC initial verification mark, the obligation imposed on Member States under Article 1(3) shall last until the end of the year following that in which the EC initial verification mark was affixed, unless separate Directives provide for a longer period. Article 9 1. When an instrument is submitted for EC initial verification, the Member State carrying out the examination shall determine: (a) whether the instrument belongs to a category exempt from EC pattern approval and, if so, whether it satisfies the technical construction and functioning requirements laid down by the separate Directives relating to that instrument; (b) whether the instrument has received EC pattern approval and, if so, whether it conforms to the approved pattern, and to the separate Directives relating to that instrument, in force on the date of issue of that EC pattern approval. 2. The examination carried out in EC initial verification relates in particular, in accordance with the separate Directives, to: (a) the metrological characteristics; (b) the maximum permissible errors; (c) the construction, in so far as this guarantees that the measurement characteristics are not likely to deteriorate to any great extent under normal conditions of use; (d) the presence of prescribed inscriptions and stamp plates or provisions for EC initial verification marking. Article 10 When an instrument has successfully undergone EC initial verification, in accordance with the requirements of this Directive and of the separate Directives, the EC partial or final verification marks described in Annex II, point 3 shall be affixed to that instrument under the responsibility of the Member State concerned in accordance with the rules laid down in that point. Article 11 When EC initial verification is not required for a category of instruments which meet the requirements of a separate Directive, the manufacturer shall, on his own responsibility, affix to the instruments in that category the special symbol described in point 3.4 of Annex I. CHAPTER IV PROVISIONS COMMON TO EC PATTERN APPROVAL AND EC INITIAL VERIFICATION Article 12 Member States shall take all necessary measures to prevent the use on instruments of marks or inscriptions liable to be confused with the EC signs or marks. Article 13 Each Member State shall notify the other Member States and the Commission of the services, agencies and institutes which are duly authorised to carry out the examinations provided for in this Directive and in the separate Directives, to issue the EC pattern approval certificates and to affix the EC initial verification marks. Article 14 Member States may require that the prescribed inscriptions be drawn up in their official language or languages. CHAPTER V CONTROL OF INSTRUMENTS IN SERVICE Article 15 The separate Directives shall specify the control requirements for instruments in service which bear EC signs or marks and in particular the maximum errors permitted in service. If national provisions in respect of instruments which do not bear EC signs or marks lay down less stringent requirements, the latter may serve as criteria for the controls. CHAPTER VI ADJUSTMENT OF DIRECTIVES TO TECHNICAL PROGRESS Article 16 The amendments necessary for adjusting to technical progress Annexes I and II to this Directive and the annexes to the separate Directives referred to in Article 1 shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive and the separate Directives, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(2). However, this procedure shall apply neither to the chapter relating to imperial units of measurement of the annex to the Directive on units of measurement nor to the annexes, concerning quantity ranges for pre-packed quantities of products, to the Directives on pre-packed products. Article 17 1. The Commission shall be assisted by the Committee for Adjustment to Technical Progress of the Directives referred to in Article 16. 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. CHAPTER VII FINAL PROVISIONS Article 18 All decisions taken pursuant to the provisions adopted in implementation of this Directive and of the separate Directives on the instruments in question and refusing to grant or extend EC pattern approval, withdrawing such approval, refusing to carry out EC initial verification or prohibiting placing on the market or entry into service shall state the reasons on which they are based. Such refusal, withdrawal or prohibition shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies. Article 19 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 20 Directive 71/316/EEC, as amended by the acts listed in Annex III, 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 III, 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 IV. Article 21 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 22 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) Opinion of 22 October 2008 (not yet published in the Official Journal). (2) Opinion of the European Parliament of 4 December 2008 (not yet published in the Official Journal) and Council Decision of 23 March 2009. (3) OJ L 202, 6.9.1971, p. 1. (4) See Annex III, Part A. (5) OJ L 184, 17.7.1999, p. 23. ANNEX I EC PATTERN APPROVAL 1. Application for EC approval 1.1. The application and the correspondence relating to it shall be drawn up in an official language in accordance with the laws of the Member State to which the application is made. The Member State has the right to require that the annexed documents should also be written in the same official language. The applicant shall send simultaneously to all Member States a copy of his application. 1.2. The application shall contain the following information: (a) the name and address of the manufacturer or the firm, or of his or its authorised representative or of the applicant; (b) the category of instrument; (c) the intended use; (d) the measurement characteristics; (e) the commercial designation, if any, or the type. 1.3. The application shall be accompanied by the documents necessary for its evaluation, in duplicate, and in particular: 1.3.1. a description in particular of: (a) the construction and operation of the instrument; (b) the protecting arrangements ensuring correct working; (c) the devices for regulation and adjustment; (d) the intended locations for: — verification marks, — seals (where applicable); 1.3.2. general arrangement drawings and, where necessary, detailed drawings of important components; 1.3.3. a schematic drawing illustrating the principles of operation and, where necessary, a photograph. 1.4. The application shall be accompanied, where appropriate, by documents relevant to the national approvals already granted. 2. Examination for EC approval 2.1. The examination shall comprise: 2.1.1. a study of the documents and an examination of the measurement characteristics of the pattern in the laboratories of the metrological service, in approved laboratories or at the place of manufacture, delivery or installation; 2.1.2. if the measurement characteristics of the pattern are known in detail, only an examination of the documents submitted. 2.2. The examination shall cover the entire performance of the instrument under normal conditions of use. Under such conditions, that instrument must maintain the measurement characteristics required. 2.3. The nature and scope of the examination mentioned in point 2.1 may be specified by separate Directives. 2.4. The metrological service may require the applicant to put at its disposal the standards and the appropriate means in terms of material and assisting personnel for the performance of the approval tests. 3. EC certificate and sign of approval 3.1. The certificate shall give the results of the examination of the pattern and shall specify the other requirements which must be complied with. It shall be accompanied by descriptions, drawings and diagrams necessary to identify the pattern and to explain its functioning. The sign of approval provided for in Article 4 shall be a stylised letter ε containing: — in the upper part, the distinguishing capital letter(s) of the Member State which granted the approval (B for Belgium, BG for Bulgaria, CZ for the Czech Republic, DK for Denmark, D for Germany, EST for Estonia, IRL for Ireland, EL for Greece, E for Spain, F for France, I for Italy, CY for Cyprus, LV for Latvia, LT for Lithuania, L for Luxembourg, H for Hungary, M for Malta, NL for Netherlands, A for Austria, PL for Poland, P for Portugal, RO for Romania, SI for Slovenia, SK for Slovakia, FI for Finland, S for Sweden, UK for the United Kingdom) and the last two digits of the year of approval, — in the lower part, a designation to be determined by the metrological service which granted approval (an identification number). An example of this approval sign is shown in point 6.1. 3.2. In the case of EC limited approval, the letter P, having the same dimensions as the stylised letter ε, shall be placed before this letter. An example of this limited approval sign is shown in point 6.2. 3.3. The sign mentioned in Article 6 is the same as the EC approval sign, except that the stylised letter ε is reversed symmetrically about a vertical axis and bears no other indication unless the separate Directives stipulate otherwise. An example of this sign is shown in point 6.3. 3.4. The sign mentioned in Article 11 is the same as the EC approval sign in a hexagon. An example of this sign is shown in point 6.4. 3.5. The signs mentioned in points 3.1 to 3.4 and affixed by the manufacturer in accordance with the provisions of this Directive must be affixed at a visible point of each instrument and all ancillary equipment submitted for verification, and must be legible and indelible. If their affixation presents technical difficulties, exceptions may be made in separate Directives or accepted after agreement among the metrological services of Member States has been reached. 4. Depositing of a sample instrument In the cases mentioned by separate Directives, the service which granted the approval may, if it considers this necessary, request the deposition of the sample instrument for which approval has been granted. Instead of that sample instrument, the service may authorise the depositing of parts of the instrument, of scale models or of drawings, and will mention this on the EC certificate of approval. 5. Announcement of approval 5.1. At the same time as the party concerned is notified, copies of the EC certificate of approval shall be sent to the Commission and to the other Member States; the latter can also obtain copies of the reports of the metrological examinations if they wish. 5.2. Withdrawal of EC pattern approval and other communications concerning the extent and validity of EC pattern approval shall also be subject to the announcement procedure mentioned in point 5.1. 5.3. A Member State which refuses to grant EC pattern approval shall inform the other Member States and the Commission of its decision. 6. Signs relative to EC pattern approval 6.1. Sign of EC pattern approval Example: EC pattern approval granted by the Metrological Service of Germany in 1971 (see point 3.1, first indent). Identification number of the EC pattern approval (see point 3.1, second indent). 6.2. Sign of EC limited pattern approval (see point 3.2) Example: EC limited pattern approval granted by the Metrological Service of Germany in 1971. Identification number of the EC limited pattern approval. 6.3. Sign of exemption from EC pattern approval (see point 3.3) Example: 6.4. Sign of EC pattern approval for instruments exempt from EC initial verification (see point 3.4) Example: EC pattern approval granted by the Metrological Service of Germany in 1971. Identification number of the EC pattern approval. ANNEX II EC INITIAL VERIFICATION 1. General points 1.1. The EC initial verification may be carried out in one or more stages (usually two). 1.2. Subject to the provisions of the separate Directives: 1.2.1. the EC initial verification shall be carried out in one stage on instruments which constitute a whole on leaving the factory, that is to say instruments which, theoretically, can be transferred to their place of installation without first having to be dismantled; 1.2.2. the EC initial verification shall be carried out in two or more stages for instruments the correct functioning of which depends on the conditions in which they are installed or used; 1.2.3. the first stage of the verification procedure must ensure, in particular, that the instrument conforms to the approved EC pattern or, in the case of instruments exempt from pattern approval, that they conform to the relevant provisions. 2. Place of the EC initial verification 2.1. If the separate Directives do not specify the place where verification is to be carried out, instruments which have to be verified in only one stage shall be verified at the place chosen by the metrological service concerned. 2.2. Instruments which have to be verified in two or more stages shall be verified by the metrological service territorially competent. 2.2.1. The last stage of verification must be carried out at the place of installation. 2.2.2. The other stages of verification shall be carried out as laid down in point 2.1. 2.3. In particular, when the verification takes place outside the office of verification the metrological service carrying out the verification may require the applicant: — to put at its disposal the standards and the appropriate means in terms of material and assisting personnel for the performance of the verification, — to provide a copy of the EC certificate of approval. 3. EC initial verification marks 3.1. Description of EC initial verification marks 3.1.1. Subject to the provisions of separate Directives, EC initial verification marks which are affixed in accordance with point 3.3 shall be as follows: 3.1.1.1. the final EC verification mark shall be composed of two stamps: (a) the first consists of a lower-case letter ‘e’ containing: — in the upper half, the distinguishing capital letter(s) of the Member State where the original check is carried out (B for Belgium, BG for Bulgaria, CZ for the Czech Republic, DK for Denmark, D for Germany, EST for Estonia, IRL for Ireland, EL for Greece, E for Spain, F for France, I for Italy, CY for Cyprus, LV for Latvia, LT for Lithuania, L for Luxembourg, H for Hungary, M for Malta, NL for Netherlands, A for Austria, PL for Poland, P for Portugal, RO for Romania, SI for Slovenia, SK for Slovakia, FI for Finland, S for Sweden, UK for the United Kingdom) together, where necessary, with one or two figures identifying a territorial or administrative subdivision, — in the lower half, the identification number of the verifying agent or office; (b) the second stamp shall consist of the last two digits of the year of the verification, in a hexagon; 3.1.1.2. the mark of EC partial verification shall consist solely of the first stamp. It shall also serve as a seal. 3.2. Shape and dimensions of marks 3.2.1. The attached drawings show the shape, dimensions and outline of the letters and numbers for the EC initial verification marks as laid down in point 3.1; the first two drawings show the various parts of the stamp and the third is an example of a stamp. The dimensions given in the drawings are relative values; they are a function of the diameter of the circle described about the lower-case letter ‘e’ and about the field of the hexagon. The actual diameters of the circles described about the marks are 1,6 mm, 3,2 mm, 6,3 mm, 12,5 mm. 3.2.2. The metrological services of Member States shall mutually exchange the original drawings of the EC initial verification marks, conforming to the models in the annexed drawings. 3.3. Affixing the marks 3.3.1. The final EC verification mark shall be affixed at the appointed location on the instrument when the latter has been completely verified and is recognised to conform to EC requirements. 3.3.2. The partial EC verification mark shall be affixed: 3.3.2.1. when verification is made in several stages, on the instrument or part of an instrument which fulfils the conditions laid down for operations other than those at the place of installation, at the place where the stamp-date is affixed or in any other place specified in the separate Directives; 3.3.2.2. in all cases as a seal, in the places specified in the separate Directives. ANNEX III PART A Repealed Directive with list of its successive amendments (referred to in Article 20) Council Directive 71/316/EEC (OJ L 202, 6.9.1971, p. 1). 1972 Act of Accession, Annex I, point X.12 (OJ L 73, 27.3.1972, p. 118). Council Directive 72/427/EEC (OJ L 291, 28.12.1972, p. 156). 1979 Act of Accession, Annex I, point X.A (OJ L 291, 19.11.1979, p. 108). Council Directive 83/575/EEC (OJ L 332, 28.11.1983, p. 43). 1985 Act of Accession, Annex I, point IX.A.7 (OJ L 302, 15.11.1985, p. 212). Council Directive 87/354/EEC (OJ L 192, 11.7.1987, p. 43). Only as regards references made to Directive 71/316/EEC in Article 1 and Annex, point 4 Council Directive 87/355/EEC (OJ L 192, 11.7.1987, p. 46). Council Directive 88/665/EEC (OJ L 382, 31.12.1988, p. 42). Only Article 1(1) 1994 Act of Accession, Annex I, point XI.C.VII.1 (OJ C 241, 29.8.1994, p. 211). Council Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36). Only Annex III, point 5 2003 Act of Accession, Annex II, point I.D.1 (OJ L 236, 23.9.2003, p. 64). Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81). Only as regards references made to Directive 71/316/EEC in Article 1 and Annex, point B.1 Commission Directive 2007/13/EC (OJ L 73, 13.3.2007, p. 10). PART B Time limits for transposition into national law (referred to in Article 20) Directive Time limit for transposition 71/316/EEC 30 January 1973 83/575/EEC 1 January 1985 87/354/EEC 31 December 1987 87/355/EEC 31 December 1987 2006/96/EC 1 January 2007 2007/13/EC 9 March 2008 ANNEX IV CORRELATION TABLE Directive 71/316/EEC This Directive Article 1(1)(a) Article 1(1), point (a) and Article 1(2) Article 1(1)(b) Article 1(1), point (b) Article 1(1)(c) Article 1(1), point (c) Article 1(2) Article 1(3) Article 1(3) Article 1(4) Article 1(4), first subparagraph Article 1(5) Article 1(4), second subparagraph Article 1(6) Article 2(1) Article 2(2) Article 2(2) Article 2(3) Article 2(3) Article 2(4) Article 2(4) Article 2(5) Article 2(5) Article 2(1) Article 3, introductory wording Article 3, introductory wording Article 3, first indent Article 3, point (a) Article 3, second indent Article 3, point (b) Article 4, first sentence Article 4, first and second paragraphs Article 4, second sentence Article 4, third paragraph Article 5(1) Article 5(1) Article 5(2), first subparagraph Article 5(2), first subparagraph Article 5(2), second subparagraph, introductory wording Article 5(2), second subparagraph, introductory wording Article 5(2), second subparagraph, first indent Article 5(2), second subparagraph, point (a) Article 5(2), second subparagraph, second indent Article 5(2), second subparagraph, point (b) Article 5(2), second subparagraph, third indent Article 5(2), second subparagraph, point (c) Article 5(2), second subparagraph, fourth indent Article 5(2), second subparagraph, point (d) Article 5(2), third subparagraph, introductory wording Article 5(2), third subparagraph, introductory wording Article 5(2), third subparagraph, first indent Article 5(2), third subparagraph, point (a) Article 5(2), third subparagraph, second indent Article 5(2), third subparagraph, point (b) Article 5(2), fourth subparagraph Article 5(2), fourth subparagraph Article 5(3) Article 5(3) Article 6 Article 6 Article 7(1), (2) and (3) Article 7(1), (2) and (3) Article 7(4), first sentence Article 7(4), first subparagraph Article 7(4), second sentence Article 7(4), second subparagraph Article 7(4), third sentence Article 7(4), third subparagraph Article 7(5) Article 7(5) Article 8(1), point (a) Article 8(1) Article 8(1), point (b) Article 8(2) Article 8(2) Article 8(3) Article 8(3) Article 8(4) Article 9(1) Article 9(1) Article 9(2), introductory wording Article 9(2), introductory wording Article 9(2), first indent Article 9(2), point (a) Article 9(2), second indent Article 9(2), point (b) Article 9(2), third indent Article 9(2), point (c) Article 9(2), fourth indent Article 9(2), point (d) Articles 10 and 11 Articles 10 and 11 Articles 12, 13 and 14 Articles 12, 13 and 14 Article 15 Article 15 Article 16, first sentence Article 16, first paragraph Article 16, second sentence Article 16, second paragraph Article 17 — Article 18(1) Article 17(1) Article 18(2), first subparagraph Article 17(2) Article 18(2), second subparagraph — Article 18(3) — Article 19 Article 18 Article 20(1) — Article 20(2) Article 19 — Articles 20 and 21 Article 21 Article 22 Annex I Annex I Points 1 and 1.1 Points 1 and 1.1 Point 1.2, introductory wording Point 1.2, introductory wording Point 1.2, first indent Point 1.2(a) Point 1.2, second indent Point 1.2(b) Point 1.2, third indent Point 1.2(c) Point 1.2, fourth indent Point 1.2(d) Point 1.2, fifth indent Point 1.2(e) Point 1.3 Point 1.3 Point 1.3.1, introductory wording Point 1.3.1, introductory wording Point 1.3.1, first indent Point 1.3.1(a) Point 1.3.1, second indent Point 1.3.1(b) Point 1.3.1, third indent Point 1.3.1(c) Point 1.3.1, fourth indent Point 1.3.1(d) Point 1.3.2 to Point 5 Point 1.3.2 to Point 5 Point 5.2 Point 5.1 Point 5.3 Point 5.2 Point 5.4 Point 5.3 Point 6 to Point 6.4 Point 6 to Point 6.4 Annex II Annex II — Annex III — Annex IV

Summary: Measuring instruments and methods of metrological control — common rules Measuring instruments and methods of metrological control — common rules SUMMARY OF: Directive 2009/34/EC on measuring instruments and methods of metrological control WHAT IS THE AIM OF THE DIRECTIVE? It sets out the general rules for EC (European Community) pattern approval, initial verification and methods of metrological control for measuring instruments. Other implementing directives on various categories of instruments cover the technical requirements in detail. The directive repeals Directive 71/316/EEC. KEY POINTS Before measuring instruments are brought in to use, EU countries are responsible for ensuring that they conform with technical requirements. This is achieved through granting EC pattern approval and verification, recognised throughout the EU. This directive covers: measuring equipment; units of measurement; the harmonisation of methods of measurement and metrological control; the means of applying harmonisation methods; methods of measurement, metrological control and marking of quantities of pre-packaged products. EC pattern approval An EC pattern approval application can be made only by the manufacturer or a representative established in the EU, in one EU country only. EU countries must ensure that they are kept informed of any modification to the approved pattern requiring additional approval, and where changes occur must inform other EU countries. A new EC pattern approval may instead be needed when a pattern is modified and where relevant directives introduce new requirements. Following approval, the EU country provides a certificate and the manufacturer applies the official approval sign to the equipment concerned. Certificates are valid for 10 years, extendable for further 10-year periods. Applications include the following information: intended use; measurement characteristics; how they are built and operate; devices to regulate and adjust them; the intended locations for verification marks (where they will be affixed to the instrument); general and detailed drawings of important components; drawings or photographs illustrating the principles of operation. The examination includes a document study and an examination of the measurement characteristics of the pattern covering the entire performance of the instrument under normal conditions of use. The country which has granted EC pattern approval may withdraw it if it was granted improperly, or if a defect is subsequently found in the equipment. It must immediately inform the other EU countries and the European Commission, and attempt to settle any disputes, in consultation with the Commission where necessary. Where new techniques are used which are not covered by a separate directive, limited EC pattern approval for up to 2 years (extendable by up to 3 years) may be granted with certain restrictions, including a limit on the number of instruments covered, and restrictions on use and the technique used. Initial verification EC initial verification is the examination of a new or reconditioned* instrument to ensure it conforms to the approved EC pattern and/or to the relevant directives, and is certified by the EC initial verification mark. The examination includes assessment of the metrological characteristics, the maximum permissible errors, and an assessment of the reliability of construction. When an instrument has passed EC initial verification, in accordance with this directive and of the separate detailed directives, the EC verification mark can be applied by the manufacturer. Checking of instruments in use Separate directives cover control requirements for measuring instruments already in use. FROM WHEN DOES THIS DIRECTIVE APPLY? It has applied since 18 May 2009. Directive 2009/34/EC revised and replaced Directive 71/316/EEC — and its subsequent amendments. BACKGROUND For more information, see: Legal metrology (European Commission). KEY TERMS Reconditioned: a used instrument that has been restored to good condition. MAIN DOCUMENT Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (Recast) (OJ L 106, 28.4.2009, pp. 7-24) RELATED DOCUMENTS Directive 2011/17/EU of the European Parliament and of the Council of 9 March 2011 repealing Council Directives 71/317/EEC, 71/347/EEC, 71/349/EEC, 74/148/EEC, 75/33/EEC, 76/765/EEC, 76/766/EEC and 86/217/EEC regarding metrology (OJ L 71, 18.3.2011, pp. 1-3) last update 08.12.2017