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32000L0013

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

Official Journal L 109 , 06/05/2000 P. 0029 - 0042

Directive 2000/13/EC of the European Parliament and of the Councilof 20 March 2000on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffsTHE 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 of the Commission,Having regard to the opinion of the Economic and Social Committee(1),Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),Whereas:(1) Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(3) has been frequently and substantially amended(4). Therefore, for reasons of clarity and rationality, the said Directive should be consolidated in a single text.(2) Differences between the laws, regulations and administrative provisions of the Member States on the labelling of foodstuffs may impede the free circulation of these products and can lead to unequal conditions of competition.(3) Therefore, approximation of these laws would contribute to the smooth functioning of the internal market.(4) The purpose of this Directive should be to enact Community rules of a general nature applicable horizontally to all foodstuffs put on the market.(5) Rules of a specific nature which apply vertically only to particular foodstuffs should be laid down in provisions dealing with those products.(6) The prime consideration for any rules on the labelling of foodstuffs should be the need to inform and protect the consumer.(7) That need means that Member States may, in compliance with the rules of the Treaty, impose language requirements.(8) Detailed labelling, in particular giving the exact nature and characteristics of the product which enables the consumer to make his choice in full knowledge of the facts, is the most appropriate since it creates fewest obstacles to free trade.(9) Therefore, a list should be drawn up of all information which should in principle be included in the labelling of all foodstuffs.(10) However, the horizontal nature of this Directive does not allow, at the initial stage, the inclusion in the compulsory indications of all the indications which must be added to the list applying in principle to the whole range of foodstuffs. During a later stage, Community provisions should be adopted, aimed at supplementing the existing rules.(11) Furthermore, in the absence of Community rules of a specific nature Member States should retain the right to lay down certain national provisions which may be added to the general provisions of this Directive, nevertheless these provisions should be subject to a Community procedure.(12) The said Community procedure must be that of a Community decision when a Member State wishes to enact new legislation.(13) Provision should also be made for the Community legislator to derogate, in exceptional cases, from certain obligations that have been fixed generally.(14) The rules on labelling should also prohibit the use of information that would mislead the purchaser or attribute medicinal properties to foodstuffs. To be effective, this prohibition should also apply to the presentation and advertising of foodstuffs.(15) With a view to facilitating trade between Member States, it may be provided that, at stages prior to sale to the ultimate consumer, only information on the essential elements should appear on the outer packaging and certain mandatory particulars that must appear on a prepackaged foodstuff need appear only on commercial documents referring thereto.(16) Member States should retain the right, depending on local practical conditions and circumstances, to lay down rules in respect of the labelling of foodstuffs sold in bulk; in such cases, information should nevertheless be provided for the consumer.(17) With the aim of simplifying and accelerating the procedure, the Commission should be entrusted with the task of adopting implementing measures of a technical nature.(18) The measures necessary for the implementing 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).(19) This Directive should be without prejudice to the obligations of the Member States concerning the time limits for transposition of the Directives set out in Annex IV, Part B,HAVE ADOPTED THIS DIRECTIVE:Article 11. This Directive concerns the labelling of foodstuffs to be delivered as such to the ultimate consumer and certain aspects relating to the presentation and advertising thereof.2. This Directive shall apply also to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers (hereinafter referred to as "mass caterers").3. For the purpose of this Directive,(a) "labelling" shall mean any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff;(b) "pre-packaged foodstuff" shall mean any single item for presentation as such to the ultimate consumer and to mass caterers, consisting of a foodstuff and the packaging into which it was put before being offered for sale, whether such packaging encloses the foodstuff completely or only partially, but in any case in such a way that the contents cannot be altered without opening or changing the packaging.Article 21. The labelling and methods used must not:(a) be such as could mislead the purchaser to a material degree, particularly:(i) as to the characteristics of the foodstuff and, in particular, as to its nature, identity, properties, composition, quantity, durability, origin or provenance, method of manufacture or production;(ii) by attributing to the foodstuff effects or properties which it does not possess;(iii) by suggesting that the foodstuff possesses special characteristics when in fact all similar foodstuffs possess such characteristics;(b) subject to Community provisions applicable to natural mineral waters and foodstuffs for particular nutritional uses, attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties.2. The Council, in accordance with the procedure laid down in Article 95 of the Treaty, shall draw up a non-exhaustive list of the claims within the meaning of paragraph 1, the use of which must at all events be prohibited or restricted.3. The prohibitions or restrictions referred to in paragraphs 1 and 2 shall also apply to:(a) the presentation of foodstuffs, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed;(b) advertising.Article 31. In accordance with Articles 4 to 17 and subject to the exceptions contained therein, indication of the following particulars alone shall be compulsory on the labelling of foodstuffs:(1) the name under which the product is sold;(2) the list of ingredients;(3) the quantity of certain ingredients or categories of ingredients as provided for in Article 7;(4) in the case of prepackaged foodstuffs, the net quantity;(5) the date of minimum durability or, in the case of foodstuffs which, from the microbiological point of view, are highly perishable, the "use by" date;(6) any special storage conditions or conditions of use;(7) the name or business name and address of the manufacturer or packager, or of a seller established within the Community.However, the Member States shall be authorised, in respect of butter produced in their territory, to require only an indication of the manufacturer, packager or seller.Without prejudice to the notification provided for in Article 24, Member States shall inform the Commission and the other Member States of any measure taken pursuant to the second paragraph;(8) particulars of the place of origin or provenance where failure to give such particulars might mislead the consumer to a material degree as to the true origin or provenance of the foodstuff;(9) instructions for use when it would be impossible to make appropriate use of the foodstuff in the absence of such instructions;(10) with respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume.2. Notwithstanding the previous paragraph, Member States may retain national provisions which require indication of the factory or packaging centre, in respect of home production.3. The provisions of this Article shall be without prejudice to more precise or more extensive provisions regarding weights and measures.Article 41. Community provisions applicable to specified foodstuffs and not to foodstuffs in general may provide for derogations, in exceptional cases, from the requirements laid down in Article 3(1), points 2 and 5, provided that this does not result in the purchaser being inadequately informed.2. Community provisions applicable to specified foodstuffs and not to foodstuffs in general may provide that other particulars in addition to those listed in Article 3 must appear on the labelling.Where there are no Community provisions, Member States may make provision for such particulars in accordance with the procedure laid down in Article 19.3. The Community provisions referred to in paragraphs 1 and 2 shall be adopted in accordance with the procedure laid down in Article 20(2).Article 51. The name under which a foodstuff is sold shall be the name provided for in the Community provisions applicable to it.(a) In the absence of Community provisions, the name under which a product is sold shall be the name provided for in the laws, regulations and administrative provisions applicable in the Member State in which the product is sold to the final consumer or to mass caterers.Failing this, the name under which a product is sold shall be the name customary in the Member State in which it is sold to the final consumer or to mass caterers, or a description of the foodstuff, and if necessary of its use, which is clear enough to let the purchaser know its true nature and distinguish it from other products with which it might be confused.(b) The use in the Member State of marketing of the sales name under which the product is legally manufactured and marketed in the Member State of production shall also be allowed.However, where the application of the other provisions of this Directive, in particular those set out in Article 3, would not enable consumers in the Member State of marketing to know the true nature of the foodstuff and to distinguish it from foodstuffs with which they could confuse it, the sales name shall be accompanied by other descriptive information which shall appear in proximity to the sales name.(c) In exceptional cases, the sales name of the Member State of production shall not be used in the Member State of marketing when the foodstuff which it designates is so different, as regards its composition or manufacture, from the foodstuff known under that name that the provisions of point (b) are not sufficient to ensure, in the Member State of marketing, correct information for consumers.2. No trade mark, brand name or fancy name may be substituted for the name under which the product is sold.3. The name under which the product is sold shall include or be accompanied by particulars as to the physical condition of the foodstuff or the specific treatment which it has undergone (e.g. powdered, freeze-dried, deep-frozen, concentrated, smoked) in all cases where omission of such information could create confusion in the mind of the purchaser.Any foodstuff which has been treated with ionising radiation must bear one of the following indications:- in Spanish:"irradiado" or "tratado con radiación ionizante",- in Danish:"bestrålet/..." or "strålekonserveret" or "behandlet med ioniserende stråling" or "konserveret med ioniserende stråling",- in German:"bestrahlt" or "mit ionisierenden Strahlen behandelt",- in Greek:"επεξεργασμένο με ιονίζουσα ακτινοβολία" or "ακτινοβολημένο",- in English:"irradiated" or "treated with ionising radiation",- in France:"traité par rayonnements ionisants" or "traité par ionisation",- in Italian:"irradiato" or "trattato con radiazioni ionizzanti",- in Dutch:"doorstraald" or "door bestraling behandeld" or "met ioniserende stralen behandeld",- in Portuguese:"irradiado" or "tratado por irradiação" or "tratado por radiação ionizante",- in Finnish:"säteilytetty" or "käsitelty ionisoivalla säteilyllä",- in Swedish:"bestrålad" or "behandlad med joniserande strålning".Article 61. Ingredients shall be listed in accordance with this Article and Annexes I, II and III.2. Ingredients need not be listed in the case of:(a) - fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated,- carbonated water, the description of which indicates that it has been carbonated,- fermentation vinegars derived exclusively from a single basic product, provided that no other ingredient has been added;(b) - cheese,- butter,- fermented milk and cream,provided that no ingredient has been added other than lactic products, enzymes and micro-organism cultures essential to manufacture, or the salt needed for the manufacture of cheese other than fresh cheese and processed cheese;(c) products comprising a single ingredient, where:- the trade name is identical with the ingredient name, or- the trade name enables the nature of the ingredient to be clearly identified.3. In the case of beverages containing more than 1,2 % by volume of alcohol, the Council, acting on a proposal from the Commission, shall, before 22 December 1982, determine the rules for labelling ingredients.4. (a) "Ingredient" shall mean any substance, including additives, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form.(b) Where an ingredient of the foodstuff is itself the product of several ingredients, the latter shall be regarded as ingredients of the foodstuff in question.(c) The following shall not be regarded as ingredients:(i) the constituents of an ingredient which have been temporarily separated during the manufacturing process and later reintroduced but not in excess of their original proportions;(ii) additives:- whose presence in a given foodstuff is solely due to the fact that they were contained in one or more ingredients of that foodstuff, provided that they serve no technological function in the finished product,- which are used as processing aids;(iii) substances used in the quantities strictly necessary as solvents or media for additives or flavouring.(d) In certain cases Decisions may be taken in accordance with the procedure laid down in Article 20(2) as to whether the conditions described in point (c)(ii) and (iii) are satisfied.5. The list of ingredients shall include all the ingredients of the foodstuff, in descending order of weight, as recorded at the time of their use in the manufacture of the foodstuff. It shall appear preceded by a suitable heading which includes the word "ingredients".However:- added water and volatile products shall be listed in order of their weight in the finished product; the amount of water added as an ingredient in a foodstuff shall be calculated by deducting from the total amount of the finished product the total amount of the other ingredients used. This amount need not be taken into consideration if it does not exceed 5 % by weight of the finished product,- ingredients used in concentrated or dehydrated form and reconstituted at the time of manufacture may be listed in order of weight as recorded before their concentration or dehydration,- in the case of concentrated or dehydrated foods which are intended to be reconstituted by the addition of water, the ingredients may be listed in order of proportion in the reconstituted product provided that the list of ingredients is accompanied by an expression such as "ingredients of the reconstituted product", or "ingredients of the ready-to-use product",- in the case of mixtures of fruit or vegetables where no particular fruit or vegetable significantly predominates in proportion by weight, those ingredients may be listed in another order provided that that list of ingredients is accompanied by an expression such as "in variable proportion",- in the case of mixtures of spices or herbs, where none significantly predominates in proportion by weight, those ingredients may be listed in another order provided that that list of ingredients is accompanied by an expression such as "in variable proportion".6. Ingredients shall be designated by their specific name, where applicable, in accordance with the rules laid down in Article 5.However:- ingredients which belong to one of the categories listed in Annex I and are constituents of another foodstuff need only be designated by the name of that category.Alterations to the list of categories in Annex I may be effected in accordance with the procedure laid down in Article 20(2).However, the designation "starch" listed in Annex I must always be complemented by the indication of its specific vegetable origin, when that ingredient may contain gluten,- ingredients belonging to one of the categories listed in Annex II must be designated by the name of that category, followed by their specific name or EC number; if an ingredient belongs to more than one of the categories, the category appropriate to the principal function in the case of the foodstuff in question shall be indicated.Amendments to this Annex based on advances in scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 20(2).However, the designation "modified starch" listed in Annex II must always be complemented by the indication of its specific vegetable origin, when that ingredient may contain gluten,- flavourings shall be designated in accordance with Annex III,- the specific Community provisions governing the indication of treatment of an ingredient with ionising radiation shall be adopted subsequently in accordance with Article 95 of the Treaty.7. Community provisions or, where there are none, national provisions may lay down that the name under which a specific foodstuff is sold is to be accompanied by mention of a particular ingredient or ingredients.The procedure laid down in Article 19 shall apply to any such national provisions.The Community provisions referred to in this paragraph shall be adopted in accordance with the procedure laid down in Article 20(2).8. In the case referred to in paragraph 4(b), a compound ingredient may be included in the list of ingredients, under its own designation in so far as this is laid down by law or established by custom, in terms of its overall weight, provided that it is immediately followed by a list of its ingredients.Such a list, however, shall not be compulsory:(a) where the compound ingredient constitutes less than 25 % of the finished product; however, this exemption shall not apply in the case of additives, subject to the provisions of paragraph 4(c);(b) where the compound ingredient is a foodstuff for which a list of ingredients is not required under Community rules.9. Notwithstanding paragraph 5 the water content need not be specified:(a) where the water is used during the manufacturing process solely for the reconstitution of an ingredient used in concentrated or dehydrated form;(b) in the case of a liquid medium which is not normally consumed.Article 71. The quantity of an ingredient or category of ingredients used in the manufacture or preparation of a foodstuff shall be stated in accordance with this Article.2. The indication referred to in paragraph 1 shall be compulsory:(a) where the ingredient or category of ingredients concerned appears in the name under which the foodstuff is sold or is usually associated with that name by the consumer; or(b) where the ingredient or category of ingredients concerned is emphasised on the labelling in words, pictures or graphics; or(c) where the ingredient or category of ingredients concerned is essential to characterise a foodstuff and to distinguish it from products with which it might be confused because of its name or appearance; or(d) in the cases determined in accordance with the procedure laid down in Article 20(2).3. Paragraph 2 shall not apply:(a) to an ingredient or category of ingredients:- the drained net weight of which is indicated in accordance with Article 8(4), or- the quantities of which are already required to be given on the labelling under Community provisions, or- which is used in small quantities for the purposes of flavouring, or- which, while appearing in the name under which the food is sold, is not such as to govern the choice of the consumer in the country of marketing because the variation in quantity is not essential to characterise the foodstuff or does not distinguish it from similar foods. In cases of doubt it shall be decided by the procedure laid down in Article 20(2) whether the conditions laid down in this indent are fulfilled;(b) where specific Community provisions stipulate precisely the quantity of an ingredient or of a category of ingredients without providing for the indication thereof on the labelling;(c) in the cases referred to in the fourth and fifth indents of Article 6(5);(d) in the cases determined in accordance with the procedure laid down in Article 20(2).4. The quantity indicated, expressed as a percentage, shall correspond to the quantity of the ingredient or ingredients at the time of its/their use. However, Community provisions may allow for derogations from this principle for certain foodstuffs. Such provisions shall be adopted in accordance with the procedure laid down in Article 20(2).5. The indication referred to in paragraph 1 shall appear either in or immediately next to the name under which the foodstuff is sold or in the list of ingredients in connection with the ingredient or category of ingredients in question.6. This Article shall apply without prejudice to Community rules on nutrition labelling for foodstuffs.Article 81. The net quantity of prepackaged foodstuffs shall be expressed:- in units of volume in the case of liquids,- in units of mass in the case of other products,using the litre, centilitre, millilitre, kilogram or gram, as appropriate.Community provisions or, where there are none, national provisions applicable to certain specified foodstuffs may derogate from this rule.The procedure laid down in Article 19 shall apply to any such national provisions.2. (a) Where the indication of a certain type of quantity (e.g. nominal quantity, minimum quantity, average quantity) is required by Community provisions or, where there are none, by national provisions, this quantity shall be regarded as the net quantity for the purposes of this Directive.Without prejudice to the notification provided for in Article 24, Member States shall inform the Commission and the other Member States of any measure taken pursuant to this point.(b) Community provisions or, where there are none, national provisions may, for certain specified foodstuffs classified by quantity in categories, require other indications of quantity.The procedure laid down in Article 19 shall apply to any such national provisions.(c) Where a prepackaged item consists of two or more individual prepackaged items containing the same quantity of the same product, the net quantity shall be indicated by mentioning the net quantity contained in each individual package and the total number of such packages. Indication of these particulars shall not, however, be compulsory where the total number of individual packages can be clearly seen and easily counted from the outside and where at least one indication of the net quantity contained in each individual package can be clearly seen from the outside.(d) Where a prepackaged item consists of two or more individual packages which are not regarded as units of sale, the net quantity shall be given by indicating the total net quantity and the total number of individual packages. Community provisions or, where there are none, national provisions need not, in the case of certain foodstuffs, require indication of the total number of individual packages.Without prejudice to the notification provided for in Article 24, Member States shall inform the Commission and the other Member States of any measure taken pursuant to this point.3. In the case of foodstuffs normally sold by number, Member States need not require indication of the net quantity provided that the number of items can clearly be seen and easily counted from the outside or, if not, is indicated on the labelling.Without prejudice to the notification provided for in Article 24, Member States shall inform the Commission and the other Member States of any measure taken pursuant to this paragraph.4. Where a solid foodstuff is presented in a liquid medium, the drained net weight of the foodstuff shall also be indicated on the labelling.For the purposes of this paragraph, "liquid medium" shall mean the following products, possibly in mixtures and also where frozen or quick-frozen, provided that the liquid is merely an adjunct to the essential elements of that preparation and is thus not a decisive factor for the purchase: water, aqueous solutions of salts, brine, aqueous solutions of food acids, vinegar, aqueous solutions of sugars, aqueous solutions of other sweetening substances, fruit or vegetable juices in the case of fruit or vegetables.This list may be supplemented in accordance with the procedure laid down in Article 20(2).Methods of checking the drained net weight shall be determined in accordance with the procedure laid down in Article 20(2).5. It shall not be compulsory to indicate the net quantity in the case of foodstuffs:(a) which are subject to considerable losses in their volume or mass and which are sold by number or weighed in the presence of the purchaser;(b) the net quantity of which is less than 5 g or 5 ml; however, this provision shall not apply to spices and herbs.Community provisions or, where there are none, national provisions applicable to specified foodstuffs may in exceptional cases lay down thresholds which are higher than 5 g or 5 ml provided that this does not result in the purchaser being inadequately informed.Without prejudice to the notification provided for in Article 24, Member States shall inform the Commission and the other Member States of any measure taken pursuant to this paragraph.6. The Community provisions referred to in paragraphs 1, second subparagraph, 2(b) and (d) and 5, second subparagraph, shall be adopted in accordance with the procedure laid down in Article 20(2).Article 91. The date of minimum durability of a foodstuff shall be the date until which the foodstuff retains its specific properties when properly stored.It shall be indicated in accordance with paragraphs 2 to 5.2. The date shall be preceded by the words:- "Best before ..." when the date includes an indication of the day,- "Best before end ..." in other cases.3. The words referred to in paragraph 2 shall be accompanied by:- either the date itself, or- a reference to where the date is given on the labelling.If need be, these particulars shall be followed by a description of the storage conditions which must be observed if the product is to keep for the specified period.4. The date shall consist of the day, month and year in uncoded chronological form.However, in the case of foodstuffs:- which will not keep for more than three months, an indication of the day and the month will suffice,- which will keep for more than three months but not more than 18 months, an indication of the month and year will suffice,- which will keep for more than 18 months, an indication of the year will suffice.The manner of indicating the date may be specified according to the procedure laid down in Article 20(2).5. Subject to Community provisions imposing other types of date indication, an indication of the durability date shall not be required for:- fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated. This derogation shall not apply to sprouting seeds and similar products such as legume sprouts,- wines, liqueur wines, sparkling wines, aromatised wines and similar products obtained from fruits other than grapes, and beverages falling within CN codes 22060091, 2206 00 93 and 2206 00 99 and manufactured from grapes or grape musts,- beverages containing 10 % or more by volume of alcohol,- soft drinks, fruit juices, fruit nectars and alcoholic beverages in individual containers of more than five litres, intended for supply to mass caterers,- bakers' or pastry cooks' wares which, given the nature of their content, are normally consumed within 24 hours of their manufacture,- vinegar,- cooking salt,- solid sugar,- confectionery products consisting almost solely of flavoured and/or coloured sugars,- chewing gums and similar chewing products,- individual portions of ice-cream.Article 101. In the case of foodstuffs which, from the microbiological point of view, are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health, the date of minimum durability shall be replaced by the "use by" date.2. The date shall be preceded by the words:- in Spanish: "fecha de caducidad",- in Danish: "sidste anvendelsesdato",- in German: "verbrauchen bis",- in Greek: "ανάλωση μέχρι",- in English: "use by",- in French: "à consommer jusqu'au",- in Italian: "da consumare entro",- in Dutch: "te gebruiken tot",- in Portuguese: "a consumir até",- in Finnish: "viimeinen käyttöajankohta",- in Swedish: "sista förbrukningsdag".These words shall be accompanied by:- either the date itself, or- a reference to where the date is given on the labelling.These particulars shall be followed by a description of the storage conditions which must be observed.3. The date shall consist of the day, the month and, possibly, the year, in that order and in uncoded form.4. In some cases it may be decided by the procedure laid down in Article 20(2) whether the conditions laid down in paragraph 1 are fulfilled.Article 111. The instructions for use of a foodstuff shall be indicated in such a way as to enable appropriate use to be made thereof.2. Community provisions or, where there are none, national provisions may, in the case of certain foodstuffs, specify the way in which the instructions for use should be indicated.The procedure laid down in Article 19 shall apply to such national provisions.The Community provisions referred to in this paragraph shall be adopted in accordance with the procedure laid down in Article 20(2).Article 12The rules concerning indication of the alcoholic strength by volume shall, in the case of products covered by tariff heading Nos 22.04 and 22.05, be those laid down in the specific Community provisions applicable to such products.In the case of other beverages containing more than 1,2 % by volume of alcohol, these rules shall be laid down in accordance with the procedure provided for in Article 20(2).Article 131. (a) When the foodstuffs are prepackaged, the particulars provided for in Articles 3 and 4(2) shall appear on the prepackaging or on a label attached thereto.(b) Notwithstanding point (a) and without prejudice to Community provisions on nominal quantities, where prepackaged foodstuffs are:- intended for the ultimate consumer but marketed at a stage prior to sale to the ultimate consumer and where sale to a mass caterer is not involved at that stage,- intended for supply to mass caterers for preparation, processing, splitting or cutting up,the particulars required under Articles 3 and 4(2) need appear only on the commercial documents referring to the foodstuffs where it can be guaranteed that such documents, containing all the labelling information, either accompany the foodstuffs to which they refer or were sent before or at the same time as delivery.(c) In the case referred to in point (b), the particulars referred to in Article 3(1) point 1, 5 and 7 and, where appropriate, that referred to in Article 10, shall also appear on the external packaging in which the foodstuffs are presented for marketing.2. The particulars mentioned in Article 3 and Article 4(2) shall be easy to understand and marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible.They shall not in any way be hidden, obscured or interrupted by other written or pictorial matter.3. The particulars listed in Article 3(1), points 1, 4, 5 and 10 shall appear in the same field of vision.This requirement may be extended to the particulars provided for in Article 4(2).4. In the case of the glass bottles intended for reuse which are indelibly marked and which therefore bear no label, ring or collar and packaging or containers the largest surface of which has an area of less than 10 cm2 only the particulars listed in Article 3(1) points 1, 4 and 5 need be given.In this case, paragraph 3 shall not apply.5. Ireland, the Netherlands and the United Kingdom may derogate from Article 3(1) and paragraph 3 of this Article in the case of milk and milk products put up in glass bottles intended for reuse.They shall inform the Commission of any measure taken pursuant to the first subparagraph.Article 14Where foodstuffs are offered for sale to the ultimate consumer or to mass caterers without prepackaging, or where foodstuffs are packaged on the sales premises at the consumer's request or prepackaged for direct sale, the Member States shall adopt detailed rules concerning the manner in which the particulars specified in Article 3 and Article 4(2) are to be shown.They may decide not to require the provision of all or some of these particulars, provided that the purchaser still receives sufficient information.Article 15This Directive shall not affect the provisions of national laws which, in the absence of Community provisions, impose less stringent requirements for the labelling of foodstuffs presented in fancy packaging such as figurines or souvenirs.Article 161. Member States shall ensure that the sale is prohibited within their own territories of foodstuffs for which the particulars provided for in Article 3 and Article 4(2) do not appear in a language easily understood by the consumer, unless the consumer is in fact informed by means of other measures determined in accordance with the procedure laid down in Article 20(2) as regards one or more labelling particulars.2. Within its own territory, the Member State in which the product is marketed may, in accordance with the rules of the Treaty, stipulate that those labelling particulars shall be given in one or more languages which it shall determine from among the official languages of the Community.3. Paragraphs 1 and 2 shall not preclude the labelling particulars from being indicated in several languages.Article 17Member States shall refrain from laying down requirements more detailed than those already contained in Articles 3 to 13 concerning the manner in which the particulars provided for in Article 3 and Article 4(2) are to be shown.Article 181. Member States may not forbid trade in foodstuffs which comply with the rules laid down in this Directive by the application of non-harmonised national provisions governing the labelling and presentation of certain foodstuffs or of foodstuffs in general.2. Paragraph 1 shall not apply to non-harmonised national provisions justified on grounds of:- protection of public health,- prevention of fraud, unless such provisions are liable to impede the application of the definitions and rules laid down by this Directive,- protection of industrial and commercial property rights, indications of provenance, registered designations of origin and prevention of unfair competition.Article 19Where reference is made to this Article, the following procedure shall apply should a Member State deem it necessary to adopt new legislation.It shall notify the Commission and the other Member States of the measures envisaged and give the reasons justifying them. The Commission shall consult the Member States within the Standing Committee on Foodstuffs set up by Council Decision 69/414/EEC(6) if it considers such consultation to be useful or if a Member State so requests.Member States may take such envisaged measures only three months after such notification and provided that the Commission's opinion is not negative.In the latter event, and before the expiry of the abovementioned period, the Commission shall initiate the procedure provided for in Article 20(2) in order to determine whether the envisaged measures may be implemented subject, if necessary, to the appropriate modifications.Article 201. The Commission shall be assisted by the Standing Committee on Foodstuffs (hereinafter referred to as "the Committee").2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 21If temporary measures prove necessary to facilitate the application of this Directive, they shall be adopted in accordance with the procedure provided for in Article 20(2).Article 22This Directive shall not affect Community provisions relating to the labelling and presentation of certain foodstuffs already adopted on 22 December 1978.Any amendments necessary to harmonise such provisions with the rules laid down in this Directive shall be decided in accordance with the procedure applicable to each of the provisions in question.Article 23This Directive shall not apply to products for export outside the Community.Article 24Member States shall ensure that the Commission receives the text of any essential provision of national law which they adopt in the field governed by this Directive.Article 25This Directive shall also apply to the French overseas departments.Article 261. Directive 79/112/EEC as amended by the Directives referred to in Annex IV, Part A, is repealed, without prejudice to the obligations of the Member States in respect of the deadlines for transposition laid down in Annex IV, Part B.2. The reference made to the repealed Directive shall be construed as references to this Directive and should be read in accordance with the correlation table set out in Annex V.Article 27This Directive enters into force on the 20th day following its publication in the Official Journal of the European Communities.Article 28This Directive is addressed to the Member States.Done at Brussels, 20 March 2000.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentJ. Gama(1) OJ C 258, 10.9.1999, p. 12.(2) Opinion of the European Parliament of 18 January 2000 (not yet published in the Official Journal) and Council Decision of 13 March 2000.(3) OJ L 33, 8.2.1979, p. 1. Directive as last amended by Directive 97/4/EC of the European Parliament and of the Council (OJ L 43, 14.2.1997, p. 21).(4) See Annex IV, Part B.(5) OJ L 184, 17.7.1999, p. 23.(6) OJ L 291, 29.11.1969, p. 9.ANNEX ICATEGORIES OF INGREDIENTS WHICH MAY BE DESIGNATED BY THE NAME OF THE CATEGORY RATHER THAN THE SPECIFIC NAME>TABLE>ANNEX IICATEGORIES OF INGREDIENTS WHICH MUST BE DESIGNATED BY THE NAME OF THEIR CATEGORY FOLLOWED BY THEIR SPECIFIC NAME OR EC NUMBERColourPreservativeAntioxidantEmulsifierThickenerGelling agentStabiliserFlavour enhancerAcidAcidity regulatorAnti-caking agentModified starch(1)SweetenerRaising agentAnti-foaming agentGlazing agentEmulsifying salts(2)Flour treatment agentFirming agentHumectantBulking agentPropellent gas(1) The specific name or EC number need not be indicated.(2) Only for processed cheeses and products based on processed cheeses.ANNEX IIIDESIGNATION OF FLAVOURINGS IN THE LIST OF INGREDIENTS1. Flavourings shall be designated either by the word "flavouring(s)" or by a more specific name or description of the flavouring.2. The word "natural" or any other word having substantially the same meaning may be used only for flavourings in which the flavouring component contains exclusively flavouring substances as defined in Article 1(2)(b)(i) of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(1) and/or flavouring preparations as defined in Article 1(2)(c) of the said Directive.3. If the name of the flavouring contains a reference to the vegetable or animal nature or origin of the incorporated substances, the word "natural" or any other word having substantially the same meaning may not be used unless the flavouring component has been isolated by appropriate physical processes, enzymatic or microbiological processes or traditional food-preparation processes solely or almost solely from the foodstuff or the flavouring source concerned.(1) OJ L 184, 15.7.1988, p. 61. Directive as amended by Commission Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).ANNEX IVPART AREPEALED DIRECTIVE AND ITS SUCCESSIVE AMENDMENTS(referred to by Article 26)Council Directive 79/112/EEC (OJ L 33, 8.2.1979, p. 1)Council Directive 85/7/EEC (OJ L 2, 3.1.1985, p. 22), only Article 1(9)Council Directive 86/197/EEC (OJ L 144, 29.5.1986, p. 38)Council Directive 89/395/EEC (OJ L 186, 30.6.1989, p. 17)Commission Directive 91/72/EEC (OJ L 42, 15.2.1991, p. 27)Commission Directive 93/102/EC (OJ L 291, 25.11.1993, p. 14)Commission Directive 95/42/EC (OJ L 182, 2.8.1995, p. 20)European Parliament and Council Directive 97/4/EC (OJ L 43, 14.2.1997, p. 21)PART BDEADLINES FOR TRANSPOSITION INTO NATIONAL LAW(referred to by Article 26)>TABLE>ANNEX VCORRELATION TABLE>TABLE>


Avis juridique important

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31999L0030

Council Directive 1999/30/EC of 22 April 1999 relating to limit values for sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air

Official Journal L 163 , 29/06/1999 P. 0041 - 0060

COUNCIL DIRECTIVE 1999/30/ECof 22 April 1999relating to limit values for sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient airTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 130s(1) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 189c of the Treaty(3),(1) Whereas, on the basis of principles enshrined in Article 130r of the Treaty, the European Community programme of policy and action in relation to the environment and sustainable development (the fifth Environment Action Programme)(4) envisages in particular amendments to legislation on air pollutants; whereas that programme recommends the establishment of long-term air-quality objectives;(2) Whereas Article 129 of the Treaty provides that health-protection requirements shall form a constituent part of the Community's other policies; whereas Article 3(o) of the Treaty provides that the activities of the Community shall include a contribution to the attainment of a high level of health protection;(3) Whereas, pursuant to Article 4(5) of Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management(5), the Council is to adopt the legislation provided for in paragraph 1 and the provisions laid down in paragraphs 3 and 4 of the same Article;(4) Whereas the limit values laid down in this Directive are minimum requirements; whereas, in accordance with Article 130t of the Treaty, Member States may maintain or introduce more stringent protective measures; whereas, in particular, stricter limit values may be introduced to protect the health of particularly vulnerable categories of the population, such as children and hospital patients; whereas a Member State may require that limit values be attained before the dates laid down in this Directive;(5) Whereas ecosystems should be protected against the adverse effects of sulphur dioxide; whereas vegetation should be protected against the adverse effects of oxides of nitrogen;(6) Whereas different types of particles can have different harmful effects on human health; whereas there is evidence that risks to human health associated with exposure to man-made particulate matter are higher than risks associated with exposure to naturally occurring particles in ambient air;(7) Whereas Directive 96/62/EC requires that action plans be developed for zones within which concentrations of pollutants in ambient air exceed limit values plus any temporary margins of tolerance applicable in order to ensure compliance with limit values by the date or dates laid down; whereas insofar as they relate to particulate matter such action plans and other reduction strategies should aim to reduce concentrations of fine particles as part of the total reduction in concentrations of particulate matter;(8) Whereas Directive 96/62/EC provides that the numerical values for limit values and alert thresholds are to be based on the findings of work carried out by international scientific groups active in the field; whereas the Commission is to take account of the most recent scientific-research data in the epidemiological and environmental fields concerned and of the most recent advances in metrology for re-examining the elements on which limit values and alert thresholds are based;(9) Whereas in order to facilitate the review of this Directive in 2003 the Commission and the Member States should consider encouraging research into the effects of the pollutants referred to herein, namely sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead;(10) Whereas standardised accurate measurement techniques and common criteria for the location of measuring stations are an important element in the assessment of ambient-air quality with a view to obtaining comparable information across the Community;(11) Whereas, in accordance with Article 12(1) of Directive 96/62/EC, the amendments necessary for adaptation to scientific and technical progress may relate solely to criteria and techniques for the assessment of concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead or detailed arrangements for forwarding information to the Commission, and may not have the effect of modifying limit values or alert thresholds either directly or indirectly;(12) Whereas up-to-date information on concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air should be readily available to the public,HAS ADOPTED THIS DIRECTIVE:Article 1ObjectivesThe objectives of this Directive shall be to:- establish limit values and, as appropriate, alert thresholds for concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air intended to avoid, prevent or reduce harmful effects on human health and the environment as a whole,- assess concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air on the basis of common methods and criteria,- obtain adequate information on concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air and ensure that it is made available to the public,- maintain ambient-air quality where it is good and improve it in other cases with respect to sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead.Article 2DefinitionsFor the purposes of this Directive:1. "ambient air" shall mean outdoor air in the troposphere, excluding work places;2. "pollutant" shall mean any substance introduced directly or indirectly by man into the ambient air and likely to have harmful effects on human health and/or the environment as a whole;3. "level" shall mean the concentration of a pollutant in ambient air or the deposition thereof on surfaces in a given time;4. "assessment" shall mean any method used to measure, calculate, predict or estimate the level of a pollutant in the ambient air;5. "limit value" shall mean a level fixed on the basis of scientific knowledge, with the aim of avoiding, preventing or reducing harmful effects on human health and/or the environment as a whole, to be attained within a given period and not to be exceeded once attained;6. "alert threshold" shall mean a level beyond which there is a risk to human health from brief exposure and at which immediate steps shall be taken by the Member States as laid down in Directive 96/62/EC;7. "margin of tolerance" shall mean the percentage of the limit value by which this value may be exceeded subject to the conditions laid down in Directive 96/62/EC;8. "zone" shall mean part of their territory delimited by the Member States;9. "agglomeration" shall mean a zone with a population concentration in excess of 250000 inhabitants or, where the population concentration is 250000 inhabitants or less, a population density per km2 which for the Member States justifies the need for ambient air quality to be assessed and managed.10. "oxides of nitrogen" shall mean the sum of nitric oxide and nitrogen dioxide added as parts per billion and expressed as nitrogen dioxide in micrograms per cubic meter;11. "PM10" shall mean particulate matter which passes through a size-selective inlet with a 50 % efficiency cut-off at 10 μm aerodynamic diameter;12. "PM2,5" shall mean particulate matter which passes through a size-selective inlet with a 50 % efficiency cut-off at 2,5μm aerodynamic diameter;13. "upper assessment threshold" shall mean a level specified in Annex V, below which a combination of measurements and modelling techniques may be used to assess ambient-air quality, in accordance with Article 6(3) of Directive 96/62/EC;14. "lower assessment threshold" shall mean a level specified in Annex V, below which modelling or objective-estimation techniques alone may be used to assess ambient-air quality in accordance with Article 6(4) of Directive 96/62/EC;15. "natural events" shall mean volcanic eruptions, seismic activities, geothermal activities, wild-land fires, high-wind events or the atmospheric resuspension or transport of natural particles from dry regions;16. "fixed measurements" shall mean measurements taken in accordance with Article 6(5) of Directive 96/62/EC.Article 3Sulphur dioxide1. Member States shall take the measures necessary to ensure that concentrations of sulphur dioxide in ambient air, as assessed in accordance with Article 7, do not exceed the limit values laid down in Section I of Annex I from the dates specified therein.The margins of tolerance laid down in Section I of Annex I shall apply in accordance with Article 8 of Directive 96/62/EC.2. The alert threshold for concentrations of sulphur dioxide in ambient air shall be that laid down in Section II of Annex I.3. In order to assist the Commission in preparing the report provided for in Article 10, until 31 December 2003 Member States shall, where practicable, record data on concentrations of sulphur dioxide averaged over ten minutes from certain measuring stations which they have selected as representative of air quality in inhabited areas close to sources and at which hourly concentrations are measured. At the same time as data are supplied on hourly concentrations in accordance with Article 11(1) of Directive 96/62/EC, Member States shall report to the Commission, for those selected measuring stations, the number of ten-minute concentrations which have exceeded 500 μg/m3, the number of days within the calendar year on which that occurred, the number of those days on which hourly concentrations of sulphur dioxide simultaneously exceeded 350 μg/m3 and the maximum ten-minute concentration recorded.4. Member States may designate zones or agglomerations within which limit values for sulphur dioxide as laid down in Section I of Annex I are exceeded owing to concentrations of sulphur dioxide in ambient air due to natural sources. Member States shall send the Commission lists of any such zones or agglomerations together with information on concentrations and sources of sulphur dioxide therein. When informing the Commission in accordance with Article 11(1) of Directive 96/62/EC, Member States shall provide the necessary justification to demonstrate that any exceedances are due to natural sources.Within such zones or agglomerations Member States shall be obliged to implement action plans in accordance with Article 8(3) of Directive 96/62/EC only where the limit values laid down in Section I of Annex I are exceeded owing to man-made emissions.Article 4Nitrogen dioxide and oxides of nitrogen1. Member States shall take the measures necessary to ensure that concentrations of nitrogen dioxide and, where applicable, of oxides of nitrogen, in ambient air, as assessed in accordance with Article 7, do not exceed the limit values laid down in Section I of Annex II as from the dates specified therein.The margins of tolerance laid down in Section I of Annex II shall apply in accordance with Article 8 of Directive 96/62/EC.2. The alert threshold for concentrations of nitrogen dioxide in ambient air shall be that laid down in Section II of Annex II.Article 5Particulate matter1. Member States shall take the measures necessary to ensure that concentrations of PM10 in ambient air, as assessed in accordance with Article 7, do not exceed the limit values laid down in Section I of Annex III as from the dates specified therein.The margins of tolerance laid down in Section I of Annex III shall apply in accordance with Article 8 of Directive 96/62/EC.2. Member States shall ensure that measuring stations to supply data on concentrations of PM2,5 are installed and operated. Each Member State shall choose the number and the siting of the stations at which PM2,5 is to be measured as representative of concentrations of PM2,5 within that Member State. Where possible sampling points for PM2,5 shall be co-located with sampling points for PM10.Within nine months of the end of each year Member States shall send the Commission the arithmetic mean, the median, the ninety-eighth percentile and the maximum concentration calculated from measurements of PM2,5 over any twenty-four hours within that year. The ninety-eighth percentile shall be calculated in accordance with the procedure laid down in Section 4 of Annex I to Council Decision 97/101/EC of 27 January 1997 establishing a reciprocal exchange of information and data from networks and individual stations measuring ambient air pollution within the Member States(6).3. Action plans for PM10 prepared in accordance with Article 8 of Directive 96/62/EC and general strategies for decreasing concentrations of PM10 shall also aim to reduce concentrations of PM2,5.4. Where the limit values for PM10 laid down in Section I of Annex III are exceeded owing to concentrations of PM10 in ambient air due to natural events which result in concentrations significantly in excess of normal background levels from natural sources, Member States shall inform the Commission in accordance with Article 11(1) of Directive 96/62/EC, providing the necessary justification to demonstrate that such exceedances are due to natural events. In such cases, Member States shall be obliged to implement action plans in accordance with Article 8(3) of Directive 96/62/EC only where the limit values laid down in Section I of Annex III are exceeded owing to causes other than natural events.5. Member States may designate zones or agglomerations within which limit values for PM10 as laid down in Section I of Annex III are exceeded owing to concentrations of PM10 in ambient air due to the resuspension of particulates following the winter sanding of roads. Member States shall send the Commission lists of any such zones or agglomerations together with information on concentrations and sources of PM10 therein. When informing the Commission in accordance with Article 11(1) of Directive 96/62/EC, Member States shall provide the necessary justification to demonstrate that any exceedances are due to such resuspended particulates, and that reasonable measures have been taken to lower the concentrations.Within such zones or agglomerations Member States shall be obliged to implement action plans in accordance with Article 8(3) of Directive 96/62/EC only where the limit values laid down in Section I of Annex III are exceeded owing to PM10 levels other than those caused by winter road sanding.Article 6LeadMember States shall take the measures necessary to ensure that concentrations of lead in ambient air, as assessed in accordance with Article 7, do not exceed the limit values laid down in Section I of Annex IV as from the dates specified therein.The margins of tolerance laid down in Section I of Annex IV shall apply in accordance with Article 8 of Directive 96/62/EC.Article 7Assessment of concentrations1. The upper and lower assessment thresholds for sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead for the purposes of Article 6 of Directive 96/62/EC shall be those laid down in Section I of Annex V.The classification of each zone or agglomeration for the purposes of the same Article 6 shall be reviewed at least every five years in accordance with the procedure laid down in Section II of Annex V. Classification shall be reviewed earlier in the event of significant changes in activities relevant to ambient concentrations of sulphur dioxide, nitrogen dioxide or, where relevant, oxides of nitrogen, particulate matter or lead.2. The criteria for determining the location of sampling points for the measurement of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air shall be those listed in Annex VI. The minimum number of sampling points for fixed measurements of concentrations of each relevant pollutant shall be as laid down in Annex VII and they shall be installed in each zone or agglomeration within which measurement is required if fixed measurement is the sole source of data on concentrations within it.3. For zones and agglomerations within which information from fixed measurement stations is supplemented by information from other sources, such as emission inventories, indicative measurement methods and air-quality modelling, the number of fixed measuring stations to be installed and the spatial resolution of other techniques shall be sufficient for the concentrations of air pollutants to be established in accordance with Section I of Annex VI and Section I of Annex VIII.4. For zones and agglomerations within which measurement is not required, modelling or objective-estimation techniques may be used.5. The reference methods for the analysis of sulphur dioxide, of nitrogen dioxide and of oxides of nitrogen and for the sampling and analysis of lead shall be as laid down in Sections I to III of Annex IX.The reference method for the sampling and measurement of PM10 shall be as laid down in Section IV of Annex IX.The provisional reference method for the sampling and measurement of PM2,5 shall be as laid down in Section V of Annex IX.The reference techniques for air-quality modelling shall be as laid down in Section VI of Annex IX.6. The date by which Member States shall inform the Commission of the methods they have used for the preliminary assessment of air quality under Article 11(1)(d) of Directive 96/62/EC shall be eighteen months after the entry into force of this Directive.7. Any amendments necessary to adapt this Article and Annexes V to IX to scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 12 of Directive 96/62/EC.Article 8Public information1. Member States shall ensure that up-to-date information on ambient concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead is routinely made available to the public as well as to appropriate organisations such as environmental organisations, consumer organisations, organisations representing the interests of sensitive populations and other relevant health-care bodies by means, for example, of broadcast media, press, information screens or computer-network services.Information on ambient concentrations of sulphur dioxide, nitrogen dioxide and particulate matter shall be updated on at least a daily basis, and, in the case of hourly values for sulphur dioxide and nitrogen dioxide, wherever practicable, information shall be updated on an hourly basis. Information on ambient concentrations of lead shall be updated on a three-monthly basis.Such information shall at least indicate any exceeding of the concentrations in the limit values and alert thresholds over the averaging periods laid down in Annexes I to IV. It shall also provide a short assessment in relation to limit values and alert thresholds and appropriate information regarding effects on health.2. When making plans or programmes available to the public under Article 8(3) of Directive 96/62/EC, including plans or programmes referred to under Articles 3(4), 5(4) and 5(5) of this Directive, Member States shall also make them available to the organisations referred to in paragraph 1.3. When an alert threshold laid down in Annex I or II is exceeded, details made available to the public in accordance with Article 10 of Directive 96/62/EC shall at least include the items listed in Section III of the Annex in question.4. Information made available to the public and to organisations under paragraphs 1 and 3 shall be clear, comprehensible and accessible.Article 9Repeals and transitional arrangements1. Council Directive 80/779/EEC of 15 July 1980 on air-quality limit values and guide values for sulphur dioxide and suspended particulates(7) shall be repealed with effect from 19 July 2001 except that Articles 1, 2(1), 3(1), 9, 15 and 16 of Directive 80/779/EEC and Annexes I, IIIb and IV thereto shall be repealed with effect from 1 January 2005.2. Council Directive 82/884/EEC of 3 December 1982 on a limit value for lead in the air(8) shall be repealed with effect from 19 July 2001 except that Articles 1, 2, 3(1), 7, 12 and 13 of Directive 82/884/EEC shall be repealed with effect from 1 January 2005.3. Council Directive 85/203/EEC of 7 March 1985 on air-quality standards for nitrogen dioxide(9) shall be repealed with effect from 19 July 2001 except that Articles 1(1), first indent, and (2), 2, first indent, 3(1), 5, 9, 15 and 16 of Directive 85/203/EEC and Annex I thereto shall be repealed with effect from 1 January 2010.4. From 19 July 2001 Member States shall employ measurement stations and other methods of air-quality assessment that comply with this Directive to assess concentrations of sulphur dioxide, nitrogen dioxide and lead in ambient air to obtain data for the purpose of demonstrating compliance with the limit values laid down in Directives 80/779/EEC, 82/884/EEC and 85/203/EEC until such time as the limit values laid down in those Directives cease to apply.5. From 19 July 2001 Member States may employ measurement stations and other methods of air-quality assessment that comply with this Directive as regards PM10 to assess concentrations of suspended particulate matter for the purpose of demonstrating compliance with the limit values for total suspended particulates laid down in Annex IV to Directive 80/779/EEC; for the purpose of demonstrating such compliance, however, the data so collected shall be multiplied by a factor of 1.2.6. Member States shall inform the Commission of any exceedances of the limit values laid down in Directives 80/779/EEC, 82/884/EEC and 85/203/EEC, together with the values recorded, the reasons for each recorded instance and the measures taken to prevent any recurrence, within nine months of the end of each year in accordance with the procedure laid down in Article 11 of Directive 96/62/EC until such time as the limit values laid down in those Directives cease to apply.7. In the zones in which a Member State considers it necessary to limit or prevent a foreseeable increase in pollution by sulphur dioxide, oxides of nitrogen or suspended particulate matter it may continue to use the guide values for the protection of ecosystems laid down in Annex II to Directive 80/779/EEC and in Annex II to Directive 85/203/EEC.Article 10Report and reviewNo later than 31 December 2003 the Commission shall submit to the European Parliament and the Council a report based on the experience acquired in the application of this Directive and, in particular, on the results of the most recent scientific research concerning the effects on human health and ecosystems of exposure to sulphur dioxide, nitrogen dioxide and oxides of nitrogen, different fractions of particulate matter and lead, and on technological developments including the progress achieved in methods of measuring and otherwise assessing concentrations of particulate matter in ambient air and the deposition of particulate matter and lead on surfaces.With a view to maintaining a high level of protection of human health and the environment and taking into account the experience acquired in the application of this Directive in Member States including, in particular, the conditions as laid down in Annex VI under which measurement has been carried out, the aforementioned report will be accompanied by proposals for the amendment of this Directive if appropriate. In particular, the Commission will examine the limit values for the second stage for PM10 with a view to making them mandatory and will consider confirming or altering the limit values for the second stage and, if appropriate, for the first stage. In addition, the Commission will give particular attention to setting limit values for PM2,5 or different fractions of particulate matter, as appropriate. Furthermore the Commission will examine the annual limit value for the protection of human health for nitrogen dioxide and will make a proposal confirming or modifying that value. It will also examine the hourly limit value for nitrogen dioxide in the light of World Health Organisation guidelines and consider whether that limit value should be confirmed or altered.The Commission will also consider whether alert thresholds can be set, consistent with other pollutants in this Directive, for PM10, PM2,5 or particular fractions of particulate matter, as appropriate.Article 11PenaltiesMember States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. Those penalties shall be effective, proportionate and dissuasive.Article 12Implementation1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 19 July 2001. They shall forthwith inform the Commission thereof.When the Member States adopt those measures, these shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.Article 13Entry into forceThis Directive shall enter into force on the twentieth day after that of its publication in the Official Journal of the European Communities.Article 14AddresseesThis Directive is addressed to the Member States.Done at Luxembourg, 22 April 1999.For the CouncilThe PresidentW. MÜLLER(1) OJ C 9, 14.1.1998, p. 6.(2) OJ C 214, 10.7.1998, p. 1.(3) Opinion of the European Parliament of 13 May 1998 (OJ C 167, 1.6.1998, p. 103), Council Common Position of 24 September 1998 (OJ C 360, 23.11.1998, p. 99) and Decision of the European Parliament of 13 January 1999 (OJ C 104, 14.4.1999, p. 44).(4) OJ C 138, 17.5.1993, p. 5.(5) OJ L 296, 21.11.1996, p. 55.(6) OJ L 35, 5.2.1997, p. 14.(7) OJ L 229, 30.8.1980, p. 30.(8) OJ L 378, 31.12.1982, p. 15.(9) OJ L 87, 27.3.1985, p. 1.ANNEX ILIMIT VALUES AND THE ALERT THRESHOLD FOR SULPHUR DIOXIDEI. Limit values for sulphur dioxideLimit values must be expressed in μg/m3. The volume must be standardised at a temperature of 293 °K and a pressure of 101,3 kPa.>TABLE>II. Alert threshold for sulphur dioxide500 μg/m3 measured over three consecutive hours at locations representative of air quality over at least 100 km2 or an entire zone or agglomeration, whichever is the smaller.III. Minimum details to be made available to the public when the alert threshold for sulphur dioxide is exceededDetails to be made available to the public should include at least:- the date, hour and place of the occurrence and the reasons for the occurrence, where known;- any forecasts of:- changes in concentrations (improvement, stabilisation, or deterioration), together with the reasons for those changes,- the geographical area concerned,- the duration of the occurence;- the type of population potentially sensitive to the occurrence;- the precautions to be taken by the sensitive population concerned.ANNEX IILIMIT VALUES FOR NITROGEN DIOXIDE (NO2) AND OXIDES OF NITROGEN (NOx) AND THE ALERT THRESHOLD FOR NITROGEN DIOXIDEI. Limit values for nitrogen dioxide and oxides of nitrogenLimit values must be expressed in μg/m3. The volume must be standardised at a temperature of 293 °K and a pressure of 101,3 kPa.>TABLE>II. Alert threshold for nitrogen dioxide400 μg/m3 measured over three consecutive hours at locations representative of air quality over at least 100 km 2 or an entire zone or agglomeration, whichever is the smaller.III. Minimum details to be made available to the public when the alert threshold for nitrogen dioxide is exceedeedDetails to be made available to the public should include at least:- the date, hour and place of the occurrence and the reasons for the occurrence, where known;- any forecasts of:- changes in concentrations (improvement, stabilisation, or deterioration), together with the reasons for those changes,- the geographical area concerned,- the duration of the occurrence;- the type of population potentially sensitive to the occurrence;- the precautions to be taken by the sensitive population concerned.ANNEX IIILIMIT VALUES FOR PARTICULATE MATTER (PM10)>TABLE>ANNEX IVLIMIT VALUE FOR LEAD>TABLE>ANNEX VDETERMINATION OF REQUIREMENTS FOR ASSESSMENT OF CONCENTRATIONS OF SULPHUR DIOXIDE, NITROGEN DIOXIDE (NO2), AND OXIDES OF NITROGEN (NOx), PARTICULATE MATTER (PM10) AND LEAD IN AMBIENT AIR WITHIN A ZONE OR AGGLOMERATIONI. Upper and lower assessment thresholdsThe following upper and lower assessment thresholds will apply:(a) SULPHUR DIOXIDE>TABLE>(b) NITROGEN DIOXIDE AND OXIDES OF NITROGEN>TABLE>(c) PARTICULATE MATTERThe upper and lower assessment thresholds for PM10 are based on the indicative limit values for 1 January 2010.>TABLE>(d) LEAD>TABLE>II. Determination of exceedances of upper and lower assessment thresholdsExceedances of upper and lower assessment thresholds must be determined on the basis of concentrations during the previous five years where sufficient data are available. An assessment threshold will be deemed to have been exceeded if during those five years the total number of exceedances of the numerical concentration of the threshold is more than three times the number of exceedances allowed each year.Where fewer than five years' data are available Member States may combine measurement campaigns of short duration during the period of the year and at locations likely to be typical of the highest pollution levels with results obtained from information from emission inventories and modelling to determine exceedances of the upper and lower assessment thresholds.ANNEX VILOCATION OF SAMPLING POINTS FOR THE MEASUREMENT OF SULPHUR DIOXIDE, NITROGEN DIOXIDE AND OXIDES OF NITROGEN, PARTICULATE MATTER AND LEAD IN AMBIENT AIRThe following considerations will apply to fixed measurement.I. Macroscale siting(a) Protection of human healthSampling points directed at the protection of human health should be sited:(i) to provide data on the areas within zones and agglomerations where the highest concentrations occur to which the population is likely to be directly or indirectly exposed for a period which is significant in relation to the averaging period of the limit value(s);(ii) to provide data on levels in other areas within the zones and agglomerations which are representative of the exposure of the general population.Sampling points should in general be sited to avoid measuring very small micro-environments in their immediate vicinity. As a guideline, a sampling point should be sited to be representative of air quality in a surrounding area of no less than 200 m2 at traffic-orientated sites and of several square kilometres at urban-background sites.Sampling points should also, where possible, be representative of similar locations not in their immediate vicinity.Account should be taken of the need to locate sampling points on islands, where that is necessary for the protection of human health.(b) Protection of ecosystems and vegetation.Sampling points targeted at the protection of ecosystems or vegetation should be sited more than 20 km from agglomerations or more than 5 km from other built-up areas, industrial installations or motorways. As a guideline, a sampling point should be sited to be representative of air quality in a surrounding area of at least 1000 km2. A Member State may provide for a sampling point to be sited at a lesser distance or to be representative of air quality in a less extended area, taking account of geographical conditions.Account should be taken of the need to assess air quality on islands.II. Microscale sitingThe following guidelines should be met as far as practicable:- the flow around the inlet sampling probe should be unrestricted without any obstructions affecting the airflow in the vicinity of the sampler (normally some metres away from buildings, balconies, trees, and other obstacles and at least 0,5 m from the nearest building in the case of sampling points representing air quality at the building line);- in general, the inlet sampling point should be between 1,5 m (the breathing zone) and 4 m above the ground. Higher positions (up to 8 m) may be necessary in some circumstances. Higher siting may also be appropriate if the station is representative of a large area;- the inlet probe should not be positioned in the immediate vicinity of sources in order to avoid the direct intake of emissions unmixed with ambient air;- the sampler's exhaust outlet should be positioned so that recirculation of exhaust air to the sampler inlet is avoided;- location of traffic-orientated samplers:- for all pollutants, such sampling points should be at least 25 m from the edge of major junctions and at least 4 m from the centre of the nearest traffic lane,- for nitrogen dioxide, inlets should be no more than 5 m from the kerbside,- for particulate matter and lead, inlets should be sited so as to be representative of air quality near to the building line.The following factors may also be taken into account:- interfering sources;- security;- access;- availability of electrical power and telephone communications;- visibility of the site in relation to its surroundings;- safety of public and operators;- the desirability of co-locating sampling points for different pollutants;- planning requirements.III. Documentation and review of site selectionThe site-selection procedures should be fully documented at the classification stage by such means as compass-point photographs of the surrounding area and a detailed map. Sites should be reviewed at regular intervals with repeated documentation to ensure that selection criteria remain valid over time.ANNEX VIICRITERIA FOR DETERMINING MINIMUM NUMBERS OF SAMPLING POINTS FOR FIXED MEASUREMENT OF CONCENTRATIONS OF SULPHUR DIOXIDE (SO2), NITROGEN DIOXIDE (NO2) AND OXIDES OF NITROGEN, PARTICULATE MATTER AND LEAD IN AMBIENT AIRI. Minimum number of sampling points for fixed measurement to assess compliance with limit values for the protection of human health and alert thresholds in zones and agglomerations where fixed measurement is the sole source of information(a) Diffuse sources>TABLE>(b) Point sourcesFor the assessment of pollution in the vicinity of point sources, the number of sampling points for fixed measurement should be calculated taking into account emission densities, the likely distribution patterns of ambient-air pollution and the potential exposure of the population.II. Minimum number of sampling points for fixed measurements to assess compliance with limit values for the protection of ecosystems or vegetation in zones other than agglomerations>TABLE>In island zones the number of sampling points for fixed measurement should be calculated taking into account the likely distribution patterns of ambient-air pollution and the potential exposure of ecosystems or vegetation.ANNEX VIIIDATA-QUALITY OBJECTIVES AND COMPILATION OF RESULTS OF AIR-QUALITY ASSESSMENTI. Data-quality objectivesThe following data-quality objectives for the required accuracy of assessment methods, of minimum time coverage and of data capture of measurement are laid down to guide quality-assurance programmes.>TABLE>The accuracy of the measurement is defined as laid down in the "Guide to the Expression of Uncertainty of Measurements" (ISO 1993) or in ISO 5725-1 "Accuracy (trueness and precision) of measurement methods and results" (1994). The percentages in the table are given for individual measurements averaged, over the period considered, by the limit value, for a 95 % confidence interval (bias + two times the standard deviation). The accuracy for continuous measurements should be interpreted as being applicable in the region of the appropriate limit value.The accuracy for modelling and objective estimation is defined as the maximum deviation of the measured and calculated concentration levels, over the period considered by the limit value, without taking into account the timing of the events.The requirements for minimum data capture and time coverage do not include losses of data due to the regular calibration or the normal maintenance of the instrumentation.By way of derogation, Member States may apply random measurements instead of continuous measurements for particulate matter and lead if they can demonstrate to the Commission that accuracy within the 95 % confidence interval with respect to continuous monitoring is within 10 %. Random sampling must be spread evenly over the year.II. Results of air quality assessmentThe following information should be compiled for zones or agglomerations within which sources other than measurement are employed to supplement information from measurement or as the sole means of air-quality assessment:- a description of assessment activities carried out;- the specific methods used, with references to descriptions of the method;- the sources of data and information;- a description of results, including accuracies and, in particular, the extent of any area or, if relevant, the length of road within the zone or agglomeration over which concentrations exceed limit value(s) or, as may be, limit value(s) plus applicable margin(s) of tolerance and of any area within which concentrations exceed the upper assessment threshold or the lower assessment threshold;- for limit values the object of which is the protection of human health, the population potentially exposed to concentrations in excess of the limit value.Where possible, Member States should compile maps showing concentration distributions within each zone and agglomeration.III. StandardisationFor sulphur dioxide and oxides of nitrogen the volume must be standardised at a temperature of 293 °K and a pressure of 101,3 kPa.ANNEX IXREFERENCE METHODS FOR ASSESSMENT OF CONCENTRATIONS OF SULPHUR DIOXIDE, NITROGEN DIOXIDE AND OXIDES OF NITROGEN, PARTICULATE MATTER (PM10 AND PM2,5) AND LEADI. Reference method for the analysis of sulphur dioxide:ISO/FDIS 10498 (Standard in draft) Ambient air - determination of sulphur dioxide - ultraviolet fluorescence method.A Member State may use any other method which it can demonstrate gives results equivalent to the above method.II. Reference method for the analysis of nitrogen dioxide and oxides of nitrogen:ISO 7996: 1985 Ambient air - determination of the mass concentrations of nitrogen oxides - chemiluminescence method.A Member State may use any other method which it can demonstrate gives results equivalent to the above method.III.A Reference method for the sampling of lead:The reference method for the sampling of lead will be that described in the Annex to Directive 82/884/EEC until such time as the limit value in Annex IV to this Directive is to be met, when the reference method will be that for PM10 as laid down in Section IV of this Annex.A Member State may use any other method which it can demonstrate gives results equivalent to the above method.III.B Reference method for the analysis of lead:ISO 9855: 1993 Ambient air - Determination of the particulate lead content of aerosols collected in filters. Atomic absorption spectroscopy method.A Member State may use any other method which it can demonstrate gives results equivalent to the above method.IV. Reference method for the sampling and measurement of PM10The reference method for the sampling and measurement of PM10 will be that described in EN 12341 "Air Quality - Field Test Procedure to Demonstrate Reference Equivalence of Sampling Methods for the PM10 fraction of particulate matter". The measurement principle is based on the collection on a filter of the PM10 fraction of ambient particulate matter and the gravimetric mass determination.A Member State may use any other method which it can demonstrate gives results equivalent to the above method or any other method which the Member State concerned can demonstrate displays a consistent relationship to the reference method. In that event the results achieved by that method must be corrected by a relevant factor to produce results equivalent to those that would have been achieved by using the reference method.Each Member State must inform the Commission of the method used to sample and measure PM10. The Commission must as soon as possible carry out intercomparison exercises for PM10 sampling and measurement methods in order to provide information for the review of this Directive in accordance with Article 10.V. Provisional reference method for the sampling and measurement of PM2,5The Commission will produce guidelines, in consultation with the committee referred to in Article 12 of Directive 96/62/EEC, for an appropriate provisional reference method for the sampling and assessment of PM2,5 by 19 July 2001.A Member State may use any other method which it considers suitable.Each Member State must inform the Commission of the method used to sample and measure PM2,5. The Commission must as soon as possible carry out intercomparison exercises for PM2,5 sampling and measurement methods in order to provide information for the review of this Directive in accordance with Article 10.VI. Reference modelling techniques:Reference modelling techniques cannot be specified at present. Any amendments to adapt this point to scientific and technical progress must be adopted in accordance with the procedure laid down in Article 12(2) of Directive 96/62/EC.