title: Commission Directive 2007/57/EC of 17 September 2007 amending certain Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for dithiocarbamates (Text with EEA relevance)

text:
               18.9.2007

               EN

               Official Journal of the European Union

               L 243/61

      COMMISSION DIRECTIVE 2007/57/EC
   of 17 September 2007
   amending certain Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for dithiocarbamates
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), and in particular Article 5 thereof,
   Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (2), and in particular Article 10 thereof,
   Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (3), and in particular Article 10 thereof,
   Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (4), and in particular Article 7 thereof,
   Whereas:

               (1)

               Maximum residue levels (MRLs) reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in terms of estimated dietary intake.

               (2)

               MRLs for pesticides are kept under review and changed to take account of new information, including new or changed uses. Information about new or changed uses has been communicated to the Commission, which should lead to changes in the residue levels of maneb, mancozeb, metiram, propineb and thiram.

               (3)

               The active substance ziram has been included in Annex I to Council Directive 91/414/EEC (5) by Commission Directive 2003/81/EC (6). The inclusion in Annex I to Directive 91/414/EEC was based on the assessment of the information submitted concerning the proposed use. The information available has been reviewed and is sufficient to allow certain MRLs to be fixed.

               (4)

               There are already Community MRLs in Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC for maneb, mancozeb, metiram, propineb and thiram. Those levels have been taken into consideration when adapting the MRLs concerned by this Directive. In particular, as in routine monitoring the residues of maneb, mancozeb, metiram, propineb, thiram and ziram cannot be individually identified, MRLs are set for the whole group of those pesticides which are also known as dithiocarbamates. However, for propineb, thiram and ziram single methods exist, although not on a routine basis. Those methods should be used on a case-by-case basis, when the specific quantification of propineb, ziram and/or thiram is required.

               (5)

               The Commission review reports which were prepared for the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, fix the Acceptable Daily Intake (ADI) and, if necessary, the Acute Reference Dose (ARfD) for those substances. The exposure of consumers of food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (7) and the opinion of the Scientific Committee for Plants (8) on the methodology employed. It has been concluded that the MRLs proposed will not lead to those ADI or ARfD being exceeded.

               (6)

               Where authorised uses of plant protection products do not result in detectable levels of pesticide residues in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data, MRLs should be fixed at the lower limit of analytical determination.

               (7)

               It is therefore necessary to modify the MRLs set out in the Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC to allow proper surveillance and control of the prohibition of their uses and to protect the consumer. Where MRLs have already been defined in the Annexes to those Directives, it is appropriate to amend them. Where MRLs have not already been defined, it is appropriate to set them for the first time.

               (8)

               Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

               (9)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Annex II to Directive 76/895/EEC the entry relating to thiram is deleted.
   Article 2
   Directive 86/362/EEC is amended in accordance with Annex I to this Directive.
   Article 3
   Directive 86/363/EEC is amended in accordance with Annex II to this Directive.
   Article 4
   Directive 90/642/EEC is amended in accordance with Annex III to this Directive.
   Article 5
   Member States shall adopt and publish, by 18 March 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 19 March 2008.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 6
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 7
   This Directive is addressed to the Member States.

      Done at Brussels, 17 September 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2007/8/EC (OJ L 63, 1.3.2007, p. 9).

      (2)  OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2007/27/EC (OJ L 128, 16.5.2007, p. 31).

      (3)  OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2007/28/EC (OJ L 135, 26.5.2007, p. 6).

      (4)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2007/39/EC (OJ L 165, 27.6.2007, p. 25).

      (5)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).

      (6)  OJ L 224, 6.9.2003, p. 29.

      (7)  Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97.7).

      (8)  Opinion of the Scientific Committee on Plants regarding questions relating to amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC (Opinion expressed by the Scientific Committee on Plants, 14 July 1998) (http://europa.eu.int/comm/food/fs/sc/index_en.html).

      ANNEX I
      In Part A of Annex II to Directive 86/362/EEC, the lines for ‘Mancozeb, maneb, metiram, propineb, zineb (expressed as CS2)’ are replaced by the following:

                     ‘Pesticide residues

                     Maximum levels in mg/kg

                     Dithiocarbamates, expressed as CS2, including mancozeb, maneb, metiram, propineb, thiram and ziram (1), (2)

                     1 Wheat, Rye, Triticale, Spelt (ma, mz)
                     2 Barley, Oats (ma, mz)
                     0,05 (4) Other cereals

                     Propineb (expressed as propilendiammine) (3)

                     0,05 (4)

                     CEREALS

                     Thiram (expressed as Thiram) (3)

                     0,1 (4)

                     CEREALS

                     Ziram (expressed as Ziram) (3)

                     0,1 (4)

                     CEREALS

         (1)  The MRLs expressed as CS2 can arise from different dithiocarbamates and therefore they do not reflect a single Good Agricultural Practice (GAP). It is therefore not appropriate to use these MRLs to check compliance with a GAP.

         (2)  In brackets the origin of the residue (ma: maneb; me: metiram; mz: mancozeb; pr: propineb; t: thiram; z: ziram).

         (3)  As all dithiocarbamates result in the final CS2 residue, discrimination among them is generally not possible. However single residue methods are available for propineb, ziram and thiram. These methods should be implemented on a case by case basis when the specific quantification of propineb, ziram and/or thiram is required.

         (4)  Indicates lower limit of analytical determination.’

      ANNEX II
      In Part B of Annex II to Directive 86/363/EEC, the lines for ‘Mancozeb, maneb, metiram, propineb, zineb (expressed as CS2)’ are replaced by the following:

                     Maximum levels in mg/kg

                     Pesticide residues

                     of meat, including fat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 0209 00, 0210, 1601 00 and 1602

                     for milk and milk products listed in Annex I under headings Nos 0401, 0402, 0405 00 and 0406

                     of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 0408

                     ‘Dithiocarbamates, expressed as CS2, including mancozeb, maneb, metiram, propineb, thiram and ziram

                     0,05 (1)

                     0,05 (1)

                     0,05 (1)

         (1)  Indicates lower limit of analytical determination.’

      ANNEX III
      In Part A of Annex II to Directive 90/642/EEC, the line for ‘Mancozeb, maneb, metiram, propineb, zineb (expressed as CS2)’ is replaced by the following:

                     ‘Pesticide residue and maximum residue level (mg/kg)

                     Groups and examples of individual products to which the MRLs apply

                     Dithiocarbamates, expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram (1), (2)

                     Propineb (expressed as propilendiammine) (3)

                     Thiram (expressed as thiram) (3)

                     Ziram (expressed as ziram) (3)

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

                                 (i)

                                 CITRUS FRUIT

                     5 (mz)

                     0,05 (4)

                     0,1 (4)

                     0,1 (4)

                     Grapefruit

                     Lemons

                     Limes

                     Mandarins (including clementines and other hybrids)

                     Oranges

                     Pomelos

                     Others

                                 (ii)

                                 TREE NUTS (shelled or unshelled)

                     0,05 (4)

                     0,1 (4)

                     0,1 (4)

                     Almonds

                     Brazil nuts

                     Cashew nuts

                     Chestnuts

                     Coconuts

                     Hazelnuts

                     Macadamia

                     Pecans

                     Pine nuts

                     Pistachios

                     Walnuts

                     0,1 (mz)

                     Others

                     0,05 (4)

                                 (iii)

                                 POME FRUIT

                     5 (ma, mz, me, pr, t, z)

                     0,3

                     Apples

                     5

                     0,1 (4)

                     Pears

                     5

                     1

                     Quinces

                     Others

                     0,1 (4)

                     0,1 (4)

                                 (iv)

                                 STONE FRUIT

                     Apricots

                     2 (mz, t)

                     3

                     Cherries

                     2 (mz, me, pr, t, z)

                     0,3

                     3

                     5

                     Peaches (including nectarines and similar hybrids)

                     2 (mz, t)

                     3

                     Plums

                     2 (mz, me, t, z)

                     2

                     2

                     Others

                     0,05 (4)

                     0,05 (4)

                     0,1 (4)

                     0,1 (4)

                                 (v)

                                 BERRIES AND SMALL FRUIT

                     0,1 (4)

                                 (a)

                                 Table and wine grapes

                     5 (ma, mz, me, pr, t)

                     Table grapes

                     1

                     0,1 (4)

                     Wine grapes

                     1

                     3

                                 (b)

                                 Strawberries (other than wild)

                     10 (t)

                     0,05 (4)

                     10

                                 (c)

                                 Cane fruit (other than wild)

                     0,05 (4)

                     0,05 (4)

                     0,1 (4)

                     Blackberries

                     Dewberries

                     Loganberries

                     Raspberries

                     Others

                                 (d)

                                 Other small fruit and berries (other than wild)

                     0,05 (4)

                     0,1 (4)

                     Bilberries

                     Cranberries

                     Currants (red, black and white)

                     5 (mz)

                     Gooseberries

                     Others

                     0,05 (4)

                                 (e)

                                 Wild berries and wild fruit

                     0,05 (4)

                     0,05 (4)

                     0,1 (4)

                                 (vi)

                                 MISCELLANEOUS

                     0,1 (4)

                     0,1 (4)

                     Avocados

                     Bananas

                     2 (mz, me)

                     Dates

                     Figs

                     Kiwi

                     Kumquats

                     Litchis

                     Mangoes

                     2 (mz)

                     Olives (table consumption)

                     5 (mz, pr)

                     0,3

                     Olives (oil extraction)

                     5 (mz, pr)

                     0,3

                     Papaya

                     7 (mz)

                     Passion fruit

                     Pineapples

                     Pomegranate

                     Others

                     0,05 (4)

                     0,05 (4)

                                 2.

                                 Vegetables, fresh or uncooked, frozen or dry

                     0,1 (4)

                                 (i)

                                 ROOT AND TUBER VEGETABLES

                     0,1 (4)

                     Beetroot

                     0,5 (mz)

                     Carrots

                     0,2 (mz)

                     Cassava

                     Celeriac

                     0,3 (ma, me, pr, t)

                     0,3

                     Horseradish

                     0,2 (mz)

                     Jerusalem artichokes

                     Parsnips

                     0,2 (mz)

                     Parsley root

                     0,2 (mz)

                     Radishes

                     Salsify

                     0,2 (mz)

                     Sweet potatoes

                     Swedes

                     Turnips

                     Yam

                     Others

                     0,05 (4)

                     0,05 (4)

                                 (ii)

                                 BULB VEGETABLES

                     0,05 (4)

                     0,1 (4)

                     Garlic

                     0,1 (mz)

                     Onions

                     1 (ma, mz)

                     Shallots

                     1 (ma, mz)

                     Spring onions

                     1 (mz)

                     Others

                     0,05 (4)

                                 (iii)

                                 FRUITING VEGETABLES

                     0,1 (4)

                                 (a)

                                 Solanacea

                     Tomatoes

                     3 (mz, me, pr)

                     2

                     Peppers

                     5 (mz, pr)

                     1

                     Aubergines

                     3 (mz, me)

                     Okra

                     0,5 (mz)

                     Others

                     0,05 (4)

                     0,05 (4)

                                 (b)

                                 Cucurbits — edible peel

                     2 (mz, pr)

                     Cucumbers

                     2

                     Gherkins

                     Courgettes

                     Others

                     0,05 (4)

                                 (c)

                                 Cucurbits — inedible peel

                     1 (mz, pr)

                     Melons

                     1

                     Squashes

                     Watermelons

                     1

                     Others

                     0,05 (4)

                                 (d)

                                 Sweetcorn

                     0,05 (4)

                     0,05 (4)

                                 (iv)

                                 BRASSICA VEGETABLES

                     0,05 (4)

                     0,1 (4)

                                 (a)

                                 Flowering brassica

                     1 (mz)

                     Broccoli (including Calabrese)

                     Cauliflower

                     Others

                                 (b)

                                 Head brassica

                     Brussels sprouts

                     2 (mz)

                     Head cabbage

                     3 (mz)

                     Others

                     0,05 (4)

                                 (c)

                                 Leafy brassica

                     0,5 (mz)

                     Chinese cabbage

                     Kale

                     Others

                                 (d)

                                 Kohlrabi

                     1 (mz)

                                 (v)

                                 LEAF VEGETABLES AND FRESH HERBS

                     0,05 (4)

                                 (a)

                                 Lettuce and similar

                     5 (mz, me, t)

                     Cress

                     Lamb's lettuce

                     Lettuce

                     2

                     Scarole (broad-leaf endive)

                     2

                     Rocket

                     Leaves and stems of brassica, including turnip greens

                     Others

                     0,1 (4)

                                 (b)

                                 Spinach and similar

                     0,05 (4)

                     0,1 (4)

                     Spinach

                     Beet leaves (chard)

                     Others

                                 (c)

                                 Watercress

                     0,3 (mz)

                     0,1 (4)

                                 (d)

                                 Witloof

                     0,5 (mz)

                     0,1 (4)

                                 (e)

                                 Herbs

                     5 (mz, me)

                     0,1 (4)

                     Chervil

                     Chives

                     Parsley

                     Celery leaves

                     Others

                                 (vi)

                                 LEGUME VEGETABLES (fresh)

                     0,05 (4)

                     0,1 (4)

                     Beans (with pods)

                     1 (mz)

                     Beans (without pods)

                     0,1 (mz)

                     Peas (with pods)

                     1 (ma, mz)

                     Peas (without pods)

                     0,1 (mz)

                     Others

                     0,05 (4)

                                 (vii)

                                 STEM VEGETABLES (fresh)

                     0,05 (4)

                     0,1 (4)

                     Asparagus

                     0,5 (mz)

                     Cardoons

                     Celery

                     Fennel

                     Globe artichokes

                     Leeks

                     3 (ma, mz)

                     Rhubarb

                     0,5 (mz)

                     Others

                     0,05 (4)

                                 (viii)

                                 FUNGI

                     0,05 (4)

                     0,05 (4)

                     0,1 (4)

                                 (a)

                                 Cultivated mushrooms

                                 (b)

                                 Wild mushrooms

                                 3.

                                 Pulses

                     0,05 (4)

                     0,1 (4)

                     0,1 (4)

                     Beans

                     0,1 (mz)

                     Lentils

                     Peas

                     0,1 (mz)

                     Lupines

                     Others

                     0,05 (4)

                                 4.

                                 Oilseeds

                     0,1 (4)

                     0,1 (4)

                     0,1 (4)

                     Linseed

                     Peanuts

                     Poppy seed

                     Sesame seed

                     Sunflower seed

                     Rapeseed

                     0,5 (ma, mz)

                     Soya bean

                     Mustard seed

                     Cotton seed

                     Hemp seed

                     Pumpkin seed

                     Others

                     0,1 (4)

                                 5.

                                 Potatoes

                     0,3 (ma, mz, me, pr)

                     0,2

                     0,1 (4)

                     0,1 (4)

                     Early potatoes

                     Ware potatoes

                                 6.

                                 Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis)

                     0,1 (4)

                     0,1 (4)

                     0,2 (4)

                     0,2 (4)

                                 7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                     25 (pr)

                     50

                     0,2 (4)

                     0,2 (4)

         (1)  The MRLs expressed as CS2 can arise from different dithiocarbamates and therefore they do not reflect a single Good Agricultural Practice (GAP). It is therefore not appropriate to use these MRLs to check compliance with a GAP.

         (2)  In brackets the origin of the residue (ma: maneb; me: metiram; mz: mancozeb; pr: propineb; t: thiram; z: ziram).

         (3)  As all dithiocarbamates result in the final CS2 residue, discrimination among them is generally not possible. However single residue methods are available for propineb, ziram and thiram. These methods should be implemented on a case by case basis when the specific quantification of propineb, ziram and/or thiram is required.

         (4)  Indicates lower limit of analytical determination.’


Avis juridique important

|

31971L0316

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

Official Journal L 202 , 06/09/1971 P. 0001 - 0013 Finnish special edition: Chapter 13 Volume 2 P. 0003  Danish special edition: Series I Chapter 1971(II) P. 0635  Swedish special edition: Chapter 13 Volume 2 P. 0003  English special edition: Series I Chapter 1971(II) P. 0707  Greek special edition: Chapter 13 Volume 1 P. 0139  Spanish special edition: Chapter 13 Volume 2 P. 0017  Portuguese special edition Chapter 13 Volume 2 P. 0017

COUNCIL DIRECTIVE  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  (71/316/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament 1;  Having regard to the Opinion of the Economic and Social Committee 2;  Whereas, in each Member State, mandatory provisions determine the technical characteristics of measuring instruments and the methods of metrological control ; whereas these requirements differ from one Member State to another ; whereas these differences hinder trade and may create unequal conditions of competition within the Community;  Whereas one of the objects of controls in each Member State is to give assurance to customers that quantities delivered correspond to the price paid ; whereas consequently the aim of this Directive is not to abolish these controls but to eliminate differences between rules in so far as these constitute a hindrance to trade;  Whereas these hindrances to the establishment and functioning of the common 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;  Whereas, 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 EEC controls;  Whereas Community technical requirements for design and functioning should ensure that instruments continuously give measurements that are sufficiently accurate for their intended purpose;  Whereas 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 carried out in particular by means of pattern approval and verification procedures ; whereas in order to achieve free movement of these instruments within the Community it is also necessary to provide for mutual recognition of controls among Member States and to establish appropriate EEC pattern approval and initial verification procedures for this purpose as well as EEC methods of metrological control, in accordance with this Directive and with the relevant separate directives;  Whereas 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;  Whereas national metrological rules cover numerous categories of measuring instruments and products ; whereas this Directive should lay down the general provisions dealing, in particular, with EEC pattern  1OJ No C 45, 10.5.1971, p. 26. 2OJ No C 36, 19.4.1971, p. 8.   approval and initial verification procedures, as well as EEC methods of metrological control ; whereas 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;  HAS ADOPTED THIS DIRECTIVE:    CHAPTER I Basic principles  Article 1 1. No Member State may prevent, prohibit or restrict the placing on the market or entry into service of a measuring instrument (hereinafter called "instrument") or of ancillary equipment if that instrument or equipment bears the mark certifying initial verification or the sign certifying EEC pattern approval as provided for in Articles 10 and 11.  2. Member States shall attach the same value to EEC pattern approval and initial verification as to the corresponding national measures.  3. Member States may require EEC pattern approval or EEC initial verification for a category of instruments only if corresponding controls are laid down for instruments of the same category satisfying national requirements which have not been harmonised at Community level.  4. For the categories of instruments with which they are concerned, separate directives will specify the measurement characteristics of and the technical requirements for their design and functioning.  They may also specify:    - whether in all Member States these instruments must undergo both EEC pattern approval and EEC initial verification or just one of these;       - the date on which national provisions conforming to the relevant separate directive are to replace completely the national provisions formerly applicable to new instruments of the same category.          CHAPTER II EEC pattern approval  Article 2 1. EEC pattern approval constitutes the admission of a manufacturer's instruments to EEC initial verification and, where the latter is not required, the authorisation to place them on the market and put them into service. If the separate directive applicable to a category of instruments exempts that category from EEC pattern approval, the instruments in that category shall be admitted directly to EEC initial verification.  2. In so far as their control equipment permits, Member States shall, at the request of the manufacturer or of his authorised representative, grant EEC pattern approval for every pattern of instrument and all ancillary equipment which satisfies the measurement characteristics and the technical design and functioning requirements laid down by the separate directive relating to the category of instrument in question.  3. Application for EEC pattern approval of a given pattern of instrument may be submitted in only one Member State.  4. A Member State which has granted EEC pattern approval shall take the necessary steps to ensure that it is kept informed of any modification or addition to the approved pattern. It shall inform the other Member States of such alterations.  Modifications or additions to an approved pattern must receive additional pattern approval from the Member State which granted EEC pattern approval, where such changes influence or might influence measurement results or the prescribed conditions for use of the instrument.  5. Member States shall grant EEC pattern approval in accordance with the provisions of this Chapter, of items 1 and 2 of Annex I, and of the relevant separate directives.   Article 3 When EEC pattern approval is granted for ancillary equipment, this approval shall specify:    - the patterns of instrument to which this equipment may be attached or in which it may be incorporated;        - the general conditions for the overall functioning of the instruments for which it is approved.          Article 4 1. If the results of the examination described in item 2 of Annex I are satisfactory, the Member State which has carried out this examination shall draw up an EEC pattern approval certificate and forward it to the applicant. In the cases provided for in Article 11 or in a separate directive the applicant must affix on each instrument and all ancillary equipment conforming to the approved pattern the approval sign shown in this certificate ; in all other cases he shall be entitled to affix the approval sign in question.  2. The provisions relating to the certificate, to the approval sign, to the deposit if any of a specimen instrument, and to the announcement of the EEC pattern approval, are set out in items 3, 4 and 6 of Annex I.   Article 5 1. EEC pattern approval shall be valid for ten years. Approval can be extended for successive periods of ten years ; the number of instruments which may be manufactured in accordance with the approved pattern shall not be limited.  When EEC pattern approval is not extended, instruments already in service which conform to the provisions of this Directive shall be considered to be approved.  2. When normal approval or extension cannot be granted for certain instruments, a limited approval or extension may be granted after the other Member States have been informed and, where appropriate, consulted. In the case provided for in the third indent, prior consultation is mandatory if the place of installation is situated in a State other than the one issuing the EEC certificate of pattern approval. EEC pattern approval may be subject to the following restrictions:    - limitation of the period of validity to less than ten years;       - limitation of the number of instruments which can be approved;       - an obligation to notify the competent authorities of the places of installation;       - limitation of use.         3. When new techniques which are not provided for in a separate directive are employed, limited EEC pattern approval may be granted after previous consultation with other Member States. This limited approval may be subject to the restrictions mentioned in paragraph 2 and to special conditions connected with the technique used.  This limited approval can, however, be granted only:    - if the separate directive for the relevant category of instruments has already entered into force;       - if the maximum permissible errors specified in the separate directives are not exceeded.         Such limited approval shall be valid for not more than two years. It may be extended for a further period of three years.  4. If the Member State which granted limited EEC pattern approval referred to in paragraph 3 considers that a new technique has proved satisfactory, it shall apply for an adjustment of the relevant directive to technical progress, in accordance with the provisions of Articles 18 and 19.   Article 6 When EEC 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 item 3.3 of Annex I.   Article 7 1. The Member State which has granted EEC 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) and (3) are not met.         2. The Member State which has granted EEC 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 that Member State is informed by another Member State of the occurrence of one of the cases covered by paragraphs 1 and 2, it shall likewise take the measures provided for in those paragraphs, after consulting with that other 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 mentioned in paragraph 1, with respect to instruments which have been exempted from EEC initial verification, if the manufacturer, after due warning, does not bring the instruments into line with the approved pattern or with the requirements of the relevant separate directive.  5. If the Member State which granted the approval disputes that the case referred to in paragraph 2 of which it has been informed has arisen, or disputes that the measures taken in pursuance of paragraph 4 are justified, the Member States concerned shall endeavour to settle the dispute.  The Commission shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement.   CHAPTER III Initial verification  Article 8 1. The EEC initial verification constitutes the inspection of a new or reconditioned instrument to confirm that it conforms to the approved pattern and/or to the requirements of the relevant separate directive ; it is certified by the EEC initial verification mark.  2. If they have the requisite equipment, Member States shall carry out EEC initial verification of instruments submitted as having the measurement characteristics and satisfying the technical construction and functioning requirements laid down by the separate directive on this category of instruments.  3. In the case of instruments bearing the EEC initial verification mark, the obligation imposed on Member States by Article 1 (1) shall last until the end of the year following that in which the EEC initial verification mark was affixed, unless separate directives make provision for a longer period.   Article 9 When an instrument is submitted for EEC initial verification, the Member State carrying out the examination shall determine:    (a) whether the instrument belongs to a category exempt from EEC pattern approval and, if so, whether it satisfies the technical construction and functioning requirements laid down by the separate directive on this category of instruments;       (b) whether the instrument has received an EEC pattern approval and, if so, whether it conforms to the approved pattern.  The inspection carried out in the EEC initial verification relates in particular, in accordance with the relevant separate directive, to:      - the measurement characteristics;           - the maximum permissible errors;           - 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;           - the presence of prescribed inscriptions and the correct positioning of the stamp plates.              Article 10 1. When an instrument has successfully undergone EEC initial verification in accordance with Article 9 and items 1 and 2 of Annex II, Member States shall affix on the instrument a partial or final EEC verification mark in accordance with item 3 of Annex II.  2. The provisions relating to the designs and characteristics of the EEC verification marks are set out in item 3 of Annex II.   Article 11 When EEC 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 item 3.4 of Annex I.    CHAPTER IV Provisions for both EEC pattern approval and EEC 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 EEC 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 authorised to affix the marks referred to in Article 10.   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 1. If Member States control instruments which are in service and which bear EEC signs or marks, and if separate directives do not specify the way in which the controls are to be carried out and the maximum errors permitted in service, the control requirements, and in particular the maximum errors permitted in service, must bear the same ratio to those applied before instruments are put into service as the ratio applied to instruments complying with national technical requirements which have not been harmonised at Community level.  2. Notwithstanding the provisions of paragraph 1 of Article 1 (1), an instrument in service which bears EEC signs or marks but does not satisfy the requirements of the relevant separate Directive, in particular with regard to maximum permissible errors, may be banned from service in the same way as an instrument bearing national marks.   CHAPTER VI EEC methods of metrological control  Article 16 1. The harmonisation of methods of measurement and of metrological control and, where appropriate, of the means necessary for their application may be regulated by separate directives.  2. Harmonisation of the requirements for marketing certain products, in particular as regards the prescription, measurement and marking of pre-packed quantities, may also be covered by separate directives.   CHAPTER VII Adjustment of directives to technical progress  Article 17 The amendments necessary to keep:    - Annexes I and II to this Directive ; and       - the technical annexes of separate directives dealing with the different categories of instruments, the legal units of measurement and EEC methods of metrological control,         in line with technical progress shall be made in accordance with the procedure laid down in Article 19.   Article 18 1. A committee hereinafter called the "Committee", is hereby set up to adjust to technical progress those directives which concern the elimination of technical barriers to trade in measuring instruments. It shall consist of representatives of the Member States with a representative of the Commission as Chairman.  2. The Committee shall adopt its own rules of procedure.   Article 19 1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the Chairman, either on his own initiative or at the request of the representative of a Member State.  2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its Opinion of the draft within a time limit set by the Chairman having regard to the urgency of the matter. Opinions  shall be adopted by a majority of twelve votes, the votes of Member States being weighted as provided in Article 148 (2) of the Treaty.  The Chairman shall not vote.  3.    (a) The Commission shall adopt the measures envisaged where they are in accordance with the Opinion of the Committee.       (b) Where the measures envisaged are not in accordance with the Opinion of the Committee, or if no Opinion is adopted, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority.       (c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.         CHAPTER VIII Final provisions  Article 20 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 EEC pattern approval, withdrawing such approval, refusing to carry out EEC initial verification or prohibiting sale or use 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 21 1. Member States shall put into force the laws, regulations and administrative provisions needed in order to comply with this Directive within eighteen months of its notification and shall forthwith inform the Commission thereof.  2. Member States shall ensure that the text of the main provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission.   Article 22 This Directive is addressed to the Member States.     Done at Brussels, 26 July 1971.  For the Council  The President  A. MORO     ANNEX I EEC PATTERN APPROVAL     1. Application for EEC 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 State to which the application is made. The Member State has the right to require 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:        - the name and address of the manufacturer or the firm, or of his or its authorised representative or of the applicant,               - the category of instrument,               - the intended use,               - the measurement characteristics,               - 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:          - the construction and operation of the instrument,                   - the protecting arrangements ensuring correct working,                   - the devices for regulation and adjustment,                   - 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 EEC approval      2.1. The examination shall comprise:        2.1.1. 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, this instrument must maintain the measurement characteristics required.            2.3. The nature and scope of the examination mentioned in 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 material and assisting personnel for the performance of the approval tests.                  3. EEC 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 of this Directive shall be a stylised letter i containing:        - in the upper part, the distinguishing capital letter of the State which granted the approval (B for Belgium, D for the Federal Republic of Germany, F for France, I for Italy, L for Luxembourg, NL for the Netherlands) 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 item 6.1.           3.2. In the case of EEC limited approval, a the letter P, having the same dimensions as the stylised letter i, shall be placed before this letter.  An example of this limited approval sign is shown in item 6.2.           3.3. The sign mentioned in Article 6 of this Directive is the same as the EEC approval sign, except that the stylised letter E is reversed symmetrically about a vertical axis.  An example of this sign is shown in item 6.3.           3.4. The sign mentioned in Article 11 of this Directive is the same as the EEC approval sign in a hexagon.  An example of this sign is shown in item 6.4.           3.5. The signs mentioned in the previous items and affixed by the manufacturer in accordance with the provisions of the 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 this 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 EEC certificate of approval.       5. Announcement of approval      5.1. EEC pattern approvals and EEC limited pattern approvals shall be published in a special Annex to the Official Journal of the European Communities. The same applies to EEC additional pattern approvals.           5.2. At the same time as the party concerned is notified, copies of the EEC 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.            5.3. Withdrawal of EEC pattern approval and other communications concerning the extent and validity of EEC pattern approval shall also be subject to the announcement procedure mentioned in items 5.1 and 5.2.           5.4. A Member State which refuses to grant EEC pattern approval shall inform the other Member States and the Commission of its decision.                  6. Signs relative to EEC pattern approval >PIC FILE= "T0011017">           ANNEX II EEC INITIAL VERIFICATION     1. General points      1.1. The EEC 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 EEC 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 EEC initial verification shall be carried out in two or more stages for instruments whose correct functioning 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 pattern or, in the case of instruments exempt from pattern approval, that they conform to the relevant provisions.                                 2. Place of the EEC 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 a verification must be carried out at the place of installation.               2.2.2. The other verification stages of a verification shall be carried out as laid down in item 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 material and assisting personnel for the performance of the verification.               - to provide a copy of the EEC certificate of approval.                                 3. EEC initial verification marks      3.1. Description of EEC initial verification marks.        3.1.1. Subject to the provisions of separate directives, EEC initial verification marks which are affixed in accordance with item 3.3 shall be as follows:          3.1.1.1. The final EEC verification mark shall be composed of two stamps:            (a) the first consists of a letter "e" containing:              - in the upper half, the distinguishing capital letter of the State where the initial verification is carried out (B for Belgium, D for the Federal Republic of Germany, F for France, I for Italy, L for Luxembourg,  NL for the Netherlands), together, where necessary, with one or two numbers identifying a territorial 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 EEC 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 EEC initial verification marks as laid down in item 3.1 ; the first two drawings show the various parts of the stamp, 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 small letter "e" and about the field of the hexagon. The actual diameters of the circles described about the marks are 1 76 mm, 3 72 mm, 6 73 mm, 12 75 mm. 3.2.2. The metrological services of Member States shall mutually exchange the original drawings of the EEC initial verification marks, conforming to the models in the annexed drawings.                          3.3. Affixing the marks        3.3.1. The final EEC 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 EEC requirements.               3.3.2. The partial EEC 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.     >PIC FILE= "T0011018">    >PIC FILE= "T0011019">    >PIC FILE= "T0011020">


Avis juridique important

|

31985L0001

Council Directive 85/1/EEC of 18 December 1984 amending Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement

Official Journal L 002 , 03/01/1985 P. 0011 - 0012 Finnish special edition: Chapter 13 Volume 14 P. 0140  Spanish special edition: Chapter 13 Volume 18 P. 0153  Swedish special edition: Chapter 13 Volume 14 P. 0140  Portuguese special edition Chapter 13 Volume 18 P. 0153

*****COUNCIL  DIRECTIVE  of 18 December 1984  amending Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement  (85/1/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas at international level the definition of the SI unit of measurement of length has been amended by the 17th General Conference on Weights and Measures (CGPM); whereas this new definition shall be used at Community level;  Whereas in a recommendation of 22 May 1981 the World Health Organization requested that the millimetre of mercury be retained in addition to the kilopascal as a unit for the measurement of the pressure of blood and other body fluids; whereas it is advisable for the Community to adopt this solution;  Whereas the barn is the unit universally used to measure the effective cross-sectional area on the occasion of nuclear reactions; whereas experience has shown that this specific unit could not easily be replaced by an SI unit; whereas it is therefore necessary to authorize its use in the nuclear field;  Whereas therefore Directive 80/181/EEC (4) should be amended accordingly,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The Annex to Directive 80/181/EEC is hereby amended as follows:  1. in point 1.1 of Chapter I the definition of the unit of length is replaced by the following:  'Unit of length  A metre is the length of the path travelled in a vacuum by light during 1/299 792 458 seconds.  (Seventeenth CGPM (1983), Resolution 1).';  2. in section 4 of Chapter I:  (a) the following is added to the table  1.2,4 //   //   // 'Quantity  // Unit  //   //  1.2.3.4 //  // Name  // Symbol  // Value  //   //   //   //   // Blood pressure and pressure of other body fluids  // Millimetre of mercury  // mm Hg(*)  // 1 mm Hg = 133,322 Pa  // Effective cross-sectional area  // Barn  // b  // 1 b = 10 -28 m2'  //  //   //   //  (b) the note is hereby replaced by the following:  'The prefixes and their symbols listed in 1.3 may be used in conjunction with the above units and symbols, with the exception of the millimetre of mercury and its symbol. The multiple of 102a is, however, called a "hectare".'  3. in Chapter II:  (a) the unit of measurement for blood pressure in the table is deleted;  (b) the note is replaced by the following:  'The prefixes and their symbols listed in 1.3 of Chapter I may be used in conjunction with the above units and symbols, with the exception of the symbol "g".'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 July 1985. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 18 December 1984.  For the Council  The President  J. BRUTON  (1) OJ No C 155, 14. 6. 1983, p. 10.  (2) OJ No C 242, 12. 9. 1983, p. 101.  (3) OJ No C 341, 19. 12. 1983, p. 1.  (4) OJ No L 39, 15. 2. 1980, p. 40.